VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-01083
Package ID: USCOURTS-cofc-1_16-vv-01083
Petitioner: J.S.
Filed: 2016-08-30
Decided: 2023-02-13
Vaccine: Hepatitis A
Vaccination date: 2015-08-04
Condition: inappropriate tachycardia and autonomic dysfunction, manifesting in a wide variety of conditions and symptoms (including joint pain, dizziness, nausea, and postural orthostatic tachycardia syndrome (“POTS”))
Outcome: denied
Award amount USD: 

AI-assisted case summary:
J.S., an 18-year-old, filed a petition for compensation under the National Childhood Vaccine Injury Act on August 30, 2016. She alleged that the Hepatitis A vaccine received on August 4, 2015, and the human papillomavirus (HPV) vaccine received on August 19, 2015, caused her to develop inappropriate tachycardia, autonomic dysfunction, and postural orthostatic tachycardia syndrome (POTS). Petitioner claimed symptoms including convulsions, shortness of breath, rapid heartbeat, loss of feeling in her left leg, joint pain, hyperventilation, heart palpitations, dizziness, and nausea, with onset approximately one day after the HPV vaccine and 16 days after the Hepatitis A vaccine.

Respondent argued that Petitioner had not met her burden to show causation-in-fact. The parties filed ten expert reports offering competing theories on whether the vaccines could cause autoimmune reactions leading to autonomic dysfunction and orthostatic intolerance. Petitioner's medical records showed multiple emergency room visits and hospitalizations following the vaccinations, with symptoms often attributed by treating physicians to anxiety reactions or pseudoseizures, and no clear physiological cause identified. While some physicians noted a temporal association with the vaccinations and one suggested a possible autoimmune reaction, extensive testing, including a tilt table test and antibody testing, did not confirm a diagnosis of POTS or other vaccine-related injury. Petitioner's expert, Dr. Lawrence Steinman, theorized molecular mimicry, suggesting the vaccines could trigger cross-reactive autoimmune responses to adrenergic receptors, leading to her symptoms. Respondent's experts, Dr. Andrew MacGinnitie and Dr. Peter Bingham, countered that POTS is not typically autoimmune, that Petitioner's antibody test results were not conclusive or timely, and that the molecular mimicry theory was not well-supported by the evidence or applicable to human disease.

The Chief Special Master denied entitlement, finding that Petitioner failed to establish a cognizable vaccine-caused injury by a preponderance of the evidence. The Chief Special Master concluded that Petitioner's symptoms were more likely related to somatization or anxiety, citing numerous instances where physicians noted psychological components to her condition and the lack of objective findings confirming a physiological injury. The Chief Special Master also found Petitioner's causation theory, particularly regarding molecular mimicry and autoimmune dysautonomia, to be unreliable and unsupported by the scientific evidence, noting that POTS is generally not considered autoimmune and that the temporal association alone was insufficient. The Chief Special Master also determined that a hearing was not necessary as the record was sufficiently developed.

Petitioner sought review of the Chief Special Master's decision, raising several objections, including that the findings were arbitrary and capricious, that tachycardia could be a primary condition, that the denial of a hearing was an abuse of discretion, and that the Chief Special Master improperly preemptively denied attorney's fees for the review. The Court of Federal Claims reviewed the decision under the arbitrary and capricious standard. The Court upheld the Chief Special Master's findings, concluding that he had considered the relevant evidence, articulated a reasoned basis for his decision, and that his conclusions were not arbitrary, capricious, or otherwise not in accordance with the law. The Court found that the Chief Special Master appropriately weighed the evidence, including the conflicting expert opinions and medical records, and that his determination that Petitioner failed to establish a cognizable injury or a reliable theory of causation was supported by the record. The Court also found that the Chief Special Master did not abuse his discretion in deciding the case on the record without a hearing, and that the issue of attorney's fees for the review was not ripe.

Consequently, the Court denied Petitioner's motion for review and sustained the Chief Special Master's decision, resulting in the denial of the claim.

Theory of causation field:
Petitioner J.S. alleged that the Hepatitis A and HPV vaccines administered on August 4 and August 19, 2015, respectively, caused her to develop inappropriate tachycardia, autonomic dysfunction, and POTS. Petitioner's theory of causation, primarily advanced by her expert Dr. Lawrence Steinman, posited molecular mimicry, where vaccine components share amino acid sequences with adrenergic receptors, triggering an autoimmune response leading to dysautonomia. Dr. Steinman cited BLAST searches showing homology between vaccine components and adrenergic receptors, and Petitioner's positive antibody test results for anti-adrenergic antibodies as evidence. Petitioner's medical records documented symptoms like tachycardia, dizziness, and jerking movements, with some physicians noting a temporal association with vaccination. Respondent's experts, Dr. Andrew MacGinnitie and Dr. Peter Bingham, argued against this theory, stating POTS is not typically autoimmune, that Petitioner's antibody results were inconclusive or not timely, and that the molecular mimicry theory lacked sufficient scientific support and epidemiological evidence. The Chief Special Master denied the claim, finding no cognizable injury was established, as Petitioner's symptoms were more likely due to somatization or anxiety, and her causation theory was unreliable and unpersuasive, lacking sufficient scientific backing. The Court of Federal Claims affirmed the Chief Special Master's decision, finding it was not arbitrary or capricious, as the Special Master had reasonably weighed the evidence and found Petitioner failed to meet her burden of proof under the Althen standard for causation.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_16-vv-01083-1
Date issued/filed: 2023-02-13
Pages: 34
Docket text: JUDGE VACCINE REPORTED OPINION re: 120 Order on Motion for Review, Judge Vaccine Order/Opinion (Reissuance of January 12, 2023 Opinion for Publication). Signed by Judge Edward H. Meyers. (skw) Service on parties made.
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Case 1:16-vv-01083-EHM Document 126 Filed 02/13/23 Page 1 of 34
In the United States Court of Federal Claims
No. 16-1083 V
Filed: January 12, 2023
Re-issued: February 13, 20231
)
J.S., )
)
Petitioner, )
)
v. )
)
SECRETARY OF HEALTH )
AND HUMAN SERVICES, )
)
Respondent. )
)
Robert J. Krakow, Law Office of Robert J. Krakow, P.C., for Petitioner.
Zoe Wade, Trial Attorney, United States Department of Justice, Torts Branch, Civil Division,
Washington, D.C., for Respondent.
OPINION AND ORDER
MEYERS, Judge.
Pending before the Court is J.S.’s petition for review of the Chief Special Master’s
decision denying her claim for compensation under the National Vaccine Injury Compensation
Program. Petitioner contends that she developed postural orthostatic tachycardia syndrome and
inappropriate tachycardia from her vaccinations for Hepatitis A and human papillomavirus. The
Chief Special Master concluded that Petitioner’s medical records did not establish either injury
by a preponderance of the evidence in this case; rather, the record indicated that it was more
likely that other causes led to her symptoms. And the Chief Special Master concluded that
Petitioner’s theory that the vaccines at issue could cause the claimed injuries would, in any
event, fail to establish causation in this case. Therefore, he denied Petitioner’s claim. Because
the Chief Special Master considered the evidence before him and articulated a reasoned basis for
his conclusion, the Court sustains the Chief Special Master’s decision denying entitlement.
I. FACTUAL AND PROCEDURAL BACKGROUND
1 The Court initially filed this opinion under seal to allow the Parties to propose redactions. This
re-issued opinion has incorporated the proposed redactions.

Case 1:16-vv-01083-EHM Document 126 Filed 02/13/23 Page 2 of 34
J.S. filed her petition for compensation under the National Childhood Vaccine Injury Act
of 1986 (the “Vaccine Act”), 42 U.S.C. § 300aa-10 to 34 (2018), on August 30, 2016, alleging
that receipt of the Hepatitis A (“Hep. A”) and human papillomavirus (“HPV”) vaccines caused
her to develop inappropriate tachycardia,2 autonomic dysfunction, and postural orthostatic
tachycardia syndrome (“POTS”).3 ECF No. 1 ¶¶ 18-20 (“Pet.”). Specifically, Petitioner claimed
that she experienced “convulsions, shortness of breath, rapid heartbeat, . . . loss of feeling in her
left leg[,] . . . pain in her joints, hyperventilation, heart palpitations, dizziness, [and] nausea, . . .
[which] were caused-in-fact by her Gardasil vaccination received on August 19, 2015.” Pet. at 3,
¶¶ 18-20. “Approximately one day after receiving the Gardasil HPV vaccination, and 16 days
after receiving . . . a Hepatitis A vaccination, [Petitioner] experienced the onset of these
conditions.” ECF No. 114 at 2.
On April 20, 2017, Petitioner filed a motion to substitute counsel and a motion requesting
interim attorney’s fees and costs for her prior counsel. ECF Nos. 30 & 31. On June 7, 2017,
Special Master Sanders issued an Order Deferring Resolution of Petitioner’s request for fees,
finding that it was speculative to determine whether the proceedings would become protracted at
that stage, and it would have been “extremely difficult to determine the case’s reasonable basis”
without Respondent’s position in the record. ECF No. 40 at 4-5. On August 2, 2018, Special
Master Sanders issued a Decision Awarding Interim Attorney’s Fees and Costs, with certain
reductions to the amount requested. ECF No. 72.
Respondent filed its Rule 4(c) Report on June 12, 2017, asserting that, “Congress
authorized the Vaccine Program to compensate only those individuals who can substantiate their
claims either through a presumption of causation (i.e., proof of a Table case) or by proving a
causal link between the alleged injuries and a covered vaccine[,] . . . [and] petitioner has not met
her prima facie burden to show causation-in-fact . . . .” ECF No. 41 at 11. In response,
Petitioner submitted “a 19-page memorandum, ECF No. 42, clarifying and correcting points
contained in Respondent’s Rule 4(c) Report[,] . . . [which] form[s], in part, the basis of
Petitioner’s challenge to the Decision in the Motion for Review.” ECF No. 114 at 2-3.
Thereafter, the Parties collectively “filed ten expert reports, offering competing takes on a
causation theory . . . that the HPV and Hep. A vaccines can stimulate the production of
autoantibodies that could be causal of autonomic disfunction, primarily manifesting as
2 Tachycardia is “excessive rapidity in the action of the heart” and sinus tachycardia is
“tachycardia originating in the sinus node.” ECF. No. 114 at 1-2 n.1 (internal citations omitted).
“Inappropriate sinus tachycardia, also called chronic nonparoxysmal sinus tachycardia, is an
unusual condition that occurs in individuals without apparent heart disease or other cause for
sinus tachycardia, such as hyperthyroidism or fever, and is generally . . . defined as a resting
heart rate >100 beats per minute (with a mean heart rate>90 beats per minute over 24 hours)
associated with highly symptomatic palpitations . . . .” Id.
3 “POTS is a circulation disorder characterized by a group of symptoms (not including
hypotension) that sometimes occur when a person assumes an upright position, including
tachycardia, tremulousness, lightheadedness, sweating, and hyperventilation.” ECF No. 109 at
26 (citing Postural orthostatic tachycardia syndrome, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=111236 (last visited July 14, 2022)).
2

Case 1:16-vv-01083-EHM Document 126 Filed 02/13/23 Page 3 of 34
orthostatic intolerance.” ECF No. 109 at 2. Summaries of Petitioner’s medical records and each
Party’s expert opinions are set forth in detail below.
On July 12, 2018, the Parties informed the Court that they were not engaged in settlement
discussions and requested a hearing date. See ECF No. 72 at 4. That day, Special Master
Sanders issued an Order providing that “[d]ue to the high volume of cases that are ready for
entitlement hearings and the limited number of Special Masters, no additional hearings will be
scheduled until further notice. Chambers will reach out to the parties when hearing dates become
available.” ECF No. 71. In March 2021, this case was reassigned to Chief Special Master
Corcoran, who directed the Parties to conclude filing expert reports and briefings, and indicated
that the matter would be resolved by a ruling on the record. See Docket Entry Order, dated
March 23, 2021. The Chief Special Master issued his Decision on July 15, 2022. ECF No. 109.
A. Petitioner’s Medical History
1. Pre-Vaccination Medical History
Petitioner was born on March 3, 1997. Pet’r’s Ex. 2 at 1 (ECF No. 6-2). Petitioner
claims that her health had been generally “stable” prior to receiving the Hep. A and HPV
vaccinations at issue, and “the emergence of symptoms [did not occur until] after the August 4,
2015 and August 19, 2015 vaccinations.” ECF No. 114 at 8-9. In issuing his decision the Chief
Special Master reviewed the administrative record, including Petitioner’s relevant medical
history, and identified “three notable events” based on her pre-vaccination medical records:
First, she saw a cardiologist in June 2008 for episodes of shortness of breath and
difficulty breathing while swimming, but her symptoms were later attributed to asthma.
Second, she underwent a head MRI on October 1, 2008, for occipital migraines, which
showed evidence for sinusitis, but was otherwise normal. Finally, in March 2012 she was
evaluated by an endocrinologist for autoimmune thyroid disease. At that time, she tested
positive for antibodies relevant to the disease, but was not yet symptomatic, although she
did report joint aches and ongoing abdominal complaints.
ECF No. 109 at 2 (citing Pet’r’s Ex. 2 at 55-56, 58-61 (ECF No. 6-2); Pet’r’s Ex. 15 at 1-2 (ECF
No. 12-1)).
Petitioner contests the significance of each “notable event[]” cited by the Chief Special
Master. First, Petitioner argues that, although the June 10, 2008, medical report suggests
“episodes of shortness of breath and difficulty breathing while swimming” related to asthma, the
“record shows no diagnosis or other reference to asthma or reactive airway disease.” ECF No.
114 at 7 (citing Pet’r’s Ex. 3 at 58-62 (ECF No. 6-3)) (emphasis in original). However, pursuant
to the 2008 report, “[a]n electrocardiogram was preformed which . . . show[ed] sinus rhythm
alternating with an atrial ectopic rhythm.” Pet’r’s Ex. 3 at 58 (ECF No. 6-3). While Petitioner’s
treating physician indicated this was “nothing of concern by itself[,]” he found Petitioner’s
“symptoms appear more compatible with reactive airway disease than the classic cardiac
findings of syncope in a pool with relevant family history.” Id. at 59. Second, Petitioner
concedes she submitted to an MRI in October 2008, which was “normal, except for noting
3

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evidence of sinusitis.”4 ECF No. 114 at 8. She suggests, however, that the MRI was intended to,
and did in fact, rule out occipital migraine as cause for her eye pain, loss of vision, and nausea,
thereby failing to render it “notable.” Id. at 7-8; see Pet’r’s Ex. 3 at 10 (ECF No. 6-3). Finally,
Petitioner agrees that her “thyroid functioning was normal, despite the presence of antibodies
indicative of autoimmune thyroid disease” in 2012. ECF No. 114 at 8. Specifically, she
“presented to Riverview Medical Center on August 17, 20125 with a history of diarrhea, fever,
nausea, abdominal pain, nasal discharge, fatigue, and cough . . . [and] had slightly positive tests
for campylobacter jejuni and Coxsackie A and B viruses.” Id. at 9; see Pet’r’s Ex. 7 at 281-300
(ECF No. 6-9). These tests indicated “strong evidence of current or recent infection.” Pet’r’s
Ex. 7 at 292-93 (ECF No. 6-9).
2. Post-Vaccination Hospitalizations
Petitioner received the Hep. A vaccine on August 4, 2015, and the first dose of the
Gardasil HPV vaccine on August 19, 2015. Pet’r’s Ex. 3 at 29 (ECF No. 6-3). On August 20,
2015, Petitioner began experiencing anxiety and hyperventilation, and sought treatment at
Riverview Medical Center. Pet’r’s Ex. 7 at 211-13 (ECF No. 6-9). There, Petitioner reported
experiencing recent feelings of sadness, was planning to leave for college the next day, and,
according to a Nurse’s Note, that she “broke up with [her] boyfriend.”6 Id. at 224. The treating
physician diagnosed her with an “anxiety reaction” and instructed her to follow up with a
psychologist in one to two days. Id. at 229. The next day, Petitioner returned to the hospital by
ambulance, again complaining of anxiety. Id. at 180-84. She appeared distressed to a degree
“inappropriate for [her] age” and underwent a complete blood panel, metabolic panel, toxicology
screen, and pregnancy test—each resulting in negative or noncontributory findings. Id. at 180-
84, 187. She was ultimately discharged with a prescription for Ativan to take as needed for her
diagnosed anxiety reaction. Id. at 189-90, 192.
On August 22, 2015, Petitioner returned to the hospital by ambulance. She appeared
awake, anxious, and to experience “twitching” movements. Pet’r’s Ex. 6 at 57, 72 (ECF No. 6-
7). She transferred to Jersey Shore Hospital for further evaluation and heightened care. Id. at
57-58, 72. Petitioner reported experiencing “3 days of episodes of tonic-clonic jerking that last
20-40 minutes each and are associated with hyperventilation.” Id.at 77. She also indicated this
“[j]erking involves all 4 extremities. . . . [She] has never had episodes like this before. . . . [She]
reports having a headache with mild sensitivity to light but states it is normal for her as she has a
4 Petitioner’s MRI radiology report references a history of occipital migraines, while otherwise
finding “[n]ormal magnetic resonance imaging of the brain” with “nonspecific . . . evidence of
left-sided maxillary sinus . . . .” Pet’r’s Ex. 3-1 at 56-57 (ECF No. 6-3).
5 Petitioner takes issue with Respondent’s “incorrect reporting of dates, [which suggests] that
Petitioner’s symptoms predated her August 4, 2015 Hepatitis A and August 19, 2015 Gardasil
vaccinations . . . .” ECF No. 114 at 8-9 n.6. Indeed, the correct date of Petitioner’s visit is
August 17, 2012, rather than August 17, 2015, as included in Respondent’s briefing. Pet’r’s Ex.
7 at 281-300 (ECF No. 6-9).
6 Petitioner disputes that she had broken up with her boyfriend and argues the hospital record is
incorrect on this point. However, resolution of this fact does not impact the resolution of this
case.
4

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h/o [history of] migraines.” Id. The medical intake form does not reference Petitioner’s hospital
visits over the preceding three days—only that she visited the “ER . . . (not admitted) for MVA 3
months ago.” Id. Petitioner received an initial diagnosis of “pseudoseizures”7 while treating
physicians continued to evaluate her. Id. at 38, 40-42, 80, 131.
Petitioner submitted to a video EEG on August 23-24, 2015, which was normal despite
jerking episodes not accompanied by electrical discharge. Id. at 92; see also id. at 40 (“EEG has
shown that [Petitioner] has not had any seizure-like activity.”). Petitioner also underwent
consultations for infectious diseases (Dr. Davis), neurological disorders (Dr. Sultan), and
psychiatric conditions (Dr. Vincent), acknowledging her recent trip to Nicaragua and familial
history of autoimmune issues, including a grandmother with myasthenia gravis. Id. at 33-42.
Dr. Davis “observed the temporal association with [Petitioner’s] receipt of the first HPV dose,
and even wondered whether she may have had an adverse reaction, but felt that her symptoms
would resolve with time.” ECF No. 109 at 4 (citing Pet’r’s Ex. 6 at 35 (ECF No. 6-7)). Dr.
Sultan cited acute anxiety disorder, indicating Petitioner was unlikely experiencing “myoclonic
seizure,” while failing to rule out PANDAS8 variant, underlying cardiac pathology, and reaction
to the Gardasil vaccine. Pet’r’s Ex. 6 at 38 (ECF No. 6-7). Dr. Vincent diagnosed Petitioner
with panic attacks and advised her to seek therapy at college, although he did not rule out
possible vaccine reaction or neurological issues. Id. at 42. The attending physician, Dr. Chin,
also found Petitioner’s “[c]ardiac evaluation [to be] normal, and [her symptoms] unlikely to be
related to an underlying cardiac etiology.” Id. at 130. On August 26, 2015, Dr. Topilow
submitted a Vaccine Adverse Event Reporting System report highlighting Petitioner’s
“twitching” and “jerking” symptoms following the HPV vaccine administered on August 19,
2015. Pet’r’s Ex. 3 at 37 (ECF No. 6-3). Petitioner’s final diagnosis was “[a]nxiety based events
not related to vaccine.” Pet’r’s Ex. 6 at 131 (ECF No. 6-7).
On September 2, 2015, Dr. Wells, a neurologist at NYU, further evaluated Petitioner.
She described for him several episodes of “prolonged tachycardia” and “myoclonic jerking”
initiating on August 20, 2015. Pet’r’s Ex. 21 at 1-6 (ECF No. 28-1). Dr. Wells reviewed a video
of an episode taken on Petitioner’s mother’s smartphone and was unable to determine if the
“jerking” movements were involuntary. Id. at 4. Dr. Wells concluded that Petitioner “appears to
be having episodes that are primarily anxiety based. They are unlikely to be seizures given the
normal video EEG while having myoclonic episodes.” Id. He surmised that the Gardasil
vaccination is an unlikely cause for her symptoms and, rather, recommended that she visit a
therapist for counseling. Id.
7 “A pseudoseizure is ‘an attack resembling an epileptic seizure but being a type of conversion
disorder; it lacks the electroencephalographic characteristics of epilepsy and the patient may be
able to stop it by an act of will.’” ECF No. 109 at 3 n.5 (citing Pseudoseizure, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=111236 (last visited
July 14, 2022)).
8 “‘PANDAS’ stands for Pediatric Autoimmune Neuropsychiatric Disorder Associated with
Streptococcus infections.” ECF No. 109 at 4 n.6 (citing Bains v. Sec’y of Health & Hum. Servs.,
No. 18-1212V, 2019 WL 4121084, at *1 (Fed. Cl. Spec. Mstr. July 26, 2019)).
5

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On September 12, 2015, Petitioner went to the emergency room at Rhode Island Hospital
complaining of “shaking, tremor episodes, . . . myoclonic jerks . . . [and] her joints beginning to
‘lock up . . . .’” ECF No. 114 at 11 (citing Pet’r’s Ex. 5 at 3-4 (ECF No. 6-6)). Petitioner’s
mother, who accompanied her to the hospital, informed physicians “that these reactions increase
with loud noises[,] ‘when she is startled and scared[,]’ . . . [and are] exacerbated by stressful
factors.” Pet’r’s Ex. 5 at 3-4 (ECF No. 6-6). The hospital administered an ECG, which was
negative, and reviewed prior psychologist consultation records, which indicated anxiety may be
causing her symptoms. Id. at 4, 15.
Five days later, on September 17, 2015, Petitioner was admitted to Riverview Medical
Center “under observation status with intravenous Ativan on call for seizure-like activity.”
Pet’r’s Ex. 7 at 90 (ECF No. 6-8). The results of her ECG were “normal” noting “normal sinus
rhythm with sinus arrhythmia.” Id. at 46. A subsequent neurology consultation suggested
“[p]robable pseudoseizures.” Id. at 67. The neurologist reported Petitioner’s condition “[s]eems
to be some stress related psycho-somatization[,] somatization . . . [or] anxiety associated panic . .
. from ongoing stress” rather than “post-vaccine complication[s] causing seizures.” Id. He
advised “further psych evaluation and treatment for . . . psycho-somatization or psych disorder”
if Petitioner’s evaluation for seizures continued to yield negative results. Id.; see Pet’r’s Ex. 9 at
25 (ECF No. 7-1) (describing “negative imaging, negative vEEG, and negative infectious
workup”).
Petitioner transferred to New York Hospital on September 18, 2015, for further
evaluation. There, her laboratory testing, autoimmune testing, and EKG were normal. Pet’r’s
Ex. 7 at 77-80, 130 (ECF No. 6-8); Pet’r’s Ex. 9 at 62 (ECF No. 7-1). A two-day video EEG
captured a “shaking episode” following a BP reading of 79/52, “but there was no evidence of
seizure activity on the EEG. The vEEG findings, along with the long duration of most of her
episodes (20-40 minutes), lack of tongue biting and incontinence, and maintenance of
awareness/verbal communication point towards a psychogenic non-epileptic seizure
(pseudoseizure).” Pet’r’s Ex. 9 at 62, 64, 70 (ECF No. 7-1) (“One of her typical spells was
captured, characterized by jerking and shaking movements with no EEG correlation[.] [These]
findings indicate nonepileptic events.”). Accordingly, Petitioner was “cleared from neurologic
perspective [and] discharged home with follow up.” Id. at 66. A pediatric resident reviewed
Petitioner’s concerns regarding the onset of symptoms following receipt of the HPV vaccination,
commenting that “[the] literature largely disclaims an association between the vaccination and
neurologic disease . . . [and] most likely this is not the underlying etiology.” Id. at 58.
Additionally, a neurology attending noted that Petitioner’s condition is “compelling for
psychogenic spells” and encouraged “therapeutic intervention” to address “an underlying
subconscious stressor causing the events.” Id. at 70-71. Petitioner was discharged on September
22, 2015. Id. at 71.
3. 2015 Medical Evaluations
On October 2, 2015, Petitioner saw Dr. Lefkowitz, a cardiologist. Pet’r’s Ex. 3 at 92
(ECF No. 6-4). Dr. Lefkowitz reviewed Petitioner’s medical history, acknowledging that her
prior “video EEG . . . showed no seizure activity during myoclonic activity” and noting
Petitioner’s record of IgA deficiency, antithyroid antibodies, and anti-insulin antibodies. Id. Dr.
Lefkowitz conducted a “sit-stand” test, which revealed an increase in heart rate, from 62 bpm to
6

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99 bpm, but no corresponding increase in blood pressure. Id. at 93. He also administered a 24
Hour Holter Report, which indicated Petitioner’s “maximum heart rate was 150 bpm . . . during
sinus tachycardia” and she experienced “46 runs of supraventricular tachycardia/paroxysmal
atrial tachycardia.” Pet’r’s Ex. 12 at 12 (ECF No. 7-4). After completing his examination, Dr.
Lefkowitz provided the following findings:
Problem #1: Shy-Drager syndrome9 (ICD-333.0) (ICD10-G90.3) The patient appears to
have developed generalized autonomic dysfunction either on the basis of a reaction to her
various vaccines that occurred at the same time, or possibly on the basis of a viral
syndrome that she acquired while traveling through the jungles of Central America. Her
MRI was apparently difficult to interpret in terms of demyelination, and should be
reevaluated. She does respond to fluids and hydration, and to salt intake. This syndrome
whether a self-limited immune response to the vaccine, i.e. a form fruste of multiple
sclerosis, or a viral response which was stimulated immune reaction such as is seen in
Guillain-Barre syndrome, with both ultimately be self-limited. They would respond to
fluid intake, and a slow increase in exercise tolerance. I believe that this will be self-
limited. I do believe she should hydrate aggressively with G2 or Smart water, and I
believe that we have shown that the tonic-clonic movements are unrelated to seizure
activity based upon the EEG. She also had no loss of urine or bowel. I think the final
answer regarding the tonic-clonic movements will depend on either a different
interpretation of the MRI, or perhaps a repeat MRI.
Problem #2: Palpitations, recurrent (ICD-785.1) (ICD10-R00.2) The patient's Holter is
consistent with inappropriate sinus tachycardia. This can be seen in the setting of
autonomic dysfunction. While I believe the autonomic dysfunction is on the basis of
either vaccines, or viral exposure, this should be a way to address whether or not the
antibody to insulin can cause autonomic dysfunction in the setting of a diabetic-like state.
I doubt that this is the case. Thyroid function testing was unremarkable, therefore she is
not hyperthyroid despite the presence of antibodies. The palpitations and inappropriate
sinus tachycardia should respond to fluids and rest, but I'm going to prescribe low-dose
metoprolol to take when they become very uncomfortable. Eventually I suspect she will
no longer needs to beta-blockade over time. Fortunately, there is no evidence of
malignant arrhythmia, or an arrhythmia that would need to be ablated.
Problem #3: Chest pain, precordial (ICD-786.51) (ICD10-R07.2) The chest pain is a little
bit more difficult to explain. The patient has a normal EKG, and normal left ventricular
function. Her right side is not dilated, and pulmonary artery systolic pressures are normal,
so I don't think it is likely that she had a pulmonary embolus that would cause her to have
pain. Her oxygen saturation is normal as well. . . . Whether or not the chest pain is
secondary to pericarditis, is unclear. While she has evidence of concordance of the
9 “Shy-Drager syndrome is another term for multiple system atrophy (“MSA”)—‘a rare,
degenerative neurological disorder affecting your body’s involuntary (autonomic) functions,
including blood pressure, breathing, bladder function and motor control.’ It shares many
Parkinson’s disease-like symptoms, such as slow movement, rigid muscles, and poor balance.”
ECF No. 109 at 7 (quoting ECF No. 106 at 8 n.6).
7

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pericardium, there is no evidence of pericarditis on her EKG, and sedimentation rate and
CRP are both normal. If she had pericarditis, she had it in the past in my opinion. . . .
Problem #4: Symptom, convulsions NOS (ICD-780.39) (ICD10- R56.9) As outlined
above, there is no correlation with seizure activity on EEG. This may be some reaction of
the central nervous system 20 over the median stimulant this. I await the repeat MRI
interpretation, and possibly a repeat neurology evaluation.
Pet’r’s Ex. 3 at 93-94 (ECF No. 6-4).
On October 13, 2015, Petitioner saw Dr. Nash, an infectious disease and pulmonary
specialist. Dr. Nash found the psychogenic seizure diagnosis incompatible with her clinical
presentation and personality/behavior presentation. Pet’r’s Ex. 4 at 3 (ECF No. 6-5).
Specifically, Dr. Nash commented that “the multiplicity of [Petitioner’s] symptoms (twitching,
shortness of breath, fever, chest pain) is well beyond what one would expect from
straightforward panic/anxiety reaction.” Id. He suggested “[t]he timing of her symptoms and the
immunizations may represent coincidence or perhaps that she had a degree of autoimmune
encephalopathy provoked by immunizations in a susceptible patient with an autoimmune
predisposition.” Id. Alternatively, he considered whether her symptoms could be caused by “an
infection that she picked up while in Nicaragua.” He concluded that the infections “that would
cause CNS symptoms typically are associated with eosinophilia and an abnormal MRI.” Id. He
also opined that “[s]he has minor orthostatic changes which are not consistent with POTS or
significant autonomic instability.” Id. Dr. Nash recommended further testing for inflammation
and infection, autoimmune encephalitis, and cerebral spinal fluid evaluation for seizure-like
activities. Id. Such testing yielded unremarkable results that did not corroborate the presence of
an autoimmune condition or autonomic dysfunction. See Id. at 7 (MRI results showing white
matter disease “associated with migraine headaches, vasculopathy, toxins, prior trauma, or prior
inflammatory diseases, all of which can give a similar appearance.”).
On November 18, 2015, Dr. Kaufmann and Dr. Palma—both neurology specialists in
dysautonomia—submitted Petitioner to neurological, autonomic, and paraneoplastic autoimmune
testing. Pet’r’s Ex. 18 at 1-3 (ECF No. 18-1). Such testing included a “tilt table” test,10 during
which Petitioner experienced “an episode of bilateral convulsive movements with no loss of
consciousness accompanied by palpitations, sinus tachycardia, and shortness of breath.” Id. at 3.
Petitioner’s blood pressure rose from 108 to 136 after 11 minutes of head-tilt, and her plasma
concentration of norepinephrine increased from 252 to 619 when tilted. Id. The results of the
autoimmune panel revealed no abnormal antibodies, and Petitioner “preserved cardiovascular
autonomic reflexes with no evidence of orthostatic hypotension.” Id. Further, her testing
indicated that Petitioner’s “observed episode, as well as her previous episodes[,] are consistent
with non-epileptic seizures.” Id. Testing did not establish that Petitioner suffered from POTS.
10 “The standard tilt table test entails the patient remaining in a supine position on an adjustable
table for twenty minutes, followed by ten minutes tilted upright, with the heart rate and blood
pressure measured minute by minute, to detect changes as position is altered.” ECF No. 109 at 7
(citing Yalacki v. Sec’y of Health & Hum. Servs., No. 14-278V, 2019 WL 1061429, at *40 n.10
(Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for review den’d, 146 Fed. Cl. 80 (2019)). This test is
“often considered the ‘gold standard’ in diagnosing POTS.” Id.
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Dr. Kaufmann and Dr. Palma concluded that “[t]he marked increase in circulating epinephrine
(from 17 to 160 pg/ml) . . . typically occurs in panic disorders.” Id.; see also ECF No. 109 at 8
n.11 (“Epinephrine is a hormone released by the adrenal glands in response to stress”). The
neurologists explained to Petitioner “how repeated panic attacks result in reuptake of epinephrine
by sympathetic nerves, and as result, episodes of sympathetic activation, like exercise, may
produce excessive epinephrine release and panic-like symptoms.” Pet’r’s Ex. 18 at 3 (ECF No.
18-1). Accordingly, they suggested techniques to improve symptoms, which included “cognitive
behavioral therapy, biofeedback[,] . . . mindfulness, yoga[,] breathing . . . [and] [b]eta-blockade
(e.g., Toprol)[,] [which] is successful for managing stage fright and other stressful situations . . .
.” Id.
Later that month, Petitioner had a follow-up appointment with Dr. Lefkowitz, where she
reported feeling “less orthostatic” and “much better overall.” Pet’r’s Ex. 3 at 97 (ECF No. 6-4).
She also stated that “[s]he no longer has palpitations, dizziness, or tremors.” Id. Dr. Lefkowitz
found her “asymptomatic” with respect to shy-drager syndrome, which had “[c]linically much
improved.” Id. at 98. He also suggested “whatever the immunoresponse that stimulated [her
convulsions] resolved nearly completely.” Id.
Despite these improvements, Petitioner was admitted to the emergency department at
Robert Wood Johnson University Hospital on December 5, 2015, exhibiting “convulsions.”
Pet’r’s Ex. 11 at 2 (ECF No. 7-3). The intake report indicates that, according to Petitioner’s
mother, she “has had pseudo-seizures since August when she received [her] first round of
Gaurdasil [sic].” Id. The initial assessment provided that Petitioner “is a 18 year old with IgA
deficiency presenting after sudden loss of consciousness and left lower extremities weakness
with likely etiology autonomic dysfunction secondary to Gardasil vaccination.” Id. at 72. While
her laboratory tests were normal, an EKG showed sinus tachycardia. Id. at 8-10.
A few days later, Petitioner was admitted to the Monmouth Medical Center Emergency
Department, complaining of “generalized body aches . . . with mild sore throat” and “occasional
chest pressure.” Pet’r’s Ex. 3 at 88 (ECF No. 6-4). The intake report now noted “a history of
POTS” and “extensive evaluation for episodes of tachycardia, leg weakness and pseudoseizures
following her initial immunization of Gardasil several years ago.” Id. at 88. While admitted,
Petitioner experienced an episode of chest pain and tachycardia; however, the ECG, EKG,
cardiac monitor, and oxygenation levels remained normal. Id. at 91. Dr. Snyder subsequently
ordered her discharge and “encouraged strongly the child start[] beta blockers11 for prevention.”
Id.
4. 2016-2020 Medical Evaluations and Treatment
In February 2016, Dr. Lefkowitz submitted Petitioner to Zio Patch Electrocardiography
Monitoring for two weeks. Pet’r’s Ex. 12 at 4 (ECF No. 7-4). The results showed a maximum
heart rate of “203 bpm which occurred during a 13 beat or 6.4 second run of ventricular
11 “Beta blockers, also known as beta-adrenergic blocking agents, can be recommended for
reducing anxiety, because they inhibit the effects of adrenaline.” ECF No. 109 at 9 n.13 (citing
Beta Blockers, Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/high-blood-
pressure/in-depth/beta-blockers/art-20044522 (last accessed on June 30, 2022)).
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tachycardia” as well as instances of premature atrial and ventricular contractions and paroxysmal
atrial tachycardia. Id. “There was no supraventricular tachycardia” and “no atrial fibrillation or
atrial flutter.” Id. Nevertheless, on June 26, 2016, Dr. Lefkowitz provided Petitioner with a
letter that indicated he “diagnosed her with an autonomic disfunction due to the HPV vaccine . . .
. [and,] [a]s a result of this, she cannot complete the course of the HPV vaccine.” Id. at 3. The
letter also cleared Petitioner to return to college “without restriction.” Id.
In April 2016, Petitioner went to Riverview Medical Center complaining of nausea,
vomiting, and abdominal pain. Pet’r’s Ex. 13 at 10 (ECF No. 9-1). Her medical history, as
reported, included POTS disease and a history “of being immunocompromised secondary to the
Gardasil vaccination.” Id. She was discharged following a physical evaluation, which did not
yield abnormal results. Id.
In September 2016, Petitioner arrived at Roger Williams Medical Center exhibiting body
tremors and hyperventilation. Pet’r’s Ex. 14 at 2 (ECF No. 10-1). While her physical evaluation
was normal, an EKG showed sinus tachycardia. Id. In November, Petitioner returned to the
emergency room “for evaluation of near syncopal episode and tachycardia onset . . . secondary to
missing a dose of Metoprolol . . . .” Pet’r’s Ex. 29 at 32 (ECF No. 56-1). She was “informed
that [she] may have pre-hypertension and hypertension based on a blood pressure reading” and
was discharged after her condition improved. Id. at 34.
In April 2017, Petitioner returned to the emergency room complaining of possible
tachycardia and seizure. Id. at 60. Her blood pressure was documented as high, in the 150s, and
her “blood pressure was fluctuating.” Id. Treating physicians reiterated that she “may have pre-
hypertension and hypertension based on a blood pressure reading” and recommended following
up with her primary care provider following discharge. Id. at 63.
In October 2017, Dr. Lefkowitz performed an echocardiogram in reaction to Petitioner’s
claim of “chest pain.” Dr. Lefkowitz also recommended an MRI to evaluate an intermittent mass
near her heart. Pet’r’s Ex. 33 at 26. Dr. Lefkowitz identified myxoma12 as possible explanation
for her presentation. Pet’r’s Ex. 33 at 27 (ECF No. 60-1). He also indicated Petitioner’s “blood
pressure goes up and her heart rate goes down as opposed to the opposite which would be more
consistent with potts [sic] syndrome.” Id. at 26. Testing suggested Petitioner’s symptoms were
“consistent with massive activation” and her pulse and blood pressure were “consistent with
orthostasis.” Id. Additionally, Petitioner’s vivid dreams, anemia, abdominal pain, and nausea
“could be associated with porphyria.” Id.
Petitioner’s medical records indicate that she did not seek medical attention again until
March 28, 2019, when she presented to North Attleboro Urgent Care with complaints of
abdominal pain. Pet’r’s Ex. 36 at 4 (ECF No. 77-1). A CT scan revealed “no acute intra-
abdominal or pelvic abnormality” and was otherwise negative, except for “[l]arge fecal loading
of the entire colon.” Id. at 25. The following year, in March 2020, Petitioner consulted Dr.
12 “Myxoma is ‘a benign tumor composed of primitive connective tissue cells and stroma
resembling mesenchyme.’” ECF No. 109 at 10 n.14 (citing Myxoma, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=111236 (last visited
July 14, 2022)).
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Vargas, a neurologist, regarding “an abnormal MRI and cognitive complaints.” Pet’r’s Ex. 38 at
12 (ECF No. 77-3). Dr. Vargas reported that “[s]ince our last visit, [Petitioner] had labs which
were WNL [within normal limits].” Id. at 12. She also indicated that Petitioner’s MRI “was
stable in terms of lesions but did show a tiny 3 mm hypoenhancing focus related to the pituitary
gland.” Id. at 12.
In 2016 and 2020, Petitioner submitted blood samples for further antibody laboratory
testing. CellTrend GmbH, a laboratory in Germany, tested Petitioner for adrenergic and
muscarinic antibodies13 in February 2016, two of which were found to be positive. Pet’r’s Ex.
16 at 1-2 (ECF No. 12-2). Further, results received in August 2016 indicated high levels of GAD
antibodies, IA-2 antibodies, Zinc Transporter 8 antibodies, and antinuclear antibodies (ANA).
Pet’r’s Ex. 15 at 11 (ECF No. 12-1). Four years later, in March 2020, Petitioner was retested by
CellTrend GmbH.14 The results showed positive levels of Anti alpha-1 adrenergic antibodies
measuring 19.4 Units/ml, Pet’r’s Ex. 37 at 1 (ECF No. 77-2), which exceeded the 2016
measurement of 7.1 Units/ml.1, Pet’r’s Ex. 16 at 1 (ECF No. 12-2). Petitioner’s results were
otherwise negative, except for one at risk value for Anti ETAR antibodies, which measured at
12.1 Units/ml. Pet’r’s Ex. 37 at 1 (ECF No. 77-2). The following month, Petitioner underwent
testing for neuromuscular antibodies at Washington University School of Medicine. The results
were negative, except one “borderline” positive reading for IgM vs Neurofascin-155, which “has
been associated with chronic and acute neuropathies with distal weakness, sensory loss and
tremor.” Pet’r’s Ex. 40 at 1 (ECF No. 77-5).
B. Expert Opinions
Petitioner relies upon expert opinions to show that her HPV vaccination caused her
claimed injuries, and Respondent relies upon expert opinions to show that Petitioner’s HPV
vaccination did not cause her claimed injuries. See ECF No. 41 at 10-11, ECF No. 43 at 1.
Ultimately, the Chief Special Master reviewed ten expert reports from four medical experts. See
Ex. 28 (ECF No. 49-1), Ex. A (ECF No. 63-1), Ex. C (ECF No. 65-1), Ex. 35 (ECF No. 68-1),
Ex. E (ECF No. 70-1), Ex. 49 (ECF No. 92-1), Ex. 60 (ECF No. 93-1), Ex. F (ECF No. 99-1),
Ex. G (ECF No. 99-14), and Ex. 63 (ECF No. 100-1).
1. Dr. Steinman’s First Report
Petitioner’s initial expert report is by Dr. Lawrence Steinman. See Pet’r’s Ex. 28 (ECF
No. 49-1). Dr. Steinman is a neurologist who has practiced adult and pediatric neurology for 37
years. Id. at 1. He is also Professor of Neurology at Stanford University. Id.
13 Petitioner filed medical literature indicating a possible connection between positive adrenergic
and muscarinic antibodies and patients diagnosed with POTS. See Pet’r’s Ex. 23 (ECF No. 42-
5). The report further suggested “[t]he temporal relationship of . . . symptoms to HPV
vaccination and the detection of numerous relevant antibodies raise[s] the hypothesis of an
autoimmune basis for [the] symptoms.” Id.
14 Petitioner indicated that such testing was secured to support an autoimmune etiology
evidenced by elevated norepinephrine levels. ECF No. 108 at 6-7.
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Dr. Steinman concluded “by a preponderance of evidence” that “the Hepatitis A vaccine
received by J.S. on August 4, 2015, and the Gardasil vaccine received by J.S. on August 19,
2015” caused Petitioner to develop an “autoimmune dysautonomia with inappropriate
tachycardia.” Id. at 18. Dr. Steinman’s theory is based “on the concept of molecular mimicry.”
Id. at 6. According to his theory, “a vaccine can trigger a cross-reactive autoimmune response
directed to self” when the vaccine contains an “effective molecular mimic.” Id. at 6-9. An
effective molecular mimic is one that is “capable of inducing clinical paralysis when injected
into an experimental animal of the right genetic background,” a standard Dr. Steinman based on
two peer reviewed papers. Id. at 9; see A. Guatam, A Viral Peptide with Limited Homology to a
Self Peptide Can Induce Clinical Signs of Experimental Autoimmune Encephalomyelitis, 161 J.
Imunol. 60 (1998), filed as Ex. 28, Ref. 16 on Oct. 29, 2017 (ECF No. 48-7); A. Guatam,
Minimum Structural Requirements for Peptide Presentation by Major Histocompatibility
Complex Class II Molecules: Implications in Induction of Autoimmunity, 91 Proc. Natl. Acad.
Sci. USA 767 (1994), filed as Ex. 28, Ref. 17 on Oct. 29, 2017 (ECF No. 48-8). According to
these papers, paralysis was induced when vaccine components shared “a stretch of 12 amino
acids where at least 5 are identical” with the patient’s adrenergic receptor. Pet’r’s Ex. 28 at 7, 9-
10 (ECF No. 49-1).
Dr. Steinman found that Petitioner has alpha 1 adrenergic receptor antibodies. Id. at 15
(discussing Ex. 16 (ECF No. 12-2)). The presence of these antibodies had been “associated with
POTS, dysautonomia and inappropriate tachycardia, which are mainly autoimmune to adrenergic
receptors.” Id. at 6 (citing H. Li, Autoimmune Basis for Postural Tachycardia Syndrome, J. Am.
Heart Assoc. 1 (2014) (filed as Ex. 28, Ref. 12 on October 29, 2017 (ECF No. 48-3)).
Theorizing that Petitioner’s Gardasil or Hep. A vaccines triggered her antibodies, Dr. Steinman
looked at the components of the vaccines and “performed BLAST searches at the website of the
National Library of Medicine to search for relevant structural homologies.” Id. at 7-8. Dr.
Steinman “found some highly relevant molecular mimics in both the hepatitis A vaccine and in
the Gardasil vaccine.” Id. at 8. When Dr. Steinman compared the Gardasil vaccine to the alpha
1 adrenergic receptor, he found one sequence of 13 amino acids that contained 7 identical amino
acids, and another sequence of 12 amino acids that contained 6 identical amino acids. Id. at 11-
12. And when he compared the Hep. A vaccine to the alpha 1 adrenergic receptor, he found one
sequence of 10 amino acids that contained 7 identical amino acids, another sequence of 8 amino
acids that contained 5 identical amino acids, and a sequence of 9 amino acids that contained 5
identical amino acids. Id. at 13-14.15 Due to the similarities, Dr. Steinman concluded that “the
components of the Gardasil vaccine and the Hepatitis A vaccine have sufficient identity to
human adrenergic receptor” to have triggered Petitioner’s antibodies. Id. at 14-15. Dr. Steinman
opined they did so, and he believed that their existence indicated that the vaccines caused
Petitioner’s autoimmune dysautonomia with inappropriate tachycardia. Id. at 18.
15 Dr. Steinman acknowledged that the “adrenergic receptor sequences elicited by Gardasil
vaccine and by the Hepatitis A vaccine are different,” but was not concerned because due to
intramolecular epitope spreading, “once tolerance is broken to one component of an antigen the
immune response can spread to other regions of the molecule.” Pet’r’s Ex. 28 at 15 (ECF No.
49-1).
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Dr. Steinman asserted that his theory is consistent with Petitioner’s symptoms. As he
pointed out, the rapid onset of adverse reactions, including syncope, has been reported following
Gardasil vaccination. Id. Also, Petitioner’s heart began racing “within a day of the Gardasil
vaccine,” and “15 to 16 days after the Hepatitis A vaccine,” a response Dr. Steinman found
“totally consistent with timing of adverse events reported in the package insert for Gardasil, and
from the velocity of the recall response described in the 2012 IOM report.” Id.
Dr. Steinman also contended that his theory and analysis satisfy the Althen test. Id. at 19.
He claimed causation is established by his theory of molecular mimicry, which shows that the
Gardasil and Hep. A vaccines elicited immunity to adrenergic receptors associated with
dysautonomia and inappropriate tachycardia. Id. He then observed that his theory proved the
vaccination was the reason for Petitioner’s injury by demonstrating that the Gardasil vaccine
antigens were sufficient to trigger a neuroinflammatory response when injected into Petitioner,
resulting in an immune response which triggered a post-vaccine antibody mediated attack on the
alpha 1 adrenergic receptor. Id. He also noted that a proximate temporal relationship between
vaccination and injury was fulfilled by the onset of “heart racing” in the day or days after the
Gardasil vaccine and 15 to 16 days after the Hep. A vaccine. Id.
2. Dr. MacGinnitie’s First Report
Respondent provided a competing opinion by Andrew MacGinnitie, M.D., Ph.D. See
Resp’t’s Ex. A (ECF No. 63-1). Dr. MacGinnitie is an Allergist/Immunologist who has
practiced for 16 years and is currently Attending Physician and Clinical Director for the Division
of Immunology at Boston Children’s Hospital overseeing clinical operations for
Allergy/Immunology, Rheumatology and Dermatology. Id. at 1. He is also Associate Professor
of Pediatrics at Harvard Medical School. Id. Dr. MacGinnitie found “to a reasonable degree of
medical certainty” that “it is extremely unlikely that J.S.’s symptoms are due to an immune
reaction triggered by vaccination.” Id. at 9. Dr. MacGinnitie based his conclusion on the
implausibility of Dr. Steinman’s theory of molecular mimicry. Id. at 4.
According to Dr. MacGinnitie, Dr. Steinman’s theory of molecular mimicry has
significant flaws regarding causation. First, according to Dr. MacGinnitie, Dr. Steinman’s
theory gives “too much credence to the presence of anti-adrenergic receptor antibodies, which
are frequently present in normal controls.” Id. at 4. Second, Dr. MacGinnitie believed that Dr.
Steinman “rel[ied] on an outdated view of molecular mimicry.” Id. Finally, Dr. MacGinnitie
believed that Dr. Steinman “ignore[d] data that POTS is not, in fact, an autoimmune condition
and that extensive epidemiologic data shows [sic] that Gardasil (HPV) and VAQTA (Hep A)
vaccines are not associated with autoimmunity.” Id.
a) POTS and Autoimmunity
Dr. MacGinnitie found that there is “little evidence and no consensus that
POTS/dysautonomia is an autoimmune disease.” Id. at 4. He observed that Dr. Steinman
“ignores data that POTS is not, in fact, an autoimmune condition and that extensive
epidemiologic data shows that Gardasil (HPV) and VAQTA (Hep A) vaccines are not associated
with autoimmunity.” Id. He also pointed to four studies that indicate “no relationship between
HPV or Hep A/VAQTA vaccination and autoimmune disease.” Id. at 8-9.
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Dr. MacGinnitie admitted that Dr. Steinman cited the Li article in support of his theory
that “POTS, dysautonomia and inappropriate tachycardia, which are mainly autoimmune to
adrenergic components.” Id. at 4. However, he pointed out that the study was “small” and that
reviewers took issue with it. Id. He also observed that the study was not “a relevant model of
human disease” because it “uses a completely different methodology in which antibodies (IgG)
from patients and controls are added to a culture of rat cremaster arterioles.” Id. 5-6.
b) CellTrend Assay
Dr. MacGinnitie observed that the Loebel article indicated “serious issues” with
Petitioner’s reliance on her CellTrend assay, which showed that she has alpha 1 adrenergic
receptor antibodies. Id. at 5; see M. Loebel, Antibodies to β Adrenergic and Muscarinic
Cholinergic Receptors in Patients with Chronic Fatigue Syndrome, 52 Brain, Behavior, and
Immunity 32 (2015) (filed as Ex. A, Tab 7 on Feb. 7, 2018 (ECF No. 63-8)). Dr. MacGinnitie
himself took issue with the assay because it “is not approved by the Food and Drug
Administration (‘FDA’),” because “J.S.’s [reference] value was 7.3, barely above the cited upper
range of normal (7.0) [in the assay] and . . . a value that is frequently seen in normal controls,”
and because a “more extensive panel of autoantibodies associated with dysautonomia was
completely negative.” Resp’t’s Ex. A at 5-6 (ECF No. 63-1) (citing Ex. 18 (ECF No. 18-1)).
Not only was Petitioner’s value only slightly above the upper range, Dr. MacGinnitie
opined that because five percent of normal individuals will have values outside the normal range,
Petitioner’s value “[wa]s likely not indicative of elevated levels, but within the range of normal
variation.” Id. at 5. Dr. MacGinnitie also distinguished the Loebel article because it was limited
to patients with Chronic Fatigue Syndrome and provided no data on POTS or autonomic
dysfunction. Id.
c) Mouse Model
Dr. MacGinnitie took issue with Dr. Steinman’s reliance on the Guatam articles, which
indicated that a vaccine with a stretch of 12 amino acids where at least 5 are identical with a
patient’s adrenergic receptor would cause humans to experience a cross-reactive autoimmune
response directed to self. Id. at 6. Dr. MacGinnitie believes the references are of “at best
marginal” significance because they rely on a mouse model, and there are “multiple examples of
data in animals failing to translate into human disease.” Id. Additionally, the mouse model used
Complete Freund’s Adjuvant, “a mix of mycobacterial proteins and mineral oil” that is “so
powerful that it is not suitable for use in human use,” whereas “[w]hile Gardasil and VAQTA
use an adjuvant, it is aluminum, which is relatively weak and well tolerated.” Id. at 6-7. The
mouse model was also “of demyelination,” which is “the basis of multiple sclerosis and related
illnesses in humans” but not the basis of dysautonomia and POTS. Id. at 6.
3. Dr. Bingham’s First Report
Respondent also filed a report by Dr. Peter M. Bingham. See Resp’t’s Ex. C (ECF No.
65-1). Dr. Bingham is a Pediatric Neurologist and clinical researcher with 25 years’ post-
residency experience in general child neurology. Id. at 1. Dr. Bingham concluded that it is
“more likely than not” that Petitioner “did not suffer her symptoms . . . as a result of Gardasil
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vaccination.” Id. at 6.16 Dr. Bingham based his theory on the lack of epidemiological evidence
associating Gardasil and POTS in the “considerable discussion in the literature, case reports,
[and] case series, regarding a potential link.” Id.
Dr. Bingham characterized Petitioner’s symptoms and positive antibody findings as
“non-specific” and that “in many cases, individuals without any neurological disease may harbor
these antibodies.” Id. at 6-8. Moreover, “[n]ot all patients with POTS harbor these antibodies.”
Id. Because not all POTS patients have the adrenergic antibodies and it is not known how many
people without POTS have the antibodies, Dr. Bingham concludes that the presence of the
antibodies does not prove that Petitioner had an autoimmune disease.
He also opined that Dr. Steinman’s opinion does not satisfy “the standards for causal
attribution set by the Institute of Medicine regarding adverse effects of medicine” because it
requires “a number of assumptions.” Id. at 6.17 For example, Dr. Bingham observed that there
was a “relatively long period of latency before induction of the autoimmune response that [Dr.
Steinman] and his colleagues elicited in mice.” Id. at 7.
Based on his review, Dr. Bingham concluded if Petitioner had POTS, it was more likely
than not that she did not develop it because of her Gardasil vaccination.
4. Dr. Steinman’s Second Report
Petitioner responded to Respondent’s experts with another report by Dr. Steinman. See
Pet’r’s Ex. 35 (ECF No. 68-1). After reading Respondent’s reports, Dr. Steinman’s “conclusions
in this matter are unchanged.” Id. at 20. Dr. Steinman acknowledged that Dr. MacGinnitie was
correct that “immunity to nervous system antigens like myelin is rather widespread in normals.”
Id. at 3. However, he reiterated that “many diseases that are adjudicated in this court do not have
a finally universally agreed mechanism of pathogenesis. Many disease entities have multiple
mechanisms of pathogenesis. The Petitioner is asked to compose a theory. I base my theory in
this case and in all others on the peer-reviewed literature.” Id. at 10. He emphasized that his role
“is not to provide a massive theory that proves how autoimmune disease is caused at a level of
certainty,” but rather “to provide a theory on how Petitioner’s disease could be caused, based on
solid peer reviewed publications.” Id. at 18. Dr. Steinman then responded to Respondent’s
reports.
a) Dr. MacGinnitie
(1) POTS and Autoimmunity
16 Dr. Bingham disagreed with Dr. Steinman that Petitioner had developed POTS because she did
not demonstrate its core symptoms, “chronic, recurrent, orthostatic intolerance.” Resp’t’s Ex. C
at 5 (ECF No. 65-1).
17 Dr. Bingham seemingly proposed that the Court rely on a test similar to the standards outlined
in the Institute of Medicine report on Adverse Effects of Vaccinations rather than the Althen test,
whose criteria he claimed are “considerably less stringent.” Resp’t’s Ex. C at 8 (ECF No. 65-1).
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Dr. Steinman emphasized that the Li article and two supplemental reports “discuss
autoantibodies in POTS.” Id. at 10; see Ex. 18; M. Thieben, Postural Orthostatic Tachycardia
Syndrome: The Mayo Clinic Experience, 82 Mayo Clin. Proc. 308 (2007), filed as Ex. 35, Ref. 1
on Apr. 19, 2018 (ECF No. 68-2); X. Wang, Autoimmunoreactive IgGs from Patients with
Postural Orthostatic Tachycardia Syndrome, 6 Proteomics Clin. Appl. 615 (2012), filed as Ex.
35, Ref. 2 on Apr. 19, 2018 (ECF No. 68-3). Dr. Steinman observed that Dr. MacGinnitie’s
statement that Dr. Steinman “ignores data that POTS is not, in fact, an autoimmune condition
and that extensive epidemiologic data shows that Gardasil (HPV) and VAQTA (Hep A) vaccines
are not associated with autoimmunity” is contradictory because “he states that POTS is not an
autoimmune disease, and then he cites four references stating that the vaccines in Petitioner’s
theory are not associated with autoimmunity.” Pet’r’s Ex. 35 at 8 (ECF No. 68-1). Dr. Steinman
reviewed Dr. MacGinnitie’s four references and noted that they did not search for POTS
specifically, and so “in no way rule out an association between POTS and the vaccines in
question.” Id.
Dr. Steinman took issue with Dr. MacGinnitie’s portrayal of his words “POTS,
dysautonomia and inappropriate tachycardia, which are mainly autoimmune to adrenergic
components,” stating the quotation was only partial and inaccurately portrayed him as qualifying
his autoimmune theory to “all POTS patients.” Id. at 10-11. Dr. Steinman then quoted the full
passage which clarified that his opinion explained increased standing plasma norepinephrine and
excessive tachycardia in “many POTS patients.” Id. Dr. Steinman defended his use of the Li
article and claimed that it “is a valid assay to measure anti-adrenergic antibodies.” Id. at 15.
(2) CellTrend Assay
Dr. Steinman disagreed that the Loebel article indicates “serious issues” with the
CellTrend assay and requested that Respondent explain what this assertion meant. Id. at 12-14.
He then responded to Dr. MacGinnitie’s comments about the FDA by explaining that lab testing
“is not necessarily ever ‘approved by the FDA.’” Id. at 13. He responded to Dr. MacGinnitie’s
comments about Petitioner’s barely elevated antibody levels by saying “‘above the cited upper
range of normal’, means EXACTLY that.” Id. at 14. He also disagreed with Dr. MacGinnitie’s
description of Exhibit 18 as “a more extensive panel of autoantibodies,” saying “it is simply a
different panel and did NOT include anti-adrenergic antibodies.” Id. at 12.
Dr. Steinman emphasized that the negative panel of antibodies Dr. MacGinnitie referred
to, the Paraneoplastic assay, Exhibit 18, did not measure anti-adrenergic antibodies, and that
Petitioner’s CellTrend assay showed high levels of M4 antibodies. Id. at 12, 15. While Dr.
Steinman admitted that “[t]he significance of antibodies to M4 in POTS is unknown,” he
emphasized that research indicates “patients with ‘idiopathic’ orthostatic hypotension (OH) have
a strong association with activating autoantibodies.” Id.
(3) Mouse Model
Dr. Steinman responded to Dr. MacGinnitie’s critiques of the mouse model by explaining
he relied on “a standard model of autoimmune disease – EAE – to support Petitioner’s theory”
because he did not have an “animal model of autoimmune POTS.” Id. at 16. Dr. Steinman also
cited a new report where researchers caused paralysis by “passively transferr[ing] T cells that
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cross-reacted with myelin basic protein and HPV.” Id. at 17; see R. Ufret-Vincenty, In Vivo
Survival of Viral Antigen-Specific T Cells that Induce Experimental Autoimmune
Encephalomyelitis, 188 J. Experimental Medicine 1725 (1998), filed as Ex. 35, Ref. 5 on Apr.
19, 2018 (ECF No. 68-6). The report concluded that “mimicry between a virus and myelin basic
protein can lead to clinical paralysis.” Pet’r’s Ex. 35 at 17 (ECF No. 68-1).
(4) Anti-Adrenergic Receptor Antibodies
Dr. Steinman acknowledged that Dr. MacGinnitie was correct that molecular mimicry
may be widespread in healthy normal individuals, but Steinman remained convinced that
“molecular mimicry is a key mechanism in understanding how tolerance to ‘self’ structures like
myelin proteins is broken.” Id. at 1-4, 18. Dr. Steinman reemphasized what he said in his first
report: “[o]ther genetic and environmental factors are necessary before these self-reactive
immune responses to neural antigens like adrenergic receptors might lead to an autoimmune
disease of the autonomic nervous system.” Id. at 3-4. Dr. Steinman also observed that he has
published nine publications on molecular mimicry from 1994-2016, whereas Respondent’s
experts have not published on the topic at all. Id. at 4-8.
b) Dr. Bingham
Dr. Steinman restated his belief that Petitioner does have autoimmune dysautonomia with
inappropriate tachycardia. Id. at 19. Dr. Steinman reiterated his reliance on the Althen criteria.
Id. Finally, Dr. Steinman defended the timing and latency before induction of the autoimmune
response elicited in mice, and stated that he “relied on the criteria in humans from the IOM
report on Adverse Vaccinations” that Dr. Bingham himself considered more stringent than
Althen. Id. at 20.
5. Dr. MacGinnitie’s Second Report
Respondent responded to Dr. Steinman’s second report by submitting another report by
Dr. MacGinnitie. See Resp’t’s Ex. E (ECF No. 70-1). Dr. MacGinnitie referred to “a very
recent article” that concludes “at this time there is no conclusive evidence support [sic] a causal
relationship between the human papillomavirus vaccine and POTS. Though a causal relationship
has been postulated, it is of utmost importance to recognize that while temporal associations may
be observed, conclusion of causality cannot be drawn from case reports and case studies due to
the small sample size and lack of a control population.” Id. at 4 (citing B. Butts, Human
Papillomavirus Vaccine and Postural Orthostatic Tachycardia Syndrome: A Review of Current
Literature, J. Child Neurology 1 (2017), filed as Ex. E, Tab 3 (ECF No. 70-4)). He also
responded to Dr. Steinman’s second report.
a) POTS and Autoimmunity
Dr. MacGinnitie reiterated that the studies cited by Dr. Steinman suggesting a possible
autoimmune cause of POTS were unreliable. Resp’t’s Ex. E at 2-3 (ECF No. 70-1). Dr.
MacGinnitie responded to Dr. Steinman’s criticism that his opinions are contradictory by
asserting that the premise that “POTS is not an autoimmune disease” was not inconsistent with
the premise that “vaccines in Petitioner’s theory are not associated with autoimmunity.” Id. at 2.
Dr. MacGinnitie also observed that he “could not find any report of POTS being successfully
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treated with immunosuppressive drugs such as steroids, which are the typical therapy for
autoimmune diseases.” Id. at 3.
b) CellTrend Assay
Dr. MacGinnitie defended his comments about the FDA, explaining that lab testing
developed and performed by a single laboratory is regulated by the Centers for Medicare &
Medicaid Services (CMS) and Centers for Disease Control (CDA), which can grant certification
under the Clinical Laboratory Improvement Amendments (CLIA), but that a kit or test developed
for use at multiple laboratories comes under FDA jurisdiction. Id. at 3-4. Dr. MacGinnitie
emphasized that the CellTrend assay has neither CLIA nor FDA certification. Id. at 4. Dr.
MacGinnitie also noted that the Loebel and Li articles present “no data relating the mild
elevation of auto-adrenergic receptor antibodies in this case with POTS.” Id. at 3.
Dr. MacGinnitie admitted that Dr. Steinman is correct that the panel of autoimmune
antibodies sent by the dysautonomia specialists did not include anti-adrenergic antibodies, but
pointed out that sending this panel instead of the CellTrend assay indicated the specialists did not
find the CellTrend assay meaningful. Id. at 3. Dr. MacGinnitie observed that while Petitioner’s
CellTrend assay showed “significant levels of anti M4 antibodies,” the article Dr. Steinman cited
to demonstrates the antibodies’ relevance “does not discuss antibodies against the M4 receptor or
present evidence that these antibodies are involved in POTS.” Id. Dr. MacGinnitie found the
presence of two anti beta-cell antibodies in Petitioner irrelevant because they are not associated
with POTS and are often seen in siblings of patients with Insulin-dependent Diabetes Mellitus,
which Petitioner’s sister has. Id.
c) Mouse Model
Dr. MacGinnitie reemphasized that the reliability of the mouse model Dr. Steinman relied
on to support his theory of molecular mimicry is “at best questionable” because it “refers to
injecting non-physiologic amounts of protein plus powerful adjuvants not used in humans
(complete Freund’s adjuvant) as a model (experimental autoimmune encephalomyelitis or EAE)
for a disease (multiple sclerosis) that no one asserts JS suffers from.” Id. at 2. Similarly, Dr.
MacGinnitie found Dr. Steinman’s newly cited Ufret-Vincenty report, that EAE can be induced
by transferring T-cells between groups of mice, irrelevant, because “even if we accept his
assertions regarding cross-reactivity and molecular mimicry,” the report does not provide an
animal model of autoimmune POTS and therefore cannot establish a foundation for his theory of
molecular mimicry. Id.
d) Anti-Adrenergic Receptor Antibodies
Dr. MacGinnitie admitted that Dr. Steinman has published more on molecular mimicry,
but emphasized that Dr. Steinman “does not present any data contradicting the fact that there is
extensive overlap between viral and bacterial proteins and human ones which far exceed the
degree of homology between proteins in Gardasil and adrenergic receptors that he cites in his
original report.” Id. at 1-2. Dr. MacGinnitie emphasized that “the presence of anti-adrenergic
and anti-cholinergic antibodies is the sole evidence of autoimmunity potentially associated with
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POTS in this case” and noted that this is a “crucial weakness” in Dr. Steinman’s opinion because
“immunity against self-antigens is common in the absence of clinical disease.” Id. at 1.
6. Dr. Brawer
Petitioner responded to Dr. MacGinnitie’s second report by filing three reports by Dr.
Arthur E. Brawer. See Pet’r’s Ex. 49 (ECF No. 92-1); Pet’r’s Ex. 60 (ECF No. 93-1); Pet’r’s Ex.
63 (ECF No. 100-1). Dr. Brawer concurred with the presence of adrenergic antibodies as one of
the grounds for satisfying the Althen test. See Pet’r’s Ex. 49 at 3 (ECF No. 92-1). However,
Petitioner “chose[] not to rely upon his expertise in presenting her case” because “Dr. Brawer did
not develop the adrenergic antibody approach any further.” Pet’r’s Mot., filed Dec. 6, 2021 at 3
(ECF No. 105).18 Because Petitioner did not rely on Dr. Brawer, the Court will not summarize
Dr. Brawer’s reports.
Respondent filed two reports in response to Dr. Brawer. See Resp’t’s Ex. F (ECF No. 99-
1) (Report by Dr. Andrew MacGinnitie, Ph.D.); Resp’t’s Ex. G (ECF No. 99-14) (Report by Dr.
Peter M. Bingham). These reports dealt with arguments made by Dr. Brawer. Because
Petitioner no longer relies on Dr. Brawer, there is no need to summarize these expert reports.
C. Chief Special Master’s Decision
On December 6, 2021, Petitioner filed a Motion for Ruling on the Record, which
included a request for a hearing. ECF No. 105. The Chief Special Master issued his Decision on
July 15, 2022, denying entitlement to compensation under the Vaccine Act and denying
Petitioner’s request for a hearing. ECF No. 109 at 26, 37 (“It is simply not the case that every
Vaccine Act Claim need be resolved by hearing—even where the [P]etitioner explicitly so
requests.”). Ultimately, the Chief Special Master found that Petitioner failed to show, “on the
basis of th[e] medical record, that she experienced any arguably vaccine-caused disease or
condition—and it is more likely her symptoms reflect somatization.” Id. at 2 (emphasis in
original). Further, the Chief Special Master emphasized that to “date, [he has] never ruled that
the HPV vaccine likely causes any form of dysautonomia. The medical science that has been
offered on this contention in case after case simply does not support that conclusion—and [he is]
aware of no counter, persuasive analyses that would suggest the alternative.” Id. at 36 (emphasis
in original). He also provided “that this particular case lacks reasonable basis going forward”
and warned that attorney’s fees would not be awarded if Petitioner “opts to extend this claim’s
life further . . . .” Id. at 36 n.41 (emphasis in original).
18 Petitioner’s reluctance to rely on Dr. Brawer may have stemmed from Dr. Brawer’s personal
attacks on Respondent’s experts. See, e.g., Pet’r’s Ex. 63 at 3 (ECF No. 100-1) (“[T]he tone of
Dr. Bingham’s report suggests that he himself may in part be suffering from a functional
neurological disorder.”). Respondent moved to strike Dr. Brawer’s second report due to this
language. See ECF No. 102. The Special Master denied the motion, but informed the Petitioner
that this sort of language was “a reason for deeming the attacking expert’s report to deserve less
weight than an even-handed report would receive.” ECF No. 104 at 2.
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Petitioner timely filed a motion for review on August 14, 2022. ECF Nos. 112 & 114.
Petitioner’s numbered objections to the Decision are as follows:
Numbered Objection 1
The Special Master’s Decision is arbitrary, capricious, an abuse of discretion and
contrary to law in finding tachycardia cannot be deemed a primary condition
compensable by the Vaccine Program (a “cognizable vaccine injury” (Dec. at 28-29, 30-
32); see Tarsell United States, 133 Fed. Cl. 782, 794 (2017). While tachycardia might
often be accompanied by other symptoms, the Decision identified no basis for denying its
status as a primary condition or cognizable vaccine injury.
Numbered Objection 2
By prospectively denying the availability of attorneys’ fees for the present Motion for
Review, the Decision was arbitrary, capricious, an abuse of discretion and contrary to
law. (Dec. at 36, fn. 41). Where the Decision determined for the first time that the
Petition had lost reasonable basis, thus denying review or improperly burdening
Petitioner with the costs of review, the special master interjected a chilling effect thereby
undermining the Vaccine Act procedure for review and appeal established in 42 U.S.C. §
300aa-12(e), and violated judicial procedure prohibiting a judge from determining an
appeal of his or her own decision. Title 28, Section 47.
Numbered Objection 3
The special master engaged in an arbitrary pattern of result-oriented and generalized
factfinding that is unsupported by the medical record. The special master’s arbitrary
factfinding featured unfounded rejection or silent avoidance of objective medical
evidence to allow the unsupported conclusion that petitioner’s condition was a mental
disorder. The Decision was arbitrary and capricious in summarily finding petitioner’s
condition was more likely a mental disorder than a physiological disorder in the face of a
medical record that contained no straightforward evidence of a mental disorder diagnosis.
The arbitrary pattern of factfinding was manifest in the Decision’s one-sided
interpretation of petitioner’s objective testing, including the interpretation of medical
findings of tachycardia, which were central to petitioner’s case, but were cast by the
special master as psychiatric (or “mental disorder”) phenomena. (Dec. at 35).
Numbered Objection 4
The Decision is arbitrary, capricious and an abuse of discretion in its internally
contradictory finding that dysautonomia might be attributable to an autoimmune process
in rare cases such as the those in the present case, where anti-adrenergic antibodies
caused heart rate increases, while simultaneously admonishing petitioners to avoid
bringing claims involving HPV vaccination and allegations of dysautonomia. Thus, while
acknowledging that in rare cases there may be a basis to pursue an autoimmune claim in
connection with the vaccine's inducement of dysautonomia, the special master foreclosed
this avenue of evidence entirely. Thus, the Decision was arbitrary in foreclosing the
possibility that petitioner could prove the very same claim the court found potentially
plausible. (Dec. at 36).
Numbered Objection 5
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The special master’s decision was arbitrary, capricious, and contrary to law in deeming
petitioner’s proffered medical theory of causation as insufficient. The Petitioner
demonstrated a sufficient relationship between molecular mimicry and the increase in
anti-adrenergic antibodies to satisfy Althen prong 1, contrary to the special master’s
holding (Dec. at 32).
Numbered Objection 6
The special master was arbitrary, capricious, and abused his discretion in denying an
evidentiary hearing where the issue of petitioner’s mental state and her behavior was
central to the Decision’s findings of fact. The abuse of discretion is evident where the
special master found that preponderant evidence strongly supports the conclusion that
“some other kind of mental disorder explains [petitioner’s] symptoms” based on a
medical record which reveals no clear psychiatric or psychological diagnosis of
Petitioner. Thus, the special master abused his discretion in substituting a diagnosis that
is absent from the medical record, while at the same time denying a hearing where the
Petitioner could fully develop the issue of her mental state. (Dec. at 35-36).
ECF No. 112 at 1-3. Respondent filed its response on September 14, 2022. ECF No.
118. After reviewing the filings, the Court upholds the Chief Special Master’s findings of fact
and conclusions of law and sustains the Chief Special Master’s decision.
II. DISCUSSION
A. Jurisdiction & Standard of Review
The United States Court of Federal Claims exercises jurisdiction to review vaccine
decisions pursuant to § 300aa-12(e)(1) of the Vaccine Act. In reviewing a special master’s
decision, this Court may:
(A) uphold the findings of fact and conclusions of law of the
special master and sustain the special master’s decision,
(B) 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
(C) 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). “Under the Vaccine Act, the Court of Federal Claims reviews the
Chief Special Master’s decision to determine if it is ‘arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with the law.’ 42 U.S.C. § 300aa-12(e)(2)(B).” Markovich v.
Sec’y of Health & Human Servs., 477 F.3d 1353, 1355-56 (Fed. Cir.), cert. denied, 552 U.S. 816
(2007).
Specifically, “[f]indings of fact of the special master are reviewed under the arbitrary and
capricious standard, conclusions of law are reviewed under the ‘not in accordance with law’
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standard, and discretionary rulings are reviewed under the abuse of discretion standard.”
Broekelschen v. Sec’y of Health & Human Servs., 89 Fed. Cl. 336, 343 (2009), aff’d, 618 F.3d
1339 (Fed. Cir. 2010) (citations omitted). “An abuse of discretion may be found when (1) the
court’s decision is clearly unreasonable, arbitrary, or fanciful; (2) the decision is based on an
erroneous conclusion of the law; (3) the court’s findings are clearly erroneous; or (4) the record
contains no evidence upon which the court rationally could have based its decision.” Simmons v.
HHS, 875 F.3d 632, 635 (Fed. Cir. 2017) (quoting Hendler v. U.S., 985 F.2d 1364, 1380 (Fed.
Cir. 1991)). As such, the Vaccine Act “provide[s] for a limited standard for appeal from the
[special] master’s decision” and its legislative history shows “that this procedure [should not] be
used frequently, but rather in those cases in which a truly arbitrary decision has been made.”
H.R. Rep. No. 101-386, at 517 (1989) (Conf. Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.
Indeed, the arbitrary and capricious standard is “well understood to be the most
deferential possible.” Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870
(Fed. Cir. 1992). As such, when evaluating factual findings of the special master, 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 & Human
Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011); see also Hodges v. Sec’y of Dept. of Health &
Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993) (“[O]n review, the Court of Federal Claims is
not to second guess the Special Master[’]s fact-intensive conclusions; the standard of review is
uniquely deferential for what is essentially a judicial process.”). “Rather, as long as a special
master’s finding of fact is ‘based on evidence in the record that [is] not wholly implausible, [the
Court is] compelled to uphold that finding as not being arbitrary or capricious.’” Porter, 663
F.3d at 1249 (first alteration in original and second alteration added) (quoting Cedillo v. Sec’y of
Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010)). Where “the special master has
‘considered the relevant evidence of record, drawn plausible inferences, [and stated] a rational
basis for the decision,’ reversible error is extremely difficult to establish.” Silva v. Sec’y of
Health & Human Servs., 108 Fed. Cl. 401, 405 (2012) (quoting Hines v. Sec’y of Health &
Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
B. Vaccine Act Legal Standard
To receive compensation under the Vaccine Act, petitioner must prove either 1) that she
suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – that
corresponds to the vaccination received, or 2) that she suffered an injury that was caused-in-fact
by a vaccine. See 42 U.S.C. §§ 300aa-13(a)(1)(A) & 300aa-11(c)(1). Here, Petitioner does not
allege, and the record does not show, that she suffered a “Table Injury” caused by the Hep. A or
HPV vaccination. See Vaccine Injury Table, 42 U.S.C. § 300aa-14. Rather, Petitioner argues
that these vaccinations caused her injury in-fact.
In Althen v. Secretary of Health & Human Services, the Federal Circuit articulated a
three-part test outlining a petitioner’s burden to establish causation-in-fact under the Vaccine
Act. 418 F.3d 1274, 1278 (Fed. Cir. 2005). To prove causation-in-fact, a petitioner must:
[S]how by preponderant evidence that the vaccination brought
about her injury by providing (1) a medical theory causally
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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.
Id.; see also Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1355 (Fed. Cir. 2019)
(holding that a petitioner must “prove[] all three Althen prongs by a preponderance of the
evidence”); 42 U.S.C. § 300aa–13(a)(1)(A) (Petitioner must prove causation-in-fact “by a
preponderance of the evidence.”). “A careful reading of Althen, shows that each prong . . . is
decided relative to the injury: (1) medical theory connecting the vaccination to the injury; (2)
cause and effect showing the vaccination was the reason for the injury; and (3) proximate
temporal relationship between the vaccination and the injury.” Broekelschen v. Sec’y of HHS,
618 F.3d 1339, 1346 (Fed. Cir. 2010) (citing Althen, 418 F.3d at 1278). Identifying the injury is
therefore a prerequisite to the analysis. Id.
The Federal Circuit has “held that causation-in-fact in the Vaccine Act context is the
same as the ‘legal cause’ in the general torts context.” De Bazan v. Sec'y of Health & Human
Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008). “Therefore, drawing from the Restatement
(Second) of Torts, the vaccine is a cause-in-fact when it is ‘a substantial factor in bringing about
the harm.’” Id. (quoting the Restatement (Second) of Torts § 431(a)). Accordingly, to establish
causation, “[Pe]titioner must show that the vaccine was ‘not only a but-for cause of the injury but
also a substantial factor in bringing about the injury.’” Id. at 1351 (quoting Shyface v. Sec’y of
Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)). A “‘substantial factor’
standard requires a greater showing than ‘but for’ causation.” Id. (quoting Shyface, 165 F.3d at
1352). But a petitioner is not required to establish the causation to a scientific certainty:
Causation in fact under the Vaccine Act is thus based on the
circumstances of the particular case, having no hard and fast per se
scientific or medical rules. The determination of causation in fact
under the Vaccine Act involves ascertaining whether a sequence of
cause and effect is “logical” and legally probable, not medically or
scientifically certain.
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). The Vaccine
Act permits proof of causation through “the use of circumstantial evidence envisioned by the
preponderance standard.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325
(Fed. Cir. 2006) (internal citation and quotation marks omitted). Petitioner’s claim must be
“substantiated by medical records or medical opinion.” Althen, 418 F.3d at 1279.
III. DISCUSSION
Petitioner presents six numbered objections for this Court’s review. Objections 1 and 3
challenge the Chief Special Master’s finding that Petitioner failed to establish a cognizable injury
compensable under the Vaccine Act. Objection 5 challenges the Chief Special Master’s finding
that, although he need not engage in a thorough Althen analysis, Petitioner failed to meet her
burden under Althen prong 1. Objection 4 challenges the Chief Special Master’s rejection of the
scientific evidence supporting the viability of Petitioner’s theory of causation. Objection 6
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challenges the Chief Special Master’s decision to decide the case on the record without a
hearing. Finally, Objection 2 challenges the Chief Special Master’s prospective denial of
attorney’s fees. See ECF No. 112 at 1-3.
A. The Chief Special Master’s finding that Petitioner failed to establish a
cognizable vaccine injury is neither arbitrary nor capricious.
Petitioner argues the “Special Master’s Decision is arbitrary, capricious, an abuse of
discretion and contrary to law in finding tachycardia cannot be deemed a primary condition
compensable by the Vaccine Program.” ECF No. 112 at 1 (citing ECF No. 109 at 28-29, 30-32).
Specifically, Petitioner claims “[w]hile tachycardia might often be accompanied by other
symptoms, the Decision identified no basis for denying its status as a primary condition or
cognizable vaccine injury . . . .” Id. Further, Petitioner alleges “an arbitrary pattern of result-
oriented and generalized factfinding that is unsupported by the medical record . . . [which]
featured unfounded rejection or silent avoidance of objective medical evidence to allow the
unsupported conclusion that petitioner’s condition was a mental disorder.” Id. at 2. According
to Petitioner, the “medical record . . . contained no straightforward evidence of a mental disorder
diagnosis. . . . [T]he Decision’s one-sided interpretation of petitioner’s objective testing,
including the interpretation of medical findings of tachycardia . . . w[as] cast by the special
master as psychiatric (or “mental disorder”) phenomena[,]” resulting in arbitrary factfinding. Id.
at 2 (citing ECF No. 109 at 35).
It is well established that the Vaccine Act “places the burden on the petitioner to make a
showing of at least one defined and recognized injury.” Lombardi v. Sec'y of Health & Human
Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011). Petitioner must, therefore, “show by a
preponderance of the evidence that she suffered from [a] medically recognized ‘injury,’ not
merely a symptom or manifestation of an unknown injury.” Lombardi, 656 F.3d at 1353. “If the
existence and nature of the injury itself is in dispute, it is the special master’s duty to first
determine which injury was best supported by the evidence presented in the record before
applying the Althen test to determine causation of that injury.” Id. at 1352 (citing Broekelschen,
618 F.3d at 1346). This duty “is mandated by the Vaccine Act, which creates a cause of action
for persons suffering a ‘vaccine-related injury . . . .’” Id. (citing 42 U.S.C. § 300aa-11(a)).
The Chief Special Master found that although the “medical record . . . strongly
establishes that Petitioner regularly sought medical treatment, often on an emergency basis, after
her vaccinations in 2015[,] . . . that record simply does not preponderantly establish any actual
injury that could be grounds for a Program claim.” ECF No. 109 at 28 (emphasis in original).
Respondent argues the Decision is “supported by the absence of reliable evidence pointing to a
physiological condition, such as a dysfunctional autonomic nervous system, that otherwise
persuasively explains her condition.” ECF No. 118 at 15-16. Specifically, the Chief Special
Master found Petitioner “was never legitimately diagnosed with POTS” and her “other reported
symptoms—whether characterized as ‘inappropriate tachycardia or something else [(e.g.,
dysautonomia)]—do not, individually or collectively, amount to a cognizable condition of any
kind that could be shown to be vaccine-caused.” ECF No. 109 at 29. Although Petitioner
exhibited symptoms suggestive of injury, such as increased heart rate and blood pressure levels,
no “testing evidence has been filed that would confirm the diagnosis.” Id. “At most,” the Chief
Special Master explains, “Respondent’s expert Dr. Bingham allowed the possibility that the
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November [2015 tilt-table] testing could support POTS—but that is not the same as an admission
(consistent with the preponderant standard applicable herein) that it was likely.” Id.
Petitioner argues that “a close review of the record reveals a clear pattern of illness—
tachycardia and arrhythmia related to autonomic dysfunction.” ECF No. 114 at 23. But
Petitioner’s symptoms, as Dr. Bingham observed, “were consistently non-specific” and
“transient/intermittent19—and this is especially true of the purported ‘inappropriate
tachycardia.’” ECF No. 109 at 29. Petitioner explains that tachycardia typically applies “to a
heart rate above 100 beats per minute” and sinus tachycardia, which originates in the sinus node,
“is normal during exercise or anxiety and occurs abnormally associated with shock, hypotension,
hypoxia, congestive heart failure, fever, and various high output states.” ECF No. 114 at 1 n.1.
Such sinus tachycardia “can in some instances be inappropriate or pathologic.” Id. Therefore,
Respondent emphasizes the Chief Special Master’s finding that sinus tachycardia, in some cases,
may merely reflect a normal physiological response to stressors—such as anxiety or exercise—
and is not in each case necessarily injurious or inappropriate. See ECF No. 109 at 29. And
“while Petitioner might have displayed occasions of post-vaccination tachycardia at times in
th[e] record, it cannot be deemed to be a persistent condition that could reasonably be linked to
vaccination.” Id.; see, e.g., Pet’r’s Ex. 18 at 1-3 (ECF No. 18-1) (autonomic testing performed in
connection with tilt-table test did not identify measurable orthostatic intolerance). That
Petitioner’s physicians prescribed medication for her condition does not, by itself, “verify[] the
validity of the diagnoses of inappropriate sinus tachycardia and autonomic disorder.” ECF No.
114 at 26. Nor does the fact that Petitioner’s heart rate rose by more than 40 points during the
November 2015 tilt-table test establish a persuasive diagnosis for POTS. See Pet’r’s Ex. 18 at 1-
3 (ECF No. 18-1). In the end, the Chief Special Master weighed the record evidence of
tachycardia and this Court does not find any basis to disturb that weighing of the evidence.
Similarly, while Petitioner reported “clonic-tonic seizures” following receipt of the Hep.
A and Gardasil vaccinations, her medical records reflect diagnoses of “pseudoseizures” and
related manifestations of an underlying psychological condition. Pet’r’s Ex. 6 at 4, 38, 40-42,
80, 130-131, 134 (ECF No. 6-7); Pet’r’s Ex. 12 at 11 (ECF No. 7-4). Petitioner argues “there
was never a confirmed psychiatric diagnosis, other than ‘anxiety,’ which . . . is frequently seen in
POTS and dysautonomia[] disorders [and where] patients ‘may be incorrectly labeled as having
panic disorder or chronic anxiety.’” ECF No. 114 at 29 (citing Pet’r’s Ex. 25, Phillip Low et al.,
Postural Tachycardia Syndrome (POTS), J Cardiovasc Electrophysiol. 2009 March; 20(3): 352–
358. (“Patients with orthostatic intolerance often present with complaints of exercise intolerance,
lightheadedness, diminished concentration, tremulousness, nausea and recurrent syncope, and
may be incorrectly labeled as having panic disorder or chronic anxiety.”)). However, the Chief
Special Master described in detail repeated instances where physicians evaluated Petitioner,
expressed the opinion that her symptoms were likely psychological in nature and related to
anxiety, and failed to identify an underlying physiological condition. See ECF No. 109 at 3-6.
19 Petitioner’s argument that “[t]he Decision elevated [her] burden of proof by requiring an
unrealistic and unreachable level of proof showing continuous tachycardia” is similarly without
merit. ECF No. 114 at 23. The Chief Special Master considered the transient and intermittent
nature of Petitioner’s symptoms in light of her medical record as a whole, rather than as a
dispositive factor in rendering his Decision.
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To be sure, “[n]o formal medical testing ever later confirmed the presence of any epileptic
etiology or factors that might cause seizure activity—and in fact the absence of such evidence
was clear not long after the relevant vaccinations.” Id. at 29; see Pet’r’s Ex. 6 at 130 (ECF No.
6-7); Pet’r’s Ex. 9 at 64-68 (ECF No. 7-1). Again, the Court will not reweigh the record
evidence.
Petitioner contends that “[t]here is nothing in the Decision that controverts the medical
record evidence showing a dysautonomia based tachycardia. A finding of arrhythmia caused by
Gardasil . . . has been validated as a ‘cognizable’ or primary vaccine injury in Court of Claims
and Office of Special Masters decisions.” ECF No. 114 at 29 (citing Tarsell v. United States,
133 Fed. Cl. 782 (2017)). However, the Special Master must “evaluate[] the utility of evidence
differently in light of all facts relevant in a specific claim,” and “a different evidentiary record
can lead to different outcomes.” Rickett v. HHS, 468 F. App’x 952, 959 (Fed. Cir. 2011). And it
is reasonable to conclude that “[b]ecause the facts of Tarsell differ widely from the facts of the
present case, a different outcome is warranted.” ECF No. 118 at 15.
In Tarsell, Petitioner developed acute disseminated encephalomyelitis within days of
receiving the tetanus-diphtheria-acellular-pertussis vaccination and suffered unexpected death
only weeks later. Tarsell, No. 10-251V, 2017 WL 4583233, at *16 (Fed. Cl. Sept. 25, 2017).
Not only did the Court find that Petitioner successfully established her claimed injury, but it also
found “preponderant evidence of a logical sequence of cause and effect,” connecting Petitioner’s
injury to her receipt of the vaccination. Id. at *16. Whether the Petitioner’s arrythmia was a
cognizable injury, based on the facts in that case, was not at issue. Conversely, here, upon
weighing the evidence in the record, the Chief Special Master found “numerous, credible
instances in which treaters proposed or surmised that Petitioner’s symptoms had a psychologic
component, reflecting either somatization, excessive anxiety, or some other mental trauma that
precipitated a heightened heart rate and other panic-like symptoms.” ECF No. 109 at 30 (citing
Pet’r’s Ex. 6 at 80 (August 21, 2018 visit with treaters finding Petitioner experienced
pseudoseizure); Pet’r’s Ex. 7 at 36 (ECF No. 6-8) (August 23, 2015 neurology consult
diagnosing Petitioner with acute anxiety disorder); Pet’r’s Ex. 9 at 47 (ECF No. 7-1) (September
22, 2015 neurology evaluation discussing recent stressors in Petitioner’s life that may have
caused seizure-like activity); Pet’r’s Ex. 13 at 213 (ECF No. 9-1) (September 19, 2015 neurology
consultation with a clinical impression of “probable pseudo-seizures”, “stress related psycho-
somatization or somatization”, and “probable anxiety associated panic”)). Accordingly, the
Chief Special Master had reasonable basis to find “[t]he possibility of a psychological factor as
causal of Petitioner’s symptoms[,] [which] also strongly negates the conclusion that Petitioner
did in fact experience something that reasonably could be seen [as] a potential vaccine injury.”
ECF No. 109 at 31.
Petitioner complains that “[i]n glossing over the persistent findings of objective evidence
over an extended time period showing tachycardia, arrhythmia, dysautonomia and autoimmunity,
in favor of a vague special master diagnosed ‘mental disorder’, the Court has engaged in an
arbitrary exercise of selective citation to the record and abused its discretion . . . .” ECF No. 114
at 30-31. To illustrate, Petitioner discusses the Chief Special Master’s discreditation of her
February 2016 CellTrend laboratory results, which showed elevated levels of adrenergic and
muscarinic antibodies. Pet’r’s Ex. 16 at 1-2 (ECF No. 12-2). Petitioner argues, because “it
cannot be determined on th[e] records that she possesse[d] these specific antibodies in the
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immediate one to ten days after the receipt of the HPV vaccine[,]” the Decision “imposed,
without explanation or justification, a heightened burden of proof on Petitioner to show the
presence of antibodies within one to ten days of vaccination.” ECF No. 114 at 36 (citing ECF
No. 109 at 31). Further, Petitioner believes the Chief Special Master ignored the “dramatic
increase [of antibodies] over time” as evidenced by testing showing increased antibody levels in
March 2020, see Pet’r’s Ex. 37 at 1 (ECF No. 77-2), which “signifies that Petitioner experienced
an autoimmune reaction rather than a manifestation of psychiatric symptoms,” ECF No. 114 at
36. However, the Chief Special Master carefully considered and weighed this evidence and did
not find it supportive of Petitioner’s claim. To be sure, “neither [P]etitioner’s treating providers,
nor her own expert, Dr. Steinman, ever related these results to [P]etitioner’s post-vaccination
symptoms.” ECF No. 118 at 17. And, showing elevated antibodies nearly five years later does
not sufficiently establish a causal connection between Petitioner’s claimed injuries, which began
within days of her vaccination.
The Chief Special Master clearly considered Petitioner’s antibody testing between 2016
and 2020 but did not find it persuasive. According to the Decision: “I give little weight to the
testing results Petitioner obtained in 2020—almost five years after her vaccination, and nearly
four years after the case was filed—suggesting she possessed certain anti-adrenergic
autoantibodies theorized to cause dysautonomia.” ECF No. 109 at 31. The Chief Special Master
found other record evidence more compelling. For example, he assessed Petitioner’s November
2015 neurological exam, where her autoimmune antibody panel was negative, and her symptoms
were described as consistent with a panic disorder. Id. at 7-8; Pet’r’s Ex. 18 at 1-3 (ECF No. 18-
1). The Chief Special Master also acknowledged reasonable objections raised by Dr.
MacGinnitie, who questioned the legitimacy of leveraging anti-adrenergic autoantibody test
results to support a causal theory for dysautonomia. ECF No. 109 at 31 n.35. It is not for this
Court to reweigh that evidence and it will not do so. The Decision also recognized that although
Petitioner’s “infectious evaluation seemed to allow for a possible autoimmune injury, [it] more
expressly discounted dysautonomia, noting that Petitioner displayed only ‘minor orthostatic
changes which are not consistent with POTS or significant autonomic instability.’” Id. at 30
(quoting Pet’r’s Ex. 4 at 3 (ECF No. 6-5)). This did not impose a heightened standard on
Petitioner; rather, the Chief Special Master had sound footing to determine that the totality of
Petitioner’s medical record, including the temporal distance between her receipt of the
vaccination and the laboratory testing, weighed against her claim. It was therefore neither
arbitrary nor capricious for the Chief Special Master to find “no record evidence . . . that
Petitioner possessed these antibodies in the fall of 2015 . . . [and to] not add any legitimate
weight to the contention that Petitioner did in fact experience an actual injury post-vaccination.”
Id. at 31.
Finally, Petitioner argues that, after multiple visits to the emergency room where she
exhibited symptoms of tachycardia, Dr. Lefkowitz “identified a persistent pattern of tachycardia
and other autonomic symptoms, which was verified by objective testing on the date of
examination.” ECF No. 114 at 24; Pet’r’s Ex. 12 at 1, 10-11 (ECF No. 7-4) (diagnosing
Petitioner with “Shy-Drager syndrome,” symptoms consistent with “inappropriate sinus
tachycardia,” and “autonomic disfunction due to the HPV vaccine”). Specifically, Petitioner
references the Zio Patch Electrocardiography Monitoring Report reviewed by Dr. Lefkowitz,
which showed instances of premature atrial and ventricular contractions and paroxysmal atrial
tachycardia. See Pet’r’s Ex. 12 at 4 (ECF No. 7-4). However, the Chief Special Master observed
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that “Dr. Lefkowitz not only appears to have relied heavily on Petitioner’s self-reported history
(which did not emphasize the extent to which her prior multiple ER visits never corroborated an
underlying psychologic explanation for her episodes)” but he also did not have the benefit of the
tilt-table results to include in his evaluation. ECF No. 109 at 30. More importantly, the Chief
Special Master did not ignore the record evidence; rather, after reviewing Petitioner’s
comprehensive medical history—including the objective evidence—he recognized multiple
instances of tachycardia. But he concluded that the record did not establish that Petitioner’s
episodes were pathologic in this case. Accordingly, he determined that, even if tachycardia can
be inappropriate in some cases, Petitioner failed to preponderantly establish a cognizable injury
here. He also found Dr. Lefkowitz’s assessment incomplete, and grounded, at least in part, on
Petitioner’s self-report of her own medical history, which he believed merited less weight. The
Chief Special Master acknowledged that “[w]hat one treater is told, or understands, about a
claimant’s history at a certain point in time can be incomplete, or reflect a tentative, initial
diagnostic proposal that later on is not confirmed by . . . testing or the course of the injured
party’s medical disease.”20 Id. Therefore, in weighing the totality of the evidence, it was
reasonable for the Chief Special Master to conclude that Dr. Lefkowitz’s diagnosis appeared
“speculative and . . . in any event unsubstantiated by the record.” Id.
“Clearly it is not . . . the role of this court to reweigh the factual evidence, or to assess
whether the special master correctly evaluated the evidence.” Munn, 970 F.2d at 870 n.10.
Indeed, the Court will not “examine the probative value of the evidence or the credibility of the
witnesses. These are all matters within the purview of the fact finder.” Id. The Court must
therefore review the Chief Special Master’s decision to determine whether it is reasonably based
on the evidence in the record. Milik, 822 F.3d at 1376. Here, the Chief Special Master
sufficiently considered the record evidence and articulated a reasonable basis for finding
Petitioner failed to demonstrate, by a preponderance, that she “experienced any cognizable
illness or injury that could be attributed to vaccination in any manner other than temporally (an
insufficient basis for entitlement, as well-recognized in the Program).” ECF No. 109 at 31. And
it is insufficient to merely highlight contrary evidence on review when it is the charge of the
Chief Special Master, rather than this Court, to weigh and assess its credibility. The Chief
Special Master appropriately considered the record evidence and his conclusion was not
arbitrary, capricious, or otherwise not in accordance with law.
B. The Chief Special Master’s finding that Petitioner failed to meet her burden
under Althen Prong 1 is neither arbitrary nor capricious.
Petitioner complains the Chief Special Master’s Decision “was arbitrary, capricious, and
contrary to law in deeming [her] proffered medical theory of causation as insufficient . . . [where
she] demonstrated a sufficient relationship between molecular mimicry and the increase in anti-
adrenergic antibodies to satisfy Althen prong 1 . . . .” ECF No. 112 at 2-3. If a Special Master
determines that the record evidence does not support the injury alleged, the Special Master need
20 The Chief Special Master also indicated Dr. Lefkowitz’s diagnosis of Shy-Drager syndrome
undercut his credibility, as this theory was rejected by both Parties’ experts, and largely
abandoned by Dr. Lefkowitz in later years. ECF No. 109 at 30; see, e.g., Pet’r’s Ex. 33 at 27
(ECF No. 60-1) (raising myxoma as a new diagnosis in October 2017).
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not “undertake and answer the separate (and frequently more difficult) question whether there is
a medical theory, supported by ‘reputable medical or scientific explanation,’ by which a vaccine
can cause the kind of injury that the petitioner claims to have suffered.” Hibbard v. Sec’y of
Health & Human Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012) (quoting Althen, 418 F.3d at
1278). Indeed, absent sufficient “proof of the asserted injury, the theory of causation is a
priori unreliable and unsupported by the evidence, and it is unnecessary to go through the
remaining Althen factors.” Hughes v. Sec’y of HHS, 154 Fed. Cl. 640, 650 (2021) (citing
Broekelschen, 618 F.3d at 1346). It was reasonable for the Chief Special Master to conclude that
Petitioner failed to establish a compensable injury, and therefore a thorough Althen analysis was
not required. For completeness, however, the Chief Special Master provided an Althen prong 1
analysis.
“Under the first [Althen] prong, a petitioner must demonstrate that the vaccine at issue
can cause the injury alleged.” Greene v. Sec’y of Health & Human Servs., 146 Fed. Cl. 655, 663
(2020) (citing Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir.
2006)). To make this showing, “a petitioner 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, 618 F.3d at 1345
(quoting Knudsen, 35 F.3d at 548–49). “The special master or court may not make such a
finding based on the claims of a petitioner alone, unsubstantiated by medical records or by
medical opinion.” 42 U.S.C. § 300aa-13(a)(1). Petitioner argues that “Dr. Steinman has
painstakingly shown how his theories of causation, especially his molecular mimicry theory, is
based on a ‘sound and reliable medical or scientific explanation.’” ECF No. 114 at 40 (quoting
Boatmon, 941 F.3d at 1351. Specifically, Petitioner cites precedent embracing molecular
mimicry “as a reliable scientific mechanism for explaining the pathophysiology of certain
immune-mediated conditions, including many demyelinating disorders.” ECF No. 114 at 41
(quoting Morgan v. Sec’y of Health & Human Servs., No. 15-1137V, 2019 WL 7498665, at *19
(Fed. Cl. Dec. 4, 2019), review denied, decision aff’d, 148 Fed. Cl. 454 (2020).
Dr. Steinman grounded his argument on theoretical homology between the HPV vaccine
and nerve receptors, theorizing that the “HPV and Hepatitis A vaccines could elicit T cell
immunity to significant stretches of the alpha-adrenergic receptor . . . [which] can spread to other
regions of the molecule.” Pet’r’s Ex. 28 at 15 (ECF No. 49-1). However, the Chief Special
Master found “insufficient reliable corroborative proof supporting the conclusion that the
homology is meaningful from a pathogenic sense. Merely showing via BLAST searches that
some homology exists between amino acid sequences in the HPV vaccine components and nerve
cells,” he explains, “does not amount to a preponderant showing that the vaccine can produce
antibodies that will likely cross-react against those cells.” ECF No. 109 at 32. The Chief Special
Master also considered, and accepted, Dr. MacGinnitie’s opinion that, “although amino acid
sequential/component homologies are easily demonstrated in nature, . . . their presence does not
also mean concurrent cross-reactivity is inevitable.” Id. To this end, he found that Respondent’s
experts “persuasively established that the vaccines at issue were highly unlikely to cause POTS
specifically or orthostatic intolerance generally.” Id. Rather, he concluded that “the medical
records filed in this case reliably suggest that Petitioner’s symptoms were more likely
attributable to somatization or some anxiety condition, rather than an independent illness,
vaccine-caused or not.” ECF No. 109 at 34 (citing Pet’r’s Ex. 7 at 224, 226–27, 233 (ECF No.
6-8) (August 20, 2015 ER visit complaining of anxiety, hyperventilation, and a panic attack);
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Pet’r’s Ex. 9 at 47 (ECF No. 7-1) (September 22, 2015 neurology evaluation noting the recent
stressors in petitioner’s life may have caused seizure-like activity); Pet’r’s Ex. 13 at 213 (ECF
No. 9-1) (September 19, 2015 neurology consultation stating the clinical impression is “probable
pseudo-seizures”, “stress related psycho-somatization or somatization”, and “probable anxiety
associated panic”)). Finally, he explained “[t]he contention that the HPV vaccine could be
associated with ‘clonic-tonic’ seizures or comparable movements is also thin . . . [as it is] largely
(if not wholly) . . . derived from the HPV vaccine package insert[,]21 . . . [which is not]
particularly probative evidence for injury causation . . . .” ECF No. 109 at 33.
It is well settled that the “Special Master has discretion to determine the relative weight
of evidence presented, including contemporaneous medical records and oral testimony.”
Whitfield v. Sec’y of HHS, 154 Fed. Cl. 167, 190-91 (2021) (citing Hibbard, 698 F.3d at
1368 (finding it was not arbitrary or capricious for the Special Master to weigh diagnoses of
different treating physicians against one another, including when their opinions conflict)). Here,
the Chief Special Master considered expert theories connecting the HPV vaccine and nerve
receptors, but, on multiple occasions, found this theory “wanting because (a) it was not reliably
shown that the vaccine could likely trigger the production of offending autoantibodies, or (b) the
claimant’s injury was not established to fall into the narrow category of autoimmune-driven
POTS (which is almost exclusively not an autoimmune condition.).” ECF No. 109 at 32. The
Chief Special Master weighed, and rejected, “opinion[s]22 to this end in many such cases” where
experts opined “that the HPV vaccine can result in the production of autoantibodies sufficient to
cause POTS through an autoimmune process—more often than not alleged to interfere with
certain adrenergic nerve receptors.” Id. at 31-32. He also determined, while the medical record
demonstrates post-vaccination instances of transient tachycardia, the causation “theory offered
by Petitioner was not reliably-established—and is otherwise unpersuasive.” Id. at 31.
In sum, “[u]nder the Vaccine Act, Special Masters are accorded great deference in
determining the . . . reliability of expert witnesses.” Cedillo, 617 F.3d at 1347; see Hanlon v.
Sec’y of Health & Human Servs., 191 F.3d 1344, 1349 (Fed. Cir. 1999). The Chief Special
Master exhaustively detailed the medical records, expert opinions, and medical literature, and
sufficiently articulated a rational basis for Petitioner’s failure to meet her burden under Althen
prong 1. ECF No. 109 at 32 (“[N]othing offered in this case by Petitioner or her experts provides
more recent or more reliable evidence supporting the conclusion that the HPV vaccine might
cause POTS (or any . . . autonomic-associated symptoms for that matter).”).
21 The Chief Special Master also explains that the HPV package insert is specific to syncope,
which generally occurs “close-in-time to vaccination.” ECF No. 109 at 33 (finding the 15-
minute observation recommendation on the insert “cannot reasonably be read to suggest that the
HPV vaccine is associated with a persistent risk of syncope”). According to the Decision,
however, there is no persuasive evidence of a close-in-time syncopal event. Id.
22 See, e.g., Pet’r’s Ex. 23 (ECF No. 42-5) (emphasizing “that a temporal relationship between
vaccination and symptom onset does not confirm causality” and “antibody presence does not
confirm vaccine causality of symptoms”).
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C. The Chief Special Master’s findings with respect to the viability of
Petitioner’s HPV claims are neither arbitrary nor capricious.
Petitioner contends that the Decision is internally inconsistent in “finding that
dysautonomia might be attributable to an autoimmune process in rare cases . . . while
simultaneously admonishing petitioners to avoid bringing claims involving HPV vaccination and
allegations of dysautonomia.” ECF No. 112 at 2 (citing ECF No. 109 at 36). Specifically,
Petitioner argues that the Chief Special Master “forecloses [such claims] entirely” by providing
that there is “no reasonable basis for Petitioner to pursue Review of the Entitlement Decision.”
ECF No. 114 at 38. In support, Petitioner explains that, “[i]t is reasonable to infer from the
Decision’s holding . . . that [while] proof could be developed in support of a dysautonomia
claim[,] . . . there simply has not been enough knowledge and research yet generated to support
such claims.” Id. And such a “forward-looking prohibition on new cases is inappropriate”
where “[t]he generalized state of scientific knowledge credited in the Decision . . . changes
month to month . . . .” Id.
Respondent is correct that “the Chief Special Master “did not ‘foreclose’ future claims,
but rather, forewarned counsel that attorney’s fees will not be awarded ad infinitum for meritless
claims that continue to present the same causal theory that has been rejected time and time
again.” ECF No. 118 at 27. Indeed, the Decision emphasizes that Petitioner’s proposed causal
theory has been evaluated, and consistently rejected, in multiple prior instances. ECF No. 109 at
36 (“I have never ruled that the HPV vaccine likely causes any form of dysautonomia.”)
(emphasis in original); see id. at 27 (citing prior cases). Specifically, the Chief Special Master
has found that such “claims reflect merely a (literal) temporal ‘coincidence’ between vaccination
and onset—something well recognized not to support causation.” Id. at 36 (citing Grant, 956
F.2d at 1148). Further, the Chief Special Master explained that current “science suggest[s]
‘dysautonomia’ is generally not autoimmune in character, and not otherwise capable of being
vaccine induced.” Id. at 2. As such, Petitioner “conflates that Chief Special Master’s
recognition that some evidence has emerged that in very rare cases POTS may be attributable to
an autoimmune process,” although it is most commonly not considered attributable, with a
connection between the HPV vaccination and dysautonomia. ECF No. 118 at 27, 29. Therefore,
while recognizing that “medical science may someday reach more reliable conclusions about this
subject matter that would present an occasion for reconsideration of [his] conclusions, that day
has yet to come.” ECF No. 109 at 36. In other words, the Chief Special Master simply made
clear that the current science does not support Petitioner’s theory. If the science changes, there
is nothing in the Decision that precludes a successful claim.
“Congress assigned to a group of specialists, the Special Masters within the Court of
Federal Claims, the unenviable job of sorting through these painful cases and, based upon their
accumulated expertise in the field, judging the merits of the individual claims.” Hodges, 9 F.3d
at 961. The standard of review attributed to this Court, therefore, “is uniquely deferential for
what is essentially a judicial process. Our cases make clear that, on our review . . . we remain
equally deferential. That level of deference is especially apt in a case in which the medical
evidence of causation is in dispute.” Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d
1362, 1366 (Fed. Cir. 2013) (citing Hodges, 9 F.3d at 961). Accordingly, the Chief Special
Master explains that the science, in its current state, does not support the vaccine theory of
causation offered by Petitioner. ECF No. 109 at 27 (“[N]ot nearly enough is known about how
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such an uncommon form of autoimmune-mediated POTS would occur to draw conclusions in
Program cases sufficient to meet the preponderance level of evidence.”). The Chief Special
Master has seen no such persuasive, well written decisions that reach a contrary outcome, or
which successfully establish that compensable tachycardia was vaccine-caused. Id. at 28. “At
most, tachycardia has been a secondary symptom of other cognizable injuries.” Id. And, while
not foreclosing future claims based on these theories with new science supporting them, it is not
arbitrary, capricious, or otherwise not in accordance with law for the Chief Special Master to
find such cases will lack reasonable basis until the science changes.
D. The Chief Special Master did not abuse his discretion is deciding not to hold
a hearing.
Petitioner argues the Chief Special Master “was arbitrary, capricious, and abused his
discretion in denying an evidentiary hearing” when he attributed Petitioner’s symptoms to
“‘some other kind of mental disorder[,]’” particularly where the “medical record . . . reveals no
clear psychiatric or psychological diagnosis . . . .” ECF No. 112 at 3 (“[T]he special master
abused his discretion in substituting a diagnosis . . . absent from the medical record”). In
support, Petitioner explains that “[a]n evidentiary hearing usually provides petitioner opportunity
to put on live testimony which aids the Special Master most in cases where witness credibility is
in issue or where there is a need . . . to obtain information not contained in, or not self-evident
from, the existing filings.” ECF No. 114 at 50 (quoting D’Toile v. HHS, 132 Fed. Cl. 421, 433-
34 (Fed. Cl. 2017), aff’d mem., 726 Fed. Appx. 809 (Fed. Cir. 2018)). Petitioner believes this
case warranted a hearing to allow exploration of divergent expert opinions, and in-depth
discussion of her medical condition, e.g., as related to whether she had a “mental disorder” and
whether her tachycardia was “transient.” Id. at 44. Respondent explains that, under the Vaccine
Act, Special Masters “promulgate rules that ‘include the opportunity for parties to submit
arguments and evidence on the record without requiring routine use of oral presentations, cross
examinations, or hearings.’” Kreizenbeck v. Sec’y of HHS, 945 F.3d 1362, 1365-66 (Fed. Cir.
2020) (citing 42 U.S.C. § 300aa-12(d)(2)(D)). Indeed, “[t]here is no requirement that oral
testimony be taken to resolve differences in scientific or expert opinion. Opportunity for
confrontation or cross examination is not required.” Id. at 1366 (quoting Hale v. HHS, 22 Cl. Ct.
403, 409 (Fed. Cl. 1991)).
“Special [M]asters have wide discretion in determining whether to conduct an evidentiary
hearing. Id. at 1365 (citing 42 U.S.C. § 300aa-12(d)(3)(B)(v) (providing that a special master
“may conduct such hearings as may be reasonable and necessary” (emphasis added)). This
discretion is limited in instances where the record is not comprehensive or fully developed,
creating a need for Special Masters to observe expert witnesses personally to assess their
credibility. See Murphy v. HHS, No. 90-882V, 1991 WL 71500, at *2 (Cl. Ct. Spec. Mstr. Apr.
19, 1991). Respondent argues that Petitioner failed to offer a “credible basis for concluding that
the Chief Special Master exceeded his discretionary authority in resolving this case . . . on the
record. Petitioner makes no claim that the record was not fully developed . . . but rather,
identifies a number of abstract benefits that a live hearing might provide.” ECF No. 118 at 31. I
agree. Where Petitioners are given a “full and fair” opportunity to present their case, see Hovey
v. Sec’y of Health & Hum. Servs., 38 Fed. Cl. 397, 400–01 (1997), Vaccine Rule 8(d) permits
Special Masters to “decide a case on the basis of written submissions without conducting an
evidentiary hearing.”
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Here, the Chief Special Master articulated a rational basis for exercising his discretion to
decide this case on the record. Specifically, he “was able to evaluate the evidentiary strength of
[Petitioner’s] asserted injury through a close review of the medical record” and determined that
the “record overwhelmingly undermines the contention that [the HPV or Hep. A] vaccination
harmed Petitioner.” ECF No. 109 at 35. Rather, the Chief Special Master found that Petitioner
failed to establish a cognizable injury, and there existed an alternative explanation for her
symptoms. Id. He found this conclusion to be “self-evident from a careful review of the record
itself, and did not require a hearing for their complete explication.” Id. Accordingly, this Court
concludes that the Chief Special Master did not abuse his discretion by opting to resolve the case
on the record.
E. Petitioner’s prospective demand for attorney’s fees is not ripe for review.
In his Decision, the Chief Special Master provided that “counsel acts at his own risk if he
opts to extend this claim’s life further, such as through unnecessary motion for review or
additional appeals.” Id. at 36 n.41. He continued to warn that he would “not award any fees
incurred for such work (although [he was] prepared to award fees reasonably devoted to the
claim’s prosecution up to this point).” Id. Petitioner argues that “[b]y prospectively denying the
availability of attorneys’ fees . . . the special master interjected a chilling effect thereby
undermining the Vaccine Act procedure for review and appeal established in 42 U.S.C. § 300aa-
12(e), and violated judicial procedure . . . .”23 ECF No. 112 at 1-2. Indeed, 28 U.S.C. § 47
provides that “[n]o judge shall hear or determine an appeal from the decision of a case or issue
tried by him.” And prospectively determining that fees will not be paid should Petitioner seek
review of his Decision effectively undermines judicial procedure. But this Court (and perhaps
the Federal Circuit) is acting the judge of Petitioner’s appeal, not the Chief Special Master.
To the extent the objection is that the Chief Special Master may not approve fees for this
Court’s (or the Circuit’s) review, that objection is not yet ripe. “The case or controversy
requirement of Article III of the United States Constitution prohibits federal courts from issuing
advisory opinions or deciding disputes that are not concrete and adverse.” Massachusetts Bay
Transp. Authority v. U.S., 21 Cl. Ct. 252, 257 (1990). “Although established under Article I, the
Claims Court traditionally has applied the case or controversy requirement unless jurisdiction
conferred by Congress demands otherwise.” Id.; see also C.W. Government Travel, Inc. v. U.S.,
46 Fed. Cl. 554, 557-58 (2000). Respondent clarifies that “[a] claim is not ripe where it rests
upon contingent future events that may not occur as anticipated, or indeed may not occur at all.”
ECF No. 118 at 21 (citing Armoring Service, Inc. v. U.S., 123 Fed. Cl. 309, 328 (2015)).
Petitioner has not submitted a request for attorney’s fees and, unless such request is
submitted and denied, this question is not ripe for review. The Chief Special Master’s comment
23 Petitioner argues that the determination this case lacks reasonable basis going forward
“deprives petitioner of counsel or, if counsel proceeds, burdens counsel with the prospect of
providing services without compensation for his or her labor, thereby obstructing the effective
prosecution of the Petition on review or appeal.” ECF No. 114 at 32. However, as previously
explained in Section C herein, I do not find the Chief Special Master’s holding with respect to
this claim’s viability—absent a change in the scientific evidence—to be arbitrary, capricious, or
otherwise not in accordance with law.
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therefore does not impede Petitioner’s right to meaningful review and does not contravene Due
Process and Equal Protection of the law.24
IV. CONCLUSION
For the reasons stated above, the Court DENIES the Petitioner’s Motion for Review and
SUSTAINS the Chief Special Master’s decision. The Clerk is directed to enter judgment
accordingly.
IT IS SO ORDERED.
s/ Edward H. Meyers
Edward H. Meyers
Judge
24 That said, the Court does have some concern about the blanket denial of fees for review of the
Chief Special Master’s decision. Simply finding Petitioner’s experts unpersuasive is not
generally a sufficient basis to find Petitioner lacked a reasonable basis to proceed. See Heath v.
HHS, No. 08-86V, 2011 WL 4433646, at *7 (Fed. Cl. Spec. Mstr. August 25, 2011). The Court,
however, will not resolve this matter until there is a fee petition and decision by the Chief
Special Master fully explaining the denial of any portion of the fees sought for this review. To
be clear, there is nothing improper with the Chief Special Master informing counsel in future
cases that fees will not be awarded for cases brought on this theory, the only potential concern is
with cutting off the reasonable basis to seek review in this case.
34

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_16-vv-01083-2
Date issued/filed: 2023-06-27
Pages: 37
Docket text: PUBLIC DECISION (Originally filed: 07/15/2022) regarding 109 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (saj) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-01083-EHM Document 129 Filed 06/27/23 Page 1 of 37
In the United States Court of Federal Claims
OFFICE OF SPECIAL
MASTERS No. 16-1083V
(to be published)
* * * * * * * * * * * * * * * * * * * * * * * * *
J.S., *
* Filed: July 15, 2022
*
* Chief Special Master Corcoran
Petitioner, *
*
v. * Human Papillomavirus Vaccine;
* Hepatitis A Vaccine;
SECRETARY OF HEALTH * Postural Orthostatic
AND HUMAN SERVICES, * Tachycardia Syndrome;
* Reliable Theory
Respondent. * Cognizable Injury
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Robert J. Krakow, Law Office of Robert J. Krakow, New York, NY, for Petitioner.
Kimberly S. Davey, U.S. Department of Justice, Washington, D.C., for Respondent.
DECISION1
On August 30, 2016, J.S. filed this action seeking compensation under the National
Vaccine Injury Compensation Program (the “Program”).2 ECF No. 1. Petitioner alleges that she
suffered from “inappropriate tachycardia” and autonomic dysfunction, manifesting in a wide
variety of conditions and symptoms (including joint pain, dizziness, nausea, and postural
orthostatic tachycardia syndrome (“POTS”)), after receipt of the human papillomavirus (“HPV”)
and Hepatitis A (“Hep. A”) vaccines on August 4 and 19, 2015. Id. at 1. After the filing of
1 This Decision will be posted on the United States Court of Federal Claims’ website in accordance with the E-
Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Decision will be available to anyone with access
to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published
Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party
has fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade
secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or
similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b).
Otherwise, the entire Decision will be available to the public in its current form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended, 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “The Program” or
“Program”]. Individual section references hereafter will be to Section 300aa of the Act.

Case 1:16-vv-01083-EHM Document 129 Filed 06/27/23 Page 2 of 37
multiple expert reports, I set a schedule to rule on the record, and the matter is now fully briefed.
Petitioner’s Motion, filed Dec. 6, 2021 (ECF No. 105) (“Mot.”); Respondent’s Opposition Brief,
filed Jan. 19, 2022 (ECF No. 106) (“Opp.”); Petitioner’s Reply Brief, filed Feb. 2, 2022 (ECF
No. 108) (“Reply”).
Collectively the parties have filed ten expert reports, offering competing takes on a
causation theory alleging that the HPV and Hep. A vaccines can stimulate the production of
autoantibodies that could be causal of autonomic dysfunction, primarily manifesting as
orthostatic intolerance. But the claim fails on a more fundamental matter: Petitioner has not
shown, on the basis of this medical record, that she experienced any arguably vaccine-caused
disease or condition—and it is more likely her symptoms reflect somatization. Dismissal is
therefore appropriate even without considering the strength of Petitioner’s “can cause”
showing—although that too was inadequate, given the science suggesting that “dysautonomia”
is generally not autoimmune in character, and not otherwise likely capable of being vaccine-
induced.
I. Factual Background
Pre-Vaccination History
Petitioner was born on March 3, 1997—and was thus 18 years old when she received the
vaccines at issue. Ex. 2 at 1. Her pre-vaccination history records three notable events. First, she
saw a cardiologist in June 2008 for episodes of shortness of breath and difficulty breathing while
swimming, but her symptoms were later attributed to asthma. Id. at 58–61. Second, she
underwent a head MRI on October 1, 2008, for occipital migraines, which showed evidence for
sinusitis, but was otherwise normal. Id. at 55–56. Finally, in March 2012 she was evaluated by
an endocrinologist for autoimmune thyroid disease. Ex. 15 at 1–2. At that time, she tested positive
for antibodies relevant to the disease, but was not yet symptomatic, although she did report joint
aches and ongoing abdominal complaints. Id.
Vaccinations and Initial ER Visits
On August 4, 2015, at a well exam J.S. received the Hep. A and pneumococcal vaccines.
Ex. 3 at 30–35. Her examination was normal, apart from a functional heart murmur. Id. Two
weeks later, she traveled to Nicaragua with her family from August 10-16, 2015. Ex. 4 at 1. Other
than experiencing a minor bacterial skin infection on her elbow after the trip, the records reveal
no reaction to this initial vaccination. Ex. 20 at 12. A few days later (August 19, 2015), Petitioner
received an influenza vaccine and the first dose of the HPV vaccine. Ex. 3 at 20, 36, 106. No
immediate reaction to vaccine administration was noted.
2

Case 1:16-vv-01083-EHM Document 129 Filed 06/27/23 Page 3 of 37
Beginning the next day, however, J.S. began experiencing a series of emergency treatment
interventions culminating in a hospital stay that same month. First, she was transported by
ambulance on August 20, 2015, to Riverview Medical Center in Red Bank, New Jersey,
complaining of anxiety, hyperventilation, and a panic attack. Ex. 7 at 211–13. There, Petitioner
reported circumstances that were possibly relevant to her sudden symptoms: she was leaving for
college the next day, had broken up with her boyfriend,3 and also indicated that she had been
feeling sad recently. Ex. 7 at 224, 226–27, 233. A review of systems revealed fatigue, shortness
of breath, anxiety and depression, and she was tachycardic, but otherwise the exam yielded
normal results. Id. at 224. Upon discharge Petitioner was assessed with an anxiety reaction and
hyperventilation, and was instructed to follow-up with psychiatry within twenty-four hours. Id.
at 223, 233–36.
Second, Petitioner returned (also by ambulance) to the emergency room the following day
(August 21), again due to anxiety. Ex. 7 at 180–81. A complete blood panel, metabolic panel,
toxicology screen, and pregnancy test were negative or resulted in findings deemed
noncontributory. Id. at 182–84. After receiving a dose of Ativan, J.S. was discharged with a
diagnosis of anxiety. Id. at 188–90. Finally, Petitioner was transported via ambulance back to the
emergency room a third time, on August 22, 2015, where she was noted to be awake, anxious,
and making jerking movements. Ex. 6 at 57, 72.
Petitioner was transferred to a hospital able to provide a higher level of care for further
evaluation of her twitching symptoms before being admitted to Jersey Shore Hospital that very
day. Ex. 3 at 24–27. She now reported a three-day history of tonic-clonic jerking movements,
lasting twenty to forty minutes each and involving all four extremities (although the records from
her treatment events discussed above do not corroborate this contention),4 along with
hyperventilation. Ex. 6 at 77–80. Reference was also again made to Petitioner’s recent trip out of
the country and her skin infection Id. at 77. Initial treater impressions were that Petitioner had
experienced pseudoseizures5 vs. “new onset seizure disorder.” Id. at 80.
3 Petitioner has disputed the accuracy of this particular fact. See e.g., Mot. at 6 n.5. I do not resolve this issue, however,
since its disposition does not alter my overall conclusion or determination that vaccination did not likely cause the
Petitioner’s symptoms.
4 In fact, this record makes no mention of Petitioner’s ER visits days before. Ex 6 at 77 (“ER only (not admitted) for
MVA 3 months ago”) (emphasis added).
5 A pseudoseizure is “an attack resembling an epileptic seizure but being a type of conversion disorder; it lacks the
electroencephalographic characteristics of epilepsy and the patient may be able to stop it by an act of will.”
Pseudoseizure, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=111236
(last visited July 14, 2022).
3

Case 1:16-vv-01083-EHM Document 129 Filed 06/27/23 Page 4 of 37
Initial Efforts to Diagnose Etiology for Petitioner’s Symptoms
During the period of J.S.’s hospitalization (which occurred in the days and month
immediately after receipt of the HPV vaccine), treaters attempted to identify the nature and cause
of her symptoms. Although these treaters took note of the fact that Petitioner had recently
received the HPV vaccine, the record suggests an initial view that her symptoms had a mostly
psychologic character.
Thus, a video EEG conducted on August 23-24, 2015, was normal—even though
Petitioner was experiencing jerking episodes, they were not accompanied by any abnormal
electrical discharge. Ex. 6 at 92. Petitioner also underwent consultations for infectious diseases
and was examined by a neurologist. Id. at 33–38. The physicians noted her recent vaccinations,
as well as her trip to Nicaragua, a family history of autoimmune issues (including a grandmother
with myasthenia gravis), and a history of “migraines presenting with jerking movements after
receiving her Gardasil vaccine.” Id. at 38. One treater specifically observed the temporal
association with J.S.’s receipt of the first HPV dose, and even wondered whether she may have
had an adverse reaction, but felt that her symptoms would resolve with time. Id. at 35. The
neurologist who reviewed Petitioner’s presentation (relying on her self-reported symptoms as
well as her recent vaccination history) had the impression “unlikely myoclonic seizure,” and
included in the differential PANDAS6 as well as an acute anxiety disorder, although he noted the
need to “[r]ule out reaction to Gardasil vaccine.” Id. at 38.
At the same time as the above encounters, Petitioner also saw a psychiatrist while an in-
patient at Jersey Shore Hospital. Ex. 6 at 40–42. The history taken by the psychiatrist took into
account J.S.’s repeated ER visits in the days before her hospitalization, noting as well that “the
video EEG has shown that she has not had any seizure-like activity.” Id. at 40. The psychiatrist
diagnosed Petitioner with a panic attack and recommended that she begin therapy after starting
college (although she also noted the need to rule out a possible vaccine reaction or neurologic
issue). Id. at 42. The hospital’s pediatric attending doctor also saw petitioner on August 24, 2015,
opining that her episodes were unlikely to have a cardiac etiology, as she had a normal EEG and
normal MRIs with and without contrast. Id. at 130, 134. Taking all the above into account
(including the already-mentioned treater speculation of a possible vaccine connection—
speculation that was not ultimately substantiated), J.S. was discharged home on August 27, 2015,
with a diagnosis of “anxiety based events not related to vaccine.” Ex. 6 at 131 (emphasis added).
On September 2, 2015, J.S. saw Dr. John Wells, a neurologist at NYU, for an additional
evaluation. Ex. 21 at 1–6. Dr. Wells noted Petitioner’s recent medical history, recording that on
August 20th she had experienced “prolonged tachycardia,” with two more days of similar events
6 “PANDAS” stands for Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus infections.
Bains v. Sec'y of Health & Hum. Servs., No. 18-1212V, 2019 WL 4121084, at *1 (Fed. Cl. Spec. Mstr. July 26, 2019).
4

Case 1:16-vv-01083-EHM Document 129 Filed 06/27/23 Page 5 of 37
that resulted in ER visits. Id. at 3. He also reviewed a video of one of her “episodes,” which had
been recorded by her mother on a smart phone while she was at the Jersey Shore Hospital, but
indicated he could not draw conclusions from it, noting as well that Petitioner’s mother had
speculated the HPV vaccine could have somehow triggered the episodes. Id. at 4. He also
observed intermittent jerks during the visit itself of “unclear nature,” but considered the normal
EEG and MRIs from her hospitalization as unsupportive of a neurologic issue. Id. at 3–4.
Dr. Wells noted no other complaints or issues that could be contributory. Ex. 6 at 4. He
ultimately proposed that Petitioner’s episodes were “primarily anxiety based,” and deemed it
“unlikely” that they were caused by her HPV vaccination. Ex. 6 at 4. Consistent with the proposed
diagnosis, Dr. Wells recommended counseling and encouraged Petitioner to avoid excessive
supplements. Id.
Further Instances of Alleged Vaccine-Caused Symptoms
Even after initial analyses pointed in the direction of a psychological explanation,
Petitioner continued to experience similar symptoms—and to inform treaters of her view that
they were vaccine-associated.
On September 12, 2015, J.S. (who had now begun college in Providence, Rhode Island)
presented to the emergency room at Rhode Island Hospital, accompanied by her mother. Ex. 5 at
3–4. She reported shaking, tremor episodes, and myoclonic jerks since receiving the HPV
vaccination three weeks earlier, adding that her symptoms increased with loud noises or when
she was startled or scared. Id. It was also stated that joint pain and concerns about them “locking
up” had prompted Petitioner and her family to seek emergency treatment. Id. An EEG was
negative, however, with a normal exam, and a psychologist who evaluated Petitioner expressed
the view that her symptoms might be anxiety related. Id. at 5. Petitioner was thus discharged.
Five days later, on September 17, 2015, Petitioner presented to Riverview Medical Center7
complaining of recurrent tonic-clonic jerking movements, and she was subsequently transferred
to Cornell/New York Presbyterian Hospital on September 18, 2015. Ex. 7 at 170–71; Ex. 8 at 5.
Petitioner’s parents (who provided the medical history) again proposed to treaters that J.S.’s
symptoms had begun after her receipt of the HPV vaccine, although the treater intake record also
noted that prior ER-related workups had proposed anxiety as the explanation. Ex. 7 at 89. An
initial exam was unremarkable and identified no notable cardiac abnormalities (although pulse
was elevated), with a full neurologic exam not possible because Petitioner was either sleeping or
unwilling to answer questions. Id. at 90.
A subsequent neurology consult resulted in the proposal that Petitioner was in fact only
7 It appears Petitioner returned home from college by this time, in part if not wholly due to her symptoms. Ex. 7 at 90.
5

Case 1:16-vv-01083-EHM Document 129 Filed 06/27/23 Page 6 of 37
experiencing pseudoseizures and panic attacks. Ex. 7 at 89–90, 127; see also Ex. 9 at 25.
Laboratory testing and an EKG were also (again) normal. Ex. 7 at 73–77. Treaters proposed that
Petitioner’s symptoms were probably pseudo-seizures attributable to stress-related psycho-
somatization, with “the likelihood of her having some postvaccine [sic] complication causing
seizures . . . to be less likely,” Id. at 66–67. However, it was agreed that further medical
evaluation was warranted, and treaters continued to take note of the vaccinations Petitioner had
recently received. Ex. 8 at 5.
While at Cornell, J.S. underwent another video EEG on September 20-22, 2015. The EEG
captured one shaking episode, but it was characterized as a psychogenic, non-epileptic seizure or
“pseudoseizure,” with no EEG correlate to suggest the contrary. Ex. 9 at 64–65, 67–68.
Accordingly, the EEG study was deemed to produce normal results, with further study
unnecessary, and Petitioner was “cleared from a neurologic perspective.” Id. at 66. A pediatric
resident note commented on petitioner’s concerns that some of her symptoms began within
twenty-four hours of the HPV vaccination, noting that “most likely this is not the underlying
etiology.” Id. at 58. A neurologist counseled petitioner’s mother regarding the “high quality
studies” that “refute an association between HPV vaccine and autoimmune events.” Id. at 70. An
extensive autoimmune work-up was negative, including normal IgA levels. Id. at 136–41.
Petitioner and her mother initially refused discharge, but eventually agreed after speaking to the
neurologist at length. Id. at 71. Petitioner was encouraged to give the therapeutic intervention
from psychiatry a chance, as her doctors felt that there was an “underlying subconscious stressor”
causing these episodes. Id. Petitioner was discharged on September 22, 2015. Id. at 67, 70.
Suggestions of Autoimmune Processes
The following month, Petitioner’s efforts to identify the cause of her maladies began to
find some support consistent with her claims herein—although, and as discussed below, these
record items are reasonably weighed against the more substantial amounts of evidence
undercutting these speculative proposals—much of which was generated more
contemporaneously with the relevant vaccination event.
For example, Petitioner saw a cardiologist, Dr. David Lefkowitz, on October 2, 2015,
informing him she had experienced a post-HPV vaccine “reaction.” Ex. 3 at 92–95. Dr. Lefkowitz
was informed that Petitioner’s heart rate had soared to 160 bpm after receipt of the HPV vaccine,
although it was also noted that her subsequent cardiac and neurologic workups had not identified
seizure activity or other issues. Id. at 92. A “sit-stand” orthostatic test conducted in connection
with this visit to Dr. Lefkowitz revealed an increase in heart rate from sitting to standing (62 bpm
to 99 bpm), but no comparable change in blood pressure. Id. at 93.
Based upon what appears to be an overall cursory exam, Dr. Lefkowitz diagnosed
6

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Petitioner with Shy-Drager syndrome,8 along with apparent generalized autonomic dysfunction
resulting in “inappropriate sinus tachycardia,” due either to “a reaction to her various vaccines
that occurred at the same time, or possibly based on a viral syndrome that she acquired while
traveling through the jungles of Central America.” Ex. 3 at 93, 84. He added, however, that her
condition, whatever the etiology, was likely to prove self-limiting, and noted as well that EEG
and EKG testing results had not suggested any underlying physiologic issue. Id. at 94.
Two weeks later, on October 13, 2015, J.S. saw an infectious disease and pulmonary
specialist, Dr. Thomas Nash, who took a detailed history and conducted a physical examination.
Ex. 4 at 1–3. Dr. Nash echoed the determinations of prior treaters that a degree of panic or anxiety
might explain her symptoms, but also opined that her complaints went “well beyond what one
would expect from straightforward panic/anxiety reaction,” adding the possibility that “she has
a degree of autoimmune encephalopathy provoked by immunizations in a susceptible patient with
an autoimmune predisposition.” Id. At the same time, however, Dr. Nash noted that J.S. displayed
only “minor orthostatic changes which are not consistent with POTS or significant autonomic
instability.” Id. at 3. Dr. Nash recommended a blood work-up for inflammation and infection, a
repeat MRI with contrast, echocardiogram, an evaluation for autoimmune encephalitis, and
possible PET scan, lumbar puncture, and cerebral spinal fluid studies for recurrent seizure-like
activities. Id.
The testing that was proposed, however, did not largely corroborate the presence of an
autoimmune condition or autonomic dysfunction—let alone any larger concerns. For example, a
brain MRI conducted on October 19, 2015, showed some nonspecific signal hyperintensity that
could be evidence of white matter disease “associated with migraine headaches, vasculopathy,
toxins, prior trauma, or prior inflammatory diseases,” but which could not be fully identified as
significant (although the lesions observed were deemed uncommon for someone of Petitioner’s
age). Ex. 4 at 7.
Petitioner next underwent a “tilt table” test often used to diagnose POTS9 on November
18, 2015, that was performed by neurology specialists in dysautonomia. Ex. 18 at 1–3. But the
test did not confirm POTS, showing instead “preserved cardiovascular autonomic reflexes with
8 As noted in Respondent’s brief, Shy-Drager syndrome is another term for multiple system atrophy (“MSA”)—“a
rare, degenerative neurological disorder affecting your body’s involuntary (autonomic) functions, including blood
pressure, breathing, bladder function and motor control.” It shares many Parkinson’s disease-like symptoms, such as
slow movement, rigid muscles, and poor balance. Symptoms typically develop in adulthood, usually in the 50s or 60s.
MSA progresses gradually, and eventually leads to death.” Opp. at 8 n.6.
9 The standard tilt table test entails the patient remaining in a supine position on an adjustable table for twenty minutes,
followed by ten minutes tilted upright, with the heart rate and blood pressure measured minute by minute, to detect
changes as position is altered. Yalacki v. Sec'y of Health & Hum. Servs., No. 14-278V, 2019 WL 1061429, at *40 n.10
(Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for review den’d, 146 Fed. Cl. 80 (2019).
7

Case 1:16-vv-01083-EHM Document 129 Filed 06/27/23 Page 8 of 37
no evidence of orthostatic hypotension.”10 Id. at 3. It was also noted that the panel testing for
autoimmune-associated antibodies revealed no abnormal antibodies present. Id. Her neurologic
examination was otherwise normal. Id. at 3. At worst, it was noted that “[d]uring the head-up tilt
position [Petitioner] had an episode of bilateral convulsive movements” but that “[t]he semiology
of this laboratory-observed episode as well as her previous episodes are consistent with non-
epileptic seizures.” Id. In fact, testing for circulating epinephrine11 performed during the test
revealed a “marked increase” that the testing treaters deemed consistent with a panic disorder,
and the episode of convulsive movements she displayed when in the “heads up” position of the
test. Id. J.S. was encouraged to utilize cognitive behavioral therapy, including yoga and breathing
exercises, to improve her symptoms, and a beta-blocker was recommended to help manage her
stress levels. Id.
At the end of November 2015, Petitioner had a follow-up visit with Dr. Lefkowitz, now
reporting that she felt better overall, and was much less “orthostatic,” without palpitations,
dizziness, or tremors. Ex. 3 at 97–98. Dr. Lefkowitz noted, however, that Petitioner’s mother had
done research and found a large number of POTS cases after the HPV vaccine. Id. Dr. Lefkowitz
reiterated his prior diagnosis of Shy-Drager syndrome, despite the fact that J.S. was overall much
improved clinically and asymptomatic. Id.
Even though Petitioner had started to report improvement in how she felt, she ended 2015
with more hospitalizations. On December 5, 2015, she was admitted to Robert Wood Johnson
University Hospital in New Brunswick, New Jersey, for “convulsions.” Ex. 11 at 2. It was again
reported that Petitioner had started to experience symptoms in association with her receipt of an
HPV vaccine dose. Id. at 68. Her mother also claimed that Petitioner had been diagnosed with
possible autonomic dysfunction due to the Gardasil vaccine (presumably by Dr. Lefkowitz), and
that she had undergone a tilt table test (although she reported the results to be “pending”). Id.12
An EKG showed sinus tachycardia, but several basic lab studies were normal, and Petitioner was
ultimately discharged. Id. at 8–10; 52–55.
A few days later, Petitioner went to the Monmouth Medical Center ER on December 9,
2015, based on a two-day history of aches and a sore throat. Ex. 3 at 88–91. Petitioner’s mother
now reported that she had a “history of POTS” (despite the negative tilt-table test), and that she
10 The tilt table test did show repeated measures reflecting a pules rise of over 30, and once over 40 beats per minute.
Ex. 18 at 3. However, the evaluation still did not conclude that Petitioner suffered from POTS. Id.
11 Epinephrine is a hormone released by the adrenal glands in response to stress. Epinephrine, Dorland’s Medical
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=16892&searchterm=epinephrine (last
visited July 14, 2022).
12 The record of the tilt table test filed in this case suggests its results had been obtained nearly three weeks before this
hospitalization incident, although it is also possible they had not yet been provided to Petitioner or her family. See
generally Ex. 18.
8

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had suffered from a variety of symptoms after her HPV vaccine. Id. at 88. But her blood pressure,
pulse, and an EKG were all normal, as was a cardiac monitor, resulting in her discharge (with
advice to follow up with Dr. Lefkowitz about the possible use of beta blockers to reduce
anxiety).13 Id. at 91.
2016-20 Medical Treatment and Testing
The medical records filed in this case (which include treatment events and physician visits,
plus testing data, through mid-2020) paint a picture consistent with the records from the late
summer—early winter of 2015: J.S. and her family continued to seek emergency and urgent care
for symptoms purportedly associated with the HPV or Hep. A vaccine—but which could
themselves never be shown to reflect some underlying physiologic condition.
Thus, in February 2016, Petitioner underwent heart rate monitoring, but no
supraventricular tachycardia or atrial fibrillation/flutter was detected. Ex. 12 at 4. She went back
to Riverview Medical Center in early April 2016 with complaints of nausea, vomiting, and
abdominal pain, reporting as well that she had a history of POTS and was
“immunocompromised” after her receipt of the HPV vaccine, but again no underlying
explanation could be found to explain her symptoms or corroborate a vaccine connection. Ex. 13
at 10. Nevertheless, Dr. Lefkowitz (who continued to treat Petitioner) wrote a note (presumably
at the request of petitioner or her mother) on June 23, 2016, stating that she had autonomic
dysfunction due to the HPV vaccination that was well controlled, and that she could likely return
to college. Ex. 12 at 3.
More treatment events occurred in the second half of 2016, but they similarly do not help
illuminate the etiology for Petitioner’s condition. See e.g., Ex. 15 at 3–4 (visit with
endocrinologist in August 2016). Petitioner returned again to a Providence ER in mid-September
2016, reporting symptoms of hyperventilation and intermittent body tremors so severe she had
difficulty speaking clearly. Ex. 14 at 1–15, Ex. 29 at 12. Petitioner attributed her symptoms to a
POTS occurrence, but her lab work produced normal results, as did a physical exam, with only
an EKG revealing some sinus tachycardia. Ex. 14 at 3. She was discharged after her mother
arrived at the hospital. Id. An ER visit two months later, in mid-November 2016, was comparable
in terms of results—discharge despite concerns for “near syncopal episode and tachycardia,”
which were attributed to missing a medication dose. Ex. 29 at 34.
In the spring of 2017, Petitioner again found herself in the ER in Providence, this time “for
tachycardia and questionable seizure.” Ex. 29 at 60. Her heartrate was documented as high, in
13 Beta blockers, also known as beta-adrenergic blocking agents, can be recommended for reducing anxiety, because
they inhibit the effects of adrenaline. See Beta Blockers, Mayo Clinic, https://www.mayoclinic.org/diseases-
conditions/high-blood-pressure/in-depth/beta-blockers/art-20044522 (last accessed on June 30, 2022). Beta blockers
specifically cause the heart to beat slower, lower blood pressure, and widen veins and arteries. Id.
9

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the 150’s, and her blood pressure was “fluctuating.” Id. Petitioner was given Ativan and fluids,
which she said helped. Id. at 63. Petitioner was advised that she might have “pre-hypertension or
hypertension,” based on a blood pressure reading, but no other lab testing results revealed a
problem other than a possible iron deficiency or somewhat elevated white blood cell count. Id.
at 85. Upon discharge, the attending physician recommended that she follow-up with her primary
care provider to arrange further evaluation for hypertension. Id.
Petitioner followed up with Dr. Lefkowitz that October, and he now characterized her
presentation as featuring “multiple symptoms that are consistent with massive activation,” while
also observing that her measured blood pressure levels and heart rate drops were contrary to the
indicia of POTS. Ex. 33 at 26. An echocardiogram was performed in reaction to Petitioner’s
claim of “chest pain,” and Dr. Lefkowitz wanted her to have an MRI to identify the placement of
an intermittent mass that was in or near her heart. Id. Dr. Lefkowitz concluded that myxoma14
might explain some of her presentation. Id. at 27. In December 2017, Petitioner wore a Zio patch
monitor due to “dizziness and palpitations,” but it revealed no notable tachycardia or beat
irregularities. Ex. 34 at 1.
There is a two-year gap in the records. Then, in March and April 2019,15 J.S. sought urgent
care for abdominal pain and constipation. Ex. 36 at 4, 8. A CT scan was negative except for
“[l]arge fecal loading of the entire colon.” Id. at 25. In the process of her treatment, Petitioner
reported that her mother had informed her that she had a “dysmotility issue related to Gardasil
vaccination.” Id. at 12. The following year (March 2020), Petitioner consulted with a neurologist
about a purportedly abnormal MRI (though it is unclear from the record when these results were
obtained). Ex. 38 at 12. Dr. Vargas noted that “[s]ince our last visit, [petitioner] had labs which
were [within normal limits].” Id. A repeat brain MRI was stable in terms of lesions but “did show
a tiny 3 mm hypoenhancing focus related to the pituitary gland,” leading to a recommendation
that a repeat MRI be performed. Id. at 15. Lab results were otherwise within normal limits. Id. at
12.
Finally, Petitioner has offered some lab test results based on samples taken in April 2020—
nearly five years post-vaccination.16 See generally Ex. 37. CellTrend lab results revealed that she
tested positive (19.4, normal range < 7.0) for anti a-1-adrenergic antibodies (an antibody often
alleged in comparable cases to evidence a mechanistic explanation for dysautonomia). Id. But
14 Myxoma is “a benign tumor composed of primitive connective tissue cells and stroma resembling mesenchyme.”
Myxoma, Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=111236 (last
visited July 14, 2022).
15 Significantly, these records (and indeed all medical records filed in this case after August 2016) reflect treatment
visits obtained since the claim’s initiation.
16 Petitioner has explained that the purpose of such testing was to support an autoimmune etiology evidenced by
elevated norepinephrine levels. Reply at 6–7.
10

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she mostly tested negative after a neuromuscular antibody panel, except for one borderline
positive value for IgM vs. neurofacin-155 of unknown significance, although it has been
associated with chronic and acute neuropathies with distal weakness, sensory loss, and tremor.
Id. at 1–2.
II. Expert Reports and Other Evidence
A. Petitioner’s Experts17
Petitioner has offered expert input from two experts—Lawrence Steinman, M.D.,
Steinman Curriculum Vitae, filed as Ex. 40 (ECF No. 52-1) (“Steinman CV”).18 and Arthur
Brawer, M.D., Brawer Curriculum Vitae, filed as Ex. 58 (ECF No. 92-10).19
1. Dr. Steinman – Dr. Steinman prepared two reports in support of
Petitioner’s claim. Report, dated Mar. 2, 2018, filed as Ex. 39 (ECF No. 47-1) (“First Steinman
Rep.”); Report, dated Jan. 14, 2019, filed as Ex. 86 (ECF No. 85-1) (“Second Steinman Rep.”).
Dr. Steinman’s reports were consistent with what he has offered in many other cases, featuring
extensive “cut and paste” sections taken directly from other articles or items of evidence. See
e.g., First Steinman Rep. at 4 (attaching in report 2016 antibody testing results from Exhibit 16),
7 (diagram reproduced from Scientific American article on how molecular mimicry works).
Dr. Steinman opined that J.S. suffers from “autoimmune dysautonomia with inappropriate
tachycardia” caused by her HPV and Hep. A vaccines. First Steinman Rep. at 3. After
summarizing her medical history, Dr. Steinman took note of the fact that in 2016 Petitioner had
tested positive for certain antibodies to adrenergic and cholinergic receptors. Id. at 4–5. He
proposed (utilizing the same methodology he has employed in countless Program cases)20 that
17 Because my disposition of this case turns on Petitioner’s inability to establish any cognizable injury, and because
the theories proposed (mostly the HPV vaccine’s purported propensity to trigger autoimmune dysfunction) have been
the subject of many prior determinations, I am greatly truncating my discussion of expert opinions offered in this case.
18 Dr. Steinman currently serves as the chairman in immunology and professor in the departments of neurology,
pediatrics, and genetics at Stanford University. Steinman CV at 1. He obtained his bachelor’s degree from Dartmouth
College before earning his medical degree from Harvard University. Id. He then completed his internship and
residency in surgery, pediatrics, and pediatric and adult neurology at Stanford University. Id. He has also completed
several fellowships in the area of immunology. Id. He is board certified in neurology, though much of his work in the
field also involves immunological concepts and theories. Id. at 2. However, he has no demonstrated expertise in
treating or diagnosing conditions attributable to autonomic dysfunction.
19 Dr. Brawer has maintained a rheumatology private practice in Long Branch, New Jersey for 44 years. Brawer,
Biographical Summary, filed as Ex. 59 (ECF No. 92-11). Previously he obtained his bachelor’s degree from Brandeis
University and medical degree from Boston University School of Medicine. Brawer CV at 1. He then completed his
internship at Genesee Hospital in Rochester, residency at Boston VA Hospital, and fellowship at Boston City Hospital
and Boston University Medical Center. Id. He is board certified in internal medicine and rheumatology. Id. at 2.
20 Specifically, Dr. Steinman performs a “BLAST” search (meaning Basic Local Alignment Search Tool), permitting
him to identify the amino acid identities between vaccine components and the receptors he deemed significant to
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via the biologic mechanism of molecular mimicry the two relevant vaccines could result in
production of the aforementioned antibodies. Id. at 6–15. In effect, Dr. Steinman maintained,
antigenic similarity, or homology, between some of the amino acid sequences of proteins in the
two vaccines and the relevant adrenergic receptors was sufficient for antibodies produced in
reaction the vaccines to mistakenly attack those receptors as well, leading to POTS and/or
dysautonomia. Id. He allowed that the sequences in question were different for the two vaccines,
but added that once immune tolerance was “broken” by one cross-reaction, the process of
“epitope spreading” could result in a broadening of the immune response—and hence (in effect)
both alleged vaccine-induced cross reactions need not occur for an autoimmune process to set up.
Id. at 15.
A few other points made by Dr. Steinman in his first report bear on how this case is being
resolved. First, he opined that Dr. Lefkowitz’s proposed Shay-Drager syndrome diagnosis was
not supported by the evidence, since Petitioner “does not have the full manifestations” of it. First
Steinman Rep. at 5–6. Second, Dr. Steinman proposed Petitioner’s initial experience of “heart
racing” within 14 to 15 days of receipt of the first HPV dose was consistent with how long an
adaptive immune response resulting in the production of the allegedly-offending autoantibodies
would take to occur. Id. at 18.
Dr. Steinman’s second report reiterated many of his prior arguments, while also taking
issue (sometimes to an unnecessarily adversarial degree) with the contentions of Respondent’s
experts. First, he denied the significance of the fact that the allegedly causal anti-adrenergic
receptor antibody could be found in a person without accompanying disease, maintaining
(through a wholesale, “cut and paste” reference to his first report) that this fact did not diminish
the importance of molecular mimicry’s explanatory power. Second Steinman Rep. at 1–4, 14.
In so doing, he vouched for his own personal knowledge of the concept over Respondent’s
expert’s comparative lack of publishing history on molecular mimicry. Id. at 5–7.
Second, Dr. Steinman disputed the contention that POTS is not usually viewed as an
autoimmune illness (although his basis for so arguing relied mostly on narrow readings of what
literature was offered in the case on the subject). Second Steinman Rep. at 8-9. Dr. Steinman
did, however, highlight literature that discussed a potential autoimmune form of POTS. Id. at
9–10; B. Butts, Human Papillomavirus Vaccine and Postural Orthostatic Tachycardia
Syndrome: A Review of Current Literature, J. Child Neurology 956, 957 (2017), filed as Ex. C,
Tab 2 on Feb. 7, 2018 (ECF No. 65-3) (“Butts”).21 He otherwise repeated his contentions about
Petitioner’s injury. This is the precisely same methodologic approach he utilizes in virtually every case in which he
offers a causation opinion. See e.g., A.T. v. Sec'y of Health & Hum. Servs., No. 16-393V, 2021 WL 6495241, at *8
(Fed. Cl. Spec. Mstr. Dec. 17, 2021); Montgomery v. Sec'y of Health & Hum. Servs., No. 15-1037V, 2019 WL
2511352, at *5 (Fed. Cl. Spec. Mstr. May 21, 2019).
21 Also cited as Respondent’s Ex. E, Tab 3.
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this form of POTS, agreeing that it was not always applicable (even if he did view it relevant to
Petitioner). Id. at 11. Petitioner had tested positive for the anti-adrenergic antibodies he deemed
relevant (albeit only “above the cited upper range of normal”—an “above” level that
Respondent’s expert observed was minimal) and caused by the HPV or Hep. A vaccine. Id. at
12–14. Otherwise, he again argued that the various elements of his molecular mimicry theory
were rooted in reliable science, and took some final issue with some of Respondent’s diagnostic
expert’s contentions as well. Id. at 15–20.
2. Dr. Brawer – Dr. Brawer prepared three reports in support of Petitioner’s
claim, one of which was the result of an in-person examination of Petitioner. Report, dated May
3, 2021, filed as Ex. 49 (ECF No. 92-1) (“First Brawer Rep.”); Report, dated May 13, 2021,
filed as Ex. 60 (ECF No. 93-1) (“Second Brawer Rep.”); Report, dated Aug. 16, 2021, filed as
Ex. 63 (ECF No. 100-1) (“Third Brawer Rep.”). He opined that J.S. suffers from a “Gardasil-
induced illness,” and found significant the testing results revealing the presence of
adrenergic antibodies. However, Petitioner has stated that she is not otherwise relying
on the reports he has prepared (see Mot. at 3), and therefore I will not further discuss Dr.
Brawer’s opinions or their bases.22
B. Respondent’s Experts
Respondent offered his own pair of experts: Andrew MacGinnitie, M.D., Ph.D.,
MacGinnitie Curriculum Vitae, filed as Ex. B (ECF No. 64-8) (“MacGinnitie CV”),23 and Dr.
Peter Bingham, M.D., Bingham Curriculum Vitae, filed as Ex. D (ECF No. 65-9) (“Bingham
CV”).24
22 Dr. Brawer’s final report included a number of unwarranted personal attacks on Respondent’s experts, Dr.
MacGinnitie and Dr. Bingham. See e.g., Third Brawer Rep. at 3 (“the tone of Dr. Bingham’s report suggests that he
himself may in part be suffering from a functional neurological disorder”). In reaction, Respondent filed a motion to
strike all or part of this supplemental report, but I ultimately denied the motion, explaining in part that the comments
resulted in no prejudice against Respondent’s experts. ECF Nos. 103, 104. However, I also noted that the fact that the
report was replete with this kind of attack only provided me with “a reason for deeming the attacking expert’s report
to deserve less weight than an even-handed report would receive.” ECF No. 104 at 2. Petitioner’s decision not to rely
on Dr. Brawer’s opinions thus had the secondary (and prudent) effect of evading the negative impact of his comments.
23 Dr. MacGinnitie is currently an attending physician as well as Clinical Director for the Division of Immunology at
Boston’s Children’s Hospital, where he oversees clinical operations for Allergy/Immunology, Rheumatology, and
Dermatology. First MacGinnitie Rep. at 1. He obtained his medical degree and Ph.D. in Pathology from the University
of Chicago Pritzker School of Medicine. First MacGinnitie Rep. at 1; MacGinnitie CV at 1. Dr. MacGinnitie is board
certified in both Allergy/Immunology and Pediatrics and maintains an active clinical practice seeing more than 1,600
patients annually. First MacGinnitie Rep. at 2. He also performs research and has published numerous articles in areas
relating to Allergy/Immunology, including vaccine reactions. Id.
24 Dr. Bingham is a clinical researcher and Professor of Neurology & Pediatrics at the University of Vermont. First
Bingham Rep. at 1; Bingham CV at 1. He obtained his medical degree from Columbia College of Physicians &
Surgeons in New York and completed a fellowship in neuromuscular diseases at The Children’s Hospital of
Philadelphia. First MacGinnitie Rep. at 1; MacGinnitie CV at 1. Dr. Bingham is board certified in Neurology and
Child Neurology and maintained a post-residency experience in general child neurology for 25 years. First Bingham
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1. Dr. Bingham – Dr. Bingham prepared two reports for Respondent. Report,
dated Feb. 7, 2018, filed as Ex. C (ECF No. 65-1) (“First Bingham Rep.”); Report, dated July
19, 2021, filed as Ex. G (ECF No. 99-14) (“Second Bingham Rep.”). He opined that there is no
reliable medical theory supporting Petitioner’s contention that the HPV vaccine can cause
POTS.
Dr. Bingham first detailed J.S.’s medical history. First Bingham Rep. at 2–5. He noted
that Petitioner’s November 18, 2015 tilt table testing showed a pulse rise of 30-40 beats per
minute with stable blood pressure, and that the record of the testing itself did not conclude or
propose that she in fact could properly be diagnosed with POTS. Id. at 5; Ex. 18 at 3. Dr.
Bingham was cautious of this diagnosis, because the core symptoms of POTS—chronic,
recurrent, orthostatic intolerance—do not otherwise appear in her chart.25 First Bingham Rep.
at 5. But Dr. Bingham acknowledged that the heart rate increase that the test revealed was
consistent with POTS. Id. He also deemed it “extremely improbable” that Petitioner had Shy-
Drager syndrome (which he characterized to be “vanishingly rare”), and hence disputed the
legitimacy of Dr. Lefkowitz’s diagnosis. Id. at 4.
Dr. Bingham next considered the broader category of orthostatic intolerance and where
POTS fits within. Orthostatic intolerance generally occurs where a patient experiences “near-
fainting” type symptoms (dizziness, palpitations, and graying-out of vision) upon standing. First
Bingham Rep. at 6. But because such symptoms often have a subjective quality, a physical exam
or tilt table assessment showing a marked pulse rise of over 40 beats per minute (in adolescents)
is critical for a reliable POTS diagnosis. Id. Dr. Bingham otherwise noted that POTS has a wide
array of symptoms and contributing factors (even idiopathic) that all fall under the umbrella of
“dysautonomia,” or dysfunction in the autonomic nervous system (which regulates a number of
bodily functions without conscious effort). Id.; G. Heyer, Postural Tachycardia Syndrome:
Diagnosis and Management in Adolescents and Young Adults Pediatric Annals e145, e146
(2017), filed as Ex. C, Tab 4 on Feb. 7, 2018 (ECF No. 65-5); Dysautonomia, Dorland’s Medical
Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=15146&searchterm=dysautonomia (last
visited July 14, 2022).
Rep. at 1. In the last 5 years, he diagnosed and managed approximately 20 cases each of postural orthostatic
tachycardia syndrome, and non-epileptic seizures, in children and adolescents. Id. He also has published numerous
articles in areas relating to pediatrics and neurology. Id. at 1–2.
25 Dr. Bingham discusses another diagnosis at length—specifically Dr. Brawer’s contention that Petitioner suffered
from a “Gardasil-induced illness”—and took issue with its legitimacy. Second Bingham Rep. at 2–4.
Additionally, Dr. Bingham argued against Dr. Steinman’s supposition that Petitioner’s positive alpha 1a adrenergic
reception antibodies and the anti-muscarinic antibodies translated to a confirmed POTS diagnosis. Id. at 6–7. Dr.
Bingham argued that in many cases, individuals without any neurological disease may harbor these antibodies, the
tests are not in wide use and have no formal FDA approval, and the rate of background positivity is still unknown. Id.
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In the context of discussing the causal theory advanced by Dr. Steinman, Dr. Bingham
referenced the Institute of Medicine (“IOM”) criteria for the strength of evidence relating to
causality, noting that these criteria require a combination of epidemiological and biological
mechanism data. First Bingham Rep. at 6. But those criteria were absent here. In particular, Dr.
Bingham could find no epidemiological evidence of an association between the HPV vaccine
and POTS or dysautonomia. Id.; J. Arana et al., Reports of Postural Orthostatic Tachycardia
Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting
System, J. Adolescent Health 577, 581 (2017), filed as Ex. C, Tab 1 on Feb. 7, 2018 (ECF No.
65-2); Butts at 962–63. He also noted that Dr. Steinman’s case for biological plausibility
attributable to a vaccine-induced cross-reaction was not supported by the results of large-scale
studies. See e.g., S. Miranda et al., Human Papillomavirus Vaccination and Risk of Autoimmune
Diseases: A Large Cohort Study of Over 2 Million Young Girls In France, Vaccine 4761, 4766–
67 (2017), filed as Ex. C, Tab 7 on Feb. 7, 2018 (ECF No. 65-8) (assessing two million female
patients in a French case-control study, with 37 percent of whom received the HPV vaccine).
And he felt that components of Dr. Steinman’s molecular mimicry-reliant theory relied heavily
on unsubstantiated assumptions, or animal studies not fully comparable to human
circumstances. First Bingham Rep. at 7.
Dr. Bingham also maintained that the record in this case did not support the conclusion
that the HPV vaccine had likely caused Petitioner’s symptoms. Overall, they were simply too
non-specific, or more likely the product of anxiety or a psychological issue. First Bingham Rep.
at 6–7. Non-epileptic seizures, for example, of the type that Petitioner’s neurologists proposed
she had experienced are typically presumed psychological in origin and are unlikely sequelae to
a vaccine. Id. at 6; Second Bingham Rep. at 1–2. Thus, the record did not lend support for the
conclusion that her overall post-vaccination symptoms and issues could be attributed to
vaccination.
2. Dr. MacGinnitie – Dr. MacGinnitie prepared 3 reports, and commented on
what was submitted by both of Petitioner’s experts. Report, dated Feb. 7, 2018, filed as Ex. A
(ECF No. 63-1) (“First MacGinnitie Rep.”); Report, dated June 11, 2018, filed as Ex. E (ECF
No. 70-1) (“Second MacGinnitie Rep.”); Report, dated July, 19, 2021, filed as Ex. F (ECF No.
99-1) (“Third MacGinnitie Rep.”).26
Dr. MacGinnitie began with a summary of the medical records, deferring to Dr. Bingham
on diagnostic issues. First MacGinnitie Rep. at 2–4. But he devoted the remainder of his report
to identifying what he deemed as weaknesses to Dr. Steinman’s molecular mimicry theory. First,
26 Dr. MacGinnitie’s third report was focused solely on addressing alleged deficiencies in Dr. Brawer’s diagnosis,
along with his theory of causation, among other things. Third MacGinnitie Rep. at 1–7. But because Petitioner has
opted not to rely on Dr. Brawer’s opinion in this case, I do not discuss this aspect of Dr. MacGinnitie’s opinion herein.
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he asserted there was an overall lack of evidence that POTS and/or dysautonomia are usually or
mostly autoimmune-mediated. Id. at 4; E. Garland et al., Postural Tachycardia Syndrome:
Beyond Orthostatic Intolerance, Current Neurology & Neuroscience Rep. 1, 8 (2015), filed as
Ex. A, Tab 5 on Feb. 7, 2018 (ECF No. 63-6) (noting that in this study, “only a small number
of [POTS] patients were studied and further research is needed to establish clinical
significance”); E. Benarroch, Postural Tachycardia Syndrome: A Heterogeneous And
Multifactorial Disorder, Mayo Clinic Proc. 1214, 1217 (2012), filed as Ex. A, Tab 6 on Feb. 7,
2018 (ECF No. 63-7) (“POTS as the only manifestation . . . of autoimmunity has not been
convincingly demonstrated”). Dr. MacGinnitie also pointed out that anti-adrenergic antibodies
that Petitioner tested positive for were likely insignificant. Low levels of these antibodies are
seen in normal controls, and J.S. did not test positive for a number of other autoantibodies
believed associated in some cases with dysautonomia. First MacGinnitie Rep. at 4–6; Ex. 18 at
3.
Second, Dr. MacGinnitie raised several other technical objections to the reliability of the
causation theory that vaccination could, via molecular mimicry, provoke an autoimmune
response sufficient to cause dysautonomia. First MacGinnitie Rep. at 6–9. Some of the animal
models relied upon by Dr. Steinman, for example, were specific to distinguishable conditions
involving nerve demyelination, which was not a plausible explanation for POTS or dysautonomia
generally. Id. at 6. There was also substantial homology in nature that did not result in
autoimmune disease. Id. at 7–8. And several large epidemiologic studies did not demonstrate any
significant incidence of autoimmune diseases after receipt of the HPV vaccine. Id. at 8-9; C.
Chao et al., Surveillance of Autoimmune Conditions Following Routine Use of Quadrivalent
Human Papillomavirus Vaccine, J. Internal Med. 194, 193–4, 201–02 (2012), filed as Ex. A,
Tab 1 on Feb. 7, 2018 (ECF No. 63-2) (analyzing a database comprised of the medical histories
of approximately 189,000 women in California did not confirm association between HPV
vaccine and autoimmune disease generally); L. Grimaldi-Bensouda et al., Autoimmune
Disorders and Quadrivalent Human Papillomavirus Vaccination of Young Female Subjects, J.
Internal Med. 398, 404–05 (2014), filed as Ex. A, Tab 4 on Feb. 7, 2018 (ECF No. 63-5)
(assessing around 1,800 patients, of which 22 percent received the HPV vaccine, and noting no
increased rate of autoimmunity following vaccination).
In his supplemental report, Dr. MacGinnitie reiterated some of his prior contentions,
expanding on some points Dr. Steinman had pointedly attempted to critique. He repeated his
argument that the common occurrence of homologic similarity between antigens and self protein
structures, along with the rarity of autoimmunity generally, undercut the weight to be given solely
to a showing of amino acid homologic identity of the kind relied on by Dr. Steinman. Second
MacGinnitie Rep. at 1–2. He again emphasized that POTS is largely not thought to be an
autoimmune condition, noting that the contrary support associating it with some kinds of
autoantibodies is extremely limited in amount or scope. Id. at 2–3. He questioned how much
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weight could be given to the testing results purporting to show Petitioner’s possession of anti-
adrenergic antibodies. Id. at 3–4. And he observed that Butts (which Dr. Steinman himself cited)
only underscored the lack of a relationship between POTS and the HPV vaccine. Id. at 5; Butts
at 963.
III. Procedural History
The Petition was initiated in August 2016, and at first assigned to different special master.
By June of 2017, after the filing of medical records and a substitution of counsel, Respondent
filed his Rule 4(c) Report opposing an entitlement award. ECF No. 41. For nearly two years
thereafter, the parties filed most of the expert reports as discussed above, and then the case saw
no activity for an entire year. In March 2021, however, the case was reassigned to me, and I
informed the parties that after some minor additional expert opinions were filed, the matter would
be resolved via ruling on the record. Docket Entry Order, dated March 23, 2021. Reports from
Dr. Brawer, and supplemental reports from Respondent’s experts, were filed through the fall of
2021, and then the parties completed briefing the matter by February 2022. The matter is fully
ripe for resolution.
IV. Parties’ Respective Arguments
Petitioner argues that she was correctly diagnosed with inappropriate tachycardia based on
treating physicians, but mostly bases this contention on Dr. Lefkowitz’s October 2015 exam.27
Mot. at 17, 26; Reply at 7–10. Otherwise, she proposes that she has met her causation-in-fact
burden based on the factors established by the Federal Circuit in Althen v. Sec'y of Health & Hum.
Servs., 418 F.3d 1274 (Fed. Cir. 2005); Mot. at 29–33; Reply at 7–10. Statements from Dr.
Steinman, she purports, support her contention that components of the Hep. A and HPV vaccines
can elicit immunity to adrenergic receptions, which are associated and cause inappropriate
tachycardia and aspects of dysautonomia and POTS via molecular mimicry. Mot. at 30–31; Reply
at 8–9. She argues that her T cells were first primed by the Hep. A vaccine and the boosted by the
HPV vaccine. Id. She links the history of response to the theory of molecular mimicry in the
Program as informative—all the while citing to caselaw involving different injuries, but still
finding them helpful in her case. See Morgan v. Sec'y of Health & Hum. Servs., No. 15-1137V,
2019 WL 7498665, at *19 (Fed. Cl. Spec. Mstr. Dec. 4, 2019), review denied, decision aff'd, 148
Fed. Cl. 454 (2020) (invoking molecular mimicry as a possible explanation for how a vaccine
might cause transverse myelitis); Tarsell v. Sec'y of Health & Hum. Servs., No. 10-251V, 2017
WL 4583233, at *6 (Fed. Cl. Spec. Mstr. Sept. 25, 2017), on remand, Tarsell v. United States, 133
Fed. Cl. 782 (2017) (explaining under the theory of autoimmunity there could be similarities to
arrhythmia (alleged in this case) to the claim herein); Mot. at 31–32.
27 More specifically, Dr. Lefkowitz diagnosed Petitioner with Shy-Drager syndrome, along with apparent generalized
autonomic dysfunction resulting in inappropriate sinus tachycardia Ex. 3 at 93, 84.
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J.S. next claims that she has demonstrated a logical sequence of cause and effect that the
Hep. A and/or HPV vaccines “did cause” her injuries. Mot. at 33–36. First, she points to Dr. Nash,
who opined that Petitioner had “a degree of autoimmune encephalopathy provoked by
immunizations in a susceptible patient with an autoimmune predisposition.” Ex. 4 at 3; Mot at 34.
Second, she recounts that as an in-patient at Jersey Shore Hospital she displayed tonic-clonic
movements that could be attributable to the HPV vaccination. Ex. 6 at 35, 38; Mot at 34; Reply at
5. She also relies on Dr. Lefkowitz, who initially suspected a vaccine origin to Petitioner’s injuries.
Ex. 12 at 1, 10–11; Mot. at 34–35. And she denies the alleged tonic-clonic episodes are attributable
to psychological stress or anxiety, to warnings on the HPV package insert that they are a known
vaccination side-effect. Mot. at 35–36; Reply at 4.
Finally, Petitioner’s onset—approximately a day after the HPV vaccine and 15 to 16 days
after the Hep. A vaccine—occurred in a post-vaccination, medically-acceptable timeframe, given
the HPV package insert warnings as well as the velocity of recall response discussed in the 2012
IOM report. Mot. 36–37. Petitioner also compared her case to that in Johnson, arguing that her
onset was quicker to manifest, and a better case than those seen before in the Program. Reply at 9;
Johnson v. Sec'y of Health & Hum. Servs., No. 14-254V, 2018 WL 2051760, at *22–25 (Fed. Cl.
Spec. Mstr. Mar. 23, 2018). Given this evidence and the nature of the theory proposed, Petitioner
asserts that a hearing is warranted to permit further inquiry and analysis. Mot. at 38.
In opposing entitlement, Respondent maintains that there is no clear diagnosis of POTS or
inappropriate tachychardia, and thus that Petitioner has not identified an “injury” outright. Opp. at
21–23. Otherwise, he argues that the Althen prongs have not been satisfied. Id. at 23–37. Petitioner
has not established that either POTS or inappropriate tachycardia are more likely than not
autoimmune, or that specifically anti-adrenergic receptor antibodies likely play a role in causing
either. Id. at 29–30. Additionally, Respondent finds Dr. Steinman’s theory unreliable, as he
heavily relies on a mouse model, which does not simply translate to human disease as Dr. Steinman
would hope, or BLAST search-confirming homologies that by themselves do not establish likely
autoimmune cross-reactivity. Id. at 26–27.
Moreover, Respondent maintained, the package insert “admissions” of HPV side effects
were undermined by the distinguishable nature of the alleged injury. Id. at 36. In particular, the
package insert only discusses syncope occurring post-vaccination as “sometimes associated with
tonic-clonic movements and other seizure-like activity.” Opp. at 36; see also Mot. at 35. But
Petitioner does not in this case argue (nor does the record show) she experienced syncope—and
the same package insert says nothing about autoimmune disease as a recognized side-effect. And
there are extensive epidemiological studies that do not demonstrate that any of the relevant
vaccines are associated with the development of any autoimmune diseases. Id. at 27–28.
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Althen prong two is also unsatisfied, Respondent argues. Petitioner’s three instances of
treater support are not credible, outweighed by many other instances of treaters stating that the
vaccines did not cause her condition. Opp. at 31–35; see also Ex. 7 at 67; Ex. 9 at 34, 58; Ex. 28
at 18. Other treaters simply noted a temporal association but did not opine on causation. Opp. at
33. The views of Dr. Lefkowitz were deemed especially unreliable. He diagnosed Petitioner with a
self-limiting form of Shy-Drager syndrome that is wholly inconsistent with what is known about it
(a neurological disease that usually results in death 6 to 10 months after the inset of symptoms). Id.
at 32; The History of Multiple System Atrophy, The MSA Coalition,
https://www.multiplesystematrophy.org/about-msa/history-multiple-system-atrophy-formerly-
shy-drager-syndrome-
sds/?gclid=EAIaIQobChMIycfvx4So9QIVB7SzCh2YWQtYEAAYASAAEgL1bvD_BwE (last
visited July 14, 2022). It was also possible that a viral infection Petitioner picked up while in
Central America could have explained some of the autoimmune etiologies embraced (if tentatively
at most) by Drs. Lefkowitz or Nash. Opp. at 32–33.
Respondent also deems Petitioner’s showing under Althen prong three to be insufficient.
Several of the Petitioner’s symptoms (in particular her tachycardia) were present prior to the
receipt of her vaccines. Opp. at 35. And there was no acceptable temporal relationship between
vaccination and alleged injury otherwise. Opp. at 36–37. Petitioner’s argument on this topic relied
heavily on the package insert for the HPV vaccine, and what it says about the possibility of syncope
as a reaction - even though (a) syncope is not alleged herein as a symptom, and (b) there is
otherwise no evidence that she experienced any true seizure activity (which Dr. Steinman
maintained could be “sometimes associated” with syncope). Id. at 37. Otherwise, Dr. Steinman’s
reliance on the 2012 IOM report to support a 14-15 day onset was misguided, since its focus was
more on when antibodies would begin to increase in production post-vaccination—not how long
it would take for those alleged anti-adrenergic antibodies to begin to cause symptoms
manifestation. Id.
V. Applicable Law
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
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Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).28
In this case, Petitioner does not assert a Table claim.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,
1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen, 418 F.3d at 1278: “(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 proximate temporal relationship between vaccination and
injury.”
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by
28 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V,
2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.
Cl. at 245 (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis
in original)).
In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum.
Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also LaLonde v. Sec’y of Health & Hum. Servs.,
746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply
identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of
proof.” (citing Moberly, 592 F.3d at 1322)). And petitioners always have the ultimate burden of
establishing their overall Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health
& Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States,
133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall burden of
proving causation-in-fact under the Vaccine Act” by a preponderance standard).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Medical records and statements of a treating physician, however, do not per se bind the
special master to adopt the conclusions of such an individual, even if they must be considered and
carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y
of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates
that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and
cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
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suppositions or bases. The views of treating physicians should be weighed against other, contrary
evidence also present in the record—including conflicting opinions among such individuals.
Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physicians’ conclusions against each other), aff’d,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must align with the theory of how the relevant vaccine can
cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.
Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,
2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denied (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Standards Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such determination is evidenced by
a rational determination).
Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed.
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Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d sub nom. Rickett v. Sec’y of Health
& Hum. Servs., 468 F. Appx. 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption
is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013); Cucuras v. Sec’y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993
F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to
accurately report the onset of their daughter’s symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie, 2005 WL 6117475, at *20. Indeed, contemporaneous
medical records are generally found to be deserving of greater evidentiary weight than oral
testimony—especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d
at 1528; see also Murphy, 23 Cl. Ct. at 733 (citing United States v. United States Gypsum Co., 333
U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony which is in conflict with
contemporaneous documents is entitled to little evidentiary weight.”)).
There are, however, situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“’[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent’”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
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reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. Lalonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,
1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the
factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharmaceuticals,
Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328,
1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed.
Cir. 1999)). “The Daubert factors for analyzing the reliability of testimony are: (1) whether a
theory or technique can be (and has been) tested; (2) whether the theory or technique has been
subjected to peer review and publication; (3) whether there is a known or potential rate of error
and whether there are standards for controlling the error; and (4) whether the theory or technique
enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316 n.2
(citing Daubert, 509 U.S. at 592–95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen, 618 F.3d at 1347 (citing Lampe, 219 F.3d at 1362). However, nothing requires the
acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the
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expert,” especially if “there is simply too great an analytical gap between the data and the opinion
proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997));
see also Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed.
Cl. Spec. Mstr. July 30, 2012), mot. for rev. denied, 108 Fed. Cl. 743 (2013), aff’d, 540 F. Appx.
999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of
competing expert testimony, based on a particular expert’s credibility, is part of the overall
reliability analysis to which special masters must subject expert testimony in Vaccine Program
cases. Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often
turn on credibility determinations”); see also Porter v. Sec’y of Health & Hum. Servs., 663 F.3d
1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are
expected to consider the credibility of expert witnesses in evaluating petitions for compensation
under the Vaccine Act”).
Expert opinions based on unsupported facts may be given relatively little weight. See
Dobrydnev v. Sec’y of Health & Hum. Servs., 556 F. Appx. 976, 992–93 (Fed. Cir. 2014) (“[a]
doctor’s conclusion is only as good as the facts upon which it is based”) (citing Brooke Group Ltd.
v. Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“[w]hen an expert assumes
facts that are not supported by a preponderance of the evidence, a finder of fact may properly reject
the expert’s opinion”)). Expert opinions that fail to address or are at odds with contemporaneous
medical records may therefore be less persuasive than those which correspond to such records. See
Gerami v. Sec’y of Health & Hum. Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec.
Mstr. Oct. 11, 2013), aff’d, 127 Fed. Cl. 299 (2014).
D. Consideration of Medical Literature
Both parties filed medical and scientific literature in this case, but not every filed item
factors into the outcome of this decision. While I have reviewed all the medical literature submitted
in this case, I discuss only those articles that are most relevant to my determination and/or are
central to Petitioner’s case—just as I have not exhaustively discussed every individual medical
record filed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016)
(“[w]e generally presume that a special master considered the relevant record evidence even
though he does not explicitly reference such evidence in his decision”) (citation omitted); see also
Paterek v. Sec’y of Health & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir. 2013) (“[f]inding
certain information not relevant does not lead to—and likely undermines—the conclusion that it
was not considered”).
E. Determining Matter on Record Rather Than at Hearing
I have opted to decide this case based on written submissions and evidentiary filings,
including the numerous expert reports that have been submitted. The Vaccine Act and Rules not
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only contemplate but encourage special masters to decide petitions (or components of a claim)
on the papers rather than via evidentiary hearing, where (in the exercise of their discretion) they
conclude that the former means of adjudication will properly and fairly resolve the case. Section
12(d)(2)(D); Vaccine Rule 8(d). The Federal Circuit has recently affirmed this practice.
Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1365–66 (Fed. Cir. 2020). It
simply is not the case that every Vaccine Act claim need be resolved by hearing—even where
the petitioner explicitly so requests.
ANALYSIS
I. Relevant Decisions Involving POTS and Orthostatic Intolerance Allegedly
Attributable to Dysautonomia
POTS is a circulation disorder characterized by a group of symptoms (not including
hypotension) that sometimes occur when a person assumes an upright position, including
tachycardia, tremulousness, lightheadedness, sweating, and hyperventilation. Postural
orthostatic tachycardia syndrome, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=111236 (last visited July 14, 2022).
POTS is seen more often in women than in men, and its etiology remains uncertain. Id. It
implicates the function of the autonomic nervous system, since it involves involuntary physical
processes like heart rate.
A tilt table test is often considered the “gold standard” in diagnosing POTS. Yalacki v.
Sec'y of Health & Hum. Servs., No. 14-278V, 2019 WL 1061429, at *35 (Fed. Cl. Spec. Mstr.
Jan. 31, 2019), mot. for review den’d, 146 Fed. Cl. 80 (2019). During the test, the patient is
secured on a table while lying flat. John Hopkins Medicine, Health Conditions and Diseases,
Postural Orthostatic Tachycardia Syndrome (POTS),
https://www.hopkinsmedicine.org/health/conditions-and-diseases/postural-orthostatic-
tachycardia-syndrome-pots (last visited July 14, 2022). The table is then raised to an almost
upright position. Id. The patient’s heart rate, blood pressure, and often blood oxygen and exhaled
carbon dioxide levels are measured during this test. Id. A POTS diagnosis is appropriate if all
three of the following criteria are met: (i) the existence of an abnormal, increased heart rate
response to being in an upright position; (ii) other symptoms worsen when upright; and (iii)
orthostatic hypotension (i.e. a drop in blood pressure) does not develop in the first three minutes
of testing. Id. A heart rate increase must occur in conjunction with a blood pressure drop for the
diagnosis to be proper.
This is not the first case in which a petitioner in a case before me has alleged that POTS,
or more generally some form of orthostatic intolerance, was vaccine-caused (usually by the HPV
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vaccine). But I have never so found.29 See e.g., Hughes v. Sec'y of Health & Hum. Servs., No.
16-930V, 2021 WL 839092 (Fed. Cl. Spec. Mstr. Jan. 4, 2021), mot. for review den’d, 154 Fed.
Cl. 640 (2021); E.S. v. Sec'y of Health & Hum. Servs., No. 17-480V, 2020 WL 9076620, at *42
(Fed. Cl. Spec. Mstr. Nov. 13, 2020), mot. for review den’d, 154 Fed. Cl. 149 (2021); McKown
v. Sec’y of Health & Hum. Servs., No. 15-1451V, 2019 WL 4072113 (Fed. Cl. Spec. Mstr. July
15, 2019); Yalacki, 2019 WL 1061429; Johnson, 2018 WL 2051760; Combs v. Sec’y of Health
& Hum. Servs., No. 14-878V, 2018 WL 1581672 (Fed. Cl. Spec. Mstr. Feb. 15, 2018); see also
Otto v. Sec’y of Health & Hum. Servs., No. 16-1144V, 2020 WL 4719285 (Fed. Cl. Spec. Mstr.
June 17, 2020) (case dismissed after hearing at claimant’s request).
As my prior written decisions state, POTS is most commonly not considered attributable to
an autoimmune process interfering with the autonomic nervous system. Rather, it is thought to
reflect the autonomic system functioning properly in response to stressors (for example,
hypovolemia, in which a person’s dehydrated states produces orthostatic imbalance). See e.g.,
McKown, 2019 WL 4072113 at *52. Moreover, while it is true that some evidence has emerged
in the last ten years that in very rare cases POTS might sometimes be attributable to an autoimmune
process—for example (and as alleged herein) one involving anti-adrenergic antibodies, which can
cause heart rate increases—this is the exception to the rule. 30
Thus, not nearly enough is known about how such an uncommon form of autoimmune-
mediated POTS would occur to draw conclusions in Program cases sufficient to meet the
preponderance level of evidence. Further, in none of these cases I have decided has it been
preponderantly established, through citation to reliable scientific evidence or expert testimony,
that the HPV vaccine itself could cause the production of anti-adrenergic autoantibodies posited
to cause POTS in some limited circumstances. See e.g., Yalacki, 2019 WL 1061429, at *20, 31
(while the petitioner was able to offer some reliable literature exploring the possibility that certain
POTS cases might be autoimmune-mediated, that evidence did not characterize the likely cause
of POTS for the majority of individuals).
29 It is certainly correct that prior decisions in different cases do not control the outcome herein. Boatmon, 941 F.3d at
1358-59; Hanlon, 40 Fed. Cl. at 630. But special masters draw upon their experience in resolving Vaccine Act claims.
Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 338–39 (2007) (“[o]ne reason that proceedings are more
expeditious in the hands of special masters is that the special masters have the expertise and experience to know the
type of information that is most probative of a claim”) (emphasis added). They would therefore be remiss in ignoring
prior cases presenting similar theories or factual circumstances, along with the reasoning employed in reaching such
decisions.
30 In fact, what currently stands as scientific support for this kind of antibody-driven POTS may become further
discredited or rebutted as time passes. See e.g., Yalacki, 2019 WL 1061429, at *18. Arguably, this may already be
happening to some degree. In Yalacki, for example, Dr. Philip Low (a world-renowned expert at the Mayo Clinic on
the autonomic nervous system (whom Dr. Steinman himself favorably cited in his own report in this case (see First
Steinman Rep. at 5)) noted that he previously had believed that a different kind of autoantibody might be important in
causing certain forms of POTS (although in only 10 percent of cases). Id. However, subsequent research disproved
any correlation to POTS, and he no longer routinely tests POTS patients for particular autoantibodies.
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Petitioners have also previously attempted to establish that the HPV vaccine, as well as
others, can more broadly stimulate autonomic dysfunction. But the result in such cases has been
comparable. See e.g., America v. Sec'y of Health & Hum. Servs., No. 17-542V, 2022 WL 278151,
at *27 (Fed. Cl. Spec. Mstr. Jan. 4, 2022) (neurocardiogenic syncope); E.S., 2020 WL 9076620
at *40 (small fiber neuropathy); K.L. v. Sec'y of Health & Hum. Servs., No. 12-312V, 2017 WL
1713110, at *15 (Fed. Cl. Spec. Mstr. Mar. 17, 2017) (seizure and partial onset epilepsy).
I am aware of no persuasive, well-written decisions in the Vaccine Program that reach
results contrary to any of the above. Nor have I identified the existence of any cases in which a
petitioner successfully established that chronic/generalized tachycardia, or an increased heart rate
over a period of time long enough to satisfy the Act’s six-month severity requirement, was
specifically vaccine-caused. At most, tachycardia has been a secondary symptom of other
cognizable injuries. See e.g., Walton v. Sec'y of Dep't of Health & Hum. Servs., No. 04-503V,
2007 WL 1467307, at *1 (Fed. Cl. Spec. Mstr. Apr. 30, 2007) (“[petitioner] claimed symptoms
of ‘fever, chest pain, nausea, headaches, dizziness, lightheadedness, racing heart rate, tired
feeling, faintness, Coxsackie-carditis with supra-ventricular tachycardia with pronounced
exhaustion pathology[]’ . . . .”) (emphasis added).
II. Petitioner Has Not Demonstrated a Cognizable Vaccine Injury
As reasoned Program case law instructs, a petitioner’s claim is premised on first
establishing the underlying existence of an injury that could be attributable to a prior vaccination.
An inability to establish an injury by preponderant evidence can be fatal to a claim. Broekelschen,
618 F.3d at 1346, 1349. It is thus often necessary at the outset of analyzing a petition to determine
whether a given alleged injury has been preponderantly established in the first place. Locane v.
Sec’y of Health & Hum. Servs., 685 F.3d 1375, 1381 n.3 (Fed. Cir. 2012); Lombardi v. Sec’y of
Health & Hum. Servs., 656 F.3d 1343, 1353 (Fed. Cir. 2011).
This case features a lengthy, ample medical record that strongly establishes that Petitioner
regularly sought medical treatment, often on an emergency basis, after her vaccinations in 2015.31
Indeed, in the month after vaccination, she was treated at an ER four times alone. And she did so
because of a series of panic attack-like episodes that were accompanied by a feeling of a racing
heartbeat. But that record simply does not preponderantly establish any actual injury that could
be grounds for a Program claim.
First, and most significantly, the alleged POTS injury—unquestionably a debilitating
medical condition, regardless of whether it can be vaccine-caused—has not been preponderantly
established. J.S. was never legitimately diagnosed with POTS. Initial testing of Petitioner’s heart
31 Petitioner’s sister also filed a case in the Program alleging similar symptoms but was denied entitlement. E.S., 2020
WL 9076620 at *6, n.21.
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rate and blood pressure levels were inconsistent with it. The subsequent, thorough tilt-table test
she underwent in November 2015 did not formally confirm the diagnosis either, even if some
elements of it (in particular an increased heart rate) were suggestive of it. Ex. 18 at 3. The record
of this testing event is facially thorough. And no subsequent testing evidence has been filed that
would confirm the diagnosis. At most, Respondent’s expert Dr. Bingham allowed the possibility
that the November testing could support POTS—but that is not the same as an admission
(consistent with the preponderant standard applicable herein) that it was likely.
Second (and without taking anything away from the feelings of distress that caused
Petitioner to seek treatment so regularly), Petitioner’s other reported symptoms—whether
characterized as “inappropriate tachycardia”32 or something else—do not, individually or
collectively, amount to a cognizable condition of any kind that could be shown to be vaccine-
caused. As observed by Dr. Bingham, her symptoms were consistently non-specific. They are
also transient/intermittent—and this is especially true of the purported “inappropriate
tachycardia.” Thus, while there are instances in which Petitioner displays an increased heart rate
on exam, she does not consistently do so, and other autonomic testing (performed at the same
time as the tilt table test) did not identify measurable orthostatic intolerance. Ex. 18 at 1–3. Again,
while Petitioner might have displayed occasions of post-vaccination tachycardia at times in this
record, it cannot be deemed to be a persistent condition that could reasonably be linked to
vaccination.
Contentions that Petitioner experienced syncope-associated “clonic-tonic” seizures are
especially spurious. The record plainly establishes that her treaters from the fall of 2015 (who
saw Petitioner in the immediate wake of claimed episodes) consistently deemed her movements
to be pseudoseizures, and attributed related symptoms to an unidentified underlying
psychological condition. See e.g., Ex. 6 at 4, 38, 40, 42, 80, 130-31, 134; Ex. 7 at 66-67, 89-90,
223, 233-36; Ex. 9 at 71. No formal medical testing ever later confirmed the presence of any
epileptic etiology or factors that might cause seizure activity—and in fact the absence of such
evidence was clear not long after the relevant vaccinations. See e.g., Ex. 9 at 64-68 (September
2015 neurologic evaluation and EEG results).33 And MRI results were largely nonspecific as
well—certainly none confirmed the kind of brain abnormalities that might explain seizure
etiology.
The only potentially-reliable evidence supporting the finding that Petitioner might have
32 As Respondent persuasively points out, it is not self-evident that (at least from Dr. Steinman’s perspective)
“inappropriate tachycardia” is a condition distinguishable from POTS. Opp. at 21-22 (citing First Steinman Rep. at
18 (alleging that the anti-adrenergic receptor antibodies are “associated with autoimmune dysautonomia, sometimes
referred to as POTS”) (emphasis added).
33 Even Dr. Lefkowitz agreed. See Ex. 12 at 11 (“I believe that we have shown that the tonic-clonic movements are
unrelated to seizure activity based upon the video EEG”).
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had some kind of cognizable injury comes from Dr Lefkowitz.34 But there are numerous reasons
to give his opinion little weight—aside from the oft-noted Program admonition that treater views
are never per se sacrosanct or dispositive. Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl.
706, 746 n.67 (2009). First, Dr. Lefkowitz’s proposal that Petitioner might have Shy-Drager
syndrome was not only not accepted by both side’s experts, but later was largely abandoned by
Dr. Lefkowitz himself (since he does not appear to have maintained or refined this initial
speculation in his exams of Petitioner in later years). See e.g., Ex. 33 at 27 (concluding that
Petitioner may have myxoma during a follow-up in October 2017); First Bingham Rep. at 4
(disputing Dr. Lefkowitz’s diagnosis as Shy-Drager has become “vanishingly rare,” and
Petitioner’s tests were not consistent with such a diagnosis); First Steinman Rep. at 5 (observing
that Petitioner does not have the full manifestations of Shy Drager syndrome). This peculiar
diagnosis alone somewhat discredits his judgment, since it is an outlier view that no other treater
ever echoed or adopted.
Second, the overall evidentiary record is inconsistent with the conclusion that Petitioner’s
symptoms were anything more than temporally related to vaccination. When evaluating disputes
about a claimant’s medical condition, it is critical to consider the overall medical history in its
totality. What one treater is told, or understands, about a claimant’s history at a certain point in
time can be incomplete, or reflect a tentative, initial diagnostic proposal that later on is not
confirmed by subsequent testing or the course of the injured party’s medical disease. Here, Dr.
Lefkowitz not only appears to have relied heavily on Petitioner’s self-reported history (which did
not emphasize the extent to which her prior multiple ER visits never corroborated an underlying
physiologic explanation for her episodes), but he evaluated her in early October 2015 - before
the negative tilt-table test conducted the next month. His opinions about her injury (and its
association with HPV vaccine) seem ultimately speculative, and are in any event unsubstantiated
by the record.
The medical record also contains numerous, credible instances in which treaters proposed
or surmised that Petitioner’s symptoms had a psychologic component, reflecting either
somatization, excessive anxiety, or some other mental trauma that precipitated a heightened heart
rate and other panic-like symptoms. See e.g., Ex. 6 at 80 (August 21, 2018 visit with treaters
finding the Petitioner experienced a pseudoseizure); Ex. 7 at 36 (August 23, 2015 neurology
consult diagnosing petitioner with acute anxiety disorder); Ex. 9 at 47 (September 22, 2015
neurology evaluation discussing recent stressors in petitioner’s life that may have caused her
seizure-like activity); Ex. 13 at 213 (September 19, 2015 neurology consultation with a clinical
impression of “probable pseudo-seizures”, “stress related psycho-somatization or
somatization”, and “probable anxiety associated panic”). As a special master, I am certainly not
34 Although Dr. Nash’s infectious evaluation seemed to allow for a possible autoimmune injury, he more expressly
discounted dysautonomia, noting that Petitioner displayed only “minor orthostatic changes which are not consistent
with POTS or significant autonomic instability.” Ex. 4 at 3.
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called upon to offer a diagnosis of my own (and am far from qualified to do so in any event). But
there are enough instances established in the record simply from the fall of 2015, in which on-
the-scene treaters offered such an opinion. The possibility of a psychological factor as causal of
Petitioner’s symptoms also strongly negates the conclusion that Petitioner did in fact experience
something that reasonably could be seen a potential vaccine injury.
I give little weight to the testing results Petitioner obtained in 2020—almost five years
after her vaccination, and nearly four years after the case was filed—suggesting she possessed
certain anti-adrenergic autoantibodies theorized to cause dysautonomia. Assuming the results of
this test are even reliable,35 it cannot be determined on this record that she possessed these
specific antibodies in the immediate one to ten days after receipt of the HPV vaccine, when her
tachycardia is alleged to have begun, and it is highly speculative to assume otherwise. There is
simply no record evidence in this case that Petitioner possessed these antibodies in the fall of
2015. These results thus do not add any legitimate weight to the contention that Petitioner did in
fact experience an actual injury post-vaccination.
Given all of the foregoing, I cannot conclude from this medical record that Petitioner “more
likely than not” experienced any cognizable illness or injury that could be attributed to
vaccination in any manner other than temporally (an insufficient basis for entitlement, as well-
recognized in the Program). Bunting, 931 F.2d at 873. Without an injury, this case cannot
proceed.
II. Petitioner’s Causation Theory is Unreliable and/or not Preponderantly Supported by
the Evidence
I need not engage in an Althen causation analysis under the circumstances. See e.g.,
Lasnetski v. Sec'y of Health & Hum. Servs., 128 Fed. Cl. 242, 264 (2016) (no error for special
master to forgo Althen analysis after determining that a petitioner had not in fact experienced the
disease or illness alleged to have been vaccine-caused), citing Hibbard, 698 F.3d at 1365. I
acknowledge, however, that the record does contain post-vaccination instances in which Petitioner
displayed transient tachycardia, and the scattered occurrences of this over time might be enough
to be deemed an injury of sorts. Could this condition be vaccine-caused? The theory offered by
Petitioner was not reliably-established—and is otherwise unpersuasive.
As noted above, I have repeatedly encountered the argument that the HPV vaccine36 can
35 Although my decision does not turn on the reliability of these specific testing results, Dr. MacGinnitie raised
reasonable objections to their trustworthiness. See e.g., First MacGinnitie Rep. at 4–5; Second MacGinnitie Rep. at
3–4.
36 Although Petitioner also asserts the Hep. A vaccine was causal, her focus is on the HPV vaccine—and I do not
otherwise find that evidence specific to the Hep. A vaccine offered in this case was any more persuasive or
preponderant on the question.
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result in the production of autoantibodies sufficient to cause POTS through an autoimmune
process—more often than not alleged to interfere with certain adrenergic nerve receptors. Dr.
Steinman has offered an expert opinion to this end in many such cases. See e.g., E.S., 2020 WL
9076620 at *10–14. But time and again, I have deemed the theory wanting, either because (a) it
was not reliably shown that the vaccine could likely trigger the production of offending
autoantibodies, or (b) the claimant’s injury was not established to fall into the narrow category of
autoimmune-driven POTS (which is almost exclusively not an autoimmune condition). Id. at 44,
50.
Against this backdrop, nothing offered in this case by Petitioner or her experts provides
more recent or more reliable evidence supporting the conclusion that the HPV vaccine might cause
POTS (or any associated autonomic-associated symptoms for that matter). On the contrary, the
theory offered is no different than what I have been presented with before.
Dr. Steinman, for example, makes the same literal arguments about theoretical homology
between components of the HPV vaccine and nerve receptors that are always presented in such
cases—but with insufficient reliable corroborative proof supporting the conclusion that the
homology is meaningful from a pathogenic sense. Merely showing via BLAST searches that some
homology exists between amino acid sequences in the HPV vaccine components and nerve cells
does not amount to a preponderant showing that the vaccine can produce antibodies that will likely
cross-react against those cells. Establishing the existence of potential homology based on internet-
driven research performed solely for this case is thus not enough to meet the preponderant burden
of establishing it more likely than not that the vaccine would cross-react as proposed. Sullivan v.
Sec’y of Health & Hum. Servs., No. 10-398V, 2015 WL 1404957, at *17–18, n.30 (Fed. Cl. Spec.
Mstr. Feb. 13, 2015) (while the law does not require Petitioner to “prove” homology in a Program
case, mere assertion that HPV strain shares sequences with human body such that molecular
mimicry might occur resulting in injury was by itself insufficient to satisfy burden). Indeed, as Dr.
MacGinnitie noted, amino acid sequential/component homologies are easily demonstrated in
nature, but their presence does not also mean concurrent cross-reactivity is inevitable. First
MacGinnitie Rep. at 4. Even Dr. Steinman so concedes. First Steinman Rep. at 15.
Arguments about the autoimmune character of POTS, or the possibility that the HPV
Vaccine could encourage the production of autoantibodies thought to be POTS-associated, were
also unreliably established. It remains true that the majority of cases of POTS are likely not
mediated by an autoimmune process. It has not been otherwise persuasively shown that the HPV
or Hepatitis A vaccines are likely to cause production of the proposed antibodies in any event
(which Petitioner did not even test positive for until years after vaccination). And Respondent’s
experts persuasively established that the vaccines at issue were highly unlikely to cause POTS
specifically or orthostatic intolerance generally. All of the above precludes me from determining
that the “can cause” prong has been met.
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The contention that the HPV vaccine could be associated with “clonic-tonic” seizures or
comparable movements is also thin from a scientific reliability perspective. This purported
association largely (if not wholly) is derived from the HPV vaccine package insert. See First
Steinman Rep. at 17. Putting aside the fact that package inserts are not deemed in the Program to
be particularly probative evidence for injury causation,37 the quoted portion by its own terms reads
as specific to syncope, which would typically occur close-in-time to vaccination. Id. (“observation
for 15 minutes after administration is recommended”) (emphasis added). It cannot be reasonably
read to suggest that the HPV vaccine is associated with a persistent risk of syncope.
Moreover, there is no evidence at all of a close-in-time syncopal event, with no arguable
reaction to the HPV vaccine until a full day later. Ex. 7 at 211-13. And any purported jerking or
seizure-like movements in the days following vaccination were not deemed legitimate seizure
activity by any treaters Petitioner saw (regardless of Petitioner’s assertions to the contrary).
Petitioner otherwise seeks to select isolated instances from the record where a syncopal-like blood
pressure drop can be shown to have temporally-occurred when a “shaking episode” purportedly
occurred (See e.g., Mot. at 7 (highlighting blood pressure reading taken immediately prior to
seizure-like episode)). But the package insert reference cannot be leveraged into a persuasive
causal theory based on this kind of incident—especially since the overall record (a) does not
corroborate POTS, (b) does not contain a diagnosis of syncope, and (c) ultimately preponderates
against a finding that Petitioner routinely suffered from similar “shaking episodes.”
Admittedly, my analysis of Petitioner’s causation showing in this case is more cursory than
what I would deem necessary in other contexts. I could easily go into the “weeds” on the points
made by Dr. Steinman about homology and the possible autoimmune mechanisms by which any
vaccine might trigger disease. But as noted above, I have repeatedly had the occasion to consider
whether medical science establishes an association between the HPV vaccine and a variety of
dysautonomic reactions, including POTS specifically or orthostatic intolerance more generally.
The same kinds of arguments made in those cases are offered herein—and they were no more
persuasive simply through their repetition. This is yet another case where Dr. Steinman has been
enlisted to offer a molecular biology-heavy opinion about homology and a potential for cross-
reactivity, but without sufficient reliable evidence to connect the various sub-components of his
theory. And no reliable scientific or medical evidence was offered that would suggest my prior
determinations should be revisited. As a result, a granular discussion of the deficiencies in
Petitioner’s causation argument would be inefficient,38 and end up repeating what I have now said
37 See Zumwalt on behalf of L.Z. v. Sec'y of Health & Hum. Servs., No. 16-994V, 2019 WL 1953739, at *17 (Fed. Cl.
Spec. Mstr. Mar. 21, 2019), review denied, decision aff'd sub nom. Zumwalt v. Sec'y of Health & Hum. Servs., 146
Fed. Cl. 525 (2019) (“. . . package inserts are generally afforded very little weight in Vaccine Program cases as proof
of causation.”).
38 My determination—not to belabor in great detail the deficiencies with Petitioner’s causation theory—is in part the
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multiple times about HPV vaccine, POTS, and dysautonomia generally.
III. Petitioner’s Condition Has a More Likely Alternative Cause
A related reason for rejecting this claim arises from the fact that the same record that
undermines the existence of any possibly vaccine-caused injury provides a credible and persuasive
alternative explanation for Petitioner’s symptoms. Although “alternative cause” is understood to
be a burden placed on Respondent, special masters are not prevented from taking into account this
kind of evidence when evaluating whether a petitioner has met her Althen burdens. Stone v. Sec'y
of Health & Human Servs., 676 F.3d 1373, 1380 (Fed. Cir. 2012) (“no evidence should be
embargoed from the special master's consideration simply because it is also relevant to another
inquiry under the statute”); de Bazan, 539 F.3d at 1353 (“[t]he government, like any defendant, is
permitted to offer evidence to demonstrate the inadequacy of the petitioner's evidence on a
requisite element of the petitioner's case-in-chief”); see also Inamdar v. Sec'y of Health & Hum.
Servs., No. 15-1173V, 2019 WL 1160341, at *19, n.13 (Fed. Cl. Spec. Mstr. Feb. 8, 2019) (the
burden of proof does not shift to Respondent to prove an alternative cause until a petitioner carries
his initial burden of proof).39
Here, the record is replete with such evidence. For the medical records filed in this case
reliably suggest that Petitioner’s symptoms were more likely attributable to somatization or some
anxiety condition, rather than an independent illness, vaccine-caused or not. See e.g., Ex. 7 at 224,
226–27, 233 (August 20, 2015 ER visit complaining of anxiety, hyperventilation, and a panic
attack); Ex. 9 at 47 (September 22, 2015 neurology evaluation noting the recent stressors in
petitioner’s life may have caused seizure-like activity); Ex. 13 at 213 (September 19, 2015
neurology consultation stating the clinical impression is “probable pseudo-seizures”, “stress
related psycho-somatization or somatization”, and “probable anxiety associated panic”).
Petitioner certainly has provided no reason for me to discount the numerous treater opinions (most
of which come close in time to vaccination, and were never subsequently rejected) that her non-
specific symptoms were not attributable to disease or vaccination.
product of the crushing caseload that burdens the Vaccine Program. Wise management of judicial resources counsels
against penning 100-page decisions in every disputed Vaccine Act case—especially when, as here, the case presents
theories that a special master has demonstrated experience addressing.
39 Given the record in this case, I would be able to find that Respondent had preponderantly established an alternative
cause for Petitioner’s symptoms even if the burden had shifted (which I do not find occurred).
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IV. This Claim was Properly Resolved Without a Hearing
In ruling on the record, I am opting against holding a hearing, over Petitioner’s objections.
The choice of how best to resolve this case is a matter that lies generally within my discretion,
but because Petitioner challenges this manner of disposition, I shall explain my reasoning.
Prior decisions have recognized that a special master’s discretion in deciding whether to
conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to afford each
party a “full and fair opportunity to present its case.” Hovey v. Sec’y of Health & Hum. Servs., 38
Fed. Cl. 397, 400–01 (citing Rule 3(b)). But that rule also includes the obligation of creation of a
record “sufficient to allow review of the special master’s decision.” Hovey, 38 Fed. Cl. at 401; see
also Kreizenbeck, 945 F.3d at 1366. Thus, the fact that a claim is legitimately disputed, such that
the special master must exercise his intellectual faculties in order to decide a matter, is not itself
grounds for a trial (for if it were, trials would be required in every disputed case). Special masters
are expressly empowered to resolve fact disputes without a hearing—although they should only
so act if a party has been given the proper “full and fair” chance to prove their claim.
In this case, no hearing was required to resolve fairly Petitioner’s claim. I was able to
evaluate the evidentiary strength of her asserted injury through a close review of the medical
record. That record overwhelmingly undermines the contention that vaccination harmed
Petitioner. Instead, preponderant evidence strongly supports the conclusion that some other kind
of mental disorder explains her symptoms. All of these matters were self-evident from a careful
review of the record itself, and did not require a hearing for their complete explication.
The fact that multiple numerous expert reports on both sides were filed is also not a
compelling reason to hold a hearing. Petitioner’s decision not to rely on Dr. Brawer’s opinions in
fact limited the number of reports in contention. Moreover, the experts at issue (in particular, Drs.
Steinman and MacGinnitie) have testified before me multiple times. And I am extremely familiar
with Dr. Steinman’s arguments about molecular mimicry as an explanation for autoimmunity, as
well as the broader theory that the HPV vaccine can cause POTS.
Thus, nothing presented by these experts was so complex that I needed to hear their live
testimony. And complexity is never a per se justification for a hearing in any event. Indeed, I have
resolved by ruling on the record science-dense cases in which both sides made credible,
reasonably-contested arguments arising from multiple expert reports. See e.g., D’Toile, 2016 WL
7664475.40 I was able to resolve the disputed issues in such cases, which were fairly disputed,
without live witness testimony. At bottom, my decision to rule without hearing reflects my
40 By contrast, I have also dismissed cases like this one, where the filing of multiple reports masked what was
determined to be a wholly unreliable claim. Kreizenbeck, 945 F.3d at 1365–66 (dismissing on record case in which
parties together offered opinions from six experts in total; petitioner attempted to convert abandoned autism injury
claim into assertion that vaccines precipitated encephalopathic reaction resulting in developmental regression).
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reasoned determination (especially after hearing many comparable claims that the HPV vaccine
can cause POTS or some other forms of dysautonomia) that this record simply does not permit the
conclusion that vaccination had anything to do with J.S.’s symptoms.
V. Comment on Program Viability of HPV/Dysautonomia Vaccine Injury Claims
As of the present date, I have never ruled that the HPV vaccine likely causes any form of
dysautonomia. The medical science that has been offered on this contention in case after case
simply does not support that conclusion—and I am aware of no counter, persuasive analyses that
would suggest the alternative. I have thus decided enough cases involving HPV vaccines and
allegations of dysautonomia to recognize the inherent weakness of such a claim from the start of
the case’s initiation. These claims reflect merely a (literal) temporal “coincidence” between
vaccination and onset—something well recognized to not support causation. Grant, 956 F.2d at
1148. While it remains possible that medical science may someday reach more reliable
conclusions about this subject matter that would present an occasion for reconsideration of my
current conclusions, that day has yet to come.
In the future, Program petitioners and their counsel must avoid bringing claims involving
the HPV vaccine and allegations of dysautonomia if they wish to receive fees.41
CONCLUSION
J.S. may have experienced a number of overlapping symptoms and conditions over many
years that have caused her and her family considerable anguish—in their efforts to treat as well
as to identify some unifying explanation for her constant need for medical care. She also no doubt
has a good faith belief that the HPV and flu vaccines had to have some relationship to her
41 I also emphasize that I find that this particular case lacks reasonable basis going forward. See Heath v. Sec'y of
Health & Hum. Servs., No. 19-749V, 2020 WL 7869438, at *2 (Fed. Cl. Spec. Mstr. Nov. 16, 2020) (“The standard
for reasonable basis is lesser (and inherently easier to satisfy) than the preponderant standard applied when assessing
entitlement, as cases with reasonable basis (because they have objective proof supporting the claim) can nevertheless
still fail to establish causation-in-fact.”) (citing Braun v. Sec'y of Health & Human Servs., 144 Fed. Cl. 72, 77 (Fed.
Cl. 2019)); see generally E.S. v. Sec'y of Health & Hum. Servs., No. 17-480V, 2021 WL 5816006, at *5 (Fed. Cl.
Spec. Mstr. Nov. 10, 2021) (warning counsel that I shall be more inclined to deny attorney’s fees in the future for
HPV and allegations of dysautonomia in cases that do not present any new or more reliable scientific or medical
evidence to support the claim—however, I would note that the case herein was filed before this fee’s decision).
Even if some objective evidence supported the claim at the time of its initiation, I have now concluded that no reliable
science supports Petitioner’s contentions, and therefore it can no longer be reasonably contended that Petitioner’s prior
symptoms are “objective” support for the claim. As a result, counsel acts at his own risk if he opts to extend this
claim’s life further, such as through unnecessary motions for review or additional appeals. I will not award any fees
incurred for such work (although I am prepared to award fees reasonably devoted to the claim’s prosecution up to this
point).
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injuries—if for no other reason than the increased tempo of her symptoms post-dated her receipt
of the vaccines.
Nevertheless, the overall picture painted herein by the objective medical record is
unsupportive of the conclusion that the HPV and Hep. A vaccines were causal of any of her post-
vaccination symptoms, despite their complex array and convoluted progression. Nor, more
fundamentally, do those symptoms add up to a discernible injury. The deficiencies of this claim
were self-evident enough that a hearing was not required to adjudicate the matter.
Accordingly, for the reasons set forth above, I deny compensation in this case and dismiss
the matter. In the absence of a timely-filed motion for review (see Appendix B to the Rules of
the Court), the Clerk shall enter judgment in accord with this decision.42
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
42 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.
37