VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-01265
Package ID: USCOURTS-cofc-1_20-vv-01265
Petitioner: Christopher Demore
Filed: 2020-09-24
Decided: 2025-03-20
Vaccine: influenza
Vaccination date: 2018-10-02
Condition: myasthenia gravis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Christopher Demore, a 67-year-old man, received an influenza vaccine on October 2, 2018. Approximately two weeks later, he developed double vision, which progressed to other stroke-like symptoms. He was eventually diagnosed with myasthenia gravis, a neurological condition, which both parties' experts agreed was the correct diagnosis. Mr. Demore alleged that the flu vaccine caused his myasthenia gravis and filed a petition for compensation under the National Vaccine Injury Compensation Program. He argued that the vaccine caused his injury through a theory of molecular mimicry, supported by expert reports. The Secretary of Health and Human Services opposed the claim, relying on expert reports that questioned the causal link. The Special Master denied the petition, finding that Mr. Demore failed to establish by a preponderance of the evidence a persuasive medical theory connecting the flu vaccine to myasthenia gravis. The Special Master noted that the evidence, including an epidemiological study, tended to undermine the claim that the flu vaccine causes myasthenia gravis, and that the proposed analogies were not sufficiently persuasive. Mr. Demore sought review of this decision in the Court of Federal Claims, arguing that the Special Master applied an incorrect legal standard by requiring more than mere plausibility for the medical theory. The Court affirmed the Special Master's decision, holding that the correct standard of proof is a preponderance of the evidence, not mere plausibility, and that the Special Master correctly applied this standard. The Court found that Mr. Demore had not met his burden of proof on the first Althen prong (medical theory) and therefore could not receive compensation.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-01265-0
Date issued/filed: 2024-10-22
Pages: 12
Docket text: PUBLIC DECISION (Originally filed: 09/26/2024) regarding 82 DECISION of Special Master. Signed by Special Master Christian J. Moran. (jjb) Service on parties made.
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Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 1 of 12
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * *
CHRISTOPHER DEMORE, *
*
Petitioner, * No. 20-1265V
* Special Master Christian J. Moran
v. *
* Filed: September 26, 2024
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * *
Leah V. Durant, Law Offices of Leah V. Durant, Washington, DC, for petitioner;
Julianna Rose Kober, United States Dep’t of Justice, Washington, DC, for
respondent.
DECISION DENYING COMPENSATION1
Christopher Demore alleges that an influenza (“flu”) vaccine caused him to
suffer a neurologic condition, myasthenia gravis. He supported his claim by
presenting reports from two experts, David Simpson (a neurologist) and Ronald
Simon (a specialist in internal medicine and immunology). The Secretary opposed
an award of compensation. The Secretary also relied upon reports from two
experts, Mark Bromberg (a neurologist) and Marcela Pasetti (a Ph.D.
immunologist, who is not a medical doctor). After the parties developed their
evidence, the parties advocated through briefs.
1 Because this Decision contains a reasoned explanation for the action taken in this case,
it must be made publicly accessible and will be posted on the United States Court of Federal
Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal
Management and Promotion of Electronic Government Services). This means the Decision will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted on the website.

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 2 of 12
Mr. Demore has not demonstrated that he is entitled to compensation. He
has not presented a persuasive theory by which the flu vaccine can cause
myasthenia gravis.
I. Events in Mr. Demore’s Medical History2
Mr. Demore was born in 1951. Exhibit 11. Around the time of vaccination,
he worked as cook at a retreat center. Exhibit 12 (damages affidavit) ¶ 5.
Although Mr. Demore had some health problems before the vaccination, these pre-
existing conditions are not relevant to present decision.
Mr. Demore received a flu vaccine on October 2, 2018. Exhibit 1 at 2. He
alleges this vaccination caused his subsequent myasthenia gravis.
Mr. Demore developed diplopia (double vision) on October 18, 2018.
Exhibit 6 at 2952. After the diplopia continued for two days, Mr. Demore sought
care at an emergency department. Exhibit 7 at 4. The doctor admitted Mr.
Demore to the hospital. He stayed for a few days and was discharged. Mr.
Demore saw multiple medical professionals both inside and outside a hospital.
Eventually, doctors ordered tests for antibodies suggestive for myasthenia
gravis. See Exhibit 7 at 12. Mr. Demore was found to have ACH receptor binding
antibodies. Exhibit 2 at 51. A doctor at Duke Health, Firas Chazli, stated that
“positive ACH receptor binding antibodies [are] suggestive of myasthenia gravis.”
Exhibit 5 at 80. In the context of this litigation, the parties’ retained experts agree
that the appropriate diagnosis is myasthenia gravis. See Exhibit 14 (report of Dr.
Simpson) at 3; Exhibit A (report of Dr. Bromberg) at 6.
The remaining medical records chart the ebbs and flows of Mr. Demore’s
myasthenia gravis. Mr. Demore also described in an affidavit how the condition
has affected his life. Exhibit 47.
II. Procedural History
The course of Mr. Demore’s case is straightforward. He initiated the case by
filing the petition on September 24, 2020. He filed medical records.
2 Because the critical issue--whether the flu vaccine can cause myasthenia
gravis--is a general question, Mr. Demore’s medical history is summarized. For
more detailed accounts, see Pet’r’s Br., filed Jan. 3, 2024, at 2-11; Resp’t’s Br.,
filed Mar. 18, 2024, at 2-11.
2

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 3 of 12
Mr. Demore was directed to identify any treating doctors who linked his flu
vaccine to his myasthenia gravis. Mr. Demore forthrightly recognized that there
were no examples. Pet’r’s Status Rep., filed Feb. 1, 2021. Because Mr. Demore
was likely to seek a report from an expert, a set of instructions was issued on
February 3, 2021.
The Secretary advised that compensation should not be awarded. Resp’t’s
Rep., filed Mar. 3, 2021.
The parties submitted a series of reports from their experts. Each expert
wrote two reports--Dr. Simpson (Exhibits 14 and 43), Dr. Simon (Exhibits 40 and
44), Dr. Bromberg (Exhibits A and E), and Dr. Pasetti (Exhibit C and F).
The next step was for the parties to argue their cases. Order, issued June 29,
2023. Mr. Demore’s primary brief was filed on January 3, 2024 and his reply brief
was filed on April 17, 2024. In between, the Secretary filed his brief on March 18,
2024.
Mr. Demore’s case can be adjudicated on the papers. Because both parties
have had a fair opportunity to present their evidence and their arguments, an
adjudication based upon the papers is appropriate. See Kreizenbeck v. Sec'y of
Health & Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2018).
III. Standards for Adjudication
A petitioner is required to establish his case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence standard
requires a “trier of fact to believe that the existence of a fact is more probable than
its nonexistence before [he] may find in favor of the party who has the burden to
persuade the judge of the fact's existence.” Moberly v. Sec’y of Health & Hum.
Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted). Proof of
medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931
F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing special master's decision that petitioners were not entitled to
compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357
(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993) (disagreeing with dissenting judge's contention that the special master
confused preponderance of the evidence with medical certainty).
3

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 4 of 12
Petitioners bear a burden “to show by preponderant evidence that the
vaccination brought about [the vaccinee’s] injury by providing: (1) a medical
theory causally connecting the vaccination and the injury; (2) a logical sequence of
cause and effect showing that the vaccination was the reason for the injury; and (3)
a showing of a proximate temporal relationship between vaccination and injury.”
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
IV. Analysis
The dispositive prong is the first Althen prong, which concerns the medical
theory. Mr. Demore proposes molecular mimicry. Pet’r’s Br. at 13.3 However, at
the appropriate level of scrutiny, Mr. Demore’s evidence is not persuasive to
establish that this theory is reliable.
A. Appellate Cases Involving Molecular Mimicry
Because special masters are often called upon to evaluate the persuasiveness
of the theory of molecular mimicry, the Court of Federal Claims and the Court of
Appeals for the Federal Circuit have considered molecular mimicry in their
appellate role opinions from special masters. In December 2019, the undersigned
identified the leading precedents as W.C. v. Sec’y of Health & Hum. Servs., 704
F.3d 1352 (Fed. Cir. 2013), and Caves v. Sec’y of Health & Hum. Servs., 100 Fed.
Cl. 119 (2011), aff’d sub nom., 463 F. App’x 932 (Fed. Cir. 2012). Tullio v. Sec’y
of Health & Hum. Servs., No. 15-51V, 2019 WL 7580149, at *12-14 (Fed. Cl.
Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149 Fed. Cl. 448 (2020). While
Tullio describes those cases in more detail, their essence appears to be that
although molecular mimicry is accepted in some contexts, special masters may
properly require some empirical evidence to show that a particular vaccine can
cause a particular disease.
In the next approximately four years, appellate authorities reviewing
decisions involving molecular mimicry have generally endorsed the approach of
looking for some evidence that persuasively shows that a portion of a vaccine
3 Dr. Simpson’s report mentioned other theories, such as neurotoxic effect of
vaccines and immune complex formation. Of this group of theories, molecular
mimicry appeared to be the most developed. See Exhibit 14 at 4. As part of the
order for briefs, Mr. Demore was directed to put forward “complete and cogent
arguments.” In response, Mr. Demore advanced only the theory of molecular
mimicry. See Pet’r’s Br. at 13-17; Pet’r’s Reply at 2-5. Thus, only molecular
mimicry is discussed in this decision.
4

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 5 of 12
resembles a portion of human tissue, which contributes to causing the disease, and
that the immune system will respond to the relevant amino acid sequence.4
Chronologically, the list of more recent appellate cases begins with the opinion in
Tullio, which denied the motion for review. 149 Fed. Cl. 448, 467-68 (2020).
Another example in which the Court of Federal Claims held that the special
master did not elevate the petitioner’s burden of proof in the context of evaluating
the theory of molecular mimicry is Morgan v. Sec’y of Health & Hum. Servs., 148
Fed. Cl. 454, 476-77 (2020), aff’d in non-precedential opinion, 850 F. App’x 775
(Fed. Cir. 2021). In Morgan, the Chief Special Master found that petitioner had
not presented persuasive evidence about a relevant antibody. Id. at 477. The Chief
Special Master also noted that the articles about the relevant disease do not list the
wild flu virus as potentially causing the disease. Id. When examining this
analysis, the Court of Federal Claims concluded: “the Chief Special Master did not
raise the burden of causation in this case; petitioner simply failed to meet it.” Id.
The Federal Circuit also evaluated the Chief Special Master’s approach in
Morgan. The Federal Circuit concluded: “We discern no error in the special
master’s causation analysis.” 850 F. App’x 775, 784 (Fed. Cir. 2021).
Most other recent appellate cases follow this path. See, e.g., Duncan v.
Sec’y of Health & Hum. Servs., 153 Fed. Cl. 642, 661 (2021) (finding the special
master did not err in rejecting a bare assertion of molecular mimicry); Caredio v.
Sec’y of Health & Hum. Servs., No. 17-79V, 2021 WL 6058835, at *11 (Fed. Cl.
Dec. 3, 2021) (indicating that a special master did not err in requiring more than
homology and citing Tullio); Yalacki v. Sec’y of Health & Hum. Servs., 146 Fed.
Cl. 80, 91-92 (2019) (ruling that special master did not err in looking for reliable
evidence to support molecular mimicry as a theory); but see Patton v. Sec’y of
Health & Hum. Servs., 157 Fed. Cl. 159, 169 (2021) (finding that a special master
erred in requiring petitioner submit a study to establish medical theory causally
connecting flu vaccine to brachial neuritis).
The Court of Federal Claims explained why petitioners must present some
evidence to show the persuasiveness of molecular mimicry as a theory in their
cases. Dennington v. Sec’y of Health & Hum. Servs., 167 Fed. Cl. 640 (2023),
appeal dismissed, No. 2024-1214 (Fed. Cir. Mar. 25, 2024). There, Ms.
4 The term “homology” is used when discussing molecular mimicry.
“Homology” is defined as “the quality of being homologous; the morphological
identity of corresponding parts; structural similarity due to descent from a common
form.” Dorland’s at 868.
5

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 6 of 12
Dennington alleged that a tetanus-diphtheria-acellular pertussis (“Tdap”) vaccine
caused her to develop GBS. Id. at 644. She supported her claim with two reports
from a neurologist, Carlo Tornatore, who put forward molecular mimicry. Id. at
647-49. The chief special master denied entitlement. Id. at 656.
Because the chief special master did not commit any error in evaluating Ms.
Dennington’s prong one evidence, the Court of Federal Claims denied a motion for
review. The Court emphasized the lack of evidence supporting Dr. Tornatore’s
opinion:
• “While Petitioner and Dr. Tornatore put forth the well-established
medical theory of molecular mimicry as the mechanism through
which the Tdap vaccine could cause GBS, nowhere in Dr. Tornatore’s
expert reports, nor in Petitioner’s briefs, do they specifically tie the
Tdap vaccine to GBS through molecular mimicry.” Id. at 653.
• “Dr. Tornatore never actually explains how molecular mimicry might
occur from the Tdap vaccine specifically, nor does he elaborate on
how molecular mimicry could cause the specific autoimmune system
reaction that could cause GBS.” Id.
• “There is nothing in Dr. Tornatore’s report that explains or even
alludes to what antigens or structures in the Tdap vaccine could share
homology with possible host antigens and how these antigens could
react in the manner GBS is believed to progress.” Id. at 654.
• “The literature upon which he relies make no mention of any causal
connection between GBS and the Tdap vaccine.” Id.
Based upon these observations, the Court criticized the lack of specificity in
Dr. Tornatore’s opinions:
In fact, because Dr. Tornatore does not offer any specific
explanation as to the distinct connection between Tdap,
molecular mimicry, and GBS, one could take Dr.
Tornatore’s causation theory and substitute any table
vaccine (e.g., the measles vaccine) and any autoimmune
disorder (e.g., autoimmune encephalitis) and Dr.
Tornatore’s expert report’s discussion of molecular
mimicry would require absolutely no changes. That is
how general his molecular mimicry theory is—it does not
6

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 7 of 12
matter which vaccine and which autoimmune disorder
are plugged in. But Althen prong one requires more.
Id.
In accordance with precedents such as W.C., Caves, Tulio, Yalacki, and
Dennington, the undersigned will look to see whether any evidence supports the
theory that flu vaccine can cause CIDP.
B. Evidence regarding Molecular Mimicry5
Preliminarily, some evidence persuasively shows that scientists sometimes
propose molecular mimicry as a method to explain how autoimmune diseases
might develop. Examples of articles about molecular mimicry in general include
Levin and Bach.6 The idea of molecular mimicry as a general concept is not
contested. What is challenged is whether Dr. Simpson and Dr. Simon have applied
the theory in the context of a flu vaccine and myasthenia gravis. See Resp’t’s Br.
at 32.
Here, relatively little direct evidence supports a causal link between the flu
vaccine and myasthenia gravis. One epidemiological study explored how people
with myasthenia gravis responded to receiving the flu shot. The authors
determined that the flu vaccine was not associated with an increase in myasthenia
gravis symptoms. Zinman at 950. 7 This article tends to undermine the
persuasiveness of a claim that the flu causes myasthenia gravis.
5 In accordance with the previous directive, this decision focuses upon the
articles that the parties have cited in their briefs. Order for Briefs, issued June 29,
2023, at 6.
6 Michael C. Levin et al., Neuronal Molecular Mimicry in Immune-Mediated
Neurologic Disease, 44 ANN. NEUROL. 87 (1998); filed as Exhibit 17.
Jean-Francois Bach, The etiology of autoimmune disease: the case of
myasthenia gravis, 1274 ANN. N.Y. ACAD. Sci. 33 (2012); filed as Exhibit 24.
7 Lorne Zinman et al., Safety of influenza vaccination in patients with
myasthenia gravis: a population-based study, 40 MUSCLE NERV. 947 (2009); filed
as Exhibit 36.
7

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 8 of 12
To attempt to reduce the evidentiary value of Zinman, Mr. Demore uses two
techniques. First, he presents his own study whose outcome conflicts with the
outcome in Zinman. For this purpose, Mr. Demore cites Sanghani.8 Pet’r Br. at
16-17. Sanghani carries minimal weight for multiple reasons. Mr. Demore
submitted only an abstract, not the whole article. The filing of an article is not in
accord with the Instructions for reports from expert witnesses. Order, issued Feb.
3, 2021, at 8. Abstracts provide less information and, therefore, are difficult to
assess. Kalajdzic v. Sec’y of Health & Hum. Servs., No. 17-792V, 2022 WL
2678877, at *13 n.16 (Fed. Cl. Spec. Mstr. June 17, 2022), mot. for rev. denied in
an unpublished opinion, (Fed. Cl. Oct. 27, 2022), aff’d 2024 WL 3064398 (Fed.
Cir. 2024); see also Hazlehurst v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 473,
488 (2009), aff’d 604 F.3d 1343 (Fed. Cir. 2010).
Moreover, Sanghani attempted to draw conclusions from data contained in
the Vaccine Adverse Events Reporting System (“VAERS”). Exhibit 42 at 2. But,
this methodology has generally been found to be unsound. H.L. v. Sec’y of Health
& Hum. Servs., 715 Fed. App'x 990, 995-96 (Fed. Cir. 2017); Analla v. Sec’y of
Health & Hum. Servs., 70 Fed. Cl. 552, 558 (2006). Thus, the Sanghani article
does not meaningfully support the proposition that the flu vaccine can cause
myasthenia gravis.
The alternative way Mr. Demore attacks the Zinman article is to argue that
as an epidemiologic study, the study is underpowered to detect a rare event, such
as, according to Mr. Denmore, instances in which a flu vaccine caused myasthenia
gravis. See Pet’r’s Br. at 16. Mr. Denmore is not wrong abstractly. Tullio, 2019
WL 7580149, at *10 (noting a larger study might find a risk undetected by smaller
studies). But, special masters cannot resolve cases based upon what some future
study might show. See Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072,
1083 (Fed. Cir. 2020). The strongest study in the record of Mr. Demore’s case is
the Zinman article, which tends to point against a finding that the flu vaccine
causes myasthenia gravis.
Although Zinman is a strong study because the authors considered the exact
vaccine-injury combination (see Smilo v. Sec’y of Health & Hum. Servs., No. 18-
1585V, 2023 WL 3918397, at *40 (Fed. Cl. Spec. Mstr. May 15, 2023)
(characterizing Zinman and two other articles as the “best evidence available on
8 Nirav Sanghani et al., Myasthenia Gravis after Vaccination in Adults the
United States: A Report from the CDC/FDA Vaccine Adverse Event Reporting
System (1990–2017), 90 NEUROLOGY 15 Suppl. (2018); abstract filed as Exhibit
42.
8

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 9 of 12
the question of whether the flu vaccine can exacerbate myasthenia gravis”), Mr.
Demore may establish his claim using indirect or circumstantial evidence.
Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir.
2006).
Circumstantial evidence includes evidence from which an inference might
be drawn. For example, Mr. Denmore contends that because molecular mimicry
could explain how the flu vaccine can cause one neurologic disorder (Guillain-
Barré syndrome), molecular mimicry can explain how the flu vaccine can cause
another neurologic disorder (myasthenia gravis). Pet’r’s Br. at 13, 15.
Whether this reasoning by analogy is persuasive depends upon various
factors. For example, how does the etiology of one disease (Guillain-Barré
syndrome) compare to the etiology of the other disease (myasthenia gravis). See
Lampe v. Sec'y of Health & Hum. Servs., 219 F.3d 1357, 1365 (Fed. Cir. 2000)
(“In order for the study to be instructive, however, its conclusions must fit the facts
of the case under consideration.”); R.V. v. Sec'y of Health & Hum. Servs., 127
Fed. Cl. 136, 142 (2016) (“advancing a similar theory under a different set of
facts” does not necessarily satisfy Althen.); Drobbin v. Sec’y of Health & Hum.
Servs., No. 14-225V, 2020 WL 3799206 at *17 (Fed. Cl. Spec. Mstr. Jan. 21,
2020) (stating it is “logical to draw comparisons between the etiology of diseases
that are so similar that doctors sometimes misdiagnose one for the other”). See also
Resp’t’s Br. at 46.
However, neither Dr. Simpson nor Dr. Simon explains why Guillain-Barré
syndrome is sufficiently similar to myasthenia gravis that the former can be used as
a proxy for the latter. See Exhibit 14 (Dr. Simpson’s report) at 5; Exhibit 40 (Dr.
Simon’s report) at 3; See also Exhibit A (Dr. Bromberg’s report) at 6.
Another type of analogy is one in which the disease (myasthenia gravis)
remains constant and the preceding event changes. Examples include articles
purporting to link West Nile virus to myasthenia gravis and case reports about
other vaccines and myasthenia gravis. Pet’r’s Br. at 16, citing, among other
exhibits, Leis.9 A primary difficulty to accepting an analogy between infections
and non-live vaccines is that “virus[es] can replicate.” Exhibit C (Dr. Pasetti) at 4.
An infection “can cause overt disease and compromise overall health, while this is
not the case with vaccines.” Id. at 4-5. Furthermore, some of the articles involving
9 A. Arturo Leis et al., West Nile Virus Infection and Myasthenia Gravis. 39
MUSCLE NERVE 26 (2014); filed as Exhibit 25.
9

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 10 of 12
vaccines (other than flu vaccine) and myasthenia gravis are case reports. E.g.,
Eddy, Hung, Biron, Valerie, Bahri, and Chung.10
In general, case reports provide little, if any, information helpful to
determining causation because they present only a temporal sequence of events in
which the vaccination preceded an adverse health event. See K.O. v. Sec’y of
Health & Hum. Servs., No. 13-472V, 2016 WL 7634491, at *11-12 (Fed. Cl. Spec.
Mstr. July 7, 2016) (discussing appellate precedent on case reports); C.f. Stricker v.
Sec’y of Health & Hum. Servs., 170 Fed. Cl. 701, 714 (2024) (noting that
petitioner did not challenge the special master’s determination that case reports
merit little weight).
A final category of analogies includes examples in which neither the
preceding event is the flu vaccine nor the studied disease is myasthenia gravis. For
example, Mr. Demore reasons that because the Covid vaccine has been associated
with some neurologic diseases, then the flu vaccine should be similarly associated
10 Setijoso Eddy et al., Myasthenia Gravis: Another Autoimmune Disease
Associated with Hepatitis C Virus Infection, 44 DIG. DIS. SCI. 186 (1999); filed as
Exhibit 27.
Hung et al., HIV-associated myasthenia gravis and impacts of HAART: One
case report and a brief review, 113 CLIN. NEUROL. NEUROSURG. 672 (2011); filed
as Exhibit 28.
Pierre Biron et al., Myasthenia Gravis After General Anesthesia and
Hepatitis B Vaccine, 148 ARCH. INTERN. MED. 2685 (1998); filed as Exhibit 32.
Domingo Valerie et al., Should Hepatitis B Vaccine be Contra-indicated in
Myasthenia Gravis?, 29 AUTOIMMUNITY 139 (1998); filed as Exhibit 33.
ME Bahri et al., Myasthenia Gravis After Hepatitis B Vaccine. Report Of
One Case, 60 ANN. RHEUM. DIS. A226 (2001); filed as Exhibit 34.
Hi Yeon Chung et al., Myasthenia gravis following human papillomavirus
vaccination: a case report, 18 BMC NEUROLOGY 222 (2018); filed as Exhibit 35.
10

Case 1:20-vv-01265-MHS Document 83 Filed 10/22/24 Page 11 of 12
with myasthenia gravis. Pet’r’s Br. at 17, citing Frontera.11 But, this level of
abstraction suffers from the same questions as the previous two types of analogies.
Why is the flu vaccine like the Covid vaccine? Why is myasthenia gravis like
GBS or cerebral venous thrombosis? Neither Mr. Demore, nor Dr. Simpson, nor
Dr. Simon connects the dots persuasively. See Herms v. Sec’y of Health & Hum.
Servs., No. 19-70V, 2024 WL 1340669, at *21 (Fed. Cl. Spec. Mstr. Jan. 23, 2024)
(stating “Petitioner does not explain how data from other unrelated vaccines could
be extrapolated to the vaccines at issue here and accordingly, the data is not
persuasive”), mot. for rev. denied, 2024 WL 3837327, at *10 (ruling that the
special master gave “adequate consideration” to literature mostly addressing
“different vaccinations, different conditions, or both”).
Overall, neither Dr. Simpson nor Dr. Simon have presented a sound and
reliable medical theory to explain how the flu vaccine can cause myasthenia gravis.
Much like Dr. Tornatore’s reports in Dennington, their reports are far too general
to be persuasive. See Exhibit 14 at 5, Exhibit 40 at 2, Exhibit 43, Exhibit 44.
In sum, Mr. Demore has not established with preponderate evidence that
molecular mimicry is a reliable theory to explain how the flu vaccine can cause
myasthenia gravis. This outcome is based upon this case’s evidence.
The outcome in Mr. Demore’s case---a denial of compensation---is
consistent with the result of two relatively recent cases. See Resp’t’s Br. at 33-34
(bringing forward these cases); Pet’r’s Reply at 4-5 (responding to these two cases
and adding a third case). Both Smilo, 2023 WL 3918397, at *37, and Kelly v.
Sec’y of Health & Hum. Servs., No. 16-1548V, 2023 WL 3274159, at *9-10 (Fed.
Cl. Spec. Mstr. May 5, 2023), found deficiencies in the theory that a flu vaccine
could cause or worsen myasthenia gravis via molecular mimicry. Although these
decisions do not constitute binding precedent, Smilo and Kelly are well-reasoned.
By way of contrast, the case Mr. Demore cited in his reply, Francis v. Sec’y
of Health & Hum. Servs., No. 99-520V, 2007 WL 1673512 (Fed. Cl. Spec. Mstr.
May 23, 2007), carries less precedential value.12 Although molecular mimicry was
credited as a theory, Id. at *16-17, Francis was decided before appellate opinions,
11 Jennifer A. Frontera et al., Neurological Events Reported after COVID-19
Vaccines: An Analysis of Vaccine Adverse Event Reporting System, 91 ANN.
NEUROL. 756 (2022); filed as Exhibit 48.
12 The better practice is for petitioners to cite supporting cases in their
primary brief, not the reply brief.
11

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such as W.C., Caves, and Dennington, suggested that a more comprehensive
showing regarding molecular mimicry was appropriate. Moreover, Francis
assessed whether molecular mimicry was “a plausible biological mechanism,”
2007 WL 1673512, at *16. This standard is too low a burden. LaLonde v. Sec’y
of Health & Hum. Servs., 746 F.3d 1334, 1339-40 (Fed. Cir. 2014); but see
Hoffman v. Sec’y of Health & Hum. Servs, No. 19-111V, 2024 WL 3688477, at
*14 (holding that biologic plausibility is the correct standard). For these reasons,
Francis does not influence the outcome of Mr. Demore’s case.
V. Conclusion
Within about two weeks of receiving a flu vaccination, Mr. Demore
developed myasthenia gravis and the short interval between events appears to have
led Mr. Demore to assert that the flu vaccine caused his myasthenia gravis.
However, the evidence regarding how the flu vaccine can cause myasthenia gravis
is lacking in persuasiveness. Thus, despite sympathy for Mr. Demore for his
suffering, he cannot receive compensation.
The Clerk's Office is instructed to enter judgment in accord with this
decision unless a motion for review is filed. Information about filing a motion for
review, including the deadline, can be found in the Vaccine Rules, which are
available on the website for the Court of Federal Claims.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
12

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DOCUMENT 2: USCOURTS-cofc-1_20-vv-01265-1
Date issued/filed: 2025-03-20
Pages: 10
Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) (originally filed February 26, 2025) reissuing 88 opinion denying motion for review, and affirming the Special Master's decision. Signed by Judge Matthew H. Solomson. (sl) Service on parties made. (Main Document 90 replaced on 3/20/2025) (vds).
--------------------------------------------------------------------------------
Case 1:20-vv-01265-MHS Document 90 Filed 03/20/25 Page 1 of 10
CORRECTED
In the United States Court of Federal Claims
No. 20-1265V
(Filed: March 20, 2025*)
)
CHRISTOPHER DEMORE, )
)
Petitioner,
)
)
v.
)
)
SECRETARY OF HEALTH AND
)
HUMAN SERVICES,
)
)
Respondent.
)
Leah V. Durant, Law Offices of Leah V. Durant, P.L.L.C., Washington, D.C., for Petitioner.
Eleanor A. Hanson, Torts Branch, Civil Division, United States Department of Justice,
Washington, D.C., for Respondent. With her on the briefs were Brian M. Boynton,
Principal Deputy Assistant Attorney General, C. Salvatore D’Alessio, Director, Heather L.
Pearlman, Deputy Director, Julia M. Collison, Assistant Director.
OPINION AND ORDER
SOLOMSON, Judge.
Petitioner, Christopher Demore, filed this action pursuant to the National Vaccine
Injury Compensation Program, 42 U.S.C. §§ 300aa-1 et seq. (“Vaccine Act”), alleging that
an influenza vaccination (“flu vaccine”) caused him injuries, including a neurological
condition known as myasthenia gravis. ECF No. 1 at 1. On September 26, 2024, Special
Master Christian J. Moran denied Mr. Demore’s petition for vaccine compensation. ECF
No. 82. The Special Master concluded that Mr. Demore did not meet his burden to prove,
by a preponderance of evidence, that the flu vaccine caused Mr. Demore’s injury. Id. at
11–12. Mr. Demore now petitions this Court for review of the Special Master’s decision.
ECF No. 84. For the reasons explained below, this Court concludes that the Special
Master applied the correct standard of review and evidentiary burden to Mr. Demore’s
claim. Accordingly, the Special Master’s decision is affirmed.
*This decision was initially issued under seal on February 26, 2025, in accordance with Rule 18(b)
of the Vaccine Rules of the United States Court of Federal Claims, to permit the parties time to
propose redactions based upon privacy concerns. The parties proposed no redactions and thus
this Court reissues the decision for publication.

Case 1:20-vv-01265-MHS Document 90 Filed 03/20/25 Page 2 of 10
I. FACTUAL AND PROCEDURAL BACKGROUND
Mr. Demore received a flu vaccine on October 2, 2018. ECF No. 82 at 2. At the
time, he was 67 years old, worked as a chef, and had no relevant pre-existing medical
conditions. ECF No. 84 at 10; ECF No. 82 at 2. Two weeks after receiving the flu vaccine,
Mr. Demore developed diplopia, or double vision. ECF No. 4 at 10. He later developed
other “stroke-like” symptoms and was seen by several medical professionals inside and
outside of a hospital. ECF No. 84 at 11; ECF No. 82 at 2. Eventually, Mr. Demore was
diagnosed with myasthenia gravis, which doctors believed to be the cause of his various
ailments. ECF No. 84 at 12; ECF No. 82 at 2. The retained experts of both parties agree
with that diagnosis. ECF No. 82 at 2. The ebbs and flows of Mr. Demore’s illness are
further documented in the medical records that were submitted as record evidence in this
case. See ECF No. 64-1. Mr. Demore’s condition has adversely affected his life; it has
limited his use of his right hand, impacted his speech, his ability to eat and drink, and
was the catalyst for further medical complications. ECF No. 64-3 at 1.
On September 24, 2020, Mr. Demore initiated this case with his filing of a petition
for compensation pursuant to the Vaccine Act. ECF No. 1. Mr. Demore asserts that the
flu vaccine caused the onset of myasthenia gravis, and that he is therefore entitled to
compensation under the Vaccine Act. ECF No. 1. On September 25, 2020, this case was
assigned to Chief Special Master Brian H. Corcoran. ECF No. 4. Mr. Demore filed his
medical records on October 5, 2020. ECF. No. 6. The case was reassigned to Special
Master Moran on November 18, 2020. ECF No. 9.
On September 26, 2024, after the case was briefed by both parties, Special Master
Moran concluded that “the evidence regarding how the flu vaccine can cause myasthenia
gravis is lacking in persuasiveness,” and, therefore, “Mr. Demore . . . cannot receive
compensation.” ECF No. 82 at 12.
On October 28, 2024, Mr. Demore filed a motion for review of the Special Master’s
decision, asking this Court both to set aside the Special Master’s conclusions of law and
to find that Mr. Demore has satisfied his burden of proving that the vaccine caused his
injuries. ECF No. 84 at 26. In the alternative, he asks this Court to remand the case to the
Special Master. Id. On November 25, 2024, Respondent filed its response. ECF No. 87.
The Court now considers Mr. Demore’s motion for review.
II. STANDARD OF REVIEW
Pursuant to the Vaccine Act, this Court has jurisdiction to review a special master’s
decision upon the filing of a petition from either party within thirty days of that decision.
42 U.S.C. § 300aa-12(e)(1). On review, this Court may:
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Case 1:20-vv-01265-MHS Document 90 Filed 03/20/25 Page 3 of 10
(A) uphold the findings of fact and conclusions of law of the
special master and sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the
special master found to be arbitrary, capricious, an abuse
of discretion, or otherwise not in accordance with law
and issue its own findings of fact and conclusions of law,
or
(C) remand the petition to the special master for further
action in accordance with the court’s direction.
42 U.S.C. § 300aa-12(e)(2).
“Under the Vaccine Act, the Court of Federal Claims reviews the Special Master’s
decision to determine if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with the law.’” Markovich v. Sec’y of Health & Hum. Servs., 477 F.3d 1353,
1355–56 (Fed. Cir. 2007). “‘Arbitrary and capricious’ is a highly deferential standard of
review: ‘[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.’” Rodriguez v. Sec’y of Health & Hum. Servs., 632
F.3d 1381, 1384 (Fed. Cir. 2011) (quoting Hines on Behalf of Sevier v. Sec’y of Health & Hum.
Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)). While a special master’s overall conclusion
is reviewed under the deferential standard of review, a special master’s conclusions of
law are reviewed de novo. Id. (citing Markovich, 477 F.3d at 1356).
Accordingly, while a special master’s decision “is entitled to deference,” Morse v.
Sec’y of Health & Hum. Servs., 93 Fed. Cl. 780, 783 (2010), this Court will find that a special
master has abused his discretion if his decision: “(1) is clearly unreasonable, arbitrary, or
fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact
findings; or (4) follows from a record that contains no evidence on which the [special
master] could rationally base [his] decision.” Wirtshafter v. Sec’y of Health & Hum. Servs.,
155 Fed. Cl. 665, 671 (2021) (quoting Ninestar Tech. Co. v. Int’l Trade Comm’n, 667 F.3d 1373,
1379 (Fed. Cir. 2012)).1
Our appellate court, the United States Court of Appeals for the Federal Circuit,
has thus explained that “the statute contemplates that fact finding will be done by the
special master.” Munn v. Sec’y of Health & Hum. Servs., 970 F.2d 863, 870 (Fed. Cir. 1992).
Indeed, Congress tasked the special masters with the “unenviable job of sorting through
these painful cases and, based upon their accumulated expertise in the field, judging the
1 See also Spahn v. Sec’y of Health & Hum. Servs., 138 Fed. Cl. 252, 257 (2018) (“This Court will find
an abuse of discretion only where the special master’s decision is clearly unreasonable, based
upon an erroneous conclusion of law, rests on erroneous fact finding, or based on a record
without evidence to support the special master’s decision.”).
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merits of the individual claims.” Hodges v. Sec’y of Dep’t of Health & Hum. Servs., 9 F.3d
958, 961 (Fed. Cir. 1993).
On a petition for review, “[t]his court does not ‘reweigh the factual evidence, or [ ]
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.” Broekelschen v. Sec’y of Health &
Hum. Servs., 618 F.3d 1339, 1349 (Fed. Cir. 2010) (citing Munn, 970 F.2d at 871). “Rather,
as long as a special master’s finding of fact is ‘based on evidence in the record that [is]
not wholly implausible, we are compelled to uphold that finding as not being arbitrary
or capricious.’” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011)
(quoting Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010)).
“The statute makes clear that, on review, the Court of Federal Claims is not to
second guess the Special Masters fact-intensive conclusions; the standard of review is
uniquely deferential for what is essentially a judicial process.” Hodges, 9 F.3d at 961.
III. DISCUSSION
To receive compensation under the Vaccine Act, a petitioner may prove either that
he suffered an injury falling within the Vaccine Injury Table (a “table claim” pursuant to
42 U.S.C. § 300aa-11(c)(1)(C)(i)), or that he suffered an injury that was caused by a covered
vaccine but which first began after the time period required by the table (a “non-table
claim” pursuant to 42 U.S.C. § 300aa–11(c)(1)(C)(ii)(II)). A table claim imposes on a
petitioner a “relaxe[d] proof of causation” burden, while a non-table claim requires the
petitioner to present proof of causation in fact. Grant v. Sec’y of Dep’t of Health & Hum.
Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992).
In this case, Mr. Demore asserts a non-table claim. See ECF No. 1 at 5. Thus, Mr.
Demore “must prove ‘actual causation’ or ‘causation in fact’ by a preponderance of the
evidence.” Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321
(Fed. Cir. 2010). The Federal Circuit has succinctly articulated the burden to prove
causation as follows:
Concisely stated, [Petitioner’s] burden is to show by
preponderant evidence that the vaccination brought about
[petitioner’s] injury by providing:
(1) a medical theory causally connecting the vaccination and
the injury;
(2) a logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and
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Case 1:20-vv-01265-MHS Document 90 Filed 03/20/25 Page 5 of 10
(3) a showing of a proximate temporal relationship between
vaccination and injury.
Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). These
elements are often called “Althen prongs” in the case law.
Mr. Demore argues that the Special Master applied the incorrect burden for a
petitioner to prove causation and that the Special Master “improperly elevated
petitioner’s burden under Althen prong one ‘not in accordance with [the] law.’” ECF
No. 84 at 14–15. In particular, Mr. Demore proposes to differentiate between a burden of
persuasion that is a “quantitative measure of the sufficient evidence provided to prove
the prima facie elements of a petition,” and the “qualitative” elements used “to evaluate
the relative merits of a petitioner’s theory of causation.” Id. at 16. Attempting to clarify
his argument, Mr. Demore explains as follows:
Stated differently, a petitioner must provide preponderant
proof of every component of the prima facie case, including
preponderant proof that the medical theory relied upon to prove
causation is plausible. Petitioner was not obligated to
affirmatively prove to a preponderance the scientific proof
necessary to affirmatively prove [petitioner’s] theory. . . .
Id. According to Mr. Demore, the burden on a petitioner is simply to prove that a
causation theory is plausible. If a proposed medical theory of causation is “biologically
plausible” then, according to Mr. Demore, a petitioner has satisfied the first prong of
Althen. Id. at 17.
This Court rejects this argument as an obfuscation and near misrepresentation of
the law.
As explained in Althen, the burden of a petitioner is “to show by preponderant
evidence that the vaccination brought about [petitioner’s] injury.” Althen, 418 F.3d at
1278. In plain terms, that means that the petitioner has the burden of proving that the
vaccine was the cause of the petitioner’s injury. Full stop. The standard of proof for that
burden is “preponderance of the evidence.” 42 U.S.C.A. § 300aa-13. Althen does not
somehow relax that statutory standard, but rather merely provides the evidentiary steps
to meet it. Althen, 418 F.3d at 1278.
Contrary to Mr. Demore’s argument, nowhere does the Vaccine Act anticipate
both “quantitative” and “qualitative” levels of proof — whatever that may mean. Simply
stated, a petitioner must prove that the subject vaccine was the cause of an injury, and
that fact must be proven by a preponderance of the evidence. The Special Master must
“determine ‘based on the record evidence as a whole and the totality of the case, whether
5

Case 1:20-vv-01265-MHS Document 90 Filed 03/20/25 Page 6 of 10
it has been shown by a preponderance of the evidence that a vaccine caused the
[petitioner’s] injury.’” Porter, 663 F.3d at 1249–50.
Here, the Special Master determined that “Mr. Demore has not established with
preponderate evidence that molecular mimicry is a reliable theory to explain how the flu
vaccine can cause myasthenia gravis.” ECF No. 82 at 11. In other words, after reviewing
the totality of the evidence regarding the medical theory that Mr. Demore presented, the
Special Master determined that Mr. Demore had not proven by preponderant evidence
that the flu vaccine caused Mr. Demore’s unfortunate case of myasthenia gravis.
The measure of whether a petitioner has met his burden of proof is a holistic one,
and the Special Master simply asks one question: has the petitioner demonstrated by the
preponderance of the evidence that the vaccine caused the injury. Here, the Special
Master answered that question in the negative. Because the Special Master applied the
correct burden of proof, this Court must defer to his decision. Morse, 93 Fed. Cl. at 783.
To the extent that Mr. Demore argues that the Special Master applied the incorrect
burden of proof — i.e., “preponderance of the evidence” instead of mere “plausibility” —
that argument is likely waived. As the Respondent points out, ECF No. 87 at 13,
Mr. Demore did not raise this argument before the Special Master, and is deemed to have
waived it. See RCFC, App. B, Vaccine Rule 8(f) (“Any fact or argument not raised
specifically in the record before the special master will be considered waived and cannot
be raised by either party in proceedings on review of a special master’s decision.”); see
also Jay v. Sec’y of Health & Hum. Servs., 998 F.2d 979, 983 n.4 (Fed. Cir. 1994) (holding that
petitioners had “abandoned” arguments not raised below).
In the alternative, and on the merits, this Court concludes that Mr. Demore is
wrong about his burden of proof. Indeed, his counsel of record in this case is not the first
to suggest a lower “plausibility” standard of proof in vaccine cases before this Court. But
while there may be a stray case excerpt or two that may be extracted out of context to
support such a position, this Court concludes it is time for this argument to be put to bed
(hopefully) once and for all.
For starters, the Vaccine Act’s plain language indicates that a petitioner must
prove by a preponderance of the evidence that he is entitled to compensation. Thus, the
statute provides: “Compensation shall be awarded under the Program to a petitioner if
the special master or court finds . . . that the petitioner has demonstrated by a
preponderance of the evidence the matters required in the petition . . . .” 42 U.S.C.A. § 300aa-
13 (emphasis added).
Second, both this Court and the Federal Circuit have repeatedly held that the
standard of proof, pursuant to the Vaccine Act, is preponderance of the evidence. For
example, in Howard v. United States, Judge Lerner demonstrated conclusively that the
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“[t]he standard for medical proof is preponderance — not plausibility.” 2023 WL
4117370, at *4 (Fed. Cl. May 18, 2023). Judge Lerner explained:
In interpreting the statute, the Federal Circuit has consistently
and unequivocally applied a preponderance standard. While
the Federal Circuit adjusted pleading standards in Althen, the
evidentiary standard remained unchanged and applied to all
three Althen prongs. . . . The case law reveals consistency, not
change. The standard has been preponderance for nearly four
decades. . . .
Id. (emphasis added).
Indeed, Judge Lerner collected a host of cases conclusively demonstrating that the
preponderance of evidence standard has always been and still remains the proper
standard of proof. 2023 WL 4117370 at *4. The Respondent, for its part, marshaled yet
additional cases here. See ECF No. 87 at 15. Together, such cases include: Kottenstette v.
Sec’y of Health & Hum. Servs., 861 F. App’x 433, 439 (Fed. Cir. 2021) (“Petitioners seeking
compensation under the Vaccine Act must prove by a preponderance of the evidence that
a covered vaccine was a cause of the injury they claim.”); Lozano v. Sec’y of Health & Hum.
Servs., 958 F.3d 1363, 1368 (Fed. Cir. 2020) (“It is undisputed that [petitioner’s] injury is in
the off-Table category, meaning that she must prove ‘actual causation’ or ‘causation in
fact’ by preponderant evidence.”); LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334,
1339 (Fed. Cir. 2014) (“[T]he statutory standard of preponderance of the evidence requires
a petitioner to demonstrate that the vaccine more likely than not caused the condition
alleged.”); Locane v. Sec’y of Health & Hum. Servs., 685 F.3d 1375, 1379 (Fed. Cir. 2012) (“To
receive compensation under the Vaccine Act a petitioner must prove by a preponderance
of the evidence that the injury at issue was caused by a vaccine.”); Boatmon v. Sec’y of
Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (“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.”).2
2 See also Wright v. Sec’y of Health & Hum. Servs., 22 F.4th 999, 1001 (Fed. Cir. 2022); Orloski v. Sec’y
of Health & Hum. Servs., 839 F. App’x 538, 542 (Fed. Cir. 2021); Sharpe v. Sec’y of Health & Hum.
Servs., 964 F.3d 1072, 1078 (Fed. Cir. 2020); Oliver v. Sec’y of Health & Hum. Servs., 900 F.3d 1357,
1361 (Fed. Cir. 2018); Olson v. Sec’y of Health & Hum. Servs., 758 F. App’x 919, 922 (Fed. Cir. 2018);
Lasnetski v. Sec’y of Health & Hum. Servs., 696 F. App’x 497, 503 (Fed. Cir. 2017); Paluck v. Sec’y of
Health & Hum. Servs., 786 F.3d 1373, 1379 (Fed. Cir. 2015); Dobrydnev v. Sec’y of Health & Hum.
Servs., 566 F. App’x 976, 979–80 (Fed. Cir. 2014); Rickett v. Sec’y of Health & Hum. Servs., 468 F.
App’x 952, 957 (Fed. Cir. 2011); Porter, 663 F.3d at 1249; Broekelschen, 618 F.3d at 1345; Moberly ex
rel. Moberly, 592 F.3d at 1322; Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1382 (Fed. Cir.
2009); de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1351–52 (Fed. Cir. 2008); Walther v.
Sec’y of Health & Hum. Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007); Althen, 418 F.3d at 1278; Guillory
v. Sec’y of Health & Hum. Servs., 104 F. App’x 712, 712 (Fed. Cir. 2004); Helms v. Sec’y of Health &
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In short, the Federal Circuit has long held that the burden of proof for a petitioner
to demonstrate that an injury was caused by a vaccine in an off-table case is
preponderance of the evidence, and that evidence of mere “plausibility” does not meet
the preponderance burden. Hodges, 9 F.3d at 961–62 (affirming special master’s rejection
of claim because “causation in-fact was not supported by a preponderance of the
evidence”).
Mr. Demore cites several cases in support of his argument that the legal standard
for proving the first Althen prong is plausibility and not preponderance of the evidence.
ECF No. 84 at 14–18 (citing Hoffman v. Sec’y of Health & Hum. Servs., 172 Fed. Cl. 477 (2024);
Andreu, 569 F.3d 1367; Paluck, 786 F.3d 1373; Sharpe, 964 F.3d 1072; Doe 93 v. Sec’y of Health
& Hum. Servs., 98 Fed. Cl. 553 (2011); and Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d
1352 (Fed. Cir. 2006)). Of those cases, only four are binding Federal Circuit cases, and
none of them support Mr. Demore’s position. In Andreu, the Federal Circuit uses the term
“plausible,” but not to make a definitive statement regarding the standard of proof. 569
F.3d at 1375. Indeed, the court throughout its decision reiterates that the standard of
proof is preponderance of the evidence. See, e.g., id. at 1380, (“[E]vidence must be viewed
. . . from the vantage point of the Vaccine Act’s preponderant evidence standard”); id. at
1382 (“Here, the totality of the evidence . . . [is] sufficient to meet the Vaccine Act’s
preponderant evidence standard.”). Moreover, as the Federal Circuit later clarified when
discussing Andreu, our appellate court “could not have endorsed a lower standard of
proof than the preponderance standard.” Kalajdzic on Behalf of A.K. v. Sec’y of Health &
Hum. Servs., 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (discussing Andreu, 569 F.3d
at 1375).
Mr. Demore’s reference to Paluck, 786 F.3d at 1380, is similarly misleading, as the
Federal Circuit in that case did not address the applicable standard of proof. Rather, the
court simply discussed the Respondent’s position on the plausibility of the medical
theory at issue. When the court in Paluck does discuss the burden of proof, the court
references the preponderance standard. Id. at 1386 (“The [petitioner’s] burden was to
show, by a preponderance of the evidence . . . .”). Mr. Demore’s cite to Sharpe, 964 F.3d
at 1083, similarly cherry-picks sentences removed from their decisional context. The
court in Sharpe was not asked to decide an issue about the petitioner’s burden of proof
and — to the extent it mentions the issue — expressly notes that the burden is
Hum. Servs., 10 F. App’x 934, 935 (Fed. Cir. 2001); Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d
1357, 1371 (Fed. Cir. 2000); Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1307 (Fed. Cir.
1999); Knudsen by Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 547 (Fed. Cir. 1994); Bradley
v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993); Cucuras v. Sec’y of Health &
Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993); Hodges, 9 F.3d at 961–62; Hellebrand v. Sec’y of
Health & Hum. Servs., 999 F.2d 1565, 1566 (Fed. Cir. 1993); Grant, 956 F.2d at 1146; Bunting v. Sec’y
of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991); Hines on Behalf of Sevier, 940 F.2d at
1524–25.
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preponderance of evidence. Id. at 1078 (“[T]he petitioner must prove that the vaccine in
fact caused her injuries by a preponderance of the evidence.”). The same is true for Mr.
Demore’s citation to Pafford, 451 F.3d 1352, where the court uses the term “plausible” in
passing. Once again, when the court does address the burden of proof, the Federal Circuit
expressly notes that the applicable standard is preponderant evidence. Id. at 1355
(“Under this court’s precedent, [petitioner] must prove by preponderant evidence . . . .”).
In sum, any reference to a standard below that of preponderance is at best dicta.
The Federal Circuit has made it clear, repeatedly and authoritatively, that a petitioner’s
burden of proof of causation in an off-table case is preponderance of the evidence.
Accordingly, once the Special Master found that Mr. Demore’s putative medical
theory was unpersuasive in terms of “causally connecting the vaccination and the injury,”
Althen, 418 F.3d at 1278, the Special Master did not need to address the second and third
prongs of Althen. Dobrydnev, 566 F. App’x at 980 (“Because petitioners must meet their
burden under all three Althen factors to prevail, a failure to do so on any one of these
factors is dispositive.”); Oliver, 900 F.3d at 1361 (“To demonstrate causation, the
petitioner’s ‘burden is to show by preponderant evidence’ each of the requirements set
forth in Althen . . . .”).
Indeed, simple logic supports the Special Master’s result here. If the medical
theory provided to account for the causality of the injury is unpersuasive (i.e., is not
supported by preponderant evidence), then no amount of additional temporal evidence
makes the injury’s connection to the vaccine anything more than a coincidence. Reaching
a different conclusion would fall into the logical trap of post hoc ergo propter hoc — “after
this, therefore because of this.” The Special Master found that Mr. Demore’s theory of
molecular mimicry, ECF No. 84 at 7, was unpersuasive, and therefore Mr. Demore failed
to meet prong one of Althen; thus, there was no need for the Special Master to reach the
second and third prongs.
Finally, the Court concludes that the Special Master did not abuse his discretion in
declining to hold a hearing, contrary to Mr. Demore’s argument. ECF No. 84 at 24. The
Vaccine Act describes the role of special masters in deciding Vaccine Program cases and
provides that “the Court of Federal Claims shall promulgate rules” governing the
adjudication of such cases, including rules that “include the opportunity for parties to
submit arguments and evidence on the record without requiring routine use of oral
presentations, cross examinations, or hearings . . . .” 42 U.S.C.A. § 300aa-12. Vaccine Rule
8(d) provides that “[t]he special master may decide a case on the basis of written
submissions without conducting an evidentiary hearing.” A hearing, pursuant to our
Rules is permissive — not mandatory — and thus “[s]pecial masters have wide discretion
in determining whether to conduct an evidentiary hearing.” Kreizenbeck v. Sec’y of Health
& Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2020); see also Oliver, 900 F.3d at 1364 n.6
(citing Burns by Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993)).
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In this case, the record was fully developed, and Mr. Demore had and took
advantage of the opportunity to present his evidence and arguments. Mr. Demore has
not identified any facts that would have necessitated the Special Master’s holding an
evidentiary hearing. There is no evidence that the lack of a hearing somehow prejudiced
Mr. Demore in his presentation of his case. This Court therefore concludes that the
Special Master did not abuse his discretion by denying Mr. Demore a hearing.
Because the Special Master applied the correct legal standard for the burden of
proof, and otherwise acted within his discretion, this Court cannot conclude that the
Special Master’s ruling was “arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with the law.” Markovich, 477 F.3d at 1355–56 (quoting 42 U.S.C.
§ 300aa–12(e)(2)(B)).
IV. CONCLUSION
This Court finds that Special Master Moran’s decision was not arbitrary,
capricious, or otherwise contrary to law. Accordingly, this Court AFFIRMS the Special
Master’s decision. The Clerk shall enter JUDGMENT for the Respondent, dismissing
this petition.
IT IS SO ORDERED.
s/Matthew H. Solomson
Matthew H. Solomson
Judge
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