VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_11-vv-00685
Package ID: USCOURTS-cofc-1_11-vv-00685
Petitioner: Trystan Sanchez
Filed: 2011-10-17
Decided: 2025-10-01
Vaccine: DTaP; Hib; IPV; pneumococcal conjugate
Vaccination date: 2009-02-05
Condition: Leigh syndrome / SDHA-related mitochondrial disease with neurodegeneration
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Trystan Sanchez, an infant, through his parents Germain and Jennifer Sanchez, filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986 on October 17, 2011. The petition alleged that Trystan's six-month vaccinations on February 5, 2009, including the DTaP vaccine, caused or significantly aggravated his Leigh's syndrome, a severe neurological disorder diagnosed in late 2014. The Sanchezes argued that the vaccinations either caused the genetic condition to be expressed or worsened its course. The respondent, the Secretary of Health and Human Services, contested entitlement.

Special Master Christian J. Moran initially denied compensation in a decision dated October 9, 2018. The Special Master found that while the Sanchezes presented a plausible medical theory that vaccines could cause the manifestation of Leigh's syndrome, the evidence did not demonstrate that this occurred in Trystan's case. The Special Master credited contemporaneous medical records over the family's testimony regarding the timeline of Trystan's decline, finding that Trystan's loss of skills began no earlier than May 2009, approximately three months after the vaccinations, which was too long a period to establish vaccine causation. The court of Federal Claims sustained this decision.

However, the Federal Circuit vacated this decision and remanded the case, finding that the Special Master had not fully considered the petitioners' challenge-rechallenge theory and had made contradictory findings regarding Trystan's arm contortions, which were central to the causation analysis. The Federal Circuit directed the Special Master to clarify the timeline and causation issues.

On remand, the Special Master issued a second entitlement decision on August 26, 2020, again denying compensation. He found that while the first Althen factor (plausible medical theory) was met, the second (logical sequence of cause and effect) and third (proximate temporal relationship) factors were not. The Special Master concluded that Trystan's symptoms, including arm contortions on February 16, 2009, were consistent with a common cold and not indicative of a neurological injury, and that the onset of Trystan's neurological problems occurred too late to be linked to the vaccinations. The court of Federal Claims again sustained the Special Master's decision.

Petitioners appealed again, and the Federal Circuit reversed the court of Federal Claims' decision, remanding the case to the Special Master for further consideration of entitlement, specifically regarding the timing of Trystan's arm contortions and the challenge-rechallenge theory. The Federal Circuit also noted that the Special Master might need to address whether Trystan's genetic mutations would have led to the same outcome regardless of the vaccinations.

Following the second remand, the Special Master issued a third decision on August 26, 2020, again denying entitlement. The Special Master found that petitioners had not met their burden for the second and third Althen factors, concluding that the sequence of events was not logical and the temporal relationship was not proximate. The court of Federal Claims sustained this decision.

Subsequently, the Federal Circuit reversed the court of Federal Claims' decision, remanding the case to the Special Master for further proceedings, specifically noting that the Special Master's findings regarding Trystan's arm contortions were contradictory and that the challenge-rechallenge theory had not been fully addressed. The Federal Circuit also suggested the Special Master might need to consider the role of Trystan's genetic mutations. The Special Master issued a decision on August 26, 2020, again denying compensation.

Petitioners sought review of this decision, and the court of Federal Claims sustained the Special Master's denial. However, the Federal Circuit reversed this decision, remanding the case for further consideration of the causation issue, particularly concerning Trystan's arm contortions and the challenge-rechallenge theory. The Special Master issued a subsequent decision on August 26, 2020, again denying entitlement.

In a later opinion on March 22, 2021, the court of Federal Claims sustained the Special Master's August 26, 2020 decision, denying petitioners' motion for review. However, this decision was later reversed by the Federal Circuit on August 11, 2022. The case was remanded again. Most recently, on April 16, 2024, Chief Judge Elaine D. Kaplan denied Petitioners' Petition for a Writ of Mandamus, which sought to have the Court decide the Secretary's motion to reopen entitlement, but ordered the Special Master to unstrike Petitioners' motion to reopen and reinstate it on the docket, while denying the motion itself. Petitioners' subsequent motion for a protective order regarding Ms. Sanchez's testimony was denied on February 18, 2025, by Chief Judge Kaplan, who found no basis for the court to intervene in interlocutory matters before the Special Master.

To date, no compensation award has been made in this case.

The later supplemental materials do not add a damages award. They show continued remand proceedings, including 2025 findings of fact and conclusions of law after years of review, mandamus, and protective-order litigation. The staged public record still does not show an injury-compensation award.

Theory of causation field:
Six-month DTaP-containing vaccine set on February 5, 2009, age about 5.7 months, alleged to cause or significantly aggravate SDHA-related Leigh syndrome/mitochondrial neurodegeneration. NO COMPENSATION AWARD TO DATE; case has an unusually long procedural history after denial, motion practice, Federal Circuit reversal/remand, mandamus/protective-order proceedings, and 2025 findings. Petitioners Germain and Jennifer Sanchez relied on Dr. Lawrence Steinman and Dr. Dmitriy Niyazov, arguing vaccination triggered metabolic stress/decompensation, seizures, dystonia, and neurodegeneration. Respondent's experts, including Dr. Gerald Raymond, attributed Trystan's course to the genetic mitochondrial disorder and disputed vaccine causation and timing. Special Master Moran's 2025 findings addressed disputed post-vaccination facts on remand; no injury-compensation damages decision appears in the staged public text.

Public staged source text:

================================================================================
DOCUMENT 1: USCOURTS-cofc-1_11-vv-00685-1
Date issued/filed: 2018-11-09
Pages: 41
Docket text: PUBLIC DECISION (Originally filed: 10/9/18) regarding 205 DECISION of Special Master. Signed by Special Master Christian J. Moran. (MRG) Service on parties made.
--------------------------------------------------------------------------------
Case 1:11-vv-00685-EDK Document 210 Filed 11/09/18 Page 1 of 41
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
TRYSTAN SANCHEZ, by and *
through his parents, GERMAIN * No. 11-685V
SANCHEZ and JENNIFER * Special Master Christian J. Moran
SANCHEZ, *
* Filed: October 9, 2018
Petitioners, *
v. * Entitlement; DTaP; Leigh’s
* syndrome; mitochondrial disorder;
SECRETARY OF HEALTH * decompensation;
AND HUMAN SERVICES, * genetic mutation; SDHA.
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Lisa A. Roquemore, Law Offices of Lisa A. Roquemore, Rancho Santa Margarita,
CA, for petitioners;
Jennifer L. Reynaud, United States Dep’t of Justice, Washington, DC, for
respondent.
PUBLISHED DECISION DENYING COMPENSATION1
Germain and Jennifer Sanchez bring this action on behalf of their son,
Trystan, claiming that his mitochondrial disease, known as Leigh’s syndrome, was
1 Because this decision contains a reasoned explanation for the action in this
case, the undersigned is required to post it on the United States Court of Federal
Claims' website in accordance with the E-Government Act of 2002. 44 U.S.C. §
3501 note (2012) (Federal Management and Promotion of Electronic Government
Services). This means the decision will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), petitioners have 14 days to
identify and move to redact medical or other information, the disclosure of which
would constitute an unwarranted invasion of privacy. If, upon review, the
undersigned agrees that the identified material fits within this definition, the
undersigned will redact such material before posting the decision.

Case 1:11-vv-00685-EDK Document 210 Filed 11/09/18 Page 2 of 41
caused or significantly aggravated by his six-month vaccinations. The parties
agree that Leigh’s syndrome is a genetic disorder caused, at least in part, by
inherited mutations in Trystan’s DNA. However, the Sanchezes argue that
Trystan’s disease would not have been expressed but for his vaccination or,
alternatively, that the course of his disease was significantly worse than it would
have been but for the vaccination. While the Sanchezes sufficiently demonstrate
that vaccines could contribute to the manifestation of Leigh’s syndrome, the
evidence does not indicate that this is what happened to Trystan. Accordingly, the
Sanchezes are not entitled to compensation.
I. Facts
The parties hold two very different accounts of Trystan’s health in the
months following the administration of his six-month vaccinations on February 5,
2009. To address this discrepancy, the undersigned held a fact hearing to take
testimony from the Sanchez family in May 2012, and issued a ruling finding facts
on April 10, 2013. For the purposes of this decision, the period in which the
parties hold divergent viewpoints about Trystan’s health is segregated from the rest
of the factual history.
A. Trystan’s Early Life and the February 5, 2009 Vaccinations
Trystan was born on August 16, 2008, to Jennifer and Germain Sanchez.
Exhibit 1 at 89. At birth, Trystan appeared to be a normal, healthy child. Id. at 89.
Trystan and his mother were discharged on August 18, 2008. Id. at 106.
Four days later, on August 22, 2008, Trystan was seen by his pediatrician for
a check-up and to be circumcised. The pediatrician observed that Trystan was
jaundiced, but otherwise the physical exam appeared to be normal. Id. at 34-35.
During this visit, Trystan received his first dose of the hepatitis B vaccine. Id. at
35-38. No adverse response is noted in the medical records. One week later, on
August 29, 2008, Trystan returned for some routine follow-up care from the
circumcision. Id. at 40. He did not return to the pediatrician again until he was
nearly six-months old. Id. at 44.
The Sanchezes testified that Trystan appeared healthy during his first six
months. Tr. 62. During that time, he would smile, laugh, play, and babble. Tr.
16-17, 27, 41, 50, 62-63, 110, 147-49, 176-77. He was also making eye contact,
did not cry that much, and began trying to crawl. Tr. 16-17, 41, 63, 148. He was
able to roll over, hold his bottle and sippy cup, and play peekaboo. Tr. 16, 50-51,
62, 110, 148, 176. Given that Trystan appeared so healthy, his parents did not take
2

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him to the doctor in his first six months following the follow-up visit from his
circumcision. Tr. 62, 177.
Trystan was taken to his six-month well-baby checkup with Dr. Philip
Brown on February 5, 2009. Exhibit 1 at 44. Dr. Brown found his growth and
development to be normal. Id. at 46. Dr. Brown noted that Trystan was meeting
his developmental milestones, including: turning to sound, self-feeding, self-
comforting, responding to his name, sitting with support, grasping and mouthing
objects, smiling, laughing, squealing, showing interest in toys, showing differential
recognition of parents, babbling reciprocally, rolling over from back to front, and
standing when placed. Trystan also had “no head lag when pulled to sit.” Id. On
this day, he received the diphtheria-tetanus-pertussis (DTaP), hepatitis B,
Haemophilus influenzae type B (Hib), and pneumococcal conjugate (PCV)
vaccines. Id. Dr. Brown recommended that Trystan return in two months to
receive further vaccinations. Id.
The Sanchezes testified that Trystan had an adverse reaction to the
vaccinations he received on February 5, 2009. They noted that after the wellness
check with Dr. Brown, Trystan was inconsolable; he cried a loud, high-pitched cry,
as if he was in pain. Tr. 18-19, 67, 177-79. He began to run a temperature of
102.2 degrees and developed a lump on his left thigh that was “really hot.” Tr. 17-
20, 32, 67-69, 113, 177-79. Mrs. Sanchez gave Trystan Tylenol for the fever,
which ebbed and flowed over the next few days. Tr. 20, 30, 68, 151, 178, 180.
The Secretary did not contest that Trystan experienced fever following vaccination.
See Joint Statement at 4, ¶ 11.
B. Controverted Aspects of Trystan’s Medical History
The parties hold significant disagreements about Trystan’s health in the
months following the February 5, 2009 vaccination. The crux of the disagreement
between the parties relates to how much weight the undersigned should give to oral
testimony when that testimony is in conflict with documents created
contemporaneously with the events that they are describing. More specifically,
Trystan’s medical records indicate that in the period following the administration
of his vaccinations in February 2009, Trystan suffered from colds but was
neurologically normal. However, members of Trystan’s family recall otherwise.
In the ruling finding facts, the undersigned largely credited the contemporaneous
medical records.
Though Trystan’s medical records and the testimony provided by his family
members are thoroughly reviewed in the ruling finding facts, both are briefly
revisited and summarized here for the purpose of this decision. In reviewing the
3

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factual history for this period, this decision divides the evidence that arises out of
the medical records from the evidence that comes from the testimony provided by
Trystan’s family.
1. Medical Records
On the morning of February 17, 2009, Trystan returned to the pediatrician
for an urgent care visit during which he was examined and treated by Physician
Assistant Jonathan P. Luna. Mr. Luna diagnosed Trystan with a “[c]ommon cold”
and “[v]iral syndrome.” Exhibit 1 at 48. Trystan’s temperature was 98.9 degrees
and “fever” was noted. Id. at 49. Mrs. Sanchez told Mr. Luna that Trystan had
been coughing and congested with fever. Id. at 49. The records do not indicate
that Mrs. Sanchez told Mr. Luna anything about Trystan exhibiting unusual arm
movements or other signs of a neurological condition. See id. at 48-51.
That next visit to the pediatrician occurred on April 29, 2009 (nearly three
months after the vaccination), when Trystan was seen by Dr. Nabil R. Seleem. Id.
at 50. The medical records note that Trystan had suffered cough and congestion
for two weeks prior to the visit. Id. However, no unusual arm movements or
developmental issues were reported. The records indicate that Dr. Seleem
performed a neurological review and further stated that he identified “no
neurological symptoms.” Ultimately, he diagnosed Trystan with an ear infection
and bronchitis and prescribed amoxicillin. Id. at 50-52.
Trystan returned to the clinic two weeks later to see Dr. Brown on May 13,
2009. Dr. Brown observed that Trystan’s symptoms appeared to be resolving, and
he recommended continued use of a humidifier. No reports of loss of skills were
made, or observed, at this time. Id. at 53.
At one year old, Trystan was seen by Physician Assistant Micaela Marin-
Tucker for a well-child exam. Exhibit 1 at 54-56. Mrs. Sanchez informed Ms.
Marin-Tucker that she “noticed a change in [Trystan’s] development about 2-3
months ago [the May-June time period] but since she had taken [Trystan to the
pediatric clinic] with Dr. Brown she thought that everything was ok.” Exhibit 1 at
54. Upon a review of systems, Ms. Marin-Tucker found that Trystan did not walk,
stand, crawl, hold his head up while sitting, or make any attempt to move his lower
extremities. She also noted in her examination that his extremities seemed soft, yet
rigid at times. As the result of her examination, Ms. Marin-Tucker ordered a
battery of lab tests. Id. at 54-55. She also referred Trystan to a neurologist,
physical therapist, and occupational therapist. Id. at 55. Additionally, Trystan
received his third hepatitis B vaccine, as well as his second doses of the
pneumococcal conjugate, DTaP, and Hib vaccines. Id. at 55. Trystan was to
4

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return to the nurse the next week to receive the remaining vaccinations that were
due, including the measles-mumps-rubella, varicella, and hepatitis A vaccines. Id.
at 55.
2. Testimony
Mr. Sanchez testified that Trystan began exhibiting unusual arm contortions
on the night of February 16, 2009, a day after his wife’s birthday, and 11 days after
Trystan’s vaccinations. Joint Statement of Uncontroverted Facts [hereinafter Joint
Statement], filed Nov. 8, 2012, at 4-5, ¶ 13; Tr. 184-86. Mrs. Sanchez testified
that, during an urgent care visit to the pediatrician the following day (February 17,
2009), she informed Physician Assistant Jonathan P. Luna that Trystan had been
coughing, congested, and febrile. Joint Statement at 5, ¶ 15; Tr. 74-75, 115. She
also testified that she told Mr. Luna of Trystan’s arm movements, but that he did
not seem concerned and did not note her concerns. Joint Statement at 5, ¶ 15 n.4;
Tr. 74-75, 115.
The Sanchezes testified that Trystan exhibited arm contortion, rigidity, and
inconsolable crying in March 2009. Joint Statement at 5-6, ¶ 16; Tr. 25, 43, 79,
135-36, 191, 219-20. Additionally, Mrs. Sanchez testified that, between her
birthday and late April 2009, when she next took Trystan to the doctor, Trystan
lost head and trunk control, no longer made eye contact, did not want to play, and
continued to have arm contortions. Joint Statement at 6, ¶ 17; Tr. 76, 78, 111-12.
According to Mrs. Sanchez, she did not return to the doctor until late April because
she had been told by the physician assistant that Trystan was fine. Joint Statement
at 6, ¶ 17; Tr. 75-77, 83, 134.
Regarding the April 29, 2009 visit with Dr. Seleem, Mrs. Sanchez testified
that, although she told Dr. Seleem about Trystan’s arm movements, he did not note
her concerns. Tr. 80, 116, 125. And, despite the indication in the medical records
that Dr. Seleem conducted a neurological exam, Mrs. Sanchez testified, based on
her observation of later neurological exams, that he did not perform a neurological
exam. Joint Statement at 7, ¶ 18 n.8; Tr. 80-81, 136-37.
As for the May 13, 2009 visit with Dr. Brown, Mrs. Sanchez and her mother
testified that Dr. Brown was not listening, was unresponsive to the issues being
brought up, and was very rude and hurried. Joint Statement at 7, ¶ 19 n.10; Tr. 85-
87, 156-58.
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In summation, Mr. and Mrs. Sanchez and their close relatives testified that
they noticed Trystan getting “sick all the time” in the six months after his February
5, 2009 vaccinations. Joint Statement at 8, ¶ 20; Tr. 20, 33, 36, 70, 164-65, 181.
They also stated that Trystan began to lose skills during the same six-month
period. Joint Statement at 8, ¶ 20; Tr. 21-23, 33, 86, 190. According to their
testimony, Trystan could no longer roll, crawl, sit, hold his bottle, make eye
contact, or try to talk. He was silent, detached, and lost the ability to control his
head, sit, stand, talk, eat and chew. Joint Statement at 8, ¶ 20 n.12; Tr. 21-23, 33,
86, 190.
3. Findings of Fact
The findings of fact and the rationale for those findings are provided in the
April 10, 2013 Ruling Finding Facts. However, the contents of this ruling are
briefly reviewed here.
Broadly speaking, the undersigned declined to favor the recollections
provided by the Sanchez family over the contemporaneously recorded medical
records as they related to Trystan’s condition following the receipt of the vaccine
on February 5, 2009. The relative weight that the undersigned gave to the
contemporaneously created medical records is consistent with the guidance
provided to fact-finders by the United States Supreme Court and the Federal
Circuit. See Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528
(Fed. Cir. 1993) (citing United States v. Gypsum, 333 U.S. 364, 396 (1947)).
Ultimately, the undersigned found that the most likely explanation for the disparity
between the medical records and the Sanchezes’ recollections was that the
Sanchezes’ recall of events was limited by the passage of time. The undersigned
did not doubt the sincerity of the Sanchezes’ beliefs and recognizes that the
Sanchezes may very well be correct in their recollections.
The undersigned recognizes that the Sanchezes have highlighted subsequent
medical records that place the onset of Trystan’s loss of skills at six months of age.
For example, the Sanchezes submitted an EEG report from September 17, 2010,
which reflects a parental report that Trystan had been “having jerking movements
at six months of age.” Exhibit 1 at 181; Joint Statement at 12, ¶ 35 n.15. In
addition, Dr. Haas stated that Trystan’s symptoms occurred “following [the
February 5] vaccination” and “repeated with the next set of vaccines at 12
months.” Exhibit 52 at 1-2. However, each of these physicians based their
histories on the parents’ subsequent narrative of events, wherein the onset of
Trystan’s neurological disorder occurred in proximity to the vaccines. The
subsequent narratives, though documented in medical records, cannot be given the
same weight as the contemporaneously created records. See Castaldi v. Sec'y of
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Health & Human Servs., No. 09-300V, 2014 WL 3749749, at *11 (Fed. Cl. Spec.
Mstr. June 25, 2014) (“the records of treating physicians can be questioned and the
weight afforded to them depends on whether the physician is noting her own
observations or merely recording statements made by the patient”), mot. for rev.
denied, 119 Fed. Cl. 407 (2014). Cf. Dobrydnev v. Sec'y of Health & Human
Servs., 566 F. App'x 976, 983 (Fed. Cir. 2014) (a special master may refrain from
crediting the finding of a doctor who obtained an inaccurate history).2
The undersigned is tasked with weighing the evidence and finding those
facts that are, more likely than not, true. Despite the Sanchezes’ sincere
recollections of events, the undersigned found that the contemporaneous medical
records spoke louder. Thus, for the purposes of this decision, the undersigned
finds that following facts to be, more likely than not, true:
 In the hours following the vaccination, Trystan developed a fever and
displayed inconsolable crying. This fever ebbed and flowed for a few
days.
 Ten days after the vaccination, on February 15, 2009, Trystan developed
another fever and was crying inconsolably again. Trystan was congested
and had difficulty breathing. His arms contorted and he was jerking
around. However, these movements were of the type typically displayed
by an infant suffering from a cold.
 Trystan’s family did not convey to Physician Assistant Luna, during the
February 17, 2009 visit, that Trystan had displayed any symptoms
consistent with a neurological injury as opposed to a cold.
 During the February 17, 2009 visit with Mr. Luna, Trystan did not
display any signs upon examination that were consistent with a
neurological injury as opposed to a cold.
2 Similarly, before Dr. Haas diagnosed Trystan as suffering from Leigh’s
syndrome, other doctors associated Trystan’s condition, as they understood it, with
a vaccination. But, these records carry little weight as they are based upon
incomplete and/or incorrect information.
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 Between the February 17, 2009 visit with Mr. Luna and the April 29,
2009 visit with Dr. Seleem, Trystan did not have any symptoms that were
inconsistent with a cold.
 Trystan was brought to see Dr. Seleem on April 29, 2009, because his
parents were concerned about his cough and congestion that had lasted
for two weeks.
 Trystan’s family did not convey to Dr. Seleem, during the April 29, 2009
visit, that Trystan had displayed any symptoms consistent with a
neurological injury as opposed to a cold.
 Dr. Seleem did not observe any signs consistent with a neurological
injury during the examination performed on Trystan during the April 29,
2009 visit. Instead, Trystan had a cold.
 The undersigned credits the report provided by Trystan’s mother to
Physician Assistant Marin-Tucker on August 17, 2009, regarding the
timeline of when Trystan first started showing signs of loss of skills.
Trystan’s mother reported that the onset was approximately 2-3 months
prior to the August 17, 2009 visit and also associated the timing with the
visit with Dr. Brown on May 17, 2009. Thus, the undersigned finds it
likely that the first signs of Trystan’s loss of skills occurred in the
beginning of May 2009, at the earliest.3
See Ruling Finding Facts, issued Apr. 10, 2013, at 11-16.
3 In the Ruling Finding Facts, the undersigned set a broad range of May 17,
2009 to June 17, 2009, as being the likely timeframe for when Trystan started
showing loss of skills. This timeframe relied on the 2-3 month range provided by
Ms. Sanchez during the August 17, 2009 appointment, and not the note that
Trystan’s loss of skills were raised during the visit to Dr. Brown on May 17, 2009.
The medical records show that Trystan’s loss of skills did not precipitate the visit
to Dr. Brown (a cold did), but it is conceivable that Ms. Sanchez raised the concern
and Dr. Brown dismissed the concern without making a record of it because the
loss of skills had been mild by that point. Regardless, the evidence does not favor
that Trystan’s loss of skills developed before May 2009.
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C. Uncontroverted Facts Following August 17, 2009 Visit
About six weeks later, on October 7, 2009, Trystan’s parents went to see Ms.
Marin-Tucker for a follow-up. In a review of Trystan’s systems, Ms. Marin-
Tucker noted no seizures, weakness, or tics. Exhibit 1 at 57. She made no
notation of tremors or twitching. Id. Upon neurologic examination, however, she
found Trystan to be unable to grasp, sit, crawl, or make much eye contact and
concluded that Trystan was “not normal for age.” Id. Mr. Sanchez reported that
there was “another child in the family with the same symptoms and doctors [could]
find nothing wrong.” Id. Ms. Marin-Tucker emphasized the importance of making
the appointment with a neurologist as soon as possible. Id. at 58.
On November 12, 2009, Trystan was taken to see a neurologist, Dr. David J.
Michelson. Id. at 140. Dr. Michelson recorded that Trystan was unable to sit
independently, his hands stayed closed, and his feet went forward when at rest. Id.
He noted that, at times, Trystan could hold his mouth open tightly and drool, but at
other times he could chew and swallow well. Id. While Trystan had previously
held his right arm stiffly behind him episodically, he had not done this lately. Id.
Dr. Michelson’s review of systems was positive for muscle spasms, global
developmental delay, weakness, walking problems, and constipation. Id. Dr.
Michelson noted that Trystan suffered from “global developmental delay of
unclear etiology, though a genetic predisposition is suspected based on the family
history and a [central nervous system] cause is suggested by the physical exam
findings.” Id. at 140-41.
An MRI performed on December 8, 2009, found abnormalities in Trystan’s
basal ganglia. Id. at 130. At this time, physicians were still considering biotin-
dependent basal ganglia disease as the most likely diagnosis, though a metabolic
disorder, such as Leigh’s syndrome, started to be considered. Id. at 130-33.
Over the course of the next five years, doctors could not identify the specific
cause of Trystan’s symptoms. In 2011, Dr. Jennifer Friedman evaluated Trystan
and considered multiple diagnoses. A mitochondrial disorder was considered
unlikely because Trystan’s muscle biopsy indicated nothing more than mild
impairments in mitochondrial function. See exhibit 10 at 7.
Trystan was evaluated by a specialist in mitochondrial disorders, Dr.
Richard Haas, for the first time in August 2012. Exhibit 26 at 1-4. Dr. Haas
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ordered sequencing of Trystan’s mitochondrial DNA to assist in the diagnosis.4 Id.
at 3. Trystan was seen again in March 2013 and the results from the mitochondrial
sequencing were discussed. The results indicated some heteroplasmy5 in a
previously unreported variant. Id. at 6. However, this was “unlikely to be the
cause of Trystan’s disease.” Exhibit 52 at 2. In a subsequent appointment, Dr.
Haas recommended that Trystan have whole exome6 sequencing performed on his
nuclear DNA. Id.
The cause of Trystan’s symptoms was finally identified in late 2014 (three
years after the petition was filed), when the results from Trystan’s whole exome
sequencing revealed two different heterozygous mutations in Trystan’s DNA.
Exhibit 59 at 1. These mutations were predicted to cause the same mitochondrial
disorder that was under consideration in Trystan’s case. Id. Based on these
results, Dr. Haas confirmed Trystan’s diagnosis of Leigh’s syndrome. Exhibit 62
at 5.
Trystan continues to suffer from developmental delays and other symptoms
such as dystonia and seizures. Exhibit 136 at 8; exhibit 140. Trystan can only
babble, though he can say the word “mom,” and he relies on signs to communicate
his wants. Exhibit 136 at 8. Fortunately, his physicians consider his progression to
4 As reviewed in section IV.A., below, mitochondria are subcellular
organelles. Interestingly, mitochondria have their own DNA, though it is a small
portion of the cell’s total DNA (the rest being contained in the nucleus of the cell).
Benjamin A. Pierce, Genetics: A Conceptual Approach 122 (5th ed. 2014).
Because Trystan was suspected to have a genetic disease of his mitochondria, and
because the mitochondrial genome is much smaller in size than the nuclear
genome, the physicians, presumably, decided to start looking there.
5 Because of how mitochondrial DNA is replicated, not all mitochondrial
DNA in a given organism is identical. Instead, some mitochondria in an organism
may have a mutation in the mitochondrial DNA while others will not. This is
referred to as heteroplasmy. Robert C King, Pamela K Mulligan, & William D.
Stansfield, A Dictionary of Genetics 216 (8th ed. 2013). The proportion of cells
with the mutation is related to the likelihood that the mutation is associated with
disease. Id.
6 Exome sequencing is genetic sequencing limited to the exons in the
genome. Exons are the expressed portion of the gene, the part that becomes
proteins. A Dictionary of Genetics at 160.
10

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be “not as severe” as the typical progression for Leigh’s syndrome. Exhibit 140 at
6.
II. Procedural History
Trystan’s parents filed a petition for compensation under the Vaccine Act on
October 17, 2011. The respondent, the Secretary of Health and Human Services,
filed his Rule 4(c) report on February 28, 2012, challenging the Sanchezes’
entitlement to compensation. Because there existed a factual dispute regarding
when Trystan’s symptoms began, a one-day fact hearing was held on May 15,
2012, in San Diego, California. Following the hearing, the parties were ordered to
begin the process of agreeing upon uncontroverted facts regarding the onset of
Trystan’s condition. Order, issued May 29, 2012. The parties were able to submit
a joint statement of uncontroverted facts on February 7, 2013. Based in part on
this joint statement, the undersigned entered the ruling finding facts on April 10,
2013.
The parties proceeded to procure expert reports that incorporated the factual
findings.7 A three-day hearing to hear testimony from the expert witnesses was set
for September 10-12, 2014. Order, issued Jan. 31, 2014. Three months before the
scheduled hearing, the Sanchezes requested a continuance for the hearing so that
Trystan could have the whole exome sequencing performed on the
recommendation of Dr. Haas. Pet’rs’ Rep., filed June 23, 2014. The Sanchezes
hoped that the sequencing would provide clarity as to Trystan’s illness. Id. Based
on the Sanchezes’ request, the hearing dates were postponed to May 2015. Order,
issued July 8, 2014. The Sanchezes were ordered to file the results of the genetic
testing as soon as they became available. Order, issued July 21, 2014.
The Sanchezes filed testing identifying Trystan’s genetic mutations on
January 23, 2015. During the ensuing status conference, the parties noted that they
needed additional expert reports, although they also decided to retain the May 2015
hearing date at that time. Order, issued Feb. 4, 2015. On February 20, 2015, the
7Although this decision does not mention each report from every expert, the
undersigned has reviewed and considered all reports submitted into evidence. See
Moriarty v. Sec'y of Health & Human Servs., 844 F.3d 1322, 1330 (Fed. Cir. 2016)
(noting that the Vaccine Act requires a special master to consider all relevant
medical and scientific evidence of record).
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Sanchezes filed a status report requesting that the May 2015 hearing be postponed.
The Secretary did not object to this request. Order, issued Mar. 3, 2015.
Accordingly, the undersigned cancelled the May 2015 hearing and scheduled a
status conference for late April 2015 to discuss the next steps. Id.
During the April 2015 status conference, the undersigned stated a concern
that the newly-filed information regarding Trystan’s genetic mutations undermined
the Sanchezes’ claim of a vaccine-injury because Trystan’s clinical course may be
consistent with what is expected based on the mutations alone. Order, issued May
8, 2015, at 1. The undersigned encouraged the Sanchezes to develop evidence that
would show that Trystan was worse than would be otherwise expected for
someone with his genetic mutations. Id. Accordingly, the Sanchezes requested
additional time to procure genetic testing from Trystan’s siblings since the results
might shed light on how Trystan’s disease course may be different than what can
be expected for someone with his same genetic mutations. Id. The Sanchezes’
request was granted and a status conference was set for June 2015, to discuss the
results from the new genetic testing and the Sanchezes’ next steps. Id. at 1-2.
On June 23, 2015, the Sanchezes filed a status report stating that the
additional genetic testing would not be complete before the end of July 2015, and
that the Sanchezes currently had an appointment scheduled with their treating
physician for late August 2015, to discuss the results of this additional genetic
testing. The undersigned set a status conference for the end of September 2015.
Order, issued June 24, 2015.
During the September 2015 status conference, the parties discussed the need
for additional expert reports in light of the new information regarding Trystan’s
genetic mutations. Order, issued Oct. 1, 2015. Over the course of the next year,
both the Sanchezes and the Secretary filed additional reports from their respective
experts as well as their prehearing briefs. See generally ECF Nos. 127-195.
In the pre-hearing status conference, the undersigned expressed a concern
that without management, the four-day hearing — a duration to which both parties
had was agreed — might not provide sufficient time to take testimony from the six
expert witnesses. In such instances, it is often necessary to schedule a continuation
of the hearing. Continuations are incredibly tolling on the Vaccine Program. They
delay the adjudication of petitioners’ claims for, often, at least a year as the parties
attempt to schedule the participation of their witnesses (often, medical
professionals with active practices and obligations in other cases), themselves, and
the special master. They also delay the adjudication of other cases. In addition,
they impose costs in the form of attorney fees, expert fees, and travel costs.
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To ensure that all testimony was taken during the four-day hearing, after
consulting with the parties, the undersigned defined the amount of time the parties
had to elicit testimony from their own witnesses on direct examination, or from the
other party’s witness on cross-examination. See order, issued Nov. 27, 2017, at 3.
Because the undersigned often asks questions of the parties’ expert witnesses, the
undersigned limited the time for his own questions. In total, for the four-day
hearing, the Sanchezes were allotted 12.5 hours; the Secretary 8.75 hours; and the
undersigned 4 hours. Id.8 The undersigned considers the time allotted to have
been sufficient to provide each party a full and fair opportunity to present its case.
See Vaccine Rule 3(b)(2). Furthermore, the undersigned found the time limits to
be reasonable for the evidence that needed to be taken in this specific case. See
Vaccine Rule 8(a) (“The special master will determine the format for taking
evidence and hearing argument based on the specific circumstances of each case”).
Cf. D'Tiole v. Sec'y of Health & Human Servs., 726 F. App'x 809, 812 (Fed. Cir.
2018) (citing 42 U.S.C. § 300aa-12(d)(3)(B)(v)) (noting that the decision to hold
an evidentiary hearing is statutorily committed to the discretion of the special
master).
A four-day hearing was held on December 4-7, 2017. During the hearing,
the Sanchezes solicited testimony from their two expert witnesses: Dr. Lawrence
Steinman and Dr. Dmitriy Niyazov. The Secretary solicited testimony from four
expert witnesses: Dr. Gerald Raymond, Dr. Stephen McGeady, Dr. Edward
Cetaruk, and Professor Dean Jones. The hearing ended half a day early, with both
parties and the undersigned not using all of their allotted time
III. Standards for Adjudication
Trystan’s condition does not constitute a Table injury under the Vaccine
Act. As an “off-Table Injury,” the Sanchezes must demonstrate that the vaccine
caused or significantly aggravated Trystan’s injury. 42 U.S.C. § 300aa-
11(c)(1)(C)(ii).
The Sanchezes’ burden of proof as an off-Table injury is explicitly defined
by Congress. The Act provides that a petitioner must show, by a preponderance of
the evidence, that the vaccine sustained or significantly aggravated the illness or
injury. See 42 U.S.C. § 300aa–13(a)(1) and 42 U.S.C. § 300aa-11(c); see also
Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)
8 The fraction of the total time was petitioners: one-half, respondent: one-
third, and special master: one-sixth.
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(noting that petitioners must prove causation by the traditional tort standard of
preponderance). As for what is necessary to meet this burden, the statute itself
only requires that the conclusion of the court or special master may not be “based
on the claims of a petitioner alone, unsubstantiated by medical records or by
medical opinion.” 42 U.S.C. § 300aa-13.
Instead, special masters must consider all the evidence and decide whether
the causal link between the vaccine and the injury was logical and legally probable.
See Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir.
1994) (“The sole issues for the special master are, based on the record evidence as
a whole and the totality of the case, whether it has been shown by a preponderance
of the evidence that a vaccine caused the [] injury”); Grant v. Sec’y of Health &
Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (“Causation in fact requires
proof of a logical sequence of cause and effect showing that the vaccination was
the reason for the injury”); Hines v. Sec'y of Health & Human Servs., 940 F.2d
1518, 1525 (Fed. Cir. 1991) (“causation in fact requires proof of a logical sequence
of cause and effect showing that the vaccination was the reason for the injury”).
In establishing whether preponderant evidence of causation exists, fact-
finders often divide the analysis into two parts. First, is it biologically plausible for
the vaccine to cause the alleged injury? If this plausibility, or “general causation”
inquiry, is satisfied, then the petitioners must next prove that the vaccine actually
caused the alleged symptoms in her particular case. See Pafford v. Sec'y of Health
& Human Servs., 451 F.3d 1352, 1356 (Fed. Cir. 2006) (finding this two-part test
to state a petitioner’s burden of proof in claims of off-Table vaccine injury
correctly); see also Moreno v. Sec'y of Health & Human Servs., No. 95-706V,
2005 WL 6120645, at *1 (Fed. Cl. Apr. 27, 2005) (applying this same two-stage
analysis).
Regardless of the framework applied by the special master, the outcome of
any decision rests simply on the question of whether there exists preponderant
evidence of causation in the case at hand; special masters must not create bars to
compensation that do not exist in the statute itself. See, e.g., Capizzano v. Sec'y of
Health & Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006) (rejecting a test that
required “epidemiologic studies, rechallenge, the presence of pathological markers
or genetic disposition, or general acceptance in the scientific or medical
communities”). In other words, the evidence must be considered in whole and
conclusions regarding causation should involve an analysis of the entire picture.
See, e.g., Knudsen, 35 F.3d at 549; see also Doe v. Sec'y of Health & Human
Servs., 601 F.3d 1349, 1357 (Fed. Cir. 2010) (endorsing the special master’s
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consideration of a factor unrelated to a vaccine in determining whether a petitioner
had presented sufficient evidence of causation-in-fact).
IV. Overview
A. Introduction to Genetic Issues
The parties agree that Trystan was born with two mutations in his nuclear9
DNA. The parties also agree that but for these mutations, Trystan would not have
developed Leigh’s syndrome. Where they disagree is whether the vaccinations
Trystan received on February 5, 2009, constituted a substantial factor in his
development of Leigh’s syndrome.
The specifics of Trystan’s genetic condition are discussed more thoroughly
in section V.C., below. However, a brief introduction is appropriate here for the
purpose of understanding how the mutation, the vaccination, and the disease are all
potentially interrelated.
Trystan inherited two different mutations in his nuclear DNA, one from his
mother and one from his father. Exhibit 59 at 1. While the mutations are different,
they both affect the same gene encoding subunit A of the succinate dehydrogenase
enzyme (SDH). The combination of the two distinct mutations to the same SDHA
gene is referred to as a compound heterozygous SDHA mutation.10 See A
Dictionary of Genetics at 98.
SDH is one enzyme (an enzyme is a type of protein) in a larger chain of
mitochondrial enzymes that are responsible for creating cellular energy, a key
function of the mitochondria more generally. See Dorland’s Illustrated Medical
Dictionary 1795 (32d ed. 2012). Consistent with the critical role of energy
production to the sustenance of life, and the role of the SDH enzyme in energy
production, the SDH enzyme is essential for life. An examination of the SDHA
9 Although the SDH enzyme is located in the mitochondria, it is encoded by
nuclear DNA, not mitochondrial DNA. See exhibit 148 (Shamima Rahman and
David Thorburn, Nuclear Gene-Encoded Leigh Syndrome Overview,
GeneReviews (July 5, 2017), https://www.ncbi.nlm.nih.gov/books/NBK320989) at
1-2.
10 Had Trystan inherited the same mutation from both his mother and his
father, he would have a homozygous mutation. See A Dictionary of Genetics at
224.
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gene in other species indicates that the coding of the gene has highly conserved
regions. See, e.g., exhibit H, tab 28 (R. Horvath et al., Leigh Syndrome Caused by
Mutations in the Flavoprotein (Fp) Subunit of Succinate Dehydrogenase (SDHA),
77 J. Neurology Neurosurgery Psychiatry 74-76 (2006)) at 2.11 Conservation of
genetic code is indicative of the code’s importance; it hints that changes to the
code are not conducive to life. See A Dictionary of Genetics at 100.
Although Trystan has two mutations and has been diagnosed with Leigh’s
syndrome, not all SDHA mutations result in Leigh’s syndrome, and not all cases of
Leigh’s syndrome are the result of SDHA mutations. See exhibit H, tab 7 (Thomas
Bourgeron et al., Mutation of a Nuclear Succinate Dehydrogenase Gene Results in
Mitochondrial Respiratory Chain Deficiency, 11 Nature 144 (1995)) at 4 (noting
that SDHA mutations can lead to cardiomyopathy and Kearns-Sayre Syndrome);
exhibit 148 (Rahman) at 4 (noting that SDHA mutations are a small fraction of the
types of mutations associated with Leigh’s syndrome). Cf. Oliver v. Sec'y of
Health & Human Servs., No. 2017-2540, 2018 WL 3945586, at *8 (Fed. Cir. Aug.
17, 2018) (Newman, J., dissenting) (noting that the lack of a one-to-one
correspondence between an SCN1A mutation and Dravet syndrome allowed for
the conclusion that a vaccine reaction was a substantial factor in the onset of the
disease).
Importantly, Leigh’s syndrome is not so much a specific pathology with an
expected course as it is a label applied to a variety of pathologies that manifest
somewhat similarly and, historically, is hallmarked by the observation of
characteristic brain lesions on post-mortem examination. Tr. 792. Using this
definition for Leigh’s is partly historical since at the time the disease was first
characterized, genetic testing and MRI were not available. As Dr. Haas notes, with
regard to Trystan, “Leigh Syndrome usually refers to a severe neurological
disorder that often presents in the first year of life and is characterized by
progressive loss of mental and movement abilities and typically results in death
within a couple years.” Exhibit 140 at 5. However, Dr. Haas also notes that “it
may be used as an umbrella term for many mitochondrial disorders” and, as a
consequence, “the variable presentation makes a prognosis challenging.” Id.
11 Citations to research articles reference the page number of the PDF
exhibit, not the page number of the published article.
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B. The Sanchezes’ Argument
The Sanchezes acknowledge that absent Trystan’s mutations he would not
have Leigh’s syndrome today; the vaccines were insufficient to cause Trystan to
develop Leigh’s syndrome. See Pet’rs’ Preh’g Br. at 23 (noting that Trystan’s
SDHA mutations provided the susceptibility for the Leigh’s syndrome). However,
the Sanchezes also argue that the vaccinations he received on February 5, 2009,
either caused his genetic condition to be expressed or, alternatively, significantly
aggravated the course of his disease. Pet’rs’ Preh’g Br. at 29. In other words, the
Sanchezes argue that the vaccination was a substantial factor in Trystan’s disease
course.12
C. The Secretary’s Argument
The Secretary contends the evidence in the record is not consistent with a
conclusion that the vaccination caused or significantly aggravated Trystan’s
condition. More specifically, the Secretary considers the Sanchezes’ theories for
how the vaccination could have caused or significantly aggravated Trystan’s
condition to not be sufficiently plausible under the standards set forth by the
Vaccine Act and the Federal Circuit. Resp’t’s Preh’g Br. at 8-11. Furthermore,
the Secretary argues that the timeline between the vaccination and the onset of
Trystan’s disease is not consistent with a conclusion that the two represent a
12 The Sanchezes argue that this case does not involve a significant
aggravation analysis. Pet’rs’ Preh’g Br. at 16-17. Although the Sanchezes offer a
significant aggravation analysis in the alternative, they argue that the question at
hand is simply whether Trystan’s vaccinations were a substantial factor in
Trystan’s disease course. Id. The Federal Circuit has held that the six-step test put
forth in Loving is the appropriate analysis for examining claims of significant
aggravation. W.C. v. Sec'y of Health & Human Servs., 704 F.3d 1352, 1357 (Fed.
Cir. 2013) (referencing Loving v. Sec'y of Health & Human Servs., 86 Fed. Cl.
135, 144 (2009)). Nonetheless, as Judge Bruggink of the Court of Federal Claims
has pointed out, the Loving framework does not provide a straightforward method
of analysis for cases in which a vaccinee had a preexisting genetic mutation. See
Barclay v. Sec'y of Health & Human Servs., 122 Fed. Cl. 189, 193 (2015).
Because the Loving test for significant aggravation incorporates the
requirement of establishing but-for causation, regardless of which construct is
followed, the outcome here is the same. As explained in the text, the Sanchezes
have not established that Trystan declined in an appropriate temporal window.
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logical sequence of cause and effect. Id. at 11-12. The Secretary further argues
that the Sanchezes cannot show that Trystan’s current condition is worse than it
would have been but for the vaccination. Id. at 13-14.
V. Analysis
The analysis consists of three sections. First, the undersigned evaluates
whether vaccinations can cause the manifestation of Leigh’s syndrome. This is the
equivalent of the first Althen prong. Second, the undersigned determines whether
the vaccination did harm Trystan in the manner proposed. This analysis essentially
combines the second and third Althen prongs. Third, the undersigned considers
Trystan’s genetic mutations and how the genetic mutations have affected Trystan’s
development.
A. The Sanchezes’ Medical Theory of Causation
The Sanchezes argue that Trystan’s Leigh’s syndrome was brought on by the
vaccinations he received on February 5, 2009. To demonstrate that vaccinations
can cause the onset of Leigh’s syndrome, the Sanchezes provide evidence showing
that the onset of Leigh’s syndrome is associated with a decompensating event13 and
that vaccination could cause such a decompensating event. Though a link between
vaccination and the onset of Leigh’s syndrome has not been established to the
standard of medical certainty, for the reasons elucidated below, the evidence
presented is sufficient to conclude that the Sanchezes’ theory is plausible insofar as
it is consistent with contemporary understanding of the biological systems at play.
Accordingly, the Sanchezes have met their statutory burden on this element as the
Federal Circuit has defined it. See Hibbard v. Sec'y of Health and Human Servs.,
698 F.3d 1355, 1365 (Fed. Cir. 2012) (noting that petitioners’ burden is to provide
a “viable medical theory by which a vaccine can cause the injury claimed by the
petitioner”).
13 Decompensation is a period of regression that is frequently seen in cases
of Leigh’s disease. Exhibit 148 (Rahman) at 1. Dr. Raymond testified that
decompensation in individuals with Leigh’s syndrome is clinically obvious and is
characterized by encephalopathy, decreased consciousness, weakness, and motor
difficulties. Tr. 794-95. Dr. Niyazov largely agreed with this characterization of
decompensation, but noted that the decompensation can be followed by periods of
prolonged stabilization and possibly even improvement. See Tr. 417.
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The first manifestation of Leigh’s syndrome is known to follow an
intercurrent illness in many, if not most, cases. Exhibit 148 (Rahman). The parties
and their respective experts do not appear to dispute this fact and the medical
literature in the record indicates that this is part of the canonical presentation of
Leigh’s syndrome. See, e.g., exhibit 148 (Rahman) at 2 (“Onset is typically
between ages three and 12 months, frequently following a viral infection”). As for
why a viral illness can precipitate onset of Leigh’s syndrome, Jeffrey D. Kingsley
et al., in the journal Pediatrics, note that:
The metabolic homeostasis of individuals with inborn errors of metabolism
is tenuously balanced and may be easily compromised by any degree of
superimposed metabolic stress. Inadequate food intake, depleted energy
stores, and impaired or excess formation of metabolic components place
considerable stress on these individuals’ ability to achieve a metabolic
balance. Febrile episodes caused by infections or other inflammatory
processes further accentuate this stress and may result in a significantly
amplified degree of morbidity and mortality in affected individuals.
Exhibit 99 (Jeffrey D. Kingsley, Immunizations for Patients with Metabolic
Disorders, 118 Pediatrics e460 (2015)) at 5.14
Thus, the pertinent question appears to be whether vaccination can induce
the type of metabolic stress that could cause decompensation.
A substantial portion of the pre-hearing briefs as well as the hearing was
spent arguing how exactly Trystan’s vaccinations, on a mechanistic level, may
have caused decompensation. The Sanchezes proffered three different
mechanisms that may have mediated the link between Trystan’s vaccines and the
decompensation: 1) ADP-ribosylation, 2) alum, and 3) oxidative stress. The
Secretary (though not always his expert witnesses) argued against these theories.
Testimony concerning these theories consumed a substantial portion of the hearing
in this case.
For all this debate regarding the mechanisms that might be involved, the
conclusion that the Sanchezes have met their burden to present a plausible medical
theory explaining how Trystan’s vaccines may have caused his injury requires only
two premises to be more-likely-than-not. First, that the vaccine that Trystan
received is known to sometimes cause fever (regardless of the mechanistic causes
14 Kingsley et al. were commenting on metabolic disorders more generally,
not Leigh’s syndrome specifically.
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of that fever). Second, fever can cause decompensation in someone with a pre-
existing mitochondrial disease.
A review of the evidence makes apparent that while the Secretary stridently
opposed the proposed mechanisms, the Secretary did not rebut either of these
general premises. Furthermore, the evidence indicates that both premises are likely
to be consistent with contemporary medical thought.
As for the first premise, there appears little question that the vaccines
Trystan received sometimes cause fever. Trystan’s undisputed fever and crying
following the vaccine appears on the package insert for that same vaccination,
exhibit 92, and even Dr. McGeady characterized Trystan’s immediate reaction to
the vaccine to be “often seen.” Tr. 729. Beyond plausibility, there appears to be
no meaningful debate about the fact that the vaccines that Trystan received actually
did cause him to develop a fever. See Tr. 734 (Dr. McGeady testifying that “I do
think [the vaccination] had something to do with the fever).”15
As for the second premise, there also appears agreement, or at least not
meaningful debate, that fever—including fever following vaccination—can result
in decompensation.
For instance, Kingsley et al. warn physicians that they should closely
monitor the possibility of fever in vaccine recipients who have metabolic disease.
Id. at 8 (“Given the pathophysiologic implications of immunization, it can be seen
that the febrile response, the anorexia, or both may contribute to a metabolic
decompensation in these patients with potentially serious consequences”). The
Kingsley authors appear not to be alone in their concern for how febrile responses
15 The uncontroverted premise that the vaccines administered on February 5,
2009, caused Trystan to suffer a fever distinguishes this case from one in which
another special master found that a petitioner had not presented a viable medical
theory connecting a FluMist vaccine to metabolic decompensation in a child with
Leigh’s syndrome and a mutation in her mitochondrial DNA. See H.L. v. Sec'y of
Health & Human Servs., No. 10-0197V, 2016 WL 3751848, at *22 (Fed. Cl. Spec.
Mstr. Mar. 17, 2016), mot. for rev. denied, 129 Fed. Cl. 165 (2016), aff'd, 715 F.
App'x 990 (Fed. Cir. 2017). In H.L., the special master found that absent a fever,
there was no evidence that a vaccine “can contribute to a regression or
decompensation in a patient with a mitochondrial disease.” Id. at 16. Thus, the
finding that H.L. did not suffer a fever in response to the FluMist vaccination
precluded the viability of her theory in that case. That is not the case here.
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to vaccination could have deleterious effects for children with inborn metabolic
disorders. They note that the Advisory Committee on Immunization Practices and
the American Academy of Pediatrics recommend that individuals with “evolving
neurologic conditions” not be vaccinated with DTaP until a treatment regimen has
been established and the condition stabilized. Id. at 4. These committees further
recommend that antipyretic medication be administered concurrently with
vaccination to reduce the possibility of post-vaccination fever. Id. These
precautions were not taken with Trystan because his inborn metabolic disease was
not known at that time.
The Secretary did not present an expert in mitochondrial diseases and
nothing in the record from the Secretary indicates that he took the position that
fever is not linked to metabolic decompensation in children with inborn
mitochondrial disorders. Even more, a review of other cases in the Vaccine
Program indicates that the Secretary has, in previous cases, not contested that fever
can cause metabolic decompensation in children with mitochondrial disorders. See
H.L., 2016 WL 3751848, at *7 (noting that both parties’ experts agreed “that
metabolic decompensation can be caused by a fever”).
Instead, in the present case, the Secretary’s challenge targeted the specific
mechanisms, whether they be mediated by ADP-ribosylation, alum, oxidative
stress, or in the opinion of one of the Secretary’s experts, Dr. McGeady,
complement fixation.16 See Tr. 729 (Dr. McGeady hypothesizing that complement
fixation explains why Trystan displayed fever and inconsolable crying after the
February 5, 2009 vaccinations). While it is true that none of the Sanchezes’
theories are perfect, the law does not require them to be. See Knudsen, 35 F.3d at
549 (“[T]o require identification and proof of specific biological mechanisms
would be inconsistent with the purpose and nature of the vaccine compensation
program”). It is not the Sanchezes’ burden to show how the vaccines caused the
onset of Trystan’s illness, but it is their burden to show that they can cause
Trystan’s illness. See Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373,
1384 (Fed. Cir. 2012). The Sanchezes have met this burden.
16 The Secretary understandably dedicated a substantial amount of his case
arguing against the specific mechanisms proposed by the Sanchezes because they
dedicated a substantial portion of their case arguing those specific mechanisms.
Compare Pet’rs’ Preh’g Br. at 17-37 (setting forth the Sanchezes’ medical theories)
with Resp’t’s Preh’g Br. at 8-11 (rebutting the Sanchezes’ medical theories).
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B. Evidence that the Vaccine Caused Trystan’s Injury
While the Sanchezes have presented sufficient evidence to establish that
Trystan’s vaccines could cause the initial manifestation of his Leigh’s syndrome,
they have not established that it actually did. This is simply due to the fact that the
timing of the manifestation of Trystan’s Leigh’s syndrome was not consistent with
the vaccination being a factor in his development of the disease.
On its face, the Sanchezes’ argument that the timing is indicative of vaccine
causation is somewhat deceptive. The Sanchezes and their experts often
incorporate into their argument the premise that February 5, 2009, marked a
turning point in Trystan’s development, wherein nothing was ever the same again.
By doing so, the Sanchezes and their experts attempt to mirror the facts of
the case study presented in Poling et al. See exhibit 84 (Jon S. Poling et al.,
Developmental Regression and Mitochondrial Dysfunction in a Child with Autism,
21 J. Child Neurology 170-72 (2006)). This article recounts the experience of a
young girl with asymptomatic mitochondrial dysfunction, who developed a fever
after immunizations to DTaP, Hib, MMR, polio, and varicella. Id. at 2. Within 48
hours after immunization, the young girl developed a fever of 102°F and was
crying inconsolably. Id. Four days later, the child could no longer climb stairs and
was having episodes of opisthotonus. Then, over the course of several months, the
child became increasingly less responsive verbally. Id. The Sanchezes argue that,
like the young girl in Poling, the vaccinations marked a turning point in Trystan’s
life wherein nothing was ever the same again.
This premise concerning the timing appears consistently throughout the
record. Trystan’s response to the vaccine has been referred to as the beginning of
“a downward cascade.” Tr. 278. Other times, the Sanchezes’ experts stated that
Trystan was healthy before the vaccine and that the deterioration began
immediately after. See Tr. 292 (“he seemed to be a healthy well child and
following that February 5th immunization . . . he had neurologic deterioration”);
Tr. 338 (noting that before the immunization Trystan seemed like a healthy child
and after the vaccination he “started having deterioration”). On other occasions,
the claim was that it began gradually after the vaccination. E.g., exhibit 68 at 8
(“developmental regression was slowly developing ever since the crying and fever
took place as the result of the vaccination”). Regardless of the specific language,
the Sanchezes’ experts have assumed the premise that Trystan “was never the same
after that first [February 5, 2009] shot.” Tr. 951.
Though the Sanchezes and their experts may believe that there is “no doubt
[that Trystan’s neurological deterioration] began on February 5th,” Tr. 293, the
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evidentiary record does not support this premise that is so central to the Sanchezes’
argument.17 Instead, as reviewed in section I.B.3, above, the record indicates that
Trystan’s loss of skills did not occur before May 2009, at the earliest. The
sequence of events in Trystan’s life make his case very different from the girl in
the Poling article. Cf. Kreizenbeck v. Sec'y of Health & Human Servs., No. 08-
209V, 2018 WL 3679843, at *28 (Fed. Cl. Spec. Mstr. June 22, 2018) (explaining
that the facts in that case were “completely distinguishable” from the young child
presented in the Poling article), mot. for rev. filed, July 20, 2018.
Accordingly, approximately three months passed between when Trystan
received the February 5, 2009 vaccinations and the earliest possible onset of his
neurological regression. The question at bar is whether a delay of this magnitude
is consistent with vaccine-causation. A review of the literature indicates that it is
not.
As an initial matter, the undersigned recognizes that the available evidence
for the appropriate time between a decompensating event and the onset of
neurological symptoms is imperfect. Nonetheless, the available evidence is
sufficient to conclude that, more likely than not, Trystan’s Leigh’s syndrome,
which presented no earlier than the beginning of May 2009, was not the result of
the vaccinations he received on February 5, 2009, approximately three months
earlier.
The most precise evidence of the appropriate timing between a
decompensating event and the onset of neurological symptoms is presented in
Edmonds et al. Exhibit 75 (Joseph L. Edmonds et al., The Otolaryngological
Manifestations of Mitochondrial Disease and the Risk of Neurodegeneration With
Infection, 128 Archives Otolaryngological Head Neck Surgery 355-62 (2009)). In
17 Dr. Niyazov’s and Dr. Steinman’s assumption of a relatively early onset
based upon parental affidavits and testimony make the present case comparable to
multiple autism cases in which a special master refrained from crediting an expert
report that assumed facts not consistent with medical records. E.g., Rogero v.
Sec'y of Health & Human Servs., No. 11-770V, 2017 WL 4277580, at *42 (Fed.
Cl. Spec. Mstr. Sept. 1, 2017) (noting that the petitioners’ failed to prove their
claim of causation because their experts relied on incorrect assumptions), mot. for
rev. denied, slip op. (Jan. 11, 2018), aff'd, No. 2018-1684, 2018 WL 4355990 (Fed.
Cir. Sept. 12, 2018).
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the Edmonds article, the authors found that in most cases the neurological setback
(in the Edmonds study, hearing loss) occurred between three to seven days
following the intercurrent infection, though in a few patients the neurological
setback occurred early in the course of the infection. Id. at 6. Based on the article,
it appears that in no case did the neurological setback occur more than seven days
following the infection. Id.
There has been some confusion in this case, and in others, regarding the
significance of Figure 3 of the Edmonds paper and thus, for clarity, the figure is
reproduced below.
Id. at 7.
The figure’s caption describes it as showing “timing of infection-associated
neurologic setbacks in patients with mitochondrial disease.” Id. The distribution
demonstrates that there is a stochastic nature to the time when neurodegenerative
events begin in relation to the intercurrent infection that is canonically associated
with the decompensation. Consistent with the data reviewed above, the
neurodegeneration sometimes occurred early in the course of the infection, but
most frequently followed the infection by three to seven days.
The confusion appears to be the result of the relationship of the figure and
the distribution of the actual results found in the paper. The Sanchezes, in their
pre-trial brief, argue that Edmonds demonstrates “neurodegeneration occurring
following infection in patients with mitochondrial disorders over a period
extending to 19 days.” Pet’rs’ Preh’g Br. at 51. The Federal Circuit, in Paluck v.
Sec'y of Health & Human Servs., interpreted the figure to show that “in at least one
patient in the Edmonds study, the neurological setback did not occur until nineteen
days after infection.” 786 F.3d 1373, 1383 (Fed. Cir. 2015).
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However, as Dr. Raymond cogently explained, the figure is merely a
schematic, not a representation of the raw data and this distinction is important
when considering the significance of the figure. Tr. 835-36. The authors expressly
state: “In a few patients (3/13), the neurologic setback occurred early in the course
of infection. In most patients (10/13), the neurologic event occurred 3 to 7 days
after the onset of infection.” Exhibit 75 (Edmonds) at 6. Thus, it follows that no
patient showed the onset of neurodegeneration more than 7 days following the
onset of the infection. See Tr. 835 (Dr. Raymond making the same point); Tr. 512-
13 (Dr. Niyazov confirming, on cross-examination, that no patient in the study had
the neurological setback more than seven days after the onset of the infection).
Had the authors observed that one of 13 patients presented with neurodegeneration
19 days after the onset of the infection, general principles of sampling and
inferential statistics suggests that some patients in the broader population have
onsets even longer than 19 days since a latency of that duration appeared in the
small sample of 13 patients. However, that is not what the article says. Instead,
the authors find that no patients had onsets greater than 7 days following infection
and Figure 3 appears to show that the authors understand that there are likely
patients in the general population with onsets beyond 7 days, though how much
longer than 7 days is merely just an educated guess. Nonetheless, a 19-day latency
appears to be, literally, off-the-charts, at least in the opinion of the authors.
The authors from exhibit 86 (John Shoffner et al., Fever Plus Mitochondrial
Disease Could be Risk Factors for Autistic Regression, 25 J. Child Neurology 429-
34 (2010)) appear to generally agree with this estimation of the appropriate timing
between the intercurrent infection and the onset of neurodegeneration.
Importantly, the Shoffner paper does not present direct evidence of the appropriate
timing between the infection and the onset of neurodegeneration. Instead, for the
purposes of their study, the authors assume autistic regression within two weeks of
a fever as being caused by the fever. Exhibit 86 (Shoffner) at 2. The authors do
not state their basis for this two week timeframe nor how liberal or conservative
the timeframe is in associating autistic regression to an infection based on timing
alone. Thus it is difficult to weigh the significance of the authors’ opinions that an
interval of less than two weeks is consistent with causation while an interval of
greater than two weeks is not. Nonetheless, it is consistent with the broader
conclusion that the appropriate interval is approximately two weeks or less.
The Poling et al. case study, referenced earlier, also provides some useful
information about what may be expected in regards to timing. See exhibit 84
(Poling) at 1. In that case, the young girl began demonstrating clear loss-of-skills
within a week of the vaccination. Poling, as a case study appearing in a medical
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journal, is limited in its contribution.18 Nonetheless, it provides further support for
the rough timeline presented in Edmonds and Shoffner.
Undoubtedly, Edmonds, Shoffner, and Poling are far from comprehensive
studies of the appropriate onset timing. They do not lend themselves to a hard and
fast deadline for when Trystan’s symptoms would have had to develop following
the vaccination, and the undersigned does not create one here. See Paluck, 786
F.3d at 1383 (holding that a hard and fast deadline of three weeks for a finding of
causation under similar circumstances was arbitrary). Nonetheless, the
undersigned must consider the evidence that as the post-vaccination interval
extends beyond two weeks, the likelihood that the decompensation is attributable
to a reaction to the vaccine, as opposed to another cause, drops. See Pafford, 451
F.3d at 1358 (“If, for example, symptoms normally first occur ten days after
inoculation but petitioner’s symptoms first occur several weeks after inoculation,
then it is doubtful the vaccination is to blame”).
To explain the delay between the vaccination and the loss of skills, the
Sanchezes argue that detecting loss of skills in a six-month-old infant is difficult
and thus—even if the temporal interval is almost always less than two weeks—
there may be a substantial delay between when skills start being lost and when
their loss is first noticed by a physician. Tr. 294-98. This point is worthy of
serious consideration. The Edmonds, Shoffner, and Poling articles involved
children appreciably older than Trystan developing forms of neurodegeneration
that are more salient. This line of reasoning is buttressed by published research
cited by the Sanchezes. This research indicates that, with regard to
neurodegeneration in young children with a different—but more common—
disorder, parents often become concerned months before the child is first
diagnosed. See exhibit 71 (Anne-Marie Bisgaard et al., Is it Possible to Diagnose
Rett Syndrome before Classical Symptoms Become Obvious? Review of 24
Danish Cases Born Between 2003 and 2012, 19 European J. Pediatric Neurology
679-87 (2015)). Furthermore, the research conveys anecdotes from parents noting
that pediatricians and other treaters can often dismiss parents’ concerns. Id. at 7-8.
As Dr. Steinman notes, and the Secretary does not rebut, physicians will often
consider a child missing one milestone as not a big problem and in such situations
doctors will often try to calm parents’ fears as oppose to stoke them. Tr. 294-98.
18 As a legal case, Poling carries even less precedential value because it was
an on-Table case.
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The Sanchezes’ argument that there may be a delay between when parents
first notice something change in a child’s development and when doctors diagnose
a child is, on its face, reasonable. The cited literature only confirms that there is
some truth to the claim. Furthermore, the undersigned believes that there is a non-
insignificant chance that the Sanchezes relayed a concern at the May 13, 2009 visit
with Dr. Brown that did not end up in the records. Nonetheless, this does not
account for the three-month period where the records show no indication of
Trystan having, or the parents being concerned about, a neurological condition.
Instead, the concern appeared to be focused on Trystan’s multiple colds. And, in
fact, understanding what may have caused the manifestation of Trystan’s disease
requires a closer look at these very colds.
The Federal Circuit has endorsed special masters’ consideration of alternate
causes in determining whether petitioners have established their prima facie case.
See Doe, 601 F.3d at 1357 (stating that the government can provide and the special
master can consider evidence of “factors unrelated” in determining whether the
petitioner established a prima facie case). Similarly, the absence of a “factor
unrelated” may very well buttress a petitioner’s claim of vaccine-causation (i.e., if
nothing else can explain the onset of the disease other than the vaccine, the
likelihood it was the vaccine is augmented).
Accordingly, as it pertains to this case, if Trystan did not experience any
other decompensating events between the vaccination and the onset of his Leigh’s
syndrome, it may very well make his parents’ claims of causation less improbable.
However, the record shows that in the months leading up to when his loss of skills
first manifested, Trystan suffered from multiple upper respiratory infections. See
exhibit 1 at 48-53. These infections are known to precipitate mitochondrial
decompensation. Exhibit 75 (Edmonds) at 3 (citing Robert K. Naviaux, The
Mitochondrial DNA Depletion Syndromes, in Atlas of Metabolic Disease (W.L.
Nyhan and P.T. Ozand eds., 1999)) (“a well-known clinical correlation of upper
respiratory tract infections (URIs) . . . with neurodegenerative setbacks in
mitochondrial disease exists”);19 see also Tr. 361 (Dr. Steinman noting that
Trystan’s infection could have contributed to the onset of his Leigh’s syndrome).
Trystan’s URIs in March-May 2009 are entirely consistent with the infections
19 Robert K. Naviaux is a colleague of Dr. Niyazov whom Dr. Niyazov
characterized as “a very trusted and respected person, an expert in the field of
mitochondrial disease.” Tr. 377-78, 526.
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being the intercurrent infection that induced his metabolic decompensation in May
or June 2009. See also H.L., 715 F. App’x 990, 996 (ruling that the special master
was not arbitrary in determining the sequence of events supported a finding that
vaccinee’s symptoms were more attributable to an URI than a vaccine-injury).
Here, the Sanchezes’ inability, or failure, to address a conspicuous and
probable alternate cause for the manifestation of Trystan’s Leigh’s syndrome
weighs against a finding that the vaccination caused Trystan’s injury. To be clear,
the Sanchezes’ failure to address the alternative cause does not per se preclude
compensation, but it does weaken their claim of causation. See Pafford v. Sec'y of
Health & Human Servs., 64 Fed. Cl. 19, 35 (2005) (noting that petitioners in
causation-in-fact cases have “the obligation to successfully eliminate potential
alternative causes of the alleged injury that have been identified in the record”),
aff’d, 451 F.3d 1352 (2006); see also Munn v. Sec'y of Health & Human Servs.,
970 F.2d 863, 865 (Fed. Cir. 1992) (“The claimant must prove by a preponderance
of the evidence that the vaccine, and not some other agent, was the actual cause of
the injury”).20 This omission on the part of the Sanchezes, in combination with the
unlikelihood of a multiple-month delay between the vaccine and the onset of his
neurodegeneration, makes a finding that the vaccine was, more likely than not, a
substantial factor in Trystan’s Leigh’s syndrome untenable. Accordingly, the
Sanchezes are not entitled to compensation under the Vaccine Act.
20 The Federal Circuit has left some ambiguity with regard to when a
petitioner has an affirmative burden to rule out an alternative cause. Compare
Pafford, 451 F.3d at 1366 (Dyk, J., dissenting) (“In summary, the majority
incorrectly holds that petitioners, in order to make a prima facie case in off-Table
cases, must establish a ‘medically accepted temporal relationship’ between vaccine
and injury and eliminate other possible causes of the injury”) with Walther v. Sec'y
of Health & Human Servs., 485 F.3d 1146, 1152 (Fed. Cir. 2007) (“the petitioner
does not bear the burden of eliminating alternative independent potential causes”).
Notwithstanding this question over the allocation of the burden of proof, the
undersigned’s decision here finds that the Sanchezes have not established a prima
face case of causation, independent of their failure to address the alternate cause.
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C. Trystan’s Condition but for the Vaccination
Because this decision finds that the Sanchezes have not established
entitlement to compensation, the outcome of this decision does not depend on the
Secretary’s argument that Trystan was “nearly certainly destined to develop
Leigh’s syndrome due to this preexisting SDHA gene mutation.” Resp’t’s Preh’g
Br. at 14-15. Nonetheless, it is worth evaluating this issue for the purpose of
preserving the record.
Because the genetic issues are complex, a general review of the material as
well as a summary of the parties’ positions may prove useful.
1. Genes, Proteins, and Disease
Proteins are the workhorse of our bodies. They are the structures that allow
our neurons to fire and our muscles to contract. They convert food to energy and
build the structures of our cells and our bodies. Everything our bodies do are done
by proteins. See generally Dorland’s at 1531 (explaining what proteins are and
what functions they perform).
Proteins’ broad range of capabilities is the result of their ability to take many
forms. The form a protein takes is determined by the sequence of amino acids that
comprise the protein. That sequence is determined by our genetic code: our DNA.
In other words, proteins give life to the code. See id. at 490, 1644 (explaining how
nucleic acid codes are transcribed and translated into proteins).
Our genetic code is the result of the comingling of our parents’ code. A
Dictionary of Genetics at 430. However, over time, variations in the code occur;
that is partly how species evolve. See id. at 158, 308. Any time there is a
permanent change in the sequence of the code, a mutation is said to have occurred.
Exhibit J (Sue Richards et al., Standards and Guidelines for the Interpretation of
Sequence Variants: A Joint Consensus Recommendation of The American College
of Medical Genetics and Genomics and The Association for Molecular Pathology,
17 Genetics in Medicine 405-24 (2015)) at 2. Because of how our DNA is
translated into proteins and the various roles of proteins in our bodies, these
changes can have a broad range of effects. They may cause a fetus to be unviable
at the earliest stages of life; they may cause a disease that does not manifest until
40 years of age; or they may cause no perceivable effect at all. They may also
cause one’s eyes to be a brilliant and unforgettable shade of green. Their effects
are largely limitless. See generally Genetics: A Conceptual Approach at 493-533.
When a mutation can cause a disease, it is referred to as pathogenic. A
Dictionary of Genetics at 345. The proclivity for a specific mutation to result in a
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disease-state is the result of how the mutation affects the function of the protein for
which it codes as well as the function of that protein in the body. Some mutations
can cause drastic changes to the protein by creating, for example, a frameshift in
the DNA code whereby the code is no longer legible. A Dictionary of Genetics at
175; exhibit J (Richards) at 9. Others might be the result of an early stop signal
that results in a truncated protein; half a book, more or less. A Dictionary of
Genetics at 319. However, mutations can also be relatively benign. For example,
a mutation in DNA can, due to the way that DNA is translated into protein, result
in no change in the actual protein. Alternatively, the mutation may result in a
change in the structure of the protein that has no effect on its function. See Harris
v. Sec'y of Health & Human Servs., No. 07-60V, 2011 WL 2446321, at *12 (Fed.
Cl. Spec. Mstr. May 27, 2011) (discussing these types of benign mutations), mot.
for review granted, decision rev'd, 102 Fed. Cl. 282 (2011), reinstated sub nom.,
Snyder v. Sec'y of Health & Human Servs., 553 F. App'x 994 (Fed. Cir. 2014).
Though there are benign mutations and deadly mutations, twin studies show
that mutations frequently do not have a one-to-one correspondence with an
outcome. See Snyder v. Sec'y of Health & Human Servs., No. 01-162V, 2009 WL
332044, at *46 (Fed. Cl. Spec. Mstr. Feb. 12, 2009) (discussing the role of twin
studies in showing the genetic cause of disease), mot. for review granted, decision
rev'd, 102 Fed. Cl. 305 (2011), reinstated, 553 F. App'x 994 (Fed. Cir. 2014). In
other words, genotypes (the genetic code) do not always necessitate phenotypes
(the biological outcome). Id. The same mutation can readily result in one
phenotype (be it a disease, a personality feature, or a physical feature such as
height) in one individual, but be completely absent in another. The proportion of
individuals that develop the phenotype associated with a mutation is referred to as
penetrance. A Dictionary of Genetics at 347. For example, not every individual
with a mutation in the BRCA1 gene develops breast or ovarian cancer because the
mutation, though pathogenic, is incompletely penetrant. See id.; Tr. 1005.
Relatedly, some mutations can result in a wide spectrum of biological
outcomes. In other words, the mutation expresses differently across individuals.
For example, identical mutations associated with intellectual disability may result
in individuals with a broad range of IQs. Like incomplete penetrance, variable
expressivity is a hallmark of genetics. A Dictionary of Genetics at 161.
Incomplete penetrance and variable expressivity highlight the complexity of
clinical genetics. Organisms are shaped not only by individual genes, but by their
environment and the interaction of the environment with not only the mutated
gene, but other genes that interact with the mutated gene. This makes it very
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difficult to predict a clinical course based on a single mutation alone. See exhibit J
(Richards) at 16.
2. Trystan’s SDHA Mutations
As reviewed above, Trystan inherited two heterozygous mutations in his
SDHA gene. Because of the nature of the mutations and their effect on the SDHA
protein, the mutations are considered pathogenic. The parties dispute whether
these two mutations made Trystan’s disease a fait accompli.
To understand the potential effect of Trystan’s inherited mutations on
Trystan’s clinical course, it is important to review Trystan’s specific mutations and
what is known about them.
Trystan’s two mutations in his DNA are referred to as c.1571C>T and
c.667delG. Exhibit 59 at 1. The first indicates that at location 1571 in the gene, a
cytosine (C) has been replaced by a thymine (T). The second indicates that a
guanine (G) that is supposed to be present at position 667 has been deleted. In the
case of the first, this mutation changes the nucleic acid code so that where there is
supposed to be an alanine in the protein, the cell now puts a valine (p.Ala524Val).
In the case of the second, the mutation changes the nucleic acid sequence in a
manner that creates a premature stop signal in the place of a signal for an amino
acid. In other words, the cell believes that no more of the nucleic acid chain needs
to be translated into amino acid, resulting in a shortened, or truncated, protein (p.
Asp223IlefsX3). For consistency, all references are made to the locations of
mutations in the DNA (in Trystan’s case, c.1571C>T and c.667delG).
The result of these mutations was that Trystan’s SDH enzyme cannot
function quite right. However, the relationship between the mutation and Trystan’s
clinical condition is not easily predicted. Both parties submitted literature to assist
in the determination of how Trystan’s mutations may speak to his expected
prognosis. A review of some of these articles and their findings is appropriate:
Exhibit H, tab 7 (Thomas Bourgeron et al., Mutation of a Nuclear Succinate
Dehydrogenase Gene Results in a Mitochondrial Respiratory Chain Deficiency, 11
Nature 144-49 (1995)) presents the first account of a mutation in SDHA being
associated with a mitochondrial disease in humans. In this study, the authors
reported that two sisters both had a homozygous mutation in SDHA (c.1684 C>T)
and that both sisters developed Leigh’s syndrome at 10 months of age. One died at
19 months and another was still alive at 13 months.
Exhibit 110 (Beatrice Parfait et al., Compound Heterozygous Mutations in
the Flavoprotein Gene of the Respiratory Chain Complex II in a Patient with Leigh
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Syndrome, 106 Human Genetics 246-43 (2000)) presents a case study of a child
with Leigh’s syndrome who, like Trystan, had a compound heterozygous mutation
of her SDHA gene. The child in Parfait shared one of his two mutations with
Trystan (c.1571 C>T). However, the other mutation was distinct between the two
children. Little is known about the course of the disease for the young child
presented in the Parfait article, other than that she presented with Leigh’s
syndrome at 9 months of age, demonstrating psychomotor delays and cerebellar
ataxia. The authors in the Parfait article took the additional step of showing that
the reduced functioning of the young child’s SDH protein was attributable to the
c.1571C>T mutation (the mutation Trystan had), confirming the mutation’s
pathogenicity.
Exhibit 94 (Rudy Van Coster et al., Homozygous Gly555Glu Mutation in
the Nuclear-Encoded 70 kDa Flavoprotein Gene Causes Instability of the
Respiratory Chain Complex II, 120A Am. J. Medical Genetics 13-18 (2003))
presents the case study of a young child with a homozygous mutation in the SDHA
gene (c.1664 G>A) whose symptoms developed at five months of age and then
died two weeks later following a respiratory infection. Though the child may have
had Leigh’s syndrome, she “died in infancy before any sign of Leigh syndrome
could develop.” Id. at 4.
Exhibit H, tab 28 (R. Horvath et al., Leigh Syndrome Cased by Mutations in
the Flavoprotein (Fp) Subunit of Succinate Dehydrogenase (SDHA), 77 J.
Neurology Neurosurgery Psychiatry 74-76 (2006) presents the case of a young girl
with a compound heterozygous mutation in her SDHA gene. Her two mutations
were not seen in any other study. The patient first showed signs of Leigh's
syndrome at five-months of age. While she had reached 10 years at the time the
study was published, she had also shown an arrest of her psychomotor
development and experienced recurrent seizures.
Exhibit H, tab 27 (Alistair T. Pagnamenta et al., Phenotypic Variability of
Mitochondrial Disease Caused by a Nuclear Mutation in Complex II, 89 Molecular
Genetics and Metabolism 214-21 (2006)) presents the case of a young boy with the
exact same mutations presented in exhibit 94 (Van Coster). However, in contrast
to the patient described in Van Coster, the patient in Pagnamenta did not develop
symptoms of Leigh’s syndrome until 22 months of age. While his onset was rapid,
he began showing an improved clinical picture after turning four. At the time the
article was published, the child was 10 years old and showed variably impaired
motor function, but did not appear to manifest any cognitive deficits and attended a
mainstream school.
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Exhibit 79 (Aviva Levitas et al., Familial Neonatal Isolated Cardiomyopathy
Caused by a Mutation in the Flavoprotein Subunit of Succinate Dehydrogenase, 18
European J. Human Genetics 1160-65 (2010)) is the most recently published
article in the record concerning the significance of SDHA mutations. The Levitas
article is unique for two reasons. First, the authors presented an examination of
fifteen individuals from two large consanguineous families, allowing for better
discrimination about the penetrance of the mutation. Second, the patients did not
present with Leigh’s syndrome. Instead, with the exception of one patient, the
subjects had, or had died of, cardiomyopathies of various severities. The onset of
the disease, or death, occurred at earlier than one year of age in all the children
studied. This is all the more fascinating because the mutation involved in Levitas
was the same exact mutation that was associated with Leigh’s syndrome in Van
Coster and Pagnamenta. Nonetheless, not a single family member developed
Leigh’s syndrome. Even more, at least one patient, the father, who had the
homozygous mutation that was also present in Van Coster and Pagnamenta (c.1664
G>A), had no symptoms of disease at all. This astonished the researchers and they
performed several follow-up studies to try to explain this finding, though they had
no success. Importantly, it was confirmed that this patient had a loss of function of
the SDH gene, much as was the case in Parfait, but nonetheless did not develop
any disease.
3. The Secretary’s Argument Regarding Trystan’s Clinical Course
In his brief, the Secretary took the position that Trystan’s clinical course was
set in stone due to his genetic mutation: “respondent’s position [is] that the current
scientific evidence demonstrates that Trystan was nearly certainly destined to
develop Leigh’s syndrome due to his preexisting SDHA gene mutations.” Resp’t’s
Preh’g Br. at 15.
The Secretary’s pre-hearing brief argued that the determination that
Trystan’s mutations were pathogenic was sufficient to conclude that Trystan was
destined to develop Leigh’s syndrome. To support this syllogism, he cited the
ACMG guidelines, a source on which both parties relied.
The ACMG proposed that the term “likely pathogenic” be used to
mean “greater than 90% certainty” that the variant is “disease-
causing.” Respondent recognizes that the chance Trystan developing
Leigh syndrome may not be 100%. . . . Nonetheless, Trystan’s
mutations are “pathogenic.” If his mutations were classified as the
lesser “likely pathogenic,” it would mean that based on an evaluation
of all currently available scientific evidence, there is a greater than
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90% chance that they would cause disease. In sum, the ACMG
Guidelines support respondent’s position that the current scientific
evidence demonstrates that Trystan was nearly certainly destined to
develop Leigh’s syndrome due to his preexisting SDHA gene
mutations. Petitioners’ argument that the vaccine in any way altered
Trystan’s actual clinical course is entirely speculation.
Resp’t’s Preh’g Br. at 14-15 (citing exhibit J (Richards) at 11-16).
Dr. Raymond saw the evidence differently from the Secretary. Dr.
Raymond did not argue that the “pathogenic” label was, itself, sufficient to
conclude that there was 90% or greater certainty that Trystan would develop
Leigh’s syndrome based on the mutation. Instead, Dr. Raymond referenced his
“clinical genetic analysis” to conclude that the mutation was 100% penetrant. Tr.
900. More specifically, he said that his opinion was “based upon the information
that we have on the functional consequences of these two alterations seen in
Trystan, as well as based upon the prior clinical experience in Parfait, that this will
result in Leigh's syndrome.” Id. (referencing exhibit 110 (Parfait)). The Parfait
article, and its significance, is discussed in more detail, below.
4. The Sanchezes’ Argument Regarding Trystan’s Clinical Course
The Sanchezes did not dispute that Trystan possessed two pathogenic
mutations in his SDHA gene, mutations that caused his SDH protein to not
function quite correctly. Pet’rs’ Preh’g Br. at 28-29 (“Trystan has two identified
mutations in his SDHA gene, which regulates mitochondrial cellular energy
metabolism. These mutations are pathogenic variants”); see also Tr. 974 (Dr.
Niyazov stating “I do not dispute pathogenicity of that mutation, I do not, because
this is a pathogenic mutation”). Instead, the Sanchezes argue something happened
to Trystan that caused his disease to manifest, resulting in his current pathology.
Pet’rs’ Preh’g Br. at 23. The Sanchezes’ argument that Trystan was okay until he
wasn’t—despite possessing a pathogenic mutation for his entire existence—is
consistent with the medical literature of other mitochondrial disorders as well as
the well-accepted fact that onset of Leigh’s syndrome usually occurs during or
following an intercurrent infection. See exhibit 148 (Rahman); see also section,
V.A, above. These sudden turns for the worse, as reviewed above, are referred to
as decompensating events.
Accordingly, the Sanchezes argue that but for the vaccination, Trystan
would never had turned for the worse or that he would have done so far later in
life. Because later onsets of Leigh’s syndrome are associated with better
outcomes, a later onset could be significant. See exhibit 97 (Kalliopi Sofou et al.,
34

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A Multicenter Study on Leigh Syndrome: Disease Course and Predictors of
Survival, 9 Orphanet Journal of Rare Diseases 52 (2014)) at 5. Dr. Steinman stated
that we might have expected Trystan’s onset of Leigh’s syndrome to have occurred
between 8 and 16 years old. Tr. 350. Dr. Niyazov, on the other hand, opined that
more likely than not, Trystan would not have developed Leigh’s syndrome. Tr.
509.
Dr. Steinman’s argument is founded on Pinard et al. Exhibit 98 (J.M.
Pinard, Syndrome de Leigh et Leucodystrophie par Deficit Partiel en Succinate
Deshydrogenase: Regression sous Riboflavin, 6 Archives Pediatrics 421-26
(1999)).21 In Pinard, the child had Leigh’s syndrome and presented with severe
neurological features at 10 months of age, but then ultimately developed only
moderate psychomotor developmental delays by the age of five. Dr. Steinman
testified that the mutation in Pinard was the “closest” he could get to Trystan’s
mutation. Tr. 335.
As for Dr. Niyazov, he stated that he based his conclusion that Trystan
would not have, more likely than not, developed Leigh’s syndrome—despite his
genetic mutation—on exhibit 79 (Levitas). Dr. Niyazov stated his argument
thusly:
THE WITNESS: More likely than not, he would not have developed
Leigh's, and can I explain why?
SPECIAL MASTER MORAN: Yes.
THE WITNESS: Based on the SDHA mutation that causes Leigh's, he had
less likelihood of developing Leigh's based on the literature that I've
provided, which 15 people who did not develop Leigh's in Levitas' article
are more than any other SDHA related Leigh's ever reported to my
knowledge. It's more than 50 percent there for no, not -- it's more likely than
not he would not have developed it, and I'm talking about SDHA, not
Leigh's in general.
Tr. 509 (referencing exhibit 79 (Levitas)).
5. Resolution of Genetic Cause
The question of Trystan’s clinical genetic course is an incredibly complex
part of what is already a complex case. Little is known with certainty, which partly
21 An English translation of this article was entered as exhibit 100.
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explains how the experts in these cases can be so far apart. For the purpose of this
analysis, the undersigned has divided the arguments into three parts. First, does
the uncontested fact that Trystan had pathogenic mutations make Trystan’s genetic
course certain? Second, was Trystan more likely than not going to develop a
severe mitochondrial disorder in his lifetime? Third, was the course of this
disorder or severity of this disorder predictable on a more likely than not basis?
a) The Significance of the Fact that Trystan’s Mutations
were Pathogenic
As noted above, the Secretary argued that the ACMG guidelines for what is
and is not a pathogenic mutation dictates that because Trystan had a pathogenic
mutation, there was, at least, a 90% chance that Trystan would develop Leigh’s
syndrome.
However, the Secretary’s argument presented in his pre-hearing brief
ignored the distinction between the concepts of pathogenicity and penetrance /
expressivity. While there is not debate that Trystan’s mutations are pathogenic, a
pathogenic genotype does not necessarily guarantee a specific phenotype due to the
phenomena of incomplete penetrance and variable expressivity. See section V.C.1,
above. This distinction between pathogenicity and penetrance / expressivity
constituted a central part of Dr. Niyazov’s opinion. See Tr. 462–96.
To be sure, the ACMG—which the Secretary cites for his conclusion that
pathogenic means that a mutation will cause a disease—also acknowledges the
importance of considering penetrance and expressivity and draws a clear
distinction between pathogenicity determinations and forward-looking conclusions
about a disease course based on the presence of a mutation alone. In fact, the
ACMG expressly disclaims the use of its pathogenicity criterion in making claims
about a patient’s future course. This express disclaimer occurs just pages after the
Secretary’s heavily cited passage:
Caution must be exercised when using these guidelines to evaluate
variants in healthy or asymptomatic individuals or to interpret
incidental findings unrelated to the primary indication for testing. In
these cases the likelihood of any identified variant being pathogenic
may be far less than when performing disease-targeted testing. As
such, the required evidence to call a variant pathogenic should be
higher, and extra caution should be exercised. In addition, the
predicted penetrance of pathogenic variants found in the absence of a
phenotype or family history may be far less than predicted based on
historical data from patients ascertained as having disease.
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Exhibit J (Richards) at 15. Thus, the ACMG guidelines for pathogenicity are
based on disease-targeted testing. In other words, testing that looks back at the
genome after the disease has already been identified in order to see if there is an
identifiable genetic cause. As noted in the text above, the probability that a genetic
mutation will actually cause a disease in a healthy or asymptomatic individual
(e.g., Trystan before the vaccination) “may be far less.” How much less is hard to
tell. Unfortunately, the experts did not address this paragraph of the ACMG
guidelines.
Ultimately, even the Secretary’s own genetics expert acknowledged that the
very fact that a mutation is pathogenic does not guarantee, or even make more
likely than not, a certain disease course. When the undersigned asked Dr.
Raymond how a mutation to the BRCA1 gene would be classified under the
ACMG guidelines—considering the fact that the mutation increases the risk for
breast and ovarian cancer, but does not make development of those cancers
certain—Dr. Raymond acknowledged that it would be a pathogenic mutation, but
not completely penetrant. Tr. 1005-06. Accordingly, the simple argument that
because Trystan’s mutation was pathogenic, his disease course was “destined,”
must be rejected.
b) Penetrance of Trystan’s Mutations
Although the Sanchezes persuasively argued that pathogenicity did not mean
that a mutation will certainly cause a disease, the evidence in the record indicates
that a mutation that causes loss of function in the SDH enzyme will eventually
manifest as a life-altering mitochondrial disease.
As noted before, the Secretary emphasizes the results from Parfait et al.
However, Dr. Raymond’s conclusion of 100% penetrance does not obviously
follow from the Parfait article alone. While exhibit 110 (Parfait) presents the
closest case of a mutation similar to Trystan, it is limited by two important factors.
First, though both Trystan and the child in Parfait had two mutations, the children
only shared one of the mutations. This makes it difficult to account for the effect
of the second, non-shared, mutation on each child’s disease course. Second, the
Parfait article (and Trystan’s own course, for that matter) only represents a single
data point. Case studies, by their nature, do not lend themselves to inferences
about the penetrance of a mutation. This is for, at least, two major reasons. First,
case studies do not draw from a large enough sample to provide meaningful
inferences about the general population. Second, case studies present no
epidemiological value due to the inherent ascertainment bias (i.e., case studies are
not written about individuals with the mutation that are asymptomatic).
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However, Parfait was not the only article in the record that discussed the
prognosis for individuals with pathogenic SDHA mutations. As reviewed above,
the results from Bourgeron, Parfait, Van Coster, Horvath, and Pagnamenta all
stand for the proposition that pathogenic mutations of the SDHA gene are
associated with causing Leigh’s syndrome. As summarized by the most recently
published article, “Pathogenic mutations in the SDHA gene have rarely been
documented in children, and all but one case have been reported in patients with
Leigh’s syndrome.” Exhibit 79 (Levitas) at 2. However, each of these case reports
face the same ascertainment bias that Parfait suffered. These studies do not tell us
about those individuals with SDHA mutations that do not manifest a disease.
Because of the rarity of SDHA mutations, it is difficult or impossible to know
about these individuals.
This concern about ascertainment biases underlined much of Dr. Niyazov’s
argument. The essence of his argument was that individuals with Trystan’s same
mutations—or other mutations that cause loss of function of the SDH enzyme—
can live with no sign of disease. And, because they have no sign of disease, they
are not genetically tested and thus their mutations remain unknown. See Tr. 1003-
04. In support of this conclusion, Dr. Niyazov relied directly on exhibit 79
(Levitas):
Q So was it your testimony that there are people walking around that have
Trystan's SDHA gene mutations that are normal?
A Yes, that's what the Levitas article showed.
Tr. 509-10. However, Dr. Niyazov’s reliance on exhibit 79 (Levitas) to show that
Trystan could have developed normally appears misplaced insofar as the logic
ultimately weighs against the Sanchezes’ argument.
The experts debate the extent to which comparisons can be drawn between
the different SDHA mutations in the different articles. For Dr. Niyazov’s
argument here, he presumes that we can meaningfully apply the findings from
exhibit 79 (Levitas) to someone with Trystan’s specific mutations to his SDHA
gene. That may or may not be true. However, if it is true, the outlook for someone
with Trystan’s mutations is very poor. While the children in exhibit 79 (Levitas)
did not develop Leigh’s syndrome, all but one developed a life-altering
mitochondrial disease.
Of course, Dr. Niyazov is correct in pointing out that the father in exhibit 79
(Levitas) had the homozygous mutation and the loss of function in his SDH protein
but was, by all appearances, healthy. This, as the authors point out, escapes
explanation. However, it represents a curious case and a reminder of the
38

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complexity of clinical genetics. It does not constitute the norm or what can be
expected.
As with most in medicine, very few things are certain. But, on balance, the
evidence favors the conclusion that, for all practical purposes, Dr. Raymond’s
genetic analysis is correct that Trystan’s mutations could be expected to be at least
close to 100% penetrant.
c) Variable Expressivity of Trystan’s Mutations
While the evidence favors that Trystan’s SDHA mutations were nearly
certainly going to manifest as a serious mitochondrial disease, the record
demonstrates that there is substantial room for variable expressivity for mutations
to SDHA. As a result, the Secretary’s argument that there was a set course for
Trystan’s disease cannot be credited entirely.
The variable expressivity of SDHA mutations is easily demonstrated by a
comparison of exhibit 94 (Van Coster), exhibit H, tab 27 (Pagnamenta), and
exhibit 79 (Levitas). All involve individuals with the same homozygous mutations
to c1664 of the SDHA gene. Despite this, as reviewed above, the variations in the
clinical course of the patients differ markedly.
The Secretary argues that the variable expressivity of the c1664 mutation is
irrelevant since Trystan had a different mutation in his SDHA gene. See Tr. 908-
09. However, the Secretary did not adequately explain why one loss-of-function
mutation to the SDHA gene would have extreme variable expressivity while
another would have none at all. It may be true that this is the case, but the
evidence in the record does not appear to support that conclusion. Instead, the
record does support the idea that “environmental factors, such as infection . . . or
other metabolic stress may have contributed to the observed difference in
phenotypes between these two patients.” Exhibit 83 (Pagnamenta) at 7.
Though the Sanchezes’ position that SDHA mutations are variably
expressive must be credited, their argument regarding Trystan’s expected clinical
genetic course was not persuasive. Dr. Steinman’s argument of an onset between
ages 8 and 16 was based on the case of a single case study, exhibit 98 (Pinard).
However, this case study did not appear to reflect the typical expected progression
that was presented in the literature. Furthermore, Dr. Steinman’s argument that the
case study in Pinard was the “closest” genetic match to Trystan’s condition did not
make sense since the patient in Pinard did not have his genome sequenced and thus
the locus of his mutation, even whether it was a SDHA mutation at all, is
unknown. At the same time, Parfait presents a patient with one of Trystan’s exact
39

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mutations and yet Dr. Steinman does not reference it at all in his opinion on the
expected clinical course.
Dr. Niyazov’s testimony regarding Trystan’s expected course was even less
persuasive. He argued that Trystan, more likely than not, would never even had
developed Leigh’s syndrome, citing exhibit 79 (Levitas). To the extent that the
mutation in exhibit 79 (Levitas) can be extended to Trystan’s mutations, the article
also showed that two-thirds of children with the mutation died before the age of
one. Exhibit 79 (Levitas) at 6. Though it may be true that the children were never
diagnosed with Leigh’s syndrome, it is also true that their progression was
considerably worse than Trystan’s. Dr. Niyazov cannot point to exhibit 79
(Levitas) for the proposition that Trystan would not have developed Leigh’s
syndrome while also ignoring the tragic fate of the vast majority of children in that
study.
In contrast, the Secretary’s argument that Trystan’s clinical course is
entirely consistent with what is known about SDHA mutations is persuasive and
must be credited based on the evidence. Trystan’s progression, by all means,
appears typical, if not better, than what would be expected for an individual with a
pathogenic mutation to his SDHA gene. Compare exhibit 97 (Sofou), exhibit H
tab 7 (Bourgeron), exhibit 110 (Parfait), exhibit 94 (Van Coster), exhibit H tab 26
(Horvath), and exhibit 83 (Pagnamenta) with exhibit 140 at 6 (Dr. Haas, Trystan’s
treating physician and an expert in mitochondrial disorders, noting that “Trystan’s
phenotype does not appear to be as severe as he is still able to feed himself at age
6”).
6. Genetics Summary
As noted previously, this decision does not rest on a finding as to what
Trystan’s expected phenotype was based on his genetic mutation. This is for the
very fact that this decision ultimately concludes that preponderant evidence does
not exist to show that Trystan’s course was affected by the vaccination.
For the purpose of preserving the record, the undersigned has examined the
evidence presented by the parties regarding the significance of Trystan’s genetic
mutations on his expected clinical course. The undersigned finds that the Secretary
provided persuasive evidence to show that Trystan’s mutations were expected to
cause serious mitochondrial disease. While the undersigned finds that the type and
course of the mitochondrial disease is extremely variable and allows for worse
outcomes to be potentially attributable to environmental factors—such as a
response to a vaccination—the evidence nonetheless supports the Secretary’s
40

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position that Trystan’s actual course is entirely consistent with what is known
about his genetic mutations.
VI. Conclusion
While the Sanchezes presented sufficient evidence to indicate that Trystan’s
vaccinations could cause the manifestation of Leigh’s syndrome, the evidence does
not support the conclusion that this is what happened to Trystan. Accordingly, the
Sanchezes claim for compensation is DENIED.
The Clerk’s Office is instructed to enter judgment in accord with this
decision.
IT IS SO ORDERED.
s/ Christian J. Moran
Christian J. Moran
Special Master
41

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_11-vv-00685-2
Date issued/filed: 2019-03-06
Pages: 17
Docket text: JUDGE VACCINE REPORTED OPINION re: 217 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Patricia E. Campbell-Smith. (TQ) Service on parties made.
--------------------------------------------------------------------------------
Case 1:11-vv-00685-EDK Document 219 Filed 03/06/19 Page 1 of 17
In the United States Court of Federal Claims
No. 11-685V
(E-Filed: March 6, 2019)1
)
TRYSTAN SANCHEZ, by and )
through his parents, GERMAIN and )
JENNIFER SANCHEZ, )
)
Vaccine; National Childhood Vaccine
Petitioners, )
Injury Act of 1986, 42 U.S.C.
)
§§ 300aa-1 to -34 (2012); Deferential
v. )
Review of the Special Master’s Fact
)
Finding and Weighing of the Evidence.
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
Lisa A. Roquemore, Rancho Santa Margarita, CA, for petitioners.
Jennifer L. Reynaud, Trial Attorney, with whom were Joseph H. Hunt, Assistant
Attorney General, C. Salvatore d’Alessio, Acting Director, Catherine E. Reeves, Deputy
Director, Heather L. Pearlman, Assistant Director, Torts Branch, Civil Division, United
States Department of Justice, Washington, DC, for respondent.
OPINION AND ORDER
CAMPBELL-SMITH, Judge.
1 Pursuant to Rule 18(b) of the Vaccine Rules of the United States Court of Federal
Claims (Appendix B to the Rules of the United States Court of Federal Claims), this
opinion was initially filed under seal on February 11, 2019. Pursuant to ¶ 4 of the
ordering language, the parties were to propose redactions of the information contained
therein on or before February 25, 2019. No proposed redactions were submitted to the
court.

Case 1:11-vv-00685-EDK Document 219 Filed 03/06/19 Page 2 of 17
On November 8, 2018, petitioners filed a motion for review of the special master’s
decision of October 9, 2018. See ECF No. 207. Petitioners were granted leave to exceed
the page limit for their motion. ECF No. 211 (order). Respondent filed its response brief
on December 7, 2018. ECF No. 213. Petitioners were granted leave to file a reply brief
not contemplated by this court’s rules, ECF No. 215 (order), which was docketed on
December 17, 2018, ECF No. 216. Petitioners’ request for oral argument, however, is
denied because no further development of the parties’ arguments is required. Petitioners’
motion is fully briefed and ripe for decision.
Like the parties, the court will cite to the special master’s entitlement decision as it
appears on the docket of this case, ECF No. 205, rather than to the decision available on
Westlaw, see Sanchez v. Sec’y of Health & Human Servs., No. 11-685V, 2018 WL
5856556 (Fed. Cl. Spec. Mstr. Oct. 9, 2018). The special master denied petitioners
compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.
§§ 300aa-1 to -34 (2012) (the Vaccine Act). As explained below, the special master’s
entitlement decision survives this court’s review. Accordingly, the court must DENY
petitioners’ motion.
I. Background
As the special master explained in his opinion, in late 2014 Trystan Sanchez was
diagnosed as having Leigh’s syndrome, a mitochondrial disorder which, in his case, was
directly related to two inherited genetic mutations. ECF No. 205 at 10, 15-16. As
summarized by the special master, petitioners argued that the vaccinations that Trystan
received on February 5, 2009, at the age of six months, “either caused his genetic
condition to be expressed or, alternatively, significantly aggravated the course of his
disease.” Id. at 17. Trystan’s symptoms of Leigh’s syndrome include “developmental
delays[,] . . . dystonia and seizures.” Id. at 10.
The special master ruled that petitioners did not establish that Trystan’s health
“declined in an appropriate temporal window” so as to satisfy “the requirement of
establishing but-for causation.” Id. at 17 n.12. Petitioners’ challenge to the special
master’s decision is multi-faceted. Some of the criticism levied against the special master
could be described as procedural in nature, where petitioners allege that the special
master did not employ a fair procedure for the assessment of the evidence before him.
Another set of petitioners’ arguments focuses more on the special master’s conclusions as
to the merits of the petition.
The court believes that its review, in these circumstances, must address procedural
aspects of the special master’s deliberations before turning to the special master’s
conclusions as to vaccine injury causation. The court reserves its brief discussion of
Trystan’s relevant medical history, which is controverted, for the causation analysis
section of this opinion. First, however, the court addresses the standard of review for the
entitlement decisions of special masters in this court’s Vaccine Program.
2

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II. Standard of Review
This court has jurisdiction to review the decision of a special master in a Vaccine
Act case. 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal
Claims reviews the decision of the special master to determine if it is ‘arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008) (quoting 42
U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of Health & Human Servs., 418
F.3d 1274, 1277 (Fed. Cir. 2005)) (alteration in original). This court uses three distinct
standards of review in Vaccine Act cases, depending upon which aspect of a special
master’s judgment is under scrutiny:
These standards vary in application as well as degree of deference.
Each standard applies to a different aspect of the judgment. Fact findings are
reviewed . . . under the arbitrary and capricious standard; legal questions
under the “not in accordance with law” standard; and discretionary rulings
under the abuse of discretion standard.
Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.
1992).
The third standard of review, abuse of discretion, is applicable when the special
master excludes evidence or otherwise limits the record upon which he relies. See id. As
this court has stated, the third standard applies to the special master’s evidentiary rulings.
Stillwell v. Sec’y of Health & Human Servs., 118 Fed. Cl. 47, 55 (2014) (citation
omitted), aff’d, 607 F. App’x 997 (Fed. Cir. 2015). Determinations subject to review for
abuse of discretion must be sustained unless “manifestly erroneous.” Piscopo v. Sec’y of
Health & Human Servs., 66 Fed. Cl. 49, 53 (2005) (citations omitted); see also Milmark
Servs., Inc. v. United States, 731 F.2d 855, 860 (Fed. Cir. 1984) (holding that decisions
that lie within the trial court’s discretion are to be sustained unless “manifestly
erroneous”) (citation omitted).
III. Analysis
A. Challenges to Procedural Aspects of the Special Master’s Decision-Making
1. The 2009 Day Planner
One of the peculiarities of this case is that Trystan’s medical condition was not
accurately diagnosed until late 2014, years after the Vaccine Act petition was filed by his
parents. ECF No. 205 at 10. By this time, both parties had filed a number of expert
reports. See ECF Nos. 47, 52, 54, 65-67, 77. Also by this time, the special master had
conducted a one-day evidentiary hearing focusing on events occurring in 2009, from the
3

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time of Trystan’s vaccinations, at six months of age, through his one-year check-up. ECF
Nos. 28, 33.
As the special master repeatedly delayed a four-day entitlement hearing in this
matter due to an ever-evolving evidentiary record, he also ordered the filing of Mrs.
Sanchez’s “baby journal” and 2009 “day planner.” ECF No. 105 at 3 (order). Both
Trystan’s baby book and Mrs. Sanchez’s 2009 day planner were filed on December 12,
2014. ECF No. 107. One of petitioners’ arguments is that the day planner, ECF No.
107-6, contained relevant evidence and that the special master did not consider this
evidence when he denied their petition. ECF No. 207 at 8; ECF No. 216 at 16.
As respondent observes, however, petitioners failed to point to the significance of
the day planner and its contents in their brief filed prior to the four-day entitlement
hearing, and failed to elicit any testimony regarding the day planner during that hearing.
ECF No. 213 at 22. Two and a half years after the day planner was filed, petitioners’
brief did not argue that the day planner supported their entitlement to compensation under
the Vaccine Act. See ECF Nos. 107-6, 173. Further, the day planner was not cited in
any of the expert reports filed after the day planner was entered into the record of this
case, nor was it referenced in expert testimony at the four-day hearing. ECF No. 213 at
22.
Petitioners cannot now argue that the special master ignored their arguments that
the day planner contained significant evidence supporting their entitlement to
compensation under the Vaccine Act, because no such arguments were made during the
phase of this litigation that addressed entitlement. Nor did petitioners introduce the day
planner as evidence during the earlier phase of this litigation that addressed events
occurring in 2009.2 There is no error or abuse of discretion in the special master’s
consideration of the voluminous evidence in the record of this case, such as the day
planner, that was not argued by petitioners to be significant or relevant. Further, even if
petitioners had timely relied on the contents of the day planner, the court agrees with
respondent, id. at 22-23, that the day planner does not undermine the rationality of the
special master’s weighing of all of the evidence in this case relevant to Trystan’s health
in 2009.3
2 Respondent notes that petitioners did not voluntarily file the day planner, but did
so only upon order of the special master, well after the special master had ruled upon the
facts relevant to events occurring in 2009. ECF No. 213 at 21-22. Respondent also notes
that petitioners did not seek any revision of the special master’s fact-finding rulings,
issued in 2013, based on the day planner’s contents, filed in 2014. Id. at 22.
3 In their reply brief, petitioners argue, for the first time, that the special master’s
directives regarding his Ruling Finding Facts, ECF No. 45, discouraged reliance on
evidence that might not conform with his fact-finding. ECF No. 216 at 13. To the extent
4

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2. Differences between the Parties’ Joint Statement of Facts and the
Special Master’s Ruling Finding Facts
Petitioners argue that the special master improperly failed to adopt the parties’
recitation of the relevant facts occurring in 2009 when he made findings of fact regarding
that period of time. In this regard, petitioners state that the special master “disregarded
many critical facts” identified by the parties, that these critical facts were “largely
ignored,” and that this practice led to “discrepancies” between the facts stated by the
parties and the facts found by the special master. ECF No. 207 at 7-8. Although the
court acknowledges that the special master’s directives as to the parties’ creation of a
joint statement of facts were less than perfectly clear, the court cannot agree with
petitioners that the special master’s fact-finding as to the events occurring in 2009 was
procedurally improper, unfair, arbitrary or capricious, contrary to law, or an abuse of
discretion.
After the one-day hearing was held with its focus on events occurring in 2009, the
special master directed the parties to each produce “proposed findings of fact,” and to
exchange these documents.4 ECF No. 31 (order). As this process reached fruition,
petitioners referenced the upcoming filing of a “(Proposed) Joint Statement of
Uncontroverted Facts.” ECF No. 39. The special master’s next order set a deadline for
the filing of the parties’ “Proposed Joint Statement of Uncontroverted Facts.” ECF No.
40.5
that this cursory argument constitutes an attempt to raise an additional ground to set aside
the special master’s entitlement decision, this argument is untimely raised and waived.
See, e.g., Arakaki v. United States, 62 Fed. Cl. 244, 246 n.9 (2004) (“The court will not
consider arguments that were presented for the first time in a reply brief or after briefing
was complete.” (citing Novosteel SA v. United States, 284 F.3d 1261, 1274 (Fed. Cir.
2002); Cubic Def. Sys., Inc. v. United States, 45 Fed. Cl. 450, 467 (1999))).
4 The written record does not capture the full content of a great number of
conference calls that the special master held with the parties. Thus, not every nuance of
the instructions given to the parties is available for the court’s review. In addition, the
special master directed the parties to present any questions to his law clerk and offered a
telephone number for this purpose. E.g., ECF No. 31 at 1. The record does not indicate
whether questions were asked of the law clerk, nor does the record memorialize any
instructions to the parties provided by the special master’s law clerk.
5 The first occurrence of the terms “Joint” and “Uncontroverted” within the title for
the upcoming filing appear in documents drafted and filed by petitioners. Compare ECF
Nos. 36, 39, with ECF Nos. 31, 37, 38.
5

Case 1:11-vv-00685-EDK Document 219 Filed 03/06/19 Page 6 of 17
The document was eventually filed. See ECF No. 43. The parties’ statement of
facts was sometimes referred to as a proposed joint statement of uncontroverted facts, but
was also referenced as the parties’ joint statement of uncontroverted facts. See ECF Nos.
43 at 1; ECF No. 44 at 1-2. Aside from any ambiguities in the title of the document, the
status or purpose of the document submitted by the parties for the special master’s review
is somewhat unclear. The court, for ease of reference, will refer to this document, ECF
No. 43, as the parties’ Joint Statement of Facts.
The court notes, first, the absence of the term “stipulation” in the title of the
document. The court cannot agree with petitioners’ view that this document constituted,
in effect, a Joint Stipulation of Facts. See ECF No. 207 at 7 & n.1 (using the term
“Stipulated Facts” to describe the parties’ Joint Statement of Facts, and discussing
“stipulations” as an example of a judicial admission); ECF No. 216 at 5-6 (contending
that the parties had stipulated to certain facts in their Joint Statement of Facts). As
respondent points out, many of the facts submitted in the Joint Statement of Facts are
controverted by respondent through the Secretary’s commentary in the footnotes of this
document, which address the lack of documentary evidence that might support certain
“proposed facts.” ECF No. 213 at 8 n.4. The court notes that of the 36 paragraphs of
factual allegations in the parties’ Joint Statement of Facts, 12 contain one or two
footnotes explaining why respondent did not support the inclusion of certain statements
of fact as proposed, relevant facts. See ECF No. 43 at 2-8, 11-12. Whatever the purpose
of the document jointly filed by the parties, the court does not consider it to be a joint
stipulation of facts.
Petitioners argue that the special master “disregarded” or “ignored” certain
pronouncements in the parties’ Joint Statement of Facts when he issued his Ruling
Finding Facts on April 10, 2013, and his entitlement decision on October 9, 2018. ECF
No. 207 at 7, 21, 43. In their view, the special master’s practice evidenced “predisposed
fact-finding.” Id. at 22. In their reply brief, petitioners state that the special master
“changed the facts.” ECF No. 216 at 6. In addition, petitioners argue that the special
master inserted controversy, in some instances, where there was none. Id. at 7.
As petitioners acknowledge, the special master incorporated some of the parties’
Joint Statement of Facts into his Ruling Finding Facts. Id. at 6 n.1. The crux of their
challenge to the special master’s Ruling Finding Facts, ECF No. 45, is that some of his
fact-finding does not give credence to representations of fact that are present either in the
parties’ Joint Statement of Facts or in Mrs. Sanchez’s 2009 day planner. ECF No. 207 at
10-13.
The court has reviewed both the parties’ Joint Statement of Facts and the special
master’s Ruling Finding Facts. The differences between these two recitations of fact
largely reflect the special master’s greater reliance on contemporaneous medical records
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and lesser reliance on the testimony provided by Sanchez family members.6 This type of
weighing of the evidence is sanctioned by binding precedent cited by the special master.
ECF No. 45 at 3 (citing Cucuras v. Sec’y of Dep’t of Health & Human Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993)). Because the special master’s Ruling Finding Facts is
neither arbitrary nor capricious in its content, and is not procedurally infirm, petitioners’
motion for review cannot succeed on this ground.7
The court observes, however, that the special master’s request for proposed
findings of facts from the parties, and his directive that a Proposed Joint Statement of
Uncontroverted Facts be filed, might mislead the parties in a future Vaccine Act case into
an attempt to produce a Joint Stipulation of Facts to which the parties would be bound.
Petitioners here cite caselaw that calls into question a court’s fact-finding that does not
adopt stipulated facts filed by the parties in a case before that court. See ECF No. 216 at
7-9 (citing authorities). If the special master intends to issue fact-findings that may not
adopt separately filed proposed findings of fact, and which also may not adopt jointly
filed proposed findings of fact, that intention is best communicated to the parties through
written orders in the record.
B. Challenges to the Special Master’s Causation Analysis
Petitioners attack the special master’s causation analysis on a number of fronts.
The court discerns five principal allegations of error in the motion for review, which are
addressed below.8 The court notes, however, that many of petitioners’ arguments about
6 The special master also noted that the mere citation of witness testimony was
unhelpful because it did not address “the truth of the underlying assertion” of fact. ECF
No. 45 at 2 n.1 (citing ECF No. 43 at 6).
7 Petitioners also allege that the special master was not always consistent in his
fact-finding regarding the events that occurred in 2009, when his Ruling Finding Facts is
compared to his entitlement decision. See ECF No. 216 at 6-7. The court finds that the
differences between the fact-finding in these two documents do not undermine the
entitlement decision’s analysis or conclusions. The differences reflect an evolution in the
special master’s understanding of the factual backdrop of this case. See infra.
8 The court does not address a number of minor criticisms of the special master’s
causation analysis in petitioners’ lengthy motion for review. As the Federal Circuit has
held, when “the special master’s conclusion was based on evidence in the record that was
not wholly implausible, we are compelled to uphold that finding as not being arbitrary or
capricious.” Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1363 (Fed. Cir.
2000). The court has considered all of petitioners’ arguments, but this special master’s
entitlement decision cannot be disturbed under the deferential standard of review
applicable here.
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causation present the undersigned with an invitation to reweigh the evidence before the
special master. This reviewing court “does not reweigh the factual evidence or assess
whether the special master correctly evaluated the evidence, nor does it examine the
probative value of the evidence.” Porter v. Sec’y of Health & Human Servs., 663 F.3d
1242, 1254 (Fed. Cir. 2011). Instead, the court must defer to the fact-finding role of the
special master.
For general guidance, the court cites here a few of the pertinent facts found by the
special master in his entitlement decision. Some of these facts are disputed by
petitioners, but the special master’s fact-finding provides a necessary framework for the
causation analysis reviewed here. The focus of petitioners’ disagreement with the special
master’s fact-finding is on the six-month period after Trystan received vaccinations on
February 5, 2009.
Trystan had an adverse reaction to the vaccinations, including fever. ECF No. 205
at 3. Over the next few months, he had colds, but was “neurologically normal.” Id. By
the beginning of May 2009, at the earliest, “Trystan first started showing signs of loss of
skills.” Id. at 8. Neurological problems were detected at a doctor’s visit on October 7,
2009. Id. at 9. It was not until late 2014 that Trystan was diagnosed with Leigh’s
syndrome. Id. at 10.
The court turns now to petitioners’ allegations of error in the special master’s
causation analysis.9
1. Challenge-Rechallenge Theory of Causation
Petitioners point to an alleged error in the special master’s causation analysis,
complaining that it “is oddly silent on the issue of challenge-rechallenge.” ECF No. 207
at 38. In petitioners’ view, the special master “disregard[ed] the evidence of ‘challenge-
rechallenge.’” Id. Petitioners argue that this portion of their theory of causation, which
focused on a second set of vaccinations given to Trystan on August 17, 2009, was “fully
briefed,” was the subject of expert reports and expert testimony, and was supported by
notations in Trystan’s medical records.10 Id. at 38-42. Because petitioners allege that the
9 Previously addressed allegations of error, such as petitioners’ criticism of the
differences between the special master’s Ruling Finding Facts and the parties’ Joint
Statement of Facts, will not be addressed again here. That procedural aspect of the case,
the court recognizes, is inextricably bound up with the entitlement decision’s causation
analysis. The Ruling Finding Facts was not erroneous, either as the procedural follow-up
to the one-day hearing and the parties’ Joint Statement of Facts, or as an example of the
special master’s weighing of the evidence before him.
10 Fully briefed may not be an apt description. The challenge-rechallenge section of
petitioners’ pre-hearing brief is not identified as such in the table of contents, and
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special master’s fact-finding as to the evidence of challenge-rechallenge was flawed, their
burden is to show that the omission of any discussion of the challenge-rechallenge aspect
of their theory of causation was arbitrary or capricious. Munn, 970 F.2d at 870 n.10.
The court has reviewed both the special master’s entitlement decision, ECF No.
205, and his Ruling Finding Facts, ECF No. 45. The entitlement decision is clearly
founded on the findings of fact issued by the special master five years earlier. See ECF
No. 205 at 6 (stating that the Ruling Finding Facts would be “briefly reviewed” in the
entitlement decision); id. at 7-8 (citing six pages of the Ruling Finding Facts); id. at 11
(again mentioning the Ruling Finding Facts). The Ruling Finding Facts shows that the
special master considered evidence of adverse symptoms related to Trystan’s second set
of vaccinations, but considered them to be less persuasive than contemporaneous medical
records. See ECF No. 45 at 15 n.11. Because the special master weighed the relevant
evidence of rechallenge symptoms, and found the evidence to be unpersuasive, it was not
error for the special master to also find petitioners’ expert testimony as to rechallenge to
be so unpersuasive as to be unworthy of mention in his entitlement decision. See ECF
No. 205 at 11 n.7 (noting that the special master had considered all expert reports,
although his decision could not discuss each of the many expert reports filed in this case).
The special master’s entitlement decision is thorough, detailed and well-reasoned.
There is no indication that the special master ignored any significant evidence provided
by petitioners. Even though the specific facet of petitioners’ causation theory that relied
on rechallenge symptoms occurring after Trystan’s second set of vaccinations was not
mentioned by the special master, he had already found that such symptoms probably did
not occur.11 For this reason, the causation analysis in the entitlement decision has not
been shown to be arbitrary or capricious. See Milik v. Sec’y of Health & Human Servs.,
822 F.3d 1367, 1382 (Fed. Cir. 2016) (affirming a special master’s denial of
compensation in a Vaccine Act case because “the special master thoroughly reviewed all
of the relevant evidence, including the expert witnesses’ testimonies and reports”).
2. Evidence of Neurodegeneration
Petitioners argue that the evidence of Trystan’s neurodegeneration in 2009, as
interpreted by their experts, shows that Trystan’s vaccine-related injury occurred within
occupies only 3 pages in a narrative of approximately 60 pages. See ECF No. 173 at
44-46.
11 As this court has held, a special master’s written decision, created pursuant to the
streamlined procedures of the Vaccine Program, need not address “every argument”
raised by a party. Doe/17 v. Sec’y of Health & Human Servs., 84 Fed. Cl. 691, 704 n.18
(2008) (citing Bradley v. Sec’y of Dep’t of Health & Human Servs., 991 F.2d 1570, 1576
(Fed. Cir. 1993)).
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an acceptable time frame. ECF No. 207 at 32-34. Respondent contends that the record
evidence of neurodegeneration does not support an earlier date of disease onset than the
date of onset found by the special master. ECF No. 213 at 23-25. The court declines
petitioners’ invitation to reweigh the evidence as to disease onset. See Porter, 663 F.3d at
1254 (noting that the reviewing court does not reweigh the evidence of record). Nothing
in the allegations of fact or expert opinions cited by petitioners shows that the special
master’s findings as to disease onset were arbitrary or capricious.
3. Precedential Guidance in Paluck II
Petitioners extensively rely on Paluck v. Sec’y of Health & Human Servs., 786
F.3d 1373 (Fed. Cir. 2015) (Paluck II), and the underlying decision from this court,
Paluck v. Sec’y of Health & Human Servs., 113 Fed. Cl. 210 (2013) (Paluck I), aff’d, 786
F.3d 1373 (Fed. Cir. 2015), for two related but distinct arguments. Petitioners’ first
argument is that the Federal Circuit’s analysis of relevant scientific articles, and the
appeals court’s conclusions about the timing of the onset of mitochondrial diseases, are
binding in this case. See ECF No. 207 at 29 (citing Paluck II, 786 F.3d at 1383-84).12
Petitioners’ second, broader argument is that the special master in this case adopted an
analytical approach for Althen Prongs II and III that was specifically rejected in Paluck
II.13 See id. at 30 (citing Paluck II, 786 F.3d at 1382-84). Neither of these arguments is
persuasive.
The court turns first to the question of whether Paluck II dictates a finding of
entitlement to Vaccine Act compensation in this case. It does not. As respondent makes
clear, there are evidentiary differences between the record in this case and the record
discussed in Paluck II. ECF No. 213 at 25-26. The Federal Circuit has held that where
evidentiary records are “significantly different,” the causation analyses in Vaccine Act
cases may be different, and may produce different results. See Moberly ex rel. Moberly
v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1325 (Fed. Cir. 2010) (noting that
the causation proved in Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569
F.3d 1367 (Fed. Cir. 2009), did not compel a finding of causation in Moberly). Applying
the precedent in Moberly to this case, petitioners have not shown that the evidentiary
12 Petitioners incorrectly cite to pages 1390 and 1391 of the reporter; the relevant
section of Paluck II is found on pages 1383 and 1384.
13 The Althen Prong II might be succinctly described as the question of whether the
vaccine was the “reason” for this illness in this child, and the Althen Prong III might be
described as the question of whether the onset of the symptoms of the illness occurred
within an appropriate time frame after the vaccination. Althen, 418 F.3d at 1278; see also
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006).
10

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record in this case is so similar to that of Paluck II that the special master was compelled
to find that Trystan’s vaccinations caused or significantly aggravated his health problems.
Turning to petitioners’ second argument, they argue that the special master’s
approach to Althen Prongs II and III in his entitlement decision was specifically rejected
in Paluck II. The court cannot agree. First, the court observes that the Federal Circuit in
Paluck II rejected an entitlement decision because the special master’s decision contained
many flaws:
Where, as here, a special master misapprehends a petitioner’s theory of
causation, misconstrues his medical records, and makes factual inferences
wholly unsupported by the record, the Court of Federal Claims is not only
authorized, but obliged, to set aside the special master’s findings of fact and
conclusions of law.
Paluck II, 786 F.3d at 1380. The rejection of the special master’s causation analysis in
Paluck II was based on a number of flaws not present here.
The court has reviewed the analysis before it and does not find that the special
master, here, misunderstood the theories of causation presented by petitioners. Nor does
the court find that the special master misconstrued Trystan’s medical records. Finally,
the court cannot conclude that the special master’s fact-finding was “wholly unsupported
by the record.” Paluck II, 786 F.3d at 1380. For these reasons, the special master’s
entitlement decision, as a whole, is unlike the decision rejected by the Federal Circuit in
Paluck II, and cannot be reversed simply because there are some similarities between the
analytical framework utilized in these two Vaccine Act cases.
As for the Althen Prong III analysis in these two cases, they are not exactly the
same. In Paluck II, the special master defined the appropriate time frame for the onset of
symptoms to be within twenty-one days. 786 F.3d at 1383-84. Given the evidence
before the special master in that case, the Federal Circuit held that he had no “reasonable
basis” for choosing twenty-one days as the limit for the appropriate time frame, or that
twenty-three days would be too late to fall within the appropriate time frame. Id. Here,
as respondent points out, there was an entirely different evidentiary record, and the
special master did not state that the appropriate time frame window closed twenty-one
days after vaccination. ECF No. 213 at 25-26.
Petitioners acknowledge that the special master, here, did not state that he had
established a hard and fast deadline for the appearance of symptoms, so as to satisfy
Althen Prong III. ECF No. 207 at 29 (citing ECF No. 205 at 26). Indeed, the special
master relied, instead, on the principle that “as the post-vaccination interval extends
beyond two weeks, the likelihood that the [decline in health] is attributable to a reaction
to the vaccine, as opposed to another cause, drops.” ECF No. 205 at 26 (citing Pafford v.
Sec’y of Health & Human Servs., 451 F.3d 1352, 1358 (Fed. Cir. 2006)). Because the
11

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special master did not use the temporal measure that was faulted in Paluck II, the decision
in Paluck II does not compel a finding here that the special master employed an
inappropriate Althen Prong III analysis.
Finally, petitioners argue that their expert testimony conforms with the type of
proof that was accepted for Althen Prong III in Paluck II. ECF No. 207 at 30-31. The
court need not decide whether the expert testimony cited by petitioners is analogous to
the expert testimony in the record discussed in Paluck II. The special master here was
obliged to consider all of the evidence before him and to weigh that evidence. See, e.g.,
Moriarty by Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1330 (Fed. Cir.
2016) (stating that the Vaccine Act “requires the special master to consider all relevant
medical and scientific evidence of record”). The special master found that two of
petitioners’ experts relied on factual assumptions that were inconsistent with Trystan’s
medical records. ECF No. 205 at 23 n.17. In his role as fact-finder, the special master
concluded that the expert opinions as to neurodegeneration relied upon by petitioners
were unpersuasive. Id. Although some of the evidence in this case may be reminiscent
of the evidence discussed in Paluck II, the court sees no error in the special master’s
weighing of the evidence in this case.14
4. Petitioners’ Analysis of Colds and Infections Criticized
Petitioners also argue that the special master incorrectly found their expert
testimony to be inadequate on the topic of the possible impact of Trystan’s colds and
other infections on his decline in health. ECF No. 207 at 37-38 (citing ECF No. 205 at
28 & n.20). That section of the entitlement opinion states that petitioners’ “inability, or
failure, to address a conspicuous and probable alternate cause for the manifestation of
Trystan’s Leigh’s syndrome weighs against a finding that the vaccination caused
Trystan’s injury.” ECF No. 205 at 28. It may be that the terms “inability” and “failure”
are somewhat harsh, but it is clear that the special master viewed the arguments presented
by petitioners on this topic to be inconsequential and inadequately persuasive.
Petitioners cite to the record to show that their experts did discuss colds and
infections to some extent. ECF No. 207 at 38. The court does not find, however, that the
special master’s characterization of this testimony as a “failure[] to address” alternative
causation was arbitrary or capricious. ECF No. 205 at 28. Further, even if the special
master had erred in his weighing of the expert testimony as to alternative causation, a
proposition with which the court cannot agree, he specifically stated that his entitlement
14 Similarly, the court cannot reweigh the evidence which petitioners cite in an effort
to establish a longer temporal window for the Althen Prong III analysis required in this
case. See ECF No. 207 at 30 n.30 (stating that their expert posited that 2-3 months was
an appropriate window for neurodegeneration after vaccination); ECF No. 216 at 16
(same).
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decision did not depend on the evidence of alternative causation, but on an “independent”
assessment of petitioners’ evidence of causation. Id. at 28 n.20. Therefore, the error
alleged by petitioners here would be a harmless error, in any case, because the special
master’s causation analysis, which focused on Althen Prongs II and III, has not been
shown to be erroneous.
5. Arm Contortions as a Cold Symptom
Petitioners’ final challenge to the special master’s entitlement ruling focuses on
his characterization of Trystan’s arm contortions on or about February 15, 2009, as being
typical of “an infant suffering from a cold.” ECF No. 205 at 7. According to petitioners,
the evidence before the special master “does not remotely indicate that the arm
contortions were consistent with a cold.” ECF No. 207 at 25. The special master’s
assessment of the evidence of Trystan’s health from February 15-17, 2009, did evolve
over time, but his fact-finding in this regard rationally supports the causation analysis
presented in the entitlement decision.
The backdrop for the special master’s recitation of facts is the presence of two
types of information in the record--that provided by Trystan’s family, and that provided
by contemporaneous medical records. As noted earlier in this opinion, the special master
favored the written records preserved by Trystan’s medical providers over oral testimony
or written allegations provided later by the Sanchez family. See, e.g., Ruling Finding
Facts, ECF No. 45 at 3-5, 8-10. The court notes that the events of February 15-17, 2009,
were established by a combination of these two types of evidence.
There is no dispute that February 15, 2009, was Mrs. Sanchez’s birthday. As
noted in the parties’ Joint Statement of Facts, Trystan fell ill beginning on that day. ECF
No. 43 at 4. He continued to be ill the next day, February 16, 2009. Id. at 4-5. Trystan
was brought to a pediatrician on February 17, 2009, where he was diagnosed with a
common cold and viral syndrome. Id. at 5. The parties disputed the evidence as to what
symptoms were reported at the pediatrician’s office. Id. at 5 n.4.
In his Ruling Finding Facts, the special master made a number of findings
regarding these three days, and Trystan’s health in the next few months. The special
master found that on February 15, 2009, Trystan had a fever and was congested. ECF
No. 45 at 12. During the night of February 16, 2009, Trystan had a worsening fever, a
stuffy nose, and was “jerking around” in his father’s arms. Id. On the morning of
February 17, 2009, Trystan was diagnosed at the pediatrician’s office with a cold and
viral syndrome, and Mrs. Sanchez reported that Trystan had been “coughing, congested,
[and] with fever.” Id. at 13.
Most significantly, the special master’s review of the evidence, including the
parents’ allegations of fact, determined that no report of “unusual arm movements” was
given to the medical staff on February 17, 2009, and that Trystan was not having arm
13

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contortions at this time. Id. The special master also found that no reports of arm
contortions were given to a medical provider on April 29, 2009, and that no arm
contortions had occurred between February 15, 2009 and April 29, 2009. Id. In his
interim fees decision issued almost three years later, which cited his Ruling Finding
Facts, the special master summarized his findings regarding Trystan’s arm contortions
and stated that these did not begin until August 2009. ECF No. 135 at 8 (citing ECF No.
45 at 13-15).
In his entitlement decision, however, there is a revised recitation of facts
pertaining to cold symptoms and arm movements occurring during those three days in
February 2009, in a section which “briefly reviewed” his Ruling Findings Facts. ECF
No. 205 at 6. On one hand, the special master, diverging from his Ruling Finding Facts,
notes that Trystan’s “arms contorted and he was jerking around” on or about February 15,
2009. Id. at 7. On the other hand, as in the Ruling Finding Facts, the special master
asserts that only cold symptoms, not neurological symptoms, were either reported to or
observed by the medical staff at the pediatrician’s office on February 17, 2009. Id.
Again, as in the Ruling Finding Facts, the special master found that no neurological
symptoms occurred between February 17, 2009 and April 29, 2009, and that no reports of
neurological symptoms, as opposed to cold symptoms, were reported to the doctor
consulted on the latter date. Id. at 8.
The differences between the special master’s Ruling Finding Facts and his
entitlement decision’s recitation of facts are not explained.15 It appears that the special
master was, over time, more receptive to the parents’ testimony as to arm contortions
occurring in mid-February 2009 by the time he wrote the entitlement decision, but wished
to specify that these manifestations were consistent with cold symptoms, not neurological
problems. Thus, where arm contortions in February 2009 were found not to have
occurred, in the Ruling Finding Facts, they are specifically mentioned in the entitlement
decision as having occurred in February 2009.
In his entitlement decision, despite the occurrence of arm contortions in February
2009, the special master concluded that no neurological symptoms were experienced in
February, March and April 2009, because no such symptoms had been reported by
Trystan’s parents to treating physicians or other medical professionals in this time period.
ECF No. 205 at 7-8. Further, based on his reading of all of the evidence, the special
master revised his finding of fact regarding the onset of symptoms of Leigh’s syndrome,
stating that these occurred at the beginning of May 2009, at the earliest. Id. at 8 & n.3.
The relatively minor adjustments to the special master’s recitation of facts, over the
15 In another instance, the entitlement decision explains why a finding of fact was
changed from the finding on the same issue in the Ruling Finding Facts. See ECF No.
205 at 8 & n.3 (changing the onset of symptoms from a possible range of May 17, 2009
through June 17, 2009, to the beginning of May 2009, at the earliest).
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course of several years of litigation, are not irrational or arbitrary, in the court’s view.
Despite these two revisions to his understanding of Trystan’s health in the first half of
2009, the special master consistently derived reasonable inferences from the record
before him.
As for petitioners’ contention that the special master could not have found that
Trystan’s arm contortions in February 2009 should be attributed to cold symptoms, as
opposed to neurological symptoms, the record, instead, plausibly supports the special
master’s finding. As respondent points out, the cold and viral syndrome diagnosis for
Trystan’s illness during this time period is documented in Trystan’s medical records.
ECF No. 213 at 20. As respondent argues, the special master derived “plausible
inferences” from these medical records, and testimony provided at the four-day
entitlement hearing, to conclude that the arm contortions exhibited by Trystan in
mid-February 2009 were consistent with cold symptoms, and not indicative of
neurological symptoms. Id. at 21.
In their reply brief, petitioners argue that nothing in the hearing transcript pages
cited by respondent could support the special master’s finding that Trystan’s arm
contortions were mere cold symptoms. ECF No. 216 at 12. Indeed, petitioners
characterize the special master’s fact-finding in this regard as an “impermissible
inference.” Id. The transcript pages cited by the parties are indeed relevant to this
dispute.
An expert in pediatrics and pediatric immunology testified at the four-day
entitlement hearing. ECF No. 201 at 41-42 (transcript). The following exchange
occurred:
Q. Do you believe the fever Trystan had eleven days after his February
5th, 2009 vaccination was a reaction to the vaccine?
A. I do not.
Q. And why is that?
A. Well, the [vaccine] reaction . . . would not be expected to persist for
that long, and there is nothing in the record that I could find, either from the
testimony of the Sanchez family or anything from the medical record itself,
that would suggest that it was other than a separate event.
Added to that is the findings, both the description of the family of
what symptoms the boy had, and the findings of Mr. Luna [at the
pediatrician’s office] when they sought medical care on the 17th of February,
were consistent with an upper respiratory infection.
15

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ECF No. 201 at 44-45. Because respondent’s expert testified that the symptoms
described by the Sanchez family, which according to their testimony included arm
contortions, were consistent with an upper respiratory infection, it was not an
impermissible inference for the special master to conclude that any arm contortions
exhibited by Trystan in mid-February 2009 should be characterized as cold symptoms,
not neurological symptoms.
There was further testimony from another expert who specifically addressed the
question of neurological symptomology before June 1, 2009, who stated that Trystan
“was seen several times by practitioners [between February 5, 2009 and June 1, 2009],
and there was no comment at all on neurologic issues.” Id. at 144. This expert also
testified that he did not believe that Trystan had a seizure during the February 15-17,
2009 time period, because his symptoms at the time were evidence of “startling awake
with a cold.” Id. at 143-44. The expert testimony cited by respondent supports the
special master’s finding that no neurological symptoms occurred in February, March and
April 2009. Although petitioners and their experts have a different view of the
significance of arm contortions in mid-February 2009, the special master’s findings in
this regard are reasonably supported by expert testimony and other evidence in the
record. The court must defer to the fact-finding role of the special master and cannot
reconsider the expert opinions and other evidence cited by petitioners. See Porter, 663
F.3d at 1254 (noting that the reviewing court does not reweigh the evidence of record).
IV. Conclusion
For the above-stated reasons, the court sustains the entitlement decision of the
special master. Accordingly, it is hereby ORDERED that:
(1) Petitioners’ motion for review, ECF No. 207, is DENIED;
(2) The decision of the special master, filed October 9, 2018, is SUSTAINED;
(3) The clerk’s office is directed to ENTER final judgment in accordance with
the special master’s decision of October 9, 2018; and,
(4) The parties shall separately FILE any proposed redactions to this opinion,
with the text to be redacted clearly blacked out, on or before February 25,
2019.
IT IS SO ORDERED.
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s/Patricia E. Campbell-Smith
PATRICIA E. CAMPBELL-SMITH
Judge
17

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_11-vv-00685-4
Date issued/filed: 2021-03-22
Pages: 37
Docket text: **REVERSED PURSUANT TO 284 C.A.F.C. MANDATE, DATED AUGUST 11, 2022. ** JUDGE VACCINE REPORTED OPINION initially filed February 12, 2021, 273 JUDGE VACCINE OPINION denying 260 Motion for Review, and SUSTAINING the special master's August 26, 2020 253 decision. Signed by Judge Patricia E. Campbell-Smith. (TQ) Service on parties made. Modified on 8/16/2022 to indicate opinion has been reversed. (dls).
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Case 1:11-vv-00685-EDK Document 275 Filed 03/22/21 Page 1 of 37
In the United States Court of Federal Claims
No. 11-685V
(E-Filed: March 22, 2021)1
)
TRYSTAN SANCHEZ, by and )
through his parents, GERMAIN and )
JENNIFER SANCHEZ, )
)
Petitioners, ) Vaccine; National Childhood Vaccine
) Injury Act of 1986, 42 U.S.C.
v. ) §§ 300aa-1 to -34; Scope of Remand;
) Review of Special Master’s Decision.
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
Lisa A. Roquemore, Rancho Santa Margarita, CA, for petitioners.
Jennifer L. Reynaud, Trial Attorney, with whom were Jeffrey Bossert Clark, Acting
Assistant Attorney General, C. Salvatore d’Alessio, Acting Director, Catherine E.
Reeves, Deputy Director, Heather L. Pearlman, Assistant Director, Torts Branch, Civil
Division, United States Department of Justice, Washington, DC, for respondent.
OPINION
CAMPBELL-SMITH, Judge.
Petitioners filed the petition in this case on October 17, 2011. See ECF No. 1.
The special master issued his initial entitlement decision on October 9, 2018. See ECF
No. 205. Thereafter, petitioners filed a motion for review with this court, see ECF No.
1 This opinion was filed on February 12, 2021, in accordance with Rule 18(b) of the
Vaccine Rules, Appendix B to the Rules of the United States Court of Federal Claims. See ECF
No. 278. Pursuant to ¶ 4 of the ordering language, the parties were to propose redactions of the
information contained therein on or before February 26, 2021. No proposed redactions were
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207, which was denied, and the special master’s decision was sustained, on February 11,
2019, see ECF No. 217.
Petitioners then filed an appeal with the United States Court of Appeals for the
Federal Circuit on April 10, 2019. See ECF No. 220. On April 7, 2020, the Federal
Circuit vacated this court’s opinion sustaining the special master’s entitlement decision
and remanded the case for further proceedings. See Sanchez v. Sec’y of Health & Hum.
Servs., 809 F. App’x 843 (2020).
The special master issued a second entitlement decision on August 26, 2020, in
which he again denied the relief requested by petitioners.2 See ECF No. 253.
Petitioners’ motion for review of the special master’s August 26, 2020 decision is the
motion now before the court. See ECF No. 260. Respondent filed its response on
October 19, 2020, see ECF No. 265, and petitioners filed a reply on October 30, 2020,
see ECF No. 269. The motion is now fully briefed and ripe for ruling. The court has
considered all of the arguments presented by the parties and addresses the issues that are
pertinent to the court’s ruling in this opinion. For the following reasons, petitioner’s
motion for review is DENIED, and the special master’s August 26, 2020 entitlement
decision is SUSTAINED.
I. Background
Trystan Sanchez was born in August 2008. See ECF No. 253 at 2. The special
master describes this case as follows:
When [Trystan] was conceived, he inherited from his father a mutation in a
gene known as an SDHA gene. Coincidentally, he inherited from his mother
a different mutation in the SDHA gene. However, these mutations were not
detected for many years. In the litigation, the parties dispute the
consequences of these mutations.
Id. More specifically, petitioners argue that “several vaccines, including the [diphtheria-
tetanus-acellular pertussis (DTaP)], caused [Trystan’s] neurodegeneration that was
ultimately diagnosed as a mitochondrial disorder, Leigh’s Syndrome.” ECF No. 260 at 9.
Respondents disagree with that assessment.
A. Overview of Trystan’s Relevant Medical History
2 Throughout this opinion, when the court cites to the special master’s August 26, 2020
decision, for clarity of the narrative, it will not always include the sources to which the special
master cited unless specifically relevant.
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The central disagreement in this case involves Trystan’s condition following his
six-month well-visit. In his post-remand decision, the special master recites the
following summary facts:
At the age of six-months, on February 5, 2009, Trystan was seen by a
pediatrician who found Trystan to be developing normally. In this
appointment, Trystan received a series of vaccinations including a dose of
the dip[h]theria-tetanus-acellular pertussis (DTaP) vaccination.
On the day and evening following the vaccination, Trystan cried
inconsolably. He also had a hot red mark on his thigh, and developed a fever
that ebbed and flowed for a few days.
On February 16, 2009, Trystan was suffering from a common cold. In the
course of this illness, he was congested, had a fever, and jerked around in his
father’s arms. Trystan also contorted his arms.
Trystan had more colds for which his parents brought him to a pediatrician
at the end of April 2009 and in May 2009. During this time, Trystan began
to lose some developmental skills.
Trystan’s parents brought him for medical attention in August 2009. During
this appointment, a physician’s assistant noticed his lack of development and
referred him to additional medical services. This referral eventually led to
an appointment with a neurologist, who also documented problems with
Trystan.
ECF No. 253 at 2-3. Several years later, Trystan was diagnosed with Leigh’s syndrome,
which is “a severe neurological disorder that often presents in the first year of life and is
characterized by progressive loss of mental and movement abilities and typically results
in death within a couple years.” Id. (citations omitted).
According to the special master, the medical records indicate that after receiving
the vaccinations on February 5, 2009, Trystan was evaluated next by a medical
professional on February 17, 2009, when petitioners took him to an urgent care facility.
See id. at 4. Trystan was evaluated by physician’s assistant Jonathon P. Luna who
diagnosed him with a “common cold” and “[v]iral syndrome.” Id. (citations omitted).
Petitioners told Mr. Luna that Trystan “had been coughing and congested with fever,” but
the records do not show that petitioners “told Mr. Luna anything about Trystan exhibiting
unusual arm movements or other signs of a neurological condition.” Id.
The testimony offered by Trystan’s father, Germain Sanchez, includes details not
recorded by Mr. Luna. He states that on February 16, 2009:
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Trystan was very hot with a fever of 103.2 and kept crying inconsolably . . . .
When I held Trystan in my arms and tried to calm him down, I noticed a
change[] in Trystan. He felt very stiff and uncomfortable. Originally, I
thought he was throwing some kind of fit and trying to show how miserable
he felt by stiffening his body. . . . I had never seen a child do that before.
Trystan began to hold his arm behind his back with a lot of tension and jerk
his head back. When I tried to comfort him and gently put his arm back to
the normal position, Trystan would go right back to holding it behind his
back again. This lasted for only a few minutes. . . . (We later learned that
this was likely a seizure, but we had no idea at the time that it was occurring.)
We continued to rock Trystan to sleep and this strange behavior slowly
subsided.
Id. (citing Germain Sanchez affidavit dated October 5, 2011).
Trystan was next seen by a medical provider on April 29, 2009, when he was
diagnosed with an ear infection and bronchitis by Dr. Nabil R. Seleem. See id. at 67. Dr.
Seleem reported “[n]o unusual arm movements or developmental issues,” and “noted
‘[n]o neurological symptoms.’” Id. (citations omitted). And on May 13, 2009, Trystan
was seen by Dr. Philip Brown, who “observed that Trystan’s infection appeared to be
resolving,” and made “[n]o reports of the loss of eye contact or an inability to roll over.”
Id. (citations omitted).
On August 17, 2009, Trystan was seen by physician’s assistant Micaela Marin-
Tucker for his one-year well-visit. See id. at 70. Ms. Marin-Tucker noted in Trystan’s
record that his mother had “noticed a change in [his] development about 2-3 months
ago.” Id. (citations omitted). “Upon a review of systems, Ms. Marin-Tucker found that
Trystan did not walk, stand, crawl, and hold his head up while sitting, or make any
attempt to move his lower extremities.” Id. at 71 (citations omitted). She further noted
that “his extremities seemed soft yet rigid at times.” Id. (citations omitted). Following
this examination, Ms. Marin-Tucker referred Trystan to a neurologist, physical therapist,
and an occupational therapist. See id. At the same appointment, “Trystan received his
third hepatitis B vaccine, as well as his second doses of the pneumococcal conjugate,
DTaP, and Hib vaccines.” Id. (citations omitted).
Ms. Marin-Tucker examined Trystan again during a follow-up visit on October 7,
2009. See id. at 72. She “noted no seizures, weakness, or tics. She made no notation of
tremors or twitching.” Id. But she “found Trystan to be unable to grasp, sit, crawl, or
make much eye contact.” Id.
On November 12, 2009, Dr. David J. Michelson, a neurologist, evaluated Trystan
and found that he was experiencing “muscle spasms, global developmental delay,
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weakness [and] walking problems,” among other things. Id. at 74. He also noted that
“[w]hile Trystan had previously held his right arm stiffly behind him episodically, he had
not done this lately.” Id. Dr. Michelson ordered an MRI, which was performed in
December 2009 and showed “problems in Trystan’s basal ganglia,” consistent with
Leigh’s syndrome.3 Id. at 74-75.
B. Petition for Compensation and Coincident Developments
In their petition, petitioners allege that the vaccinations Trystan received on
February 5, 2009, “were the actual cause of Trystan’s symptoms including fever and
subsequent seizure activity/disorder leading to his development issues.” ECF No. 1 at 12.
In support of the petition, petitioners submitted medical records, testimony from family
members, and expert testimony, including testimony from Dr. Lawrence Steinman, a
pediatric neurologist. See ECF No. 253 at 3-4.
Petitioner’s expert, Dr. Steinman, relied on Mr. Sanchez’s report of Trystan’s
unusual arm movements on February 16, 2009, in his evaluation. See id. at 4. In his first
report, Dr. Steinman first stated that “‘[e]leven days [after receiving the vaccinations] in
the context of a febrile illness, [Trystan] may have had a seizure, manifest[ed] by
stiffening and holding his arm behind his back with a lot of tension and jerked his head
back.’” See id. at 5 (citing Dr. Steinman’s September 28, 2011 report) (emphasis in
original and internal quotation marks omitted). Later in the report, Dr. Steinman’s
assessment of Trystan’s arm movements appears more definitive; he notes that Trystan
“‘was given multiple vaccines, he suffered from fever and he suffered from seizures.’”
Id. (citing Dr. Steinman’s September 28, 2011 report). Despite this apparent
inconsistency, the special master characterizes the remainder of Dr. Steinman’s report as
“premised upon Trystan having a seizure.” Id.
In Dr. Steinman’s opinion, the vaccines “triggered” Trystan’s seizures, and but for
the vaccinations, Trystan “would not have suffered such devastating neurological
consequences.” Id. (quoting Dr. Steinman’s September 28, 2011 report) (quotation
marks omitted). According to respondent, however, Trystan did not suffer neurological
consequences close enough in time to receiving the vaccines to be entitled to
compensation. See id. Of particular relevance to the outcome of this case, “the parties
and their experts disputed whether Trystan displayed unusual arm movements starting in
February 2009.” Id. at 6.
3 Trystan continued to receive medical care after the December 2009 MRI, but because the
central issue in this case relates to the events in 2009, the court will omit the detailed recitation
of those facts here and instead will include any relevant aspects of that care in the analysis
section of this opinion.
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On April 10, 2013, the special master issued a document titled Ruling Finding
Facts, ECF No. 45, which was intended to serve as the basis for expert reports and
ultimately an entitlement decision. See id. at 6-8. In the ruling, the special master
concluded, among other things, that “Trystan did not begin to exhibit arm contortions” at
the time of the February 17, 2009 urgent care visit. ECF No. 45 at 13. He also found that
between the February 17, 2009 urgent care visit and the next pediatrician visit on April
29, 2009, Trystan “did not lose control of his head and trunk, nor did he stop making eye
contact or stop wanting to play anymore. He did not exhibit arm contortions.” Id.
During the following years of this litigation, however, the facts and expert
opinions related to Trystan’s condition continued to develop. In 2014, Trystan underwent
genetic testing which revealed “a heterozygous mutation in the SDHA gene.” ECF No.
253 at 10. Thereafter, Trystan was diagnosed with Leigh’s syndrome. See id. at 12 n.7.
Petitioners presented several expert reports, including one from Dr. Dmitriy Niyazov, an
expert in mitochondrial disorders, in which the doctors opined that Trystan’s Leigh’s
syndrome initially manifested as the inconsolable crying and fever he experienced after
the February 5, 2009 vaccinations. See id. at 12-13. Dr. Niyazov also took the view that
absent the vaccinations, Trystan’s genetic mutations may not have developed into Leigh’s
syndrome at all. See id. at 13. Dr. Steinman issued another report, dated December 10,
2015, in which, according to the special master, he “roughly presented the same view.”
Id.
In response to Dr. Niyazov’s and Dr. Steinman’s reports, respondent produced a
report from Dr. Gerald Raymond, an expert in genetics and neurology.4 See id. at 5-6,
14. In this report, Dr. Raymond concluded that Trystan is “‘a child with Leigh syndrome
secondary to mutations in the gene SDHA. This is the sole cause of his neurologic
condition and the onset was not caused by immunizations received and his disease course
is consistent with the condition and was not aggravated by the receipt of vaccination.’”
Id. at 14 (quoting Dr. Raymond’s March 16, 2016 report). After the parties exchanged
additional expert reports to address this disagreement, the special master set the case for a
hearing, and ultimately found that petitioners were not entitled to compensation. See id.
at 14-15; ECF No. 205.
After this court sustained that entitlement decision, see ECF No. 217, the Federal
Circuit vacated that decision, and remanded the case to the special master for further
proceedings, noting that the special master’s decision “left certain critical issues
4 Respondent has also presented expert testimony from Dr. Stephen J. McGeady, Dr.
Edward Cetaruk, and Dr. Dean Jones. See ECF No. 253 at 27-30. Their opinions will be
discussed more fully where relevant.
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unresolved,”5 see Sanchez, 809 F. App’x at 844. On remand, the special master
permitted the parties to file additional expert reports and held an additional hearing. See
ECF No. 253 at 20-21. After considering the Federal Circuit’s April 7, 2020 decision and
the record in this case, the special master issued his August 26, 2020 decision, of which
petitioners now seek review. See id. at 21; ECF No. 260.
II. Legal Standards
This court has jurisdiction to review the decision of a special master in a Vaccine
Act case. See 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal
Claims reviews the decision of the special master to determine if it is ‘arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008) (quoting 42
U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of Health & Hum. Servs., 418
F.3d 1274, 1277 (Fed. Cir. 2005)).
This court uses three distinct standards of review in Vaccine Act cases, depending
upon which aspect of a special master’s judgment is under scrutiny.
These standards vary in application as well as degree of deference. Each
standard applies to a different aspect of the judgment. Fact findings are
reviewed . . . under the arbitrary and capricious standard; legal questions
under the “not in accordance with law” standard; and discretionary rulings
under the abuse of discretion standard.
Munn v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.
1992).
As the Federal Circuit has held, when reviewing a special master’s decision, this
court does not “reweigh the factual evidence, assess whether the special master correctly
evaluated the evidence, or examine the probative value of the evidence or the credibility
of the witnesses—these are all matters within the purview of the fact finder.” Porter v.
Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011). “Rather, as long
as a special master’s finding of fact is ‘based on evidence in the record that [is] not
wholly implausible, we are compelled to uphold that finding as not being arbitrary or
capricious.’” Id. (quoting Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328,
1338 (Fed. Cir. 2010)). Under this standard “reversible error is ‘extremely difficult to
demonstrate’ if the special master ‘has considered the relevant evidence of record, drawn
plausible inferences and articulated a rational basis for the decision.’” Lampe v. Sec’y of
5 The United States Court of Appeals for the Federal Circuit’s decision and the scope of
the remand is the subject of some dispute between the parties and is addressed more fully below.
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Health & Hum. Servs., 219 F.3d 1357, 1360 (quoting Hines v. Sec’y of Health & Hum.
Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
Petitioners bear the burden of proving, by a preponderance of the evidence, that
“the vaccination brought about [their] injury by providing: (1) a medical theory causally
connecting the vaccination and the injury; (2) a logical sequence of cause and effect
showing that the vaccination was the reason for the injury; and (3) a showing of a
proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at
1278. “Because causation is relative to the injury, . . . petitioner[s] must provide a
reputable medical or scientific explanation that pertains specifically to the petitioner[s’]
case, although the explanation need only be ‘legally probable, not medically or
scientifically certain.’” Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339,
1345 (Fed. Cir. 2010) (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543,
548-49 (Fed. Cir. 1994)). If petitioners “satisf[y] this burden, [they are] ‘entitled to
recover unless [respondent] shows, also by a preponderance of evidence, that the injury
was in fact caused by factors unrelated to the vaccine.’” Althen, 418 F.3d at 1278
(quoting Knudsen, 35 F.3d at 547).
III. Analysis
A. The Federal Circuit’s Opinion Remanding the Case
The Federal Circuit summarized petitioner’s three primary grounds for appeal as
follows:
First, the petitioners contend that the rulings of the special master and the
Claims Court are contrary to the 2015 decision of this court in Paluck v.
Secretary of Health & Human Services, 786 F.3d 1373 (Fed. Cir. 2015).
Second, they argue that the central component of the special master’s
ruling—that Trystan’s Leigh’s syndrome was not triggered by his February
5, 2009, vaccinations—is contrary to the evidence. Third, they argue that the
special master failed to address their “challenge-rechallenge” argument, i.e.,
their contention that the combination of the first vaccination in February
2009, and the second vaccination, in August 2009, triggered or aggravated
Trystan’s condition.
Sanchez, 809 F. App’x at 850. The Circuit noted its “extremely limited” authority to
review the special master’s factual findings, see id., and then addressed each issue in turn.
1. Paluck
Petitioners in Paluck sought compensation for injuries sustained by their minor
son, who had an underlying mitochondrial disorder, after he received a series of
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vaccinations at his one-year well-visit. Paluck, 786 F.3d at 1377-78. In that case, the
child developed a fever, irritability, and fatigue within forty-eight hours of receiving the
vaccinations, and his doctors documented neurological decline within twenty-three days.
See id. at 1381-82. The special master concluded that the child’s decline was not
sufficiently “linear” to establish entitlement to compensation, but both this court and the
Federal Circuit disagreed. Id. at 1382-83. The Federal Circuit held that the special
master’s decision was arbitrary and capricious because he had failed to consider “‘the
record as a whole,’” in reaching this conclusion. Id. at 1382 (quoting 42 U.S.C. § 300aa-
13(a)(1)).
The Federal Circuit also found that the special master had erred in setting a strict
timeframe within which symptoms must be apparent, made inferences unsupported by the
record, and arbitrarily disregarded record evidence. See id. at 1383-85. Accordingly, the
Circuit affirmed this court’s decision granting petitioner’s motion for review and vacating
the special master’s decision to deny compensation. See id. at 1386.
In reviewing the present case, the Federal Circuit first noted the similarities
between this case and its decision in Paluck: “Like this case, Paluck involved a child
with a mitochondrial disorder. And, as in this case, the evidence in Paluck showed that
vaccines can activate the immune system, which in an individual with mitochondrial
disease can result in oxidative stress that can, in turn, cause progressive neurological
deterioration over time.” Sanchez, 809 F. App’x at 851. The Circuit, however,
concluded that there were sufficient differences between this case and Paluck, that Paluck
alone did not address all of the issues at bar. Id. Specifically, the Circuit noted that: “In
this case, unlike in Paluck, the special master did not adopt a strict time limit or a
requirement of ‘linearity’ for the manifestation of signs of Trystan’s neurological
regression. . . . Nor did the special master draw the improper inferences noted by this
court in Paluck or disregard medical evidence or the observations of the treating
physicians.” Id.
2. Causation Analysis
The Federal Circuit next addressed petitioners’ arguments related to the special
master’s causation analysis. Id. at 852. Specifically, petitioners argued that Trystan’s
fever and inconsolable crying following his February 5, 2009 vaccinations, along with his
arm contortions eleven days later, on February 16, 2009, are evidence that Trystan “had
suffered an adverse neurological event.” Id. In his original entitlement decision, the
special master rejected this argument, concluding that Trystan’s symptoms on February
16, 2009 were typical cold symptoms. See id. The Circuit explained petitioners’
argument on appeal as follows:
The petitioners do not challenge the finding that Trystan was suffering from
a cold, but they contend that the evidence shows that he was also suffering
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from a neurological injury at that time. In particular, the petitioners dispute
the special master’s finding that Trystan’s symptoms—his arm contortions
in particular—were symptoms of a cold. That finding, they contend, is
wholly lacking in record support.
Id.
In this regard, the Circuit identified a discrepancy between the facts included in
the special master’s Ruling Finding Facts and the published entitlement decision:
In his 2013 Ruling Finding Facts, the special master found that although
Trystan “kept kicking his feet and jerking around” in his father’s arms on that
evening, he “did not begin to exhibit arm contortions” at that time, and he
“did not exhibit arm contortions” between that time and the time Ms. Sanchez
took him to the doctor in late April 2009. In the 2018 Published Decision
Denying Compensation, however, the special master found that on that
evening, Trystan’s “arms contorted and he was jerking around.”
Id. Given the centrality of this fact to petitioner’s theory of causation, the Circuit found
that the contradiction between the two documents was “significant.” Id.
In the 2013 Ruling Finding Facts, the special master noted that: “The parties are
ordered to provide this ruling to any expert they retain. If the expert’s opinion is not
consistent with these findings of fact, the opinion is likely to not be persuasive.” ECF
No. 45 at 16. The Federal Circuit noted that defendant’s experts relied on the 2013
Rulings Finding Fact, and “did not have before them the special master’s later finding
that Trystan’s arm contortions began as early as February 16.” Sanchez, 809 F. App’x at
852. In addition, the Circuit noted, if the special master changed his view of the date on
which Trystan’s arm contortions began based on his father’s testimony, that could lend
credence to Dr. Steinman’s opinion. See id. at 852-53. For these reasons, the Circuit
found it “necessary to remand for further consideration of the causation issue in light of
the special master’s findings in 2018 regarding Trystan’s arm contortions.” Id. at 853.
The Federal Circuit also concluded that, in his causation analysis, the special
master did not carefully delineate between the second and third Althen factors, and
directed the special master to do so on remand. See id. The Circuit explained that:
it is important for the special master to make explicit findings as to two
separate issues: (1) whether there was a logical sequence of cause and
effect linking Trystan’s vaccinations and his injuries as well as a proximate
temporal relationship between the vaccinations and the onset of the injuries;
and (2) whether Trystan’s infections between February and May of 2009
caused the manifestation of his Leigh’s syndrome, independent of his
vaccinations.
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Id. If, however, “the special master finds that the petitioners have not met their burden as
to the first issue, it is unnecessary for the special master to address the second issue.” Id.
3. Challenge-Rechallenge
Next, the Federal Circuit held that the special master failed to fully consider
petitioners’ challenge-rechallenge theory, which is a “theory of causation . . . that the
combined effect of the February and August vaccinations caused or aggravated Trystan’s
condition.” Id. at 854. The special master focused on the findings in the 2013 Ruling
Finding Facts, but did not account for petitioners’ expert testimony offered after that
ruling was made, which focused on the challenge-rechallenge theory. See id.
The Circuit also found that the medical records from August 17, 2009, the date on
which Trystan received his second round of vaccinations, and October 7, 2009, the date
on which he was seen for a follow-up visit, may indicate some “loss of skills during [that]
period.” Id. It was, therefore, an error for the special master to not explicitly address the
challenge-rechallenge theory. Id.
4. Whether Trystan’s Leigh’s Syndrome Would Have Been the Same
Regardless of the Vaccinations
Finally, the Federal Circuit held that “it may be necessary for the special master to
address . . . whether [respondent] showed, because of Trystan’s mutations, the timing and
severity of his Leigh’s syndrome would have been the same, regardless of the effect of
the vaccinations.” Id. The Circuit noted that the science on this point “has been
developing rapidly,” and suggested that “the special master on remand may wish to give
the parties an opportunity to supplement the record with any relevant medical research or
reports postdating the hearing held by the special master two and one-half years ago.” Id.
B. The Special Master’s Decision on Remand
Following the Federal Circuit’s opinion remanding the case, the special master
accepted supplemental expert and status reports from the parties, and held a hearing on
July 9, 2020, during which the parties’ experts testified. See ECF No. 245 (transcript of
hearing).
On August 26, 2020, the special master issued a lengthy new entitlement decision
taking into account the Federal Circuit’s opinion. See ECF No. 253. After recounting
the factual and procedural background of this case, and discussing the qualifications of
the parties’ experts, the special master addressed the petitioners’ burden under the test set
forth by the Federal Circuit in Althen. See id. at 1-31. As noted above, petitioners bear
the burden of proving, by a preponderance of the evidence, that “the vaccination brought
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about [the] injury by providing: (1) a medical theory causally connecting the vaccination
and the injury; (2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.” 6 Althen, 418 F.3d at 1278.
1. First Althen Factor
The special master found, as he had in his first entitlement decision, that
petitioners met their burden to prove a “medical theory causally connecting the
vaccination and the injury.” Id. (citations omitted); ECF No. 253 at 31-34; see also ECF
No. 205. He also noted that on appeal, despite the fact that respondent argued in a
footnote that the special master had committed a harmless error with regard to the first
Althen factor, the parties did not address the matter fully before the Federal Circuit. See
ECF No. 253 at 32. And, the special master understood the Federal Circuit to “endorse
the theory that vaccines can cause fever and fever can cause neurodegeneration based
upon its opinion in Paluck.” Id.
Furthermore, the special master reasoned, the law of the case doctrine “precludes
relitigation of issues explicitly or implicitly decided on appeal.” Id. at 33-34 (citing
Travelers Ins. Co. v. United States, 72 Fed. Cl. 316, 325 (2006) (“The doctrine [of the
law of the case], of course does not constrain a trial court’s consideration of an issue that
has not been considered on appeal. . . . But the doctrine extends to issues that were
implicitly addressed.”); and Am. Satellite Co. v. United States, 34 Fed. Cl. 468, 480
(1995) (quotation omitted)). Here, because respondent raised the issue of a harmless
error with regard to the first Althen factor on appeal, and the Federal Circuit did not
direct the special master to reconsider his findings, the special master declined to do so.
See id. at 34.
6 After a lengthy discussion of causation under Althen, the special master addressed an
alternative theory under which he also found that petitioners were not entitled to compensation.
See ECF No. 253 at 80-97. Respondent argued, and the special master agreed, that Trystan’s
genetic mutations “constitute the sole substantial cause of [his] Leigh’s syndrome.” Id. at 81.
The special master considered this question in response to the Federal Circuit’s comment in its
decision remanding this case for further proceedings that “it may be necessary for the special
master to address . . . whether the Secretary showed, because of Trystan’s mutations, the timing
and severity of his Leigh’s syndrome would have been the same, regardless of the effect of the
vaccinations.” Sanchez v. Sec’y of Health & Hum. Servs., 809 F. App’x 843, 854 (Fed. Cir.
2020); see also ECF No. 253 at 20 (special master noting the Federal Circuit’s invitation to
consider this issue further). Because the court agrees with the special master that petitioners
have not met their burden to prove causation under Althen, the special master’s decision on this
alternative theory is unnecessary to sustain his entitlement decision. Accordingly, the court
declines to review the strength of the scientific data bearing on the likely manifestation of
Trystan’s Leigh’s syndrome absent administration of the vaccines.
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“Accordingly, the finding in the October 9, 2018 decision remains undisturbed.
The theory that the DTaP vaccine can cause neurodegeneration, potentially through the
intermediate step of a fever, is sound and reliable under prong 1.” Id.
2. Second Althen Factor
The second factor, and most complicated part of the Althen analysis in this case,
required the special master to evaluate whether petitioners had shown, by a
preponderance of the evidence, “a logical sequence of cause and effect showing that the
vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. In this section, the
special master addressed the timing of the onset of Trystan’s neurodegeneration, and
drew conclusions as to what that timing indicates about the causal relationship between
the vaccinations and Trystan’s injury. See ECF No. 253 at 38-80.
According to petitioners, “Trystan’s response to the vaccine changed his life.” Id.
at 41. Petitioner’s expert Dr. Steinman testified at the post-remand hearing that after the
vaccinations, “Trystan started a ‘downward cascade,’” and experienced a continuous
process of neurodegeneration and loss of skill from that point. Id. And Dr. Niyazov
offered his opinion that Trystan’s “‘developmental regression was slowly developing
ever since the crying and fever took place as a result of the vaccination.’” Id. (quoting
Dr. Niyazov’s expert report, ECF No. 127-1 at 8).
After reviewing a series of previously-decided vaccine cases that petitioners argue
militate in favor of compensation, see id. at 42-46, the special master reviewed Trystan’s
medical history between February 5, 2009—the date on which he received the vaccine—
and December 2009, see id. at 46-75, and gave particular attention to the notes made by
Trystan’s treating physicians, see id. at 75-80.
a. Trystan’s Neurodegeneration
i. February 5, 2009
According to the special master, Trystan’s pediatrician, Dr. Philip Brown, found
Trystan’s “growth and development to be normal” at his six-month well-visit. Id. at 46.
Dr. Brown specifically found that Trystan was meeting the following developmental
milestones: “turning to sound, self-feeding, self-comforting, responding to his name,
sitting with support, grasping and mouthing objects, smiling, laughing, squealing,
showing interest in toys, showing differential recognition of parents, babbling
reciprocally, rolling over from back to front, and standing when placed.” Id. at 46-47.
He also noted that Trystan had “no head lag when pulled to sit.” Id. at 47. At the visit,
Trystan received the DTaP, hepatitis B, Haemophilus influenzae type B, inactivated
polio, and pneumococcal conjugate vaccines. See id.
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After the wellness visit, Trystan cried inconsolably, developed a fever that ebbed
and flowed for several days, and developed a lump on his left thigh. See id. The special
master found that, of these three facts, the inconsolable crying was the “most important,”
because it “can be a manifestation of an encephalopathy or injury to the nervous system.”
Id. In support of this conclusion, the special master cited to testimony from both
petitioners’ and respondent’s experts—Dr. Steinman, Dr. Niyazov, and Dr. Raymond, as
well as a previously decided vaccine case, Estep v. Secretary of Health & Human
Services, No. 90-1062V, 1992 WL 357811, at *3 (Fed. Cl. Spec. Mstr. Nov. 3, 1992),
mot. for rev. denied, 28 Fed. Cl. 664 (1993). See id. The special master also concluded,
however, that inconsolable crying is not necessarily a sign of injury, it could also be an
expression of discomfort or pain. See id. at 47-48. Respondent’s experts Dr. McGeady
and Dr. Raymond testified that Trystan’s crying was the latter. See id. at 48.
The special master further concluded that “the presence of a fever is non-specific”
due to broad agreement that vaccines can cause an elevated temperature as part of a
normal response. Id. None of the experts expressed any unusual concern about the lump
on Trystan’s thigh. See id. at 48-49.
In the special master’s view, petitioners and their experts “appear to place undue
weight on Trystan’s health on February 5-7, 2009. They seem to reason that because
inconsolable crying can be a manifestation of an encephalopathy or injury to the nervous
system, Trystan must have suffered a neurological injury.” Id. at 49. Considering the
evidence as a whole, however, “Trystan’s health could be entirely compatible with an
expected response to the vaccination given in the morning of February 5, 2009.” Id.
ii. February 16-17, 2009
Trystan again developed a fever, along with congestion, on February 15, 2009.
See id. at 54. Around midnight on February 16, 2009, Trystan’s fever increased, and he
began to cry very loudly. See id. Mr. Sanchez attempted to calm Trystan, but he
“startle[d] awake like he could not breathe through his stuffy nose.” Id. at 54-55. Mr.
Sanchez testified that when he was trying to calm Trystan, “‘he kept kicking his feet and
jerking around’” in his arms, “‘almost as if he didn’t want to be held.’” Id. at 55.
Petitioners did not take Trystan to the urgent care that night because after they gave him
some fever reducing medication, Trystan fell asleep. See id.
The next morning, February 17, 2009, Trystan was examined by a physician’s
assistant Mr. Luna, and was diagnosed with a “‘[c]ommon cold,’” and “‘[v]iral
syndrome,’” and his fever was noted. Id. Mr. Luna’s notes, however, “do not indicate
that Ms. Sanchez told Mr. Luna anything about Trystan exhibiting unusual arm
movements or other signs of a neurological condition.” Id.
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The parties’ experts presented opposing theories about Trystan’s symptoms, which
included “high-pitched cry[ing], fever, congestion, startling awake, jerking around, and
arm contortions.” Id. Dr. Steinman first opined that Trystan had experienced a seizure,
and later identified the reaction as dystonia. See id. Both Dr. Steinman and Dr. Niyazov
believe Trystan’s reaction was evidence of “an episode of neurodegeneration.” Id. The
special master noted that “[i]n contrast, in the December 2017 hearing, Dr. Raymond
maintained that these conditions (except for the arm contortions) reflected a common
cold.” Id.
Considering the foregoing, the special master concluded that the evidence shows
that Trystan was suffering from a common cold or upper respiratory infection, from
which he recovered. See id. at 55-56. The special master found Dr. Steinman’s and Dr.
Niyazov’s “skepticism over such a basic point” reduced their credibility. Id. at 56. He
also found that the evidence indicated that Trystan’s February 15, 2009 fever was
different from his February 5, 2009 fever—and that there was no demonstrated
connection between the second fever and the vaccinations. See id.
The special master then noted that “[b]eyond the fever and congestion that are part
of a common cold, Trystan also cried, startled awake, jerked around in his father’s arms,
and, most importantly for this remand decision, contorted his arms. These behaviors are
the foundations for Dr. Steinman’s opinion that Trystan suffered a seizure or dystonia.”
Id. Dr. Steinman’s credibility, however, was compromised by the fact that his opinion
evolved over time. See id.
Dr. Steinman first suggested, based on Mr. Sanchez’s account of Trystan’s
behavior on the night of February 16, 2009, that Trystan had suffered a seizure. See id.
During the December 2017 hearing, Dr. Steinman acknowledged that a seizure could
only be diagnosed conclusively by an electroencephalogram (EEG), and that in the
absence of an EEG “we’re not very good at guessing.” See id. at 56-57. In light of this
weakness in his theory, Dr. Steinman then opined that “Trystan’s arm contortions were
dystonic posturing.” Id. at 57. Notably, the special master stated that Dr. Steinman’s
new opinion on dystonia was also based on Mr. Sanchez’s account of Trystan’s behavior
on the night of February 16, 2009. See id. At the time that the special master issued his
post-remand decision, Dr. Steinman was of the opinion that Trystan suffered from both
dystonia and seizures. See id. at 58.
The special master found Dr. Steinman’s opinion unpersuasive for four reasons.
First, as Dr. Steinman himself acknowledged, seizure activity cannot be confidently
diagnosed absent an EEG, a test that was not performed on Trystan in mid-February
2009. See id. Second, when Trystan did develop seizures, they “involved deviation of
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his head and eye, an altered consciousness, and a postictal period.”7 Id. Based on the
difference in presentation and passage of time before confirmed seizures, the special
master concluded that petitioners had not demonstrated a pattern of seizures beginning in
February 2009. See id. Third, respondent’s expert disagreed with Dr. Steinman that
Trystan had suffered seizures. See id. And fourth, while the records from Trystan’s
treating physician, Dr. Haas, include a note about arm contortions, that note was made on
August 7, 2012, and was apparently a record of the narrative from Ms. Sanchez about
Trystan’s condition following the vaccinations. See id. Dr. Haas “did not assess the arm
contortions as indicative of a seizure or neurological issues.” Id. For these reasons, the
special master found that petitioners had not “established with preponderant evidence that
Trystan suffered a seizure on February 16, 2009.” Id. at 59.
Having rejected petitioners’ theory that Trystan suffered a seizure on February 16,
2009, the special master then turned to the issue of whether Trystan had suffered
dystonia, which he defined as “‘dyskinetic movements due to disordered tonicity of
muscle.’” Id. He further explained that the term dyskinetic comes from the root word
dyskinesia, which means “‘distortion or impairment of voluntary movement, as in tic,
spasm, or myoclonus.’” Id. Dystonia originates in the basal ganglia, and “can be a
manifestation of many neurologic disorders,’” including Leigh’s syndrome. Id. Based
on expert testimony and medical journal arguments, the special master concluded that
“[t]he cumulative probability of having an onset of Leigh’s syndrome with dystonia at six
months is approximately five percent.” Id.
Dr. Steinman and Dr. Raymond disagreed as to whether a six-month old was
likely to manifest dystonia by moving his arm behind his back, and Mr. Sanchez testified
Trystan had done on the night of February 16, 2009. See id. at 4, 60. According to Dr.
Raymond, six-month-old children would not have myelination progression sufficient to
allow such movement. See id. at 60. Dr. Steinman emphasized the progressive nature of
myelination, and believed dystonia was possible at six months of age. See id. The
special master noted that “[a]s an abstract question whether six-month-old infants are
sufficiently myelinated to experience dystonia by moving their arms backward is difficult
to answer on this case’s evidentiary record.” Id. He concluded, however, that Dr.
Raymond’s fellowship in developmental neuropathology qualified him better to answer
the question than Dr. Steinman’s fellowship in chemical immunology. See id. at 60-61.
“This difference in advanced specialization would break any tie in Dr. Raymond’s favor.”
Id. at 61.
7 In the citations accompanying this sentence, the special master includes a reference to
“Exhibit 138 at 99 (Dr. Wong’s Dec. 7, 2010 report).” This citation appears to include a
typographical error, as it is a reference to Dr. Nicole M. Antonio’s July 12, 2016 report, which
appears at ECF No. 166-2, which is Exhibit 138 at 99-103. Dr. Valarie Wong’s December 7,
2010 report appears at ECF No. 116-2 at 9-11, which is Exhibit 138 at 9-11.
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With regard to Trystan’s case specifically, Dr. Raymond opined that if he had
experienced dystonia on February 16, 2009, it would have been “persistent and obvious,”
while Dr. Steinman asserted that dystonia could be “intermittent.” Id. Dr. Steinman,
however, “could not specify how frequently even ‘intermittent’ dystonia appears.” Id.
The special master found the contention that “Trystan could have dystonia in February
but not again for many months” unpersuasive. Id. Based on the foregoing, the special
master concluded that petitioners “have not shown by preponderant evidence that
Trystan’s February 16, 2009 arm contortions were a manifestation of a seizure or an
episode of dystonia,” and that the “arm contortions do not constitute a neurologic
abnormality caused by his vaccination.” Id. at 62.
iii. End of February to Beginning of April 2009
After the February 17, 2009 visit with Mr. Luna, Trystan did not see a medical
provider again until April 29, 2009. See id. In the 2013 Ruling Finding Facts, the special
master found, and repeated in his post-remand entitlement decision, as follows:
12. Sometime [after February 17, 2009], Trystan’s extended family
gathered to watch a boxing match. During this gathering, Trystan was sick,
crying, fussy, and congested. He was not contorting his arms nor was he
limp or rigid.
13. Between [Ms. Sanchez]’s birthday and the next time she took him to
the doctor nearly two months later in late April, Trystan suffered from cough
and congestion episodically. During this time, he did not lose control of his
head and trunk, nor did he stop making eye contact or stop wanting to play
anymore. He did not exhibit arm contortions.
Id. at 63 (quoting ECF No. 45 at 13) (citations omitted). He also characterized these facts
as “not contested.” Id. Neither of petitioners’ experts could identify facts to the contrary,
but noted that it was possible for parents to miss signs of delayed development in such a
young child. See id. at 63-64.
Petitioners’ experts also argued that Trystan experienced a fade response, a
phenomenon written about by Dr. Bob Naviaux in an article called Commentary on,
Fever Plus Mitochondrial Disease Could Be Risk Factors for Autistic Regression by
Shoffner et al. See id. at 64. Dr. Niyazov, who relied on the article, could not say
whether the article was peer-reviewed, but relayed his personal confidence in Dr.
Naviaux. See id. The special master also noted that the article addressed children with
autism, not Leigh’s syndrome. See id. In the article, Dr. Naviaux describes children with
mitochondrial disease who suffer a fade response when they regress. See id. When a
child experiences a fade response, which can occur between two and ten days after a
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fever, “‘their consciousness fades,’” and the “‘child can become difficult to fully awaken,
or will stop walking, stop talking, stiffen or lose muscle tone, or have a seizure, or a
stroke-like episode.’” Id.
The special master found, however, that there was “not preponderant evidence that
Trystan experienced a fade.” Id. at 65. According to the special master, “[t]here is no
evidence that in the months after his February 5, 2009 vaccination, Trystan began to lose
consciousness or was difficult to awaken. In contrast, the [2013] Ruling Finding Facts
found that Trystan continued to play.” Id. And the episode of arm contortions
experienced by Trystan on February 16, 2009 was “short-lived, singular, and did not
signify a neurologic injury due to vaccination.” Id. On this basis, the special master
found that the Naviaux article was “inapt,” id., and found Trystan’s case to be materially
different from the caselaw offered as analogous by petitioners, see id. at 65-66.
iv. April to May 2009
Based on the medical records presented in this case, the special master found that
Trystan had “relatively good health” from the end of February 2009 to mid-April 2009.
Id. at 67. On April 29, 2009, however, Trystan was diagnosed with an ear infection and
bronchitis by Dr. Seleem, who noted that Trystan had been suffering from a cough and
congestion for about two weeks. See id. At that time, Dr. Saleem noted “‘[n]o
neurological symptoms.’” Id. Trystan was next seen by Dr. Brown on May 13, 2009, at
which time his ear infection was clearing. See id. The doctor’s notes include no concern
about loss of eye contact or ability to roll over. See id.
In presenting their theories, petitioners’ experts “largely ignored the visits with Dr.
Seleem and Dr. Brown.” Id. at 68. A fact that, the special master reasoned, is
“inconsistent with [Dr. Steinman’s] later testimony that ‘infections . . . can devastate or
kill’ children with mitochondrial diseases.” Id. After the special master questioned Dr.
Steinman on this point, Dr. Steinman opined that Trystan’s late-April, early-May illness
did not contribute to his neurological decline because he did not have a fever. See id. at
68-69. Dr. Niyazov, for his part, indicated that such illness could contribute to Trystan’s
decline, but maintained his theory that Trystan’s decline began on February 5, 2009. See
id. at 69. The special master did not credit this theory: “The flaw . . . is that . . .
[petitioners] have not presented persuasive evidence that Trystan’s decline started on
February 5, 2009.” Id.
v. August 2009
On August 8, 2009, Trystan cried inconsolably. See id. at 70. At some points of
the day, his body was limp; at others, he contorted his arms. See id. On August 17,
2009, Trystan was seen by physician’s assistant Ms. Marin-Tucker for his one-year well-
visit. See id. at 69, 70. At that visit, Ms. Sanchez reported to Ms. Marin-Tucker, that she
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“‘noticed a change in [Trystan’s] development about 2-3 months ago but since she had
taken [Trystan to the pediatric clinic] with Dr. Brown she thought that everything was
ok.’” Id. at 70 (citations omitted). Ms. Sanchez contradicted these notes when she
testified more than two years later that she had actually reported that Trystan’s
developmental changes began five to six months prior to the visit with Ms. Marin-
Tucker.8 See id. at 70 n.39.
During the visit, Ms. Marin-Tucker found that “Trystan did not walk, stand, crawl,
and hold his head up while sitting, or make any attempt to move his lower extremities.
She also noted in her examination that his extremities seemed soft, yet rigid at times.” Id.
at 71. Ms. Marin-Tucker referred Trystan to a neurologist, physical therapist, and
occupational therapist, and administered his second doses of the pneumococcal
conjugate, DTaP, and Hib vaccines, with directions to return the following week for the
measles, mumps, rubella, varicella, and hepatitis A vaccines. See id.
According to the special master, Trystan’s presentation at the August 17, 2009
well-visit was consistent both with Dr. Raymond’s explanation that “problems
originating in the basal ganglia would present . . . first with hypotonia and later with
dystonia,” and with Dr. Naviaux’s fade response theory. Id.
vi. October to December 2009
Petitioners took Trystan for a follow-up visit with Ms. Marin-Tucker on October
7, 2009. See id. at 72. “Ms. Marin-Tucker noted no seizures, weakness, or tics,” and
“made no notation of tremors or twitching.” Id. at 72. She did find, however, that
Trystan was “unable to grasp, sit, crawl, or make much eye contact.” Id.
Dr. Steinman interpreted this report as evidence that Trystan’s neurological
condition had further deteriorated—a conclusion the special master found to be
reasonable. See id. Due to this decline, the special master evaluated whether Trystan had
experienced a challenge-rechallenge reaction. See id. “A rechallenge event occurs when
a patient who had an adverse reaction to a vaccine suffers worsened symptoms after an
additional injection of the vaccine.” Capizzano v. Sec’y of Health & Hum. Servs., 440
F.3d 1317, 1322 (Fed. Cir. 2006). In addition, according to Dr. Raymond, “‘[t]he
challenge should meet the criteria of same latency and same effects, and must exclude
well-accepted alternative explanations.’” ECF No. 253 at 72.
8 The special master noted that Ms. Marin-Tucker’s report that Ms. Sanchez had noticed
changes in Trystan’s development two to three months before his August 17, 2009 well-visit—
between May 17, 2009 and June 17, 2009—suggests a logical connection between his late-April,
early-May illness and his decline. See id. at 69-70. This timeline fits more neatly with the
theories advanced by the medical literature that decline would occur within about two weeks of
the inciting event. See id. at 70.
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Petitioners contested Dr. Raymond’s additional criteria, but the special master
ultimately decided that the nuance was immaterial because petitioners “have not
established the challenge aspect” of the challenge-rechallenge theory because they “have
not presented preponderant evidence that Trystan suffered any neurologic problem within
at least one month of the February 5, 2009 vaccine.” Id. at 73. He concluded that, “by
simple definition, without a ‘challenge,’ there can be no ‘rechallenge.’” Id. Moreover,
the reactions Trystan displayed after each set of vaccinations were not sufficiently
similar. See id.
The special master stated his conclusion with regard to the second Althen factor,
as follows:
In sum, this section . . . has considered both how [petitioners’] experts
predicted an adverse reaction to the vaccination would appear and how
Trystan actually appeared. Because of the dichotomy between the predicted
and the actual, the sequence of events is not logical. Thus, [petitioners] have
not met their burden regarding prong 2.
Id. at 75.
vii. Treating Doctors
As part of his analysis of the second Althen factor, and in accord with the Federal
Circuit’s directive, the special master took particular note of the information available
from Trystan’s treating physicians. See id. (citing Capizzano, 440 F.3d at 1326). He
concluded, however, that petitioners “overstate the significance of these reports.” Id. He
summarized the basis for his conclusions for each of four treating physicians.
First, in 2010 and 2011, Dr. Jennifer Friedman raised the possibility that Trystan
may have acute disseminated encephalomyelitis (ADEM), which could be related to a
vaccination. See id. The special master discounted this opinion because Trystan suffers
from Leigh’s syndrome, not ADEM. See id.
Second, Dr. Akhil Sharma’s notes included, on October 2, 2013—and again on
June 26, 2015—a conclusion that Trystan had a “‘probable vaccine induced injury.’” Id.
at 76. This conclusion, however, was based not on Dr. Sharma’s evaluation, but on Ms.
Sanchez’s recitation of Trystan’s history. See id. For this reason, the special master
concluded that “Dr. Sharma’s reports carry little persuasive value.” Id.
Third, Dr. Haas, who first saw Trystan on August 7, 2012, recorded Trystan’s
medical history as recited by petitioners, much like Dr. Sharma. See id. In those notes,
he stated: “Trystan is a 4 year old boy who had acute onset regression and dystonia at 6
months of age, following vaccination, which repeated with the next set of vaccines at 12
months.” Id. at 77. The special master first notes that Dr. Haas’ observation that Trystan
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experienced symptoms “following vaccination” is a “recitation of a chronological
sequence of events [and] is not the same as an opinion regarding causation.” Id. at 78.
Moreover, these statements pre-date Trystan’s Leigh’s syndrome diagnosis. See id.
After the diagnosis was made, Dr. Haas wrote a letter in which he stated: “Trystan Evan
Sanchez has a mitochondrial disease caused by Complex II deficiency of the respiratory
chain. This is a genetic disease causing in Trystan dystonia, developmental delay,
encephalopathy, neuromuscular disease[, and an] abnormal MRI.” Id. In the letter, Dr.
Haas did not link Trystan’s condition to the vaccinations. See id. Finally, the special
master considered Dr. Haas’ statement that due to his Leigh’s syndrome, “‘it is medically
acceptable for [Trystan] to avoid immunizations.’” Id. The special master concluded
that “a recommendation to avoid vaccinations is not necessarily the same as a statement
that a vaccine caused an injury.” Id.
And fourth, Dr. Derek Wong saw Trystan on January 28, 2016. In recording
Trystan’s history, Dr. Wong quoted from Dr. Haas’ notes and documented Ms. Sanchez’s
recollection of Trystan’s developmental delays. See id. at 79. Dr. Wong acknowledged
Trystan’s Leigh’s syndrome diagnosis, and noted that his “manifestations include
developmental regression, following vaccines and/or viral syndrome.” Id. at 80. In the
special master’s view, “Dr. Wong’s record provides little assistance to [petitioners]”
because “[a]t best . . . Dr. Wong recognizes a temporal sequence in which Trystan’s
developmental regression ‘follow[ed] vaccines and/or viral syndrome.’” Id.
To summarize his findings based on the treating physician’s reports, the special
master stated:
In summary, the records from four doctors who treated Trystan do not help
[petitioners] meet their burden of showing that the DTaP vaccination
contributed to Trystan’s Leigh’s syndrome. Dr. Friedman presented her
opinion before Trystan’s Leigh’s syndrome was diagnosed after genetic
studies. Dr. Sharma and Dr. Haas obtained histories that are not entirely
accurate. Even so, Dr. Sharma, Dr. Haas, and Dr. Wong appear to present
temporal sequences. Accordingly, while these reports have been considered,
they do not constitute persuasive evidence for [petitioners].
Id.
3. Third Althen Factor
In his analysis of the third Althen factor, the special master explained that the
inquiry has two parts. See id. at 34. “[T]he proximate temporal relationship prong
requires preponderant proof that the onset of symptoms occurred within a timeframe for
which, given the medical understanding of the disorder’s etiology, it is medically
acceptable to infer causation-in-fact.” Id. (quoting de Bazan, 539 F.3d at 1352). In other
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words, “[a] petitioner must show the ‘timeframe for which it is medically acceptable to
infer causation’ and that the onset of the disease occurred in this period.” Id. (quoting
Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542-43 (2011), recons.
denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d without op. 503 F.
App’x 952 (Fed. Cir. 2013)). The parties dispute both parts of the third Althen factor.
With regard to the appropriate timeframe for inferring causation, the special
master reviewed a series of medical journal articles in his first entitlement decision,
which he concluded were not comprehensive, but “suggested that neurodegeneration
would occur within approximately two weeks.” Id. at 35. The special master also noted,
however, that on the basis of the Federal Circuit’s decision in Paluck, 786 F.3d at 1383,
he would not set a “hard and fast deadline.” Id. Because the Federal Circuit did not
“correct this approach” on appeal, the special master did not revise the approach on
remand. Id. at 38.
The second part of the third factor required the special master to determine
“whether [petitioners] presented persuasive evidence that Trystan began to suffer lasting
neurologic problems within approximately two weeks of the vaccination.” Id. He
concluded that, based on his analysis of the second Althen factor, that petitioners had
failed to carry this burden. See id.
Specifically, the special master found that within two weeks of his February 5,
2009 vaccinations, Trystan “experience[d] two episodes”—the “fever, inconsolable
crying and a mark on his leg” the night after receiving the vaccinations, and “fever,
congestion, restlessness, jerking around, and arm contortions” eleven days later. Id. at
66. The special master concluded, however, that the two episodes lacked context to
suggest they were “behaviors that suggested any neurologic problems from February 17,
2009, to at least May 1, 2009.” Id. Accordingly, the special master held that Trystan’s
neurologic problems began “well beyond the approximate two-week onset of symptoms
anticipated by [petitioners’] medical theory,” and as such, petitioners had failed to carry
their burden with regard to the third Althen factor.9 Id. at 66-67.
C. Motion for Review
Petitioners’ motion for review now before the court proceeds in four parts. First,
petitioners allege that the special master went beyond the Federal Circuit’s mandate on
remand by considering additional evidence and expert testimony with regard to Trystan’s
9 The special master noted in his decision that “[t]o be clear, in determining that
[petitioners] have not met their burden regarding prong 3, [he did] not consider[] the effect of the
colds for which Trystan was treated on April 29, 2009 and May 13, 2009.” ECF No. 253 at 67
n.37.
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arm contortions, and relied on an “unfounded newly created fact” as a result. ECF No.
260 at 27, 24-42. Second, petitioners argue that the special master arbitrarily and
capriciously failed to consider the record as a whole in determining whether petitioners
carried their burden to prove causation, including with regard to their challenge-
rechallenge theory. See id. at 42-51. Third, petitioners argue that the special master
arbitrarily and capriciously failed to consider the record as a whole in concluding that the
infections Trystan suffered between February and May 2009 caused his Leigh’s
syndrome to manifest independent of the vaccines. See id. at 51-54. And finally,
petitioners argue that the special master’s decision that Trystan’s Leigh’s syndrome was
the sole and substantial cause of his neurological condition was arbitrary and capricious
because he relied on only one reference. See id. at 54-74.
The court will only review the first two of petitioners’ four arguments. As the
court has previously explained, in reviewing the initial entitlement decision in this case,
the Federal Circuit concluded that, in his causation analysis, the special master did not
carefully delineate between the second and third Althen factors, and directed the special
master to do so on remand. See Sanchez, 809 F. App’x at 853. The Circuit explained
that:
it is important for the special master to make explicit findings as to two
separate issues: (1) whether there was a logical sequence of cause and effect
linking Trystan’s vaccinations and his injuries as well as a proximate
temporal relationship between the vaccinations and the onset of the injuries;
and (2) whether Trystan’s infections between February and May of 2009
caused the manifestation of his Leigh’s syndrome, independent of his
vaccinations.
Id. If, however, “the special master finds that the petitioners have not met their burden as
to the first issue, it is unnecessary for the special master to address the second issue.” Id.
In the post-remand entitlement decision, the special master found that petitioners did not
meet their burden on the first issue, and the court sustains that decision in this opinion.
Accordingly, as the Federal Circuit explicitly stated, addressing the second issue is
unnecessary.
The court will likewise refrain from review of the special master’s determination
that Trystan’s genetic mutations “constitute the sole substantial cause of [his] Leigh’s
syndrome.” ECF No. 253 at 81. The special master considered this question in response
to the Federal Circuit’s comment in its decision remanding this case for further
proceedings that “it may be necessary for the special master to address . . . whether the
Secretary showed, because of Trystan’s mutations, the timing and severity of his Leigh’s
syndrome would have been the same, regardless of the effect of the vaccinations.”
Sanchez, 809 F. App’x at 855; see also ECF No. 253 at 20 (special master noting the
Federal Circuit’s invitation to consider this issue further). Because the court sustains the
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special master’s conclusion that petitioners have not met their burden to prove causation
under Althen, the special master’s decision on this alternative theory is unnecessary to
sustain his entitlement decision. Accordingly, the court declines to review the strength of
the scientific data bearing on the likely manifestation of Trystan’s Leigh’s syndrome
absent administration of the vaccines.
1. Evidence and Testimony Regarding Trystan’s Arm Contortions
a. Scope of the Mandate
As an initial matter, petitioners argue that the special master “went beyond the
scope of the [m]andate by ordering additional expert reports and testimony on the issue of
whether the arm contortions in February of 2009 were consistent with a cold.” ECF No.
260 at 24. According to petitioners, the Federal Circuit wanted the special master “to
address causation given his finding of the arm contortions on February 16, 2009 and
given that the finding that it was consistent with a cold was unsupported.” Id. (emphasis
in original). Petitioners, therefore, ask the court to exclude “any new facts obtained from
the expert reports filed post remand and/or at the Remand hearing on July 10, 2020.” Id.
“The mandate rule provides that ‘issues actually decided [on appeal]—those
within the scope of the judgment appealed from, minus those explicitly reserved or
remanded by the court—are foreclosed from further consideration’” Amado v. Microsoft
Corp., 517 F.3d 1353, 1360 (Fed. Cir. 2008) (quoting Engel Indus., Inc. v. Lockformer
Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999)). “Unless remanded by [the appellate] court,
all issues within the scope of the appealed judgment are deemed incorporated within the
mandate and thus are precluded from further adjudication.” Engel, 166 F.3d at 1383.
Petitioners fundamentally misunderstand the Federal Circuit’s decision on this
point. The relevant section of the opinion reads as follows:
In support of their argument on causation, the petitioners point to testimony
from their experts that Trystan’s fever and inconsolable crying were
evidence of the onset of neurodegeneration, and that Trystan’s arm
contortions on February 16, 2009, only 11 days after his vaccinations, were
also indicative that he had suffered an adverse neurological event.
The special master rejected that argument, in large part because he
concluded that Trystan was diagnosed with a cold on February 17, and that
his symptoms the night before were of the type typically displayed by
infants suffering from a cold. The petitioners do not challenge the finding
that Trystan was suffering from a cold, but they contend that the evidence
shows that he was also suffering from a neurological injury at that time. In
particular, the petitioners dispute the special master’s finding that Trystan’s
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symptoms—his arm contortions in particular—were symptoms of a cold.
That finding, they contend, is wholly lacking in record support.
Analyzing this issue is complicated by the manner in which the special
master made factual findings relating to the events of February 16, 2009. In
his 2013 Ruling Finding Facts, the special master found that although
Trystan “kept kicking his feet and jerking around” in his father’s arms on
that evening, he “did not begin to exhibit arm contortions” at that time, and
he “did not exhibit arm contortions” between that time and the time Ms.
Sanchez took him to the doctor in late April 2009. In the 2018 Published
Decision Denying Compensation, however, the special master found that on
that evening, Trystan’s “arms contorted and he was jerking around.”
That discrepancy is significant. The government’s expert witnesses,
testifying based on the special master’s 2013 findings, said that the
symptoms exhibited by Trystan on the night of February 16, 2009—
inconsolable, high-pitched crying and “jerking around” in his father’s
arms—were consistent with a cold and were not indicative of a seizure.
However, the government’s witnesses did not have before them the special
master’s later finding that Trystan’s arm contortions began as early as
February 16. Moreover, if the special master’s 2018 finding was based on
the testimony of Trystan’s father, it seems plausible that Mr. Sanchez’s
testimony—that Trystan repeatedly held his arm behind his back and kept
returning it to that position—could be regarded as evidence of a seizure or
dystonia, as the petitioners’ expert Dr. Steinman testified. And a seizure or
dystonia at that time, Dr. Steinman testified, “could be evidence of brain
damage.”
Importantly, because of the change in the findings made with respect to the
arm contortions, the special master’s finding that Trystan’s behavior on the
night of February 16 was consistent with a cold is not supported by expert
testimony that specifically addressed the arm contortions. Because this
issue is of central importance to the causation analysis, it is necessary to
remand for further consideration of the causation issue in light of the special
master’s findings in 2018 regarding Trystan’s arm contortions.
Sanchez, 809 F. App’x at 852-53. Contrary to petitioner’s assertion, the Federal Circuit
did not find that the special master’s conclusion that Trystan’s arm contortions on
February 16, 2009, were consistent with a cold to be definitively unsupported by the
evidence. The court agrees with respondent’s assertion that “the Federal Circuit made
plain that the question remained open as to whether the arm contortions were evidence of
a seizure, dystonia, or a cold, because respondents’ experts had not been permitted, prior
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to the special master’s 2018 Decision, to offer testimony on this fact pattern.” ECF No.
265 at 20-21 n.15.
Because the Circuit explicitly remanded this case for further consideration of
causation as a result of the out-of-date information on which some experts based their
opinions, the special master did not exceed the scope of the mandate by allowing the
experts to supplement their opinions. See Amado, 517 F.3d at 1360. In the court’s view,
the special master’s decision to consider further expert reports and testimony on the
causation issue in light of the finding that Trystan contorted his arms on February 16,
2009, is a logical correction of the error identified by the Federal Circuit.
b. Frequency of Trystan’s Arm Contortions
Petitioners next argue that the special master erred when he “failed to consider the
record as a whole,” and relied upon “a critical unfounded newly created fact” in reaching
his decision. ECF No. 260 at 27. According to petitioners, the special master’s
conclusion that Trystan’s arm contortions on February 16, 2009 “were a one-time event
. . . . is without any evidentiary basis,” and they insist that “the evidence is
overwhelmingly at odds with this newly created finding.” Id. at 28.
Petitioners assert that the “newly created fact permeates the entire Remand
Decision,” id. at 27, but the root of the objection appears to be the special master’s
conclusion that “Trystan did not display any neurologic problems for weeks after the
February 16, 2009 incident,” ECF No. 253 at 43. According to petitioners, the evidence
shows that “Trystan suffered the arm contortions for at least a month and several times a
day.” ECF No. 260 at 34. They also suggest that had the special master properly
considered the evidence, he would have concluded that it demonstrated “a progression of
symptoms,” indicating neurological injury. Id. at 34.
As an initial matter, the special master’s post-remand decision does not say that
Trystan’s arm contortions were a “one-time event.” That phrase, as used by petitioners,
is misleading. The special master, in fact, found that “Trystan contorted his arm on
February 16, 2009, [but] this isolated event was not a manifestation of a neurologic
problem. For the relevant time after the February 5, 2009 vaccine, Trystan was
developing normally.” ECF No. 253 at 98 (emphasis added). In discussing Trystan’s
arm contortions as an isolated event, the special master was designating the event as
isolated only within the relevant timeframe. Elsewhere in the opinion, the special master
noted that Trystan did develop neurological problems, but found that those problems
manifested “no sooner than May 1, 2009.” Id. at 97; see also ECF No. 45 at 14 (noting in
the 2013 Ruling Finding Facts that Trystan contorted his arms on August 8, 2009).
Accordingly, to the extent that petitioners expand the inquiry beyond the relevant
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timeframe—which they do not seriously contest in their motion for review10—the
argument is immaterial to the special master’s conclusions with regard to whether
petitioners have carried their burden under Althen. See ECF No. 260 at 28 (noting, but
not objecting to, the special master’s conclusion that “he would again primarily look for
evidence of neurologic decline within two weeks of the vaccination,” but “if Trystan’s
neurologic decline were to occur slightly outside of two weeks, then [petitioners] could
meet their burden regarding Althen prong three”); see also ECF No. 253 at 36 (noting
that petitioners argued in post-remand briefing that “neurodegeneration would often
occur within two weeks, possibly three weeks after the inciting event”) (citing ECF No.
247 at 53-64).
A vast majority of petitioners’ lengthy argument on this point invites the court to
reweigh the evidence considered by the special master. See ECF No. 260 at 33-42. Such
an exercise is not permitted by the scope of this court’s review. The court does not
“reweigh the factual evidence, assess whether the special master correctly evaluated the
evidence, or examine the probative value of the evidence or the credibility of the
witnesses—these are all matters within the purview of the fact finder.” Porter, 663 F.3d
at 1249. On review, “reversible error is ‘extremely difficult to demonstrate’ if the special
master ‘has considered the relevant evidence of record, drawn plausible inferences and
articulated a rational basis for the decision.’” Lampe, 219 F.3d at 1360 (quoting Hines,
940 F.2d at 1528). Accordingly, the court will restrict its analysis to whether petitioners
have identified either any relevant evidence of record not considered by the special
master or any implausible inferences drawn by the special master, and whether
petitioners have demonstrated that the special master failed, in this case, to articulate a
rational basis for his decision.
In support of their argument that the special master erred in finding that “Trystan
did not display any neurologic problems for weeks after the February 16, 2009 incident,”
ECF No. 253 at 43, petitioners point to two categories of evidence—medical records and
family testimony, see ECF No. 260 at 29-33.
Petitioners identify the following medical records as relevant to establishing the
frequency of Trystan’s arm contortions: (1) August 17, 2009 well-visit notes; (2) Dr.
10 The only reference to petitioners’ disagreement with the special master’s definition of the
relevant time frame is in a footnote, in which petitioners state “[p]etitioners do not agree as
previously outlined in their Federal Circuit appeal that onset symptoms must occur within two
weeks of the vaccination. However, for purposes of this Motion for Review, the arm contortions
did occur within approximately two weeks.” ECF No. 260 at 50-51 n.21. This assertion is an
insufficient basis for a substantive review of the relevant time frame, as determined by the
special master. Petitioners must advance their relevant arguments at each stage of the
proceedings, and the court cannot be charged with an obligation to review prior filings to discern
which arguments petitioners are reasserting.
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Michelson’s November 12, 2009 notes; (3) December 24, 2009 pediatrician notes; (4) Dr.
Katrina Dipple’s May 10, 2010 notes; (5) Dr. Friedman’s August 2, 2010 notes; and (6)
Dr. Haas’s August 7, 2012 notes. As outlined above, the special master explicitly
considered and discussed four of these six reports. See e.g., ECF No. 253 at 8, 69-72
(discussing Ms. Marin-Tucker’s August 17, 2009 notes); id. at 8-9, 74-75 (discussing Dr.
Michelson’s November 12, 2009 notes); id. at 8-9, 14, 74 (discussing Dr. Friedman’s
August 2, 2010 notes); id. at 10, 13, 58-59, 76-78 (discussing Dr. Haas’s August 7, 2009
notes). Accordingly, any argument that the special master failed to consider this
evidence is unfounded.
Moreover, it was not implausible for the special master to conclude that these
notes failed to establish preponderant evidence that Trystan’s arm contortions on
February 16, 2009, were not an indication of neurological injury. Of these records, only
two include notes that specifically indicate that Trystan’s arm contortions happened
repeatedly. Dr. Friedman’s August 2, 2010 notes state that Trystan’s episodes of arm
contortions “would happen again intermittently, maybe 10 times a day, lasting a minute
or two at a time,” and “continued [with] high frequency for about a . . . month.” ECF No.
6-5 at 24. And Dr. Haas’ August 7, 2010 notes state that “11 days after [his six-month]
vaccination, he had an episode of ‘contortion’ in the upper limbs,” for “minutes at a
time,” and “continued [with] high frequency for about a . . . month.” See ECF No. 48-1
at 1. In his entitlement decision, however, the special master specifically considered the
notes made by Trystan’s treating physicians, including both Dr. Friedman and Dr. Haas,
but found them unpersuasive evidence for petitioners.
Dr. Friedman’s notes were the source of some debate between the parties as early
as 2014, and the special master specifically instructed the parties that their experts were
not to rely on “Dr. Friedman’s record for the basis of events in Trystan’s life between
February 2009 through November 2009.” ECF No. 253 at 9 (citing ECF No. 63 at 2
(January 31, 2014 order)). The special master found Dr. Friedman’s notes unreliable for
the purpose of establishing Trystan’s history prior to her August 2, 2010 examination
because they were not a contemporaneous record of his condition, and instead were
petitioners’ “account of remote events in Trystan’s life.” Id. Indeed, just before the
passage cited by petitioners, Dr. Friedman notes that Trystan “was accompanied to the
visit today by his parents who provided the his[to]ry.” ECF No. 6-5 at 24. The special
master repeated his concern with the passage of time in the post-remand decision, and
discounted the value of Dr. Haas’ notes—which were made two years after Dr.
Friedman’s—for the same reason. See ECF No. 253 at 58, 74.
The final two medical records identified by petitioners as evidence contrary to the
special master’s findings are of no assistance to their case. Petitioners are correct that the
December 24, 2009 pediatrician’s note states as follows: “extremity contracted upper
and lower extremities, spastic quadriplegia of all extremities.” ECF No. 6-2 at 26. It also
states: “Neurologic exam: normal for age.” Id. And Dr. Dipple’s May 10, 2010 notes
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included the following assessment under “review of systems”: “Neurologic: global
developmental delay, abnormal movements, hypertonicity.” Id. at 45. Even assuming
that either doctor’s note intended to record arm contortions, they appear to relate solely to
Trystan’s condition on the date of the exam and do not speak to his condition in the
weeks following his February 5, 2009 vaccinations, nor do they speak to a pattern within
the relevant time period.
Petitioners also object to what they claim was the special master’s failure to fairly
consider testimony from petitioners’ family members about Trystan’s condition with
regard to the frequency of his arm contortions. See ECF No. 260 at 31-33. They include
the following: (1) testimony about Trystan’s condition at a family gathering in March
2009; (2) Ms. Sanchez’s testimony with regard to Trystan’s condition as reported at his
April 2009 doctor’s visit; (3) Mr. Sanchez’s testimony about Trystan’s condition at the
time of his May 13, 2009 doctor’s visit; (4) testimony about Trystan’s condition the day
of Ms. Sanchez’s baby shower on August 8, 2009; and (5) Mr. Sanchez’s testimony that
Trystan continued to contort his arms prior to his April 2009 doctor’s visit. See id.
As previously noted, petitioners acknowledge, but do not dispute, the special
master’s conclusion that “he would again primarily look for evidence of neurologic
decline within two weeks of the vaccination,” but “if Trystan’s neurologic decline were
to occur slightly outside of two weeks, then [petitioners] could meet their burden
regarding Althen prong three.” See ECF No. 260 at 28. After Trystan’s visit with Mr.
Luna on February 17, 2009, he was next seen by a medical provider on April 29, 2009,
when he was diagnosed with an ear infection and bronchitis by Dr. Seleem. See ECF No.
253 at 67. Dr. Seleem reported “[n]o unusual arm movements or developmental issues,”
and “noted ‘[n]o neurological symptoms.’” Id. (citations omitted).
The court has reviewed the family testimony identified by petitioners, and has
found several instances in which that testimony indicates that Trystan contorted his arms
in the days following his February 17, 2009 appointment with Mr. Luna. See ECF No.
33 at 34-36 (Lupe Sanchez’s testimony); 156 (Emma Fernandez’s testimony); 189-90
(Germain Sanchez’s testimony). This testimony was taken on May 15, 2012, prior to the
special master’s 2013 Ruling Finding Facts. See id. at 2.
In the special master’s 2013 Ruling Finding Facts, he stated:
12. Sometime [after February 17, 2009], Trystan’s extended family
gathered to watch a boxing match. During this gathering, Trystan was sick,
crying, fussy, and congested. He was not contorting his arms nor was he limp
or rigid.
13. Between Jennifer’s birthday and the next time she took him to the
doctor nearly two months later in late April, Trystan suffered from cough and
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congestion episodically. During this time, he did not lose control of his head
and trunk, nor did he stop making eye contact or stop wanting to play
anymore. He did not exhibit arm contortions.
ECF No. 45 at 13 (citations omitted). The special master specifically relies on these
findings in his post-remand decision, and characterizes “[t]hese facts [as] not contested.”
ECF No. 253 at 63. As such, the question before the court is whether the special master
erred in relying on these findings of fact in rendering his post-remand decision without
more explicitly explaining the basis on which he had previously reached these
conclusions. The court finds that such reliance was not in error.
These factual findings were clearly part of the record well in advance of the
Federal Circuit’s review, having been issued on April 10, 2013. See ECF No. 45. The
court further notes that Trystan’s condition between February 17, 2009 and April 29,
2009 was the subject of much debate between the parties. The special master explains, in
his post-remand decision, that the available medical records were at odds with the
recollection of certain family members. See ECF No. 253 at 4-5. In an effort to resolve
the factual dispute, the special master held a hearing on May 15, 2012, at which he heard
testimony from five family members. See id. at 6-7. He then directed the parties to work
through their factual disputes, and based in part on the parties’ efforts, the special master
issued his 2013 Ruling Finding Facts. See id. at 7. It, therefore, appears to the court that
the special master not only invited the testimony from petitioners’ family members, but
went through a deliberate process of reaching factual findings considering the evidence
before him.
Furthermore, in its decision remanding this case to the special master, the Federal
Circuit specifically noted the conflict between the family’s testimony and the medical
records relating to Trystan’s condition after the February 17, 2009 examination:
Trystan suffered from coughing and congestion episodically for the next
couple of months. Ms. Sanchez testified that during that period, Trystan
continued to have arm contortions, sometimes several times a day. In
addition, she testified that Trystan “started to lose control of his head,” that
his “trunk . . . was not as strong,” that he “didn’t have any eye contact,” and
that he “didn’t want to play” anymore. Again, however, the special master
did not credit Ms. Sanchez’s testimony because it was not corroborated by
medical reports.
Sanchez, 809 F. App’x at 846. Despite having discussed this factual dispute, the Circuit
neither criticized the special master’s conclusion, nor remanded the case for further
consideration on this point. The Circuit’s conclusion with regard to arm contortions
related only to the need to clarify the causation analysis in light of the discrepancy in the
record with regard to whether Trystan contorted his arms on the night of February 16,
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2009. See id. at 852-53. Accordingly, because whether the special master failed to
appropriately consider the family’s testimony in making his 2013 factual findings was
“within the scope of the judgment appealed from,” but was not “explicitly reserved or
remanded” by the Circuit, it is “foreclosed from further consideration” by this court.
Amado, 517 F.3d at 1360.
For the foregoing reasons, the court finds that petitioners have not identified any
relevant evidence of record that the special master failed to consider or any implausible
inferences drawn by the special master with respect to whether Trystan contorted his
arms in the weeks following February 16, 2009. In addition, the court finds that
petitioners have not demonstrated that the special master failed to articulate a rational
basis for his decision in this regard. The special master’s decision on this issue,
therefore, is sustained. See Lampe, 219 F.3d at 1360.
2. Petitioners’ Failure to Prove Causation
In its remand decision, the Federal Circuit found that the special master
improperly combined the analysis of the second and third Althen factors. See Sanchez,
809 F. App’x at 853. The Circuit directed the special master to consider “whether there
was a logical sequence of cause and effect linking Trystan’s vaccinations and his injuries
as well as a proximate temporal relationship between the vaccinations and the onset of
the injuries.”11 Id. As is reflected in the court’s summary of the special master’s post-
remand entitlement decision, the special master reviewed the record in painstaking detail
with regard to petitioners’ proof of causation. In their motion for review, petitioners do
not argue that the special master failed to comply with the mandate, but argue that he
nevertheless committed reversible error in his analysis of the issues.
a. Second Althen Factor and the Challenge-Rechallenge Theory
The second Althen factor requires the special master to determine whether
petitioners have demonstrated, by a preponderance of the evidence, “a logical sequence
of cause and effect showing that the vaccination was the reason for the injury.” Althen,
418 F.3d at 1278. As the court summarized above, the special master considered at great
length the issue of whether petitioners had met this burden. See ECF No. 253 at 38-50.
He ultimately concluded as follows:
11 The Federal Circuit also instructed that the special master should consider “whether
Trystan’s infections between February and May of 2009 caused the manifestation of his Leigh’s
syndrome, independent of his vaccinations,” but only if petitioners meet their burden to show the
requite logical sequence of cause and effect and proximate temporal relationship. Sanchez, 809
F. App’x at 853. Because the court sustains the special master’s conclusion that petitioners did
not make the initial showing, the second analysis is unnecessary.
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In sum, this section . . . has considered both how [petitioners’] experts
predicted an adverse reaction to the vaccination would appear and how
Trystan actually appeared. Because of the dichotomy between the predicted
and the actual, the sequence of events is not logical. Thus, [petitioners] have
not met their burden regarding prong 2.
Id. at 75.
In their motion for review, petitioners criticize the special master for finding flaws
with Trystan’s treating physicians’ notations that the vaccine may have caused his
injuries. See ECF No. 260 at 43. Petitioners claim that each of the doctors was “thinking
about the vaccination as being the cause of Trystan’s issues.” Id. Even assuming this to
be the case, the special master fully considered the records, and articulated a rational
basis for discounting the notes that suggested that a vaccination caused Trystan’s injuries.
The court will not reweigh the evidence or review the special master’s credibility
determinations. Porter, 663 F.3d at 1249.
To summarize his findings based on the treating physician’s reports, the special
master stated:
In summary, the records from four doctors who treated Trystan do not help
[petitioners] meet their burden of showing that the DTaP vaccination
contributed to Trystan’s Leigh’s syndrome. Dr. Friedman presented her
opinion before Trystan’s Leigh’s syndrome was diagnosed after genetic
studies. Dr. Sharma and Dr. Haas obtained histories that are not entirely
accurate. Even so, Dr. Sharma, Dr. Haas, and Dr. Wong appear to present
temporal sequences. Accordingly, while these reports have been considered,
they do not constitute persuasive evidence for [petitioners].
ECF No. 253 at 80. The court finds this explanation, and the extensive discussion of
each doctor’s records that preceded it, see id. at 75-80, sufficient to survive this court’s
review.
Next, petitioners argue that the special master erred in finding that they did not
meet their burden with regard to the second Althen factor because the “evidence shows
that Trystan[’s] response to the DTAP vaccine was consistent with the theories
articulated.” ECF No. 260 at 44 (emphasis in original). Specifically, petitioners contend
that Trystan experienced symptoms that were “[c]onsistent with the vaccine package
insert,” such as “fever, inconsolable crying and fussiness within the time indicated,” and
that his condition thereafter was consistent with the medical theories articulated by their
experts, Dr. Steinman and Dr. Niyazov. Id. Petitioners then claim that the special master
did not consider all of the relevant evidence because he did not discuss the fact that
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“Trystan did experience what one would expect based on Dr. Steinman’s theories and Dr.
Niyazov’s theory.” Id.
This argument is simply not supported by the record. The special master
thoroughly discussed the competing medical theories over the course of dozens of pages
in his post-remand decision. See ECF No. 253 at 41-75. The fact that his analysis was
perhaps not organized in the way petitioners would have preferred, or did not reach the
conclusion they would have favored, does not make it legally deficient.
Petitioners’ final challenge to the special master’s decision on the second Althen
factor relates to their assertion of a challenge-rechallenge theory. See ECF No. 260 at
45-48. In the post-remand decision, the special master noted that “‘[a] rechallenge event
occurs when a patient who had an adverse reaction to a vaccine suffers worsened
symptoms after an additional injection of the vaccine.’” ECF No. 253 at 72 (quoting
Capizzano, 440 F.3d at 1322). He also noted Dr. Raymond’s testimony that “‘[t]he
challenge should meet the criteria of same latency and same effects, and must exclude
well-accepted alternative explanations.’” Id. And although the special master did not
explicitly require that the challenge and rechallenge event be the same, he noted a long
list of cases that tend to support Dr. Raymond’s opinion, and notes that similarity
between the events “would seem to contribute to the strength of the challenge-rechallenge
paradigm.”12 Id. at 73.
Ultimately, the special master concluded as follows:
Dwelling on the nuanced points of challenge-rechallenge seems unnecessary
in this case. [Petitioners] have not established the challenge aspect. As
explained above, [petitioners] have not presented preponderant evidence that
Trystan suffered any neurologic problem within at least one month of the
February 5, 2009 vaccine. And, by simple definition, without a “challenge,”
there can be no “rechallenge.”
Id.
In the motion for review, petitioners do not contest that a challenge is necessary
before a rechallenge can be established; instead, they insist that they have demonstrated a
challenge event, and that the special master committed reversible error in finding
12 In their motion for review, petitioners claim that the special master “impermissibly
rais[es] the burden of proof” by requiring them to show that the rechallenge reaction and timing
are “exactly the same” as the challenge reaction. ECF No. 260 at 47. The special master,
however, was not so categorical. The court does not understand his statement that similarity in
reaction and timing “would seem to contribute to the strength of the challenge-rechallenge
paradigm,” to raise petitioner’s burden beyond a preponderant showing. ECF No. 253 at 73.
33

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otherwise. See ECF No. 260 at 46-48. The primary basis for petitioners’ argument on
this point is their insistence that Trystan’s arm contortions on February 16, 2009 were
evidence of a neurologic injury.
Petitioners have identified no evidence of record that the special master failed to
consider, nor any implausible inference that he made. See Lampe, 219 F.3d at 1360.
Moreover, petitioners effectively ask the court to reweigh the evidence related to whether
Trystan suffered a neurologic injury on February 5, 2009, and to judge the credibility of
witnesses, two tasks that fall outside the scope of this court’s review. Porter, 663 F.3d at
1242. For this reason, the court sustains the special master’s conclusion that petitioners
have not demonstrated a challenge-rechallenge injury.
b. Third Althen factor
The third Althen factor requires petitioners to prove, by preponderant evidence, “a
proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at
1278. As the special master noted at the outset of his discussion of the third Althen factor
in his post-remand decision:
“[T]he proximate temporal relationship prong requires preponderant proof
that the onset of symptoms occurred within a timeframe for which, given the
medical understanding of the disorder’s etiology, it is medically acceptable
to infer causation-in-fact.” de Bazan v. Sec’y of Health & Human Servs.,
539 F.3d 1347, 1352 (Fed. Cir. 2008). Thus, the third prong of Althen
implicitly has two parts. A petitioner must show the “timeframe for which it
is medically acceptable to infer causation” and that the onset of the disease
occurred in this period. Shapiro v. Secʼy of Health & Human Servs., 101
Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other grounds,
105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir.
2013).
ECF No. 253 at 34.
In his initial entitlement decision, the special master found—based on a review of
the available medical literature and caselaw—that the relevant time period for
establishing Trystan’s injury was approximately two weeks, but declined to set a hard
deadline. He summarized this approach in the post-remand decision, as follows:
While [the cited] cases suggest that sometimes the interval between the
vaccination and the onset of symptoms is too long to support a finding of
causation-in-fact, Paluck cautions against defining the limits too rigidly.
With this guidance, the undersigned attempted to point out that the evidence,
imperfect as it might be, seemed to coalesce around a finding that two weeks
34

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from vaccination to the onset of neurologic decline is an interval that would
support a finding of causation. Decision at 25, 2018 WL 5856556, at *15.
Yet, at the same time, the undersigned tried to balance what the evidence
showed with Paluck’s recognition that more studies would be helpful. Cf.
Sharpe v. Sec’y of Health & Human Servs., 964 F.3d 1072, 1083 (Fed. Cir.
2020) (criticizing special master for noting that different evidence could lead
to a different result).
On appeal, the Federal Circuit did not correct this approach. Because the
mandate does not remand for reconsideration of the first part of Althen prong
3, the undersigned will again primarily look for evidence of neurologic
decline within two weeks of the vaccination. However, if Trystan’s
neurologic decline were to occur slightly outside of two weeks, then
[petitioners] could meet their burden regarding Althen prong 3.
Id. at 37-38. On this basis, the special master concluded that petitioners failed to show an
injury within approximately two weeks because “[w]hen the record is considered as a
whole, the symptoms that Trystan displayed on February 5, 2009, as well as on February
15-16, 2009, including his arm contortions, are not manifestations of a neurologic
disorder.” Id. at 38.
Petitioners make no substantive argument on this point in their motion for review.
After summarizing the Federal Circuit’s decision, recounting the special master’s
conclusion as articulated in the post-remand decision, and repeating their disagreement
with the special master’s finding that Trystan’s arm contortions on February 16, 2009,
were not evidence of an neurologic injury, see ECF No. 260 at 49-50, petitioners state as
follows:
If the record as a whole was properly considered, then the evidence
overwhelmingly shows that the arm contortions, like in Markovich,
continued for at least a month and several times a day. The failure to consider
and analyze the record as a whole was error and arbitrary and capricious.
Petitioners submit that the arm contortions, at minimum, commenced within
the time parameters outlined by [the special master]. The full analysis on
Temporal Association is within Petitioner’s Post Remand Hearing Brief filed
July 29, 2020 at pages 39-64. This Remand Decision, accordingly, must be
set aside.
Id. at 51.
The court finds this argument unconvincing for several reasons. First, as the court
has discussed at length in this opinion, it sustains the special master’s conclusion that
Trystan’s arm contortions on February 16, 2009, were not a manifestation of neurologic
35

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injury. As such, to the extent that petitioners’ argument is premised on a foundational
disagreement on that point, it cannot succeed. Second, if there is more to petitioners’
argument than has been previously addressed, it is insufficient for petitioners to simply
assert that the special master failed to consider the record as a whole without identifying
the specific errors. And finally, petitioners cannot incorporate by reference their July 29,
2020 post-remand hearing brief into their motion for review. Petitioners must advance
their relevant arguments at each stage of the proceedings, and the court cannot be charged
with an obligation to review prior filings to discern which arguments petitioners are
reasserting. Moreover, the July 29, 2020 brief was filed before the special master issued
his post-remand decision. Thus, any arguments made therein would need to be addressed
in light of his new decision to have any bearing on this court’s review thereof.
For the foregoing reasons, the court finds that petitioners have identified no
evidence of record that the special master failed to consider, nor any implausible
inference he made with regard to the third Althen factor, and have not shown that his
decision lacked a rational basis. See Lampe, 219 F.3d at 1360. Accordingly, the special
master’s conclusion that petitioners have not carried their burden on the third Althen
factor is sustained.
IV. Conclusion
The court reiterates the acknowledgement, by the Federal Circuit and the special
master, of petitioners’ dedication to their son as demonstrated by their commitment to
this long and complicated litigation. The court’s decision to sustain the special master’s
post-remand decision is made after careful consideration of the record, and with respect
for petitioners’ position.
For the above-stated reasons, however, the court sustains the entitlement decision
of the special master. Accordingly,
(1) Petitioners’ motion for review, ECF No. 260, is DENIED;
(2) The decision of the special master, filed on August 26, 2020, ECF No. 253,
is SUSTAINED;
(3) The clerk’s office is directed to ENTER final judgment in accordance with
the special master’s August 26, 2020 decision; and
(4) The parties shall separately FILE any proposed redactions to this opinion,
with the text to be redacted blacked out, on or before February 26, 2021.
IT IS SO ORDERED.
36

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s/Patricia E. Campbell-Smith
PATRICIA E. CAMPBELL-SMITH
Judge
37

================================================================================
DOCUMENT 4: USCOURTS-cofc-1_11-vv-00685-5
Date issued/filed: 2021-03-22
Pages: 37
Docket text: **REVERSED PURSUANT TO 284 C.A.F.C. MANDATE, DATED AUGUST 11, 2022. ** JUDGE VACCINE REPORTED OPINION initially filed February 12, 2021, 273 JUDGE VACCINE OPINION denying 260 Motion for Review, and SUSTAINING the special master's August 26, 2020 253 decision. Signed by Judge Patricia E. Campbell-Smith. (tjk) Service on parties made. Due to Clerk's Office error this documents was previously removed. Modified on 8/18/2022 (tjk).
--------------------------------------------------------------------------------
Case 1:11-vv-00685-EDK Document 286 Filed 03/22/21 Page 1 of 37
In the United States Court of Federal Claims
No. 11-685V
(E-Filed: March 22, 2021)1
)
TRYSTAN SANCHEZ, by and )
through his parents, GERMAIN and )
JENNIFER SANCHEZ, )
)
Petitioners, ) Vaccine; National Childhood Vaccine
) Injury Act of 1986, 42 U.S.C.
v. ) §§ 300aa-1 to -34; Scope of Remand;
) Review of Special Master’s Decision.
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
Lisa A. Roquemore, Rancho Santa Margarita, CA, for petitioners.
Jennifer L. Reynaud, Trial Attorney, with whom were Jeffrey Bossert Clark, Acting
Assistant Attorney General, C. Salvatore d’Alessio, Acting Director, Catherine E.
Reeves, Deputy Director, Heather L. Pearlman, Assistant Director, Torts Branch, Civil
Division, United States Department of Justice, Washington, DC, for respondent.
OPINION
CAMPBELL-SMITH, Judge.
Petitioners filed the petition in this case on October 17, 2011. See ECF No. 1.
The special master issued his initial entitlement decision on October 9, 2018. See ECF
No. 205. Thereafter, petitioners filed a motion for review with this court, see ECF No.
1 This opinion was filed on February 12, 2021, in accordance with Rule 18(b) of the
Vaccine Rules, Appendix B to the Rules of the United States Court of Federal Claims. See ECF
No. 278. Pursuant to ¶ 4 of the ordering language, the parties were to propose redactions of the
information contained therein on or before February 26, 2021. No proposed redactions were
submitted to the court.

Case 1:11-vv-00685-EDK Document 286 Filed 03/22/21 Page 2 of 37
207, which was denied, and the special master’s decision was sustained, on February 11,
2019, see ECF No. 217.
Petitioners then filed an appeal with the United States Court of Appeals for the
Federal Circuit on April 10, 2019. See ECF No. 220. On April 7, 2020, the Federal
Circuit vacated this court’s opinion sustaining the special master’s entitlement decision
and remanded the case for further proceedings. See Sanchez v. Sec’y of Health & Hum.
Servs., 809 F. App’x 843 (2020).
The special master issued a second entitlement decision on August 26, 2020, in
which he again denied the relief requested by petitioners.2 See ECF No. 253.
Petitioners’ motion for review of the special master’s August 26, 2020 decision is the
motion now before the court. See ECF No. 260. Respondent filed its response on
October 19, 2020, see ECF No. 265, and petitioners filed a reply on October 30, 2020,
see ECF No. 269. The motion is now fully briefed and ripe for ruling. The court has
considered all of the arguments presented by the parties and addresses the issues that are
pertinent to the court’s ruling in this opinion. For the following reasons, petitioner’s
motion for review is DENIED, and the special master’s August 26, 2020 entitlement
decision is SUSTAINED.
I. Background
Trystan Sanchez was born in August 2008. See ECF No. 253 at 2. The special
master describes this case as follows:
When [Trystan] was conceived, he inherited from his father a mutation in a
gene known as an SDHA gene. Coincidentally, he inherited from his mother
a different mutation in the SDHA gene. However, these mutations were not
detected for many years. In the litigation, the parties dispute the
consequences of these mutations.
Id. More specifically, petitioners argue that “several vaccines, including the [diphtheria-
tetanus-acellular pertussis (DTaP)], caused [Trystan’s] neurodegeneration that was
ultimately diagnosed as a mitochondrial disorder, Leigh’s Syndrome.” ECF No. 260 at 9.
Respondents disagree with that assessment.
A. Overview of Trystan’s Relevant Medical History
2 Throughout this opinion, when the court cites to the special master’s August 26, 2020
decision, for clarity of the narrative, it will not always include the sources to which the special
master cited unless specifically relevant.
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The central disagreement in this case involves Trystan’s condition following his
six-month well-visit. In his post-remand decision, the special master recites the
following summary facts:
At the age of six-months, on February 5, 2009, Trystan was seen by a
pediatrician who found Trystan to be developing normally. In this
appointment, Trystan received a series of vaccinations including a dose of
the dip[h]theria-tetanus-acellular pertussis (DTaP) vaccination.
On the day and evening following the vaccination, Trystan cried
inconsolably. He also had a hot red mark on his thigh, and developed a fever
that ebbed and flowed for a few days.
On February 16, 2009, Trystan was suffering from a common cold. In the
course of this illness, he was congested, had a fever, and jerked around in his
father’s arms. Trystan also contorted his arms.
Trystan had more colds for which his parents brought him to a pediatrician
at the end of April 2009 and in May 2009. During this time, Trystan began
to lose some developmental skills.
Trystan’s parents brought him for medical attention in August 2009. During
this appointment, a physician’s assistant noticed his lack of development and
referred him to additional medical services. This referral eventually led to
an appointment with a neurologist, who also documented problems with
Trystan.
ECF No. 253 at 2-3. Several years later, Trystan was diagnosed with Leigh’s syndrome,
which is “a severe neurological disorder that often presents in the first year of life and is
characterized by progressive loss of mental and movement abilities and typically results
in death within a couple years.” Id. (citations omitted).
According to the special master, the medical records indicate that after receiving
the vaccinations on February 5, 2009, Trystan was evaluated next by a medical
professional on February 17, 2009, when petitioners took him to an urgent care facility.
See id. at 4. Trystan was evaluated by physician’s assistant Jonathon P. Luna who
diagnosed him with a “common cold” and “[v]iral syndrome.” Id. (citations omitted).
Petitioners told Mr. Luna that Trystan “had been coughing and congested with fever,” but
the records do not show that petitioners “told Mr. Luna anything about Trystan exhibiting
unusual arm movements or other signs of a neurological condition.” Id.
The testimony offered by Trystan’s father, Germain Sanchez, includes details not
recorded by Mr. Luna. He states that on February 16, 2009:
3

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Trystan was very hot with a fever of 103.2 and kept crying inconsolably . . . .
When I held Trystan in my arms and tried to calm him down, I noticed a
change[] in Trystan. He felt very stiff and uncomfortable. Originally, I
thought he was throwing some kind of fit and trying to show how miserable
he felt by stiffening his body. . . . I had never seen a child do that before.
Trystan began to hold his arm behind his back with a lot of tension and jerk
his head back. When I tried to comfort him and gently put his arm back to
the normal position, Trystan would go right back to holding it behind his
back again. This lasted for only a few minutes. . . . (We later learned that
this was likely a seizure, but we had no idea at the time that it was occurring.)
We continued to rock Trystan to sleep and this strange behavior slowly
subsided.
Id. (citing Germain Sanchez affidavit dated October 5, 2011).
Trystan was next seen by a medical provider on April 29, 2009, when he was
diagnosed with an ear infection and bronchitis by Dr. Nabil R. Seleem. See id. at 67. Dr.
Seleem reported “[n]o unusual arm movements or developmental issues,” and “noted
‘[n]o neurological symptoms.’” Id. (citations omitted). And on May 13, 2009, Trystan
was seen by Dr. Philip Brown, who “observed that Trystan’s infection appeared to be
resolving,” and made “[n]o reports of the loss of eye contact or an inability to roll over.”
Id. (citations omitted).
On August 17, 2009, Trystan was seen by physician’s assistant Micaela Marin-
Tucker for his one-year well-visit. See id. at 70. Ms. Marin-Tucker noted in Trystan’s
record that his mother had “noticed a change in [his] development about 2-3 months
ago.” Id. (citations omitted). “Upon a review of systems, Ms. Marin-Tucker found that
Trystan did not walk, stand, crawl, and hold his head up while sitting, or make any
attempt to move his lower extremities.” Id. at 71 (citations omitted). She further noted
that “his extremities seemed soft yet rigid at times.” Id. (citations omitted). Following
this examination, Ms. Marin-Tucker referred Trystan to a neurologist, physical therapist,
and an occupational therapist. See id. At the same appointment, “Trystan received his
third hepatitis B vaccine, as well as his second doses of the pneumococcal conjugate,
DTaP, and Hib vaccines.” Id. (citations omitted).
Ms. Marin-Tucker examined Trystan again during a follow-up visit on October 7,
2009. See id. at 72. She “noted no seizures, weakness, or tics. She made no notation of
tremors or twitching.” Id. But she “found Trystan to be unable to grasp, sit, crawl, or
make much eye contact.” Id.
On November 12, 2009, Dr. David J. Michelson, a neurologist, evaluated Trystan
and found that he was experiencing “muscle spasms, global developmental delay,
4

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weakness [and] walking problems,” among other things. Id. at 74. He also noted that
“[w]hile Trystan had previously held his right arm stiffly behind him episodically, he had
not done this lately.” Id. Dr. Michelson ordered an MRI, which was performed in
December 2009 and showed “problems in Trystan’s basal ganglia,” consistent with
Leigh’s syndrome.3 Id. at 74-75.
B. Petition for Compensation and Coincident Developments
In their petition, petitioners allege that the vaccinations Trystan received on
February 5, 2009, “were the actual cause of Trystan’s symptoms including fever and
subsequent seizure activity/disorder leading to his development issues.” ECF No. 1 at 12.
In support of the petition, petitioners submitted medical records, testimony from family
members, and expert testimony, including testimony from Dr. Lawrence Steinman, a
pediatric neurologist. See ECF No. 253 at 3-4.
Petitioner’s expert, Dr. Steinman, relied on Mr. Sanchez’s report of Trystan’s
unusual arm movements on February 16, 2009, in his evaluation. See id. at 4. In his first
report, Dr. Steinman first stated that “‘[e]leven days [after receiving the vaccinations] in
the context of a febrile illness, [Trystan] may have had a seizure, manifest[ed] by
stiffening and holding his arm behind his back with a lot of tension and jerked his head
back.’” See id. at 5 (citing Dr. Steinman’s September 28, 2011 report) (emphasis in
original and internal quotation marks omitted). Later in the report, Dr. Steinman’s
assessment of Trystan’s arm movements appears more definitive; he notes that Trystan
“‘was given multiple vaccines, he suffered from fever and he suffered from seizures.’”
Id. (citing Dr. Steinman’s September 28, 2011 report). Despite this apparent
inconsistency, the special master characterizes the remainder of Dr. Steinman’s report as
“premised upon Trystan having a seizure.” Id.
In Dr. Steinman’s opinion, the vaccines “triggered” Trystan’s seizures, and but for
the vaccinations, Trystan “would not have suffered such devastating neurological
consequences.” Id. (quoting Dr. Steinman’s September 28, 2011 report) (quotation
marks omitted). According to respondent, however, Trystan did not suffer neurological
consequences close enough in time to receiving the vaccines to be entitled to
compensation. See id. Of particular relevance to the outcome of this case, “the parties
and their experts disputed whether Trystan displayed unusual arm movements starting in
February 2009.” Id. at 6.
3 Trystan continued to receive medical care after the December 2009 MRI, but because the
central issue in this case relates to the events in 2009, the court will omit the detailed recitation
of those facts here and instead will include any relevant aspects of that care in the analysis
section of this opinion.
5

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On April 10, 2013, the special master issued a document titled Ruling Finding
Facts, ECF No. 45, which was intended to serve as the basis for expert reports and
ultimately an entitlement decision. See id. at 6-8. In the ruling, the special master
concluded, among other things, that “Trystan did not begin to exhibit arm contortions” at
the time of the February 17, 2009 urgent care visit. ECF No. 45 at 13. He also found that
between the February 17, 2009 urgent care visit and the next pediatrician visit on April
29, 2009, Trystan “did not lose control of his head and trunk, nor did he stop making eye
contact or stop wanting to play anymore. He did not exhibit arm contortions.” Id.
During the following years of this litigation, however, the facts and expert
opinions related to Trystan’s condition continued to develop. In 2014, Trystan underwent
genetic testing which revealed “a heterozygous mutation in the SDHA gene.” ECF No.
253 at 10. Thereafter, Trystan was diagnosed with Leigh’s syndrome. See id. at 12 n.7.
Petitioners presented several expert reports, including one from Dr. Dmitriy Niyazov, an
expert in mitochondrial disorders, in which the doctors opined that Trystan’s Leigh’s
syndrome initially manifested as the inconsolable crying and fever he experienced after
the February 5, 2009 vaccinations. See id. at 12-13. Dr. Niyazov also took the view that
absent the vaccinations, Trystan’s genetic mutations may not have developed into Leigh’s
syndrome at all. See id. at 13. Dr. Steinman issued another report, dated December 10,
2015, in which, according to the special master, he “roughly presented the same view.”
Id.
In response to Dr. Niyazov’s and Dr. Steinman’s reports, respondent produced a
report from Dr. Gerald Raymond, an expert in genetics and neurology.4 See id. at 5-6,
14. In this report, Dr. Raymond concluded that Trystan is “‘a child with Leigh syndrome
secondary to mutations in the gene SDHA. This is the sole cause of his neurologic
condition and the onset was not caused by immunizations received and his disease course
is consistent with the condition and was not aggravated by the receipt of vaccination.’”
Id. at 14 (quoting Dr. Raymond’s March 16, 2016 report). After the parties exchanged
additional expert reports to address this disagreement, the special master set the case for a
hearing, and ultimately found that petitioners were not entitled to compensation. See id.
at 14-15; ECF No. 205.
After this court sustained that entitlement decision, see ECF No. 217, the Federal
Circuit vacated that decision, and remanded the case to the special master for further
proceedings, noting that the special master’s decision “left certain critical issues
4 Respondent has also presented expert testimony from Dr. Stephen J. McGeady, Dr.
Edward Cetaruk, and Dr. Dean Jones. See ECF No. 253 at 27-30. Their opinions will be
discussed more fully where relevant.
6

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unresolved,”5 see Sanchez, 809 F. App’x at 844. On remand, the special master
permitted the parties to file additional expert reports and held an additional hearing. See
ECF No. 253 at 20-21. After considering the Federal Circuit’s April 7, 2020 decision and
the record in this case, the special master issued his August 26, 2020 decision, of which
petitioners now seek review. See id. at 21; ECF No. 260.
II. Legal Standards
This court has jurisdiction to review the decision of a special master in a Vaccine
Act case. See 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal
Claims reviews the decision of the special master to determine if it is ‘arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008) (quoting 42
U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of Health & Hum. Servs., 418
F.3d 1274, 1277 (Fed. Cir. 2005)).
This court uses three distinct standards of review in Vaccine Act cases, depending
upon which aspect of a special master’s judgment is under scrutiny.
These standards vary in application as well as degree of deference. Each
standard applies to a different aspect of the judgment. Fact findings are
reviewed . . . under the arbitrary and capricious standard; legal questions
under the “not in accordance with law” standard; and discretionary rulings
under the abuse of discretion standard.
Munn v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.
1992).
As the Federal Circuit has held, when reviewing a special master’s decision, this
court does not “reweigh the factual evidence, assess whether the special master correctly
evaluated the evidence, or examine the probative value of the evidence or the credibility
of the witnesses—these are all matters within the purview of the fact finder.” Porter v.
Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011). “Rather, as long
as a special master’s finding of fact is ‘based on evidence in the record that [is] not
wholly implausible, we are compelled to uphold that finding as not being arbitrary or
capricious.’” Id. (quoting Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328,
1338 (Fed. Cir. 2010)). Under this standard “reversible error is ‘extremely difficult to
demonstrate’ if the special master ‘has considered the relevant evidence of record, drawn
plausible inferences and articulated a rational basis for the decision.’” Lampe v. Sec’y of
5 The United States Court of Appeals for the Federal Circuit’s decision and the scope of
the remand is the subject of some dispute between the parties and is addressed more fully below.
7

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Health & Hum. Servs., 219 F.3d 1357, 1360 (quoting Hines v. Sec’y of Health & Hum.
Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
Petitioners bear the burden of proving, by a preponderance of the evidence, that
“the vaccination brought about [their] injury by providing: (1) a medical theory causally
connecting the vaccination and the injury; (2) a logical sequence of cause and effect
showing that the vaccination was the reason for the injury; and (3) a showing of a
proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at
1278. “Because causation is relative to the injury, . . . petitioner[s] must provide a
reputable medical or scientific explanation that pertains specifically to the petitioner[s’]
case, although the explanation need only be ‘legally probable, not medically or
scientifically certain.’” Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339,
1345 (Fed. Cir. 2010) (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543,
548-49 (Fed. Cir. 1994)). If petitioners “satisf[y] this burden, [they are] ‘entitled to
recover unless [respondent] shows, also by a preponderance of evidence, that the injury
was in fact caused by factors unrelated to the vaccine.’” Althen, 418 F.3d at 1278
(quoting Knudsen, 35 F.3d at 547).
III. Analysis
A. The Federal Circuit’s Opinion Remanding the Case
The Federal Circuit summarized petitioner’s three primary grounds for appeal as
follows:
First, the petitioners contend that the rulings of the special master and the
Claims Court are contrary to the 2015 decision of this court in Paluck v.
Secretary of Health & Human Services, 786 F.3d 1373 (Fed. Cir. 2015).
Second, they argue that the central component of the special master’s
ruling—that Trystan’s Leigh’s syndrome was not triggered by his February
5, 2009, vaccinations—is contrary to the evidence. Third, they argue that the
special master failed to address their “challenge-rechallenge” argument, i.e.,
their contention that the combination of the first vaccination in February
2009, and the second vaccination, in August 2009, triggered or aggravated
Trystan’s condition.
Sanchez, 809 F. App’x at 850. The Circuit noted its “extremely limited” authority to
review the special master’s factual findings, see id., and then addressed each issue in turn.
1. Paluck
Petitioners in Paluck sought compensation for injuries sustained by their minor
son, who had an underlying mitochondrial disorder, after he received a series of
8

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vaccinations at his one-year well-visit. Paluck, 786 F.3d at 1377-78. In that case, the
child developed a fever, irritability, and fatigue within forty-eight hours of receiving the
vaccinations, and his doctors documented neurological decline within twenty-three days.
See id. at 1381-82. The special master concluded that the child’s decline was not
sufficiently “linear” to establish entitlement to compensation, but both this court and the
Federal Circuit disagreed. Id. at 1382-83. The Federal Circuit held that the special
master’s decision was arbitrary and capricious because he had failed to consider “‘the
record as a whole,’” in reaching this conclusion. Id. at 1382 (quoting 42 U.S.C. § 300aa-
13(a)(1)).
The Federal Circuit also found that the special master had erred in setting a strict
timeframe within which symptoms must be apparent, made inferences unsupported by the
record, and arbitrarily disregarded record evidence. See id. at 1383-85. Accordingly, the
Circuit affirmed this court’s decision granting petitioner’s motion for review and vacating
the special master’s decision to deny compensation. See id. at 1386.
In reviewing the present case, the Federal Circuit first noted the similarities
between this case and its decision in Paluck: “Like this case, Paluck involved a child
with a mitochondrial disorder. And, as in this case, the evidence in Paluck showed that
vaccines can activate the immune system, which in an individual with mitochondrial
disease can result in oxidative stress that can, in turn, cause progressive neurological
deterioration over time.” Sanchez, 809 F. App’x at 851. The Circuit, however,
concluded that there were sufficient differences between this case and Paluck, that Paluck
alone did not address all of the issues at bar. Id. Specifically, the Circuit noted that: “In
this case, unlike in Paluck, the special master did not adopt a strict time limit or a
requirement of ‘linearity’ for the manifestation of signs of Trystan’s neurological
regression. . . . Nor did the special master draw the improper inferences noted by this
court in Paluck or disregard medical evidence or the observations of the treating
physicians.” Id.
2. Causation Analysis
The Federal Circuit next addressed petitioners’ arguments related to the special
master’s causation analysis. Id. at 852. Specifically, petitioners argued that Trystan’s
fever and inconsolable crying following his February 5, 2009 vaccinations, along with his
arm contortions eleven days later, on February 16, 2009, are evidence that Trystan “had
suffered an adverse neurological event.” Id. In his original entitlement decision, the
special master rejected this argument, concluding that Trystan’s symptoms on February
16, 2009 were typical cold symptoms. See id. The Circuit explained petitioners’
argument on appeal as follows:
The petitioners do not challenge the finding that Trystan was suffering from
a cold, but they contend that the evidence shows that he was also suffering
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from a neurological injury at that time. In particular, the petitioners dispute
the special master’s finding that Trystan’s symptoms—his arm contortions
in particular—were symptoms of a cold. That finding, they contend, is
wholly lacking in record support.
Id.
In this regard, the Circuit identified a discrepancy between the facts included in
the special master’s Ruling Finding Facts and the published entitlement decision:
In his 2013 Ruling Finding Facts, the special master found that although
Trystan “kept kicking his feet and jerking around” in his father’s arms on that
evening, he “did not begin to exhibit arm contortions” at that time, and he
“did not exhibit arm contortions” between that time and the time Ms. Sanchez
took him to the doctor in late April 2009. In the 2018 Published Decision
Denying Compensation, however, the special master found that on that
evening, Trystan’s “arms contorted and he was jerking around.”
Id. Given the centrality of this fact to petitioner’s theory of causation, the Circuit found
that the contradiction between the two documents was “significant.” Id.
In the 2013 Ruling Finding Facts, the special master noted that: “The parties are
ordered to provide this ruling to any expert they retain. If the expert’s opinion is not
consistent with these findings of fact, the opinion is likely to not be persuasive.” ECF
No. 45 at 16. The Federal Circuit noted that defendant’s experts relied on the 2013
Rulings Finding Fact, and “did not have before them the special master’s later finding
that Trystan’s arm contortions began as early as February 16.” Sanchez, 809 F. App’x at
852. In addition, the Circuit noted, if the special master changed his view of the date on
which Trystan’s arm contortions began based on his father’s testimony, that could lend
credence to Dr. Steinman’s opinion. See id. at 852-53. For these reasons, the Circuit
found it “necessary to remand for further consideration of the causation issue in light of
the special master’s findings in 2018 regarding Trystan’s arm contortions.” Id. at 853.
The Federal Circuit also concluded that, in his causation analysis, the special
master did not carefully delineate between the second and third Althen factors, and
directed the special master to do so on remand. See id. The Circuit explained that:
it is important for the special master to make explicit findings as to two
separate issues: (1) whether there was a logical sequence of cause and
effect linking Trystan’s vaccinations and his injuries as well as a proximate
temporal relationship between the vaccinations and the onset of the injuries;
and (2) whether Trystan’s infections between February and May of 2009
caused the manifestation of his Leigh’s syndrome, independent of his
vaccinations.
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Id. If, however, “the special master finds that the petitioners have not met their burden as
to the first issue, it is unnecessary for the special master to address the second issue.” Id.
3. Challenge-Rechallenge
Next, the Federal Circuit held that the special master failed to fully consider
petitioners’ challenge-rechallenge theory, which is a “theory of causation . . . that the
combined effect of the February and August vaccinations caused or aggravated Trystan’s
condition.” Id. at 854. The special master focused on the findings in the 2013 Ruling
Finding Facts, but did not account for petitioners’ expert testimony offered after that
ruling was made, which focused on the challenge-rechallenge theory. See id.
The Circuit also found that the medical records from August 17, 2009, the date on
which Trystan received his second round of vaccinations, and October 7, 2009, the date
on which he was seen for a follow-up visit, may indicate some “loss of skills during [that]
period.” Id. It was, therefore, an error for the special master to not explicitly address the
challenge-rechallenge theory. Id.
4. Whether Trystan’s Leigh’s Syndrome Would Have Been the Same
Regardless of the Vaccinations
Finally, the Federal Circuit held that “it may be necessary for the special master to
address . . . whether [respondent] showed, because of Trystan’s mutations, the timing and
severity of his Leigh’s syndrome would have been the same, regardless of the effect of
the vaccinations.” Id. The Circuit noted that the science on this point “has been
developing rapidly,” and suggested that “the special master on remand may wish to give
the parties an opportunity to supplement the record with any relevant medical research or
reports postdating the hearing held by the special master two and one-half years ago.” Id.
B. The Special Master’s Decision on Remand
Following the Federal Circuit’s opinion remanding the case, the special master
accepted supplemental expert and status reports from the parties, and held a hearing on
July 9, 2020, during which the parties’ experts testified. See ECF No. 245 (transcript of
hearing).
On August 26, 2020, the special master issued a lengthy new entitlement decision
taking into account the Federal Circuit’s opinion. See ECF No. 253. After recounting
the factual and procedural background of this case, and discussing the qualifications of
the parties’ experts, the special master addressed the petitioners’ burden under the test set
forth by the Federal Circuit in Althen. See id. at 1-31. As noted above, petitioners bear
the burden of proving, by a preponderance of the evidence, that “the vaccination brought
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about [the] injury by providing: (1) a medical theory causally connecting the vaccination
and the injury; (2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and (3) a showing of a proximate temporal relationship
between vaccination and injury.” 6 Althen, 418 F.3d at 1278.
1. First Althen Factor
The special master found, as he had in his first entitlement decision, that
petitioners met their burden to prove a “medical theory causally connecting the
vaccination and the injury.” Id. (citations omitted); ECF No. 253 at 31-34; see also ECF
No. 205. He also noted that on appeal, despite the fact that respondent argued in a
footnote that the special master had committed a harmless error with regard to the first
Althen factor, the parties did not address the matter fully before the Federal Circuit. See
ECF No. 253 at 32. And, the special master understood the Federal Circuit to “endorse
the theory that vaccines can cause fever and fever can cause neurodegeneration based
upon its opinion in Paluck.” Id.
Furthermore, the special master reasoned, the law of the case doctrine “precludes
relitigation of issues explicitly or implicitly decided on appeal.” Id. at 33-34 (citing
Travelers Ins. Co. v. United States, 72 Fed. Cl. 316, 325 (2006) (“The doctrine [of the
law of the case], of course does not constrain a trial court’s consideration of an issue that
has not been considered on appeal. . . . But the doctrine extends to issues that were
implicitly addressed.”); and Am. Satellite Co. v. United States, 34 Fed. Cl. 468, 480
(1995) (quotation omitted)). Here, because respondent raised the issue of a harmless
error with regard to the first Althen factor on appeal, and the Federal Circuit did not
direct the special master to reconsider his findings, the special master declined to do so.
See id. at 34.
6 After a lengthy discussion of causation under Althen, the special master addressed an
alternative theory under which he also found that petitioners were not entitled to compensation.
See ECF No. 253 at 80-97. Respondent argued, and the special master agreed, that Trystan’s
genetic mutations “constitute the sole substantial cause of [his] Leigh’s syndrome.” Id. at 81.
The special master considered this question in response to the Federal Circuit’s comment in its
decision remanding this case for further proceedings that “it may be necessary for the special
master to address . . . whether the Secretary showed, because of Trystan’s mutations, the timing
and severity of his Leigh’s syndrome would have been the same, regardless of the effect of the
vaccinations.” Sanchez v. Sec’y of Health & Hum. Servs., 809 F. App’x 843, 854 (Fed. Cir.
2020); see also ECF No. 253 at 20 (special master noting the Federal Circuit’s invitation to
consider this issue further). Because the court agrees with the special master that petitioners
have not met their burden to prove causation under Althen, the special master’s decision on this
alternative theory is unnecessary to sustain his entitlement decision. Accordingly, the court
declines to review the strength of the scientific data bearing on the likely manifestation of
Trystan’s Leigh’s syndrome absent administration of the vaccines.
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“Accordingly, the finding in the October 9, 2018 decision remains undisturbed.
The theory that the DTaP vaccine can cause neurodegeneration, potentially through the
intermediate step of a fever, is sound and reliable under prong 1.” Id.
2. Second Althen Factor
The second factor, and most complicated part of the Althen analysis in this case,
required the special master to evaluate whether petitioners had shown, by a
preponderance of the evidence, “a logical sequence of cause and effect showing that the
vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. In this section, the
special master addressed the timing of the onset of Trystan’s neurodegeneration, and
drew conclusions as to what that timing indicates about the causal relationship between
the vaccinations and Trystan’s injury. See ECF No. 253 at 38-80.
According to petitioners, “Trystan’s response to the vaccine changed his life.” Id.
at 41. Petitioner’s expert Dr. Steinman testified at the post-remand hearing that after the
vaccinations, “Trystan started a ‘downward cascade,’” and experienced a continuous
process of neurodegeneration and loss of skill from that point. Id. And Dr. Niyazov
offered his opinion that Trystan’s “‘developmental regression was slowly developing
ever since the crying and fever took place as a result of the vaccination.’” Id. (quoting
Dr. Niyazov’s expert report, ECF No. 127-1 at 8).
After reviewing a series of previously-decided vaccine cases that petitioners argue
militate in favor of compensation, see id. at 42-46, the special master reviewed Trystan’s
medical history between February 5, 2009—the date on which he received the vaccine—
and December 2009, see id. at 46-75, and gave particular attention to the notes made by
Trystan’s treating physicians, see id. at 75-80.
a. Trystan’s Neurodegeneration
i. February 5, 2009
According to the special master, Trystan’s pediatrician, Dr. Philip Brown, found
Trystan’s “growth and development to be normal” at his six-month well-visit. Id. at 46.
Dr. Brown specifically found that Trystan was meeting the following developmental
milestones: “turning to sound, self-feeding, self-comforting, responding to his name,
sitting with support, grasping and mouthing objects, smiling, laughing, squealing,
showing interest in toys, showing differential recognition of parents, babbling
reciprocally, rolling over from back to front, and standing when placed.” Id. at 46-47.
He also noted that Trystan had “no head lag when pulled to sit.” Id. at 47. At the visit,
Trystan received the DTaP, hepatitis B, Haemophilus influenzae type B, inactivated
polio, and pneumococcal conjugate vaccines. See id.
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After the wellness visit, Trystan cried inconsolably, developed a fever that ebbed
and flowed for several days, and developed a lump on his left thigh. See id. The special
master found that, of these three facts, the inconsolable crying was the “most important,”
because it “can be a manifestation of an encephalopathy or injury to the nervous system.”
Id. In support of this conclusion, the special master cited to testimony from both
petitioners’ and respondent’s experts—Dr. Steinman, Dr. Niyazov, and Dr. Raymond, as
well as a previously decided vaccine case, Estep v. Secretary of Health & Human
Services, No. 90-1062V, 1992 WL 357811, at *3 (Fed. Cl. Spec. Mstr. Nov. 3, 1992),
mot. for rev. denied, 28 Fed. Cl. 664 (1993). See id. The special master also concluded,
however, that inconsolable crying is not necessarily a sign of injury, it could also be an
expression of discomfort or pain. See id. at 47-48. Respondent’s experts Dr. McGeady
and Dr. Raymond testified that Trystan’s crying was the latter. See id. at 48.
The special master further concluded that “the presence of a fever is non-specific”
due to broad agreement that vaccines can cause an elevated temperature as part of a
normal response. Id. None of the experts expressed any unusual concern about the lump
on Trystan’s thigh. See id. at 48-49.
In the special master’s view, petitioners and their experts “appear to place undue
weight on Trystan’s health on February 5-7, 2009. They seem to reason that because
inconsolable crying can be a manifestation of an encephalopathy or injury to the nervous
system, Trystan must have suffered a neurological injury.” Id. at 49. Considering the
evidence as a whole, however, “Trystan’s health could be entirely compatible with an
expected response to the vaccination given in the morning of February 5, 2009.” Id.
ii. February 16-17, 2009
Trystan again developed a fever, along with congestion, on February 15, 2009.
See id. at 54. Around midnight on February 16, 2009, Trystan’s fever increased, and he
began to cry very loudly. See id. Mr. Sanchez attempted to calm Trystan, but he
“startle[d] awake like he could not breathe through his stuffy nose.” Id. at 54-55. Mr.
Sanchez testified that when he was trying to calm Trystan, “‘he kept kicking his feet and
jerking around’” in his arms, “‘almost as if he didn’t want to be held.’” Id. at 55.
Petitioners did not take Trystan to the urgent care that night because after they gave him
some fever reducing medication, Trystan fell asleep. See id.
The next morning, February 17, 2009, Trystan was examined by a physician’s
assistant Mr. Luna, and was diagnosed with a “‘[c]ommon cold,’” and “‘[v]iral
syndrome,’” and his fever was noted. Id. Mr. Luna’s notes, however, “do not indicate
that Ms. Sanchez told Mr. Luna anything about Trystan exhibiting unusual arm
movements or other signs of a neurological condition.” Id.
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The parties’ experts presented opposing theories about Trystan’s symptoms, which
included “high-pitched cry[ing], fever, congestion, startling awake, jerking around, and
arm contortions.” Id. Dr. Steinman first opined that Trystan had experienced a seizure,
and later identified the reaction as dystonia. See id. Both Dr. Steinman and Dr. Niyazov
believe Trystan’s reaction was evidence of “an episode of neurodegeneration.” Id. The
special master noted that “[i]n contrast, in the December 2017 hearing, Dr. Raymond
maintained that these conditions (except for the arm contortions) reflected a common
cold.” Id.
Considering the foregoing, the special master concluded that the evidence shows
that Trystan was suffering from a common cold or upper respiratory infection, from
which he recovered. See id. at 55-56. The special master found Dr. Steinman’s and Dr.
Niyazov’s “skepticism over such a basic point” reduced their credibility. Id. at 56. He
also found that the evidence indicated that Trystan’s February 15, 2009 fever was
different from his February 5, 2009 fever—and that there was no demonstrated
connection between the second fever and the vaccinations. See id.
The special master then noted that “[b]eyond the fever and congestion that are part
of a common cold, Trystan also cried, startled awake, jerked around in his father’s arms,
and, most importantly for this remand decision, contorted his arms. These behaviors are
the foundations for Dr. Steinman’s opinion that Trystan suffered a seizure or dystonia.”
Id. Dr. Steinman’s credibility, however, was compromised by the fact that his opinion
evolved over time. See id.
Dr. Steinman first suggested, based on Mr. Sanchez’s account of Trystan’s
behavior on the night of February 16, 2009, that Trystan had suffered a seizure. See id.
During the December 2017 hearing, Dr. Steinman acknowledged that a seizure could
only be diagnosed conclusively by an electroencephalogram (EEG), and that in the
absence of an EEG “we’re not very good at guessing.” See id. at 56-57. In light of this
weakness in his theory, Dr. Steinman then opined that “Trystan’s arm contortions were
dystonic posturing.” Id. at 57. Notably, the special master stated that Dr. Steinman’s
new opinion on dystonia was also based on Mr. Sanchez’s account of Trystan’s behavior
on the night of February 16, 2009. See id. At the time that the special master issued his
post-remand decision, Dr. Steinman was of the opinion that Trystan suffered from both
dystonia and seizures. See id. at 58.
The special master found Dr. Steinman’s opinion unpersuasive for four reasons.
First, as Dr. Steinman himself acknowledged, seizure activity cannot be confidently
diagnosed absent an EEG, a test that was not performed on Trystan in mid-February
2009. See id. Second, when Trystan did develop seizures, they “involved deviation of
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his head and eye, an altered consciousness, and a postictal period.”7 Id. Based on the
difference in presentation and passage of time before confirmed seizures, the special
master concluded that petitioners had not demonstrated a pattern of seizures beginning in
February 2009. See id. Third, respondent’s expert disagreed with Dr. Steinman that
Trystan had suffered seizures. See id. And fourth, while the records from Trystan’s
treating physician, Dr. Haas, include a note about arm contortions, that note was made on
August 7, 2012, and was apparently a record of the narrative from Ms. Sanchez about
Trystan’s condition following the vaccinations. See id. Dr. Haas “did not assess the arm
contortions as indicative of a seizure or neurological issues.” Id. For these reasons, the
special master found that petitioners had not “established with preponderant evidence that
Trystan suffered a seizure on February 16, 2009.” Id. at 59.
Having rejected petitioners’ theory that Trystan suffered a seizure on February 16,
2009, the special master then turned to the issue of whether Trystan had suffered
dystonia, which he defined as “‘dyskinetic movements due to disordered tonicity of
muscle.’” Id. He further explained that the term dyskinetic comes from the root word
dyskinesia, which means “‘distortion or impairment of voluntary movement, as in tic,
spasm, or myoclonus.’” Id. Dystonia originates in the basal ganglia, and “can be a
manifestation of many neurologic disorders,’” including Leigh’s syndrome. Id. Based
on expert testimony and medical journal arguments, the special master concluded that
“[t]he cumulative probability of having an onset of Leigh’s syndrome with dystonia at six
months is approximately five percent.” Id.
Dr. Steinman and Dr. Raymond disagreed as to whether a six-month old was
likely to manifest dystonia by moving his arm behind his back, and Mr. Sanchez testified
Trystan had done on the night of February 16, 2009. See id. at 4, 60. According to Dr.
Raymond, six-month-old children would not have myelination progression sufficient to
allow such movement. See id. at 60. Dr. Steinman emphasized the progressive nature of
myelination, and believed dystonia was possible at six months of age. See id. The
special master noted that “[a]s an abstract question whether six-month-old infants are
sufficiently myelinated to experience dystonia by moving their arms backward is difficult
to answer on this case’s evidentiary record.” Id. He concluded, however, that Dr.
Raymond’s fellowship in developmental neuropathology qualified him better to answer
the question than Dr. Steinman’s fellowship in chemical immunology. See id. at 60-61.
“This difference in advanced specialization would break any tie in Dr. Raymond’s favor.”
Id. at 61.
7 In the citations accompanying this sentence, the special master includes a reference to
“Exhibit 138 at 99 (Dr. Wong’s Dec. 7, 2010 report).” This citation appears to include a
typographical error, as it is a reference to Dr. Nicole M. Antonio’s July 12, 2016 report, which
appears at ECF No. 166-2, which is Exhibit 138 at 99-103. Dr. Valarie Wong’s December 7,
2010 report appears at ECF No. 116-2 at 9-11, which is Exhibit 138 at 9-11.
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With regard to Trystan’s case specifically, Dr. Raymond opined that if he had
experienced dystonia on February 16, 2009, it would have been “persistent and obvious,”
while Dr. Steinman asserted that dystonia could be “intermittent.” Id. Dr. Steinman,
however, “could not specify how frequently even ‘intermittent’ dystonia appears.” Id.
The special master found the contention that “Trystan could have dystonia in February
but not again for many months” unpersuasive. Id. Based on the foregoing, the special
master concluded that petitioners “have not shown by preponderant evidence that
Trystan’s February 16, 2009 arm contortions were a manifestation of a seizure or an
episode of dystonia,” and that the “arm contortions do not constitute a neurologic
abnormality caused by his vaccination.” Id. at 62.
iii. End of February to Beginning of April 2009
After the February 17, 2009 visit with Mr. Luna, Trystan did not see a medical
provider again until April 29, 2009. See id. In the 2013 Ruling Finding Facts, the special
master found, and repeated in his post-remand entitlement decision, as follows:
12. Sometime [after February 17, 2009], Trystan’s extended family
gathered to watch a boxing match. During this gathering, Trystan was sick,
crying, fussy, and congested. He was not contorting his arms nor was he
limp or rigid.
13. Between [Ms. Sanchez]’s birthday and the next time she took him to
the doctor nearly two months later in late April, Trystan suffered from cough
and congestion episodically. During this time, he did not lose control of his
head and trunk, nor did he stop making eye contact or stop wanting to play
anymore. He did not exhibit arm contortions.
Id. at 63 (quoting ECF No. 45 at 13) (citations omitted). He also characterized these facts
as “not contested.” Id. Neither of petitioners’ experts could identify facts to the contrary,
but noted that it was possible for parents to miss signs of delayed development in such a
young child. See id. at 63-64.
Petitioners’ experts also argued that Trystan experienced a fade response, a
phenomenon written about by Dr. Bob Naviaux in an article called Commentary on,
Fever Plus Mitochondrial Disease Could Be Risk Factors for Autistic Regression by
Shoffner et al. See id. at 64. Dr. Niyazov, who relied on the article, could not say
whether the article was peer-reviewed, but relayed his personal confidence in Dr.
Naviaux. See id. The special master also noted that the article addressed children with
autism, not Leigh’s syndrome. See id. In the article, Dr. Naviaux describes children with
mitochondrial disease who suffer a fade response when they regress. See id. When a
child experiences a fade response, which can occur between two and ten days after a
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fever, “‘their consciousness fades,’” and the “‘child can become difficult to fully awaken,
or will stop walking, stop talking, stiffen or lose muscle tone, or have a seizure, or a
stroke-like episode.’” Id.
The special master found, however, that there was “not preponderant evidence that
Trystan experienced a fade.” Id. at 65. According to the special master, “[t]here is no
evidence that in the months after his February 5, 2009 vaccination, Trystan began to lose
consciousness or was difficult to awaken. In contrast, the [2013] Ruling Finding Facts
found that Trystan continued to play.” Id. And the episode of arm contortions
experienced by Trystan on February 16, 2009 was “short-lived, singular, and did not
signify a neurologic injury due to vaccination.” Id. On this basis, the special master
found that the Naviaux article was “inapt,” id., and found Trystan’s case to be materially
different from the caselaw offered as analogous by petitioners, see id. at 65-66.
iv. April to May 2009
Based on the medical records presented in this case, the special master found that
Trystan had “relatively good health” from the end of February 2009 to mid-April 2009.
Id. at 67. On April 29, 2009, however, Trystan was diagnosed with an ear infection and
bronchitis by Dr. Seleem, who noted that Trystan had been suffering from a cough and
congestion for about two weeks. See id. At that time, Dr. Saleem noted “‘[n]o
neurological symptoms.’” Id. Trystan was next seen by Dr. Brown on May 13, 2009, at
which time his ear infection was clearing. See id. The doctor’s notes include no concern
about loss of eye contact or ability to roll over. See id.
In presenting their theories, petitioners’ experts “largely ignored the visits with Dr.
Seleem and Dr. Brown.” Id. at 68. A fact that, the special master reasoned, is
“inconsistent with [Dr. Steinman’s] later testimony that ‘infections . . . can devastate or
kill’ children with mitochondrial diseases.” Id. After the special master questioned Dr.
Steinman on this point, Dr. Steinman opined that Trystan’s late-April, early-May illness
did not contribute to his neurological decline because he did not have a fever. See id. at
68-69. Dr. Niyazov, for his part, indicated that such illness could contribute to Trystan’s
decline, but maintained his theory that Trystan’s decline began on February 5, 2009. See
id. at 69. The special master did not credit this theory: “The flaw . . . is that . . .
[petitioners] have not presented persuasive evidence that Trystan’s decline started on
February 5, 2009.” Id.
v. August 2009
On August 8, 2009, Trystan cried inconsolably. See id. at 70. At some points of
the day, his body was limp; at others, he contorted his arms. See id. On August 17,
2009, Trystan was seen by physician’s assistant Ms. Marin-Tucker for his one-year well-
visit. See id. at 69, 70. At that visit, Ms. Sanchez reported to Ms. Marin-Tucker, that she
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“‘noticed a change in [Trystan’s] development about 2-3 months ago but since she had
taken [Trystan to the pediatric clinic] with Dr. Brown she thought that everything was
ok.’” Id. at 70 (citations omitted). Ms. Sanchez contradicted these notes when she
testified more than two years later that she had actually reported that Trystan’s
developmental changes began five to six months prior to the visit with Ms. Marin-
Tucker.8 See id. at 70 n.39.
During the visit, Ms. Marin-Tucker found that “Trystan did not walk, stand, crawl,
and hold his head up while sitting, or make any attempt to move his lower extremities.
She also noted in her examination that his extremities seemed soft, yet rigid at times.” Id.
at 71. Ms. Marin-Tucker referred Trystan to a neurologist, physical therapist, and
occupational therapist, and administered his second doses of the pneumococcal
conjugate, DTaP, and Hib vaccines, with directions to return the following week for the
measles, mumps, rubella, varicella, and hepatitis A vaccines. See id.
According to the special master, Trystan’s presentation at the August 17, 2009
well-visit was consistent both with Dr. Raymond’s explanation that “problems
originating in the basal ganglia would present . . . first with hypotonia and later with
dystonia,” and with Dr. Naviaux’s fade response theory. Id.
vi. October to December 2009
Petitioners took Trystan for a follow-up visit with Ms. Marin-Tucker on October
7, 2009. See id. at 72. “Ms. Marin-Tucker noted no seizures, weakness, or tics,” and
“made no notation of tremors or twitching.” Id. at 72. She did find, however, that
Trystan was “unable to grasp, sit, crawl, or make much eye contact.” Id.
Dr. Steinman interpreted this report as evidence that Trystan’s neurological
condition had further deteriorated—a conclusion the special master found to be
reasonable. See id. Due to this decline, the special master evaluated whether Trystan had
experienced a challenge-rechallenge reaction. See id. “A rechallenge event occurs when
a patient who had an adverse reaction to a vaccine suffers worsened symptoms after an
additional injection of the vaccine.” Capizzano v. Sec’y of Health & Hum. Servs., 440
F.3d 1317, 1322 (Fed. Cir. 2006). In addition, according to Dr. Raymond, “‘[t]he
challenge should meet the criteria of same latency and same effects, and must exclude
well-accepted alternative explanations.’” ECF No. 253 at 72.
8 The special master noted that Ms. Marin-Tucker’s report that Ms. Sanchez had noticed
changes in Trystan’s development two to three months before his August 17, 2009 well-visit—
between May 17, 2009 and June 17, 2009—suggests a logical connection between his late-April,
early-May illness and his decline. See id. at 69-70. This timeline fits more neatly with the
theories advanced by the medical literature that decline would occur within about two weeks of
the inciting event. See id. at 70.
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Petitioners contested Dr. Raymond’s additional criteria, but the special master
ultimately decided that the nuance was immaterial because petitioners “have not
established the challenge aspect” of the challenge-rechallenge theory because they “have
not presented preponderant evidence that Trystan suffered any neurologic problem within
at least one month of the February 5, 2009 vaccine.” Id. at 73. He concluded that, “by
simple definition, without a ‘challenge,’ there can be no ‘rechallenge.’” Id. Moreover,
the reactions Trystan displayed after each set of vaccinations were not sufficiently
similar. See id.
The special master stated his conclusion with regard to the second Althen factor,
as follows:
In sum, this section . . . has considered both how [petitioners’] experts
predicted an adverse reaction to the vaccination would appear and how
Trystan actually appeared. Because of the dichotomy between the predicted
and the actual, the sequence of events is not logical. Thus, [petitioners] have
not met their burden regarding prong 2.
Id. at 75.
vii. Treating Doctors
As part of his analysis of the second Althen factor, and in accord with the Federal
Circuit’s directive, the special master took particular note of the information available
from Trystan’s treating physicians. See id. (citing Capizzano, 440 F.3d at 1326). He
concluded, however, that petitioners “overstate the significance of these reports.” Id. He
summarized the basis for his conclusions for each of four treating physicians.
First, in 2010 and 2011, Dr. Jennifer Friedman raised the possibility that Trystan
may have acute disseminated encephalomyelitis (ADEM), which could be related to a
vaccination. See id. The special master discounted this opinion because Trystan suffers
from Leigh’s syndrome, not ADEM. See id.
Second, Dr. Akhil Sharma’s notes included, on October 2, 2013—and again on
June 26, 2015—a conclusion that Trystan had a “‘probable vaccine induced injury.’” Id.
at 76. This conclusion, however, was based not on Dr. Sharma’s evaluation, but on Ms.
Sanchez’s recitation of Trystan’s history. See id. For this reason, the special master
concluded that “Dr. Sharma’s reports carry little persuasive value.” Id.
Third, Dr. Haas, who first saw Trystan on August 7, 2012, recorded Trystan’s
medical history as recited by petitioners, much like Dr. Sharma. See id. In those notes,
he stated: “Trystan is a 4 year old boy who had acute onset regression and dystonia at 6
months of age, following vaccination, which repeated with the next set of vaccines at 12
months.” Id. at 77. The special master first notes that Dr. Haas’ observation that Trystan
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experienced symptoms “following vaccination” is a “recitation of a chronological
sequence of events [and] is not the same as an opinion regarding causation.” Id. at 78.
Moreover, these statements pre-date Trystan’s Leigh’s syndrome diagnosis. See id.
After the diagnosis was made, Dr. Haas wrote a letter in which he stated: “Trystan Evan
Sanchez has a mitochondrial disease caused by Complex II deficiency of the respiratory
chain. This is a genetic disease causing in Trystan dystonia, developmental delay,
encephalopathy, neuromuscular disease[, and an] abnormal MRI.” Id. In the letter, Dr.
Haas did not link Trystan’s condition to the vaccinations. See id. Finally, the special
master considered Dr. Haas’ statement that due to his Leigh’s syndrome, “‘it is medically
acceptable for [Trystan] to avoid immunizations.’” Id. The special master concluded
that “a recommendation to avoid vaccinations is not necessarily the same as a statement
that a vaccine caused an injury.” Id.
And fourth, Dr. Derek Wong saw Trystan on January 28, 2016. In recording
Trystan’s history, Dr. Wong quoted from Dr. Haas’ notes and documented Ms. Sanchez’s
recollection of Trystan’s developmental delays. See id. at 79. Dr. Wong acknowledged
Trystan’s Leigh’s syndrome diagnosis, and noted that his “manifestations include
developmental regression, following vaccines and/or viral syndrome.” Id. at 80. In the
special master’s view, “Dr. Wong’s record provides little assistance to [petitioners]”
because “[a]t best . . . Dr. Wong recognizes a temporal sequence in which Trystan’s
developmental regression ‘follow[ed] vaccines and/or viral syndrome.’” Id.
To summarize his findings based on the treating physician’s reports, the special
master stated:
In summary, the records from four doctors who treated Trystan do not help
[petitioners] meet their burden of showing that the DTaP vaccination
contributed to Trystan’s Leigh’s syndrome. Dr. Friedman presented her
opinion before Trystan’s Leigh’s syndrome was diagnosed after genetic
studies. Dr. Sharma and Dr. Haas obtained histories that are not entirely
accurate. Even so, Dr. Sharma, Dr. Haas, and Dr. Wong appear to present
temporal sequences. Accordingly, while these reports have been considered,
they do not constitute persuasive evidence for [petitioners].
Id.
3. Third Althen Factor
In his analysis of the third Althen factor, the special master explained that the
inquiry has two parts. See id. at 34. “[T]he proximate temporal relationship prong
requires preponderant proof that the onset of symptoms occurred within a timeframe for
which, given the medical understanding of the disorder’s etiology, it is medically
acceptable to infer causation-in-fact.” Id. (quoting de Bazan, 539 F.3d at 1352). In other
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words, “[a] petitioner must show the ‘timeframe for which it is medically acceptable to
infer causation’ and that the onset of the disease occurred in this period.” Id. (quoting
Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542-43 (2011), recons.
denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d without op. 503 F.
App’x 952 (Fed. Cir. 2013)). The parties dispute both parts of the third Althen factor.
With regard to the appropriate timeframe for inferring causation, the special
master reviewed a series of medical journal articles in his first entitlement decision,
which he concluded were not comprehensive, but “suggested that neurodegeneration
would occur within approximately two weeks.” Id. at 35. The special master also noted,
however, that on the basis of the Federal Circuit’s decision in Paluck, 786 F.3d at 1383,
he would not set a “hard and fast deadline.” Id. Because the Federal Circuit did not
“correct this approach” on appeal, the special master did not revise the approach on
remand. Id. at 38.
The second part of the third factor required the special master to determine
“whether [petitioners] presented persuasive evidence that Trystan began to suffer lasting
neurologic problems within approximately two weeks of the vaccination.” Id. He
concluded that, based on his analysis of the second Althen factor, that petitioners had
failed to carry this burden. See id.
Specifically, the special master found that within two weeks of his February 5,
2009 vaccinations, Trystan “experience[d] two episodes”—the “fever, inconsolable
crying and a mark on his leg” the night after receiving the vaccinations, and “fever,
congestion, restlessness, jerking around, and arm contortions” eleven days later. Id. at
66. The special master concluded, however, that the two episodes lacked context to
suggest they were “behaviors that suggested any neurologic problems from February 17,
2009, to at least May 1, 2009.” Id. Accordingly, the special master held that Trystan’s
neurologic problems began “well beyond the approximate two-week onset of symptoms
anticipated by [petitioners’] medical theory,” and as such, petitioners had failed to carry
their burden with regard to the third Althen factor.9 Id. at 66-67.
C. Motion for Review
Petitioners’ motion for review now before the court proceeds in four parts. First,
petitioners allege that the special master went beyond the Federal Circuit’s mandate on
remand by considering additional evidence and expert testimony with regard to Trystan’s
9 The special master noted in his decision that “[t]o be clear, in determining that
[petitioners] have not met their burden regarding prong 3, [he did] not consider[] the effect of the
colds for which Trystan was treated on April 29, 2009 and May 13, 2009.” ECF No. 253 at 67
n.37.
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arm contortions, and relied on an “unfounded newly created fact” as a result. ECF No.
260 at 27, 24-42. Second, petitioners argue that the special master arbitrarily and
capriciously failed to consider the record as a whole in determining whether petitioners
carried their burden to prove causation, including with regard to their challenge-
rechallenge theory. See id. at 42-51. Third, petitioners argue that the special master
arbitrarily and capriciously failed to consider the record as a whole in concluding that the
infections Trystan suffered between February and May 2009 caused his Leigh’s
syndrome to manifest independent of the vaccines. See id. at 51-54. And finally,
petitioners argue that the special master’s decision that Trystan’s Leigh’s syndrome was
the sole and substantial cause of his neurological condition was arbitrary and capricious
because he relied on only one reference. See id. at 54-74.
The court will only review the first two of petitioners’ four arguments. As the
court has previously explained, in reviewing the initial entitlement decision in this case,
the Federal Circuit concluded that, in his causation analysis, the special master did not
carefully delineate between the second and third Althen factors, and directed the special
master to do so on remand. See Sanchez, 809 F. App’x at 853. The Circuit explained
that:
it is important for the special master to make explicit findings as to two
separate issues: (1) whether there was a logical sequence of cause and effect
linking Trystan’s vaccinations and his injuries as well as a proximate
temporal relationship between the vaccinations and the onset of the injuries;
and (2) whether Trystan’s infections between February and May of 2009
caused the manifestation of his Leigh’s syndrome, independent of his
vaccinations.
Id. If, however, “the special master finds that the petitioners have not met their burden as
to the first issue, it is unnecessary for the special master to address the second issue.” Id.
In the post-remand entitlement decision, the special master found that petitioners did not
meet their burden on the first issue, and the court sustains that decision in this opinion.
Accordingly, as the Federal Circuit explicitly stated, addressing the second issue is
unnecessary.
The court will likewise refrain from review of the special master’s determination
that Trystan’s genetic mutations “constitute the sole substantial cause of [his] Leigh’s
syndrome.” ECF No. 253 at 81. The special master considered this question in response
to the Federal Circuit’s comment in its decision remanding this case for further
proceedings that “it may be necessary for the special master to address . . . whether the
Secretary showed, because of Trystan’s mutations, the timing and severity of his Leigh’s
syndrome would have been the same, regardless of the effect of the vaccinations.”
Sanchez, 809 F. App’x at 855; see also ECF No. 253 at 20 (special master noting the
Federal Circuit’s invitation to consider this issue further). Because the court sustains the
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special master’s conclusion that petitioners have not met their burden to prove causation
under Althen, the special master’s decision on this alternative theory is unnecessary to
sustain his entitlement decision. Accordingly, the court declines to review the strength of
the scientific data bearing on the likely manifestation of Trystan’s Leigh’s syndrome
absent administration of the vaccines.
1. Evidence and Testimony Regarding Trystan’s Arm Contortions
a. Scope of the Mandate
As an initial matter, petitioners argue that the special master “went beyond the
scope of the [m]andate by ordering additional expert reports and testimony on the issue of
whether the arm contortions in February of 2009 were consistent with a cold.” ECF No.
260 at 24. According to petitioners, the Federal Circuit wanted the special master “to
address causation given his finding of the arm contortions on February 16, 2009 and
given that the finding that it was consistent with a cold was unsupported.” Id. (emphasis
in original). Petitioners, therefore, ask the court to exclude “any new facts obtained from
the expert reports filed post remand and/or at the Remand hearing on July 10, 2020.” Id.
“The mandate rule provides that ‘issues actually decided [on appeal]—those
within the scope of the judgment appealed from, minus those explicitly reserved or
remanded by the court—are foreclosed from further consideration’” Amado v. Microsoft
Corp., 517 F.3d 1353, 1360 (Fed. Cir. 2008) (quoting Engel Indus., Inc. v. Lockformer
Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999)). “Unless remanded by [the appellate] court,
all issues within the scope of the appealed judgment are deemed incorporated within the
mandate and thus are precluded from further adjudication.” Engel, 166 F.3d at 1383.
Petitioners fundamentally misunderstand the Federal Circuit’s decision on this
point. The relevant section of the opinion reads as follows:
In support of their argument on causation, the petitioners point to testimony
from their experts that Trystan’s fever and inconsolable crying were
evidence of the onset of neurodegeneration, and that Trystan’s arm
contortions on February 16, 2009, only 11 days after his vaccinations, were
also indicative that he had suffered an adverse neurological event.
The special master rejected that argument, in large part because he
concluded that Trystan was diagnosed with a cold on February 17, and that
his symptoms the night before were of the type typically displayed by
infants suffering from a cold. The petitioners do not challenge the finding
that Trystan was suffering from a cold, but they contend that the evidence
shows that he was also suffering from a neurological injury at that time. In
particular, the petitioners dispute the special master’s finding that Trystan’s
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symptoms—his arm contortions in particular—were symptoms of a cold.
That finding, they contend, is wholly lacking in record support.
Analyzing this issue is complicated by the manner in which the special
master made factual findings relating to the events of February 16, 2009. In
his 2013 Ruling Finding Facts, the special master found that although
Trystan “kept kicking his feet and jerking around” in his father’s arms on
that evening, he “did not begin to exhibit arm contortions” at that time, and
he “did not exhibit arm contortions” between that time and the time Ms.
Sanchez took him to the doctor in late April 2009. In the 2018 Published
Decision Denying Compensation, however, the special master found that on
that evening, Trystan’s “arms contorted and he was jerking around.”
That discrepancy is significant. The government’s expert witnesses,
testifying based on the special master’s 2013 findings, said that the
symptoms exhibited by Trystan on the night of February 16, 2009—
inconsolable, high-pitched crying and “jerking around” in his father’s
arms—were consistent with a cold and were not indicative of a seizure.
However, the government’s witnesses did not have before them the special
master’s later finding that Trystan’s arm contortions began as early as
February 16. Moreover, if the special master’s 2018 finding was based on
the testimony of Trystan’s father, it seems plausible that Mr. Sanchez’s
testimony—that Trystan repeatedly held his arm behind his back and kept
returning it to that position—could be regarded as evidence of a seizure or
dystonia, as the petitioners’ expert Dr. Steinman testified. And a seizure or
dystonia at that time, Dr. Steinman testified, “could be evidence of brain
damage.”
Importantly, because of the change in the findings made with respect to the
arm contortions, the special master’s finding that Trystan’s behavior on the
night of February 16 was consistent with a cold is not supported by expert
testimony that specifically addressed the arm contortions. Because this
issue is of central importance to the causation analysis, it is necessary to
remand for further consideration of the causation issue in light of the special
master’s findings in 2018 regarding Trystan’s arm contortions.
Sanchez, 809 F. App’x at 852-53. Contrary to petitioner’s assertion, the Federal Circuit
did not find that the special master’s conclusion that Trystan’s arm contortions on
February 16, 2009, were consistent with a cold to be definitively unsupported by the
evidence. The court agrees with respondent’s assertion that “the Federal Circuit made
plain that the question remained open as to whether the arm contortions were evidence of
a seizure, dystonia, or a cold, because respondents’ experts had not been permitted, prior
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to the special master’s 2018 Decision, to offer testimony on this fact pattern.” ECF No.
265 at 20-21 n.15.
Because the Circuit explicitly remanded this case for further consideration of
causation as a result of the out-of-date information on which some experts based their
opinions, the special master did not exceed the scope of the mandate by allowing the
experts to supplement their opinions. See Amado, 517 F.3d at 1360. In the court’s view,
the special master’s decision to consider further expert reports and testimony on the
causation issue in light of the finding that Trystan contorted his arms on February 16,
2009, is a logical correction of the error identified by the Federal Circuit.
b. Frequency of Trystan’s Arm Contortions
Petitioners next argue that the special master erred when he “failed to consider the
record as a whole,” and relied upon “a critical unfounded newly created fact” in reaching
his decision. ECF No. 260 at 27. According to petitioners, the special master’s
conclusion that Trystan’s arm contortions on February 16, 2009 “were a one-time event
. . . . is without any evidentiary basis,” and they insist that “the evidence is
overwhelmingly at odds with this newly created finding.” Id. at 28.
Petitioners assert that the “newly created fact permeates the entire Remand
Decision,” id. at 27, but the root of the objection appears to be the special master’s
conclusion that “Trystan did not display any neurologic problems for weeks after the
February 16, 2009 incident,” ECF No. 253 at 43. According to petitioners, the evidence
shows that “Trystan suffered the arm contortions for at least a month and several times a
day.” ECF No. 260 at 34. They also suggest that had the special master properly
considered the evidence, he would have concluded that it demonstrated “a progression of
symptoms,” indicating neurological injury. Id. at 34.
As an initial matter, the special master’s post-remand decision does not say that
Trystan’s arm contortions were a “one-time event.” That phrase, as used by petitioners,
is misleading. The special master, in fact, found that “Trystan contorted his arm on
February 16, 2009, [but] this isolated event was not a manifestation of a neurologic
problem. For the relevant time after the February 5, 2009 vaccine, Trystan was
developing normally.” ECF No. 253 at 98 (emphasis added). In discussing Trystan’s
arm contortions as an isolated event, the special master was designating the event as
isolated only within the relevant timeframe. Elsewhere in the opinion, the special master
noted that Trystan did develop neurological problems, but found that those problems
manifested “no sooner than May 1, 2009.” Id. at 97; see also ECF No. 45 at 14 (noting in
the 2013 Ruling Finding Facts that Trystan contorted his arms on August 8, 2009).
Accordingly, to the extent that petitioners expand the inquiry beyond the relevant
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timeframe—which they do not seriously contest in their motion for review10—the
argument is immaterial to the special master’s conclusions with regard to whether
petitioners have carried their burden under Althen. See ECF No. 260 at 28 (noting, but
not objecting to, the special master’s conclusion that “he would again primarily look for
evidence of neurologic decline within two weeks of the vaccination,” but “if Trystan’s
neurologic decline were to occur slightly outside of two weeks, then [petitioners] could
meet their burden regarding Althen prong three”); see also ECF No. 253 at 36 (noting
that petitioners argued in post-remand briefing that “neurodegeneration would often
occur within two weeks, possibly three weeks after the inciting event”) (citing ECF No.
247 at 53-64).
A vast majority of petitioners’ lengthy argument on this point invites the court to
reweigh the evidence considered by the special master. See ECF No. 260 at 33-42. Such
an exercise is not permitted by the scope of this court’s review. The court does not
“reweigh the factual evidence, assess whether the special master correctly evaluated the
evidence, or examine the probative value of the evidence or the credibility of the
witnesses—these are all matters within the purview of the fact finder.” Porter, 663 F.3d
at 1249. On review, “reversible error is ‘extremely difficult to demonstrate’ if the special
master ‘has considered the relevant evidence of record, drawn plausible inferences and
articulated a rational basis for the decision.’” Lampe, 219 F.3d at 1360 (quoting Hines,
940 F.2d at 1528). Accordingly, the court will restrict its analysis to whether petitioners
have identified either any relevant evidence of record not considered by the special
master or any implausible inferences drawn by the special master, and whether
petitioners have demonstrated that the special master failed, in this case, to articulate a
rational basis for his decision.
In support of their argument that the special master erred in finding that “Trystan
did not display any neurologic problems for weeks after the February 16, 2009 incident,”
ECF No. 253 at 43, petitioners point to two categories of evidence—medical records and
family testimony, see ECF No. 260 at 29-33.
Petitioners identify the following medical records as relevant to establishing the
frequency of Trystan’s arm contortions: (1) August 17, 2009 well-visit notes; (2) Dr.
10 The only reference to petitioners’ disagreement with the special master’s definition of the
relevant time frame is in a footnote, in which petitioners state “[p]etitioners do not agree as
previously outlined in their Federal Circuit appeal that onset symptoms must occur within two
weeks of the vaccination. However, for purposes of this Motion for Review, the arm contortions
did occur within approximately two weeks.” ECF No. 260 at 50-51 n.21. This assertion is an
insufficient basis for a substantive review of the relevant time frame, as determined by the
special master. Petitioners must advance their relevant arguments at each stage of the
proceedings, and the court cannot be charged with an obligation to review prior filings to discern
which arguments petitioners are reasserting.
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Michelson’s November 12, 2009 notes; (3) December 24, 2009 pediatrician notes; (4) Dr.
Katrina Dipple’s May 10, 2010 notes; (5) Dr. Friedman’s August 2, 2010 notes; and (6)
Dr. Haas’s August 7, 2012 notes. As outlined above, the special master explicitly
considered and discussed four of these six reports. See e.g., ECF No. 253 at 8, 69-72
(discussing Ms. Marin-Tucker’s August 17, 2009 notes); id. at 8-9, 74-75 (discussing Dr.
Michelson’s November 12, 2009 notes); id. at 8-9, 14, 74 (discussing Dr. Friedman’s
August 2, 2010 notes); id. at 10, 13, 58-59, 76-78 (discussing Dr. Haas’s August 7, 2009
notes). Accordingly, any argument that the special master failed to consider this
evidence is unfounded.
Moreover, it was not implausible for the special master to conclude that these
notes failed to establish preponderant evidence that Trystan’s arm contortions on
February 16, 2009, were not an indication of neurological injury. Of these records, only
two include notes that specifically indicate that Trystan’s arm contortions happened
repeatedly. Dr. Friedman’s August 2, 2010 notes state that Trystan’s episodes of arm
contortions “would happen again intermittently, maybe 10 times a day, lasting a minute
or two at a time,” and “continued [with] high frequency for about a . . . month.” ECF No.
6-5 at 24. And Dr. Haas’ August 7, 2010 notes state that “11 days after [his six-month]
vaccination, he had an episode of ‘contortion’ in the upper limbs,” for “minutes at a
time,” and “continued [with] high frequency for about a . . . month.” See ECF No. 48-1
at 1. In his entitlement decision, however, the special master specifically considered the
notes made by Trystan’s treating physicians, including both Dr. Friedman and Dr. Haas,
but found them unpersuasive evidence for petitioners.
Dr. Friedman’s notes were the source of some debate between the parties as early
as 2014, and the special master specifically instructed the parties that their experts were
not to rely on “Dr. Friedman’s record for the basis of events in Trystan’s life between
February 2009 through November 2009.” ECF No. 253 at 9 (citing ECF No. 63 at 2
(January 31, 2014 order)). The special master found Dr. Friedman’s notes unreliable for
the purpose of establishing Trystan’s history prior to her August 2, 2010 examination
because they were not a contemporaneous record of his condition, and instead were
petitioners’ “account of remote events in Trystan’s life.” Id. Indeed, just before the
passage cited by petitioners, Dr. Friedman notes that Trystan “was accompanied to the
visit today by his parents who provided the his[to]ry.” ECF No. 6-5 at 24. The special
master repeated his concern with the passage of time in the post-remand decision, and
discounted the value of Dr. Haas’ notes—which were made two years after Dr.
Friedman’s—for the same reason. See ECF No. 253 at 58, 74.
The final two medical records identified by petitioners as evidence contrary to the
special master’s findings are of no assistance to their case. Petitioners are correct that the
December 24, 2009 pediatrician’s note states as follows: “extremity contracted upper
and lower extremities, spastic quadriplegia of all extremities.” ECF No. 6-2 at 26. It also
states: “Neurologic exam: normal for age.” Id. And Dr. Dipple’s May 10, 2010 notes
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included the following assessment under “review of systems”: “Neurologic: global
developmental delay, abnormal movements, hypertonicity.” Id. at 45. Even assuming
that either doctor’s note intended to record arm contortions, they appear to relate solely to
Trystan’s condition on the date of the exam and do not speak to his condition in the
weeks following his February 5, 2009 vaccinations, nor do they speak to a pattern within
the relevant time period.
Petitioners also object to what they claim was the special master’s failure to fairly
consider testimony from petitioners’ family members about Trystan’s condition with
regard to the frequency of his arm contortions. See ECF No. 260 at 31-33. They include
the following: (1) testimony about Trystan’s condition at a family gathering in March
2009; (2) Ms. Sanchez’s testimony with regard to Trystan’s condition as reported at his
April 2009 doctor’s visit; (3) Mr. Sanchez’s testimony about Trystan’s condition at the
time of his May 13, 2009 doctor’s visit; (4) testimony about Trystan’s condition the day
of Ms. Sanchez’s baby shower on August 8, 2009; and (5) Mr. Sanchez’s testimony that
Trystan continued to contort his arms prior to his April 2009 doctor’s visit. See id.
As previously noted, petitioners acknowledge, but do not dispute, the special
master’s conclusion that “he would again primarily look for evidence of neurologic
decline within two weeks of the vaccination,” but “if Trystan’s neurologic decline were
to occur slightly outside of two weeks, then [petitioners] could meet their burden
regarding Althen prong three.” See ECF No. 260 at 28. After Trystan’s visit with Mr.
Luna on February 17, 2009, he was next seen by a medical provider on April 29, 2009,
when he was diagnosed with an ear infection and bronchitis by Dr. Seleem. See ECF No.
253 at 67. Dr. Seleem reported “[n]o unusual arm movements or developmental issues,”
and “noted ‘[n]o neurological symptoms.’” Id. (citations omitted).
The court has reviewed the family testimony identified by petitioners, and has
found several instances in which that testimony indicates that Trystan contorted his arms
in the days following his February 17, 2009 appointment with Mr. Luna. See ECF No.
33 at 34-36 (Lupe Sanchez’s testimony); 156 (Emma Fernandez’s testimony); 189-90
(Germain Sanchez’s testimony). This testimony was taken on May 15, 2012, prior to the
special master’s 2013 Ruling Finding Facts. See id. at 2.
In the special master’s 2013 Ruling Finding Facts, he stated:
12. Sometime [after February 17, 2009], Trystan’s extended family
gathered to watch a boxing match. During this gathering, Trystan was sick,
crying, fussy, and congested. He was not contorting his arms nor was he limp
or rigid.
13. Between Jennifer’s birthday and the next time she took him to the
doctor nearly two months later in late April, Trystan suffered from cough and
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congestion episodically. During this time, he did not lose control of his head
and trunk, nor did he stop making eye contact or stop wanting to play
anymore. He did not exhibit arm contortions.
ECF No. 45 at 13 (citations omitted). The special master specifically relies on these
findings in his post-remand decision, and characterizes “[t]hese facts [as] not contested.”
ECF No. 253 at 63. As such, the question before the court is whether the special master
erred in relying on these findings of fact in rendering his post-remand decision without
more explicitly explaining the basis on which he had previously reached these
conclusions. The court finds that such reliance was not in error.
These factual findings were clearly part of the record well in advance of the
Federal Circuit’s review, having been issued on April 10, 2013. See ECF No. 45. The
court further notes that Trystan’s condition between February 17, 2009 and April 29,
2009 was the subject of much debate between the parties. The special master explains, in
his post-remand decision, that the available medical records were at odds with the
recollection of certain family members. See ECF No. 253 at 4-5. In an effort to resolve
the factual dispute, the special master held a hearing on May 15, 2012, at which he heard
testimony from five family members. See id. at 6-7. He then directed the parties to work
through their factual disputes, and based in part on the parties’ efforts, the special master
issued his 2013 Ruling Finding Facts. See id. at 7. It, therefore, appears to the court that
the special master not only invited the testimony from petitioners’ family members, but
went through a deliberate process of reaching factual findings considering the evidence
before him.
Furthermore, in its decision remanding this case to the special master, the Federal
Circuit specifically noted the conflict between the family’s testimony and the medical
records relating to Trystan’s condition after the February 17, 2009 examination:
Trystan suffered from coughing and congestion episodically for the next
couple of months. Ms. Sanchez testified that during that period, Trystan
continued to have arm contortions, sometimes several times a day. In
addition, she testified that Trystan “started to lose control of his head,” that
his “trunk . . . was not as strong,” that he “didn’t have any eye contact,” and
that he “didn’t want to play” anymore. Again, however, the special master
did not credit Ms. Sanchez’s testimony because it was not corroborated by
medical reports.
Sanchez, 809 F. App’x at 846. Despite having discussed this factual dispute, the Circuit
neither criticized the special master’s conclusion, nor remanded the case for further
consideration on this point. The Circuit’s conclusion with regard to arm contortions
related only to the need to clarify the causation analysis in light of the discrepancy in the
record with regard to whether Trystan contorted his arms on the night of February 16,
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2009. See id. at 852-53. Accordingly, because whether the special master failed to
appropriately consider the family’s testimony in making his 2013 factual findings was
“within the scope of the judgment appealed from,” but was not “explicitly reserved or
remanded” by the Circuit, it is “foreclosed from further consideration” by this court.
Amado, 517 F.3d at 1360.
For the foregoing reasons, the court finds that petitioners have not identified any
relevant evidence of record that the special master failed to consider or any implausible
inferences drawn by the special master with respect to whether Trystan contorted his
arms in the weeks following February 16, 2009. In addition, the court finds that
petitioners have not demonstrated that the special master failed to articulate a rational
basis for his decision in this regard. The special master’s decision on this issue,
therefore, is sustained. See Lampe, 219 F.3d at 1360.
2. Petitioners’ Failure to Prove Causation
In its remand decision, the Federal Circuit found that the special master
improperly combined the analysis of the second and third Althen factors. See Sanchez,
809 F. App’x at 853. The Circuit directed the special master to consider “whether there
was a logical sequence of cause and effect linking Trystan’s vaccinations and his injuries
as well as a proximate temporal relationship between the vaccinations and the onset of
the injuries.”11 Id. As is reflected in the court’s summary of the special master’s post-
remand entitlement decision, the special master reviewed the record in painstaking detail
with regard to petitioners’ proof of causation. In their motion for review, petitioners do
not argue that the special master failed to comply with the mandate, but argue that he
nevertheless committed reversible error in his analysis of the issues.
a. Second Althen Factor and the Challenge-Rechallenge Theory
The second Althen factor requires the special master to determine whether
petitioners have demonstrated, by a preponderance of the evidence, “a logical sequence
of cause and effect showing that the vaccination was the reason for the injury.” Althen,
418 F.3d at 1278. As the court summarized above, the special master considered at great
length the issue of whether petitioners had met this burden. See ECF No. 253 at 38-50.
He ultimately concluded as follows:
11 The Federal Circuit also instructed that the special master should consider “whether
Trystan’s infections between February and May of 2009 caused the manifestation of his Leigh’s
syndrome, independent of his vaccinations,” but only if petitioners meet their burden to show the
requite logical sequence of cause and effect and proximate temporal relationship. Sanchez, 809
F. App’x at 853. Because the court sustains the special master’s conclusion that petitioners did
not make the initial showing, the second analysis is unnecessary.
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In sum, this section . . . has considered both how [petitioners’] experts
predicted an adverse reaction to the vaccination would appear and how
Trystan actually appeared. Because of the dichotomy between the predicted
and the actual, the sequence of events is not logical. Thus, [petitioners] have
not met their burden regarding prong 2.
Id. at 75.
In their motion for review, petitioners criticize the special master for finding flaws
with Trystan’s treating physicians’ notations that the vaccine may have caused his
injuries. See ECF No. 260 at 43. Petitioners claim that each of the doctors was “thinking
about the vaccination as being the cause of Trystan’s issues.” Id. Even assuming this to
be the case, the special master fully considered the records, and articulated a rational
basis for discounting the notes that suggested that a vaccination caused Trystan’s injuries.
The court will not reweigh the evidence or review the special master’s credibility
determinations. Porter, 663 F.3d at 1249.
To summarize his findings based on the treating physician’s reports, the special
master stated:
In summary, the records from four doctors who treated Trystan do not help
[petitioners] meet their burden of showing that the DTaP vaccination
contributed to Trystan’s Leigh’s syndrome. Dr. Friedman presented her
opinion before Trystan’s Leigh’s syndrome was diagnosed after genetic
studies. Dr. Sharma and Dr. Haas obtained histories that are not entirely
accurate. Even so, Dr. Sharma, Dr. Haas, and Dr. Wong appear to present
temporal sequences. Accordingly, while these reports have been considered,
they do not constitute persuasive evidence for [petitioners].
ECF No. 253 at 80. The court finds this explanation, and the extensive discussion of
each doctor’s records that preceded it, see id. at 75-80, sufficient to survive this court’s
review.
Next, petitioners argue that the special master erred in finding that they did not
meet their burden with regard to the second Althen factor because the “evidence shows
that Trystan[’s] response to the DTAP vaccine was consistent with the theories
articulated.” ECF No. 260 at 44 (emphasis in original). Specifically, petitioners contend
that Trystan experienced symptoms that were “[c]onsistent with the vaccine package
insert,” such as “fever, inconsolable crying and fussiness within the time indicated,” and
that his condition thereafter was consistent with the medical theories articulated by their
experts, Dr. Steinman and Dr. Niyazov. Id. Petitioners then claim that the special master
did not consider all of the relevant evidence because he did not discuss the fact that
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“Trystan did experience what one would expect based on Dr. Steinman’s theories and Dr.
Niyazov’s theory.” Id.
This argument is simply not supported by the record. The special master
thoroughly discussed the competing medical theories over the course of dozens of pages
in his post-remand decision. See ECF No. 253 at 41-75. The fact that his analysis was
perhaps not organized in the way petitioners would have preferred, or did not reach the
conclusion they would have favored, does not make it legally deficient.
Petitioners’ final challenge to the special master’s decision on the second Althen
factor relates to their assertion of a challenge-rechallenge theory. See ECF No. 260 at
45-48. In the post-remand decision, the special master noted that “‘[a] rechallenge event
occurs when a patient who had an adverse reaction to a vaccine suffers worsened
symptoms after an additional injection of the vaccine.’” ECF No. 253 at 72 (quoting
Capizzano, 440 F.3d at 1322). He also noted Dr. Raymond’s testimony that “‘[t]he
challenge should meet the criteria of same latency and same effects, and must exclude
well-accepted alternative explanations.’” Id. And although the special master did not
explicitly require that the challenge and rechallenge event be the same, he noted a long
list of cases that tend to support Dr. Raymond’s opinion, and notes that similarity
between the events “would seem to contribute to the strength of the challenge-rechallenge
paradigm.”12 Id. at 73.
Ultimately, the special master concluded as follows:
Dwelling on the nuanced points of challenge-rechallenge seems unnecessary
in this case. [Petitioners] have not established the challenge aspect. As
explained above, [petitioners] have not presented preponderant evidence that
Trystan suffered any neurologic problem within at least one month of the
February 5, 2009 vaccine. And, by simple definition, without a “challenge,”
there can be no “rechallenge.”
Id.
In the motion for review, petitioners do not contest that a challenge is necessary
before a rechallenge can be established; instead, they insist that they have demonstrated a
challenge event, and that the special master committed reversible error in finding
12 In their motion for review, petitioners claim that the special master “impermissibly
rais[es] the burden of proof” by requiring them to show that the rechallenge reaction and timing
are “exactly the same” as the challenge reaction. ECF No. 260 at 47. The special master,
however, was not so categorical. The court does not understand his statement that similarity in
reaction and timing “would seem to contribute to the strength of the challenge-rechallenge
paradigm,” to raise petitioner’s burden beyond a preponderant showing. ECF No. 253 at 73.
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otherwise. See ECF No. 260 at 46-48. The primary basis for petitioners’ argument on
this point is their insistence that Trystan’s arm contortions on February 16, 2009 were
evidence of a neurologic injury.
Petitioners have identified no evidence of record that the special master failed to
consider, nor any implausible inference that he made. See Lampe, 219 F.3d at 1360.
Moreover, petitioners effectively ask the court to reweigh the evidence related to whether
Trystan suffered a neurologic injury on February 5, 2009, and to judge the credibility of
witnesses, two tasks that fall outside the scope of this court’s review. Porter, 663 F.3d at
1242. For this reason, the court sustains the special master’s conclusion that petitioners
have not demonstrated a challenge-rechallenge injury.
b. Third Althen factor
The third Althen factor requires petitioners to prove, by preponderant evidence, “a
proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at
1278. As the special master noted at the outset of his discussion of the third Althen factor
in his post-remand decision:
“[T]he proximate temporal relationship prong requires preponderant proof
that the onset of symptoms occurred within a timeframe for which, given the
medical understanding of the disorder’s etiology, it is medically acceptable
to infer causation-in-fact.” de Bazan v. Sec’y of Health & Human Servs.,
539 F.3d 1347, 1352 (Fed. Cir. 2008). Thus, the third prong of Althen
implicitly has two parts. A petitioner must show the “timeframe for which it
is medically acceptable to infer causation” and that the onset of the disease
occurred in this period. Shapiro v. Secʼy of Health & Human Servs., 101
Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other grounds,
105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir.
2013).
ECF No. 253 at 34.
In his initial entitlement decision, the special master found—based on a review of
the available medical literature and caselaw—that the relevant time period for
establishing Trystan’s injury was approximately two weeks, but declined to set a hard
deadline. He summarized this approach in the post-remand decision, as follows:
While [the cited] cases suggest that sometimes the interval between the
vaccination and the onset of symptoms is too long to support a finding of
causation-in-fact, Paluck cautions against defining the limits too rigidly.
With this guidance, the undersigned attempted to point out that the evidence,
imperfect as it might be, seemed to coalesce around a finding that two weeks
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from vaccination to the onset of neurologic decline is an interval that would
support a finding of causation. Decision at 25, 2018 WL 5856556, at *15.
Yet, at the same time, the undersigned tried to balance what the evidence
showed with Paluck’s recognition that more studies would be helpful. Cf.
Sharpe v. Sec’y of Health & Human Servs., 964 F.3d 1072, 1083 (Fed. Cir.
2020) (criticizing special master for noting that different evidence could lead
to a different result).
On appeal, the Federal Circuit did not correct this approach. Because the
mandate does not remand for reconsideration of the first part of Althen prong
3, the undersigned will again primarily look for evidence of neurologic
decline within two weeks of the vaccination. However, if Trystan’s
neurologic decline were to occur slightly outside of two weeks, then
[petitioners] could meet their burden regarding Althen prong 3.
Id. at 37-38. On this basis, the special master concluded that petitioners failed to show an
injury within approximately two weeks because “[w]hen the record is considered as a
whole, the symptoms that Trystan displayed on February 5, 2009, as well as on February
15-16, 2009, including his arm contortions, are not manifestations of a neurologic
disorder.” Id. at 38.
Petitioners make no substantive argument on this point in their motion for review.
After summarizing the Federal Circuit’s decision, recounting the special master’s
conclusion as articulated in the post-remand decision, and repeating their disagreement
with the special master’s finding that Trystan’s arm contortions on February 16, 2009,
were not evidence of an neurologic injury, see ECF No. 260 at 49-50, petitioners state as
follows:
If the record as a whole was properly considered, then the evidence
overwhelmingly shows that the arm contortions, like in Markovich,
continued for at least a month and several times a day. The failure to consider
and analyze the record as a whole was error and arbitrary and capricious.
Petitioners submit that the arm contortions, at minimum, commenced within
the time parameters outlined by [the special master]. The full analysis on
Temporal Association is within Petitioner’s Post Remand Hearing Brief filed
July 29, 2020 at pages 39-64. This Remand Decision, accordingly, must be
set aside.
Id. at 51.
The court finds this argument unconvincing for several reasons. First, as the court
has discussed at length in this opinion, it sustains the special master’s conclusion that
Trystan’s arm contortions on February 16, 2009, were not a manifestation of neurologic
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injury. As such, to the extent that petitioners’ argument is premised on a foundational
disagreement on that point, it cannot succeed. Second, if there is more to petitioners’
argument than has been previously addressed, it is insufficient for petitioners to simply
assert that the special master failed to consider the record as a whole without identifying
the specific errors. And finally, petitioners cannot incorporate by reference their July 29,
2020 post-remand hearing brief into their motion for review. Petitioners must advance
their relevant arguments at each stage of the proceedings, and the court cannot be charged
with an obligation to review prior filings to discern which arguments petitioners are
reasserting. Moreover, the July 29, 2020 brief was filed before the special master issued
his post-remand decision. Thus, any arguments made therein would need to be addressed
in light of his new decision to have any bearing on this court’s review thereof.
For the foregoing reasons, the court finds that petitioners have identified no
evidence of record that the special master failed to consider, nor any implausible
inference he made with regard to the third Althen factor, and have not shown that his
decision lacked a rational basis. See Lampe, 219 F.3d at 1360. Accordingly, the special
master’s conclusion that petitioners have not carried their burden on the third Althen
factor is sustained.
IV. Conclusion
The court reiterates the acknowledgement, by the Federal Circuit and the special
master, of petitioners’ dedication to their son as demonstrated by their commitment to
this long and complicated litigation. The court’s decision to sustain the special master’s
post-remand decision is made after careful consideration of the record, and with respect
for petitioners’ position.
For the above-stated reasons, however, the court sustains the entitlement decision
of the special master. Accordingly,
(1) Petitioners’ motion for review, ECF No. 260, is DENIED;
(2) The decision of the special master, filed on August 26, 2020, ECF No. 253,
is SUSTAINED;
(3) The clerk’s office is directed to ENTER final judgment in accordance with
the special master’s August 26, 2020 decision; and
(4) The parties shall separately FILE any proposed redactions to this opinion,
with the text to be redacted blacked out, on or before February 26, 2021.
IT IS SO ORDERED.
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s/Patricia E. Campbell-Smith
PATRICIA E. CAMPBELL-SMITH
Judge
37

================================================================================
DOCUMENT 5: USCOURTS-cofc-1_11-vv-00685-8
Date issued/filed: 2024-04-16
Pages: 5
Docket text: JUDGE VACCINE UNREPORTED OPINION (PUBLIC VERSION) re: 470 Sealed Opinion and Order on Petitioners' Petition for a Writ of Mandamus; Petitioners' Motion Requesting Claims Court Entertain Respondents Motion to Reopen Judgment on Entitlement. Signed by Chief Judge Elaine D. Kaplan. (tbs) Service on parties made.
--------------------------------------------------------------------------------
Case 1:11-vv-00685-EDK Document 474 Filed 04/16/24 Page 1 of 5
In the United States Court of Federal Claims
)
TRYSTAN SANCHEZ, by and through his )
parents, GERMAINE SANCHEZ and )
JENNIFER SANCHEZ, )
) No. 11-685V
Petitioners, ) (Filed Under Seal: March 22, 2024;
) Re-issued: April 16, 2024)*
v. )
)
SECRETARY OF HEATH AND HUMAN )
SERVICES, )
)
Respondent. )
)
Lisa A. Roquemore, Law Office of Lisa A. Roquemore, Rancho Santa Margarita, CA, with
whom was Richard Gage, Richard Gage, PC, Cheyenne, WY, for Petitioners.
Jennifer L. Reynaud, Senior Trial Attorney, Torts Branch, Civil Division, U.S. Department of
Justice, Washington, DC, with whom were Debra A. Filteau Begley, Senior Trial Attorney,
Heather L. Pearlman, Deputy Director, C. Salvatore D’Alessio, Director, and Brian M. Boynton,
Principal Deputy Assistant Attorney General, for Respondent.
OPINION AND ORDER
KAPLAN, Chief Judge.
In this case, Germaine and Jennifer Sanchez seek compensation under the National
Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa–1 to –34, as amended (“Vaccine
Act” or “Act”), on behalf of their son, Trystan. The case is currently before this Court on
Petitioners’ Petition for a Writ of Mandamus. ECF No. 461. That Petition asks the Court to direct
the Special Master “to cease interfering with the jurisdiction of this Court and allow Petitioners’
[Motion Requesting Claims Court Entertain Respondent’s Motion to Reopen Judgment on
Entitlement, ECF No. 444 [hereinafter “Petitioners’ Motion”],] to be filed and ruled on by a
judge of this Court.” ECF No. 461 at 2.
For the reasons set forth below, the Court agrees that the Special Master should not have
stricken Petitioners’ Motion. It will therefore direct that the Clerk reinstate the motion on the
docket. The Court concludes, however, that it lacks jurisdiction to intervene in the on-going
* Pursuant to Vaccine Rule 18(b) of the Court of Federal Claims, the Court initially filed this
opinion and order under seal on March 22, 2024, and the parties were afforded fourteen days to
propose redactions. Neither party proposed any redactions. The Court therefore publicly reissues
the opinion and order initially filed under seal without any redactions.

Case 1:11-vv-00685-EDK Document 474 Filed 04/16/24 Page 2 of 5
proceedings before the Special Master in the manner contemplated by Petitioners’ Motion.
Therefore, Petitioners’ Motion is denied.
BACKGROUND
The issue whether the Sanchezes are entitled to compensation under the Vaccine Act has
been before both the Court of Federal Claims (“CFC”) and the court of appeals twice. See
Sanchez ex rel. Sanchez v. Sec’y of Health & Hum. Servs., 34 F.4th 1350 (Fed. Cir. 2022)
[hereinafter Sanchez II], rev’g 152 Fed. Cl. 782 (2021); Sanchez ex rel. Sanchez v. Sec’y of
Health & Hum. Servs., 809 F. App’x 843 (Fed. Cir. 2020) [hereinafter Sanchez I], rev’g 142 Fed.
Cl. 247 (2019). Most recently, in a May 2022 opinion, the court of appeals reversed the Special
Master’s ruling denying entitlement and remanded the case back to him for a ruling on damages.
See Sanchez II, 34 F.4th at 1356.
As a result of that remand, the case is now before the Special Master for the third time.
On August 30, 2022, about three weeks after the court of appeals’ mandate issued in Sanchez II,
see Mandate of CAFC, ECF No. 284, the Special Master issued a Damages Order, ECF No. 288,
to initiate the damages phase of the case. Since that time, the parties have submitted additional
medical records, documents, and expert reports relevant to damages.
At some point during the proceedings on remand, the Secretary claims that he discovered
that Petitioners or their counsel had in their possession additional medical records that they did
not file during the entitlement phase. See Status Conf. Tr., May 24, 2023, ECF No. 378-1. On
August 16, 2023, the Secretary filed a motion requesting that the Special Master reopen the
record for purposes of holding further proceedings relevant to entitlement, based on what he
characterized as “newly discovered and highly probative evidence that [is] materially relevant to
a fact finding that is dispositive on entitlement.” See Respondent’s Motion to Reopen
Entitlement, ECF No. 379 [hereinafter “Respondent’s Motion to Reopen”]. Petitioners filed an
opposition to this motion in September. ECF No. 392. The parties have since filed additional
briefs concerning the issues raised in Respondent’s Motion to Reopen, see ECF Nos. 379, 384,
392, 401, 412, 441, and the Special Master has held several proceedings during which the issues
raised by the discovery of the documents and the Respondent’s Motion to Reopen were
discussed, ECF Nos. 387, 403, 411, 413, 421, 423, 435, 440.
In the meantime, in a December 2023 Order concerning an upcoming status conference,
the Special Master sua sponte raised questions about whether—given the Secretary’s intent to
call her as a witness in connection with his Motion to Reopen—Petitioners’ counsel could
continue to represent the Sanchezes consistent with the rules of professional conduct. See ECF
No. 439. In addition, given the pending motions, and the uncertainty surrounding counsel’s
continued representation of Petitioners, Special Master Moran also cancelled the hearing on
damages that was originally scheduled for January 4 and 5. ECF No. 440.
On January 17, 2024, Petitioners filed a “Motion Requesting Claims Court Entertain
Respondent’s Motion to Reopen Judgment on Entitlement.” See Petitioners’ Motion. In that
Motion, Petitioners ask that the Court exercise its “general supervisory authority,” and decide
Respondent’s Motion to Reopen itself. Id. at 1–2. They contend that the issues raised in the
government’s motion are purely legal ones, involve matters of first impression, and therefore
should be decided by a court, and not the Special Master. Id. They also contend that the Court’s
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intervention is appropriate because the Special Master “has already veered off track” by raising
the issue of whether Petitioners’ attorney can continue to represent him. Id. at 8.
On February 8, 2024, the day after briefing on Petitioners’ Motion was completed, the
Special Master issued an Order purporting to deny the Motion and directing the Clerk to strike it
on the grounds that it was “not well-founded procedurally.” ECF No. 454. In response, on
March 6, 2024, Petitioners filed the Petition for a Writ of Mandamus that is currently before the
Court. ECF No. 461.
DISCUSSION
As discussed during the status conference held on March 14, 2024, this Court’s view is
that the Special Master lacked the authority to strike or resolve a motion that requested the
court’s intervention in an action before him on remand. The extent of the court’s jurisdiction to
grant the relief sought in Petitioners’ Motion was a matter for the court to decide in the first
instance, subject to review by the court of appeals. Instead, the Special Master took it upon
himself to decide that the Motion was “procedurally improper,” and so should be stricken.
The Court will therefore direct the Clerk to unstrike Petitioners’ Motion and reinstate it
on the docket. In light of that action, Petitioners’ request that the Court issue a Writ of
Mandamus that directs the special master “to cease interfering with the jurisdiction of the court”
will be denied. See Cheney v. U.S. Dist. Ct. for D.C., 542 U.S. 367, 380 (2004) (quoting Kerr v.
U.S. Dist. Ct. for N. Dist. of Cal., 426 U.S. 394, 403 (1976)) (explaining the remedy of
mandamus is an extraordinary one that may be invoked only when “the party seeking issuance of
the writ [has] no other adequate means to attain the relief he desires.”).
Nevertheless, the Court concludes that Petitioners’ Motion, which requests that this Court
entertain Respondent’s Motion to Reopen, must be denied. Denial is required because the Court
lacks jurisdiction to grant Petitioners the relief they request: namely, that it intervene in the on-
going proceedings before the Special Master on remand and resolve the Secretary’s pending
Motion to Reopen itself. See ECF No. 444 at 11.
The Vaccine Act states that a Special Master “to whom a petition has been assigned shall
issue a decision on such petition with respect to whether compensation is to be provided under
the Program and the amount of such compensation.” 42 U.S.C. § 300aa-12(d)(3)(A). It further
states that the special master’s decision “shall . . . (i) include findings of fact and conclusions of
law, and (ii) be issued as expeditiously as practicable,” id. at § 300aa-12(d)(3), and that “the
decision of the special master may be reviewed by the United States Court of Federal Claims in
accordance with subsection (e),” 42 U.S.C. § 300aa-12(d)(3)(A). Subsection (e), in turn, gives
the parties thirty days to file a “motion to have the court review the decision.” 42 U.S.C. §
300aa-12(e).
Under the statute, the type of “decision of the special master” that can serve as the
“trigger” for the Court’s jurisdiction, is a decision that “resolves the question of ‘whether
compensation is to be provided’ and, if so, ‘the amount of such compensation.’” J.T. v. Sec’y of
Health & Hum. Servs., 125 Fed. Cl. 164, 166 (2016) (quoting 42 U.S.C. § 300aa-12(d)(3)(A));
see also Weiss v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 624, 626 (2004) (explaining “the
statute contemplates that a ‘decision’ by a special master will resolve the ultimate issues in the
3

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case, including whether compensation is appropriate and if it is, its quantum.”); See Lemire v.
Sec’y of Health & Hum. Servs., 60 Fed. Cl. 75, 80 (2004) (finding that the United States Court
of Federal Claims lacked jurisdiction to review a Special Master's Order because the Order was
not a final Decision indicating whether compensation was to be awarded and the amount of such
compensation if awarded); Spratling v. Sec’y of Health & Hum. Servs., 37 Fed. Cl. 202, 203
(1997) (concluding that the United States Court of Federal Claims lacked jurisdiction over a
motion for review when the Special Master had not yet issued a final Decision on the petition);
Vessels v. Sec’y of Health & Hum. Servs., 65 Fed. Cl. 563, 567 (2005) (explaining that Lemire,
Weiss, and Spratling all “accord with the principle that this Court’s Vaccine Act jurisdiction
extends only to the special masters’ final decisions regarding compensation”).
Petitioners identify nothing in the Vaccine Act that would authorize this Court to exercise
jurisdiction over a vaccine case where there is no “decision” by the Special Master before it that
resolves entitlement and, if appropriate, calculates the damages due. Their resort to the Court’s
supposed “supervisory authority” over special masters finds no support in the statutory language
and, in any event, begs the question of how and when that authority may be exercised.
Moreover, in this case, the Special Master has not made any decision at all that the Court
might review, whether it be one that concerns entitlement and damages, or anything else.
Petitioners are not asking the Court to perform its review function. Instead, they ask the Court to
insert itself into the proceedings on remand to take decision-making authority from the Special
Master and itself rule on Petitioners’ Motion in the first instance.
There is nothing in the Vaccine Act that gives the Court authority to intervene in a matter
that the court of appeals has remanded to the Special Master before he issues a final decision on
entitlement and, as appropriate, damages. To the contrary, the statute states that—upon a
decision by the Special Master, and a timely motion seeking review, the Court of Federal Claims
“shall have jurisdiction to undertake a review of the record of the proceedings,” after which it
may either “uphold the findings of fact and conclusions of law of the special master and sustain
the special master's decision,” “set aside any findings of fact or conclusion of law of the special
master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law and issue its own findings of fact and conclusions of law,” or “remand the petition to
the special master for further action in accordance with the court's direction.” 42 U.S.C. § 300aa-
12(e)(2).
In short, the enumeration of authorities the statute provides to the Court does not include
the authority to step in and decide motions that are pending before the Special Master. Nor have
Petitioners identified a single case in which a judge on this court undertook to do so.
The Court appreciates Petitioners’ frustration that—after more than twelve years, two
stops in the Court of Federal Claims, and two trips to the court of appeals that finally resulted in
a favorable decision on entitlement—the Special Master is now considering whether to reopen
the record on that topic. The Court, of course, has no way of knowing the extent to which (if any)
Petitioners’ actions are responsible for this most recent round of delay, and the Court expresses
no opinion on that topic. Nonetheless, it agrees that—given the extraordinary length of time this
case has been pending and the catastrophic nature of Trystan’s injuries—it behooves the Special
Master to expedite to the greatest extent possible the proceedings on remand, including the
resolution of Respondent’s Motion to Reopen.
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Case 1:11-vv-00685-EDK Document 474 Filed 04/16/24 Page 5 of 5
CONCLUSION
On the basis of the foregoing, Petitioners’ Petition for a Writ of Mandamus, ECF No.
461, is DENIED. The Clerk is directed, nonetheless, to UNSTRIKE Petitioners’ Motion
Requesting Claims Court Entertain Respondent’s Motion to Reopen Judgment on Entitlement,
ECF No. 444, and REINSTATE it on the docket. As reinstated, Petitioners’ Motion, ECF No.
444, is DENIED.
IT IS SO ORDERED.
s/ Elaine D. Kaplan
ELAINE D. KAPLAN
Chief Judge
5

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DOCUMENT 6: USCOURTS-cofc-1_11-vv-00685-11
Date issued/filed: 2025-02-18
Pages: 5
Docket text: JUDGE VACCINE UNREPORTED OPINION (PUBLIC VERSION) of 521 Opinion denying Petitioners' Motion for Protective Order. Signed by Chief Judge Elaine D. Kaplan. (aa) Service on parties made.
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Case 1:11-vv-00685-EDK Document 540 Filed 02/18/25 Page 1 of 5
In the United States Court of Federal Claims
)
TRYSTAN SANCHEZ, by and through his )
parents, GERMAIN SANCHEZ and )
JENNIFER SANCHEZ, )
) No. 11-685V
Petitioners, ) (Filed Under Seal: December 2,
) 2024; Reissued: February 18,
v. ) 2025)*
)
SECRETARY OF HEATH AND HUMAN )
SERVICES, )
)
Respondent. )
)
Lisa A. Roquemore, Law Office of Lisa A. Roquemore, Rancho Santa Margarita, CA, with
whom was Richard Gage, Richard Gage, PC, Cheyenne, WY, for Petitioners.
Jennifer L. Reynaud, Senior Trial Attorney, Torts Branch, Civil Division, U.S. Department of
Justice, Washington, DC, with whom were Heather L. Pearlman, Deputy Director, C. Salvatore
D’Alessio, Director, and Brian M. Boynton, Principal Deputy Assistant Attorney General, for
Respondent.
OPINION AND ORDER
KAPLAN, Chief Judge.
This case is currently before the Court on Petitioners’ Motion for Protective Order, ECF
No. 520 (Pet’rs’ Mot.). For the reasons set forth below, Petitioners’ Motion is DENIED.
BACKGROUND
I. Prior Proceedings
Germain and Jennifer Sanchez brought this action seeking compensation under the
National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34, as amended
(“Vaccine Act” or “Act”), on behalf of their son, Trystan. At the present time, the case is before
Special Master Christian Moran on remand from the court of appeals in Sanchez ex rel. Sanchez
* Pursuant to Vaccine Rule 18(b) of the Court of Federal Claims, the Court initially filed this
opinion and order under seal on December 2, 2024, and the parties were afforded fourteen days
to propose redactions. Neither party proposed any redactions. The Court therefore publicly
reissues the opinion and order initially filed under seal without any redactions.

Case 1:11-vv-00685-EDK Document 540 Filed 02/18/25 Page 2 of 5
v. Sec’y of Health & Hum. Servs., 34 F.4th 1350 (Fed. Cir. 2022) [hereinafter Sanchez II]. In
that opinion, the court of appeals reversed Special Master Moran’s ruling denying entitlement to
compensation and remanded the case back to him for a determination of damages. See 34 F.4th
at 1356.
As this Court explained in Sanchez ex rel. Sanchez v. Sec’y of Health & Hum. Servs.,
No. 11-685V, 2024 WL 1637913 (Fed. Cl. Mar. 22, 2024) [hereinafter Sanchez III] after the
court of appeals remanded the case to the Special Master, the government filed a motion seeking
to reopen the record on entitlement. Its motion was based on what it characterized as “newly
discovered and highly probative evidence that [is] materially relevant to a fact finding that is
dispositive on entitlement.” See Sanchez III, 2024 WL 1637913, at *1 (alteration in original)
(quoting Respondent’s Motion to Reopen Entitlement, ECF No. 379).
After the government filed its Motion to Reopen Entitlement, the Special Master issued
an order questioning whether—given the government’s intent to call Petitioners’ counsel as a
witness in connection with its motion—she could continue to represent the Sanchezes consistent
with rules of professional conduct. See ECF No. 439. Petitioners then sought relief from this
Court, requesting that it, rather than the Special Master, decide the government’s motion. See
ECF No. 444.
The Court concluded that it lacked authority to intervene in the ongoing proceedings
before the Special Master on remand and resolve the Secretary’s pending Motion to Reopen
Entitlement. See Sanchez III, 2024 WL 1637913, at *2–3. It therefore denied Petitioners’ motion
asking it to rule on the government’s motion. Id. at *3.
II. The Current Motion
Petitioners have now filed their Motion for Protective Order, which is currently before
this Court. This time, Petitioners’ requests for intervention are related to the Special Master’s
order requiring Ms. Sanchez to testify in person concerning the government’s Motion to Reopen
Entitlement. Pet’rs’ Mot. at 3, 17; see also Order, ECF No. 500. Petitioners have objected to
having Ms. Sanchez testify in light of her ongoing treatment for post-traumatic stress disorder
(PTSD), alleging that Ms. Sanchez’s therapist was of the view that requiring her to do so “will
only continue to trigger her PTSD and as such only serves to continue setting her back” in her
treatment. Pet’rs’ Status Rep. at 2, ECF No. 503.
In response to Petitioners’ objections, the Special Master directed them to perfect their
request that Ms. Sanchez be excused from testifying by filing a motion for a protective order.
Order Re: Claim of PTSD at 1, ECF No. 504. He advised that Petitioners could support their
motion with a statement from Ms. Sanchez’s therapist. Id. at 2. He provided a list of the
questions the therapist should address in her statement. Questions Proposed to Ms. Sanchez’s
Therapist, ECF No. 504-1.1 He also directed that, if Petitioners chose to provide a statement from
1 Pursuant to the parties’ agreement, the Special Master subsequently tabled the requirement that
Ms. Sanchez’s therapist address the questions he posed in the Order Re: Claim of PTSD. See
Order, ECF No. 505.
2

Case 1:11-vv-00685-EDK Document 540 Filed 02/18/25 Page 3 of 5
the therapist, they must file, as a separately numbered exhibit, “all material in the therapist’s
possession or control generated from therapy with Ms. Sanchez from the last three years.” Order
Re: Claim of PTSD at 2.
On September 18, 2024, Petitioners filed a renewed motion for a protective order, as the
Special Master directed, Pet’rs’ Renewed Mot. for Protective Order, ECF No. 508, along with a
September 4, 2024 letter from Mikal Britt, a licensed clinical social worker, Ex. 332, ECF No.
507-1. Ms. Britt stated that she had been treating Ms. Sanchez for PTSD, depression, and
generalized anxiety since February 9, 2023. Ex. 332 at 1. She explained that she had seen Ms.
Sanchez on September 29, 2023, two days after a hearing on damages and that “the stress and
intensity of being interrogated on the stand re-triggered Mrs. Sanchez’s trauma responses,”
including “a freeze response, disassociation, sweaty palms, rapid heartbeat, tingling sensations in
arms, dry mouth, and involuntary shaking.” Id.; see also Order, ECF No. 403. Ms. Britt also
reported that Ms. Sanchez had been experiencing “racing thoughts, anger, nightmares, low self-
esteem, insomnia, and excessive worry/rumination.” Ex. 332 at 1. Ms. Britt opined that the
hearing had caused “a major set-back in [Ms. Sanchez’s] recovery and healing.” Id. Ms. Britt
concluded that having Ms. Sanchez testify would be, in her medical opinion, “both inappropriate
and potentially harmful” and that she was “worried for [Ms. Sanchez’s] mental/emotional well-
being and [did] not recommend or endorse that she participates in this hearing and undergo this
type of stress.” Id.
In their renewed motion for a protective order, Petitioners declined to produce the records
Ms. Britt has maintained regarding her treatment of Ms. Sanchez. Pet’rs’ Renewed Mot. for
Protective Order. They argued that the records were covered by the psychotherapist-patient
privilege, recognized by the Supreme Court in Jaffee v. Redmond, 518 U.S. 1, 14–17 (1996). Id.
at 3. The Special Master construed the objection as a third motion for a protective order, See
Order, ECF No. 509, which he denied on October 28, 2024, Order Denying Mot. for Protective
Order, ECF No. 516. He concluded that Petitioners had waived any psychotherapist-patient
privilege that they might possess by raising Ms. Sanchez’s mental health in resisting an
obligation to provide live in-person testimony in connection with the government’s Motion to
Reopen Entitlement. Order Denying Mot. for Protective Order at 5. The Special Master therefore
issued an order directing Ms. Britt to produce all documents in her possession concerning Ms.
Sanchez’s treatment by November 26, 2024. Id. at 6–7.
On November 25, having lost the issue before the Special Master, Petitioners filed their
Motion for Protective Order. They ask that the Court strike the Special Master’s October 28,
2024 order that compels the production of Ms. Sanchez’s mental health records. Pet’rs’ Mot. at
10–11, 18; see also Order Denying Mot. for Protective Order. In addition, they request that the
Court reassign this case to a different special master. Pet’rs’ Mot. at 11–18.
DISCUSSION
3

Case 1:11-vv-00685-EDK Document 540 Filed 02/18/25 Page 4 of 5
The Vaccine Act states that a special master “to whom a petition has been assigned shall
issue a decision on such petition with respect to whether compensation is to be provided under
the Program and the amount of such compensation.” 42 U.S.C. § 300aa-12(d)(3)(A). It further
states that “[t]he decision of the special master may be reviewed by the United States Court of
Federal Claims in accordance with subsection (e).” Id. Subsection (e), in turn, gives the parties
thirty days to file a “motion to have the court review the decision.” 42 U.S.C. § 300aa-12(e)(1).
For the reasons set forth in this Court’s previous opinion, the Court of Federal Claims’
jurisdiction in the Vaccine Act to review the decisions of special masters extends to decisions
that resolve whether compensation is to be awarded and, if so, in what amount. See Sanchez III,
2024 WL 1637913, at *2–3. The Special Master’s determinations regarding the assertion of
evidentiary privileges or similar matters involving the ongoing proceedings before him do not
fall into this category. Further, as the Court also held in its previous opinion, it does not have
what Petitioners call “supervisory authority” over the special masters that would justify its
intervention in such interlocutory determinations. Id.
Petitioners’ invocation of the collateral order doctrine as a basis for this Court to review
their assertion of the psychotherapist-patient privilege is similarly unavailing. See Pet’rs’ Mot. at
6–9. Under that doctrine, the jurisdiction of the courts of appeals to review final decisions by the
district courts under 28 U.S.C. § 1291 may include not only judgments that “terminate an action”
but also a “small class” of collateral rulings that are appropriately deemed “final” even before
“the whole case is adjudicated.” Cohen v. Beneficial Indus. Loan Corp., 337 U.S. 541, 545–46
(1949). “That small category includes only decisions that are conclusive, that resolve important
questions separate from the merits, and that are effectively unreviewable on appeal from the final
judgment in the underlying action.” Swint v. Chambers Cnty. Comm’n, 514 U.S. 35, 42 (1995).
“In applying Cohen’s collateral order doctrine,” the Supreme Court has “stressed that it
must ‘never be allowed to swallow the general rule that a party is entitled to a single appeal, to
be deferred until final judgment has been entered.’” Mohawk Indus., Inc. v. Carpenter, 558 U.S.
100, 106 (2009) (quoting Digit. Equip. Corp. v. Desktop Direct, Inc., 511 U.S. 863, 868 (1994)).
This “admonition,” the Court has observed, “reflects a healthy respect for the virtues of the final-
judgment rule.” Id. In particular, “[p]ermitting piecemeal, prejudgment appeals . . . undermines
‘efficient judicial administration’ and encroaches upon the prerogatives of district court judges,
who play a ‘special role’ in managing ongoing litigation.” Id. (quoting Firestone Tire & Rubber
Co. v. Risjord, 449 U.S. 368, 374 (1981)).
Petitioners argue that an order compelling the production of privileged information meets
the criteria the Supreme Court has established to invoke the collateral order doctrine. Pet’rs’
Mot. at 6–9. They support their argument by reproducing in full several pages of the decision of
the D.C. Circuit in In re Sealed Case, 381 F.3d 1205 (D.C. Cir. 2004). Pet’rs’ Mot. at 6–8. That
case involved a lower court’s order compelling a party to produce information that allegedly was
protected by the psychotherapist-patient privilege. In re Sealed Case, 381 F.3d at 1207–08. In
finding that the collateral order doctrine applied to the lower court’s decision, the court of
appeals relied on the reasoning of United States v. Philip Morris Inc., 314 F.3d 612 (D.C. Cir.
2004), which held that an order to produce information allegedly protected by the attorney-client
privilege was subject to collateral review. In re Sealed Case, 381 F.3d at 1209–10.
4

Case 1:11-vv-00685-EDK Document 540 Filed 02/18/25 Page 5 of 5
But the ruling in Philip Morris was in conflict with the decisions of other circuits that
held that orders compelling production of information allegedly protected by the attorney-client
privilege are not subject to collateral appeals. See Mohawk Indus., 558 U.S. at 105 n. 1. And the
conflict between the D.C. Circuit and five other circuits concerning that issue was resolved
against the D.C. Circuit’s position. See id. at 103. The Supreme Court held that “disclosure
orders adverse to the attorney-client privilege [do not] qualify for immediate appeal under the
collateral order doctrine,” reasoning that “[p]ostjudgment appeals, together with other review
mechanisms, suffice to protect the rights of litigants and preserve the vitality of the attorney-
client privilege.” Id. The same reasoning would apply to disclosure orders adverse to other
privileges, such as the psychotherapist-patient privilege.
Finally, Petitioners ask that the Court reassign this case to another special master. Pet’rs’
Mot. at 11–18. The Court lacks the authority to do so. Rule 3(d) of the Vaccine Rules of the
United States Court of Federal Claims provides that “[w]hen necessary for the efficient
administration of justice, the chief special master may reassign the case to another special
master.” (emphasis added). If Petitioners believe that reassignment of this matter to a different
special master is necessary for the effective administration of justice, they may direct such a
request to the Chief Special Master.
CONCLUSION
On the basis of the foregoing, Petitioners’ Motion for Protective Order, ECF No. 520, is
DENIED.
Pursuant to Vaccine Rule 18(b), this Opinion will be held for fourteen days to afford each
party an opportunity to object to the public disclosure of any financial or medical information
furnished by that party. An objecting party must provide the court with a proposed redacted
version of the decision and must provide a justification for each proposed redaction by December
16, 2024. In the absence of an objection, the entire decision will be made public.
IT IS SO ORDERED.
s/ Elaine D. Kaplan
ELAINE D. KAPLAN
Chief Judge
5

================================================================================
DOCUMENT 7: USCOURTS-cofc-1_11-vv-00685-14
Date issued/filed: 2025-10-22
Pages: 16
Docket text: PUBLIC ORDER/RULING (Originally filed: 09/30/2025) regarding 608 Findings of Fact & Conclusions of Law. Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
--------------------------------------------------------------------------------
Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 1 of 16
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
GERMAIN SANCHEZ and *
JENNIFER SANCHEZ, *
parents of T.S., *
* No. 11-685V
Petitioners, * Special Master Christian J. Moran
v. *
*
SECRETARY OF HEALTH * Filed: September 30, 2025
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Lisa A. Roquemore, Law Offices of Lisa A. Roquemore, Rancho Santa Margarita,
CA, and Richard Gage, Richard Gage, P.C., Cheyenne, WY for petitioners;
Jennifer L. Reynaud, Zoe Wade, and Madylan Yarc, United States Dep’t of Justice,
Washington, DC, for respondent.
FINDINGS REGARDING DAY PLANNER1
Mr. and Ms. Sanchez claim a vaccination harmed their son, T.S. Although
the Federal Circuit found that they were entitled to compensation, the Secretary is
seeking a sanction of dismissal for litigation misconduct. One, but not the only,
basis concerns the production of Ms. Sanchez’s day planner. Ms. Sanchez testified
at a hearing held on June 2-3, 2025. Based upon all the evidence and arguments,
1 Because these Findings contain a reasoned explanation for the action in this case, the
undersigned is required to post them on the United States Court of Federal Claims' website in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). This means the Findings will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b),
petitioners have 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the
undersigned agrees that the identified material fits within this definition, the undersigned will
redact such material before posting the decision.

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 2 of 16
the undersigned finds that litigation misconduct (tampering) occurred with respect
to the production of the day planner.
BACKGROUND
Creation of Day Planner in 2008-09
At the age of six months, T.S. received the vaccinations at issue. At the
time, Ms. Sanchez had many obligations. She was pregnant with another child.
She was working for the United States Postal Service as a mail carrier. Tr. 4139.
She also was responsible for paying the family’s bills. Id. at 4132. She recorded
much of the information about her family’s life in a day planner.2 Mrs. Sanchez
also charted some information about her health as well as T.S.’s health in the day
planner.
The day planner appears to be a typical planner.3 Each week (Monday to
Sunday) appears on two facing pages. The day planner runs from August 2008
through December 2009. The pages are bound with metal rings, which are
separable. At the bottom right of every pair of pages, there is a mini-calendar
showing the current month and the next month. A sample page is shown below:
2 Sometimes, the "day planner" is referred to as a "journal," “calendar,” or “day timer.”
However, Ms. Sanchez's day planner is not the same as T.S.'s baby book.
3 A black and white photocopy of a portion of the day planner was filed as Exhibit 58 on
December 12, 2014. A color photocopy of the complete day planner, with redactions on
information regarding passwords, is in the record as Court Exhibit 1004.
2

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 3 of 16
According to reviews of this day planner posted to Amazon, most people found it
useful.4
Ms. Sanchez filled in the weekly planner by hand with ink. The day planner
contains reminders about upcoming appointments, birthdays, family events, work
schedules, and bill payments. Additionally, Ms. Sanchez often wrote notes and
recaps of her appointments, events, and overall day afterwards, noting things such
as what doctors had said, stating whether she enjoyed the events, and
memorializing various activities she had done. Ms. Sanchez also wrote about her
own health and pregnancy symptoms. The day planner proceeds conventionally
from its start date of July 28, 2008 through March 13, 2009.
However, in the version filed as an exhibit, on March 14, 2009, the pages
switch to November dates. March 14, 2009 through April 10, 2009 are instead
filled with the pages for November 14, 2009 through December 4, 2009, with
handwritten corrections over the November and December dates to conform them
to March and April dates. Exhibit 58 at 11-14; Exhibit 1004 at 39-42; Tr. 4104.
The last page in this range has been hand-adjusted to cover twelve days instead of
five, realigning the dates so that the next page properly falls back to Saturday, April
4 The undersigned used the ISBN number located on the back of the day planner (978-1-
60434-137-9) to search for it on Amazon. The reviews are in the record as Court Exhibit 1005.
3

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 4 of 16
11, 2009. The remainder of the pages in the day planner have the correct dates,
including the November and December 2009 pages. A sample of pages with the
date discrepancies is shown below:
4

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 5 of 16
Initiation of Litigation and Gathering Documents in 2011
Approximately 17 months after T.S.'s vaccination, Mr. and Ms. Sanchez
consulted attorney Lisa Roquemore. Timesheets.5 Ms. Roquemore agreed to
represent the family in April 2011. Timesheets at 7; Supp’l Decl. ¶ 10.6
For the family to succeed in their claim, Mr. and Ms. Sanchez were required
to establish that T.S. first developed problems within a time for which an inference
of causation is appropriate. Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d
1347, 1353 (Fed. Cir. 2008). The predominant way for demonstrating when a
vaccinee first manifested a symptom or sign of an injury allegedly related to a
vaccination is to rely upon medical records created during the critical time.
Arguably, in the absence of a medical record created during the critical time,
another relevant source of information could be another document created during
the critical time. See Richardson v. Sec’y of Health & Hum. Servs., No. 90-324V,
5 The Timesheets were attached to petitioners’ first motion for an award of attorneys’ fees
and costs on an interim basis, filed Sep. 16, 2014, as Exhibit 2.
6 Ms. Roquemore detailed her representation of the family in a Supplemental Declaration
in support of the first motion for attorneys’ fees and costs, filed Dec. 12, 2014.
5

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 6 of 16
1991 WL 67483, at *2-3 (Cl. Ct. Spec. Mstr. Apr. 16, 1991) (crediting oral
testimony based upon a diary).
Ms. Roquemore began to develop the case more actively in August 2011.7 A
problem was that the medical records created on February 17, 2009; April 29,
2009; and May, 13, 2009 do not memorialize any complaint to a health care
provider about arm contortions, which could be understood as a manifestation of a
neurologic problem. Exhibit 1 at 48-53. The first medical record recognizing arm
contortions was created by a neurologist, Dr. Michelson, on November 12, 2009.
Exhibit 1 at 140. And even this note does not state when the arm contortions first
began.
Ms. Sanchez provided her day planner to Ms. Roquemore. Supp’l Decl.
¶ 16; Tr. 4115. In August 2011 Ms. Roquemore reviewed the day planner often.
See Timesheet entries for Aug. 5, 2011; Aug. 17, 2011; Aug. 23, 2011 (“Review
Jennifer’s Journal for 2009. (.8)”; Aug. 25, 2011; Aug. 29, 2011 (“Review
‘original’ of journal for half of 2008 and all of 2009. (.5)”.
In August and September 2011, Ms. Roquemore assisted her clients and
other family members with preparing affidavits. See, e.g., Timesheet entries for
Aug. 5, 2011; Aug. 17, 2011; Sep. 1, 2011; Sep. 5, 2011; Sep. 6, 2011; Sep. 7,
2011.
On behalf of the Sanchezes, Ms. Roquemore submitted the petition for filing
on October 17, 2011. Ms. Roquemore submitted a first set of exhibits, which did
not include the day planner. Ms. Roquemore maintained that the Vaccine Rules
require the submission of only medical records and because the day planner is not
a medical record, she did not have to present the day planner. Supp’l Decl. ¶¶ 50,
52. (Whether Ms. Roquemore correctly understood her duty as an officer of the
court is not addressed in this finding.)
Rather than relying upon medical records that T.S.’s doctors created while
treating him 2009, Mr. and Ms. Sanchez relied upon their own recollections.
According to Ms. Sanchez, Mr. Sanchez, and other family members, within about
two weeks of the vaccination, T.S. began to contort his arm. See Exhibits 3-7
(affidavits).
7 The Secretary's pending motion for sanctions also is based upon misconduct concerning
the lack of production of medical records created by Dr. Valencia and Dr. Brown in August 2011.
However, the present finding of fact does not address the records created by Dr. Valencia or Dr.
Brown.
6

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 7 of 16
Resolution of Dispute over Onset of Arm Contortions in 2012
The Secretary reviewed this evidence, including the affidavits. The
Secretary maintained that “petitioners have not shown that T.S. suffered from
either seizures or developmental delay within an appropriate temporal relationship
to the February 5, 2009 vaccines.” Resp’t’s Rep’t, filed Feb. 28, 2012, at 11.
In due course, a hearing to receive oral testimony about T.S.'s health was
scheduled. Order, issued March 23, 2012 (scheduling a hearing for May 15, 2012).
Leading up to the hearing, Ms. Roquemore conferred with the Sanchezes and
collectively they considered whether to submit the day planner. Ultimately, the
decision was made to not submit the day planner. Tr. 4395-99; Supp’l Decl. ¶ 50;
see also Tr. 4189; Timesheet entries for Mar. 8-9, 2012.8
Following the hearing, the undersigned found how the evidence
preponderated. The evidence weighed in favor of finding that T.S. did not contort
his arms in February, March, or April 2009. Ruling Finding Facts, ¶¶ 11-17, 2013
WL 1880825, issued Apr. 10, 2013. The undersigned credited the accuracy of Ms.
Marin-Tucker’s August 17, 2009 medical record that memorialized Ms. Sanchez’s
statement that she noticed a change in T.S.’s development two to three months
before the appointment and did not accept Ms. Sanchez’s testimony that the change
started five to six months earlier. Id. at *8 n. 10. The basic reasoning was that if
T.S. were contorting his arms as frequently as his family asserted, then Ms.
Sanchez would have sought treatment, and a doctor would have memorialized a
complaint about arm contortions. See Ruling. The Ruling did not find that any
family member testified dishonestly.
8 Relevant portions of Ms. Roquemore’s timesheet entries include:
3/8/2012 “Review day planner in day to day detail and draft memorandum
regarding pros and cons of providing day planner as evidence (1.1). Telephonic conference with
Jennifer Sanchez . . . and go over day planner in detail so that clients can decide whether it gets
filed based on risks and benefits addressed. Go over declarations compared to day planner and
medical records. [time for these activities, including activities omitted by the ellipses totals 1.3].
Review e-mail from Jennifer requesting my memorandum pertaining to day timer. (1) Draft e-
mail in response. (.1).”
3/9/2012 “Review e-mail from Jennifer regarding decision to not use the day timer.
(.1) Draft e-mail in response and regarding trial date (.1).”
In her supplemental declaration, Ms. Roquemore averred: “Decisions made in this
particular case regarding whether to file certain day timers/planners, and photos are decisions
that, I felt, were decisions to be made by the attorney and the client, which is what happened.”
7

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 8 of 16
Discovery of Day Planner in 2014
The Sanchezes sought an award of Ms. Roquemore’s attorneys’ fees and
costs on an interim basis. Pet’rs’ Mot. for Interim Fees, filed Sep. 16, 2014. Ms.
Roquemore’s timesheets are Exhibit 2 to that document.
The timesheets revealed that Ms. Sanchez created a day planner in 2009,
which had not been produced into evidence. Upon being informed via Ms.
Roquemore’s time entry that a day planner existed, the Secretary sought production
of it. See Resp’s Resp. filed Nov. 24, 2024, at 2 n.1; Order, issued Dec. 2, 2014.
Ms. Sanchez averred that she “made a few notes regarding T.S.” Exhibit 56
(affidavit) at 2. A copy of the day planner was filed in black and white as Exhibit
58.
The production of the day planner in 2014 did not affect whether Mr. and
Ms. Sanchez were entitled to compensation. See Opinion and Order, 142 Fed. Cl.
247, 251 (2019) (denying motion for review), vacated on other grounds, 809 Fed.
App’x 843 (Fed. Cir. Apr. 7, 2020).
Finding of Entitlement and Pending Motion for Sanctions
A long series of events followed, but none particularly concerned the
production of the day planner. Eventually, the Federal Circuit found that Mr. and
Ms. Sanchez were entitled to compensation and the Federal Circuit remanded to
determine damages. 34 F.4th 1350 (Fed. Cir. 2022). As part of the discovery
process for quantifying the amount of compensation, the Secretary discovered that
Ms. Sanchez failed to produce multiple medical records during the entitlement
stage. These belatedly produced documents are a foundation for the pending
motion to reopen. Resp’t’s Mot. to Reopen, filed Aug. 16, 2023; Resp’t’s Comp.
Br., filed Jan. 11, 2024; Pet’rs’ Comp. Resp., filed May 9, 2024.
The omission of these medical records also serves as a basis for the
Secretary's pending motion for sanctions, filed Oct. 23, 2024. As relevant to this
finding, the Secretary also argued: “While it is possible that Ms. Sanchez altered
the Day Planner on her own initiative, it is logical to infer that Ms. Roquemore was
at least aware of the alteration, given her close and repeated study of the
document.” Resp’t’s Mot. for Sanctions at 11.
Mr. and Mrs. Sanchez contended that the Secretary could have discovered
why the pages were as they were in 2014, approximately one decade earlier.
Pet’rs’ Resp., filed Nov. 6, 2024, at 10. Mr. and Ms. Sanchez did not assert that the
day planner was authentic. At best, they argued that the Secretary’s discovery of
8

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out-of-order pages “does not mean Mrs. Sanchez’[s] day planner was not a true
and correct copy.” Id.9
Hearing and Post-Hearing Activities
In anticipation of testimony about the production of evidence, Ms. Sanchez
was directed to bring her original day planner to the hearing. Order, issued May 6,
9 The entirety of petitioners’ response to the Secretary’s argument that misconduct
occurred in 2014 when the day planner was submitted is as follows:
Respondent submits that Mrs. Sanchez[’s] declaration, (Exhibit 56 at 3) stated that
Exhibit 58 was a true and correct copy of [her] 2009 Day Planner. Then, Respondent
alleges, without any evidence, that the Day planner had been altered. First, it needs to be
observed that Petitioner was not the one who wanted to file the Day Planner. It was not
relied upon during the entitlement phase of the case. Rather, she was Ordered to file it
when Respondent wanted it produced and had questions about it during the 2014 Fee
Application process. Although Respondent had the Day Planner in 2014, and admittedly
commented upon it during the first Motion for Review proceeding, Respondent did
nothing to discover why the pages were as they were, which does not mean Mrs.
Sanchez' day planner was not a true and correct copy. As it was noted by Respondent,
Respondent had, again, ample opportunity to raise this issue and did not. Instead,
Respondent now makes up a fiction to fit his narrative. Respondent then argues, in an
inuendo fashion, it was possible that Mrs. Sanchez altered the Day planner on her own
initiative, but it is logical to infer that Ms. Roquemore was at least aware of the
alterations and did not correct the Special master's misunderstanding that pursuant to
Vaccine Rule 2c (2) (discussing the requirement to file all medical records.) that
"petitioners appear to have complied with the obligation." First Respondent assumes a
misunderstanding existed by this court. And, more importantly, Respondent is taking
things out of context. The Special master was specifically referring to Medical records
when he stated that it appeared we had complied with the obligation.
... 1. The undersigned is concerned about the completeness of petitioners'
presentation of evidence. Pursuant to Vaccine Rule 2( c )(2), petitioners are
required to submit all medical records. Petitioners appear to have complied with
this obligation.
(See Order, issued Dec. 2, 2014) (Emphasis added.)
The Day Planner is not a medical record. The Special Master and Ms.
Roquemore had a difference of opinion of what the Rules versus the Guidelines required
at the time of the filing of the Petition in 2011. The bottom line regarding this issue and
nearly every issue raised in Respondent's frivolous motion, is that Respondent presents a
very misleading and inaccurate argument; and, Respondent had this Day Planner in 2014
and did nothing.
Pet’rs’ Resp., filed Nov. 6, 2024, at 10-11.
9

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 10 of 16
2025. She testified on June 2, 2025. To accommodate Ms. Sanchez's post-
traumatic stress disorder, she was given more frequent and longer breaks whenever
she felt stressed.
Ms. Sanchez testified that she modified her day planner because the original
day planner contained a “manufacturer defect.” Tr. 4105.10 Ms. Sanchez
recognized that when the petitioners submitted the day planner as Exhibit 58 in
2014, she did not disclose that she had altered the day planner when she was using
it in 2009. Tr. 4112; see also Exhibit 56 (affidavit attesting to the genuineness of
Exhibit 58).
Ms. Sanchez presented the original day planner from 2009. After the
hearing, the undersigned submitted the original day planner to the Clerk’s Office as
an exhibit that the Clerk’s Office will retain until the disposition of this case and
any ensuing appellate review. Order, issued June 25, 2025. A color copy of the
day planner was filed into evidence as Court Exhibit 1004. Id.
Information from the original day planner (the ISBN number) was used to
search for product reviews. Those were filed as Court Exhibit 1005. Order, issued
June 25, 2025.
After the hearing, the undersigned advised, in part, that the evidence
supported a finding that “Ms. Sanchez altered the day planner prior to submitting it
into evidence.” Order, issued June 23, 2025. Mr. and Ms. Sanchez were permitted
time to present evidence such as a statement from the day planner’s manufacturer
that the day planner was printed in error. Id.
Mr. and Ms. Sanchez submitted information about manufacturing of day
planners generally. Exhibits 349-51 (filed July 24, 2025), Exhibit 352 (filed Aug.
21, 2025). The Secretary maintained that “the current record, viewed as a whole,
still supports the Court’s finding that Ms. Sanchez altered her day planner before
submitting it into evidence." Resp’t’s Status Rep’t, filed Sep. 17, 2025.
STANDARDS FOR ADJUDICATION
The Secretary did not propose a standard by which the motion for sanctions
should be adjudicated. See Resp’t’s Mot., filed Oct. 23, 2024. Mr. and Ms.
Sanchez propose “clear and convincing evidence.” Pet’rs’ Resp., filed Nov. 6,
2024. “Clear and convincing evidence,” in turn, means “evidence which produces
10 The explanation of a manufacturing defect was not raised previously. See, e.g., Pet’rs’
Resp., filed Nov. 6, 2024, at 10-11; see also footnote 9, quoting this source.
10

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 11 of 16
in the mind of the trier of fact an abiding conviction that the truth of a factual
contention is ‘highly probable.’” Miller v. Department of Justice, 842 F.3d 1252,
1257-58 (Fed. Cir. 2016).
ANALYSIS
To start, the day planner, as filed, is--to use a nonjudgmental word--unusual.
Most pages contained a small representation of the full calendar for the current
month and next month. However, for a period beginning in March, which is when
T.S. was contended to be contorting his arms multiple times per day, the pattern is
disrupted. The pages from March 14 through April 10 show small representations
of the calendars for November and December, rather than March and April or April
and May. Court Exhibit 1004 at 39-42. In addition, the printed name of the month
(“November”) has been crossed out in handwriting and replaced with the name of
the current month (“March”). The pages from November 2009, which are near the
back of the book, are much less worn. During her testimony, Ms. Sanchez agreed
that these “true” November pages are crisper, more pristine, and straighter than the
pages in the rest of the book. Tr. 4108.
The ensuing question is: how did these abnormalities in the day planner
develop? The parties presented two alternatives. In her testimony, Ms. Sanchez
suggested it was a “manufacturer defect.” Tr. 4105. In disagreement, the Secretary
accused Ms. Sanchez of opening the spiral rings that bind the day planner’s pages,
removing the original pages from March 2009, and installing replacement pages.
Tr. 4111. Based upon the current record, the Secretary is much more persuasive.
Ms. Sanchez's argument that a company, which is in the business of
manufacturing and selling day planners, erred in creating a calendar appears
unlikely. The purpose of a day planner is to organize and to keep track of events
and this purpose is contingent upon an accurate representation of days, weeks, and
months of the year. January is the first month, February is the second month et
cetera. Sundays precede Mondays and Mondays precede Tuesdays. It is difficult
to see how a company could deviate. However, the evidence that Mr. and Ms.
Sanchez produced after the hearing shows that “day planners---other than the kind
used by Ms. Sanchez---may have had occasional manufacturing defects.” Resp’t’s
Status Rep., filed Sep. 17, 2025. This evidence makes Ms. Sanchez’s account
conceivable, but it remains unlikely.
The Amazon reviews for Ms. Sanchez’s day planner do not mention a
manufacturing defect or any issue with the pages. The planner received an average
rating of 4.2 out of 5 stars, with complaints being that the cover was not sturdy, the
pages needed to be bigger, and that one purchaser in 2014 received a 2006 version
11

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of the day planner instead of the 2008-2009 version. Exhibit 1005. This evidence,
which is about the day planner Ms. Sanchez purchased and used, merits more
weight than reviews of other products that Ms. Sanchez did not use. See, e.g.,
Exhibit 352.
In addition, other circumstances surrounding the day planner call into
question its genuineness and authenticity. First, the calendar as produced shows
that on February 16, 2009, Ms. Sanchez wrote, “[T.S.] didn’t sleep well. He was
crying a lot, making weird movements [with] his arms and hands.” Exhibit 58 at 8;
Court Exhibit 1004 at 36. Then, on February 17, 2009, Ms. Sanchez noted that she
brought T.S. to urgent care and she was “worried about [T.S.]. He’s not the
same.”11 Id. Provided these notations are truthful, they could be strong evidence
that T.S. was contorting his arm on February 16, 2009. However, Ms. Roquemore
studied the day planner to see whether it corroborated the family members’ account
that T.S.’s abnormal arm movements started close to his mother’s birthday on
February 15. Supp’l Decl. ¶ 16; see also Tr. 4375. She averred that she found “a
few notations” that corroborated the timeline, but that she ultimately “did not feel
that the day timer added much; and, from prior experience, calendars and day
timers are subject to misinterpretation or a different interpretation notwithstanding
the author testifying as to any given meaning within the day planner.” Supp’l
Decl. ¶ 16. Ms. Roquemore further stated that “Decisions made in this particular
case regarding whether to file certain day timers/planners, and photos are decisions
that, I felt, were decisions to be made by the attorney and the client, which is what
happened.” Id. at ¶ 50; see also Tr. 4396. During the hearing, Ms. Sanchez could
not recall who ultimately decided that the day planner would not be filed. Tr.
4189-90.
Another abnormality appears on the pages for February 2 through February
8, 2009. There is an entry on Monday, February 2, 2009 about T.S.’s 6 month
checkup, vaccination, and subsequent “cranky, fussy” mood and fever. This entry
is crossed out and then moved to February 5, 2009, which was the true date of the
appointment and vaccination. The comment “silly me” appears next to the
erroneous entry, indicating that Ms. Sanchez filled in the wrong date and later
corrected herself. The entries for Tuesday, February 3, and Wednesday, February
4, are mostly whited out, with the exception of “I feel so sick” written on February
3. The white-out is not visible on scanned copies of the day planner, and only
became apparent upon examination of the physical day planner. To show this, a
11 The February 17, 2009 appointment was with PA Luna. T.S. was diagnosed with a
common cold and viral syndrome. Exhibit 1 at 48-49.
12

Case 1:11-vv-00685-EDK Document 613 Filed 10/22/25 Page 13 of 16
photograph of the page has been substituted for the scanned copy of the page in the
color exhibit. See Exhibit 58 at 6; compare Court Exhibit 1004 at 34. Through the
page, one can read that the whited-out entries once said “T.S. is fussy, cranky” and
“Still fussy”. It appears that these entries were also moved to later dates; Friday,
February 6, reads “T.S. is so fussy, cranky. Hard sleeping” while Saturday,
February 7, reads “Still cranky & fussy.” It is unclear why these were whited out
instead of simply crossed out as with the other entry. And, as with the February 16
and 17 entries regarding T.S.’s movements, this information seems relevant and
helpful to the Sanchezes’ claim, and it is unclear why the day planner would not
have been filed to show this information. The photograph of these pages is shown
below.
Next, when Ms. Sanchez was finally ordered to produce the day planner, she
averred it was a “true and accurate” copy. Exhibit 56 ¶ 5. As noted above, she did
not disclose that the “true and accurate” day planner contained a manufacturing
defect. Including this information would have enhanced Ms. Sanchez’s credibility.
13

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Furthermore, Ms. Roquemore studied the day planner for a relatively
lengthy amount of time.12 Special masters, including the undersigned, have found
that Ms. Roquemore charges an unreasonable amount of time for some activities.
See, e.g., First Decision Awarding Attorneys’ Fees and Costs, issued Feb. 17, 2016,
2016 WL 909186 (excessive time spent preparing for a one-day hearing); Basdakis
v. Sec'y of Health & Hum. Servs., No. 20-1158V, 2025 WL 455394 (Fed. Cl. Spec.
Mstr. Jan. 16, 2025) (reduction of 10% for excessive billing practices); J.T. v. Sec'y
of Health & Hum. Servs., No. 12-618V, 2018 WL 4623163 (Fed. Cl. Spec. Mstr.
Apr. 20, 2018) (excessive billing on various tasks including determining lost
earnings, reading and analyzing a ruling, and moving for redaction); D.S. v. Sec'y
of Health & Hum. Servs., No. 10-77V, 2017 WL 6397826 (Fed. Cl. Spec. Mstr,
Nov. 20, 2017) (excessive client communications, duplicative billing, and
administrative tasks); Broekelschen v. Sec'y of Health & Hum. Servs., No. 07-
137V, 2011 WL 2531199 (Fed. Cl. Spec. Mstr. June 3, 2011) (unreasonable amount
of time spent on briefing and preparing for oral argument), mot. for rev. denied,
102 Fed. Cl. 719 (2011). Even so, it is difficult to understand how much time
could be spent on a relatively benign and short document. Yet, in the hearing,
when asked about a time entry concerning her review of “dates of entries,” Ms.
Roquemore testified that she could not recall any details. Tr. 4380. In addition,
despite Ms. Roquemore’s study of the day planner, neither she nor Ms. Sanchez
apparently thought to explain the alleged manufacturing defect when the planner
was filed. See Exhibit 56 ¶ 5 (Declaration of Jennifer Sanchez, providing
information about the day planner and other exhibits with no mention of the
abnormalities). When asked about this at the hearing, Ms. Sanchez testified that
she “did not know it was a manufacturer’s defect” until recently, but that she fixed
the pages at the time because they were “messed up.” She could not recall whether
she discussed the abnormalities with Ms. Roquemore in 2014. Tr. 4113-15.
As already stated, the undersigned finds Ms. Sanchez’s statement that her
day planner contained a manufacturing defect not to be credible. Instead, the
evidence clearly and convincingly favors a finding that Ms. Sanchez altered the
day planner before submitting it into evidence.
The undersigned reaches this conclusion with reluctance. Until now, the
undersigned has not questioned Ms. Sanchez’s veracity or good faith. Although
12 Due to the overlapping nature of some entries, determining exactly how long Ms.
Roquemore spent reviewing the day planner is not possible. In August 2011, she reviewed the
day planner on five dates and the entries for two dates total 1.3 hours. In March 2012, she spent
more than one hour reviewing the day planner and creating a memorandum about the pros and
cons of producing it as evidence.
14

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the April 10, 2013 Ruling rejected portions of Ms. Sanchez’s testimony, the
undersigned did not suggest that Ms. Sanchez was not truthful. However, the same
can no longer be said.
When the evidence clearly and convincingly shows that Ms. Sanchez altered
evidence, then that conclusion must be reached. See Cal. Penal Code § 134
(preparing false documentary evidence)13; People v. Lucero, 254 Cal. Rptr. 3d 233,
285-88 (2019) (materiality is not an element of offense of preparing false
documentary evidence); People v. Blaydon, 317 P.2d 24, 29 (1957) (evidence that
body of instrument was in defendant's handwriting; signature was forged;
defendant handed the instrument with the forged signature to attorney for probate;
and that instrument was filed for probate “constitutes proof of the corpus delicti of
the offenses charged”); see also 35 Am. Jur. Proof of Facts 3d 567 (1996)
(discussion of United States v. Sloan, CR-69-137 (WD Tenn. 1970), in which
defendant was convicted of perjury for producing documents dated from 1958 but
written in ink that was not made until 1960). The outcome that Ms. Sanchez
altered evidence will be considered in adjudication of the pending motion for
sanctions.
Some portions of the Sanchezes’ opposition to the Secretary’s motion to
reopen suggest that mistakes about the belated production of medical records
happened innocently. Pet’rs’ Resp., filed May 9, 2024, at 11 (“some medical
records that were not originally received and/or inadvertently not filed, came to
light in the Summer 2023”). On the topic of the failure to produce medical
records, the excuse of inadvertence may or may not be true. But, that excuse of
innocence does not explain the day planner’s irregularities. As found here, the
evidence clearly and convincingly supports a finding that Ms. Sanchez
manipulated the pages. Her actions must have been intentional.
CONCLUSION
Purposeful misconduct in litigation, when established, is a problem that
could merit significant consequences to deter others. See Nat’l Hockey League v.
Metropolitan Hockey Club, Inc., 427 U.S. 639, 643 (1976). Further analysis of
how the present finding of fact affects the issues in the pending motion for
sanctions is deferred.
13 “Every person guilty of preparing any false or ante-dated book, paper, record,
instrument in writing, or other matter or thing, with intent to produce it, or allow it to be
produced for any fraudulent or deceitful purpose, as genuine or true, upon any trial, proceeding,
or inquiry whatever, authorized by law, is guilty of felony.”
15

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IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
16

================================================================================
DOCUMENT 8: USCOURTS-cofc-1_11-vv-00685-15
Date issued/filed: 2025-10-23
Pages: 17
Docket text: PUBLIC ORDER/RULING (Originally filed: 10/01/2025) regarding 610 Findings of Fact & Conclusions of Law. Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
--------------------------------------------------------------------------------
Case 1:11-vv-00685-EDK Document 614 Filed 10/23/25 Page 1 of 17
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
GERMAIN SANCHEZ and *
JENNIFER SANCHEZ, *
parents of T.S., *
* No. 11-685V
Petitioners, * Special Master Christian J. Moran
v. *
*
SECRETARY OF HEALTH * Filed: October 1, 2025
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Lisa A. Roquemore, Law Offices of Lisa A. Roquemore, Rancho Santa Margarita,
CA, and Richard Gage, Richard Gage, P.C., Cheyenne, WY for petitioners;
Jennifer L. Reynaud, Zoe Wade, and Madylan Yarc, United States Dep’t of Justice,
Washington, DC, for respondent.
FINDINGS REGARDING DR. VALENCIA’S
AND DR. BROWN’S MEDICAL RECORDS1
Mr. and Ms. Sanchez claim that vaccinations harmed their son, T.S., and the
Federal Circuit determined they are entitled to compensation. The Secretary
attempts to change that result via two procedural routes---a motion to reopen the
entitlement phase of the case and a motion for sanctions. Both motions rest, in
part, upon two medical records from doctors created in 2011 following visits from
T.S. and Ms. Sanchez. A purpose for these visits was for Ms. Sanchez to request
1 Because these Findings contain a reasoned explanation for the action in this case, the
undersigned is required to post them on the United States Court of Federal Claims' website in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). This means the Findings will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b),
petitioners have 14 days to identify and move to redact medical or other information, the
disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the
undersigned agrees that the identified material fits within this definition, the undersigned will
redact such material before posting the decision.

Case 1:11-vv-00685-EDK Document 614 Filed 10/23/25 Page 2 of 17
that the doctors “correct” earlier medical records that failed to mention T.S. was
contorting his arm unusually. One is by Dr. Valencia and the other is by Dr.
Brown. Both doctors declined to change their earlier medical records and
memorialized the request in their records. These 2011 medical records were not
produced until after the case entered the damages phase in 2023. Ms. Sanchez and
an attorney representing her, Lisa Roquemore, testified about the production of
these documents at a hearing held on June 2-3, 2025. The undersigned finds that
the totality of the evidence and arguments clearly and convincingly establishes that
Ms. Sanchez and Ms. Roquemore (a) possessed those documents before November
2011, (b) failed to submit the documents into the record when they were required
to be submitted, and (c), therefore, purposely withheld the documents.
BACKGROUND
2009
When T.S. was six months old, Ms. Sanchez brought him to Dr. Philip S.
Brown on February 5, 2009. Exhibit 1 at 44. T.S. received a series of
vaccinations.
Ms. Sanchez and other family members averred that within about two
weeks, T.S. developed arm contortions. Exhibits 3-8 (affidavits). Ms. Sanchez
further testified that these arm contortions happened multiple times per day.
Accompanied by her mother, Ms. Sanchez brought T.S. to Dr. Brown again
on May 13, 2009. Exhibit 1 at 53.2 On this date, in short, Dr. Brown memorialized
that Ms. Sanchez was complaining that T.S. had congestion. Dr. Brown diagnosed
T.S. as having a resolving upper respiratory infection. Notably, Dr. Brown did not
memorialize any complaints about arm contortions. However, Ms. Sanchez
maintains that she told Dr. Brown about abnormal arm movements.
About three months later, Ms. Sanchez brought T.S. to the office of a
different pediatrician. This pediatrician is Dr. Rainilda P. Valencia. For T.S.’s first
2 The May 13, 2009 appointment with Dr. Brown is the third time that a
medical professional saw T.S. after the February 5, 2009 vaccination. These other
two medical professionals did not memorialize any complaints about arm
contortions in their records created during this time. See Exhibit 1 at 48-51
(Physician Assistant Jonathan Luna on Feb. 17, 2009), 50-52 (Dr. Seleem on Apr.
29, 2009). These records do not meaningfully affect issues for this Finding.
2

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visit, which was on August 19, 2009, he was seen by Physician Assistant Micaela
Marin-Tucker. According to Ms. Marin-Tucker’s record, Ms. Sanchez told her she
“noticed a change in [T.S.’s] development about 2-3 months ago but since she had
taken [T.S. to the pediatric clinic] with Dr. Brown she thought that everything was
ok.” Exhibit 1 at 54. If accurate, this history places the onset of T.S.’s
developmental delay around May 19 to June 19. Ms. Marin-Tucker’s August 19,
2009 record does not memorialize any complaint about arm contortions. However,
Ms. Sanchez maintains that she told Ms. Marin-Tucker about arm contortions. Tr.
4050.
Following the August 19, 2009 visit with Ms. Marin-Tucker, T.S. began to
be treated by numerous doctors as his parents attempted to learn what was
affecting him. These efforts continued for years but they are generally not relevant
to the production of records from Dr. Brown and Dr. Valencia
2011
In April 2011, Ms. Roquemore agreed to represent Mr. and Ms. Sanchez.
Timesheets at 7; Supp’l Decl. ¶ 10. 3 Ms. Roquemore directed Ms. Sanchez to
obtain all medical records. Ms. Roquemore did not obtain medical records
personally. Tr. 4266.
By August 2011, Ms. Roquemore had received some medical records from
Ms. Sanchez. Ms. Roquemore was further developing the case. On August 5,
2011, Ms. Roquemore spoke with Ms. Sanchez about “upcoming doctor
appointments and clarifications of medical records. Further discuss journal
entries.” Timesheets at 15. Because Ms. Sanchez had informed Ms. Roquemore
that she (Ms. Sanchez) had told T.S.’s doctors that he was moving strangely, Ms.
Roquemore suggested that Ms. Sanchez “attempt to obtain clarification by T.S.’s
doctors to see what was recalled and if the doctor was willing to provide a
clarification letter.” Supp’l Decl. ¶ 15; see also Exhibit 56 ¶ 6; Tr. 4068, 4300.
Ms. Sanchez brought T.S. to see Dr. Valencia on August 6, 2011. One chief
complaint was “WELL CHILD CHECK.” Exhibit 262 at 1. T.S.’s medical history
included that he was seeing specialists at Rady Children’s Hospital in San Diego,
such as neurologists, orthopedists, and specialists in metabolic disorders. Dr.
3 The Timesheets were attached to petitioners’ first motion for an award of attorneys’ fees
and costs on an interim basis, filed Sep. 16, 2014, as Exhibit 2.
Ms. Roquemore detailed her representation of the family in a Supplemental Declaration
in support of the first motion for attorneys’ fees and costs, filed on Dec. 12, 2014.
3

Case 1:11-vv-00685-EDK Document 614 Filed 10/23/25 Page 4 of 17
Valencia conducted a general pediatric examination. Her assessments included
cerebral palsy, developmental delay not otherwise specified, and otitis media.
In the ensuing medial record dated August 6, 2011, Dr. Valencia discussed
Ms. Sanchez’s proposal to modify an earlier medical record:
[Ms. Sanchez] wants her lawyer to talk to us as she is
trying to get compensation from VAERS for his condition
now. She needs letters to give them a strong case and she
was asking me to change Micaela Marin-Tucker's (PA)
notes on her first visit ESP the ROS and the onset of
symptoms. Per Mom she believes our office did not “do
anything wrong but instead is helping her son and that
she is not going after us but she needs supplemental
support from another agency”. In conclusion I and my PA
(Micaela Marin-Tucker) advised Mom that "we can not
change or ALTER" any of our previous documents since
they are considered PERMANENT RECORDS and that
our note[] is based on the interview and assessments at
the time of visit and that it will be hard to recall anything
on those visits unless they were documented.
Exhibit 262 at 1. When this August 6, 2011 medical record was produced in 2023,
it contained the following footer:
Within two weeks of the August 6, 2011 appointment at Dr. Valencia’s
office, Ms. Roquemore reviewed an “e-mail from J. Sanchez regarding meeting
with Dr. Micaela.”4 Timesheets at 15 (Aug. 17, 2011). Ms. Roquemore conferred
with Ms. Sanchez about “more details of meeting and items needing clarifying.
Further discuss upcoming meeting with Dr. Brown. Further discuss status of
journal, date of entries, and other witness statements.” Id.
In the following week, Ms. Roquemore reviewed “medical records for office
visit with Dr. Micaela” and she had a telephone conference with “Dr. Micaela’s
4 At this time, Ms. Sanchez and Ms. Roquemore believed that Micaela Marin-Tucker was
a physician. However, they learned later that Ms. Marin-Tucker is a physician’s assistant in Dr.
Valencia’s office.
4

Case 1:11-vv-00685-EDK Document 614 Filed 10/23/25 Page 5 of 17
office to discuss medical record.” Timesheets at 16 (Aug. 22, 2011); accord Supp’l
Decl. ¶ 17 (Ms. Roquemore “was even called upon to discuss the issues with
Micaela’s/Dr. Valencia’s office”). The following day, Ms. Roquemore spoke with a
malpractice attorney about a clarification letter. Timesheets at 16 (Aug. 23, 2011);
Supp’l Decl. ¶ 17.5 Ultimately, Ms. Marin-Tucker’s August 17, 2009 medical
record was not changed. See Supp’l Decl. ¶ 17 (“the attempt to obtain clarification
of what was reported to them [Dr. Valencia and Ms. Marin-Tucker] by Jennifer
turned out to be a dead end”).
Ms. Sanchez brought T.S. to see Dr. Brown on August 19, 2011. Dr. Brown
summarized that the purpose of the visit was to address Ms. Sanchez’s request that
Dr. Brown “write a clarifying letter concerning my last office visit (5/13/09).”
Exhibit T at 17.6 Dr. Brown then memorialized information from Ms. Sanchez:
“The 5/13/11 [sic, should probably be 5/13/09] visit was for nasal congestion. His
mother says that shortly after his first immunization she noticed he occasionally
moved his arms in a strange way. She says she told every provider on his 3
subsequent visits in our office about these movements and no one was concerned.
She was hoping I would remember her mentioning these movements and would
clarify my notes.” Id.
Dr. Brown then elicited additional information from Ms. Sanchez: “When I
asked her to demonstrate the movement she was seeing, she described and
demonstrated a tonic extension and internal rotation or her arms. This can represent
[decerebrate] posturing consistent with a seizure.” Exhibit T at 17. Dr. Brown
communicated his response to Ms. Sanchez: “Had I been told of that activity on
any of T.S.’s visits, I would not only have documented that in the chart, but I would
also had ordered an EEG (and MRI if the EEG were abnormal). Therefore, I do not
believe that particular arm movement was brought to my attention on T.S.’s only
visit with me after the immunizations.”
Dr. Brown also conducted “a brief exam.” He stated T.S. suffered from
“some sort of degenerative neurologic process with an insidious onset that has left
him significantly disabled. Based on the timing of the process and no conclusive
diagnosis after 2 years of testing, an immunization reaction cannot be totally
discounted.” Exhibit T at 17-18.
5 In her oral testimony, Ms. Roquemore clarified that the malpractice attorney represented
Dr. Valencia’s medical practice.
6 Dr. Brown wrote his letter using ALL CAPITAL LETTERS. However, his letter is
quoted above using more traditional capitalization.
5

Case 1:11-vv-00685-EDK Document 614 Filed 10/23/25 Page 6 of 17
Dr. Brown added that “a copy of this encounter has been faxed and mailed
to mother's lawyer, Lisa Roquemore at 949-222-2022
18191 Von Karman Ave. Suite 470 Irvine, CA. 92612.” Id. at 18.
While the issue of entitlement to compensation was being resolved, Mr. and
Ms. Sanchez filed other medical records from Dr. Brown and Dr. Valencia. Two
medical records from Dr. Brown were included in the initial packet. See Exhibit 1
at 44-47 (Feb. 5, 2009) and at 53 (May 13, 2009). One medical record from Dr.
Valencia’s office was filed within Exhibit 1 at pages 54-56 (Aug. 17, 2009).
However, neither Dr. Valencia’s August 6, 2011 medical record nor Dr. Brown’s
August 19, 2011 medical record were filed in the initial set of material.7
Within one month of the petition being filed, Ms. Roquemore directed Ms.
Sanchez to obtain updated medical records. Timesheets at 22 (entry for Oct. 21,
2011: “Telephonic conference with [Ms. Sanchez] regarding setting up a meeting
and regarding obtaining all 2011 medical records so we can file [a] Statement of
Completeness”). On October 24, 2011, Ms. Sanchez emailed Ms. Roquemore
medical records, Ms. Roquemore reviewed those records, and a paralegal filed
them as the next set of exhibits. Id. at 23. The next day, Ms. Roquemore
“Review[ed] several more emails from client with additional medical records (.1).
[and] Review[ed] additional medical records of Dr. Valencia and UCSD
biochemical genetics laboratory.” Id. (entry for Oct. 25, 2011). On October 26,
2011, the paralegal filed additional records from Dr. Valencia’s office as Exhibit
11. This set of records from Dr. Valencia contains the same footer as the footer that
appears on Dr. Valencia’s August 6, 2011 medical record filed as Exhibit 262:
However, the August 6, 2011 medical record was not included within other records
from Dr. Valencia’s office filed as Exhibit 11. Nevertheless, Ms. Roquemore
certified that the medical records filed into court were complete via the statement
of completion.
7 Arguably, the existence of these documents was disclosed via Ms. Roquemore’s
timesheets in 2014. However, the present Findings do not address the petitioners’ argument that
the Secretary waived a right to seek production of documents.
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2023-25
The Federal Circuit found that Mr. and Ms. Sanchez were entitled to
compensation. 34 F.4th 1350 (Fed. Cir. 2022). As part of the process for
quantifying damages, Mr. and Ms. Sanchez requested reimbursement of out-of-
pocket expenses for T.S.’s August 6, 2011 visit with Dr. Valencia. After the
Secretary requested support for these expenses, Mr. and Ms. Sanchez filed the
August 6, 2011 medical record from Dr. Valencia as Exhibit 262 on April 12, 2023.
The production in 2023 of a previously unproduced medical record created
in 2011 prompted the Secretary to request authority to issue subpoenas for the 2011
records. Dr. Brown’s responded to the subpoena by producing the August 19, 2011
medical record, which the Secretary filed as part of Exhibit T at pages 17-18. In
response to other subpoenas and as part of the damages process, other medical
records such as visits with physical therapists and occupational therapists were
produced. However, these other records are also not important to determining
issues around the production of Dr. Valencia’s and Dr. Brown’s records.
Dr. Valencia’s 2011 record and Dr. Brown’s 2011 record are at the
foundation of the Secretary’s motion to reopen. See Resp’t’s Mot. to Reopen, filed
Aug. 16, 2023. The failure to produce these records is also a basis for the
Secretary’s pending motion for sanctions. Resp’t’s Mot. for Sanctions, filed Oct.
23, 2024.
A hearing was held in Riverside, California. On June 2, 2025, Ms. Sanchez
testified. Ms. Roquemore testified on June 3, 2025.
During the hearing, the Secretary requested the production of emails
between Ms. Sanchez and Ms. Roquemore. Tr. 4264. Speaking on behalf of Mr.
and Ms. Sanchez, Mr. Gage objected on the ground of attorney-client privilege and
attorney work product. Id. The issue was not resolved during the hearing.
After the hearing, the undersigned advised that the evidence supported five
findings. Of these five findings, four are relevant here.8 These are:
2. Ms. Sanchez possessed Dr. Valencia’s record before
the October 27, 2011 statement of completion was filed;
8 The first tentative finding, omitted here, concerned Ms. Sanchez’s 2008-2009 day
planner.
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3. Ms. Roquemore possessed Dr. Valencia’s record before
the October 27, 2011 statement of completion was filed;
4. Ms. Sanchez possessed Dr. Brown’s letter before the
October 27, 2011 statement of completion was filed; and
5. Ms. Roquemore possessed Dr. Brown’s letter before
the October 27, 2011 statement of completion was filed."
Order, issued June 23, 2025. This order permitted Mr. and Ms. Sanchez to submit
additional evidence, including emails. The order reminded Mr. and Ms. Sanchez to
consider the attorney-client privilege and work product doctrine if they choose to
submit the emails.
Mr. and Ms. Sanchez addressed the tentative findings. Of the four points
listed above, Mr. and Ms. Sanchez challenged only point 3, which is “Ms.
Roquemore possessed Dr. Valencia’s record before the October 27, 2011 statement
of completion was filed.” Pet’r’s Status Rep., filed July 23, 2025. In other words,
Mr. and Ms. Sanchez did not challenge the other three points, which were that,
before the statement of completion was filed, (2) Ms. Sanchez possessed Dr.
Valencia’s record, (4) Ms. Sanchez possessed Dr. Brown’s record, and (5) Ms.
Roquemore possessed Dr. Brown’s record. With respect to the issue of whether
Ms. Roquemore possessed Dr. Valencia’s record, Mr. and Ms. Sanchez stated “Ms.
Roquemore provided Mr. Gage with an email from Mrs. Sanchez to Ms.
Roquemore dated October 25, 2011 with Dr. Valencia records attached. Upon
inspection by Mr. Gage, the documents were attached to the October 25, 2011
email were the 2010 records filed as Exhibit 11. No 2011 records were attached.”
Pet’rs’ Status Report, filed July 23, 2025, at 2. They requested a status conference
to discuss how they might maintain the attorney-client privilege. Id.
Before the status conference was held, the Secretary presented his views.
The Secretary requested the production of “all relevant emails, collected in such a
way to preserve the original file type and metadata, filed on either a USB drive or
CD.” Resp’t’s Status Rep’t, filed Aug. 8, 2025, at 2. The Secretary also argued that
Mr. and Ms. Sanchez have waived attorney-client privilege.
A status conference was held. A primary point of discussion was whether a
different special master could adjudicate any assertion of attorney-client privilege.
The answer was no. Order, issued Aug. 13, 2025, citing Estes v. United States, 128
Fed. Cl. 285, 288 (2016); Weston/Bean Joint Venture v. United States, 128 Fed. Cl.
1 (2014); Vaccine Rule 3(a). The August 13, 2025 order allowed Mr. and Ms.
Sanchez an opportunity to submit either the emails or a privilege log asserting a
8

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privilege with an in camera inspection of documents. The August 13, 2025 order
also explained that if Mr. and Ms. Sanchez were submitting the emails, they would
be required to authenticate the emails. Mr. and Ms. Sanchez moved for an
additional thirty days to submit any of these additional materials. The motion was
granted. Order, issued Aug. 22, 2025. Mr. and Ms. Sanchez did not submit
anything further. Therefore, the matter is ready for adjudication.
ASSESSMENT
The purpose of this Finding is to determine, based upon the documents
referenced above and the testimony from Ms. Sanchez and Ms. Roquemore,
whether Ms. Sanchez and Ms. Roquemore were aware of the medical records from
Dr. Valencia and Dr. Brown during the entitlement phase of the case and whether
they should have been produced as exhibits. The significance of these findings is
deferred until a complete resolution of the motion to reopen and motion for
sanctions.
In evaluating the evidence regarding Ms. Sanchez’s and Ms. Roquemore’s
awareness of and possession of the medical records from Dr. Valencia and Dr.
Brown, the undersigned is looking for clear and convincing evidence. Although
“the normal standard in civil suits is the ‘preponderance’ standard,” Thomas v.
Nicholson, 453 F.3d 1279, 1283 (Fed. Cir. 2005), an elevated burden is appropriate
here. In the potentially analogous circumstance in which a party alleged to have
infringed a patent seeks a finding that the patent was procured due to inequitable
conduct based upon a failure to present information to the Patent and Trademark
Office, the burden of proof is clear and convincing. Therasense, Inc. v. Becton,
Dickinson & Co., 649 F.3d 1276, 1291 (Fed. Cir. 2011) (en banc); Ohio Willow
Wood Co. v. Alps South, LLC, 813 F.3d 1350, 1357 (Fed. Cir. 2016).9 “Clear and
9 In Therasense, the en banc Federal Circuit reviewed the evidentiary burdens for
establishing inequitable conduct and determined that a higher burden was appropriate because, in
part, the “inequitable conduct regarding any single claim renders the entire parent
unenforceable,” making it the “‘atomic bomb’ of patent law.” 649 F.3d at 1288. The differences
between patent litigation and litigation in the Vaccine Program may make an analogy inapt. For
example, although the en banc Federal Circuit was concerned that the doctrine of inequitable
conduct was being raised too frequently in district courts (“the inequitable conduct doctrine has
plagued not only the courts but also the entire patent system”), the Vaccine Program has,
fortunately, had relatively few cases when petitioners did not file all the medical records.
In any event, if the clear and convincing burden is excessively high, any error would
appear harmless in the sense that findings supported by clear and convincing evidence would
also be supported by preponderant evidence.
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convincing evidence,” in turn, means “evidence which produces in the mind of the
trier of fact an abiding conviction that the truth of a factual contention is ‘highly
probable.’” Miller v. Department of Justice, 842 F.3d 1252, 1257-58 (Fed. Cir.
2016).
Dr. Valencia
The evidence clearly and convincingly establishes that both Ms. Sanchez
and Ms. Roquemore possessed Dr. Valencia’s August 6, 2011 medical record by
October 27, 2011. This date is the date on which Ms. Roquemore filed a statement
of completion.
The documentary evidence makes these findings almost inescapable. In the
Secretary’s May 9, 2024 motion, the Secretary pointed out that the date-stamped
footer on the August 6, 2011 record matched the footer on the remainder of Dr.
Valencia’s records produced as Exhibit 11. The Secretary, therefore, argued that
the August 6, 2011 record should have been produced in 2011. Resp’t’s Comp. Br.,
filed Jan. 11, 2024, at 5-9. The Secretary made essentially the same argument in
support of his contentions regarding litigation misconduct. Resp’t’s Mot. for
Sanctions, filed Oct. 23, 2024, at 7-9.
A close read of the petitioners’ response to the pending motions suggests
these points are not disputed. With respect to Dr. Valencia’s August 6, 2011
medical record, the thrust of the Sanchezes’ argument is that the information
contained in the August 6, 2011 medical record does not change the findings of fact
about T.S.’s health in 2009. Pet’rs’ Comp. Resp., filed May 9, 2024, at 26-28.
Notably, Mr. and Ms. Sanchez did not argue that Ms. Sanchez did not possess this
document in October 2011. See id. When given a chance in 2024 to explain with
evidence the discrepancy in Dr. Valencia’s records, Mr. and Ms. Sanchez did not
present any evidence. This lack of response is surprising because when people are
accused of litigation misconduct, one response might be some like “the accusation
is based upon a misunderstanding of the facts. Here’s what actually happened . . .”
It was only after a hearing was commenced that any evidence was introduced that
could explain why Dr. Valencia’s August 6, 2011 medical record was not filed until
years later.
The evidence further clearly and convincingly supports a finding that Ms.
Roquemore possessed Dr. Valencia’s August 6, 2011 medical record by October
27, 2011. As documented in Ms. Roquemore’s timesheets, Ms. Roquemore
directed Ms. Sanchez to obtain updated medical records on October 21, 2009. Dr.
Valencia’s office printed the records on October 21, 2011. Ms. Roquemore’s
timesheets also show that Ms. Sanchez sent an email with medical records on
10

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October 25, 2011. Ms. Roquemore reviewed records from Dr. Valencia on that
day. Ms. Roquemore’s paralegal filed the medical records of Dr. Valencia on
October 26, 2011. A statement of completion was filed on October 27, 2011.
From the assertions made during the hearing, Ms. Sanchez and Ms.
Roquemore appear to have two points in rebuttal. (Again, neither point was raised
in the May 9, 2024 Comprehensive Response to the Motion to Reopen.) First, Ms.
Sanchez suggested in her oral testimony that the August 6, 2011 medical record
may have somehow gotten separated from the other records such that when Ms.
Sanchez emailed records to Ms. Roquemore, the August 6, 2011 record was
missing. Tr. 4117-18, 4202. But, this argument is not credible. Ms. Sanchez
testified that she sent original records (not copies) to Ms. Roquemore, that she did
not “do anything with the records” before sending them to Ms. Roquemore, and
that she did not reorganize them. Tr. 4032. This process leaves little chance for
medical records to get misplaced accidentally. Ms. Sanchez also stated that she
found the August 6, 2011 record in a box of records, but it was not with the other
records from Dr. Valencia’s office. Tr. 4117-18. However, even if the August 6,
2011 medical record got separated from other documents, the August 6, 2011
medical record would still have been possessed by Ms. Sanchez, albeit in a
different place. Ms. Sanchez testified that she did not return to Dr. Valencia’s
office in 2023 to receive a new set of records; rather, she located them again in her
house during the damages phase, meaning this record was not acquired between
October 2011 and April 2023. Tr. 4224. In short, Ms. Sanchez did not offer any
plausible denial regarding her receipt of Dr. Valencia’s August 6, 2011 medical
record in October 2011, and agreed that it was a fair assumption that she had the
record in her possession since October of 2011. Tr. 4225. The evidence clearly
and convincingly supports a finding that Ms. Sanchez possessed Dr. Valencia’s
August 6, 2011 medical record in October 2011. Although given the opportunity to
comment upon a tentative finding that Ms. Sanchez possessed Dr. Valencia’s
record before the October 27, 2011 statement of completion was filed, Mr. and Ms.
Sanchez did not make any argument about this tentative finding. Petr’s Status
Rep., filed July 23, 2025.
Second, there is an argument that Ms. Roquemore did not receive the August
6, 2011 medical record in 2011 because Ms. Roquemore’s timesheets present
information in two separate sentences. “Review several more emails from client
with additional medical records. (.1) Review additional medical records from Dr.
Valencia and UCSD biochemical genetics laboratory. (.4).” Timesheets at 23
(entry for Oct. 25, 2011). To the extent Ms. Sanchez or Ms. Roquemore is offering
an argument that the emails Ms. Roquemore received did not include the medical
records from Dr. Valencia, this argument splits hairs too finely.
11

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A natural reading of Ms. Roquemore’s timesheets is that Ms. Sanchez sent
emails containing the medical records that Ms. Roquemore devoted more time to
reviewing later than day. In Ms. Roquemore’s testimony, she did not deny that she
received Dr. Valencia’s records by email. At best, Ms. Roquemore testified that
she did not know in 2025 what she read in 2011. Tr. 4883-84, 4287. But, Ms.
Roquemore did not identify any different records she received by email. In any
event, Ms. Roquemore indisputably received some of Dr. Valencia’s records
because they were filed as Exhibit 11. And, to repeat, the pages in Exhibit 11
contain the footer showing they were printed on 10/21/2011. That same footer
appears on the August 6, 2011 record filed as Exhibit 262. This consistency is a
clear and convincing basis for finding that Ms. Sanchez and Ms. Roquemore
possessed Dr. Valencia’s record by October 27, 2011.
The circumstances under which Dr. Valencia came to write the August 6,
2011 medical record further supports a finding that clear and convincing evidence
shows that Ms. Roquemore, at a minimum, should have known that Dr. Valencia
created some document in August 2011. In August 2011, Ms. Sanchez and Ms.
Roquemore planned for Ms. Sanchez to seek a clarification of Ms. Marin-Tucker’s
August 19, 2009 medical record. (To repeat, the August 19, 2009 medical record
placed the onset of T.S.’s developmental delay no earlier than May 19, 2009.) Ms.
Sanchez and Ms. Roquemore communicated before and after the August 6, 2011
visit. Timesheets at 15 (entries for Aug. 5, 2011 and Aug. 17, 2011). Ms.
Roquemore even listened to an audio recording of the visit. Timesheets at 16
(entry for Aug. 29, 2011). Ms. Roquemore spoke to someone in Dr. Valencia’s
office and a malpractice attorney, who represented Dr. Valencia’s medical practice.
Timesheets at 16 (entry for Aug. 23, 2011). (In her oral testimony, Ms. Roquemore
did not remember the names of the people with whom she spoke.) Thus, it is
highly probable that Ms. Roquemore knew in August 2011 that Dr. Valencia had
written a letter regarding a request for clarification or that Ms. Roquemore should
have known in August 2011 that Dr. Valencia had written a letter regarding a
request for clarification.
Although Mr. and Ms. Sanchez contested a tentative finding that Ms.
Roquemore possessed Dr. Valencia’s August 6, 2011 before the statement of
completion was filed (Pet’rs’ Status Rep., filed July 23, 2025), their belatedly
asserted arguments are not persuasive. Their argument is based upon emails that
have not been produced. Further, Ms. Roquemore has not explained how she
supposedly retrieved the emails from October 2011. This absence of explanation is
significant because Mr. Gage, as an officer of the court, can vouch only for what
Ms. Roquemore gives to him.
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Whether Ms. Sanchez or Ms. Roquemore possessed Dr. Valencia’s August 6,
2011 letter before the petition was filed on October 11, 2011 does not affect the
outcome of either the motion to reopen or the motion for sanctions. As explained
above, the evidence clearly and convincingly weighs in favor of finding that both
Ms. Sanchez and Ms. Roquemore possessed the record when Ms. Roquemore
certified the completeness of medical records. If the August 6, 2011 medical
record had been filed on October 26, 2011 with the remainder of Dr. Valencia’s
medical records, the various findings of fact made during entitlement could have
taken into consideration this medical record. The fact that Ms. Sanchez and Ms.
Roquemore had, but did not produce, Dr. Valencia’s August 6, 2011 medical record
makes the previous findings of fact vulnerable to revision. This Finding will also
be considered in adjudication of the Secretary’s motion for sanctions.
Dr. Brown
The evidence clearly and convincingly favors a finding that Ms. Roquemore
possessed Dr. Brown’s August 19, 2011 letter on August 24, 2011. This finding is
primarily based upon two sources of information: Dr. Brown’s letter and Ms.
Roquemore’s timesheets.
Dr. Brown’s letter begins with a statement that Ms. Sanchez came “with a
request for me to write a clarifying letter.” Exhibit T at 17. The day Ms. Sanchez
brought T.S. to see Dr. Brown, August 19, 2011, was a Friday. Dr. Brown’s letter
ends with an addendum: “a copy of this encounter has been faxed and mailed to
mother's lawyer, Lisa Roquemore at 949-222-2022
18191 Von Karman Ave. Suite 470 Irvine, CA. 92612.” Exhibit T at 18.
Normally, a stamped document placed in the mail is presumed to reach its
destination. See Charlson Realty Co. v. United States, 384 F.2d 434, 274 (Ct. Cl.
1967); Policy Analysis Co. Inc., v. United States, 50 Fed. Cl. 626, 632 (2001).
This presumption also extends to materials that are faxed. See Morgan Tire of
Sacramento, Inc. v. Goodyear Tire & Rubber Co., 60 F.Supp.3d 1109, 1117 (E.D.
Ca. 2014).
Here, a resort to a presumption regarding mailing or faxing is not required.
On Wednesday, August 24, 2011, Ms. Roquemore “[r]eviewed letter from Dr.
13

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Brown.” Timesheet at 16.10 She also emailed Ms. Sanchez regarding Dr. Brown
and petition.
When combined, Dr. Brown’s statement that he is mailing and faxing a letter
to Ms. Roquemore plus Ms. Roquemore’s statement that she reviewed a letter from
Dr. Brown a few days later are sufficient to conclude that the evidence clearly and
convincingly favors a finding that Ms. Roquemore reviewed Dr. Brown’s August
19, 2011 letter. Any arguments to the contrary are rejected.
One possible contrary argument is that Ms. Roquemore did not receive Dr.
Brown’s August 19, 2011 letter and, instead, reviewed some other letter from Dr.
Brown on August 24, 2011. To ascertain whether this was likely, Ms. Roquemore
was ordered to produce the Dr. Brown letter she reviewed. See Order, issued May
16, 2024; see also Resp’t’s Comp. Br., filed Jan. 11, 2024, at 28. After a
“thorough” search, Ms. Roquemore averred that she could not find this document.
Pet’rs’ Notice, filed Aug. 21, 2024. Thus, when Ms. Roquemore testified on June
3, 2025, she maintained that she did not “know” whether she had reviewed the
August 19, 2011 letter on August 24, 2011. Tr. 4253-54. But, Ms. Roquemore’s
credibility was significantly reduced by her demeanor in testifying and by her
failure to identify an alternative letter.
A second possible contrary argument is that Dr. Brown’s August 19, 2011
letter is not a “medical record.” In Ms. Roquemore’s June 3, 2025 testimony, Ms.
Roquemore seemed to be suggesting that she did not know in 2011 that Dr.
Brown’s August 19, 2011 letter constituted a medical record that the Vaccine Act
required to be filed. Any such suggestion borders on frivolous. First, to the extent
that Ms. Roquemore is testifying that she did not review the August 19, 2011 letter
in August 2011, this testimony is rejected as false and inconsistent with the clear,
convincing, and contemporaneous evidence showing she did. Next, if Ms.
Roquemore is maintaining that the Vaccine Act requires petitioners to file
treatment records (as opposed to records seeking clarification), that argument is
contradicted by the words of the statute. The Vaccine Act does not distinguish
between medical records created for the purpose of treatment and records created
for the purpose of accuracy. The Vaccine Act simply requires production of “all
provider notes.” 42 U.S.C. § 300aa–11(c)(2).11 Finally, Ms. Roquemore
10 Ms. Roquemore’s receipt of Dr. Brown’s letter negates any argument regarding the lack
of a HIPPA authorization. See Pet’rs’ Comp. Resp., filed May 9, 2024, at 34.
11 The Vaccine Act provides:
14

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recognized during her June 3, 2025 testimony that Dr. Brown’s August 19, 2011
letter is a medical record. Tr. 4342. Indications that Dr. Brown’s August 19, 2011
letter is a medical record includes the notation that Dr. Brown conducted a “brief
exam.” Exhibit T at 17. Although Ms. Roquemore’s agreement that Dr. Brown’s
letter constituted a medical record came in the context of a question about her
knowledge in 2025, the same information about Dr. Brown’s letter was available in
2011.
In short, the clear and convincing evidence contained in the present record
establishes that Ms. Roquemore possessed and had actual knowledge of Dr.
Brown’s August 19, 2011 medical record before Ms. Roquemore filed the petition
and submitted a statement of completion. Again, although Mr. and Ms. Sanchez
could have challenged the tentative finding that Ms. Roquemore possessed Dr.
Brown’s letter, they did not. See Pet’rs’ Status Rep., filed July 23, 2025. From Ms.
Roquemore’s possession and knowledge of Dr. Brown’s letter, Mr. and Ms.
Sanchez’s knowledge can be inferred via either of two methods.
First, on the date Ms. Roquemore received Dr. Brown’s August 19, 2011
medical record, Ms. Roquemore emailed Ms. Sanchez about “Dr. Brown and
Petition.” Timesheets at 16 (entry for Aug. 24, 2011). It is highly probable that
Ms. Roquemore informed her client that Dr. Brown was disagreeing with Ms.
Sanchez’s assertion that she (Ms. Sanchez) told Dr. Brown in May 2009 that T.S.
was having unusual arm movements. It seems likely, although perhaps not
convincingly established, that Ms. Roquemore actually delivered Dr. Brown’s
August 19, 2011 medical record to Ms. Sanchez via email. But, it is not necessary
to penetrate what is potentially protected by the attorney-client privilege or the
work product doctrine. Ms. Roquemore’s email about Dr. Brown is a sufficient
basis to conclude the evidence clearly and convincingly favors a finding that Ms.
Sanchez knew about Dr. Brown’s August 19, 2011 medical record.
Even if there were some doubt in the evidence---and there is no doubt that
Ms. Roquemore received Dr. Brown’s August 19, 2011 medical letter and
communicated with Ms. Sanchez about it on August 24, 2011, then the law
provides a different method: the knowledge of an attorney is imputed to the client.
The Federal Circuit recognizes this principle. See Immunocept, LLC v. Fulbright
“A petition for compensation under the Program for a vaccine-related injury or death
shall contain . . .
(2) . . . post-injury inpatient and outpatient records (including all provider notes).”
42 U.S.C. § 300aa–11(c).
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& Jaworski, LLP, 504 F.3d 1281, 1287 (Fed. Cir. 2007) (“the imputation analysis
involves determining whether an attorney was acting within the scope of his
authority or employment when he discovered or reasonably should have
discovered the critical information. Noticeably absent from the imputation rule is a
requirement that the attorney have a duty to disclose information to the client”);
Florida Dehydration Co. v. United States, 101 F.Supp. 361, 363 (Ct. Cl. 1951)
(“notice to an attorney is notice to the client"). In California, the imputation
principle is especially strong. One California case states:
Under general agency principles, an attorney is his
client's agent, and ... the agent's knowledge is imputed to
the principal even where ... the agent does not actually
communicate with the principal, who thus lacks actual
knowledge of the imputed fact. . . . This rule of imputed
notice is irrebuttable. . . . And it includes things the agent
not only knows with regard to the subject matter of his
agency, but by inquiry notice should know.
Roche v. Hyde, 51 Cal. App. 5th 757, 265 Cal. Rptr. 301, 332 (2020) (citations and
quotation marks omitted).12
Although either of these two points are a sufficient basis for finding that the
evidence clearly and convincingly supports a finding that “Ms. Sanchez possessed
Dr. Brown’s letter before the October 27, 2011 statement of completion was filed,”
Mr. and Ms. Sanchez were given an opportunity to rebut this tentative finding. See
Order, issued June 23, 2025 (point 4). However, they raised no argument against
this finding. See Pet’rs’ Status Rep., filed July 23, 2025.
After Ms. Roquemore came into possession of Dr. Brown’s August 19, 2011
medical records, it was incumbent upon Ms. Roquemore to file the document and
to maintain it. The Vaccine Act requires petitioners to file all provider notes with
the petition. 42 U.S.C. § 300aa–11(c)(2). This Finding means that Mr. and Ms.
Sanchez and Ms. Roquemore did not comply with the statute. This lack of
compliance will be considered in evaluating the pending motion for sanctions. The
failure of Mr. and Ms. Sanchez and Ms. Roquemore to disclose Dr. Brown’s
August 19, 2011 letter may justify the reopening of entitlement.
12 Immunocept and Roche mention what the attorney “should have discovered” or
“should know.” However, here, what Ms. Roquemore “should” have discovered or “should”
have known does not play a role because Ms. Roquemore actually knew about the Dr. Brown
medical record.
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CONCLUSION
The Secretary’s August 16, 2023 motion to reopen and October 23, 2024
motion for sanctions involved the lack of production of Dr. Valencia’s August 6,
2011 medical record and Dr. Brown’s August 19, 2011 medical record. A hearing
was held on this topic during which the two people who knew about the events in
2011, Ms. Sanchez and Ms. Roquemore, testified. The evidence clearly and
convincingly favors finding that both Ms. Sanchez and Ms. Roquemore knew
about and/or possessed both Dr. Valencia’s August 6, 2011 medical record and Dr.
Brown’s August 19, 2011 medical record by October 27, 2011. These findings will
be considered upon adjudication of the August 16, 2023 motion to reopen and the
October 23, 2024 motion for sanctions.
IT IS SO ORDERED.
s/ Christian J. Moran
Christian J. Moran
Special Master
17