VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-01526
Package ID: USCOURTS-cofc-1_15-vv-01526
Petitioner: A.E.S.
Filed: 2015-12-15
Decided: 2025-06-25
Vaccine: Pediarix (DTaP/IPV/Hep B); Hib; PCV13; RotaTeq
Vaccination date: 2013-12-16
Condition: post-vaccinal encephalopathy and death
Outcome: compensated
Award amount USD: 300000

AI-assisted case summary:
On December 15, 2015, Abigail and Daniel Sims filed a petition under the National Vaccine Injury Compensation Program on behalf of their deceased infant daughter, A.E.S. A.E.S. was eleven weeks old on December 16, 2013, when she received the Pediarix (DTaP/IPV/hepatitis B), Haemophilus influenzae type b (Hib), Prevnar 13 (PCV13), and RotaTeq vaccines. Petitioners alleged that these vaccinations caused A.E.S. to suffer a Table encephalopathy leading to her death, or alternatively, an off-Table encephalopathy, pulmonary edema, visceral congestion, and death. 

A.E.S. was described as a healthy, breastfed infant who was alert and engaged. On the day of vaccination, she received the shots at approximately 11:00 AM. Petitioners reported that in the afternoon, A.E.S. became unusually quiet, tired, fussy, and exhibited a distant gaze without normal eye contact. She also fed less and seemed to be seeking comfort rather than nourishment. Later that evening, between approximately 5:45 PM and 6:15 PM, Mr. Sims found A.E.S. in her bassinet, pale, with blue lips, and struggling to breathe, positioned with her head extended back. Despite resuscitation efforts at Baptist Memorial Hospital, A.E.S. was pronounced dead at approximately 7:15 PM, about eight hours after her vaccinations. The autopsy classified the cause of death as undetermined, but noted findings consistent with Sudden Unexplained Infant Death (SUID). The autopsy also revealed an abnormally heavy brain (595 grams, exceeding the expected range of 461-555 grams) with cerebral edema, as well as pulmonary edema and visceral congestion. There was no evidence of trauma or infection.

Petitioners presented expert testimony from Dr. Robert Shuman, a pediatric neurologist, who opined that the vaccinations caused an encephalopathy with cerebral edema and axial herniation leading to death. He linked A.E.S.'s altered behavior, poor feeding, and abnormal gaze to this condition. Petitioners also presented Dr. M. Eric Gershwin, an immunologist, who supported an off-Table inflammatory theory involving vaccine-triggered immune activation and cytokine-mediated injury. 

Respondent relied on expert testimony from Dr. Christine McCusker, a pediatric immunologist, and Dr. Brent Harris, a neuropathologist. Respondent argued that the evidence was consistent with SUID, that epidemiological studies did not link vaccines to SIDS, and that the parents' later descriptions of A.E.S.'s condition were not credible. Dr. Harris agreed the brain was heavy and edematous but disputed that the autopsy proved vaccine-related encephalopathy. Dr. McCusker suggested Long QT syndrome as a possible explanation, though no genetic testing supported this. 

On March 7, 2024, Special Master Mindy Michaels Roth found Petitioners entitled to compensation, crediting the parents' testimony and Dr. Shuman's opinion. She concluded A.E.S. suffered a DTaP Table encephalopathy within 72 hours of vaccination, leading to her death. She also found entitlement on the off-Table theory, noting that Respondent had not proven an alternative cause. 

On January 8, 2025, Special Master Roth awarded damages. She awarded the statutory $250,000 death benefit and $50,000 for pain and suffering, totaling $300,000. The Special Master reasoned that while A.E.S. experienced distress, her awareness was limited due to her age, and her suffering lasted hours. 

Respondent sought review. On June 25, 2025, Judge Carolyn N. Lerner sustained the Special Master's decision. The court found the Special Master properly applied the Table-encephalopathy standard, reasonably credited the parents' testimony and Dr. Shuman's opinion, and reasonably concluded A.E.S.'s death was a sequela of the encephalopathy. The court also found Respondent had not shown an alternative cause. The total award of $300,000 was upheld. Petitioners were represented by Michael G. McLaren of Black McLaren Jones Ryland & Griffee, P.C.

Theory of causation field:
Pediarix (DTaP/IPV/Hep B), Hib, PCV13, and RotaTeq on December 16, 2013, at age about 11 weeks, followed by alleged Table encephalopathy and death the same day. COMPENSATED after entitlement litigation and damages. Petitioners Abigail and Daniel Sims relied on pediatric neurology/autopsy evidence from Dr. Shuman and immunology evidence from Dr. Gershwin; respondent relied on Dr. Barnhart, Dr. Harris, and Dr. MacLennan and argued SUID/SIDS or non-vaccine explanations. Special Master Horner credited the parents' account, found acute encephalopathy within the Table window, found no better alternative cause, and awarded $300,000 total ($250,000 death benefit plus $50,000 pain and suffering). Judge Carolyn N. Lerner denied respondent's motion for review and sustained entitlement on June 25, 2025. Later attorney-fee decision did not change merits outcome.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-01526-2
Date issued/filed: 2024-04-01
Pages: 53
Docket text: PUBLIC RULING (Originally filed: 3/7/2024) regarding 97 Ruling on Entitlement. Signed by Special Master Mindy Michaels Roth. (dkj) Service on parties made.
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Case 1:15-vv-01526-CNL Document 99 Filed 04/01/24 Page 1 of 53
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-1526V
Filed: March 7, 2024
* * * * * * * * * * * * * * *
ABIGAIL SIMS and DANIEL SIMS, on *
behalf of their deceased daughter, A.E.S., *
*
Petitioners, *
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * *
Michael G. McLaren, Esq., Black McLaren, et al., PC, Memphis, TN, for petitioners.
Voris E. Johnson, Esq., U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT1
Roth, Special Master:
On December 15, 2015, Abigail and Daniel Sims (“petitioners”) filed a petition on behalf
of their minor daughter, A.E.S., for compensation under the National Vaccine Injury
Compensation Program.2 Petitioners allege that A.E.S. died on December 16, 2013, as a result of
the Pediarix (DTaP/IPV/HepB), Hib, PCV13, and RotaTeq vaccinations she received that day.
Petition, ECF No. 1.
After reviewing all the evidence filed herein, I find that the vaccines A.E.S. received on
December 16, 2013 contributed to her death.
1 Because this Ruling contains a reasoned explanation for the action taken in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims' website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means
the Ruling will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b),
Petitioners has 14 days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. If, upon review, the undersigned finds that the identified material fits
within this definition, such material will be redacted from public access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation,
all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012).

Case 1:15-vv-01526-CNL Document 99 Filed 04/01/24 Page 2 of 53
I. Procedural History
Petitioners filed their petition on December 15, 2015. ECF No. 1. Petitioners filed
supporting medical records and affidavits over the months that followed. ECF Nos. 9, 12.
Respondent filed his Rule 4(c) Report on May 12, 2016, recommending against
compensation. ECF No. 14.
Thereafter, petitioners filed additional medical records and an expert report and medical
literature from Dr. Robert Shuman.3 ECF Nos. 23, 26.
Respondent filed expert reports from Dr. Christine McCusker and Dr. Brent Harris, as well
as supporting medical literature.4 ECF Nos. 35-38. A status conference was held on October 11,
2017, during which the parties were encouraged to discuss settlement. ECF No. 39. In a status
report filed on November 20, 2017, respondent advised that he intended to defend the case. ECF
No. 40.
On June 15, 2018, petitioners filed an expert report and supporting medical literature from
Dr. Eric Gershwin. ECF Nos. 43-46. Respondent filed a responsive expert report and literature
from Dr. McCusker on September 24, 2018, and petitioners filed a supplemental report from Dr.
Gershwin on December 7, 2018. ECF Nos. 50-51. On January 29, 2019, respondent filed a status
report indicating that no further expert reports would be filed. ECF No. 53.
An entitlement hearing was scheduled for December 17 and 18, 2020. ECF No. 55.
Petitioners filed additional medical literature, a prehearing brief, and amended petition on
October 22, 2020. Petitioners’ Pre-Hearing Brief (“Pet. Pre-H Brief”), ECF No. 59; ECF Nos. 58,
60. The amended petition alleged that on December 16, 2013, A.E.S. was administered Pediarix
(DTap/IPV/HepB), Hib, PCV13 and RotaTeq vaccinations from which she suffered injuries
including “an on-Table encephalopathy which led to her death. In the alternative, the above
vaccinations caused an Off-Table encephalopathy, pulmonary edema, visceral congestion, and
death.” Amended Petition at 1, ECF. No. 60.
On November 12, 2020, respondent filed his pre-hearing brief. Respondent’s Pre-Hearing
Brief (“Resp. Pre-H Brief”), ECF No. 61. On the same date, petitioners filed additional medical
literature, medical literature summaries, and demonstrative exhibits. ECF Nos. 62-66. Respondent
filed his medical literature summaries on November 19, 2020. ECF No. 69. The parties filed a joint
pre-hearing submission on December 3, 2020. Joint Pre-Hearing Submission (“Joint Sub.”), ECF
No. 75.
A virtual hearing was held on December 17 and 18, 2020. During the hearing, Drs. Shuman
and McCusker referenced additional literature which was ordered to be filed after the hearing. ECF
3 In the interim, petitioners filed four unopposed motions for extensions of time to file expert reports, which were
granted. ECF Nos. 18-22.
4 In the interim, respondent filed two unopposed motions for extensions of time to file expert reports, which were
granted. ECF Nos. 33-34.
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No. 79. On February 1, 2021, petitioners filed their additional literature and respondent filed a
supplemental report and the additional literature from Dr. McCusker. ECF Nos. 86-87.
The parties filed post-hearing briefs on May 3, 2021. Petitioners’ Post-Hearing Brief (“Pet.
Post-H Brief”), ECF No. 90; Respondent’s Post-Hearing Brief (“Resp. Post-H Brief”), ECF No.
89.
This matter is now ripe for decision.
II. Overview of the Case
On December 16, 2013 at approximately 11:00 am, A.E.S. was administered Pediarix, Hib,
PCV13, and Rotateq vaccinations at her two-month well-baby check-up. See Petition, ECF No. 1;
Amended Petition, ECF No. 60. Between 5:45 and 6:15 pm, A.E.S. was found in her bassinet face
up and barely breathing with a pale blue tint to her skin. En route to the hospital, A.E.S. stopped
breathing. Despite resuscitation efforts, she was pronounced dead at approximately 7:15 pm.
Petitioners allege that the vaccinations administered to A.E.S. caused her to suffer a Table
encephalopathy leading to her death or, alternatively, a non-Table encephalopathy, pulmonary
edema, visceral congestion, and death. Amended Petition at 1.
Respondent disagrees, arguing that the coroner concluded A.E.S. died of Sudden
Unexplained Infant Death (“SUID”) and vaccines are not implicated as a cause of SIDS/SUID.
Resp. Post-H Brief at 3, 15-16. The medical examiner concluded that the cause of death was
“undetermined” and the findings were consistent with SUID. Pet. Ex. 3 at 1,4.
The differential diagnosis of sudden death in infants can be challenging and complex. A
distinction exists between sudden unexplained infant death (“SUID”) and sudden infant death
syndrome (“SIDS”). The two are not synonymous and the distinction will be further clarified
below. Infants may die suddenly and unexpectedly for a variety of reasons, but a determination of
SIDS can only be made after a thorough autopsy, death scene investigation, and review of the
clinical history. Even after such due diligence, approximately 85% of SIDS cases remain
unexplained, and the other 15% comprise a host of medical disorders, accidental and non-
accidental trauma, and overlay. Pet. Ex. 55 at 3.5 In 1989, SIDS was redefined by a panel convened
by the National Institute of Child Health and Human Development as “[t]he sudden death of an
infant under one year of age which remains unexplained after a thorough case investigation,
including performance of a complete autopsy, examination of the death scene, and review of the
clinical history.” Id. SIDS is now defined as the sudden, unexpected death of an infant under the
age of 1, usually during sleep, that remains unexplained after a thorough death scene investigation,
including the performance of a complete autopsy and review of the circumstances of death and
clinical history. Id. at 3-4 (emphasis added). Based on this definition, SIDS is a diagnosis of
exclusion used when other possibilities have been ruled out. Id. at 4.
The parties agreed that the medical records and autopsy report are accurate, to the extent
that they are consistent with petitioners’ affidavits and hearing testimony. Joint Pre-Hearing
5 POTTER’S PATHOLOGY OF THE FETUS, INFANT AND CHILD 841 (Enid Gilbert-Barness ed., 2nd ed. 2007), filed as “Pet.
Ex. 55.”
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Submission (“Joint Sub.”) at 1, ECF No. 75. The parties further agreed that, to the extent the
affidavits and hearing testimony of the petitioners’ conflict with the medical records or include
information not covered in the medical records, the special master will need to determine which
evidence is more credible or whether such additional evidence is credible. Id.
The parties dispute the significance of the autopsy findings, specifically the presence of
cerebral edema. Joint Sub. at 1.
Petitioners initially presented multiple theories to satisfy Althen Prong I. However, at the
time of the hearing, petitioners advised that “[t]he following theories are no longer to be considered
by the Court: direct toxic insult from pertussis toxin, polysaccharide conjugates of pneumococcus,
or Tween80; and maternal transmission of antibody.” Pet. Post-H Brief at 14 n.2; Tr. at 172.
III. Issues to be Determined
a. Whether A.E.S. suffered a Table encephalopathy, as defined by the Qualifications and
Aids to Interpretation (“QAI”), 42 C.F.R. § 100.3(b)(2)(i)(a) (effective July 23, 2015
to March 20, 2017), leading to her death.
b. Alternatively, if A.E.S. did not suffer a Table encephalopathy, whether petitioners have
satisfied their burden under the three prongs of Althen for an off-Table encephalopathy
and vaccine-related death.
IV. Factual Evidence
A. Affidavits and Testimony of Abigail Sims, Daniel Sims, and Rocky Kennedy
1. Affidavits and Testimony of Daniel Sims
Mr. Sims submitted two affidavits. See Pet. Ex. 8; Pet. Ex. 136. Mr. Sims is the biological
father of A.E.S. The following are his affirmations: A.E.S. was a healthy infant, developing
normally. Pet. Ex. 8 at 1-2. On December 16, 2013, he accompanied his wife to the pediatrician
for A.E.S.’s well child appointment at which she received Pediarix, Hib, PCV13, and RotaTeq
vaccines. Id. at 1.
Mr. Sims cared for A.E.S. that day after his wife went to work. Pet. Ex. 8 at 2. At about
5:00 pm, he fed and burped A.E.S. and laid her on her back in her bassinet to sleep. Id. When he
checked on her around 5:45 pm, A.E.S. was not breathing and had a bluish tint to her upper lip.
He picked her up, put her in the car, and drove to Baptist Memorial Hospital where his wife
worked, calling Mrs. Sims from the car. Id.
The doctors in the emergency room worked on A.E.S. for about an hour but were unable
to resuscitate her. She was pronounced dead at 7:15 pm. Pet. Ex. 8 at 2.
A.E.S.’s death had a profound impact on the family, forcing them to leave their apartment
and get rid of all things that reminded them of her death. Pet. Ex. 8 at 2. About a year after A.E.S.
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died, the Sims had another child. He and his wife often stayed up at night after their son received
his vaccinations to make sure he did not stop breathing. Id. at 2-3.
In his second affidavit, Mr. Sims clarified that he went with his wife to the pediatrician’s
office for A.E.S.’s well child visit on December 16, 2013, but remained in the waiting room with
their two sons. After A.E.S. received her shots, they went home. Pet. Ex. 136 at 1. A.E.S seemed
tired after her vaccinations. Id.
At that time, Mr. Sims was a stay-at-home father. When they arrived home from the
pediatrician’s office, Mr. Sims held A.E.S. on the couch, then watched TV while his wife fed her.
That afternoon, A.E.S. was “spaced out,” and not cuddling or snuggling as usual. Pet. Ex. 136 at
2. Mr. Sims drove his wife to work. Upon returning home, he gave the boys a snack while they
watched cartoons and A.E.S. napped. The boys then went to play in their room. A.E.S. was fussing,
so he fed her again. Id. She fed less and a bit slower than usual. He placed her in her bassinet face
up, neck neutral, arms at her side, and hands unclenched. He went back to the kitchen to wash the
dishes. Id. There was no baby monitor, so he checked on her periodically as was their routine.
When he returned after finishing the dishes, he found A.E.S. with slightly blue lips, turned onto
her side with her head canted upward and tilted back a good bit with her mouth open. Id. She was
pale, her eyes were closed, and one hand was clenched. Mr. Sims heard A.E.S. exhale as he picked
her up. She was limp but still warm to the touch. He held her close to his chest, went to the living
room to call his wife and get the boys dressed and into the car. Id. at 3. Mr. Sims thought he felt
A.E.S. move twice in his arms in the four minutes it took him to get her and the boys into the car.
It took six minutes to get to the hospital. Once at the ER, the doctors worked on A.E.S. for around
an hour. She was pronounced dead at 7:15 pm. Id. at 3.
“Rocky the medical examiner” spoke to him and his wife at the hospital not long after
A.E.S. died. Mr. Sims provided Rocky with the events of the afternoon, and Rocky made the
diagrams contained in his written report. Pet. Ex. 136 at 3.
Mr. Sims testified at the hearing. He was 40 years old and worked for the facilities
maintenance department at the University of Mississippi. Tr. 45-46. When A.E.S. was born, he
was a stay-at-home dad homeschooling their two sons. Tr. 47. His wife worked at the hospital
from 3:00 pm until anywhere between 7:00 pm and 11:00 pm, depending on what was going on
the hospital floor where she worked. Tr. 49.
Mr. Sims stated his wife’s pregnancy and birth of A.E.S. were without complication. Tr.
47. He described A.E.S. as alert, wide awake, always looking around, with a “presence on her
face.” She would fall asleep in your arms and sometimes cooed back when you spoke to her. Tr.
50. She was breastfed, so his wife would pump and leave bottles for him when she was at work.
Tr. 50-51. A.E.S had no problem taking a bottle. Tr. 51.
Mr. Sims stated they lived in a two-bedroom apartment. His wife had a lot on her plate so
he would get up early, get everything ready for the day, feed and dress the boys, and take care of
the house. Tr. 51.
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Mr. Sims did not notice anything unusual about A.E.S. on the morning of December 16,
2013. They all went to the pediatrician, and he stayed in the waiting room with the boys while his
wife took A.E.S. to have her vaccines. Tr. 52-53. He was surprised that A.E.S. was very quiet
when his wife came back out because the boys always came out in tears after shots. A.E.S. was
quiet on the ride home. He held her on the couch while his wife got ready for work, and they all
took his wife to work. Tr. 53.
After returning home, A.E.S. was quiet and tired. He recalled the boys being tired after
getting shots, so he thought it was part of the side effects of her vaccines. Tr. 55. He sat on the
couch with her for 30 to 40 minutes, fed her, and laid her down to nap. Tr. 55-57, 76. He described
A.E.S. as “super spaced out”; not “locking on to any one person”, but “just kind of looking up, just
looking around the room” with her mouth more open than usual. She seemed “not all there.” Tr.
59-60. She was quiet, not fussy. Tr. 77. He recalled it taking longer than normal for her to feed,
like she was not interested, and she ate very slowly. Tr. 55-56, 77. She looked very tired, so he put
her on her back in the bassinet, facing up, arms at her sides, legs straight. Tr. 57.
He then went to the kitchen to clean the dishes and check on the boys. About 20 minutes
later, he went back to check on A.E.S. Tr. 58. They did not have a baby monitor, so he would
check on her every 5-20 minutes to see if she was still asleep. Tr. 59-60. When he went in to check
on her, “[H]er head was extended back. Her mouth was open. She was half onto her side. Her arms
were slightly back. It looked like she was almost trying to turn onto her side slightly.” Tr. 58, 61.
Her head was “. . . facing upward in the bassinet with her mouth open, her eyes slightly closed.
And her lips were blue at the ends.” Tr. 62. When he picked her up, she made a noise “like
exhaling”, and he looked at her to see if she was going to make another noise then clutched her to
his chest, grabbed the phone, and called his wife. As he was calling, he told the boys to get their
shoes and coats on. Tr. 58-59, 63. She was limp and very, very pale. Tr. 62-63. He put A.E.S. in
her car seat in the house. At that point, he thought she had already died. Tr. 63. They left the house
heading to the hospital in less than four minutes. Tr. 59. He got to the hospital in under six minutes.
His wife was waiting there, grabbed the car seat with A.E.S., and ran into the hospital. He parked
the car and ran into the hospital carrying the boys. Tr. 64. His wife’s coworkers took the boys, and
he ran to where his wife was. Three or four doctors were there trying to revive A.E.S. She was
pale and very limp. He held his wife until a doctor came over and told them A.E.S. was gone. Tr.
65-66. He later learned that she had respirations and a heartbeat when they arrived at the hospital.
Tr. 63-64.
Mr. Sims did not recall much of the details after that, but they went to another room where
Mr. Kennedy, who he had met a couple times at the hospital, came to talk to them. He tried to
answer the questions as best as he could. Tr. 66-67. He confirmed the information contained in
Mr. Kennedy’s report but noted they did not have a baby monitor. Tr. 69-73; see Pet. Ex. 7 at 7-9.
He was directed to the diagram on page 8. He told Mr. Kennedy that “[h]er head was extended
back. Her mouth was open. Her eyes were slightly open. One arm was over the other. She had one
leg that was slightly, like, cocked back, almost as if she was trying to roll to her side with her head
extended back. Her mouth was open. And her face was, like, extremely pale.” Tr. 73.
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2. Affidavit and Testimony of Abigail Sims
Mrs. Sims submitted two affidavits. See Pet. Ex. 9; Pet. Ex. 135. She is A.E.S.’s biological
mother. Mrs. Sims affirmed the following: prior to December 16, 2013, A.E.S. was a healthy baby.
On December 16, 2013, she and Mr. Sims took A.E.S. to the pediatrician, where she was given
Pediarix, Hib, PCV13, and RotaTeq vaccines. Pet. Ex. 9 at 1-2.
Mrs. Sims received a telephone call from Daniel while at work between 5:45 pm and 6:00
pm that he found A.E.S. in her bassinet, not breathing. He was on the way to the ER at the hospital
where she worked. Once at the hospital, the doctors worked on A.E.S. for about an hour in the ER.
A.E.S. was pronounced dead at 7:15 pm. Pet. Ex. 9 at 2.
Mrs. Sims was profoundly affected by the death of A.E.S. She and Mr. Sims stayed up at
night taking turns holding their son, who was born a year later, after he received his vaccinations,
unable to sleep out of fear he too would stop breathing. Pet. Ex. 9 at 2.
In her second affidavit, Mrs. Sims affirmed that she and her husband took A.E.S. to the
doctor on December 16, 2013. A.E.S. was seen by a nurse, not a doctor, and given her shots; they
were told she was growing wonderfully and was healthy and perfect. Pet. Ex. 135 at 1.
A.E.S. was breastfed on demand between 5-8 ounces per feeding, so Mrs. Sims pumped
and left bottles while she was at work. A.E.S. would usually sleep for an hour or so after feeding.
Pet. Ex. 135 at 2.
A.E.S. was a happy baby, who had just started cooing, smiling, and rolling over in the
weeks prior to her death. Pet. Ex. 135 at 2.
After A.E.S. was given her shots, Mrs. Sims sat and fed her until she calmed down before
leaving the doctor’s office. At home, Mrs. Sims held her until she had to get ready for work at 3:00
pm. A.E.S. slept most of time, opened her eyes sometimes but was not making eye contact and
had a distant look, as though she was looking past Mrs. Sims. She did not cuddle. Pet. Ex. 135 at
2.
Mrs. Sims put A.E.S. in her car seat in the house so she could get ready for work. Mr. Sims
drove her to work with the children in the car. Pet. Ex. 135 at 2. Mr. Sims called her at work and
said A.E.S.’s upper lip was blue, and he was bringing her to the ER. She met him downstairs and
carried A.E.S. into the ER. A.E.S. was not breathing. Pet. Ex. 135 at 3. The ER doctors worked on
A.E.S. for around an hour and pronounced her dead at 7:15 pm. “Rocky Kennedy the medical
examiner” spoke to her and Mr. Sims in the ER after A.E.S. died. The family went home to
Jackson, Mississippi afterward to stay with family until A.E.S.’s funeral. Id.
At hearing, Mrs. Sims stated she is a project manager for federal grants at the University
of Mississippi School of Pharmacy. Tr. 9. She now has four boys, ages 12, 9, 5, and 10 months.
A.E.S. was her third child, born between the 9-year-old and 5-year-old. Tr. 8. Mrs. Sims studied
nursing but decided it was not for her and went into finance. She took CPR courses and worked at
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two hospitals as administrative staff while she was in school. At the time of A.E.S.’s death, she
was a floor secretary at Baptist Memorial Hospital North Mississippi. Tr. 9-10.
Mrs. Sims described her pregnancy, labor, and delivery as normal. A.E.S. was born without
complications and was healthy thereafter with no illnesses. Tr. 11. At the time of A.E.S.’s death,
Mrs. Sims was in school at the University of Mississippi from 8:00 am until about 1:00 pm and
worked at the hospital from 3:00 pm to 11:00 pm. Finals had just ended, so things were more
relaxed. Tr. 12. Mr. Sims took care of the children when she was in school and at work. A.E.S.
was a happy baby and very connected to the family. Tr. 13. Mrs. Sims showed a picture of A.E.S.
a few weeks before she died. Pet. Ex. 102.
A.E.S. was fed only breastmilk, every two to three hours or every four to five hours at night
but was a frequent feeder. She would nap for about two hours at a time. Tr. 15. At the time of her
death, she was smiling, cooing, and babbling and could roll from back to side to belly and from
belly to side, but getting back on her back took some frustration. Tr. 16-17. She typically ate about
four ounces, fell asleep while feeding, woke somewhat when burped, then drifted back to sleep.
Tr. 16.
On the day A.E.S. died, the family awoke around 7:00 or 8:00 am. Mrs. Sims prepared
breakfast for everyone; she always fed A.E.S. with the family. She breastfed about three times that
morning before they left for the pediatrician. Tr. 14. They all went to the pediatrician, and Mr.
Sims stayed in the waiting room with the boys while she went to the examining room with A.E.S.
A.E.S. was examined by a nurse, noted as perfect, healthy, and on track in height and weight. She
received the vaccinations in her thighs. A.E.S. cried, so Mrs. Sims nursed her to calm her before
they all went home. Tr. 19-21. Mrs. Sims showed a picture of A.E.S taken by Mr. Sims at the
pediatrician’s office at around 12:00 or 12:15 pm, after her vaccinations. Tr. 39; see Pet. Ex. 103.
Once back home, Mrs. Sims held A.E.S. on the couch until she had to get ready for work
at around 2:30 pm. She described A.E.S. that afternoon as sleepy, fussy, and looking really tired.
She was not “looking at me” but “kind of looking past me” like she was daydreaming. She “was
just needing me, so I just held her until I had to get ready” for work. She was feeding every 20 to
30 minutes but not really feeding, she was seeking comfort. Tr. 21-22. A.E.S. was normally a very
happy baby who hardly cried, but that afternoon she was fussy, whining, whimpering and “had a
quiet look in her eye.” Tr. 21-22. When awake, she had a quiet whine, like she had a headache and
didn’t want to make noise. Tr. 40. Mrs. Sims walked with her and soothed her knowing she did
not feel well after her shots. Tr. 23. She spit up but was not actively vomiting. Tr. 41.
The family had one car and did not have a babysitter, so they all took her to work, which
was about seven minutes away, at around 2:50 pm. Tr. 24. When at work, Mr. Sims would text her
but knew she was not allowed take calls until her break, so it was odd when he called that day. Tr.
25. Mrs. Sims went into a supply closet to take the call. Tr. 26. Mr. Sims was incoherent, saying
he could not wake someone, then she realized it was A.E.S. She went to the head nurse while on
the phone with her husband. The head nurse called down to the ER to alert them and said an
ambulance would take 10 minutes to get to the Sims’s apartment. Mrs. Sims told her husband to
drive to the ER which would be faster. Mr. Sims called back from the car. Tr. 26-27. He was
panicked driving and arrived within four or five minutes. Tr. 28. Mrs. Sims waited at the ER
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entrance, grabbed the car seat from the car, and ran into the ER. Tr. 29. A.E.S. looked slightly
grayish, her lips were blue, but she was still warm to the touch. The first doctor she saw pulled
A.E.S. out of the car seat and turned her over, patting her back and looking for a pulse. She did not
recall if there was a pulse, but A.E.S. was not breathing at that point. The doctor brought A.E.S.
into a room where nurses and staff were waiting and started CPR, administering medications, and
suctioning. Mrs. Sims was in her uniform, so she doesn’t think they realized she was the mother.
She stayed in the room the entire time until a doctor approached her and said there was nothing
more they could do. Tr. 29-31.
Mrs. Sims knew Rocky Kennedy. He was always called for a death at the hospital, and she
worked on a hospice and renal failure unit. Tr. 31. Mr. Kennedy spoke to her and Mr. Sims. They
answered all his questions. She does not know if he went to their apartment, because they left the
next day to stay with family in Jackson. A.E.S. was buried there. Tr. 33-34.
Both Mr. and Mrs. Sims described their apartment to Mr. Kennedy as a two-bedroom
apartment where A.E.S. slept in a bassinet in their bedroom. Tr. 17, 34-35. They did not have a
baby monitor as reflected on the form. Tr. 41. Mrs. Sims knew about SIDS and took precautions
with all her children. A.E.S. was always placed on her back in her bassinet, with nothing in the
bassinet except maybe a pacifier, which she was not fond of. They stopped swaddling her at around
3-4 weeks old because she didn’t seem to like it. Tr. 17-19.
After A.E.S. died Mrs. Sims had another baby who was born at 37 and a half weeks and
was very small. They were told he had Long QT syndrome, probably because he was not full-term.
He was on a cardiac monitor for the first six months, which went off frequently when he cried
because his heart rate would go up. Tr. 36-37. His EKG was normal at his pediatric cardiologist
visit at one month old. The doctor told them that they don’t know how many babies are born with
Long QT syndrome because EKGs are not done on healthy babies when there is no history of SIDS
in the family, so it may be more common than is known. Their son is fine now. Tr. 38.
3. Report and Testimony of Rocky Kennedy, CMEI
An investigation report was generated by Rocky Kennedy, CMEI, which included
references to the ER record and the autopsy report. The report history included a 11-week-old who
had a check-up and received vaccinations earlier in the day, with no reactions noted throughout
the rest of the day until the stated incident. Pet. Ex. 7 at 1. A Sudden Unexplained Infant Death
Investigation (“SUIDI”) form was completed by Mr. Kennedy on December 16, 2013. Pet. Ex. 7
at 7-14. The form included a host of questions with answer options to be used during witness
interviews, including but not limited to the medical history of both mother and baby during
pregnancy, where the baby was found, how the baby was positioned both before and after being
found, what the baby was wearing, the surrounding environment, resuscitation attempts, an
incident scene investigation, a diagram of the baby when found, and a summary from the
pathologist. Pet. Ex. 7 at 7-14. Mr. Kennedy’s notes on the form included: blueness top lip, baby
was pale, well baby, routine vaccinations received the morning of death, and that the “apartment
is very clean and well kept.” Id. at 9, 12. On a diagram, Mr. Kennedy wrote, “on back, slightly left
lateral arms over the side; head/neck back/ slightly left”. Id. at 13. A copy of the death certificate
was attached. Id. at 15-16.
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Mr. Kennedy testified at hearing. He is the county medical examiner investigator (“CMEI”)
for Lafayette County. Tr. 80-81. He has a bachelor’s degree in business communications from
Georgetown College in Kentucky, graduated from Mid-America College of Funeral Technology,
and is licensed in funeral procedures in the State of Mississippi. He is certified as a county medical
examiner investigator in Lafayette County to conduct death investigations as required by the
elected coroners and appointed deputy coroners. He is also trained and certified through the
Mississippi State Medical Examiner’s office as a sudden unexplained death investigator. Tr. 81.
If a death takes place in the hospital, he is called by the hospital. Otherwise, he is contacted by 911
in Lafayette County for all deaths occurring in the county. Tr. 82. He has been in this position
since 2009. He previously worked in a funeral home as a licensed funeral director and embalmer,
and he was also deputy coroner to the previous medical examiner in Oxford. Tr. 83. He investigates
about 48 to 50 deaths a month, but much more during the pandemic. Tr. 84.
Mr. Kennedy knew Mrs. Sims from the hospital and was impressed by her working to put
herself through school while still being home with her children during the day. He would not ever
forget the emotions he saw Mr. and Mrs. Sims go through when A.E.S. died. Tr. 84.
Mr. Kennedy was already at the hospital investigating another death when A.E.S. died. Tr.
84. He gives the same attention to all deaths, but his questions are different for an unexplained
infant death. Tr. 85.
Mr. Kennedy confirmed Petitioner’s Exhibit 7 was his report. Tr. 85. He printed the form
on the morning of December 17, 2013, which is why that date is reflected. Tr. 86. He issued a
permit requesting that the State Medical Examiner complete a post-mortem examination. At that
time, autopsies were conducted in Jackson, Mississippi, but now the Medical Examiner’s Office
and Mississippi Crime Lab are in Pearl, Mississippi. Tr. 87. He prepared the SUIDI Reporting
Form. Tr. 88; Pet. Ex. 7 at 7. The information on the form came from interviewing the petitioners
in the emergency room and from a follow-up phone call. Tr. 88-89. Mr. Sims provided the
information about A.E.S.’s positioning as contained in box 18 of the form. See Pet. Ex. 7 at 8. Mr.
Sims did not use the word “hyperextended”; that word is contained on the standard form. Mr. Sims
said her head was back and to the left. Tr. 90-91. He uses a doll or stuffed animal to help the
parents give information. Tr. 91, 97. The child was not wedged between two things. Tr. 92-93;
Pet. Ex. 7 at 8. Mr. Kennedy manually inputs the information he receives from the interviews into
the online case reporting system. Based on information from Mr. Sims, box 31 includes “blue
present on top lip”, and box 32 includes “limp, flexible.” Tr. 93; Pet. Ex. 7 at 9. The information
on page 9 about A.E.S.’s medical history and vaccines the morning of December 16, 2013 came
from his interview with the parents. The list of vaccines came from the Children’s Clinic of Oxford
and was entered later. Tr. 94. The information on page 10 came from the parents, the medical
records at Baptist Hospital, and the care provider. Tr. 94; Pet. Ex. 7 at 10. The information that
A.E.S. took six ounces of breast milk came from Mr. Sims who fed her last and Ms. Sims who
said that the bottles normally contained six ounces. Tr. 95; Pet. Ex. 7 at 10.
Mr. Kennedy did not recall going to the Sims’s home, although the notation that the
“apartment was very clean and well kept” suggests that he did. Tr. 91, 96-97; Pet Ex 7 at 12.
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Mr. Kennedy stated that Mr. and Mrs. Sims were very forthcoming when he questioned
them, with no inconsistencies which he noted on the form. He referred them to grief counseling.
Mr. Sims provided the information for the body diagram. Tr. 98-99. All the check marks were
based on information from the parents. There was no trauma, injury, poisoning, or intoxication.
Tr. 99. He did not know why the boxes for asphyxia, environmental hazards, or preterminal
resuscitative treatment were not marked off, but there were no signs of that seen. Tr. 100. The
information that A.E.S. had received immunizations that day with no reaction until the incident
was provided by her parents. Tr. 100.
B. Medical History
1. Medical History Prior to the December 16, 2013 Vaccinations
A.E.S. was born on October 1, 2013, following an uneventful pregnancy and birth. Pet. Ex.
1 at 1; Pet. Ex. 5 at 82; Pet. Ex. 6 at 99; see generally Pet. Ex. 4. Mrs. Sims was 24 years old during
her pregnancy with A.E.S. On September 6, 2013, Mrs. Sims was administered a Tdap vaccine as
part of her routine prenatal visit. Pet. Ex. 6 at 21.
A.E.S was petitioners’ third child, joining two older brothers. Pet. Ex. 2 at 6. A.E.S.
weighed 6 pounds, 11 ounces at birth with Apgar scores6 of 9 and 9. Pet. Ex. 6 at 99.
A.E.S. was a well, breastfed child with no concerns in the first two months of life. Pet. Ex.
2 at 8-10.
2. Medical History Following the December 16, 2013 Vaccinations
A.E.S. was presented for a well-baby check at approximately 11 weeks old on December
16, 2013 at around 11:00 am. Pet. Ex. 2 at 16-17; Pet. Ex. 7 at 9. She was meeting all milestones
for her age: she followed with her eyes to midline, awoke to loud noise, responded to sound, lifted
her chest when prone, kept her head steady when in a sitting position, spontaneously smiled, and
interacted with her mother. Pet. Ex. 2 at 16. Physical examination was normal. Id. at 18. She was
administered Pediarix, Hib, PCV13 and RotaTeq vaccinations. Id. at 7; 18-19.
At approximately 6:34 p.m., A.E.S. arrived at Baptist Memorial Hospital in an infant
carrier via private vehicle. She was pale. Mr. Sims reported that A.E.S. stopped breathing eight
minutes prior to arrival. A nurse removed her from the carrier and carried her to a trauma room.
She had no pulse. Pet. Ex. 5 at 10-12, 58. CPR was started, she was intubated and given
epinephrine. Id. at 58. Her temperature was 96 degrees. Id. at 10-12; 57-58. Respiratory arrest,
cardiac arrest, and cyanosis were documented. Pet. Ex. 5 at 6. The record includes “gross
pulmonary edema from trachea.” Initial cardiac rhythm was “asystole.” Cardiac arrest and sepsis
were circled in the “DDX” section of the form, with anaphylaxis written in. Id. at 11. The History
of Present Illness documented a “normal day – shots – ate normally.” Id. at 10; Pet. Ex. 7 at 1. Mr.
Sims reported giving A.E.S. a bottle, burping her, and putting her into her bassinet to sleep at
6 The Apgar score is “a numerical expression of the condition of a newborn infant, usually determined at 60 seconds
after birth, being the sum of points gained on assessment of the heart rate, respiratory effort, muscle tone, reflex
irritability, and color.” Apgar score, DORLAND’S ILLUSTRATED MEDICAL DICTIONARY 1654 (33rd ed. 2019)
[hereinafter “DORLAND’S”].
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approximately 5:30 pm. Pet. Ex. 7 at 7. When Mr. Sims checked on A.E.S. at approximately 6:15
pm, she was struggling to breath, her lips were blue, and she was pale. Id. at 1, 7. All attempts at
resuscitation failed, and A.E.S. was pronounced dead at 7:15 pm. Pet. Ex. 5 at 11, 57-58.
3. Autopsy Report
Dr. Erin Barnhart of the Mississippi State Medical Examiner’s Office for Lafayette County
performed the autopsy. Pet. Ex. 3. She noted an 11-week-old who died on December 16, 2012
[sic].7 General findings on autopsy included thymic, epicardial, and pleural petechiae8, pulmonary
edema9, and visceral congestion. The cause and manner of death were “undetermined.” Pet. Ex. 3
at 1.
Autopsy findings were generally unremarkable, except for a brain weight of 595 grams.10
Pet. Ex. 3 at 3. Microscopic descriptions included vascular congestion11 of the heart, intra-alveolar
edema and congestion of the lungs, congestion and focal intraparenchymal blood in the thymus,
and congestion of the liver, pancreas, spleen, and kidney. Id. at 3-4.
Dr. Barnhart documented a normal breast-fed baby who received her 12-week vaccinations
that morning, was fed, burped, and placed on her back in a bassinette to sleep. She was found
approximately 45 minutes later by her father, pale with blue discoloration of the upper lip. Pet. Ex.
3 at 4. She was taken to the ER and attempts at resuscitation were unsuccessful. There were no
congenital abnormalities or acute injuries, toxicology was negative, and the histology was
consistent with gross findings. Id. Dr. Barnhart concluded that the cause and manner of death were
best classified as undetermined, with findings consistent with Sudden Unexpected Infant Death
(SUID). Pet. Ex. 3 at 4.
VI. The Medical Experts
At the time of the hearing, petitioners pursued only the claims raised in their amended
petition which included “an on-Table encephalopathy…” or, in the alternative “an off-Table
encephalopathy, pulmonary edema, visceral congestion, and death” as a result of the Pediarix
(DTap/IPV/HepB), Hib, PCV13, and RotaTeq vaccinations A.E.S. received on December 16,
2013. Amended Petition at 1, ECF No. 60; Pet. Post-H Brief at 14 n.2.
The four experts involved in this case are well known to the Court, equally impressive in
their respective specialties, and all recognized as experts in their respective fields.
This is not a SIDS/SUID case as more fully set forth below and agreed upon by the
respective pathologists, Drs. Shuman and Harris.
7 The autopsy is incorrect. The year of A.E.S.’s death and the subsequent autopsy should be 2013.
8 Petechiae are pinpoint, non-raised, perfectly round, purplish red spots caused by intradermal or submucous
hemorrhage. Petechia, DORLAND’S 1401.
9 Edema is “the presence of abnormally large amounts of fluid in the intracellular tissue spaces of the body, usually
referring to subcutaneous tissues.” Edema, DORLAND’S 587.
10 The expected range for brain weight was 461-555 grams. Pet. Ex. 3 at 3.
11 Congestion is the excessive or abnormal accumulation of fluid, as of blood in a part. Congestion, DORLAND’S 398.
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Accordingly, only those expert opinions regarding an on-Table encephalopathy or,
alternatively, an off-Table encephalopathy and vaccine-related death, will be included in this
decision.
A. Petitioners’ Expert, Dr. Robert Shuman
1. Qualifications
Dr. Shuman graduated from Cornell University School of Arts and Sciences in 1963 with
a degree in experimental psychology. He received his medical degree from Stanford University
School of Medicine in 1968. Pet. Ex. 17 at 1. Dr. Shuman is board certified in pathology
(neuropathology), neuroimaging, and neurology with a special competence in child neurology. Id.
at 2. Dr. Shuman was in private practice at Child Neurology, Inc. from 1991-2006. Id. Dr. Shuman
describes himself as a “pediatric neurobiologist,” which he defines as a person who spends their
life studying the development of children, their aberrations, the treatment for those aberrations,
and prevention. Tr. 103. Dr. Shuman retired from private practice in 2006 and has not seen patients
in a clinical setting since. Tr. 167-68. He now derives part of his income from litigation consulting
and has been involved in many cases over the years, including about 11 vaccine cases since 2000.
Tr. 125. When asked, Dr. Shuman did not believe he has had more than three cases, excluding
Program cases, involving fatalities or reviewing autopsy reports. However, he has friends who are
in pathology and they talk, he maintains his memberships in the American Academy of Pathology
and in Neurology, he reads daily about neurology and pathology, and he maintains his board
certifications. Tr. 169-70. He does not have any specialized training in immunology or toxicology
but is interested in the principles of toxicology and developmental metabolism as it relates to
toxicology. The papers related to neurotoxicology contained in his CV are from the 1970s. Tr. 170.
2. Opinion
Dr. Shuman issued two reports in this case and testified at hearing. Pet. Ex. 16; Pet. Ex. 92.
a. Dr. Shuman’s First Report
In his first report, Dr. Shuman opined that the vaccines received by A.E.S. on December
16, 2013 caused her death by encephalopathy, cerebral edema, brainstem herniation, and
cardiopulmonary failure hours later. Pet. Ex. 16 at 36.
Dr. Shuman noted a normal medical history and a healthy baby who received routine
vaccinations just before noon on December 16, 2013 and was found clinically dead later that day.
Pet. Ex. 16 at 16, 18. In the ER, “[D]uring resuscitation, her lungs became increasingly difficult to
ventilate, produced increasing amounts of frothy edema…obtainable blood pressures
progressively worsened” and she was pronounced dead 7+ hours after her vaccinations. Id. at 16.
“This course of progressively worsening collapse of the cardiopulmonary system is atypical for
SIDS” and A.E.S. did not die of SIDS. Id. at 16, 26.
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Dr. Shuman defined SIDS as “[t]he sudden death of an infant under one year of age which
remains unexplained after a thorough case investigation, including performance of a complete
autopsy, examination of the death scene, and review of the clinical history.” Pet Ex. 16 at 26.
According to Dr. Shuman, A.E.S. had no risk factors associated with SIDS. Pet. Ex. 16 at
24. She had no brain abnormalities, a normal birth weight, was growing normally in weight, length,
and head circumference, no evidence of infection post-mortem, and was in a safe sleeping
environment on her back on a hard surface with no bed clothes to entangle her. Id. SIDS is less
common in girls, and A.E.S. was born full-term with no epidemiological or environmental risk
factors for or family history of SIDS. Id.
Dr. Shuman discussed the vaccines A.E.S. received which included the Pediarix vaccine
containing diphtheria, tetanus, and acellular pertussis (DTaP), recombinant hepatitis B, and
inactivated polioviruses 1, 2, and 3; Hib vaccine; Prevnar 13 vaccine containing 13 antigens of
pneumococcal conjugate; and Rotateq rotavirus vaccine, administered orally. Pet. Ex. 16 at 18. In
total, she received ten vaccines in four different preparations with three adjuvants in three separate
injection sites, which “constitutes a profound immunologic challenge.” Id.
Dr. Shuman noted that the current DTaP contains three acellular pertussis antigens rather
than the 3000 antigens previously contained in the whole cell DTP. The change to acellular
pertussis was made in hopes that the acellular pertussis toxin would be less toxic while retaining
immunogenicity. Pet. Ex. 16 at 19.12 Citing Steinman, Dr. Shuman explained that the pertussis
toxin in DTaP targets the brain producing hypotonic spells, systemic and neurologic collapse,
coma, and seizures. Pet. Ex. 16 at 28; Pet. Ex. 62.13
Dr. Shuman discussed the Prevnar 13 vaccine as containing 13 polysaccharide antigens of
13 pneumococcal variants, with the antibodies produced equaling only half the mass of the antigen
provoking it, but still qualitatively significant in an infant. Pet. Ex. 16 at 20. He provided the data
following administration of Prevnar 13 vaccines at two, four, and six months of age and the
statistics associated with SIDS, inferring that the closer one is to a notable event, the more likely
it is that the notable event caused the result. Fifty percent of deaths occurred within 24 hours of
vaccination, which is worthy of investigation. Id. at 23-24.
Dr. Shuman noted that the package insert for Prevnar 13 includes apnea observed in
premature infants.14 Pet. Ex. 16 at 21. He added that the pneumococcal polysaccharides in the
Prevnar 13 are not as toxic as pertussis toxin, but the package insert shows they have been linked
to cardiac mediated-cyanosis, vascular (cardiac)-mediated pallor, respiratory-mediated apnea, and
nervous system-mediated hypotonia. Id. at 28. Table 4 of the package insert shows that of infants
12 This literature supports a reduction of adverse events believed to have stemmed from the increased reactogenicity
of the 3000 different proteins contained in the whole cell pertussis vaccine versus 2-5 proteins contained in the
acellular pertussis vaccine. Further, the whole cell pertussis vaccine also contains neurotoxins, including endotoxin,
pertussis toxin, and adenylate cyclase. Pet. Ex. 34 at 1.
13 Lawrence Steinman et al., Pertussis toxin is required for pertussis vaccine encephalopathy, 82 PROC. NATL. ACAD.
SCI. USA 8733 (1985), filed as “Pet. Ex. 62.”
14 The Prevnar 13 insert notes that the data is insufficient to assess the effects of concomitant administration of Prevnar
13 with HPV, MCV4, tetanus toxoid, and Tdap. Prevnar 13 is a conjugate vaccine containing Diphtheria CRM protein.
Pet. Ex. 35 at 24.
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two to 12 months of age vaccinated with Prevnar 13, 80% suffer irritability, 70% slept too much,
and 50% had diminished appetite. Pet. Ex. 16 at 28; Pet. Ex. 3515 at 9. According to Dr. Shuman,
these “misbehaviors” show disrupted brain function in infants because “[t]he CNS of the younger
infant is most susceptible to neural toxicity.” Pet. Ex. 16 at 28.
Dr. Shuman discussed the autopsy findings as inconsistent with SIDS. There were no
findings of chronic stress such as cellular infiltrates in organs or evidence of chronic immune
stimulation in the thymus or spleen. Pet. Ex. 16 at 28-29. He explained that in normal infants, fetal
hemoglobin (HgbF) diminishes and converts to adult hemoglobin (HgbA), but in SIDS babies
chronic hypoxic stress stimulates the synthesis of HgbF and impedes the shift to HgbA, chronically
impairing respirations. Id. at 27. Chronic stress in SIDS babies is also seen in the persistence of or
regression to fetal fat from paravertebral fat. Pet. Ex. 16 at 29. Further, there was no extramedullary
hematopoiesis16 present in the liver, kidney, and spleen which also suggests chronic stress, chronic
hypoxemia, or SIDS when present. A.E.S.’s heart was normal, with no signs of cardiomyopathy
or chronic adrenergic stress. The lungs were congested consistent with “acute, severe, clinically
apparent congestive heart failure and pulmonary edema.” Id. Histologically, the thymus showed
deep medullary bleeding consistent with severe congestive heart failure but no subserosal petechia,
which are more superficial but may occur in SIDS. Id. at 30. The lungs were heavy at 120 grams,
affirming the clinical impression of persistent, progressive pulmonary edema with increasing
stiffness of the lungs, causing difficulty in ventilating during CPR. Id. The ER record documented
frothy edema from her airway during CPR, further affirming the histopathologic findings of
proteinaceous fluid in the bronchioles and the congestion of the alveolar capillaries. Succinctly,
there were no signs of chronic stress of the organs indicative of SIDS. Id. at 31.
Further, A.E.S.’s brain weight of 595 grams was consistent with cerebral edema. Pet. Ex.
16 at 31. Dr. Shuman explained that when the brain swells, it pushes down on the brainstem, the
more it pushes, the more the brainstem is compressed and the greater the compromise of normal
brain function. Id. at 27. The hallmarks of the compression of the brainstem from edema include
uncal17 grooving, coning of the cerebellar tonsils, and caudal displacement of the medulla into the
foramen magnum. He conceded none of these findings were documented by the medical examiner
in this case because when the skull cap is removed “the squeezing, distorting, rostral-caudal pile-
driving nature of the cerebral edema on the brainstem and cerebellum are lost once the tough
fibrous constraints of the dura are released” and the brain flows back into its premorbid shape. Pet.
Ex. 16 at 31. Here, the brain was heavy due to edema with increased prominence of the perivascular
and pericellular spaces around neurons of their satellite cells, and of the oligodendroglia along the
fiber tracts. There were rare, mild, and scattered early acute ischemic cell changes in the brain
consistent with rapid death. There was no reactive or chronic gliosis, no evidence of chronic
hypoxemia, and no evidence of chronic disease. Id.
Dr. Shuman argued that the findings of cerebral edema, pulmonary edema, and congestive
heart failure are not features of SIDS. As stated above, findings of SIDS include petechial
15 PREVNAR 13 Highlights of Prescribing Information, Pfizer (2016), filed as “Pet. Ex. 35.”
16 Hematopoiesis is the formation and development of blood cells. Hematopoeisis, DORLAND’S 823.
17 Uncal is “of or pertaining to the uncus.” Uncal, DORLAND’S 1970. The uncus is “the medially curved anterior end
of the parahippocampal gyrus.” Uncus, DORLAND’S 1971.
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hemorrhages in the conjunctivae, pleura, and thymus, thymic atrophy, fetal fat, adrenal stress, or
extramedullary hematopoiesis, none of which were present here. Pet. Ex. 16 at 36.
In Dr. Shuman’s opinion, the DTaP and/or Prevnar 13 vaccinations received on December
16, 2013 caused encephalopathy and cerebral edema, which pushed down on and caused brainstem
herniation affecting respiration and causing cardiopulmonary failure resulting in death hours after
the vaccinations. The evolution of the encephalopathy between vaccination and death is unknown
but not uncommon in a very young, non-verbal infant with no behavioral repertoire to express
distress. Pet. Ex. 16 at 36. Once the cerebral edema caused axial herniation and the brainstem was
impaired, death ensued soon after. A.E.S. “was not resuscitable because the brainstem could not
resume control of the viscera.” Id. She suffered multiorgan failure rapidly thereafter, and the
occurrence of her encephalopathy within 72 hours of vaccination constitutes a “table”
encephalopathy. Id. at 36-37.
b. Dr. Shuman’s Supplemental Report
In his supplemental report, Dr. Shuman noted Dr. Harris’s agreement that the brain weight
on autopsy was heavy. Dr. Shuman referred to the brain weight as a “robust sign of cerebral
edema” citing data from Kayser, Shulz, and Coppoletta, each from different times in history but
all defining A.E.S.’s brain as unusually heavy and exceeding the mean weight for a female child
by more than two standard deviations. In the absence of malformation, such heaviness is objective
evidence of cerebral edema. Pet. Ex. 92 at 1-2; Pet. Ex. 4718; Pet. Ex. 4819; Pet. Ex. 49.20 Dr.
Shuman added that the younger the baby, the smaller the behavioral repertoire to display
autonomic impairment: “[y]oung infants don’t cry loudly about their distress. They die quietly.”
Id. at 3.
Dr. Shuman explained how the vaccines A.E.S. received can affect the brain. He submitted
that although term infants are born with intact and functioning blood brain barriers (“BBB”),
toxic/inflammatory environments can break down the BBB via destructive immunological
processes. Pet. Ex. 92 at 3-4. Vaccines elicit cytokines necessary for inducing an immunological
response. DTaP, Hib, and PCV vaccines are proven to stimulate the production and circulation of
proinflammatory cytokines including interleukins (“IL”) -1β (beta) and IL-6, tissue necrosis factor
alpha (“TNF-α”), and granulocyte colony stimulating factor (“G-CSF”):
IL-1β stimulates macrophage production, T-cell production and fever. IL-6
stimulates T and B cells and produces acute phase reactions such as [inflammation]
and fever in the host. TNF-α stimulates formed macrophages to make more
cytokines (in a positive feedback loop), stimulates inflammatory invasion by
monocytes which then transform into more macrophages, and ‘activates’
endothelial cells.
18 Klaus Kayser et al., Height and Weight in Human Beings: Autopsy Report 9-123 (Munich University of Applied
Sciences 1987), filed as “Pet. Ex. 47.”
19 Dale M. Schulz et al., Weights of Organs of Fetuses and Infants, 74 ARCHIVES OF PATHOLOGY 244 (1962), filed as
“Pet. Ex. 48.”
20 Joseph M. Coppoletta & S.B. Wolbach, Body Length and Organ Weights of Infants and Children, 9 AM. J.
PATHOLOGY 55 (1933), filed as “Pet. Ex. 49.”
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Pet. Ex. 92 at 4. This increases vascular permeability and can cause separation of the endothelial
cell lining of the blood vessel walls, leading to leaking of fluid and protein resulting in
accumulation in the tissue causing swelling or edema. Id. The changes to the endothelium from
inflammation is known as endothelial activation, and TNF-α is a potent cytokine activator of
endothelial cells. Id. at 5. G-CSF stimulates the development and maturation of granulocytes that,
when mature, cluster to ensure tissue lysis and necrosis at the site where they collect and
degranulate. Id.
Dr. Shuman cited Kashiwagi to show that the production of the IL-1β cytokine is provoked
more during the first year of life than later in life and more significantly by multiple vaccines rather
than by a single vaccine. Pet. Ex. 92 at 5; Pet. Ex. 65.21 Kashiwagi only provided age-related data
for IL-1β and not IL-6, TNF-α, or G-CSF, but showed markedly increased circulating cytokines
in those with fever. Circulating levels of potentially damaging cytokines was also seen in data
from the H1N1 flu pandemic in 2009, which showed markedly increased serology levels of four
cytokines in infants hospitalized with H1N1 flu when compared with those less sick, not
hospitalized infants with the flu. Pet. Ex. 92 at 5.
Thus, Kashiwagi demonstrated both: an increase in cytokine production with an increased
number of vaccines and an increase in cytokine production in those under the age of one. Pet. Ex.
92 at 5. Here, A.E.S. received multiple vaccinations containing numerous antigens intramuscularly
and the RotaTeq vaccine orally. The vaccines generated cytokines that circulated to A.E.S.’s brain,
disrupted the BBB, produced severe rapid cerebral edema, and caused A.E.S.’s death by axial
herniation. Id. A.E.S. suffered a malignant form of cerebral edema which was widespread, rapidly
progressive, and lethal within 6-8 hours after vaccination. Id. at 4.
c. Dr. Shuman’s Testimony
Dr. Shuman defined encephalopathy as a disturbance of the brain, or abnormal or depressed
expression of brain function: “…broadly speaking, an encephalopathy is a deviation, a depressive
deviation, a negative deviation of behavior from that expected of that person.” Tr. 127-28.
Behaviors associated with encephalopathy are age dependent and different in infants, children, and
adults. Tr. 128. He referenced the American College of Obstetrics and Gynecology as stating it is
well-established that encephalopathy is a depression in the expected functions of an infant at that
stage of development. Tr. 128-29.
Dr. Shuman stated that the autopsy findings showed objective signs of cerebral edema: a
full and flattened brain “obviously under pressure,” brain weight at least two standard deviations
above the mean for a 10-week-old female, and the absence of inflammation or other obvious cause
of death in the limited samples of the brain taken. Tr. 133-40, 142. He stated that encephalopathy
is a dysfunction of brain tissue. As the brain swells, it takes up more space and the pressure within
the skull increases. The brain is somewhat like fluid and when the volume and pressure increase,
the brain shifts and cuts off vessels between the compartments. The pressure pushes downward on
the brainstem, which causes bradycardia and interferes with functions such as focus, gaze,
21 Yasuyo Kashiwagi et al., Production of inflammatory cytokines in response to diphtheria-pertussis-tetanus (DPT),
haemophilus influenzae type b (Hib), and 7-valent pneumococcal (PCV7) vaccines, 10 HUMAN VACCINES &
IMMUNOTHERAPIES 677 (2014), filed as “Pet. Ex. 65” and “Resp. Ex. E, Tab 4.”
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tracking, sucking, and swallowing. Tr. 134-36. The fontanelle of the newborn skull does not
protect against mass expansion. The dura is fibrous and inelastic and does not give way, though
the bone plates do move a little bit under the pressure. Tr. 133-34. The brain edema that was present
shows the pressure the brain was under with its appearance on autopsy being flattened and smooth
rather than corrugated and folded nicely with the sulci effaced, which is the external expression of
cerebral edema. Tr. 137. Cerebral edema and heaviness were the only abnormal findings in her
brain. Tr. 173, 138-39. Dr. Shuman conceded the brain examination was quite limited and it was
uncertain what may have been missed by the pathologist. Tr. 137-40.
Dr. Shuman cited Von Kries to show how cytokines generated by vaccination can induce
cerebral edema. Tr. 146; Pet. Ex. 144.22 In Von Kries the European Union’s FDA withdrew a
Pediarix equivalent vaccine manufactured by Sanofi Pasteur from the European market after three
children died. Tr. 146; Pet Ex. 144. The study compared the incidence of sudden unexpected death
in age-determined groups of children who had been exposed to a vaccine in the preceding seven
to ten days and those who had not. All the children were autopsied. The three who died after
vaccination were a 12-month-old found dead in his bed two days after vaccination; a 17-month-
old found dead in her crib less than 24 hours after vaccination; and a 22-month-old found dead
within 24 hours of vaccination. All received the hexavalent vaccine, died unobserved, and had
cerebral edema on autopsy; none had inflammatory cell infiltrates indicative of SIDS. Tr. 148-49.
All three cases are similar to A.E.S. following the hexavalent vaccine. Tr. 150. Dr. Shuman agreed
Von Kries did not find proof of causal relationship between the vaccination and death. Tr. 174.
Dr. Shuman discussed Traversa, a study filed by respondent, to show that the first
immunizations at two months of age have more adverse reactions than subsequent vaccinations at
four and six months old because two months olds are more fragile. Tr. 152-53. The Traversa study
concluded that the highest relative risk was within seven days of the first vaccine dose, which is
administered when the risk of sudden unexpected death is greater. Tr. at 156-57; Resp. Ex. A, Tab
16 at 9. Dr. Shuman pointed to Table 5 of Traversa to show a risk increase of almost three times
with hexavalent vaccines like A.E.S. received. Tr. 157-59; Resp. Ex. A, Tab 16 at 8. Traversa
included a different vaccine with different adjuvants from a different manufacturer than the one
used in Von Kries. Tr. 152-54; Resp. Ex. A, Tab 1623 at 9. In Dr. Shuman’s opinion, Traversa
validated the findings of Von Kries and other articles that were not submitted. Tr. 174-75.
Dr. Shuman added that A.E.S.’s thighs showed swelling at the injection sites on the autopsy
photographs, an indication of an inflammatory reaction of the local tissue, which should occur for
cytokine release by circulation. Tr. 161; Pet. Ex. 18 at 2. He added that the vascular system is very
reactive to cytokines and the cytokines released by adjuvanted vaccinations, which include IL-1,
IL-6, tumor necrosis factor, C55 complement, and some prostaglandins, are extraordinarily and
systemically vasoreactive on the brain and pulmonary vasculatures showing their effects by
producing cerebral and pulmonary edema, third-spacing, hypovolemic hypotension, shock, and
progressive encephalopathic death as seen with A.E.S. Tr. 162-63.
22 Rüdiger von Kries et al., Sudden and unexpected deaths after the administration of hexavalent vaccines (diphtheria,
tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilius influenzae type b): is there a signal?, 164 EUR. J.
PEDIATRICS 61 (2004), filed as “Pet. Ex. 144.”
23 Giuseppe Traversa et al., Sudden Unexpected Deaths and Vaccinations during the First Two Years of Life in Italy:
A Case Series Study, 6 PLOS ONE e16363 (2011), filed as “Resp. Ex. A, Tab 16.”
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Dr. Shuman disagreed with Dr. McCusker that the congestion of the organs and the frothing
of the lungs was from resuscitation efforts. He stated the frothing was indicative of the edema fluid
transmuting across vasculature in the pulmonary space. The frothing was the pulmonary edema
fluid bubbling up through the tracheobronchial tree and was part of the third-spacing. The same
thing that occurred in the pulmonary vasculature occurred in the brain vasculature, producing
cerebral edema. “…[S]he was third-spacing peripherally, she was third-spacing pulmonarally, she
was third-spacing in the head, and she was, as a result, becoming hypovolemic and hypotensive.”
This was all related to the process of the cytokines. Tr. 175-77. He was not suggesting that the
release of cytokines from the vaccinations caused the brain edema by direct toxic insult and
deferred to Dr. Gershwin for further explanation. Tr. 172.
Dr. Shuman stated that basic knowledge of the repertoire of infant behaviors is necessary
to determine if an infant is suffering an encephalopathy. Tr. 129. Two-month-olds are expected to
be able to maintain body temperature, blood pressure, and respiration, roll up and cuddle in your
arms, fall into you, and turn toward you to nestle like a newborn. They can focus on you, smile
responsively when you are within their gaze and track you for a little bit. They should reach toward
an object but not necessarily grasp it, more like a push forward. They should begin to develop head
control, so when pulled up to sit they help by bringing the head in the midline of the body. Resting
tone should be in flexion. They begin to roll at two months from front to back and back to front.
Tr. 129-31. The focus here would be on A.E.S.’s visual gaze, fixation and feeding behavior,
specifically if she was able to root if she fed well before. It was unclear whether A.E.S. was rooting,
able to suck, or if she withdrew milk on the afternoon of her death. Tr. 131.
Relying on the parents’ observations, Dr. Shuman determined that A.E.S. was
encephalopathic, displaying an altered mental state for a two-month-old child: she was irritable,
unable to self-soothe, did not feed well, and did not have normal gaze or social response. Tr. 140-
41. The father described her as “less cuddleable” and cuddling is a baby’s adaptive response to
touch. Tr 143-44. The mother described a “quiet look in her eye” which was a lack of visual focus
and engagement, a primary infant ability. Tr. 144. The mother described her as not really being
there and not responding, indicating a lack of emotional responsivity, which is the basis of
emotional bonding between mother and baby that starts at birth and broadens in the behavioral
repertoire. Tr. 144. Further, the mother described her appearing to have a headache. An infant
cannot point to pain but can express discomfort, and her mother described comforting her and
responding to her persistent distress. Tr. 145-46. When discovered in her bassinet, A.E.S. was in
hyperextension with her arms extended, which is a decerebrate posture and a sign of axial
herniation and encephalopathy. Tr. 140. Dr. Shuman was confused by the father reporting that she
drank a bottle, because the autopsy showed only “a trace of mucoid food in the stomach”. Tr. 136-
37. In Dr. Shuman’s opinion, A.E.S. was in the process of encephalic encephalopathy which
completed between the time the mother went to work and before the father found her. Tr. 141-42.
Encephalopathy also requires a clinical diagnosis, and he relied on the parents’ testimony for the
necessary clinical information. There was nothing in the medical records that described the clinical
signs necessary to make a diagnosis. Tr. 171.
Based on the evidence, Dr. Shuman concluded that A.E.S. was encephalopathic with a
decreased level of consciousness indicated by decreased or absent responses to her environment,
clinical signs of absent eye contact, and absent or inconsistent responses to external stimuli, which
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correlated with significant progressive cerebral edema and axial gradation and compression of
function of the brain tissue. Tr. 163. This resulted from a biologically fragile two-month-old
receiving 23 antigens by injection in her thighs and the rotavirus vaccine by mouth. Tr. 150-51;
159. The vaccines contained cytotoxic compounds to make them more antigenic and was an
overwhelming antigen exposure at a fragile age of development. As a result, she was “found dead
with subtle signs of compressive encephalopathic disturbance manifested by changes in mood,
soothing, sucking, cuddling and gaze.” Tr. 160. The PCV13 and Pediarix vaccines warn about
apnea and bradycardia with arrest requiring resuscitation in premature infants. This includes
infants born between 26- and 36-weeks gestational age who remained in the neonatal ICU for eight
to 16 weeks postnatal age and were vaccinated during that time, with as many as 15% having
apneas, bradycardias, and diminished cardiopulmonary function. These babies were monitored,
but some still needed resuscitation. This shows how vulnerable younger infants are to toxins as
supported by the Von Kries study and explains what led to the encephalopathy that A.E.S. died
from. Tr. 164-65.
Dr. Shuman concluded that his opinions are plausible to his scientific mind but cannot be
proven by laboratory experiment because no ethics program would allow the testing that would be
needed on human infants. Tr. 166.
B. Petitioners’ Expert, Dr. M. Eric Gershwin
1. Qualifications
Dr. Gershwin received his undergraduate degree from Syracuse University in 1966, and
his medical degree from Stanford University in 1971. Pet. Ex. 64 at 1. He is board certified in
allergy and clinical immunology, as well as internal medicine with a subspeciality in
rheumatology. Id. at 2. Dr. Gershwin is currently the Director of the Allergy-Clinical Immunology
Program and a Professor of Medicine (Rheumatology and Allergy) at the University of California
Davis School of Medicine. Id. at 1-2.
2. Opinion
a. Dr. Gershwin’s First Report
Dr. Gershwin acknowledged Drs. Shuman and Harris’s agreement that the autopsy showed
the brain weight to be heavier than normal and consistent with cerebral edema, which is unusual
and not characteristic of SIDS. Pet. Ex. 63 at 1.
Dr. Gershwin submitted that A.E.S. received multiple vaccines which caused the cytokine
production that is a plausible and likely explanation for the cerebral edema and enlarged brain
found on autopsy that that led to death. Pet. Ex. 63 at 1-2. Dr. Gershwin explained that cytokine
signaling at the BBB is a crucial feature of dynamic regulation, but the interface of cytokines with
the BBB can also affect the function of the brain and cause disease. Id. While the BBB can
selectively transport several cytokines including IL-1α, IL-1β, IL-1 receptor antagonist, IL-6,
TNF-α, leukemia inhibitory factor, ciliary neurotrophic factor, and many adipokines, it can also
restrict some cytokines from crossing the BBB with many cytokines and peptides being degraded
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before reaching the central nervous system (“CNS”) parenchyma. However, a lack of permeation
does not prevent cytokines from affecting cerebral vascular functions, including modification of
tight junction structures and endothelial signaling. Id. at 2.
According to Dr. Gershwin, cerebral edema is the clinical manifestation of inflammation.
He referred to Dr. Shuman’s opinion that A.E.S.’s cerebral edema resulted in axial herniation
leading to her fatal outcome. Pet. Ex. 63 at 1.
b. Dr. Gershwin’s Supplemental Report
Dr. Gershwin agreed there was no evidence of an excessive cytokine response following
A.E.S.’s vaccination but submitted that no two individuals respond the same to vaccinations. Pet.
Ex. 97 at 1. Two children can produce a similar level of cytokines from the same vaccination, but
one may develop fever while the other may not. Id. Since an MRI or CT was not done, there is no
information about the fine structure of A.E.S.’s brain. It is also unknown whether A.E.S. was
genetically predisposed to brain edema, because genetic studies and sophisticated mapping of the
brain for underlying target differences to be compared with other children would be required to
confirm this. Importantly, however, the cerebral brain edema seen on autopsy was abnormal and
cannot be explained other than by an underlying abnormality of her target tissue, which would
make her more susceptible to cytokine-mediated inflammation. Simply stated, A.E.S. was more
fragile. Id. Dr. Gershwin opined that the vaccinations were the “only logical explanation” for the
neuropathology A.E.S. suffered. Id. at 2.
c. Dr. Gershwin’s Testimony
At hearing, Dr. Gershwin conceded that the cytokines produced by the vaccinations
received by A.E.S. was no more than expected. However, the objective finding of brain swelling
was rare, therefore, “there had to be something that was defective on a genetic basis with a receptor
in [A.E.S.’s] brain that essentially made her a susceptible host…” Tr. 181. Routine two-month-old
vaccinations do not cause an acute encephalopathy, but if the host is susceptible with a “potpourri
of cytokines, as you would expect to be produced by an innate or first-responder immune
system…it is plausible.” Tr. 182.
Dr. Gershwin explained that the immune system is designed to protect us from the outside
world. Tr. 182. When exposed to an infection or a vaccine, the innate immune system begins to
operate, producing immune cells called cytokines or chemokines which can do almost anything,
like produce or prevent inflammation or lead to or reduce swelling. Tr. 183-84. These cytokines
mediate and enable communication between the innate and adaptive immune systems as well as
between innate cells and other body tissues. Tr. 184. The cytokines signal cell behavior for the
whole body. Swelling means some other vessel, interstitial cell, or component is leaking fluid due
to the presence of cytokines. Tr. 184. Vaccines produce cytokines and chemokines at the vaccine
site which drain into the lymph nodes, circulate around the body, and can cross the blood brain
barrier producing biologic effects. Tr. 185-88.
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Dr. Gershwin discussed Kashiwagi to illustrate the presence of various cytokines after
vaccination. Tr. 191-92, 201; Pet. Ex. 65.24 In addition to the cytokines produced from the
vaccination process, a protein, or “complement” is also produced which contributes to
inflammation, “all of whom have implications for swelling of the brain if you have a genetic defect,
a flaw.” Tr. 188-89. Dr. Gershwin referenced Hervé to explain what happens when a vaccine enters
the body and to provide the “logical and plausible explanation” for what occurred in this case. Tr.
194-95; Pet. Ex. 104.25 Hervé showed that within minutes of a vaccination, resident immune cells
including mass cells, monocytes, and macrophages are activated and release soluble factors, pro-
inflammatory cytokines, chemokines, effectors of the complement cascade, and vasodilators. Tr.
195; Pet. Ex. 104 at 4. Pan illustrated the biology and mechanism that is well-established by the
cited literature. Tr. 201-03; Pet. Ex. 66.26
Dr. Gershwin agreed that none of the articles propose that the cytokines released in
response to vaccinations cross the blood brain barrier and cause cerebral edema but stated that is
because of the rarity of the event. He explained that other than VAERS reports, “[t]here is no
experimental study or observational study or case theories that I can cite that will support that that
evidence has already been produced. I can produce what the logic is, discuss it with relation to
[A.E.S.], but that is as far as I can go.” Tr. 204. He added no one is going study such rare events,
but the basis for the vaccine court is the idea that rare events occur. Tr. 205.
Dr. Gershwin referred to encephalopathy as the brain being “sick” which results from
anything that injures oxygen delivery to the brain including trauma, stroke, constriction of a blood
vessel, swelling from insult, infections, or neurodegenerative and autoimmune disorders. Tr. 195.
Cytokines are “incredible players” in encephalopathy. They are produced in the periphery in
response to vaccination but are also produced in the brain itself by the microglial cells. Tr. 196.
According to Dr. Gershwin, the nature of the encephalopathy dictates what other materials
played a role, such as complement and prostaglandins. Tr. 197. Thousands of cytokines with
different functions based on their locations were produced after the many vaccines A.E.S. received.
Tr. 205. The proinflammatory cytokine variants of IL-1 and IL-6, for example, could be released
causing cerebral edema, but no study was done following the vaccinations received by A.E.S. so
he is unable to specify which cytokines were produced in her blood that crossed the blood brain
barrier. Tr. 206. However, studies that have been done on infections such as influenza and Reyes
Syndrome show that proinflammatory cytokines can cause encephalopathy. In his opinion
proinflammatory cytokines can produce swelling and edema anywhere in the body, and there is
“no reason to think that the brain is an exception.” Tr. 206-07.
Dr. Gershwin disagreed that cytokines released after vaccinations are only a “drop in the
bucket.” The purpose of vaccination is to “fool the body” into thinking it has the infection. Tr. 315.
He agreed that babies are faced with challenges all the time but that is different than the
physiological events of mounting an immune response as described by Hervé. Tr. 315; Pet. Ex.
24 Kashiwagi et al., supra note 21.
25 Caroline Hervé et al., The how’s and what’s of vaccine reactogenicity, 4 NPJ VACCINES 39 (2019), filed as “Pet. Ex.
104.”
26 Weihong Pan et al., Cytokine Signaling Modulates Blood-Brain Barrier Function, 17 CURRENT PHARMACEUTICAL
DESIGNS 3729 (2011), filed as “Pet. Ex. 66.”
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104.27 Hervé showed that every vaccine has the capacity to activate PPR (pattern, recognition, and
receptors). This involves a variety of cells in a “promiscuous” response that stimulates downstream
events and the critical biology mediated by cytokines. Tr. 316-18; Pet. Ex. 104 at 2.28 Notably,
Hervé was authored by vaccine manufacturer GlaxoSmithKline and published in Nature, which
has “the highest impact factor of any medical journal.” Tr. 318-19. Dr. Gershwin further disagreed
that immune responses in identical twins are the same. Tr. 319. He agreed that cytokines have a
half-life of 19 minutes but noted that the immune response is a continuous event and while a given
cytokine may only last minutes, it does not mean each starts and stops being produced in that time.
Tr. 316. Kashiwagi showed the elevation of prostaglandins to be the same following one or three
bacterial vaccines but noted the level was still higher than that found in the normal population. Tr.
315-16; Pet. Ex. 65.29
Dr. Gershwin stated that even though there was only a small portion of brain pathology for
examination here, it showed significant swelling. Tr. 318. He added that prolonged QT Syndrome
would not explain the dominant finding of edema and size of A.E.S.’s brain on autopsy. Tr. 314.
While there is a role for inflammatory mediators in prolonged QT Syndrome and at least a report
of ventricular arrhythmia in those who receive the flu vaccine, he disagreed that prolonged QT
Syndrome played any role in this case. If it did, the role of cytokines in that condition would also
need to be discussed. Tr. 314.
Dr. Gershwin concluded that the vaccinations received by A.E.S. were a substantial factor
in causing encephalopathy and death. Tr. 197. The autopsy did not show infection or metabolic
disorder; swelling on the brain was the only significant feature seen. The multiple vaccines A.E.S.
received released cytokines and chemokines that entered the blood, crossed the blood brain barrier,
and either individually or in combination activated her genetically susceptible brain or microglial
cells to produce cerebral edema. Tr. 198-99. The fact that A.E.S.’s encephalopathy and death
occurred so rapidly implies a cytokine-mediated event which is an immunological response as
illustrated in Hervé. Tr. 199. The number of cytokines produced had no bearing on his opinion:
“[t]here has to be a genetic basis” for her response to the vaccinations, and genetic events occur
even though the vast majority are harmless. Tr. 199, 207. The temporal relationship is consistent
with vaccine causation. Tr. 200.
C. Respondent’s Expert, Dr. McCusker
1. Qualifications
Dr. McCusker a pediatric immunologist and allergist. She is currently an associate
professor of pediatrics and division director of pediatric allergy, immunology, and dermatology at
Montreal Children’s Hospital at the McGill University Health Centre. She is also a clinician
scientist at McGill University Research Institute. Resp. Ex. B; Tr. 261. She received her medical
degree from McMaster University Medical School in 1993. Dr. McCusker is board certified in
pediatrics and completed post-doctoral research in immunology. Resp. Ex. B at 2.
27 Hervé et al., supra note 25.
28 Id.
29 Kashiwagi et al., supra note 21.
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2. Opinion
a. Dr. McCusker’s First Report
Dr. McCusker disagreed that A.E.S. suffered a “rapid but silent onset of encephalopathy
with asymptomatic catastrophic cerebral edema” resulting from the vaccines she received or that
the vaccines caused cytokine and complement activation that led to apoptosis in her brain and
cerebral edema. Resp. Ex. A at 5-6.
Dr. McCusker explained that when the body encounters a pathogen, the innate immune
system signals the release of proinflammatory mediators, including cytokines, which function to
communicate information to immune cells to help direct the nature and magnitude of the
developing immune response. Resp. Ex. A at 6. The initial cascade of inflammation from the cells
released to the site of infection or trauma is usually transient and tightly regulated. Id. The
cytokines released by the innate immune system include TNF-α, IL-6, IL-1β and the interferon
family of cytokines; most responses induce cytokine release without any systemic symptoms. Id.
Vaccination induces cytokine release causing local effects like pain and redness or systemic effects
like fever and malaise. The purpose of the immune response is to decrease replication of the
invading organism and increase the basal metabolic rate to allow for activation of the adaptive
immune system which generates immunological memory. The effects of cytokines are limited and
resolve with elimination of acute infection or with the adaptive immune response effectively
neutralizing the pathogen. Id. Cytokine response from vaccination is less than cytokine response
from a natural infection and the “innate system is comparatively poorly activated.” Id. Subsequent
exposure to the same pathogen in the form of antibodies results in rapid clearance of the pathogen
from the body with only limited activation of the innate, proinflammatory pathways. Dr. McCusker
opined “[t]here were no signs of significant cytokine activity in this child.” Id.
Dr. McCusker disagreed that Prevnar 13 vaccine has demonstrated any association with
encephalopathy post-licensure; the only side effects identified in studies include fever, irritability,
and decreased or increased sleepiness. Resp. Ex. A at 5. Dr. McCusker submitted that the total IgG
antibodies generated were the expected level for an infant, whether generated in response to the
vaccine or to naturally acquired antigens. The antibodies are distributed throughout the body, not
restricted to the intravascular compartment. Id.
Dr. McCusker discussed the implication of Long QT syndrome and other channelopathies
in SUID and noted their appearance in 20% of SUID patients. She suggested A.E.S.’s younger
sibling having prolonged QT after birth raised the possibility that A.E.S. did too. However, no
genetic studies were done. Resp. Ex. A at 3, 7.
Dr. McCusker added that studies show no evidence of a causal relationship between
vaccination and SIDS, with studies “sufficiently powered” to account for rare events providing
epidemiological evidence for a temporal association only. Resp. Ex. A at 7. Dr. McCusker
concluded that the medical examiner ruled this a SUID case, there was no evidence of cytokine
activation, the mechanisms proposed by petitioners are not consistent with or supported by current
literature, and there is no evidence that the vaccinations received by A.E.S. caused her death. Id.
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b. Dr. McCusker’s Supplemental Report
In her supplemental report, Dr. McCusker addressed the opinions of Drs. Gershwin and
Harris. Resp. Ex. E.
Dr. McCusker referred to “cytokine” as a general term for cell-to-cell communication
proteins, with most cytokine events occurring locally without significant systemic signaling. An
example of a systemic cytokine effect would be fever caused by cytokines like IL-1β, IL-6, and
TNF-α. Resp. Ex. E at 2. Cytokines are the initial response released at the site of trauma or
infection, are transient, tightly regulated, and shape the innate and adaptive responses. Resp. Ex.
E at 2. Over 50 cytokines have been identified, each bind to specific receptors, and the effect of
the binding is dependent on the recipient cell. Id.
Dr. McCusker agreed that vaccinations activate immune responses in part through cytokine
upregulation:
[o]ne study of cytokine levels following vaccination of healthy volunteers
demonstrated increases in IL6 and IL1β levels in peripheral blood which peaked at
approximately 3 hours post vaccination. By 32 hours, these levels had normalized.
In this study of healthy volunteers IL1β levels started at 4.7pg/ml and increased to
a maximum of 4.8 pg/ml at 8 hours post vaccination. IL6 levels were 2.1 pg/ml at
baseline and were maximal at 5.8 pg/ml at 8 hours and finally IL1Ra was 188 pg/ml
at baseline and increased to a maximum of 413 pg/ml at 5 hours post vaccination.
Resp. Ex. E at 3 (citing Resp. Ex. E, Tab 3).30
Dr. McCusker described Kashiwagi as showing that within 48 hours of vaccination, serum
cytokine levels are very low, with only small amounts of IL-6 and TNFα detected. The
development of fever was independent of the cytokine levels in the blood. Resp. Ex. E at 3; Resp.
Ex. E, Tab 4.31 The data suggests that cytokines are produced and released by the peripheral
immune system with no evidence that the levels are sufficient to influence the development of
brain edema as theorized by petitioners’ expert. Resp. Ex. E at 3.
Dr. McCusker disagreed that A.E.S. died from cytokines passing through or interacting
with the BBB and causing life-ending edema. Resp. Ex. E at 3. She referred to Suntharlingam,
which assessed the safety of a T-cell immunomodulatory agent that when injected into adults
resulted in a “cytokine storm” or rapid systemic inflammatory response syndrome (SIRS), to show
that no one developed signs of encephalopathy or significant brain edema even when extreme
levels of peripheral cytokines were released. The neurological symptoms observed included
delirium from high fever, partial amnesia, localized numbness, difficulty concentrating, and
headaches Resp. Ex. E at 3; Resp. Ex. E, Tab 5.32
30 Aroon D. Hingorani et al., Acute Systemic Inflammation Impairs Endothelium-Dependent Dilatation in Humans,
102 CIRCULATION 994 (2000), filed as “Resp. Ex. E, Tab 3.”
31 Kashiwagi et al., supra note 21.
32 Ganesh Sutharalingam et al., Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412,
355 N.E. J. MED. 1018 (2006), filed as “Resp. Ex. E, Tab 5.”
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Dr. McCusker cited Ron-Harel to explain that the microglial cells present in the normal
brain release cytokines themselves, including IL-6 to maintain homeostasis. Resp. Ex. E at 3-4;
Resp. Ex. E, Tab 6.33 Moidunny showed that the cytokines present in the brain are essential for
neuroprotection and neuromodulation. Resp. Ex. E at 4; Resp. Ex. E, Tab 7.34 When exposed to
stressors such as brain injury and neurodegeneration, these microglial cells increase the release of
IL-1 and IL-6 to maintain homeostasis. Resp. Ex. E at 2, 4.
Dr. McCusker agreed that an overexpression of cytokines in the CNS can be detrimental
to the brain and lead to cognitive defects. Resp. Ex. E at 4. Quan listed several ways peripheral
inflammatory events may signal the brain and result in different effects including: localized
inflammation which activates the CNS through local nerve stimulation but has no clinically
significant CNS response; a greater local inflammation that signals the CNS through nerve
stimulation but results in sickness behavior and fever; systemic inflammation that activates both
neural and BBB-dependent neural-immune afferents; and significant immune challenge resulting
in activation via the peripheral nerves and the BBB. Resp. Ex. E at 4; Resp. Ex. E, Tab 11.35 The
first two reflect responses from vaccination. Local cytokine production at the vaccination site
stimulates the release of cytokines that may result in sickness behaviors with no evidence that these
low concentrations of peripheral cytokines can result in brain edema or SIDS. Resp. Ex. E at 5.
Dr. McCusker contends that none of the literature relied on by petitioners support a theory
that peripheral cytokines released following vaccination can generate life-ending brain edema.
Resp. Ex. E at 5-7. Further, the literature shows that even a cytokine storm does not disrupt the
BBB causing death. Resp. Ex. E at 7.
Dr. McCusker added that A.E.S. showed no clinical signs of immune activation, acute
cerebral edema or increased intracranial pressure in the 90 minutes prior to being found
unresponsive. Resp. Ex. E at 7. However, literature shows that Long QT Syndrome and other
channelopathies are implicated in up to 20% of sudden infant deaths and there was a family history
of Long QT Syndrome. Therefore, Long QT Syndrome is a plausible explanation for A.E.S.’s
clinical picture. There is no evidence that the December 16, 2013 vaccinations contributed to
A.E.S.’s death. Id.
c. Dr. McCusker’s Testimony
Dr. McCusker had no concerns with the multiple vaccinations that A.E.S. received, stating
that studies show no change in adverse events when adding vaccines to the vaccine schedule for
infants. Tr. 262-64. In fact, vaccine cocktails contain hundreds of different antigens, while
newborns are exposed to hundreds of thousands of antigens every day. Vaccines are “a bit of a
drop in the bucket” in comparison to the antigens the body sees every day. Tr. 264.
33 Noga Ron-Harel et al., Brain homeostasis is maintained by “danger” signals stimulating a supportive immune
response with the brain’s borders, 25 BRAIN, BEHAVIOR, & IMMUNITY 1036 (2011), filed as “Resp. Ex. E, Tab 6.”
34 Shamsudheen Moidunny et al., Interleukin-6-type cytokines in neuroprotection and neuromodulation: oncostatin
M, but not leukemia inhibitory factor requires neuronal adenosine A
1
receptor function, 114 J. NEUROCHEMISTRY
1667 (2010), filed as “Resp. Ex. E, Tab 7.”
35 Ning Quan, In-depth conversation: Spectrum and kinetics of neuroimmune afferent pathways, 40 BRAIN, BEHAVIOR,
& IMMUNITY 1 (2014), filed as “Resp. Ex. E, Tab 11.”
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Dr. McCusker discussed Kashiwagi as showing that one or multiple vaccines do not result
in significant dose-dependent cytokine expression in a person and in fact, patients receiving a
single monovalent vaccine had the highest expression of certain cytokines. Thus, cytokine
responsiveness to a vaccination does not have a dose/response relationship in infants. Tr. 266-71;
Resp. Ex. E, Tab 436 at Tables 1 and 2. When noted that Tables 1 and 2 of Kashiwagi did not
include the vaccines A.E.S. received because they did not exist at the time of the study, Dr.
McCusker responded, “regardless of the number of antigens that have been given to the child, the
variation in the cytokines expressed – a total amount of cytokines expressed is not significantly
different whether it’s one, two or three.” Tr. 271-73. Therefore, giving the Prevnar 13 vaccine at
the same time as the Tdap, Hib, polio, and other vaccines does not increase cytokines any more
than what was shown on the tables in Kashwagi. Tr. 273. She admitted that Kashiwagi was the
only study done on cytokine levels following vaccination, so the cytokines levels are not a
“hundred percent.” Tr. 273. However, based on the way the immune system works, a combination
of vaccines does not seem to significantly increase or change the adverse events and inflammation;
the cytokine levels are similar in range whether you give one, two, or three vaccines. Tr. 273-74.
Dr. McCusker stated that increasing the number of antigens actually decreases the efficacy
of each component to stimulate their own response. Tr. 274. Therefore, from an immunological
perspective, the question is not if the system is being blasted with too much stimulus, because the
stimulus comes from the fixed amount of antigen, but rather whether one can synthesize
appropriate immune responses to many different antigens at a given time. Tr. 274-75.
Dr. McCusker discussed Hervé, noting it was a review article, so the primary data is not
available. Tr. 267; Pet. Ex. 104.37 Hervé discussed the balance between reactogenicity,
minimization of adverse events, and the need for controlled trials to make proper judgments about
whether a vaccine is causally implicated in something. Tr. 276-77; Pet. Ex. 104.38 Hervé also noted
the difficulties in determining whether symptoms are caused by a vaccine or illness, since both
share the same signs and symptoms. Tr. 276-77; Pet. Ex. 104 at 2. Hervé was a twin study where
one was vaccinated and the other was given a placebo, then three weeks later, the opposite was
done. 88 percent reported low grade fever, 24 percent reported moderate fever, and 7 percent
reported high fever in the placebo group. This showed that much of what is attributed to
vaccinations is not vaccine related. Tr. 277-78.
Dr. McCusker explained further that the symptoms of fever, malaise, and headache
described in Hervé were the result of cytokine signaling at the inflammation site that stimulates
the vagus nerve, and moves to the pituitary, “not the presence of cytokines that are crossing the
blood-brain barrier.” Tr. 278; Pet. Ex. 10439 at 4. The process is like dropping a pebble in a pond:
the largest circle is where the pebble goes in then it gets smaller and smaller the further away from
the pebble it gets.40 Kashiwagi shows that the cytokines are inactivating as they circulate away
from the injection site. Tr. 278-79. Further, the half-life of IL-1β in circulation is about 19 minutes,
36 Kashiwagi et al., supra note 21.
37 Hervé et al., supra note 25.
38 Id.
39 Id.
40 Common knowledge dictates that it is the reverse—the circles get larger as they move away from where the pebble
is dropped.
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so its ability to cause significant toxic damage and local symptoms is mediated by cytokines. Tr.
279-80. It takes three hours for vaccines to be detected in muscles, meaning cytokine release
requires that amount of time before it can be seen in the lymph nodes. Tr. 280. Therefore, the
behavioral changes described by the mother on the way home from the doctor’s office would not
be cytokine-mediated behaviors because they occurred prior to the time it takes for cytokines to
be detectible in the muscle. Tr. 281.
Dr. McCusker stated there are many kinds of cytokines, which are all mechanistically the
same: they all bind to receptors, the receptors tell them what to do, and they do what they are told.
Tr. 283-84. However, the way the cytokines are regulated or released is different. Proinflammatory
cytokines are involved in inflammation in the periphery, not necessarily in the CNS. Their role is
to open the blood vessels to permit movement of cells to the area of inflammation: “[s]o if you
don’t see evidence of inflammatory cells at the site, you would hypothesize, at least reasonably,
that the inflammation or the edema that you are seeing is not inflammatory edema.” Tr. 284-85.
Dr. McCusker continued that the BBB exists to regulate what happens in the CNS and
while a few cytokines can diffuse across the BBB, the diffusion is controlled. Tr. 285-86. The
cytokines that diffuse across the BBB do so through a receptor which transports it across the BBB
or through peripheral signaling through the vagus nerve. Tr. 286. Cytokines can also signal through
receptors on the membrane, which signal the brain that something is happening. It does not
necessarily mean the cytokine enters the CNS, but the brain gets the message that it’s present. Tr.
286-87.
Dr. McCusker disagreed that A.E.S. had a genetic anomaly in the brain making her unable
to process cytokines properly. However, assuming she did, a baby’s system is stimulated so much
in the first two months of life, it would have been apparent earlier and “probably embryologically
lethal” if the brain was not able to handle cytokines properly. Tr. 288-89.
Dr. McCusker described SIDS as a catch-all phrase, which excludes infants who have an
obvious cause of death. Within that catch-all is a group of children who would qualify as sudden
unexplained infant death, “meaning that they don’t qualify as SIDS” but the distinction is not often
used. Tr. 289-90.
Dr. McCusker maintained that the literature she submitted showed no increase in the rate
of death following vaccination. She acknowledged that Moro looked at mortality data from
VAERS, a referral-based and not rigorously checked data site, but still believed it captured some
data about SIDS. Tr. 290-91; Resp Ex. A, Tab 15.41 Von Kries picked up a signal but felt more
investigation was necessary, and this led to Vennemann. Both found there may be an increased
risk of sudden death in older children, but no increase for two-month-olds so the study is
inapplicable to A.E.S. Tr. 295-97; Pet. Ex. 14442; Resp. Ex. A, Tab 17.43 Vennemann and Kuna,
both large studies using meta-analysis to examine several different populations, found no
41 Pedro L. Moro et al., Deaths Reported to the Vaccine Adverse Event Reporting System, United States, 1997-2013,
61 CLINICAL INFECTIOUS DISEASES 980 (2015), filed as “Resp. Ex. A, Tab 15.”
42 von Kries et al., supra note 22.
43 M.M.T. Vennemann et al., Do immunisations reduce the risk for SIDS? A meta-analysis, 25 VACCINE 4875 (2007),
filed as “Resp. Ex. A, Tab 17.”
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association between sudden infant death and vaccination. Tr. 291; Resp. Ex. A, Tab 1744; Resp.
Ex. A, Tab 18.45
Dr. McCusker discussed Traversa, pointing out that it was a case series of low-level
scientific rigor, significant methodological flaws, and findings more likely by chance than by
causation. Tr. 292-95; Resp. Ex. A, Tab 16.46 She acknowledged that all studies have some
limitations, but the more patients and data involved, the better the possibility of finding “that low
signal, that rare kid.” None of the studies cited showed an association between infant death and
vaccination. Tr. 295.
According to Dr. McCusker, A.E.S. had no clinical signs or symptoms of excessive
cytokine activation or acute cerebral edema. Tr. 297. The father’s description was not of an
encephalopathic baby that would “send a parent running” to the ER. He described a sleepy baby
similar to his other children after vaccinations. Tr. 298. The mother described A.E.S. as quiet on
the ride home but not encephalopathic, adding that there could be many reasons for why A.E.S.
was sleepy like a lot of activity that day, a change in routine, something going on before her receipt
of vaccines, or normal behavior that the parents are remembering more acutely with hindsight. Tr.
298-99, 306.
Dr. McCusker stated in her years of practice seeing encephalopathic children in the ER,
they are not quiet. They are in pain, won’t and can’t eat, are nauseous, and have severe headache
and vomiting. If there was significant cerebral edema leading to increased cranial pressure, then
significant changes to behavior would have been expected, “not soft behavioral changes as
described.” Tr. 299. The children she has treated had encephalitis due to viral infection, tumor, or
metabolic issues, not vaccinations. She has seen two patients with axial herniation. Tr. 307.
On cross examination, Dr. McCusker stated that there is no explanation for why some
children develop fever after vaccination and others do not, but all have genetic differences. Tr.
307-08. She disagreed that proinflammatory cytokines are released immediately following
vaccination, stating that Dr. Gershwin’s cited literature shows a three-hour timeframe exists for
the release of proinflammatory mediators. There is an immediate, local release of proinflammatory
cytokines at the injection site from the abrasion to the skin, not the content of the vaccine. Tr. 308-
09. Dr. McCusker disagreed that cytokines can permeate the BBB in a dysregulated manner. Tr.
309.
Dr. McCusker described Long QT Syndrome as a cardiac arrythmia, meaning the heart
becomes dysrhythmic and stops beating normally which is often genetic. Not all genetic causes
are known, but the whole population is referred to as channelopathies: problems regulating the
movement of fluids, solutes, sodium, potassium, magnesium, and calcium et cetera in and out of
the cell. Channelopathies can lead to noninflammatory edema. Tr. 300-01. The literature shows
that Long QT Syndrome is associated with 20% of sudden infant deaths. There is no literature that
associates vaccines with sudden infant death. Tr. 303. A.E.S.’s younger sibling had Long QT
44 Id.
45 Ronny Kuhnert et al., Reanalyses of case-control studies examining the temporal association between sudden infant
death syndrome and vaccination, 30 VACCINE 2349, filed as “Resp. Ex. A, Tab 18.”
46 Traversa et al., supra note 23.
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Syndrome which could explain what happened to A.E.S. Tr. 301, 303. Dr. McCusker conceded
she did not see A.E.S.’s siblings medical records and no genetic testing was done but offered Long
QT Syndrome as “an important possibility to consider in the differential diagnosis”, not a
probability. Tr. 310-11.
In responding to whether the acellular pertussis vaccine can cause encephalopathy, Dr.
McCusker stated it would depend on one’s definition of encephalopathy. If it included a change of
behavior, then yes. If defined as cerebral edema leading to mortality, “that has not been
demonstrated in large studies.” Tr. 312. She agreed the CDC cautions that encephalopathy
following acellular pertussis vaccine is a contraindication to additional DTaP vaccines. Tr. 312.
d. Dr. McCusker’s Post-Hearing Supplemental Report
Following the hearing, Dr. McCusker submitted additional literature and a supplemental
report briefly summarizing the “small selection of available studies of safety and efficacy of
combination vaccines and the rationale behind their use.” Resp. Ex. F; Resp. Ex. F, Tabs 1-6.
D. Respondent’s Expert, Dr. Brent Harris
1. Qualifications
Dr. Harris is a board certified anatomic and neuropathologist and neuropathologist, a
member of the American Association of Neuropathologists, and a fellow of the College of
American Pathologists. Resp. Ex. C at 1; Resp Ex. D at 1. He has practiced for 17 years at Stanford
University Medical Center, Dartmouth Medical School, and Georgetown University Medical
Center. He is currently an attending pathologist, tenured associate professor of neurology and
pathology, and the director of neuropathology at Georgetown University Medical Center in
Washington, DC. He is also the sole neuropathology consultant for the Washington, DC Office of
the Chief Medical Examiner and Howard University Hospital, and serves as a neuropathology
consultant for the Washington, DC Veterans’ Administration Hospital. In each of these
institutions, he has multiple roles as a clinical pathologist, educator, and physician-scientist
researcher. Dr. Harris has reviewed over 10,000 surgical pathology and autopsy cases throughout
his career, approximately 10% of which were pediatric cases. Resp. Ex. C at 1; Resp Ex. D at 1.
2. Opinion
a. Dr. Harris’s Report
Dr. Harris noted that A.E.S. was a well baby on December 16, 2013. There were no signs
typical of anaphylaxis after receipt of her vaccinations. Resp. Ex. C at 3-4.
Dr. Harris discussed the autopsy as showing no signs of trauma, malformation, or skin
rashes with fixed, purple “liver (sic) mortis”47 extending over the posterior surfaces of the body,
except for pressure areas. Resp. Ex. C at 3. There were no pathological abnormalities of the brain,
47 Livor mortis is the “discoloration appearing on dependent parts of the body after death, as a result of cessation of
circulation, stagnation of blood, and settling of the body by gravity.” Livor mortis, DORLAND’S 1055.
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but the brain weighed 595g, not the expected 461-555g. The heart, lungs, and thymus were normal
but for petechiae. The liver was congested. The gastrointestinal and genitourinary tracts were
normal. There were no abnormalities reported in other organs or tissues. X-rays were normal.
Histological findings included congestion in the liver, kidneys, lungs (with intra-alveolar edema),
pancreas, spleen, and thymus (with focal intraparenchymal blood). The brain and adrenals were
normal. Toxicology studies were negative. Metabolic screening and genetic studies and cultures
were not performed. There was nothing untoward at the scene; the baby was found on her back
without obstruction of the face. Resp. Ex. C at 3.
Dr. Harris believed the autopsy findings were “likely correct” and included that “the brain
appears grossly swollen bilaterally on superior surfaces. Inferior and lateral surface photos of the
brain are not provided. No gross description of laryngeal/tracheal edema/erythema is made.” Resp.
Ex. C at 4. Microscopic sections showed mild congestion in the lungs with some alveolar
macrophages and proteinaceous material, several areas of bacterial collections in alveoli with no
infection suspected, and some areas of acute hemorrhage in the thymus but no other significant
pathological abnormalities seen from sections of the adrenals, liver, pancreas, kidney, spleen,
lungs, colon, or heart. There were no excess eosinophils48 noted in the organs. Id.
According to Dr. Harris, the autopsy was insufficient for a SIDS workup. Resp. Ex. C at 4.
There were only small pieces of the brain sectioned and the hippocampus was not sampled
bilaterally, which is important to rule out structural abnormalities that could produce seizures. The
samples taken showed no ischemic or structural changes in the pyramidal and dentate areas. The
medulla, a “key area” sometimes found to have abnormalities in SIDS cases, was not sampled. Id.
Dr. Harris acknowledged that there was “mild edema and congestion” in all fragments of
brain tissue that was sampled, characterized by neuropil vacuolation and perivascular/perineuronal
clearing, but submitted the findings were difficult to gage because fixation/processing of the tissue
can also mimic edematous appearance. There were “[n]o significant reactive micro- or astrogliosis
findings seen in the brain sections. Sections from other organs also show some degree of
congestion but no findings of infection or metabolic abnormalities.” Resp. Ex. C at 4.
Dr. Harris noted the cause of death was “undetermined” based on a history of no prior
illness, no foul play, and no pathological findings to explain her death. Resp. Ex. C at 4. However,
he added that a neuropathologist was not consulted and despite microscopic examination of the
brain, the examination was minimal and incomplete. Id.
Dr. Harris discussed anaphylaxis as a rare reaction to vaccines, well-described in the
literature for adults and children, but not described on autopsy in infants. Resp. Ex. C at 5. He
added that there are no consistent pathological findings for anaphylaxis, but some include upper
airway edema, airway mucus accumulation, hyperinflation of the lungs, pulmonary congestion and
edema, eosinophils in many organs, and cutaneous erythema or edema. Id.; Resp. Ex. C, Tab 2.49
He agreed there was pulmonary edema and congestion observed here but that is a common and
48 An eosinophil is “a granular leukocyte with a nucleus that usually has two lobes connected by a slender thread of
chromatin, and cytoplasm containing coarse, round granules that are uniform in size.” Eosinophils, DORLAND’S 622.
49 Paul A. Greenberger et al., Fatal anaphylaxis: postmortem findings and associated comorbid diseases, 98 ANN.
ALLERGY ASTHMA IMMUNOLOGY 252 (2007), filed as “Resp. Ex. C, Tab 2.”
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non-specific finding in all age groups on autopsy. Excess eosinophils were not noted. Brain edema
is not described in forensic anaphylaxis literature. Resp. Ex. C at 5.
Dr. Harris agreed SIDS cannot be invoked in this case because of an incomplete sampling
of brain tissue, no clear environmental trigger, and the medical examiner did not conclude that
SIDS was the cause of death. Resp. Ex. C at 5. Further, he agreed there was edema of the brain,
though he referred to it as “mild”. Finally, he agreed with the pathological descriptions of the
lungs, heart, liver, and adrenals, but did not see possible early ischemic cell changes in the cortex
of the brain or reactive gliosis. Id.
Dr. Harris agreed A.E.S. had a heavy brain with gross evidence of swelling and mild edema
on microscopic examination but asserted that herniation is very difficult to assess on an infant
brain at autopsy. Resp. Ex. C at 6. There was an insufficient finding of hypoxia-ischemia or
infection to explain the edema. Id. He disagreed that Dolgopol applied in this case because it
discussed the neuropathological changes in infants who died from pertussis infection
encephalopathy with autopsies showing variable edema, hemorrhages, and neurodegeneration.
While A.E.S. had mild edema, there were no hemorrhages or neurodegenerative changes seen and
no signs of cell death on the brain tissue. Id.; Pet. Ex. 19.50
In Dr. Harris’s opinion, the cause of death here is “unknown” because the autopsy was
incomplete with inadequate brain tissue sampling to investigate for SIDS and no finding or history
of suffocation. Resp. Ex. C at 6.
b. Dr. Harris’s Testimony
At hearing, Dr. Harris discussed his research involving the study of how brain cells change
from young to middle to old age and their relationship to normal biology or predisposition to
neurodegenerative disease. Tr. 218-19. As a clinical and forensic neuropathologist, Dr. Harris
consults with the DC Chief Medical Examiner, looks at autopsies, and examines the brain to
determine the pathology for the cause of death. He is also the director of the brain bank at
Georgetown, where tissue is retained with the permission of the family to study how different
diseases occur. Tr. 219-21.
Dr. Harris has been a consultant to the medical examiner on SIDS cases for the past eight
years and has seen 30-40 SIDS cases per year. Tr. 222. For infants under the age of one, a diagnosis
of sudden infant death is broken into categories of unexplained or unexpected, and then
subcategorized into SIDS, unexplained, or relating to suffocation. Tr. 221. When examining the
brains of children in these cases, they look for genetic defects, metabolic diseases, structural
changes of the hippocampi that can lead to seizures, infectious processes or organisms that can
infect the brain, evidence of inflammation, and hypoxic ischemic changes. Tr. 224.
While deferring to the immunologist, Dr. Harris stated that anaphylaxis usually occurs
within minutes of exposure causing skin changes, difficulty breathing, and excess eosinophils in
the tissues. There was no testimony or clinical signs here of anaphylaxis. Tr. 227. With a
50 Vera B. Dolgopol, Changes in the Brain in Pertussis with Convulsions, 46 ARCHIVES CLINICAL NEUROPSYCHOLOGY
477 (1941), filed as “Pet. Ex. 19.”
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hypersensitivity reaction, he would expect to see redness and swelling at the injection site and
enlargement of the lungs with pulmonary edema. By six hours later, there would be increased
numbers of eosinophils in multiple tissues including the lungs and airways and at the local site
where the drug was delivered. He would not expect to see cerebral edema. Tr. 229-30.
Dr. Harris stated that the final diagnoses contained in the autopsy report represent the
“bottom line big picture” of the medical examiner’s most important findings. Here, the final
autopsy findings included thymic, epicardial, and pleural petechiae, pulmonary edema, and
visceral congestion. However, pulmonary edema is a nonspecific though significant finding that
could be seen in conditions other than hypersensitivity reaction. Tr. 245-47, 252. Cerebral edema
was not included under autopsy findings. Tr. 256-57.
Dr. Harris explained that tissue viewed during autopsy is not fresh; it goes through a
fixation process to help allow for better staining and stability under a microscope. Sometimes, the
fixation process changes the tissue, and it becomes vacuolated.51 Tr. 230. Therefore, when
examining the tissue, one must recognize that vacuolation of the brain tissue is an artifact,
“meaning it doesn’t have anything to do with a patient’s condition.” Tr. 230. However, based on
the brain heaviness here, photographs that suggested swelling of the brain, and microscopic
observations, he was “fairly comfortable to say that this is more likely edema rather than an artifact
of fixation.” Tr. 231.
Dr. Harris stated that A.E.S.’s brain was significantly heavier than expected for a child her
age. The swelling or edema of the brain was “an abnormal finding or a pathological finding. It’s
not normal. But we don’t know what the cause of that swelling is in many cases of infant death,
sadly.” Tr. 231-32. The brain weight was a “pathological abnormality” with no infection. Tr. 250-
51. The congestion in the organs was also a pathological abnormality. Tr. 251.
Noting that he is a pathologist and not an immunologist, neurologist, or pediatrician, he
described “encephalopathy” as a nonspecific, clinical term for dysfunction of the brain. He noted
that a pathology report would never contain a diagnosis of encephalopathy. Tr. 231-32.
Dr. Harris described the many types of different cells that make up the brain, particularly
glial cells, which have different subtypes and functions. Tr. 235. Glial cells serve as markers for
problems happening in the brain, including trauma, hypoxia, ischemia, brain tumors, and reactions
to inflammatory cells. Their shape and appearance under the microscope change when they
become reactive. Tr. 235-36. Hypoxia (low oxygen) and/or ischemia (low blood flow) cause a
“cascade of changes” to the brain tissue which can be seen microscopically. Tr. 233-34. Seeing
these changes in infant brain tissue is more challenging, but the earliest change would be seen as
edema 6-12 hours after a hypoxic and/or ischemic event. 12-18 hours later, neurons would appear
shrunken and redder in color. Tr. 234. Dr. Harris claimed that while he did not see signs of hypoxia
or ischemia on the autopsy slides, he could not dispute that the edema that was seen was early
signs of a hypoxia or ischemic event. He would want to see more areas of brain tissue samples to
make that judgment. He could only say that usually it requires at least six hours for these changes
to be seen. Tr. 235.
51 Vacuoles are any membrane-bound space or cavity within a cell. Vacuole, DORLAND’S 1988. Vacuolated means
containing vacuoles. Vacuolated, DORLAND’S 1987.
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Initially, Dr. Harris stated that he did not see evidence of herniation on the superior surface
of the brain. Tr. 236. He concurred that the gelatinous nature of the brain tissue makes it more
challenging to observe herniation and that other signs, such as internal and external hemorrhage
with downward herniation of the brainstem, may be present with herniation but were not
mentioned by the medical examiner. An experienced neuropathologist would recognize early
herniation even in infant cases, but he could not speak to the medical examiner’s level of
competence. Tr. 237-38. He noted that key sections of the brain were not sampled including the
brainstem, which is the most detrimental area of herniation; “…not having those makes it very
difficult, unfortunately, to say whether or not there was herniation in this case.” Tr. 236-37.
However, he could not “rule it out or rule in it” from a pathological standpoint. Tr. 237, 256.
When further pressed on whether brainstem herniation occurred in this case, Dr. Harris
repeated the challenges of making a judgment without imaging studies or a full examination of the
brain, adding that even with the degree of swelling on the surface of the brain, overall weight of
the brain, and what he heard clinically, he could not rule it in or rule it out. Tr. 238-39. He could
only say that the pathological evidence showed mild cerebral edema, and the medical examiner
was appropriate in concluding the cause of death was undetermined; he probably would have done
the same. Tr. 240.
Dr. Harris then discussed the literature on SIDS stating it does not often discuss
vaccinations, and when it does “it’s all over the place.” Temporal proximity of SIDS to vaccination
does not suggest a relationship, especially since SIDS usually occurs between one month and one
year of age, the same timeframe during which vaccines are given. There is no clear causation or
temporal relationship found between SIDS and an immunization or other medication. Tr. 241.
However, Dr. Harris stated this is not a SIDS case because “[b]y definition you cannot
make a diagnosis of SIDS without a full sampling of the tissues.” Tr. 243, 252. The sampling of
the lungs and brain taken were insufficient, with no samples of the brainstem done, which is a
necessary step to determining SIDS. Tr. 225, 252-53. His review of the autopsy slides showed a
fair amount of congestion or increased blood within the vessels in all the organs but no
inflammation suggestive of infectious disease or eosinophils indicative of a hypersensitivity
reaction or anaphylaxis. Tr. 226. There was “only a very, very small sampling of brain tissue”, but
there was edema around the cells without malformation seen. Tr. 226. There were no clear
environmental factors for a diagnosis of SIDS found, either. Tr. 253-54; Resp. Ex. C at 5. Based
on the evidence, SIDS cannot be invoked in this case, and Dr. Harris agreed with the medical
examiner that there was no conclusive cause of death. Tr. 254.
Dr. Harris stated the testimony about A.E.S.’s hyperextension of her neck when found gave
him pause for possible suffocation though he had never seen hyperextension of the neck cause an
airway problem. Tr. 244, 254. He agreed that the term “hyperreflexia” was contained on the
investigation report which he reviewed but had not given much thought to until he heard the
testimony. He was then asked by respondent’s counsel if he could still exclude SIDS in this case.
Tr. 257. Petitioners’ counsel objected, stating that Dr. Harris had all the information in his
possession when he issued his opinions in this case, including his opinion that this was not a SIDS
case, and to opine differently now would amount to a new opinion. Tr. 258. I agreed that if Dr.
Harris was to now say he could not rule out SIDS in this case, he would be contradicting his own
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testimony. Also, Mr. Kennedy had testified that “hyperextension” was the only option on his form
and was not a word used by the father. Further, I would be unable to accept a suggestion that a
baby of this age who moves and turns their head upward while on their back could suffocate
themselves. Therefore, Mr. Kennedy’s testimony explaining why he checked “hyperextension” on
the form, Mr. Sims’s description of how he found A.E.S., and Dr. Harris’s testimony based on the
evidence, points to an unexplained death rather than a SIDS case. Tr. 258-59. Respondent’s
counsel stated that he was not asking Dr. Harris to change his answer. I advised that all the evidence
would be weighed when the time came for a decision in this case. Tr. 259.
Dr. Harris concluded that he did not believe vaccines were the cause of A.E.S.’s death. Tr.
241-42. When asked, based on the evidence, if he could definitively say that her death was not the
result of her vaccines, he stated “[y]eah, I base my opinion, though, on the medical literature and
the fact that the timing of this autopsy or of the vaccination could not have been an anaphylactic
reaction. And I’m not aware of any literature to suggest that vaccination other than anaphylaxis
could lead to a death like this.” Tr. 242. However, “[he didn’t] have an explanation for another
diagnosis in this case.” Tr. 242-43. There was no trauma and no evidence of neurological disease
other than edema. Tr. 255-56.
VII. Applicable Law
A. Legal Standard Regarding Causation
The Vaccine Act provides two avenues for petitioners to receive compensation. First, a
petitioners may demonstrate a “Table” injury—i.e., an injury listed on the Vaccine Injury Table
that occurred within the provided time period. § 11(c)(1)(C)(i). “In such a case, causation is
presumed.” Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006);
see § 13(a)(1)(B). Second, where the alleged injury is not listed on the Vaccine Injury Table, a
petitioners may demonstrate an “off-Table” injury, which requires that the petitioners “prove by a
preponderance of the evidence that the vaccine at issue caused the injury.” Capizzano, 440 F.3d at
1320; see § 11(c)(1)(C)(ii). Initially, a petitioners must provide evidence that he or she suffered,
or continues to suffer, from a definitive injury. Broekelschen v. Sec’y of Health & Human Servs.,
618 F.3d 1339, 1346 (Fed. Cir. 2010). A petitioners need not show that the vaccination was the
sole cause, or even the predominant cause, of the alleged injury; showing that the vaccination was
a “substantial factor” and a “but for” cause of the injury is sufficient for recovery. See Pafford v.
Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006); Shyface v. Sec’y of Health
& Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999).52
To prove causation for an “off-Table” injury, petitioners must satisfy the three-pronged test
established in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen
requires that petitioners show by preponderant evidence that a vaccination petitioners received
caused his or her injury “by providing: (1) a medical theory causally connecting the vaccination
and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the
52 The Vaccine Act also requires petitioners to show by preponderant evidence the vaccinee suffered from the “residual
effects or complications” of the alleged vaccine-related injury for more than six months, died from the alleged vaccine-
related injury, or required inpatient hospitalization and surgical intervention as a result of the alleged vaccine-related
injury. § 11(c)(1)(D). It is undisputed that this requirement is satisfied in this case.
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reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination
and injury.” Id. at 1278. Together, these prongs 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.’” Stone v. Sec’y of
Health & Human Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012) (quoting Shyface, 165 F.3d at 1352-
53). Causation is determined on a case-by-case basis, with “no hard and fast per se scientific or
medical rules.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994).
Petitioners are not required to identify “specific biological mechanisms” to establish causation,
nor are they required to present “epidemiologic studies, rechallenge, the presence of pathological
markers or genetic disposition, or general acceptance in the scientific or medical communities.”
Capizzano, 440 F.3d at 1325 (quoting Althen, 418 F.3d at 1280). “[C]lose calls regarding causation
are resolved in favor of injured claimants.” Althen, 418 F.3d at 1280.
Each of the Althen prongs requires a different showing. The first Althen prong requires
petitioners to provide a “reputable medical theory” demonstrating that the vaccines received can
cause the type of injury alleged. Pafford, 451 F.3d at 1355-56 (citation omitted). To satisfy this
prong, petitioners’s “theory of causation must be supported by a ‘reputable medical or scientific
explanation.’” Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009) (quoting Althen, 418 F.3d at 1278). This theory need only be “legally probable,
not medically or scientifically certain.” Id. at 1380 (emphasis omitted) (quoting Knudsen, 35 F.3d
at 548). Nevertheless, “petitioners [must] proffer trustworthy testimony from experts who can find
support for their theories in medical literature.” LaLonde v. Sec’y of Health & Human Servs., 746
F.3d 1334, 1341 (Fed. Cir. 2014).
The second Althen prong requires proof of a “logical sequence of cause and effect.”
Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1278). In other words, even if the
vaccinations can cause the injury, petitioners must show “that it did so in [this] particular case.”
Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 962 n.4 (Fed. Cir. 1993) (citation omitted).
“A reputable medical or scientific explanation must support this logical sequence of cause and
effect,” id. at 961 (citation omitted), and “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,” Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1385 (Fed. Cir.
2015) (quoting Andreu, 569 F.3d at 1375). Petitioners is not, however, required “to eliminate
alternative causes as part of establishing [their] prima facie case.” Doe v. Sec’y of Health & Human
Servs., 601 F.3d 1349, 1357-58 (Fed. Cir. 2010); see Walther v. Sec’y of Health & Human Servs.,
485 F.3d 1146, 1152 (Fed. Cir. 2007) (holding that a “petitioners does not bear the burden of
eliminating alternative independent potential causes”).
To satisfy the third Althen prong, petitioners must establish a “proximate temporal
relationship” between the vaccination and the alleged injury. Althen, 418 F.3d at 1281. This
“requires preponderant proof that the onset of symptoms occurred within a timeframe for which,
given the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir.
2008). Typically, “a petitioners’s failure to satisfy the proximate temporal relationship prong is
due to the fact that onset was too late after the administration of a vaccine for the vaccine to be the
cause.” Id. However, “cases in which onset is too soon” also fail this prong; “in either case, the
temporal relationship is not such that it is medically acceptable to conclude that the vaccination
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and the injury are causally linked.” Id.; see also Locane v. Sec’y of Health & Human Servs., 685
F.3d 1375, 1381 (Fed. Cir. 2012) (“[If] the illness was present before the vaccine was administered,
logically, the vaccine could not have caused the illness.”).
B. Legal Standard Regarding Fact Finding
The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. § 11(c)(2). Medical
records created contemporaneously with the events they describe are presumed to be accurate and
“complete” such that they present all relevant information on a patient’s health problems. Cucuras
v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). In making
contemporaneous reports, “accuracy has an extra premium” given that the “proper treatment
hang[s] in the balance.” Id. Contemporaneous medical records that are clear, consistent, and
complete warrant substantial weight “as trustworthy evidence.” Id. Indeed, “where later testimony
conflicts with earlier contemporaneous documents, courts generally give the contemporaneous
documentation more weight.” Campbell ex rel. Campbell v. Sec’y of Health & Human Servs., 69
Fed. Cl. 775, 779 (2006); see United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1948). But
petitioners can support their claim with oral testimony if it is credible and consistent with the
medical records. See, e.g., Stevenson ex rel. Stevenson v. Sec’y of Health & Human Servs., No. 90-
2127V, 1994 WL 808592, at *7 (Fed. Cl. Spec. Mstr. June 27, 1994) (crediting the testimony of a
fact witness whose “memory was sound” and “recollections were consistent with the other factual
evidence”). In short, “the record as a whole” must be considered. § 13(a).
C. Evaluating Expert Testimony
Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of his or her claim. Lampe v. Sec’y of
Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). The Supreme Court’s opinion in
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), requires that courts
determine the reliability of an expert opinion before it may be considered as evidence. “In short,
the requirement that an expert’s testimony pertain to ‘scientific knowledge’ establishes a standard
of evidentiary reliability.” Id. at 590 (citation omitted). Thus, for Vaccine Act claims, a “special
master is entitled to require some indicia of reliability to support the assertion of the expert
witness.” Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1324 (Fed.
Cir. 2010). The Daubert factors are used in the weighing of the reliability of scientific evidence
proffered. Davis v. Sec’y of Health & Human 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”). 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). And nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder ex rel. Snyder v. Sec’y
of Health & Human Servs., 88 Fed. Cl. 706, 743 (2009) (quoting Gen. Elec. Co. v. Joiner, 522
U.S. 136, 146 (1997)).
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D. Consideration of Medical Literature
Finally, although this decision discusses some but not all the literature in detail, the
undersigned reviewed and considered all of the medical records and literature submitted in this
matter. See Moriarty ex rel. Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1328
(Fed. Cir. 2016) (“We generally presume that a special master considered the relevant record
evidence even though [s]he does not explicitly reference such evidence in h[er] decision.”);
Simanski v. Sec’y of Health & Human Servs., 115 Fed. Cl. 407, 436 (2014) (“[A] Special Master
is ‘not required to discuss every piece of evidence or testimony in her decision.’” (citation
omitted)), aff’d, 601 F. App’x 982 (Fed. Cir. 2015).
XI. Discussion
Petitioners allege that the vaccines administered to A.E.S. caused her to suffer a Table
encephalopathy and death, or alternatively, resulted in an off-Table encephalopathy and death.
Drs. Shuman and Harris agree this case does not meet the criteria for SIDS. Pet. Ex. 16 at
24, 26-29; Resp. Ex. C at 4-6. “I agree [with Dr. Shuman] that SIDS cannot be invoked in this
case, as an incomplete sampling of brain tissue and no clear environmental trigger is present. The
medical examiner also did not diagnose the death as SIDS.” Resp. Ex. C at 5; Tr. 243, 253-54.
Therefore, this case involves an 11-week-old infant who died between six and seven hours
following the receipt of her first set of multiple vaccinations and had a finding of brain
swelling/edema with pulmonary and cardiovascular congestion on autopsy. The cause of death
was “undetermined.” See Pet. Ex. 7 at 3.
A. A.E.S. suffered a Table encephalopathy and death.
The Qualifications and Aids to Interpretation (QAI) to the Vaccine Injury Table defines an
encephalopathy occurring within 72 hours of a DTaP vaccine as a Table injury:
(2) Encephalopathy. For purposes of paragraph (a) of this section, a vaccine
recipient shall be considered to have suffered an encephalopathy only if such recipient
manifests, within the applicable period, an injury meeting the description below of an acute
encephalopathy, and then a chronic encephalopathy persists in such person for more than
6 months beyond the date of vaccination.
(i) An acute encephalopathy is one that is sufficiently severe to require
hospitalization (whether or not hospitalization occurred).
(A) For children less than 18 months of age who present without an
associated seizure event, an acute encephalopathy is indicated by a
significantly decreased level of consciousness lasting for at least 24
hours. Those children less than 18 months of age who present following
a seizure shall be viewed as having an acute encephalopathy if their
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significantly decreased level of consciousness persists beyond 24 hours
and cannot be attributed to a postictal state (seizure) or medication.
* * *
(C) Increased intracranial pressure may be a clinical feature of acute
encephalopathy in any age group.
(D) A “significantly decreased level of consciousness” is indicated by the
presence of at least one of the following clinical signs for at least 24
hours or greater (see paragraphs (b)(2)(i)(A) and (b)(2)(i)(B) of this
section for applicable timeframes):
(1) Decreased or absent response to environment (responds, if at
all, only to loud voice or painful stimuli);
(2) Decreased or absent eye contact (does not fix gaze upon
family members or other individuals); or
(3) Inconsistent or absent responses to external stimuli (does not
recognize familiar people or things).
(E) The following clinical features alone, or in combination, do not
demonstrate an acute encephalopathy or a significant change in either
mental status or level of consciousness as described above: Sleepiness,
irritability (fussiness), high-pitched and unusual screaming, persistent
inconsolable crying, and bulging fontanelle. Seizures in themselves are
not sufficient to constitute a diagnosis of encephalopathy. In the absence
of other evidence of an acute encephalopathy, seizures shall not be
viewed as the first symptom or manifestation of the onset of an acute
encephalopathy.
* * *
(iii) An encephalopathy shall not be considered to be a condition set forth in the
Table if in a proceeding on a petition, it is shown by a preponderance of the evidence that
the encephalopathy was caused by an infection, a toxin, a metabolic disturbance, a
structural lesion, a genetic disorder or trauma (without regard to whether the cause of the
infection, toxin, trauma, metabolic disturbance, structural lesion or genetic disorder is
known). If at the time a decision is made on a petition filed under section 2111(b) of the
Act for a vaccine-related injury or death, it is not possible to determine the cause by a
preponderance of the evidence of an encephalopathy, the encephalopathy shall be
considered to be a condition set forth in the Table.
(iv) In determining whether or not an encephalopathy is a condition set forth in the
Table, the Court shall consider the entire medical record.
See 42 C.F.R. § 100.3(b)(2) (effective July 23, 2015 to March 20, 2017).
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In their post-hearing filings, petitioners argued that:
the Federal Circuit in Jay v. Secretary of HHS, 998 F.2d 979, 983 (Fed. Cir. 1993),
held, “[w]e can find nothing in the Vaccine Act which precludes death from being
used as evidence of a table injury, here encephalopathy.” “[T]here is no more
profound and permanent change in the level of consciousness than death.” Id. at
983 n.6. “Thus, according to the Federal Circuit, the special master must consider
the fact of death together with the other evidence in an on-Table encephalopathy
case.” Kincaid v. Sec'y of HHS, Case No. 02-1766V, 2003 U.S. Claims LEXIS 403,
2003 WL 23119834 *24 (Fed. Cl. Spec. Mstr. Nov. 26, 2003) (citing Jay v.
Secretary of HHS, 998 F. 2d. 979, 983 (Fed. Cir. 1993). Also, the fact that a
vaccinee has a table encephalopathy but dies before the number of hours required
under the table does not defeat a petitioner’s table claim. See Kincaid v. Sec’y of
HHS; Williams v. Sec’y of HHS; Sword v. Sec’y of HHS.
See Petitioners’ Post-Hearing Brief (“Pet. Post-H Brief”) at 8.
Respondent argued that the cases petitioners relied on are over 20 years old. Respondent’s
Post-Hearing Brief (“Resp. Post-H Brief”) at 9. The Court of Federal Claims has since addressed
Jay in Waterman v. Sec’y of Health & Human Servs., 123 Fed. Cl. 564, 575 (2015) (citing Hodges
v. HHS, 9 F.3d 958, 960 (Fed. Cir. 1993) and quoting Hellebrand v. Sec’y of Health & Human
Servs., 999 F.2d. 1565, 1571 (Fed. Cir. 1993), noting that death does not independently establish
the existence of a Table Injury, and to conclude so regarding any death that occurs within 72 hours
of receipt of a DTaP vaccine would be at odds with the plain language of the Vaccine Act. Resp.
Post-H Brief at 9. Thus, petitioners must rely on more than just A.E.S.’s death and must prove that
an acute encephalopathy as defined in the QAI occurred prior to her death, with her death occurring
as a sequela of the acute encephalopathy. Id.
The parties agreed that the applicable definition of acute encephalopathy is “a significantly
decreased level of consciousness lasting for at least 24 hours.” Respondent’s Pre-Hearing
Submission (“Resp. Pre-H Sub.”) at 6 (citing 42 C.F.R. § 100.3(b)(2)(i)(A) (effective July 23,
2015 to March 20, 2017).
However, respondent argued that death does not independently establish the existence of a
Table Injury; petitioners must rely on more than just death and must prove that an acute
encephalopathy as defined in the QAI occurred prior to her death, with death occurring as a sequela
of the acute encephalopathy; the QAI definition of acute encephalopathy is “a significantly
decreased level of consciousness lasting for at least 24 hours”; and petitioner “cannot prove that
A.E.S. suffered from a significantly decreased level of consciousness for at least 24 hours, because
she died less than 24 hours after her vaccinations.” Resp. Post-H Brief at 9; Resp. Pre-H Sub at 4.
Respondent’s argument suggests the impossible in a situation where a death occurs in less
than 24 hours. The clinical features of an encephalopathy clearly cannot exist for 24 hours when
death occurs before that time. However, respondent’s argument relies on only part of the statute.
The regulation continues with exceptions to a finding of encephalopathy:
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an encephalopathy shall not be considered to be a condition set forth in the Table if in a
proceeding on a petition, it is shown by a preponderance of the evidence that the
encephalopathy was caused by an infection, a toxin, a metabolic disturbance, a structural
lesion, a genetic disorder or trauma (without regard to whether the cause of the infection,
toxin, trauma, metabolic disturbance, structural lesion or genetic disorder is known)
42 C.F.R. § 100.3(b)(2)(iii). All the above were ruled out in this case. Here, the experts agree and
the medical records and autopsy report support that there was no infectious process, metabolic
disorder, pathological anomalies, trauma, prenatal or perinatal CNS injury found, only swelling
and inflammation of the brain on autopsy.
The regulation continues, “[i]f at the time a decision is made on a petition filed under
section 2111(b) of the Act for a vaccine-related injury or death, it is not possible to determine the
cause by a preponderance of the evidence of an encephalopathy, the encephalopathy shall be
considered to be a condition set forth in the Table.” Further, “[i]n determining whether or not an
encephalopathy is a condition set forth in the Table, the Court shall consider the entire medical
record.” See 42 C.F.R. § 100.3(b)(2)(iii-iv) (effective July 23, 2015 to March 20, 2017).
Here, a preponderance of the evidence shows that A.E.S. was a well 11-week-old baby
when she received her vaccinations between 11:00 and 11:30 am on December 16, 2013. Pet. Ex.
2 at 16-20; Pet. Ex. 7 at 9. While there are some discrepancies in the record, Mr. Sims recalled
giving A.E.S. a bottle before putting her in her bassinet at approximately 5:30 pm. He noted that
she ate more slowly than usual and seemed uninterested. Tr. 55-56, 77; Pet. Ex. 136 at 2. However,
Mrs. Sims stated that A.E.S. appeared to breastfeed more for comfort because she was not feeling
well throughout the afternoon before Mrs. Sims went to work, but she was uncertain if A.E.S. was
actually eating. Tr. 21-22. The autopsy did not mention any food content in the stomach. Pet. Ex.
7 at 4-5. Further, the parents described A.E.S. that afternoon as sleeping more, only opening her
eyes sometime but not making eye contact, not tracking, having a distant look as though looking
past her mother, not cuddling, fussing and whining as if she had a headache. Tr. 21-22, 40, 59-60;
Pet. Ex. 135 at 2. At approximately 5:30 pm, six and a half hours after her vaccinations, she was
placed on her back in her bassinet. At around 6:15 pm, she was found face up on her back with her
head tilted upward to the left, hand clenched, pale, and blue around her lips. Pet. Ex. 7 at 7-9; Tr.
57-58. Dr. Shuman referred to her positioning as a decerebrate posture, a sign of axial herniation
and encephalopathy. Tr. 140. When she was picked up, A.E.S. was limp but warm to the touch,
and Mr. Sims thought he felt her move and exhale. Tr. 62-63; Pet. Ex. 136 at 2; Pet. Ex. 7 at 7-9.
She was unresponsive upon arrival at the hospital. Pet. Ex. 5 at 10-12. Cardiac rhythm strips
showed evidence of some electro-cardiac activity, but she had no pulse and resuscitation efforts
were unsuccessful. Id. at 12, 55-56, 58. She was pronounced dead at 7:15 p.m., approximately
eight hours after her vaccinations. Id. at 10-12, 57-58. The autopsy revealed a heavy brain at 595g
compared to an expected 461-555g, and cerebral edema. Pet. Ex. 3 at 3. The cause and manner of
death was listed as undetermined and “consistent with Sudden Unexplained Infant Death (SUID).”
Id. at 4.
Drs. Shuman and Harris agreed the brain was heavy and there was cerebral edema. See Pet.
Ex. 16 at 31; Pet. Ex. 92 at 1-2; Resp. Ex. C at 3-4, 6; Tr. 133-140, 231-32; 250-52. Dr. Gershwin
referred to cerebral edema as the clinical manifestation of inflammation. Pet. Ex. 63 at 1.
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It is undisputed that there is no evidence that A.E.S. died of a factor unrelated to the
administration of the vaccines. In fact, Dr. Harris admitted he didn’t “have an explanation for
another diagnosis in this case.” Tr. 242-43. Dr. McCusker suggested the possibility of a condition
suffered briefly by a sibling born after A.E.S.’s death, but she could not say that it was probable
that A.E.S. had that condition. She conceded she never reviewed the sibling’s records nor was any
genetic testing done. Tr. 310-11.
Further, the regulation provides that “[i]ncreased intracranial pressure may be a clinical
feature of acute encephalopathy in any age group.” 42 C.F.R. § 100.3(b)(2)(i)(C) (effective July
23, 2015 to March 20, 2017). Both Drs. Shuman and Harris agreed that A.E.S.’s brain was
abnormally heavy with edema on autopsy. Dr. Shuman concluded that A.E.S. developed an
encephalopathy with cerebral edema which caused axial herniation that led to her death. Pet. Ex.
16 at 36-37; see Pet. Ex. 92. Dr. Harris agreed that the brain was abnormally heavy and that there
was edema, but did not see early ischemic injury, reactive gliosis, hemorrhage, or
neurodegenerative changes, or evidence of cell death. Resp. Ex. C at 5-6. However, he could not
refute that the edema seen on autopsy was not an early sign of hypoxia-ischemia although it usually
takes 6-12 hours for such changes to be seen as edema. Tr. 233-34. Further, Dr. Harris could not
rule out axial herniation as described by Dr. Shuman. Tr. 236-37, 256. Both experts agreed that
once the skull was removed on autopsy, the brain would move back into place, relieving the
pressure caused by swelling within the closed compartment of the brain. Pet. Ex. 16 at 31; Tr. 236-
37. Thus, the existence of intracranial pressure cannot be ruled out.
Further, while respondent’s experts argued that A.E.S. did not show behaviors of an
encephalopathic child, they agreed that a systemic reaction severe enough to cause characteristic
and perceptible encephalopathic behaviors would have required at least six to eight hours, which
is the exact time frame from the time A.E.S. received her vaccines until she was found
unresponsive in her bassinet. See Tr. 235; Pet. Ex. 7 at 7, 9. It is unknown what transpired while
A.E.S. was in her bassinet alone between approximately 5:30 and 6:15 pm. Respondent argues that
A.E.S. did not suffer a systemic reaction because there was no contemporaneous observation of a
reaction, but reaching such a conclusion would be unreasonable. The absence of any report of a
systemic reaction such as high fever or seizure is of limited value and merely shows that no
reaction was recorded, not that a reaction did not occur when A.E.S. was unobserved during her
last 45 minutes of responsive life. A.E.S.’s positioning when she was found by her father—pale
with blue lips, fists clenched, and head upward to the left—suggests that something occurred, even
if it was not witnessed. The result was the death of an 11-week-old child with no cause of death
found on autopsy and a heavy brain and cerebral edema agreed to be pathologically abnormal.
We do not have the luxury of knowing what A.E.S.’s behaviors would have been had she
survived. We have only the reports of the parents about her behavior in the afternoon following
receipt of her vaccines that morning: she was sleepy and fussy, not making eye contact, not
cuddling, feeding slowly, appearing “out of it”, not looking at her mother and not tracking. Dr.
Shuman opined that these behaviors are demonstrative of A.E.S. being encephalopathic based on
the behavioral repertoire of an 11-week-old. Tr. 140-41. The autopsy showed a brain heavier than
normal for a baby her age. See Pet. Ex. 7 at 5. Although the autopsy was arguably deficient, there
is no dispute among the pathologists that tissue samples taken showed swelling of the brain. See
Pet. Ex. 16 at 31; Resp. Ex. C at 4. Anatomically and pathologically, A.E.S. was otherwise normal.
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The preponderant evidence shows a healthy baby who received multiple routine
vaccinations in the morning, was whining and fussing as though in pain, not focusing, tracking,
cuddling or feeding normally that afternoon. She was pronounced dead at 7:15 pm, eight hours
after her vaccinations. The pathologists agreed that the only abnormalities on autopsy were a heavy
brain and edema. They also agreed based on the evidence that this is not a SIDS case. When asked
if the vaccinations contributed to A.E.S.’s death, Dr. Harris conceded, “I don’t have an explanation
for another diagnosis in this case.” Tr. 242-43. There was no trauma and no evidence of
neurological disease other than edema. Tr. 255-56. When asked if the DTaP vaccine can cause an
acute encephalopathy, Dr. McCusker would only say that if one’s definition of encephalopathy
was cerebral edema leading to mortality, then “that has not been demonstrated in large studies.”
However, she agreed that the CDC cautions that encephalopathy following acellular pertussis
vaccine is a contraindication to additional DTaP vaccines. Tr. 312.
Dr. Shuman testified that the signs of an encephalopathy in an infant A.E.S.’s age are
limited and difficult to assess due to an infant’s behavioral repertoire at that stage of development.
See Tr. 129, 140-41, 163. However, the behaviors that are the within the repertoire of an 11-week-
old that were demonstrated by A.E.S.—irritability, inability to self-soothe, not cuddling, not
tracking or making eye contact, and sleeping more—were indicative of an altered state and
decreased level of consciousness in the afternoon following her vaccinations sufficient to satisfy
the Table requirements for an encephalopathy.53 Therefore, I find that A.E.S. suffered from a Table
encephalopathic event with cerebral edema following the receipt of multiple vaccinations that
resulted in her death.
B. In the alternative, the vaccinations received by A.E.S. caused cerebral
edema, encephalopathy, and death.
The legislative scheme that created Table injuries established a presumption of causation
that alleviates the need for an actual causation determination. Having determined that A.E.S.
suffered a Table encephalopathy, a causation analysis is unnecessary, but to be thorough, the off-
Table causation-in-fact claim will be addressed as well.
1. Althen Prong I: Petitioners Have Provided a Reputable Medical
Theory.
Vaccines can cause encephalopathy. The Institute of Medicine has written extensively
about the relationship between pertussis and encephalopathy, concluding that the “evidence is
53 As discussed further below regarding Prong I, Dr. Gershwin opined that, though rare, pro-inflammatory cytokines
released in response to vaccination can cross the BBB, causing an inflammatory process affecting the brain and
causing cerebral edema. Tr. 205-07. In Nuttall, Special Master Hastings concluded that there was no definition of
encephalitis in the 2015 QAI and special masters accordingly need to apply the ordinary meaning of the term, which
simply means any inflammation of the brain. Nuttall v. Sec'y of Health & Human Servs., No. 07-0810V, 2015 WL
691272 (Fed. Cl. Spec. Mstr. Jan. 20, 2015), aff'd, 122 Fed. Cl. 821 (2015), aff'd, 640 F. App'x 996 (Fed. Cir. 2016).
While there was no claim of encephalitis in the instant matter, it was undisputed that there was swelling of the brain.
The interpretation of encephalitis in Nuttall creates the hypothetical possibility that an alternative avenue exists
whereby petitioners here could be eligible for a Table claim irrespective of the requirement of 24 hours of reduced
consciousness.
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consistent with a causal relation between DPT vaccine and acute encephalopathy.” Pet. Ex. 10154
at 1; see also Pet. Ex. 1955; Pet. Ex. 2056; Pet. Ex. 2157; Pet. Ex. 3058; Pet. Ex. 3359; Pet. Ex. 3460;
Pet. Ex. 6261; Pet. Ex. 99.62 The National Childhood Encephalopathy Study (NCES) reported on
1000 cases of serious neurological illnesses in early childhood and their relationship to vaccines
containing pertussis. The results suggested that DPT immunization was associated with an
increased risks of seizures and encephalopathy within 7 days. Pet. Ex. 60 at 1, 463; see also Pet.
Ex. 59.64
The foregoing studies address the whole cell DTP, not the currently used acellular DTP,
which has also been found to have adverse reactions, “[t]here are just fewer reactions to DTaP than
to whole cell DTP.” Johnson v. Sec'y of Health & Hum. Servs., No. 07-138V, 2010 WL 3291932
at *15 (Fed. Cl. Spec. Mstr. July 30, 2010); see also Pet. Ex. 16 at 19. Zielinski studied the rate of
systemic adverse reactions to whole cell DTP when compared with acellular DTP and found that
systemic adverse reactions occurred after receipt of either vaccine, but twice as often with receipt
of whole cell DTP. Pet. Ex. 100.65
Several vaccine cases have addressed the distinction between the DTP and DTaP vaccine
formulations, concluding that the epidemiological findings relating to the safety of DTP vaccines
cannot be transferred to the DTaP. See, e.g., Sharpe v. Sec’y of Health & Human Servs., No. 14-
65V, 2018 WL 7625360, at *31-32 (Fed. Cl. Spec. Mstr. Nov. 5, 2018); Taylor v. Sec'y of Health
& Human Servs., No. 05-1133V, 2012 WL 4829293, at *30 (Fed. Cl. Spec. Mstr. Sept. 20, 2012);
Holmes v. Sec'y of Health & Human Servs., No. 08-185V, 2011 WL 2600612, at *20 (Fed. Cl.
Spec. Mstr. Apr. 26, 2011); Simon v. Sec'y of Health & Human Servs., No. 05-941V, 2007 WL
1772062, at *7 (Fed. Cl. Spec. Mstr. June 1, 2007); Grace v. Sec'y of Health & Human Servs., No.
04-[redacted], 2006 WL 3499511, at *9 (Fed. Cl. Spec. Mstr. Nov. 30, 2006).
54 INST. OF MED., Adverse Effects of Pertussis and Rubella Vaccines 86 (Christopher P. Howson et al. eds., 1991),
filed as “Pet. Ex. 101.”
55 Dolgopol, supra note 50.
56 J. H. Menkes & M. Kinsbourne, Workshop on Neurologic Complications of Pertussis and Pertussis Vaccination,
21 NEUROPEDIATRICS 171 (1990), filed as “Pet. Ex. 20.”
57 B. A. Halperin et al., Kinetics of the Antibody Response to Tetanus-Diphtheria-Acellular Pertussis Vaccine in
Women of Childbearing Age and Postpartum Women, 53 CLINICAL INFECTIOUS DISEASES 885 (2011), filed as “Pet.
Ex. 21.”
58 Pediarix Highlights of Prescribing Information, GlaxoSmithKline, filed as “Pet. Ex. 30.”
59 CDC, Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS)—United
States 1991-2001, Morbidity & Mortality Weekly Report (2003), filed as “Pet. Ex. 33.”
60 Erick Sell & Berge A. Minassian, Demystifying vaccination-associated encephalopathy, 5 NEUROLOGY 465 (2006),
filed as “Pet. Ex. 34.”
61 Steinman et al., supra note 13.
62 CDC, Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Young Children
Recommendations of the Advisory Committee on Immunization Practices (ACIP), Morbidity & Mortality Weekly
Report (1997), filed as “Pet. Ex. 99.”
63 D. L. Miller et al., Pertussis immunization and serious acute neurological illness in children, 282 BRITISH MED. J.
1595 (1981), filed as “Pet. Ex. 60.”
64 Nicola Madge et al., The National Childhood Encephalopathy Study: A 10-Year Follow-Up, 68 DEVELOPMENTAL
MED. & CHILD NEUROLOGY 1 (1993), filed as “Pet. Ex. 59.”
65 Andrzej Zielinksi & Magdalena Rosinska, Comparison of Adverse Effects Following Immunization with Vaccine
Containing Whole-Cell vs. Acellular Pertussis Components, 92 PRZEGLĄD EPIDEMIOLOGICZNY 589 (2008), filed as
“Pet. Ex. 100.”
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However, literature demonstrates that encephalopathy is a known risk of DTaP vaccination.
In the DTaP Vaccine Information Statement (“VIS”), the CDC cautions that any child who
suffered a brain or nervous system disease within seven days of a dose of DTaP should not get
another dose. Pet. Ex. 98.66 The Morbidity and Mortality Weekly Report distributed by the CDC
provides that if encephalopathy occurs within seven days of administration of DTaP or DTP,
subsequent vaccination with DTaP or DTP is contraindicated. Pet. Ex. 99 at 17-18.67 The package
insert for the DTaP vaccine warns that “[e]ncephalopathy (e.g., coma, decreased level of
consciousness, prolonged seizures) within 7 days of administration of a previous dose of a
pertussis-containing vaccine that is not attributable to another identifiable cause is a
contraindication to administration of any pertussis-containing vaccine, including PEDIARIX.”
Pet. Ex. 30 at 4.68 Thus, sufficient medical literature demonstrates, and the CDC accepts, that DTaP
can cause encephalopathy.
Further, the package inserts for both the DTaP and Prevnar 13 vaccines contain warnings
of apnea in premature infants. Pet. Ex. 16 at 21. Prevnar 13 is a conjugate vaccine which contains
Diphtheria CRM protein. The package insert states that data is insufficient to assess the effects of
concomitant administration of Prevnar 13 with HPV, MCV4, tetanus toxoid, and Tdap. Pet. Ex.
35 at 21, 24-25.69 The pneumococcal polysaccharides in the Prevnar 13 vaccine, though not as
toxic as pertussis toxin, have been linked to cardiac-mediated cyanosis, vascular pallor,
respiratory-mediated apnea, and nervous system-mediated hypotonia. Id. at 20-21; Pet. Ex. 16 at
28. Table 4 of the package insert shows that 80% of infants vaccinated with Prevnar 13 suffer
irritability, 70% at two months sleep too much, and 50% had diminished appetite. Pet. Ex. 16 at
28 (citing Pet. Ex. 35 at 9).
According to Drs. Shuman and Gershwin, Pediarix, Hib, PCV13, and RotaTeq
vaccinations can, individually or in combination, produce cerebral edema, axial herniation, and
death through the circulation of cytokines to the brain. Pet. Ex. 16; Pet. Ex. 63; Pet. Ex. 6570; Pet.
Ex. 6671; Pet. Ex. 92; Pet. Ex. 97.
While the experts did not agree that A.E.S.’s vaccines were the cause of her death, they did
agree about the body’s immune response to receiving vaccinations. According to Dr. Shuman,
vaccines can affect the brain through immunological processes that can be destructive. Pet. Ex. 92
at 4. Vaccines elicit cytokines necessary in inducing immunological response. The DTaP, Hib, and
PCV vaccines are proven to stimulate the production and circulation of proinflammatory cytokines
including IL-1β, IL-6, and TNF-α. IL-1β stimulates macrophage production, T-cell production,
and can cause fever. IL-6 stimulates T and B cells and can cause acute phase reactions such as
inflammation and fever. TNF-α stimulates formed macrophages to make more cytokines (in a
positive feedback loop) and inflammatory invasion by monocytes, which then transform into more
macrophages, and activate endothelial cells. Pet. Ex. 92 at 4. The increase of vascular permeability
causes separation of the endothelial cell lining of the blood vessel walls, leading to the leaking of
66 CDC, Vaccine Information Statement: DTaP Vaccine (2007), filed as “Pet. Ex. 98.”
67 CDC, supra note 62.
68 GlaxoSmithKline, supra note 58.
69 Pfizer, supra note 15.
70 Kashiwagi et al., supra note 21.
71 Pan et al., supra note 26.
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fluid and protein from the blood which accumulates in the tissue and causes swelling or edema.
Id. These changes to the endothelium result in inflammation known as endothelial activation. TNF-
α is a potent cytokine activator of endothelial cells.72 Id. at 5. Dr. Shuman added that the production
of IL-1β is “provoked by vaccines more in the first year of life than later in life” and is
“significantly more provoked by multiple vaccines than it is by single vaccines.” Id.
Dr. Gershwin explained that the innate immune system produces proinflammatory
cytokines and chemokines in response to infections and vaccines which can cause or prevent
inflammation. These immune cells enable communication between the innate and adaptive
immune systems, as well as between the innate cells and other tissues of the body. Tr. 182-85.
Kashiwagi illustrated the various cytokines present in the body after vaccination. Tr. 191-92, 201;
Pet. Ex. 65.73 Vaccines produce cytokines and chemokines at the vaccination site—which is why
there is swelling at the site—which drain into the lymph nodes, circulate around the body, and can
cross the blood brain barrier, producing biologic effect. Adaptive cells then present and build
antibodies and cytotoxic T-cells. Tr. 185-88; Pet. Ex. 10474 at 4.
Acknowledging that no literature has addressed which proinflammatory cytokines
produced in the blood after vaccination can cross the BBB, Dr. Gershwin believes it would be
variants such as IL-1 and IL-6. Studies do show that influenza infection produces proinflammatory
cytokines that can cause encephalopathy, and Reyes Syndrome produces proinflammatory
cytokines that causes swelling in the body. Proinflammatory cytokines produce swelling and
edema anywhere in the body, so there is no reason to believe the brain after vaccination is an
exception. Tr. 205-07. Dr. Gershwin added this is an extremely rare event, making it unlikely to
be studied, but it happened to A.E.S. and rare events are the basis for the vaccine program. Tr. 205.
Dr. McCusker similarly described an initial cascade of inflammation during an innate
immune response at the site of infection or trauma, but argued it is transient and tightly regulated
with most cytokine events occurring locally without generating a systemic effect. Resp. Ex. A at
6; Resp. Ex. E at 2. She acknowledged that proinflammatory cytokines can cause local pain,
redness, systemic fever, and malaise, which is the body’s way of stopping replication of the
pathogen and increasing basal metabolic rate to activate the adaptive immune system to generate
immunological memory. Resp. Ex. A at 6. She added, however, the effects are limited and usually
resolve when the acute infection is eliminated or when the adaptive immune response neutralizes
the pathogen. Id.
According to Dr. McCusker, the cytokines produced by vaccination are far less than those
produced by natural infection and are therefore not sufficient for the development of brain edema.
Resp. Ex. A at 6; Resp. Ex. E at 3; Resp. Ex. E, Tab 4.75 Further, vaccines and infections in general
72 Dr. McCusker relied on Hingorani to show that the timing associated with an increase of inflammatory cytokines
was within hours of vaccination and to conclude that A.E.S. could not have had signs of encephalopathy. See Resp.
Ex. E at 3; Tr. 281. However, Hingorani actually discusses how the inflammatory process caused by the increase in
cytokines can disrupt vascular homeostasis and arterial circulation. The authors found an association between even
mild systemic inflammatory response to cytokines and profound suppression of endothelium-dependent relaxation in
circulation thought to be associated with increased cardiovascular risk. Resp. Ex. E, Tab 3 at 3.
73 Kashiwagi et al., supra note 21.
74 Hervé et al., supra note 25.
75 Kashiwagi et al., supra note 21.
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are not known to disrupt the BBB. Resp. Ex. E at 5-6; Pet. Ex. 85.76 She relied on Suntharalingam
to show that even after a T-cell immunomodulatory agent is injected into adults, creating a
“cytokine storm” or rapid onset of systemic inflammatory response syndrome (SIRS), no one
developed signs of encephalopathy or significant brain edema. Resp. Ex. E at 3; Resp. Ex. E, Tab
5.77 However, this study involved adults, not infants.
Dr. McCusker explained that the brain contains microglial cells which release cytokines
under baseline conditions and increase the release of IL-1 and IL-6 to maintain homeostasis when
exposed to stressors such as acute brain injury and neurodegeneration. Resp. Ex. E at 2, 4; see
Resp. Ex. E, Tab 678, Resp. Ex. E, Tab 7.79 She acknowledged that an overexpression of cytokines
in the CNS can be detrimental to the brain and that cytokines can “diffuse across the BBB” through
receptors or through the vagus nerve but contends this does not mean cytokines enter the CNS,
only that the brain gets the message of their presence. Tr. 286-87; Resp. Ex. E at 4; Resp. Ex. E,
Tab 11.80
Succinctly, Dr. McCusker stated that the literature relied on by petitioners’ experts does
not support peripheral cytokine release after vaccination being capable of generating life-ending
brain edema, and even a cytokine storm cannot cause disruption of the BBB causing death. Resp.
Ex. E at 6; Resp. Ex. A, Tab 1381 at 5.
The literature does demonstrate that encephalopathy is a known risk of DTaP vaccination
and that both DTaP and Prevnar 13 vaccines have been associated with apnea in premature infants.
Pet. Ex. 9882; Pet. Ex. 99 at 17-1883; Pet. Ex. 3084; Pet. Ex. 16 at 21. The Prevnar 13 vaccine has
also been linked to cardiac-mediated cyanosis, vascular pallor, respiratory mediated apnea, and
nervous system-mediated hypotonia. Pet. Ex. 16 at 28. The additional literature filed by Dr.
McCusker after the hearing provides that the data is insufficient to assess the effects of concomitant
administration of Prevnar 13 with HPV, MCV4, tetanus toxoid, and Tdap. Pet. Ex. 35 at 21, 24-
2585; Resp. Ex. F. A.E.S. received a hexavalent vaccine containing DTaP/IPV/HepB, Hib, Prevnar
13 (PCV13), and RotaTeq vaccinations on the day of her death.
Petitioners have presented preponderant evidence to show that on rare occasions, the
release of proinflammatory cytokines in response to vaccines can cause a systemic inflammatory
response to an antigen load that can overwhelm immunomodulatory controls, resulting in
encephalopathy and cerebral edema. Petitioners have satisfied Prong I.
76 William A. Banks & Abba J. Kastin, Review: Interactions Between the Blood-Brain Barrier and Endogenous
Peptides: Emerging Clinical Implications, 295 AM. J. MED. SCI. 459 (1996), filed as “Pet. Ex. 85.”
77 Suntharalingam, supra note 32.
78 Ron-Harel et al., supra note 33.
79 Moidunney et al., supra note 34.
80 Quan, supra note 35.
81 Rafael Ponce, Adverse Consequences of Immunostimulation, 5 J. IMMUNOTOXICOLOGY 33 (2008), filed as “Resp.
Ex. A, Tab 13.”
82 CDC, supra note 66.
83 CDC, supra note 62.
84 GlaxoSmithKline, supra note 58.
85 Pfizer, supra note 15.
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2. Althen Prong II: Petitioners Have Provided a Logical Sequence of
Cause and Effect
The autopsy findings in this case were unremarkable, except for a brain weight of 595
grams and cerebral edema. Pet. Ex. 3 at 3. The medical examiner concluded that the cause and
manner of death were best classified as “undetermined”, and the findings were consistent with
Sudden Unexpected Infant Death (SUID). Pet. Ex. 3 at 4.
As the person who conducted the autopsy, Dr. Barnhart’s views are entitled to some
deference. Nordwall v. Sec’y of Health & Human Servs., 83 Fed. Cl. 477, 488 (2008). However,
findings of a treating doctor are not sacrosanct. Snyder v. Sec’y of Health & Human Servs., 88 Fed.
Cl. 706, 745 n.67 (2009).
There is little dispute between the pathologist who performed the autopsy and those hired
in this case about the autopsy findings. All agreed that there was heavy brain, brain edema, and
the cause of death was “undetermined” based on the history of no prior illness, no foul play, and
no pathological findings to explain her death.
Dr. Harris agreed A.E.S.’s brain was heavier than expected in a child her age and the
swelling or edema was “an abnormal finding or a pathological finding. It’s not normal. But we
don’t know what the cause of that swelling is in many cases of infant death, sadly.” Tr. 231-32.
Further, he stated that the brain weight was a “pathological abnormality.” Tr. 250-51. The
congestion in the organs was also a pathological abnormality. Tr. 251; Pet. Ex. 3 at 3-4.
Dr. Shuman opined the heavy brain was consistent with cerebral edema caused by the
multiple vaccines A.E.S. received at one time constituting a “profound immunologic challenge.”
Pet. Ex. 16 at 18, 31. The cytokines generated from the vaccines circulated to A.E.S.’s brain,
disrupted the cerebral blood brain barrier, and produced severe rapid cerebral edema causing death
by axial herniation. A.E.S. suffered a malignant form of cerebral edema which was widespread,
rapidly progressive, and lethal within 6-8 hours of vaccination. Id. at 36-37.
Dr. Shuman referred to the autopsy photographs showing swelling at the injection sites on
A.E.S.’s thighs, indicating an inflammatory reaction of the local tissue, necessary for cytokine
release and spread by circulation. Tr. 161; Pet. Ex. 18 at 2. Dr. Shuman stated that the vascular
system is very reactive to cytokines and the cytokines released and activated by adjuvanted
vaccines, including IL-1, IL-6, tumor necrosis factor, C55 complement, and some prostaglandins,
are extraordinarily and systemically vasoreactive on the brain and pulmonary vasculatures. This is
demonstrated by their producing cerebral and pulmonary edema, third-spacing, hypovolemic
hypotension, shock, and progressive encephalopathic death, as seen with A.E.S. Tr. 162-63.
Dr. Shuman explained that the pertussis toxin in the DTaP vaccine targets the brain,
clinically and experimentally producing hypotonic spells, systemic and neurologic collapse, coma,
and seizures. Pet. Ex. 16 at 28; Pet. Ex. 62.86 The pneumococcal polysaccharides in the Prevnar
13 vaccine have been linked to cardiac mediated-cyanosis, vascular (cardiac)-mediated pallor,
respiratory-mediated apnea, and nervous system-mediated hypotonia. Id. at 28. The package insert
86 Steinman et al., supra note 13.
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at Table 4 shows that of infants from two to 12 months of age vaccinated with Prevnar 13, 80%
suffer irritability, 70% of two-month-old infants slept too much, and 50% had diminished appetite.
Pet. Ex. 16 at 28; Pet. Ex. 3587 at 9. These “misbehaviors” show disrupted brain function in infants,
which become less frequent in older infants, because “[t]he CNS of the younger infant is most
susceptible to neural toxicity.” Pet. Ex. 16 at 28.
Dr. Shuman described the weight of A.E.S.’s brain as a “robust sign of cerebral edema”,
with objective findings on autopsy including a full and flattened brain “obviously under pressure,”
a brain weight at least two standard deviations above the mean for a 10-week-old female, and the
absence of inflammation or other obvious cause of death in the limited samples of the brain taken.
Tr. 133-140, 142; Pet. Ex. 92 at 1-2; Pet. Ex. 4788; Pet. Ex. 4889; Pet. Ex. 49.90 He explained that
when the brain swells, it takes up more space and the pressure within the skull increases. The brain
is somewhat like fluid, and it shifts compartments and cuts off vessels between the compartments
when the volume and pressure increase. When brain pushes against brain, the pressure pushes
downward on the brainstem, which causes bradycardia and interferes with functions such as focus,
gaze, tracking, sucking, and swallowing. Tr. 133-36; Pet. Ex. 16 at 27. Once the cerebral edema
causes axial herniation and the brainstem is impaired, death ensues soon after. A.E.S. “was not
resuscitable because the brainstem could not resume control of the viscera” and she suffered
multiorgan failure and death soon after. Pet. Ex. 16 at 36-37.
Dr. Harris agreed A.E.S.’s brain was heavy with swelling and mild edema, but explained
herniation is very difficult to assess on an infant brain at autopsy. Resp. Ex. C at 6. However, there
were insufficient findings of hypoxia-ischemia or infection to explain the edema on the brain. Id.
He disagreed that Dolgopol applied in this case because it discussed the neuropathological changes
in infants who died from pertussis infection encephalopathy with autopsies showing variable
edema, hemorrhages, and neurodegeneration, while A.E.S. had mild edema with no hemorrhages,
neurodegenerative changes, or signs of cell death on the brain tissue. Id.; Pet. Ex. 19.91 Dr. Harris
admitted that while he did not see signs of hypoxia or ischemia on the autopsy slides, he could not
dispute that the edema could be an early sign of a hypoxic or ischemic event. Tr. 235.
Dr. Harris concurred that the gelatinous nature of the brain tissue makes it more challenging
to observe herniation on autopsy and noted that the medical examiner did not mention other signs
of herniation such as internal and external hemorrhage, but he added that he did not know the level
of competence of the medical examiner to recognize early herniation in an infant. Tr. 236-37. He
stated that key sections of the brain, including the brainstem, were not sampled and “…not having
those makes it very difficult, unfortunately, to say whether or not there was herniation in this case.”
Tr. 236-37. However, he could not “rule it out or rule it in” from a pathological standpoint. Tr.
237, 256. When pressed on the issue, he expressed the challenges in assessing brainstem herniation
without imaging studies or a full examination of the brain. He explained that even with the degree
of swelling on the surface of the brain, the overall weight of the brain, and what he heard clinically,
he could not say that a herniation occurred. Tr. 238-39. However, he also could not rule in or out
87 Pfizer, supra note 15.
88 Kayser et al., supra note 18.
89 Schulz et al., supra note 19.
90 Coppoletta & Wolbach, supra note 20.
91 Dolgopol, supra note 50.
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inflammation in other areas of the brain because of the scant amount of brain tissue sampled. Tr.
239. He stated he too would have concluded the cause of death was undetermined based on the
pathological findings and mild cerebral edema had he been the medical examiner. Tr. 240.
Drs. Shuman and McCusker disagreed about the congestion of the organs and the frothing
of the lungs. Dr. McCusker stated it was from resuscitation efforts, while Dr. Shuman stated it was
indicative of fluid transmuting across the vasculature in the pulmonary space, which similarly
occurred in the brain vasculature, producing cerebral edema and causing A.E.S. to become
hypovolemic and hypotensive. This was all related to the process of the cytokines. Tr. 172, 175-
77; Pet. Ex. 3 at 3-4. Dr. Harris argued that pulmonary edema and congestion are common and
non-specific findings in all age groups on autopsy. Resp. Ex. C at 5.
Dr. Shuman discussed the repertoire of encephalopathic behaviors in an infant at A.E.S.’s
age and noted A.E.S.’s irritability, inability to soothe, and not having a normal gaze or social
response as described by her parents. Tr. 129-31, 140-46. He added A.E.S. was in a decerebrate
posture when found, a sign of axial herniation and encephalopathy. Tr. 140. Based on the evidence,
he concluded that A.E.S. was encephalopathic with a decreased level of consciousness as indicated
by decreased or absent responses to her environment, and clinical signs of absent eye contact and
absent or inconsistent responses to external stimuli. These behaviors correlate with significant
progressive cerebral edema, axial gradation, and compression of function of the brain tissue. Tr.
163. The process of A.E.S.’s encephalopathy completed at some time between the time when her
mother left for work and before her father found her in the bassinet. Tr. 141-42.
Dr. McCusker disagreed, stating that A.E.S. showed no clinical signs of immune activation,
acute cerebral edema or increased intracranial pressure in the 90 minutes prior to being found
unresponsive. Tr. 298-99, 306; Resp. Ex. E at 7. In her experience, an encephalopathic child is not
quiet with “soft behavioral changes” but is in pain, won’t eat, is nauseous, vomiting, and has a
severe headache. Tr. 299.
As expected, petitioner’s experts concluded that the multiple vaccines received by A.E.S.
six to eight hours prior to her death were the cause of her death. Respondent’s experts disagreed.
However, Dr. Harris was candid in his inability to rule in or out the conclusions reached by Dr.
Shuman. Further, when asked if he could definitively say that A.E.S.’s death was not the result of
the vaccines, he stated, “Yeah, I base my opinion, though, on the medical literature and the fact
that the timing of this autopsy or of the vaccination could not have been an anaphylactic reaction.
And I’m not aware of any literature to suggest that vaccination other than anaphylaxis could lead
to a death like this.” Tr. 242. However, “I don’t have an explanation for another diagnosis in this
case.” Tr. 242-43. There was no trauma and no evidence of neurological disease other than edema.
Tr. 255-56.
A.E.S. did not live long enough to display all the characteristic behaviors typically
associated with encephalopathy in an infant, but her behavior in the hours following the
vaccinations followed by an unresponsive state and subsequent death and autopsy findings satisfy
Prong II.
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3. Althen Prong III: Petitioners Have Demonstrated a Proximal
Temporal Relationship
Dr. Gershwin opined that the temporal association between the vaccines A.E.S. received
and her encephalopathy and death is “consistent.” Tr. 200. The rapid onset of A.E.S.’s
encephalopathy would imply a cytokine-mediated event because something that occurred so
rapidly would be immunological. Tr. 199.
Dr. Harris stated that changes on the brain from hypoxia-ischemia typically take at least
six hours and agreed that the edema seen on the autopsy could have been an early sign of
hypoxia/ischemia. However, he “could not make that judgment without seeing multiple areas of
the brain.” Tr. 233-34.
A.E.S. received the vaccinations at approximately 11:00 am on December 13, 2016. Pet.
Ex. 2 at 16-19; Pet. Ex. 7 at 9. She was found unresponsive in her bassinet at approximately 6:15
pm that day, seven hours after her vaccinations. She was pronounced dead at approximately 7:15
pm. Pet. Ex. 7 at 1, 7; Pet. Ex. 5 at 11, 57-58. Dr. Shuman explained that the behaviors Ms. Sims
described - a distant look in A.E.S.’s eyes, not making eye contact, whimpering, and acting “the
way you would if you had a headache,” all abnormal for her - were indicative of the distress A.E.S.
was experiencing. Tr. 22-23, 40, 142-46; Pet. Ex. 135 at 2. The ER record documents “cardiac
arrest and sepsis with anaphylaxis. Pet. Ex. 5 at 11.
While Dr. McCusker disagreed that A.E.S. showed any clinical signs of immune activation,
acute cerebral edema, or increased intracranial pressure, she did state that it takes at least three
hours for cytokines to release after vaccination. Tr. 280-81, 298-99, 306; Resp Ex. E, Tab 492;
Resp. Ex. E at 7. A.E.S. was found unresponsive at 6:15 pm, approximately seven hours after
vaccination and well outside the time at which cytokines are released into the muscle as stated by
Dr. McCusker based on Kashiwagi.93 Further, while the subtle changes in A.E.S.’s regular
behavior in the afternoon following her receipt of the subject vaccinations were described by her
parents, it is unknown how A.E.S.’s behavior changed and evolved or what occurred from the time
she was laid down in her bassinet around 5 pm until was found unresponsive around 6:15 pm. The
literature supports that cytokine release could have occurred as early as three hours post-
vaccination, accounting for her early behavior changes. Accordingly, petitioners have presented
preponderant evidence to satisfy Prong III.
C. Burden Shifting: Alternative Cause
Petitioners addressed the issue of alternative cause, submitting that there was no evidence
of infection on gross or microscopic examination or cultures post-mortem. Pet. Ex. 16 at 24. There
was no indication of predisposing chronic stress on autopsy. Id. at 28. The features of the home
environment, the sleeping site, its materials, and the position of A.E.S.’s body were inconsistent
with SIDS. Id. Cerebral edema is not a feature of SIDS, but it was a marked feature on the autopsy
in this case. Pulmonary edema and congestive heart failure are not features of SIDS, but both were
92 Kashiwagi et al., supra note 21.
93 Id.
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present when A.E.S. was brought to the ER. Pet. Ex. 16 at 36. This case does not fit the classic
profile of SIDS. Id. at 26. Dr. Harris agreed that SIDS cannot be invoked in this case. Tr. 253-54.
Respondent submits that a mere showing of temporal relationship between vaccines and
injury “nor a simplistic elimination of other potential causes of the injury suffices without more,
to meet the burden of showing actual causation.” Resp. Post-H Brief at 25 (quoting Althen, 418 F.
3d at 1278). This holds true for respondent as well. The burden shifts to respondent to show an
alternative cause once petitioners have satisfied Althen.
Dr. McCusker submits that Long QT Syndrome is “one plausible explanation for [A.E.S.’s]
clinical picture and death”, because her sibling born after her death had Long QT after birth and
was sent home from the hospital with an apnea monitor. Resp. Ex. A at 7; Resp. Ex. E at 7; Pet.
Ex. 15 at 5. Dr. McCusker submitted that Long QT and channelopathies “have been implicated in
up to 20% of sudden infant deaths,” and the fact that A.E.S.’s sibling had Long QT early in life
“raises the possibility that A.E.S. may also have had prolonged QT.” Resp. Ex. A at 7; Resp. Ex.
E at 7. However, genetic studies were never done, and an EKG done at a follow-up examination
after the birth of A.E.S.’s sibling was normal, and petitioners were assured the baby was fine. Tr.
36-38.
Dr. McCusker’s alternative explanation for the death of A.E.S is unsupported, speculative,
and/or conclusory in nature. In order to prove alternative causation, respondent must “present
sufficient evidence to prove that the alternative factor was the sole substantial factor in bringing
about the injury.” Deribeaux, 717 F.3d at 1367. The Vaccine Act limits the scope of unrelated
factors by excluding any “idiopathic, unexplained, unknown, hypothetical or undocumentable
cause, factor, injury, illness or condition.” § 13(a)(2)(A). “In other words, alternative causes that
are ‘idiopathic, unexplained, unknown, hypothetical or undocumentable’ cannot overcome a
petitioner’s prima facie case.” Doe, 601 F.3d at 1357 (quoting § 13(a)(2)(A)).
In the 11 weeks since her birth and prior to her death, A.E.S. slept in her parents’ room and
showed no signs of sleep apnea. Further, although A.E.S.’s sibling born after her death
demonstrated concerns for Long QT Syndrome after birth, in Dr. McCusker’s own words, she
described Long QT as only a “plausible” explanation for A.E.S.’s death and conceded that genetic
studies were not done. It is well-established that a plausible or possible theory is insufficient to
prove that an injury occurred. Moberly, 592 F.3d at 1322; Boatmon v. Sec'y of Health & Human
Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019).
Accordingly, because petitioners have carried their burden in establishing a prima facie
case of causation and respondent has failed to establish an alternative cause that is more than
speculative, petitioners are entitled to compensation.
VII. Conclusion
Upon careful evaluation of all the evidence submitted in this matter—the medical records,
the testimony of petitioners and the experts, and the medical literature—I find that petitioners have
shown that they are entitled to compensation under the Vaccine Act. Accordingly, this matter shall
proceed to damages.
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IT IS SO ORDERED.
s/ Mindy Michaels Roth
Mindy Michaels Roth
Special Master
53

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DOCUMENT 2: USCOURTS-cofc-1_15-vv-01526-3
Date issued/filed: 2025-02-03
Pages: 9
Docket text: PUBLIC DECISION (Originally filed: 01/08/2025) regarding 106 DECISION of Special Master. Signed by Special Master Mindy Michaels Roth. (dkj) Service on parties made.
--------------------------------------------------------------------------------
Case 1:15-vv-01526-CNL Document 107 Filed 02/03/25 Page 1 of 9
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-1526V
Filed: January 8, 2025
* * * * * * * * * * * * * * *
ABIGAIL SIMS and DANIEL SIMS, on *
behalf of their deceased daughter, A.E.S., *
*
Petitioners, *
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * *
Michael McLaren, Esq., Black McLaren, et al., PC, Memphis, TN, for petitioners.
Voris Johnson, Esq., U.S. Department of Justice, Washington, DC, for respondent.
DECISION AWARDING DAMAGES1
Roth, Special Master:
On December 15, 2015, Abigail and Daniel Sims (“petitioners”) filed a petition on behalf
of their minor daughter, A.E.S., for compensation under the National Vaccine Injury
Compensation Program.2 Petitioners allege that A.E.S. died on December 16, 2013, as a result of
the Pediarix (DTaP/IPV/HepB), Hib, PCV13, and RotaTeq vaccinations she received that day.
Petition, ECF No. 1.
A Ruling on Entitlement was issued on March 7, 2024, finding petitioners entitled to
compensation. ECF No. 97. As this is a death case, the $250,000.00 statutory death benefit applies.
§ 300aa-15(a)(2), (4). The only damages in dispute are pain and suffering.
1 Because this Decision contains a reasoned explanation for the action in this case, the undersigned is required to post
it on the United States Court of Federal Claims’ website in accordance with the E-Government Act of 2002. 44 U.S.C.
§ 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the
Decision will be available to anyone with access to the Internet. In accordance with Vaccine Rule 18(b), petitioner
has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an
unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this
definition, the undersigned will redact such material from public access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation,
all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012).
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The parties were unable to come to an agreement on an amount for pain and suffering
damages and agreed to have the issue resolved by ruling on the record. They submitted
simultaneous briefs outlining their respective positions. ECF No. 104-05.
After consideration of all the evidence and for the reasons detailed below, I find that
petitioners are entitled to $50,000.00 for A.E.S.’s pain and suffering.
I. Relevant Procedural History
Petitioners filed their petition on December 15, 2015. ECF No. 1.
An entitlement hearing was held via Zoom on December 17 and 18, 2020. ECF No. 55.
Following the hearing, both parties filed additional literature, and respondent filed a supplement
expert report. Resp. Ex. F, Tabs 1-6, ECF No. 86; Pet. Ex. 144-151, ECF No. 87.
The parties filed simultaneous post-hearing briefs on May 3, 2021. ECF Nos. 89-90. On
March 7, 2024, a Ruling on Entitlement was issued, finding petitioners entitled to compensation.
ECF No. 97. The case then proceeded to damages. ECF No. 98.
After several months of negotiation, petitioner filed a motion for a status conference on
July 31, 2024. ECF No. 102. The motion outlined petitioners’ position, that they were seeking pain
and suffering and the statutory death benefit as set forth in their demand to respondent on June 4,
2024, and that no Medicaid lien existed. Id. Further, petitioners explained that respondent proposed
a proffer amount on June 20, 2024, that petitioner agreed to on July 16, 2024. However, after
respondent provided the proposed written proffer, petitioners asked whether certain language
could be added to clarify petitioners’ rights should respondent seek review of the entitlement
decision. Id. Respondent then withdrew the proffer on July 23, 2024, and the parties’ damages
discussions reached an impasse. With the consent of respondent, petitioners requested a status
conference to discuss the resolution of damages. Respondent asked that the conference be
recorded. Id.
A recorded status conference was held on August 20, 2024, and the parties agreed to submit
simultaneous briefs for a ruling on the record on damages. ECF No. 103.
On October 21, 2024, the parties simultaneously filed their respective briefs in support of
damages. ECF Nos. 104-05.
The issue of pain and suffering is now ripe for adjudication.
II. Overview of the Case
At approximately 11:00 am on December 16, 2013, A.E.S. was administered Pediarix, Hib,
PCV13, and Rotateq vaccinations at her two-month well-baby check-up. She was 11 weeks old.
See Petition, ECF No. 1; Amended Petition, ECF No. 60. Between 5:45 and 6:15 pm, A.E.S. was
found in her bassinet face up and barely breathing with a pale blue tint to her skin. A.E.S. stopped
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breathing on the way to the hospital. Despite resuscitation efforts, A.E.S. was pronounced dead at
approximately 7:15 pm. Amended Petition at 1.
Petitioners alleged that the vaccinations administered to A.E.S. caused her to suffer a Table
encephalopathy leading to her death or, alternatively, an off-Table encephalopathy, pulmonary
edema, visceral congestion, and death. Amended Petition at 1. Entitlement was found on both the
Table and off-Table claims. See Ruling on Entitlement, ECF No. 97.
III. Legal Framework
The Vaccine Act provides for compensation for pain and suffering, including “actual and
projected pain and suffering and emotional distress from the vaccine-related injury…not to exceed
$250,000.” § 15(a)(4). The petitioner bears the burden of proof for each element of compensation
requested. Brewer v. Sec’y of Health & Human Servs., No. 93-0092V, 1996 WL 147722, at *22
(Fed. Cl. Spec. Mstr. Mar. 18, 1996).
In the instant matter, petitioners seek an award for pain and suffering in addition to the
statutory death benefit. Pain and suffering and emotional damages are “inherently subjective” and
cannot be calculated mathematically. I.D. v. Sec’y of Health & Human Servs., No. 04-1593V, 2013
WL 2448125, at *9 (Fed. Cl. Spec. Mstr. May 14, 2013). In determining an award of pain and
suffering, special masters should consider the awareness of the injury, severity of the injury, and
duration of the suffering. Id.; McAllister v. Sec’y of Health & Human Servs., No. 91-1037V, 1993
WL 777030, at *3 (Fed Cl. Spec. Mstr. Mar. 26, 1993), vacated and remanded on other grounds,
70 F.3d 1240 (Fed. Cir. 1995).
In the past, special masters determined pain and suffering on a continuum, where only the
most severely injured received the full $250,000.00 amount available for pain and suffering. See,
e.g., Hocraffer v. Sec’y of Health & Human Servs., No. 99-533V, 2007 WL 914914, at *5-6 (Fed.
Cl. Spec. Mstr. Feb. 28, 2007) (discussing the development of the “continuum of injury” for awards
of pain and suffering). This approach was explicitly rejected by the Court of Federal Claims in
2013. In Graves v. Sec’y of Health & Human Servs., Judge Merow stated that this approach forced
“all suffering awards into a global comparative scale in which the individual petitioner’s suffering
is compared to the most extreme cases and reduced accordingly.” 109 Fed. Cl. 579, 589-90 (2013).
Instead, pain and suffering damages should be assessed independently of the $250,000.00 statutory
limit, after which the cap is “applied.” Id. at 587-88. Judge Merow determined the appropriate
award of pain and suffering damages using the three McAllister factors and looking to prior pain
and suffering awards made in both Vaccine Program cases and comparable injury cases outside of
the Vaccine Program. Id. at 589-91. Similarly, a special master may look to prior pain and suffering
awards to aid in her resolution of the appropriate amount of compensation for pain and suffering.
Jane Doe 34 v. Sec’y of Health & Human Servs., 87 Fed. Cl. 758, 768 (2009) (finding that “there
is nothing improper in the chief special master’s decision to refer to damages for pain and suffering
awarded in other cases as an aid in determining the proper amount of damages in this case.”).
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IV. The Parties’ Arguments
A. Petitioners’ Arguments
Petitioners argue that A.E.S. suffered from extreme pain, suffering, and distress, and
accordingly request an award of $250,000.00 for her pain and suffering. Thus, petitioners request
damages in the amount of $500,000.00, comprised of $250,000.00 in pain and suffering and the
$250,000.00 statutory death benefit. Petitioners’ Brief (“Pet. Br.”) at 12.
Petitioners contend that A.E.S. received her vaccinations between 11:00 and 11:30 am, and
that the nurse was “heavy-handed with the shot and jabbed [A.E.S.] harder than Ms. Sims thought
necessary.” Pet. Br. at 10. That afternoon, A.E.S. was whimpering, fussy, whining, with “a quiet
look in her eye”, not focusing, and Mrs. Sims had to comfort her and “respond[] to her persistent
distress.” Pet. Br. at 10 (citing Pet. Ex. 2 at 16-19; Pet. Ex. 7 at 9; Tr. 21-22; Pet. Ex. 135 at 2).
When awake, A.E.S. whined quietly, as though she had a headache and did not want to make noise.
Pet. Br. at 10 (citing Tr. 40). Mrs. Sims walked with her and soothed her, knowing she did not feel
well after her shots. Once at the hospital, Mrs. Sims watched as the medical professionals
administered medications and performed chest compressions and suctioning. Pet. Br. at 10 (citing
Tr. 30, 40).
Mr. Sims described A.E.S as very tired that afternoon. When he went to check on A.E.S.
after laying her down for a nap, he found her face up in her bassinet with her mouth open, eyes
slightly closed, and in a state of hyperextension with her arms extended. Pet. Br. at 11. A.E.S. was
pale and her lips were blue. When Mr. Sims picked her up, she made a sound like exhaling. Once
at the hospital, Mr. Sims also watched as the doctors attempted to resuscitate and “revive his baby.”
Id. The parents knew A.E.S. was still alive because they felt a pulse and she was shallowly
breathing when Mr. Sims found her at approximately 6:15 pm. Further, she had a pulse but
decreased respirations upon presentation to the ER. Id. (citing Pet. Ex. 7 at 1, 7).
Petitioners’ expert Dr. Shuman described the irritability, difficulty and inability to be
consoled, and lack of visual gaze responsiveness as A.E.S. being in the process of encephalic
encephalopathy. Pet. Br. at 7 (citing Tr. 17-20, 141). He further noted that A.E.S. was fed her last
bottle just prior to being put in her bassinet at 5:30 pm, but she did not feed well, which is another
indication of abnormal encephalic functioning. Pet. Br. at 7-8. When A.E.S. was found at 6:15 pm,
she was struggling to breathe in a position of “hyperextension and she had her arms extended.” Id.
at 8 (quoting Tr. 140). Dr. Shuman referred to this positioning as “decerebrate posture”, indicative
of axial herniation and a sign of encephalopathy. Pet. Br. at 11 (quoting Tr. 140). A.E.S. died
shortly thereafter, at approximately 7:15 pm. Pet. Br. at 11; Pet. Ex. 5 at 11, 57-58.
Petitioners argue that A.E.S.’s behaviors indicate her awareness of injury and that she was
“able to feel pain and experience distress” in the time between receipt of the vaccinations and her
death. Pet. Br. at 7. Dr. Shuman referred to the distant look, not making eye contact, whimpering,
and acting like she had a headache as an indication of the distress A.E.S. was experiencing. Id.
(citing Tr. 142-46). He added that an infant that young cannot express discomfort, but her mother
responded to her behaviors by comforting her and responding to “persistent distress.” Id.
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Petitioners submitted that they were not aware of any reasoned decisions by a special
master awarding pain and suffering damages for a vaccine-related infant death in the Vaccine
Program but provided the following cases to assist the court in its decision. Pet. Br. at 8.
Petitioners submitted Boatmon v. Sec'y of Health & Human Servs., 138 Fed. Cl. 566 (2018),
aff'd on other grounds, 941 F.3d 1351 (Fed. Cir. 2019). Boatmon involved the death of a five-
month-old infant the day after vaccination. Like A.E.S., he was a healthy baby who received his
vaccines at a well-baby visit. He then stopped laughing and cooing, and became quiet and
withdrawn later that day. He developed a fever that night, did not sleep well, and was found
unresponsive following a nap the next day. He died shortly thereafter. Pet. Br. at 8. After
entitlement was found for petitioners, respondent filed a proffer of $300,000.00 for all damages.
Id. Petitioners herein infer that based on the proffer, respondent valued the infant’s pain and
suffering in Boatmon at $50,000.00. Id. at 9. Petitioners argue that the fact that petitioners in
Boatmon stipulated to that amount of damages does not mean the amount for pain and suffering
was reasonable; petitioners accept proffers for a host of reasons that may have nothing to do with
the merits of their case, such as monetary need or the desire to avoid additional delays or the stress
of litigation. Id.
Petitioners also offered Oliveira v. Jacobson, 846 A.2d. 822 (R.I. 2004), a civil action for
medical malpractice involving the death of an infant 27 minutes after his birth. Pet. Br. at 9-10.
The jury awarded $100,000.00 for pain and suffering based on fact witness testimony that the baby
struggled to breath, attempted to cry, gasped for air, was intubated three times, and repeatedly
received chest compressions during the 27 minutes of his life, which the Supreme Court concluded
was “extremely traumatic and unpleasant.” Id.; Oliveira, 846 A.2d, 827-28. In comparing A.E.S.
to the infant in Oliveira, petitioners submit that the end of A.E.S.’s life “was extremely traumatic,
painful, and distressing.” Pet. Br. at 10. Petitioners further argue that Oliveira was decided over
20 years ago, so the award for the same or similar pain and suffering should be higher now. Id.
B. Respondent’s Arguments
Respondent detailed the medical records, affidavits, and testimony of the petitioners.
Respondent’s Brief (“Resp. Br.”) at 1-4. Specifically, he referred to Mrs. Sims’s testimony that
A.E.S. cried after her vaccinations, but once nursed calmed down and they went home. Resp. Br.
at 4 (citing Tr. 20). Mrs. Sims held A.E.S. on the couch until she had to go to work at 2:30 pm,
and during this time A.E.S. was sleepy and fussy, whining and whimpering at a low volume,
making eye contact but not in a way that seemed like she was really seeing, cuddling, and feeding
every 20 to 30 minutes for comfort. Id. (citing Tr. 22). A.E.S. spit up, which was normal, but was
not vomiting. Id. (citing Tr. 41). Mr. Sims drove Mrs. Sims to work at around 2:50 pm, and the
next time she saw A.E.S. was in the ER. Id. (citing Tr. 29).
Mr. Sims stated that A.E.S was “very quiet” on the ride home from the doctor’s office and
seemed “kind of drawn back” and “super spaced out” but not fussy. He attributed her behavior to
the vaccines because his sons were the same way after their vaccines. Resp. Br. at 5 (citing Tr. 55,
60, 76-77). He held A.E.S. while his wife got ready for work, then he drove Mrs. Sims to work
with the children. Upon returning home, Mr. Sims held A.E.S. on the couch, gave her a bottle, and
put her in the bassinet. She was “extremely tired.” Resp. Br. at 5 (citing Tr. 55-56, 77). She took
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longer to feed and did not finish her bottle, but she did not vomit. Id. He placed her face up in the
bassinet and when he returned, her head was extended back, her mouth was open, and she was half
on her side with her arms slightly back. He picked her up and she made a noise as if she was
exhaling. He called his wife and drove to the hospital with A.E.S. and his sons. Id. (citing Tr. 57-
59, 61).
Respondent agreed that petitioners are entitled to the $250,000.00 death benefit based on
the ruling on entitlement. Therefore, the only issue to be determined is the appropriate amount for
pain and suffering. Resp. Br. at 6.
After outlining the three Graves factors for valuing pain and suffering, respondent argued
that because A.E.S. was an infant, her ability to understand her injury is impossible to know, and
the severity of her injury is “somewhat unclear from the record.” Resp. Br. at 7. Respondent noted
that petitioners told the medical examiner Mr. Kennedy that A.E.S. had a normal day and fed
normally after the vaccinations. Resp. Br. at 7 (citing Pet. Ex. 5 at 10; Pet. Ex. 7 at 1). However,
at hearing and in their affidavits, petitioners described A.E.S. as spaced out, quiet, sleepy, distant,
and fussy, but nothing so concerning that they felt the need to seek medical attention. Thus, “[i]t
would therefore seem that whatever symptoms A.E.S. experienced prior to her death were not
overly severe.” Id. Further, the duration of her injury was at most six-and-a half hours, and
therefore any pain and suffering award should fall on the lower end of the spectrum. Id.
Respondent argued that Boatmon is the most comparable recent case in the Program.
Boatmon, 138 Fed. Cl. 566. In that case, the infant received his four-month immunizations,
developed a fever that night, did not sleep well, was given Advil at 4:00 am and 8:00 am for his
ongoing fever, and was found unresponsive in his crib around 2:30 pm the following afternoon.
Petitioners were found entitled to compensation and accepted a proffer of $300,000.00 in damages.
Resp. Br. at 7-8; see Boatmon v. Sec’y of Health & Human Servs., No. 13-611V, 2018 WL 829155,
at *1 (Fed. Cl. Spec. Mstr. Jan. 19, 2018). According to respondent, the amount indicates that the
parties agreed to $50,000.00 for the infant’s pain and suffering in that case. Resp. Br. at 8.
Therefore, respondent argued that the award for pain and suffering should not exceed
$50,000.00, and the Court should take into consideration that the duration of the injury in Boatmon
was longer than the duration in this case. Resp. Br. at 8.
Respondent concluded that the $250,000.00 death benefit and an amount arguably less than
$50,000.00 that fairly compensates A.E.S.’s estate for her pain and suffering prior to her death is
an appropriate award in this case. Resp. Br. at 8.
V. Discussion
A. Actual Pain and Suffering
Petitioners’ request for compensation for pain and suffering is based on the vaccine-injured
individual’s ability to understand the injury, the degree of severity of the injury, and the duration
of time that the individual is subjected to the injury. McAllister v. Sec’y of Dep’t of Health &
Human Servs., No. 91-1037V, 1993 WL 777030 at *3 (Fed.Cl. Spec. Mstr. Mar. 26, 1993), vacated
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on other grounds sub nom. McAllister v. Sec'y of Health & Human Servs., 70 F.3d 1240 (Fed. Cir.
1995). The ability to comprehend an individual’s injury can be understood by looking to the
individual’s awareness of their injury or pain. See id. (petitioner’s “mental cognition” to recognize
and appreciate her loss was considered). Special masters also consider the age of the individual in
the analysis of emotional suffering. See DeLozier, next friend of L.T. v. Sec’y of Health & Human
Servs., 152 Fed. Cl. 558, 564 (2021) (awarding $50,000.00 for a less severe subtype of alopecia
due to petitioner suffering the stigma and embarrassment of hair loss at 3-5 years old and
considering her age against that of a teenager or adult in the same situation). Awareness of an
injury “is often deemed a function of whether the injured party was mentally competent . . .
suggesting that injuries experienced by an infant or very young child, whose mental cognition was
not yet fully developed, might not meet these criteria.” See DeLozier, next friend of L.T. v. Sec'y
of Health & Human Servs., No. 15-124V, 2020 WL 5742643 at *4 (Fed. Cl. Spec. Mstr. Aug. 11,
2020), review granted, cause remanded, 152 Fed. Cl. 558 (2021), order clarified, 154 Fed. Cl. 392
(2021).
The duration of an individual’s injury relates to the length of time the individual suffered3
the injury from onset onward. See McAllister, No. 91-1037V, 1993 WL 777030 at *3. Larger
awards are applied to cases where the individual experiences the most extreme pain for the longest
time prior to death. See Graves v. Sec’y of Health & Human Servs., 109 Fed. Cl. 579, 588 (2013).
Special masters have held that a period of days or months is relatively brief when compared to
other vaccine-injured petitioners who suffer over years or decades. Id. at 589. However, the Court
of Federal Claims has emphasized the importance of examining what occurred throughout the
duration of the injury, leading to the discussion of severity. Compare id. at 580 (awarding the
statutory cap for pain and suffering to a child who died forty-five days after onset of symptoms
because she suffered from unremitting seizures) with Bragg v. Sec’y of Health & Human Servs.,
No. 08-477V, 2012 WL 404773 (Fed. Cl. Spec. Mstr. Jan. 18, 2012) (awarding $25,000.00 to an
82-year-old individual who experienced fever, dehydration, and difficulty breathing resulting in
intubation for six days prior to his death). When a child’s suffering was limited to hours or days
rather than months, special masters have awarded less for pain and suffering. Boatmon v. Sec’y of
Health & Human Servs., No. 13-611V, 2018 WL 829155, at *1 (Fed. Cl. Spec. Mstr. Jan. 19,
2018) (suggesting that respondent’s proffer indicated that $50,000.00 of the compensation
awarded was for the pain and suffering of a five-month-old who died within one day of
vaccination).4
The severity of an injury relates to the amount of pain or loss of normal function imposed
by the injury. See DeLozier, 2020 WL 5742643 at *4. Special masters have looked towards
continued pain and treatment of the injury in determining the severity for purposes of awarding
pain and suffering. Compare Pozil v. Sec'y of Health & Human Servs., No. 21-0351V, 2023 WL
7106486 at *5 (Fed. Cl. Spec. Mstr. Aug. 2, 2023) (awarding $145,000.00 when petitioner reported
pain for less than two months after multiple surgeries for restorative dental work because his initial
treatment and surgery was extensive) and Marcillo v. Sec'y of Health & Human Servs., No. 20-
3 The length of time that the injury will persist is also a factor when considering future pain and suffering. In this case,
A.E.S. is deceased so there is no calculation to be made regarding A.E.S.’s future pain and suffering.
4 As discussed in both parties’ briefs on damages, the ruling on entitlement in Boatmon was ultimately reversed by
the Federal Circuit. Pet. Br. at 8; Resp. Br. at 8. However, due to the factual similarities, the parties’ determination of
damages in Boatmon is still instructive in the instant matter.
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2061V, 2023 WL 3452274 at *7 (Fed. Cl. Spec. Mstr. May 15, 2023) (awarding the $250,000.00
pain and suffering maximum because petitioner underwent extraordinary initial treatment, suffered
an infection, and had to wear braces for two years following surgery) with Hietpas v. Sec'y of
Health & Human Servs., No. 19-1702V, 2021 WL 688620 at *6 (Fed. Cl. Spec. Mstr. Jan. 5, 2021)
(awarding $140,000.00 when petitioner underwent restorative dental work that included wearing
an intraoral splint for 18 hours per day for a year).
The decision in the instant matter is in no way meant to minimize the last few hours of
A.E.S.’s life. Certainly, there is no injury more severe than death. Petitioners were found entitled
to compensation for the death of A.E.S. and therefore are automatically awarded the statutory
death benefit. During the afternoon following her vaccinations, A.E.S. was not her usual self, was
“spaced out”, fussing, not cuddling or snuggling, feeding less, and seeking comfort. Pet. Ex. 136
at 2. Dr. Shuman testified that A.E.S.’s behavior demonstrated her distress, and the hyperextended
positioning of her body when found was indicative of an encephalopathic process. Pet. Br. at 7-8
(citing Tr. 22-23, 40, 142-46). As specifically addressed in the ruling on entitlement, what
transpired in the 45 minutes to an hour after A.E.S. was put in her bassinet remains unknown, and
how or why she came to be in the posture in which she was found unobserved. Respondent did not
attempt to describe A.E.S.’s awareness of her injury, but rather asserted that her age made it
“impossible to know” her ability to understand her injury. Resp. Br. at 7.
One’s pain and suffering are incredibly difficult to translate into money, so special masters
look to similar cases for guidance. See, e.g., Doe 34, 87 Fed. Cl. at 768. However, there are very
few cases that are instructive in this matter. In Graves, the full $250,000.00 was awarded where
the child suffered from seizures for forty-five days preceding her death. Graves, 109 Fed. Cl. at
580. In Boatmon, as discussed by both parties herein, the proffered award appeared to be
$50,000.00 for pain and suffering for the death a five-month-old, one day after his vaccinations.
See Boatmon, 2018 WL 829155 at *1. The facts of Boatmon bear some similarities to the instant
matter. Like A.E.S., the infant in Boatmon was withdrawn and fussy, but unlike A.E.S., he suffered
from fever and sleeplessness. Further, while A.E.S. lived for approximately eight hours after
receiving her vaccinations, the infant’s death in Boatmon was 24 hours later. Id. Additionally, in
Rodela, the proffer included an award of $60,000.00 in pain and suffering for a child who suffered
encephalitis that led to her death approximately 19 days after vaccination. Rodela v. Sec'y of Health
& Human Servs., No. 17-236V, 2024 WL 4039678 (Fed. Cl. Spec. Mstr. Aug. 8, 2024). The child
in Rodela was one year old at the time of her vaccination and suffered an observed seizure prior
to her death. In addition to the seizure, the child displayed sickness behaviors in the 19 days
between her vaccination and leading up to her death. She was described by her parents as cranky,
unable to be comforted, not nursing well, and eating less. Her symptoms were similar to those of
A.E.S., but for a much longer duration. Rodela v. Sec'y of Health & Human Servs., No. 17-236V,
2024 WL 2034220 at *4-*6 (Fed. Cl. Spec. Mstr. Apr. 5, 2024).
Respondent argues that, based on Boatmon and the differences in duration of the respective
injuries, an award for pain and suffering in this case should be less than $50,000.00. Resp. Br. 8.
While I find this argument persuasive, and though the duration in Boatmon was longer than that in
the instant matter, it has been several years since the proffer in Boatmon. A.E.S. was clearly not
feeling well, and her autopsy showed swelling of the brain. It is unclear how swelling on the brain
will manifest behaviorally in an 11-week-old infant. While some infants may cry or scream, others
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like A.E.S. may be subdued, whimpering, and moaning. Her ability to understand her injury at 11
weeks old is limited and not well understood, and while A.E.S. certainly had the awareness to feel
unwell and react to pain following her vaccinations, those responses appear to be more primal than
knowing. However, petitioners testified at length about how A.E.S.’s behavior was abnormal for
her, and I find this testimony from her parents to be relevant to her pain and suffering.
Based on a review of the entire record, consideration of the facts and circumstances
presented here, analysis of other cases, and my own expertise in deciding Vaccine Program cases,
I find an award of $50,000.00 to be appropriate and reasonable for actual pain and suffering.
VI. Conclusion
In determining an award in this case, I do not take likely the loss petitioners have suffered.
For the reasons discussed above and based on consideration of the record as a whole, petitioners
are awarded:
A lump sum payment of $300,000.00, representing compensation for petitioners’
actual pain and suffering ($50,000.00) and the statutory death benefit
($250,000.00), to be paid through an ACH deposit to petitioners’ counsel’s
IOLTA account for prompt disbursement.
This amount represents compensation for all damages that would be available under
42 U.S.C. § 300aa-15(a).
The Clerk of Court is directed to enter judgment in accordance with this decision.5
IT IS SO ORDERED.
s/Mindy Michaels Roth
Mindy Michaels Roth
Special Master
5 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of a notice renouncing
the right to seek review.
9

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_15-vv-01526-4
Date issued/filed: 2025-06-25
Pages: 23
Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 115 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Carolyn N. Lerner. (ce) Service on parties made.
--------------------------------------------------------------------------------
Case 1:15-vv-01526-CNL Document 118 Filed 06/25/25 Page 1 of 23
In the United States Court of Federal Claims
ABIGAIL SIMS AND DANIEL SIMS, on
behalf of their deceased daughter, A.E.S.,
Petitioners,
v. No. 15-15261
(Filed: June 25, 2025)
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent.
Michael G. McLaren, Black McLaren Jones Ryland & Griffee, P.C., Memphis, TN, for
Petitioners.
Voris Edward Johnson, Civil Division, United States Department of Justice, Washington, DC,
for Respondent.
OPINION AND ORDER
LERNER, Judge.
Petitioners, Abigail and Daniel Sims, filed a claim under the National Vaccine
Compensation Act of 1986 (“Vaccine Act”) for the 2013 death of their daughter A.E.S. Petition,
ECF No. 1; see also 42 U.S.C. § 300aa-11. On January 8, 2025, the Special Master awarded
compensation to Petitioners. Decision on Damages (hereinafter “Decision”) at 9, ECF No. 106;
Sims v. Sec’y of Health & Hum. Servs., No. 15-1526V, 2025 WL 394573 (Fed. Cl. Spec. Mstr.
Jan. 8, 2025).
A.E.S. received four vaccinations on December 16, 2013. Ruling on Entitlement
(hereinafter “Ruling”) at 1, ECF No. 97; Sims v. Sec’y of Health & Hum. Servs., No. 15-1526V,
2024 WL 1367151 (Fed. Cl. Spec. Mstr. Mar. 7, 2024). The Special Master determined the
vaccinations contributed to her death later that day. Id. Respondent, the Secretary of Health and
Human Services, seeks review of the Special Master’s Decision and challenges the findings in
her Ruling. See Resp’t’s Mot. for Review (hereinafter “Resp’t Mot.”) at 1, ECF No. 108;
Resp’t’s Mem. Supp. Mot. for Rev. (hereinafter “Resp’t Mem.”) at 1, ECF No. 109; see also 42
1 This Opinion was originally filed under seal on June 10, 2025. The Court provided the parties
the opportunity to review the Opinion for any proprietary, confidential, or other protected
information and submit proposed redactions no later than June 24, 2025. The parties did not
propose any redactions.

Case 1:15-vv-01526-CNL Document 118 Filed 06/25/25 Page 2 of 23
U.S.C. § 300aa-12(e)(1) (stating parties may request the U.S. Court of Federal Claims to review
a special master’s decision).
A petitioner has two avenues to receive compensation for alleged vaccine injuries. Munn
v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863, 865 (Fed. Cir. 1992). First, a petitioner
may show by a preponderance of the evidence that she suffered an injury listed on the Vaccine
Injury Table within the specified timeframe. Capizzano v. Sec’y of Health & Hum. Servs., 440
F.3d 1317, 1319 (Fed. Cir. 2006) (citing Munn, 970 F.2d at 865). That the vaccine caused the
Table injury is presumed. Id. at 1320. Alternatively, a petitioner can allege an off-Table injury
when her injury is not listed on the Table or if she did not suffer the injury within the prescribed
timeframe. de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008).
For off-Table injuries, a petitioner must show by a preponderance of the evidence that the
vaccine caused the injury. See 42 U.S.C. § 300aa–11(c)(1)(C)(ii)(1); Althen v. Sec’y of Health &
Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (laying out a three-prong analysis for proving
causation-in-fact for off-Table injuries).
If the petitioner meets her burden under either avenue, the Vaccine Act authorizes
compensation provided “there is not a preponderance of the evidence that the . . . injury . . . or
death described in the petition is due to factors unrelated to the administration of the vaccine.”
42 U.S.C. § 300aa–13(a)(1)(B). “[I]n both Table and off-Table cases the government bears the
burden of establishing alternative causation by a preponderance of the evidence.” Walther v.
Sec’y of Health & Hum. Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007).
The Special Master determined Petitioners met their burden to show A.E.S. suffered a
Table injury. Ruling at 38–43 (citing 42 C.F.R. § 100.3(b)(2) (July 23, 2015) (most recently
amended in 2022). Specifically, the Special Master found A.E.S. demonstrated the Table’s
requisite clinical signs of an encephalopathy (an injury to the brain) and, as a result, died less
than nine hours after receiving the vaccines. Id. at 43. Alternatively, the Special Master
concluded Petitioners satisfied their burden under the Althen test to prove that an off-Table
vaccine injury caused encephalopathy, as well as cerebral edema and death. Id. at 43–51. She
also determined Respondent failed to establish an alternative cause, and there was “no evidence
that A.E.S. died of a factor unrelated to the administration of the vaccines.” Id. at 42, 51–52.
Petitioners were awarded $300,000 in damages. Decision at 9.
Respondent contends the Special Master made arbitrary and capricious factual findings
and acted contrary to law. Resp’t Mot. at 1; Resp’t Mem. at 1–2. The Secretary argues the
Special Master improperly relied on A.E.S.’s death alone to find a Table injury and made factual
findings based solely on Petitioners’ uncorroborated testimony despite discrepancies with the
medical record. Resp’t Mem. at 12–17. Alternatively, Respondent asserts the Special Master
erred in applying prongs one and two of the Althen test in her off-Table injury analysis. Id. at
17–20. Finally, Respondent claims the Special Master improperly disregarded evidence that
A.E.S.’s death resulted from other factors, including evidence A.E.S. suffered a sudden
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unexplained infant death (“SUID”). 2 Id. at 8–12. Petitioners maintain the Special Master made
neither legal errors nor arbitrary factual findings. Pet’rs’ Resp. to Mot. for Rev. (hereinafter
“Pet’rs Resp.”) at 1, ECF No. 111.
Having considered the record, the Special Master’s Ruling, and the parties’ legal
arguments, the Court DENIES Respondent’s Motion for Review and SUSTAINS the Special
Master’s Decision. See 42 U.S.C. § 300aa-12(e)(2)(A). Respondent has not demonstrated the
Special Master made either an error of law or arbitrary factual findings in her Table injury
analysis. Rather, Respondent’s arguments amount to mere disagreement with the Special
Master’s factual findings and weighing of the evidence. That is not a basis for this Court to set
aside the Special Master’s thorough and well-reasoned Ruling. See Hines ex rel Sevier v. Sec’y
of Health & Hum. Servs., 940 F.2d 1518, 1527 (Fed. Cir. 1991). In addition, the Special Master
properly concluded Respondent failed to establish an alternative cause. Since the Special Master
needed only to find a Table injury to award damages, the Court does not reach the parties’
arguments about whether her off-Table injury finding was erroneous.
I. Background
Petitioners sought compensation under the Vaccine Act on December 15, 2015. Ruling
at 1. The Special Master held an Entitlement Hearing from December 17–18, 2020. See
Transcript (hereinafter “Tr.”), ECF Nos. 81 (Tr. pages 1–212) & 82 (Tr. pages 213–333).
Factual determinations were based on affidavits, testimony, A.E.S.’s medical history both before
and after her vaccinations, the autopsy report, a medical examiner’s investigative report, and
each party’s medical experts’ opinions. Ruling at 4–35. The Special Master also summarized
the legal standards for fact-finding, the evaluation of expert testimony, and the consideration of
medical literature. Id. at 37–38. She stated she “reviewed and considered all of the medical
records and literature submitted in this matter.” Id. at 38. The Court summarizes below the
relevant facts from the Special Master’s Ruling.
A. Medical History and Autopsy
A.E.S.’s medical history showed no cause for health concerns prior to her vaccinations.
Id. at 11. At approximately eleven weeks old, she received the Pediatrix (DTaP/IPV/HepB),
Hib, PCV13 (Prevnar 13), and RotaTeq vaccinations during a routine check-up on December 16,
2013 at around 11:00 AM. Id. at 11–12 (citing Pet’rs’ Ex. 2 (Children’s Clinic of Oxford, P.A.
Medical Records) at 7, ECF No. 9-2). The Special Master notes the check-up documented
“A.E.S. was a well, breastfed child with no concerns in the first two months of life.” Id. at 11
(citing Pet’rs’ Ex. 2 at 8–10).
2 The Special Master explained the distinction between SUID and sudden infant death syndrome
(“SIDS”); “[t]he two are not synonymous.” Ruling at 3. SIDS is a specific “diagnosis of
exclusion used when other possibilities have been ruled out.” Id. SUID, on the other hand, is an
umbrella term that encompasses instances when infants “die suddenly and unexpectedly for a
variety of reasons” and is not itself a diagnosis. Id.
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Later that day, at approximately 6:34 PM, Mr. Sims arrived at the hospital with A.E.S in
acute distress. Id. Mr. Sims reported that eight minutes before arriving, A.E.S. stopped
breathing. Id. Mr. Sims stated he fed A.E.S. with a bottle, burped her, and put her into her
bassinet at 5:30 PM before finding her struggling to breathe, pale, and with blue lips at 6:15 PM.
Id. at 11–12 (citing Pet’rs’ Ex. 7 (Lafayette County Coroner’s Report) at 1, 7, ECF No. 9-7).
The hospital documented that she had no pulse and had suffered respiratory arrest, cardiac arrest,
sepsis, anaphylaxis, and cyanosis, as well as a “gross pulmonary edema from trachea.” Id. at 11
(citing Pet’rs’ Ex. 5 (Baptist Memorial Hospital of North Mississippi Medical Records (A.E.S.))
at 6, 11, ECF No. 9-5). Yet, under “History of Present Illness,” the hospital indicated: “normal
day – shots – ate normally.” Id. (citing Pet’rs’ Ex. 5 at 10). A.E.S. was pronounced dead at
7:15 PM, after all resuscitation efforts failed. Id. at 12 (citing Pet’rs’ Ex. 5 at 11, 57–58).
The autopsy report, prepared by Dr. Erin Barnhart, stated the cause and manner of death
were “best classified as undetermined.” Id. at 12 (citing Pet’rs’ Ex. 3 (Mississippi State Medical
Examiner’s Office Autopsy Report) at 4, ECF No. 9-3). She documented a normal breastfed
baby. Id. The Special Master summarized the autopsy as noting “visceral congestion,”
“intradermal or submucous hemorrhage” in three areas, and “pulmonary edema,” defined as the
“presence of abnormally large amounts of fluid in the intracellular tissue spaces” in the lungs.
Id. at 12 n.8, n.9 (citations omitted). Dr. Barnhart noted the autopsy’s findings were “consistent
with Sudden Unexplained Infant Death (SUID).” Id. at 12 (citing Pet’rs’ Ex. 3 at 4). The
autopsy also included photographs. See Pet’rs’ Ex. 18, ECF No. 25. The Special Master
concluded the autopsy findings were “generally unremarkable, except for a brain weight of 595
grams.” Ruling at 12. “The expected range for brain weight was 461-555 grams.” Id. at 12 n.10
(citing Pet’rs’ Ex. 3 at 3).
B. Affidavits and Testimony of Daniel and Abigail Sims
Mr. Sims submitted two affidavits, the first on March 29, 2016 and the second on
November 12, 2020. Ruling at 4; see also Pet’rs’ Ex. 8 (Affidavit of Daniel Sims), ECF No.
12-1; Pet’rs’ Ex. 136 (Second Affidavit of Daniel Sims), ECF No. 65-2. In his first affidavit, he
recalled feeding and burping A.E.S. and placing her in her bassinet at about 5:00 PM. Ruling at
4 (citing Pet’rs’ Ex. 8 at 2). He found A.E.S. not breathing and with a bluish tint to her upper lip
at around 5:45 PM, after which he drove her to the hospital. Id. In his second affidavit, Mr.
Sims stated A.E.S. was “spaced out” and not cuddling or snuggling as usual while he fed her the
first time. Id. at 5 (citing Pet’rs’ Ex. 136 at 2). Later, he stated A.E.S. was fussing, so he fed her
again, and she fed a bit slower than usual. Id. He then placed her in her bassinet and checked on
her periodically. Id. When he checked on her the last time, A.E.S. had turned onto her side with
her head tilted back, had slightly blue lips, and looked pale. Id. at 4–5 (citing Pet’rs’ Ex. 136 at
1). As he picked her up, he heard her exhale. Id. at 5. He recalled she was limp, although he
thought he felt her move twice as he took her to the car. Id.
During his testimony, Mr. Sims stated that before her vaccinations A.E.S. was alert and
wide awake, and she was always looking around with a “presence on her face.” Id. (citing Tr. at
50). After her vaccinations, he was surprised A.E.S. was very quiet on the ride home. Id. at 6.
He testified that once home she was “super spaced out,” was not “locking on to any person,” and
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was “not all there.” Id. (citing Tr. at 59–60). He recalled she looked very tired and so he put her
into her bassinet facing up. Id. (citing Tr. at 57). The family did not have a baby monitor, but he
checked on her every five to twenty minutes. Id. (citing Tr. at 59–60). The last time he checked
on her, she “looked like she was almost trying to turn onto her side slightly,” was “facing upward
in the bassinet with her mouth open,” and her lips were blue. Id. at 6 (citing Tr. at 58, 61–62).
He then took A.E.S. to the hospital. Id. After his daughter’s death, Mr. Sims provided details of
what happened at home to Mr. Robert Kennedy, the County Medical Examiner Investigator
(“CMEI”). Id. (citing Tr. at 66–67). Mr. Sims told Mr. Kennedy the position in which he found
A.E.S. and that her face was “extremely pale.” Id. (citing Tr. at 73).
Mrs. Sims also submitted two affidavits, the first on March 29, 2016 and the second on
November 12, 2020. Id. at 7; see also Pet’rs’ Ex. 9 (Affidavit of Abigail Sims), ECF No. 12-2;
Pet’rs’ Ex. 135 (Second Affidavit of Abigail Sims), ECF No. 65-1. In her first affidavit, she
stated A.E.S. was a healthy baby prior to her vaccinations. Ruling at 7 (citing Pet’rs’ Ex. 9 at 1–
2). Mrs. Sims recalled that while at work after the vaccinations, Mr. Sims called between 5:45
PM and 6:00 PM en route to the hospital after finding A.E.S. not breathing. Id. In her second
affidavit, Mrs. Sims stated that once at home after the vaccinations, A.E.S. was not making eye
contact, had a distant look, and did not cuddle. Id. (citing Pet’rs’ Ex. 135 at 2).
During her testimony, Mrs. Sims stated A.E.S. breastfed approximately three times in the
morning before her vaccinations. Id. at 8 (citing Tr. at 14). After the vaccinations, A.E.S. was
sleepy, fussy, and looked tired. Id. A.E.S. was not “looking at [her]” but “kind of looking past
[her]” and “had a quiet look in her eye.” Id. (citing Tr. at 21–22). Mrs. Sims also stated that
while A.E.S. tried to nurse several times, she was uncertain if she was actually feeding much. Id.
(citing Tr. at 21–22). She recalled it seemed like A.E.S. had a headache and she spit up but did
not vomit. Id. (citing Tr. at 40–41).
Mrs. Sims testified that when A.E.S. arrived at the hospital, she was slightly grayish with
blue lips but still warm to the touch. Id. at 9. Mrs. Sims did not recall if A.E.S. had a pulse but
noted she was not breathing. Id. Mrs. Sims also said she answered all of Mr. Kennedy’s
questions. Id. She stated she took precautions to avoid SIDS, including always placing A.E.S.
on her back in her bassinet. Id.
C. Medical Examiner Robert Kennedy’s Investigative Report and Testimony
Mr. Kennedy, the CMEI, produced an investigative report based on the emergency room
medical record and the autopsy. Id.; see also Pet’rs’ Ex. 7. He reported that after A.E.S.’s
vaccinations, there were no reactions noted throughout the rest of the day until she was found
unresponsive. Ruling at 9 (citing Pet’rs’ Ex. 7 at 1). On December 16, 2013, the day of A.E.S.’s
death, he completed a Sudden Unexplained Infant Death Investigation form, which included
several witness interview answers and diagrams of how A.E.S. was positioned before and after
being found unresponsive. Id. (citing Pet’rs’ Ex. 7 at 7–14). He documented “blueness top lip,
baby was pale” and that A.E.S. was found “on back, slightly left lateral arms over the side;
head/neck back/slightly left.” Id. (citing Pet’rs’ Ex. 7 at 9, 12–13). At the hearing, Mr. Kennedy
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testified he completed the form based on information provided by Petitioners, and they were very
forthcoming when he questioned them, with no inconsistencies. Id. at 11 (citing Tr. 91, 96–99).
D. Medical Experts
Petitioners offered Dr. Robert Shuman and Dr. M. Eric Gershwin as medical experts. Id.
at 13–23. Respondent presented the medical experts Dr. Christine McCusker and Dr. Brent
Harris. Id. at 23–35. The Special Master noted all “four experts involved in this case are well
known to the Court, equally impressive in their respective specialties, and all recognized as
experts in their respective fields.” Id. at 12. She explained since Petitioners were only pursuing
claims of “an on-Table encephalopathy” or, in the alternative, “an off-Table encephalopathy,
pulmonary edema, visceral congestion, and death,” her decision solely focused on expert
opinions relevant to those claims. Id. at 12–13. The Special Master noted SIDS was ruled out as
a cause of A.E.S.’s death, as both Petitioners’ expert, Dr. Shuman, and Respondent’s expert, Dr.
Harris, agreed the evidence did not support a SIDS diagnosis. Id. at 12, 13, 32. The Special
Master stated she considered all medical literature submitted in the case, even though her
decision did not discuss it all in detail. Id. at 38.
1. Petitioners’ Expert, Dr. Robert Shuman
In support of Petitioners, Dr. Shuman submitted two reports and testified at the hearing.
Id. at 13–20; see also Pet’rs’ Ex. 16 (Expert Report of Dr. Shuman), ECF No. 23-7; Pet’rs’ Ex.
92 (Supplemental Report of Dr. Shuman), ECF No. 46-3. His first report found the progressive
worsening of A.E.S.’s cardiopulmonary system during the resuscitation efforts was inconsistent
with SIDS, she had no risk factors for SIDS, and the autopsy findings were inconsistent with
SIDS. Ruling at 13–15. Instead, he stated A.E.S.’s brain weight of 595 grams was consistent
with cerebral edema. Id. at 15 (citing Pet’rs’ Ex. 16 at 31). And he pointed out cerebral edema,
pulmonary edema, and congestive heart failure are not features of SIDS. Id. Dr. Shuman
concluded either the DTaP vaccine, Prevnar 13 vaccine, or the combination of both caused
encephalopathy and cerebral edema, which caused cardiopulmonary failure resulting in A.E.S.’s
death. Id. at 16.
In his supplemental report, Dr. Shuman noted A.E.S.’s heavy brain weight, as
documented in the autopsy, was a “robust sign of cerebral edema.” Id. (citing Pet’rs’ Ex. 92 at
1–2). He explained how the vaccines A.E.S. received can affect the brain, including by eliciting
cytokines (proteins that help regulate the immune system), which can cause swelling or edema.
Id. at 16–17 (citing Pet’rs’ Ex. 92 at 5). He concluded the vaccines generated cytokines, which
circulated to A.E.S.’s brain and caused a malignant cerebral edema that was lethal within six to
eight hours. Id. at 17 (Pet’rs’ Ex. 92 at 4).
At the hearing, Dr. Shuman defined encephalopathy as a disturbance of the brain, or an
abnormal or depressed expression of brain function that causes “a negative deviation of behavior
from that expected of that person.” Id. (citing Tr. 127–28). He testified the autopsy findings
showed objective signs of cerebral edema, including a full and flattened brain “obviously under
pressure,” with the brain weight at least two standard deviations above the mean. Id. (citing Tr.
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at 133–40, 142). There was an absence of inflammation or other obvious cause of death. Id. He
stated the pathologist’s brain examination was limited and may have missed some details. Id. at
18 (citing Tr. at 137–40). He noted A.E.S.’s thighs showed swelling at the injection sites on the
autopsy photographs, which could occur when cytokines circulate. Id. (citing Tr. at 161; Pet’rs’
Ex. 18 at 2). He did not think the organ congestion and the frothing of the lungs were the result
of resuscitation efforts. Id. at 19.
Dr. Shuman testified a diagnosis of encephalopathy requires an analysis of infant
behavior, with a focus on visual gaze, fixation, and feeding behavior. Id. (citing Tr. at 131).
Based on Petitioners’ observations, he determined A.E.S. displayed an altered mental state, was
irritable, could not self-soothe, did not feed properly, and did not have a normal gaze or normal
social responses. Id. (citing Tr. at 140–41). He expressed confusion that A.E.S. reportedly drank
a bottle because the autopsy showed only “a trace of mucoid food in the stomach.” Id. (citing Tr.
at 136–37). He relied on the parents’ testimony for his diagnosis since nothing in the medical
records described the clinical signs necessary to diagnose encephalopathy. Id. (citing Tr. at 171).
Dr. Shuman concluded A.E.S. was encephalopathic with a decreased level of consciousness,
inconsistent responses to external stimuli, and clinical signs of absent eye contact. Id. at 19–20
(citing Tr. at 163).
2. Petitioners’ Expert, Dr. M. Eric Gershwin
In support of Petitioners, Dr. Gershwin provided two reports and testified at the hearing.
Id. at 20–23; see also Pet’rs’ Ex. 63 (Expert Report of Dr. Gershwin), ECF No. 43-1; Pet’rs’ Ex.
97 (Supplemental Report of Dr. Gershwin), ECF No. 52-1. In his first report, Dr. Gershwin
concluded A.E.S. suffered from cerebral edema. Ruling at 20 (citing Pet’rs’ Ex. 63 at 1). He
opined that multiple vaccines together caused cytokine production, which led to cerebral edema
and an enlarged brain and resulted in her death. Id. (citing Pet’rs’ Ex. 63 at 1–2). However, in
his supplemental report Dr. Gershwin noted no evidence of an excessive cytokine response
following A.E.S.’s vaccination. Id. at 21 (citing Pet’rs’ Ex. 97 at 1). Still, he believed A.E.S.
was more fragile than a normal infant and the vaccinations were the “only logical explanation”
for the injury A.E.S. suffered. Id. (citing Pet’rs’ Ex. 97 at 2).
At the hearing, Dr. Gershwin testified “there had to be something that was defective on a
genetic basis with a receptor in [A.E.S.’s] brain that essentially made her a susceptible host” to
the cytokines. Id. (citing Tr. at 181) (alternation in original). He noted that none of the medical
literature with which he was familiar indicated that the cytokines released in response to
vaccinations have crossed the blood brain barrier, but he opined this was due to the rarity of the
event. Id. at 22. Dr. Gershwin stated cytokines released after vaccinations are not only a “drop
in the bucket,” as vaccines are designed to “fool the body” into thinking it has the infection. Id.
(citing Tr. at 315). He noted A.E.S.’s brain showed significant swelling and that another
explanation offered—“prolonged “QT Syndrome”—would not explain the cerebral edema and
size of A.E.S.’s brain on autopsy. Id. at 23 (citing Tr. at 314). He concluded the vaccinations
were a substantial factor in her encephalopathy and death. Id. (citing Tr. at 197).
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3. Respondent’s Expert, Dr. Christine McCusker
In support of Respondent, Dr. McCusker submitted three reports and testified at the
hearing. Id. at 23–30; see also Resp’t’s Ex. A (Expert Report of Dr. McCusker), ECF No. 35-1;
Resp’t’s Ex. E (Supplemental Report of Dr. McCusker), ECF No. 50-1; Resp’t’s Ex. F (Third
Report of Dr. McCusker), ECF No. 86-1. In her first report, Dr. McCusker disagreed A.E.S.
suffered an encephalopathy and cerebral edema from her vaccinations. Ruling at 24 (citing
Resp’t’s Ex. A at 5–6). She opined A.E.S. did not display signs of significant cytokine activity
and the cytokine response from vaccination is less than the cytokine response from a natural
infection. Id. (citing Resp’t’s Ex. A at 6). She also disagreed the Prevnar 13 vaccine has
demonstrated any association with encephalopathy after licensure. Id. (citing Resp’t’s Ex. A at
5).
Dr. McCusker discussed that A.E.S.’s younger sibling suffered from “Long QT
Syndrome” after birth and suggested A.E.S. may have suffered from the same condition. Id.
She noted “Long QT Syndrome” has been implicated in SUID cases. Id. However, she
acknowledged no genetic testing was performed that could have confirmed A.E.S. had the
condition. Id. (citing Resp’t’s Ex. A at 3, 7). Dr. McCusker observed the medical examiner
ruled this a SUID case, and studies show no evidence of a causal relationship between
vaccination and SIDS. Id. (citing Resp’t’s Ex. A at 7). She concluded there was no evidence of
cytokine activation or evidence the vaccinations caused A.E.S.’s death. Id. (citing Resp’t’s Ex.
A at 7).
In her supplemental report, Dr. McCusker admitted vaccinations activate immune
responses in part through cytokines but there is no evidence the cytokine levels are sufficient to
cause brain edema. Id. at 25 (citing Resp’t’s Ex. E at 3). She concluded A.E.S. showed no
clinical signs of immune activation, acute cerebral edema, or increased intracranial pressure in
the ninety minutes prior to Mr. Sims finding her unresponsive. Id. at 26 (citing Resp’t’s Ex. E at
7). Rather, “Long QT Syndrome” was a plausible explanation for A.E.S.’s symptoms. Id.
At the hearing, Dr. McCusker argued studies show no concern about infants receiving
multiple vaccinations at once, and a combination of vaccines does not significantly increase or
change the likelihood of adverse events and inflammation. Id. 26–27 (citing Tr. at 262–64). She
also disagreed with Dr. Gershwin that A.E.S. had a genetic anomaly, which made her unable to
process cytokines properly. Id. at 28. Dr. McCusker asserted that if A.E.S. did, the condition
would likely have been lethal while she was still in the womb. Id. at 28 (citing Tr. at 288–89).
Dr. McCusker did not find the descriptions of A.E.S.’s behavior consistent with an
encephalopathic baby, which would “send a parent running” to the ER. Id. at 29 (citing Tr. at
298). She stated children experiencing an encephalopathy are in pain, will not and cannot eat,
are nauseous, and suffer from severe headaches and vomiting, “not soft behavioral changes as
described.” Id. (citing Tr. at 299). Although she thought “Long QT Syndrome” was an
“important possibility to consider in the differential diagnosis,” she did not see A.E.S.’s sibling’s
medical records and there was no genetic testing. Id. at 30 (citing Tr. at 310–11). After the
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hearing, Dr. McCusker submitted a supplemental report documenting the safety of combining
multiple vaccines. Id.; see also Resp’t’s Ex. F.
4. Respondent’s Expert, Dr. Brent Harris
In support of Respondent, Dr. Harris submitted a report and testified at the hearing. Id. at
30–35; see also Resp’t’s Ex. C (Expert Report of Dr. Harris), ECF No. 35-3. In his report, Dr.
Harris noted there were no pathological abnormalities in A.E.S.’s brain, but her brain weighed
595 grams, instead of the expected 461–555 grams. Ruling at 30–31. He opined the autopsy
findings were “likely correct” and that “the brain appears grossly swollen bilaterally on superior
surfaces.” Id. at 31 (citing Resp’t’s Ex. C at 4). Dr. Harris determined the autopsy was
insufficient for a SIDS diagnosis, in part due to inadequate sampling. Id. (citing Resp’t’s Ex. C
at 4). He did note “mild edema and congestion” in all sampled brain tissue. Id. (citing Resp’t’s
Ex. C at 4).
Dr. Harris acknowledged medical literature documents rare instances of anaphylaxis after
vaccines, which can result in edema, but he said forensic anaphylaxis literature does not
document brain edema. Id. at 31–32 (citing Resp’t’s Ex. C at 5). He also found no evidence
A.E.S. suffered hemorrhages or neurodegenerative changes and no signs of cell death on her
brain tissue. Id. at 32 (citing Resp’t’s Ex. C at 6). He concluded the cause of death was
“unknown.” Id. (citing Resp’t’s Ex. C at 6).
Dr. Harris had been a consultant on SIDS cases for eight years and testified he would not
expect to see cerebral edema in an autopsy of a SIDS case. Id. at 32–33 (citing Tr. at 229–30).
He noted A.E.S.’s autopsy findings did not specifically include cerebral edema, but tissue is not
fresh during an autopsy. Id. at 33 (citing Tr. at 230). Based on the heaviness of A.E.S.’s brain
and other observations, he was “fairly comfortable to say that this is more likely edema” in
A.E.S.’s case. Id. (citing Tr. at 231). Dr. Harris determined A.E.S.’s heavy brain was a
pathological abnormality without a known cause. Id. (citing Tr. at 250–51).
Dr. Harris explained “encephalopathy” is a non-specific clinical term for dysfunction of
the brain and a pathology report would never contain a diagnosis of encephalopathy. Id. (citing
Tr. at 231–32). Regarding whether A.E.S. suffered brain herniation, Dr. Harris testified he could
not “rule it [in or] out.” Id. at 34 (citing Tr. at 237, 256). He opined the medical examiner
appropriately concluded the cause of death was undetermined. Id. (citing Tr. at 254). He
reiterated this is not a SIDS case because “you cannot make a diagnosis of SIDS without a full
sampling of the tissues.” Id. (citing Tr. at 243, 252). Overall, Dr. Harris did not believe vaccines
were the cause of A.E.S.’s death, and he was “not aware of any literature to suggest that
vaccination . . . could lead to a death like this.” Id. at 35 (citing Tr. at 242). However, he did not
“have an explanation for another diagnosis in this case.” Id. (citing Tr. at 242–43).
II. Standard of Review
In reviewing a special master’s decision, the Court of Federal Claims may:
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(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).
The standards in section 300aa-12(e)(2)(B) “vary in application as well as degree of
deference” as each “standard applies to a different aspect of the judgment.” Munn, 970 F.2d at
870 n.10. The Court evaluates fact findings “under the arbitrary and capricious standard; legal
questions under the ‘not in accordance with law’ standard; and discretionary rulings under the
abuse of discretion standard.” Id. Thus, the Court of Federal Claims “reviews the special
master’s decision essentially for legal error or factual arbitrariness.” Bradley v. Sec’y of Health
& Hum. Servs., 991 F.2d 1570, 1574 (Fed. Cir. 1993).
This Court reviews de novo whether a special master did not act in accordance with the
law. Althen, 418 F.3d at 1279. “‘Not in accordance with the law’ refers to the application of the
wrong legal standard.” Rodriguez v. Sec'y of Health & Human Servs., 632 F.3d 1381, 1384 (Fed.
Cir. 2011) (citing Markovich v. Sec'y of Health & Human Servs., 477 F.3d 1353, 1356 (Fed. Cir.
2007)). The Court owes “no deference to the . . . special master on questions of law.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010).
The standard of review for factual findings is “the most deferential possible.” Munn, 970
F.2d at 870. When reviewing a special master’s findings of fact, the Court does “not reweigh the
factual evidence, assess whether the special master correctly evaluated the evidence, or examine
the probative value of the evidence or the credibility of the witnesses—these are all matters
within the purview of the fact finder.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242,
1249 (Fed. Cir. 2011) (citing Broekelschen, 618 F.3d at 1349). The Vaccine Act “makes clear
that, on review, the Court of Federal Claims is not to second guess the Special Masters[’]
fact-intensive conclusions; the standard of review is uniquely deferential for what is essentially a
judicial process.” Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)
(citing Munn, 970 F.2d at 870); see also Snyder ex rel. Snyder v. Sec’y of Health & Hum. Servs.,
88 Fed. Cl. 706, 718 (2009) (“[T]he law is settled that neither the Court of Federal Claims nor
the Federal Circuit can substitute its judgment for that of the special master merely because it
might have reached a different conclusion.”).
“[S]pecial masters have broad discretion to weigh evidence and make factual
determinations.” Dougherty v. Sec’y of Health & Hum. Servs., 141 Fed. Cl. 223, 229 (2018). A
special master does not need to “discuss every item of evidence in the record” when making a
factual finding “so long as the decision makes clear that the special master fully considered a
party’s position and arguments on point.” Snyder v. Sec’y of Health & Hum. Servs., 36 Fed. Cl.
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461, 466 (1996), aff’d, 117 F.3d 545 (Fed. Cir. 1997) (citation omitted); see also Hazlehurst v.
Sec’y of Health & Hum. Servs., 604 F.3d 1343, 1352 (Fed. Cir. 2010) (noting a reviewing court
should presume the fact finder has considered all the material in the record, regardless of whether
she mentions it all). Furthermore, a “special master’s decision often times is based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen, 618 F.3d at 1347 (citing Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,
1362 (Fed. Cir. 2000)). And a special master’s credibility findings “are virtually
unchallengeable on appeal.” Lampe, 219 F.3d at 1362.
III. Discussion
The Special Master found, in turn, that Petitioners met their burden to show (1) A.E.S.
suffered the Vaccine Injury Table’s requirements for an encephalopathy and (2) in the
alternative, the vaccines caused an off-Table injury and death. Ruling at 38–51. She also
concluded Respondent failed to show an alternative cause. Id. at 51–52.
Respondent argues the Special Master erred in her Table injury analysis because she
improperly relied on A.E.S.’s death alone to find the Table injury and made factual findings
based solely on Petitioners’ uncorroborated statements, despite discrepancies with the medical
record. Resp’t Mem. at 12–17. Respondent also claims the Special Master erred in her
off-Table injury analysis because she misapplied prongs one and two of the Althen test. Id. at
17–20. Finally, Respondent contends the Special Master did not properly consider Respondent’s
evidence of likely alternative causes for A.E.S.’s death, including SUID and SIDS. Id. at 8–12.
The Court holds the Special Master did not err in her Table injury finding or in
determining Respondent failed to show an alternative cause by a preponderance of the evidence.
To receive compensation under the Vaccine Act, Petitioners are required to show a Table injury
or an off-Table injury; either is sufficient. See Althen, 418 F.3d at 1276. Since the Special
Master properly found a Table injury, her analysis could have ended there. Therefore, this Court
upholds the Special Master’s decision based solely on her Table injury finding. The Court does
not reach the parties’ arguments about the Special Master’s off-Table injury finding.
A. The Special Master’s Table Injury Finding Was Proper.
The Court reviews the Special Master’s conclusions of law about the Table injury
requirements de novo without deference. Broekelschen, 618 F.3d at 1345. Since Petitioners
filed their claim on December 15, 2015, their petition must be evaluated under the regulation in
effect from July 23, 2015 to March 20, 2017. See 42 U.S.C. § 300aa-14(c)(4) (“Any
modification . . . of the Vaccine Injury Table shall apply only with respect to petitions for
compensation under the Program which are filed after the effective date of such regulation.”); 42
C.F.R. § 100.3(a) (July 23, 2015) (Vaccine Injury Table). The applicable Vaccine Injury Table
defines an encephalopathy that occurred within 72 hours of the administration of a DTaP vaccine
as a Table injury. 42 C.F.R. § 100.3(a) (July 23, 2015).
The Qualifications and Aids to Interpretation (“QAIs”) further state a petitioner can show
the Table injury “only if such recipient manifests, within the applicable period . . . an acute
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encephalopathy, and then a chronic encephalopathy persists in such person for more than 6
months.” Id. § 100.3(b)(2). “An acute encephalopathy is one that is sufficiently severe so as to
require hospitalization (whether or not hospitalization occurred).” Id. § 100.3(b)(2)(i). Given
her death within nine hours of vaccination, A.E.S. did not suffer a chronic encephalopathy lasting
more than six months. However, a petitioner can also recover if “[a]ny acute complication or
sequela (including death)” of an encephalopathy “arose within the [72-hour] time period
prescribed.” Id. § 100.3(a).
For a child less than 18 months of age, the QAIs state an acute encephalopathy “is
indicated by a significantly decreased level of consciousness lasting for at least 24 hours.” Id.
§ 100.3(b)(2)(i)(A).
A ‘significantly decreased level of consciousness’ is indicated by the presence of at
least one of the following clinical signs for at least 24 hours or greater . . . (1)
Decreased or absent response to environment . . . ; (2) Decreased or absent eye
contact . . . ; or (3) Inconsistent or absent responses to external stimuli . . .
Id. § 100.3(b)(2)(i)(D). Meanwhile, “[s]leepiness, irritability (fussiness), high-pitched and
unusual screaming, persistent inconsolable crying, and bulging fontanelle” do not “alone, or in
combination, . . . demonstrate an acute encephalopathy.” Id. § 100.3(b)(2)(i)(E). Further,
“[i]ncreased intracranial pressure may be a clinical feature of acute encephalopathy in any age
group.” Id. § 100.3(b)(2)(i)(C). Petitioners must demonstrate the Table injury requirements by a
preponderance of the evidence. Capizzano, 440 F.3d at 1320.
1. The Special Master Did Not Err in Finding Petitioners Met the
Table’s Requirements for an Encephalopathy Even Though A.E.S.
Died Less Than 24 Hours After Vaccination.
The relevant QAIs state the clinical signs of a significantly decreased level of
consciousness need to be present for at least 24 hours. 42 C.F.R. § 100.3(b)(2)(i)(D) (July 23,
2015). In the Memorandum in support of the Motion for Review, Respondent argued the Special
Master made a legal error in applying this requirement. Resp’t Mem. at 13. Since A.E.S. died
less than 24 hours after being vaccinated, Respondent claimed Petitioners “cannot prove an acute
encephalopathy lasting more than 24 hours,” as required by the QAIs. Id. at 13. However, in
response to this Court’s Order for Supplemental Briefing, Respondent reversed course. Resp’t’s
Resp. to Order for Suppl. Briefing (hereinafter “Resp’t Suppl.”) at 5, ECF No. 113. In the
response, Respondent concedes “the Special Master was authorized to—and ultimately did—find
that A.E.S.’s death was a compensable sequela of an acute encephalopathy even though A.E.S.
died less than 24 hours after vaccination.” Id.
The Special Master observed Respondent’s original reading of the QAIs “suggests the
impossible . . . . The clinical features of an encephalopathy clearly cannot exist for 24 hours
when death occurs before that time.” Ruling at 40. Thus, the Special Master analyzed whether
A.E.S. suffered the requisite clinical signs of an encephalopathy prior to her death and whether
the encephalopathy resulted in her death. Id. at 41–43. Whether the Special Master committed
an error of law in this regard is now uncontested by either party. But since this Court reviews
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questions of law without deference, the Court must determine whether the Special Master legally
erred to sustain her Table injury finding. Broekelschen, 618 F.3d at 1345. The Court finds she
did not.
The Vaccine Injury Table states a petitioner can recover for a “sequela (including death)”
of an encephalopathy that arose within the requisite 72-hour time period. 42 C.F.R. § 100.3(a)
(July 23, 2015). The Table does not explicitly require a death from encephalopathy to occur
more than 24 hours after the administration of the DTaP vaccine. “The Court must assess ‘a
[regulatory] scheme in its entirety’ and ‘give full effect to all words contained within [a] statute
or regulation, thereby rendering superfluous as little of the statutory or regulatory language as
possible.’” HealthRev, LLC v. United States, 172 Fed. Cl. 73, 83 (2024) (quoting Hanser v.
McDonough, 56 F.4th 967, 970 (Fed. Cir. 2022) (alteration in original). Here, the Court must
parse the Table’s language allowing for recovery for “any . . . death” resulting from an
encephalopathy “within the [72-hour] time period prescribed” along with the QAIs’ requirement
that the clinical signs of an encephalopathy are present for at least 24 hours. 42 C.F.R.
§§ 100.3(a), 100.3(b)(2)(i)(D) (July 23, 2015).
The U.S. Court of Appeals for the Federal Circuit has held the Table’s language about a
“sequela (including death)” within the specified time period requires a petitioner to show (1) the
Table injury “occurred within the time period specified in the Table” and (2) the “death occurred
as a sequela” (i.e. result) of the injury. Hellebrand v. Sec’y of Health & Hum. Servs., 999 F.2d
1565, 1569 (Fed. Cir. 1993). To assess the first prong, the Court must consider whether the
Special Master could legally find Petitioners showed a Table injury within the 72-hour time
period even though the Special Master did not find A.E.S. suffered the clinical signs of
encephalopathy for at least 24 hours. See 42 C.F.R. § 100.3(b)(2)(i)(D) (July 23, 2015). In
doing so, the Court must reconcile Hellebrand with the Federal Circuit’s decisions in Jay v. Sec’y
of Health & Hum. Servs., 998 F.2d 979, 983 (Fed. Cir. 1993), and Hodges. 9 F.3d at 959.
In Jay, the Federal Circuit reversed a special master’s summary judgment ruling that a
child who died eighteen hours after vaccination—and whose autopsy listed SIDS—did not suffer
an encephalopathy. 998 F.2d at 981–84. The court ruled the special master erred “in failing to
grant summary judgment that [the child] did suffer an encephalopathy.” Id. at 983. “[T]he death
occurred within the 3 day table injury time frame for an encephalopathy” and the special master
had improperly discredited a medical expert who testified “that an encephalopathy occurred
based on [the child’s] entire history including the fact of death.” Id. at 983–84. The expert found
the relevant symptoms of encephalopathy, including “unconsolable crying for six or more hours,
. . . and then the subsequent death all occur[ed] within a twenty-four-hour period of time.” Id. at
983 n.5. And the court held there is “nothing in the Vaccine Act which precludes death from
being used as evidence of a table injury, here encephalopathy.” Id. at 983. Indeed, “there is no
more profound and permanent change in level of consciousness than death.” Id. at 983 n.6.
The Vaccine Injury Table relevant in Jay did not require that for an encephalopathy the
requisite clinical signs of a significantly decreased level of consciousness had to be present for at
least 24 hours. See 42 U.S.C. 300aa-14(a)-(b) (1986) (original Vaccine Injury Table). But it did
include the same language allowing for recovery for any “sequela (including death)” of an
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encephalopathy within the specified 72-hour period that is in the 2015 regulation. See id.; 42
C.F.R. § 100.3(a) (July 23, 2015).
In Hodges, the Federal Circuit considered whether petitioners could recover for a Table
injury where a child died “within 3.5 hours” of vaccine administration. 9 F.3d at 959. The court
held petitioners had demonstrated the child suffered symptoms that were among the “statutory
indica” of the Table injury because the child was “pale, unresponsive, and in cardiovascular and
respiratory arrest.” Id. at 959–60. However, the court found these were also “symptoms of her
death” and did “not independently establish” the Table injury. Id. at 960. Thus, petitioners failed
to show the Table injury requirements within the specified time period. Id. Similarly, in
Hellebrand the court found “the presence of cardiovascular or respiratory arrest alone” did not
satisfy a petitioner’s burden to show a Table injury. 999 F.2d at 1569.
Neither Hodges nor Hellebrand conclusively address whether the Table’s minimum
duration period for a non-death related symptom disqualifies a victim who exhibits that symptom
but dies before the duration period ends. Respondent contends the court held in Hodges that
“death alone is not compensable if a [T]able injury has not been established, regardless of the
interval between vaccination and death.” Resp’t Suppl. at 4 (citing Hodges, 9 F.3d at 960). But
this language appears in the court’s summary of the respondent’s argument, not in the holding.
Hodges, 9 F.3d at 960. And even so, it does not address whether a petitioner can establish a
Table injury in a shorter time frame than otherwise required in the event of an intervening death.
Nor did either Hodges or Hellebrand explicitly disavow Jay. See Resp’t Mem. at 13 n.4
(acknowledging Jay is “equally binding”). And in Jay, the Federal Circuit determined “over six
hours of intermittent screaming” followed by death was sufficient to meet the Table’s
requirements for an encephalopathy. 998 F.2d at 983.
The Court of Federal Claims was confronted with the inverse posture to this matter in
Waterman v. Sec’y of Health & Hum. Servs., 123 Fed. Cl. 564, 566 (2015). In that case, the
relevant QAIs included the same 24-hour requirement for the clinical signs of encephalopathy,
and a special master found the petitioners had not met the Table’s requirements where a child
died less than 24 hours after vaccination. Id. But the Court did not affirm the special master on
the grounds that a petitioner can never establish the Table’s requirements for an encephalopathy
where the injured party dies in less than 24 hours. Id. at 573–74 (finding the petitioners failed to
prove their child’s death “was a sequela of” encephalopathy). Rather, the Court found the special
master properly evaluated the medical records and expert opinions and reasonably concluded the
petitioners had “not pointed to any evidence that suggest[ed] [the child’s] loss of consciousness
was a result of an encephalopathy.” Id. at 574. The Court held death is not precluded “from
being used as evidence of a [T]able injury,” but “symptoms of death do not independently
establish the existence of a Table injury.” Id. at 575 (citing Jay, 998 F.2d at 983; Hodges, 9 F.3d
at 960) (alteration in original).
Respondent correctly notes it would be “at odds with the plain language of the [Vaccine]
Act” to allow “recovery for any death that occurs within seventy-two hours of receipt of a DTaP
vaccine.” Resp’t Mem. at 13 (citing Waterman, 123 Fed. Cl. at 575 (quoting Hellebrand, 999
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F.2d at 1571)) (alteration in original). But the Vaccine Act also does not deny recovery for any
death resulting from an encephalopathy that occurs within 24 hours of a DTaP vaccine.
Thus, the reasonable interpretation of binding precedent and the 2015 regulation is that a
petitioner can recover for an encephalopathy that results in death less than 24 hours after
vaccination. But to do so, a petitioner must show the deceased suffered clinical signs of an
encephalopathy, as defined in the QAIs, prior to death that are not also symptoms of death. In
this case, the Special Master found Petitioners met this burden. Ruling at 43.
2. The Special Master Reasonably Found Petitioners Met Their Burden
To Show A.E.S. Suffered the Table Requirements for an
Encephalopathy.
Respondent contends the Special Master erred by failing to affirmatively find clinical
symptoms of acute encephalopathy as required by the Table and determining A.E.S.’s “death
itself was sufficient to establish a Table encephalopathy.” Resp’t Mem. at 17; see also Resp’t
Supp. at 5 (“The pivotal question here is whether a preponderance of the evidence supported the
Special Master’s finding that A.E.S. did, in fact, experience an acute encephalopathy prior to her
death.”). The Court finds the Special Master did not commit either an error of law in applying
the Table requirements for an encephalopathy or make arbitrary factual findings in determining
Petitioners met their burden.
In assessing both whether Petitioners met their burden to show A.E.S. suffered the Table’s
requirements for an encephalopathy and whether the encephalopathy resulted in her death, the
Special Master relied on expert medical opinions. Ruling at 41–43. Given the competing expert
testimony, the Special Master’s Table injury decision was appropriately based on her
determination of “the credibility of the experts and the relative persuasiveness of their competing
theories.” Broekelschen, 618 F.3d at 1347. “[A]rguments as to the weighing of evidence . . .
particularly where witness credibility is involved, do not demonstrate reversible error.” Hines ex
rel Sevier, 940 F.2d at 1527. These credibility determinations are “virtually unreviewable” on
appeal. Bradley, 991 F.2d at 1575 (citing Hambsch v. Dept. of the Treasury, 796 F.2d 430, 436
(Fed. Cir. 1986)). This Court must defer to the Special Master’s factual determinations and
cannot “reweigh the factual evidence.” Porter, 663 F.3d at 1249.
a. The Special Master Did Not Err in Determining A.E.S. Suffered an
Encephalopathy Within 72 Hours of Vaccination.
The Special Master properly based her Table injury finding on both a requisite clinical
symptom—decreased or absent eye contact—together with A.E.S.’s subsequent death within
nine hours of her vaccinations. See Ruling at 42–43. Thus, Hellebrand’s first prong was
satisfied since the Table injury “occurred within the [72-hour] time period specified in the
Table.” 999 F.2d at 1570. The Special Master made the following specific findings based on
Petitioners’ testimony and affidavits, as well as a corroborating medical opinion:
[T]he behaviors that are [] within the repertoire of an 11-week-old that were
demonstrated by A.E.S.—irritability, inability to self-soothe, not cuddling, not
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tracking or making eye contact, and sleeping more—were indicative of an altered
state and decreased level of consciousness in the afternoon following her
vaccinations sufficient to satisfy the Table requirements for an encephalopathy . . .
that resulted in her death.
Ruling at 43. She found credible Dr. Shuman’s testimony “that these behaviors are
demonstrative of A.E.S. being encephalopathic based on the behavioral repertoire of an
11-week-old.” Id. at 42 (citing Tr. at 140–41).
The factual finding that A.E.S. was “not tracking or making eye contact” corresponded
with a clinical sign of significantly decreased level of consciousness in the QAIs. See 42 C.F.R.
§ 100.3(b)(2)(i)(D)(2) (July 23, 2015) (stating the requisite decreased level of consciousness can
be shown by “[d]ecreased or absent eye contact”). And under the regulation, Petitioners need
only to demonstrate one of the clinical signs. Id. § 100.3(b)(2)(i)(D) (requiring the “presence of
at least one of the . . . clinical signs”) (emphasis added).3 Importantly, the key clinical sign—
decreased or absent eye contact—is not a symptom of A.E.S.’s death since it required A.E.S. to
be awake. In other words, the decreased eye contact “was not merely a consequence of the dying
process.” Pet’rs’ Resp. to Order for Suppl. Briefing at 3, ECF No. 114.
Respondent contends the Special Master did not affirmatively find evidence that A.E.S.
exhibited the requisite clinical signs of a Table encephalopathy. Resp’t Mem. at 17. Rather,
Respondent argues the Special Master granted Petitioners “a factual presumption about what the
evidence might have been if it were available as grounds for granting them a legal presumption
of causation” afforded by the Table. Id. (citing Ruling at 42) (referring to the Special Master’s
statement that she did “not have the luxury of knowing what [A.E.S.]’s behaviors would have
been had she survived”). The Special Master acknowledged Respondent’s experts’ arguments
that “systemic reaction severe enough to cause characteristic and perceptible encephalopathic
behaviors would have required at least six to eight hours.” Ruling at 42 (citing Tr. at 235). And
she stated additional clinical signs may have occurred “when A.E.S. was unobserved during her
last 45 minutes of responsive life.” Id. Thus, Respondent claims the Special Master legally
erred by “effectively—and erroneously—determin[ing] that the death by itself was sufficient to
establish a Table encephalopathy.” Resp’t Mem. at 17.
But the Special Master did not base her final determination on any suppositions or factual
presumptions. She made specific findings about A.E.S.’s behavior based on the parents’
testimony and affidavits, which were corroborated by medical opinion. Ruling at 41–43. Most
importantly, the Special Master determined A.E.S. was “not tracking or making eye contact” in
the afternoon following her vaccination and that a medical expert diagnosed A.E.S. with an
encephalopathy based on the reported behavior. Id. at 43.
3 The Special Master also found A.E.S. displayed some behaviors that the QAIs state are alone
insufficient to demonstrate an acute encephalopathy. These behaviors do not contradict an
encephalopathy. 42 C.F.R. § 100.3(b)(2)(i)(E) (July 23, 2015) (“The following clinical features
alone, or in combination, do not demonstrate an acute encephalopathy or a significant change in
either mental status or level of consciousness . . . : Sleepiness, irritability (fussiness).”).
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b. The Special Master Reasonably Credited the Parents’ Affidavits
and Testimony.
Respondent argues the Special Master erred because she “relied primarily upon
petitioners’ second affidavits (which were prepared almost seven years after [A.E.S.]’s
death[)] . . . and their testimony at hearing, which were significantly different from the histories
they gave to both the treating physicians at the hospital and the medical examiner.” Resp’t Mem.
at 15. Respondent contends the Special Master should have given “considerable weight” to the
contemporaneous medical records that do not contain information about A.E.S.’s behavior at
home beyond noting A.E.S. had a “normal” day. Id. at 14–15. Further, Petitioners reported “[n]o
reactions” to the medical examiner. Resp’t Suppl. at 6 (alteration in original). See also Ruling at
9. But the Special Master did not err.
Contemporaneous medical records are generally considered trustworthy evidence. See
Cucuras v. Sec’y of Dep’t of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). And
“where later testimony conflicts with earlier contemporaneous documents, courts generally give
the contemporaneous documentation more weight.” Campbell ex rel. Campbell v. Sec’y of
Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (citing United States v. U.S. Gypsum Co., 333
U.S. 364, 395–96 (1948)). But there is “no basis for presuming that medical records are accurate
and complete even as to all physical conditions.” Kirby v. Sec’y of Health & Hum. Servs., 997
F.3d 1378, 1383 (Fed. Cir. 2021). This Court has noted:
[T]here are, at times, reasons why medical records do not accurately reflect all the
symptoms a given patient was experiencing at a particular time—in the case of a
young child, a given observation may have been overlooked by the caregiver,
particularly under traumatic circumstances, or that symptom may have been
relayed, but misreported or not recorded by the medical professional.
Campbell, 69 Fed. Cl. at 779. And the Federal Circuit recently reaffirmed it is not “per se
arbitrary and capricious” to credit “credible and corroborated testimony” over “conflicting or
absent contemporaneous records.” Hinton v. Sec’y of Health & Hum. Servs., No. 2023-2161,
2025 WL 763153 at *6 (Fed. Cir. Mar. 11, 2025) (internal quotation marks and quotation
omitted).
The Special Master acknowledged “there are some discrepancies in the record” regarding
the Petitioners’ statements, including that the “autopsy did not mention food content in the
stomach” while both parents recalled feeding A.E.S. Ruling at 41. However, she also noted
Mrs. Sims “was uncertain if A.E.S. was actually eating.” Id. (citing Tr. at 21–22). While
A.E.S.’s medical records do not corroborate the behaviors her parents later described, they also
do not affirmatively contradict or rule them out. See id. at 9–11.
In Kirby, the Federal Circuit held a reasonable fact finder may conclude testimony does
not conflict with medical records where those “medical records are silent about the existence
of . . . symptoms, [and] they are also silent about the nonexistence of such symptoms.” Kirby,
997 F.3d at 1383. Respondent argues Kirby is inapposite here because the medical records note a
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“normal day” and “[n]o reactions,” which conflicts with Petitioners’ testimony. Resp’t Suppl. at
6 (alteration in original). But the Kirby court specifically found that medical records silent on
vaccine injury did not contradict later testimony, even when the records included general
statements from a patient that she was “feeling fine” and had “no complaints.” Kirby, 997 F.3d
at 1383–84.
Here, the Special Master noted Dr. Shuman’s testimony that “the signs of an
encephalopathy in an infant at A.E.S.’s age are limited and difficult to assess.” Ruling at 43
(citing Tr. at 129, 140–41, 163). This could explain why the parents reported a normal day and
no reaction to the hospital personnel, “particularly under traumatic circumstances” on the day of
their child’s death. See Campbell, 69 Fed. Cl. at 779. Thus, it was reasonable for the Special
Master to conclude the medical records do not undermine Petitioners’ later testimony.
The Special Master, within her purview as the fact finder, appropriately credited the
parents’ second affidavits and testimony, along with Dr. Shuman’s opinion, in finding a Table
injury. Ruling at 43. Respondent claims the Special Master should have discounted Petitioners’
testimony on the basis that their memories may have become “less reliable over time.” Resp’t
Suppl. at 7. But Respondent’s arguments amount to mere disagreement with how the Special
Master weighed evidence and assessed the credibility of the testimony. The Special Master was
in the best position to make credibility determinations, and this Court will not second guess those
determinations. See Hines ex rel Sevier, 940 F.2d at 1520.
c. The Special Master Did Not Rely on Unsubstantiated Claims.
Respondent argues the Special Master’s fact finding was arbitrary and capricious and
contrary to law because she relied on Petitioners’ claims alone, which is prohibited by the
Vaccine Act. Resp’t Mem. at 15 (citing 42 U.S.C. § 300aa-13(a)(1)). But the Special Master did
not rely “entirely on petitioners’ unsubstantiated testimony to conclude [A.E.S.] suffered an acute
encephalopathy.” Id. The Vaccine Act states a special master may not find a petitioner is entitled
to compensation “based on the claims of a petitioner alone, unsubstantiated by medical records
or medical opinion.” 42 U.S.C. § 300aa-13(a)(1) (emphasis added). The statute’s “words are
unambiguous.” Meeks v. West, 216 F.3d 1363, 1366 (Fed. Cir. 2000). It permits a petitioner’s
claims to be substantiated by medical opinion and does not require evidence from the medical
records. See Althen, 418 F.3d at 1280 (finding section 300aa–13(a)(1) permits the use of
“medical opinion as proof”).
Here, the Special Master considered A.E.S.’s parents’ affidavits and testimony together
with the competing diagnoses offered by each side’s experts. Ruling at 41–43. She ultimately
credited Dr. Shuman’s medical opinion to find Petitioners satisfied the Table’s requirements for
an encephalopathy. And the Special Master considered Dr. Shuman’s reliability, noting he has a
“special competence in child neurology” and has spent his “life studying the development of
children.” Id. at 13; see also Hirmiz v. Sec’y of Health & Hum. Servs., 119 Fed. Cl. 209, 217
(2014) (“While a special master may base his or her decision on medical opinion alone, . . . he or
she is entitled to require some indicia of reliability to support the assertion of the expert
witness.”) (citations omitted). Dr. Shuman testified that while there “was nothing in the medical
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records that described the clinical signs necessary to make a diagnosis,” he was able to “conclude
that A.E.S. was encephalopathic” based “on the parents’ observations.” Ruling at 19. Moreover,
as discussed above, the medical records do not contradict Petitioners’ descriptions of A.E.S.’s
behavior.
While it would have been improper for the Special Master to rest her conclusions on
Petitioners’ statements alone, Respondent points to no authority suggesting it was improper for
Dr. Shuman to base his medical opinion on the parents’ reported observations. See Resp’t Mem.
at 15. The Federal Rules of Evidence permit an expert to base an opinion on facts or data that he
did not personally observe “[i]f experts in the particular field would reasonably rely on those
kinds of facts or data.” Fed. R. Evid. 703. Respondent’s experts did not suggest it was
impermissible to base a diagnosis of encephalopathy on the parents’ descriptions of A.E.S.’s
behavior. Ruling at 29. They disagreed that the reported behavior was severe enough to
diagnose A.E.S. with an encephalopathy, but they did not question the method of diagnosis. Id.
at 42. Nor did they suggest the lack of an encephalopathy diagnosis in the autopsy contradicted
Petitioners’ experts. In fact, Respondent’s expert Dr. Harris testified that “a pathology report,”
such as an autopsy, “would never contain a diagnosis of encephalopathy.” Id. at 33 (citing Tr. at
231–32). Thus, Dr. Shuman did not “base[] his opinion on facts not substantiated by the record.”
Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993). Nor did he make any
factual assumptions. See Dobrydnev v. Sec’y of Health & Hum. Servs., 566 F. App’x 976, 982–
983 (Fed. Cir. 2014). Dr. Shuman provided a valid medical opinion substantiating Petitioners’
claims.
The Special Master, within her discretion, found Dr. Shuman’s opinion more convincing
than the Respondent’s experts’ conflicting opinions. See Broekelschen, 618 F.3d at 1347 (citing
Lampe, 219 F.3d at 1361). Her conclusion properly relied on Dr. Shuman’s medical opinion that
A.E.S.’s behavior in the afternoon following her vaccination was “demonstrative of A.E.S. being
encephalopathic.” Ruling at 42–43. Thus, the Special Master’s determinations were not
“unsubstantiated by . . . medical opinion.” 42 U.S.C. § 300aa-13(a)(1).
d. The Special Master Reasonably Determined A.E.S.’s Death
Occurred as a Sequela of the Encephalopathy.
The Special Master’s findings also properly satisfy Hellebrand’s second prong because
A.E.S.’s “death occurred as a sequela” of an encephalopathy. 999 F.2d at 1569. Since causation
is presumed in Table injury cases, Petitioners did not need to show the vaccines caused the
encephalopathy and resulting death. Capizzano, 440 F.3d at 1320. They needed only to
demonstrate the encephalopathy resulted in A.E.S.’s death. Hellebrand, 999 F.2d at 1569. The
Special Master credited Dr. Shuman’s opinion that “A.E.S. developed an encephalopathy with
cerebral edema which caused axial herniation that led to her death.” Ruling at 42 (citing Pet’rs’
Ex. 16 at 36–37). And she noted Dr. Harris’ testimony that he did not “have an explanation for
another diagnosis in this case.” Id. (citing Tr. at 242–43). The Special Master also ruled out
other causes of death, finding there “was no trauma and no evidence of neurological disease
other than edema.” Id. at 43. Instead, she determined “the only abnormalities on autopsy were a
heavy brain and edema.” Id.
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After weighing all the record evidence and the competing expert testimony, the Special
Master concluded “A.E.S. suffered from a Table encephalopathic event with cerebral edema
following the receipt of multiple vaccinations that resulted in her death.” Id. She based her
conclusions on the medical records and “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). Thus, she properly found A.E.S.’s death “occurred as a sequela” of the
encephalopathy. Hellebrand, 999 F.2d at 1569.
3. The Special Master Did Not Need to Conclusively Determine Whether
A.E.S. Suffered Increased Intracranial Pressure.
To support the position that there is insufficient evidence A.E.S. was encephalopathic,
Respondent argues the Special Master never conclusively found A.E.S. experienced increased
intracranial pressure. See Resp’t Mem. at 16. The Special Master reviewed the autopsy and
noted both Petitioners’ expert, Dr. Shuman, and Respondent’s expert, Dr. Harris, “agreed that
A.E.S.’s brain was abnormally heavy with edema on autopsy.” Ruling at 42 (first citing Pet’rs’
Ex. 16 at 36–37; and then citing Resp’t’s Ex. C at 5–6). And she stated “[b]oth experts agreed
that once the skull was removed on autopsy, the brain would move back into place, relieving the
pressure caused by swelling within the closed compartment of the brain.” Id. (first citing Pet’rs’
Ex. 16 at 31; and then citing Tr. at 236–37). Based on this evidence, the Special Master
concluded “the existence of intracranial pressure cannot be ruled out.” Id. Respondent is correct
this is not an affirmative finding. See Resp’t Mem. at 16.
However, the Special Master did not need to make a conclusive determination to satisfy
the Table’s requirements for an encephalopathy. The QAIs state “[i]ncreased intracranial
pressure may be a clinical feature of acute encephalopathy in any age group.” 42 C.F.R.
§ 100.3(b)(2)(i)(C) (July 23, 2015) (emphasis added). This language confirms increased
intracranial pressure is not necessary to find the Table injury. As discussed above, the Special
Master properly found A.E.S. suffered the requisite decreased level of consciousness within the
72-hour time period. She therefore did not err in finding a Table encephalopathy occurred
despite not making a conclusive finding of increased intracranial pressure.
B. The Special Master Did Not Err in Finding Respondent Failed To Establish
an Alternative Cause.
Since Petitioners have met their burden to show a Table injury, they are entitled to
compensation so long as “there is not a preponderance of the evidence that the . . . injury . . . or
death described in the petition is due to factors unrelated to the administration of the vaccine.”
42 U.S.C. § 300aa–13(a)(1)(B); see also Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144,
1149 (Fed. Cir. 1992) (“[T]he Vaccine Act requires, in addition to a Table Injury or causation in
fact, the absence of alternative causes.”). Respondent bears the burden of showing an alternative
cause. See Walther, 485 F.3d at 1151. The Vaccine Act excludes as unrelated factors any
“idiopathic, unexplained, unknown, hypothetical or undocumentable cause, factor, injury, illness
or condition.” 42 U.S § 300aa–13(a)(2)(A).
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The Special Master found Respondent failed to “show an alternative cause.” Ruling at
52. Respondent did not establish by a preponderance of the evidence that the encephalopathy
“was caused by an infection, a toxin, a metabolic disturbance, a structural lesion, a genetic
disorder or trauma.” 42 C.F.R. § 100.3(b)(2)(iii) (July 23, 2015). The Special Master further
noted “there is no evidence that A.E.S. died of a factor unrelated to the administration of the
vaccines.” Ruling at 42; see also id. at 51–52 (holding Petitioners demonstrated “there was no
evidence of infection on gross or microscopic examination or cultures post-mortem[,] . . . no
indication of predisposing chronic stress,” and the “case does not fit the classic profile of
SIDS”).
Respondent contends the Special Master “intentionally ignore[ed] epidemiological
evidence related to SIDS/SUID that was critical” to the alternative cause defense. Resp’t Mem.
at 8. Respondent further argues her finding that “[t]his is not a SIDS/SUID case” was “flatly
contradicted by the evidence” and “effectively deprived” Respondent of the opportunity to
present a meaningful defense on that ground. Id. at 9. These arguments are unconvincing.
The Special Master considered pathologist Dr. Barnhart’s conclusion that the cause of
death was “best classified as undetermined” and her statement that the autopsy findings were
“consistent with Sudden Unexplained Infant Death (SUID).” Ruling at 12, 41; see also Nordwall
ex rel. Tori v. Sec’y of Health & Hum. Servs., 83 Fed. Cl. 477, 488 (2008) (“An autopsy report
by a medical examiner is without question a contemporaneous medical record . . . and should be
given the same probative weight as other medical records.”). But these conclusions are not at
odds with the finding that A.E.S. suffered an encephalopathy.
As discussed above, SUID, unlike SIDS, is not a specific diagnosis and includes
instances where an infant “die[s] suddenly and unexpectedly for a variety of reasons.” Ruling at
3. The Special Master noted Dr. Harris’ conclusion that “a pathology report would never contain
a diagnosis of encephalopathy.” Id. at 33 (citing Tr. at 231–32). She also considered that the
“autopsy revealed a heavy brain at 595g compared to an expected 491–555g, and cerebral
edema,” which experts from both sides agreed was unusual. Id. at 41–42. Thus, the Special
Master reasonably weighed the autopsy findings and concluded they were consistent with
encephalopathy despite the pathologist’s statement about SUID. And as the fact finder, the
Special Master was empowered to find Petitioners had met their burden to show a Table injury
and that A.E.S.’s injury was therefore not due to an unknown cause. Capizzano, 440 F.3d at
1319.
The Special Master further explained a “distinction exists between sudden unexplained
infant death (‘SUID’) and sudden infant death syndrome (‘SIDS’).” Ruling at 3. SIDS is a
specific “diagnosis of exclusion used when other possibilities have been ruled out,” including
through “a thorough autopsy, death scene investigation, and review of the clinical history.” Id.
The Special Master considered whether there was evidence of SIDS and concluded it was not the
cause of death. Id. at 38, 51–52. See Doe v. Sec’y of Health & Hum. Servs., 601 F.3d 1349,
1358 (Fed. Cir. 2010) (holding a special master properly considered evidence of SIDS where an
expert discounted “SIDS as a possible cause”). She determined the symptoms A.E.S. displayed
while at home, A.E.S.’s body positioning, and the presence of cerebral edema, pulmonary
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edema, and congestive heart failure on the autopsy are all contrary to the classic profile of SIDS.
Ruling at 51–52. Indeed, Respondent’s expert Dr. Harris conceded a SIDS diagnosis was not
possible in this case, as there was “an incomplete sampling of brain tissue and no clear
environmental trigger [was] present.” Id. at 38 (first citing Resp’t’s Ex. C at 5; and then citing
Tr. at 243, 253–54).
The Special Master did not discuss some of Respondent’s exhibits regarding SIDS, but
she did not need to “discuss every item of evidence in the record.” Munoz v. Sec’y of Health &
Hum. Servs., 174 Fed. Cl. 276, 284 (2024) (citation omitted). It is generally presumed a special
master “considered the relevant record evidence even though he does not explicitly reference
such evidence in his decision.” Moriarty v. Sec'y of Health & Hum. Servs., 844 F.3d 1322, 1328
(Fed. Cir. 2016) (citing Hazlehurst, 604 F.3d at 1352). This presumption does not apply when a
special master indicates otherwise. Id. But here, the Special Master specifically stated that
“although [her] decision discusses some but not all the literature in detail, [she] reviewed and
considered all of the medical records and literature submitted.” Ruling at 38.
The Special Master also properly considered Dr. McCusker’s discussion of
epidemiological studies showing a lack of association between SIDS and vaccines, including Dr.
McCusker’s statement that these studies include some “sudden unexplained infant death[s] . . .
[that] don’t qualify as SIDS.” Id. at 28–30 (quotation omitted). Thus, the Special Master did not
ignore epidemiological studies or evidence related to SUID and SIDS or deprive Respondent of
the ability to raise a meaningful defense. As the appropriate fact finder, she weighed the
evidence and found that these potential causes of injury were less convincing than the competing
evidence A.E.S. suffered an encephalopathy.
The Special Master also reasonably determined Dr. McCusker’s suggestion that “Long
QT Syndrome” is “one plausible explanation for [A.E.S.’s] clinical picture and death . . . [was]
unsupported, speculative and/or conclusory in nature.” Id. at 52; see also Deribeaux v. Sec’y of
Health & Hum. Servs., 717 F.3d 1363, 1368 (Fed. Cir. 2013) (holding that to show an alternative
cause the Secretary “had to present sufficient evidence to prove that the alternative factor was the
sole substantial factor in bringing about the injury”) (citing de Bazan, 539 F.3d at 1354). In
rejecting this theory, the Special Master noted Dr. McCusker’s acknowledgment that no genetic
testing was done on A.E.S. Ruling at 52. As such, Dr. McCusker’s theory was unsupported. Id.
In sum, the Special Master did not err in finding that, because Respondent “failed to establish an
alternative cause that is more than speculative, [P]etitioners are entitled to compensation.” Id.
IV. Conclusion
Respondent has not demonstrated the Special Master made an error of law or arbitrary
factual findings in determining Petitioners met their burden to show a Table injury. Rather, the
Special Master applied the correct legal standard and reviewed all the evidence in this case,
including competing medical expert opinions. Her decision is appropriately supported by the
record, which she determined showed an infant who received the DTaP vaccine and developed
clinical signs consistent with an encephalopathy that led to her death approximately eight hours
later.
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Moreover, the Special Master properly determined Respondent failed to show an
alternative cause. The Special Master fully considered the different medical theories offered by
each side’s experts and concluded Petitioners’ experts were more credible. Accordingly, the
Court DENIES Respondent’s Motion for Review, ECF No. 108, and SUSTAINS the Special
Master’s Decision. ECF No. 106. The Clerk of the Court shall enter judgment for Petitioners
accordingly.
IT IS SO ORDERED.
s/ Carolyn N. Lerner
CAROLYN N. LERNER
Judge
23

================================================================================
DOCUMENT 4: USCOURTS-cofc-1_15-vv-01526-cl-extra-11306193
Date issued/filed: 2026-04-06
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10838850
--------------------------------------------------------------------------------
           In the United States Court of Federal Claims
                                    OFFICE OF SPECIAL MASTERS
                                             No. 15-1526V
                                         Filed: March 11, 2026

    * * * * * * * * * * * * * *                         *
    ABIGAIL SIMS and DANIEL SIMS, on                    *
    behalf of their deceased daughter, A.E.S.,          *
                                                        *
                   Petitioner,                          *
    v.                                                  *
                                                        *
    SECRETARY OF HEALTH                                 *
    AND HUMAN SERVICES,                                 *
                                                        *
             Respondent.                                *
    * * * * * * * * * * * * *                      *    *

Michael G. McLaren, Esq., Black McLaren, et al., PC, Memphis, TN, for petitioner.
Voris E. Johnson, Esq., US Department of Justice, Washington, DC, for respondent.

                         DECISION ON ATTORNEYS’ FEES AND COSTS 1

Roth, Special Master:

        On December 15, 2015, Abigail and Daniel Sims (“petitioners”) filed a petition on behalf
of their minor daughter, A.E.S., for compensation under the National Vaccine Injury
Compensation Program. 2 Petitioners alleged that A.E.S. died on December 16, 2013, as a result of
the Pediarix (DTaP/IPV/HepB), Hib, PCV13, and RotaTeq vaccinations she received that day.
Petition, ECF No. 1. Petitioners were found entitled to compensation and a decision awarding
damages issued on January 8, 2025. ECF No. 106.

       On February 7, 2025, respondent filed a motion for review of the ruling on entitlement.
ECF No. 108. The matter was assigned to Judge Lerner, who ordered both parties to file
supplemental briefs. ECF Nos. 110, 112. Both parties filed their respective briefs on May 23, 2025.


1
  Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims' website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means
the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b),
Petitioners have 14 days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. If, upon review, the undersigned finds that the identified material fits
within this definition, such material will be redacted from public access.
2
  National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation,
all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2018).
ECF Nos. 113-14. On June 10, 2025, Judge Lerner issued an order denying the motion for review.
ECF No. 115. Judgment entered the following day. ECF No. 116.

         On November 7, 2025, petitioners filed the instant motion for attorneys’ fees and costs
requesting $6,416.10 in personal costs and, on behalf of counsel, a total of $146,029.18,
representing $143,953.10 in attorneys’ fees and $2,076.08 in costs. Motion for Fees, ECF No. 120.
Respondent filed his response on November 12, 2025, advising he was satisfied the statutory
requirements for an award of fees and costs are met. Response, ECF No. 121. Petitioners did not
file a reply.

       After consideration, petitioners’ motion is GRANTED in part.

                                       I.     Legal Framework

        The Vaccine Act permits an award of “reasonable attorneys’ fees” and “other costs.” §
15(e)(1). If a petitioner succeeds on the merits of his or her claim, the award of attorneys' fees is
automatic. Id.; see Sebelius v. Cloer, 133 S. Ct. 1886, 1891 (2013). However, a petitioner need not
prevail on entitlement to receive a fee award as long as the petition was brought in “good faith”
and there was a “reasonable basis” for the claim to proceed. § 15(e)(1).

        The Federal Circuit has endorsed the use of the lodestar approach to determine what
constitutes “reasonable attorneys' fees” and “other costs” under the Vaccine Act. Avera v. Sec’y of
Health & Human Servs., 515 F.3d 1343, 1349 (Fed. Cir. 2008). Under this approach, “an initial
estimate of a reasonable attorneys' fees” is calculated by “multiplying the number of hours
reasonably expended on the litigation times a reasonable hourly rate.” Id. at 1347–48 (quoting
Blum v. Stenson, 465 U.S. 886, 888 (1984)). That product is then adjusted upward or downward
based on other specific findings. Id.

        Special masters have substantial discretion in awarding fees and may adjust a fee request
sua sponte, apart from objections raised by respondent and without providing petitioners with
notice and opportunity to respond. See Sabella v. Sec’y of Health & Human Servs., 86 Fed. Cl.
201, 209 (2009). Special masters need not engage in a line-by-line analysis of petitioner's fee
application when reducing fees. See Broekelschen v. Sec’y of Health & Human Servs., 102 Fed.
Cl. 719, 729 (2011).

                                            II.   Discussion

       A. Reasonable Hourly Rate

        A “reasonable hourly rate” is defined as the rate “prevailing in the community for similar
services by lawyers of reasonably comparable skill, experience and reputation.” Avera, 515 F.3d
at 1348 (quoting Blum, 465 U.S. at 896 n.11). In general, this rate is based on “the forum rate for
the District of Columbia” rather than “the rate in the geographic area of the practice of petitioner's
attorney.” Rodriguez v. Sec'y of Health & Human Servs., 632 F.3d 1381, 1384 (Fed. Cir. 2011)
(citing Avera, 515 F. 3d at 1349). There is a “limited exception” that provides for attorney's fees
to be awarded at local hourly rates when “the bulk of the attorney's work is done outside the forum


                                                   2
jurisdiction” and “there is a very significant difference” between the local hourly rate and forum
hourly rate. Id. This is known as the Davis County exception. See Hall v. Sec'y of Health & Human
Servs., 640 F.3d 1351, 1353 (2011) (citing Davis Cty. Solid Waste Mgmt. & Energy Recovery
Special Serv. Dist. v. U.S. EPA, 169 F.3d 755, 758 (D.C. Cir. 1999)).

        For cases in which forum rates apply, McCulloch provides the framework for determining
the appropriate hourly rate range for attorneys’ fees based upon the attorneys' experience. See
McCulloch v. Sec’y of Health & Human Servs., No. 09–293V, 2015 WL 5634323 (Fed. Cl. Spec.
Mstr. Sept. 1, 2015). The Office of Special Masters has accepted the decision in McCulloch and
has issued a Fee Schedule for subsequent years. 3

      Petitioners request the following hourly rates on behalf of the attorneys and staff who
worked on this case:

                               Name           2022     2023     2024     2025
                               MGM            -        -        $550     $584
                               WEC            $435     $450     $478     $519
                               CJW            $395     $410     $435     $472
                               HGF            -        -        $386     $417
                               Paralegals     $167     $172     $183     $199

       Most of the requested rates are consistent with what the attorneys and paralegals at the firm
have previously been awarded. See, e.g., Cravotta v. Sec'y of Health & Human Servs., No. 23-
2051V, 2025 WL 2452159 (Fed. Cl. Spec. Mstr. July 24, 2025); Sims on behalf of A.E.S. v. Sec'y
of Health & Human Servs., No. 15-1526V, 2023 WL 2234265 (Fed. Cl. Spec. Mstr. Feb. 27,
2023); Gregory v. Sec'y of Health & Human Servs., No. 21-1857V, 2025 WL 1588104 (Fed. Cl.
Spec. Mstr. Apr. 23, 2025).

        However, the rates requested for HGF (Hallie Flanagan) require adjustment. Petitioners
stated in their motion that Ms. Flanagan began practicing law at a firm in 2019. She joined
counsel’s firm in 2023 and provided “general assistance with vaccine injury cases”. Ms. Flanagan
attended the Vaccine Injury Program Bar Conference in 2024, and she was admitted to practice
before the U.S. Court of Federal Claims in 2025. Petitioners argued Ms. Flanagan should be
awarded $386 for 2024, as she had five years’ experience in practice and this rate fell within the
range established in the Fee Schedule for attorneys with 4-7 years’ experience in 2024 ($305 -
$407). They also argued that Ms. Flanagan should be awarded $417 for 2025, as she had six years’
experience and this rate fell within the range established in the Fee Schedule for attorneys with 4-
7 years’ experience in 2025 ($328 - $438). Motion for Fees at 8-9.

       Though the requested rates fall within the ranges established in the Fee Schedule, Ms.
Flanagan did not have demonstrated vaccine experience in 2024 and was not admitted to practice

3
  The OSM Attorneys’ Forum Hourly Rate Fee Schedules are available on the U.S. Court of Federal Claims website
at OSM Attorneys' Forum Hourly Rate Fee Schedules | Court of Federal Claims | United States. The hourly rates
contained within the schedules are updated from the decision in McCulloch v. Sec’y of Health & Human Servs., No.
09-293V, 2015 WL 5634323 (Fed. Cl. Spec. Mstr. Sept. 1, 2015).

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before this Court until 2025. 4 The rates at the higher end of the established ranges are generally
reserved for “comparably experienced counsel who also have lengthy experience in the Program.”
Carpenter v. Sec’y of Health & Human Servs., No. 21-2192V, 2023 WL 9119058, at *2 (Fed. Cl.
Spec. Mstr. Dec. 5, 2023) (emphasis in original) (citing McCulloch, 2015 WL 5634323, at *17);
Davis v. Sec’y of Health & Human Servs., No. 21-2090V, 2025 WL 1927508, at *2 (Fed. Cl. Spec.
Mstr. June 13, 2025) (same). Given her lack of experience in the Program, it is not appropriate to
award Ms. Flanagan rates on the higher end of the experience ranges. Thus, I find it reasonable to
compensate Ms. Flanagan at the rates of $336 for 2024 and $372 for 2025. Both rates fall within
the ranges established in the Fee Schedule and reflect Ms. Flanagan’s years of practice along with
her experience in the Vaccine Program. The increased rate for 2025 reflects her additional
experience in the practice of law in general, experience in the Vaccine Program specifically, and
admission to the Court. Applying the reduced hourly rates to Ms. Flanagan’s hours results in a
reduction of $2,931.50 in fees awarded. 5

         B. Hours Reasonably Expended

         Attorneys’ fees are awarded for the “number of hours reasonably expended on the
litigation.” Avera, 515 F.3d at 1348. Counsel should not include in their fee requests hours that are
“excessive, redundant, or otherwise unnecessary.” Saxton ex rel. Saxton v. Sec'y of Health &
Human Servs., 3 F.3d 1517, 1521 (Fed. Cir. 1993) (quoting Hensley v. Eckerhart, 461 U.S. 424,
434 (1983)). “Unreasonably duplicative or excessive billing” includes “an attorney billing for a
single task on multiple occasions, multiple attorneys billing for a single task, attorneys billing
excessively for intra office communications, attorneys billing excessive hours, [and] attorneys
entering erroneous billing entries.” Raymo v. Sec'y of Health & Human Servs., 129 Fed. Cl. 691,
703 (2016). While attorneys may be compensated for non-attorney-level work, the rate must be
comparable to what would be paid for a paralegal or secretary. See O'Neill v. Sec'y of Health &
Human Servs., No. 08–243V, 2015 WL 2399211, at *9 (Fed. Cl. Spec. Mstr. Apr. 28, 2015).
Clerical and secretarial tasks should not be billed at all, regardless of who performs them. See, e.g.,
McCulloch, 2015 WL 5634323, at *26. Hours spent traveling are ordinarily compensated at one-
half of the normal hourly attorney rate. See Scott v. Sec'y of Health & Human Servs., No. 08–756V,
2014 WL 2885684, at *3 (Fed. Cl. Spec. Mstr. June 5, 2014) (collecting cases). And “it is
inappropriate for counsel to bill time for educating themselves about basic aspects of the Vaccine
Program.” Matthews v. Sec'y of Health & Human Servs., No 14–1111V, 2016 WL 2853910, at *2
(Fed. Cl. Spec. Mstr. Apr. 18, 2016). Ultimately, it is “well within the Special Master's discretion
to reduce the hours to a number that, in [her] experience and judgment, [is] reasonable for the work
done.” Saxton, 3 F.3d at 1522. In exercising that discretion, special masters may reduce the number
of hours submitted by a percentage of the amount charged. See Broekelschen, 102 Fed. Cl. at 728–
29 (affirming the Special Master’s reduction of attorney and paralegal hours); Guy v. Sec'y of
Health & Human Servs., 38 Fed. Cl. 403, 406 (1997) (same).




4
  Having not yet been admitted to the bar of the U.S. Court of Federal Claims, Ms. Flanagan’s 2024 rate could have
been that of the highest paralegal rate. Nevertheless, she is awarded an attorney rate because she attended the vaccine
bar conference that year.
5
  $336 x 6.7 hours = $2,251.20; $372 x 57.7 = $21,464.40; $26,647.10 (fees at requested rates) - $23,715.60 (fees at
awarded rates) = $2,931.50.

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        Upon review of the billing records, the entries adequately describe the work performed,
and the time billed corresponds with that work. The bulk of the time was spent preparing and
briefing for the motion for review. Additionally, petitioners appropriately requested payment for
hours billed after their second motion for interim fees was filed. No entries appear objectionable,
nor did respondent raise any objection. Apart from the slight reduction to adjust Ms. Flanagan’s
hourly rates, the requested fees are awarded.

         C. Reasonable Costs

         Like attorneys’ fees, a request for reimbursement of attorneys’ costs must be reasonable.
Perreira v. Sec’y of Health & Human Servs., 27 Fed. Cl. 29, 34 (Fed. Cl. 1992). Petitioners request
a total of $2,076.08 in costs on behalf of counsel. Motion for Fees, Exhibit 2. This amount includes
costs associated with postage, photocopies, and computer-assisted research. Id. These costs are
routinely awarded in vaccine cases and are supported by the receipts filed.

        Petitioners also request $6,416.10 in personal costs for mileage to meet with their attorneys,
as well as probate fees and expenses to establish an estate on behalf of their deceased daughter for
these proceedings. Motion for Fees, Exhibit 3. These costs are reasonable and supported by
adequate documentation.

         Petitioners are awarded $2,076.08 in costs incurred by counsel and $6,416.10 in personal
costs.

                                              III.    Conclusion

        Based on the foregoing, petitioners’ Motion for Attorneys’ Fees and Costs is GRANTED
in part. Petitioners are hereby awarded a total of $149,513.78, representing $141,021.60 in
attorneys’ fees, $2,076.08 in costs incurred by counsel, and $6,416.10 in costs incurred by
petitioners, to be paid through an ACH deposit to petitioners’ counsel’s IOLTA account for
prompt disbursement.

         The Clerk of Court is directed to enter judgment in accordance with this decision. 6

         IT IS SO ORDERED.

                                                     s/Mindy Michaels Roth
                                                     Mindy Michaels Roth
                                                     Special Master




6
 Entry of judgment can be expedited by each party’s filing of a notice renouncing the right to seek review. Vaccine
Rule 11(a).

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