VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-00989
Package ID: USCOURTS-cofc-1_16-vv-00989
Petitioner: K.A.
Filed: 2016-08-11
Decided: 2022-04-18
Vaccine: Tdap
Vaccination date: 2013-08-12
Condition: Guillain-Barré syndrome
Outcome: denied
Award amount USD: 

AI-assisted case summary:
K.A., a 51-year-old medical researcher, received a Tdap vaccine on August 12, 2013. He subsequently developed symptoms consistent with Guillain-Barré syndrome (GBS), with onset reported around August 29, 2013, approximately 18 days after vaccination. K.A. filed a petition alleging the Tdap vaccine caused his GBS, an off-Table injury. The case involved extensive expert testimony from both sides, with petitioner's expert, Dr. Lawrence Steinman, proposing two causation theories: first, that the alum adjuvant in the Tdap vaccine could cause GBS, and second, that molecular mimicry between vaccine components and nerve structures could trigger GBS. Respondent's expert, Dr. Kathleen Collins, argued that K.A.'s symptoms were more likely caused by an intercurrent upper respiratory infection (URI) or influenza-like illness (ILI) that he experienced prior to the onset of GBS. The Chief Special Master denied entitlement, finding that K.A. failed to establish by a preponderance of the evidence that the Tdap vaccine caused his GBS under either of the proposed theories. The decision noted that the medical records strongly supported the conclusion that an intercurrent URI was the more likely cause of K.A.'s GBS, and that the expert testimony did not sufficiently establish a causal link between the vaccine and the injury. K.A. appealed this decision, arguing that his requests for an infectious disease expert were improperly denied and that the Chief Special Master misconstrued the law regarding causation. The reviewing court affirmed the Chief Special Master's decision, finding no abuse of discretion in denying additional experts or a hearing, and agreeing that the evidence did not preponderantly support a vaccine-related injury. The case was ultimately denied.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_16-vv-00989-2
Date issued/filed: 2023-02-10
Pages: 37
Docket text: JUDGE VACCINE REPORTED OPINION re: 111 Order on Motion for Review. Signed by Senior Judge Marian Blank Horn. (jm5) Service on parties made.
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Case 1:16-vv-00989-MBH Document 121 Filed 02/10/23 Page 1 of 37
REDACTED OPINION
In the United States Court of Federal Claims
No. 16-989V
Filed: October 17, 2022
Redacted Version Issued for Publication: February 10, 20231
* * * * * * * * * * * * * * *
*
K.A.,
*
Petitioner, *
*
v.
*
*
SECRETARY OF HEALTH AND
*
HUMAN SERVICES,
*
Respondent. *
*
* * * * * * * * * * * * * *
*
Robert J. Krakow, Law Office of Robert J. Krakow, P.C., New York, NY, for
petitioner.
Nina Ren, Trial Attorney, Torts Branch, Civil Division, United States Department
of Justice, Washington, DC, for respondent. With her were Heather L. Pearlman,
Assistant Director, Torts Branch, C. Salvatore D’Alessio, Acting Director, Torts Branch,
Brian M. Boynton, Principal Deputy Assistant Attorney General, Civil Division.
O P I N I O N
HORN, J.
On August 11, 2016, petitioner K.A. filed a petition for compensation with the
National Vaccine Injury Compensation Program (Vaccine Program), under the National
Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1–300aa-34 (2018) (Vaccine
Act), for an off-Table injury. See 42 U.S.C. § 300aa-11(c)(1)(C)(ii) (2018). Petitioner
claimed that an August 12, 2013 Tetanus Diphtheria acellular-Pertussis (Tdap)
vaccination caused him to experience Guillain-Barré syndrome. On April 18, 2022, Chief
Special Master Brian H. Corcoran denied petitioner’s claim for an award of
1 This Opinion was issued under seal on October 17, 2022. Petitioner proposed
redactions to the Opinion, which were incorporated into this version. The court made
additional conforming redactions for consistency. Consistent with Chief Special Master
Brian H. Corcoran’s February 1, 2023 Order, the Opinion refers to petitioner by the
initials “K.A.”

Case 1:16-vv-00989-MBH Document 121 Filed 02/10/23 Page 2 of 37
compensation, finding that petitioner had not shown, by a preponderance of the
evidence, that he was entitled to compensation. Subsequently, petitioner filed a Motion
for Review of the Chief Special Master’s decision denying his claim pursuant to Rule 23
and Rule 24 of the Vaccine Rules of the United States Court of Federal Claims (2021)
(Vaccine Rules) in the United States Court of Federal Claims.
F I N D I N G S O F F A C T
On August 12, 2013, petitioner, a medical researcher, received the Tdap vaccine,
when he was fifty-one years old. Prior to receiving the vaccine, petitioner had a medical
history of high cholesterol, hypertension, and a chronic leg condition. Following his
vaccination, on September 1, 2013, petitioner was admitted to the North Shore
University Hospital Emergency Department in Manhasset, New York and petitioner
reported that he had experienced three days of flu-like symptoms, including dry cough,
chills, and swelling of his throat. The medical professionals treating petitioner noted that
he appeared neurologically sound and was not in distress, although they observed
petitioner displaying many common symptoms of an upper respiratory infection or
influenza like illness (URI/ILI), including fever, chills, weakness, nasal discharge,
congestion, dyspnea, and cough. Petitioner was discharged the following day on
September 2, 2013, and petitioner maintains that he continued to experience a fever
through September 3, 2013.
On September 4, 2013, petitioner was discovered in his driveway complaining of
numbness on his left side, and was transported via ambulance to the emergency
department at St. Francis Hospital in Roslyn, New York. Emergency responders noted
that petitioner walked with an “unsteady gait” and that he had been treated for flu-like
symptoms recently. The same day, September 4, 2013, petitioner was admitted to St.
Francis Hospital for further evaluation. Medical records from petitioner’s September 4,
2013 visit to St. Francis Hospital indicate that petitioner stated
[t]he current episode started in the past 7 days. The problem occurs
intermittently. The problem has been unchanged. Associated symptoms
include weakness. Pertinent negatives include no numbness. Nothing
aggravates the symptoms. He has tried nothing for the symptoms.
[P]atient presents to the emergency department for evaluation of
weakness of the left arm leg and face. Patient states symptoms are [sic]
originally began approximately 5 days ago when he was attempting to
climb a hill and noticed weakness in the left leg. Patient then states that he
developed incoordination of the left face when attempting to brush his
teeth this morning. Patient denies loss of sensation however states he has
a tingling sensation diffusely over the left side of his body. There are no
specific modifying factors. Severity of symptoms mild to moderate.
(alterations added). With regard to his neurological symptoms, petitioner’s admitting
physician Dr. Subash Viswanathan reported that petitioner was “unable to forcefully
2

Case 1:16-vv-00989-MBH Document 121 Filed 02/10/23 Page 3 of 37
closed [sic] left eye. Left face shows mild weakness. Otherwise cranial nerves 2-12
intact. There is subjective weakness of the left arm and left leg. However patient is able
to move both extremities with good strength. There is no sensory deficit.” (alteration
added). Dr. Viswanathan also noted
Pt [patient] had the “flu” 2 weeks ago, not receiving abx [antibiotics].
Denies recent travel or diarrhea. Was an URI. The past week first noted
left leg weakness while climbing. Had presented to NSUH [North Shore
University Hospital], where he works doing bench research on HIV
[Human Immunodeficiency Virus] nephropathy, where he was admitted.
CT [Computed tomography] chest was negative. After discharge he has
been noting a weakness and numbness of the left face/arm/leg. He denies
any vision change but there is some burning sensation in the left eye. He
noted toothpaste dripping from the left mouth while brushing his teeth. He
also complains of bloating and unable to make a BM. His BP [blood
pressure] has been high.
(alterations added). CT scans of petitioner’s brain and chest did not yield any significant
abnormalities. Lab results indicated, however, that petitioner had the antibodies for the
West Nile Virus, which indicated that he had contracted West Nile Virus at some point in
the past.
On September 4, 2013, Dr. Michael Han, another treating physician, indicated
“[m]uch of his [petitioner’s] symptoms and findings are non-specific, though bifacial
weakness is most prominent and perhaps most helpful in narrowing down differential. A
major consideration would be AIDP [Acute Inflammatory Demyelinating
Polyneuropathy]/GBS (Guillan [sic] Barre Syndrome) with all the above features,
including potential autonomic dysfunction.” (alterations added). Dr. Han also indicated
that petitioner had suffered a “recent URI [upper respiratory infection] 2 weeks ago.”
(alteration added). During his stay at St. Francis Hospital, petitioner complained
primarily of weakness. Petitioner also reported to Dr. Han that he had experienced flu
like symptoms two weeks prior, and that he developed left leg weakness and difficulty
climbing over a small hill near his home shortly thereafter.
On September 5, 2013, Dr. Teresa Deangelis, a neurologist, examined petitioner
and reported that “[a] major consideration would be AIDP/GBS (Guillain Barre
Syndrome).” Dr. Deangelis likewise noted that petitioner had experienced “recent URI 2
weeks ago.” Dr. Deangelis’ treatment notes indicate that she started petitioner on a five-
day course of intravenous immunoglobulin therapy on September 5, 2013, which is a
blood product used to treat patients with antibody deficiencies, including neurological
disorders such as Guillain-Barré syndrome. On September 6, 2013, petitioner went
through a rheumatology consult with Dr. William Given, who indicated that petitioner
“states that he was well until about 2 weeks ago when he developed NP [nonproductive]
cough, pharyngitis, malaise, and elevated temperature.” (alteration added). Dr. Given
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Case 1:16-vv-00989-MBH Document 121 Filed 02/10/23 Page 4 of 37
reported that it appeared that petitioner “developed weakness and paresthesias[2]
following what appears to be a viral illness a couple of weeks ago.” (alteration added).
On the same day, September 6, 2013, petitioner had an infectious disease consult with
Dr. Dava Klirsfield. Dr. Klirsfield’s assessment indicated: “Patient with bell’s palsy, left
sided weakness and hyporeflexic, recent tetanus shot and flu-like illness, imaging
shows a dermoid in occipital bone on right, suspect a demyelinating disorder[3] possibly
post viral or post vaccine.” (alteration added). Dr. Klirsfield’s assessment also indicated
that petitioner’s positive West Nile Virus antibodies test had “unclear significance,” and
ordered additional laboratory testing. On September 10, 2013, following two consistent
lumbar punctures, Dr. Doina Glodan diagnosed petitioner with “Guillain-Barre syndrome
post recent viral URI.” Petitioner remained at St. Francis Hospital until September 17,
2013, at which time he was discharged to Glen Cove Hospital, a rehabilitation facility in
Glen Cove, New York. Petitioner’s medical records from his date of discharge indicate
that petitioner stated that he “[f]eels like he is getting better. No new complaints.” While
at Glen Cove Hospital, petitioner received physical therapy, occupational therapy, and
commenced a speech therapy program.
On September 22, 2013, petitioner’s medical records indicate that “he developed
acute right facial weakness with right hemiparesis, and CAT scan of the head revealed
no new acute pathology, and the patient after contacting primary neurology was
transferred to North Shore University Hospital for further investigation and treatment.”
Treatment notes from North Shore University Hospital state that petitioner displayed
increased lethargy, weakness, and right sided numbness and tingling that started two to
three days prior, with trace reflexes and worsened right-side issues. Petitioner’s
admittance documents from North Shore University Hospital indicate that he was
experiencing “new onset of R [right] side numbness/tingling weakness in the setting of
recently diagnosed of [sic] AIDP.” (alterations added).
On September 24, 2013, petitioner began plasmapheresis treatment.4
Petitioner’s treatment notes state that, as a result of the plasmapheresis treatment,
petitioner exhibited “significant improvement” in strength and respiration. According to
2 Paresthesias is defined as “tingling or pricking (‘pins and needles’), caused chiefly by
pressure on or damage to peripheral nerves.” Encyclopedia of Virology 738 (Dennis H.
Bamford & Mark Zuckerman eds., 4th ed. 2021).
3 “A demyelinating disorder is any condition that causes damage to the protective
covering (myelin sheath) that surrounds nerve fibers in your brain, the nerves leading to
the eyes (optic nerves) and spinal cord.” Demyelinating disease: What can you do about
it?, MAYO CLINIC, https://www.mayoclinic.org/diseases-conditions/multiple-
sclerosis/expert-answers/demyelinating-disease/faq-20058521 (last visited Feb. 10,
2023).
4 Plasmapheresis “is a nonsurgical therapy that removes and replaces a patient’s blood
plasma.” Plasmapheresis Program, UC SAN DIEGO HEALTH,
https://health.ucsd.edu/specialties/apheresis/pages/plasmapheresis.aspx (last visited
Feb. 10, 2023).
4

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petitioner’s medical records, thereafter, on September 26, 2013, petitioner saw a
dietician who indicated in petitioner’s medical history that petitioner had initially
presented “with progressive weakness post tetanus shot 8 weeks ago.” The dietician
also noted that petitioner had reported that “he kept losing weight since after his tetanus
shot despite adequate intake.” On October 8, 2013, petitioner was discharged from
North Shore University Hospital and returned to Glen Cove Hospital for further
rehabilitation, where he stayed until October 21, 2013.
On October 21, 2013, petitioner was “discharged home with supervision from
friends and family with a follow up with Dr. Han.” Petitioner had an initial evaluation at
Transitions Rehabilitation on October 23, 2013, when he stated that he was in “good
health until September of this year.” The following day, on October 24, 2013, petitioner
was hospitalized at North Shore University Hospital after he was “FOUND LYING ON
FLOOR AOX3 -LOC C/O SEVERE HEAD ACHE 10/10 PAIN SCALE, PT WAS JUST
RELEASED MONDAY FROM REHAB FOR A NEUROLOGICAL REACTION TO A
TETNUS SHOT 2 MONTHS AGO AND STARTED GETTING HEAD ACHE TONIGHT.”
(capitalization in original). Petitioner’s medical records from North Shore University
Hospital, dated October 24, 2013, indicate that he was “violently vomiting” and was
experiencing “generalized weakness.” A CT scan from the North Shore University
Hospital Emergency Department of petitioner’s head showed a “6 mm left extra-axial
collection with mass effect, no shift. Denies any photophobia, vision loss, neck pain,
increased weakness, fever/chills.” On October 25, 2013, petitioner underwent a
magnetic resonance imaging (MRI) scan of petitioner’s brain, which revealed “[s]mall
bilateral subacute subdural hematomas with diffuse dural enhancement,” which “raise
the possibility of intracranial hypotension.” Petitioner also received a blood patch for
suspected spinal tap CSF leak.5 On October 27, 2013, petitioner underwent a repeat
head CT scan, which revealed an interval increase in size in the left subdural
hematoma. Petitioner was started on Dialudid and his previously prescribed Neurontin
dose was increased. Neurosurgery advised that no intervention was necessary.
Petitioner continued to follow up with Dr. Han through the end of 2013, and Dr. Han
reported petitioner’s overall improvement.
Petitioner did not visit Dr. Han again until September 2, 2014, at which time
petitioner reported that he was still experiencing painful paresthesias in his feet, but no
longer required a cane to walk. Petitioner also reported that “[h]is balance is still a bit off
though he feels that he is 99% back to normal.” Dr. Han advised petitioner to continue
on his then-current course of medication and to see Dr. Han again in 4-6 months.
Petitioner saw Dr. Han on November 24, 2015 and Dr. Han’s treatment notes from the
November 24, 2015 visit state that petitioner continued to experience “paresthesias,”
and Dr. Han theorized that “this still could be residual from Guillain-Barre,” but that “we
should not ignore the possibility of another neuropathic process such as diabetes or
5 A cerebrospinal fluid (CSF) leak occurs when there is a hole or tear in the outermost
layer of the membranes surrounding the brain and spinal cord, which allows the fluid to
escape. CSF Leak (Cerebrospinal fluid leak), MAYO CLINIC,
https://www.mayoclinic.org/diseases-conditions/csf-leak/symptoms-causes/syc-
20522246 (last visited Feb. 10, 2023).
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borderline diabetes.” Dr. Han ordered an electromyography (EMG) procedure and
advised petitioner to continue with his previously prescribed Neurotonin. On December
4, 2015, petitioner underwent an EMG that “did not demonstrate the concern for
possible axonal of demyelinating polyneuropathy.” Dr. Han ordered an “MRI
lumbosacral spine to rule out a significant herniated disc with nerve root compression,”
which petitioner went through on December 4, 2015.
On May 20, 2016, petitioner had an appointment with Dr. Adam Criss for
“reevaluation of Guillain-Barre syndrome.” Treatment notes indicate that petitioner
“continues to do well although still has neuropathic pains associated with this syndrome.
He’ll continue with Neurontin 600/300/300. Weight loss and increased physical activity
was encouraged. I will see him back in 6 months.”
Procedural History
On August 11, 2016, petitioner filed a petition seeking compensation under the
Vaccine Act, 42 U.S.C. § 300aa-11(c)(1)(C)(ii), alleging that the August 12, 2013 Tdap
vaccination more likely than not caused his GBS, with the onset of the injury taking
place on or about August 21, 2013. Special Master Mindy M. Roth was the Special
Master initially assigned to petitioner’s case. During the pendency of petitioner’s case,
he filed his medical records in nineteen exhibits and submitted two declarations. On
February 23, 2017, respondent filed its Rule 4(c) report, pursuant to the Vaccine Rules,
opposing compensation because “the medical records alone do not provide
preponderant proof of a vaccine-related injury, and petitioner has not provided a reliable
expert report in support of his claim.” In addition, respondent stated that “the records
also reflect that petitioner’s treating physicians were immediately concerned that his
symptoms were indicative of ‘Guillain-Barre syndrome post recent viral URI.’”
Respondent also argued that “petitioner has failed to rule out other potential causes for
his injury. Petitioner had positive test results for both CMV [cytomegalovirus] and EBV
[Epstein-Barr virus] infections, two known antecedents associated with GBS.”
(alterations added).
On March 22, 2017, Special Master Roth held a status conference with the
parties, after which petitioner filed additional medical records and his first expert report
authored by neurologist-immunologist Dr. Lawrence Steinman on August 4, 2017 in
support of petitioner’s case. On December 4, 2017, respondent filed its first expert
report authored by immunologist Kathleen Collins, M.D., Ph.D. In her expert report, Dr.
Collins stated that “the medical record better supported the conclusion that Petitioner’s
GBS was attributable to the ‘influenza-like illness’ that he appeared to have experienced
in the interval between his vaccination and onset of neurologic symptoms.” On February
20, 2018, petitioner filed Dr. Steinman’s second expert report, in which Dr. Steinman
characterized “Dr. Collins’s ILI terminology as imprecise.” On June 13, 2018,
respondent filed Dr. Collins’ second expert report and first response to Dr. Steinman’s
expert report. On December 28, 2018, petitioner filed Dr. Steinman’s third expert report,
which “‘repeated his prior challenge to Dr. Collins’s use of ILI.” On May 7, 2019,
respondent filed Dr. Collins’ third expert report, in which Dr. Collins defended her theory
of ILI as the more likely the cause of petitioner’s GBS. On July 29, 2019, Special Master
Roth held a status conference to discuss petitioner’s aluminum adjuvant causation
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theory. During the status conference, respondent expressed the implausibility of
petitioner’s aluminum adjuvant theory and Special Master Roth allowed petitioner to file
and assert a new causation theory of molecular mimicry. On October 7, 2019, petitioner
filed Dr. Steinman’s fourth expert report, wherein Dr. Steinman proffered, for the first
time, molecular mimicry as a new causation theory, which he contended co-existed with
his prior aluminum adjuvant theory. As explained in the Chief Special Master’s
Entitlement Decision:
Specifically, he [Dr. Steinman] (a) attempted to propose the degree of
amino acid homology that would be necessary, arguing that five (and
perhaps even four) out of a twelve amino acid string is sufficient (b)
performed “BLAST”[6] searches with an online government database for
the antigenic components of the Tdap vaccine, in order to identify the
amino acids comprising them, and (c) compared them to identified GBS
targets.
(internal references omitted; alterations added). Thereafter, respondent filed Dr. Collins’
fourth, and final, expert report on January 23, 2020.
More than three years and seven months after petitioner filed his petition for
compensation under the Vaccine Act, and following four expert reports filed by petitioner
and four expert reports filed by respondent, on March 23, 2020, petitioner asked to
retain an infectious disease expert in order to file another expert report, in addition to
the expert reports previously filed by Dr. Steinman. Then on May 22, 2020, petitioner
filed a formal motion for leave to file an expert report from an infectious disease
specialist as well as an expert report from a specialist in biostatistics. Petitioner stated:
Respondent’s primary and persistent defense to petitioner’s claim that the
Tdap vaccine caused his Guillain Barré syndrome (“GBS”) is the argument
that petitioner had viral symptoms after his vaccination. Respondent
argued in his Rule 4(c) Report that petitioner’s symptoms “were indicative
of ‘Guillain-Barre syndrome post recent viral URI.” [sic] Respondent
presents several citations to the medical record purporting to support his
argument. Respondent also argues in his Rule 4(c) Report that “petitioner
has failed to rule out other potential caused [sic] for his injury. Petitioner
had positive test results for both CMV [Cytomegalovirus] and EVC [Ellis-
van Creveld] infections, two known antecedents associated with GBS.”
6 As explained in a footnote to the Chief Special Master’s Entitlement Decision:
Basic Local Alignment Search Tool (“BLAST”) is a medical/scientific
internet resource that assists researchers in finding regions of similarity
between biological sequences of amino acids. The program compares
nucleotide or protein sequences to sequence databases and calculates
the statistical significance. BLAST, U.S. National Library of Medicine,
https://blast.ncbi.nlm.nih.gov/Blast.cgi
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(internal citations omitted; alteration added). Petitioner argued that respondent had
previously “filed four expert reports from an expert in infectious disease,” that pointed to
an “influenza-like illness” as an “alternative cause” for petitioner’s GBS. According to
petitioner,
[b]ecause the controversy in this case focuses in large part on
respondent’s claim that an infectious disease caused [K.A.]’s GBS and
because respondent has relied on the opinion of a specialist in infectious
disease, petitioner submits that it is appropriate for petitioner to file an
expert report from a specialist in infectious disease.
(alterations added).
On June 12, 2020, Special Master Roth issued an Order which, in relevant part,
denied petitioner’s motion for file to file both the additional requested expert report from
an infectious disease expert, as well as from a biostatistics expert. The text of Special
Master Roth’s Order stated:
On May 22, 2020, petitioner filed a Motion for Leave to file an expert
report from an infectious disease specialist and an expert report from a
specialist in biostatistics. See ECF No. 71. Petitioner’s Motion is hereby
DENIED.
On June 4, 2020, petitioner filed an unopposed Motion for Extension of
Time until June 22, 2020, to file a supplemental expert report from Dr.
Steinman. See ECF No. 72. Petitioner’s Motion is hereby GRANTED.
Petitioner shall file a supplemental expert report from Dr. Steinman by
Monday, June 22, 2020.
A status conference will be scheduled following the submission of Dr.
Steinman’s supplemental report.
Based on the foregoing, the following is hereby ORDERED:
1) Petitioner shall file a supplemental expert report from Dr. Steinman by
no later than Monday, June 22, 2020.
(capitalization and emphasis in original). Pursuant to Special Master Roth’s Order, on
June 22, 2020, petitioner filed Dr. Steinman’s fifth, and final, expert report.
On January 27, 2021, the case was reassigned to Chief Special Master
Corcoran. On April 26, 2021, petitioner renewed his request for leave to file expert
reports from specialists in infectious disease and biostatistics, which request had been
denied previously by Special Master Roth. Chief Special Master Corcoran issued an
Order on April 27, 2021 directing petitioner to file his motion for a ruling on the record by
June 29, 2021. On July 2, 2021, petitioner filed his motion for a ruling on the record in
support of his entitlement to compensation under the Vaccine Act and his motion for
leave to file additional expert reports from experts in infectious disease and biostatistics.
On September 13, 2021, respondent filed its response to petitioner’s motion for ruling
on the record. On October 12, 2021, petitioner filed a reply brief which included a
footnote which stated that “petitioner acknowledges the Court’s authority to decide this
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case without an evidentiary hearing during which the experts’ presentations can be
explored, in the context of the present case, where petitioner’s theory is closely
contested, a hearing would supply valuable elaboration of petitioner’s case and a
hearing should be conducted.” Prior to issuing his Entitlement Decision, Chief Special
Master Corcoran did not issue orders addressing petitioner’s request for an evidentiary
hearing or to allow petitioner to present additional experts.
On April 18, 2022, Chief Special Master Corcoran issued his Entitlement
Decision in which he denied petitioner’s claims in full. The Chief Special Master stated
that petitioner had not established that he met the requirements to receive
compensation based on the test in Althen v. Secretary of Health & Human Services,
418 F.3d 1274 (Fed. Cir. 2005).7 Regarding the first prong of the Althen test, the
medical theory causally connecting the vaccination and the injury, id. at 1278, the Chief
Special Master noted: “Two causation theories were ultimately advanced in this case,
but neither was preponderantly established.” The Chief Special Master indicated that
“[i]t was wise of Petitioner to “supplement” his case with a second causation theory, for
the first one Dr. Steinman proposed—that alum included in the Tdap vaccine as an
adjuvant can produce demyelination—was woefully inadequate,” noting in a footnote,
“[i]ndeed, Petitioner largely seems to have walked away from his first theory by the time
of his reply brief.” The Chief Special Master determined that “individual components of
the [aluminum adjuvant] theory, as reliably established as they were, were not
persuasively connected to other preponderant evidence to establish that the Tdap
vaccine likely can cause GBS solely on the basis of the inclusion of the aluminum
adjuvant.” (emphasis in original; alteration added). Regarding petitioner’s second
causation theory, molecular mimicry, Chief Special Master Corcoran explained:
Petitioner’s second theory was one that, more often than not in Program
cases, is the primary theory offered to explain how virtually any vaccine
could produce an autoimmune disease—via molecular mimicry. But not
only was it proposed late in the game, but it too was not preponderantly
shown to be likely causal. All Dr. Steinman did was offer evidence
suggesting a theoretic possibility of homology between Tdap vaccine
components and locations in the nerve structures where an autoimmune
attack might occur. But this is a relatively easy showing to make, given the
prevalence of homology in nature. It does not amount to a showing that a
7 As described below, the United States Court of Appeals for the Federal Circuit in
Althen explained:
Concisely stated, Althen’s burden is to show by preponderant evidence
that the vaccination brought about her injury by providing: (1) a medical
theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the 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 at 1278.
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cross-reaction instigated by the Tdap vaccine resulting in GBS is “more
likely than not.” And Dr. Collins offered evidence and testimony raising
reasonable questions about whether every variant of GBS inherently
unfolds only from molecular mimicry causing the production of cross-
reactive autoantibodies, or only at the identified myelin targets.
(emphasis in original). Therefore, for the first Althen prong, the Chief Special Master
concluded that “neither of the causation theories offered was preponderantly
established with sufficient reliable medical or scientific evidence, despite Dr. Steinman’s
ample credentials to opine on the subject.”
Regarding the second Althen prong, the logical sequence of cause and effect
showing that the vaccination was the reason for the injury, id., the Chief Special Master
indicated that “[s]everal items of record evidence weigh against Petitioner’s assertion
that the Tdap vaccine he received likely ‘did cause’ his GBS. In particular, the majority
of immediate treaters did not propose vaccination to be causal, finding far more
significant the indisputable evidence of an intercurrent URI,” and, furthermore, “the
record reveals several instances in which treaters proposed that Petitioner’s URI did
play a role in his subsequent neurologic injury.” (emphasis in original). The Chief
Special Master concluded: “Overall, the medical records strongly support the conclusion
that Petitioner’s intercurrent URI likely caused his GBS—not that it was caused by the
Tdap vaccine.” Therefore, the Chief Special Master determined
[p]etitioner has not preponderantly established that the Tdap vaccine can
cause GBS, under either of the two causation theories ventured over the
case’s six-year life—and even if he had, the record demonstrates it is far
more likely his GBS was attributable to an intercurrent upper respiratory
infection (“URI”) than vaccination.
Regarding the third Althen prong, the showing of a proximate temporal
relationship between vaccination and injury, id., Chief Special Master Corcoran noted
that “Petitioner’s success in establishing that the timeframe for his onset of symptoms
post-vaccination was medically acceptable (in terms of vaccine causation) is not
consistent from theory to theory,” and concluded that “because the claim fails on the
first two Althen prongs, Petitioner’s ability to preponderantly support the third prong
does not avail him.”
Chief Special Master Corcoran also indicated in the Entitlement Decision that an
evidentiary hearing was not necessary and that “[t]he case was appropriately decided
on the papers.” In his Entitlement Decision, the Chief Special Master indicated that the
parties had previously filed numerous expert reports, which Chief Special Master
Corcoran characterized as a “back-and-forth between Drs. Steinman and Collins over
Petitioner’s initial causation theory.” Chief Special Master Corcoran also stated:
Notably (and after the case had existed for nearly three years), it was
discussed during a July 2019 status conference (perhaps in reaction to
questions about whether the case was likely to settle) that Respondent
deemed Petitioner’s causation theory implausible—prompting the special
master formerly presiding over the case to order a deadline for Petitioner
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to file a new report, but this time “modifying” the theory to allege molecular
mimicry as the causal mechanism. Scheduling Order, dated July 19, 2019
(ECF No. 59). Dr. Steinman did so by that fall, and another, shorter round
of expert report filings occurred, with the final report (from Dr. Steinman)
filed in June 2020.
On May 18, 2022, after Chief Special Master Corcoran issued his Entitlement
Decision petitioner timely filed a Motion for Review of the Chief Special Master’s
Entitlement Decision in the United States Court of Federal Claims, in which petitioner
puts forth three numbered objections:
Numbered Objection One
1. Denial of Petitioner’s repeated requests to retain an infectious disease
expert resulted in an unbalanced review of Petitioner’s presentation of
Althen Prong 2 and constituted an abuse of discretion under the
circumstances of this case.
Numbered Objection Two
2. In the case at bar, the Chief Special Master failed to recognize that the
posited medical theory of molecular mimicry went well beyond the mere
identification of homologies[8] between components of the Tdap vaccine
and self-antigen such as human myelin protein, leading to GBS (Dec. at
40). The court’s misconstruction of the record and incorrect application of
the law requires vacatur of the Decision. The court compounded its error
by holding that Petitioner’s causal medical theory was “undercut” by
epidemiological evidence as to causation for which an expert was denied
to Petitioner despite repeated requests throughout the case (Dec. at 40-
41).
Numbered Objection Three
3. While Petitioner argued in the course of his Motion for Ruling on the
Record that he had carried the burden of proof preponderantly for each
prong of Althen, including prong 1, the court misinterpreted the law in
rejecting an alternative argument that, in light of recent case law, Althen
prong 1 could be properly established by a biologically plausible
evidentiary showing founded upon a sound and reliable medical or
scientific explanation.
(capitalization and emphasis in original; alteration added).
8 A “homology” is an antigenic similarity “between the vaccine’s component and self
neurologic structures.” See Caredio v. Sec’y of Health & Hum. Servs., No. 17-79V, 2021
WL 4100294, at *13 (Fed. Cl. Spec. Mstr. July 30, 2021), review denied, No. 17-79V,
2021 WL 6058835 (Fed. Cl. Dec. 3, 2021). In Caredio, Dr. Steinman, who offered expert
testimony for the Caredio petitioner, “admitted that demonstrating a theoretical basis for
homology is only the first step to establishing a possible causal association.” Id.
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On June 16, 2022, respondent filed its response to petitioner’s Motion for
Review, in which respondent argues that
[b]ecause petitioner had a full and fair opportunity to present his case,
including filing five expert reports over three years addressing the ILI/URI
issue in the case and modifying his causation theory, the Chief Special
Master appropriately decided this case on the existing record, as further
input from an infectious disease expert for petitioner was neither required
nor warranted.
Respondent also argues that “[t]he Chief Special Master properly applied the law,
including Torday [v. Secretary of Health & Human Services, No. 07-372V, 2009 WL
5196163 (Fed. Cl. Spec. Mstr. Dec. 10, 2009)], and acted within his discretion in
deciding this case without a hearing.” (alteration added). In its response, respondent
asserts that the Chief Special Master considered the appropriate and relevant evidence,
“and stated a rational basis in concluding that petitioner failed to demonstrate how the
Tdap vaccine can cause GBS via molecular mimicry under Althen prong 1.” Finally,
respondent argues that the Chief Special Master applied the correct evidentiary
standard in evaluating whether petitioner preponderantly met the Althen prong 1, and
that the “Federal Circuit precedent requires a petitioner to present more than a
‘plausible theory’ of vaccine causation.” After the Motion for Review was fully briefed,
this court held oral argument.
DISCUSSION
When reviewing a Special Master’s decision, the assigned Judge of the United
States Court of Federal Claims shall:
(A) uphold the findings of fact and conclusions of law of the special master
and sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the special master
found to be arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with law and issue its own findings of fact and conclusions
of law, or
(C) remand the petition [filed under § 300aa-11] to the special master for
further action in accordance with the court's direction.
Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 867 (Fed. Cir. 1992) (alteration
in original); see also 42 U.S.C. § 300aa-12(e)(2) (2018). The legislative history of the
Vaccine Act states: “The conferees have provided for a limited standard for appeal from
the [special] master’s decision and do not intend that this procedure be used frequently,
but rather in those cases in which a truly arbitrary decision has been made.” H.R. Conf.
Rep. No. 101-386, at 516–17, reprinted in 1989 U.S.C.C.A.N. 3018, 3120 (alteration
added).
In Markovich v. Secretary of Health & Human Services, the United States Court
of Appeals for the Federal Circuit wrote, “[u]nder the Vaccine Act, the Court of Federal
Claims reviews the Chief Special Master’s decision to determine if it is ‘arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with the law.’ 42
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U.S.C. § 300aa-12(e)(2)(B).” Markovich v. Sec’y of Health & Hum. Servs., 477 F.3d
1353, 1355–56 (Fed. Cir.), cert. denied, 552 U.S. 816 (2007); see also Kirby v. Sec’y of
Health & Hum. Servs., 997 F.3d 1378, 1381 (Fed. Cir. 2021); Sharpe v. Sec’y of Health
& Hum. Servs., 964 F.3d 1072, 1077 (Fed. Cir. 2020) (“This court thus performs the
same task as the Court of Federal Claims and reviews the special master’s legal
determinations de novo, fact findings under an arbitrary and capricious standard, and
discretionary rulings for an abuse of discretion.” (citing Munn v. Sec’y of Health & Hum.
Servs., 970 F.2d at 870-73, 870 n.10)); see also K.G. v. Sec’y of Health & Hum. Servs.,
951 F.3d 1374, 1379 (Fed. Cir. 2020); Oliver v. Sec’y of Health & Hum. Servs., 900 F.3d
1357, 1360 (Fed. Cir. 2018) (citing Milik v. Sec’y of Health & Hum. Servs., 822 F.3d
1367, 1375–76 (Fed. Cir. 2016)); Deribeaux ex rel. Deribeaux v. Sec’y of Health & Hum.
Servs., 717 F.3d 1363, 1366 (Fed. Cir.), reh’g and reh’g en banc denied (Fed. Cir.
2013) (The United States Court of Appeals for the Federal Circuit stated that “we
‘perform[ ] the same task as the Court of Federal Claims and determine[ ] anew whether
the special master’s findings were arbitrary or capricious.’” (alterations in original)
(quoting Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1360 (Fed. Cir.
2000))); W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1355 (Fed. Cir. 2013);
Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 1355, 1363 (Fed. Cir. 2012); de
Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008); Avera v.
Sec’y of Health & Hum. Servs., 515 F.3d 1343, 1347 (Fed. Cir.) (“Under the Vaccine
Act, we review a decision of the special master under the same standard as the Court of
Federal Claims and determine if it is ‘arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law.’” (quoting 42 U.S.C. § 300aa-12(e)(2)(B))), reh’g
and reh’g en banc denied (Fed. Cir. 2008); Althen v. Sec’y of Health & Hum. Servs., 418
F.3d at 1277; Faup v. Sec’y of Health & Hum. Servs., 147 Fed. Cl. 445, 458 (2019);
Dodd v. Sec’y of Health & Hum. Servs., 114 Fed. Cl. 43, 47 (2013); Taylor v. Sec’y of
Health & Hum. Servs., 108 Fed. Cl. 807, 817 (2013). The abuse of discretion standard
is applicable when the special master excludes evidence or limits the record upon which
he or she relies. See Munn v. Sec’y of Health & Hum. Servs., 970 F.2d at 870. The
United States Court of Appeals for the Federal Circuit has indicated that:
These standards vary in application as well as degree of deference. Each
standard applies to a different aspect of the judgment. Fact findings are
reviewed by us, as by the Claims Court judge, under the arbitrary and
capricious standard; legal questions under the “not in accordance with
law” standard; and discretionary rulings under the abuse of discretion
standard. The latter will rarely come into play except where the special
master excludes evidence.
Id. at 871 n.10; see also Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d at 1381 (“We
do not reweigh the factual evidence, assess whether the special master correctly
evaluated the evidence, or examine the probative value of the evidence or the credibility
of the witnesses—these are all matters within the purview of the fact finder” (citing
Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011)));
Carson ex rel. Carson v. Sec’y of Health & Hum. Servs., 727 F.3d 1365, 1369 (Fed. Cir.
2013); Deribeaux ex rel. Deribeaux v. Sec’y of Health & Hum. Servs., 717 F.3d at 1366;
W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d at 1355; Griglock v. Sec’y of Health &
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Hum. Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012); Porter v. Sec’y of Health & Hum.
Servs., 663 F.3d at 1249 (explaining that the reviewing court “do[es] not reweigh the
factual evidence, assess whether the special master correctly evaluated the evidence,
or examine the probative value of the evidence or the credibility of the witnesses—these
are all matters within the purview of the fact finder” (citing Broekelschen v. Sec’y of
Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010)), reh’g and reh’g en banc
denied (Fed. Cir. 2012); Dodd v. Sec’y of Health & Hum. Servs., 114 Fed. Cl. at 56.
“[T]he special masters have broad discretion to weigh evidence and make factual
determinations.” Dougherty v. Sec’y of Health & Hum. Servs., 141 Fed. Cl. 223, 229
(2018). As explained by the Federal Circuit:
With regard to both fact-findings and fact-based conclusions, the key
decision maker in the first instance is the special master. The Claims
Court owes these findings and conclusions by the special master great
deference—no change may be made absent first a determination that the
special master was “arbitrary and capricious.”
Munn v. Sec’y of Health & Hum. Servs., 970 F.2d at 870; see also 42 U.S.C. § 300aa-
12(e)(2)(B).
“‘[R]eversible error is extremely difficult to demonstrate if the special master has
considered the relevant evidence of record, drawn plausible inferences and articulated a
rational basis for the decision.’” Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d at
1381 (quoting Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d at 1360); see also
Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d at 1363 (“[I]f the special master ‘has
considered the relevant evidence of record, drawn plausible inferences and articulated a
rational basis for the decision, reversible error will be extremely difficult to
demonstrate.’” (quoting Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528
(Fed. Cir. 1991))); Porter v. Sec’y of Health & Hum. Servs., 663 F.3d at 1253–54;
Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d at 1360; Avila ex rel. Avila v. Sec’y
of Health & Hum. Servs., 90 Fed. Cl. 590, 594 (2009); Dixon v. Sec’y of Health & Hum.
Servs., 61 Fed. Cl. 1, 8 (2004) (“The court’s inquiry in this regard must therefore focus
on whether the Special Master examined the ‘relevant data’ and articulated a
‘satisfactory explanation for its action including a rational connection between the facts
found and the choice made.’” (quoting Motor Vehicle Mfrs. Association v. State Farm
Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (quoting Burlington Truck Lines, Inc. v.
United States, 371 U.S. 156, 168 (1962)))).
As noted by the United States Court of Appeals for the Federal Circuit:
Congress assigned to a group of specialists, the Special Masters within
the Court of Federal Claims, the unenviable job of sorting through these
painful cases and, based upon their accumulated expertise in the field,
judging the merits of the individual claims. The statute makes clear that,
on review, the Court of Federal Claims is not to second guess the Special
Masters [sic] fact-intensive conclusions; the standard of review is uniquely
deferential for what is essentially a judicial process. Our cases make clear
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that, on our review we remain equally deferential. That level of deference
is especially apt in a case in which the medical evidence of causation is in
dispute.
Deribeaux ex rel. Deribeaux v. Sec’y of Health & Hum. Servs., 717 F.3d at 1366–67
(alterations in original) (quoting Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958,
961 (Fed. Cir. 1993)); Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d at 1363;
Locane v. Sec’y of Health & Hum. Servs., 685 F.3d 1375, 1380 (Fed. Cir. 2012). The
United States Court of Appeals for the Federal Circuit has explained that the reviewing
courts “‘do not sit to reweigh the evidence. [If] the special master's conclusion [is] based
on evidence in the record that [is] not wholly implausible, we are compelled to uphold
that finding as not being arbitrary and capricious.’“ Deribeaux ex rel. Deribeaux v. Sec’y
of Health & Hum. Servs., 717 F.3d at 1367 (modification in original) (quoting Lampe v.
Sec’y of Health & Hum. Servs., 219 F.3d at 1363); see also K.G. v. Sec’y of Health &
Hum. Servs., 951 F.3d at 1379 (“With respect to factual findings, however, we will
uphold the special master’s findings of fact unless they are clearly erroneous.” (citing
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d at 1278)); Hibbard v. Sec’y of Health
& Hum. Servs., 698 F.3d at 1363 (citing Cedillo v. Sec’y of Health & Hum. Servs., 617
F.3d 1328, 1338 (Fed. Cir. 2010)).
The United States Court of Appeals for the Federal Circuit has explained that:
A petitioner can establish causation in one of two ways. Id. [Broekelschen
v. Sec’y of Health & Hum. Servs., 618 F.3d at 1341] If the petitioner shows
that he or she received a vaccination listed on the Vaccine Injury Table, 42
U.S.C. § 300aa–14, and suffered an injury listed on that table within a
statutorily prescribed time period, then the Act presumes the vaccination
caused the injury. Andreu [ex rel. Andreu] v. Sec’y of Health & Hum.
Servs., 569 F.3d 1367, 1374 (Fed. Cir. 2009). Where, as here, the injury is
not on the Vaccine Injury Table, the petitioner may seek compensation by
proving causation-in-fact.
Milik v. Sec’y of Health & Hum. Servs., 822 F.3d at 1379 (alterations added) see also
W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d at 1356; Broekelschen v. Sec’y of
Health & Hum. Servs., 618 F.3d at 1346; Pafford v. Sec’y of Health & Hum. Servs., 451
F.3d 1352, 1356 (Fed. Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2006), cert.
denied, 551 U.S. 1102 (2007); Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144,
1147–48 (Fed. Cir. 1992); Faup v. Sec’y of Health & Hum. Servs., 147 Fed. Cl. at 458;
Dodd v. Sec’y of Health & Hum. Servs., 114 Fed. Cl. at 50; Paluck v. Sec’y of Health &
Hum. Servs., 104 Fed. Cl. 457, 467–68 (2012).
When proving eligibility for compensation for a petition under the Vaccine Act, a
petitioner must establish by a preponderance of the evidence that he received a vaccine
set forth in the Vaccine Injury Table and that injury caused by the vaccination occurred
within the required amount of time. See Althen v. Sec’y of Health & Hum. Servs., 418
F.3d at 1278; see also 42 U.S.C. § 300aa-11(c)(1)(A). Regarding the preponderance of
the evidence standard, the Vaccine Act requires “‘the trier of fact to believe that the
existence of a fact is more probable than its nonexistence before [he] may find in favor
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of the party who has the burden to persuade the [judge] of the fact's existence.’”
Moberly ex rel. Moberly v. Sec’y of Health and Hum. Servs., 592 F.3d 1315, 1322 n.2
(Fed. Cir. 2010) (alterations in original) (quoting Concrete Pipe & Prods. of Cal., Inc. v.
Constr. Laborers Pension Trust for S. Cal., 508 U.S. 602 (1993)). In demonstrating this
preponderance of evidence, petitioner may not rely on his or her testimony alone to
establish preponderant evidence of vaccine administration. According to the Vaccine
Act, “[t]he special master or court may not make such a finding based on the claims of a
petitioner alone, unsubstantiated by medical records or by medical opinion.” 42 U.S.C.
§ 300aa-13(a)(1).
In weighing the evidence, the Special Master has discretion to determine the
relative weight of the evidence presented, including contemporaneous medical records
and oral testimony. See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed.
Cir. 1993) (finding that the Special Master had thoroughly considered evidence in
record, had discretion not to hold an additional evidentiary hearing); see also Hibbard v.
Sec’y of Health & Hum. Servs., 698 F.3d at 1368 (finding it was not arbitrary or
capricious for the Special Master to weigh diagnoses of different treating physicians
against one another, including when their opinions conflict).
“Clearly it is not then the role of this court to reweigh the factual evidence,
or to assess whether the special master correctly evaluated the evidence.
And of course we do not examine the probative value of the evidence or
the credibility of the witnesses. These are all matters within the purview of
the fact finder.”
Dodd v. Sec’y of Health & Hum. Servs., 114 Fed. Cl. at 56 (quoting Munn v. Sec’y of
Health & Hum. Servs., 970 F.2d at 870 n.10); see also Broekelschen v. Sec’y of Health
& Hum. Servs., 618 F.3d at 1349; Rich v. Sec’y of Health & Hum. Servs., 129 Fed. Cl.
642, 655 (2016); Paluck v. Sec’y of Health & Hum. Servs., 104 Fed. Cl. at 467 (“So long
as those findings are ‘based on evidence in the record that [is] not wholly implausible,’
they will be accepted by the court.” (quoting Lampe v. Sec’y of Health & Hum. Servs.,
219 F.3d at 1363 (alteration in original))). “Determinations subject to review for abuse of
discretion must be sustained unless ‘manifestly erroneous.’“ Heddens v. Sec’y of Health
& Hum. Servs., 143 Fed. Cl. 193 (2019) (quoting Piscopo v. Sec’y of Health & Hum.
Servs., 66 Fed. Cl. 49, 53 (2005) (citations omitted)).
Additionally, a Special Master is “not required to discuss every piece of evidence
or testimony in [his or] her decision.” Snyder ex rel. Snyder v. Sec’y of Health & Hum.
Servs., 88 Fed. Cl. 706, 728 (2009) (brackets added). As explained by a Judge of the
United States Court of Federal Claims:
“[W]hile the special master need not address every snippet of evidence
adduced in the case, see id. [Doe v. Sec’y of Health & Hum. Servs., 601
F.3d 1349, 1355 (Fed. Cir. 2010)], he [or she] cannot dismiss so much
contrary evidence that it appears that he ‘simply failed to consider
genuinely the evidentiary record before him [or her].’“
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Paluck ex rel. Paluck v. Sec’y of Health & Hum. Servs., 104 Fed. Cl. at 467 (quoting
Campbell v. Sec’y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (2011))) (alteration
added). A Special Master is required to acknowledge that “the purpose of the Vaccine
Act’s preponderance standard is to allow the finding of causation in a field bereft of
complete and direct proof of how vaccines affect the human body,” even if the possible
link between the vaccine and the injury is “hitherto unproven.” Althen v. Sec’y of Health
& Hum. Servs., 418 F.3d at 1280; see also Porter v. Sec’y of Health & Hum. Servs., 663
F.3d at 1261. In that vein, “close calls regarding causation are resolved in favor of
injured claimants.” Althen v. Sec’y of Health & Hum. Servs., 418 F.3d at 1280 (citing
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548–49 (Fed. Cir. 1994)).
Under the off-Table theory of recovery, a petitioner is entitled to compensation if
he or she can demonstrate, by a preponderance of the evidence, that the recipient of
the vaccine sustained, or had significantly aggravated, an illness, disability, injury, or
condition not set forth in the Vaccine Injury Table, but which was caused by a vaccine
that is listed on the Vaccine Injury Table. See 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii)(I),
300aa-13(a)(1)(A); see also LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334,
1339 (Fed. Cir. 2014); W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d at 1356
(“Nonetheless, the petitioner must do more than demonstrate a ‘plausible’ or ‘possible’
causal link between the vaccination and the injury; he must prove his case by a
preponderance of the evidence.” (quoting Moberly ex rel. Moberly v. Sec’y of Health &
Hum. Servs., 592 F.3d at 1322)); Hines v. Sec’y of Health & Hum. Servs., 940 F.2d at
1525. While scientific certainty is not required, the Special Master “is entitled to require
some indicia of reliability to support the assertion of the expert witness.” Moberly ex rel.
Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d at 1324; see also Hazlehurst v.
Sec’y of Health & Hum. Servs., 88 Fed. Cl. 473, 479 (2009), aff’d, 604 F.3d 1343 (Fed.
Cir. 2010) (quoting Andreu ex rel. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d at
1379).
To establish causation in fact for a Non-Table claim, such as petitioner’s claim in
the above captioned case, a petitioner must satisfy all three of the elements established
by the United States Court of Appeals for the Federal Circuit in Althen v. Secretary of
Health & Human Services, 418 F.3d at 1278. See Sanchez v. Sec’y of Health & Hum.
Servs., 34 F.4th 1350 (Fed. Cir. 2022); Deribeaux ex rel. Deribeaux v. Sec’y of Health &
Hum. Servs., 717 F.3d at 1367; Porter v. Sec’y of Health & Hum. Servs., 663 F.3d at
1249; Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d at 1322;
Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d at 1355; Capizzano v. Sec’y of
Health & Hum. Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006); C.K. v. Sec’y of Health &
Hum. Servs., 113 Fed. Cl. 757, 766 (2013).
With regard to the first Althen prong, “a medical theory causally connecting the
vaccination and the injury,” the Federal Circuit in Althen analyzed the preponderance of
evidence requirement as allowing medical opinion as proof, even without scientific
studies in medical literature that provide “objective confirmation” of medical plausibility.
See Althen v. Sec’y of Health & Hum. Servs., 418 F.3d at 1278, 1279–80; see also
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Shapiro v. Sec’y of Health & Hum. Servs., 105 Fed. Cl. 353, 358 (2012), aff’d, 503 F.
App’x 952 (Fed. Cir. 2013). In rejecting a requirement that a claimant under the Vaccine
Act prove confirmation of medical plausibility from the medical community and medical
literature, the Federal Circuit in Althen v. Secretary of Health & Human Services, relied
on Knudsen v. Secretary of Health & Human Services, 35 F.3d 543, 548–49 (Fed. Cir.
1994), in which the Federal Circuit wrote, “to require identification and proof of specific
biological mechanisms would be inconsistent with the purpose and nature of the
vaccine compensation program. The Vaccine Act does not contemplate full blown tort
litigation in the Court of Federal Claims.” Althen v. Sec’y of Health & Hum. Servs., 418
F.3d at 1280. Rather, a petitioner must preponderantly establish that the vaccine at
issue can cause the petitioner’s injury by providing a “‘reputable medical or scientific
explanation’ for its theory.” Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351,
1359 (Fed. Cir. 2019) (quoting Moberly ex rel. Moberly v. Sec’y of Health and Hum.
Servs., 592 F.3d at 1322). “While it does not require medical or scientific certainty, it
must still be ‘sound and reliable.’” Id. (quoting Knudsen v. Sec’y of Health & Hum.
Servs., 35 F.3d at 548–49).
The second prong of the Althen test requires the petitioner to demonstrate “a
logical sequence of cause and effect showing that the vaccination was the reason for
the injury” by a preponderance of the evidence. Althen v. Sec’y of Health & Hum.
Servs., 418 F.3d at 1278; see also Sanchez v. Sec’y of Health & Hum. Servs., 34 F.4th
at 1353; Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d at 1355. In order to prevail,
the petitioner must show “that the vaccine was not only a but-for cause of the injury but
also a substantial factor in bringing about the injury.” Althen v. Sec’y of Health & Hum.
Servs., 418 F.3d at 1278 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d
1344, 1352–53 (Fed. Cir. 1999)). In Capizzano v. Secretary of Health and Human
Services, 440 F.3d at 1326, the Federal Circuit stated, “‘[a] logical sequence of cause
and effect’ means what it sounds like-the claimant’s theory of cause and effect must be
logical. Congress required that, to recover under the Vaccine Act, a claimant must prove
by a preponderance of the evidence that the vaccine caused his or her injury.”
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d at 1326 (quoting 42 U.S.C.
§§ 300aa–11(c)(1)–13(a)(1) (2006)); see also Cozart v. Sec’y of Health & Hum. Servs.,
126 Fed. Cl. 488, 498 (2016) (quoting Althen v. Sec’y of Health & Hum. Servs., 418
F.3d at 1278).9
9 The third prong of the Althen test requires the petitioner to demonstrate, by a
preponderance of evidence, that there is “a proximate temporal relationship between
vaccination and injury.” Althen v. Sec’y of Health & Hum. Servs., 418 F.3d at 1278; see
also Sanchez v. Sec’y of Health & Hum. Servs., 34 F.4th at 1353. The United States
Court of Appeals for the Federal Circuit emphasized the importance of a temporal
relationship in Pafford v. Secretary of Health and Human Services, when it noted that,
“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 v. Sec’y of Health &
Hum. Servs., 451 F.3d at 1358. “Evidence demonstrating petitioner’s injury occurred
within a medically acceptable time frame bolsters a link between the injury alleged and
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According to the Federal Circuit in Capizzano v. Secretary of Health and Human
Services, evidence used to satisfy one of the Althen prongs may overlap with and be
used to satisfy another prong. See Capizzano v. Sec’y of Health & Hum. Servs., 440
F.3d at 1326 (“We see no reason why evidence used to satisfy one of the Althen III
[Althen v. Sec’y of Health & Hum. Servs., 418 F.3d at 1274] prongs cannot overlap to
satisfy another prong.” (alteration added)). If a petitioner satisfies the Althen burden and
meets all three prongs of the test, the petitioner prevails, “unless the government
demonstrates that the injury was caused by factors unrelated to the vaccine.” Sanchez
v. Sec’y of Health & Hum. Servs., 34 F.4th at 1353 (alteration added) (citing 42 U.S.C.
§ 300aa-13(a)(1)(B)); see also Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d at
547 (brackets in original; quotation omitted).
As indicated above, in the case currently before the court, petitioner argues that
denial by the Chief Special Master of his “repeated requests to retain an infectious
disease expert resulted in an unbalanced review of Petitioner’s presentation of Althen
Prong 2 and constituted an abuse of discretion under the Circumstances of this Case.”
(capitalization in original). Petitioner also asserts that although
[r]espondent argued in his responding brief that an influenza-like illness,
an upper respiratory infection, or cytomegalovirus likely caused
Petitioner’s GBS. There exists no evidence in this case that a pathogen
was present in [K.A.] prior to the onset of his GBS that supports
Respondent’s speculation about an infectious causal factor for [K.A.]’s
GBS.”
(alterations added). Petitioner continues:
Chief Special Master Corcoran relied upon the existence of an intercurrent
upper respiratory infection as the likely cause of onset of GBS in rejecting
Petitioner’s showing of Althen prong 2. Thus, in the court’s own view,
Petitioner could not have established his claim by a preponderance of the
evidence without a more effective counterpoint to an unidentified
infectious disease as causative agent.
Petitioner also asserts that “Chief Special Master Corcoran’s slant in assessing
the evidence was manifest in his pronouncement, not founded in the record, that [K.A.]’s
initial symptoms, ‘appear[ed] broader than the common post-vaccination malaise.’”
the vaccination at issue under the ‘but-for’ prong of the causation analysis.” Id. (citing
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d at 1326). The court notes that
Chief Special Master’s conclusions regarding the third prong of the Althen test was not
one of the bases for petitioner’s numbered objections in petitioner’s May 18, 2022
Motion for Review of the Chief Special Master’s Entitlement Decision, and, therefore, is
not addressed in this Opinion. The court also notes that in the Chief Special Master’s
Entitlement Decision, the Chief Special Master indicated, “because the claim fails on the
first two Althen prongs, Petitioner’s ability to preponderantly support the third prong
does not avail him.”
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(second alteration in original). Petitioner asserts that the “only undisputed diagnosis was
the post-vaccination onset of GBS.” Petitioner argues that
[c]learly, the proposition that the initial symptoms, “appear[ed] broader”
than would be induced by vaccination should have been addressed by an
infectious disease expert retained by the Petitioner, who would be familiar
with both symptoms of vaccination and infection. Multiple critical aspects
of this case required clarification by – and even turned upon – the
expertise and perspective of an infectious disease specialist presented by
the Petitioner.
Only after more than three years and seven months after petitioner filed his petition for
compensation and after petitioner filed the first four expert reports authored by Dr.
Steinman did petitioner belatedly urge that an infectious disease expert could have
“opined on the relationship” between petitioner’s initial flu-like symptoms and those
present at the onset of his GBS, despite the presence of URI symptoms, which, as the
Chief Special Master noted, the majority of [petitioner’s] treaters deemed the URI most
likely causal.” (alteration added).
Moreover, as noted above, Dr. Collins filed expert reports on December 4, 2017,
June 13, 2018, and May 7, 2019, all of which addressed, and rejected, petitioner’s initial
causation theory that aluminum adjuvant in the Tdap vaccine caused petitioner’s GBS.
Further, even after Dr. Collins, in her fourth and final expert report dated January 23,
2020, addressed petitioner’s alternate theory of molecular mimicry on behalf of the
respondent, petitioner had an opportunity to file another expert report by Dr. Steinman
on June 22, 2020.
With respect to the Chief Special Master’s review by the expert reports authored
Dr. Steinman offered by petitioner, petitioner argues that Chief Special Master Corcoran
“characterized Dr. Steinman’s challenge to Respondent’s reliance upon an unidentified
‘influenza-like illness’ as mere ‘quibbling.’” Petitioner argues that the Chief Special
Master’s “persistent criticism and denigration of Petitioner’s lone expert implicates the
harm that flowed from the Court’s refusal, over the course of assignment to two special
masters, to permit retention of the relevant experts.” In the Motion for Review in this
court, petitioner argues, “[w]hile Dr. Steinman has unparalleled qualifications in
neurology and neuroimmunology and specific areas such as molecular mimicry, his
singular focus upon the non-specificity of terms such as ‘influenza-like illness’ during his
dialogue with Dr. Collins may reflect the limits of his expertise in the separate field of
infectious disease.” (citation omitted). Petitioner also stresses that the Chief Special
Master criticized petitioner’s expert for his lack of expertise in infectious diseases while
denying petitioner the opportunity to retain an expert qualified in the field. Petitioner
further states that “the presiding special masters[10] failed to afford each party a full and
10 The court notes that petitioner’s request “to file an expert report from an infectious
disease specialist and an expert report from a specialist in biostatistics” was denied on
June 12, 2020, by Special Master Roth before the case was transferred to the Chief
Special Master. Chief Special Master Corcoran, however, also did not grant petitioner’s
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fair opportunity to present his case, failed to afford a hearing, and failed to create a
record sufficient to allow review of the respective orders denying the retention of
experts.” (alteration added).
In response, respondent argues that the Chief Special Master, pursuant to
Vaccine Rule 8(a), gave “each party a full and fair opportunity” to present their case,
and also notes that a Special Master “will determine the format for taking evidence and
hearing argument based on the specific circumstances of each case and after
consultation with the parties.’” Respondent notes that, in the above captioned case,
petitioner “filed five expert reports over three years, modified his causation theory, and
now seeks, after an unexplained multi-year delay, additional experts to cover the same
ground already covered by Dr. Steinman.” (alteration added). Respondent also points
out that petitioner’s “medical record, filed between August 2016 and January 2017, is
replete with references to petitioner’s ILI/URI as a potential cause of his GBS.”
Respondent argues that in its February 23, 2017 Rule 4(c) report, respondent
“specifically identified petitioner’s ILI/URI as evidence against entitlement.” Therefore,
according to respondent, “petitioner, represented by experienced counsel, could have
retained an infectious disease expert then. Instead, he chose to proceed with Dr.
Steinman alone to address the ILI/URI issue until objecting at the ‘eleventh-hour.’” In
addition, according to respondent,
in his five reports, Dr. Steinman variously discussed epidemiological
studies, the “possibility of an infectious disease etiology,” and opined that
“the priority of the potential CMV or EBV infections in triggering disease is
lower than the likelihood that the vaccination triggered the disease.” Thus,
not only did petitioner have both the time and opportunity before the case
was adjudicated to retain an infectious disease expert, petitioner’s expert
actually did address the ILI/URI issue in regard to his GBS.
(internal citations omitted).
Further, respondent argues that the “Chief Special Master appropriately
considered petitioner’s own detailed reports of flu-like symptoms and the comments of
his treating physicians regarding ILI/URI” because a Special Master “‘is entitled to
consider the record as a whole in determining causation, especially in a case involving
multiple potential causes acting in concert, and no evidence should be embargoed from
the special master’s consideration[.]’” (quoting Stone v. Sec’y of Health & Hum. Servs.,
676 F.3d 1373, 1380 (Fed. Cir. 2012)). Finally, respondent argues that “[t]he Chief
Special Master correctly considered the ILI/URI evidence in evaluating the sufficiency of
petitioner’s proof that the Tdap vaccine did cause his GBS under Althen prong 2.”
In reaching a conclusion in each vaccine case, the Special Master considers the
factual and supporting record in a petitioner’s case as filed before the Special Master
including the petitioner’s contemporaneous medical records, as well as expert reports, if
any. The expert reports are reviewed by the Special Master for their content and for the
renewed request for expert reports from an infectious disease specialist and a specialist
in biostatistics.
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expert’s expertise and credibility. See Broekelschen v. Sec’y of Health & Hum. Servs.,
618 F.3d at 1348 (quoting Hines v. Sec’y of Health & Hum. Servs., 940 F.2d at 1528);
see also Munn v. Sec’y of Health & Hum. Servs., 970 F.2d at 870. 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, their previous testimony and their previously filed expert reports.
In weighing the expertise and credibility of both petitioner’s and respondent’s
experts, the Chief Special Master, in his Entitlement Decision, did “not give substantial,
if any, weight to Dr. Steinman’s objections that the term of art ‘influenza-like illness’ to
describe Petitioner’s URI is scientifically indeterminate—since filed record evidence
from competent medical and scientific professionals employ the term in their own
studies.” In his Entitlement Decision, Chief Special Master Corcoran addressed Dr.
Steinman’s role as an expert for petitioner during the pendency of the case, as well as
times he had previously testified in vaccine cases. For example, the Chief Special
Master criticized Dr. Steinman’s fifth and final report as “reflect[ing] the same bickering
quality, or wholesale reproduction of prior arguments, that characterizes most of his
prior reports filed in this case.” Additionally, the Chief Special Master wrote in a footnote
in his Entitlement Decision, that “Dr. Steinman also engaged in conduct I have in the
past criticized him for: commenting on the standards governing Program cases, and
elaborating on how he performs his role as expert, rather than simply providing the
medical/scientific opinion for which he has been retained.” In the above captioned case,
Chief Special Master Corcoran also criticized what he called “Dr. Steinman’s legal
pronouncements” and correctly noted that expert witnesses are not allowed to interpret
“the meaning of Program caselaw or the applicable legal standards.” In this regard, the
Chief Special Master wrote that “[n]one of Dr. Steinman’s reports in this case were
prepared while I was presiding over this matter—but in future cases in which Dr.
Steinman is retained that are assigned to me, I will not compensate time spent on
opinions on legal issues that he is not qualified to address.” (emphasis in original). The
Chief Special Master summarized his view of Dr. Steinman’s role in the above
captioned case by noting: “Altogether, Dr. Steinman offered more than 70 pages of
expert opinion on this matter, (as discussed below and throughout this Decision), I do
not conclude the significant effort was ultimately well spent.”
The Chief Special Master, however, gave more credit to respondent’s expert Dr.
Collins. Chief Special Master Corcoran noted that in Dr. Collins’ fourth and final expert
report, “Dr. Collins also emphasized again her opinion that an influenza-like illness was
a far more likely cause of Petitioner’s GBS in this case,” and determined that “Dr.
Collins also persuasively showed that many facially-reliable studies had included
‘influenza-like illness’ as a potentially causal agent of GBS, despite Dr. Steinman’s
protestations.”
All Special Masters have a responsibility to “afford[ ] each party a full and fair
opportunity to present its case and create[e] a record sufficient to allow review of the
special master’s decision.” See Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d
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1362, 1366 (Fed. Cir. 2020); see also Doles v. Sec’y of Health & Hum. Servs., 159 Fed.
Cl. 241, 246 (2022) (“[T]he special masters are bound by an obligation to be fair to both
parties, and to provide both parties the opportunity to present a case”) (emphasis in
original). A Special Master, however, also has the responsibility and authority to
“determine the format for taking evidence and hearing argument based on the specific
circumstances of each case.” Vaccine Rule 3(b)(2), 8(a) (2021). Although Chief Special
Master Corcoran’s choices of words regarding Dr. Steinman and his expert reports may
have been pointed and critical, his comments as a veteran Special Master were based
on Chief Special Master Corcoran’s varied experiences in the Vaccine Program,
including with Dr. Steinman as an expert witness. As explained by another Judge of the
United States Court of Federal Claims:
That the Special Master “was far more impressed and persuaded by the
testimony of Dr. Wiznitzer” does not show any bias, and shows that the
Special Master in fact did exactly what the Federal Circuit has
admonished special masters to do in vaccine cases. See Porter, 663 F.3d
at 1250 (“Indeed, this court has unambiguously explained that special
masters are expected to consider the credibility of expert witnesses in
evaluating petitions for compensation under the Vaccine Act.”). The
decision shows that the Special Master considered the testimony of both
experts, and indeed, it recaps a significant amount of information from
both experts, but in the end, the Master concluded that Dr. Wiznitzer was
the more trustworthy. The Special Master, as fact finder, “has broad
discretion in determining credibility because he saw the witnesses and
heard the testimony.” Bradley, 991 F.2d at 1575. For this reason, the
Special Master’s determination on credibility is “virtually unreviewable,”
Porter, 663 F.3d at 1251, and to the extent that it is reviewable, this Court
sees nothing arbitrary or capricious in the Special Master’s findings here.
Vaughan v. United States, 107 Fed. Cl. 212, 224 (2012).
After weighing all of the parties’ submissions, including the numerous expert
reports and petitioner’s medical records, Chief Special Master Corcoran found Dr.
Steinman’s opinions less credible than those of Dr. Collins. The weight to be given to
each expert is within the discretion of each trier of fact, based on the facts in the record
in each case. See Porter v. Sec’y of Health & Hum. Servs., 663 F.3d at 1249. This court
notes that initially Dr. Steinman offered a causation theory that the Tdap vaccine’s
aluminum adjuvant can cause GBS. Only in his fourth expert report did Dr. Steinman
proffer molecular mimicry as a new causation theory, which he contended co-existed
with his prior aluminum adjuvant theory. Petitioner tries to justify his delay for requesting
to add an infectious disease expert late in the case, stating that “[w]hile Respondent
argues that the issue of influenza-like-illness was already apparent, both the extent of
that reliance and the ambiguity and limited value of that approach was not apparent until
Respondent’s expert, Dr. Collins, had made her case across her expert reports.”
Because petitioner’s contemporaneous medical records from the time shortly after his
Tdap vaccination, when he was medically examined, to the time the record was closed
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prior to the Chief Special Master’s review, and the issuance of his decision, there are
repeated references to the existence of an influenza-like illness or upper respiratory
illness, as a potential cause of petitioner’s GBS. Petitioner, therefore, was on notice of
the URI/ILI as a potential cause of his GBS well before he filed his petition with the
Office of Special Masters. Moreover, respondent’s Rule 4(c) report, filed on February
23, 2017, specifically identified petitioner’s ILI/URI as evidence against entitlement, for
petitioner to consider.
This court notes that petitioner’s contemporaneous medical records, which
receive great evidentiary weight, contained repeated references to his URI/ILI as a
possible causation of his medical issues and a factor in his Guillain-Barré syndrome
following his Tdap vaccination. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d
1525, 1528 (Fed. Cir. 1993) (“Medical records, in general, warrant consideration as
trustworthy evidence. The records contain information supplied to or by health
professionals to facilitate diagnosis and treatment of medical conditions. With proper
treatment hanging in the balance, accuracy has an extra premium. These records are
also generally contemporaneous to the medical events.”). In petitioner’s case, a number
of petitioner’s contemporaneous medical records indicate, not only the existence of a
URI/ILI, but that the URI/ILI was likely the cause of petitioner’s GBS. Chief Special
Master Corcoran specifically relied on these medical records when evaluating the
likelihood that the Tdap vaccine caused petitioner’s GBS. Chief Special Master
Corcoran indicated that “not only is there incontrovertible evidence that Petitioner first
experienced URI symptoms before neurologic-related symptoms, but also that the
majority of his treaters deemed the URI most likely causal. The vaccine does not
deserve greater weight simply because it is ‘known’ whereas the precise nature of the
infection is not.” (emphasis in original). The court notes that Chief Special Master
Corcoran stated in his Entitlement Decision that in Dr. Collins’ fourth and final expert
report, “Dr. Collins also emphasized again her opinion that an influenza-like illness was
a far more likely cause of Petitioner’s GBS in this case.”
Based on the contemporaneous medical records in the record before the Chief
Special Master, the relative weight and credibility of the theories advanced by the expert
witnesses for each party to the litigation, the decision issued by Chief Special Master
Corcoran was reasonable and was supported by Dr. Collins’ theory that petitioner’s
URI/ILI more than likely caused the GBS. Therefore, this court determines that Chief
Special Master’s decision not to grant to petitioner’s request for additional experts, after
petitioner filed numerous contemporaneous medical records, and five expert reports
author by Dr. Steinman, did not result in denying petitioner a full and fair opportunity to
present his case.
Although not one of his specific numbered objections, petitioner also asserts that
the Chief Special Master’s decision to deny a hearing in his case was unreasonable.
Petitioner argues that the Chief Special Master’s denial of a hearing constituted a failure
“to afford each party a full and fair opportunity to present his case.” Petitioner argues
that a hearing was necessary because “Chief Special Master Corcoran has called into
question the credibility of Dr. Steinman as a witness,” and “a hearing would afford Dr.
Steinman, a true expert in this area, the opportunity to clarify his position as to why the
theory of molecular mimicry, in this case, addresses the issues of inflammation and
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pathology and their relationship to Guillain Barre Syndrome (GBS).” The court notes
that petitioner’s first request for a hearing appears to have been made on October 12,
2021, after Dr. Steinman had submitted all five of his expert reports in the above
captioned case. Petitioner argues that the denial of a hearing “prejudiced Petitioner in
the proceedings” because it “limited the court’s ability to assess the evidence proffered
by Dr. Steinman, the Petitioner’s sole expert witness.” In response, respondent argues,
citing Vaccine Rule 8(d) (2021), that “[i]t is well-established, however, that a special
master ‘may decide a case on the basis of written submissions without conducting an
evidentiary hearing.’” Respondent also cites 42 U.S.C. § 300-aa-12(d)(3)(B)(v), stating
that Special Masters have it within their discretion to allow “such hearings as may be
reasonable and necessary.” Respondent indicates that Chief Special Master Corcoran
found that “a hearing was not needed to decide this case.” Respondent argues:
Since the filing of the Rule 4(c) report, petitioner has known respondent’s
position on petitioner’s ILI/URI as a relevant factor regarding vaccine
causation for his GBS. Petitioner cannot now reasonably object after
initially agreeing to a ruling on the record by belatedly at the “eleventh-
hour” requesting a hearing in his reply brief. C.f. Novosteel SA v. U.S.,
Bethlehem Steel Corp., 284 F.3d 1261, 1274 (Fed. Cir. 2002) (“Raising
the issue for the first time in a reply brief does not suffice; reply briefs reply
to arguments made in the response brief—they do not provide the moving
party with a new opportunity to present yet another issue for the court’s
consideration.”); see also In re Osterman, 296 F. App’x 900, 902 n.1 (11th
Cir. 2008) (“[A] passing reference to an issue in a reply brief, offered
without substantive argument in support, is insufficient to constitute raising
the issue”). Because the Chief Special Master properly applied the law
and acted within his discretion in deciding this case on the record, his
Decision should be affirmed.
(alteration in original).
As noted above, petitioner’s petition for compensation, dated August 11, 2016,
and petitioner’s initial brief, dated July 2, 2021, did not request for an evidentiary
hearing. When he issued his Entitlement Decision, the Chief Special Master explained
his decision “not to hold a hearing,” which Chief Special Master Corcoran indicated he
understood at the time was “a determination that the parties largely accepted.” In a
footnote, Chief Special Master Corcoran indicated:
Petitioner’s initial ruling on the record brief did not oppose deciding this
case on the papers. On Reply, however, Petitioner included a footnote
setting forth some process objections: that he was denied the opportunity
to offer his own infectious disease expert (by the special master previously
assigned to the case) to counter Dr. Collins’s arguments, and that,
although he noted my discretion to choose how best to decide the case, a
hearing was warranted since the petitioner’s theories were “closely
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contested.”[11] Putting aside the underwhelming and somewhat eleventh-
hour nature of this objection, I nevertheless determine (as explained
herein) that the claim could be, and was, fairly adjudicated solely on the
basis of the papers—and as already noted hearings are not held simply
because the parties disagree on entitlement.
(internal reference omitted; alteration added). The Chief Special Master also indicated
that “[d]etermining how best to resolve a case is a matter that lies generally within my
discretion,” and that “[i]t was wholly fair to both sides to resolve this case on the papers
and after briefing by the parties.” Chief Special Master Corcoran indicated that “[o]ver
the case’s nearly six years, Petitioner was afforded the opportunity to offer five written
expert reports” and “was also permitted to modify his causation theory entirely, after
Respondent voiced objections to its sufficiency.” (emphasis in original). Moreover, the
Chief Special Master concluded that petitioner’s second theory of causation, molecular
mimicry, is “one with which I have substantial familiarity—meaning I did not need to
hear live testimony from Dr. Steinman to understand or react to it.”
Courts review a Special Master’s determination to deny an evidentiary hearing
for an abuse of discretion. See Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d
at 1364 (“We review a special master’s decision to hold an evidentiary hearing for an
abuse of discretion.”); see also Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863 at
870 n.10. “Determinations subject to review for abuse of discretion must be sustained
unless ‘manifestly erroneous.’” Heddens v. Sec’y of Health & Hum. Servs., 143 Fed. Cl.
at 193 (quoting Piscopo v. Sec’y of Health & Hum. Servs., 66 Fed. Cl. at 53 (citations
omitted)). Moreover, Special Masters have “wide discretion in determining whether to
conduct an evidentiary hearing.” Kreizenbeck v. Sec’y of Health & Hum. Servs., 945
F.3d at 1365; see also Oliver v. Sec’y of Health & Hum. Servs., 900 F.3d 1357, 1364
n.6 (Fed. Cir. 2018) (holding that “Chief Special Master acted within her discretion in
denying” the petitioner’s request for a hearing); Burns v. Sec’y of Health & Hum. Servs.,
3 F.3d at 417 (holding that “the special master acted within her discretion to determine
that an additional [evidentiary] hearing on expert medical testimony was not necessary”)
(alteration added); Simanski v. Sec’y of Health & Hum. Servs., 671 F.3d 1368, 1371
(Fed. Cir. 2012) (noting that “the Vaccine Rules provide that the special masters can
decide cases on written submissions, including, in appropriate cases, by summary
judgment”). Nevertheless, the “special master’s discretion to rule on the record is not
without limitation.” Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d at 1365.
Because Special Masters are required to “afford[ ] each party a full and fair opportunity
to present its case and creat[e] a record sufficient to allow review of the special master’s
decision,” a special master “must determine that the record is comprehensive and fully
developed before ruling on the record.” Id. at 1366 (alterations in original) (citing
11 A note in petitioner’s October 12, 2021 reply brief stated that “petitioner
acknowledges the Court’s authority to decide this case without an evidentiary hearing
during which the experts’ presentations can be explored.” Petitioner, however, also
stated, “in the context of the present case, where petitioner’s theory is closely
contested, a hearing would supply valuable elaboration of petitioner’s case and a
hearing should be conducted.”
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Simanski v. Sec’y of Health & Hum. Servs., 671 F.3d at 1380 (finding that it was a
violation of due process for a special master to rule on the record at “an early
procedural stage” before respondent had “present[ed] its position with respect to the
petition and the supporting evidence”) (alteration added)); see also Oliver v. Sec’y of
Health & Hum. Servs., 900 F.3d 1357, 1364 n.6 (Fed. Cir. 2018) (holding that because
“the record was fully developed” and no legal or factual errors necessitated a hearing, it
was within the Chief Special Master’s discretion to deny the petitioner’s request for an
evidentiary hearing); Burns v. Sec’y of Health & Hum. Servs., 3 F.3d at 417.
Before Chief Special Master Corcoran, the record included petitioner’s medical
history prior to August 12, 2013 when petitioner received the vaccination at issue, his
contemporaneous medical records from 2013 to 2016, as well as five expert reports that
together spanned over seventy pages from petitioner’s expert, Dr. Steinman, as well as
four expert reports from Dr. Collins on behalf of respondent. The record also contained
medical literature included with each of the experts’ reports, including the results of Dr.
Steinman’s BLAST searches. Unlike in Simanski v. Secretary of Health & Human
Services, 671 F.3d at 1380, in which the Federal Circuit found that it was a violation of
due process for a special master to rule on the record at “an early procedural stage,” the
above captioned case was not at an “early procedural stage” based on the length of
time from the filing of the case to when the parties submitted their respective briefs,
which included the time to gather the relevant medical records of petitioner, to produce
the numerous expert reports submitted by both experts, and for time for each expert to
respond to the opposing expert. Moreover, petitioner had two years to file a request for
additional expert(s) to challenge Dr. Collins’ arguments that a URI/ILI caused
petitioner’s GBS. See Hines v. Sec’y of Health & Hum. Servs., 940 F.2d at 1526
(holding that “principles of fundamental fairness to both parties” were not violated when
the petitioner had the opportunity to “discredit” and “rebut” the information (emphasis in
original)).
Moreover, throughout the pendency of his case, petitioner received multiple
extensions of time to file the expert reports authored by Dr. Steinman. In addition, on
July 29, 2019, almost three years after the petition was filed, Special Master Roth held a
status conference with the parties, during which the respondent indicated that
petitioner’s aluminum adjuvant causation theory was implausible. This prompted Special
Master Roth to allow Dr. Steinman to submitted another expert report regarding
petitioner’s alterative causation theory regarding molecular mimicry as the causation
mechanism, although denying petitioner’s request to submit expert reports at such a
late stage in the case from brand new experts.
Because a reviewing court should only overturn a special master’s decision if it is
“manifestly erroneous,” see Heddens v. Sec’y of Health & Hum. Servs., 143 Fed. Cl. at
193, and given the contemporaneous medical records in the record before Chief Special
Master Corcoran when he issued his Entitlement Decision, as well as the numerous
extensions and opportunities that petitioner was granted to supplement the record, and
even to propose a second causation theory, it was not manifestly erroneous or an
abuse of discretion for Chief Special Master Corcoran to deny petitioner’s request to
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submit additional expert testimony or to conclude that petitioner’s case could be decided
on the papers without an evidentiary hearing.
As to the Chief Special Master’s rejection of petitioner’s molecular mimicry
alternative causation theory, the Chief Special Master reviewed Dr. Steinman’s expert
report on the subject in this case. Before this court, however, petitioner argues that
the Chief Special Master failed to recognize that the posited medical
theory of molecular mimicry went well beyond the mere identification of
homologies between components of the Tdap vaccine and self-antigen
such as human myelin protein, leading to GBS. The court’s
misconstruction of the record and incorrect application of the law requires
vacatur of the Decision. The court compounded its error by holding that
Petitioner’s causal medical theory was “undercut” by epidemiological
evidence as to causation for which an expert was denied to Petitioner
despite requests throughout the case.
Petitioner argues that the “Chief Special Master held, inter alia, that Petitioner could not
rely upon mere amino acid homologies identified through a BLAST search.” (emphasis
in original). Petitioner argues that Dr. Steinman’s expert report went well beyond that
standard and demonstrated how the homologies would produce an immune response.
At the oral argument before this court, petitioner argued that when advancing a theory
of molecular mimicry in vaccine cases, the standard is that it is insufficient to perform
only a BLAST search to demonstrate potential homologies. Additionally, petitioner
argues that Chief Special Master Corcoran’s rejection of the petitioner’s theory of
molecular mimicry and the Chief Special Master’s “undue reliance upon epidemiology in
this context” constitutes an abuse of discretion. Petitioner asserts that the “Chief Special
Master’s Decision turned, in part, upon Baxter I [R. Baxter et al., Acute Demyelinating
Events Following Vaccines: A Case-Centered Analysis, 63 Clin. Infect. Diseases: An
Official Publication of the Infectious Disease Soc. of Am., 1456 (2016) & II [R. Baxter et
al., Lack of Association of Guillain-Barre Syndrome with Vaccinations, 57 Clin. Infect.
Diseases: an Official Publication of the Infectious Diseases Soc. of Am. 197, 203
(2013)].” (alterations added). In the Entitlement Decision, the Chief Special Master
found that “Epidemiologic evidence offered by Respondent also undercuts Petitioner’s
showing.” (capitalization in original). In his Entitlement Decision, the Chief Special
Master wrote:
Baxter II—a large-scale study identifying no association between Tdap
and GBS—was particularly harmful. It was far more relevant to Petitioner’s
claim herein than Baxter I (authored by almost all of the same individuals
as Baxter II), which Dr. Steinman favorably cited but which only showed a
possible association between Tdap and ADEM [acute disseminated
encephalomyelitis]—a distinguishable central nervous system-impacting
demyelinating disease. The very fact that Dr. Steinman chose to cite
Baxter I is telling—if one epidemiologic study not fully on point is
nevertheless supportive of his theory, how can a study directly on point
(since it involved the injury at issue in this case), and written by largely the
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same group of scientific professionals, not also bear on the case’s
outcome?
(emphasis in original; alteration added).
Citing the legal analysis of one of his own, prior decisions, Yalacki v. Secretary of
Health & Human Services, 14-278V, 2019 WL 1061429 (Fed. Cl. Spec. Mstr., Jan. 31,
2019), review denied, 146 Fed. Cl. 80 (2019), Chief Special Master Corcoran concluded
that petitioner’s molecular mimicry theory “was not preponderantly shown to be likely
causal,” and stated “that molecular mimicry is not a ‘get out of jail free card’ in the
[Vaccine] Program, entitling claimants who hire Dr. Steinman (or someone else
sufficiently conversant with molecular biology and the relevant databases) to
compensation, merely because it has scientific reliability as a general matter.” Chief
Special Master Corcoran determined:
Without some reason to further find that the relevant vaccine can be
causal of the specific injury at issue—however that might be
demonstrated—establishing a potentiality for molecular mimicry alone
does not meet the preponderant standard of proof, no matter what degree
of amino acid identity (sequential or not) Dr. Steinman can demonstrate
with a BLAST search.
(emphasis in original).
Petitioner argues that Yalacki decision “does not appear to have considered the
type of multi-layered, filtered investigation utilized by Dr. Steinman in establishing a
theory of molecular mimicry in this case.” Although petitioner appears to agree that the
injury in Yalacki, like the injury here, involves autonomic dysfunction. Petitioner,
however, attempts to distinguish the Yalacki case on the grounds that the petitioner’s
injury in Yalacki was “induced by a different vaccine” and the “evidence (and science)
[in Yalacki] that the cross-reaction would target the self-antigen was undeveloped.”
Respondent does not specifically address petitioner’s use of Yalacki v. Secretary of
Health & Human Services other than to assert that “[t]he Chief Special Master properly
applied the law.”
Additionally, respondent argues that Dr. Steinman’s efforts, “as correctly noted by
the Chief Special Master, were wholly misplaced. Here, petitioner acknowledges he
cannot rely on mere homologies to establish causation.” Respondent continues that “Dr.
Steinman never adequately addressed the central ‘criticism of his theory’—namely,
although homologies are common and pathogenic cross-reactions are uncommon,
‘most human beings are not plagued by autoimmune pathology.” Respondent further
asserts that “Dr. Steinman never actually provided any relevant, reliable, persuasive
evidence that identify what genetic or environmental factors ‘are necessary before [ ]
self-reactive immune responses to myelin might trigger GBS,’ ‘either theoretically or in
[p]etitioner’s specific case.’” (alterations in original). Respondent asserts that
the Chief Special Master aptly observed, petitioner relied exclusively on
mouse models studying experimental autoimmune encephalomyelitis
(“EAE”) to support the contention that the homologies found could cause
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neuroinflammation in humans. But EAE translates to ADEM in humans, “a
neuroinflammatory demyelinating disorder that impacts the brain and
spinal cord.” Petitioner never explained how ADEM sufficiently compares
to petitioner’s specific “pharyngeal-cervical-brachial variant” of GBS, or
even to GBS in general.
(capitalization in original; internal citations omitted).
Respondent, citing Andreu ex rel. Andreu v. Secretary of Health & Human
Services, 569 F.3d at 1379, states that “the Chief Special Master appropriately
considered the epidemiological evidence submitted by both parties.” Respondent
asserts that epidemiological evidence is not necessary to prove causation under the
Vaccine Act, but that “‘the special master can consider it in reaching an informed
judgment as to whether a particular vaccination likely caused a particular injury.’”
Although petitioner alleges that the Chief Special Master erred in considering
epidemiological evidence, both parties filed epidemiological evidence and analyses, and
according to respondent, “epidemiology is considered by special masters in nearly
every contested Vaccine Program case.” Indeed, Dr. Steinman discussed
epidemiological studies, the “possibility of an infectious disease etiology,” but argued
that “the priority of the potential CMV [cytomegalovirus] or EBV [Epstein-Barr virus]
infections in triggering disease is lower than the likelihood that the vaccination triggered
the disease.” (alterations added). Respondent argues, therefore, that “[t]he Chief
Special Master here acted within his discretion,” in considering epidemiological
evidence and deciding that petitioner did not meet his burden of proof on the first Althen
prong.
In the case currently before the court, petitioner’s expert, Dr. Steinman,
presented epidemiological evidence by citing the Baxter I study, which the Chief Special
Master found should necessarily allow him to look at the Baxter II study as well.
Notably, epidemiologic evidence can be considered in a special master’s Althen prong
one determination, even though it is not required. See Taylor v. Sec’y of Health & Hum.
Servs., 108 Fed. Cl. at 820 (finding that “the Special Master did not err in considering
epidemiological evidence, along with the clinical record, expert testimony and other
medical literature, to reach her informed judgment that Petitioner’s theory of causation
was more unlikely than not”); see also Andreu ex rel. Andreu v. Sec’y of Health & Hum.
Servs., 569 F.3d at 1379 (finding that “where such [epidemiological] evidence is
submitted, the special master can consider it in reaching an informed judgment as to
whether a particular vaccination likely caused a particular injury” (alteration added)). As
noted by a different Special Master in Pierson v. Secretary of Health & Human Services,
a “petitioner must offer more than superficial invocation of molecular mimicry as the
causal mechanism,” and “[i]t also cannot be enough that a medical expert can simply
identify homologous peptides from a generic BLAST search that are not, in any way,
linked to the biological process that is dysfunctional or has suffered injury.’” Pierson v.
Sec’y of Health & Hum. Servs., No. 17-1136V, 2022 WL 322836, at *25 (Fed. Cl. Spec.
Mstr. Jan. 19, 2022) (quoting Brayboy v. Sec’y of Health & Hum. Servs., No. 15-183V,
2021 WL 4453146, at *19 (Fed. Cl. Spec. Mstr. Aug. 30, 2011)).
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The court notes that Dr. Steinman’s molecular mimicry theories have had mixed
success before different Special Masters. A number of Special Masters have
determined causation was not met in instances in which Dr. Steinman argued a theory
of molecular mimicry. See, e.g., Mason v. Sec’y of Health & Hum. Servs., No. 17-
1383V, 2022 WL 600415, at *6, *26 (Fed. Cl. Spec. Mstr. Feb. 4, 2022) (Chief Special
Master Corcoran found that Althen prong one was not met when Dr. Steinman argued
that molecular mimicry could trigger chronic inflammatory demyelinating polyneuropathy
even after his “BLAST searches revealed several common sequences, such as
GSASGVSECRF (shared between MBP and the target antigen of the 2014-2015 flu
vaccine), which had five of eleven identical amino acids, and he proposed as a result
that this homology with vaccine components was sufficient for a damaging cross-attack
by immune cells.”); D.G. v. Sec’y of Health & Hum. Servs., No. 11-5777V, 2019 WL
2511769, at *128, *193 (Fed. Cl. Spec. Mstr. May 24, 2019) (Special Master Millman
found no causation in fact when “Dr. Steinman said he talks a lot about molecular
mimicry in this case, but he does not have a known molecular mimic that he can
identify.”); Chinea v. Sec’y of Health & Hum. Servs., No. 15-095V, 2019 WL 1873322, at
*15 (Fed. Cl. Spec. Mstr. Mar. 15, 2019) (Chief Special Master Corcoran found no
causation when “Dr. Steinman next proposed a mechanism by which the flu vaccine
could have caused Mrs. Chinea’s GBS.”); Perez v. Sec’y of Health & Hum. Servs., No.
10–659V, 2015 WL 9483680, at *7, *13 (Fed. Cl. Spec. Mstr. Dec. 8, 2015) (Special
Master Hamilton-Fieldman found petitioner did not meet Althen prong one when Dr.
Steinman argued that molecular mimicry was the reason that petitioner’s tetanus
vaccine caused his GBS.); but see Pierson v. Sec’y of Health & Hum. Servs., 2022 WL
322836, at *12, *39 (Special Master Horner that causation-in-fact was proven
preponderantly in cases in which “Dr. Steinman base[d] his theory of how the Prevnar
13 vaccine can cause GBS through the concept of molecular mimicry.” (alteration
added)); Koller v. Sec’y of Health & Hum. Servs., No. 16-439V, 2021 WL 5027947, at
*8, *23 (Fed. Cl. Spec. Mstr. Oct. 8, 2021) (Special Master Gowan held that all three
Althen prongs were met after Dr. Steinman used molecular mimicry to argue that the
Prevnar 13 vaccine caused petitioner’ GBS.). The court notes, of course, that each of
above cited decisions of the Special Masters was based specifically on the medical
histories and facts of the specific petitioners involved. Moreover, as explained by the
Federal Circuit in Boatmon:
To the extent the Court of Federal Claims required that special masters
cite and distinguish the decisions of other special masters, it was
incorrect. As the Court of Federal Claims itself acknowledged, “[a] Special
Master is not bound to follow the opinions of other Special Masters.” Id.;
see also Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630
(1998) (“Special masters are neither bound by their own decisions nor by
cases from the Court of Federal Claims, except, of course, in the same
case on remand.”), aff'd, 191 F.3d 1344 (Fed. Cir. 1999). The government
also acknowledges this on appeal. Appellee’s Br. 18 n.1 (“The decisions of
other special masters . . . are not binding precedent.”); id. at 22 (“[S]pecial
masters’ decisions are non-binding.”). By extension, special masters are
not required to distinguish non-binding decisions of other special masters.
That is, in part, because “[c]ausation in fact under the Vaccine Act is . . .
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based on the circumstances of the particular case.” Knudsen, 35 F.3d at
548.
Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d at 1358–59 (alterations in original).
The court has reviewed petitioner’s objection that the “Chief Special Master failed
to recognize that the posited medical theory of molecular mimicry went well beyond the
mere identification of homologies between components of the Tdap vaccine and self-
antigen such as human myelin protein, leading to GBS.” Petitioner did not offer reliable
evidence to support the petitioner’s theory that molecular mimicry between the Tdap
antigens and self-structures associated with the initial attack on petitioner’s nerves was
the mechanism driving the autoimmune process. Therefore, based on the record before
Chief Special Master Corcoran, this court finds that the Chief Special Master’s decision
that petitioner has not established by a preponderance of the evidence that the Tdap
vaccine likely caused the production of antibodies associated with autonomic damage
or interference sufficient to cause GBS and that those same antibodies did lead to a
pathogenic process was not arbitrary or capricious, or an abuse of discretion.
Petitioner also argues that Chief Special Master Corcoran applied the wrong
evidentiary standard to the first Althen prong, and argues that the correct legal standard
is whether it is “biologically plausible,” not whether petitioner has preponderantly
established, that the Tdap vaccine could have caused GBS. In response, respondent
argues “[t]he Chief Special Master properly required petitioner to present preponderant
evidence in support of Althen prong 1, and correctly noted that Federal Circuit
precedent requires a petitioner to present more than a ‘plausible theory’ of vaccine
causation.”
In his Entitlement Decision, Chief Special Master Corcoran noted:
Before discussing the success of Petitioner’s Althen prong one showing,
review of his framing of the legal standard applicable is warranted. For
Petitioner fully misstates that standard, proposing a version that, if
adopted, would obliterate the existing distinction between Table and non-
Table claims in the Vaccine Program. Reply at 3. As I noted above, the
most recent controlling/precedential Federal Circuit caselaw directly
addressing the subject states explicitly that the first Althen prong requires
a preponderant showing—just like the other two prongs. Boatmon, 941
F.3d at 1359; LaLonde, 746 F.3d at 1339; see also Moberly, 592 F.3d at
1322.
(emphasis in original).
Consistent with petitioner’s arguments before the Chief Special Master, in his
Motion for Review in this court, petitioner cites to a decision of the Chief Special Master
in Morgan v. Secretary of Health & Human Services, No. 15-1137V, 2019 WL 7498665
(Fed. Cl. Spec. Mstr. Dec. 4, 2019), review denied, 148 Fed. Cl. 454 (2020), aff’d, 850
F. App’x 775 (Fed. Cir. 2021)), a recent decision by a Judge of the United States Court
of Federal Claims reversing Chief Special Master Corcoran’s decision in J. v. Secretary
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of Health & Human Services, 155 Fed. Cl. 20 (2021), and a recent, non-precedential
Federal Circuit decision in Kottenstette v. Secretary of Health & Human Services, No.
2020-2282, 861 F. App’x 433 (Fed. Cir. 2021), in an attempt to argue that the current
legal standard under the first Althen prong is whether it is biologically plausible
petitioner’s Tdap vaccine could have caused GBS. Despite the petitioner’s attempts to
refashion the first Althen prong standard, in 2019, the Federal Circuit in Boatmon v.
Secretary of Health & Human Services, 941 F.3d 1351, reiterated the Federal Circuit’s
long standing holding that a petitioner bears the burden to prove actual causation by a
preponderance of the evidence.12 The Federal Circuit in Boatmon explained:
In off-Table cases like this one, it is the petitioners’ burden to prove actual
causation by a preponderance of the evidence. Moberly, 592 F.3d at
1322. The Vaccine Act “relaxes proof of causation for injuries satisfying
the Table[,] . . . but does not relax proof of causation in fact for non-Table
Injuries.” Id. (quoting Grant, 956 F.2d at 1148). A petitioner must provide a
“reputable medical or scientific explanation” for its theory. Id. While it does
not require medical or scientific certainty, it must still be “sound and
reliable.” Knudsen, 35 F.3d at 548–49.
. . .
We have consistently rejected theories that the vaccine only “likely
caused” the injury and reiterated that a “plausible” or “possible” causal
theory does not satisfy the standard. Moberly, 592 F.3d at 1322 (rejecting
a “more relaxed standard” of whether the condition was “likely caused” by
the vaccine and reiterating that “proof of a ‘plausible’ or ‘possible’ causal
link between the vaccine and the injury . . . is not the statutory standard”);
see also LaLonde, 746 F.3d at 1339 (“However, in the past we have made
clear that simply identifying a ‘plausible’ theory of causation is insufficient
12 The court notes that the Federal Circuit appears to have issued one precedential
decision on the issue of the correct legal standard for causation since the Boatmon
decision. See Kirby v. Sec'y of Health & Hum. Servs., 997 F.3d 1378. In Kirby, the
Federal Circuit observed that
[t]he government relies on Boatmon v. Secretary of Health & Human
Services, 941 F.3d 1351, 1359 (Fed. Cir. 2019), but that case is inapt
because the special master there “articulated a lower ‘reasonable’
standard” in assessing the petitioners’ medical theory of causation. Here,
by contrast, the special master recited the correct legal standard. J.A. 33
(“[P]etitioners must provide a reputable medical theory . . . based on a
sound and reliable medical or scientific explanation.”) (internal quotation
marks omitted).
Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d at 1384 (alterations in original).
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for a petitioner to meet her burden of proof.” (quoting Moberly, 592 F.3d at
1322)).
Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d at 1359–60 (emphasis and
alterations in original). Chief Special Master Corcoran properly cited to the Federal
Circuit’s precedential decision in Boatmon v. Secretary of Health & Human Services, to
conclude that petitioner must present preponderant evidence to prevail under the first
Althen prong. Therefore, this court finds that Chief Special Master Corcoran applied the
correct legal standard for petitioner to meet the first Althen prong, which as determined
above, petitioner failed to meet.
Petitioner also “seeks review of the Chief Special Master’s conclusion that
Torday v. Secretary of Health & Human Services, No. 07-372V, 2009 WL 5196163
(Fed. Cl. Spec. Mstr. December 10, 2009), is not ‘useful’ to disposition of the case at
bar.” (internal citation omitted). The court notes that the Chief Special Master only
referenced Torday twice in his Entitlement Decision, both times in footnotes. The Chief
Special Master noted in a footnote:
As Respondent observed in his opposition brief, Dr. Steinman’s misplaced
reliance on Torday as requiring specification of a precise infection to
counter the known quantity of a vaccination really invokes a Shyface-like
analysis from a case where more than one factor was deemed potentially
causal, leading the special master to give less weight to the unknown
precise nature of the infection. Torday, 2009 WL 5196163, at *3–4.
Additionally, in a separate footnote, Chief Special Master Corcoran stated:
Respondent herein also reacted directly to Dr. Steinman’s non-medical
exegesis into Vaccine Program legal standards, noting that the case he
cited to defend his view that a known vaccine should be favored as causal
over a non-specifically identified infection did not quite mean what he
represented. Opp. at 27–28, citing Torday v. Sec’y of Health & Hum.
Servs., No. 07-372V, 2009 WL 5196163, at *3–4 (Fed. Cl. Spec. Mstr.
Dec. 10, 2009). Torday, Respondent maintained, stood only for the
proposition that when it was undisputed that the vaccine at issue and an
unspecified illness could be causal, and the evidence was otherwise
deemed close, it was reasonable to find the vaccine as causal. Here, by
contrast, Dr. Collins and Respondent did not concede the Tdap vaccine
was causal. Opp. at 28. Respondent’s reading of Torday is superior to Dr.
Steinman’s—and it only underscores why medical/scientific experts like
Dr. Steinman are better off not opining on the meaning of Program
caselaw or the applicable legal standards (although as discussed in this
Decision, I give no weight at all to Dr. Steinman’s legal pronouncements,
and do not otherwise deem Torday a useful guiding decision).
(emphasis in original).
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Petitioner claims that “[w]hile Respondent has not conceded that the Tdap
vaccine can be causal to Petitioner’s development of GBS, a court may find that it can
be causal and apply the logic of Torday here.” Petitioner argues:
All that is known about the days immediately after vaccination is that there
were symptoms, which form the basis for Respondent's position in this
case. It is not known to what these symptoms were attributable. There is
no direct evidence that an infectious disease existed, at all. The symptoms
may have been attributable to the formative stage of GBS, or perhaps
another explanation. A court, in weighing a speculative, possibly non-
existent infectious disease, without identification or specificity, could
reasonably find recourse to the method employed in Torday, whereby
preponderance was established, by just a feather's weight, to a known
causal factor such as vaccination.
Respondent challenges petitioner’s reading of Torday, and correctly points out
that “Torday is nonprecedential, and the Chief Special Master is not bound by its
analysis. Nevertheless, the Chief Special Master clearly considered Torday
distinguishable from the present case.” (citation omitted).
In Torday, the petitioner developed GBS after receiving the flu vaccine. See
Torday v. Sec’y of Health & Hum. Servs., 2009 WL 5196163, at *1. Expert witnesses for
petitioner Torday and the respondent disagreed as to whether the vaccine or an
intervening upper respiratory infection caused petitioner Torday’s GBS. See id. at *3. In
Torday, then-Chief Special Master Golkiewicz indicated that “the issue to be decided is
actually quite narrow” because both experts agreed that the vaccine or an upper
respiratory infection could have caused petitioner’s GBS and that both met the third
Althen prong. See id. In Torday, then-Chief Special Master Golkiewicz stated:
The preponderance of evidence standard is often described as 50 percent
plus a feather. In this case, the undersigned interprets the experts’
testimony to be that the vaccine and URI are potentially of equal
culpability. However, when forced to choose, the experts disagree for the
reasons stated as to which potential cause gets the feather. In resolving
this case, the undersigned accepts and credits Dr. Steinman’s logic that
the known causative agent, the vaccine, should be weighted more heavily
than the unknown agent causing the URI, which may or may not be a
potential cause of GBS. Thus, the undersigned finds that the 50 percent
and the feather goes to the vaccine as the cause of Mr. Torday’s GBS.
Id. at *4 (alteration added). In the Torday decision, then-Chief Special Master
Golkiewicz indicated that he ruled in favor of petitioner Torday “by the slimmest of
margins.” Id.
As noted above, in his Entitlement Decision for the above captioned case, Chief
Special Master Corcoran indicated he did not “deem Torday a useful guiding decision.”
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Notably, the vaccine at issue in Torday, an influenza vaccination, was different than the
Tdap vaccine administered to petitioner in the above captioned case.
As Chief Special Master Corcoran stated in his Entitlement Decision, “it is
incorrect that evidence regarding possible alternative causes should not be included in
a special master’s weighing, absent definitive proof of the nature of the infection.” In his
Entitlement Decision, Chief Special Master Corcoran found that not only is there
“incontrovertible evidence that Petitioner first experienced URI symptoms before
neurologic-related symptoms, but also that the majority of [petitioner’s] treaters deemed
the URI most likely causal. The vaccine does not deserve greater weight simply
because it is ‘known’ whereas the precise nature of the infection is not.” (emphasis in
original; alteration added). In his Entitlement Decision, Chief Special Master Corcoran,
citing Randolph v. Secretary of Health & Human Services, No. 15-146V, 2021 WL
5816271, at *21 (Fed. Cl. Spec. Mstr. Nov. 12, 2021), indicated that “medical science
cannot always test for or identify a specific infection.” According to Chief Special Master
Corcoran,
[t]here are circumstances where experts on both sides concede two or
more factors could be causal of injury (including vaccination), resulting in
entitlement for the petitioner if the special master concludes that the
vaccine was at least a ‘substantial’ factor (even if not the primary or
predominant factor). Deribeaux v. Sec’y of Health & Hum. Servs., 105
Fed. Cl. 583, 589 (June 4, 2012). But here, there was no concession by
Dr. Collins that the Tdap vaccine can be causal at all—and I have found
that Petitioner did not preponderantly establish this to the case. Thus, the
mere fact that temporarily [sic] Petitioner received the Tdap vaccine before
onset of his URI does not compel me into a Shyface determination that the
URI was not likely solely causal.
(emphasis in original; alteration added). In fact, in her January 23, 2020 expert report,
Dr. Collins stated,
[t]he timing of [K.A.]’s symptoms in relationship to the Tdap vaccine is
most likely coincidental. An influenza-like illness that followed the vaccine
and preceded development of GBS is more likely than not the cause of
[K.A.]’s GBS. There is no evidence that aluminum in the Tdap vaccination
causes GBS, while conversely there is a known association between
influenza-like infection and the development of GBS. Therefore, I do not
believe the evidence in this case is supportive of the conclusion that the
Tdap vaccine caused or substantially contributed to [K.A.]’s symptoms.
(alteration added).
After examining petitioner’s medical records and all the expert reports, Chief
Special Master Corcoran found that
[p]etitioner has not preponderantly established that the Tdap vaccine can
cause GBS, under either of the two causation theories ventured over the
case’s six-year life—and even if he had, the record demonstrates it is far
36

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more likely his GBS was attributable to an intercurrent upper respiratory
infection (“URI”) than vaccination.
Chief Special Master Corcoran’s analysis and conclusions and rejection of the Torday
analysis as a basis for his Entitlement Decision was not arbitrary, capricious, or an
abuse of discretion, given the facts of petitioner’s medical records in the above
captioned case.
CONCLUSION
This court finds that Chief Special Master Corcoran’s examination of the record
before the court in petitioner’s case, including the multiple, albeit conflicting, expert
opinions by Dr. Steinman and Dr. Collins, petitioner’s contemporaneous medical
records and the literature submitted, resulted in a decision which was not “arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law.” 42 U.S.C.
§ 300aa-12(e)(2)(B). The Chief Special Master’s Entitlement Decision is affirmed.
Petitioner’s Motion for Review is DENIED. The Clerk of the Court shall enter
JUDGMENT consistent with this Opinion.
IT IS SO ORDERED.
s/Marian Blank Horn
MARIAN BLANK HORN
Judge
37

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_16-vv-00989-3
Date issued/filed: 2023-06-27
Pages: 45
Docket text: PUBLIC DECISION (Originally filed: 04/18/2022) regarding 98 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (mva) Service on parties made.
--------------------------------------------------------------------------------
Case 1:16-vv-00989-MBH Document 122 Filed 06/27/23 Page 1 of 45
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-989V
(To be Published)
* * * * * * * * * * * * * * * * * * * * * * * * *
K.A., *
*
Petitioner, *
* Chief Special Master Corcoran
v. *
* Dated: April 18, 2022
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * *
Robert J. Krakow, Law Office of Robert Krakow, P.C., New York, NY, for Petitioner.
Nina Ren, U.S. Dep’t of Justice, Washington, DC, for Respondent.
ENTITLEMENT DECISION1
On August 11, 2016, K.A. filed a petition seeking compensation under the National
Vaccine Injury Compensation Program (“Vaccine Program”).2 Petitioner alleges that he
experienced Guillain Barré syndrome (“GBS”) due to the administration of a Tetanus Diphtheria
acellular-Pertussis (“Tdap”) vaccine on August 12, 2013. Petition at 1 (ECF No. 1).
1 This Decision will be posted on the Court of Federal Claims’s website in accordance with the E-Government Act of
2002, 44 U.S.C. § 3501 (2012)). This means that the Decision will be available to anyone with access to the
internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion
of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days
within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial
or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the
disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the
whole Decision will be available to the public. Id.
2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”).
Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

Case 1:16-vv-00989-MBH Document 122 Filed 06/27/23 Page 2 of 45
I proposed (after the case’s transfer to me in January 2021) that the matter could reasonably
be decided on the record, and the parties have offered briefs in support of their respective positions.
Petitioner’s Motion, dated July 2, 2021 (ECF No. 84) (“Mot.”); Respondent’s Opposition, dated
Sept. 13, 2021 (ECF No. 88) (“Opp.”); Petitioner’s Reply, dated Oct. 12, 2021 (ECF No. 89)
(“Reply”). Now, after review of the medical record, briefs, and multiple expert reports, I deny
entitlement. Petitioner has not preponderantly established that the Tdap vaccine can cause GBS,
under either of the two causation theories ventured over the case’s six-year life—and even if he
had, the record demonstrates it is far more likely his GBS was attributable to an intercurrent upper
respiratory infection (“URI”) than vaccination.
I. Factual Background
Vaccination and Onset of Neurologic Issues/Symptoms
Mr. K.A., a medical researcher, was fifty-one years old when he received a Tdap vaccine on
August 12, 2013, through his employer. Ex. 1 at 2. The medical evidence filed in this case pertaining
to Petitioner’s pre-vaccination history suggests he suffered from high cholesterol, hypertension, and a
chronic leg condition for which he underwent surgery several years post-vaccination. See Ex. 2 at 2;
Ex. 18; Ex. 75 at 57, 111. Petitioner acknowledges that “[w]ithin a short time” after receiving the
vaccine, he experienced a “bad headache, body pains, sore throat and fever,” which he believed to
be “a routine flu.” Ex. 10 at 8. Thus, he was experienced flu-like symptoms prior to the onset of
his alleged vaccine-caused neurologic injury, and these symptoms appear broader than the
common post-vaccination malaise.
Less than three weeks later, on September 1, 2013, Petitioner went to the North Shore
University Hospital (“North Shore”) Emergency Department (“ED”), where he reported three days
(meaning beginning on or around August 29th) of flu-like symptoms (dry cough, chills) and a
feeling of swelling in his throat, which he had been attempting to self-treat with over-the-counter
medications based on the supposition that he had some kind of URI. Ex. 9 at 6, 9, 17. On exam, ED
treaters noted that Petitioner appeared neurologically sound and was not in distress, although they
observed him to display many common URI symptoms (fever, chills, weakness, nasal discharge,
congestion, dyspnea, cough, etc.). Id. at 11, 17. Mr. K.A. was ultimately discharged from North Shore
the next day, and he maintains he was still experiencing a fever on September 3, 2013. Id. at 6–11;
Ex. 10 at 5.
Then, on September 4, 2013, Petitioner was discovered on his driveway complaining of
numbness on his left side, and transported by ambulance to the St. Francis Hospital ED in Roslyn,
New York. Ex. 3 at 8–9. Emergency responders noted that he was displaying an unsteady gait, and
also that he had recently been treated for flu-like symptoms. Ex. 2 at 5–6. Upon arrival at the hospital,
Mr. K.A. informed treaters that his neurologic symptoms had begun “approximately” five days ago,
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“when he was attempting to climb a hill and noticed weakness in the left leg,” followed by a feeling of
“incoordination” on the left side of his face while brushing his teeth. Ex. 3 at 9. (Petitioner
contradictorily represented in this same record, however, that “[t]he current episode” began seven days
before (Id.)). He had not experienced any loss of sensation, but felt tingling generally over the left side
of his body. Id. Overall, Petitioner deemed his symptoms “mild to moderate.” Id.
Evaluation and Treatment
On exam, admitting physician Subhash Viswanathan, M.D., noted that Mr. K.A. could not
forcefully close his left eye, and that he had left face weakness plus left arm and leg weakness. Ex.
3 at 10–12. His cranial nerves appeared intact, however, and he displayed no sensory defect. Id. at
12. CT scans of Petitioner’s brain and chest were unremarkable, although lab results showed a
positive IgG for West Nile virus (“WNV”), but a negative IgM.3 Id. at 15–20, 63. A lumbar puncture
supported the diagnosis of GBS of the “pharyngeal-cervical-brachial variant.” Id. at 67. A neurologist
who saw Petitioner at this time, Michael Han, M.D., concurred in the proposed GBS diagnosis, taking
specific note of the fact that Petitioner had recently experienced a URI. Ex. 3 at 15, 19–20.
Mr. K.A. was subsequently admitted to the hospital for further evaluation. Ex. 3 at 16.
Weakness was his initial primary complaint, and in providing a history Petitioner noted that he had
experienced a URI with flu-like symptoms, thereafter, developing the left leg weakness that had
resulted in his ED visit on September 4th. Id. at 20, 21. An MRI of the brain was performed after
Petitioner’s admission but revealed no acute changes. Id. at 30. Another neurologist, Teresa Deangelis,
M.D., examined Petitioner the next day (September 5th), noting again the URI preceding his
neurologic symptoms, and she began Petitioner on a five-day course of intravenous
immunoglobulin therapy.4 Id. at 36–37. Petitioner also underwent a rheumatology consult with
William Given, M.D., on September 6, 2013, and Dr. Given opined (consistent with the other
treaters who had by this time seen Petitioner) that “[t]he patient is . . . a gentleman who has
developed weakness and paresthesias following what appears to be a viral illness a couple of weeks
ago.” Id. at 41.
Petitioner also had at this time an infectious disease consult with Dava Klirsfeld, M.D.,
providing the same history he had given other treaters (URI, subsequent symptoms, etc.)—although this
time he included the fact that he had received the Tdap vaccine three weeks prior as well. Ex. 3 at 47–
3 As I noted in a prior decision, “Immunoglobulin G (IgG) and Immunoglobulin M (IgM) are antibodies produced in
response to infection, and their titer levels can help monitor or detect immune deficiencies. IgM is an indicator of
current infection, while IgG reflects exposure to a past infection.” Knorr v. Sec'y of Health & Hum. Servs., No. 15-
1169V, 2018 WL 6991548, at *4 n.7 (Fed. Cl. Spec. Mstr. Dec. 7, 2018).
4 Intravenous immunoglobulin, or “IVIG,” is a blood product used to treat patients with antibody deficiencies,
including neurological disorders. Clinical Uses of Intravenous Immunoglobulin, NCBI (2005),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1809480/ (lasted visited on Apr. 13, 2022). It is commonly
prescribed to treat diseases believed to be autoimmune in nature, with the aim of increasing the effectiveness of an
individual's immune response.
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48. Dr. Klirsfeld’s assessment included the view that Petitioner had experienced “a demyelinating
disorder possibly post viral or post vaccine.” Id. at 53 (emphasis added). Dr. Klirsfeld also deemed the
positive WNV IgG serum test “of unclear significance,” and ordered more laboratory testing. Id.
A second lumbar puncture was consistent with the prior one, and on September 10, 2013,
Doina Glodan, M.D., diagnosed petitioner with “Guillain-Barré syndrome post recent viral URI.” Ex.
3 at 126, 217. Other treaters who saw Petitioner in this time frame also seemed to accept the URI as
likely causal. See, e.g., id. at 127 (Joyce Ott, PT, recording that Petitioner had a history of “recent viral
URI”), 130 (Dr. Deangelis noting “recent URI 2 weeks ago”), 154 (David Brieff, M.D., opining that
“[p]ositive WNV serology likely reflects old infection or cross reaction from other flavivirus infection
in past”). But Petitioner did not test positive for any specific infections, such as the Epstein-Barr
virus (“EBV”). Id. at 268–85.
Mr. K.A. remained at St. Francis Hospital until September 17, 2013, after which he was
discharged to a rehabilitation facility. Ex. 3 at 213, 216. His coordination had now improved, although
he continued to report facial weakness, fatigue, and back and shoulder pain. Id. There, he attended
physical, occupational, and speech therapy, remaining in rehab until September 22, 2013. Ex. 12 at
8. On that date, however, Petitioner developed acute right facial weakness with hemiparesis, and was
accordingly transferred to North Shore on the same day for treatment and evaluation. Id. He now
displayed increasing lethargy, weakness, and right sided numbness and tingling that started two to
three days prior, with trace reflexes and worsened right-side issues (in contrast to improvements on his
left side). Ex. 9 at 44–49; Ex. 5 at 27.
Petitioner was admitted to North Shore based on his emerging “right side
numbness/tingling weakness” in the setting of “recently diagnosed AIDP,”5 and treaters began him
on a course of plasmapheresis6 on September 24, 2013. Ex. 5 at 30; Ex. 9 at 48. This treatment
was continued for some time, and Petitioner’s symptoms improved as a result. Ex. 9 at 53.
Additional testing performed during this hospitalization revealed a recent cytomegalovirus (“CMV”)
infection, but was equivocal regarding the presence of EBV. Ex. 9 at 178–80. Notably, on September
26, 2013, a dietician who saw Petitioner indicated in the record from that visit that Petitioner had
initially presented “with progressive weakness post tetanus shot 8 weeks ago,” although it appears
from this record that the dietician was merely taking down a history rather than offering an
informed view on causation. Id. at 1064.
5 AIDP refers to “acute inflammatory demyelinating polyradiculoneuropathy” Polyradiculoneuropathy, Dorland’s
Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=40276 (last visited Apr. 13,
2022).
6 Plasmapheresis is the process of drawing blood, removing the plasma therefrom, and replacing it with another
substance, such as albumin or type-specific fresh frozen plasma. Plasmapheresis, Dorland’s Medical Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=39455&searchterm=plasmapheresis (last visited Apr.
13, 2022). It is often employed in the treatment of disease processes believed to be autoimmune in nature.
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Mr. K.A. was discharged for further rehabilitation at a different facility on October 8, 2013, and
he underwent rehab therapy through October 21st before being released for additional outpatient therapy.
Ex. 9 at 57; Ex. 7 at 78; Ex. 12 at 193–540. In the course of that treatment, he informed caregivers
of his view that his symptoms followed (and hence were potentially related to) his receipt of the
Tdap vaccine. Ex. 7 at 5–7. For the remainder of that fall, Petitioner saw Dr. Han for follow-up
treatment, and Dr. Han noted Petitioner’s overall improvement. Ex. 5 at 58–60, 62.
Treatment in 2014 and Beyond
There is a subsequent, almost nine-month gap in the medical record, with Petitioner not visiting
Dr. Han again until September 2014. Ex. 5 at 65. Petitioner then reported that he still was experiencing
painful paresthesias in his feet, but no longer needed to use a cane despite some imbalance issues,
and described himself as “99% back to normal.” Id. Dr. Han advised Mr. K.A. that he should continue
on his existing medication, and asked him to return in four to six months. Id. at 67. Petitioner received
a comparable positive evaluation from a different treater. Ex. 75 at 69, 130. Similar prognoses were
offered in 2015. See, e.g., id. at 68, 126 (2015 visits with Dr. Han); Ex. 5 at 80–81 (2016 visits with
Dr. Han). No other records from the subsequent timeframe bear on the causation issues presented
in this case.
II. Expert Reports
A. Lawrence Steinman, M.D.
Dr. Steinman submitted five expert reports on behalf of Petitioner. Report, dated Aug. 2,
2017, filed as Ex. 21 (ECF No. 30-1) (“First Steinman Rep.”); Report, dated Feb. 18, 2018, filed
as Ex. 22 (ECF No. 40-1) (“Second Steinman Rep.”); Report, dated Dec. 27, 2018, filed as Exhibit
46 (ECF No. 54-1) (“Third Steinman Rep.”); Report, dated Oct. 7, 2019, filed as Exhibit 48 (ECF
No. 61-1) (“Fourth Steinman Rep.”); Report, dated June 22, 2020, filed as Exhibit 71 (ECF No.
74-1)(“Fifth Steinman Rep.”). Altogether, Dr. Steinman offered more than 70 pages of expert
opinion on this matter, (as discussed below and throughout this Decision), I do not conclude the
significant effort was ultimately well spent.
As shown in his CV, Dr. Steinman received his B.A. from Dartmouth College and his M.D.
from Harvard Medical School. Ex. 24 at 1 (ECF No. 48-2) (Dr. Steinman’s Curriculum Vitae
(“Steinman CV”)). He then completed residencies in neurology and pediatrics at Stanford
University. Steinman CV at 1. He has worked as a professor of neurology and pediatrics at Stanford
for the past forty-one years (thirty-seven years at the time of filing). Id. Dr. Steinman has also
published over four hundred peer-reviewed publications on immunology, neurology, and
autoimmune disease. Id. at 5–45. He has special expertise in the study of immunology, having
several articles published on the issues. Id. at 5–45. Dr. Steinman is part of the American
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Association of Immunologists and the Clinical Immunology Society, with patents in the field and
many papers on the topic. Id. at 2.
Dr. Steinman has demonstrated expertise in treatment of GBS and associated
neuroinflammatory conditions, and has been honored in his field of practice for his specific
expertise in the study of multiple sclerosis. First Steinman Rep. at 2–3. And he is a frequent expert
in the Vaccine Program. By his own count (as of 2017, meaning over four years ago), Dr. Steinman
had testified 20 times—although (as a somewhat recent decision establishes) by the spring of 2019
his reports and opinions had been featured in 40 published Vaccine Program decisions. D.G. v.
Sec'y of Health & Hum. Servs., No. 11-577V, 2019 WL 2511769, at *191 n.171 (Fed. Cl. Spec.
Mstr. May 24, 2019).
First Report
Dr. Steinman began his report with an overview of GBS, which he characterized as an
inflammatory neuropathy singling out peripheral nerves and that was likely autoimmune in
pathogenesis. First Steinman Rep. at 4–6. He also noted that the record strongly supported the
appropriateness of the diagnosis in this case, adding that Respondent did not appear to disagree
with it. Id. at 6. In addition, there was some record evidence of potential alternative explanations
(spider bites; presence of WNV antibodies in CSF testing; Petitioner’s URI), and Dr. Steinman
added that “[i]nfection with [cytomegalovirus] and/or [Epstein Barr Virus] are two possibilities
for the GBS trigger”—presumably interpreting the evidence of Petitioner’s URI as possibly
establishing such an infection despite a lack of record evidence proving either’s existence. But he
ultimately proposed that the Tdap vaccine more likely explained Petitioner’s GBS, “because there
is a clear underlying mechanism to explain how the vaccine is the trigger” in comparison to those
two wild infections. Id. at 7.
Next, Dr. Steinman outlined his theory for how the Tdap vaccine could trigger GBS. First,
he noted that the Institute of Medicine (the “IOM”) had evaluated the role that the alum adjuvant
contained in the Tdap vaccine is believed to increase the vaccine’s immunogenicity. First Steinman
Rep. at 7–8; Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality (K.
Stratton et al., eds., 2012), filed as Ex. 23 (ECF No. 48-1) (“2012 IOM Rep.”).7 In addition to
describing the impact on immune response, it also noted that “alum may directly activate cells of
the innate immune system through its effect on local inflammasome complexes leading to the
release of inflammatory mediators.” 2012 IOM Rep. at 88. Dr. Steinman’s overall causation theory
stemmed from the potentiality for this process to become aberrant.
7 Dr. Steinman’s First Report erroneously refers to this document as having been published in 2011. First Steinman
Rep. at 7. More concerning is the fact that Petitioner has unhelpfully filed the entire 800-plus pages of the IOM 2012
Report, rather than only the specifically-relevant and cited selections. See generally Ex. 23. This is wasteful and
unnecessary, and counsel in the future should show greater care in offering medical and scientific literature (which
already in most Vaccine Program cases is filed excessively, and out of all proportion to its overall utility).
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Dr. Steinman offered several additional items of literature confirming the immunogenic
contributory role of alum as an adjuvant, although one item noted that “the basis for its
adjuvanticity remains poorly understood.” First Steinman Rep. at 8 (quoting H. Li et al., Aluminum
Hydroxide Adjuvants Activate Capsase-1 and Induce IL-1β and IL-18 Release, 178 J. Immunol.
5271 (2007), filed as Ex. 33 (ECF No. 49-1)) (“Li”). He later noted that the 2012 IOM Report had
questioned whether Tdap-like vaccines could be reasonably associated with GBS, but retorted that
none of the literature he relied upon in this case had been considered in that report. First Steinman
Rep. at 10–11; 2012 IOM Rep. at 587 (referencing ten studies, and concluding that “the
mechanistic evidence regarding an association between diphtheria toxoid-, tetanus toxoid-, or
acellular pertussis-containing vaccine and GBS” was inadequate). Dr. Steinman also cited the
Tdap vaccine’s package insert, which he noted admitted an increased risk of GBS after receipt of
the vaccine—if the recipient previously experienced GBS within six weeks of a prior dose of a
vaccine containing tetanus toxoid. First Steinman Rep. at 11; Adacel,8 Highlights of Prescribing
Information,
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm
142764.pdf (last visited Apr. 13, 2022) at 2, filed as Ex. 25 (ECF No. 48-3) (“Tdap package
insert”). Notably, however, the Tdap package insert relies on an older IOM report not offered in
this case (and presumably supplanted by the 2012 IOM Report filed by Petitioner, which itself
only denies the ability to ascertain mechanistically if the vaccine is or is not causal). Tdap package
insert at 2 n.1, 4.
Second, Dr. Steinman highlighted the importance of the fact (as Li had noted) that certain
pro-inflammatory cytokines—in particular, IL-1β and IL-18—were activated in response to the
alum adjuvant. First Steinman Rep. at 8; Li at 5275. IL-1β, he proposed, was “strongly unregulated
during active GBS.” First Steinman Rep. at 8; K. Nyati, et al., Correlation of Matrix
Metalloproteinases-2 and -9 with Proinflammatory Cytokines in Guillain-Barré Syndrome, 88 J.
Neurosci. R. 3540 (2010), filed as Ex. 34 (ECF No. 49-2) (“Nyati”). Another article also directly
implicated IL-18 “in the pathogenesis of acute immune-mediated [peripheral nervous system]
demyelination.” S. Jander & G. Stoll, Interleukin-18 is Induced in Acute Inflammatory
Demyelinating Polyneuropathy, 114 J. Neuroimm. 253 (2001), filed as Ex. 35 (ECF No. 49-3)
(“Jander & Stoll”). And he noted that the predominant animal model used to study autoimmune
peripheral demyelinating diseases like GBS, experimental autoimmune neuritis (“EAN”), had
observed that treatments to suppress IL-18 seemed to in turn reduce autoantibody responses
driving GBS—suggesting its importance to GBS’s pathogenesis. A. Yu et al., Neutralizing
Antibodies to IL-18 Ameliorate Experimental Autoimmune Neuritis by Counter-Regulation of
Autoreactive Th1 Responses to Peripheral Myelin Antigen, 61 J. Neuropathol. & Experimental
Neurol. 614 (2002), filed as Ex. 36 (ECF No. 49-4) (“Yu”).
8 Adacel is the trade name for the Tdap vaccine version administered in this case. Ex. 50.
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Dr. Steinman deemed these articles to provide “a strong scientific foundation” for his
theory. First Steinman Rep. at 9. But, on close review, they are less supportive than he assumed.
Nyati, for example, noted that GBS’s pathology in part requires breach of the blood nerve barrier
by both immune cells specific to the disease’s course (i.e. autoantibodies) as well as non-specific
macrophages (immune cells that react to any pathogen without specificity). Nyati at 3540. A
specific kind of enzyme is also involved in this breaching process, and Nyati’s authors determined
that the enzyme “can regulate the expression and activation of cytokines and hence play a complex
role in inflammatory diseases” like GBS. Id. at 3541. Nyati looked specifically at the correlation
between this enzyme level and levels of proinflammatory cytokines like IL-1β, finding the latter
were higher during the later, progressive stages of the disease. Id. at 3545. But because the presence
of these cytokines was observed in connection with a different immune process—and, more
significantly, that this aspect of the process resulting in GBS was not deemed instigative of it (and
indeed likely occurred after the disease process had already begun)—Nyati clearly does not stand
for the proposition that merely increasing levels of IL-1β will cause GBS. At most, it is the enzyme
studied in Nyati that promotes the cytokines at issue.
Jander & Stoll was similarly read by Dr. Steinman far more broadly than the actual article
allows. Its authors deemed it to be a “widely accepted” concept that T-helper cells (which as a
general matter encourage adaptive immune responses—for example, by aiding B cell production
of antibodies specific to a particular pathogen) played an important role in GBS’s pathogenesis,
and that some T-helper cells were understood to cause upregulation of certain proinflammatory
cytokines. Jander & Stoll at 253. At the same time, “[a]ntigen-presenting cells such as activated
macrophages” were encouraging production of cytokines like IL-18, which in turn had the capacity
to “favor a [T-helper cell]-like polarization of T cell-mediated immune responses.” Id. Through
both an animal study and small-sample measurement of the cytokine levels in 36 GBS patients,
Jander & Stoll determined that there was “a role for macrophage-derived IL-18 in the pathogenesis
of [T-helper cell]-mediated autoimmune demyelination in the [peripheral nervous system].” Id. at
257. This finding (like Nyati’s) is thus far narrower than Dr. Steinman posits, as it observes
increases in a relevant cytokine dependent on a factor other than initial vaccination, and moreover
that influences a sub-step in the pathogenesis of GBS, as opposed to instigating the process at the
outset. It says nothing about what initially causes the cytokine-promoting macrophages to react.
Yu is no different. Its authors relied on the EAN animal model to specifically consider “the
function of IL-18 in T-cell-mediated EAN,” noting at the outset that although high levels of IL-18
had been measured in GBS patients (relying for this proposition specifically from Jander & Stoll),
but that not much was known about the role the cytokine plays in the course of autoimmune
diseases. Yu at 614. Yu attempted to approach the question from an opposite end, evaluating what
would occur if anti-IL-18 antibodies were used as therapy. Id. By finding that an anti-IL-18
treatment could effectively “attenuate” EAN, Yu’s authors concluded they had illustrated the
cytokine’s importance to the disease, with some suggestion that the same ameliorative effect was
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possible outside the context of the EAN experiment (which relies on use of an artificially-
stimulated adjuvant to heighten the immune reaction, so that different variables can be tested). Id.
at 615, 621. But, like Jander & Stoll, Yu’s authors were focused on T-helper cells, based on the
fact that “EAN is predominantly a T cell-mediated disease”—something not understood about
GBS9—and hence Yu’s findings were limited to how IL-18 upregulation interacts with T-helper
cells and (in turn) “T cell-activation by antigen-presenting cells,” or macrophages. Id. at 620.10
The remainder of Dr. Steinman’s first report addressed the other two causation prongs that
a Program petitioner must satisfy. He proposed that the second, “did cause” prong was met—but
mainly in conclusory fashion, noting that literature insufficiently (in his view) provided a
convincing mechanistic connection between certain wild virus infections (EBV or CMV) and
GBS, and otherwise taking issue with the 2012 IOM Report’s conclusion that the immune
processes thought to drive GBS were not convincingly connected to the Tdap vaccine. First
Steinman Rep. at 10–11. He also endorsed the onset of Mr. K.A.’s GBS as occurring in a
medically-acceptable timeframe, when measured from date of vaccination. To do so, however, Dr.
Steinman invoked an item of literature specific to the flu vaccine. First Steinman Rep. at 11; L.
Schonberger et al., Guillain-Barré Syndrome Following Vaccination in the National Influenza
Immunization Program, United States, 1976–1977, 110 Am. J. Epidemiol. 105 (1979), filed as Ex.
42 (ECF No. 49-10) (“Schonberger”). Because Petitioner’s onset occurred approximately three
weeks11 after vaccination, it was within Schonberger’s observed interval. Schonberger at 109.
Second Report
By the time of the filing of his supplemental report, Dr. Steinman had the benefit of having
reviewed the first report prepared by Respondent’s Expert, Kathleen Collins, M.D. Thereupon
began a “tit-for-tat,” bickering exchange between the two that stretched over the next seven reports
9 Blackburn v. Sec'y of Health & Hum. Servs., No. 10-410V, 2015 WL 425935, at *15 (Fed. Cl. Spec. Mstr. Jan. 9,
2015) (peripheral neuropathies usually felt to be mediated by B cell-produced antibodies).
10 Dr. Steinman also extensively discussed a study in which scientists suppressed IL-18 in EAN—but without a
reduction in associated symptoms (thus undermining the contention that this cytokine was a central driver of
pathogenesis). R. Duan et al., IL-18 Deficiency Inhibits Both Th1 and Th2 Cytokine Production but Not the Clinical
Symptoms in Experimental Autoimmune Neuritis, 183 J. Neurolimm. 162 (2007), filed as Ex. 38 (ECF No. 49-6)
(“Duan”). Duan’s authors determined specifically a “net effect of no influence of IL-18 deficiency on EAN severity.”
Duan at 166. However, Dr. Steinman attempted to minimize Duan’s significance, noting that it was a study performed
on genetically-engineered, or “gene knockout” animals, and arguing that the findings in such a study were less useful
or trustworthy, since he felt that medical science recognized that this technology had become “old and is now
considered flawed.” First Steinman Rep. at 10.
11 Dr. Steinman somewhat erroneously identifies onset as occurring 18 days post-vaccination, or by August 30, 2013
(based on the August 12th vaccination)—even though the medical record states that around this time Petitioner sought
treatment for URI symptoms only, with his neurologic complaints not beginning until five days later (September 4th).
Ex. 9 at 6, 9, 11, 17. But since either date (August 30th or September 5th) is adequate from a temporal standpoint to fit
Petitioner’s timeframe theory (based on molecular mimicry as the causal mechanism), this difference does not
meaningfully undermine Dr. Steinman’s third prong opinion.
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collectively filed by both experts. While for the most part their interaction sheds limited light on
the contested issues, some reasonable elaborations or clarifications were provided—and as
discussed below, eventually Petitioner (at the urging of the special master then responsible for the
case) modified his theory entirely.
The first third of Dr. Steinman’s supplemental report was spent quibbling with Dr.
Collins’s use of the term “influenza-like illness” in proposing a more likely cause for Petitioner’s
GBS. See generally Second Steinman Rep. at 1–3. Dr. Steinman deemed it insufficiently precise,
and therefore not a reliable diagnosis upon which to base an argument about an alternative cause
(despite the fact that the record in this case clearly establishes that Petitioner was experiencing a
URI before his first manifestation of neurologic symptoms—even if no specific virus was
identified).12 He was not prepared to accept an illness that had not been specifically identified, by
testing or otherwise, as an explanation for Petitioner’s GBS, given the undeniable, identified “fact”
of receipt of the Tdap vaccine. And he attempted an item-by-item rebuttal of literature Dr. Collins
had referenced as contaminated by a similar amount of imprecision.
Turning to the central aspects of his theory, Dr. Steinman conceded that “[t]here is no
epidemiologic proof that alum containing vaccines are related to GBS.” Second Steinman Rep. at
3. But (block-quoting his own initial report), Dr. Steinman disputed the significance of this lack
of proof, in light of the fact that no such epidemiologic evidence could ever completely “rule out”
the possibility that a vaccine could be causal of GBS, or was in this case. Id. at 3–4. He noted that
the 2012 IOM Report he had previously discussed in his first report had (when considering the
epidemiologic evidence) stated only that the evidence was “inadequate to accept or reject” a Tdap-
GBS association, leaving the matter open. Id. at 4. He also highlighted an item of epidemiologic
evidence that in his view allowed for a potential Tdap association with acute disseminated
encephalomyelitis (“ADEM”), a neuroinflammatory demyelinating disorder that impacts the brain
and spinal cord (and hence somewhat comparable to GBS). R. Baxter et al., Acute Demyelinating
Events Following Vaccines: A Case-Centered Analysis, 63 Clin. Infect. Diseases: An Official
Publication of the Infectious Diseases Soc. of Am., 1456 (2016), filed as Ex. 44 (ECF No. 51-1)
(“Baxter I”). Thus, Dr. Steinman maintained that some epidemiologic evidence did not rebut the
possibility that an alum-adjuvanted vaccine could cause injury as he had proposed—even though
Baxter I does not address GBS, a distinguishable peripheral neuropathy. Baxter I at 1456.
12 Dr. Steinman also engaged in conduct I have in the past criticized him for: commenting on the standards governing
Program cases, and elaborating on how he performs his role as expert, rather than simply providing the
medical/scientific opinion for which he has been retained. See, e.g., Rolshoven v. Sec'y of Health & Hum. Servs., No.
14-439V, 2018 WL 1124737, at *21 (Fed. Cl. Spec. Mstr. Jan. 11, 2018). (Notably as well, in Rolshoven as here, Dr.
Steinman’s causation theory was based in part of the cytokine-stimulative impact of a vaccine’s alum adjuvant.
Rolshoven, 2018 WL 1124737, at *20). Indeed, he block-quoted in his second report an entire paragraph from a prior
Program decision in support of his contention about the lack of weight to be given to the term “influenza-like illness.”
Second Steinman Rep. at 2. None of Dr. Steinman’s reports in this case were prepared while I was presiding over this
matter—but in future cases in which Dr. Steinman is retained that are assigned to me, I will not compensate time spent
on opinions on legal issues that he is not qualified to address.
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In other regards, Dr. Steinman merely vouched for the opinion he had previously offered.
In reaction to Dr. Collins’s contention that the individual items of literature he previously cited did
not directly establish an alum/adjuvant-GBS association, Dr. Steinman protested that (a) the items
offered were individually reliable, having been published in reputable journals, and (b) he
reasonably relied on this evidence as links in his overall theory chain. Second Steinman Rep. at 4–
6. Thus, articles like Li or Nyati were useful in at least demonstrating alum’s impact on the
immune process—and that it could trigger upregulation of cytokines significant to GBS’s
pathogenesis. Id. at 6–8.
Third Report
In reaction to the four-page rebuttal offered by Dr. Collins, Dr. Steinman offered 12
additional report pages—although discerning how the ongoing expert exchange was being
expanded or improved upon with new, worthwhile points is exceedingly difficult.
First (and continuing his commentary on the legal standards relevant to the case’s
resolution—despite his admission that “I am not a lawyer” (Third Steinman Rep. at 1)), Dr.
Steinman spent a considerable amount of time maintaining that the term “influenza-like illness”
could not credibly be employed, given its vague character, to establish a persuasive alternative
explanation for Petitioner’s GBS. Third Steinman Rep. at 1–2. He deemed the known fact of
Petitioner’s receipt of the Tdap vaccine to outweigh the unestablished possibility of an intercurrent
infection that could not be precisely identified (even though the fact of Petitioner’s URI symptoms
cannot be contested). Id. at 2.
Second, Dr. Steinman objected to Dr. Collins’s general contention that his overall theory
was nothing more than a series of loosely-connected, “cherry-picked” studies that were
inconsistent overall (in part because they were a combination of animal and human studies with
differing and distinguishable methodologies). Third Steinman Rep. at 2–3. After expressing
umbrage at the use of the term “cherry picking” generally (and emphasizing his vast expertise
testifying in Vaccine Program cases—and the attendant knowledge he presumably had gained
from how claims should be evaluated, in light of the fact that vaccine injury causation could never
be determined to any degree of scientific certainty), Dr. Steinman endeavored to explain how the
individual components of his theory connected. Id. at 3–4.
He thus reiterated that alum had been demonstrated by reliable science to upregulate certain
pro-inflammatory cytokines (albeit in the context of promoting immunogenicity)—but also that it
could do so even outside the context of experiments relying on the use of additional stimulative
agents to enhance the response (the reason Dr. Collins had criticized the invocation of such other
evidence). Third Steinman Rep.at 5; J. Mannhalter et al., Modulation of the Human Immune
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Response by the Non-Toxic and Non-Pyrogenic Adjuvant Aluminum Hydroxide: Effect on Antigen
Uptake and Antigen Presentation, 61 Clin. Exp. Immunol. 143, 144 (1985), filed as Ex. 47 (ECF
No. 54-2) (“Mannhalter”) (evaluating the influence of the adjuvant on the immune process by in
vitro testing of vaccinated blood samples, adding tetanus toxoid antigens to the samples).
Dr. Steinman further underscored his prior contention that a number of human studies
“covered the effect of alum on the human immune response,” based on blood testing from
individuals diagnosed with GBS. Third Steinman Rep. at 6. He included a block quote from Li,
followed by several lengthy cites to Dr. Collins’s second report, in an effort to bolster the reliability
of this part of his opinion. Id. at 6–7. He did the same with Jander & Stoll, and added even more
lengthy block quotes from his prior reports as support (rather than offering new commentary based
on additional scientific support not previously referenced or highlighted). Id. at 7–8. And he
repeated the view that articles like Yu (demonstrating suppression of IL-18 via antibody treatments
in animal studies) were better evidence of the association of the cytokine to the demyelination
characteristic of GBS than animal experiments involving gene “knockout” (which he had
previously acknowledged produced results contrary to his primary contentions). Id. at 8–9.
Fourth Report
Dr. Steinman’s fourth report arrived three years into the claim’s life—and also after the
special master previously presiding over the case had expressed the willingness to entertain a
revised causation theory (since Respondent was deeming the adjuvant-based theory to be
implausible).13 This report thus pivoted to a “new” theory, albeit one that Dr. Steinman has offered
repeatedly in Vaccine Program cases past and present: that the autoimmune process leading to
GBS was instigated by the Tdap vaccine via the mechanism of molecular mimicry.
Dr. Steinman began his foray into this second/alternative causation theory by briefly
vouching for his own expertise, in both the fields of immunology as well as neuroinflammatory
autoimmune disease. Fourth Steinman Rep. at 1. He represented that his prior theory was not
“mutually exclusive” from his new theory, which focused on “how the contents of the [Tdap]
vaccine a) trigger via molecular mimicry immune responses to myelin components that are known
to be targeted in GBS.” Id.
First, Dr. Steinman listed the specific antigenic components of the Tdap vaccine. Fourth
Steinman Rep. at 2–3. Second, he turned to a brief review of the general concept of molecular
mimicry, in which “shared structures on a virus or bacteria or in a vaccine can trigger a cross-
reactive response to self.” Id. at 3 (citations omitted). Such sharing, or “homology,” is established
by showing amino acid (the building blocks of protein) identity (whether or not sequential)
13 See Section III below, discussing the case’s procedural history.
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between the foreign presenting antigen and the self structure. If antigen and self structure are
sufficiently similar, then antibodies produced by the immune system in reaction to the foreign
antigen (and intended to attack it) will also, if mistakenly, attack self. But because homology is
common in nature (given the total limited number of amino acids that constitute proteins), it is
important to focus on homology specific to the “disease-related” situs for the cross-reactive attack.
Id. at 4.14 In the case of GBS, it is understood that the relevant situs are ganglioside structures
found on the surface of myelin basic protein molecules. Id.
Dr. Steinman thereafter engaged in the same overall mimicry showing that characterizes
most of his expert reports in which the theory is offered. See generally Fourth Steinman Rep. at
5–16. Specifically, he (a) attempted to propose the degree of amino acid homology that would be
necessary, arguing that five (and perhaps even four) out of a twelve amino acid string is sufficient
(Id. at 5–8) (b) performed “BLAST” searches15 with an online government database for the
antigenic components of the Tdap vaccine, in order to identify the amino acids comprising them
(Id. at 8–10), and (c) compared them to identified GBS targets. Id. at 10–15. Dr. Steinman also
compared the amino acids found in the protein components of the vaccine’s tetanus toxoid and
diphtheria toxin components with those making up neurofascin, a nerve protein expressed at
certain nerve nodes believed to be situses for demyelinating autoimmune attack (although more
specifically associated with a distinguishable peripheral neuropathy, chronic inflammatory
demyelinating polyneuropathy (“CIDP”)). Id. at 9–13; J. Devaux et al., Neurofascin-155 IgG4 in
Chronic Inflammatory Demyelinating Polyneuropathy, 86 Neurology® 800, 800 (2016), filed as
Ex. 63 (ECF No. 63-3). He concluded from the foregoing that “a compelling case” existed in
support of his contention that “molecular mimics in the [Tdap] vaccine . . . triggered GBS due to
homologies with antigens that are homologous mimics of the vaccine and which are targeted in
this neuroinflammatory condition.” Fourth Steinman Rep. at 17.
Dr. Steinman’s fourth report provided little else to substantiate this alternative/new
causation theory, however, outside his detailed review of the molecular biology data supporting
his contentions. He offered only a single additional paragraph, maintaining that “immunity to
nervous system antigens like myelin is rather widespread in normal individuals”—presumably
conceding (comparable to his earlier admission about the common nature of homology) that a
pathogenic cross-reaction between antigens and self, driven by antibodies, is uncommon. Fourth
Steinman Rep. at 17. As a result, “[o]ther genetic and environmental factors are necessary before
these self-reactive immune responses to myelin might trigger GBS”—but Dr. Steinman provided
14 Dr. Steinman’s Fourth Report includes verbatim citations to charts and block-quotes from articles that appear in
nearly all reports he offers in the Program when molecular mimicry is alleged as a causal theory—and therefore I do
not cite them herein.
15 Basic Local Alignment Search Tool (“BLAST”) is a medical/scientific internet resource that assists researchers in
finding regions of similarity between biological sequences of amino acids. The program compares nucleotide or
protein sequences to sequence databases and calculates the statistical significance. BLAST, U.S. National Library of
Medicine, https://blast.ncbi.nlm.nih.gov/Blast.cgi (last visited Apr. 13, 2022).
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nothing to identify what they might be, either theoretically or in Petitioner’s specific case. Id. And
he referenced no other literature or independent support for his contention that the Tdap vaccine
could cause GBS via molecular mimicry.
Fifth Report
Dr. Steinman’s last report concluded the expert exchange—aalthough it reflects the same
bickering quality, or wholesale reproduction of prior arguments, that characterizes most of his
prior reports filed in this case. Thus, the first whole page of the final report represented Dr.
Steinman’s renewed reaction to Dr. Collins’s “cherry picking” contention. Fifth Steinman Rep. at
1–2. He also reproduced sections or charts from his prior reports, such as the schematic contained
in his fourth report showing how Dr. Steinman’s BLAST search for amino acid homologies with
self structures supports causation. Id. at 11.
Nevertheless, Dr. Steinman did make some salient points bearing on his opinion (and
regarding both proposed causation theories). First, he reacted to Dr. Collins’s reference to one
article as unsupportive of the alum adjuvant causation theory. Fifth Steinman Rep. at 2; A.
Linneberg et al., Association of Subcutaneous Allergen-Specific Immunotherapy with Incidence of
Autoimmune Diesease, Ischemic Heart Disease, and Mortality, 129 J. Allergy Clin. Immunol. 413
(2012), filed as Ex. D, Tab 3 (ECF No. 57-3) (“Linneberg”). Dr. Steinman noted that Linneberg’s
focus was on allergic disease, which meant it evaluated individuals with “immune responses biased
towards what is called Th2” cells—a kind of specialized T-helper cell.16 Fifth Steinman Rep. at 2.
But because “[m]ost autoimmune diseases are considered [mediated by] Th1” cells,17 Linneberg’s
alum findings reflected “a poor starting point for assessment of whether alum could increase
propensity to GBS or to any autoimmune disease.” Id. at 2–3.
Dr. Steinman went on to represent (again) that Dr. Collins’s embrace of an “influenza-like
illness” as causal of Petitioner’s GBS was medically and scientifically imprecise. Fifth Steinman
Rep. at 3–6. There was no evidence of what precisely had caused Petitioner’s URI symptoms—
and the specific kinds of infections associated with GBS (CMV, EBV, etc.) were not demonstrated
present either, Id. at 3–4. The proposed alternative cause was to Dr. Steinman inadequately
16 The T-helper cell encourages the production of antibodies to antigens that interact with B-cells. Helper Cells,
Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=64157 (last visited
Apr. 13, 2022).
17 Notably, this contention is somewhat in tension with (a) the greater likelihood that peripheral neuropathies like GBS
are B-cell mediated (i.e. through production of cross-reactive autoantibodies), and (b) the fact that the molecular
mimicry theory espoused in this case depends on vaccine antigens (which are intended to “teach” the immune system
to recognize the antigen when presented in wild form—through the production of antibodies—by stimulating B cells)
cause the production of cross-reactive autoantibodies. This is the intended mechanism of the tetanus component of the
vaccine. See Tdap package insert at 3 (“[]rotection against disease is due to the development of neutralizing antibodies
to tetanus toxin”). It thus reflects Dr. Steinman’s tendency to shift his argument, back and forth from B to T cells,
depending on how he is questioned or what he wishes to emphasize. See, e.g., Blackburn, 2015 WL 425935, at *29.
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established. Otherwise, even the formal definition of “influenza-like illness” was no more than an
“unconfirmed” diagnostic description, lacking in the precision needed to embrace it as more likely
causal than the known fact of vaccination. Id. at 5–6.
Other aspects of Dr. Collins’s argument, as highlighted in her final report, also received
Dr. Steinman’s criticism. One item of epidemiology, for example (sharing many of the same
authors as Baxter I) was deemed flawed by Dr. Steinman, since its own authors admitted that the
possibility of a vaccine-GBS association could not be excluded. Fifth Steinman Rep. at 7; R. Baxter
et al., Lack of Association of Guillain-Barré Syndrome with Vaccinations, 57 Clin. Infect.
Diseases: an Official Publication of the Infectious Diseases Soc. of Am. 197, 203 (2013), filed as
Ex. A, Tab 6 (ECF No. 37-6) (“Baxter II”). The 2012 IOM Report similarly kept the door open to
an association between Tdap and GBS, deeming the evidence for or against a causal relationship
ultimately equivocal. Fifth Steinman Rep. at 8–9. And in any event, the IOM’s analytic purposes
and standards for evaluating vaccine safety generally were far higher than “the one relevant to
determining Vaccine Act causation.” Id. at 10.
B. Kathleen Collins, M.D., Ph.D.
Dr. Collins submitted four expert reports on behalf of Petitioner. Report, dated Nov. 28,
2017, filed as Ex. A (ECF No. 36-1) (“First Collins Rep.”); Report, dated June 8, 2018, filed as
Ex. C (ECF No. 43-1) (“Second Collins Rep.”); Report, dated May 6, 2019, filed as Ex. D (ECF
No. 56-1) (“Third Collins Rep.”); Report, dated Jan. 23, 2020, filed as Ex. E (ECF No. 66-1)
(“Fourth Collins Rep.”).
As shown in her CV, Dr. Collins received her B.A. from Wellesley College and her M.D.
and Ph.D. from John Hopkins, University School of Medicine. Ex. B (ECF No. 36-2) (Dr. Collin’s
Curriculum Vitae (“Collins CV”)) at 1. She then had postdoctoral training in Internal Medicine at
the Brigham and Women’s Hospital, Infectious Disease Clinical Fellow, Research Fellow at
Harvard University, and a Postdoctoral Fellowship at the Massachusetts Institute of Technology.
Id. Dr. Collins was a professor of Microbiology and Immunology at the University of Michigan’s
Medical School. Id. She has conducted several studies on HIV, with publication of additional
studies pending. Id. at 5–7. She also currently has graduate students and postdoctoral fellows she
is training. Id. at 10. Dr. Collins has given several presentations on the topic and similar topics. Id.
at 14–17. She has published several articles and reviews/book chapters on the topics of HIV,
treatment of HIV, infection, and reactivation. Id. at 18–23.
First Report
Dr. Collins first summarized the materials she reviewed in preparing her report and
recounted the medical facts specific to Mr. K.A.’s case. First Collins Rep. at 1–4. In so doing, she
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emphasized that Petitioner’s treaters “consistently attributed the GBS to a prior respiratory
infection,” citing examples from the record. Id. at 2. She also briefly defined GBS, describing its
pathogenesis of autoimmunity consistent with what Dr. Steinman proposed, and noting also the
association between GBS and the Campylobacter jejuni bacterial infection. Id. at 4.
Next, Dr. Collins reviewed Dr. Steinman’s causation theory, noting that he relied on the
alum adjuvant as causal—but that the scientific and medical evidence he cited in support did not
actually “demonstrate that alum causes GBS,” and otherwise was not even relevant to his
contention. First Collins Rep. at 4. Li, for example, actually demonstrated that “[a]lum, when used
by itself, did not stimulate cytokine production” by the immune cells that were studied, and thus
was not supportive of the alum’s role proposed by Dr. Steinman. Id. at 4–5; Li at 5276 (“[o]ur
results clearly show that Alum by itself is incapable of promoting IL-1β transcription,” and
“aluminum particles were reported to be unable to activate the inflammasome” alone). Rather, the
stimulative effect of alum was dependent upon the introduction of other experimental agents,
diminishing the conclusion that the alum alone could be pathogenic in the manner proposed. First
Collins Rep. at 5.
The same distinctions could be drawn for other items of literature that Dr. Steinman cited.
Nyati, Dr. Collins observed, only concluded that certain levels of proinflammatory cytokines
(including IL-1β) were higher at different phases of GBS’s progression—not that alum caused
their specific upregulation or otherwise drove the disease process at the outset. First Collins Rep.
at 5; Nyati at 3543–45. Jander & Stoll similarly only observed increased levels of IL-1β in studied
animals and a small human sample of GBS patients, but made no determinations about the
propensity of vaccine adjuvants to trigger the condition. First Collins Rep. at 5; Jander & Stoll at
257. And three other animal studies that relied on inducing demyelinating disease only provided
further evidence that the cytokines identified by Dr. Steinman played a role in the progression of
disease (although the studies relying on genetically-altered animal subjects—which Dr. Steinman
went to great lengths to distinguish (see footnote 10, above)—seemed to undermine the conclusion
about the significance of IL-18). First Collins Rep. at 5–6. Overall, Dr. Collins interpreted these
articles and studies to provide no support for his contention that alum in the Tdap vaccine can
produce GBS, even if the identified cytokines themselves can be harmful at certain stages in the
disease’s progression if elevated. Id. at 6. Rather, there was more reliable support for viral or
bacterial infections as a trigger. Id. And in so asserting, Dr. Collins referenced items of literature
filed by Dr. Steinman that supported this conclusion. Id (citations omitted).18
18 Dr. Collins even took issue with Dr. Steinman’s Schonberger reference in support of a flu vaccine/GBS link, arguing
that the association “was specific to the 1976 vaccination,” and hence inherently limited—and in any event that the
version of the vaccine then in use was not shown to include alum as an adjuvant. First Collins Rep. at 6. In fact, it is
the case that the version of the flu vaccine administered in the U.S. generally does not contain an adjuvant. See Centers
for Disease Control and Prevention, Vaccine Adjuvants, https://www.cdc.gov/vaccinesafety/concerns/adjuvants.html
(last visited Apr. 14, 2022), filed as Ex. A, Tab 13 (ECF No. 38-3) (“Vaccine Adjuvants”), at 1–2 (explaining the
vaccines that usually include adjuvants). Only a recently-licensed version of the flu vaccine contains an adjuvant.
Vaccine Adjuvants at 2.
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Dr. Collins also pointed to other literature evidence suggesting an adjuvant like alum would
not likely be causal of disease. She noted that the majority of vaccines include some kind of
adjuvant, with aluminum particularly common. First Collins Rep. at 6; Centers for Disease Control
and Prevention, Vaccine Adjuvants, https://www.cdc.gov/vaccinesafety/concerns/adjuvants.html
(last visited Apr. 14, 2022), filed as Ex. A, Tab 13 (ECF No. 38-3), at 1–2 (aluminum adjuvant
found in Hepatitis A and B, DTaP/Tdap, Hib, HPV, and pneumococcal vaccines). But reliable
studies had found no association between many of these adjuvanted vaccines and autoimmune
disorders, including GBS. First Collins Rep. at 7; G. Deceuninck et al., Absence of Association
Between Guillain-Barré Syndrome Hospitalizations and HPV-Vaccine, Expert Review of
Vaccines, (2017), filed as Ex. A, Tab 4 (ECF No. 37-4) (no increase in incidence of GBS after
receipt of HPV vaccine, based on 100 cases analyzed).
A larger study that looked more specifically at the possibility of a Tdap-GBS relationship
(among a large number of vaccines) found the same absence of an association. See generally
Baxter II. Baxter II began with a sample pool of the more than three million members of Kaiser
Permanente of Northern California, an integrated healthcare delivery system. Baxter II at 198.
From that pool, Baxter II’s authors identified 415 individuals between 1994 and 2006 who
experienced GBS, based on accepted diagnostic definitions of the disease. Id. at 199–200. Of that
total, only 25 patients had even received a vaccine within six weeks of symptoms onset—and only
three of that subset had received a tetanus-containing vaccine. Id. at 200. It also employed a “case-
centered” analysis,19 observing no statistically-significant increased incidence of post-Tdap GBS.
Id. at 200–02.20
Finally, Dr. Collins proposed that the medical record better supported the conclusion that
Petitioner’s GBS was attributable to the “influenza-like illness” that he appeared to have
experienced in the interval between his vaccination and onset of neurologic symptoms. First
Collins Rep. at 7. CMV and EBV infections were in particular associated with GBS, although, as
Dr. Collins admitted, the record was a bit more equivocal on identifying either as present in
Petitioner’s case. Id. Regardless, there was literature support connecting URI-type infections with
GBS. See, e.g., C. Tam et al., Guillain-Barré Syndrome and Preceding Infection with
Campylobacter, Influenza and Epstein-Barr Virus in the General Practice Research Database,
19 Baxter II defines this to be an analysis in which researchers “look back from the date of onset of the [relevant]
adverse event and determine whether there is a clustering of vaccinations (exposures) in the risk interval prior to
onset.” Baxter II at 198. The methodology is “best suited to outcomes hypothesized to have an acute onset during a
transient period of increased risk after exposure”—a “risk interval.” Id. The intervals used in Baxter II—six weeks
and ten weeks—are consistent with Petitioner’s onset and Dr. Steinman’s timeframe contentions.
20 In conducting their case-centered analysis, Baxter II’s authors noted that within the study’s three million-plus patient
population in the relevant Kaiser Permanente Northern California care group, approximately 1.9 million doses of
DTaP (the childhood version of Tdap) were administered, with no observed instances of GBS in any risk interval (as
compared to one instance of post-Tdap GBS—underscoring the significance of a lack of association. Baxter II at 200.
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PLoS One e344 (2007), filed as Ex. E, Tab 3 (ECF No. 66-4) (“Tam”); J. Stowe et al., Investigation
of the Temporal Association of Guillain-Barré Syndrome with Influenza Vaccine and Influenzalike
illness using the United Kingdom General Practice Research Database, 169 Am. J. Epidemiol.
382 (2008), filed as Ex. E, Tab. 23 (ECF No. 66-24) (“Stowe”); H. Lehmann et al., Guillain-Barré
Syndrome After Exposure to Influenza Virus, 10 Lancet Infect. Dis. 643, 644–45 (2010), filed as
Ex. A, Tab 10 (ECF No. 37-10) (review article taking into account Tam, Stowe, and other items
of literature, and observing increased incidence of GBS after influenza-like illnesses).
Second Report
Dr. Collins prepared a second report to respond briefly to Dr. Steinman’s rebuttal points in
his own second report. Regarding his contention that “influenza-like illness” was too vague of a
basis for a finding of an alternative cause for Petitioner’s GBS, she proposed that the term was in
her experience commonly employed to describe “the symptoms caused by a [URI],” adding that it
was often difficult to identify through testing a precise viral cause for such symptoms. Second
Collins Rep. at 1. In addition, Dr. Collins deemed it significant that reliable literature she had
offered to support the association between GBS and a variety of wild virus infections had also
employed the term, suggesting it had more general support than Dr. Steinman argued (and noting
other instances where reputable studies utilized it). Id. at 1–2 (citations omitted).
Dr. Collins next reiterated her prior point that a number of reliable epidemiologic studies
showed no association between alum-adjuvanted vaccines (including Tdap) and GBS. Second
Collins Rep. at 2–3. The fact that Baxter I had observed a potential relationship between ADEM
and Tdap was overshadowed by Baxter II’s explicit findings of a lack of an association with the
relevant injury, GBS. Id; Baxter II at 203. In response, Dr. Steinman had shown no reasoned
grounds for disputing these findings, and even conceded he could offer no epidemiologic proof in
response. Second Collins Rep. at 3. Instead, he had (in Dr. Collins’s words) “‘cherry picked’ minor
results from different papers utilizing disparate experimental systems to form his hypothesis”—
resulting in a theory that was, even taken in total, weak. Id. Thus, he over-relied on in vitro studies
associating alum and cytokine increases that the 2012 IOM Report had deemed not wholly
worthwhile for present purposes, while emphasizing the role of cytokine upregulation in promotion
of GBS generally—even though the IOM had expressly questioned “the oversecretion of cytokines
as an operative mechanism” for vaccine-instigated disease. 2012 IOM Report at 76.
Third Report
Dr. Collins began her third report by highlighting some of the medical record evidence
establishing that in fact Mr. K.A. had experienced the kinds of symptoms that would be associated
with an “influenza-like illness,” as the term is defined by the Centers for Disease Control, adding
that the explanatory power of this evidence in identifying an etiology for Petitioner’s GBS “did
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not require identification of a specific organism,” but could instead be supported merely by the
“complex of symptoms that Mr. K.A. experienced.” Third Collins Rep. at 1. She emphasized that
the association between a wild influenza infection and GBS was better-established than between
the flu vaccine and GBS. Id.; F. DeStefano et al., Principal Controversies in Vaccine Safety in the
United States, Clinical Infectious Diseases: An Official Publication of the Infections Diseases
Society of America (Stanley Plotkin, ed. 2019), filed as Ex. D, Tab 1 (ECF No. 57-1)
(“DeStefano”). Thus, Petitioner’s established URI better explained the cause of his GBS than the
Tdap vaccine, despite the fact that the specific nature of his infection could not be ascertained.
Next, Dr. Collins again reviewed her contentions that direct evidence she had offered
refuted Dr. Steinman’s theory that alum-adjuvanted vaccines could cause GBS—since the studies
she offered demonstrated no increase of GBS post-vaccination. Third Collins Rep. at 2. Indeed,
DeStefano referenced additional studies that undercut directly a connection between autoimmunity
and aluminum adjuvants. DeStefano at 4–5; Linneberg. Linneberg’s authors considered a sample
of 18,000 patients who received specific kind of injection-based treatment (containing aluminum
hydroxide as an adjuvant) for allergies, but experienced a lower incidence of autoimmune-
mediated diseases than the controls, suggesting at least that the alum adjuvant was not generally
pathogenic. Linneberg at 416, 418. Of course (and as Dr. Steinman observed), Linneberg’s focus
is distinguishable from the issues raised by this case.
In Dr. Collins’s view, because Dr. Steinman could not identify support for his theory from
literature directly testing his hypothesis (and indeed, in her view such literature undermined his
theory), he instead engaged in the selective invocation of scientific evidence she had previously
criticized. Third Collins Rep. at 2. Mannhalter, for example, did observe a heightened cytokine (as
well as cellular immune, in the form of T cells) response in human sera that had received an
aluminum-adjuvanted tetanus toxoid-containing vaccine (in comparison to subjects who only
received tetanus toxoid alone)—but did not say anything about the capacity of the vaccine to cause
GBS as a result of this increase. Collins Third Rep. at 2–3; Mannhalter at 149. In fact, Mannhalter’s
authors explicitly observed that the aluminum adjuvant was “free of side effects” like toxicity or
antigenicity, when compared to bacterial adjuvants, underscoring that the adjuvant was unlikely
to be disease-causing in the manner proposed by Dr. Steinman. Collins Third Rep. at 3; Mannhalter
at 150 (noting the benefits of an aluminum hydroxide adjuvant over a bacterial-based adjuvant).
Dr. Collins then summarized (for the second time) the literature offered by Dr. Steinman,
pointing out that no specific article individually established that the adjuvant components of the
Tdap vaccine could cause GBS, or even the lesser contention that certain cytokine increases “are
associated with the use of aluminum containing vaccines in humans.” Collins Third Rep. at 4. In
reaction to Dr. Steinman’s protestations that a more “perfect experiment” directly establishing the
proposed causal link was impossible (and thus that he was forced to rely on a chain of indirect
determinations), Dr. Collins noted that actually a number of studies had looked directly at the
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results of receipt of adjuvant-containing vaccines, but observed no increase in autoimmune
disorders (although some studies were not specific to the Tdap vaccine). Id; T. Verstraeten et al.,
Analysis of Adverse Events of Potential Autoimmune Aetiology in a Large Integrated Safety
Database of AS04 Adjuvanted Vaccines, 26 Vaccine 6640 (2008), filed as Ex. A, Tab. 3 (ECF No.
37-3) (observing no association between HPV and HBV vaccines with aluminum-component
adjuvant and large number of autoimmune conditions, including GBS; more than 60,000 subjects
considered).
Regarding Dr. Steinman’s arguments about the Tdap vaccine package insert, Dr. Collins
observed that the insert’s seeming embrace of a tetanus toxoid-oriented GBS risk was based upon
a 1994 IOM Report, which she deemed superseded by subsequent determinations. Third Collins
Rep. at 5–6; Tdap Package Insert at 2, 4 n.1. Moreover, Baxter II (published in 2013) was in her
view (as previously argued) reliable epidemiologic proof establishing no evidence of an increased
risk of GBS after the Tdap vaccine. Third Collins Rep. at 6. DeStefano had embraced this finding.
Third Collins Rep. at 6–7; DeStefano at 4 (referencing Baxter II). Thus, the bases for the package
insert’s warnings were well outdated (and in any event GBS was not even included as a potential
adverse event for an individual who had not been previously diagnosed with it post-vaccination).
Third Collins Rep. at 7; Tdap package insert at 2, 4 n.1 (relying on 1994 IOM Report).
Fourth Report
Dr. Collins’s final report reacted to the second causation theory embraced by Dr. Steinman,
involving molecular mimicry between Tdap antigenic components and nerve structures associated
with GBS. She acknowledged that Dr. Steinman was able to establish via animal models the
potentiality of molecular mimicry as driving certain autoimmune diseases, like ADEM, but denied
that this was helpful in establishing that the same kind of process was likely to cause GBS in a
human. Fourth Collins Rep. at 9. In addition, while Dr. Collins did not dispute that Dr. Steinman
had demonstrated homology between certain of the Tdap vaccine’s antigenic components and self
nerve-associated structures, she contended that this was insufficient by itself to establish molecular
mimicry as the likely pathogenic mechanism, given how often homology occurred in nature
without causing disease. Id; 2012 IOM Rep. at 70.
Dr. Collins otherwise revisited some of her earlier points, although she emphasized aspects
of her argument that were less highlighted in previous reports. For example, she noted again some
of the wild infections, viral and bacterial, that are known to be associated with GBS—
Campylobacter jejuni, CMV, and EBV. Fourth Collins Rep. at 2–5. Although all were understood
to be likely GBS triggers, they could not be said in each case to be mediated via molecular mimicry
(thus diminishing the overall value of that as an explanatory mechanism herein for GBS across-
the-board).
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A Campylobacter bacterial infection, for example, was deemed likely to cause a particular
kind of GBS—acute motor axonal neuropathology (“AMAN”)—via autoantibodies produced as a
result of molecular mimicry. Fourth Collins Rep. at 2. But this GBS variant was distinguishable
from the most common form experienced in the U.S., AIDP (likely the version Mr. K.A. suffered
from), the triggering pathogenesis of which was less well understood. Id. at 2–3. CMV infections
were also associated with GBS, but studies regarding antibodies once believed to drive GBS after
a CMV infection had “not borne out a role for molecular mimicry” under such circumstances,
whereas other immune cells (notably T cells) not likely attributable to molecular mimicry did seem
pathogenic in such circumstances. Id. at 3; D. Orlikowski et al., Guillain-Barré Syndrome
following Primary Cytomegalovirus Infection: A Prospective Cohort Study, 52 Clin. Infect.
Diseases 837, 843 (2011) filed as Ex. E, Tab 12 (ECF No. 66-13) (“Orlikowski”) (impact of CMV
infection itself, and associated viral replication, more likely to drive CMV-caused GBS than
antibody response to infection; antibody response was more associated with secondary reaction to
infection).
Dr. Collins also emphasized again her opinion that an influenza-like illness was a far more
likely cause of Petitioner’s GBS in this case. Despite the lack of definitive proof identifying
Petitioner’s precise infection, Petitioner’s memorialized symptoms were evidence of a URI that
reasonably could be considered an influenza-like illness. Fourth Collins Rep. at 4–5. She noted as
well that literature she had filed specifically included the category “influenza-like illness” as a pre-
GBS causal risk factor—contrary to Dr. Steinman’s assertion that the term/concept was
unscientifically vague. Id. at 5–7; Tam at 5 (noting a previously-unreported “18-fold increased risk
of GBS in the two months following [an influenza-like illness],” based on a case-control study
involving ten years of data for UK GBS patients). Other literature stood for the same contention.
Fourth Collins Rep. at 6–8; Stowe at 4 (out of 690 studied individuals, 99 reported a pre-GBS
onset influenza-like illness; no greater incidence of GBS post-flu vaccination seen in comparison
to greater risk after influenza-like illness); L. Grimaldi-Bensouda et al., Guillain-Barré Syndrome,
Influenzalike Illnesses, and Influenza Vaccination During Seasons with and without Circulating
A/H1N1 Viruses, 174 Am. J. Epidemiol. 326 (2011), filed as Ex. E, Tab 25 (ECF No. 66-25)
(greater risk of GBS post-influenza-like illness).21
III. Procedural History and Parties’ Arguments
21 In fact, a different study showed that receipt of a specific version of the flu vaccine was associated with a reduced
risk of GBS. Fourth Collins Rep. at 8; C. Vellozzi et al., Cumulative Risk of Guillain-Barré Syndrome Among
Vaccinated and Unvaccinated Populations During the 2009 H1N1 Influenza Pandemic, 104 Am. J. Pub. Health 696,
698 (2014), Filed as Ex. E, Tab 25 (ECF No. 66-26).
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A. Procedural History
As noted, the case was filed in August 2016, and initially assigned to a different special
master. After the filing of records was completed, Respondent filed his Rule 4(c) Report opposing
compensation in February 2017. ECF No. 21. Over the next two years, the parties began filing
expert reports, and the back-and-forth between Drs. Steinman and Collins over Petitioner’s initial
causation theory described above began.
Notably (and after the case had existed for nearly three years), it was discussed during a
July 2019 status conference (perhaps in reaction to questions about whether the case was likely to
settle) that Respondent deemed Petitioner’s causation theory implausible—prompting the special
master formerly presiding over the case to order a deadline for Petitioner to file a new report, but
this time “modifying” the theory to allege molecular mimicry as the causal mechanism. Scheduling
Order, dated July 19, 2019 (ECF No. 59). Dr. Steinman did so by that fall, and another, shorter
round of expert report filings occurred, with the final report (from Dr. Steinman) filed in June
2020.
The case was subsequently reassigned to me in January 2021. ECF No. 79. I proposed that
the case be resolved on the record, and set a schedule for briefs. The final brief was filed in October
2021, and the matter is now ripe for decision.
B. Briefs For and Against Causation
Motion for Entitlement
Petitioner’s brief in favor of entitlement included several lengthy excerpts from the record
and from Dr. Steinman’s prior reports, but it also summarized his arguments for why he should be
found to have preponderantly established his burden of proof. First, Petitioner maintained under
either “sound and reliable” theory proposed by Dr. Steinman that the “can cause” prong had been
established (although Petitioner seemed to stress the newer molecular mimicry theory over the
theory relying on the adjuvant). Mot. at 23–31, 45–47. Dr. Steinman, he maintained, was eminently
qualified to offer the molecular mimicry, and the methodology he employed to explain how
antigenic components of the Tdap vaccine could cause a cross-reaction in the nerves leading to
GBS was based on reliable and accepted science. Id. at 45–47.
The other two causation prongs were also satisfied, Petitioner argued. The second, “did
cause” prong was established because no alternative viral cause had been identified, and some
treaters had speculated that his GBS could have a vaccine association. Mot. at 48. The timeframe
for his symptoms onset, beginning in 18–19 days post-vaccination, was consistent with accepted
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literature like Schonberger for how long it would take for an autoimmune process driven by
molecular mimicry to begin and to start manifesting symptoms. Id. at 49–50. Nor, Petitioner
argued, did Respondent disagree that the timeframe was acceptable. Id. at 50. And Respondent
had not otherwise carried his burden (assuming a burden shift) to establish a “factor unrelated”—
here, the unspecified “influenza-like illness”—as more likely causal of Mr. K.A.’s GBS. Id. at 50–
52.
Opposition
Respondent’s opposition to entitlement contests all of the above. Regarding the first
causation prong, he maintains that Dr. Steinman’s adjuvant-based theory is “speculative and
premised on untenable leaps in logic that lack reliable medical support.” Opp. at 19. Reiterating
some of Dr. Collins’s criticisms, Respondent notes that the items of literature offered either were
isolated experimental incidents (and hence too artificial to say anything meaningful about how
alum’s adjuvant role would cause a pathogenic cytokine response in vivo), or inadequately linked
to GBS’s instigation. Id. at 20–21. Dr. Steinman also acknowledged he lacked persuasive direct
proof, relying instead on the vaccine’s package insert—despite the low probative value given to
that kind of evidence in the Program. Id. at 22. And the timeframe for such a cytokine-driven
pathologic process would be far shorter than the 18 days in this case. Id. at 23, citing Montgomery
v Sec’y of Health & Hum. Servs., No. 15-1037V, 2019 WL 2511352, at *5 (Fed. Cl. Spec. Mstr.
May 21, 2019) (theory relying on alum to spark cytokine reaction would require evidence of close-
in-time reaction to vaccination—not onset occurring 10 or more days post-vaccination).
The second theory, relying on molecular mimicry as the proposed mechanism, was in
Respondent’s estimation no more successful. Although Respondent conceded that “the general
concept of molecular mimicry is an accepted theory of causation for human autoimmune disease
under certain circumstances,” he argued that it had not in this case been shown to explain
persuasively how the Tdap vaccine could lead to GBS. Opp. at 25. In particular, this was because
Dr. Steinman had minimized the likely role Petitioner’s intercurrent URI had played in causing
GBS. Id. There was ample record evidence of the infection and the symptoms it spawned before
GBS onset, and the mere fact that the infection had not been precisely identified did not matter.
Id. at 26–28.22 Otherwise, the mere showing of homology alone was not enough to establish
22 Respondent herein also reacted directly to Dr. Steinman’s non-medical exegesis into Vaccine Program legal
standards, noting that the case he cited to defend his view that a known vaccine should be favored as causal over a
non-specifically identified infection did not quite mean what he represented. Opp. at 27–28, citing Torday v. Sec’y of
Health & Hum. Servs., No. 07-372V, 2009 WL 5196163, at *3–4 (Fed. Cl. Spec. Mstr. Dec. 10, 2009). Torday,
Respondent maintained, stood only for the proposition that when it was undisputed that the vaccine at issue and an
unspecified illness could be causal, and the evidence was otherwise deemed close, it was reasonable to find the vaccine
as causal. Here, by contrast, Dr. Collins and Respondent did not concede the Tdap vaccine was causal. Opp. at 28.
Respondent’s reading of Torday is superior to Dr. Steinman’s—and it only underscores why medical/scientific experts
like Dr. Steinman are better off not opining on the meaning of Program caselaw or the applicable legal standards
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molecular mimicry as a likely causal mechanism, since homology more often than not when
occurring does not lead to autoimmune diseases. Id. at 29. Rather, more must be shown—but,
Respondent noted, it could not (especially in the face of studies cited by Dr. Collins, like Baxter
II, showing no association between the Tdap vaccine and GBS). Id.
The “did cause” prong was also unsatisfied, Respondent argued, given the evidence
suggesting Petitioner’s intercurrent infection was causal (coupled with an absence of record proof
suggesting the presence of an aberrant immune response). Opp. at 30–31. Petitioner’s timeframe
arguments solely relied on Schonberger, which involved the flu vaccine (and as noted above would
not be applicable in any event to the adjuvant causation theory). Id. at 31–32. And Respondent
contended that Petitioner’s evidentiary failings, as identified above, meant the burden had never
shifted to Respondent to prove any alternative cause for Petitioner’s GBS (despite the record
evidence strongly suggesting there was in fact such an explanation, in the form of the unidentified
infection). Id. at 32–33.
Reply
On reply, Petitioner reiterated his argument that his causal theories were preponderantly
established (although he more clearly embraced molecular mimicry as his favored theory). Reply
at 7 (specifically “putting aside the adjuvant theory” as “unnecessary” to succeed on the first
prong). However, he also modified his legal argument a bit as far as the standard applied to the
theory. He now argued that a somewhat-recent Federal Circuit decision (issued shortly before his
first brief had been filed) had “clarified” (in connection with another intervening Court of Federal
Claims determination)23 that the standard for the first prong was only “biologically plausible”
rather than a preponderance. Reply at 3 (citing Kottenstette v. Sec’y of Health & Hum. Servs., 861
Fed. Appx. 433 (Fed. Cir. 2021)). And because molecular mimicry was an accepted and reliable
theory for how autoimmune disease processes occur, it met that standard, given Dr. Steinman’s
detailed showing of homology as well as likely disease target antigens where a cross-reaction
would be expected to occur. Reply at 7–8.
Petitioner noted again that there was an absence of clear proof of what the intercurrent
infection was that Petitioner had experienced (and certainly limited direct proof that it was EBV
(although as discussed in this Decision, I give no weight at all to Dr. Steinman’s legal pronouncements, and do not
otherwise deem Torday a useful guiding decision).
23 J. v. Sec’y of Health & Hum. Servs., No. 16-864V, 2021 WL 3627107, at *19 (2021). In this single Court decision,
one Court of Federal Claims judge proposed that the standard enunciated in another Federal Circuit decision, Boatmon
v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019), had been distinguished as not otherwise
displacing a prior “plausibility” standard—despite the plain language of Boatmon to the contrary. Putting aside,
however, that this determination in no way governs the outcome of this matter, I also find (as discussed below) that it
does not provide helpful readings of Federal Circuit law on the question of the proper legal standard in Vaccine Act
cases.
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or CMV, despite suggestions to the contrary by Respondent), while the evidence of the vaccination
was undisputed, making it an inherently superior explanation for Petitioner’s GBS. Reply at 4–6.
And regardless of other possible explanations, Petitioner claimed he had shown that the Tdap
vaccine could be a substantial factor as well, entitling him to compensation. Id. at 10.
IV. Relevant Legal Standards
A. Standards for Vaccine Claims
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).24
In this case, Petitioner cannot assert a Table claim based on CIDP.
For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344,
1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1) a
24 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V,
2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
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medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause
and effect showing that the vaccination was the reason for the injury; and (3) a showing of
proximate temporal relationship between vaccination and injury.”
Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must
only be “legally probable, not medically or scientifically certain.” Id. at 549.
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not empowered by
statute to conclusively resolve what are essentially thorny scientific and medical questions, and
thus scientific evidence offered to establish Althen prong one is viewed “not through the lens of
the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence
standard.” Id. at 1380. Accordingly, special masters must take care not to increase the burden
placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.
Cl. at 245.
In discussing the evidentiary standard applicable to the first Althen prong, the Federal
Circuit has consistently rejected the contention that it can be satisfied merely by establishing the
proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum.
Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also LaLonde v. Sec’y of Health & Hum. Servs.,
746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply
identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of
proof” (citing Moberly, 592 F.3d at 1322)). And petitioners always have the ultimate burden of
establishing their overall Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health
& Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States,
133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall burden of
proving causation-in-fact under the Vaccine Act” by a preponderance standard).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
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in vaccine cases, as treating physicians are likely to be in the best position to determine whether a
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
Medical records and statements of a treating physician, however, do not per se bind the
special master to adopt the conclusions of such an individual, even if they must be considered and
carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y
of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates
that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and
cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the
opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their
suppositions or bases. The views of treating physicians should be weighed against other, contrary
evidence also present in the record—including conflicting opinions among such individuals.
Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious
for special master to weigh competing treating physicians’ conclusions against each other), aff’d,
698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,
2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review denied, 100 Fed.
Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must align with the theory of how the relevant vaccine can
cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.
Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d
mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,
2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review denied (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Law Governing Analysis of Fact Evidence
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [ ] relevant medical and scientific evidence contained in the record,” including
“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained
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in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,
injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are
contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special
master is then required to weigh the evidence presented, including contemporaneous medical
records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.
1993) (determining that it is within the special master's discretion to determine whether to afford
greater weight to contemporaneous medical records than to other evidence, such as oral testimony
surrounding the events in question that was given at a later date, provided that such determination
is evidenced by a rational determination).
As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as
trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95
Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his
contemporaneous medical records, the special master's decision to rely on petitioner's medical
records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.
Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked
propositions explains why such records deserve some weight: (i) sick people visit medical
professionals; (ii) sick people attempt to honestly report their health problems to those
professionals; and (iii) medical professionals record what they are told or observe when examining
their patients in as accurate a manner as possible, so that they are aware of enough relevant facts
to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,
2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.
Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to
conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL
6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are often found to be deserving of greater evidentiary weight than oral testimony—especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).
However, the Federal Circuit has also noted that there is no formal “presumption” that
records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health
& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which
compelling oral testimony may be more persuasive than written records, such as where records are
deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl.
775, 779 (2006) (“like any norm based upon common sense and experience, this rule should not
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be treated as an absolute and must yield where the factual predicates for its application are weak
or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten records which are, themselves,
inconsistent, should be accorded less deference than those which are internally consistent”)
(quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination regarding a witness's credibility
is needed when determining the weight that such testimony should be afforded. Andreu, 569 F.3d
at 1379; Bradley v. Sec'y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent, and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,
No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person's failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional's failure to document everything
reported to her or him; (3) a person's faulty recollection of the events when presenting testimony;
or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,
1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the
factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.
Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).
Under Daubert, the factors for analyzing the reliability of testimony are:
(1) whether a theory or technique can be (and has been) tested; (2) whether the
theory or technique has been subjected to peer review and publication; (3) whether
there is a known or potential rate of error and whether there are standards for
controlling the error; and (4) whether the theory or technique enjoys general
acceptance within a relevant scientific community.
Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).
In the Vaccine Program the Daubert factors play a slightly different role than they do when
applied in other federal judicial settings, like the district courts. Typically, Daubert factors are
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employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are
used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &
Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold, to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.
Respondent frequently offers one or more experts in order to rebut a petitioner’s case.
Where both sides offer expert testimony, a special master's decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.
Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for
review denied, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on
a particular expert's credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court
has unambiguously explained that special masters are expected to consider the credibility of expert
witnesses in evaluating petitions for compensation under the Vaccine Act”).
D. Consideration of Medical Literature
Both parties filed numerous items of medical and scientific literature in this case, but not
every filed item factors into the outcome of this Decision. While I have reviewed all the medical
literature submitted in this case, I discuss only those articles that are most relevant to my
determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed
every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322,
1328 (Fed. Cir. 2016) (“[w]e generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision”) (citation
omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. Appx. 875, 884 (Fed. Cir.
2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the
conclusion that it was not considered”).
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E. Standards for Ruling on the Record
I am resolving Petitioner’s claim on the filed record. The Vaccine Act and Rules not only
contemplate but encourage special masters to decide petitions on the papers where (in the exercise
of their discretion) they conclude that doing so will properly and fairly resolve the case. Section
12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been
affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.
2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21
n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided
case on the papers in lieu of hearing and that decision was upheld). I am simply not required to
hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health
& Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his
discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health &
Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).
ANALYSIS
I. Prior Reasoned Determinations Involving Tdap and GBS
There is a large body of reasoned decisions25 discussing the alleged association between
the Tdap vaccine and GBS—but it cannot be said that the Program has developed a consistent
view as to what the science preponderantly “says” about the subject. Overall, it appears that the
outcome in such cases is mostly a function of the evidence before the special master, with no clear
trend one way or the other.
Thus, several cases decided in the past ten years found no causal association between Tdap
vaccine and GBS. See, e.g., Winkler v. Sec’y of Health & Hum. Servs., No. 18-203V, 2021 WL
6276203 (Fed. Cl. Spec. Mstr. Dec. 10, 2021), mot. for review docketed, Jan. 10, 2022 (ECF No.
62); Montgomery v. Sec’y of Health & Hum. Servs., No. 15-1037V, 2019 WL 2511352 (Fed. Cl.
Spec. Mstr. May 21, 2019); Tompkins v. Sec’y of Health & Hum. Servs., No. 10-261V, 2013 WL
3498652 (Fed. Cl. Spec. Mstr. Jue 21, 2013), mot. for review den’d, 117 Fed. Cl. 713 (2014); see
also Isaac v. Sec’y of Health & Hum. Servs., 108 Fed Cl. 743 (2013) (affirming special master
denial of claim alleging tetanus vaccine was causal of GBS), mot. for review den’d, 540 Fed. App’x
999 (Fed. Cir. 2013). These cases and the present matter have much in common.26
25 As already noted, although prior decisions from different cases do not control the outcome herein, special masters
may reasonably take into account, for guidance, the logic of reasoned entitlement determinations. In fact, it is wise to
do so, given how often similar causation theories or fact patterns arise in Vaccine Program cases.
26 I recently have denied entitlement in two cases where the petitioner alleged that a somewhat-related peripheral
neuropathy featuring demyelination, CIDP, was caused by the Tdap vaccine. Sanchez v. Sec’y of Health & Hum.
Servs., No. 18-1012V, 2022 WL 1013264 (Fed. Cl. Spec. Mstr. Mar. 11, 2022); Houston v. Sec’y of Health & Hum.
Servs., No. 18-420V, 2021 WL 4259012 (Fed. Cl. Spec. Mstr. Aug. 19, 2021). However, CIDP is a distinct illness
from GBS, despite their sharing of some features—and my holdings relied in part on finding that arguments regarding
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In Winkler, for example, the petitioner (as here) offered molecular mimicry as his causal
theory, noting also that certain known causes of GBS, like a Campylobacter infection, are
understood to have molecular mimicry as their mechanism. Winkler, 2021 WL 6276203, at *23.
But the special master determined that the claim turned not on the petitioner’s first prong success,
but rather on the fact that he had a demonstrated gastrointestinal infection, and that this infection
was more likely causal (making it impossible to find that the vaccine “did cause” GBS). Id. at *23–
25. Thus, evidence of a petitioner’s intercurrent illness was dispositive, regardless of the
persuasiveness of the causal theory.
Montgomery, by contrast, expressly found that a theory comparable to that offered herein
was insufficient. There as here, the petitioner relied on Dr. Steinman, who opined (in what the
special master deemed a “less-developed theory”)27 that the aluminum adjuvant in the Tdap
vaccine triggered an aberrant autoimmune response. Montgomery, 2019 WL 2511352, at *5. But
the special master rejected the theory, observing that critical details necessary to render the overall
theory preponderant (such as the degree of cytokine upregulation stimulated by the adjuvant, or
the duration of the response, which would implicate the initial, innate immune response) were
missing. Id. Facially, it is difficult to ascertain how the showing made in the present case was any
better.
Tompkins is an older decision, but its age underscores the extent to which (in the ensuing
period) there have been few scientific discoveries or breakthroughs over the past several years that
might better establish a Tdap-GBS association. The Tompkins special master denied entitlement
in a case alleging that a number of vaccines received at the same time, including the Tdap vaccine,
caused a petitioner’s GBS, but the causal theory put forward attempted to assert that the vaccines
could also individually trigger the disease. Tompkins, 2013 WL 3498652, at *15. The petitioner’s
expert, however, relied heavily on VAERS passive surveillance data,28 and otherwise invoked a
a GBS-Tdap association could not simply be superimposed on a case involving a distinguishable injury. Sanchez,
2022 WL 1013264, at *23; Houston, 2021 WL 4259012, at *17–18.
27 The Montgomery petitioner seems to have primarily maintained that a human papillomavirus vaccine, administered
at the same time as the Tdap vaccine, had caused her GBS. Montgomery, 2019 WL 2511352, at *4–5. That theory
(which as here relied on molecular mimicry) was rejected as unreliable, despite the kind of BLAST search-homology
showing also made in this case. Id.
28 The Vaccine Adverse Event Reporting System (“VAERS”) is a national warning system designed to detect safety
problems in U.S.-licensed vaccines. See About VAERS, VAERS, https://vaers hhs.gov/about.html (last visited Apr. 5,
2022). It is managed by both the CDC and the FDA. VAERS monitors and analyzes reports of vaccine related injuries
and side effects from both healthcare professionals and individuals. But it has been observed in the Program that
VAERS data is not particularly probative of causation unless supplemented with other reliable evidence—since a
VAERS report only establishes a temporal, post-vaccination occurrence, and thus shines no light of causation itself.
See also Vig v. Sec'y of Health & Human Servs., No. 01–198V, 2013 WL 6596683, at *17 (Fed. Cl. Spec. Mstr. Nov.
14, 2013) (“VAERS is a stocked pond, containing only reports of adverse events after vaccinations but no data about
the number of vaccines administered or the occurrence of the same adverse event in individuals who have not been
vaccinated”).
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number of theories (molecular mimicry, or endotoxin in tetanus-containing vaccines) that were
only cursorily discussed. Id. at *19–23.
But there are also a few recent cases going the other way. See, e.g., Mohamad v. Sec’y of
Health & Hum. Servs., No. 16-1075V, 2022 WL 711604 (Fed. Cl. Spec. Mstr. Jan. 27, 2022). The
Mohamad special master (who also decided Montgomery) ruled in the petitioner’s favor in a Tdap-
GBS case—but the analysis largely turned on the experts’ disagreement as to whether (based on
the demonstrated evolution of the government’s published scientific/medical conclusions about
Tdap causality) it could be said that the government had effectively conceded causation. The
special master reviewed publications setting forth the government’s view at different times, as well
as some of the underlying studies it relied upon, concluding that in fact the Government had
acknowledged that the vaccine could (albeit rarely) be causal, and therefore (primarily due to this
admission) the first prong was met. Mohamad, 2022 WL 711604, at *17–18. This analysis
included a brief discussion of the 2012 IOM Report filed by Petitioner in this case, as well as the
Program’s subsequent treatment of the issue along with two subsequent publications. Id. at *13–
15. The special master in Mohamad gave special emphasis to a 2019 publication that (consistent
with the package insert offered in this case) offered as a “precaution” that Tdap was to be carefully
considered for individuals who previously had experienced GBS within six weeks of a tetanus
toxoid-containing vaccine’s prior receipt. Id. at *15.
A few important points distinguish Mohamad, however (besides the obvious fact that it
does not control this outcome—and that almost all of the publications it evaluated were not offered
as evidence herein). First, that special master appears to have been presented only with the
argument that the Government had conceded the first prong, with both side’s experts devoting
most of their attention to that question (as opposed to the immunologic capacity of the vaccine to
be causal—a matter that has been addressed a length in this case by Drs. Collins and Steinman).
Mohamad, 2022 WL 711604, at *18 n.27. Second, there were specific issues with the credibility
of Respondent’s experts, and the resulting persuasiveness of their arguments. Id. at *8–9, *16–17.
Also, the facts of this case do not present the circumstances for the precaution that the Mohamad
special master deemed significant; it is not established on this record that Petitioner previously
experienced GBS after receipt of a dose of a tetanus toxoid-containing vaccine. And there was far
less obvious evidence of an intercurrent infection that could explain the petitioner’s GBS than
here—making the present case far more similar to Winkler.
Another recent case more supportive of a Tdap-GBS association (and cited specifically by
Petitioner in his ruling on the record brief) is Swaiss v. Sec’y of Health & Hum. Servs., No. 15-
286V, 2019 WL 6520791 (Fed. Cl. Spec. Mstr. Nov. 4, 2019). But it too is distinguishable. There,
a special master determined that small fiber neuropathy (characterized in Swaiss as “a variant” of
GBS) could be caused by the Tdap vaccine via the mechanism of molecular mimicry. Swaiss, 2019
WL 6520791, at *23–27. But small fiber neuropathy is not the injury alleged in this case.
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Moreover, the Swaiss special master acknowledged that the evidence offered to associate GBS and
Tdap generally was somewhat lacking (although a favorable prong one determination was still
made, based on the special master’s reasoning that research into the causes of small fiber
neuropathy was extremely limited, and that it would be therefore unfair to petitioner to hold the
paucity of such evidence against him). Id. at *27. No such considerations obtain in this case, which
involves the “classic” form of GBS, AIDP—a far more well-studied version.
It is true, as Petitioner’s Reply observes, that reasoned determinations involving Tdap
vaccine and GBS are dwarfed by the many instances in which prior Program cases alleging GBS
after the Tdap vaccine have settled. Reply at 8–9, 9 n.6; see also Mohamad, 2022 WL 711604, at
*19–20 (listing cases). But settlements cannot be invoked against the settling party to suggest a
concession or waiver, and they do not otherwise provide reasoned guidance of any kind. See, e.g.,
Randazzo v. Sec'y of Health & Hum. Servs., No. 18-1513V, 2021 WL 829572, at *4 (Fed. Cl. Spec.
Mstr. Feb. 1, 2021) (discussing low relevance of settled SIRVA claims in comparison to reasoned
decisions). In such settled cases, no formal determination has been made as to the substance of the
claim, and Respondent’s determination to settle such claims cannot be construed fairly to reflect
the tacit view that such claims have validity (since parties settle for many reasons beyond their
assessment of a claim’s actual merits). I thus do not factor these kinds of cases into my
determination.
II. Petitioner Has Not Carried His Burden of Proof
A. Petitioner Mischaracterizes his Prong One Burden
Before discussing the success of Petitioner’s Althen prong one showing, review of his
framing of the legal standard applicable is warranted. For Petitioner fully misstates that standard,
proposing a version that, if adopted, would obliterate the existing distinction between Table and
non-Table claims in the Vaccine Program. Reply at 3.
As I noted above, the most recent controlling/precedential Federal Circuit caselaw directly
addressing the subject states explicitly that the first Althen prong requires a preponderant
showing—just like the other two prongs. Boatmon, 941 F.3d at 1359; LaLonde, 746 F.3d at 1339;
see also Moberly, 592 F.3d at 1322. LaLonde, decided eight years ago, provides some insight into
the reasoning for this standard. There, the Circuit was presented with a petitioner’s appeal from a
special master’s determination that the DTaP vaccine (the version of Tdap administered to infants)
had not caused a 17-month old minor to experience a focal brain injury. LaLonde, 746 F.3d at
1336–37. The special master deciding the case determined that the petitioner’s expert had admitted
in several regards that he could not substantiate his opinion with independent reliable evidence.
Id. at 1338. On appeal, however, the petitioner referenced Althen’s oft-cited admonition that “the
purpose of the Vaccine Act’s preponderance of the evidence standard is to “allow the finding of
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causation in a field bereft of complete and direct proof of how vaccines affect the human body”
(Althen, 418 F.3d at 1280), relying on that to argue in turn that the special master had required
proof of a precise biologic mechanism, contrary to the Circuit’s determination in Knudsen. Id. at
1339. In effect, the petitioner argued, the special master was demanding scientific certainty.
The LaLonde majority disagreed. What the special master had done was not mandate that
a specific mechanism be shown, but had instead “merely required that [the expert] support his
testimony with a reputable or scientific explanation that pertained specifically” to the relevant
facts. LaLonde, 746 F.3d at 1340. More importantly, in so doing the Circuit (referencing its earlier
Moberly decision) emphasized that (consistent with the Act’s express requirements) mere
“identification” of a plausible theory did not meet the “statutory standard of preponderance of the
evidence.” Id. at 1339. In other words, the expert’s recited theory lacked a sufficiently reliable
foundation to establish causation—independent of whether the theory on its face, and when given
an expert’s imprimatur, was plausible.
Moberly, decided four years prior to LaLonde, reached a consistent result—but even more
strongly demonstrates the rationale for requiring a preponderant showing on the first Althen prong.
Moberly also involves a DPT-containing vaccine, and (consistent with LaLonde) an injury to an
infant rather than adult. After entitlement was denied, the petitioners on appeal maintained that the
special master had elevated their prong one burden, requiring scientific certainty rather than mere
preponderance. Moberly, 592 F.3d at 1321. The Circuit cited the evidentiary standard set forth in
Althen, and then observed as follows:
While the petitioners acknowledge that the statute requires proof of causation by a
preponderance of the evidence, see 42 U.S.C. § 300aa–13(a)(1)(A), they appear to
be arguing for a more relaxed standard. They repeatedly characterize the test as
whether [the infant’s] condition was “likely caused” by the DPT vaccine. By that
formulation, however, they appear to mean not proof of causation by the traditional
“more likely than not” standard, but something closer to proof of a “plausible” or
“possible” causal link between the vaccine and the injury, which is not the
statutory standard. Similarly, the petitioners object to the use of the term
“causation in fact” by the special master and the Court of Federal Claims, because
they claim that proof that a vaccine “in fact” caused an injury would require
conclusive scientific evidence. But this court has regularly used that term to
describe the causal requirement for off-Table injuries and has made clear that
the applicable level of proof is not certainty, but the traditional tort standard
of “preponderant evidence.”
Id. at 1322 (emphasis added). The Moberly panel went on to note that although causation was
presumed in Table cases (which have other more lenient features favorable to claimants), “the tort
standard of causation is applicable” to non-Table claims. Id. As a result, to argue for a lesser
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standard for causation in the non-Table context was to “conflate the burden of proof imposed for
off-Table injuries with the lenient presumptions applicable to Table injuries.” Id.
Nothing the Circuit has decided in the intervening ten to fifteen years suggests that this
preponderant requirement was a temporary frolic and detour, pivoting momentarily from the
“norm” of plausibility. It was embraced as recently as 2019. Boatmon, 941 F.3d at 1360 (“[w]e
have consistently rejected theories that the vaccine only “likely caused” the injury and reiterated
that a “plausible” or “possible” causal theory does not satisfy the standard”). I note also that
requiring preponderance for each individual Althen prong arises from a reasonable reading of not
only the Act but the Althen decision itself. The Act specifically states that petitioners must
demonstrate “by a preponderance of the evidence the matters required by the petition.” Section
13(a)(1)(A) (emphasis added). It does not say that some “matters” need not be preponderantly
established. And in Althen’s syntax, preponderance stands outside, and hence modifies, all three
of its enumerated prongs. Althen, 418 F.3d at 1278.29 There is no logical reason to read it as
requiring preponderance when establishing the vaccine “did cause” injury, but not when a
petitioner must demonstrate his satisfaction of the “can cause” element.
Petitioner incorrectly maintains that the Circuit in Kottenstette altered the above
understanding. Reply at 3. Kottenstette was yet another case involving the DTaP vaccine allegedly
causing an infant injury, and it does comment on Boatmon—but not to make the point that Boatmon
misstated the evidentiary standard applied to Althen prong one. Rather, the Kottenstette panel was
distinguishing the Boatmon panel’s determination (in affirming reversal of the special master’s
entitlement determination) that the deciding special master in that case had applied the wrong
burden of proof in assessing the claimant’s showing. Boatmon, 941 F.3d at 1359 (“[t]he Special
Master deviated from the correct ‘reputable,’ ‘sound and reliable’ standard and articulated a lower
‘reasonable’ standard” in considering the first Althen prong). The Kottenstette panel, by contrast,
found that the special master involved in the decision it was reviewing30 had articulated the proper
overall preponderant requirement—and thus (in the Kottenstette panel’s view) had not committed
the same error of mistakenly construing the burden as in Boatmon. Kottenstette, 861 F. App’x at
440–41. The Kottenstette panel thus does not characterize the Boatmon articulation of the first
29 “Concisely stated, Althen's burden is to show by preponderant evidence that the vaccination brought about her
injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of
cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal
relationship between vaccination and injury.” Althen 418 F.3d at 1278 (emphasis added).
30 The procedural history in Kottenstette was somewhat complicated. There, a special master after hearing decided a
claim in the petitioners’ favor, and not long after retired. On appeal, the Court reversed, and the matter was remanded
to a different special master, who re-decided the case in light of the legal standard articulated by that judge.
Kottenstette, at 434–35. The appeal to the Circuit was based on the revised finding, which was now unfavorable to the
petitioners, and the Circuit’s analysis took into account how the original special master presiding over the case had
applied the law initially (in favor of entitlement).
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Althen prong standard to be erroneous, nor does it say anywhere that mere plausibility is sufficient
to establish the first Althen prong.
Petitioner’s reading of Kottenstette is thus wholly inconsistent with the principles
differentiating Table claims and causation-in-fact claims—a distinction observed in Moberly. The
significance of this distinction would be utterly lost if Petitioner’s plausibility standard governed
the “can cause” prong. For a standard of mere plausibility applied to the first Althen prong would
be one that claimants would never fail to meet, and would thus be functionally equivalent to a
Table claim’s causation presumption. The general intuition that a vaccine preceding an injury
might have caused that injury is easily fleshed out to the level of plausibility with some scientific
evaluation of a vaccine’s components, and how they could, in theory, chemically cause an aberrant
immune response. There is no shortage of experts who would be willing to so opine; indeed, even
Respondent’s experts consistently admit at trial, in my experience, that it is not “impossible” for a
given vaccine to cause an injury in a susceptible person, given how little remains known about the
precise functioning of the immune system. But the Vaccine Act was not intended to so lower a
petitioner’s burden for causation-in-fact claims—even if scientific certainty is never the proper
standard.
B. Petitioner Has Not Preponderantly Met his Burden of Proof
1. Althen Prong One
Two causation theories were ultimately advanced in this case, but neither was
preponderantly established.
Alum as Adjuvant Theory
It was wise of Petitioner to “supplement” his case with a second causation theory, for the
first one Dr. Steinman proposed—that alum included in the Tdap vaccine as an adjuvant can
produce demyelination—was woefully inadequate.31
Dr. Steinman’s theory heavily relies on what is known about the intended function of the
aluminum adjuvant—and certainly the substantiating support offered for these small contentions
was reliable. It was also reasonably submitted that cytokines play some role in GBS pathogenesis,
at various points in the disease’s course. But as I have observed in numerous prior cases, claimants
cannot prevail simply by pointing to how vaccines are expected to function, and then extrapolating
such contentions into the basis for an argument about pathologic process that is not also
corroborated with vaccination. Palattao v. Sec’y of Health & Hum. Servs., No. 13-591V, 2019 WL
989380, at *36 (Fed. Cl. Spec. Mstr. Feb. 4, 2019) (“claimants cannot transmute scientific evidence
31 Indeed, Petitioner largely seems to have walked away from his first theory by the time of his reply brief.
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exploring how vaccines normally function in the immune system into a reliable and persuasive
causation theory that any vaccine can be pathogenic without a more specific showing that applies
to the circumstances at hand,”) (citing Olson v. Sec’y of Health & Hum. Servs., No. 13-439V, 2017
WL 3624085 (Fed. Cl. Spec. Mstr. July 14, 2017), mot. for review den’d, 135 Fed. Cl. 670 (2017),
aff’d, 2018 WL 6721291 (Fed. Cir. 2018)).
Thus, these individual components of the theory, as reliably established as they were, were
not persuasively connected to other preponderant evidence to establish that the Tdap vaccine likely
can cause GBS solely on the basis of the inclusion of the aluminum adjuvant. Petitioner could
point to no direct proof on the subject—and while he was not required to do so, the absence of
evidence (as reliably shown by Dr. Collins) that the inclusion of aluminum as an adjuvant is the
“X factor” leading to GBS meant that Petitioner needed much more other additional circumstantial
proof to connect all the dots. Dr. Collins also successfully demonstrated that direct studies
pertaining to adjuvanted vaccines did not produce outcomes consistent with Petitioner’s theory.
See, e.g., First Collins Rep. at 7. For if it is the adjuvant that is causal, then any vaccine containing
it should be associated with an increased risk of GBS—but this is not the case.
I have before rejected this kind of adjuvant-centered theory in other contexts.32 Zumwalt v.
Sec'y of Health & Hum. Servs., No. 16-994V, 2019 WL 1953739, at *18 (Fed. Cl. Spec. Mstr.
Mar. 21, 2019), mot. for review den’d, 146 Fed. Cl. 525 (2019) (“[t]he fact that vaccines are known
to stimulate cytokine production (in part due in some cases to the inclusion of an adjuvant) does
not amount to a reliable causation theory that such stimulation is necessarily disease-causing”).
Nothing about how the theory was presented in this case made it more likely. And the Tdap
package insert (which at most provides indirect support for a vaccine association, in circumstances
distinguishable from the present) is weak proof supporting causation as a general matter.
Werderitsh v. Sec'y of Health & Human Servs., No. 99–319V, 2005 WL 3320041, at *8 (Fed. Cl.
Spec. Mstr. Nov. 10, 2005). At bottom, the adjuvant theory offered in this case over-relies on a
conclusion that a component common to many vaccines, and included for the specific purpose of
heightening immunogenicity, can promulgate disease—in the face of ample evidence that it “more
likely than not” does not do so.33
32 For example, petitioners have argued that aluminum is a toxic metal that harms the body—despite the fact that
individuals naturally ingest greater amounts of aluminum than via vaccination, but without attendant harm. McKown
v. Sec’y of Health & Hum. Servs., No. 15-1451V, 2019 WL 4072113, at *34 (Fed. Cl. Spec. Mstr. July15, 2019). In
other cases, claimants’ experts have proposed a theory entitled “autoimmune/inflammatory syndrome induced by
adjuvants,” or “ASIA”—but special masters have noted that it lacks both medical community acceptance as well as
overall substantiation. Pearson v Sec’y of Health & Hum. Servs., No. 17-489V, 2019 WL 1150044, at *11 (Fed. Cl.
Spec. Mstr. Feb. 7, 2019); Garner v. Sec’y of Health & Hum. Servs., No. 15-063V, 2017 WL 1713184 (Fed Cl. Spec.
Mstr. Mar. 24, 2017), mot. for review den’d, 133 Fed. Cl. 140 (July 31, 2017). Admittedly, Dr. Steinman’s theory is
somewhat distinguishable—but was no more credible.
33 By contrast, other vaccines have been credibly associated with GBS without consideration of the presence of an
adjuvant at all. Thus, the theory that the flu vaccine can cause GBS is not only far better corroborated (so much so
that it constitutes a Table claim—and hence the Government recognizes enough science supports it for causation to
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Dr. Steinman objects to some of Dr. Collins’s arguments that individual items of literature
he has offered were “cherry picked,” and do not by themselves prove his theory, maintaining in
defense of their reference that they are meant to be viewed collectively. This objection has some
merit. First, it is unquestionably the case (as the Circuit captured in the Althen opinion, with its
phrase “a field bereft of complete and direct proof of how vaccines affect the human body” (Althen,
418 F.3d at 1280)) that Program petitioners can never be faulted for their inability to brandish a
single, all-encompassing and scientifically-reliable piece of evidence showing that a vaccine is
clearly causal of an injury. That kind of evidence simply does not exist.34 Second, the very fact
that the Program combines a preponderant, “more likely than not” causation standard with very
few (if any) limits on the kinds of evidence that can be offered to meet it, means that claimants
may satisfy their burden by connecting individual items of proof (circumstantial or otherwise) that,
individually, only partially address the greater issue.
But this does not mean that tying together items standing for reasonable and reliable, but
very narrow, points will always produce a theory that is in total preponderantly established. The
causal chain an expert forges must do more than simply make leaps from “stone to stone” without
some additional support—and without proposing a reliable reason for making the leap. Thus, the
argument that (a) vaccines cause cytokine upregulation, (b) cytokines are part of the pathogenic
process in GBS, therefore (c) vaccines can cause GBS, leaves out a number of necessary
intermediate steps, such as (a) when can the amount of cytokine production generally become
excessive, (b) does this occur with vaccination, and (c) how central are those cytokines to the
relevant disease process (and in the case of vaccination, they must be an initial instigating factor).
The absence, or presence, of other corroborative evidence (e.g., what environmental factors are
deemed causal of the injury that are comparable to a vaccine, or is anything scientifically known
about the disease’s biologic mechanisms) can also be significant. Here, that necessary connective
evidence was wholly lacking, and I therefore cannot conclude that the causation theory relying on
the alum adjuvant was preponderantly established.
Molecular Mimicry Theory
Petitioner’s second theory was one that, more often than not in Program cases, is the
primary theory offered to explain how virtually any vaccine could produce an autoimmune
disease—via molecular mimicry. But not only was it proposed late in the game, but it too was not
preponderantly shown to be likely causal. All Dr. Steinman did was offer evidence suggesting a
be conceded), but does not at all rely on alum as an adjuvant, since the flu vaccine most often administered does not
contain one.
34 Indeed, even the flu vaccine-GBS association is mainly based on a string of propositions, including (a) that
molecular mimicry between flu vaccine components and nerve cross-attack targets can be shown, and (b) that an
epidemiologic study now over 40 years old reliably established a high incidence of GBS after receipt of the flu vaccine,
when compared to those who did not receive it.
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theoretic possibility of homology between Tdap vaccine components and locations in the nerve
structures where an autoimmune attack might occur. But this is a relatively easy showing to make,
given the prevalence of homology in nature. It does not amount to a showing that a cross-reaction
instigated by the Tdap vaccine resulting in GBS is “more likely than not.” And Dr. Collins offered
evidence and testimony raising reasonable questions about whether every variant of GBS
inherently unfolds only from molecular mimicry causing the production of cross-reactive
autoantibodies, or only at the identified myelin targets. See, e.g., Fourth Collins Rep. at 2-5;
Orlikowski.
I once again emphasize (as I have in many prior cases) that molecular mimicry is not a
“get out of jail free card” in the Program, entitling claimants who hire Dr. Steinman (or someone
else sufficiently conversant with molecular biology and the relevant databases) to compensation,
merely because it has scientific reliability as a general matter. Yalacki v. Sec'y of Health & Hum.
Servs., No. 14-278V, 2019 WL 1061429, at *34 (Fed. Cl. Spec. Mstr. Jan. 31, 2019), mot. for
review den’d, 146 Fed. Cl. 80 (2019) (“it is not enough for a claimant to invoke the concept of
molecular mimicry along with some identified homology between an amino acid sequence and a
target antigen in order to carry her burden”). Without some reason to further find that the relevant
vaccine can be causal of the specific injury at issue—however that might be demonstrated—
establishing a potentiality for molecular mimicry alone does not meet the preponderant standard
of proof, no matter what degree of amino acid identity (sequential or not) Dr. Steinman can
demonstrate with a BLAST search.
Epidemiologic evidence offered by Respondent also undercuts Petitioner’s showing.35
Baxter II—a large-scale study identifying no association between Tdap and GBS—was
particularly harmful. It was far more relevant to Petitioner’s claim herein than Baxter I (authored
by almost all of the same individuals as Baxter II), which Dr. Steinman favorably cited but which
only showed a possible association between Tdap and ADEM—a distinguishable central nervous
system-impacting demyelinating disease. The very fact that Dr. Steinman chose to cite Baxter I is
telling—if one epidemiologic study not fully on point is nevertheless supportive of his theory, how
can a study directly on point (since it involved the injury at issue in this case), and written by
largely the same group of scientific professionals, not also bear on the case’s outcome?
35 Even though Program petitioners are never obligated to offer epidemiologic evidence, it is well-established by
controlling Federal Circuit caselaw that relevant epidemiologic evidence can be taken into account by a special master
in weighing a claimant’s success on the first Althen prong. Taylor v. Sec'y of Health & Human Servs., 108 Fed. Cl.
807, 819–21 (Fed. Cl. 2013) (special master did not err in considering epidemiological evidence); Andreu, 569 F.3d
at 1379 (a special master may assess epidemiological evidence in “reaching an informed judgment as to whether a
particular vaccination likely caused a particular injury.”).
Such evidence is reasonably subject to the same reliability and methodology considerations that apply to all
scientific/medical evidence offered, and it should not be viewed as dispositive per se. But it deserves weight when it
exists, and it can serve to weaken confidence in a claimant’s causal showing.
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My evaluation of Dr. Steinman’s theory also takes into account, to a small extent, conduct
reflected in his reports that undermined his persuasiveness. This case provides yet another example
of Dr. Steinman’s unfortunate proclivities as an expert when offering opinions in Program cases.
Vaccine Program experts should confine their testimony to the scientific and medical issues that
their training and expertise renders them competent to comment upon. They should not discuss the
legal standards that govern entitlement decisions (beyond perhaps offering testimonial caveats
consistent with those standards).36 Yet Dr. Steinman wasted numerous pages of his report
(frequently appending the relatively-useless proviso that he is “not a lawyer”) to opining directly
on the proper application of those legal standards, and even invoked prior decisions as precedential
support. See, e.g., Second Steinman Rep.at 1; Third Steinman Rep. at 1. I have in the past criticized
Dr. Steinman for engaging in similar conduct. See, e.g., Rolshoven v. Sec'y of Health & Hum.
Servs., No. 14-439V, 2018 WL 1124737, at *21 (Fed. Cl. Spec. Mstr. Jan. 11, 2018). He will
continue to do harm to his credibility as an expert if he does not stop acting in this fashion.37
I emphasize that my reaction to the above is not the primary basis for my determination
that the first Althen prong was not met. Rather, neither of the causation theories offered was
preponderantly established with sufficient reliable medical or scientific evidence, despite Dr.
Steinman’s ample credentials to opine on the subject. But it is well within the bounds of the
exercise of my duties as a special master to take into account the totality of facts pertaining to an
expert’s presentation in evaluating credibility and persuasiveness. The special master is not a
“potted plant” in Vaccine Act proceedings, obligated to ignore what experts actually say or do in
a case out of the concern that a negative reaction might prejudice the petitioner. Here—and in
addition to the fact that the causal theories offered were based on unreliable science or medicine,
and otherwise not preponderantly established—Dr. Steinman undermined his showing.
2. Althen Prong Two
36 Thus, counsel often conclude their direct examination of an expert by asking the expert whether he or she holds the
opinion offered “to a reasonable degree of medical probability,” or whether something contended is simply “more
likely than not.”
37 In addition, I note that the molecular mimicry theory was only offered as a substitute for an initial theory that over
time proved problematic—and after multiple reports on that theory had been filed. I acknowledge that Dr. Steinman
purports that the two theories are equally valid, and could both explain causation, alone or taken together. Fourth
Steinman Rep. at 1. But (in my experience with Dr. Steinman as an expert—having seen his reports, or listened to his
testimony, many times over the past eight years) molecular mimicry is more often than not the primary, if not sole,
causation theory he espouses—and he did not embrace it in this case at the outset. Indeed, Dr. Steinman was
comfortable relying on the adjuvant theory enough to defend it multiple times against Dr. Collins’s attacks, and over
a nearly three-year period, without any hedging or qualification. If this theory were so ironclad, why was there any
need to supplement it with an alternative? While I have evaluated molecular mimicry on its own terms, and based
almost wholly on the evidence and testimony offered for it, the fact that it was Petitioner’s “second choice” suggests
to a small degree a lack of faith in its applicability.
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Several items of record evidence weigh against Petitioner’s assertion that the Tdap vaccine
he received likely “did cause” his GBS. In particular, the majority of immediate treaters did not
propose vaccination to be causal, finding far more significant the indisputable evidence of an
intercurrent URI. See, e.g., Ex. 3 at 15, 19–20 (Dr. Han), 36–37 (Dr. Deangelis), 41 (Dr. Given),
126–27 (Dr. Glodan). On the other hand, during an infectious disease consult Dr. Klirsfeld noted
as well that the injury could be “possibly” vaccine-associated. Ex. 3 at 53. But this initial
speculation never developed into an acting diagnostic hypothesis, and so the weight of treater
views evidenced in this record does not support vaccine causation. (A subsequent dietician’s
mention of the vaccination deserves even less weight—not only is such a professional’s view less
informed than the neurologic or other disease specialist treaters who saw Dr. K.A., but the record
at issue suggests this was simply mentioned as part of the patient history). Ex. 9 at 1064.
At the same time, the record reveals several instances in which treaters proposed that
Petitioner’s URI did play a role in his subsequent neurologic injury. I also do not give substantial,
if any, weight to Dr. Steinman’s objections that the term of art “influenza-like illness” to describe
Petitioner’s URI is scientifically indeterminate—since filed record evidence from competent
medical and scientific professionals employ the term in their own studies. See, e.g., Ex. 3 at 47
(using the term “flu-like”).
Dr. Steinman nevertheless objects to giving this evidence weight in the absence of proof
of the specific nature of the infection. In so arguing, Petitioner notes correctly that the record is
ambiguous and inconclusive on this point. Thus, initial testing for WNV was positive for a
resolved, but not current, infection (Ex. 3 at 15–20, 53, 63), and Petitioner did not test positive for
EBV (although evidence of a resolved CMV was identified). Id. at 268–85; Ex. 9 at 178–80. I
cannot say on this record that the evidence preponderantly establishes the specific infectious agent
behind Petitioner’s URI.
But (putting aside the fact that Dr. Steinman relies in part on his own reading of Program
case law for these contentions about infection specificity—despite his lack of expertise to so
opine), it is incorrect that evidence regarding possible alternative causes should not be included in
a special master’s weighing, absent definitive proof of the nature of the infection. Section
13(b)(1)(A) (special master empowered to consider “any diagnosis, conclusion, medical judgment
. . . which is contained in the record regarding the nature, causation, and aggravation of the
petitioner’s illness”). Here, not only is there incontrovertible evidence that Petitioner first
experienced URI symptoms before neurologic-related symptoms, but also that the majority of his
treaters deemed the URI most likely causal. The vaccine does not deserve greater weight simply
because it is “known” whereas the precise nature of the infection is not. Indeed—medical science
cannot always test for or identify a specific infection, as has been observed in prior cases. Randolph
v. Sec’y of Health & Hum. Servs., No. 15-146V, 2021 WL 5816271, at *21 (Fed. Cl. Spec. Mstr.
Nov. 12, 2021) (“[c]ausation claims do not succeed merely because Respondent cannot prove with
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certainty what was causal”). Dr. Collins also persuasively showed that many facially-reliable
studies had included “influenza-like illness” as a potentially causal agent of GBS, despite Dr.
Steinman’s protestations. See, e.g., Tam; Stowe. And since scientific certainty is not the relevant
evidentiary standard, it cannot be the case that Respondent must meet that standard in rebutting a
petitioner’s showing.
This is also not an instance in which what is referred to as a Shyface analysis assists
Petitioner. There are circumstances where experts on both sides concede two or more factors could
be causal of injury (including vaccination), resulting in entitlement for the petitioner if the special
master concludes that the vaccine was at least a “substantial” factor (even if not the primary or
predominant factor). Deribeaux v. Sec’y of Health & Hum. Servs., 105 Fed. Cl. 583, 589 (June 4,
2012). But here, there was no concession by Dr. Collins that the Tdap vaccine can be causal at
all38—and I have found that Petitioner did not preponderantly establish this to the case. Thus, the
mere fact that temporarily Petitioner received the Tdap vaccine before onset of his URI does not
compel me into a Shyface determination that the URI was not likely solely causal.
Overall, the medical records strongly support the conclusion that Petitioner’s intercurrent
URI likely caused his GBS—not that it was caused by the Tdap vaccine.39
3. Althen Prong Three
Petitioner’s success in establishing that the timeframe for his onset of symptoms post-
vaccination was medically acceptable (in terms of vaccine causation) is not consistent from theory
to theory. Little was offered to substantiate the timeframe for Mr. K.A.’s 18 to 19-day onset
(August 31, 2013, or September 1, 2013) under the theory that the adjuvant caused his GBS.
Indeed, since this theory depended on an innate, cytokine-driven reaction to the vaccine, the
38 As Respondent observed in his opposition brief, Dr. Steinman’s misplaced reliance on Torday as requiring
specification of a precise infection to counter the known quantity of a vaccination really invokes a Shyface-like
analysis from a case where more than one factor was deemed potentially causal, leading the special master to give less
weight to the unknown precise nature of the infection. Torday, 2009 WL 5196163, at *3–4.
39 As noted, I do not find that Petitioner has established that the Tdap vaccine can cause GBS, so the burden of proof
never shifted to Respondent to prove a “factor unrelated.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347,
1354 (Fed. Cir. 2008). I have otherwise reasonably included, in my weighing of evidence for and against Petitioner,
the record proof pertaining to Petitioner’s URI, finding that it undercuts Petitioner’s contentions that the Tdap vaccine
was causal. Stone v. Sec'y of Health & Human Servs., 676 F.3d 1373, 1380 (Fed. Cir. 2012) (“no evidence should be
embargoed from the special master's consideration simply because it is also relevant to another inquiry under the
statute”); see also de Bazan, 539 F.3d at 1353 (“[t]he government, like any defendant, is permitted to offer evidence
to demonstrate the inadequacy of the petitioner's evidence on a requisite element of the petitioner's case-in-chief”).
But I also note that even if I had found that Petitioner had met his initial causation burden, the record before me would
preponderantly establish that the URI was more likely causal—and hence Respondent on this record would have met
his burden had it shifted. The record persuasively establishes that not only are a variety of infectious processes
(including “influenza-like illness”) associated with GBS more convincingly than the Tdap vaccine, but also that
treaters overall proposed that Petitioner’s own history was consistent with that relationship.
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pathologic process would have likely occurred far closer in time to vaccination—suggesting that
even an onset around three weeks post-vaccination would be too long. Opp. at 23, citing
Montgomery, 2019 WL 2511352, at *5.
As noted, however, Petitioner seems to have opted to place more emphasis on Dr.
Steinman’s second causation theory—that molecular mimicry between vaccine antigens and self
structures associated with the initial attack on the nerves was the mechanism driving the
autoimmune process. Facially, a three-week onset for such a process is more medically reasonable,
taking into account (a) how long the adaptive immune response (in which antibodies would be
produced in reaction to vaccine antigens and then start cross-reacting with self tissues) would take
generally, plus (b) literature like Schonberger. Keja v. Sec’y of Health & Hum. Servs., No. 17-
1511V, 2021 WL1736816, at *21 (Fed. Cl. Spec. Mstr. Apr. 2, 2021). Of course, Schonberger is
not specific to Tdap vaccine at all, diminishing its evidentiary value. But had I found that the Tdap
vaccine “can cause” GBS, then the fact that the timeframe of onset occurred when, from a medical
standpoint, it would be expected to occur would inure to Petitioner’s benefit. As it stands, however,
and because the claim fails on the first two Althen prongs, Petitioner’s ability to preponderantly
support the third prong does not avail him.
III. This Case Was Appropriately Decided on the Papers
In ruling on the record, I am choosing not to hold a hearing—a determination that the
parties largely accepted.40 Determining how best to resolve a case is a matter that lies generally
within my discretion, but I shall explain why I determined that a hearing was unnecessary.
Prior decisions have recognized that a special master’s discretion in deciding whether to
conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to “afford[] each
party a full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400–01 (citing Rule
3(b)). But that rule also includes the obligation of creation of a record “sufficient to allow review
of the special master’s decision.” Id. Thus, the fact that a claim is legitimately disputed, such that
the special master must exercise his intellectual faculties in order to decide a matter, is not itself
grounds for a trial (for if it were, trials would be required in every disputed case). Special masters
are expressly empowered to resolve fact disputes without a hearing—although they should only
so act if a party has been given the proper “full and fair” chance to prove their claim.
40 Petitioner’s initial ruling on the record brief did not oppose deciding this case on the papers. On Reply, however,
Petitioner included a footnote setting forth some process objections: that he was denied the opportunity to offer his
own infectious disease expert (by the special master previously assigned to the case) to counter Dr. Collins’s
arguments, and that, although he noted my discretion to choose how best to decide the case, a hearing was warranted
since the petitioner’s theories were “closely contested.” Reply at 5 n.4. Putting aside the underwhelming and somewhat
eleventh-hour nature of this objection, I nevertheless determine (as explained herein) that the claim could be, and was,
fairly adjudicated solely on the basis of the papers—and as already noted hearings are not held simply because the
parties disagree on entitlement.
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It was wholly fair to both sides to resolve this case on the papers and after briefing by the
parties. Over the case’s nearly six years, Petitioner was afforded the opportunity to offer five
written expert reports—so many that the reports began to repeat prior arguments and/or devolve
into expert bickering as they piled up. Petitioner was also permitted to modify his causation theory
entirely, after Respondent voiced objections to its sufficiency. And the second theory proposed
was one with which I have substantial familiarity—meaning I did not need to hear live testimony
from Dr. Steinman to understand or react to it. It cannot be denied, given the overall procedural
history, that Petitioner received a reasonable chance to prove his claim.
CONCLUSION
A Program entitlement award is only appropriate for claims supported by preponderant
evidence. Here, Petitioner has not made such as showing. Petitioner is therefore not entitled to
compensation.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.41
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
41 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices
renouncing their right to seek review.
45