GOODWIN v. SECRETARY OF HEALTH AND HUMAN SERVICES

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
TRENTON GOODWIN, *
* No. 19-503V
Petitioner, *
* Special Master Christian J. Moran
v. *
*
SECRETARY OF HEALTH * Filed: October 7, 2025
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Kirk “Trip” Otto, Rawls Law Group, Richmond, VA, and Isaiah Kalinowksi,
Bosson Legal Group, Fairfax, VA, for Petitioner;
Lauren Kells and Sara DeStefano, United States Dep’t of Justice, Washington, DC,
for Respondent.
PUBLISHED DECISION ON REMAND
DENYING ENTITLEMENT TO COMPENSATION1
Trenton Goodwin alleges a human papillomavirus (“HPV”) vaccine was the
cause-in-fact of an incidence of transverse myelitis that he developed. 2 The
1 Because this Decision contains a reasoned explanation for the action taken in this case,
it must be made publicly accessible and will be posted on the United States Court of Federal
Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal
Management and Promotion of Electronic Government Services). This means the Decision will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted on the website.
2 Sheri McCluskey originally brought this claim on behalf of her son. After Mr.
Goodwin reached the age of majority, he became petitioner. Order, issued March 24, 2024. This
decision refers to petitioner as “Mr. Goodwin,” although most steps in the litigation were carried
out by Ms. McCluskey on Mr. Goodwin’s behalf.
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Secretary contested Mr. Goodwin’s allegation. Both Mr. Goodwin and the
Secretary retained experts. After the Court’s Opinion and Order remanding the
case, a hearing was held.
Mr. Goodwin is not entitled to compensation. A preponderance of the
evidence shows that he developed transverse myelitis 68 days after the vaccination.
This latency is outside the period for which an inference of causation is
appropriate. In addition, Mr. Goodwin has not demonstrated that the HPV vaccine
can cause transverse myelitis by presenting a reliable theory. Finally, there is an
absence of evidence that Mr. Goodwin developed an antibody that is essential to
his expert’s theory of causation. For these reasons, compensation is denied.
I. Summary of Evidence about Mr. Goodwin
A. Before Vaccination and Vaccination
Mr. Goodwin was born in 2004. Exhibit 3. He received various
vaccinations throughout his life, starting with a diphtheria-tetanus-acellular
pertussis vaccine in 2004 when he was an infant. Id. A report from 2018 states
that he had a seizure (staring spells) when he was 7 years old. Exhibit 7 at 650.
He also had autism. Id. at 649; Tr. 45-46.
When Mr. Goodwin was nearly 13 years old, he was seen for a variety of
problems, including mental health issues. A checkbox form for review of systems
shows that Mr. Goodwin was positive for constipation and negative for bladder
leakage. Exhibit 80 at 143 (Sep. 28, 2017).3 Most of the history of present illness
reflects mental health problems. However, in this context, Ms. McCluskey
“reports enuresis.” Id. at 144. “Enuresis” is a medical term for “urinary
incontinence.” Dorland’s Illus. Med. Dictionary 621 (33rd ed.).
Roughly two months later, Ms. McCluskey provided information to school
officials to assist with Mr. Goodwin receiving educational programming that was
appropriate for him. Ms. McCluskey stated that Mr. Goodwin was “toilet-trained
by age three and one half years. He currently toilets independently, but
occasionally has an accident at night. He waits until the last minute and reports he
3 This medical record, which contains information about Mr. Goodwin’s health before the
vaccination, was filed after the hearing. The Secretary cited it in his August 11, 2025 brief. In
contrast, Mr. Goodwin did not cite any medical records obtained after the hearing and, instead,
maintained that the “facts are substantially the same as previously described in both Petitioner’s
Brief on Entitlement, and Respondent’s Brief on Entitlement.” Pet’r’s Post-Hearing Br. at 1.
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does not feel the need to go.” Exhibit 79 at 82 (Dec. 1, 2017). There was also a
note, from either Ms. McCluskey or a teacher that he “had an accident (bowel
movement) in pants recently at school.” Id.
At the age of 13 years, when he was in sixth grade, on March 22, 2018, Mr.
Goodwin attended a well-child visit at Texas Health Family Care with Ms.
McCluskey. Exhibit 6 at 2-24. The primary provider was a nurse practitioner,
Justin Eric Decoux. Academically, Mr. Goodwin was doing well. He also had
signs of a learning disability, delayed speech. Id. Mr. Goodwin’s past medical
history included attention deficit hyperactivity disorder, asthma, autism, eczema,
obsessive compulsive disorder, and oppositional defiant disorder. Exhibit 6 at 4.
Ms. McCluskey reported that there was “no bed wetting.” Id. at 2. Upon the
review of systems, Mr. Goodwin was negative “for dysuria, frequency and
urgency.” Id. at 5. Ms. McCluskey also stated that she was concerned about her
son possibly having a seizure recently. However, she did not take him to an
emergency room. Id. at 3. Mr. Decoux referred the family to a neurologist. Id. at
7, 48.
Mr. Decoux planned to update the vaccinations. Exhibit 6 at 7-8.
Accordingly, Mr. Goodwin received the allegedly causal HPV vaccine on March
22, 2018. Exhibit 3 at 1; Exhibit 6 at 7. Although he received other vaccines on
that date, Mr. Goodwin’s claim rests upon the HPV vaccine.
B. Interlude between Vaccination and Hospitalization
Ms. McCluskey and Mr. Goodwin returned to Texas Health Family Care the
following day, March 23, 2018. Exhibit 6 at 25-45. He was complaining about
dizzy spells. Id. at 25. He was diagnosed with otitis media and given a
prescription for amoxicillin-clavulanate. Id. at 29. Another prescription was for
meclizine, a medication for nausea. Id. Ms. McCluskey was informed that if Mr.
Goodwin did not improve in the next 2-3 days or if he worsens with a high fever,
they should return to the medical office or go to an emergency room. Id. at 29.
Via an affidavit submitted after remand, Ms. McCluskey averred that
employees of Jean McClung Middle School called her at the end of March and
early April 2018 because Mr. Goodwin had lost control of his bladder. Exhibit 43
(signed Nov. 13, 2024). A record created approximately a year and a half later
recounts that Ms. McCluskey informed neurologists Lauren Tardo and Benjamin
Greenberg that approximately “1.5 – 2 weeks” after receiving vaccines on March
22, 2018, Mr. Goodwin “started having episodes of bowel and bladder
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incontinence at school.” Exhibit 42 at 2394 (Dec. 13, 2019).4 Ms. McCluskey also
told Dr. Tardo that “episodes of incontinence continued a few times per week
during April and this continued into May.” Id.
Ms. McCluskey and Mr. Goodwin returned to Texas Health Family Care on
April 11, 2018. Exhibit 6 at 56-72. Nurse Practitioner Decoux saw him again.
The complaint was a “fever blister on right side of mouth, X2 weeks now.” Id. at
51. Although the medical record documents Ms. McCluskey’s description of the
blister, she testified “it was a pimple.” Tr. 59. The April 11, 2018 record does not
memorialize any concerns about loss of bladder control. See Exhibit 6. The
review of systems states “Negative for tingling and sensory changes.” Id. at 53.
Mr. Decoux diagnosed “herpes labialis without complication” and prescribed
acyclovir. Id. at 54.
The next appointment at Texas Health Family Care occurred on May 10,
2018.5 Exhibit 6 at 73-94. Ms. McCluskey told Mr. Decoux that Mr. Goodwin
was “having hearing issues” at school and home. Id. at 73. This note does not
memorialize a complaint about loss of bladder control. See id. The review of
systems was positive for hearing loss and negative for dizziness and tingling. Id. at
75. After a hearing test, Mr. Decoux diagnosed Mr. Goodwin as having “Bilateral
hearing loss, unspecified hearing loss type.” Id. at 76. Mr. Decoux referred Mr.
Goodwin to an audiologist with an expectation that a referral to an ENT might be
appropriate. Id. at 77, 93.
C. Hospitalization
At nearly 10:00 PM on May 30, 2018, Ms. McCluskey brought Mr.
Goodwin to an emergency department at Texas Health Hurst-Euless-Bedford.
Exhibit 78 at 46. The chief complaint was heat exposure that occurred while he
was doing yard work. During their evaluations, medical personnel determined that
Mr. Goodwin was ataxic. Id. at 50. Thus, Mr. Goodwin was transferred to a
hospital that had additional resources. Id. at 50, 69.
Early in the morning on May 31, 2018, Ms. McCluskey brought Mr.
Goodwin to the emergency department at Cook Children’s. Exhibit 7 at 64
(nurse’s triage note from 2:33 A.M.). Ms. McCluskey reported that Mr. Goodwin
4 This history appears to be carried into the record for a June 12, 2020 telehealth
appointment. Exhibit 41 at 912.
5 Mr. Goodwin does not recount this episode in his November 18, 2024 brief.
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“was outdoors throughout the day today, helping his Mother clean out her car.
[Mr. Goodwin] became overheated around 1800 and started vomiting.” Id.6 This
note states that Mr. Goodwin was being transferred to Cook Children’s from THR
HEB. In addition to continued vomiting, Mr. Goodwin had difficulty with
walking, balance, and coordination. Id. Mr. Goodwin was hospitalized.
While in the hospital, Mr. Goodwin underwent various tests, including
MRIs. The MRI of the thoracic spine was consistent with transverse myelitis.
Exhibit 7 at 1349; see also id. at 99. The neurologists whom the parties retained
agreed that transverse myelitis is an appropriate diagnosis. See Exhibit 11 (Dr.
Steinman’s report) at 15, Exhibit A (Dr. Ghosh’s report) at 7. The interval
between March 22, 2018 (the date of vaccination) and May 30, 2018 (the potential
onset of symptoms) is 68 days.7
While Mr. Goodwin was in the hospital, a neurologist (Warren Marks) and
nurse practitioner (Marcie Mara Baldwin) saw Mr. Goodwin on June 26, 2018 at
approximately 10:00 A.M. Exhibit 7 at 112-16. This note comments upon a
possible link between the vaccine and the transverse myelitis:
Have previously discussed vaccines 8 weeks+ prior to
onset of TM, doubtful cause of TM, TM has multiple
causes, comes in clusters in the community. Further
vaccines per PCP [presumably primary care physician] or
ID [presumably infectious diseases] and Red Book but
would not give him anything for about a year to let the
immune system calm down.
Id. at 113.8
6 Given the context of the outdoor activities and the early hour, the reference to “today”
appears to mean May 30, 2018. See Pet’r’s Post-Remand Br. at 3.
7 Although the Secretary’s Rule 4(c) Report states that the onset of Mr. Goodwin’s illness
was 69 days post-vaccination, the parties have since referenced an onset of 68 days. This
Decision adopts the parties’ presentation.
8 Similar passages about vaccines “8 weeks+ prior” are found in the hospital records. See
Exhibit 7 at 313 (June 26, 2018 case management note by Nurse Lisa Wafer); Id. at 108 (June
27, 2018 progress note written by Nurse Practitioner Baldwin and signed by Dr. Marks); Id. at
311 (June 27, 2018 case management note written by Nurse Joan Ford); Id. at 102 (June 28, 2018
progress note written by Nurse Practitioner Baldwin and signed by Dr. Marks); Id. at 310 (June
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Mr. Goodwin remained hospitalized for transverse myelitis until June 29,
2018. Exhibit 7 at 73 (discharge summary). In the hospital, a pediatric urologist
stated that Mr. Goodwin was suffering from “urine retention secondary to
transverse myelitis.” Exhibit 7 at 90. Other medical professionals noted that Mr.
Goodwin had difficulty with balance and walking. See, e.g., id. at 88-89 (report
from occupational therapist, dated June 5, 2018); id. at 133 (report from
neurologist describing ataxic gait).
At discharge, Dr. Marks endorsed a report written by a nurse practitioner.
This report states that Mr. Goodwin “has progressed to walking stand by assist
using a wheelchair for distances re: fatigue. He requires minimal assistance with
ADLs [activities of daily living]. He initially required I/O [intraosseous]
catheterizations but has since begun to void spontaneously.” Exhibit 7 at 76. In an
examination, Mr. Goodwin had a “sensory deficit, decreased light touch, pressure
and temperature is present below the hip, able to feel the touch but not
differentiate.” Id. The discharge instructions included that Mr. Goodwin “Needs
24 hour adult supervision.” Id. at 79. He was also expected to follow up with
therapists and his primary care physician in the next weeks. Id. at 80.
D. Remainder of 2018
After Mr. Goodwin’s discharge, many medical records discuss residual
problems stemming from his transverse myelitis. Although these medical records
would be relevant to determining the amount of compensation for the transverse
myelitis, they tend not to be relevant to determining whether the vaccine caused
the transverse myelitis. For details about these records, see Pet’r’s Post-Remand
Br. at 6-7; Resp’t’s Post-Remand Br. at 3-9.9
However, some records do touch upon the issue of causation. On July 13,
2018, Ms. McCluskey brought her son to see a pediatric neurologist, Adrian Lacy.
Exhibit 7 at 2746-54. Dr. Lacy’s history begins with a lengthy summary of events
during Mr. Goodwin’s recent hospitalization. As part of this recitation of history,
28, 2018 case management note written by Nurse Ford). It appears that all derive from the June
26, 2018 progress note from Nurse Practitioner Baldwin and Dr. Marks.
9 The parties filed several briefs after the case was remanded. The briefs filed on
November 18, December 9, and December 23, 2024 are referred to as the parties’ Post-Remand
briefs and reply. Although cited as “Post-Remand,” these briefs functioned as pre-hearing briefs.
The briefs filed on August 11, September 5, and September 8, 2025 are referred to as the parties’
Post-Hearing briefs and replies.
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Dr. Lacy noted: “No CSF studies are seen in EPIC.[10] Serum NMO/MOG
antibodies are also not seen. He did have vaccination in March, menactra and
DTAP and HPV.” Id. at 2749. Since the discharge from the hospital, Mr.
Goodwin “is walking only short distances, uses wheelchair for longer distances.
He does not have control of bladder.” Id. Dr. Lacy, Ms. McCluskey, and Mr.
Goodwin “discussed idiopathic transverse myelitis, and other potential syndromes,
including NMO and MOG antibody syndromes, which may relapse.” Id. at 2753.
Dr. Lacy, accordingly, ordered testing to detect antibodies associated with NMO
and MOG. Id. at 2754; see also id. at 2769 (telephone or email exchange between
Dr. Lacy and a nurse).
The testing for the antibody associated with NMO was negative. Exhibit 7
at 2983 (date of result: Aug. 6, 2018). On August 7, 2018, Dr. Lacy informed Ms.
McCluskey that the results for NMO were negative. Exhibit 7 at 3022. This led to
an exchange of telephone messages memorialized in the chart.
Ms. McCluskey asked if the vaccines could have been the cause. Id. Dr.
Lacy’s response was to “defer this [question] to ID [infectious diseases] to follow
up results of their testing. Epidemiology does not show an increased rate of
children receiving vaccines having transverse myelitis.” Id.
While there is a result for the NMO test, the result of any test for MOG
antibodies does not appear in the medical records. See Exhibit 29 (Dr. Steinman’s
second report) at 6 (“the evaluation never succeeded in measuring anti-MOG
antibodies and never reported either positive or negative results in the chart”).
E. More Recent Medical Records
Mr. Goodwin spent most of 2019 living in Pittsburgh, Pennsylvania. There,
he was treated for a musculoskeletal curve, which the doctors associated with his
transverse myelitis. See Exhibit 40 at 179.
This problem remained when he returned to Texas. See Exhibit 42 at 2539,
2542-43 (discussing Mr. Goodwin’s spinal curvature at a November 12, 2019
appointment). He also had follow-up appointments with a urologist. Id. at 2562.
Mr. Goodwin saw neurologists, Dr. Tardo and Dr. Greenberg, on December
13, 2019. It was at this appointment that Ms. McCluskey first reported that Mr.
Goodwin “started having episodes of bowel and bladder incontinence at school”
10 Epic is the name of a system for creating and storing medical records electronically.
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within two weeks of his vaccination. Exhibit 42 at 2394. After an examination
and review of the May 31, 2018 MRI images, Dr. Tardo assessed Mr. Goodwin as
having acute flaccid myelitis. She wrote: “Exam today demonstrated LMN
findings in his back which likely lead to his rapid scoliosis and UMN findings in []
his lower extremities (brisk reflexes, up-going toes). Presentation at this time is
most consistent with acute flaccid myelitis affecting the thoracic spine.” She
ordered another MRI and lab testing and directed Mr. Goodwin to physical
therapy.
The source of material for the lab studies was collected on the date of the
appointment with Doctors Tardo and Greenberg, December 13, 2019. Exhibit 42
at 2442. A Mayo Clinic Laboratory reported that the test for NMO was negative
and the test for MOG was also negative. Id. As discussed below, the parties
dispute the significance of the negative result for MOG antibodies.
The follow up MRIs took place on January 6, 2020. The brain MRI showed
“No significant intracranial abnormality.” Exhibit 42 at 2260. The interpreting
radiologist noted: “No evidence of optic neuritis.” Id.
For Mr. Goodwin’s spine, the radiologist obtained imaging for his cervical,
thoracic, and lumbar spines. Exhibit 42 at 2263-71. The radiologist compared the
results from the earlier MRIs from May 31, 2018. Across these three images, the
radiologist found that “The previously noted abnormal signal intensity within the
ventral thoracic spinal cord has essentially resolved. There appears to be some
subtle cystic change in the ventral cord at the T3 level.” Id. at 2263. The
radiologist also noted the “Interval development of prominent S-shaped spinal
scoliosis.” Id.
Mr. Goodwin’s experience in physical therapy for transverse myelitis does
not help determine the cause of the transverse myelitis. Similarly, Mr. Goodwin’s
follow up appointments with orthopedists, urologists, and neurologists appear not
to affect the expert’s opinions regarding causation. For details, see Resp’t’s Post-
Remand Br. at 8-9; Resp’t’s Post-Hearing Br. at 10-13.
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II. Procedural History
A. Events in Litigation before and until Remand
1. Events before Expert Reports
Mr. Goodwin’s mother, Sheri McCluskey, initiated the litigation by filing a
petition on April 4, 2019 when Mr. Goodwin was still a minor. Mr. Goodwin filed
his medical records on various dates.
The Secretary disputed Mr. Goodwin’s entitlement to compensation.
Resp’t’s Rep. The Secretary questioned whether an onset of 69 days was
appropriate. Id. at 8.
The parties retained experts. Mr. Goodwin retained Lawrence Steinman.
Before remand, Dr. Steinman wrote four reports. Exhibits 11, 27, 29, and 37.
The Secretary retained two experts: Partha Ghosh, a pediatric neurologist,
and S. Mark Tompkins, who has earned a Ph.D. in immunology but is not a
medical doctor. Each wrote three reports before remand. Dr. Ghosh’s reports are
Exhibits A, AA, and JJ. Dr. Tompkins’s reports are Exhibits K, CC, and LL. A
recitation of the key points from the expert reports, beginning with the earliest
report follows:
2. Dr. Steinman and His First Report
Dr. Steinman has often been retained by petitioners in the Vaccine Program,
and special masters have become accustomed to reviewing his opinions. Dr.
Steinman graduated from Harvard Medical School in 1973. He completed his
residency at Stanford University Hospital in pediatrics in 1974, held fellowships
between 1975-1977, and returned to Stanford as a resident in pediatric and adult
neurology from 1977-1980. Dr. Steinman thereafter served in various academic
roles, primarily at Stanford University, which he continues to the present. He
served as chairman of Stanford’s Program in Immunology from 2002-2011 and
since 2008 he has been the incumbent of the George A. Zimmerman Chair as
professor of neurological sciences, neurology, and pediatrics. He has been board
certified in neurology since 1984. Exhibit 12 at 1-2.
Dr. Steinman is an attending neurologist at Stanford. Exhibit 11. He has
published hundreds of articles related to neuroinflammation, including transverse
myelitis, acute disseminated encephalomyelitis, neuromyelitis optica and multiple
sclerosis, and had cared for over 50 individuals with transverse myelitis or
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neuromyelitis optica in the five years prior to writing his first expert report for this
case in 2020. Id.
In his first report, Dr. Steinman reviewed his qualifications and disclosed the
material he reviewed. Exhibit 11 at 1-4. Dr. Steinman also summarized the
pertinent medical records, by, in part, quoting from the Secretary’s report. Id. at 4-
5. Dr. Steinman described transverse myelitis and asserted that Mr. Goodwin
suffered from transverse myelitis. Id. at 5-6. These foregoing aspects of Dr.
Steinman’s first report are not meaningfully disputed.
Dr. Steinman disclosed a theory how the HPV-9 vaccine can cause
transverse myelitis. Exhibit 11 at 6-15. As discussed in more detail below, Dr.
Steinman relies upon the theory of molecular mimicry. By searching a computer
database, Dr. Steinman identified portions of the HPV vaccine and portions of
myelin oligodendrocyte glycoprotein that share sequences of amino acids. Id.
Citing a paper by Jarius et al., Dr. Steinman asserted that “MOG is known to be
targeted in transverse myelitis.” Id. at 11. Dr. Steinman maintained that his three-
step process, which is further assessed below, “make a compelling theory that
molecular mimics in the HPV9 vaccine received by petitioner could trigger
immunity to MOG culminating in transverse myelitis.” Id. at 15 (emphasis in
original).
Dr. Steinman next discussed the timing. Dr. Steinman stated: “The onset
following the immunization on March 22, 2018 was May 30, 2018. . . . The
interval would be approximately 9 weeks and 5 days.” Exhibit 11 at 15. As to
why this interval is one for which an inference of causation is appropriate, Dr.
Steinman wrote two sentences: “An interval of several months was reported in a
series by Menge et al on neuromyelitis optica following HPV vaccination. The
intervals in the four cases were 5 months case 1, 5 months in case 2, unknown
interval case 3, and 5 months in case 4.” Id. at 16.
For the second Althen prong, Dr. Steinman wrote one sentence: “The theory
is logical in that it is based on the concept of molecular mimicry which is widely
recognized and where there is considerable support in the peer reviewed literature
including the papers cited here.” Exhibit 11 at 16. Dr. Steinman dismissed any
non-vaccine potential causes. Id.
3. Dr. Ghosh and His First Report
Dr. Ghosh received his degree in medicine from the University of Calcutta
in India in 1999. He completed a residency in pediatrics in 2003 and a fellowship
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in neurology in 2006, both at the Postgraduate Institute of Medical Education and
Research in India. Dr. Ghosh then completed a residency in pediatrics and a
fellowship in child neurology at the Cleveland Clinic in Ohio between 2007 and
2012, and fellowships in neuromuscular disorders and clinical neuropsychology at
the Mayo Clinic in Rochester, Minnesota between 2012 and 2014. Since 2014, Dr.
Ghosh has taught classes in neurology at Harvard Medical School and has worked
as an attending neurologist at Boston Children’s Hospital. He has been the director
of the EMG laboratory at Boston Children’s Hospital since 2014, and the co-
director of the hospital’s Muscular Dystrophy Association Care Center since 2017.
Dr. Ghosh is board-certified by the American Board of Psychiatry and Neurology
with a special qualification in Child Neurology and is a diplomate of the American
Board of Electrodiagnostic Medicine. Exhibit B.
Dr. Ghosh has published more than 60 peer-reviewed articles on “various
topics of pediatric neurology,” including transverse myelitis. Exhibit A at 1-2. At
the time of writing his report, he had seen more than five cases of transverse
myelitis in the previous five years. Id. at 2.
Like Dr. Steinman, Dr. Ghosh began his first report by presenting his
qualifications and listing the material he reviewed. Exhibit A at 1-2. Dr. Ghosh
recited events from Mr. Goodwin’s medical records and summarized information
about transverse myelitis. Id. at 2-7. Dr. Ghosh mentioned---twice---that he did
not see any results of tests for MOG antibodies. Id. at 3, 6. Dr. Ghosh agreed that
Mr. Goodwin suffered from acute transverse myelitis, which Dr. Ghosh
abbreviated as “ATM.” Id. at 5. Thus, much of this background material is not
meaningfully disputed.
As to the means by which the HPV vaccine could cause transverse myelitis,
Dr. Ghosh deferred to the Secretary’s second expert, Dr. Tompkins. Exhibit A at
7. However, Dr. Ghosh introduced several articles, including articles by Agmon-
Levin, Baxter, the Institute of Medicine, and Pidcock. Id. at 7-10. These articles
are discussed in more detail below.
As to timing, Dr. Ghosh disagreed with Dr. Steinman’s reliance on Menge.
Dr. Ghosh maintained: “NMO [neuromyelitis optica] and ATM are not the same
disease and the cases cited by petitioner’s expert do not support a proximate
temporal relationship between the HPV vaccine and ATM.” Exhibit A at 10. In
his conclusion, Dr. Ghosh emphasized the long latency between the vaccination
and the onset of the transverse myelitis:
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Even when we find a possible association between these
two entities [vaccinations and transverse myelitis], it is
clear that the strongest case for a causal relationship is
when vaccines were administered within a month of
development of ATM. Hence, I conclude that in this
case, onset of ATM after 68 days following vaccinations
lacks significant causal relationship.
Id. at 11.
4. Dr. Tompkins and His First Report
Dr. Tompkins received a Ph.D. in Immunology and Molecular Pathogenesis
from Emory University in 1997. Exhibit K; Exhibit L. He did postdoctoral work
in Immunology at Northwestern University and in Virology/Immunology at the
Center for Biologics Evaluation and Research in the FDA. Exhibit L. Since 2005,
he has taught courses in the Department of Infectious Diseases within the College
of Veterinary Medicines at the University of Georgia, progressing from an
assistant professor to a full professor to the assistant department head and
curriculum coordinator. Id. His research “focuses on understanding the
interactions of influenza virus and influenza vaccines with the host.” Exhibit K at
1. Dr. Tompkins has co-authored over 90 peer-reviewed articles and book chapters
on immunology and virology, serves as an ad hoc reviewer for NIH study sections
and scholarly journals, and serves on the editorial board for several journals. He
has not published in peer-reviewed journals about “the vaccine or adverse events
related to this case.” Id. at 1-2. Dr. Tompkins is not licensed to practice medicine
and holds no board certifications.
As with Dr. Steinman and Dr. Ghosh, Dr. Tompkins starts his report by
presenting his qualifications, listing the materials he reviewed, and summarizing
events from Mr. Goodwin’s medical records. Exhibit K at 1-4. Again, this
background material is not meaningfully disputed.
The controverted aspects of Dr. Tompkins’s report concern molecular
mimicry. He asserts: “while molecular mimicry is extensively studied and is an
accepted hypothesis for how various insults (e.g. infection) may turn an
individual’s immune system against itself, there is a paucity of experimental
evidence demonstrating a wild type infection (meaning no manipulation of the
system) triggering autoimmune disease through molecular mimicry.” Exhibit K at
4. Dr. Tompkins offers more specific challenges to aspects of Dr. Steinman’s
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three-step process, but a description of these details is deferred until section VI.A.
below.
As to timing, Dr. Tompkins disputed Dr. Steinman’s reliance on Menge. Dr.
Tompkins offered at least three arguments, including the discrepancy in latency as
reported by Menge and as reported in other articles by Pidcock and De Goede. Id.
at 5-6. Dr. Tompkins maintains that “it is unlikely that the HPV9 vaccine resulted
in TM almost 10 weeks later.” Id. at 6. Dr. Tompkins supported this assertion by
referencing studies about the duration of antibodies following human
papillomavirus vaccines. Id. at 6-7.
Dr. Tompkins also asserted that: “there is considerable data demonstrating
the safety of HPV vaccines.” Exhibit K at 7. He cited a study by the World Health
Organization.
Finally, for Mr. Goodwin’s case, Dr. Tompkins suggested that the evidence
surrounding herpes virus “is at least as strong, if not stronger” than the evidence
regarding the HPV vaccine. Exhibit K at 7. Dr. Tompkins maintained that an
opinion based upon the herpes virus “fulfills the three criteria of Althen.” Id. at 8.
5. Dr. Steinman’s Second Report
As both Dr. Ghosh and Dr. Tompkins had challenged aspects of Dr.
Steinman’s opinion, Dr. Steinman addressed both in his next report. With respect
to Dr. Ghosh, Dr. Steinman asserts that two of the four patients in the Menge
article “could well have been MOG driven transverse myelitis cases.” Exhibit 27
at 2. As to whether Mr. Goodwin had MOG antibodies, Dr. Steinman agreed with
Dr. Ghosh that results of testing for MOG antibodies were not found. Id.
Dr. Steinman’s response to Dr. Tompkins repeats Dr. Steinman’s assertion
that two of the Menge patients could have MOG. Exhibit 27 at 4. Thus, Dr.
Steinman implies that the presence of a case report of a neurologic disease
developing about five months after a vaccination means that the latency in Mr.
Goodwin’s case (about two and a half months) is an interval for which an inference
of causation is appropriate. Id. In further support of timing, Dr. Steinman cites the
duration of antibody responses. Id. at 4-5.
Dr. Steinman also defended his proposal of molecular mimicry in response
to Dr. Tompkins’s criticisms of it. Dr. Steinman contended that Dr. Tompkins
seems to be asking for studies done specifically on Mr. Goodwin. Exhibit 27 at 3-
4.
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Finally, Dr. Steinman responded to Dr. Tompkin’s identification of herpes
virus as a potential alternative cause. Dr. Steinman opined that herpes virus was
not likely because a Blast search failed to detect much homology between herpes
simplex virus-1 and MOG. Exhibit 27 at 6.
6. Dr. Ghosh’s Second Report
Dr. Ghosh made two points in his second report. First, he argued that the
patients in Menge suffered from NMO, not transverse myelitis. Exhibit AA at 1-2.
Second, he argued that Mr. Goodwin’s transverse myelitis was idiopathic, not
associated with MOG antibodies. Id. at 2-4.
7. Dr. Tompkins’s Second Report
Dr. Tompkins identified a few issues from Dr. Steinman’s previous report to
which he wanted to respond. First, Dr. Tompkins challenged molecular mimicry in
the context of Mr. Goodwin’s case. Dr. Tompkins asserted that “there is no
experimental evidence from an animal model of neuropathy or similar system
demonstrating that the HSV L1 capsid is presented by antigen-presenting cells to
elicit cross-reactive T cells that also recognize MOG epitopes (e.g.
CWKITLFVIV), that then attack neuronal tissues and trigger autoimmune
disease.” Exhibit LL at 2. In this context, Dr. Tompkins also cited studies about
the safety of the HPV vaccine.
Dr. Tompkins’s second and third points argue against the latency between
the HPV vaccination and the onset of Mr. Goodwin’s transverse myelitis. The
second point discussed the Menge article. The third point discussed the duration of
T cells. Exhibit LL at 3.
Dr. Tompkins’s fourth point maintained that herpes virus can trigger a
neuropathy like transverse myelitis. Dr. Tompkins proposed that the herpes virus
can directly infect neurons. Exhibit LL at 4. Thus, to Dr. Tompkins, he was not
proposing molecular mimicry, making Dr. Steinman’s use of Blast searches
irrelevant. He also cited a series of case reports in which an infection with herpes
virus preceded the development of myelitis. Id.
8. Dr. Steinman’s Third Report
Much of Dr. Steinman’s third opinion was focused on defending his reliance
on Menge. Dr. Steinman stated that he cited Menge because “it is the only article
[Dr. Steinman] can find in the literature that links HPV vaccine to cases where
longitudinally extensive transverse myelitis is seen.” Exhibit 29 at 1. Dr.
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Steinman maintained that the disease affecting Mr. Goodwin, transverse myelitis,
is a “prominent feature of NMO,” the disease studied in Menge. Id. at 4.
Dr. Steinman also explained why his Blast search involving MOG fit Mr.
Goodwin’s case. Noting that Dr. Lacy had ordered a test for MOG antibodies but
no result appears, Dr. Steinman distinguished between the “absence of evidence”
and “evidence of absence.” Exhibit 29 at 6-8. Thus, Dr. Steinman appears to
suggest that Mr. Goodwin could have developed antibodies to MOG.
Dr. Steinman further asserted that his opinion regarding molecular mimicry
should be credited, despite Dr. Tompkins’s criticisms. Exhibit 29 at 8-9.11 Dr.
Steinman added another case report in which an HPV vaccination preceded the
onset of NMO. Id. at 9, citing Chang. Dr. Steinman also asserted that the
antibodies generated through a process starting with an HPV vaccination persist for
at least two years. Id. at 10.
Finally, Dr. Steinman responded to Dr. Tompkin’s raising a herpes infection
as a possible alternative cause. Among other points, Dr. Steinman asserted that
PCR testing was not done to show herpes. Id. at 10.
9. Dr. Ghosh’s Third Report
Dr. Ghosh’s third report tends to repeat what he previously asserted. Dr.
Ghosh stated that the patients in the Menge article suffered from NMO, not acute
transverse myelitis. In response to Dr. Steinman’s statement that the Menge article
was the only article linking HPV vaccine to longitudinally extensive transverse
myelitis, Dr. Ghosh answered: “The Menge paper was published in 2012. If there
was any association with the HPV vaccine and longitudinally extensive TM, one
would expect many more reported cases of HPV and longitudinally extensive
11 Dr. Steinman also extensively quoted from a decision of a special master in White v.
Sec'y of Health & Hum. Servs., No. 15-1521V, 2019 WL 7563239 (Fed. Cl. Spec. Mstr. Dec. 19,
2019). Exhibit 29 at 1-3. Dr. Steinman’s discussion of legal precedents exceeds his role. See,
e.g., D.G. v. Sec'y of Health & Hum. Servs., No. 11-577V, 2019 WL 2511769, at *189 (Fed. Cl.
Spec. Mstr. May 24, 2019). As a doctor, Dr. Steinman should focus upon medicine. See Exhibit
29 at 4 (Dr. Steinman defining his job as “educat[ing] the Court.”). Mr. Goodwin is represented
by attorneys, who are capable of bringing forward analogous legal precedents. Although White
is an example in which a special master credited Dr. Steinman’s molecular mimicry theory, 2019
WL 7563239, at *23-24, this ruling does not constitute binding precedent. Boatmon v. Sec’y of
Health & Hum. Servs., 941 F.3d 1351, 1358 (Fed. Cir. 2019).
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transverse myelitis to have been published in the last nine years, especially given
the millions of HPV vaccines that have been administered.” Exhibit JJJ at 2.
Dr. Ghosh also commented about MOG antibodies. Dr. Ghosh stated:
“MOG antibodies were not tested in the case of TDG. However, one cannot
conclude- as Dr. Steinman does- that if TDG's physicians had tested for MOG
antibody, the test could have been positive, and that this hypothetical positive
result proves the association of MOG associated transverse myelitis with HPV
vaccine.” Id. at 3.
10. Dr. Tompkins’s Third Report
Although in Dr. Tompkins’s second report he had identified four issues with
Dr. Steinman’s opinion, Dr. Tompkins identified six short disputes in his third
report. First, there was a continued discussion over whether Mr. Goodwin could
have suffered from MOG-associated transverse myelitis. Exhibit CCC at 2.
Second, Dr. Tompkins returned to the Menge article. He asserted: “Case reports
do not provide evidence of causation and Menge et al. (2012) does not offer
evidence associating the [HPV] vaccination with disease.” Id. at 3. Dr. Tompkins
addressed Dr. Steinman’s recently cited case report, Chang. Dr. Tompkins also
maintained that the “absence of VAERS data or other similar studies suggesting a
possible safety signal involving HPV vaccination and TM argues strongly that
there is no evidence of association.” Id. at 3.
Dr. Tompkins’s third and fourth point concerned the timing. Dr. Tompkins
stated that Menge’s “single case with information on timing of vaccination had a
five-month interval between vaccination and onset of symptoms. This is sparse
support for Dr. Steinman’s hypothesis.” Exhibit CCC at 3. Dr. Tompkins also
disputed whether the duration of antibodies “can explain onset of TM or NMO.”
Id. at 4. Dr. Tompkins continued: “A 42-day risk period is widely used to
determine temporal association between vaccination and an adverse event. This
risk window is based upon many epidemiologic studies with infections and/or
vaccinations. Dr. Steinman fails to provide an argument as to why this time
interval should be different for HPV vaccination and onset of TM.”
Fifth, Dr. Tompkins stated, “we are left with no experimental evidence that
HPV infection or vaccination with HPV L1 proteins can cause any autoimmune
disease, including TM.” Exhibit CCC at 4.
Sixth, Dr. Tompkins maintained that an infection with herpes virus is a
plausible trigger for neuropathy. Exhibit CCC at 5.
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11. Dr. Steinman’s Fourth Report
Dr. Steinman’s response to Dr. Ghosh essentially repeated what Dr.
Steinman had said previously. This repetition is not terribly surprising as Dr.
Ghosh’s most recent report generally reiterated what Dr. Ghosh had said before.
In response to Dr. Tompkins, Dr. Steinman added references about
molecular mimicry in the contest of Epstein-Barr virus potentially causing multiple
sclerosis. Exhibit 37 at 3-5. Dr. Steinman has frequently relied upon these
articles.
12. Events after Submission of Expert Reports
After the parties filed this series of reports, a status conference was held. A
primary question was whether 68 days is an appropriate interval. The parties
agreed to submit briefs. Order, issued May 24, 2022.
Both parties advocated. Mr. Goodwin filed his primary brief on July 25,
2022, and his reply on December 21, 2022. In between, the Secretary submitted
his brief on September 23, 2022.
Mr. Goodwin was found not entitled to compensation. First Entitlement
Decision, issued April 16, 2024, 2024 WL 2033563. The reason was that Mr.
Goodwin had not established that 68 days was an interval for which an inference of
causation was appropriate.
Mr. Goodwin challenged this determination. Pet’r’s Mot. for Rev., filed
May 16, 2024. The Court granted the motion for review and vacated the April 16,
2024 decision on October 10, 2024. 2024 WL 4758470.
B. Events in Litigation after Remand
Following remand, the parties worked commendably quickly and
cooperatively to expedite proceedings. For example, within about two weeks of
the Opinion and Order remanding the case, Mr. Goodwin asked for and received
authorization to subpoena medical records.
Due, in part, to the end-of-the-year holidays and commitments in other
cases, Mr. Goodwin and the Secretary jointly requested that the Court extend the
deadline for completing the remand for an additional 60 days (or until March 10,
2025). The Court ruled that the Vaccine Act does not allow the Court to extend the
time for remand beyond 90 days. Order, issued Oct. 28, 2024, citing 42 U.S.C.
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§ 300aa–12(e)(2). However, the Court added that “there does not appear to be a
consequence for exceeding the 90-day remand period.” Id., citing Greene v. Sec’y
of Health & Hum. Servs., No. 11-631V, slip. op. at 3 (Fed. Cl. May 30, 2018) and
Paluck v. Sec’y of Health & Hum. Servs., 111 Fed. Cl. 160, 165 (2013). The
Court, therefore, interpreted the parties’ joint request “as a waiver of their ability to
request any action on enforcing the Court’s 90-day remand order until after the
period of their requested extension---March 10, 2025---has passed.” Id. With
cooperation from the parties, a hearing was scheduled for January 9-10, 2025.
Order, issued Nov. 5, 2024.12
Mr. Goodwin submitted updated medical records on November 15, 2024.
Exhibits 40-41. In a comprehensive memorandum, he argued that he met all
Althen prongs. Pet’r’s Post-Remand Br.13 He also submitted additional medical
articles.14 Finally, Mr. Goodwin introduced an affidavit from his mother, the
original petitioner. Ms. McCluskey avers that around March 30, 2018, someone
from her son’s middle school called her to say he had lost control of his bladder,
and he needed clean clothes. Exhibit 43. In response to this assertion, Mr.
Goodwin was directed to obtain records from the school system. Order, issued
Nov. 25, 2024.
The Secretary maintained that Mr. Goodwin was not entitled to
compensation. Resp’t’s Post-Remand Br. Although the Secretary agreed that Mr.
Goodwin suffered from transverse myelitis (Resp’t’s Post-Remand Br. at 13-14),
the Secretary basically contested four points. First, the Secretary contended that a
preponderance of the evidence did not support a finding that Mr. Goodwin
experienced episodes of losing his bladder. Resp’t’s Post-Remand Br. at 14-16.
Second, largely based upon the opinions from Dr. Tompkins, the Secretary
challenged the reliability of molecular mimicry as a theory to explain how the
human papillomavirus vaccine can cause transverse myelitis. Id. at 16-21; see also
id. at 28-30 (discussing non-binding decisions from special masters rejecting Dr.
Steinman’s opinions). Third, the Secretary argued that the timing presented an
12 Scheduling a hearing in the Vaccine Program to take place approximately two months
later is remarkably quick. The parties’ flexibility and willingness to prioritize the hearing in this
post-remand case is greatly appreciated.
13 The July 25, 2022 brief and the December 21, 2022 reply addressed only Althen prong
three.
14 Normally, the submission of medical articles without an accompanying report from an
expert explaining the relevance of the medical articles is frowned upon, if not forbidden.
However, the expedited nature of a remand supported the use of shortcuts.
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interval for which an inference of causation was not appropriate. Id. at 14-16. To
some degree, the Secretary’s arguments overlapped with the arguments whether
Mr. Goodwin lost control of his bladder. The Secretary added that Dr. Steinman
disclosed an opinion that the onset of transverse myelitis was 68 days after
vaccination. Resp’t’s Post-Remand Br. at 16, citing Exhibit 11 (Dr. Steinman’s
report). Finally, the Secretary maintained that Mr. Goodwin had not established a
logical sequence of cause and effect. Resp’t’s Post-Remand Br. at 21-24. The
Secretary raised several points, including the lack of persuasive evidence regarding
Althen prongs one and two, the lack of statements from treating doctors supporting
causation, the lack of proof regarding MOG antibodies, and the presence of a
potential alternative cause (an infection with herpes virus).
Two aspects of the Secretary’s arguments required prompt attention. Thus, a
status conference was held on December 17, 2024. Mr. Goodwin stated that his
mother and he would testify at the upcoming fact hearing regarding the episodes of
bladder loss. In addition, Mr. Goodwin planned to obtain a supplemental report
from Dr. Steinman discussing whether episodes of loss of bladder were early
manifestations of transverse myelitis.
Mr. Goodwin submitted an affidavit on December 20, 2024, averring that
there were times “before [he] was in the hospital” that he lost his balance and lost
control of his bladder in school. Exhibit 57.15 He noted that the school nurse had
to call his mother to bring him a change of clothes. Id. Although Mr. Goodwin
attempted to corroborate the phone calls by subpoenaing records from T-Mobile
and AT&T, Mr. Goodwin eventually determined that these records did not
establish that the school system had telephoned his mother. See Pet’r’s Status
Rep., filed Jan. 22, 2025 (addressing AT&T records) and Pet’r’s Status Rep., filed
Feb. 26, 2025 (addressing T-Mobile records).16
Dr. Steinman’s supplemental report was filed on December 23, 2024.
Exhibit 58.17 Dr. Steinman opined that the onset of Mr. Goodwin’s TM was within
two weeks of his March 22, 2018 vaccination and that the loss of bladder control
and loss of leg mobility in March and April 2018 were the initial manifestations of
15 Mr. Goodwin’s affidavit was originally mislabeled as exhibit 49.
16 The problem was that Ms. McCluskey did not remember her cell phone number
accurately.
17 When this report was first filed, it was erroneously labeled as Exhibit 50.
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TM. His opinions on the first and second Althen prongs “remain[ed] unchanged.”
Id. at 3.
Dr. Ghosh’s supplemental report, which was prepared quickly, brought
forward essentially two points. Exhibit SSS (dated Dec. 30, 2024). First, Dr.
Ghosh discussed the December 13, 2019 appointment with Dr. Tardo. Dr. Ghosh
noted the results of the physical examination, the lab tests, and the MRIs. In Dr.
Ghosh’s view, Mr. Goodwin “did not have recurrence of myelitis or optic neuritis,
which is commonly seen in neuromyelitis optica (NMO), MOG-associated
conditions or multiple sclerosis (MS).” Id. at 3. Thus, Dr. Ghosh “strongly
disagree[d] with Dr. Steinman's assertion of bringing NMO and MOG in this case
(Ex. 50) when it is clear that the petitioner neither has NMO or MOG.” Id. Next,
Dr. Ghosh discussed the significance of the assertion that Mr. Goodwin had
intermittent episodes of urinary incontinence in April and May 2018. Dr. Ghosh
opined that these symptoms could not be attributable to the spinal cord “without
any objective clinical or radiological evidence.” Id. at 4. Dr. Ghosh added:
“Moreover, in ATM, progression to nadir is between 4 hours and 21 days
following onset of symptoms, which does not fit with petitioner’s temporal course
of urinary incontinence.” Id.
Although the parties had strived to schedule a hearing relatively promptly,
events interfered. The federal Government was unexpectedly closed for the first
day of the scheduled two-day hearing due to the funeral for former President
Carter. See Order, issued Jan. 2, 2025. In a status conference, the parties
expressed their preference that the hearing be completed on consecutive days.
Thus, the second day of the hearing was also canceled. Order, issued Jan. 3, 2025.
The parties agreed to hold the hearing on March 19-20, 2025. Order, issued Jan.
17, 2025.
During this extension, Mr. Goodwin filed additional evidence. For example,
Mr. Goodwin filed attendance records from his school from March through April
2018. Exhibit 67-68. Unfortunately, some information was no longer available as
the school system retains complete information for only five years. The submitted
material shows that on three occasions, Mr. Goodwin was “present.” “Present,” in
turn, means that “the student was present at school but missed part of his
instructional day. The entry might occur if a student has a Doctor’s Appt.”
Exhibit 68 at 1 (email from a paralegal of the school district).
The hearing was held, as scheduled for a second time, on March 19-20,
2025. Again, the attorneys and witnesses cooperated to make sure that the hearing
was held as soon as possible. Part of this cooperation involved starting the hearing
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at 10:30 A.M. Eastern Time to reflect that Dr. Steinman was testifying from the
Pacific Time Zone.
During the hearing, Ms. McCluskey, Mr. Goodwin, Dr. Steinman, Dr.
Ghosh, and Dr. Tompkins testified. Ms. McCluskey provided information about
medical professionals who treated her son and whose records had not been
produced previously. For example, when the family lived in McKeesport,
Pennsylvania before moving to Texas, Ms. McCluskey brought Mr. Goodwin to a
pediatrician. Tr. 37. Similarly, on May 30, 2018, when Mr. Goodwin was not
feeling well, the family brought him to an emergency room in Bedford before he
was transferred to Cook Children’s Hospital. Tr. 61-62.
Ms. McCluskey and Mr. Goodwin otherwise generally narrated events that,
in their view, happened between the vaccination and May 30, 2018. More
specifically, Ms. McCluskey and Mr. Goodwin each discussed the two episodes in
which Mr. Goodwin lost control of his bladder and wet his pants. Tr. 23-24, 84.
Dr. Steinman’s direct testimony was generally in accord with the opinions
he had disclosed in his reports. For example, just as he wrote in his second report,
Dr. Steinman testified that the results of MOG testing were absent. Tr. 102.
(Other details of Dr. Steinman’s oral testimony are presented in the context of
various topics below.)
On cross-examination, Dr. Steinman was again asked about testing for MOG
antibodies. Dr. Steinman was surprised to learn that testing from December 13,
2019 showed that Mr. Goodwin did not have MOG antibodies. Tr. 154-56.18 Dr.
Steinman’s spontaneous answer was that the testing occurred too late
(approximately 18 months later) to detect MOG antibodies. Thus, Dr. Steinman
opined that the negative test for MOG in December 2019 did not mean that Mr.
Goodwin also did not have MOG antibodies in May 2018.
18 Dr. Steinman suggested that he was being unfairly surprised with this information. Tr.
158. However, there was nothing unfair. Dr. Tardo and Dr. Greenberg ordered the MOG testing
as part of the visit in which they memorialized Ms. McCluskey’s history about two episodes of
loss of bladder control. Exhibit 42 at 2394. Due to the importance of this medical record as a
primary piece of evidence supporting a theory that Mr. Goodwin’s transverse myelitis started
less than 68 days after vaccination, Dr. Steinman should have been aware of it. Moreover, Dr.
Ghosh identified the results of the December 13, 2019 MOG testing in his December 30, 2024
report. Exhibit SSS at 2-3. Thus, Dr. Steinman should have known about the results of the 2019
MOG testing before his testimony.
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At approximately 9:00 A.M. on the day after Dr. Steinman testified, Mr.
Goodwin submitted two articles about the duration of MOG antibodies. Exhibits
74-75. Off the record, the Secretary objected to the introduction of articles during
the hearing. See Tr. 444-45. The Secretary’s objection was well-founded.
However, despite the Secretary’s valid point about the need for an orderly
presentation of material, the Secretary’s objection was overruled and neither
Exhibit 74 nor Exhibit 75 were struck from the record. The basic reason was that
since the Court’s remand, the parties have been attempting to proceed quickly. In
the attempt to move expeditiously, some steps were taken out of normal order. For
example, the Secretary filed his post-remand brief before Dr. Ghosh completed the
disclosure of his opinions. In this sequence, both Mr. Goodwin’s counsel and Dr.
Steinman missed Mr. Goodwin’s negative MOG results. Thus, to avoid penalizing
Mr. Goodwin for the mistakes of professionals he has retained, Dr. Steinman’s two
new articles about MOG antibodies remained in the record.19
During the hearing, Dr. Ghosh and Dr. Tompkins testified in accord with the
opinions expressed in their reports, which are summarized above. Additional
details about their oral testimony are discussed below.20
Following the hearing, the Secretary was permitted to file a supplemental
report from Dr. Ghosh regarding the two articles about MOG antibodies that Dr.
Steinman located during the hearing. Exhibit WWW. With that report, Dr. Ghosh
cited another article. Exhibit XXX. The presentation of that material closed the
evidence regarding the duration of MOG antibodies. See Order, issued April 15,
2025.
Mr. Goodwin also filed additional factual information, including his school
records and some pre-vaccination medical records. Exhibits 79-80.
The parties jointly proposed that they both submit briefs 45 days after the
last medical record was filed, which they did on August 11, 2025. They also
19 On the other hand, Mr. Goodwin also filed an article about narcolepsy (Exhibit 76) on
the morning of the second day of the hearing. After a discussion about the appropriateness of
submitting articles during the hearing, Mr. Goodwin agreed to withdraw the narcolepsy article.
Arguably, the narcolepsy article could support an argument that the latency between vaccination
and an onset of a disease can encompass 68 days. However, the 68-day latency has been the
primary issue throughout this litigation. Mr. Goodwin could not claim surprise. Thus, the article
about narcolepsy is not part of the record.
20 Counsel’s cross-examination of Dr. Tompkins was particularly effective.
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defended their positions through replies. With the submission of these briefs, the
case is ready for adjudication.21
III. Standards for Adjudication
A petitioner is required to establish his case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a); see also Townsend v. Sec’y of Health &
Hum. Servs., 170 Fed Cl. 130, 141 (2024), appeal docketed, No. 24-1740 (Fed.
Cir. April 25, 2024). The preponderance of the evidence standard requires a “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 v. Sec’y of Health & Hum. Servs., 592 F.3d
1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted). Proof of medical certainty is
not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed.
Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing special master’s decision that petitioners were not entitled to
compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357
(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993) (disagreeing with dissenting judge's contention that the special master
confused preponderance of the evidence with medical certainty).
This decision resolves three issues. First, whether preponderant evidence
supports a finding that Mr. Goodwin experienced urinary incontinence shortly after
receiving the vaccine. Second, assuming that there is preponderant evidence
showing Mr. Goodwin sometimes lost control of his bladder, whether these
episodes of urinary incontinence are manifestations of transverse myelitis. Third,
whether Mr. Goodwin has met his burden to show that the HPV vaccine caused his
transverse myelitis.
21 As mentioned in the procedural history, the resolution of Mr. Goodwin’s case exceeded
the time anticipated in the Court’s October 10, 2024 Opinion and Order. Nevertheless, the
parties complied with the spirit, if not exactly the letter of the Opinion and Order. In the same
vein, the issuance of this Decision within about one month of the final submission attempts to
demonstrate a good faith effort to prioritize Mr. Goodwin’s case.
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IV. First Issue: Whether Mr. Goodwin Suffered Urinary Incontinence in
March and April 2018
A. Introduction
Before the First Entitlement Decision, issued April 16, 2024, the parties
agreed that the onset of Mr. Goodwin’s transverse myelitis was on May 30, 2018.
See Pet’r’s Br. regarding Timing, filed July 25, 2022, at 6, 8; Resp’t’s Resp., filed
Sep. 23, 2022, at 5. However, upon remand, the recent discovery of evidence led
Mr. Goodwin to propose a different onset date, which was within one to two weeks
of the vaccination. See Pet’r’s Post-Remand Br. at 36; Pet’r’s Post-Hearing Br. at
19. The Secretary disputes the assertion in two respects. First, the Secretary
disputes the persuasiveness of the evidence underlying the assertion that Mr.
Goodwin experienced episodes of urinary incontinence. Resp’t’s Post-Remand Br.
at 14-16; Resp’t’s Post-Hearing Br. at 18-19. Second, Dr. Ghosh opined that
episodes of urinary incontinence were not manifestations of transverse myelitis.
Exhibit SSS at 4.22 The Secretary’s first point raises a pure question of fact:
whether preponderant evidence establishes that Mr. Goodwin had episodes of
urinary incontinence in March and April 2018. (The Secretary’s second point
regarding the diagnostic significance is discussed next in section V below).
B. Additional Standards for Adjudicating Questions of Fact
From time to time, the parties in the Vaccine Program disagree over whether
(or when) a vaccinee developed problems and special masters resolve these
disputes routinely. See, e.g., Britt v. Sec’y of Health & Hum. Servs., No. 17-
1352V, 2021 WL 4282596 (Fed. Cl. Spec. Mstr. Aug. 27, 2021). In determining
how the evidence preponderates, a basic starting point is that medical records are
presumptively accurate in describing events that occurred contemporaneously with
the creation of the medical records. Cucuras v. Sec’y of Health & Hum. Servs.,
993 F.2d 1525, 1528 (Fed. Cir. 1993); Martinez v. Sec’y of Health & Hum. Servs.,
165 Fed. Cl. 76, 90 (2023). From this starting point, special masters have
sometimes reasoned that the lack of documentation in a medical record created
close in time to when the event allegedly happened can be a basis for finding that
the alleged event did not happen. See Bradley v. Sec'y of Health & Human Servs.,
991 F.2d 1570, 1574 (Fed. Cir. 1993) (rejecting an argument that the special
22 Due to the rapid schedule of events after the Court’s remand, neither Dr. Steinman nor
Dr. Ghosh had issued supplemental reports addressing the potential of urinary incontinence
before the parties filed their briefs.
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master was arbitrary in relying upon “the absence of medical records”); see also
Britt, 2021 WL 4282596, at *2 (collecting appellate cases).
However, the Federal Circuit has cautioned that medical records are not
always complete. Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1382-
83 (Fed. Cir. 2021). Thus, a special master may credit later accounts about what
allegedly happened despite the lack of documentation in a medical record created
around the time of the event. See La Londe v. Sec’y of Health & Hum. Servs., 110
Fed. Cl. 184, 203 n.33 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). Even after
the Federal Circuit’s opinion in Kirby, a special master may reject testimonial
assertions about when events allegedly happened provided that the special master
considers the entire record. Trinnaman v. Sec’y of Health & Hum. Servs., 171
Fed. Cl. 317, 325-26 (2024) (denying motion for review).
C. Summary of Parties’ Evidence and Arguments
Mr. Goodwin relies upon two types of evidence. The first is medical records
created during appointments with neurologists, Dr. Tardo and Dr. Greenberg.
Exhibit 42 at 2394 (Dec. 13, 2019).23 Ms. McCluskey reported that after receiving
vaccines on March 22, 2018 “~1.5-2 weeks later in April 2018 [Mr. Goodwin]
started having episodes of bowel and bladder incontinence at school.”24 The
second type of evidence is a series of testimonial assertions. The category of
testimonial assertions includes Ms. McCluskey’s affidavit (Exhibit 43), Mr.
Goodwin’s affidavit (Exhibit 57), Ms. McCluskey’s oral testimony during the
hearing, and Mr. Goodwin’s testimony during the hearing. Mr. Goodwin argues
that this evidence should be credited. Pet’r’s Post-Remand Reply at 1-6; Pet’r’s
Post-Hearing Br. at 19-20. Mr. Goodwin argues: “These incidents of incontinence
are either true, or were dishonestly reported, then intentionally left hidden during
the expert reports, initial dismissal, the appeal, and the remand of the case. There is
no other logical explanation.” Id. at 19.
In contrast, the Secretary tends to rely upon a lack of evidence. The
Secretary points out that Ms. McCluskey did not present this chronology to doctors
between March 2018 and December 2019. Resp’t’s Br. at 15. The Secretary
23 Technically, petitioner’s brief identified a June 12, 2020 progress note. Pet’r’s Post-
Remand Br. at 37, citing Exhibit 41 at 912. In doing so, Mr. Goodwin appears to have
overlooked an earlier notation described in the text.
24 This history appears to be carried into the record for a June 12, 2020 telehealth
appointment. Exhibit 41 at 912.
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further argues that Mr. Goodwin’s supporting evidence merits little weight as the
affidavits were “made retrospectively for purposes of litigation.” Id. The
Secretary further characterizes the accounts presented to Dr. Tardo and Dr.
Greenberg as “subjective reports.” Resp’t’s Post-Hearing Br. at 18.
D. Assessment
The evidence preponderates in favor of finding that Mr. Goodwin
experienced two episodes of bladder incontinence in March or April 2018. The
primary basis is that his pre-vaccination records, which were not filed until after
the hearing, document other instances in which Mr. Goodwin had accidents. See
Exhibit 80 at 144 (Sep. 28, 2017); Exhibit 79 at 82 (Dec. 1, 2017). This evidence
alters the picture.
Before these pre-vaccination records were filed, it appeared that the alleged
March and April 2018 episodes were new.25 If Mr. Goodwin had not previously
experienced urinary incontinence as a teenager, then episodes of urinary
incontinence could be alarming. An abrupt start to a new problem could prompt
loving parents, like Ms. McCluskey, to seek medical attention for their child. In
this situation, a memorialization of the episodes in medical records could
reasonably be expected.
On the other hand, the September 28, 2017 and December 1, 2017 medical
records establish that Mr. Goodwin had at least some episodes of enuresis. Thus,
any episodes that arose in March and April 2018 would not necessarily have
shocked his mother. In March and April 2018, Ms. McCluskey did not search for
answers about the cause for incontinence on the internet and she did not start to
buy Mr. Goodwin adult diapers. Tr. 57. Mr. Goodwin’s experience with urinary
incontinence also helps explain why no medical record from Texas Family Health
memorializes the episodes of incontinence. See Exhibit 6 at 56-72 (April 11,
2018); Exhibit 6 at 73-94 (May 10, 2018).26 It seems likely that the family did not
25 Ms. McCluskey stated that the episodes of urinary incontinence in April and May were
“unusual” and that Mr. Goodwin “never had problems with his bladder before 2018.” Tr. 14, 47;
accord Tr. 84 (Mr. Goodwin). This testimony, which was provided before Ms. McCluskey’s
attorney had filed the pre-vaccination records, is not accurate.
26 Ms. McCluskey testified that she brought Mr. Goodwin to the doctor’s office following
the second episode of urinary incontinence. Tr. 14, 24, 58; see also Tr. 85 (Mr. Goodwin’s
testimony). In light of the omission of any complaints about urinary incontinence in the relevant
medical records, this testimony is rejected as inaccurate.
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view the episodes as something requiring medical attention, perhaps because of
Mr. Goodwin’s autism.
The school records provide a modicum of support for the assertions that Mr.
Goodwin experienced two episodes of urinary incontinence. On March 29, 2018,
April 13, 2018, April 18, 2018, and April 23, 2018, he was marked “present.”
Exhibit 67 at 21-22. “Present,” in turn, means “student was present at school but
missed part of his instructional day. The entry might occur if a student . . . does not
attend some of their classes.” Exhibit 68. An absence from class due to a need to
receive clean clothes is consistent with a notation of “present.” See Pet’r’s Post-
Hearing Br. at 19.27
Finally, in December 2019, Ms. McCluskey told Doctors Greenberg and
Tardo about the episodes. Exhibit 42 at 2394. Unlike the school attendance
records, the record from December 2019 was not created around the time the
episodes of urinary incontinence took place, which was April and May 2018. The
lack of contemporaneousness means that the December 2019 record could be less
valuable due to the passage of time, which impairs people’s memories. On the
other hand, the Secretary has not otherwise impeached the accuracy of this
account.
In short, sufficient evidence preponderates in favor of finding that Mr.
Goodwin experienced two episodes of urinary incontinence within two weeks of
his vaccination. Whether these episodes are manifestations of his transverse
myelitis is discussed next.
V. Second Issue: When did Mr. Goodwin’s Transverse Myelitis Begin
“If there is a dispute as to the nature of the petitioner's injury, the special
master may opine on the nature of the petitioner's injury.” Contreras v. Sec'y of
Health & Human Servs., 844 F. 3d 1363, 1368 (Fed. Cir. 2017).
Any finding that Mr. Goodwin experienced episodes of urinary incontinence
would not necessarily determine that these episodes marked the beginning of
transverse myelitis. Although urinary incontinence can be a symptom of
27 To be sure, the school records do not establish that Mr. Goodwin had episodes of
urinary incontinence beyond a reasonable doubt. For example, the nurse’s notes do not
memorialize any trips to the nurse’s office around this time. But, the lack of notation in the
nurse’s notes is not controlling because it is not entirely clear that a nurse would have logged a
visit for a non-medical reason, such as a change in clothes, and because the nurse’s notes were
obtained years later and may not be complete.
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transverse myelitis, see Marco v. Sec’y of Health & Hum. Servs., No. 15-1178,
2018 WL 8755888 (Fed. Cl. Spec. Mstr. Aug. 1, 2018), urinary incontinence can
be associated with other conditions as well. See Curry v. Sec’y of Health & Hum.
Servs., No. 22-729V, 2025 WL 1693655 (Fed. Cl. Spec. Mstr. Apr. 28, 2025)
(doctors considered whether urinary retention was a manifestation of prostatitis).
Based primarily upon the medical records from Doctors Tardo and
Greenberg, Dr. Steinman opined that the onset of Mr. Goodwin’s transverse
myelitis was 7-14 days after the HPV vaccination. Exhibit 58 at 3. Dr. Steinman
did not explain how transverse myelitis would exist in Mr. Goodwin for such a
long time before it was diagnosed.28
Dr. Ghosh opined that he “did not think the earlier intermittent symptoms of
urinary incontinence or a single brief episode of leg weakness could be attributable
to spinal cord involvement without any objective clinical or radiological evidence.”
Exhibit SSS at 4. In addition, Dr. Ghosh referenced the diagnostic criteria for
acute transverse myelitis.
In 2002, a group of experts proposed a set of diagnostic criteria with some
inclusion criteria and some exclusion criteria. Exhibit C. Of the six inclusive
criteria, the relevant one is: “Progression to nadir between 4 h and 21 d following
the onset of symptoms.” Id. at 500 (table 1). The authors explained that the
“maximal deficit is arbitrary” but “valid based on the authors’ clinical experience
and review of the literature.” Id. at 501. A purpose of this criterion was to
distinguish acute transverse myelitis from “a slowly progressive or stuttering
hereditary myelopathy, spinal cord tumor, myelopathy due to a dural arteriovenous
fistulas, and a chronic progressive form of [multiple sclerosis].” Id.
Special masters have relied upon this set of criteria. See Eloyan v. Sec’y of
Health & Hum. Servs., No. 18-1450V, 2023 WL 9053983 at *9 (Fed. Cl. Spec.
Mstr. Nov. 17, 2023) (finding petitioner did not suffer transverse myelitis due to
progression of symptoms for longer than 21 days and citing cases reaching similar
conclusions); White v. Sec’y of Health & Hum. Servs., No. 15-1521V, 2019 WL
7563239 at *19 (Fed. Cl. Spec. Mstr. Dec. 19, 2019) (finding vaccinee suffered
from transverse myelitis).
28 Dr. Steinman emphasizes that one of the authors of the report, Dr. Greenberg, is a “an
expert on transverse myelitis.” Exhibit 58 at 1. However, Dr. Greenberg did not conclude that
Mr. Goodwin’s transverse myelitis started shortly after the vaccination. Dr. Greenberg and his
associate, Dr. Tardo, simply memorialized the history given to them by Ms. McCluskey.
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The experts disagreed about the value of the Working Group criteria. Dr.
Steinman emphasized that the diagnostic criteria can be “arbitrary.” Tr. 96-98. Dr.
Ghosh agreed with the Working Group’s definition that the nadir for transverse
myelitis should occur between 4 hours and 21 days of the onset of symptoms. Tr.
198; see also Tr. 223-24.
The authors of the Working Group had extensive experience in studying and
treating patients with transverse myelitis. Dr. Steinman has not persuasively
established a reason for revising what the authors proposed as diagnostic criteria
for transverse myelitis.29 Dr. Ghosh sensibly relies upon the published diagnostic
criteria in opining that even if Mr. Goodwin experienced two episodes of loss of
bladder in early or mid-April, these episodes would not be manifestations of
transverse myelitis. See Salah v. Sec’y of Health & Hum. Servs., No. 18-1772V,
20224 WL 1925381, at *17 (Fed. Cl. Spec. Mstr. Apr. 12, 2024) (considering the
21-day maximum time to nadir in determining when a vaccinee’s transverse
myelitis began).
Another problem with the opinion that Mr. Goodwin’s transverse myelitis
starting with two episodes of urinary incontinence in early or mid-April is the ways
in which this opinion is inconsistent with other information. Both Ms. McCluskey
and Mr. Goodwin testified that Mr. Goodwin had two, and only two, episodes of
urinary incontinence. Tr. 14, 85. If Mr. Goodwin’s episodes of urinary
incontinence were due to transverse myelitis (meaning that he had an inflammatory
lesion in his spinal cord), then Mr. Goodwin would be expected to experience more
episodes of urinary incontinence. Dr. Ghosh testified that “urinary incontinence
would not be attributed to transverse myelitis when the symptoms are very
transient and did not persist.” Tr. 197. He stated that if these were symptoms of
transverse myelitis, Mr. Goodwin would have reached nadir within three weeks of
the onset of the first symptoms, i.e., by the third or fourth week of April. Tr. 198.
Dr. Steinman did not persuasively explain a way that any spinal cord lesion would
have healed without any intervention. See Tr. 162-63.
29 Mr. Goodwin asserts that Dr. Steinman “treats more transverse myelitis patients.”
Pet’r’s Post-Hearing Br. at 20. However, Mr. Goodwin fails to cite evidence for this assertion.
Dr. Steinman stated that in the last five years, he has treated about five patients with transverse
myelitis. Tr. 93. Dr. Ghosh stated that over the last ten years, he has treated 10-15 patients with
transverse myelitis. Tr. 190. Thus, Dr. Steinman’s and Dr. Ghosh’s recent experience with
treating patients with transverse myelitis is roughly comparable, about one patient per year. In
this situation, Dr. Steinman does not possess such greater experience with transverse myelitis
that his opinion regarding the diagnostic criteria should be credited.
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Relatedly, when Mr. Goodwin unquestionably was experiencing transverse
myelitis at Cook Children’s Hospital, he reported that he was having trouble
voiding. Exhibit 7 at 92. In other words, his problem was urinary retention, not
urinary incontinence. Although transverse myelitis can be associated with urinary
incontinence if the symptom persists and is not transient, transverse myelitis is
most commonly associated with urinary retention. Tr. 197. Dr. Steinman did not
persuasively explain how one person could experience one problem and then
evolve into the other problem without any medical intervention over the course of
approximately six weeks. He agreed that it was “a puzzle,” and stated that he
didn’t “have a very strong opinion of moving from day 68,” but that he could not
ignore the episodes of bladder incontinence in early April. Tr. 162-63.
Finally, Mr. Goodwin contends that “There is no other proposed reason for
why this young man, with no history of wetting his pants at school, wet his pants
twice roughly two weeks after his HPV vaccination.” Pet’r’s Post-Hearing Br. at
20. Mr. Goodwin’s statement of “no history of wetting his pants at school” is
inconsistent with the records filed after the hearing in which Ms. McCluskey stated
that he was having enuresis and in which Mr. Goodwin was reported to have had
an accident. See Exhibit 80 at 144. While it might be technically correct to assert
that Mr. Goodwin had “no history of wetting his pants at school,” Mr. Goodwin
seems to be overlooking the more general point that he did not always control his
bladder.30
In short, while Mr. Goodwin did experience two episodes of urinary
incontinence, the evidence does not preponderate in favor of finding that these
episodes were manifestations of the transverse myelitis that was manifest on May
30, 2018. This finding, in turn, affects the third Althen prong, which is discussed
below.
VI. Third Issue: Whether the HPV Vaccination Caused Mr. Goodwin’s
Transverse Myelitis
With the resolution of those two preliminary issues, the analysis turns to the
heart of the case: whether Mr. Goodwin established with preponderant evidence
that the HPV vaccine caused his transverse myelitis. Because transverse myelitis
is not listed on the Vaccine Table, Mr. Goodwin bears the burden of showing that
the vaccine was the cause-in-fact of the injury. The elements are well known.
30 Mr. Goodwin makes a more refined argument in attempting to distinguish loss of
bladder control while sleeping from loss of bladder control while awake. See Pet’r’s Post-
Hearing Reply at 7. However, even loss of bladder control while sleeping would be unusual.
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Petitioners bear a burden “to show by preponderant evidence that the vaccination
brought about [the vaccinee’s] injury by providing: (1) a medical theory causally
connecting the vaccination and the injury; (2) a logical sequence of cause and
effect showing that the vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination and injury.” Althen v.
Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
A. Althen Prong One: A Medical Theory
“To meet prong one, ‘a petitioner must provide a reputable medical or
scientific explanation that pertains specifically to the petitioner's case, although the
explanation need only be legally probable, not medically or scientifically certain.”
Dennington v. Sec’y of Health & Hum. Servs., 167 Fed. Cl. 640, 651-52 (2023)
(internal quotation marks and citations omitted), appeal dismissed, No. 2024-1214,
2024 WL 1255318 (Fed. Cir. Mar. 25, 2024).31 A petitioner does not prevail on
prong one simply by invoking the “magic words” molecular mimicry. Instead, “a
petitioner needs to cite to evidence, circumstantial or otherwise, suggesting reason
to find it plausible that the proposed autoimmune cross-reaction triggered by the
relevant vaccine does occur.” Townsend, 170 Fed. Cl. at 142.
The evidence regarding whether the HPV vaccine can cause transverse
myelitis can be categorized into three types. The first is epidemiology and other
studies. The second is case reports. The third is the opinion of Dr. Steinman.
1. Epidemiology and Other Studies
For a lengthy discussion of the value of epidemiologic studies in the Vaccine
Program, see Tullio v. Sec’y of Health & Hum. Servs., No. 15-51V, 2019 WL
7580149, at *5-8 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149
Fed. Cl. 448, 475 (2020).
The Secretary’s experts cited various epidemiological articles in an attempt
to undermine the contention that the HPV vaccine can cause transverse myelitis.
For the reasons discussed below, the Secretary’s effectiveness was mixed.
31 Mr. Goodwin maintains that “the tension between the terms ‘plausible theory’ and
‘preponderance of the evidence’ is very real in the Vaccine Injury Compensation Program.”
Pet’r’s Post-Hearing Reply at 2. It appears that the reviewing Court has already resolved this
issue in Dennington. Thus, an elaboration on the different precedents is not required.
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a) Baxter
Dr. Ghosh cited an article by Baxter et al. Exhibit A at 8. For this study, the
researchers consulted the Vaccine Safety Datalink. Exhibit H.32 They looked for
instances of either transverse myelitis or another demyelinating disease (acute
disseminated encephalomyelitis, which is often abbreviated “ADEM”).
Approximately two million doses of an HPV vaccine were considered as part of
this study. The adjusted odds ratio of developing transverse myelitis in 5-28 days
after an HPV vaccine was zero. Exhibit H at 2, table 2.
With respect to Baxter, Mr. Goodwin and his team did relatively little to
challenge Baxter’s value. In the course of his testimony, Dr. Steinman referred to
the 2012 IOM report. Tr. 116-27. Under the heading “Epidemiological
Evidence,” this report stated: “No studies were identified in the literature for the
committee to evaluate the risk of transverse myelitis after the administration of
HPV vaccine.” While this statement about a lack of epidemiology may have been
accurate when the report was written, the Baxter study was published in 2016.
Mr. Goodwin argues that “lazy or biased epidemiology cannot be used to
disprove a causative link.” Pet’r’s Post-Hearing Br. at 22. This argument appears
to lack any evidentiary foundation, in part, as Mr. Goodwin did not cite any
evidence that would justify characterizing the Baxter researchers as either “lazy” or
“biased.” Mr. Goodwin also argues that “Epidemiologic studies that do not take
Lazarus33 or VAERS reports into account must be viewed with caution. Scientific
studies must take actual data and actual limitations into account, or they are of little
value.” Pet’r’s Post-Hearing Br. at 21. Again, this argument seems to be one
coming from an attorney, not one based upon evidence. The data for the Baxter
study is the information contained in the Vaccine Safety Datalink.34 Mr. Goodwin
has failed to show that the Baxter researchers failed to take “actual data . . . into
account.” Furthermore, Mr. Goodwin has not explained why researchers who are
32 The Secretary filed the Baxter article in its manuscript form. Thus, citations to specific
pages do not correspond to the pagination in the published journal.
33 The Lazarus report was also filed by Mr. Goodwin and is discussed in Section VI.A.1.d
below.
34 The Vaccine Safety Datalink is “a collaborative effort of the Centers for Disease
Control (“CDC”), a governmental agency, and eight large non-governmental organizations that
provide health care, known as ‘managed care organizations.’” In re Claim for Vaccine Injuries
Resulting in Autism Spectrum Disorder, 2007 WL 1983780, at *4 (Fed. Cl. Spec. Mstr. May 25,
2007).
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using the Vaccine Safety Datalink should also use VAERS reports.35 In short, Mr.
Goodwin’s attempts to minimize the reliability of the Baxter study largely fell
flat.36
Thus, the Baxter study tends to undermine the claim that HPV vaccines can
cause transverse myelitis. But, as a single epidemiological study, Baxter is not
dispositive. Epidemiology cannot be used to prove a negative. Heddens v. Sec'y
of Health & Hum. Servs., 143 Fed. Cl. 193, 199 (2019) (“the special master did not
abuse his discretion in considering epidemiology and did not elevate petitioner’s
burden of proof”).
b) World Health Organization
Dr. Tompkins cited a report from the World Health Organization. Exhibit K
at 7. A committee from the World Health Organization reviewed the safety of
vaccines for human papillomavirus. This committee cited various studies that
generally did not find that the receipt of a vaccine for human papillomavirus
increased the risk of developing different diseases. Thus, the World Health
Organization considered the vaccines to be safe. Exhibit X at 6-9; accord Tr. 265-
68. However, this report carries less weight because the underlying studies appear
not to have investigated a potential link to transverse myelitis.
35 By way of contrast, researchers who are using the VAERS system may want to
consider the Lazarus study. See Section VI.A.1.d below.
36 The Baxter authors addressed the limitations of their study, acknowledging: “The
method depends on selection of an appropriate risk (exposure) interval, so if the interval is
misspecified, an increased risk could have been missed.” Exhibit H at 6. Dr. Steinman also
noted this “pitfall,” but explained that Baxter and colleagues selected this interval based on the
1976 swine flu studies, which is also “the basis for a lot of intervals in the vaccine table.” Tr.
186. He stated, “you work with the best tools at hand, the best data at hand, but you have to
admit to the limitations.” Id. Given the general acceptance of this interval, Baxter remains a
credible study. See Martinez v. Sec'y of Health & Hum. Servs., No. 16-738V, 2022 WL
4884923, at *30 (Fed. Cl. Spec. Mstr. Sept. 9, 2022) (“It is reasonable to contend, as Petitioners
do, that Baxter contains some methodologic weaknesses that limit how much probative weight
its findings should receive. But it still undermines Petitioner's theory—especially given the
degree to which Petitioners relied on case reports in the alternative”) (internal citation omitted),
mot. for rev. denied, 165 Fed. Cl. 76 (2023).
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c) Donahue
Dr. Tompkins cited an article by James G. Donahue et al. Exhibit LL at 3.
The researchers accessed two years of data collected at six cites in the Vaccine
Safety Datalink. Exhibit PP at 2.37 The researchers looked for people developing
peripheral neuropathies, Guillain-Barré syndrome, or chronic inflammatory
demyelinating polyneuropathy. Although these researchers “did not identify any
new safety concerns,” Id. at 7, this (lack of) finding has less relevance in the
present case, which concerns transverse myelitis.
d) Shimabukuro
Dr. Tompkins also cited an article by Tom T. Shimabukuro et al. Exhibit LL
at 3. In this project, the researchers looked at VAERS reports filed from December
2014 to December 2017.38 During these three years, approximately 28 million
doses of the nine-virus version of the HPV vaccine were distributed. Exhibit OO
at page 1.39 The researchers “calculated crude 9vHPV AE [adverse events]
reporting rates for all reports and serious reports by dividing the number of reports
by the total number of doses of 9vHPV distributed in the United States from 2014
through 2017. We also calculated crude AE reporting rates for the following
prespecified conditions of interest.” For this three-year period, the researchers did
not find any reports of transverse myelitis. Id. at 6. The researchers commented
on the value of their findings:
VAERS data cannot be used to assess risk of AEs and
generally cannot be used to determine if a vaccination
caused an AE. Crude AE reporting rates using vaccine
doses distributed should be interpreted with caution
because the actual number of doses administered is not
known and the amount of underreporting of AEs is also
not known. Limitations notwithstanding, VAERS is a
valuable monitoring system to detect potential vaccine
37 The Secretary filed a manuscript version of the Donahue article. Thus, the cites to
pages do not correspond to the pagination in the published journal.
38 On cross-examination, Dr. Tompkins acknowledged that one of the co-authors worked
for the manufacturer of an HPV vaccine, Merck. Tr. 384; see also Pet’r’s Post-Hearing Reply at
10.
39 The Secretary filed a manuscript version of the Shimabukuro article. Thus, the cites to
pages do not correspond to the pagination in the published journal.
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safety concerns that might require further assessment in
more robust systems.
Exhibit OO at 7.
Unlike Baxter, which Mr. Goodwin did not really challenge in any effective
way, the Shimabukuro article was attacked by Mr. Goodwin in two different
respects. First, Mr. Goodwin’s attorneys located at least some examples of
VAERS reports showing that after an HPV vaccination, a person developed
transverse myelitis in the relevant time. Exhibit 70.
Second, Mr. Goodwin introduced the Lazarus report. Exhibit 50. It appears
that the Agency for Healthcare Research and Quality, a component of the
Department of Health and Human Services, awarded a grant to Harvard Pilgrim
Health Care, Inc. One purpose of the grant was to “develop systems to monitor
ambulatory care electronic medical records for adverse effects following vaccine
administration.” Exhibit 50 at 3 (Aim 1). The grantees focused on electronic
medical records created by Atrius Health, which “employs approximately 700
physicians to serve 500,000 patients . . . . throughout the greater Metropolitan
Boston area.” Id. at 6. Within Atrius Health, “[e]very patient receiving a vaccine
was automatically identified, and for the next 30 days, their health care diagnostic
codes, laboratory tests, and medication prescriptions [were] evaluated for values
suggestive of an adverse vaccine event. When a possible adverse event was
detected, it was recorded, and the appropriate clinician was to be notified
electronically.” Id. at 3-4. The researchers collected “preliminary data” “from
June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45
different vaccines) were given to 376,452 individuals. Of these doses, 35,570
possible reactions (2.6 percent of vaccinations) were identified.” Id. at 6.
Although the report is not perfectly clear on this point, it appears that the
researchers looked to see whether the potential adverse vaccine events they
identified were reported to VAERS. They wrote: “fewer than 1% of vaccine
adverse reports are reported.” Id. at 6. Further, the researchers stated that:
“Unfortunately, there was never an opportunity to perform system performance
assessments because the necessary CDC contacts were no longer available and the
CDC consultants responsible for receiving data were no longer responsive to our
multiple requests to proceed with testing and evaluation.” Id.
During the hearing, there was a limited amount of testimony about the
Lazarus report. For example, Dr. Steinman did not testify about it. Through cross-
examination of Dr. Tompkins, Mr. Goodwin proposed that (a) if there were one
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36
report of transverse myelitis following a vaccine per year included in the VAERS
database, and (b) Lazarus’s assertion that fewer than one percent of vaccine
adverse events that occur within 30 days of a vaccination are reported to VAERS,
then (c) the actual number of transverse myelitis events following vaccination
would be 100 per year. Further, because transverse myelitis has an incidence of
approximately 1400 cases per year, the share of transverse myelitis cases that occur
within 30 days after a vaccination would be approximately seven percent
(100/1400). Tr. 392-401. Mr. Goodwin argues that this analysis constitutes a
“signal” that the Secretary should further investigate. Pet’r’s Post-Hearing Br. at
21.
Mr. Goodwin raises some intriguing ideas about the Lazarus report. One
question is how the Lazarus group defined “adverse events.” If “adverse events”
included relatively common, but probably transient, events such as redness or
swelling at the injection site, then the conclusion that fewer than one percent of
adverse events were reported to VAERS seems more likely. However, if the
suggestion is that 99 out of 100 doctors whose patients developed transverse
myelitis within a month of a vaccine failed to submit a report to VAERS, then the
suggestion appears more questionable.
e) Summary on Epidemiology
Overall, the value of this evidence is mixed. Two articles (the report from
the World Health Organization and the Donohue article) did not directly study
transverse myelitis. The Shimabukuro article relied upon VAERS data, which is a
questionable methodology. See, e.g., Analla v. Sec'y of Health & Hum. Servs., 70
Fed. Cl. 552, 558 (2006) (upholding special master’s concerns about the reliability
of VAERS data and noting expert testimony that VAERS data “offers very little
information regarding causality”); Ryman v. Sec'y of Health & Hum. Servs., 65
Fed. Cl. 35, 43 (2005) (special master did not “act arbitrarily or capriciously in
refusing to accord substantial weight to the VAERS reports”). In this regard, Dr.
Tompkins appears to lack a background in epidemiology sufficient to mitigate
these weaknesses. See Tr. 420. On the other hand, Baxter did look for an
association between HPV vaccines and transverse myelitis and did not find an
association. Its methodology was not impeached in a meaningful way. Thus,
Baxter tends to make Mr. Goodwin’s claim that an HPV vaccine can cause
transverse myelitis less likely.
2. Case Series and Case Reports
The second category of evidence is the set of case series and case reports.
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a) Agmon-Levin and Pidcock
The record includes articles by Agmon-Levin et al. and Pidcock et al. They
are roughly similar. In Agmon-Levin, the researchers surveyed medical journals,
looking for instances in which a person received a vaccine and then developed
transverse myelitis. Exhibit G at 1198. Over the course of approximately 39
years, they identified 37 instances involving a variety of vaccines. Id. at 1200;
accord Tr. 435. However, this research was conducted before HPV vaccines were
widely available and none of the examples involve the HPV vaccine.
In Pidcock, the researchers collected information about 47 children who
were treated at the Johns Hopkins Transverse Myelitis Center from January 2000
to February 2004. Exhibit J at 1475. They found that “Twenty-eight percent of
cases (13/47) had a confirmed immunization or allergy shot within 30 days . . . of
the first symptom of ATM [acute transverse myelitis].” Id. at 1476. However, this
study too was before the HPV vaccine.
Dr. Steinman did not cite either Agmon-Levin or Pidcock in his reports. He
also did not discuss these articles during his testimony. Mr. Goodwin cites
Agmon-Levin in the context of prong 3. See Pet’r’s Post-Hearing Br. at 22. Thus,
a more detailed analysis of this article is deferred until then.
b) Package Insert
As a foundation for his computer search, Dr. Steinman relied upon the
manufacturer’s package insert. Exhibit 11 at 4; see also Tr. 102. The package
insert also presents information about safety studies. For a detailed examination of
components of a package insert, see Cottingham v. Sec'y of Health & Hum. Servs.,
No. 15-1291V, 2021 WL 6881248, at *30-33 (Fed. Cl. Spec. Mstr. Sept. 27, 2021),
mot. for rev. denied, 159 Fed. Cl. 328 (2022), aff’d without op., 2023 WL 7545047
(Fed. Cir. 2023).
On cross-examination of Dr. Tompkins, Mr. Goodwin probed the usefulness
of information reported in the package insert. Tr. 369-79. Mr. Goodwin
characterizes Merck’s clinical trials as “abysmal.” Pet’r’s Post-Hearing Br. at 21.
Whether Merck’s clinical trials were actually substandard is irrelevant to Mr.
Goodwin’s case. But see In re Gardasil Prods. Liab. Litig., 770 F.Supp.3d 893,
910 (W.D.N.C. Mar. 11, 2025) (MDL) (discussing post-licensing reports of
adverse events). For Mr. Goodwin’s case, the critical question is whether the
information presented in the package insert can be understood to support a finding,
on a more probable than not scale, that the HPV vaccine can cause transverse
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myelitis. It does not. Exhibit 15 at 9; Werderitsh v. Sec’y of Health & Hum.
Servs., No. 99-319V, 2005 WL 3320041, at *7 (Fed. Cl. Spec. Mstr. Nov. 10,
2005) (“federal regulations specifically preclude the contents of drug product
labels, as reproduced in the PDR, from serving as admissions regarding
causation").40
c) Menge and Chang
As part of his report supporting causation, Dr. Steinman initially identified
the Menge article. Exhibit 11 at 17. Dr. Tompkins identified Chang. Exhibit CCC
at 3.
Both articles present instances in which people received an HPV vaccine and
then developed some type of demyelinating disease. Exhibit 25, Exhibit EEE.41
On the question of whether the antecedent event (vaccination) caused the
subsequent event (disease), these case reports carry little weight. See K.O. v. Sec'y
of Health & Hum. Servs., No. 13-472V, 2016 WL 7634491, at *11 (Fed. Cl. Spec
Mstr. July 7, 2016) (discussing the limited value of case reports).
Accordingly, the general evidence does not support a finding that it is likely
that the HPV vaccine can cause transverse myelitis. Nevertheless, because this
general evidence is not required, Dr. Steinman’s theory is explored next.
3. Molecular Mimicry
To explain how the HPV vaccine can cause transverse myelitis, Dr.
Steinman relied upon molecular mimicry. In the Vaccine Program, petitioners
frequently assert this theory. For a list of more than 75 examples, see Hoffman v.
40 Mr. Goodwin seems to suggest that how the manufacturer of the HPV vaccine acquired
information about adverse events was suspicious. Pet’r’s Post-Hearing Reply at 10-11; see also
Tr. 372-81 (questioning by counsel). This argument is difficult to follow and, therefore, not
persuasive. Mr. Goodwin’s burden is to show with affirmative evidence that the HPV vaccine
“can cause” transverse myelitis. See Pafford v. Sec'y of Health & Hum. Servs., 451 F.3d 1352,
1355-56 (Fed. Cir. 2006) (recognizing “can cause” as the equivalent of Althen prong one). For
the reasons explained in the text, information presented in the package insert does not support a
finding that the HPV vaccine can cause transverse myelitis. Whether the package insert supports
an alternative finding that the HPV cannot cause transverse myelitis is not the same question.
41 Menge also appears in the record as Exhibits BB and NNN. Chang also appears in the
record as Exhibit PPP.
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Sec'y of Health & Hum. Servs., No. 19-111V, 2024 WL 4444773, at *8 (Fed. Cl.
Spec. Mstr. Sept. 13, 2024) (appendices).
a) Appellate Precedents regarding Molecular Mimicry
Because special masters are often called upon to evaluate the persuasiveness
of the theory of molecular mimicry, the Court of Federal Claims and the Court of
Appeals for the Federal Circuit have considered molecular mimicry in their
appellate role opinions from special masters. In December 2019, the undersigned
identified the leading precedents as W.C., 704 F.3d 1352, and Caves v. Sec’y of
Health & Hum. Servs., 100 Fed. Cl. 119 (2011), aff’d without op., 463 F. App’x
932 (Fed. Cir. 2012). Tullio v. Sec’y of Health & Hum. Servs., No. 15-51V, 2019
WL 7580149, at *12-14 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied,
149 Fed. Cl. 448 (2020). While Tullio describes those cases in more detail, their
essence appears to be that although molecular mimicry is accepted in some
contexts, special masters may properly require some empirical evidence to show
that a particular vaccine can cause a particular disease.
In the next approximately five years, appellate authorities reviewing
decisions involving molecular mimicry have generally endorsed the approach of
looking for some evidence that persuasively shows that a portion of a vaccine
resembles a portion of human tissue, which contributes to causing the disease, and
that the immune system will respond to the relevant amino acid sequence.42
Chronologically, the list of more recent appellate cases begins with the opinion in
Tullio, which denied the motion for review. 149 Fed. Cl. 448, 467-68, 478 (2020).
Another example in which the Court of Federal Claims held that the special
master did not elevate the petitioner’s burden of proof in the context of evaluating
the theory of molecular mimicry is Morgan v. Sec’y of Health & Hum. Servs., 148
Fed. Cl. 454, 476-77 (2020), aff’d in non-precedential opinion, 850 F. App’x 775
(Fed. Cir. 2021). In Morgan, the Chief Special Master found that petitioner had
not presented persuasive evidence about a relevant antibody. Id. at 477. The Chief
Special Master also noted that the articles about the relevant disease do not list the
wild Tdap virus as potentially causing the disease. Id. When examining this
42 The term “homology” is used when discussing molecular mimicry. “Homology” is
defined as “the quality of being homologous; the morphological identity of corresponding parts;
structural similarity due to descent from a common form.” Dorland’s Medical Dictionary 868
(32nd ed. 2012).
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analysis, the Court of Federal Claims concluded: “the Chief Special Master did not
raise the burden of causation in this case; petitioner simply failed to meet it.” Id.
The Federal Circuit also evaluated the Chief Special Master’s approach in
Morgan. The Federal Circuit concluded: “We discern no error in the special
master’s causation analysis.” 850 F. App’x 775, 784 (Fed. Cir. 2021).
Most other recent appellate cases follow this path. See, e.g., Faulkenberry
on behalf of WCF v. Sec’y of Health & Hum. Servs., 176 Fed. Cl. 700, 709 (2025)
(finding special master acted within his discretion to reject the theory of molecular
mimicry); Stricker v. Sec’y of Health & Hum. Servs., 170 Fed. Cl. 701, 720-21
(2024) (finding the special master did not require scientific certainty in assessing
molecular mimicry); Duncan v. Sec’y of Health & Hum. Servs., 153 Fed. Cl. 642,
660-61 (2021) (finding the special master did not err in rejecting a bare assertion of
molecular mimicry); Caredio v. Sec’y of Health & Hum. Servs., No. 17-79V, 2021
WL 6058835, at *11 (Fed. Cl. Dec. 3, 2021) (indicating that a special master did
not err in requiring more than homology and citing Tullio); Yalacki v. Sec’y of
Health & Hum. Servs., 146 Fed. Cl. 80, 91-92 (2019) (ruling that special master
did not err in looking for reliable evidence to support molecular mimicry as a
theory); but see Doles v. Sec’y of Health & Hum. Servs., No. 2023-2404, 2025
WL 1177875, at *5 (Fed. Cir. Apr. 23, 2025) (noting the Secretary’s expert did not
challenge molecular mimicry); Patton, 157 Fed. Cl. at 169 (finding that a special
master erred in requiring petitioner submit a study to establish medical theory
causally connecting Tdap vaccine to brachial neuritis).
When evaluating a theory of molecular mimicry, one opinion from the Court
of Federal Claims is especially illuminating (even if the opinion is not binding).
The Court of Federal Claims explained why petitioners must present some
evidence to show the persuasiveness of molecular mimicry as a theory in their
cases. Dennington v. Sec’y of Health & Hum. Servs., 167 Fed. Cl. 640 (2023),
appeal dismissed, No. 2024-1214, 2024 WL 1255318 (Fed. Cir. Mar. 25, 2024).
There, Ms. Dennington alleged that a tetanus-diphtheria-acellular pertussis
(“Tdap”) vaccine caused her to develop GBS. Id. at 644. She supported her claim
with two reports from a neurologist, Carlo Tornatore, who put forward molecular
mimicry. Id. at 647-49. The chief special master denied entitlement. Id. at 656.
The Court of Federal Claims denied a motion for review because the chief
special master did not commit any error in evaluating Ms. Dennington’s prong one
evidence. The Court emphasized the lack of evidence supporting Dr. Tornatore’s
opinion:
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• “While Petitioner and Dr. Tornatore put forth the well-established
medical theory of molecular mimicry as the mechanism through
which the Tdap vaccine could cause GBS, nowhere in Dr. Tornatore’s
expert reports, nor in Petitioner’s briefs, do they specifically tie the
Tdap vaccine to GBS through molecular mimicry.” Id. at 653.
• “Dr. Tornatore never actually explains how molecular mimicry might
occur from the Tdap vaccine specifically, nor does he elaborate on
how molecular mimicry could cause the specific autoimmune system
reaction that could cause GBS.” Id. at 653-54.
• “There is nothing in Dr. Tornatore’s report that explains or even
alludes to what antigens or structures in the Tdap vaccine could share
homology with possible host antigens and how these antigens could
react in the manner GBS is believed to progress.” Id. at 654.
• “The literature upon which he relies make no mention of any causal
connection between GBS and the Tdap vaccine.” Id.
Based upon these observations, the Court criticized the lack of specificity in
Dr. Tornatore’s opinions:
In fact, because Dr. Tornatore does not offer any specific
explanation as to the distinct connection between Tdap,
molecular mimicry, and GBS, one could take Dr.
Tornatore’s causation theory and substitute any table
vaccine (e.g., the measles vaccine) and any autoimmune
disorder (e.g., autoimmune encephalitis) and Dr.
Tornatore’s expert report’s discussion of molecular
mimicry would require absolutely no changes. That is
how general his molecular mimicry theory is—it does not
matter which vaccine and which autoimmune disorder
are plugged in. But Althen prong one requires more.
Id.
These cases provided a foundation for evaluating Mr. Goodwin’s theory and
evidence.
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b) Evidence
Dr. Steinman’s theory is presented as a series of five steps.43 These are
reviewed below.
The first step is to identify the components of the vaccine, which is the HPV
vaccine in this case. Dr. Steinman relied upon the package insert. Exhibit 11 at 6-
7; Tr. 102. This step is not controverted.
The second step is to identify portions of human tissue potentially attacked
in the relevant disease, which is transverse myelitis in this case. Dr. Steinman
identified a protein known as myelin oligodendrocyte glycoprotein (“MOG”).
Exhibit 11 at 11; Tr. 102. Dr. Ghosh acknowledged that MOG is a potential target
of an autoimmune reaction leading to transverse myelitis. Tr. 225.
In the third step, Dr. Steinman enters the relevant protein sequences into a
computer program known as the Basic Local Alignment Search Tool (BLAST).
Dr. Steinman’s use of the BLAST program is potentially disputed in two respects.
First, there appears to be some question as to whether the BLAST program should
be used to detect the degree of similarity between proteins to look for potential
cross-reactions. See Tr. 121-22 (Dr. Steinman’s discussion of the Silvanovich
article). However, compared to other cases, the Secretary did not meaningfully
develop this argument. See, e.g., Gamboa-Avila v. Sec’y of Health & Hum.
Servs., No. 18-925V, 2023 WL 6536207, at *14 (Fed. Cl. Spec. Mstr. Sep. 11,
2023), mot. for rev. denied, 170 Fed. Cl. 441 (2024), appeal docketed, No. 24-1765
(Fed. Cir. May 1, 2024). Second, Dr. Tompkins testified that to obtain the results
Dr. Steinman used, Dr. Steinman altered the standard settings for BLAST searches.
Tr. 287-88; see also Resp’t’s Post-Hearing Br. at 21-22; Pet’r’s Post-Hearing Br. at
13.
Mr. Goodwin defends Dr. Steinman’s BLAST search methods, arguing that
Dr. Tompkins does not explain whether the default settings are designed for
specific molecular mimicry searches, or how the default settings relate to the
question of whether there is sufficient alignment between proteins. Pet’r’s Post-
Hearing Reply at 8. This latter point pertains to the fourth step of Dr. Steinman’s
method.
43 This decision’s enumeration of steps differs from how Dr. Steinman presents them.
Dr. Steinman does not number the first two steps. Thus, Dr. Steinman’s “first” step corresponds
to this decision’s “third” step.
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In the fourth step, Dr. Steinman examines the degree of similarity that the
BLAST search produced. Dr. Steinman is looking to see whether five amino acids
out of a string of 12 amino acids align. Exhibit 11 at 9; Tr. 104, 110, 143. The
source of this criterion is a series of papers often referred to as the Gautam articles.
The parties disputed the usefulness of this standard. Dr. Steinman pointed to
the Gautam articles on which he served as a co-author as well as a more recent
articles connecting the Epstein-Barr virus to multiple sclerosis. Tr. 106-10
(discussing the Lanz article and the Santernarzod article). By way of contrast, Dr.
Tompkins discussed articles that stated that similarities between viral and human
proteins are not surprising because of the limited number of amino acids. Tr. 280-
84 (discussing Silvanovich and Kanduc).
A close review of the evidence shows that homology at a level of five out of
12 amino acids can produce an adverse cross-reaction sometimes, but not always.
See Sparrow v. Sec’y of Health & Hum. Servs., No. 18-295V, 2024 WL 1599165,
at *24 (Fed. Cl. Mar. 19, 2024) (citing Dr. Steinman’s testimony about a Gautam
paper), mot. for rev. denied, 173 Fed. Cl. 177 (2024), appeal docketed, No. 25-
1161 (Fed. Cir. May 7, 2025). In this regard, Dr. Tompkins is persuasive when he
testified “there’s so much overlap between, in this case, viral and human peptides,”
that “having homology is a first step, but it’s certainly far from sufficient to define
molecular mimicry as a mechanism for autoimmune disease.” Tr. 283-84.
Before going on to Dr. Steinman’s final step, which he labels as step three
and this decision calls step five, a legal argument must be addressed. After
describing the Gautam standard and the results of Dr. Steinman’s BLAST searches,
Mr. Goodwin argues: “This simple fact [of the detection of a homology more
frequent than five out of 12] is the end of the inquiry.” Pet’r’s Post-Hearing Br. at
7. Later, Mr. Goodwin adds: “one could simply remove the [fifth] step and just
check for 5 out of 12 homology. This approach worked in the Gautum papers.”
Id. at 11.
If Mr. Goodwin is simply arguing that a BLAST search’s detection of a
homology at a level of five out of 12 makes Dr. Steinman’s theory of molecular
mimicry persuasive, then this argument is rejected. Kanduc shows that homology
occurs frequently enough that if homology, by itself, led to an autoimmune
reaction, then autoimmune diseases would be much more common. See Exhibit
VVV. One set of authors maintained that: “new computational and experimental
screening tools make identification of candidate epitopes almost too easy. Indeed,
those attracted by the concept of epitope mimicry must now be wondering less
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about how autoimmunity is provoked and more about why it does not happen more
often.” Exhibit MM (Benoist and Mathis) at 800.
Further, when Dr. Steinman was collaborating with his colleagues on the
experiments that led to the Gautam papers, Dr. Steinman did not stop with
identifying amino acid sequences with various degrees of homology. Dr. Steinman
and colleagues varied the composition of a certain peptide for myelin basis protein,
known as Ac1-11, by changing the amino acids. See, e.g., Exhibit 21 (Gautam) at
606, figure 1.A. They also assessed how different compositions affected the
uptake of thymidine. Id. at figure 1.B. From this information, Dr. Steinman and
colleagues were able to determine which sequences of amino acids stimulated T
cells. Dr. Steinman and colleagues continued. They wondered whether difference
sequences “might trigger the onset of autoimmunity through molecular mimicry.
To examine this issue, [the researchers] were particularly interested in determining
whether peptides with multiple alanines could initiate responses in vivo.” Id. at
607. Thus, the researchers gave different peptides to mice to stimulate an
autoimmune disease, experimental autoimmune encephalitis. Id. at 607, especially
Table 1. In short, Dr. Steinman’s work in the Gautam experiments show that
although homology at a level of 5 out of 12 amino acids sometimes shows that an
autoimmune reaction can occur, homology at that level does not always lead to an
autoimmune reaction.
Regardless of whether Mr. Goodwin is arguing that further support for the
theory of molecular mimicry is not needed, Dr. Steinman certainly attempted to
present some additional support. In his fifth step, Dr. Steinman consulted the
immune epitope database (“IEDB”). Exhibit 11 at 13. The IEDB “catalogs
experimental data on antibody and T cell epitopes studied in humans, non-human
primates, and other animal species in the context of infectious disease, allergy,
autoimmunity, and transplantation.” Id. (citation omitted). The IEDB lists
peptides that have been used in experiments. But, many peptides listed in the
IEDB may not have an immunologic function. Tr. 289-90. Because the IEDB is
so general, special masters have found Dr. Steinman’s reliance on the IEDB not
persuasive. Anderson v. Sec’y of Health & Hum. Servs., No. 20-830V, 2024 WL
4892529, at *15-16 (Fed. Cl. Spec. Mstr. Nov. 1, 2024); Le v. Sec'y of Health &
Hum. Servs., No. 16-1078V, 2023 WL 3049203, at *30 (Fed. Cl. Spec. Mstr. Mar.
30, 2023) (noting that the Secretary's expert had “effectively discredited” Dr.
Steinman's use of BLAST searches and the IEDB); L.R. / Baxter v. Sec’y of Health
& Hum. Servs., No. 16-922, 2024 WL 1912575, at *20-21 (Fed. Cl. Spec. Mstr.
Mar. 28, 2024). Thus, an article’s appearance in the IEDB is less important than
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what the article says. Dr. Tompkins is persuasive when he stated that the reference
needs to be reviewed. Tr. 291.44 This process led to the Mars article.
Dr. Steinman came across the Mars paper after he saw a particular epitope in
the IEDB step of his filtration. Tr. 168. Although Dr. Steinman included a
screenshot from the IEDB in his first report, Dr. Steinman did not include Mars
among the references in his first report. See Exhibit 11 at 15.45
In response to Dr. Steinman’s first report, Dr. Tompkins located the Mars
article and discussed it.46 Dr. Tompkins asserted that “the epitope described in this
paper and found by Dr. Steinman in IEDB may not be cross-reactive with the HPV
18 peptide and may not be biologically relevant in humans.” Exhibit K at 5.
When Dr. Steinman responded to Dr. Tompkins, Dr. Steinman maintained
that, in Dr. Steinman’s opinion, Dr. Tompkins is demanding too much proof of his
theory. Exhibit 27 at 3-4. Without specifically citing Mars, Dr. Tompkins
answered Dr. Steinman in Dr. Tompkins’s next report. Dr. Tompkins wrote:
“there is no experimental evidence from an animal model of neuropathy or similar
system demonstrating that the HSV L1 capsid is presented by antigen-presenting
cells to elicit cross-reactive T cells that also recognize MOG epitopes (e.g.
CWKITLFVIV), that then attack neuronal tissues and trigger autoimmune
disease.” Exhibit LL at 2. Dr. Steinman did not contradict Dr. Tompkins’s
assertion that “there is no experimental evidence from an animal.” Instead, Dr.
Steinman stated that although he has created animal models for other diseases, he
did not expect that such work would be funded by the Vaccine Program. Exhibit
29 at 9. In turn, Dr. Tompkins acknowledged that Dr. Steinman has not developed
an animal model. “So, we are left with no experimental evidence that HPV
infection or vaccination with HPV L1 proteins can cause any autoimmune disease,
including TM.” Exhibit CC at 4.
44 To the extent that Dr. Steinman’s purpose of consulting the IEDB to ask whether “has
anyone seen at least part of [an amino acid] sequence in their experiments that the immune
system actually recognizes,” Tr. 106; accord Pet’r’s Post-Hearing Br. at 10, this purpose adds
little, if anything.
45 With the benefit of hindsight, Mr. Goodwin might have been better served if Dr.
Steinman had explained in his first report why Mars was useful.
46 Because Dr. Tompkins was the first expert to include Mars among his references, the
Secretary filed the Mars article, designating it Exhibit N. This history explains why an article
that Dr. Steinman maintains supports his opinion is designated with a letter, not a number.
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The extent to which Mr. Goodwin is advancing Mars is not clear. Various
clues suggest that Dr. Steinman found that this article was not especially
supportive. Dr. Steinman did not cite Mars in his first report. See Exhibit 11. He
testified that he was not “extolling” Mars. Tr. 125.
Similarly, Mr. Goodwin also seems not to rely on Mars heavily. In his two
briefs filed before the hearing, Mr. Goodwin did not cite Mars at all. See Pet’r’s
Post-Remand Br., Pet’r’s Post-Remand Reply. As part of Dr. Steinman’s direct
examination, Mr. Goodwin elicited relatively little testimony from Dr. Steinman.
See Tr. 125. Presumably, if Mars were an important part of Mr. Goodwin’s
evidence, then Mr. Goodwin would have spent more time on this article. Cf. Tr.
334 (special master suggesting that Mr. Goodwin may want to question Dr.
Steinman about Mars in rebuttal testimony).
The brevity of Dr. Steinman’s discussion of Mars in either his written
reports or oral testimony may have contributed to some confusion. After the
hearing, Mr. Goodwin argues that Dr. Tompkins did not understand how Dr.
Steinman was using the IEDB. Pet’r’s Post-Hearing Br. at 9. Mr. Goodwin
contends that Dr. Steinman uses the IEDB “to ask ‘has anyone seen at least a part
of that sequence in their experiments as something that the immune system
actually recognizes?’” Id. at 10. If that is the sole purpose of checking the IEDB,
then the step has relatively little value as the special masters have found in
Anderson, Le, and L.R. / Baxter.
By way of contrast, Mr. Goodwin recognizes that Dr. Steinman is not using
the IEDB to show “the same exact amino acids caus[e] the exact same disease.”
Pet’r’s Post-Hearing Br. at 8. “Dr. Steinman never claims that this third [fifth] step
is to refine the homology or claim that molecular mimicry would work the same
way in any study discovered in the IEDB search.” Id. at 12. Consistent with this
view, Mr. Goodwin argues that “one could simply remove [Dr. Steinman’s] third
step and just check for 5 out of 12 homology.” Id. at 11.
With this understanding, a discussion of the details of the Mars article
appears unnecessary. To be clear, although the Mars article has been reviewed, see
Tr. 168, Mr. Goodwin is not arguing that the experiments in Mars are roughly
analogous to what he alleges happened to him.47
47 As to whether the mice in the Mars experiment resemble Mr. Goodwin, Dr. Tompkins
raised some differences, such as the presence of a potent adjuvant and a model for multiple
sclerosis, not transverse myelitis. Tr. 296, 428.
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4. Summary/conclusion on Althen Prong One
In sum, the evidence does not preponderate in a finding that the HPV
vaccine can cause TM. Mr. Goodwin did not effectively undermine the Baxter
article. Even if other epidemiological studies were weakened by Mr. Goodwin’s
arguments, a neutralized study does not in turn mean that TM is associated with the
HPV vaccine. The other proffered evidence, case reports and case studies, carry
little weight and do not lend much support to Mr. Goodwin’s theory. Finally, Dr.
Steinman has not presented persuasive and reliable evidence for finding that his
proposed homology can cause a cross-reaction.
B. Althen Prong Three: Timing
The timing prong actually contains two parts. A petitioner must show the
“timeframe for which it is medically acceptable to infer causation” and the onset of
the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101
Fed. Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105
Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).
1. Onset
As discussed above, after the Court’s remand, Mr. Goodwin obtained and
filed medical records that support an opinion that his transverse myelitis was first
manifest within approximately two weeks of his HPV vaccination. Exhibit 42 at
2394-97. Notes from Dr. Greenburg on June 12, 2020 (approximately two years
after Mr. Goodwin’s initial hospitalization) stated that Ms. McCluskey reported
that Mr. Goodwin experienced episodes of bowel and bladder incontinence a
school about 1.5 to 2 weeks after his March 22, 2018 vaccination. Exhibit 41 at
912. She stated that these episodes “continued a few times per week during April
and this continued into May.” Id. Ms. McCluskey also filed an affidavit, dated
November 13, 2024, recounting that Mr. Goodwin had a seizure during a blood
draw around March 29, 2018, and then lost bladder control at school around March
30, 2018. Exhibit 43. She stated that he had another bladder accident a couple
days later, and that he lost mobility in his legs briefly sometime in early April
2018. Id.
Based upon an acceptance of the accuracy of this information, Dr. Steinman
presented an alternative opinion. Exhibit 58. Dr. Steinman opined that “the events
in March and April 2018, beginning 7 to 14 days after [Mr. Goodwin’s] HPV
vaccination, were the initial manifestations of his transverse myelitis.” Id. at 3. He
therefore placed the date of onset between seven and fourteen days post-
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vaccination. However, Dr. Ghosh disagreed. He noted that these urinary
symptoms and leg weakness were not reported in histories prior to December 13,
2019, and that there was no “objective documentation of urinary problems or
neurological deficits in the medical record.” Exhibit SSS at 3. He stated, “I do not
think the earlier intermittent symptoms of urinary incontinence or a single brief
episode of leg weakness could be attributable to spinal cord involvement without
any objective clinical or radiological evidence.” Id. at 4. Furthermore, he noted
that the progression to nadir in ATM is between 4 hours and 21 days of onset,
which would not fit with Mr. Goodwin’s course. Id. He maintained that onset was
68 days post-vaccination.
The evidence does not weigh in favor of accepting that the onset of Mr.
Goodwin’s injury was 7 to 14 days post-vaccination. As explained in Section V,
above, Mr. Goodwin has not carried his burden of showing with preponderant
evidence that the two episodes of loss of bladder control were manifestations of his
transverse myelitis.
Thus, for these reasons, Dr. Ghosh is persuasive in asserting that the onset of
Mr. Goodwin’s transverse myelitis was on May 30, 2018. This date is 68 days
after the vaccination.
2. Appropriate Interval
The second part of the timing is prong is to determine the “timeframe for
which it is medically acceptable to infer causation.” Shapiro, 101 Fed. Cl. at 542-
43. The Federal Circuit has explained the significance of the medically acceptable
time frame.
Evidence demonstrating petitioner's injury occurred
within a medically acceptable time frame bolsters a link
between the injury alleged and the vaccination at issue
under the “but-for” prong of the causation analysis. . . .
If, for example, symptoms normally first occur ten days
after inoculation but petitioner’s symptoms first occur
several weeks after inoculation, then it is doubtful the
vaccination is to blame. In contrast, if symptoms
normally first occur ten days after inoculation and
petitioner’s symptoms do, in fact, occur within this
period, then the likelihood increases that the vaccination
is at least a factor.
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Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1358 (Fed. Cir. 2006).
The April 16, 2024 First Entitlement Decision found that Mr. Goodwin had
not established that 68 days was an interval for which an inference of causation
was appropriate. 2024 WL 2033563. However, the Court vacated this decision.
Order and Opinion, issued Oct. 10, 2024, 2024 WL 4758470. The Court did not
mandate a particular result.
The evidence regarding the appropriate interval has been considered again.
The evidence on remand also includes some evidence, such as the witnesses’ oral
testimony, that was produced after the remand. The evidence preponderates in
favor of finding that 68 days is outside the interval for which an inference of
causation in appropriate.
The basis for this finding is that Dr. Ghosh’s testimony and opinion about
the appropriate interval are persuasive and credited. He stated that a maximum
amount of time for molecular mimicry to happen is six weeks, which is 42 days.
Tr. 433. The basis for Dr. Ghosh’s opinion are studies that evaluated when the
swine flu could cause Guillain-Barré syndrome. Tr 433-34; see Benedict v. United
States, 785 F. Supp. 97, 99 (N.D. Ohio 1991) (epidemiology does not support 69
days).
As part of Dr. Steinman’s direct testimony, he discussed the Langmuir and
Schonberger articles that looked at the incidence of Guillain-Barré syndrome after
swine flu. Tr. 134-35.48 However, Dr. Steinman discounted Langmuir and
Schonberger because those studies were done more than 50 years ago. Tr. 135.
Dr. Steinman’s suggestion that Langmuir and Schonberger are outdated is
not credible. A primary reason for rejecting Dr. Steinman’s opinion about
Langmuir and Schonberger in the present case is that it is inconsistent with Dr.
Steinman’s opinion in other cases. “When addressing credibility, previously
published expert reports and testimony by the same expert, may be reviewed and
considered by the Special Master. Repeat experts who have testified or submitted
expert reports regularly in a particular field have to live with, or explain away,
48 Because the Schonberger and Langmuir articles are critical articles on this topic,
special masters are generally familiar with them. Limited reliance upon this background is
permitted. See Whitecotton v. Sec’y of Health & Hum. Servs., 81 F.3d 1099, 1104 (Fed. Cir.
1996). However, this decision’s discussion of the Schonberger and Langmuir articles is limited
because neither study is in evidence. Unlike some cases cited later in the decision, Dr. Steinman
did not include Schonberger or Langmuir among his references. See Exhibit 11 at 17-18.
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their previous testimony and their previously filed expert reports.” K.A. v. Sec'y of
Health & Hum. Servs., 164 Fed. Cl. 98, 116 (2022), aff’d without opinion, No.
2023-1315, 2024 WL 2012526 (Fed. Cir. May 7, 2024).
One example of Dr. Steinman relying upon Schonberger and Langmuir came
from an opinion a special master issued while the motion for review was pending:
Dr. Steinman stated that “two to 42 days seems like
friendly turf for just about any vaccine-related case” that
he has seen. Tr. 151.
* * *
Further, he offered the Menge paper, which discussed
Gardasil vaccine and four cases of NMO with onset
within the six-to-seven-week timeframe as support for
the timeframe associated with various vaccines and
neuroinflammatory conditions. Tr. 69-70; Pet. Ex. 40.65
He added that the six-to-seven-weeks is within the 2-42-
day timeframe established by epidemiologists Dr.
Shoenberger and Dr. Langmuir as an acceptable interval
between a vaccine and a potential injury, specifically
Guillain-Barré Syndrome (“GBS”). Tr. 70-71. He stated
he was not going to try to fit it into a box other than to
say that based on the literature provided, it was within a
medically appropriate timeframe for onset. Tr. 155.
While imperfect because it is a different vaccine and a
different disease, the best he can do is rely on
Shoenberger and the Menge paper on NMO. He
acknowledged that petitioner did not have NMO. Tr.
155-56; Pet. Ex. 40.
Girardi v. Sec'y of Health & Hum. Servs., No. 17-181V, 2024 WL 4565887, at
*12-13 (Fed. Cl. Spec. Mstr. Sept. 27, 2024).
The example of Girardi is just one of many. Dr. Steinman has relied upon
Schonberger and Langmuir in multiple cases. See, e.g., Cobb v. Sec'y of Health &
Hum. Servs., No. 17-1123V, 2023 WL 6457568, at *23 (Fed. Cl. Spec. Mstr. Aug.
21, 2023) (discussing Schonberger and Langmuir and finding that Dr. Steinman
“provided persuasive testimony on the applicability of those studies to” a case
involving the HPV vaccine and narcolepsy); Pierson v. Sec'y of Health & Hum.
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Servs., No. 17-1136V, 2022 WL 322836, at *32 (Fed. Cl. Jan. 19, 2022)
(discussing Schonberger and Langmuir and finding that Dr. Steinman was
“persuasive in placing the outermost medically appropriate onset date for vaccine-
caused GBS at eight weeks, or 56 days, post-vaccination”); Robinson v. Sec'y of
Health & Hum. Servs., No. 14-952V, 2021 WL 2371721, at *8, 22-23 (Fed. Cl.
Spec. Mstr. Apr. 12, 2021) (noting that Dr. Steinman cited Schonberger and
Langmuir, and finding that “Dr. Steinman provided persuasive testimony on the
applicability” to a case of the flu vaccine causing multiple sclerosis); Rolshoven v.
Sec'y of Health & Hum. Servs., No. 14-439V, 2018 WL 1124737, at *9 (Fed. Cl.
Spec. Mstr. Jan. 11, 2018) (noting Dr. Steinman’s reliance on Schonberger and
Langmuir to support the timing aspect of his theory); Giannetta v. Sec'y of Health
& Hum. Servs., No. 13-215V, 2017 WL 4249946, at *21, 24-25 (Fed. Cl. Sept. 1,
2017) (discussion of Schonberger and Langmuir and finding that Dr. Steinman
persuasively testified that 42 days was an appropriate onset for multiple sclerosis
after a meningococcal vaccine); Quackenbush-Baker v. Sec'y of Health & Hum.
Servs., No. 14-1000V, 2018 WL 1704523, at *19, 23 (Fed. Cl. Spec. Mstr. Mar.
14, 2018) (noting that Dr. Steinman cited Schonberger and Langmuir and finding
that “Dr. Steinman's explanation of the timing and his supporting literature are also
persuasive”).
The work of Langmuir, in turn, is generally accepted in the medical
community. Its general acceptance is one factor, although not a dispositive factor,
for finding that Dr. Ghosh’s opinion that the maximum duration for molecular
mimicry is six weeks is reliable and persuasive. See Terran v. Sec’y of Health &
Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999) (authorizing a special master to
use the Daubert factors, including whether a theory “enjoys general acceptance
within a relevant scientific community,” as a “tool or framework for conducting
the inquiry into the reliability of the evidence”).
A basis that Langmuir’s time is generally accepted includes Dr. Ghosh’s
testimony and Dr. Steinman’s opinion in other cases.49 Evidence also includes the
Baxter study in which the authors looked for various conditions, including
transverse myelitis, that developed within 2-42 days of a vaccination. Exhibit H at
4; Tr. 175, 186, 217-18. The researchers explicitly explained why they selected
this period:
49 Dr. Tompkins accepted a narrower window, one limited to a maximum of four weeks.
Tr. 302, 304; But see Exhibit CCC (Dr. Tompkins’s third report) at 4 (accepting a “42-day risk
period”).
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On the basis of prior studies and expert opinion, we used
2 exposure intervals: (1) 5-28 days as the most likely
interval following immunization to result in a
demyelination illness and (2) 2-42 days as reassurance
that we are not missing an increased risk with the same
type of vaccine, beyond the shorter 5- to 28- day
exposure interval.
Exhibit H at 4.
The researchers in Pidcock limited their analysis to cases of acute transverse
myelitis within 30 days of vaccination. Exhibit J at 2. The decision by the
Pidcock researchers not to extend their analysis to a longer period of time (say 75
days or 90 days after vaccination) leads to an inference that these researchers did
not consider a longer period relevant to the analysis. See Kirby v. Sec’y of Health
& Hum. Servs., 997 F.3d 1378, 1381 (Fed. Cir. 2021) (recognizing that a special
master may draw “plausible inferences”). After all, if the Pidcock researchers had
thought that a period of 75 days or 90 days would capture cases of transverse
myelitis potentially caused by an infection or vaccination, then the Pidcock
researchers would have extended their analysis to this much time.
The same reasoning can be found when looking at the Lazarus / Pilgrim
report. Exhibit 50. As reviewed above (see Section VI.A.1), researchers used
computerized records to search to see whether vaccinees experienced any “adverse
vaccine event.” Notably, the period these researchers selected was “30 days.” Id.
at 3. Again, if a longer period were relevant, the researchers would have searched
computers with a different parameter.50
To be sure, other researchers have presented instances in which a person
developed a neurologic problem more than 42 days after a vaccination. Prominent
examples in the Mr. Goodwin’s case include Menge and Agmon-Levin.
50 Mr. Goodwin observes, accurately, that Baxter and Pidcock did not study potential
effects of vaccines extending to 68 days. Pet’r’s Post-Remand Br. at 41-43; Pet’r’s Post-Hearing
Br. at 22-23. Although this observation is correct, there are two problems with attempting to use
a lack of study to extend the appropriate temporal relationship to 68 days. First, as noted in the
text, the choice to use either 42 days (Baxter) or 30 days (Pidcock) tends to show that longer
intervals are not informative. Second, to the extent that Mr. Goodwin is implying that if a study
did look at a longer interval, then the study would have discovered something, this argument
would not be based upon evidence.
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The Menge paper is a case series examining four instances of patients with
NMO symptoms after receipt of an HPV vaccine. Exhibit BB at 1. Across the
four cases, the onset occurred 4 months, 5 months, an unknown time, and 5 months
after the vaccinees’ most recent vaccination. Id. The authors stated that “NMO
may have been triggered by a recent HPV vaccination,” but acknowledged that
“the data currently available cannot establish a pathogenic link.” Id. at 2.
Of the four examples, Dr. Steinman opined that the latter two of these four
cases might have been TM cases due to their negative MOG antibodies. Tr. 137.
Thus, because one of the latter two cases has an unknown onset, there is effectively
one report, which has an onset of a neurologic problem five months after an HPV
vaccine. Even if none of the cases in Menge were instances of TM, Dr. Steinman
maintained that the paper has comparative value to Mr. Goodwin’s case, but he did
not elaborate as to why. Tr. 139. Dr. Steinman admitted that the case reports do
not speak to causation, but maintained that one should not “draw hard lines in the
sand unless we’re talking about the 1976 swine flu.” Tr. 179. For a disease that is
sufficiently rare and has a limited information base, Dr. Steinman opined that “six
months may be okay.” Tr. 181.
Another potential useful article is Agmon-Levin. See Pet’r’s Post-Remand
Br. at 43 (citing Exhibit G). In this paper, the researchers, including Yehuda
Shoenfeld, consulted various databases and located 37 cases in which a person
developed transverse myelitis after various vaccines over a 39-year period. Exhibit
G.51 “In most of these reported cases the temporal association was between several
days and 3 months, although a longer time frame up to several years was also
suggested.” Id. at 1202.52 Agmon-Levin and colleagues reported cases of
transverse myelitis “4 years,” “6 years,” and “9 years” after an oral polio vaccine.
Id. at 1200 (Table 1).
Just as it was fair to reason that the Pidcock researchers did not analyze
cases that occurred more than 30 days after vaccination because the researchers
51 Agmon-Levin conducted their research before the HPV vaccine was widely available.
52 Of the group of 37 cases, 28 instances occurred in four weeks or less from the
vaccination. Exhibit G at 1200 (table 1). Four weeks is within the period that Dr. Ghosh
proposed as generally accepted. Agmon-Levin also reports that cases occurred “3 months,” “2
months,” “3 months,” and “12 weeks” after the vaccination. Exhibit G at 1200 (table 1). Thus,
although Agmon-Levin and colleagues are accurate when they state that “most” cases had an
onset of less than three months, it is also accurate to state that a majority of cases (28 out of 37)
had an onset of four weeks or less.
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presumably thought those cases were not relevant, it seems fair to infer that when
Menge (and colleagues) and Agmon-Levin (and colleagues) included cases with
longer latencies that the Menge authors and Agmon-Levin authors thought a causal
connection was possible.53 In his work as an expert in the Vaccine Program, Dr.
Shoenfeld has testified “any vaccine can cause any autoimmune disease at any
time.” Harris v. Sec’y of Health & Hum. Servs., No. 10-322V, 2014 WL 3159377
at *14 (Fed. Cl. Spec. Mstr. June 10, 2014); accord Johnson v. Sec’y of Health &
Hum. Servs., No. 14-254V, 2018 WL 2051760, at *12 (Fed. Cl. Spec. Mstr. Mar.
23, 2018).
Thus, some evidence shows that some learned people suggest that a vaccine
can cause transverse myelitis that develops within five months of the vaccination.
Examples of these people include Dr. Menge, Dr. Agmon-Levin, Dr. Shoenfeld,
and Dr. Steinman. However, the presence of this evidence, which favors
petitioner’s position, does not mean that petitioner wins automatically. See Doe 11
v. Sec’y of Health & Hum. Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010) (noting
the presence of some evidence that does not support a special master’s finding does
not make the finding arbitrary); Kindle v. Sec’y of Health & Hum. Servs., No. 20-
1423, 2025 WL 2251738, at *19 (Fed. Cl. Aug. 7, 2025) (ruling that a special
master was not arbitrary in finding that 9 weeks was an inappropriate amount of
time). The question is not whether one individual or a handful of individuals
would accept the temporal relationship is correct.54 The question is whether the
temporal relationship is “medically acceptable.” Althen, 418 F.3d at 1281.
53 Mr. Goodwin seems to argue that Dr. Ghosh accepted a causal latency could extend to
90 days based upon Agmon-Levin. Pet’r’s Post-Hearing Br. at 22, citing Tr. 437. This appears
to be a misinterpretation of Dr. Ghosh’s opinion. At page 437, Dr. Ghosh accepted that the
“temporal association” was as long as “three months” in “most cases” reported by Agmon-Levin.
54 To prevail under Althen, a theory must be supported by sound and reliable evidence. If
just the opinion of one person automatically showed that a vaccination preceded the onset of a
disease within a period for which an inference of causation is appropriate, then Althen prong
three would be effectively meaningless. Experts retained from petitioners always assert that the
timing is appropriate. See Hennessey v. Sec’y of Health & Hum. Servs., 91 Fed. Cl. 126, 142
(2010) (stating that Dr. Shoenfeld’s opinion that a vaccine can cause any autoimmune injury at
any time would make Althen prong three a “nullity”). Here, although Dr. Steinman supported
Mr. Goodwin’s claim, the Secretary is “is permitted to offer evidence to demonstrate the
inadequacy of the petitioner's evidence on a requisite element of the petitioner’s case[-]in-chief.”
Bazan v. Sec'y of Health & Hum. Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008). The Secretary
effectively and persuasively countered Dr. Steinman’s opinion with Dr. Ghosh’s opinion.
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As stated earlier, Dr. Ghosh’s opinion, which rests upon epidemiologic
studies, is more persuasive than Dr. Steinman’s opinion, which rests upon the
Menge case report. See Exhibit 11 at 16 (citing Menge); Exhibit 29 at 1 (stating
that Menge is “the only article [Dr. Steinman could] find in the literature that links
HPV vaccine to cases where longitudinally extensive transverse myelitis is seen”);
Exhibit 37 at 2 (discussing Menge); Tr. 178-79 (Dr. Steinman stating that “in this
context, case reports are important,” but acknowledging that “it has to be a bigger
picture than just case reports”). This conclusion appears consistent with the
Federal Circuit’s reasoning:
Moreover, the Special Master's requirement for strong
temporal evidence is consistent with the third prong of
the Althen test: demonstrating a proximate temporal
relationship between the vaccination and the injury. See
Althen, 418 F.3d at 1278. Again, without some evidence
of temporal linkage, the vaccination might receive blame
for events that occur weeks, months, or years outside of
the time in which scientific or epidemiological evidence
would expect an onset of harm.
Pafford, 451 F.3d at 1358.
3. Summary for prong 3
The evidence preponderates in a finding that Mr. Goodwin’s condition
began 68 days post-vaccination. Mr. Goodwin has not established that any
episodes of incontinence were symptoms of his transverse myelitis. Furthermore,
it is widely accepted in the scientific community that 42 days is an acceptable
timeframe to infer causation. Mr. Goodwin has not shown that 68 days would also
be within an acceptable limit.
C. Althen Prong Two: Logical Sequence
The final element of petitioner’s causation-in-fact claim is the “logical
sequence of cause and effect.” Given that Mr. Goodwin has established neither a
theory nor appropriate timing, it follows as a matter of logic that he cannot
establish a logical sequence of cause and effect, linking the HPV vaccination to his
transverse myelitis. See Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl.
119, 145 (2011), aff’d without opinion, 463 F. App’x 932 (Fed. Cir. 2012).
Nevertheless, if simply for the sake of completeness, this aspect is also evaluated.
Within this element, three items merit extensive discussion: the views of treating
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doctors, the (lack of) evidence for the MOG antibody, and the potential presence of
an alternative cause.55
1. Treating Doctors
With respect to the second Althen prong, the Federal Circuit has instructed
special masters to consider carefully the views of a treating doctor. Capizzano v.
Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006).
Here, two doctors wrote that the vaccine was not likely to be the cause of the
transverse myelitis. First, Dr. Marks stated that: “Have previously discussed
vaccines 8 weeks+ prior to onset of TM, doubtful cause of TM, TM has multiple
causes, comes in clusters in the community.” Exhibit 7 at 113 (June 26, 2018).
Second, Dr. Lacy deferred a question about the vaccine as a cause to infectious
diseases. He added: “Epidemiology does not show an increased rate of children
receiving vaccines having transverse myelitis.” Exhibit 7 at 3022 (Aug. 7, 2018).
These statements do not assist Mr. Goodwin in meeting his burden regarding prong
2.56
2. MOG Antibodies
A logical presentation can entail showing that Mr. Goodwin’s response to
the HPV vaccine was consistent with the theory articulated by petitioner’s expert.
See Hibbard v. Sec'y of Health & Human Servs., 698 F.3d 1355, 1364 (Fed. Cir.
2012); Dodd v. Sec'y of Health & Human Servs., 114 Fed. Cl. 43, 52-57 (2013);
La Londe v. Sec'y of Health & Human Servs., 110 Fed. Cl. 184, 205 (2013), aff’d,
746 F.3d 1334 (Fed. Cir. 2014). Here, Dr. Steinman’s theory is that the HPV
vaccine caused an attack on MOG. Exhibit 11 at 11, Tr. 102, 130. Thus, it is
55 Dr. Steinman’s opinion regarding the second Althen prong was one sentence. Exhibit
11 at 17. Thus, it does not add much, if anything.
56 Ms. McCluskey testified that the doctors who treated her son during his hospitalization
were “dismissive” of the idea that a vaccine caused his transverse myelitis. Tr. 19. This
testimony was not expected as she had not previously disclosed this opinion. See Exhibit 1
(affidavit, dated Mar. 28, 2019) and Exhibit 43 (affidavit dated Nov. 13, 2024). Whereas Ms.
McCluskey’s testimony suggests she took a negative view of the doctor’s dismissal of the causal
relationship (Tr. 19), she otherwise felt they were “conscientious” and “interested in Trenton’s
well-being” (Tr. 63-64).
Regardless, even if Ms. McCluskey’s testimony is credited and these doctors’ views are
given less weight, the evidence becomes neutral at best. That the doctors may have been quick
to dismiss vaccine causation does not mean that they ignored a clear case of vaccine injury—that
is, failure to thoroughly consider a possibility does not mean that the possibility was the answer.
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“logical” for there to be some evidence that Mr. Goodwin developed anti-MOG
antibodies.
Evidence about how a vaccinee did (and did not) respond can be considered.
See Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1362-63 (Fed. Cir.
2019) (when petitioners’ theory was predicated upon an assertion that the child-
vaccinee had a brain stem defect, special master erred in assuming this defect);
Howard v. United States, No. 16-1592, 2023 WL 4117370, at *7 (Fed. Cl. 2023)
(when petitioner’s theory involved the pathogenic role of antibodies, the special
master did not err in noting the absence of those antibodies), aff’d without op., No.
2023-1816, 2024 WL 2873301 (Fed. Cir. 2024); Baldwin v. Sec’y of Health &
Hum. Servs., 147 Fed. Cl. 431, 447 (2020) (petitioner “was required to prove by a
preponderance of the evidence that one of her expert's theories actually occurred”);
Yalacki v. Sec’y of Health & Hum. Servs., 146 Fed. Cl. 80, 93-94 (2019) (when
petitioner claimed to have suffered an autoimmune problem, special master did not
err in looking for evidence of autoimmunity); Copenhaver v. Sec’y of Health &
Hum. Servs., 129 Fed. Cl, 176, 182-83 (2016) (“Petitioners’ theory relies on the
presence of cytokines. It would be completely unjustified to leap to the conclusion
that cytokines caused [the child / vaccinee’s] death when there is a complete lack
of evidence that cytokines were even present at the time of his death"); Cedillo v.
Sec’y of Health & Hum. Servs., 89 Fed. Cl. 158, 181 (2009) (ruling that special
master reasonably found that petitioners did not establish prong two when they
failed to show that the measles virus persisted in the child-vaccinee), aff'd in
relevant part, 617 F.3d 1328, 1343-44 (Fed. Cir. 2010); L.R. / Baxter v. Sec’y of
Health & Hum. Servs., No. 16-922V, 2024 WL 1912575, at *21-22 (Fed. Cl. Spec.
Mstr. Mar. 28, 2024) (although Dr. Steinman assumed that the child-vaccinee had
dormant antibodies, petitioner did not prove the existence of these antibodies);
Quintana v. Sec’y of Health & Hum. Servs., No. 15-1273V, 2022 WL 621698, at
*36 (Fed. Cl. Spec. Mstr. Feb. 15, 2022), mot. for rev. denied, 2022 WL 1873849
(Fed. Cl. 2022).
Here, there is not preponderant evidence that Mr. Goodwin developed anti-
MOG antibodies. Information on this topic comes, in a way, from two sources.
First, when Mr. Goodwin was first hospitalized, the results of any tests for anti-
MOG antibodies were never returned. Tr. 102, 112, 154. In this context, Dr.
Steinman maintains that the “absence of evidence is not evidence of absence.” Tr.
113. True enough. But, the absence of evidence is also not affirmative evidence
of presence.
Second, at the end of 2019, Doctors Tardo and Greenberg ordered MOG
testing. The result was negative. Exhibit 42 at 2442.
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Despite the Secretary’s objection, Mr. Goodwin was permitted to introduce
two articles about the persistence of MOG antibodies during the hearing. These
are the articles by Forcadela (Exhibit 74) and Huda (Exhibit 75). To compensate
for Mr. Goodwin’s presentation of literature during the hearing, the Secretary
addressed those articles via a supplemental report from Dr. Ghosh in which he
discussed a different article on the persistence of MOG antibodies, the Ren article.
Exhibit VVV. Thereafter, the parties sparred over which articles are most
probative. See Pet’r’s Post-Hearing-Br. at 3-5; Resp’t’s Post-Hearing Br. at 26-27.
Although these articles have been reviewed, a detailed discussion is not
needed to resolve Mr. Goodwin’s case. Collectively and generally, the articles
stand for the proposition that MOG antibodies sometimes remain for as long as
approximately 18 months after the onset of the disease and sometimes MOG
antibodies do not persist that long. An interpretation that is favorable to Mr.
Goodwin’s case is that the articles do not make the scenario in which (a) Mr.
Goodwin was positive for MOG antibodies in June 2018 yet (b) Mr. Goodwin was
negative for MOG antibodies in December 2019 absolutely impossible.
If Dr. Steinman’s opinion plus the Forcadela and Huda articles neutralized
the negative MOG results from 2019, there remains a lack of evidence showing
that Mr. Goodwin had MOG antibodies in June 2018. At best for Mr. Goodwin,
there is no reliable evidence about his status in June 2018. But, Mr. Goodwin
bears the burden of proving his case. A finding that the evidence is in equipoise or
a finding that there is no relevant evidence means that the party with the burden of
proof loses. In re: Claims for Vaccine Injuries Resulting in Autism Spectrum
Disorder or a Similar Neurodevelopmental Disorder, 2004 WL 1660351, at *8
(Fed. Cl. Spec. Mstr. July 16, 2004) (“in legal factfinding, if there is no evidence,
the factual issue is simply resolved against the party having the ‘burden of
proof’”); see also Cox v. Merit Syst. Prot. Bd., 817 F.3d 100, 101 (Fed. Cir. 1987)
(“Because [petitioner] . . . offered no evidence in support of his assertion, . . . he
failed to carry his burden of proof”).
With respect to the absence of evidence, Mr. Goodwin’s case resembles
Howard. Mark Howard alleged that a tetanus-diphtheria-acellular pertussis
vaccine caused him to suffer chronic inflammatory demyelinating polyneuropathy.
Howard v. Sec’y of Health & Hum. Servs., No. 16-1592V, 2022 WL 4869354, at
*1 (Fed. Cl. Spec. Mstr. Aug. 31, 2022). To support his claim, Mr. Howard
presented reports from an expert, Kazim Sheikh, who opined that the vaccine could
lead to antibodies that would attack portions of the nervous system. Id. at *9. The
chief special master found that Mr. Howard was not entitled to compensation
because, in part, “No testing results established the existence of any of the
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autoantibodies proposed by Dr. Sheikh to be associated with CIDP.” Id. at *26.
After Mr. Howard challenged the denial of compensation through a motion for
review, the Court of Federal Claims found the result was not arbitrary. Howard v.
United States, No. 16-1592V, 2023 WL 4117370 (May 18, 2023). With respect to
the detection of antibodies, the Court reasoned: “Because Petitioner's theory relied
on the pathogenetic role of certain antibodies, Petitioner cannot then fault the
Decision for noting the absence of evidence preponderantly indicating their
presence.” Id. at *7. Upon an appeal, the Federal Circuit affirmed the judgment
without an opinion.57 Howard v. Sec’y of Health & Hum. Servs., No. 2023-1816,
2024 WL 2873301 (Fed. Cir. 2024).
Although neither the chief special master’s decision in Howard, nor the
opinion from the Court of Federal Claim, nor the Federal Circuit’s determination
constitute binding precedent, the reasoning is persuasive. When a petitioner
proposes the vaccine leads to the production of certain antibodies, whether those
antibodies were detected in the petitioner is a relevant consideration. When this
rationale is used in Mr. Goodwin’s case, his evidence is lacking. He has not
persuasively shown that he developed anti-MOG antibodies as the theory from Dr.
Steinman predicts.
These two reasons are sufficient grounds to find that Mr. Goodwin did not
carry his proof regarding Althen prong two. Nevertheless, one more factor is also
analyzed.
3. Alternative Causes
Whether an argument regarding an alternative cause for the vaccinee’s
injury should be considered within Althen prong two is not entirely clear.
Compare Winkler v. Sec’y of Health & Hum. Servs., 88 F.4th 958, 962 (Fed. Cir.
2023) (ruling special master did not err in considering a potential alternative cause
in prong two); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1357
(Fed. Cir. 2006) (ruling that the special master could consider alternative causes);
id. at 1360 (Dyk, J., dissenting) (the “majority holds that petitioner seeking
57 Petitioner-Appellant raised the antibody issue, arguing, in part, that the special master
“used an incorrect legal standard and elevated the burden of proof required for petitioner's
evidence of medical theory” when he ruled that “a connection between the toxoid and any
specific antibody arguably relevant to CIDP” would be necessary to “flesh out Petitioner’s
theory.” Brief for Petitioner-Appellant, Howard v. Sec’y of Health & Hum. Servs., No. 2023-
1816, 2023 WL 4583434, at *17-23; see also Reply for Petitioner-Appellant, 2023 WL 6214990
at *13-14.
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compensation . . . must establish . . . an absence of ‘alternative causes’ of the
injury”) with Walther v. Sec’y of Health & Hum. Servs., 485 F.3d 1146, 1149
(ruling that requiring a “petitioner to establish a lack of alternative causation was
erroneous”).
Here, Dr. Tompkins, but not Dr. Ghosh, proposed that Mr. Goodwin’s
infection with a herpes virus caused Mr. Goodwin’s transverse myelitis. Exhibit K
at 7-8. There are several problems with this opinion.
Preliminarily, Dr. Tompkins is not a medical doctor. Although his
qualifications as a Ph.D. immunologist allow Dr. Tompkins to critique some
aspects of Dr. Steinman’s opinion, it is not readily apparent that he can assign an
etiology to a disease a person is suffering. Tr. 300; But see Koehn v. Sec'y of
Health & Hum. Servs., 773 F.3d 1239, 1243-44 (Fed. Cir. 2014) (stating that a
special master erred in giving less weight to the testimony of Ph.D. immunologist).
More significantly, Dr. Tompkins struggled to explain how a herpes virus
can cause transverse myelitis. In his reports before the hearing, he disclosed that
he was not relying upon molecular mimicry. Exhibit LL at 4. He seemed to
propose direct replication or bystander activation. Id. At the hearing, Dr.
Tompkins stated, “I’m not really even suggesting a mechanism of bystander
activation.” Tr. 302. Later, Dr. Tompkins said the theory was bystander
activation. Tr. 421. In any event, the discussion of bystander activation was not
robust.
Regardless, the proposal that the herpes virus caused Mr. Goodwin’s
transverse myelitis runs into the same problem as the theory that the HPV vaccine-
--timing. On April 11, 2018, Ms. McCluskey reported that Mr. Goodwin had a
cold sore for about two weeks. Exhibit 6 at 51. Thus, the apparent manifestation
of the herpes infection was about March 28, 2018. See Tr. 407-11; Pet’r’s Post-
Hearing Br. at 26. Thus, the latency between the manifestation of the infection and
the onset of transverse myelitis is 63 days.
Although the latency for herpes infection to onset of transverse myelitis (63
days) is shorter than the latency for HPV vaccination to onset of transverse
myelitis (68 days), the latency for the infection is still long. The latency exceeds
the 42-day limit, which is generally accepted. See Tr. 207 (Dr. Ghosh: the
anticipated interval for a herpes infection to cause transverse myelitis is within
three or four weeks).
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61
For these reasons, the Secretary did not present a persuasive argument that a
herpes infection caused Mr. Goodwin’s transverse myelitis. This lack of
persuasiveness regarding a potential alternative cause does not affect the outcome
of Mr. Goodwin’s claim because the burden did not shift to the Secretary to rebut
Mr. Goodwin’s evidence. See LaLonde v. Sec’y of Health & Hum. Servs., 746
F.3d 1334, 1340 (Fed. Cir. 2014). Mr. Goodwin’s claim fails because he has not
met the burden of proof. The fact that neither the HPV vaccine nor the herpes
infection has been persuasively shown to have caused Mr. Goodwin’s transverse
myelitis simply means that something else caused it. Special masters may reach
this conclusion. See Bazan v. Sec'y of Health & Hum. Servs., 539 F.3d 1347,
1353-54 (Fed. Cir. 2008).
VII. Conclusion
Mr. Goodwin’s transverse myelitis was a traumatic experience, which
continues to have consequences for his health approximately seven years later.
Both Ms. McCluskey and he deserve sympathy for what they have endured.
However, special masters are required to resolve cases based upon evidence.
Here, the evidence does not persuasively show that the HPV vaccination caused
Mr. Goodwin’s transverse myelitis. Thus, he cannot be awarded compensation.
Pursuant to Vaccine Rule 28.1(a), the Clerk's Office is directed to provide
this decision to the assigned judge. The Clerk’s Office is also instructed to enter
judgment in accord with this decision unless a motion for review is filed.
Information about filing a motion for review, including the deadline, can be found
in the Vaccine Rules, which are available on the website for the Court of Federal
Claims.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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Appendix: List of Articles Cited1
1. N. Agmon-Levin et al., Transverse myelitis and vaccines: a multi-analysis,
18 LUPUS 1198 (2009). Filed as Exhibit G.
2. R. Baxter et al., Acute Demyelinating Events Following Vaccines: A Case-
Centered Analysis, 63 CLIN. INFECT. DIS. 1456 (2016). Filed as Exhibit H.
3. Christophe Benoist & Diane Mathis, Autoimmunity provoked by infection:
how good is the case for T cell epitope mimicry?, 2 NAT. IMMUNOL. 797
(2001). Filed as Exhibit MM.
4. Hyeyeon Chang et al., Recurrent optic neuritis and neuromyelitis optica-IgG
following first and second human papillomavirus vaccinations, 144 CLIN.
NEUROLOG. NEUROSURG 126 (2016). Filed as Exhibits EEE and PPP.
5. Christian G.E.L. De Goede et al., Acquired transverse myelopathy in
children in the United Kingdom--a 2 year prospective study, 14 EUR. J.
PAEDIATR. NEUROL. 479 (2010). Filed as Exhibits R and SS.
6. James G. Donahue et al., Near Real-Time Surveillance to Assess the Safety
of the 9-Valent Human Papillomavirus Vaccine, 144 PEDIATRICS 1 (2019).
Filed as Exhibit PP.
7. Mirasol Forcadela et al., Timing of MOG-IgG Testing Is Key to 2023
MOGAD Diagnostic Criteria, 11 NEUROL. NEUROIMMUNOL.
NEUROINFLAMM. 1 (2023). Filed as Exhibit 74.
8. Anand M. Gautam et al., A Polyalanine Peptide with only Five Native
Myelin Basic Protein Residues Induces Autoimmune Encephalomyelitis,
176 J. EXP. MED. 605 (1992). Filed as Exhibit 21.
9. Anand M. Gautam et al., Minimum structural requirements for peptide
presentation by major histocompatibility complex class II molecules:
implications in induction of autoimmunity, 91 PROC. NATL. ACAD. SCI. USA
767 (1994). Filed as Exhibit 22.
1 All articles have been considered.
Case 1:19-vv-00503-ZNS Document 188 Filed 01/08/26 Page 62 of 64

10.Anand M. Gautam et al., A viral peptide with limited homology to a self
peptide can induce clinical signs of experimental autoimmune
encephalomyelitis, 161 J. IMMUNOL. 60 (1998). Filed as Exhibit 23.
11.Saif Huda et al., Predictors of relapse in MOG antibody associated disease: a
cohort study, 11 BMJ OPEN 1 (2021). Filed as Exhibit 75.
12.Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality
1 (2012). Filed as Exhibit 52.
13.Institute of Medicine, The Childhood Immunization Schedule and Safety:
Stakeholder Concerns, Scientific Evidence, and Future Studies 1 (2013).
Filed as Exhibit 51.
14. Darja Kanduc et al., Massive peptide sharing between viral and human
proteomes, 29 PEPTIDES 1755 (2008). filed as Exhibit VVV.
15.Tobias V. Lanz et al., Clonally expanded B cells in multiple sclerosis bind
EBV EBNA1 and GlialCAM, 603 NATURE 321 (2022). Filed as Exhibit 49.
16.Ross Lazarus, Electronic Support for Public Health–Vaccine Adverse Event
Reporting System (ESP: VAERS) 1 (2010). Filed as Exhibit 50.
17.Lennart T. Mars et al., CD8 T Cell Responses to Myelin Oligodendrocyte
Glycoprotein-Derived Peptides in Humanized HLA-A*0201-Transgenic
Mice, 179 J. IMMUNOL. 5090 (2007). Filed as Exhibit N.
18.Til Menge et al., Neuromyelitis optica following human papillomavirus
vaccination, 79 NEUROLOGY 285 (2012). Filed as Exhibits 25, BB, and
NNN.
19.F.S. Pidcock et al., Acute transverse myelitis in childhood: center-based
analysis of 47 cases, 68 NEUROLOGY 1474 (2007). Filed as Exhibits J, Q,
and RR.
20.Changhong Ren et al., Clinical and Radiologic Features Among Children
With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Myelitis,
143 PEDIATR. NERUOL. 96 (2023). Filed as Exhibit XXX.
21.Neda Sattarnezhad et al., Antibody reactivity against EBNA1 and GlialCAM
differentiates multiple sclerosis patients from healthy controls, 122 PROC.
NATL. ACAD. SCI. USA 1 (2025). Filed as Exhibits 63 and 73.
Case 1:19-vv-00503-ZNS Document 188 Filed 01/08/26 Page 63 of 64

22.Tom T. Shimabukuro et al., Safety of the 9-Valent Human Papillomavirus
Vaccine, 144 PEDIATRICS 1 (2019). Filed as Exhibits OO and HHH.
23.Tom T. Shimabukuro et al., Safety monitoring in the Vaccine Adverse Event
Reporting System (VAERS), 43 VACCINE 4398 (2019). Filed as Exhibits P,
QQ, and GGG.
24.Andre Silvanovich et al., The value of short amino acid sequence matches
for prediction of protein allergenicity, 90 TOXICOL. SCI. 252 (2006). Filed as
Exhibit UUU.
25.World Health Organization, Meeting of the Global Advisory Committee on
Vaccine Safety, 7–8 June 2017, 92 WKLY. EPIDEMIOL. REC. 393 (2017).
Filed as Exhibit X.
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