Hiatt v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 19-1363V

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ANGELA HIATT, * Chief Special Master Corcoran

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Petitioner, * Filed: October 24, 2025

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v. *

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SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

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Respondent. *

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Richard Gage, Law Offices of Richard Gage, Cheyenne, WY, for Petitioner.

Mary Holmes, U.S. Department of Justice, Washington, DC, Respondent.

ENTITLEMENT DECISION 1

On September 6, 2019, Angela Hiatt filed a petition seeking compensation under the

National Vaccine Injury Compensation Program (the “Vaccine Program). 2 Petitioner alleges that

she suffered Guillain-Barré syndrome (“GBS”) as a result of receiving the tetanus-diphtheria-

acellular-pertussis (“Tdap”) and human papillomavirus (“HPV”) vaccines on February 16, 2017.

Petition (ECF No. 1) at 1. She has since narrowed her claim to focusing solely on the Tdap vaccine.

Petitioner’s Brief, filed Feb. 25, 2025 (ECF No. 77) (“Br.”) at 6–7.

I determined that this matter could be fairly resolved via ruling on the record, and both

sides filed briefs in support of their positions. See Br.; Respondent’s Opposition, filed Mar. 26,

2025 (ECF No. 80) (“Opp.”); Petitioner’s Reply, filed Apr. 2, 2025 (ECF No. 81) (“Reply”). The

1

Under Vaccine Rule 18(b), each party has fourteen (14) days within which to request redaction “of any information

furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or

confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly

unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public

in its present form. Id.

2

The Vaccine Program comprises Part 2 of the 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).

matter is now ripe for resolution. For the reasons set forth in more detail below, I hereby deny

entitlement. Petitioner has not preponderantly established that the Tdap vaccine can cause GBS,

or did so to her.

I. Factual Background

Ms. Hiatt received both the Tdap and HPV vaccines on February 16, 2017, at the office of

her primary care provider (“PCP”). Ex. 1 at 44–46. She was 45 years old at the time. There is no

medical record evidence indicating that she experienced any unusual reaction to the vaccines in

the week immediately after.

On February 27, 2017 (now eleven days post-vaccination), Petitioner went to the

emergency department (“ED”) of McKay Dee Hospital in Ogden, Utah, with complaints of chest

and back pain that she reported had begun earlier that morning. Ex. 5 at 95. She also reported left-

sided jaw pain, which she associated with a recent sinus cold. Id. Evaluation for cardiac issues

revealed nothing of concern, and she was treated with antacids and discharged with a diagnosis of

non-cardiac chest pain. Id.

That same day Petitioner went to see her PCP for further evaluation of the pain symptoms

that had caused her to visit the ED. Ex. 1 at 42. She also reported symptoms of upper respiratory

infection with facial pressure and ear pain. Id. Her PCP assessed her with an upper respiratory

infection with non-cardiac chest and thoracic back pain, and directed her to follow up if her

symptoms did not improve. Id. at 42–43. Petitioner returned to the ED later that same day,

however, due to her concerns about worsening chest pain. Ex. 5 at 29. She was reevaluated for

cardiac issues, and also underwent a lung scan to test for pulmonary emboli, but the work-up was

negative, and she was discharged again with pain medication and antihistamines. Id.

Three days later (March 1, 2017), Ms. Hiatt went back to her PCP for evaluation of ongoing

chest pain plus weakness and hand/foot/tongue numbness. Ex. 1 at 39. She now reported that she

was experiencing nausea, vomiting, and “stomach flu” symptoms in the days before her chest pain

started (something Petitioner had not informed treaters at either of the February 27th medical

encounters, although this was deemed possibly to reflect prior gastric band surgery she had

experienced). Id. Her PCP’s impression was epigastric abdominal pain, chest pain, anemia,

weakness, and fatigue, and blood testing was ordered, along with a cardiac stress test (which

resulted in no significant findings). Id. at 40, 41.

Because of Petitioner’s ongoing symptoms, she was admitted to South Ogden Regional

Medical Center based upon a three-day history of progressive weakness and a one-week history of

back pain. Ex. 9 at 55. At this time she specifically reported a preceding gastrointestinal illness

with nausea, vomiting, and diarrhea the week prior. Id. Exam now revealed an absence of deep

tendon reflexes, weakness, and sensory deficits in her legs and arms. Id. at 59. And a thoracic spine

2

MRI yielded normal findings, but she tested positive for elevated protein levels in her

cerebrospinal fluid. Id. at 26; 123.

Based upon her overall presentation, a consulting neurologist proposed that Petitioner had

GBS preceded by gastrointestinal flu-like illness. Ex. 9 at 26–27 (“this increase in protein by 20

over the upper range of protein for CSF as well as the cell count being normal with given history

is probably consistent with Gillain-Barre [sic] syndrome and warrant treatment for this”). She was

admitted to the intensive care unit because of respiratory distress, and within days required

intubation and ventilatory assistance. Id. at 65. While hospitalized, Petitioner received a five-day

course of IVIG, and after some gradual improvement was transferred to Northern Utah

Rehabilitation Hospital on March 15, 2017. Id. at 3–4, 118.

By April 13, 2017, Petitioner was able to walk and perform personal tasks independently,

and was discharged from rehab at that time. Ex. 6 at 40–41. She continued thereafter to experience

neurologic sequelae of her GBS, however. Ex. 4 at 8–10. She required some physical therapy that

summer, and continued to experience balance issue and limb weakness and numbness into the fall.

Ex. 1 at 21, 45; Ex. 4 at 2–4, 5–7. Other evidence of Petitioner’s medical treatment in 2018 does

not bear on causation, and I therefore do not include discussion of it herein. 3

II. Expert Reports

A. Petitioner’s Expert – Dr. Carlo Tornatore

Dr. Tornatore is a neurologist, and he prepared a single written report in this case. See

Report, dated Feb. 7, 2024, filed as Ex. 36 (ECF No. 56-1) (“Tornatore Rep.”).

Dr. Tornatore graduated from Cornell University with a Bachelor of Arts and Sciences in

Neurobiology, and attended Georgetown University Medical Center, where he received a Master

of Science in Physiology. He subsequently graduated from medical school at Georgetown

University School of Medicine, completing a residency in the Department of Neurology at

Georgetown University Hospital. Tornatore Rep. at 1. Dr. Tornatore also completed a fellowship

in Molecular Virology at the National Institute of Health in Bethesda, Maryland. Id. He has

published multiple articles addressing demyelinating disorders and their pathology. Id. at 2.

Currently, Dr. Tornatore serves as a Professor and Chairman of the Department of Neurology at

Georgetown University Medical Center, Chairman and Neurologist-in-Chief of the Department of

Neurology at Medstar Georgetown University Hospital in Washington, D.C., and Medstar Health’s

3

Petitioner also filed multiple personal and witness statements that described onset and Petitioner’s state after

vaccination. See Affidavit, dated Apr. 26, 2021, filed as Ex. 14 (ECF No. 27-1); Affidavit, dated Apr. 26, 2021, filed

as Ex. 15 (ECF No. 27-2); Affidavit, dated Apr. 26, 2021, filed as Ex. 16 (ECF No. 27-3); Affidavit, dated Apr. 26,

2021, filed as Ex. 17 (ECF No. 27-4); Affidavit, dated Sep. 27, 2022, filed as Ex. 32 (ECF No. 46-1); Affidavit, dated

Nov. 1, 2022, filed as Ex. 33 (ECF No. 47-1); Physician Letter, dated Nov. 1, 2022, filed as Ex. 34 (ECF No. 47-2).

However, because this case turns on general causation, I forgo including a discussion of those documents.

3

Regional Director Neurology. Id. at 1. Throughout his clinical career, Dr. Tornatore has cared for

several hundred patients with acute and post-acute GBS. Id. at 2.

Dr. Tornatore’s report began with a detailed review of Petitioner’s medical history,

although he stressed certain aspects of it over others. Tornatore Rep. at 2–8. For example, he

observed that her first medical encounter eleven days post-vaccination featured complaints of back

pain, which he noted could be a presenting symptom of GBS. Id. at 2–3, 20. This evolved not only

to radiating pain in the chest and jaw, but finger tingling and numbness. Id. at 3. Treaters over

time, and based upon additional exams and lab findings, embraced a GBS diagnosis, and Dr.

Tornatore found no reason to question it himself. Id. at 4–6, 8–9.

Dr. Tornatore next provided a brief explanation of GBS. He deemed it an “autoimmune

demyelinating neuropathy” impacting the peripheral nervous system, and understood to be

instigated by antigens from either a viral/bacterial infection or (in some limited cases) vaccination.

Tornatore Rep. at 9. A cross-reactive attack on nerve myelin by autoantibodies produced in

response to the stimulating foreign antigens would drive GBS. Its symptomatic features include

extremity weakness and numbness, and it could also cause facial weakness. Id.

The cross-reactivity of the autoantibodies driving GBS would occur as a result of molecular

mimicry between the presenting foreign antigens and self-tissue myelin structures. Tornatore Rep.

at 9–10; R. Hughes & D. Cornblath, Guillain-Barré Syndrome, 366 Lancet 1653, 1660 (2005),

filed as Ex. 37 (ECF No. 56-2) (“Hughes & Cornblath”). The general concept of mimicry, or shared

homology between amino acid sequences in viral/bacterial antigens and host structures, was well

accepted in science—along with the fact that this could result in antibodies produced in reaction

to a foreign antigen to mistakenly attacking self. Id. at 9. But Dr. Tornatore acknowledged that

medical science had not identified a specific cross-reactive antibody likely causal for most patients

suffering from the common form of GBS, acute inflammatory demyelinating polyneuropathy

(“AIDP”). Id. at 10–11; Hughes & Cornblath at 1659.

Nevertheless, Dr. Tornatore maintained that components of the Tdap vaccine could likely

trigger an autoimmune process leading to GBS from molecular mimicry. Tornatore Rep. at 11–12.

In support of this contention, he began with a review of government publications or notifications

that he deemed to concede this possibility. The website of the “Centers for Disease Control” (the

“CDC”), for example, notes that “certain vaccines” have been associated with GBS (although the

screenshot provided in Dr. Tornatore’s report says nothing about Tdap specifically, let alone GBS

risk due to any of its wild infectious components). 4 Dr. Tornatore also referenced a document

4

Petitioner, however, only listed the URL to the CDC’s website in his report, but did not file anything as it relates to

this particular reference. See Centers for Disease Control and Prevention, Guillain-Barré Syndrome, (May 15, 2024)

https://www.cdc.gov/campylobacter/guillain-barre.html

[https://web.archive.org/web/20240515063152/https://www.cdc.gov/campylobacter/guillain-barre.html] (last visited

October 22, 2025).

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published in 2017 by the “Advisory Committee on Immunization Practices (the “ACIP”), which

advised treaters to take care in administering tetanus-containing vaccines to individuals who had

previously experienced GBS within six weeks of receipt of a prior dose of tetanus-containing

vaccine. Tornatore Rep. at 11–12 (citing E. Ezeanolue et al., “Best Practices Guidance of the

Advisory Committee on Immunization Practices (ACIP),” General Best Practice Guidelines for

Immunization, https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-

recs.pdf (2017) (last visited Oct. 22, 2025), filed as Ex. 38 (ECF No. 56-3) (“Ezeanolue”), at 54).

He also noted this precaution was repeated in the CDC “Morbidity and Mortality Weekly Report”

from 2018. J. Liang et al., “Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the

United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP),”

67 Morbidity and Mortality Weekly Report 1 (2018), filed as Ex. 39 (ECF No. 56-4).

Medical science provided a reliable reason to associate Tdap vaccine antigenic components

with GBS, Dr. Tornatore contended. Tornatore Rep. at 12–17. He pointed to existing medical and

scientific support for the idea that a specific wild bacterial infection (Campylobacter jejuni) has

been associated with GBS mediated by cross-reacting autoantibodies that (as a result of mimicry

between the antigens of the bacterial infection and nerve structures) mistakenly attacked self. Id.

at 12. But much of Dr. Tornatore’s causation theory focused not on Tdap but upon the

distinguishable influenza (“flu”) vaccine. In support, he offered some items of literature commonly

seen in Program cases, but mainly relevant to the flu vaccine or its variants. Id. at 12, 13–17. 5

Nevertheless, Dr. Tornatore opined that Tdap antigens could prompt a similar cross-

reaction despite their differences from the flu vaccine components, due to molecular mimicry.

Many animal model experiments had observed that neuropathic symptoms could be induced by

flu virus or vaccine components due to amino acid sequential homology with myelin basic protein

(“MBP”) 6 in live subjects. 7 Tornatore Rep. at 13–16. Thus, “viruses/vaccines bearing such

5

I do not include these citations or a discussion of them—both because they are far more often than not referenced in

Program cases involving GBS, and because they are primarily relevant to the flu vaccine. See, e.g., L. Schonberger et

al., Guillain-Barré Syndrome Following Vaccination in the National Influenza Immunization Program, United States,

1976–1977, 110 Am. J. Epid. 105 (1979), filed as Ex. 42 (ECF No. 56-7) (“Schonberger”).

6

MBP is defined as “a basic protein (MW 18,000) that constitutes about 30 per cent of myelin proteins; elevated levels

of MBP occur in acute exacerbation of multiple sclerosis and acute cerebral infarction.” Myelin Basic Protein,

Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=100535 (last visited

Oct. 22, 2025).

7

Dr. Tornatore also briefly referenced another kind of mechanism that could explain an autoimmune process prompted

by a foreign antigen—“degeneracy” of T and B cells nonspecific to the presenting antigen. Tornatore Rep. at 13; D.

Mason, A Very High Level of Crossreactivity is an Essential Feature of the T Cell Receptor, 19 Immunol. Today 395

(Sept. 1998), filed as Ex. 45 (ECF No. 56-10). But he did not provide details as to how this kind of nonspecific

activation was likely vaccine-sparked, and overall relied more heavily on the standard kind of molecular mimicry

mechanism (cross-reactivity driven by autoantibodies generated by antigenic mimics) usually featured in Program

cases.

5

[homologous] peptides may contribute to the pathogenesis of autoimmune inflammatory CNS

activity”—and it was “unlikely that [only] a single viral peptide is responsible for the induction of

autoimmune inflammatory CNS disease.” Id. at 15.

In order to connect existing scientific support for an autoimmune mechanism for GBS in

the context of the flu vaccine to the circumstances of this case, Dr. Tornatore noted that additional

research had proposed another GBS target antigen. Tornatore Rep. at 17–18; H. Inglis et al.,

Antibody Responses to Peptides of Peripheral Nerve Myelin Proteins P0 and P2 in Patients with

Inflammatory Demyelinating Neuropathy, 78 J. Neurol. Neurosurg. Psych. 419 (2007), filed as Ex.

51 (ECF No. 57-5) (“Inglis”) (finding sample of GBS patients displayed increased antibody

reactivity to “P2” peripheral myelin protein). This P2 protein had “significant homology” with the

tetanus toxin, and Dr. Tornatore relied on his own BLAST search 8 to substantiate the contention.

Tornatore Rep. at 18–19. In effect, because “epitopes from tetanus toxin bear resemblance” to a

peptide relevant to experimentally-induced forms of CNS and peripheral neuropathies, then it was

likely the same kind of mimicry could occur, and drive GBS, in the context of a Tdap vaccine’s

administration. Id. at 20.

Dr. Tornatore did, however, endeavor to offer some literature specific to the putative

association between the Tdap vaccine and GBS. For example, he cited to an article that evaluated

VAERS 9 passive surveillance data. N. Souayah et al., Guillain-Barré Syndrome After Vaccination

in United States: Data from the Centers for Disease Control and Prevention/Food and Drug

Administration Vaccine Adverse Event Reporting System (1990-2005), 11 Neuromusc. Dis. 1

(2009), filed as Ex. 22 (ECF No. 20-8) (“Souayah”). Souayah noted a number of other vaccines

that might also be associated with GBS, although (a) a flu vaccine association was the most

commonly-observed, and (b) tetanus-containing vaccines came in third place in term of how often

8

According to its own website, the “Basic Local Alignment Search Tool” (BLAST) “finds regions of local similarity

between sequences. The program compares nucleotide or protein sequences to sequence databases and calculates the

statistical significance of matches. BLAST can be used to infer functional and evolutionary relationships between

sequences as well as help identify members of gene families.” https://blast.ncbi.nlm.nih.gov/Blast.cgi (last visited Oct.

22, 2025). It is common in the Program for immunology experts to utilize BLAST searches when arguing about

whether a vaccine’s protein components mimic self-structures.

9

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 October

22, 2025). 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 does not independently confirm the

reported adverse event either. 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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post-vaccination GBS was reported. Souayah at 2 tbl. 1, 3. Souayah’s authors also acknowledged

the limitations on reliance on uncorroborated VAERS report data. Id. at 5.

Another such article is a case report—and it often surfaces in cases in which claimants

allege GBS to have been caused by the Tdap vaccine. Tornatore Rep. at 12 (citing J. Pollard & G.

Selby, Relapsing Neuropathy Due to Tetanus Toxoid: Report of a Case, 37 J. Neurol. Sci. 113

(1978), filed as Ex. 43 (ECF No. 56-8) (“Pollard & Selby”). Pollard & Selby, however, is a 47

year-old case report—and it involved an individual who experienced three documented instances

of relapse of neuropathic symptoms after receipt of a tetanus toxoid vaccine—a fact pattern

distinguishable from this Petitioner’s experience (and as noted below, there are other reasons to

question Pollard & Selby’s probative value in this case).

Dr. Tornatore also emphasized an article that observed the aforementioned relapse risk of

GBS symptoms in individuals previously diagnosed with GBS but who had received a tetanus

toxoid-containing vaccine. R. Hughes et al., Risk of Relapse of Guillain-Barré Syndrome or

Chronic Inflammatory Demyelinating Polyradiculopathy, 73 Muscle & Nerve 1230, 1231 (Sep.

1996), filed as Ex. 56 (ECF No. 57-10) (“Hughes”) (describing case series reports of 110 patients

with GBS or CIDP over 12-year period; identifying only two instances of a temporal relationship

to vaccination, but stressing (from an “overcautious” position) the risk of receiving a second

vaccine if a person experienced a symptoms relapse within 12 weeks of a prior dose). Hughes,

however (like Pollard & Selby) is far more probative of relapse risk in existing patients than to the

present circumstances).

Otherwise, Dr. Tornatore maintained that an eleven-day, post-vaccination onset was

medically acceptable, although he relied on a study specifically relevant to the flu vaccine for

support. 10 Tornatore Rep. at 21–22. And he deemed it “highly improbable” that Petitioner’s

gastrointestinal symptoms explained her GBS, since a Campylobacter jejuni infection was never

confirmed, and the kind of GBS associated with such a bacterial infection was usually axonal in

nature (as opposed to AIDP, which Petitioner likely experienced). Id. at 22.

B. Respondent’s Experts

1. Kourosh Rezania, M.D. – Dr. Rezania, a neurologist, offered a single expert

report for Respondent. Report, dated Dec. 20, 2024, filed as Ex. A (ECF No. 72-1) (“Rezania

Rep.”).

Dr. Rezania received his medical degree from Tehran University School of Medicine.

Curriculum Vitae, filed as Ex. B (ECF No. 72-2) (“Rezania CV”), at 2. He then completed an

10

See Schonberger at 112 fig. 5.

7

internship in Internal Medicine at New York Hospital, followed by his residency in Adult

Neurology at Mount Sinai Medical Center. Id. Thereafter, Dr. Rezania completed fellowships in

Neurophysiology and Neuromuscular Medicine at the University of Chicago. Id. He is currently a

professor of Neurology, as well as the Director of the Neuromuscular Fellowship Program and the

ALS Multidisciplinary Clinic at the University of Chicago Pritzker School of Medicine. Rezania

Rep. at 1. Dr. Rezania is board certified by the American Board of Psychiatry and Neurology in

Adult Neurology and Psychiatry, and Neuromuscular Medicine, in addition to Electromyography

by the American Board of Neuromuscular and Electrodiagnostic Medicine. Rezania CV at 2. He

has published over 60 peer-reviewed publications, with a primary focus on various neuromuscular

diseases, and has evaluated and treated numerous patients with GBS over the course of his clinical

career. Rezania Rep. at 1.

Dr. Rezania accepted Petitioner’s GBS diagnosis. Rezania Rep. at 3–4. He also conceded

that its onset likely occurred on February 27, 2017, as evidenced by Petitioner’s complaints of

“severe thoracic radicular pain.” Id. at 4. But Dr. Rezania gave more weight to the possibility that

it was attributable to a prior, or intercurrent, infection than did Dr. Tornatore. Her nausea and

vomiting were reported (at Petitioner’s February 27, 2017 ED visit) to have begun a few days

earlier (but after vaccination), and it was reasonable to assume a viral infection was more likely

explanatory. Id. Because Petitioner was never tested for possible “viral suspects,” however, it

could not be ascertained what might have been a credible alternative causal explanation—but

regardless, in almost half of all GBS cases only an idiopathic (and hence unidentified) cause can

be offered. Id. at 6; B. van den Berg et al., Guillain-Barre Syndrome: Pathogenesis, Diagnosis,

Treatment and Prognosis 10 Nat. Rev. Neurol 469, 469 (2014), filed as Ex. A-3 (ECF No. 73-3)

(stating that [t]wo-thirds of patients report symptoms of a recent respiratory or gastrointestinal

tract infection before the onset of GBS” … but “[i]n about half of patients with GBS, a specific

type of receding infection can be identified.”).

By contrast, Dr. Rezania doubted the Tdap vaccine could have been causal of Petitioner’s

GBS. For starters, the risk of GBS after such a vaccine was much lower than the risk associated

with the flu vaccine (and even the updated version of that vaccine posed less of a risk than the one

associated with GBS during the swine flu epidemic in the 1970s). Rezania Rep. at 4; D. Salmon et

al., Association Between Guillain-Barre Syndrome and Influenza A (H1N1) 2009 Monovalent

Inactivated Vaccines in the USA: a Meta-Analysis. 381 Lancet 1461, 1461 (2013), filed as Ex. A-

8 (ECF No. 73-8) (suggesting only a “small increased risk” of GBS associated with the influenza

A (H1N1) 2009 monovalent inactivated vaccine). At most, some case reports speculated that there

could be an association with the Tdap vaccine, but they did not constitute especially persuasive

evidence.

Dr. Rezania questioned the probative value of other items of evidence cited in Dr.

Tornatore’s Report. Ezeanolue, for example, not only settled on the less-impactful use of the word

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“precaution” (rather than “contraindication”), but it also suggested the absence of “strong evidence

of a significant association” between GBS and Tdap. Rezania Rep. at 4; Ezeanolue at 56. And

Souayah relied on passive surveillance data intended for use as “signal detection,” and thus was

not reliable proof of causation. Rezania Rep. at 5 (“VAERS data may be incomplete, imprecise,

incidental, or unable to be substantiated, and it should not be used independently to ascertain

vaccine-related adverse events”). In addition, Dr. Rezania challenged the probative value of

evidence offered by Dr. Tornatore specific to the flu vaccine—not only because such evidence

involved a different vaccine, but also due to the fact that the articles in question often did not

actually support causation meaningfully. Id. at 5–6.

Dr. Tornatore’s attempt to establish homologic similarity between the tetanus component

of Tdap and MBP nerve elements was also unsuccessful, in Dr. Rezania’s estimation. Rezania

Rep. at 6. Dr. Tornatore’s own personal findings (from desktop computer research) could not be

relied upon in the first place, since they did not reflect peer-reviewed and published determinations.

Id. Inglis aside, “the target antigen in the majority of AIDP (the GBS variant the petitioner had)

cases is yet unrecognized, and there is no clear evidence of molecular mimicry between specific

pathogens and components of myelin or Schwann cells in the majority of AIDP patients.” Id; N.

Shahrizaila et al., Guillain-Barre Syndrome, 397 Lancet 1214, 1218 (2021), filed as Ex. A-24 (ECF

No. 73-24) (indicating that autoantibodies against myelin proteins are not detected in individuals

with AIDP, and that anti-neurofascin antibodies are quite rare); H. Koike et al., Emerging

Infection, Vaccination, and Guillain-Barre Syndrome: A Review. 10 Neurol. Ther. 523, 523

(2021), filed as Ex. A-25 (ECF No. 73-25) (concluding that “mimicry between specific pathogens

and myelin or Schwann cell components has not been clearly demonstrated in AIDP”). Homology

alone also was not predictive of an autoimmune cross-reactive event. And Dr. Tornatore’s BLAST

research did not also include evidence suggesting what cross-reactivity would lead to—antibody

or T cells—furthering the degree to which he speculated as to the negative impact stemming from

the putative existence of homology. Rezania Rep. at 6.

2. Olajumoke Fadugba, M.D. – Dr. Fadugba is a medical and academic

immunologist, and she prepared one written report. See Report, dated Dec. 16, 2024, filed as Ex.

C (ECF No. 72-3) (“Fadugba Rep.”).

Dr. Fadugba attended the University of Delaware for her undergraduate degree, and

Vanderbilt University School of Medicine for her medical degree. Curriculum Vitae, filed as Ex.

D (ECF No. 72-4) (“Fadugba CV”), at 1. She then completed an internship and residency in

Internal Medicine at Washington University School of Medicine, followed by a fellowship in

Allergy and Immunology at Vanderbilt University School of Medicine. Id. She currently is an

Associate Professor of Clinical Medicine at the University of Pennsylvania School of Medicine,

as well as the Fellowship Program Director and Chief of the Allergy and Immunology Section at

the University of Pennsylvania. Id.; Fadugba Rep. at 1. Dr. Fadugba is board certified by the

American Board of Internal Medicine and the American Board of Allergy and Immunology.

9

Fadugba CV at 1–2. She is involved in evaluating and treat vaccine responses in both a clinical

and immunologic setting, as well as vaccine reactions reported by his adult patients. Fadugba Rep.

at 1.

The initial section of Dr. Fadugba’s report featured an overview of Petitioner’s relevant

medical history. Fadugba Rep. at 2–6. She also provided a brief description of GBS, emphasizing

that it is usually a post-infectious condition (especially related to prior gastrointestinal or

respiratory symptoms). Id. at 6–9; R. Bellanti & S. Rinaldi, Guillain-Barré Syndrome: A

Comprehensive Review, 31 Eur. J. Neurol. 1, 1 (Aug. 2024), filed as Ex. C-1 (ECF No. 73-28)

(“Bellanti & Rinaldi”). GBS is associated with a number of specific infections (although not with

any of the Tdap vaccine’s component analogs). Bellanti & Rinaldi at 3. Dr. Fadugba acknowledged

that medical science hypothesized the existence of a “humoral mechanism” (meaning mediated by

antibodies) for how GBS might occur, but noted that specific “anti-myelin antibodies have yet to

be identified” (although she also allowed that certain ganglioside-specific autoantibodies were

associated with at least one variant form of GBS). Fadugba Rep. at 7, 8. Indeed, almost half of all

GBS patients did not test positive for any known autoantibodies even putatively associated with

the condition. Id.

Dr. Fadugba did not accept Dr. Tornatore’s causation theory as evidentiarily-established,

and she specifically took issue with several of his contentions. First, she denied the significance of

certain government publication statements about the risks of GBS in association with the Tdap

vaccine. Fadugba Rep. at 8–9. The ACIP precaution about administration of the Tdap vaccine to

individuals who had previously both experienced GBS and after prior Tdap vaccination itself noted

the insufficiency of evidence of causality (pro or con) with respect to the two, and that passive

surveillance data had not suggested otherwise. Fadugba Rep. at 9; Ezeanolue at 56. Thus, the

precaution against a second administration of the vaccine to individuals who previously incurred

GBS after vaccination was not itself strong evidence of causation.

Second, Dr. Fadugba deemed unpersuasive the evidence cited by Dr. Tornatore as

suggesting that molecular mimicry was a likely mechanism for how “autoimmune neurologic

conditions like GBS” occur. Fadugba Rep. at 9. Evidence specific to cross-reactivity occurring in

the wake of a Campylobacter jejuni infection, she noted, was far more robust than evidence of the

same kind of reaction after receipt of the Tdap vaccine. Id. at 9–10. Indeed, since the time of the

1970s swine flu epidemic (and resulting studies showing an association between the flu vaccine in

use at that time and GBS), subsequent studies had more often than not failed to show such a link.

See, e.g., A. Babazadeh et al., Influenza Vaccination and Guillain–Barré Syndrome: Reality or

Fear, 7 J. Trans. Intern. Med. 137, 140 (2019), filed as Ex. C-4 (ECF No. 73-31) (“Babazadeh”)

(stating that “[i]n fact [the] 1976 H1N1 influenza vaccine in New Jersey is the only proven

10

association of GBS and influenza vaccination”). 11 Dr. Tornatore, however, could only cite to a

number of fairly-old studies involving animal model experiments which were not only applicable

primarily to the flu vaccine, but could not be deemed strong evidence of how a human would react

to an analogous vaccine stimulus. Fadugba Rep. at 10–11. And other studies suggesting T cell

recognition of MBP could not reasonably be understood to also mean that this lead to autoimmune

disease (especially in the disparate context of a tetanus-containing vaccine). Id. at 11–12.

Dr. Fadugba similarly took issue with the argument advanced by Dr. Tornatore that (based

on his own BLAST search) homology could be demonstrated between the P2 protein (which other

studies had suggested could be an antigenic target for neuropathic autoimmune conditions) and

tetanus toxin—allowing the analogy that if the flu vaccine could react against that protein, so too

could the Tdap tetanus component. Fadugba Rep. at 12. She noted in reaction that a mere showing

of sequential homology as not enough to establish that the homologous antigen is likely to cause

an autoimmune-mediated disease process. Id. Rather, medical science understood that several

criteria needed to be satisfied. L. Peterson & R. Fujinami, Molecular Mimicry, in Autoantibodies

13–19 (2nd ed. 2007), filed as Ex. C-9 (ECF No. 73-36). But those had not been met in this case.

Dr. Tornatore’s showing of epitope similarity was too “nonspecific,” with no independent

evidence showing that the tetanus toxin was believed to have similarity with relevant host nerve

sequences, no evidence that Petitioner possessed cross-reactive antibodies that could have

prompted a pathogenic response, no independent epidemiologic evidence 12 that the Tdap vaccine

likely causes GBS, and no reproducible animal model results supporting the theory either. Fadugba

Rep. at 13–14. Otherwise, Dr. Tornatore over-relied on case reports of studies interpreting passive

surveillance data—weak proof of causation. Id. at 14.

While there was overall, Dr. Fadugba opined, insufficient direct proof that the Tdap

vaccine could cause GBS, there existed sound epidemiologic evidence for the contrary position.

Fadugba Rep. at 14–15. One large-scale study involving thousands of Kaiser Permanente managed

11

Dr. Fadugba also in this context briefly questioned the persuasive value of Dr. Tornatore’s contention that immune

“degeneracy” (in which “a single T cell receptor may recognize thousands of different peptide sequences”) explained

how many vaccines could result in the same aberrant response known to occur for one, despite their differences.

Fadugba Rep. at 10. Were this true, she reasoned, one would expect to see “an unquantifiable prevalence of

autoimmune disease in the general population”—as well as any number of different environmental triggers for GBS—

yet this was not so. Id.

12

I fully recognize that the Program itself never requires claimants to offer epidemiologic evidence affirmatively

supporting their causation theory. I also note that the criteria that medical professionals or scientists might apply in

evaluating whether molecular mimicry has a persuasive explanatory basis for a given autoimmune condition is not

congruent with the Program’s causation prongs or evidence used to support them. Nevertheless—and as I have ruled

in other cases—the fact that these kind of criteria are what experts consider important in analyzing the applicability

of molecular mimicry to a given disease or illness is something a special master can reasonably consider, in evaluating

overall if it is “more likely than not” that molecular mimicry has explanatory value when affirmatively offered in a

Vaccine Act case to explain how or why a vaccine could have caused a particular injury. Cerrone v. Sec’y of Health

& Hum. Servs., No. 17-1158V, 2023 WL 3816718 (Fed. Cl. Spec. Mstr. June 1, 2023), mot. for review den’d, 168

Fed. Cl. 745 (2023), aff’d, 146 F.4th 1113 (Fed. Cir. 2025).

11

care program participants identified no association between the Tdap vaccine and GBS. R. Baxter

et al., Lack of Association of Guillain-Barré Syndrome with Vaccinations, 57 Clin. Infect. Dis. 197

(July 2013), filed as Ex. C-13 (ECF No. 73-40) (“Baxter”). During the study period, only 415 cases

of GBS were confirmed (out of x>30 million person-years), and the calculated risk for developing

GBS after a tetanus vaccine between the observed six-week interval and the prior 12 months for

tetanus diphtheria combination was 1.4—which both the authors of the study and Dr. Fadugba

interpreted as not supportive of an association between the Tdap vaccine and GBS. Id. at 197;

Fadugba Rep. at 15. Baxter’s authors maximized the validity of their results by incorporating

methods that allowed them to control confounders that can render uncontrolled studies invalid,

such as only using confirmed cases of GBS, and employing a case-centered design with a

comparison group. Baxter at 197. 13

Dr. Fadugba concluded with a discussion of Petitioner’s onset and its medical acceptability,

measured from the date of vaccination. Fadugba Rep. at 15–16. Dr. Tornatore offered literature

specific to the flu vaccine for this aspect of his opinion, and did not identify comparable literature

specific to tetanus-containing vaccines. Id. at 15. She admitted, however, that an 11-day onset was

otherwise “biologically plausible.” Id. Dr. Fadugba also proposed that the medical record better

supported the conclusion that a concurrent or preexisting infection explained Petitioner’s GBS,

since Petitioner’s treatment history established evidence of both “viral upper respiratory tract

symptoms” and gastrointestinal issues before or around the time of her hospitalization. Id. at 16.

III. Procedural History

The Petition was filed more than six years ago. The matter remained in “pre-assignment

review” for eight months, while Petitioner endeavored to obtain and file records relevant to the

claim. It was thereafter assigned to a different special master in the spring of 2020, and the parties

spent nearly three years attempting to settle the claim (culminating in an unsuccessful alternative

dispute resolution effort). Respondent’s Rule 4(c) Report opposing compensation was at long last

filed in April 2023 (ECF No. 53), and the parties next engaged in expert discovery through the end

of 2024. The matter was reassigned to me in the winter of 2025, and at that time I set a schedule

for ruling on the record, with briefing completed in April of this year. The claim is now ripe for

resolution.

IV. Parties’ Arguments

Petitioner

13

Dr. Fadugba also referenced a comparable study focusing on the HPV vaccine but finding no link. Fadugba Rep. at

15 (citing T. Boender et al., Risk of Guillain-Barré Syndrome after Vaccination Against Human Papillomavirus: A

Systematic Review and Meta-Analysis, 1 January 2000 to 4 April 2020, 27 Euro. Surveill. 4:2001619 (Jan. 2022), filed

as Ex. C-14 (ECF No. 73-41). However (and as noted above), because Petitioner’s causation contentions focus only

on the Tdap vaccine, I do not include analysis of the causal role, if any, of the HPV vaccine.

12

Petitioner maintains that all three causation prongs established by the Federal Circuit in

Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005), are satisfied herein.

Br. at 8, 10, 16–17. 14 First, she argues that the “can cause” prong is met. Id. at 17–22. In so

contending, Petitioner maintains that the Program has effectively “accepted” a causal association

between tetanus toxoid-containing vaccines and GBS. Br. at 22. To support this proposition, she

notes that a number of older Program cases recognized an association, relying on prior

governmental publications akin to what Dr. Tornatore invokes or independent case reports like

Pollard & Selby. Id. at 17–19. A 2011 “Institute of Medicine” publication on vaccine-associated

adverse events later downplayed the strength of evidence on the association. But it seemed to

require a level of proof approaching certainty that does not apply in Vaccine Act cases. Id. at 19–

20.

Subsequent decisions in the Program expressly recognized that the Government had likely

conceded causation over time, even if superseding publications did not expressly so state. Br. at

20–21; Mohamad v. Sec’y Health & Hum. Servs., 2022 WL 711604 (Fed. Cl. Spec. Mstr. Jan. 27,

2022), mot. for review den’d, No. 16-1075V, 2024 WL 4943421 (Fed. Cl. Nov. 12, 2024). And

some subsequent publications, like Ezeanolue, bulwarked that conclusion. Br. at 21. In addition,

more often than not Tdap-GBS cases are settled—and from that Petitioner noted “the obvious

implication is that settling so many cases seems to be an admission that Respondent accepts the

association between tetanus vaccines and GBS.” Id. at 22.

Petitioner also argues that Dr. Tornatore’s causation theory was preponderantly

established. Br. at 22–23. Dr. Tornatore observed (referencing Hughes & Cornblath) that GBS’s

pathogenesis likely implicates molecular mimicry as its mechanism, and that the homology

demonstrated by Dr. Tornatore between the tetanus toxin and the P2 protein established the

possibility of an autoimmune cross-reaction. Id. at 23. Petitioner’s contentions regarding the

second and third prongs are more succinct. Id. at 23–25. In effect, she maintains both are met

(although she only references Dr. Tornatore’s opinion with respect to the third prong in so

contending). Id. at 24.

On Reply, Petitioner insists that the tetanus vaccine can cause GBS, and in fact should be

on the Vaccine Injury Table, given the strength of evidence supporting the association. Reply at

1–2. Petitioner again points to prior decisions from Special Masters where entitlement was found

in favor of Petitioner for tetanus-GBS claims, and where Respondent settled over seventy cases

for tetanus-GBS claims. Id. (discussing Harris v. Sec’y of Health & Hum. Servs., No. 18-944V,

14

Petitioner also devoted much of her brief to the proposition that she need only demonstrate a “biologically plausible

theory,” rather than meet the preponderant, “more likely than not” standard that facially governs causation claims. Br.

at 8, 9–16. But to the extent there was previously any doubt about this question, it was disposed of by the Federal

Circuit as of this past summer. Cerrone, 146 F.4th at 1121 (a petitioner’s assertion that Althen prong one requires only

a showing of plausibility “understates the burden [a petitioner] bears under the first factor in the Althen formulation”).

I therefore do not address those aspects of Petitioner’s brief that mischaracterize her legal obligations.

13

2023 WL 2583393 (Fed. Cl. Feb. 21, 2023); Mohamad, 2022 WL 711604. Further, Petitioner

argues that Respondent cannot carry his burden of establishing the existence of a causal “factor

unrelated,” since no alternatively-causal virus has been identified. Id. at 3–7.

Respondent

Respondent contends that the Petitioner has failed her requisite showing on all three Althen

prongs. First, he maintains the initial Althen “can cause” prong is not met. Opp. at 11–14. Although

Dr. Tornatore asserts that the Government has conceded a causal role of the Tdap vaccine in GBS,

the “precaution” warning in Ezeanolue did not include reliable findings of a causal relationship,

and thus constituted only a conservative warning about limited circumstances, based on a few case

report instances as well. Id. at 11–12. And it otherwise was inapplicable to Ms. Hiatt, who had not

been shown to have previously experienced post-Tdap vaccine GBS. Id. at 12.

More specifically, the theory that the Tdap vaccine could spark an autoimmune cross-

reaction via autoantibodies created due to mimicry between the vaccine’s tetanus component and

self-nerve tissues was speculative and dependent on evidence relating to other vaccines or non-

analogous infections, or studies that actually did not demonstrate pathogenic effects from

molecular mimicry’s causation of autoantibodies. Opp. at 12–13. The very concept of molecular

mimicry has widespread acceptance in the medical and scientific community—and yet no “reliable

or reproduceable evidence in the literature of tetanus vaccine causing GBS” had been offered in

this action. Id. at 13. Instead, outdated case reports (like Pollard & Selby) or studies considering

VAERS data, like Souayah, were referenced—weak support for causation. Id.

Petitioner also failed to meet the other two Althen prongs, Respondent argued. Her primary

contemporaneous treaters never accepted the Tdap vaccine as causal—while proposing a

preceding gastrointestinal illness may have been. Opp. at 14 (citing Ex. 9 at 26–27). Actual

treatment evidence, like lab work, supported this conclusion—and it was consistent with Dr.

Tornatore’s concession that most individuals who experienced GBS did so after a prior infection.

Tornatore Rep. at 11. Thus, the “did cause” prong was unmet. The timeframe prong also had not

been satisfied, since (given that prong one causation had not been demonstrated), it could not also

be shown that there was any possible medically-acceptable timeframe for onset. Opp. at 16.

V. Applicable Law

A. Petitioner’s Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that

he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—

corresponding to one of the vaccinations in question within a statutorily prescribed period of time

or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table

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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 ex rel. 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). 15 There is no Table claim for GBS caused by a tetanus-containing vaccine.

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 Health & Hum. Servs., 165 F.3d 1344, 1352–53

(Fed.Cir.1999)); Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006).

A petitioner may not receive a Vaccine Program award based solely on his assertions; rather, the

petition must be supported by either medical records or by the opinion of a competent physician.

Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a

Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal

Circuit in Althen, 418 F.3d at 1278: “(1) a medical theory causally connecting the vaccination and

the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason

for the injury; and (3) a showing of proximate temporal relationship between vaccination and

injury.”

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners

must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the

type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a

petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”

Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must

only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,

epidemiological studies, demonstration of a specific mechanism, or even a generally accepted

15

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).

15

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 v.

Sec'y of Health & Hum. Servs, 121 Fed. Cl. 230, 245 (2015), vacated and remanded, 844 F.3d

1363 (Fed. Cir. 2017).

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 Cerrone v. Sec’y of Health & Hum.

Servs., 146 F.4th 1113, 1121 (Fed. Cir. 2025) (petitioner’s argument that Althen prong one requires

only a showing of plausibility “understates the burden [a petitioner] bears under the first factor in

the Althen formulation”); Kalajdzic v. Sec’y of Health & Hum. Servs., No. 2023-1321, 2024 WL

3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for a less than preponderance standard”

deemed “plainly inconsistent with our precedent” (citing Moberly, 592 F.3d at 1322)); Boatmon v.

Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also Howard v. Sec'y of

Health & Hum. Servs., 2022 WL 4869354 (Fed. Cl. Spec. Mstr. Aug. 31, 2022), mot. for review

den’d, 2023 WL 4117370, at *4 (Fed. Cl. May 18, 2023) (“[t]he standard has been preponderance

for nearly four decades”), aff’d, 2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished). And

petitioners always have the ultimate burden of establishing their overall Vaccine Act claim with

preponderant evidence. W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir.

2013) (citations omitted); Tarsell v. United States, 133 Fed. Cl. 782, 793 (2017) (noting that

Moberly “addresses the petitioner’s overall burden of proving causation-in-fact under the Vaccine

Act” by a preponderance standard).

The second Althen prong requires proof of a logical sequence of cause and effect, usually

supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,

569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs., 956

F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions

and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d

at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored

in vaccine cases, as treating physicians are likely to be in the best position to determine whether a

‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)

(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly

trustworthy evidence, since they are created contemporaneously with the treatment of the patient.

Cucuras, v. Sec’y of Dept. of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

16

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 den’d, 100 Fed.

Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between

the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the

phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant

proof that the onset of symptoms occurred within a timeframe which, given the medical

understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan v.

Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is

a medically acceptable timeframe must align with the theory of how the relevant vaccine can cause

an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum. Servs.,

101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012), aff’d mem.,

503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V, 2013

WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. den’d (Fed. Cl. Dec. 3, 2013),

aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Legal Standards Governing Factual Determinations

The process for making determinations in Vaccine Program cases regarding factual issues

begins with consideration of the medical records. Section 11(c)(2). The special master is required

to consider “all [ ] relevant medical and scientific evidence contained in the record,” including

“any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained

in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability,

injury, condition, or death,” as well as the “results of any diagnostic or evaluative test which are

contained in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special

master is then required to weigh the evidence presented, including contemporaneous medical

records and testimony. See Burns v. Sec'y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.

17

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, 993 F.2d at 1528 (“[i]t

strains reason to conclude that petitioners would fail to accurately report the onset of their

daughter's symptoms”).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL

6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records

are often found to be deserving of greater evidentiary weight than oral testimony—especially

where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also

Murphy v. Sec'y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d

1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States

v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral

testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight.”)).

However, the Federal Circuit has also noted that there is no formal “presumption” that

records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health

& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which

compelling oral or written testimony (provided in the form of an affidavit or declaration) may be

more persuasive than written records, such as where records are deemed to be incomplete or

inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any

norm based upon common sense and experience, this rule should not be treated as an absolute and

must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL

6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less

18

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

den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x 999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d

at 1339). Weighing the relative persuasiveness of competing expert testimony, based on a

particular expert's credibility, is part of the overall reliability analysis to which special masters

must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26

(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);

see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court

has unambiguously explained that special masters are expected to consider the credibility of expert

witnesses in evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Both parties filed numerous items of medical and scientific literature in this case, but not

all such items factor into the outcome of this decision. While I have reviewed all the medical

literature submitted 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., No. 2015–5072,

2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special master

considered the relevant record evidence even though he does not explicitly reference such evidence

in his decision”) (citation omitted); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F.

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App’x 875, 884 (Fed. Cir. 2013) (“[f]inding certain information not relevant does not lead to—and

likely undermines—the conclusion that it was not considered”).

E. Determination to Resolve Case without a Hearing

I have opted to decide entitlement in this case based on written submissions and evidentiary

filings, including the expert reports filed by each side. The Vaccine Act and Rules not only

contemplate but encourage special masters to decide petitions on the papers rather than via

evidentiary hearing, where (in the exercise of their discretion) they conclude that the former means

of adjudication will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d).

The choice to do so has been affirmed on appeal. See D'Toile v. Sec'y of Health & Human Servs.,

No. 15-85V, 2018 WL 1750619, at *2 (Fed. Cir. Apr. 12, 2018); see also Hooker v. Sec'y of Health

& Human 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 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. See Hovey v. Sec'y of Health & Human Servs., 38 Fed. Cl. 397, 402–

03 (1997) (special master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d

at 417.

ANALYSIS

I. Overview of GBS and its Treatment in Prior Program Cases

There is no dispute in this case as to the propriety of the GBS diagnosis. See, e.g., Opp. at

11. But some discussion of the condition’s features will still be helpful in resolving causation. GBS

has been defined as an acute, monophasic peripheral neuropathy involving rapidly-progressive and

ascending weakness and paralysis, and which is thought to have an autoimmune mechanism.

Bellanti & Rinaldi at 5. It usually presents with “pain, numbness, paraesthesia, or weakness in the

limbs.” Hughes & Cornblath at 1661; Bellanti & Rinaldi at 5.

Reliable scientific evidence supports the conclusion that GBS can be vaccine-caused—

specifically by the flu vaccine (although the risk from a wild flu infection is much greater). Bellanti

& Rinaldi at 3. Consistent with this, a large body of reasoned Program decisions 16 recognize an

association between the flu vaccine and GBS (as well as other related peripheral neuropathies).

Indeed, there is a Table claim for GBS due to receipt of a flu vaccine. 42 C.F.R. § 100.3.14. This

means the Government accepts that sufficiently-probative and reliable science on the topic exists

to justify conceding causation, at least for Program purposes. Haskins v. Secretary of Health &

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Although prior decisions from different cases do not control the outcome herein, special masters may reasonably

take into account, for guidance, the logic of such reasoned determinations. In fact, it is wise to do so, given how often

similar causation theories or fact patterns arise in Vaccine Program cases.

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Hum. Servs., No. 18-1776V, WL 2020 1870279 (Fed. Cl. Spec. Mstr. Mar. 13, 2019). Even in

cases where a Table element for such a claim cannot be met (for example, when onset is too short

or too long to fit within the timeframe of 3–42 days set for the claim), any subsequent causation-

in-fact analysis performed by the special masters rarely requires the claimant to offer proof in

support of the first Althen prong, “can cause” element; instead, it is reasonably assumed to be

satisfied already. See Welch v. Sec’y of Health & Hum. Servs. No. 18-494V, 2019 WL 349360

(Fed. Cl. Spec. Mstr. July 2, 2019).

Other vaccines have also been found causal of GBS, although there is disagreement among

the special masters as to the preponderant strength of these proposed associations. See, e.g., Gross

v. Sec’y of Health & Hum. Servs., No. 17-1075, 2022 WL 9669651, at *36–37 (Fed. Cl. Spec.

Mstr. Sept. 22, 2022) (finding the pneumococcal vaccine caused GBS); but see Trollinger v. Sec’y

of Health & Hum. Servs., No. 16-473V, 2023 WL 2521912, at *30 (Fed. Cl. Spec. Mstr. Feb. 17,

2023), mot. for review den’d, 167 Fed. Cl. 127 (2023) (holding that the pneumococcal vaccine was

not shown to cause GBS); Bielak v. Sec’y of Health & Hum. Servs., No. 18-761V, 2022 WL

18058244, at *3 (Fed. Cl. Spec. Mstr. Dec. 9, 2022) (same). It thus cannot be said that the Program

has developed a consistent view as to what the science preponderantly “says” about causation of

GBS when the flu vaccine is not involved. Instead, it appears that the outcome in such cases is

mostly a function of the evidence before the special master (along with a special master’s

individual views about the applicability of causation theories to different vaccines), with no clear

trend one way or the other.

This is definitely true for claims that the Tdap vaccine can cause GBS. Several cases

decided in the past ten years (some of which I authored) found no causal association between the

two. 17 See, e.g., Kaczerowski v. Sec’y of Health & Hum. Servs., No. 21-758V, 2025 WL 2798865,

at *29–38 (Fed. Cl. Spec. Mstr. Aug. 28, 2025); Dennington v. Sec'y of Health & Hum. Servs., No.

18-1303V, 2023 WL 2965239 (Fed. Cl. Spec. Mstr. Apr. 17, 2023), mot. for review den’d, 167

Fed. Cl. 640 (2023), appeal dismissed, No. 2024-1214, 2024 WL 1255318 (Fed. Cir. Mar. 25,

2024); 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. June 21, 2013), mot. for review den’d, 117 Fed. Cl. 713 (2014);

Isaac, 2012 WL 3609993 at 19. 18

17

I have also decided a few cases in which I determined that the petitioner failed to establish a causal association

between the Tdap vaccine and CIDP—a different injury from GBS, although also still a peripheral neuropathy (and

Program claimants frequently rely on GBS-specific evidence in arguing that a vaccine can cause CIDP). See, e.g.,

DeVaughn v. Sec'y of Health & Hum. Servs., No. 22-832V, 2025 WL 758128 (Fed. Cl. Spec. Mstr. Feb. 10, 2025);

Howard, 2022 WL 4869354 at *26; Sanchez v. Sec’y of Health & Hum. Servs., No. 18-1012V, 2022 WL 1013264, at

*1 (Fed. Cl. Spec. Mstr. Mar. 11, 2022).

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I recently decided another case involving the contention that the Tdap vaccine can cause GBS, but resolution turned

on the third Althen prong, rendering that decision less valuable for guiding the present outcome. Langert v. Sec’y of

Health & Hum. Servs., No. 22-809V, 2025 WL 1892418 (Fed. Cl. Spec. Mstr. June 13, 2025).

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Prior Tdap-GBS cases have often involved causation theories comparable to what is

offered here. In my recent Kaczerowski decision, a petitioner employed Dr. Tornatore, as here.

And in that case, Dr. Tornatore relied on numerous contentions and specific items of literature that

have been offered in this case as well. See, e.g., Kaczerowski, 2025 WL 2798865, at *2–10. But I

deemed his showing not to meet the preponderant standard—even though the petitioner filed four

reports from Dr. Tornatore, allowing him ample opportunity to refine his opinion in response to

the critiques raised by Respondent’s experts.

In Isaac, a petitioner proposed molecular mimicry as the causal mechanism. Issac, 2012

WL 3609993, at *6. But the special master determined that the petitioner’s expert had over-relied

on a single case report (Pollard & Selby—also offered here) to prove causation, without adequately

substantiating the mechanism. Id. at *20–21. This determination was affirmed on appeal at the

Court of Federal Claims and Federal Circuit. In Tompkins, the special master denied entitlement

in a case alleging that a number of vaccines received at the same time (including Tdap) 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, and otherwise invoked a number of

theories (molecular mimicry, or endotoxin in tetanus-containing vaccines) that were only cursorily

substantiated. Id. at *19–23.

Admittedly (and as vociferously stressed by Petitioner), some special masters have deemed

causation demonstrated in Tdap vaccine-GBS cases. See Harris, 2023 WL 2583393; Mohamad,

2022 WL 711604, at *18. In Mohamad, a special master ruled in a petitioner’s favor in a Tdap-

GBS case, but almost wholly based on the determination that the Government had effectively

conceded the first Althen Prong. In particular, the special master observed that (a) in 2011, the

IOM had noted a precaution to receipt of the Tdap vaccine in the future if an immunized individual

had developed GBS within six weeks of a prior dose, and (b) this precaution note (along with an

acknowledgment of the possibility of encephalopathy in a seven-day timeframe) had been

maintained in subsequent ACIP reports, despite interim findings that the tetanus-GBS link was not

as well-established as previously thought. Mohamad, 2022 WL 711604, at *13–15. From this (and

also due to credibility determinations specific to the experts who had testified in that case), the

special master concluded that the first Althen prong was satisfied. Id. at *7, 15–18.

As I have noted in other cases, however, the argument that the temporal sequence of

governmental publications discussing GBS as a possible adverse event from receipt of the Tdap

vaccine, coupled with treatment advice against giving it again to a person who previously also

experienced Tdap vaccine-associated GBS, does not amount to persuasive proof that the

Government “knows” there is causal association. Kaczerowski, 2025 WL 2798865, at *34. And

efforts to broadly apply the same thinking applicable to the flu vaccine and GBS to all other

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covered vaccines are not sufficient either. Instead, a claimant seeking to prove the Tdap vaccine

caused an individual’s GBS needs to offer some overall combination of proof with some specificity

to the Tdap vaccine’s components, rather than analogizing to the flu vaccine. This showing must

be preponderantly established—not simply that it is biologically plausible a vaccine could impact

the immune system in such a way that it could lead to an autoimmune demyelinating disease, but

that it likely does so.

II. Petitioner Has not Carried Her Burden of Proof

It is understood in the Vaccine Program that because claimants must preponderantly

establish all three Althen prongs to receive damages, special masters need only evaluate those

causation elements relevant to a denial of entitlement. Dobrydnev v. Sec’y of Health & Hum.

Servs., 566 Fed. Appx. 976, 980 (Fed. Cir. 2014). Here, I find the first Althen prong has not been

satisfied (and that failure alone is grounds for denying entitlement).

First, I do not find that it has been shown that the Government has conceded a Tdap-vaccine

causal association. As noted in Kaczerowski, that kind of reasoning was actually rejected by a prior

special master in the Tompkins decision, issued in 2013—nearly 10 years before Mohamad.

Kaczerowski, 2025 WL 2798865, at *34 (referencing Tompkins, 2013 WL 3498652, at *26). It

certainly could be ascertained that Government publications have not affirmatively stated that

there is no possible Tdap vaccine-GBS relationship—and I do not conclude that either. But clearly

and over time, commentary on GBS as a possible adverse effect of receipt of a Tdap vaccine moved

away from the view that the association was well-founded to a more neutral position. While the

issue may be legitimately disputed in the context of a Vaccine Program claim, the Government

cannot be said to have conceded the point entirely.

What of the more recent publications discussing treatment precautions about the use of the

Tdap vaccine? Those precautions apply solely to circumstances not relevant to this case, since

Petitioner never had GBS before after receipt of a prior Tdap vaccine dose. Moreover (and as Dr.

Fadugba persuasively established), the precaution is itself weak proof of causation, and documents

offered to substantiate it contain equivocal statements about the strength of any purported

association. Fadugba Rep. at 9. I do not deny that this precaution provides some support for

Petitioner’s causation theory—but it is ultimately too flimsy and irrelevant to the facts of this case

to aid Petitioner all that much.

Second, Respondent’s willingness to settle petitions alleging GBS after receipt of a Tdap

vaccine is not itself reliable proof that the causation theory advanced herein has preponderant

support. I have addressed the exact same contention in other cases where I denied entitlement. See,

e.g., Howard, 2022 WL 4869354, at *22–23. No matter how many times Respondent may have

resolved cases involving the same theory or injury, the choice by a litigant to settle a case does not

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stand as evidence that the causal theory underlying such claims is correct, preponderantly-

established, or reflects reasoning the Respondent shares (and of course the decision to settle any

case is not evidence of the strength of one side’s position that can be deemed persuasive authority

by as judicial neutral). Only reasoned decisions by other special masters (which do exist—and

which admittedly in some instances are favorable to Petitioner herein) deserve any consideration

as guidance. A list of cases in which petitioners “won” is not proof of causation.

Finally, there are too many substantive deficiencies in Dr. Tornatore’s theory as

specifically crafted herein for me to find that it has been preponderantly established. As noted

above, the theory was largely consistent with what Dr. Tornatore offered in Kaczerowski—a recent

case in which I also found the Tdap vaccine-GBS association not to have been preponderantly

established, and which provides useful guidance here as well (since the theories presented in both

cases were so similar). To summarize:

• While there is evidence suggesting that flu vaccine components could cause an

autoimmune-cross reaction with MBP sufficient to spark GBS, that evidence

cannot be applied in blanket fashion to the Tdap vaccine (or other disparate

vaccines for that matter);

• The wild-analogs to the TDAP vaccine components have not been shown to be

associated with GBS (for example, a tetanus wild bacterial infection);

• Passive surveillance data or case reports are weak proof of causation, and only

demonstrate a naked temporal association with vaccination;

• Existing epidemiologic evidence better supports the conclusion that the Tdap

vaccine is not likely associated with GBS; and

• Naked showings of putative amino acid sequential homology between antigens

compared to tetanus toxin and MBP-like proteins are speculative and/or insufficient

alone to prove an autoimmune cross-reaction between Tdap vaccine and the

identified self-antigen is “more likely than not” to lead to GBS.

See Kaczerowski, 2025 WL 2798865, at *33–38.

Dr. Tornatore made no additional causation arguments that distinguish the opinion he

offered in this case from what he proposed in Kaczerowski, and identified no more recent studies

bulwarking the putative vaccine association, while relying on numerous items of literature (Pollard

& Selby; Souayah; Ezeanolue; Hughes & Cornblath) also filed in this matter. Respondent,

however, referenced herein two epidemiologic studies more directly contradicting the conclusion

that the Tdap vaccine is associated with GBS. Babazadeh at 3; Baxter at 197. As a result, I have

25

been provided with no evidence in this case that would suggest I should diverge from my

determination in Kaczerowski. It has not been preponderantly demonstrated that “more likely than

not” the Tdap vaccine can cause GBS. Indeed, if anything the showing in this case (in which Dr.

Tornatore prepared a single report, not the four discussed in Kaczerowski) was even less well-

substantiated.

As a final point, I acknowledge that the special masters are not in agreement on the question

of Tdap vaccine causation of GBS, and this may lead to inconsistent outcomes. But this is

understood always to be possible in the Vaccine Program—often because the personal

medical/health circumstances of each allegedly injured party can impact the aberrant capacity of a

vaccine, as well as due to differences in the evidence offered from case to case. Special masters are

no more compelled to follow each other’s decisions than any trial judge would be in a district court.

Having now ruled in many Tdap-GBS cases, I can reasonably observe that overall the evidence

suggesting that there is a causal relationship between the two is quite thin.

CONCLUSION

A Program entitlement award is only appropriate for claims supported by preponderant

evidence. Here, Petitioner has not made such a 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. 19

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

19

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.

26