VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_21-vv-01601
Package ID: USCOURTS-cofc-1_21-vv-01601
Petitioner: Cristian Garcia
Filed: 2021-07-22
Decided: 2025-06-27
Vaccine: Tdap
Vaccination date: 2020-10-02
Condition: anti-N-methyl-D-aspartate receptor encephalitis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Cristian Garcia, a 26-year-old adult, received a Tdap vaccine on October 2, 2020. Eighteen days later, he experienced a seizure, which marked the onset of his illness. He subsequently developed worsening confusion and other symptoms, leading to a diagnosis of anti-N-methyl-D-aspartate receptor (anti-NMDAR) encephalitis. Mr. Garcia filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that the Tdap vaccine caused his condition. The case proceeded as an off-Table claim, meaning Mr. Garcia had to prove causation. Petitioner's expert, Dr. Kristen Babinski, proposed several theories for how the Tdap vaccine could cause anti-NMDAR encephalitis, including exacerbation of underlying autoimmune disease, re-stimulation of pre-existing T and B cell clones, and a mechanism involving microRNAs. Respondent's expert, Dr. Stephen Hedrick, a molecular biologist, contested these theories, arguing that the available data did not support a causal link between the Tdap vaccine and anti-NMDAR encephalitis. He highlighted the low number of reported cases in VAERS and the lack of evidence that the Tdap vaccine could weaken the blood-brain barrier. After a hearing, the Chief Special Master denied entitlement. The decision found that Petitioner failed to establish a sound and reliable medical theory connecting the Tdap vaccine to anti-NMDAR encephalitis (Althen prong one) and did not demonstrate a logical sequence of cause and effect showing the vaccine caused the injury (Althen prong two). The court later denied Petitioner's motion for review, affirming the Special Master's decision. Mr. Garcia was not compensated.

Theory of causation field:
Tdap vaccine on October 2, 2020, age 26, followed 18 days later by seizure, confusion, and anti-NMDAR encephalitis. DENIED. Petitioner Cristian Garcia relied on Dr. Kristen Babinski, who proposed vaccine-triggered autoimmune mechanisms including exacerbation of underlying autoimmune disease, restimulation of immune clones, and microRNA effects. Respondent's Dr. Stephen Hedrick disputed biologic plausibility and causal support. Chief Special Master Corcoran denied entitlement January 3, 2025; Chief Judge Kaplan affirmed June 27, 2025.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_21-vv-01601-0
Date issued/filed: 2025-05-30
Pages: 25
Docket text: PUBLIC DECISION (Originally filed: 01/03/2025) regarding 64 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made.
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Case 1:21-vv-01601-EDK Document 69 Filed 05/30/25 Page 1 of 25
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 21-1601V
* * * * * * * * * * * * * * * * * * * * * * * * *
*
CRISTIAN GARCIA, * Chief Special Master Corcoran
*
Petitioner, * Filed: January 3, 2025
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Ronald C. Homer, Conway, Homer, P.C., Boston, MA, for Petitioner.
Felicia Langel, U.S. Dep’t of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION1
On July 22, 2021, Cristian Garcia filed a petition for compensation under the National
Vaccine Injury Compensation Program (the “Vaccine Program”). 2 Petitioner alleges that he
experienced anti-N-methyl-D-aspartate receptor encephalitis (“anti-NMDAR encephalitis”) as a
result of a tetanus-diphtheria-acellular pertussis (“Tdap”) vaccine administered to him on October
2, 2020. See generally Petition (ECF No. 1).
A hearing in the matter was held on August 26, 2024. Now, after review of the complete
medical record as filed, expert reports, medical/scientific literature, and the parties’ briefs, I deny
entitlement. Petitioner has not demonstrated it is likely that the Tdap vaccine can cause this specific
form of encephalitis.
1 Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information
furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its present form. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).
All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.

Case 1:21-vv-01601-EDK Document 69 Filed 05/30/25 Page 2 of 25
I. Factual Background
Vaccination and Initial Seizure
Mr. Garcia was twenty-six years old when he received the Tdap vaccine on October 2,
2020. Ex. 1 at 4. He had no history of neurological concerns (Ex. 7 at 7–14), and there is no record
evidence of any immediate post-vaccination issues or symptoms.
On October 20, 2020 (eighteen days post-vaccination), Petitioner appeared to suffer a
seizure while driving, making some vocalizations before becoming unresponsive and exhibiting
shaking movements. Ex. 4 at 31. The emergency medical services (“EMS”) records state that “[t]he
patient was disoriented and could not answer my questions appropriately, he did not know the year
or the day of the week . . .. All signs pointed that the patient had experienced a seizure.” Ex. 3 at
5–6. Petitioner was transported to the Layton Hospital Emergency Department (“ED”) in Layton,
Utah. Ex. 3 at 5–6; Ex. 4 at 31. There, he seemed alert but “a bit foggy,” and he displayed normal
vital signs and no neurological deficits. Id. Petitioner, however, reported recent headaches at the
back of his head, although no fever or neck pain. Id. A head CT yielded normal results, and
Petitioner was diagnosed with a seizure and referred to outpatient neurology. Ex. 4 at 31–33; Ex.
7 at 21.
A little less than a week later, Petitioner had a telehealth visit on October 26, 2020, with
neurologist Mohamed Sadiq, M.D. Ex. 7 at 21. He informed Dr. Sadiq that since his seizure, he
had been experiencing “intermittent episodes of confusion and impaired comprehension.” Id. Dr.
Sadiq diagnosed Petitioner with a generalized seizure and attempted to expedite the obtaining of a
brain MRI and electroencephalogram (“EEG”).3 Id. at 16.
A brain MRI was performed at Layton Hospital’s ED that same day. Ex. 4 at 11. Although
alert, Petitioner appeared to have an “odd affect” and was moderately confused. Id. The imaging-
yielded normal results, and a lumbar puncture revealed a normal total protein and high white blood
cell count. Id. at 11, 16, 18. However, because of Petitioner’s worsening symptoms, the ED treater
opted to evaluate him for a possible infectious meningitis/encephalitis and administered Acyclovir,
an antiviral medication. Id. at 11. To that end, Petitioner was transferred on October 26th to McKay-
Dee Hospital (“McKay-Dee”) in Ogden, Utah, for further evaluation and EEG monitoring. Id.; Ex.
3 at 8.
3 “Electroencephalogram” is defined as “a recording of the potentials on the skull generated by currents emanating
spontaneously from nerve cells in the brain. The normal dominant frequency of these potentials is about 8 to 10 cycles
per second and the amplitude about 10 to 100 microvolts. Fluctuations in potential are seen in the form of waves,
which correlate well with different neurologic conditions and so are used as diagnostic criteria.”
Electroencephalogram, Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=15813&searchterm=electroencephalogram (last visited Jan.
3, 2025).
2

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Hospitalization and Progression of Symptoms
Upon admission to McKay-Dee, Petitioner was evaluated by hospitalist Kory Anderson,
M.D. Ex. 6 at 22. This record takes specific note of the fact that Petitioner had received his first
dose of the Tdap vaccine three weeks before. Id. Dr. Anderson also noted in the contemporaneous
record from this visit that “[i]t looks like [headache] is common with TDAP >10% of the time, but
not sure if 3 weeks out it is. It looks like < 1% of the time [TDAP] can cause a meningitis and/or
seizure—again, not sure if 2 weeks+ from the vaccine if it would cause such an issue.” Id. at 27.
Despite this vaccine-oriented speculation, Dr. Anderson diagnosed Petitioner with viral meningitis
of “[u]nclear source,” and a seizure disorder “likely due to acute infection.” Id.
While at McKay-Dee, Petitioner also saw a different neurologist, Dr. John Greenert. Dr.
Greenert observed that Petitioner’s EEG results were normal, as well as the fact that Petitioner had
experienced two episodes of confusion since admission, including one in which he “seemed to
have automatisms, fidgeting with his fingers, picking at his clothes, or making slight tongue
movements.” Ex. 6 at 31–33. Dr. Greenert diagnosed Petitioner with “suspected viral
meningoencephalitis,” although he also took note of Petitioner’s receipt of the Tdap vaccine in
early October. Id. at 33, 34.
On October 28, 2020, Dr. Greenert re-evaluated Petitioner after he had become acutely
agitated overnight, appearing confused and throwing things around the room. Ex. 15 at 64. Dr.
Greenert noted that Petitioner’s wife “continue[d] to feel this [was] all due to the Tdap shot.” Id.
Petitioner’s blood testing yielded normal results, however, as was an autoimmune serum panel
(which included testing for the NMDAR antibody), and a whole-body CT scan was negative for
malignancy. Dr. Greenert started Petitioner on a continuous EEG to monitor for seizure activity.
Id. at 64–67; Ex. 6 at 37–39, 44–45.
The next day (and although a repeat brain MRI had yielded normal results), Petitioner had
another seizure, was persistently tachycardic, and was confused. Ex. 6 at 20, 41; Ex. 5 at 70.
Petitioner was therefore transferred to the University of Utah Hospital for continued specialized
workup. Id.; Ex. 5 at 2. Medical records from this admission confirmed the presence of ongoing
seizures, and contained a diagnosis of infectious or autoimmune encephalitis, with a secondary
seizure disorder and acute encephalopathy. Ex. 6 at 19, 20. In addition, Petitioner speculated that
his symptoms might be attributable to work and financial stress, although his wife again expressed
a concern “about the role of a Tdap vaccine he received 3 weeks prior.” Ex. 8 at 147. A new
neurologist—Safdar Ansari, M.D.—assessed Petitioner with “new seizure with
encephalopathy/behavior changes in [an] otherwise young person [was] most concerning for an
autoimmune encephalitis after a negative infectious work-up [], such as NMDA encephalitis.” Id.
at 152. Dr. Ansari proposed continuing treatments Petitioner had already been receiving (including
3

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IVIG,4 acyclovir, and anti-seizure medications), repeating a lumbar puncture, and placing
Petitioner on a continuous EEG. Id. at 153.
Confirmation of Anti-NMDAR Encephalitis
While at the University of Utah Hospital, Petitioner was also seen by a specialist—
autoimmune neurologist Justin Abbatemarco, M.D. Dr. Abbatemarco noted in his write-up that
“[Petitioner] had a TDAP vaccination on 10/2 [complicated by] severe arm pain. A few days later,
he noted some generalized myalgias, insomnia, and headaches of which [were] very unusual for
him. No clear fever but [his] wife noted he wanted the room cold at night. These symptoms
persisted until 10/20.” Ex. 8 at 178. Dr. Abbatemarco interpreted Petitioner’s overall clinical
presentation and laboratory findings as “concerning for [an] autoimmune encephalitis (most
specifically NMDAR),” and he added plasma exchange therapy (“PLEX”)5 to the treatment
regimen. Id. at 179.
Lab results subsequently obtained for Petitioner were consistent with Dr. Abbatemarco’s
suspicions. Serum testing initially had revealed for Petitioner an NMDAR antibody titer of 1:10
(reference range: < 1:10), or “high-normal.” Id. at 406. But a repeat lumbar puncture performed
on October 31, 2020, now showed a high white blood cell count and a higher NMDAR antibody
titer of 1:32. Id. at 430–33. Additionally, the encephalopathy-autoimmune analysis of Petitioner’s
cerebrospinal fluid (“CSF”) showed an NMDAR antibody titer of 1:4 (reference range: <1:2). Id.
at 428–29. And the continuous EEG revealed a “delta brush”6—a nonspecific finding that
nevertheless is sometimes seen in NMDAR encephalitis. Id. at 532–33.
By November 2, 2020, the University of Utah Hospital’s neurology critical care unit
attending physician assessed Petitioner with anti-NMDAR encephalitis with “[e]tiology unclear,”
adding that “[Petitioner] did receive tDAP vaccination and there is [a] case report of possible
NMDA encephalitis after tDAP.” Ex. 8 at 162. He was subsequently discharged on November 8,
2020. Id. at 132. The discharge summary noted that “[t]he etiology of [his] NMDA encephalitis
4 “Intravenous Immunoglobulin” is defined as “a pooled antibody, and a biological agent used to manage various
immunodeficiency states and a plethora of other conditions, including autoimmune, infectious, and inflammatory
states.” Intravenous Immunoglobulin (IVIG), National Library of Medicine,
https://www.ncbi.nlm.nih.gov/books/NBK554446/ (last visited Jan. 3, 2025).
5 “Plasma Exchange” is “a procedure in which a machine is used to separate the plasma (the liquid part of the blood)
from the blood cells. After the plasma is separated from the blood cells, the blood cells are mixed with a liquid to
replace the plasma and are returned to the body. Plasma exchange is often done to remove extra antibodies, abnormal
proteins, or other harmful substances from the blood. It may be used to treat certain types of blood disorders,
autoimmune disorders, nervous system disorders, or other conditions. Also called plasmapheresis.” Plasma Exchange,
National Cancer Institute, https://www.cancer.gov/publications/dictionaries/cancer-terms/def/plasma-exchange (last
visited Jan. 3, 2025).
6 “Delta Brush” is defined as a “transient pattern[] characterized by a slow delta wave with superimposed fast activity”
on an EEG. Characteristics and Clinical Significant of Delta Brushes in the EEG of Premature Infants, National
Library of Medicine, https://pmc.ncbi.nlm.nih.gov/articles/PMC6123866/ (last visited Jan. 3, 2025).
4

Case 1:21-vv-01601-EDK Document 69 Filed 05/30/25 Page 5 of 25
[was] unclear,” reiterating statements made by Petitioner’s wife about her views of a vaccine
relationship, but adding that only a single case report seemed to corroborate that possibility. Id. at
135.
Subsequent Treatment
Petitioner had a follow-up visit with another neurologist, Stacey Clardy, M.D., Ph.D., on
November 24, 2020. Ex. 8 at 79. He was noted to be making progress in his recovery and exhibited
no personality changes, but had limited recall of his hospitalization, and was apathetic and anxious.
Id. Petitioner was still on the medication regimen previously set for him while hospitalized, and
he reported that he had not had any additional seizures. Id. In assessing Petitioner and proposing
future treatment, Dr. Clardy also commented on the possible explanation for Petitioner’s illness,
noting that although “[Petitioner’s] TDaP vaccination may have played a role in [his] presentation
given it’s temporal relationship to symptom onset . . . ,7 there is limited evidence/literature on this
topic and given our current understanding of NMDA we do not believe this precipitated his
illnesses. We would recommend staying up-to-date on all vaccinations including a yearly flu
vaccine especially given his immunosuppressed state.” Id. at 84.
In the early spring of 2021, Petitioner experienced a bit of a relapse, characterized by
fatigue and declining cognitive function. Ex. 8 at 18–41. Dr. Abbatemarco in response ordered
additional testing, but a repeat MRI and EEG yielded normal results. Id. Only the lumbar puncture
(which otherwise revealed a normal white blood cell count and total protein) showed a somewhat-
high NMDAR antibody titer of 1:5. Id. That May, Petitioner saw Dr. Clardy again, noting
continued fatigue, apathy, and anxiety, but also that he was not experiencing seizures and
otherwise was working. Ex. 13 at 101. Dr. Clardy deemed his presentation to constitute “a
significant recovery” despite the residual symptoms, adding that greater improvement might take
a year or more. Id. at 104.
The final records filed in this case are from the following year—March 2022, when
Petitioner saw a different neurologist, Suzanne Liu, M.D. Ex. 13 at 4. Petitioner reported that his
energy level and sleep were improved, his work was going well, and he was functioning normally,
although his wife felt his personality and emotions had not recovered. Id. at 5. Further medication
and follow-up with treaters were proposed. Id. at 8–9.
7 Other treaters Petitioner saw around this time also acknowledged the temporal association between Petitioner’s
vaccination and his development of anti-NMDAR encephalitis. See, e.g., Ex. 12 at 21 (documenting December 18,
2020, visit with seizure clinic neurologist Tawnya Constantino, M.D.).
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II. Hearing Testimony
A. Petitioner’s Expert — Dr. Kristen Babinski, M.D., Ph.D.
Dr. Babinski, a neurologist, prepared a single written report and testified at hearing. See
generally Tr. at 5–55; Report, dated Apr. 9, 2023, filed as Ex. 18 (ECF No. 32-1) (“Babinski
Rep.”).
Dr. Babinski received her undergraduate degree in Biochemistry from Colgate University,
her Ph.D. in Biochemistry from Duke University, followed by her medical degree from the
University of North Carolina School of Medicine. Curriculum Vitae, filed as Ex. 19 (ECF No. 32-
2) (“Babinski CV”) at 1; Tr. at 5–6. She then completed an internship at Lenox Hill Hospital,
followed by her residency in Neurology at New York University School of Medicine. Babinski
CV at 1; Tr. at 6. Thereafter, Dr. Babinski completed a fellowship in Multiple Sclerosis
(Neurology) at New York University School of Medicine. Id. She is currently the Director of
Multiple Sclerosis and an Assistant Professor of Neurology at Tufts Medical Center, as well as a
Neurohospitalist at MetroWest Medical Center. Babinski CV at 1–2; Tr. at 6. Over the course of
her career, Dr. Babinski has treated and managed approximately 5,000 patients, a majority of
whom suffer from a central nervous system disorder. Tr. at 7. She is board certified by the
American Board of Neurology and Psychiatry. Babinski CV at 2. Dr. Babinksi admitted, however,
that she has no direct expertise in the topic of immunology. Tr. at 39.
Dr. Babinksi began her testimony with a review of Petitioner’s relevant medical history.
See generally Tr. at 11–15. Based on those records (and more specifically the testing results and
views of contemporaneous treaters), Dr. Babinski opined that Petitioner had been properly
diagnosed with anti-NMDAR encephalitis, according to accepted diagnostic criteria. Id. at 16, 19–
20.
Anti-NMDAR encephalitis, Dr. Babinski maintained, features neuroinflammation in the
brain, and manifests with such symptoms as “seizures, confusion, agitation, speech disturbances,
depressed consciousness, [and] autonomic instability.” Tr. at 16, 18–19; J. Dalmau et al.,
Paraneoplastic Anti-N-methyl-d-aspartate Receptor Encephalitis Associated with Ovarian
Teratoma, 61 Ann Neurol 25 (2007), filed as Ex. 57 (ECF No. 55-8). It is rare and largely impacts
younger individuals, and is most often (i.e., 60 percent of the time) associated with coincident
neoplasms/tumors (which instigate the production of the antibodies responsible for the resulting
encephalitic cross-reaction). Tr. at 17–18. Anti-NMDAR encephalitis can often begin with
nonspecific symptoms such as headache or flu-like malaise, progressing (especially in children
and young men) to seizures. Id. at 18–19. Testing for the specific antibodies to the NMDA receptor
is the “only test” to confirm its existence. Id. at 19.
Dr. Babinski went on to explain anti-NMDAR encephalitis’s pathophysiology. It is
typically characterized as “an immune-mediated disease” propagated by its characteristic
antibodies that attack a specific cortical neuron glutamate receptor. Id.; J. Dalmau et al., An Update
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on Anti-NMDA Receptor Encephalitis for neurologists and Psychiatrists: Mechanisms and
Models, 18 Lancet Neurol 1045, 1051 (2019), filed as Ex. 25 (ECF No. 32-8) (stating that
“[p]athological and immunological evidence exists [showing] that NMDAR antibodies are
synthesized systemically and within the CNS by antibody-producing cells that are able to cross the
blood-brain barrier”). The treatments most effective against it, such as steroids or drug therapies
that impact B cell antibody production, all underscore its inflammatory nature. Tr. at 27–28. The
specific antibodies that drive the disease process (assuming they are generated systemically) cross
the “blood brain barrier” (“BBB”) that protects the central nervous system, binding to NMDAR
and disrupting that receptor’s function. Id. at 20–21, 26. This is what in turn causes the clinical
symptoms associated with this form of encephalitis. Id. For the BBB to be permeable enough to
cross requires the influence of factors sufficient to weaken it, such as cytokines (immune system
messenger cells). Id. at 27.
Vaccination, Dr. Babinski proposed, has been reliably associated with anti-NMDAR
encephalitis. Tr. at 22;8 S. Martin et al., Anti-NMDA Receptor Encephalitis and Vaccination: A
Disproportionality Analysis, 13 Front Pharmocol 1 (2022), filed as Ex. 36 (ECF No. 32-19)
(“Martin”). Martin, for example, revealed that the World Health Organization’s
“pharmacovigilance database”9 (akin to VAERS10 reporting in the United States) had revealed a
number of complaints of anti-NMDAR encephalitis after receipt of various vaccines—with a
statistically significant association for the Tdap vaccine in particular. Tr. at 30–31; Martin at 1.
Martin also considered a number of case reports underscoring the purported association. Tr. at 31.
Dr. Babinski contrasted the evidentiary value of case reports with the purported difficulty of
obtaining a more scientifically-reliable large-scale epidemiologic study, maintaining that such a
study would not be feasible given the number of subjects required. Tr. at 33 (stating “you’d
probably had to develop a study with a few hundred million patients, which would be an impossible
task”). On cross, however, Dr. Babinski admitted that Martin’s showing of an association did not
involve the form of the Tdap vaccine at issue in this case. Id. at 51–52. And she accepted that its
8 On cross-examination, Dr. Babinski admitted that the package insert for Tdap did not include anti-NMDAR
encephalitis as a contemplated adverse event. Tr. at 41–44. Of course, the Program does not typically give great weight
to package inserts, pro or con causation, since marketing licensure testing results are not meaningful evidence of
causation either way. Zumwalt v. Sec’y of Health & Hum. Servs., No. 16-994V, 2019 WL 1953739, at *17 (Fed. Cl.
Spec. Mstr. Mar. 21, 2019) ) (“ …package inserts are generally afforded very little weight in Vaccine Program cases
as proof of causation”), mot. for review den’d, 146 Fed. Cl. 525 (2019).
9 “VigiBase” is “the WHO global database of adverse event reports for medicines and vaccines. It is the largest
database of its kind in the world, with around 40 million reports of suspected adverse effects of medicines submitted
by member countries of the WHO PIDM since 1968. It is continuously updated with incoming reports.” About
VigiBase, Uppsala Monitoring Centre, https://who-umc.org/vigibase/ (last visited Jan. 3, 2025).
10 VAERS “is a national early warning system to detect possible safety problems in U.S.-licensed vaccines” and
“accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.”
About VAERS, Vaccine Adverse Event Reporting System, https://vaers.hhs.gov/index.html (last visited Jan. 3, 2025).
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findings were better at identifying a “signal” pointing toward a possible causal relationship than
as constituting reliable proof of causation. Id. at 52.
Dr. Babinski further proposed that vaccines might be capable of stimulating existing, but
nonspecific, T and B cell lymphocyte clones, encouraging the production of the relevant
antibodies. Tr. at 23–24; D. Endres et al., Psychiatric Presentation of Anti-NMDA Receptor
Encephalitis, 10 Frontiers Neurology 1, 7 (2019), filed as Ex. 27 (ECF No. 32-10) (“Endres”).
Endres is a case report involving a 22-year-old female patient who developed an acute polymorphic
psychotic episode three days after receiving a booster Tdap-IPV vaccination. Its authors suggested
the vaccination physiologically led to stimulation of “[p]reexisting specific T- and B-lymphocyte
clones . . . ., causing them to proliferate and leading to excessive antibody synthesis.” Endres at 7.
The relevant autoantibodies can also be detected in a meaningful minority number of healthy
subjects, as well as individuals with distinguishable neurological conditions like Parkinson’s
disease. Tr. at 25–26; C. Hammer et al., Neuropsychiatric Disease Relevance of Circulating Anti-
NMDA Receptor Autoantibodies depends on Blood-Brain Barrier Integrity, 19 Molecular
Psychiatry 1 (2013), filed as Ex. 60 (ECF No. 55-11); L. Dahm et al., Seroprevalence of
Autoantibodies against Brain Antigens in Health and Disease, 76 Ann Neurol 82 (2014), filed as
Ex. 56 (ECF No. 55-7). It is theorized that an inflammatory trigger akin to what vaccination
represents (due to its encouragement of cytokine production) would be sufficient to “restimulate
the B cells” responsible for the anti-NMDAR antibodies. Tr. at 28. The same cytokines could (and
at the same time) weaken the BBB sufficient for the autoantibodies to cross it, resulting in anti-
NMDAR encephalitis. Id.
As an alternative mechanism, Dr. Babinski offered the possibility that microRNA11 found
in vaccines might also be a driver of anti-NMDAR encephalitis. Tr. at 29; H. Wang, Anti-NMDA
Receptor Encephalitis and Vaccination, 18 Int J Mol Sci 1 (2017), filed as Ex. 40 (ECF No.49-
21). In effect, Dr. Babinski maintained, certain microRNA particles can play a role in the receptor
binding that result in NMDAR-encephalitis—and a “phylogenetic relationship” had been shown
between one type of microRNA and “the viruses or bacteria specifically used for vaccinations,”
thus suggesting that receipt of a vaccine could lead to the illness in this alternative manner. Tr. at
29.
The same medical record that supported the anti-NMDAR encephalitis diagnosis also, in
Dr. Babinski’s view, corroborated the contention that Petitioner’s disease was due to vaccination.
That record showed that Petitioner had no pre-vaccination medical issues, developing disease only
in the wake of vaccination. Tr. at 36. Contemporaneous treaters also seemed to take note of at least
11 “microRNA” is defined as “any of a number of very small (20–22 nucleotides) RNA molecules that act as negative
regulators of gene expression by binding to specific segments of messenger RNA, thus interfering with translation.
MicroRNAs are important in the regulation of cellular development, differentiation, proliferation, apoptosis, and the
stress response; abnormalities of miRNA expression are involved in the development of malignancies.” microRNA,
Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=31439&searchterm=microRNA (last visited Jan. 3, 2025).
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the temporal relationship between vaccination and disease here, and there was no other explanation
for Petitioner’s illness (like a detected teratoma/tumor or known infectious cause). Id. at 36–37.
And the timeframe in which Petitioner’s initial, non-specific symptoms (myalgia, headaches) first
appeared—a few days post-vaccination—was consistent with literature (again, largely case reports
finding onset after vaccination). Id. at 37.
Besides setting forth her opinion, Dr. Babinski took some time to identify deficiencies she
saw in the contentions of Respondent’s expert (Dr. Stephen Hedrick). For example, she disputed
the argument that data about predicted number of instances of anti-NMDAR encephalitis (when
compared to the number of Tdap vaccines administered) was meaningful. Tr. at 34–36. She
proposed that Dr. Hedrick had actually miscalculated the predicted incidence of Tdap vaccine-
caused anti-NMDAR encephalitis—and when done correctly (especially given the rarity of the
injury), the adverse events reporting data relied upon confirmed an association. Id. at 35. At the
same time, Dr. Babinski accepted that VAERS reporting (from which these data were derived)
was causally unreliable, at least since not all adverse events were likely reported. Id. at 36.12
On cross, Dr. Babinski admitted that she had mainly relied on case reports to bulwark her
proposed mechanism of vaccines restimulating B-cells to produce autoantibodies (and hence in
the context of an “underlying systemic autoimmune disease”), but that none of those reports
directly involved the Tdap vaccine and anti-NMDAR encephalitis. Tr. at 46. Only one case report,
Endres, involved an individual with preexisting antibodies to the NMDA receptors, but the
antibodies were only detected in her blood and not her cerebrospinal fluid. Id. at 47. Thus, the
pathogenic antibodies had to come from outside the BBB—but Dr. Babinski could not identify
independent evidence establishing the capacity of the Tdap vaccine to cause weakening of the
BBB in the first place. Id. at 48.
Dr. Babinski further acknowledged that it could not be ascertained from the record whether
Petitioner himself had possessed the relevant antibodies before onset of his disease (and hence
whether he was one of the low percentage of individuals in that category). Tr, at 48–49. Indeed—
Petitioner had initially tested negative for the anti-NMDAR antibodies in his blood on October 28,
2020—after he had manifested initial symptoms. Id.; Ex. 6 at 37–39. But Dr. Babinski emphasized
in response that a test performed two days later was positive—and in any event the titer levels
overall were low, suggesting merely to her that “some of those tests might not have captured the
antibodies,” even though they were likely present (and thus the negative test result was not
necessarily reliable). Tr. at 50; M. Guasp et al., Clinical Features of Seronegative, but CSF
Antibody-Positive, Anti-NMDA Receptor Encephalitis, 3 Neurol. Neuroinflamm. 1 (2020), filed as
12 Of course, Dr. Babinski relied on comparable, semi-self-reported data from WHO databases to support her
contention that there was a Tdap vaccine association. See generally Martin. Petitioner has not demonstrated why one
set of data could produce a reliable determination, whereas another could not, when both collections of data
comparably involve reports of adverse events as opposed to confirmed events.
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Ex. 59 (ECF No. 55-10) (concluding that “NMDAR antibodies are not detected in the serum of
15% of the patients with anti-NMDAR encephalitis”).
Finally, when asked why Petitioner tested negative initially for the anti-NMDAR
antibodies at the outset of his late-October hospitalization (when his disease process was likely
already in swing), Dr. Babinski maintained it was possible damage from the antibodies was
attributable to their production “intrathecally” (meaning within the space between the spinal cord
and its covering membranes), with antibodies thereafter leaking systemically into the blood from
there, but in titers too low to be measured. Tr. at 57.13 (Of course, this would mean a disease
process initiated non-systemically was driving the disease, inconsistent with Petitioner’s theory of
vaccine-caused antibodies generated in the periphery, and then finding their way into the central
nervous system).
B. Respondent’s Expert — Dr. Stephen Hendrick, Ph.D.14
Dr. Hedrick is a molecular biologist and chemist with expertise in immunology, and he
offered a single written report along with his testimony. See generally Tr. at 61–130; Report, dated
Feb. 29, 2024, filed as Ex. B (ECF No. 41-1) (“Hedrick Rep.”). Although he accepted Petitioner’s
anti-NMDAR diagnosis, he denied the illness had been vaccine-caused (or could be).
Dr. Hedrick received his undergraduate degree in Biology and his Ph.D. in Molecular
Biology and Biochemistry at the University of California, Irvine. Curriculum Vitae, filed as Ex.
B-1 (ECF No. 41-2) (“Hedrick CV”) at 1; Tr. at 61. Thereafter he completed a postdoctoral
fellowship at the national Institutes of Health. Id.; Hedrick Rep. at 1. He is currently a distinguished
Professor, Emeritus at the University of California, San Diego, having retired from the University
in 2021. Tr. at 61; Hedrick Rep. at 1. Over the course of his career, Dr. Hedrick lectured on
immunology, virology, and the history and biology of epidemic diseases, as well as an
immunology course for the American Association of Immunology. Tr. at 62–63; Hedrick Rep. at
1. He has published approximately 178 peer-reviewed articles, with a particular focus on T cell
immunology. Id.; Hedrick CV at 2–11. Dr. Hedrick, however, does not have the requisite training
in central nervous system illnesses or epidemiology. Tr. at 104.
13 In fact, Dr. Babinski acknowledged that some studies suggested that in the context of anti-NMDAR encephalitis,
“antibody values are usually much higher in the CNS than they are in the serum” (Tr. at 58)—although this could
mean either that it should be expected that blood tests for antibodies will be somewhat equivocal, or that the disease
is more likely to originate in a non-systemic manner (making it less likely to be propagated by vaccine-driven
pathology starting in the periphery).
14 Respondent also filed an expert report from a neurologist, Dr. Jagannadha Avasarala, who provided an opinion
largely specific to the propriety of the proposed diagnosis. See Report, dated Aug. 28, 2023, filed as Ex. A (ECF No.
35-1). But the parties do not dispute that Petitioner experienced anti-NMDAR encephalitis, and Respondent therefore
did not call Dr. Avasarala to testify. As a result, I do not include in this Decision a summary of Dr. Avasarala’s opinion.
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Dr. Hedrick characterized anti-NMDAR encephalitis as a chronic autoimmune disease
with certain known etiologies, such as tumors or other neoplasias, or “neurotropic viruses” capable
of causing nerve inflammation, like the herpes virus. Tr. at 67, 128.15 Many cases, however, have
no known explanation. Id. at 68. In either case, antigens to the NMDA receptors would be
generated and interfere with those same receptors. Id. In addition, certain T-helper cells would
assist in the process of generating these antibodies, releasing cytokines that could also “loosen[]”
the BBB. Id. If these processes become chronic, then encephalitis will occur. Id. Dr. Hedrick
acknowledged that anti-NMDAR encephalitis is antibody-mediated and hence autoimmune in
nature. Id. at 103, 107, 122. And he accepted that genetic susceptibility and environmental factors
could play a role in its development. Id. at 107.
It made sense to Dr. Hedrick that Petitioner tested positive for the anti-NMDA antibodies.
Indeed (and echoing Dr. Babinski) he noted that even healthy people have tested positive for them
(although he explained that the presence of the antibodies was likely an artifact of the innate
immune response, and could therefore be differentiated from the kinds of antibodies that would
become pathogenic in driving anti-NMDAR encephalitis). Tr. at 71, 72. Dr. Hedrick also deemed
these preexisting antibodies to have limited pathogenic potential, if any. Id. at 121.16 But he
maintained that scientific and medical literature showed these antibodies would more often than
not be seen in the cerebrospinal fluid as opposed to the blood serum. Id. at 69. In fact, “the most
pathogenic way of the disease progressing” would be where “secondary lymph node-like
structures, organs, in the central nervous system produce an immune response” localized to the
central nervous system. Id. at 70, 122 (noting the pathogenic character of these kinds of antibodies
when found in the CSF); Hedrick Rep. at 3.
Vaccines, Dr. Hedrick maintained, like Tdap were unlikely to result in anti-NMDAR
encephalitis.17 He referenced his own review of VAERS data, which revealed only four reported
15 This, Dr. Hedrick maintained, explained why Petitioner was immediately administered an antiviral drug during his
October 26, 2020, Layton Hospital ED visit. Ex. 4 at 11.
16 On cross-examination, Petitioner noted that some literature actually supported the pathogenic potential of these
existing autoantibodies. Tr. at 121–22; E. Castillo-Gómez et al., All Naturally Occurring Autoantibodies against the
NMDA Receptor Subunit NR1 have Pathogenic Potential Irrespective of Epitope and Immunoglobulin Class, 22 Mol
Psychiatry 1776 (2017), filed as Ex. 55 (ECF No. 55-6). Dr. Hedrick in response admitted he had not reviewed that
article, but he maintained that IgM-type antibodies (meaning ones recently generated) would not themselves likely be
able to penetrate the BBB. Tr. at 122.
17 Petitioner attempted on cross to establish Dr. Hedrick’s bias against causation, and also to uncover an overly-strict
view of what level of evidence would be sufficient to “prove” a causal relationship in this case. See generally Tr. at
110–13. I do not give great weight to this aspect of his testimony, however, since whether the legal standard for
causation is met is ultimately the product of a special master’s analysis and not merely derived from an expert’s say-
so (meaning the expert’s personal standards for proof do not bind my determinations, or necessarily discredit the
expert). As I have noted in other cases, while an expert may have views about what kinds or amounts of evidence are
needed to convince them personally of a causal relationship, those views are not a substitute for the Program’s “more
likely than not” standard—and therefore experts are not discredited merely because they demand a higher level of
proof than the Program does. At worst, restrictive views on such matters might lead to giving the expert’s opinion less
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cases of anti-NMDAR encephalitis after receipt of the Tdap vaccine, derived from thirty years of
data. Tr. at 91–92.18 The “signal” of a relationship should have shown up if there were even a
possible association. Id. at 92, 97.19 Dr. Hedrick acknowledged, however, that Respondent’s own
diagnostic expert (who did not testify at hearing) had seemed to concede that anti-NMDAR
encephalitis could be vaccine-associated (or at least a factor increasing the risk of encephalitis),
although Dr. Hedrick attributed this view to an overreliance on temporality with vaccination. Id.
at 119–20.
Dr. Babinski’s reference to Martin was deemed unpersuasive by Dr. Hedrick. He argued
that the sample considered in Martin consisted of self-reported adverse events (equivalent to
VAERS reports), and was therefore not likely representative of the total body of individuals with
anti-NMDAR encephalitis, since the percentage of individuals considered to possess the relevant
antibody did not conform to the expected proportion. Tr. at 93–95; Martin at 3. Martin’s actual
findings relevant to this claim (development of anti-NMDAR encephalitis with DTP-Polio
vaccination occurring in only 8 out of 51 individuals) was also likely incorrect, or too small overall
to be meaningful. Tr. at 94. And Martin’s authors themselves had disclaimed that their findings
had causal significance. Martin at 5. Dr. Hedrick allowed, however, that Martin noted the likely
under-reporting of an anti-NMDAR diagnosis (although he maintained that this actually meant
that the likelihood of vaccine-induced encephalitis was even lower). Tr. at 116–18.
There was alternative evidence also suggesting a non-vaccine-encephalitis relationship, in
Dr. Hedrick’s view. Tr. at 98–99; N. Klein et al., Post-Marketing Safety Evaluation of a Tetanus
Toxoid, Reduced Diphtheria Toxoid and 3-Component Acellular Pertussis Vaccine Administered
to a Cohort of Adolescents in a United States Health maintenance Organization, 29 Pediatric
Infectious Disease Journal 613, 617 (2010), filed as Ex. A-4 (ECF No. 35-5) (“Klein”). Klein
studied 13,427 individuals, aged ten to eighteen-years old, who received the Tdap vaccine as a part
of their routine health care, but observed no increased risk for medically-attended neurologic
events, medically-attended hematologic events, or allergic reactions, as well as no increased risk
for new onset chronic illnesses. Klein at 617. On cross-examination, however, Dr. Hedrick
admitted that Klein might not be sufficiently powered to detect the kind of rare occurrence that a
vaccine injury would represent (especially with regard to the background rate for anti-NMDAR
encephalitis in the general population). Tr. at 114–16.
weight (just as an overly-generous view of what is needed to establish causation—for example, an over-reliance on a
vaccine’s temporal relationship with an injury—would also be discounted).
18 On cross-examination, Dr. Hedrick admitted that anti-NMDAR encephalitis was not described by medical science
before 2007—meaning that earlier-in-time VAERS reports logically would not have referenced it as an adverse event.
Tr. at 109. But he maintained that his conclusions about the limited VAERS reporting of an association were still
reliable, since his search had focused merely on the claim of a post-vaccine “encephalitis.” Id.
19 Dr. Hedrick did also admit, however, that VAERS data itself is limited by its self-reporting quality, as well as the
fact that not all medical providers are aware of this reporting system. Tr. at 96.
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Dr. Hedrick also questioned whether Petitioner had offered sufficient reliable evidence to
establish cytokines upregulated solely due to vaccination could weaken the BBB. Tr. at 74; W.
Banks, Blood-Brain Barrier Transport of Cytokines: A Mechanism for Neuropathology, 11 Curr
Pharm Des. 973 (2005), filed as Ex. 53 (ECF No. 55-4); J. Roth et al., Signaling the Brain in
Systemic Inflammation: Role of Sensory Circumventricular Organs, 1 Front Biosci 290 (2004),
filed as Ex. 67 (ECF No. 55-18). At most, certain cytokine-encouraging T cells (T helper cells in
particular) might cause the production of the type of cytokines capable of allowing weakening of
the BBB, but their activation would most likely occur in the presence of “acute viral infections.”
Tr. at 75. Otherwise, the BBB was not subject to being “broken down routinely on a systemic
basis,” and not in reaction to a “mild immune insult” attributable to a vaccination.” Id. at 75–76.
More specifically, the Tdap vaccine was not itself likely to cause the production of the
specific kinds of cytokines implicated in BBB breakdown. The T-helper cells most associated with
BBB weaking, he maintained, would not be stimulated by the Tdap vaccine’s aluminum adjuvant.
Tr. at 76. Rather, the T-helper cell this adjuvant stimulates leads to the production of other
cytokines “not thought to be inflammatory to break down the [BBB].” Id.; Hedrick Rep. at 3. The
Tdap vaccine’s actual antigenic components would not themselves cause this cytokine production.
Tr. at 76. And Dr. Hedrick could identify no other reliable evidence supporting the conclusion that
a routine immunization would likely lead to BBB breakdown. Id. at 84–85.
Dr. Hedrick agreed on cross-examination that pro-inflammatory cytokines were otherwise
involved in BBB breakdown, but denied that a systemic source for them would result in this
occurrence. Tr. at 125; A. Iwasaki, Immune Regulation of Antibody Access to Neuronal Tissues,
23 Trends Molecular Medicine 227 (2017), filed as Ex. B-15 (ECF No. 41-16). He also allowed
that even if vaccines did not themselves directly stimulate production of the relevant cytokines,
the cytokines they did stimulate could promote T-helper cells responsible for manufacture of other
cytokines associated with BBB breakdown. Tr. at 126–27; H. Li et al., Aluminum Hydroxide
Adjuvants Activate Caspase-1 and Induce IL-1ß and IL-18 Release, 178 J. Immunology 5271,
5275 (2007), filed as Ex. B-18 (ECF No. 41-19) (finding IL-1ß to specifically promote CD4+ T-
cell responses).
The same distinction in cytokines capable of BBB attack, Dr. Hedrick maintained,
explained why other vaccines allegedly associated with anti-NMDAR encephalitis could not be
analogized to the Tdap vaccine. For example, Dr. Babinski had proposed in her report that the
inactivated polio virus vaccine had been so associated (pointing to Endres as evidence of it), but
Dr. Hedrick noted that the immune response such a vaccine elicits could not be compared to the
Tdap vaccine. Babinski Rep. at 5; Tr. at 78–79. Vaccines containing inactivated viral particles
were fare more likely to prompt a more comprehensive innate response (since the viruses would
be recognized by existing innate immune system complexes), resulting in the kind of inflammatory
cytokine production proposed to be capable of BBB weakening. Id. (Dr. Hedrick later noted that
Endres did not identify the presence of CSF antibodies in the individual case it discussed—making
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it an outlier, since literature specific to anti-NMDAR encephalitis suggested the relevant antibodies
would nearly always be identified in CSF if also present in the blood serum. Id. at 83–84).
Dr. Hedrick then set forth his understanding of Petitioner’s causation theory and its
different components. One version of the theory, he maintained, assumed that Petitioner had some
“preexisting autoimmunity” systemwide that the Tdap vaccine had exacerbated or re-stimulated.
Tr. at 65, 80. But he deemed testing for the antibody performed on Petitioner was too inconclusive
to conclude that he had in fact likely possessed the anti-NMDAR antibody prior to vaccination. Id.
at 73.
In addition, Dr. Hedrick maintained that literature offered to support this part of the
causation theory was unpersuasive. One article, for example, did not involve the Tdap vaccine, but
instead a straight comparison of certain antibody levels pre- and post-vaccination, without any
baseline comparison to a non-vaccinated sample—thus not permitting the conclusion that the
vaccine was responsible. E. Wiesik-Szewczyk et al., Anti-Influenza Vaccination in Systemic Lupus
Erythematosus Patients: An Analysis of Specific Humoral Response and Vaccination Safety, 29
Clin Rheumatol 605 (2010), filed as Ex. 42 (ECF No. 49-23) (“Wiesik”). The studied sample in
Wiesik, moreover, consisted of lupus patients already known to have “clearly dysregulated
immune systems,” as opposed to the Petitioner in this case. Tr. at 81; Wiesik at 607. And nothing
in the record allowed the conclusion that Petitioner possessed a preexisting autoimmune disease
in any event. Tr. at 88. Another such article involved a live attenuated vaccine not comparable to
Tdap. Id. at 82; M. Farez & J. Correale, Yellow Fever Vaccination and Increased Relapse Rate in
Travelers with Multiple Sclerosis, 68 Arch Neurol 1267 (2011), filed as Ex. 28 (ECF No. 49-9)
(“Farez”). Such a vaccine would inherently have a greater immune-stimulative capacity. Tr. at 82.
And Farez also involved a distinguishable disease as well. Farez at 1267.
Preexisting nonspecific immune cell activation was also, in Dr. Hedrick’s view, not likely
to lead to anti-NMDAR encephalitis after vaccination. He deemed this part of Dr. Babinski’s
theory to involve the concept of “bystander activation,” in which an immune insult (such as
infection—or arguably a vaccine) can cause other existing, nonspecific but autoreactive immune
cells to activate secondarily to an immune stimulation, causing a process that can exacerbate the
effects of the initial antigenic stimulus and thereby breaking tolerance to the antigen. Tr. at 86–87.
While the subsequent process would be autoimmune, bystander activation would not involve
preexisting autoimmune disease. Id. at 88. Dr. Hedrick acknowledged that a variety of cytokines
could encourage secondary bystander activation, but stressed that “you have to have an ongoing
memory response to the antigen you’re talking about” for the process to occur. Id. at 128.
Dr. Hedrick deemed other aspects of Petitioner’s theory lacking. For example, Petitioner’s
prior exposure to components of the Tdap vaccine (say, in receipt of the comparable “DTaP”
version administered to children) did not make it more likely he would have suffered an aberrant
reaction from immune memory, since individuals “get reimmunized all the time” but do not
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routinely experience subsequent reactions after their immune system again confronts a previously-
administered vaccine). Id. at 91; Hedrick Rep. at 4.
On cross-examination, Petitioner asked Dr. Hedrick about an article Respondent had filed
establishing the pathogenic nature of the NMDAR antibodies via an animal model. Tr. at 122; Y.
Ding et al., Anti-NMDAR Encephalitis Induced in Mice by Active Immunization with a Peptide
from the Amino-Terminal Domain of the GluN1 Subunit, 18 J. Neuroinflammation 1 (2021), filed
as Ex. B-8 (ECF No. 41-9) (“Ding”). The researchers in Ding had immunized mice directly with
the relevant antibodies—but also used pertussis toxin to “stimulate the encephalitis.” Tr. at 123;
Ding at 2. Dr. Hedrick noted in response, however, that the results Ding’s authors obtained had to
be attributed more to the use of a special and particularly-strong adjuvant only used in experimental
settings (although he also admitted the symptoms manifested after use of the pertussis toxin). Tr.
at 124. And he stressed that the Tdap vaccine does not contain pertussis toxin, but instead a less
immunogenic toxoid only. Id. at 131.
III. Procedural History
This claim was initiated in the summer of 2021. After completion of “pre-assignment
review” (performed to ensure that sufficient records to analyze the claim have been filed), the
matter was assigned to my docket a year later. Respondent filed his Rule 4(c) Report contesting
entitlement in November 2022, and the parties then obtained and filed expert reports through
March 2024. Prior to then, I set the case for hearing, to be held in August 2024. Trial proceeded
as scheduled, and the claim is now ripe for resolution.
IV. Relevant Legal Standards
A. Petitioner’s Overall Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).20
Petitioner advances a causation-in-fact claim, since anti-NMDAR encephalitis is not an injury
listed on the Vaccine Injury Table.
20 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. App’x. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,
1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec'y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a
medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause
and effect showing that the vaccination was the reason for the injury; and (3) a showing of
proximate temporal relationship between vaccination and injury.”
Each Althen prong requires a different showing. Under Althen prong one, petitioners must
provide a “reputable medical theory,” demonstrating that the vaccine received can cause the type
of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.
Cl. at 245 (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis
in original)).
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In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theory’s scientific or medical plausibility. See Kalajdzic v. Sec’y of Health &
Hum. Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for
a less than preponderance standard” with respect to the first Althen prong deemed “plainly
inconsistent with our precedent” (citing Moberly, 592 F.3d at 1322)); Boatmon v. Sec’y of Health
& Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also Howard v. Sec'y of Health & Hum.
Servs., 2023 WL 4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance
for nearly four decades”), aff’d, 2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). And
petitioners always have the ultimate burden of establishing their overall Vaccine Act claim with
preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir.
2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that
Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine
Act” by a preponderance standard).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Medical records and statements of a treating physician, however, do not per se bind the
special master to adopt the conclusions of such an individual, even if they must be considered and
carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y
of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates
that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and
cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases. The views of treating physicians should be weighed against other, contrary
evidence also present in the record—including conflicting opinions among such individuals.
Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physicians’ conclusions against each other), aff’d,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
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2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must align with the theory of how the relevant vaccine can
cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.
Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,
2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. den’d (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Standards Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [ ] relevant medical and scientific evidence contained in the record,” including
“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained
in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,
injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special
master is then required to weigh the evidence presented, including contemporaneous medical
records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.
1993) (determining that it is within the special master's discretion to determine whether to afford
greater weight to contemporaneous medical records than to other evidence, such as oral testimony
surrounding the events in question that was given at a later date, provided that such determination
is evidenced by a rational determination).
As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as
trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95
Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his
contemporaneous medical records, the special master's decision to rely on petitioner's medical
records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked
propositions explains why such records deserve some weight: (i) sick people visit medical
professionals; (ii) sick people attempt to honestly report their health problems to those
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professionals; and (iii) medical professionals record what they are told or observe when examining
their patients in as accurate a manner as possible, so that they are aware of enough relevant facts
to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,
2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.
Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to
conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are often found to be deserving of greater evidentiary weight than oral testimony—especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
However, the Federal Circuit has also noted that there is no formal “presumption” that
records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health
& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which
compelling oral or written testimony (provided in the form of an affidavit or declaration) may be
more persuasive than written records, such as where records are deemed to be incomplete or
inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any
norm based upon common sense and experience, this rule should not be treated as an absolute and
must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL
6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less
deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)).
Ultimately, a determination regarding a witness's credibility is needed when determining the
weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of
Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,
No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person's failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional's failure to document everything
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reported to her or him; (3) a person's faulty recollection of the events when presenting testimony;
or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,
1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the
factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.
Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).
Under Daubert, the factors for analyzing the reliability of testimony are:
(1) whether a theory or technique can be (and has been) tested; (2) whether
the theory or technique has been subjected to peer review and publication;
(3) whether there is a known or potential rate of error and whether there are
standards for controlling the error; and (4) whether the theory or technique
enjoys general acceptance within a relevant scientific community.
Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).
In the Vaccine Program the Daubert factors play a slightly different role than they do when
applied in other federal judicial settings, like the district courts. Typically, Daubert factors are
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are
used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &
Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts in order to rebut a petitioner’s case.
Where both sides offer expert testimony, a special master's decision may be “based on the
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credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.
Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for
review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on
a particular expert's credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court
has unambiguously explained that special masters are expected to consider the credibility of expert
witnesses in evaluating petitions for compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Both parties filed medical and scientific literature in this case, but not all such items factor
into the outcome of this decision. While I have reviewed all the medical literature submitted, I
discuss only those articles that are most relevant to my determination and/or are central to
Petitioner’s case—just as I have not exhaustively discussed every individual medical record filed.
Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir.
Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision”) (citation
omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir.
2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the
conclusion that it was not considered”).
ANALYSIS
I. Treatment of Anti-NMDAR Claims in the Vaccine Program
Several other special masters have been tasked with determining if anti-NMDAR
encephalitis (or some form of autoimmune encephalitis comparable to it) is attributable to a
vaccine. In the majority of instances, causation has not been found. See, e.g., Faulkenberry v. Sec’y
of Health & Hum. Servs., No. 19-238V, 2024 WL 4892507 (Fed. Cl. Spec. Mstr. Nov. 1, 2024)
(Moran, S.M.); Baxter v. Sec’y of Health & Hum. Servs., No. 16-922V, 2024 WL 1912575 (Fed.
Cl. Spec. Mstr. Mar. 28, 2024) (Oler, S.M.); Baron v. Sec’y of Health & Hum. Servs., No. 14-
341V, 2019 WL 2273484 (Fed. Cl. Spec. Mstr. Mar. 18, 2019) (Young, S.M.); Lehner v. Sec’y of
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Health & Hum. Servs., No. 08-554V, 2015 WL 5443461 (Fed. Cl. Spec. Mstr. July 22, 2015)
(Vowell, C.S.M.). In most such cases, the existence of post-vaccination anti-NMDAR encephalitis
was not disputed, but the claimants could not demonstrate the vaccine was causal.
In Lehner, the petitioners argued that their minor daughter developed an autoimmune
encephalopathy as a result of her receipt of the flu vaccine. Lehner, 2015 WL 5443461, at *1.
Their causation theory involved two parts—first, that voltage-gated potassium channel (“VGKC”)
antibodies are pathogenic, or a marker for autoimmune neurologic disease; and second, that VGKC
antibodies can be caused by an autoimmune response to the flu vaccine. Id. at *42. To bulwark the
notion that the flu vaccine could cause these specific antibodies to occur, Petitioners relied on
several items of medical literature—most of which, however, discussed different types of
autoimmune encephalitis, or different vaccinations than at issue therein. Id. at *48. Moreover, the
Lehner special master noted that none of the child’s treating physicians attributed her receipt of
the flu vaccine as causal of her purported autoimmune encephalopathy, but merely relied on a
temporal relationship between the vaccination and her sudden loss of language and social skills.
Thus, the special master determined that the petitioners had failed to meet their burden under
Althen. Id. at *51.
In Baron, petitioners alleged that their minor daughter developed anti-NMDAR
encephalitis following receipt of the Hepatitis A and flu vaccines. Baron, 2019 WL 2273484, at
*1. These petitioners’ proposed causation theory—“an increase in proinflammatory cytokines
caused by the vaccinations resulted in a breakdown of [the] BBB,” and thus NMDA receptor
antibodies were created as a result of the vaccine-induced immune response—was found to have
failed to meet Althen prong one, because there was insufficient evidence to support the notion that
the vaccines at issue could cause the creation of the specific antibody necessary for anti-NMDAR
encephalitis to occur. Id. at *17. Moreover, contentions regarding the overall role of pro-
inflammatory cytokines in the breakdown of the BBB were not only too vague in delineating how
the mechanism applied to the vaccinee specifically, but were unsupported by any medical literature
demonstrating the relevant vaccines produce the necessary pro-inflammatory cytokines in
sufficient levels to even permeate the BBB. Id. at *19.
The Baxter petitioners argued that a child’s receipt of the MMR and/or varicella vaccines
caused him to develop anti-NMDAR encephalitis via molecular mimicry. Baxter, 2024 WL
1912575, at *18. Petitioners’ expert opined that amino acid peptide homology could be shown
between components of the MMR and varicella vaccines and the NMDA receptor, meaning that
the vaccines could cause the generation of antibodies that would also cross-react against the
NMDA receptors due to similarity. Id. However, the special master found unpersuasive
petitioners’ proffered sequence homologies—noting that much of the medical literature offered in
support of sequence homology between components of the relevant vaccinations and the NMDA
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receptor did not involve anti-NMDAR encephalitis. Id. at *19–21. Thus, Petitioners could not meet
their burden of proof on prong one. Id. at *21.
Finally, in Faulkenberry, a petitioner alleged her minor son had developed anti-NMDAR
encephalitis after receiving the hepatitis A and/or flu vaccines. Faulkenberry, 2024 WL 4892507,
at *1. The petitioner’s expert relied on molecular mimicry as in Baxter, noting that it “is a reliable
and accepted theory within the medical community that persuasively explains how the vaccines .
. . more probably than not could cause the onset of anti-NMDARE.” Id. at *9. However, the special
master found the theory to be too general, and with little to no applicability to the vaccinee’s case,
as well as lacking any specific citations for how the vaccines at issue could lead to the development
of anti-NMDAR encephalitis. Id. Absent any evidence suggesting that the hepatitis A and/or flu
vaccine could generate the necessary antibodies to cause anti-NMDAR encephalitis, causation
could not be preponderantly established. Id. at *16.
II. Petitioner Has Not Carried His Althen Burden of Proof
I deem Petitioner’s showing in this case on the first Althen prong21 to be inadequate, for
reasons similar to why the special masters in the aforementioned cases denied entitlement. It
simply has not been preponderantly demonstrated that the Tdap vaccine can likely produce the
specific anti-NMDAR antibodies thought to cause this form of encephalitis. Dr. Babinski did not
purport to show homology even though she invoked molecular mimicry as a mechanism, and while
she displayed good command of the subject of anti-NMDAR encephalitis, her expertise did not
extend to matters involving purportedly pathogenic immunologic responses that would result in
such an injury. In addition, her reliance on case report associations (a weak form of causation
proof) was not enough to show the specific vaccine at issue could result in production of the
relevant autoantibodies. And overall, testimony from both experts about the nature of this form of
encephalitis (which seems in some cases to more likely begin within the CNS) is not consistent
with systemically-driven creation of autoantibodies finding their way to the relevant receptors.
Moreover, even if the Tdap vaccine could cause the production of the relevant antibodies
in the periphery—i.e., outside the central nervous system (due to the locus of vaccine
administration in Petitioner’s arm)—it has not been preponderantly established that cytokines
upregulated by vaccination would also likely breach the BBB in the same way cytokines
attributable to an active infection or tumor could. Dr. Hedrick persuasively established that the
type of cytokines likely to increase BBB permeability were not likely vaccine-associated—and
that in fact, vaccination generally was not the kind of immune stimulative event sufficient at all to
raise this as an actual risk. Tr. at 75–76, 84–85, 125.
21 Because petitioners must establish all three Althen prongs to be deemed entitled to compensation, the failure to meet
any single prong is fatal to a claim—and therefore all three need not be addressed in an entitlement decision.
Dobrydnev v. Sec’y of Health & Hum. Servs., 566 Fed. Appx. 976, 980 (Fed. Cir. 2014).
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In many respects, Petitioner’s theory amounts more to an effort to retroactively explain
how a vaccine-caused process leading to anti-NMDAR encephalitis might occur than a
scientifically-reliable theory for how it likely does occur. The manner of the proposed BBB-
breakdown, for example, attempts to leverage what is known about vaccine-induced cytokine
production into an after-the-fact theory—but without evidence suggesting that vaccination
affirmatively is likely to promote BBB weakening. I often am confronted with similar theories, but
find them wanting in their effort to conflate what is expected from vaccination with a pathologic
process. Osenbach v. Sec’y of Health & Hum. Servs., No. 16-419V, 2023 WL 5714809, at *29
(Fed. Cl. Spec. Mstr. Aug. 8, 2023), appeal docketed No. 2024-1663 (Fed. Cir. Apr. 8, 2024).
Here, too, Petitioner’s argument founders.
This is not a case where Respondent’s expert strongly rebutted the entirety of Petitioner’s
evidentiary showing. Dr. Hedrick, for example, offered a number of arguments about predicted
incidence of vaccine-caused anti-NMDAR encephalitis that were not particularly robust, or relied
on statistical comparisons that did not in turn derive from sound epidemiologic evidence. But it is
a petitioner’s initial burden to make a prima facie showing of causation—and that showing must
be preponderant and scientifically-medically reliable. Petitioner’s showing was simply too general
and vague to succeed. Indeed, it would arguably apply to any vaccination that preceded
manifestation of encephalitic symptoms.
I also cannot find on this record that the Tdap vaccine likely “did cause” Petitioner’s anti-
NMDAR encephalitis (assuming the first Althen prong were met). There is little preponderant
record evidence that Petitioner experienced any unusual levels of inflammation after his early
October vaccination that would be consistent with the alleged BBB-breaching cytokine reaction,
with over two weeks passing before Petitioner’s October 20, 2020 seizure while driving. Then,
Petitioner did not even immediately test positive for the relevant autoantibodies (based on blood
testing—which would have picked up the existence of these antibodies had they been systemically
generated) when he first sought hospitalization on October 28, 2020—now more than three weeks
post-vaccination. If the Tdap vaccine had in fact been instigating the production of harmful
autoantibodies, why were they not then detected—and after Petitioner had manifested a number of
concerning symptoms? Dr. Babinski did not credibly explain these findings away.
I do acknowledge Petitioner can on this matter point to some instances of treater
speculation that the temporal association with onset and vaccination was suspicious. But more
holistic considerations of Petitioner’s medical history, generated after his onset and subsequent
hospitalization, discounted a vaccination cause. See, e.g., Ex. 8 ay 79, 84 (Dr. Clardy’ late-
November 2020 assessment). I give that evidence greater weight.
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CONCLUSION
Claimants must carry their burden of proof—here, by preponderantly establishing, via an
offering of sufficient evidence, how the Tdap vaccine could cause anti-NMDAR encephalitis. This
has not been accomplished in this case. Accordingly, I deny entitlement.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of
the Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.22
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
22 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file
notices renouncing their right to seek review.
25

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_21-vv-01601-1
Date issued/filed: 2025-06-27
Pages: 13
Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 70 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge Elaine D. Kaplan. (ah) Service on parties made.
--------------------------------------------------------------------------------
Case 1:21-vv-01601-EDK Document 72 Filed 06/27/25 Page 1 of 13
In the United States Court of Federal Claims
)
CRISTIAN GARCIA, )
)
Petitioner, )
) No. 21-1601V
v. ) (Filed Under Seal: June 12, 2025
) Reissued for Publication:
SECRETARY OF HEALTH AND HUMAN ) June 27, 2025)*
SERVICES, )
)
Respondent. )
)
)
Ronald C. Homer, Conway, Homer, P.C., Boston, MA, for Petitioner.
Felicia D. Langel, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice,
Washington, DC, with whom were Julia M. Collison, Assistant Director, Heather L. Pearlman,
Deputy Director, C. Salvatore D’Alessio, Director, and Yaakov M. Roth, Acting Assistant
Attorney General, for Respondent.
OPINION AND ORDER
This case arises under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.
§§ 300aa-1 to -34 (“Vaccine Act” or “the Act”). Petitioner, Cristian Garcia, alleges that he
developed anti-N-methyl-D-aspartate receptor (“anti-NMDAR” or “anti-NMDA receptor”)
encephalitis as a result of receiving the tetanus-diphtheria-acellular-pertussis (“Tdap”) vaccine.
See Decision of Spec. Mstr., ECF No. 64 [hereinafter “Dec.”]; see also Garcia v. Sec’y of Health
& Hum. Servs., 2025 WL 1544677, 2025 U.S. Claims LEXIS 1412 (Fed. Cl. Spec. Mstr. Jan. 3,
2025). Chief Special Master Brian Corcoran denied entitlement on the grounds that Mr. Garcia
failed to satisfy prongs one and two of the three-pronged test of causation set forth in Althen v.
Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005). The Chief Special Master held
that: 1) Petitioner did not provide a medical theory based on a “sound and reliable medical or
scientific explanation” supporting his assertion that the Tdap vaccine can cause anti-NMDAR
encephalitis (prong one), see Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355–56
(Fed. Cir. 2006); and 2) Petitioner did not provide a logical sequence of cause and effect showing
that the vaccination did cause his injury (prong two).
* Pursuant to Vaccine Rule 18(b), this opinion was initially filed on June 12, 2025, and the
parties were afforded fourteen days to propose redactions. The parties did not propose any
redactions and, accordingly, this Opinion is reissued in its original form for publication.

Case 1:21-vv-01601-EDK Document 72 Filed 06/27/25 Page 2 of 13
The case is currently before the Court on Petitioner’s motion for review. Pet’r’s Mot. for
Rev., ECF No. 65. In his motion, Petitioner alleges that the Chief Special Master’s findings were
not based on the record as a whole, as required by statute, because the Chief Special Master
allegedly failed to take into consideration two reports that the Petitioner’s expert prepared in
response to the reports of the Secretary’s experts.
For the reasons set forth below, the Court finds that Petitioner has not established that the
Chief Special Master failed to consider the two reports at issue and that, even if he did, such
error was harmless. Petitioner’s motion for review is therefore DENIED.
BACKGROUND
I. Mr. Garcia Is Diagnosed with Anti-NMDAR Encephalitis
The factual background of this case is set forth in the Chief Special Master’s decision.
Dec. at 2–5. To summarize, Mr. Garcia received the Tdap vaccine on October 2, 2020. Pet’r’s
Ex. 1, at 4, ECF No. 13-1. He was then twenty-six years old, had no history of neurological
problems, and had never before experienced any adverse reaction to a vaccine. See Pet’r’s Ex. 7,
at 7–14, ECF No. 13-7.
On October 20, 2020, eighteen days after he received the vaccine, Mr. Garcia had a
seizure while driving, marking the onset of his disease. See Pet’r’s Ex. 4, at 31–33, ECF No. 13-
4; Pet’r’s Ex. 3, at 5–6, ECF No. 13-5; Pet’r’s Ex. 7, at 16, 21. After experiencing worsening
symptoms and undergoing a series of tests, see, e.g., Pet’r’s Ex. 4, at 11, 16, 18; Pet’r’s Ex. 3, at
8; Pet’r’s Ex. 6, at 22, 27, 31–34, 37–39, 44–45, ECF No. 13-6; Pet’r’s Ex. 15, at 64–67, ECF
No. 21-3; Pet’r’s Ex. 5, at 2, 70, ECF No. 13-5, Mr. Garcia was diagnosed with anti-NMDAR
encephalitis, Pet’r’s Ex. 8, at 135, 162, ECF No. 13-8.
Anti-NMDAR encephalitis is an autoimmune, neuroinflammatory disease. Its exact
etiology is in many cases unknown. It results when specific antibodies, known as NMDA
receptor antibodies, bind to a certain subunit of NMDA receptors found in the central nervous
system and block their proper functioning. Dec. at 6–7, 11. Symptoms of anti-NMDAR
encephalitis include seizures, confusion, agitation, speech disturbances, depressed consciousness,
and autonomic instability. Hr’g Tr. 16:7–11, ECF No. 63.
After his diagnosis, Mr. Garcia received a variety of treatments. Although he had shown
signs of “significant recovery,” as of 2022, he continued to suffer from lingering neurological
symptoms. See Pet’r’s Ex. 8, at 18–41, 79, 84; Pet’r’s Ex. 13, at 4–5, 8–9, 101, 104, ECF No. 21-
1.
II. Petitioner’s Theory of Causation
Petitioner’s expert in this case was Kristen Babinski, MD, PhD.1 Dr. Babinski prepared
an expert report in support of Petitioner’s claim. Pet’r’s Ex. 18, ECF No. 32-1. She also prepared
1 Dr. Babinski received a bachelor’s degree in biochemistry from Colgate University, a PhD in
biochemistry from Duke University, and an MD from the University of North Carolina School of
Medicine. Pet’r’s Ex. 19, at 1, ECF No. 32-2. She was a Neurology Resident, Neurology Chief
2

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written responses to the opinions of the government’s two experts, Jagannadha Avasarala, MD,
PhD, and Stephen Hedrick, PhD. Pet’r’s Ex. 45, ECF No. 38-1; Pet’r’s Ex. 50, ECF No. 60-1. In
addition, she testified at the entitlement hearing.
In her expert report, Dr. Babinski discussed the prevalence of anti-NMDAR encephalitis
following vaccination as reflected in the medical literature2 and the Vaccine Adverse Events
Reporting System (“VAERS”) database.3 She acknowledged that “the mechanism for vaccine
induced anti-NMDAR encephalitis is unclear,” but identified three possible theories to support
the existence of such a mechanism. Pet’r’s Ex. 18, at 6–7.
Resident, and Multiple Sclerosis (Neurology) Fellow at the New York University School of
Medicine. Id. She currently serves as the Assistant Professor of Neurology and Director of
Multiple Sclerosis at Tufts Medical Center. Id.
2 The medical literature cited reported the cases of: 1) a 15-year-old girl who showed symptoms
of the illness five weeks after administration of a booster vaccination against tetanus/diphtheria/
pertussis and polio (Tdap-IPV), Pet’r’s Ex. 18, at 5 (citing Pet’r’s Ex. 33, ECF No. 32-16
(Hofmann et al. (2011))); 2) a 22-year-old woman whose symptoms developed three days after
receiving a Tdap-IPV booster, id. (citing Pet’r’s Ex. 27, ECF No. 32-10 (Endres et al. (2019)));
3) two patients who developed the disorder after vaccination against H1N1 influenza, id. at 6
(citing Pet’r’s Ex. 25, ECF No. 32-8 (Dalmau et al. (2011))); and 4) a two-year-old child who
developed anti-NMDAR encephalitis 17 days after receiving the second dose of the Japanese
encephalitis vaccination, id. (citing Pet’r’s Ex. 40, ECF No. 32-23 (Wang (2017))). In addition,
Dr. Babinski cited a case report published in 2017 which “describe[d] a patient who developed
postural orthostatic tachycardia syndrome (POTS) with a positive serum anti-NMDA receptor
antibody, without evidence of encephalitis, after vaccination with a bivalent human papilloma-
virus (HPV) vaccine, Cervarix.” Id. (citing Pet’r’s Ex. 21, ECF No. 32-4 (Blitshteyn & Brook
(2017))). She also cited literature which reported “four cases of autoimmune encephalitis after
vaccination against yellow fever,” three of whom developed anti-NMDAR encephalitis.” Id.
(citing Pet’r’s Ex. 24, ECF No. 32-7 (Coeckelbergh & Reynders (2021)); Pet’r’s Ex. 32, ECF
No. 32-15 (Guedes et al. (2021))). Finally, Dr. Babinski observed “anti-NMDAR encephalitis
was also reported following administration of the Pfizer-BioNTech and BNT162b2 COVID-19
vaccines in 2021 and 2022, respectively.” Id. (citing Pet’r’s Ex. 29, ECF No. 32-12 (Flannery et
al. (2021)); Pet’r’s Ex. 35, ECF No. 32-18 (Lee et al. (2022))).
3 VAERS “is a national early warning system to detect possible safety problems in U.S.-licensed
vaccines,” and it “accepts and analyzes reports of adverse events (possible side effects) after a
person has received a vaccination.” Dec. at 7 n.10 (quoting About VAERS, Vaccine Adverse
Event Reporting System, https://vaers.hhs.gov/about.html (last visited April 16, 2025)).
According to Dr. Babinski, the VAERS database for autoimmune encephalitis and vaccines
produced 74 reports, three of which were associated with the Tdap vaccine, one with the DTaP
(diphtheria and tetanus toxoids and acellular pertussis) vaccine, one with the DTaP-IPV (DTaP
plus inactivated poliovirus vaccine), and one with the DTaP-IPV-HIB (DTaP, inactivated
poliovirus, and Haemophilus B conjugate vaccine). Pet’r’s Ex. 18, at 6.
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The first theory, she said, “suggests that there may be an exacerbation of an underlying
systemic autoimmune disease with central nervous system activity following vaccination.”
Pet’r’s Ex. 18, at 6; see also Hr’g Tr. 22:14–16. She observed that “[i]t has been shown that the
influenza vaccination can transiently increase anti-nuclear antibodies (ANA) and anti-double-
stranded DNA titers in patients with systemic lupus erythematosus.” Pet’r’s Ex. 18, at 6 (citing
Pet’r’s Ex. 42, ECF No. 32-25 (Wiesik-Szewczyk et al. (2010))). In addition, “[i]t has also been
reported that patients with relapsing-remitting multiple sclerosis develop relapses and new MRI
lesions after YF (yellow fever) 17D-204 immunization.” Id. (citing Pet’r’s Ex. 28, ECF No. 32-
11 (Farez & Correale (2011))).
A second hypothesis, according to Dr. Babinski, “suggests that some individuals have
pre-existing specific T- and B-cell lymphocyte clones that are re-stimulated by vaccination,”
which “causes them to proliferate and synthesize excess antibodies.” Id. (citing Pet’r’s Ex. 27,
ECF No. 32-10 (Endres et al. (2019))). Dr. Babinski observed that “[r]esearch has shown that
antibody-secreting cells releasing functional NMDA receptor antibodies are part of the human
naïve B-cell repertoire and might be much more common than previously assumed.” Id. (citing
Pet’r’s Ex. 41, ECF No. 32-24 (Wenke (2019))).” She theorized that “[a] vaccine’s effect of
boosting antibody production may lead to a transient increase in the NMDA receptor antibody
levels, thereby causing clinical symptoms and detectable antibodies.” Id. (citing Pet’r’s Ex. 27
(Endres et al. (2019))).
At the hearing, Dr. Babinski further explained that—to become pathogenic—the
circulating NMDA receptor antibodies would need to cross the blood-brain barrier. Hr’g. Tr.
26:6–27:1. She posited that cytokines generated by a vaccination can alter the permeability of the
blood-brain barrier, allowing antibodies to cross into the central nervous system. See Hr’g Tr.
27:4–15, 28:14–16. There, the antibodies bind to the NMDA receptors in the brain causing the
symptoms associated with anti-NMDAR encephalitis.
As a final theory, Dr. Babinski noted that “the association between anti-NMDA receptor
encephalitis and vaccination” had been investigated “by analyzing the phylogenetic relationship
of microRNAs (miRNAs) and the phylogenetic relationship of certain viruses and bacteria.”
Pet’r’s Ex. 18, at 6 (citing Pet’r’s Ex. 40, ECF No. 32-23 (Wang (2017))). She explained that
“miRNAs are small RNA molecules approximately 22 nucleotides long that can upregulate or
downregulate their target gene expression post-transcriptionally.” Id. (citing Pet’r’s Ex. 23, ECF
No. 32-6 (Chuang & Jones (2007))). Dr. Babinski postulated that “[r]esults of [the Wang] study
showed that from a phylogenetic perspective, anti-NMDAR encephalitis could be caused by
Japanese encephalitis virus vaccination, H1N1 influenza vaccination and DPT-polio
vaccination.” Id. at 6–7 (citing Pet’r’s Ex. 40 (Wang (2017))).
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III. The Secretary’s Response
The Secretary’s expert was Steven M. Hedrick, PhD.4 Dr. Hedrick prepared an expert
report. Resp’t’s Ex. B, ECF No. 41-1. He also testified at the entitlement hearing.5
In his report, Dr. Hedrick opined on the statistical probability that the Tdap vaccine
causes anti-NMDAR encephalitis. Id. at 5. He observed that the VAERS database covering 1990
to 2023 revealed only two clear cases of anti-NMDAR encephalitis following a Tdap or DTaP
vaccination, out of what he estimated were at least 300 million vaccinations administered. Id. He
explained that—assuming anti‐NMDAR encephalitis occurs at a rate of 1 per million per year,
for 40 million people over 30 years (1991–2023)—the expected number of cases of Tdap or
DTaP-caused anti‐NMDAR encephalitis would be approximately 1200. Id. However, he noted,
this number “is orders of magnitude more than the number of reported vaccine‐related adverse
events specific for anti‐NMDAR encephalitis.” Id. “Combined with safety studies showing no
increased risk for medically attended neurologic or allergic reactions,” he wrote, “there is no
evidence that Tdap or DTaP vaccinations increase the probability of anti‐NMDAR encephalitis.”
Id. (citing Resp’t’s Ex. B-16, ECF No. 41-17 (Klein et al. (2010))).
Dr. Hedrick also rejected the notion that molecular mimicry could be at play. He pointed
out that “[t]he case studies of anti‐NMDAR encephalitis cited by Dr. Babinski include the
spectrum of vaccines: Tdap‐IPV, H1N1 influenza vaccination, Japanese encephalitis vaccine,
human papillomavirus (HPV) vaccine, yellow fever vaccine, and COVID‐19 vaccines.” Id. “If
these rare case studies are to be taken as evidence,” he said, “the conclusion is that there is no
proposed vaccine specificity, meaning there must not be any form of molecular mimicry where
an immune response to the vaccine components cross‐react with NMDAR.” Id. “Since these
cited vaccines are all very different in composition,” he wrote, Dr. Babinski’s “theory must be
that any immune provoking entity is capable of causing this disease.” Id.
Dr. Hedrick also criticized Dr. Babinski’s reliance on the theory that “a vaccine may
exacerbate an underlying autoimmune disease, i.e., some individuals have pre‐existing specific
T‐ and B‐cell lymphocyte clones that are re‐stimulated by vaccination.” Id. Dr. Hedrick noted
that “there is no evidence in the lab tests that 26‐year‐old Mr. Garcia harbored autoimmunity,
cryptic or otherwise—for example, he had no anti‐nuclear antibodies (ANA), a common
characteristic of autoimmunity.” Id.
4 Dr. Hedrick received his undergraduate degree in biology and his PhD in molecular biology
and biochemistry from the University of California, Irvine. Resp’t’s Ex. B-1, at 1, ECF No. 41-2.
Dr. Hedrick was a postdoctoral fellow at the National Institutes of Health. Resp’t’s Ex. B, at 1.
He currently serves as a Distinguished Professor, Emeritus at the University of California, San
Diego, having retired from the University in 2021. Id.
5 The Secretary also submitted a report written by Jagannadha Avasarala, MD, PhD, a Professor
of Neurology and Director of MS and Neuroimmunology Program at the University of Kentucky
Medical Center. Resp’t’s Ex. A, ECF No. 35-1. That report is discussed below.
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Dr. Hedrick rejected Dr. Babinski’s theory “that some individuals have pre‐existing
autoreactive T‐ and B‐cell lymphocyte clones that are re‐stimulated by vaccination.” Id. He
observed that “[t]his does not explain how such cells are activated by toxoids in aluminum salts,
and signaled to migrate and gain access to the central nervous system via a breakdown in the
[blood-brain barrier].” Id.
Dr. Hedrick further observed that “[m]ost autoimmune encephalitides, that is
autoantibody‐mediated encephalitis diseases, occur in patients with no apparent immunologic
triggers—neither viral infections, teratoma allografts, nor vaccinations.” Id. at 6. Moreover, he
said, “[o]ur understanding of Tdap and its immunogenicity does not include activity that would
cause the breakdown of the [blood-brain barrier] and the incitement of an autoimmune
encephalitis.” Id.; see also Hr’g Tr. 84:22–25 (stating that there is no evidence “that a routine
vaccine, such as Tdap[,] will cause a breakdown of the blood-brain barrier”). “Importantly,” Dr.
Hedrick noted, “there is no evidence for increased encephalitis in Tdap vaccinees compared with
the general population.” Resp’t’s Ex. B, at 6.
Dr. Hedrick concluded that,
Hearing the story of the petitioner falling victim to a debilitating disease in the
weeks following vaccination, the very human reaction is to assume that one caused
the other. However, a dispassionate evaluation of the biology and epidemiology
considering the hundreds of millions of vaccinations that have been given, along
with the lack of biological evidence to support a cause and effect, there is a high
probably that the two events were coincidental. In my opinion, more likely than
not, this very unfortunate disease process experienced by Mr. Garcia occurred
independently from the Tdap vaccination.
Id.
IV. The Chief Special Master’s Decision
Mr. Garcia filed his petition for compensation on July 22, 2021. Pet., ECF No. 1. The
Secretary filed his Rule 4(c) report on November 25, 2022. ECF No. 30. An entitlement hearing
was held on August 26, 2024. See Hr’g Tr., ECF No. 63.
On January 3, 2025, the Chief Special Master issued an opinion finding Petitioner not
entitled to compensation. He found that Petitioner had failed to satisfy prongs one and two of the
three-prong test for establishing causation set forth in Althen. Dec. at 23–24.6
With respect to prong one, the Chief Special Master found that the Petitioner failed to
provide a reputable medical theory causally connecting the vaccination and the injury. He
concluded that “[i]t simply has not been preponderantly demonstrated that the Tdap vaccine can
6 Because a petitioner must satisfy all three prongs of the Althen test, it was not necessary for the
Chief Special Master to consider the third prong after deciding that Petitioner failed at prongs
one and two. See Dec. at 23 n.21 (citing Dobrydnev v. Sec’y of Health & Hum. Servs., 566 Fed.
Appx. 976, 980 (Fed. Cir. 2014)).
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likely produce the specific anti-NMDAR antibodies thought to cause this form of encephalitis.”
Id. at 23. He noted that while Dr. Babinski “displayed good command of the subject of anti-
NMDAR encephalitis, her expertise did not extend to matters involving purportedly pathogenic
immunologic responses that would result in such an injury.” Id. He dismissed her “reliance on
case report associations” which he characterized as “a weak form of causation proof,” that “was
not enough to show the specific vaccine at issue could result in production of the relevant
autoantibodies.” Id.
In addition, he found that “overall, testimony from both experts about the nature of this
form of encephalitis (which seems in some cases to more likely begin within the [central nervous
system] is not consistent with systemically-driven creation of autoantibodies finding their way to
the relevant receptors.” Id. “[E]ven if the Tdap vaccine could cause the production of the
relevant antibodies in the periphery—i.e., outside the central nervous system (due to the locus of
vaccine administration in Petitioner’s arm),” he observed, “it has not been preponderantly
established that cytokines upregulated by vaccination would also likely breach the [blood-brain
barrier] in the same way cytokines attributable to an active infection or tumor could.” Id. He
concluded that “Dr. Hedrick persuasively established that the type of cytokines likely to increase
[blood-brain barrier] permeability were not likely vaccine-associated—and that in fact,
vaccination generally was not the kind of immune stimulative event sufficient at all to raise this
as an actual risk.” Id. (citing Hr’g Tr. 75–76, 84–85, 125).
The Chief Special Master made it clear that his decision was based on what he viewed as
the generality and lack of precision in Petitioner’s medical theory. He observed that “[t]his is not
a case where Respondent’s expert strongly rebutted the entirety of Petitioner’s evidentiary
showing.” Id. at 24. “[F]or example,” he explained, Dr. Hedrick “offered a number of arguments
about predicted incidence of vaccine-caused anti-NMDAR encephalitis that were not particularly
robust, or relied on statistical comparisons that did not in turn derive from sound epidemiologic
evidence.” Id. But regardless of these flaws in Dr. Hedrick’s analysis, he emphasized, “it is a
petitioner’s initial burden to make a prima facie showing of causation—and that showing must
be preponderant and scientifically-medically reliable.” Id. “Petitioner’s showing,” he found,
“was simply too general and vague to succeed.” Id. “Indeed,” he explained, that showing “would
arguably apply to any vaccination that preceded manifestation of encephalitic symptoms.” Id.
Finally, the Chief Special Master stated that he also could not find that the Tdap vaccine
“likely ‘did cause’” Petitioner’s anti-NMDAR encephalitis, as required to satisfy Althen prong 2.
Id. He noted that “[t]here is little preponderant record evidence that Petitioner experienced any
unusual levels of inflammation after his early October vaccination that would be consistent with
the alleged [blood-brain barrier]-breaching cytokine reaction, with over two weeks passing
before Petitioner’s October 20, 2020 seizure while driving.” Id. And “[t]hen,” he observed,
“Petitioner did not even immediately test positive for the relevant autoantibodies (based on blood
testing—which would have picked up the existence of these antibodies had they been
systemically generated) when he first sought hospitalization on October 28, 2020—now more
than three weeks post-vaccination.” Id. “If the Tdap vaccine had in fact been instigating the
production of harmful autoantibodies,” he posited, “why were they not then detected—and after
Petitioner had manifested a number of concerning symptoms?” Id. He concluded that “Dr.
Babinski did not credibly explain these findings away.” Id.
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V. Motion for Review
Petitioner filed his motion for review of the Chief Special Master’s decision and a
supporting memorandum on February 3, 2025. Pet’r’s Mot. for Rev.; Pet’r’s Mem. Supp. Mot.
for Rev., ECF No. 66 [hereinafter Pet’r’s Mem.]. In his motion, Petitioner argues that in
rendering his opinion, the Chief Special Master did not take into consideration Petitioner’s
Exhibit 45 (Dr. Babinski’s report in response to Dr. Avasarala’s expert report) or Petitioner’s
Exhibit 50 (Dr. Babinski’s report in response to Dr. Hedrick’s expert report). In doing so,
Petitioner contends, the Chief Special Master violated his statutory obligation to render a
decision that takes into account all relevant evidence.
The Secretary filed a response to the motion for review on March 3, 2025. Resp’t’s Resp.
to Pet’r’s Mot. for Rev., ECF No. 68. The Secretary contends that Petitioner has not established
that the Chief Special Master did not consider the two exhibits in question. He also argues that
even if the Chief Special Master failed to do so, the error was harmless and does not supply a
basis for reversing the Chief Special Master’s finding on entitlement.
DISCUSSION
I. Jurisdiction
Congress established the National Vaccine Injury Compensation Program in 1986 to
provide a no-fault compensation system for vaccine-related injuries and deaths. Figueroa v.
Sec’y of Health & Hum. Servs., 715 F.3d 1314, 1316–17 (Fed. Cir. 2013). The Vaccine Act is
remedial legislation that “should be construed in a manner that effectuates its underlying spirit
and purpose.” Id. (quoting Cloer v. Sec’y of Health & Hum. Servs., 675 F.3d 1358, 1362 (Fed.
Cir. 2012) (en banc)).
A petition seeking compensation under the Vaccine Act is filed in the Court of Federal
Claims, after which the Clerk of the Court forwards it to the Chief Special Master for assignment
to a special master. 42 U.S.C. § 300aa-11(a)(1). The special master to whom the petition is
assigned “issue[s] a decision on such petition with respect to whether compensation is to be
provided under the [Vaccine Act] and the amount of such compensation.” Id. § 300aa-
12(d)(3)(A).
The Vaccine Act grants the Court of Federal Claims jurisdiction to review the decisions
of special masters with authority to:
(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.
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42 U.S.C. § 300aa-12(e)(2); see also RCFC App. B, Vaccine Rule 27.
II. Standard of Review
The court reviews a special master’s legal determinations de novo, applying the “not in
accordance with law” standard. Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592
F.3d 1315, 1321 (Fed. Cir. 2010); Althen, 418 F.3d at 1278–79. Judicial review of a special
master’s factual determinations, on the other hand, is circumscribed and “uniquely deferential.”
Milik v. Sec’y of Health & Hum. Servs., 822 F.3d 1367, 1376 (Fed. Cir. 2016) (quoting Hodges
v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)). The court may only set
aside a special master’s factual determinations where they are arbitrary, capricious, and/or reflect
an abuse of discretion. Moberly, 592 F.3d at 1321. In conducting judicial review, the court does
not reweigh the evidence, examine its probative value, or judge the credibility of the witnesses,
for those “are all matters within the purview of the fact finder.” Porter v. Sec’y of Health &
Hum. Servs., 663 F.3d 1242, 1254 (Fed. Cir. 2011) (citing Broekelschen v. Sec’y of Health &
Hum. Servs., 618 F.3d 1339, 1349 (Fed. Cir. 2010)). Thus, if a special master “‘has considered
the relevant evidence of record, drawn plausible inferences[,] and articulated a rational basis for
the decision,’ then reversible error is ‘extremely difficult to demonstrate.’” Milik, 822 F.3d at
1376 (quoting Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
III. Petitioner Has Not Established that the Chief Special Master Failed to Consider Dr.
Babinski’s Responses to the Reports of the Government’s Experts
The Vaccine Act provides that “‘[c]ompensation shall be awarded . . . to a petitioner if
the special master or court finds on the record as a whole’ that the petitioner has met his
evidentiary burdens.” Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1327 (Fed.
Cir. 2016) (quoting 42 U.S.C. § 300aa-13(a)(1)). The evidence the special master is required to
consider includes medical records or reports “contained in the record regarding the nature,
causation, and aggravation of the petitioner’s . . . injury” as well as “all other relevant medical
and scientific evidence contained in the record.” 42 U.S.C. § 300aa-13(b).
As the court of appeals has observed, this statutory language “indicates that a special
master, reviewing the entire record of the case before him, must consider all relevant medical
and scientific evidence contained in the record, which includes any relevant medical records or
reports. The language also instructs that the special master ‘shall’ consider the entire record,
which includes this relevant evidence, when assigning the weight given to particular evidence.”
Moriarty, 844 F.3d at 1327–28.
In this case, as noted, Petitioner argues that the Chief Special Master failed to consider
Petitioner’s Exhibit 45 (Dr. Babinski’s November 26, 2023 supplemental report in response to
Dr. Avasarala’s review of petitioner’s case) or Petitioner’s Exhibit 50 (Dr. Babinski’s July 10,
2024 supplemental report responding to the opinions of Dr. Hedrick). He bases these assertions
on: 1) the fact that the Chief Special Master did not specifically cite the reports in his decision;
and 2) the Chief Special Master’s statement that Dr. Babinski had “prepared a single written
report.” Pet’r’s Mem. at 2 (quoting Dec. at 6).
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Petitioner’s argument lacks merit. In cases arising under the Vaccine Act, the Court
“generally presume[s] that a special master considered the relevant record evidence even though
he does not explicitly reference such evidence in his decision.” Moriarty, 844 F.3d at 1328
(citing Hazlehurst v. Sec’y of Health & Hum. Servs., 604 F.3d 1343, 1352 (Fed. Cir. 2010)). A
special master is not required to discuss “every piece of medical literature a petitioner files or
references in his or her final decision.” K.L. v. Sec’y of Health & Hum. Servs., 134 Fed. Cl. 579,
609 (2017). And “failing to discuss every piece of evidence will not alter the presumption that a
Special Master has considered the entire record in his or her decision to grant or deny
compensation.” Id. (citing Moriarty, 844 F.3d at 1328). Therefore, the fact that the Chief Special
Master did not cite Dr. Babinski’s rebuttal reports in response to the government’s experts does
not establish that he failed to consider them.
To be sure, the presumption that a special master has considered all of the relevant
evidence of record must give way where a special master expressly states that they have not done
so. In Moriarty, for example, the special master expressly stated that he had not considered
certain relevant reports because they were not discussed at the hearing. The court of appeals held
that, in the face of this express statement, the presumption was not applicable. 844 F.3d at 1328;
see also Medtronic, Inc. v. Daig Corp., 789 F.2d 903, 906 (Fed. Cir. 1986) (“We presume that a
fact finder reviews all the evidence presented unless he explicitly expresses otherwise.”).
In this case, the Chief Special Master did not state, expressly or otherwise, that he did not
consider Dr. Babinski’s supplemental reports. To the contrary, the Chief Special Master stated
that he had conducted a review “of the complete medical record as filed, expert reports, medical/
scientific literature, and the parties’ briefs.” Dec. at 1. He also stated that he would discuss only
the medical literature and records that were most relevant to his determination and/or were
central to Petitioner’s case. Dec. at 21 (citing Moriarty, 844 F.3d at 1328).
Petitioner’s argument that the Chief Special Master did not consider Dr. Babinski’s
supplemental reports is thus based almost entirely on the Chief Special Master’s passing
observation when introducing Dr. Babinski’s opinion that she had “prepared a single written
report and testified at hearing.” See Pet’r’s Mem. at 2 (quoting Dec. at 6). As Petitioner
recognizes, when the Chief Special Master stated that Dr. Babinski had prepared a “single
written report,” he was referring to her April 9, 2023 expert report, which provided the bases for
her opinion that the Tdap vaccine that Mr. Garcia received was the cause of his anti-NMDAR
encephalitis. Pet’r’s Ex. 18. The other two reports she prepared were not for the purposes of
presenting Mr. Garcia’s affirmative case, but rather to respond to the submissions of the
government’s experts. See generally Pet’r’s Exs. 45, 50.
It is conceivable, therefore, that the Chief Special Master referred to “a single written
report” because, in fact, there was only a single written report that presented Petitioner’s
affirmative case. Or perhaps it is the case that this observation merely reflects a lack of care or
precision of language when describing Dr. Babinski’s contributions to Petitioner’s case. Either
way, the Chief Special Master’s passing observation that Dr. Babinski prepared a single written
report hardly represents the kind of express statement Moriarty and Medtronic require to rebut
the presumption that all relevant evidence was taken into consideration.
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IV. Even Assuming that the Chief Special Master Did Not Consider Petitioner’s
Exhibits 45 and 50, the Error Was Harmless
For the reasons set forth above, the Court has concluded that Petitioner failed to rebut the
presumption that the Chief Special Master considered all relevant evidence, including
Petitioner’s Exhibits 45 and 50, when he rendered his decision. But even if he did not consider
those exhibits, that error would be harmless and does not provide a basis for reversing his
entitlement decision. See SolarWorld Americas, Inc. v. United States, 962 F.3d 1351, 1359 (Fed.
Cir. 2020) (“The party that ‘seeks to have a judgment set aside because of an erroneous ruling
carries the burden of showing that prejudice resulted.’” (quoting Shinseki v. Sanders, 556 U.S.
396, 409 (2009))).
For example, Petitioner alleges that the Chief Special Master did not consider Petitioner’s
Exhibit 45 (Dr. Babinski’s response to the report prepared by Dr. Avasarala). Even if true, the
error would have no effect on the outcome of the case. The Chief Special Master did not rely on
Dr. Avasarala’s opinion when he ruled that Petitioner had failed to meet his burden under Althen
prongs one and two. To the contrary, he expressly stated that it was unnecessary to discuss Dr.
Avasarala’s report because he believed it largely concerned the accuracy of Petitioner’s
diagnosis, a matter that was not in dispute. Dec. at 10 n.10.
To be sure, Dr. Avasarala’s report also discussed the World Health Organization’s
criteria for assessing the probability that a vaccination was responsible for an adverse event. See
Resp’t’s Ex. A, at 4–7. But the Secretary did not cite or rely on this aspect of Dr. Avasarala’s
opinion in his prehearing brief. See Resp’t’s Prehearing Brief, ECF No. 45. And the Chief
Special Master did not cite or rely upon it either when he found that Petitioner failed to
demonstrate causation. Therefore, Petitioner was not prejudiced by the Chief Special Master’s
alleged failure to consider Dr. Babinski’s critiques of Dr. Avasarala’s report.
There is similarly no merit to Petitioner’s argument that he was prejudiced by the Chief
Special Master’s alleged failure to consider Petitioner’s Exhibit 50 (Dr. Babinski’s written
response to Dr. Hedrick’s report). Petitioner notes that the Chief Special Master stated in his
opinion that “[i]t simply has not been preponderantly demonstrated that the Tdap vaccine can
produce the specific anti-NMDAR antibodies thought to cause this form of encephalitis.” Pet’r’s
Mem. at 9, 11 (quoting Dec. at 23). According to Petitioner, had the Chief Special Master
considered Petitioner’s Exhibit 50, he would have understood that Dr. Babinski’s theory was not
that the vaccine can produce NMDAR antibodies, but that “vaccination can trigger the process
by which circulating, pre-existing, NMDAR antibodies in the periphery can reach the NMDA
receptors in the brain.” Pet’r’s Mem. at 11 (citing Pet’r’s Ex. 50, at 4).
But the record makes clear the Chief Special Master was aware of—and considered—this
theory. Dr. Babinski discussed her theory involving pre-existing NMDAR antibodies at some
length during the entitlement hearing. See Hr’g Tr. 23–28, 46–51, 55–57. The Chief Special
Master described her testimony in his opinion. See Dec. at 8–9. The theory was also put before
the Chief Special Master in Petitioner’s prehearing brief at pages 42–44, ECF No. 43, and in
Petitioner’s prehearing reply brief at pages 6–7, ECF No. 61. The latter, in turn, cited Petitioner’s
Exhibit 50. See Pet’r’s Prehearing Reply Br. at 4–7. The Chief Special Master also reviewed and
cited the medical literature Dr. Babinski referenced in support of this theory in her report. See
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Dec. at 13 (citing Pet’r’s Ex. 53, ECF No. 55-4; Pet’r’s Ex. 67, ECF No. 55-18). The Chief
Special Master thus did not “fail[] to consider the medical expert opinion proffered by Dr.
Babinski,” Pet’r’s Mem. at 11; he simply found the theory unpersuasive, Dec. at 23.
Petitioner also contends that the Chief Special Master’s alleged failure to consider
Petitioner’s Exhibit 50 caused him to erroneously state that Dr. Babinski had “invoked molecular
mimicry as a mechanism.” Pet’r’s Mem. at 9, 11 (quoting Dec. at 23). As Petitioner observes,
Dr. Babinski explicitly stated in her response to Dr. Hedrick’s report that “[m]olecular mimicry
was not proposed as a potential biological mechanism.” Pet’r’s Ex. 50, at 3. Petitioner contends
that he was prejudiced by the Chief Special Master’s failure to consider Dr. Babinski’s
disclaimer, claiming that “the Chief Special Master denied entitlement on the basis that petitioner
did not provide enough evidence to support molecular mimicry as a mechanism.” Pet’r’s Mem.
at 12 n.11; id. at 13 n.12.
Petitioner’s argument regarding molecular mimicry is a red herring. Although the Chief
Special Master briefly and mistakenly referenced molecular mimicry, his decision was not based
on the absence of evidence for that mechanism. Instead, the decision rests on the conclusion that
Petitioner failed to present persuasive evidence for any of the theories Dr. Babinski did advance.
Dec. at 7–8, 23–24. As the Chief Special Master explained, “testimony from both experts about
the nature and form of [anti-NMDAR] encephalitis . . . is not consistent with systemically-driven
creation of autoantibodies finding their way to the relevant receptors.” Id. at 23 (emphasis
added). The core issue here was not how the autoimmunity developed, but whether Petitioner
showed that the Tdap vaccine could initiate or facilitate the crossing of the blood-brain barrier in
a way that would allow any antibodies, whether pre-existing or produced by the Tdap vaccine, to
reach NMDA receptors within the central nervous system. The Chief Special Master found no
persuasive evidence that it could. See id. at 24 (explaining that Dr. Babinski “attempts to
leverage what is known about vaccine-induced cytokine production [to explain the breakdown of
the blood-brain barrier] . . . without evidence suggesting that vaccination affirmatively is likely
to promote [blood-brain barrier] weakening”).
Similarly, Petitioner contends that—because the Chief Special Master allegedly never
reviewed Petitioner’s Exhibit 50—he did not understand why Dr. Babinski rejected as unreliable
Dr. Hedrick’s calculation of the predicted incidence of Tdap-caused anti-NMDAR encephalitis.
As noted above, Dr. Hedrick opined that the number of cases of Tdap-caused anti-NMDAR
encephalitis that could be predicted were many times higher than the number of incidents
reported in VAERS. In her response to Dr. Hedrick’s report, Dr. Babinski identified a number of
flaws in Dr. Hedrick’s calculations. See Pet’r’s Ex. 50, at 2–3. But the Chief Special Master did
not credit Dr. Hedrick’s calculations or give them any weight. To the contrary, he stated that
“[t]his is not a case where Respondent’s expert strongly rebutted the entirety of Petitioner’s
evidentiary showing,” noting that “Dr. Hedrick, for example, offered a number of arguments
about predicted incidence of vaccine-caused anti-NMDAR encephalitis that were not particularly
robust, or relied on statistical comparisons that did not in turn derive from sound epidemiologic
evidence.” Dec. at 24.
Finally, the Court notes that Petitioner’s motion for review does not address the Chief
Special Master’s ruling that Althen prong 2 was also not satisfied because Petitioner had failed to
show that the Tdap vaccine likely did cause him to develop anti-NMDAR encephalitis.
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Case 1:21-vv-01601-EDK Document 72 Filed 06/27/25 Page 13 of 13
Specifically, the Chief Special Master found, the evidence did not show “that Petitioner
experienced any unusual levels of inflammation after his early October vaccination that would be
consistent with the alleged [blood-brain barrier]-breaching cytokine reaction.” Id.
To show causation, a petitioner must satisfy all three Althen prongs. So far as the Court
can tell, there is nothing in Dr. Babinski’s responses to the Secretary’s experts that undermines,
or even affects, the Chief Special Master’s conclusion that prong two was not satisfied. For that
reason alone, even assuming that the Chief Special Master did not consider Petitioner’s Exhibits
45 and 50, the error did not affect the Chief Special Master’s ruling regarding prong two and
therefore had no effect on the ultimate outcome of the case.
CONCLUSION
For the foregoing reasons, Petitioner’s motion for review is DENIED and the decision of
the special master is SUSTAINED. The Clerk is directed to enter judgment accordingly.
IT IS SO ORDERED.
/s/ Elaine D. Kaplan
ELAINE D. KAPLAN
Judge
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