VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-00111
Package ID: USCOURTS-cofc-1_19-vv-00111
Petitioner: Duane Hoffman
Filed: 2019-01-22
Decided: 2024-10-07
Vaccine: influenza
Vaccination date: 2017-01-07
Condition: chronic inflammatory demyelinating polyneuropathy (CIDP)
Outcome: compensated
Award amount USD: 

AI-assisted case summary:
Duane Hoffman, born in 1960, received an influenza vaccine on January 7, 2017, while hospitalized for a COPD exacerbation. He had been diagnosed with chronic lymphocytic leukemia (CLL) in 2015. Shortly after vaccination, he developed low back pain, followed by leg pain, weakness, and numbness. Initially diagnosed with Guillain-Barré syndrome (GBS), his diagnosis was later changed to chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2017. Mr. Hoffman alleged the flu vaccine caused his CIDP. Initially, he pursued a claim for GBS under the Vaccine Injury Table, but as his diagnosis shifted to CIDP (an exclusionary criterion for GBS Table claims), the case was reassigned to pursue an off-Table claim for CIDP. The Special Master initially denied compensation, finding Mr. Hoffman failed to establish a persuasive medical theory connecting the flu vaccine to CIDP and that he had not met the burden of proof. On review, the Court of Federal Claims found the Special Master had applied an incorrect legal standard by requiring a "persuasive theory" rather than a "biologically plausible theory" supported by preponderant evidence. The case was remanded. Upon remand, the Special Master, applying the correct standard, found that Mr. Hoffman had presented preponderant evidence linking the flu vaccine to CIDP via a biologically plausible theory of molecular mimicry, and that he had also met the second prong of the Althen test by showing a logical sequence of cause and effect. Therefore, entitlement to compensation was granted. A separate order for damages will follow.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_19-vv-00111-0
Date issued/filed: 2024-02-01
Pages: 26
Docket text: PUBLIC DECISION (Originally filed: 1/10/2024) regarding 89 DECISION of Special Master, Signed by Special Master Christian J. Moran. (dksc) Service on parties made. (Main Document 90 replaced on 2/12/2024 to correct a citation on page 19 of the Decision.) (fm). (Main Document 90 replaced on 3/11/2024 to correct a typo on page 12 of the Decision.) (fm).
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Case 1:19-vv-00111-RTH Document 90 Filed 02/01/24 Page 1 of 26
CORRECTED
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * *
DUANE HOFFMAN, *
* No. 19-111V
Petitioner, * Special Master Christian J. Moran
*
v. *
* Filed: January 10, 2024
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * *
Isaiah Kalinowski, Bosson Legal Group, P.C., Fairfax, VA, for petitioner;
Felicia D. Langel, United States Dep’t of Justice, Washington, DC, for respondent.
DECISION DENYING COMPENSATION1
Duane Hoffman alleges that an influenza (“flu”) vaccine caused him to
develop a neurologic problem, chronic inflammatory demyelinating
polyneuropathy (“CIDP”). Mr. Hoffman supported his claim with reports from a
neurologist retained for this litigation, Zurab Nadareishvili. The Secretary disputes
Mr. Hoffman’s claim that the flu vaccine injured him and has, likewise, supported
his position with reports from a neurologist the Secretary retained for this
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.
1

Case 1:19-vv-00111-RTH Document 90 Filed 02/01/24 Page 2 of 26
litigation, Michael Wilson. Following the submission of these reports, the parties
advocated through memoranda.
For the reasons explained below, Mr. Hoffman is not entitled to
compensation. Mr. Hoffman has based part of his claim on a level of proof
(plausibility) that is lower than the required level of proof, which is preponderant
evidence. Under the correct burden of proof, Mr. Hoffman has failed to show how
a flu vaccine can cause CIDP. Thus, he is not entitled to compensation.
I. Background2
Mr. Hoffman was born in 1960. For many years, he worked as a
corrections officer, although he was not employed when he received the allegedly
causal flu vaccination in 2017. Exhibit 23 (affidavit regarding damages).
More than two years before the flu vaccination, Mr. Hoffman was diagnosed
with chronic lymphocytic leukemia (“CLL”). Exhibit 10 at 7 (Mar. 31. 2015).
The Secretary’s expert, Dr. Wilson, has proposed that the leukemia is associated
with an increased risk for CIDP. Exhibit A at 5.
In January 2017, Mr. Hoffman was hospitalized due to an exacerbation of
chronic obstructive pulmonary disease. Exhibit 4 at 657. While hospitalized, Mr.
Hoffman received the flu vaccine. Exhibit 1. (Mr. Hoffman also received a
pneumococcal vaccine but his claim rests upon the flu vaccine.)
Mr. Hoffman was diagnosed with low back pain on January 24, 2017.
Exhibit 4 at 819, 862. This pain continued and Mr. Hoffman developed other
problems for which he was admitted to Riverside Methodist Hospital. In Riverside
Methodist Hospital, Mr. Hoffman underwent tests, including an EMG/NCS. Based
upon the results, Mr. Hoffman’s doctors diagnosed him with a neurologic disorder,
Guillain-Barré syndrome. Exhibit 7 at 261, 876-81.
2 Events in Mr. Hoffman’s life are presented summarily because this case is being
resolved on an element of proof, the causal theory allegedly connecting flu vaccines to CIDP,
that is largely independent of what happened to Mr. Hoffman. In addition, the parties agree that
the medical records accurately describe what happened to Mr. Hoffman close in time to when the
medical record was created. Thus, there are no disputes about what transpired in Mr. Hoffman’s
case. For more detailed accounts of the medical records, see Am. Pet., filed Sep. 17, 2020, at 1-
6; Resp’t’s Resp., filed Sep. 21, 2022, at 2-5.
2

Case 1:19-vv-00111-RTH Document 90 Filed 02/01/24 Page 3 of 26
Guillain-Barré syndrome is:
(i) … an acute monophasic peripheral neuropathy that encompasses a
spectrum of four clinicopathological subtypes described below. For each
subtype of GBS, the interval between the first appearance of symptoms and
the nadir of weakness is between 12 hours and 28 days. This is followed in
all subtypes by a clinical plateau with stabilization at the nadir of symptoms,
or subsequent improvement without significant relapse. Death may occur
without a clinical plateau. Treatment related fluctuations in all subtypes of
GBS can occur within 9 weeks of GBS symptom onset and recurrence of
symptoms after this time-frame would not be consistent with GBS.
(ii) The most common subtype in North America and Europe, comprising
more than 90 percent of cases, is acute inflammatory demyelinating
polyneuropathy (AIDP), which has the pathologic and electrodiagnostic
features of focal demyelination of motor and sensory peripheral nerves and
nerve roots. . . . AIDP [is] typically characterized by symmetric motor
flaccid weakness, sensory abnormalities, and/or autonomic dysfunction
caused by autoimmune damage to peripheral nerves and nerve roots. The
diagnosis of AIDP. . . requires:
(A) Bilateral flaccid limb weakness and decreased or absent deep
tendon reflexes in weak limbs;
(B) A monophasic illness pattern;
(C) An interval between onset and nadir of weakness between 12
hours and 28 days;
(D) Subsequent clinical plateau (the clinical plateau leads to either
stabilization at the nadir of symptoms, or subsequent improvement
without significant relapse; however, death may occur without a
clinical plateau); and,
(E) The absence of an identified more likely alternative diagnosis.
* * *
(v) To qualify as any subtype of GBS, there must not be a more likely
alternative diagnosis for the weakness.
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Case 1:19-vv-00111-RTH Document 90 Filed 02/01/24 Page 4 of 26
(vi) Exclusionary criteria for the diagnosis of all subtypes of GBS include
the ultimate diagnosis of any of the following conditions: chronic immune
demyelinating polyradiculopathy (CIDP) . . .
42 C.F.R. § 100.3(c)(15).
Mr. Hoffman’s doctors prescribed a standard treatment for GBS, the
infusion of intravenous immunoglobulin (“IVIG”). In early 2017, when Mr.
Hoffman’s doctors were treating him for GBS, at least one doctor stated that the flu
vaccine caused Mr. Hoffman’s GBS. Exhibit 7 at 266; see also Exhibit 4 at 1053
(note, from an unknown source, that Mr. Hoffman’s allergies include the flu
vaccine).
Mr. Hoffman attempted rehabilitation for several months and sought care
from various doctors. One neurologist, Geoffrey Eubank, ordered a test for anti-
ganglioside antibodies. The results were negative. Exhibit 9 at 32.
Approximately eight months after the diagnosis of GBS, Mr. Hoffman saw
Dr. Eubank again. Exhibit 19 at 66 (Oct. 9, 2017). Dr. Eubank changed the
diagnosis to CIDP. He explained his rationale. Dr. Eubank
previously thought that [Mr. Hoffman] had Guillain
Barre syndrome but . . . [h]e continued to have some
worsening this summer and subsequently improved with
a course of IVIG for 5 days. This would not be typical for
Guillain Barre which should be more of a monophasic
illness.
Id.
Another neurologist, Timothy Rust, confirmed the diagnosis of CIDP.
Exhibit 19 at 58 (Dec. 13, 2017). Dr. Rust wrote that “CLL can be associated with
peripheral nervous system pathology similar to non-Hodgkin lymphoma, including
a relatively high rate of CIDP.” Id.
The diagnosis of CIDP is accepted by the neurologists retained to provide
opinions. Exhibit 30 at 7; Exhibit A at 3-4.3 “CIDP” stands for “chronic
3 In the Vaccine Program, petitioners often allege that a vaccine caused them to suffer
CIDP. Thus, special masters are generally familiar with CIDP. For some examples of recent
4

Case 1:19-vv-00111-RTH Document 90 Filed 02/01/24 Page 5 of 26
inflammatory demyelinating polyneuropathy,” which explains the basic
information about the disease. See Exhibit A at 4. Although most cases of CIDP
develop insidiously, CIDP can develop abruptly as in Mr. Hoffman’s case. Exhibit
30 at 7, Exhibit A at 4.
As discussed below, the etiology of CIDP is “poorly understood.” Exhibit A
at 5. According to Dr. Nadareishvili, “An abundance of clinical and experimental
research has led to the conclusion that CIDP is mediated by humoral and cellular
immunity against Schwann cell/myelin target antigens in the nerves, thus its
classification as an autoimmune disease.” Exhibit 30 at 9. A primary question in
this litigation is whether the flu vaccine can provoke an autoimmune attack, which
leads to CIDP.
II. Procedural History
Initially, Mr. Hoffman alleged that the flu vaccine caused him to suffer GBS.
Pet., filed Jan. 22, 2019, ¶ 15. He sought compensation via the Vaccine Injury
Table and adjudication through the special processing unit of the Office of Special
Masters. Id. ¶ 20-21. The case was assigned to the special processing unit. Mr.
Hoffman periodically filed medical records.
The Secretary reviewed the evidence and recommended that compensation
be denied. Resp’t’s Rep., filed June 12, 2020. The Secretary maintained that
based upon the records from Dr. Eubank and Dr. Rust, Mr. Hoffman suffered from
CIDP, not GBS. Id. at 8. Because resolution through the special processing unit
seemed infeasible, the case was reassigned. Notice, issued June 25, 2020.
Mr. Hoffman changed his claim. He alleged that the flu vaccine was the
cause-in-fact of his CIDP. Am. Pet., filed Sep. 17, 2020.
Mr. Hoffman supported his claim that the flu vaccine caused his CIDP with
a report from Dr. Nadareishvili. Exhibit 30. Dr. Nadareishvili stated that CIDP is
opinions about CIDP, see Radford v. Sec’y of Health & Hum. Servs., No. 18-704V, 2023 WL
2159306, at *7-12 (Fed. Cl. Spec. Mstr. Feb. 22, 2023); Berg v. Sec’y of Health & Hum. Servs.,
No. 16-650V, 2021 WL 6883495 at *24-37 (Fed. Cl. Spec. Mstr. Dec. 14, 2021); Tomsky v.
Sec’y of Health & Hum. Servs., No. 17-1132V, 2020 WL 5587365, at *8-18 (Fed. Cl. Spec.
Mstr. Aug. 24, 2020).
5

Case 1:19-vv-00111-RTH Document 90 Filed 02/01/24 Page 6 of 26
similar to GBS. He proposed that the flu vaccine can cause CIDP via molecular
mimicry. Id. at 7-16.
The Secretary countered by presenting a report from a neurologist, Michael
Wilson. Exhibit A. Dr. Wilson disputed molecular mimicry as a theory to explain
how a flu vaccine might cause CIDP. Id. at 4-5. Dr. Wilson noted that to the
extent that molecular mimicry might predict an attack on gangliosides as causing
CIDP, this theory would not explain what happened to Mr. Hoffman because a test
for anti-ganglioside antibodies was negative. Id. at 5. Finally, Dr. Wilson
suggested that chronic lymphocytic leukemia is associated with CIDP. Id. at 5.
Dr. Nadareishvili responded to Dr. Wilson in a report filed on January 11,
2022. Exhibit 63. Dr. Nadareishvili contended that Dr. Wilson did not explain
how CLL can cause CIDP. Id. at 3.
Dr. Wilson replied that he did not say that CLL can cause CIDP because
“No one knows what triggers CIDP.” Exhibit C at 2 (filed Mar. 14, 2022). In an
ensuing status conference, the Secretary was asked how Mr. Hoffman’s chronic
lymphocytic leukemia affects the case given that Dr. Wilson has not presented any
mechanism by which CLL can cause CIDP. The Secretary stated that he might
obtain a report from a different expert and Mr. Hoffman objected to adding a new
expert on the ground that Mr. Hoffman’s CLL had been in the record. The
Secretary eventually reported that he was not interested in settlement and will
continue to defend the case. Resp’t’s Status Rep., filed Apr. 27, 2022.
The parties were directed to file briefs. Order, issued July 18, 2022. Mr.
Hoffman filed his primary brief on August 22, 2022 and his reply on October 5,
2022. In between, the Secretary filed his brief on September 21, 2022.
With the submission of the reply, Mr. Hoffman’s case is ready for
adjudication. Mr. Hoffman requested a ruling that he was he entitled to
compensation based upon the record. He did not seek a hearing. See Pet’r’s Br. at
2, 4. The Secretary also did not request a hearing. See Resp’t’s Br. 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).
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Case 1:19-vv-00111-RTH Document 90 Filed 02/01/24 Page 7 of 26
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).
When a petitioner, like Mr. Hoffman, claims that a vaccine caused an injury
not listed on the Vaccine Injury Table, such as CIDP, the elements of a petitioner’s
case are well defined. A petitioner bears 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).
Mr. Hoffman’s case is being resolved upon prong one exclusively. Thus, an
examination of the remaining prongs is not required.
IV. Analysis
Two steps are required to evaluate Mr. Hoffman’s assertion that a flu
vaccine can cause CIDP. The first is to determine the level of proof on this
element. The second is to assess whether the evidence satisfies the standard. An
additional aspect is to compare the outcome in Mr. Hoffman’s case with the
7

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outcome in other cases evaluating the Althen’s first prong in the context of a flu
vaccine allegedly causing CIDP.
A. Burden of Proof for Althen Prong One
Mr. Hoffman recognizes that his burden of proof is preponderant evidence.
Pet’r’s Br. at 8, quoting 42 U.S.C. § 300aa–13(a)(1)(A). But, Mr. Hoffman argues
that a medical theory proposing a causal connection between a vaccine and an
injury needs to be only plausible. Id. at 17-18 (citing cases); Pet’r’s Reply at 4-11.
Consistent with this position, Mr. Hoffman contends that the theory Dr.
Nadareishvili proposes is plausible. E.g. Pet’r’s Br. at 23-24.
On the other hand, the Secretary argues that any medical theory must be
persuasive and reliable. Resp’t’s Br. at 7-8. The Secretary, therefore, criticizes
Mr. Hoffman for using the wrong standard. Id. at 12.
Plausibility requires a lower degree of evidence than probability. Cerrone v.
Sec’y of Health & Hum. Servs., No. 17-1158V, 2023 WL 9185794 (Fed. Cl. Nov.
6, 2023), appeal docketed, No. 24-1281 (Fed. Cir. Dec. 22, 2023); Jane Doe 93 v.
Sec’y of Health & Hum. Servs., No. Redacted, 2011 WL 2326966, at *1 (Fed. Cl.
Spec. Mstr. May 9, 2011). An evidentiary scale might include markers for “what
is possible,” “what is plausible,” “what is persuasive,” “what is convincing,” and
“what is certain.”
Repeatedly, Mr. Hoffman juxtaposes “plausible” with “certainty.” He
argues: “The lack of a proven pathway is an issue for those concerned with
scientific certainty; biologic plausibility has clearly been achieved, at least for the
foremost experts on the condition.” Pet’r’s Br. at 26. For other examples, see
Pet’r’s Br. at 32, 40. This contrast, however, is misleading. The correct burden of
proof is neither plausibility nor certainty. The correct burden of proof is
preponderant evidence, sometimes referred to as “probability” or “probable.”
An extensive analysis of this issue is not required in this decision because
within the last two calendar years, judicial officers have already held that the
burden of proof for Althen prong one is persuasive evidence. Two opinions from
the Court of Federal Claims stand out for their reasoning: Trollinger v. Sec’y of
Health & Hum. Servs., 167 Fed. Cl. 127, 137 (2023), and Howard v. Sec’y of
Health & Hum. Servs., No. 16-1592V, 2023 WL 4117370, at *4-5 (Fed. Cl. May
18, 2023) (discussing cases decided before Moberly), appeal docketed, No. 2023-
8

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1816 (Fed. Cir. Apr. 28, 2023).4 Special masters have reached the same
conclusion. Singleton v. Sec’y of Health & Hum. Servs., No. 17-1474V, 2023 WL
3595653, at *20 (Fed. Cl. Spec. Mstr. May 23, 2023); J.D. v. Sec’y of Health &
Hum. Servs., No. 14-742V, 2022 WL 16543853, at *27 (Fed. Cl. Spec. Mstr. Aug.
31, 2022).
The reasoning in those opinions is persuasive. The undersigned also holds
that a petitioner’s burden regarding Althen prong one is to present persuasive
evidence.
A holding that Mr. Hoffman must present a persuasive theory, by itself, may
justify a finding that Mr. Hoffman did not meet his burden of proof. As noted
above, Mr. Hoffman consistently contended that his proof of a medical theory was
plausible. Proof at merely a plausible level is insufficient as a matter of law as
illustrated in Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351 (Fed. Cir.
2019). There, the petitioners’ expert presented a theory that was “only
‘plausible.’” Id. at 1360, quoting the special master’s decision. The Federal
Circuit held that the “Special Master erred in allowing a theory that was at best
‘plausible’ to satisfy the Petitioners’ burden of proof.” Id.
Given the outcome in Boatmon, which was a Federal Circuit’s affirmance of
a judgment denying compensation, it appears that a similar outcome should be
reached here, a decision denying compensation. However, it is conceivable that
the evidence surpasses the correct threshold even if Mr. Hoffman, himself, did not
categorize his case that way. For this reason and to demonstrate that all evidence
relevant to Althen prong one has been considered, the undersigned will next
evaluate Mr. Hoffman’s proposed theory.
B. Molecular Mimicry as a Theory
Through Dr. Nadareishvili, Mr. Hoffman advances molecular mimicry as a
biologically plausible way that a flu vaccine can cause CIDP. Pet’r’s Br. at 24-40;
4 These opinions from the Court of Federal Claims are not binding precedent. However,
they remain a type of precedent from an appellate tribunal capable of persuading by their
reasoning.
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see also Exhibit 30 at 11.5 Multiple appellate cases have provided guidance on
how special masters should assess molecular mimicry. These non-binding
precedents are discussed as a preliminary matter. After this foundation, the
evidence is further evaluated.
1. Appellate Cases regarding Molecular Mimicry
Because special masters are often called upon to evaluate the persuasiveness
of the theory of molecular mimicry, the Court of Federal Claims and the Court of
Appeals for the Federal Circuit have considered molecular mimicry in their
appellate role of reviewing opinions.6 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 Dep’t. 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 three years, appellate authorities reviewing
decisions involving molecular mimicry have generally endorsed the approach of
looking for some evidence that persuasively shows that a portion of a vaccine
resembles a portion of human tissue, which contributes to causing the disease, and
that the immune system will respond to the relevant amino acid sequence.7
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).
5 Although Mr. Hoffman alludes to “other pathologic mechanisms,” Pet.’r’s Br. at 24, he
has not developed any argument with regard to pathologic mechanisms except for molecular
mimicry.
6 The briefs would have been improved if they had discussed any appellate cases about
molecular mimicry.
7 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.
10

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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).
Very recently, 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 docketed, No. 2024-1214 (Fed. Cir. Dec. 1, 2023). There, Ms.
Dennington alleged that a tetanus-diphtheria-acellular pertussis (“Tdap”) vaccine
caused her to develop GBS. Id. at 644. She supported her claim with two reports
from a neurologist, Carlo Tornatore, who put forward molecular mimicry. Id. at
647-49. The chief special master denied entitlement. Id. at 656.
In an opinion made available to the public on October 6, 2023, the Court of
Federal Claims denied a motion for review because the chief special master did not
commit any error in evaluating Ms. Dennington’s prong one evidence. The Court
emphasized the lack of evidence supporting Dr. Tornatore’s opinion:
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• “While Petitioner and Dr. Tornatore put forth the well-established
medical theory of molecular mimicry as the mechanism through
which the Tdap vaccine could cause GBS, nowhere in Dr. Tornatore’s
expert reports, nor in Petitioner’s briefs, do they specifically tie the
Tdap vaccine to GBS through molecular mimicry.” Id. at 653.
• “Dr. Tornatore never actually explains how molecular mimicry might
occur from the Tdap vaccine specifically, nor does he elaborate on
how molecular mimicry could cause the specific autoimmune system
reaction that could cause GBS.” Id.
• “There is nothing in Dr. Tornatore’s report that explains or even
alludes to what antigens or structures in the Tdap vaccine could share
homology with possible host antigens and how these antigens could
react in the manner GBS is believed to progress.” Id. at 654.
• “The literature upon which he relies make no mention of any causal
connection between GBS and the Tdap vaccine.” Id.
Based upon these observations, the Court criticized the lack of specificity in
Dr. Tornatore’s opinions:
In fact, because Dr. Tornatore does not offer any specific
explanation as to the distinct connection between Tdap,
molecular mimicry, and GBS, one could take Dr.
Tornatore’s causation theory and substitute any table
vaccine (e.g., the measles vaccine) and any autoimmune
disorder (e.g., autoimmune encephalitis) and Dr.
Tornatore’s expert report’s discussion of molecular
mimicry would require absolutely no changes. That is
how general his molecular mimicry theory is—it does not
matter which vaccine and which autoimmune disorder
are plugged in. But Althen prong one requires more.
Id.
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.
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2. Evidence regarding Molecular Mimicry
Evidence regarding whether molecular mimicry is a persuasive theory to
explain how a flu vaccine could cause CIDP falls into two broad, and somewhat
overlapping, categories. The first is evidence about flu vaccines (or flu infections)
and CIDP. The second is evidence about flu vaccine (or flu infections) and GBS.
“A petitioner must provide a reputable medical or scientific explanation that
pertains specifically to the petitioner’s case, although the explanation need only be
legally probable, not medically or scientifically certain.” Broekelschen v. Sec’y of
Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (internal quotation
marks and citation omitted). Due to the requirement that the explanation “pertains
specifically to the petitioner’s case,” the analysis starts with the evidence that
directly concerns the condition for which Mr. Hoffman seeks compensation, CIDP.
a) Flu Infections, Flu Vaccines, and CIDP
CIDP is considered an “immune-mediated neuropathy.” Exhibit 30 at 9.
This means that a person’s immune system attacks components of the nervous
system. A similar term is “autoimmune.” See Exhibit 32 at 768 (Lunn and
Sheikh).8
Beyond the point that CIDP is autoimmune in origin, relatively little is
understood about CIDP. An article published in 2015 states: “Although CIDP is
classed as an autoimmune disorder in which an aberrant immune response is
directed towards components of the peripheral nerve causing demyelination and
axonal damage, the exact mechanisms underlying the development of
immunopathology remain to be defined.” Exhibit 50 at 1 (Mathey).9 A similar
point is made in another 2015 article: “no specific antibody has yet been identified
8 “Exhibit 31” is shown on the actual medical article; however, the comprehensive exhibit
list, submitted on April 1, 2023, indicates that this article is “Exhibit 32.” “Exhibit 31” is shown
on Dr. Nadareishvili’s curriculum vitae as well. The comprehensive exhibit list indicates that
Dr. Nadareishvili’s curriculum vitae is “Exhibit 31.” It appears that the Exhibit number on the
medical article is inaccurate. This decision will cite to this medical article as Exhibit 32.
9 Petitioner submitted this article in manuscript form. Therefore, the page cites are to the
pdf version, rather than the version that appears in printed journals.
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as the causative factor in CIDP, in spite of the compelling indirect evidence.”
Exhibit 62 at 662 (Dalakas).
Consistent with these articles that he cited, Dr. Nadareishvili wrote “the
precise pathogenesis” of CIDP is “not well fully [sic] delineated. No expert in the
fields of neurology or immunology would claim to understand exactly how a
particular immune trigger leads inexorably to CIDP.” Exhibit 30 at 12.
This lack of understanding does not prevent Dr. Nadareishvili from
proposing that the flu vaccine can cause CIDP via molecular mimicry. Molecular
mimicry, as noted in multiple judicial opinions, is frequently proposed by doctors
supporting claims that a vaccine injured someone. See, e.g., Dennington, 2023
WL 6529518. Dr. Nadareishvili cited a 2006 article co-written by one of the
originators of the theory of molecular mimicry, Robert S. Fujinami. Exhibit 35
(Fujinami).
References postulating molecular mimicry as contributing to CIDP appear
scant in Mr. Hoffman’s case. (There are, however, multiple references about
molecular mimicry and GBS, which are discussed below.) For CIDP specifically,
one article from more than two decades ago suggested the body’s response to a
malignant melanoma might lead to CIDP through molecular mimicry. Exhibit 41
(Weiss). Another article discusses molecular mimicry between melanoma cells
and myelin. Exhibit 62 at 662 (Dalakas). The originating Weiss article, in turn,
was cited in a chapter about CIDP in a leading neurology text book. Exhibit 51 at
2228, 2245 (Hahn). (Weiss is reference 231 in the chapter by Hahn). These
authors raised molecular mimicry as a “potentially relevant mechanism in the
pathogenesis of CIDP.” Id. at 2245. They continued: “Although CIDP is rarely
associated with carcinomas, the connection with melanoma is of great interest
because both melanoma and Schwann cells derive from neural crest tissues and
share common antigens.” Id.
Although not in the context of molecular mimicry, the authors of this
textbook chapter discussed the potential link between infections or vaccinations
and CIDP. They wrote: “Whereas AIDP [acute inflammatory demyelinating
polyneuropathy, which is a type of GBS] can often be linked to a preceding viral or
bacterial infection, this association is much less apparent in CIDP.” Exhibit 51 at
2223. The lack of association might be because of “the common delay in making
the diagnosis (on average 6 to 12 months from onset of symptoms),” such that
“patients may simply no longer recall such prodromal events.” Id. These authors
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reviewed four studies, of which one (McCombe) was submitted as an exhibit here.
Hahn and colleagues interpreted the data:
The observation that onset or relapse of CIDP was linked
to infections or immunization in 19% to 32% of reported
cases suggests that the association is higher than
expected by chance alone. However, none of the reported
studies had examined in parallel the incidence of
infections in control populations. Therefore, a direct or
indirect relationship between CIDP and the preceding
events remains to be established.
Id. at 2224.
In an article published in 1987, McCombe and colleagues reported
information about 92 cases of CIDP. Of this group, 29 people (or 32 percent) gave
a history of an event in the preceding six weeks. Exhibit 55 at 1622 (McCoumbe).
Of the 29 people, four reported receiving a vaccine--- 1 reported a smallpox
vaccination, 2 reported the Salk polio vaccination, and 1 reported a tetanus
vaccination. Id. As the Secretary pointed out, no one reported receiving the flu
vaccination. Resp’t’s Br. at 14 n.11.
Another survey of 100 people with CIDP was reported in 1990 by Bouchard
and colleagues. Exhibit 56 (Bouchard). Of this group, 16 patients “noted an
infectious event within 6 weeks before the initial neurologic manifestations.” Id. at
499. Again, Bouchard did not report any instances of any vaccination preceding
the onset of CIDP. See Resp’t’s Br. at 14 n.11.
A third article discussing a potential connection between infections and/or
immunizations and CIDP is Kuitwaard. Exhibit 60. This article potentially carried
great weight in supporting the theory that a flu vaccine can cause CIDP because
Mr. Hoffman maintained this article presented “evidence of a rechallenge
response, which is a strong measure of biologic plausibility.” Pet’r’s Br. at 36.
However, this description oversells the data Kuitwaard contains.
Kuitwaard and others reported the results of a survey that they sent to
members of the Dutch society of neuromuscular disorders. Exhibit 60 at 310
(Kuitwaard). The researchers received responses from 76 CIDP patients. The
patients completed the questionnaire on average approximately six years after the
onset of their CIDP (range 0-29 years). Id. at 312. Eight CIDP patients (about 11
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percent) reported receiving a vaccination within the preceding 8 weeks. Id. “Of
the 24 patients who received a flu vaccination (range 1–17 times) after being
diagnosed with CIDP, five reported an increase in symptoms after one or more
vaccinations.” Id.
The authors recognized some methodological limitations. Among them was
the possibility of “recall bias” due to the “retrospective nature of part of the
questionnaires.” Id. at 315. The authors explained: “It is difficult to draw firm
conclusions from a questionnaire in which patients report their recurrences after
vaccinations themselves.” Id. The authors did not suggest any warnings about
vaccinations; they wrote: “The common seasonal flu vaccinations seem relatively
safe in patients who … still have active CIDP.” Id.
Kuitwaard carries relatively little persuasive value. A key part of this article
reports about the experience of 24 people, which is a relatively small number. See
Radford v. Sec’y of Health & Hum. Servs., No. 18-704V, 2023 WL 2159306, at *9
(Fed. Cl. Spec. Mstr. Feb. 22, 2023). In essence, Kuitwaard is an article that
collects numerous case reports into a series.
An example of an article containing a single case report was written by J.M.
Brostoff and others. These authors reported that a 74-year-old man received a flu
vaccination and two days later, developed neurologic problems, which were
eventually diagnosed as CIDP. Exhibit 44 at 229 (Brostoff). In the authors’
discussion, they wrote:
Viruses and viral vaccines have been proposed as
putative triggers in the pathogenesis of autoimmune
disease [2] with postulated mechanisms including antigen
mimicry, triggering self-reactive T-cell clones, and
cytokine upregulation that may induce aberrant MHC
class II expression. Whilst autoimmune neurological
sequelae of influenza vaccination have been described,
the development of CIDP after influenza vaccination has
not been previously reported.
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Id.10 They also postulated: “The patient’s progressive deterioration soon after
vaccination suggests that this case of CIDP was triggered by vaccination.” Id.
The Institute of Medicine (now known as the National Academy of
Medicine) considered the Brostoff case report but found that it “did not contribute
to the weight of mechanistic evidence.” Exhibit A, tab 4 at 335 (Stratton). This
article did not contain information consistent with causation beyond temporality
and the temporal relationship may have been too short. Id.
In the context of litigation, case reports often do not receive much
consideration as evidence of causation. 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). In accord with these authorities, the undersigned
declines to afford the Kuitwaard case series or the Brostoff case report much
weight in determining whether the flu vaccine can cause CIDP.
The foregoing analysis addresses the articles about CIDP that the parties put
forward in their briefs. To a large extent, these articles constitute the main direct
evidence regarding flu vaccine causing CIDP. These are the articles on which Dr.
Nadareishvili has based his opinion. See Exhibit 30 at 7-16 (discussing general
causation).
Beyond these articles, Dr. Nadareishvili does not add much on CIDP. He
spends a great deal of attention on GBS, which is discussed below. With respect to
CIDP, he states “that autoimmunity in CIDP is most likely mediated by antibodies
directed against myelin antigens, along with autoreactive T cells and macrophages
that invade the myelin sheath, axonal membranes, and/or the nodes of Ranvier.”
Exhibit 30 at 11. The actual source of this statement is Dalakas. Exhibit 62 at 1.
This statement reveals the lack of knowledge about CIDP as Dr. Nadareishvili
identifies three components of the immune system (antibodies, autoreactive T
cells, and macrophages) that might attack three components of the nervous system
(the myelin sheath, axonal membranes, and the nodes of Ranvier). The lack of
10 The reference to “mimicry” makes this the third article discussing molecular mimicry
in the context of CIDP.
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information is shown more vividly in the Dalakas article: “no specific antibody has
yet been identified as the causative factor in CIDP, in spite of the compelling
indirect evidence.” Exhibit 62 at 662 (Dalakas). Dalakas also points out that
unlike GBS, “there is no convincing evidence that viral infections are antecedent
events in CIDP.” Id.
At the end of the day, there is not sufficient evidence to support a finding
that molecular mimicry is a persuasive theory to explain how flu vaccines might
cause CIDP. The basic problem, as Dr. Wilson explains, is that “No one knows
what triggers CIDP.” Exhibit C at 2. As Dalakas states, the medical community
does not know the antigen that could be the target for an autoimmune attack.
Exhibit 62 at 662. For a complex list of potential targets, see Exhibit 32 at 769
(Lunn and Sheikh). Without having some well-informed ideas of the target antigen
and how an attack on the antigen leads to CIDP, it is difficult to accept, on a more
likely than not basis, the proposition that the flu vaccine contributes to a poorly
understand process.
The lack of definitiveness in Dr. Nadareishvili’s reports makes his reports
comparable to the reports in Dennington, which were found insufficient to explain
how Tdap vaccine might cause GBS. Dennington and earlier cases such as W.C.,
Caves, and Yalacki contradict Mr. Hoffman’s contention that: “To demand direct
evidence in medical literature explaining precisely how influenza vaccine causes
CIDP, and identification of the specific antibody triggered and the neurologic
structure that is the targeted antigen would elevate Petitioner’s burden contrary to
the law.” Pet’r’s Reply at 6. As discussed in section IV.A. above, Mr. Hoffman
attempts to lower his burden of proof.
Although the difference in perspective regarding the burden of proof
appears to be the main point of departure between Dennington and Mr. Hoffman’s
case, the evidence differs as well. The main contrast might be Dr. Nadareishvili’s
attempted analogy between GBS and CIDP. That point is taken up next.
b) Flu infections, flu vaccines, and GBS
Mr. Hoffman heavily relies upon an analogy between Guillain-Barré
syndrome and chronic inflammatory demyelinating polyneuropathy. In his view,
because Guillain-Barré syndrome is a demyelinating disorder of the peripheral
nervous system that has been linked to the flu vaccine, it is reasonable to infer that
chronic inflammatory demyelinating polyneuropathy, which is also a
demyelinating disorder of the peripheral nervous system, is linked to the flu
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vaccine. Pet’r’s Br. at 19-24; Pet’r’s Reply at 6-8. Contrastingly, the Secretary
argues that this analogy is inapt because Guillain-Barré syndrome differs from
chronic inflammatory demyelinating polyneuropathy. Resp’t’s Br. at 9-10.
Mr. Hoffman’s attempted method of proof is legitimate. Petitioners may try
to establish their cases through circumstantial evidence. Capizzano v. Sec’y of
Health & Hum. Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006). Whether the
reasoning is persuasive depends upon several factual propositions.
GBS is both similar to and different from CIDP. One simple point of
similarity is that both conditions are believed to involve an attack on the myelin in
peripheral nerves. One simple point of contrast is that GBS is a monophasic
disease and CIDP is a chronic disease. For purposes of determining whether a flu
vaccine can cause CIDP, which is actually a question Mr. Hoffman’s claim raises,
a key point regarding the analogy between GBS and CIDP is what is known about
the etiology of the two conditions.
The etiology of GBS is coming into focus. Detailed experiments with
animal models have demonstrated that molecular mimicry between an infectious
organism, C. jejuni, and portions of peripheral nerves, known as gangliosides, can
cause GBS. Exhibit 49 (Yuki). Infections with C. jejuni, which cause
gastrointestinal distress, have preceded cases of GBS in humans. Winkler v. Sec’y
of Health & Hum. Servs., No. 18-203V, 2021 WL 6276203, at *2 (Fed. Cl. Spec.
Mstr. Dec. 10, 2021), mot. for rev. denied, 2022 WL 1528779 (Fed. Cl. May 13,
2022), aff'd, 88 F.4th 958 (Fed. Cir. 2023). Thus, review articles have reported
molecular mimicry as a mechanism by which GBS can develop. See, e.g., Exhibit
32 at 759 (certain subtypes of GBS “provide some of the best available evidence to
support the hypothesis of molecular mimicry as a pathogenic mechanism
underlying post-infections autoimmune disorders”) (Lunn and Sheikh); Exhibit 39
at 286 (Yan); Exhibit 42 at 371 (Sheikh); Exhibit 61 at 2607 (Willison and Yuki).
Furthermore, some epidemiologic studies, particularly involving the 2009
H1N1 flu vaccine, have discovered a slight increase in the incidence of GBS
among people receiving a flu vaccine. 80 Fed. Reg. 45132, 45145-46 (July 29,
2015). But, according to the Secretary, “there is no evidence demonstrating that
current formulations of the seasonal influenza vaccine can cause GBS.” Id. at
45146. Overall, the Secretary found that the evidence and policy grounds
supported a proposal to associate the flu vaccine with GBS on the Vaccine Injury
Table. 80 Fed. Reg. 45132, 45145-46 (July 29, 2015). The Secretary eventually
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adopted this proposed modification. 82 Fed. Reg. 6294 (Jan. 19, 2017).11 The
change to the Vaccine Injury Table was in accordance with activities at the Office
of Special Masters. See Heinzelman v. Sec’y of Health & Hum. Servs., No. 07-
01V, 2008 WL 5479123, at *5 (Fed. Cl. Spec. Mstr. Dec. 11, 2008) (finding that
the Secretary did not contest the first Althen prong when a petitioner alleged a flu
vaccine caused her GBS), mot. for rev. denied, 98 Fed. Cl. 808, 812-15 (2011)
(addressing burden of proof for potential causative factors other than a vaccine),
aff’d on unrelated point regarding damages, 681 F.3d 1374 (Fed. Cir. 2012); see
also Woods v. Sec’y of Health & Hum. Servs., No. 10-377V, 2012 WL 4010485,
at *7 (Fed. Cl. Spec. Mstr. Aug. 23, 2012) (noting that parties informally resolve
most flu vaccine-GBS cases).
However, the data that allowed the Secretary to associate the flu vaccine
with GBS is lacking for CIDP. There is neither the quality nor the quantity of
evidence regarding any causes of CIDP. The contrast in knowledge about the
causes of GBS and in knowledge about the causes of CIDP is reflected in multiple
articles. See, e.g., Exhibit 32 at 758-67 (Lunn and Sheikh). A group assembled to
form the Brighton Collaboration GBS Working Group maintained that CIDP “is
thought to be clinically and pathologically distinct from GBS.” Exhibit A, tab 3 at
602 (Sejvar).
Under these circumstances, the inference that Mr. Hoffman requests---a
finding that the flu vaccine can cause CIDP because the flu vaccine can cause
GBS---is at least one step too far to be persuasive. Although it seems likely that
preponderant evidence shows that the flu vaccine can cause GBS, this evidence is
not certain. See Exhibit 47 (Wang) (finding no link between flu vaccines and GBS
antiganglioside antibodies). Of course, due to the Secretary’s listing the flu
vaccine and GBS on the Vaccine Injury Table, the parties no longer litigate
whether the flu vaccine can cause GBS. The point is not to suggest that the
Secretary somehow reached the wrong conclusion. The point is that one of Mr.
Hoffman’s postulates, that the flu vaccine can cause GBS, is someplace above
tentative but someplace below established. Any attempt to extend the proposition
that the flu vaccine can cause GBS should acknowledge that the starting point has
11 While the Secretary delayed implementing this rule, 82 Fed. Reg. 11321 (Feb. 22,
2017), the Vaccine Injury Table has been changed.
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some questions. The analogy between GBS and CIDP also falters because the
evidence about the causes of GBS have not been found as causes for CIDP.
Accordingly, Mr. Hoffman’s proposed comparison to GBS does not carry
such persuasive value that this evidence overcomes the shortfalls regarding the
evidence about CIDP specifically. See section IV.B.2.a) above; see also Howard,
2023 WL 4117370, at *6 (finding that special master was not arbitrary in declining
to extend research on GBS to CIDP). Accordingly, Mr. Hoffman has failed to
meet his burden of proof regarding Althen prong one.
C. Other Cases from the Vaccine Program
The foregoing analysis is based upon the evidence and the parties’
arguments about the evidence. See 42 U.S.C. § 300aa–13(a)(1) (directing a special
master to consider “the record as a whole”). Another point meriting consideration
is how other judicial officers have addressed similar points, even though those
resolutions are not binding. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d
1351, 1358-59 (Fed. Cir. 2019). Decisions from special masters do not bind other
special masters because, in part, different special masters can weigh even similar
evidentiary records differently. Lampe v. Sec’y of Health & Hum. Servs., 219
F.3d 1357, 1368 (Fed. Cir. 2000).
The parties were encouraged to identify relevant cases involving a reasoned
outcome. Order for Briefs, issued July 18, 2022, at 6. The parties cited Mason v.
Sec’y of Health & Hum. Servs., No. 17-1383V, 2022 WL 600415 (Fed. Cl. Spec.
Mstr. Feb. 4, 2022), and Jacunski v. Sec’y of Health & Hum. Servs., No. 09-524V,
2014 WL 5168422 (Fed. Cl. Spec. Mstr. Sep. 23, 2014). Resp’t’s Br. at 13-14, 19;
Pet’r’s Reply at 15 (arguing that Jacunski reached an incorrect conclusion
regarding the IOM report).
In Jacunski, the petitioner’s expert relied on “molecular mimicry” to support
that the vaccines significantly aggravated the petitioner’s CIDP, suggesting that
“an antigen within the influenza vaccine erroneously prompted [p]etitioner’s
immune system to attack her own issues, thereby exacerbating her CIDP.”
Jacunksi, 2014 WL 5168422, at *12. The special master found that there was no
merit in the petitioner’s expert’s theory:
But, Dr. Morgan failed to offer any evidence or even any
explanation to support this vague suggestion. In his
expert report and his testimony, Dr. Morgan introduced
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the concept of an antigen that is part of the influenza
vaccine, which may have caused a harmful response.
However, when pressed for more details, he had no idea
what particular antigen within the vaccine might have
caused the alleged molecular mimicry effect. Indeed, he
acknowledged that he knows of no evidence to support
the idea that a flu vaccine can cause CIDP via molecular
mimicry -- “it’s a theory” was the best he could offer.
Id. (citations omitted).
In a more recent case, John Mason alleged that a flu vaccine caused him to
suffer CIDP. Mason, 2022 WL 600415, at *1. He relied upon reports from a
neurologist, Lawrence Steinman, who has often assisted people claiming that a
vaccine injured them. Dr. Steinman proposed molecular mimicry with an attack on
myelin basic protein and other components of the nervous system. Id. at *4-8.
The chief special master denied the claim because Mr. Mason suffered from CIDP
before he received the vaccination, a sequence of events precluding a finding of
causation. Id. at *1, 23-26. Although unnecessary to the outcome, the chief
special master also evaluated the first Althen prong, whether a flu vaccine can
cause GBS. The chief special master stated: “I have identified no more-recent
reasoned decisions in which a special master explained how or why the flu vaccine
was likely causal of the claimant’s CIDP.” Id. at *22. Although the chief special
master recognized that some special masters have found that flu vaccine can cause
CIDP, the basis for those findings was questionable as
special masters have consistently relied on the fact that
CIDP and GBS have tended to be lumped together as
comparable peripheral neuropathies—leading them to
assume that the extensive science supporting causation
for GBS after vaccination applies to CIDP, but without
close consideration of the actual persuasiveness of a
claimant’s prong one showing, based on expert opinions
or relevant literature specific to CIDP.
Id.
The chief special master eventually concluded that “despite my reasoned
doubts, the record as developed in this case preponderates—if barely— in
Petitioner’s favor” on Althen prong one. Id. at *26. The chief special master
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recounted the differences between GBS and CIDP, demonstrating that a
comparison was not appropriate. “However, two considerations [led] [the chief
special master] to determine that (regardless of these misgivings) the first Althen
prong was in this case preponderantly established---if only by inches.” Id. at *27.
Those factors were: first, the presence of “some reliable literature (specifically
Kira and Devaux)” and second, the “prior Program findings on the issue of flu
vaccine being causal of CIDP.” Id. The chief special master recognized that that
the outcome on prong one might have differed if the Secretary had “attempt[ed] to
rebut Dr. Steinman’s points on causation.” Id. at *27 n.21.
Mason differs from Mr. Hoffman’s case in multiple respects. First, unlike
Dr. Nadareishvili, Dr. Steinman arguably identified points of homology. Second,
the Kira and Devaux articles that the chief special master highlighted in Mason are
not part of the record in Mr. Hoffman’s case. Third, in Mr. Hoffman’s case, the
Secretary has presented the opinion of Dr. Wilson, who opined that “there is a
dearth of data . . . that suggest an increased risk for CIDP in influenza-vaccinated
persons.” Exhibit A at 5. Accordingly, if it is taken for granted that the evidence
in Mason crossed the evidentiary standard “by inches,” it is easy to conclude that
the evidence in Mr. Hoffman’s case falls short. None of the factors that were
critical to the chief special master’s assessment in Mason are present in Mr.
Hoffman’s case.
D. Synopsis regarding Prong One
To meet his burden regarding Althen prong one, Mr. Hoffman has presented
the theory of molecular mimicry. This theory is not fanciful. It may very well be
the case that molecular mimicry is a biologically plausible theory to explain how
the flu vaccine might cause GBS.
However, as explained in section IV.A, “biologic plausibility” is not the
evidentiary standard. Under the correct evidentiary standard, Mr. Hoffman’s
evidence fails to measure up. There is little reliable support for claiming that the
flu vaccine can cause CIDP, in part, because there is little understanding about any
cause of CIDP.
V. Comments on Remaining Althen Prongs
When petitioners fail to establish one Althen prong, additional analysis is
not required. Mr. Hoffman’s case is resolved solely on the basis of Althen prong
one.
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If Mr. Hoffman had succeeded on Althen prong one, then it is likely that he
would have prevailed on Althen prong three, which concerns timing. See Exhibit
A at 5. Persuasive proof on timing is not dispositive because “[t]emporal
association is not sufficient, however, to establish causation in fact.” Grant v.
Sec’y of Health & Hum. Servs., 956 F.2d 1144 (Fed. Cir. 1992).
Finally, any analysis of Althen prong two is complicated for at least two
reasons. First, to the extent that Mr. Hoffman’s molecular mimicry theory is
premised on the idea that there is homology between a flu vaccine and
gangliosides, this theory appears not to explain how Mr. Hoffman’s CIDP
developed because he tested negative for anti-ganglioside antibodies. Exhibit 9 at
32; see also Resp’t’s Br. at 11.
Second, Dr. Wilson stated that Mr. Hoffman’s pre-existing CLL is
“associated with an increased risk of CIDP.” Exhibit A at 5. The evidentiary
value of this statement appears unclear as Dr. Wilson’s supplemental report
clarifies that he “intentionally did not use the words ‘cause’ or ‘causal’ when
discussing the association between hematologic malignancies and CIDP.” Exhibit
C at 2. An in-depth evaluation is not required to resolve Mr. Hoffman’s case.
VI. Conclusion
Mr. Hoffman merits sympathy for suffering a chronic condition. But he has
not presented persuasive evidence that a flu vaccine was the cause of his CIDP.
Therefore, Mr. Hoffman is not entitled to 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
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Appendix: Medical Literature Cited12
(listed alphabetically by lead author’s last name)
1. C. Bouchard et al., Clinicopathologic findings and prognosis of chronic inflammatory
demyelinating polyneuropathy, 52 NEUROLOGY 498 (1999), filed as Exhibit 56.
2. J.M. Brostoff et al., Post-influenza vaccine chronic inflammatory demyelinating
polyneuropathy, 37 AGE AND AGEING 229 (2008), filed as Exhibit 44.
3. Marinos Dalakas, Pathogenesis of immune-mediated neuropathies, 1852 BIOCHIM
BIOPHYS ACTA 658 (2014), filed as Exhibit 62.
4. Robert Fujinami et al., Molecular Mimicry, Bystander Activation, or Viral Persistence:
Infections and Autoimmune Disease, 19 CLIN MICROBIOL REV 80 (2006), filed as Exhibit
35.
5. Angelika Hahn et al., Chronic Inflammatory Demyelinating Polyradiculoneuropathy, 99
NEUROLOGY 2221 (2005), filed as Exhibit 51.
6. Krista Kuitwaard et al., Recurrences, vaccinations and long-term symptoms in GBS and
CIDP, 14 JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM 310 (2009), filed as Exhibit 60.
7. Michael Lunn & Kazim Sheikh, Peripheral Neuropathies, 5 THE AUTOIMMUNE DISEASES
757 (2014); filed as Exhibit 32.13
8. Emily Mathey et al., Chronic inflammatory demyelinating polyradiculoneuropathy: from
pathology to phenotype, 86 J NEUROL NEUROSURG PSYCHIATRY 973 (2015), filed as
Exhibit 50.
12 Although this appendix provides bibliographic information for all articles cited in the
decision, all articles have been reviewed.
13 “Exhibit 31” is shown on the actual medical article; however, the comprehensive
exhibit list, submitted on April 1, 2023, indicates that this article is “Exhibit 32.” “Exhibit 31” is
shown on Dr. Nadareishvili’s curriculum vitae as well. The comprehensive exhibit list indicates
that Dr. Nadareishvili’s curriculum vitae is “Exhibit 31.” It appears that the Exhibit number on
the medical article is inaccurate. This decision will cite to this medical article as Exhibit 32.
25

Case 1:19-vv-00111-RTH Document 90 Filed 02/01/24 Page 26 of 26
9. P.A. McCombe et al., Chronic Inflammatory Demyelinating Polyradiculoneuropathy: A
Clinical And Electrophysiological Study of 92 Cases, 110 BRAIN 1617 (1987), filed as
Exhibit 55.
10. James Sejvar et al., Guillain-Barre syndrome and Fisher syndrome: Case definitions and
guidelines for collection, analysis, and presentation of immunization safety data, 29
VACCINE 599 (2011), filed as Exhibit A, tab 3.
11. K.A. Sheikh et al., Campylobacter jejuni lipopolysaccharides in Guillain-Barre
syndrome: Molecular mimicry and host susceptibility, 51 NEUROLOGY 371 (1998), filed
as Exhibit 42.
12. Kathleen Stratton et al., Influenza Vaccine, ADVERSE EFFECTS OF VACCINES: EVIDENCE
AND CAUSALITY 293 (2012), filed as Exhibit A, tab 4.
13. David Wang et al., No evidence of a link between influenza vaccines and Guillain-Barre
syndrome – associated antiganglioside antibodies, 6 INFLUENZA OTHER RESPIR VIRUSES
159 (2011), filed as Exhibit 47.
14. M.D. Weiss et al., Molecular mimicry in chronic inflammatory demyelinating
polyneuropathy and melanoma, 51 NEUROLOGY 1738 (1998), filed as Exhibit 41.
15. Hugh Willison & Nobuhiro Yuki, Peripheral neuropathies and anti-glycolipid antibodies,
125 BRAIN 2591 (2002), filed as Exhibit 61.
16. Wei Xing Yan et al., P0 Protein Is a Target Antigen in Chronic Inflammatory
Demyelinating Polyradiculoneuropathy, 50 ANN NEUROL 286 (2001), filed as Exhibit 39.
17. Nobuhiro Yuki et al., Carbohydrate mimicry between human ganglioside GM1 and
Campylobacter jejuni lipooligosaccharide causes Guillain-Barre Syndrome, 101 PROC
NATL ACAD SCI 11404 (2004), filed as Exhibit 49.
26

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_19-vv-00111-1
Date issued/filed: 2024-08-07
Pages: 21
Docket text: JUDGE VACCINE REPORTED OPINION (PUBLIC VERSION) re: 101 Unreported Judge Vaccine Opinion granting 91 Motion for Review and remanding this case. Signed by Judge Ryan T. Holte. (jf) Service on parties made.
--------------------------------------------------------------------------------
Case 1:19-vv-00111-RTH Document 106 Filed 08/07/24 Page 1 of 21
In the United States Court of Federal Claims
No. 19-111
(Filed: 7 August 2024*)
***************************************
DUANE HOFFMAN, *
*
Petitioner, *
*
v. *
*
SECRETARY OF HEALTH AND HUMAN *
SERVICES, *
*
Respondent. *
*
***************************************
Isiah Kalinowski, Bosson Legal Group, of Fairfax, VA, for petitioner.
Felicia Langel, Trial Attorney, Civil Division, Department of Justice, of Washington,
DC, for respondent.
OPINION AND ORDER
HOLTE, Judge.
“‘[W]hile most of the Nation[] . . . enjoy[s] great[] benefit from immunization programs,
a small but significant number have been gravely injured.’” Cloer v. Sec’y of Health & Hum
Servs., 654 F.3d 1322, 1325 (Fed. Cir. 2011) (quoting H.R. Rep. No. 99-908 at 4 (1986)).
“‘[F]or the relatively few who are injured by vaccines,’” Congress determined the
“‘opportunities for redress and restitution [were] limited, time-consuming, [and] expensive.’” Id.
Congress thus “created the Vaccine Program” to “compensate injured persons quickly and fairly”
for injuries “either presumed or proven to be causally connected to vaccines.” Id.
Petitioner Duane Hoffman moved for review of Special Master Moran’s decision holding
petitioner is not entitled to compensation under the National Vaccine Injury Compensation
Program, 42 U.S.C. §§ 300aa-1–300aa-34 (“Vaccine Act”). Mr. Hoffman, who suffers from
chronic lymphocytic leukemia and chronic obstructive pulmonary disease, received the influenza
(“flu”) vaccine on 7 January 2017. Seventeen days later, Mr. Hoffman experienced low back
pain and bilateral lower extremity pain, weakness, and numbness. Mr. Hoffman was diagnosed
* This opinion was initially filed under seal on 8 July 2024 pursuant to Vaccine Rule 18(b) of the Rules of the Court
of Federal Claims. The Court provided the parties 14 days to submit proposed redactions, if any, before the opinion
was released for publication. Neither party proposed redactions. This opinion is now reissued for publication in its
original form.
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with Guillain-Barré syndrome shortly thereafter. On 9 October 2017, after months of
unsuccessful treatment, Mr. Hoffman’s diagnosis was changed to chronic immune demyelinating
polyradiculopathy (“CIDP”). Mr. Hoffman alleges his CIDP was caused by the flu vaccine. On
10 January 2024, Special Master Moran denied Mr. Hoffman’s petition for compensation. In
doing so, the Special Master concluded “Mr. Hoffman has failed to meet his burden of proof
regarding Althen prong one” because “Mr. Hoffman based part of his claim on a level of proof
(plausibility) that is lower than the required level of proof, which is preponderant evidence.”
Corrected Decision Deny. Compensation (“SM Dec.”) at 2, 21, ECF No. 90.1
Pursuant to the Vaccine Act, a petitioner must show “by a preponderance of the
evidence,” 42 U.S.C. § 300aa-13(a)(1)(A), he “sustained . . . [the relevant] illness, disability,
injury, or condition not set forth in the Vaccine Injury Table . . . which was caused by [the]
vaccine.” 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(II) (emphasis added). As interpreted by the Federal
Circuit, and as relevant here, the Vaccine Act therefore requires petitioners to “show by
preponderant evidence that the vaccination brought about [their] injury by providing: (1) a
medical theory causally connecting the vaccination and the injury. . . .” Broekelschen v. Sec’y of
Health & Hum. Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010). The Federal Circuit has clarified,
however, petitioners can “me[e]t th[is] first . . . prong[] of the Althen test” by presenting “a
‘biologically plausible’ theory.” See Andreu ex rel. Andreu v. Sec’y of Dept. of Health & Hum.
Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009). Thus, by requiring Mr. Hoffman to present
“persuasive evidence” of a “persuasive theory,” see SM Dec. at 8–9, the Special Master
“impermissibly rais[ed] . . . [Mr. Hoffman’s] burden under the Vaccine Act.” Andreu, 569 F.3d
at 1378. For this reason, and as further explained below, the Court grants petitioner’s Motion for
Review, vacates the Special Master’s decision, and remands this case for further proceedings
consistent with this Opinion and Order.
I. Petitioner’s Medical History and Flu Vaccination
The Court’s recitation of the background facts draws from the Special Master’s Corrected
Public Decision Denying Compensation, SM Dec. at 2 n.2 (“[T]he parties agree that the medical
1 The concept of a “preponderance of the evidence,” also called “persuasive evidence” by the Special Master and
respondent in this case, is well understood. See SM Dec. at 8. As explained by the Federal Circuit more than thirty
years ago, “the ‘preponderance of the evidence’ standard refer[s] to[,] in the Vaccine Act[,] . . . proof by a simple
preponderance, of ‘more probable than not’ causation.” See Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d
1317, 1326 (Fed. Cir. 2006) (quoting Althen v. Sec’y of Health & Hum Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005);
then citing (citing Hellebrand v. Sec’y of Health & Human Servs., 999 F.2d 1565, 1572–73 (Fed.Cir.1993)); Tr. at
30:7–10 (“[PETITIONER:] I want to differentiate the scale of preponderant evidence [which is] 50 percent [and] a
feather, which is . . . a perfect description [since it] is an enumerative quantitative scale [from plausibility.]”); Tr. at
22:7–8 (“[RESPONDENT:] We typically refer to [preponderance of the evidence] as 51 percent.”); see also
Preponderance of the Evidence, BLACK’S LAW DICTIONARY (11th ed. 2019) (“[t]he greater weight of the
evidence”). Preponderance of the evidence is, as explained by Justice Thomas, an “evidentiary standard” of proof.
See Concrete Pipe & Prods of California, Inc. v. Constr. Laborers Pension Trust for S. California, 508 U.S. 602,
651 n.* (1993) (Thomas, J., concurring). Plausibility, on the other hand, is less a quantitative probability standard
and more a qualitative inquiry into whether a fact is “[c]onceivably true,” see Plausible, BLACK’S LAW DICTIONARY
(11th ed. 2019), or credible. See Plausible, WEBSTER’S THIRD NEW INTERNATIONAL DICTIONARY (3rd ed. 2021)
(“4a: superficially worthy of belief: credible”); see also Tr. at 30:10–20 (“[PETITIONER:] [T]he Federal Circuit
decisions . . . talk[] about a scale that’s different [than the quantitative preponderance scale], and that’s weighing the
theory, and it goes between possible . . . and medical certainty.”).
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records accurately describe what happened to Mr. Hoffman close in time to when the medical
record was created. Thus, there are no disputes about what transpired in Mr. Hoffman’s case.”),
and the parties’ briefing before the Court. See Mot. for Review and Mem., ECF Nos. 91, 91-1;
Resp’t’s Resp. at 1, ECF No. 93 (“Respondent adopts and incorporates the facts and procedural
history as set forth in th[e Special Master’s] Decision which, to respondent’s understanding, are
accurate and not in dispute.”).
In March 2015, petitioner Duane Hoffman was diagnosed with chronic lymphocytic
leukemia (CLL). See Pet’r’s Medical Records from Ohio Hematology Oncology (“OH
Oncology”), Pet’r’s Ex. 8 at 3, ECF No. 7-9. He also suffers from chronic obstructive
pulmonary disease (COPD). See Pet’r’s Medical Records from Marion General Hospital
(“Marion General Records”), Pet’r’s Ex. 4 at 651, ECF No. 7-5. In January 2017, Mr. Hoffman
was hospitalized due to “an exacerbation of” his COPD. SM Dec. at 2; see Marion General
Records at 657; see also Mot. for Review at 1. On 7 January 2017, while hospitalized, Mr.
Hoffman received an influenza vaccine. See Vaccination Record from Marion General Hospital
(“Vaccination Record”), Pet’r’s Ex. 1 at 1, ECF No. 7-2. Approximately twenty days later, Mr.
Hoffman “presented with bilateral lower extremity pain, weakness, and numbness.” Mot. for
Review at 1 (citing Marion General at 825–27); see Pet’r’s Medical Records from Riverside
Methodist Hospital (“Riverside Methodist Records”), Pet’r’s Ex. 7 at 25, ECF No. 7-8; see also
SM Dec. at 2 (“Mr. Hoffman was diagnosed with low back pain on January 24, 2017.”). At that
time, he “went to the emergency room at Marion General Hospital” and was subsequently
“transferred to Riverside Methodist Hospital [(“Riverside”)] where his records indicate that his
lower back pain began four days” earlier. Resp’t’s Rep. at 2, ECF No. 25; see Riverside
Methodist Records at 53. Following continued pain, Mr. Hoffman underwent additional
examination and diagnostic testing first at Marion General Hospital and then again at Riverside
and was subsequently diagnosed “with a neurologic disorder, Guillain-Barré syndrome [(GBS)].”
SM Dec. at 2 (citing Riverside Methodist Records at 261, 876–81).
Mr. Hoffman was treated for GBS using a “standard” course of intravenous
immunoglobulin (IVIG). SM Dec. at 4. During this treatment, “at least one doctor stated that
the flu vaccine caused Mr. Hoffman’s GBS.” Id. (citing Riverside Methodist Records at 266).
“[E]ight months after [his] diagnosis of GBS, Mr. Hoffman saw Dr. Eubank,” a neurologist he
had seen earlier in his treatment. Id. (citing see Pet’r’s Updated Medical Records from
OhioHealth Neurological Physicians (“Neurological Update”), Pet’r’s Ex. 19 at 66, ECF No. 18-
3). On 9 October 2017, during a follow-up with Dr. Eubank, Mr. Hoffman’s diagnosis was
changed to chronic immune demyelinating polyradiculopathy (“CIDP”). Id. (citing Neurological
Update at 66). Dr. Eubank explained he “previously thought that [Mr. Hoffman] had [GBS] but
[because] . . . [Mr. Hoffman] continued to have some worsening . . . and subsequently improved
with a course of IVIG for 5 days,[ th]is would not be typical for” GBS. Id. (quoting
Neurological Update at 66). A second neurologist, Dr. “Timothy Rust[,] confirmed th[is]
diagnosis” and noted “‘CLL can be associated with peripheral nervous system pathology similar
to non-Hodgkin lymphoma, including a relatively high rate of CIDP.’” Id. (quoting Neurological
Update at 58). At the time of his visit with Dr. Rust, petitioner “was having difficulty walking
and . . . ha[d] muscle atrophy in his hands and burning pain in his feet.” Resp. Rep. at 6 (quoting
Neurological Update at 59). According to the Special Master, “[a]lthough most cases of CIDP
develop insidiously, [it] can develop abruptly as in Mr. Hoffman’s case.” Id. at 5 (citing Expert
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Case 1:19-vv-00111-RTH Document 106 Filed 08/07/24 Page 4 of 21
Report of Dr. Zurab Nadareishvili (“ZN Report”), Pet’r’s Ex. 30 at 7, ECF No. 46-2); see Mot.
for Review at 2 (“Petitioner’s diagnosis is acute onset [CIDP].”).
II. The Petition and Procedural History Before the Special Master
Although Mr. Hoffman now alleges his flu vaccine caused him to develop CIDP, he
initially “alleged [it] . . . caused him to suffer GBS.” SM. Dec. at 5; see Petition Against
Secretary of Health and Human Services (“Pet.”) at 5–7, ECF No. 1. As GBS is listed on the
Vaccine Injury Table for the flu vaccination, Mr. Hoffman “sought compensation via the
Vaccine Injury Table and adjudication through the special processing unit of the Office of
Special Masters.” Id. (citing Pet. at 5).
“The Secretary [of Health and Human Services] maintained that based upon the records
from Dr. Eubank and Dr. Rust, Mr. Hoffman suffered from CIDP, not GBS. . . . [Thus,]
resolution through the special processing unit seemed infeasible, [and] the case was reassigned.”
SM Dec. at 5; see Reassignment Order, ECF No. 26 (“On June 12, 2020, Respondent filed his
Rule 4 Report, arguing there is evidence that Petitioner’s injury may have been [CIDP] rather
than [GBS] as alleged. . . . Pursuant to Vaccine Rule 3(d), the above-captioned case is hereby
reassigned.”). Following reassignment, Special Master Moran required petitioner to submit a
“status report . . . indicating whether he intend[ed] to pursue a non-Table CIDP claim” because
respondent’s earlier-filed report indicated “that petitioner was ultimately diagnosed with CIDP,
which is an exclusionary criterion for a GBS Table claim.” See 2 July 2020 Order at 1, ECF No.
28. On 3 August 2020, petitioner filed a status report stating he “does intend to pursue an off-
Table [CIDP] . . . case in this matter.” Status Rep. at 1, ECF No. 29. On 17 September 2020,
petitioner filed his Amended Petition explaining his “change in diagnosis to CIDP” and alleging
“the vaccination administered actually caused the injuries complained of.” Am. Pet. at 6, ECF
No. 32.
A. The Special Master’s Decision Denying Compensation
Following this reassignment and petition amendment, petitioner continued to file medical
records and filed his expert report from Dr. Zurab Nadareishvili on 19 May 2021. See ZN
Report. Special Master Moran then required respondent to file its expert report by 19 July 2021.
See 20 May 2021 Non-PDF Order. Following an extension of time, respondent filed its expert
report by Dr. Michael Wilson on 17 September 2021. See Expert Report of Dr. Michael Wilson
(“Wilson Report”), ECF No. 53-1. On 22 August 2022, petitioner filed a motion for summary
judgment, ECF No. 78-1, “respectfully ask[ing] this court to find that the vaccination at issue
actually caused [his] injuries, and to conclude that [p]etitioner is thereby entitled to
compensation.” Id. at 3. In response, respondent alleged “petitioner has failed to meet his
burden of proof to show a causal relationship between the flu vaccine and his CIDP,” meaning
petitioner’s claim should be denied. Resp’t’s Sum. J. Resp. at 8, ECF No. 83. On 10 January
2024, Special Master Moran denied compensation. See SM Dec. at 2, 24. Special Master Moran
concluded “Mr. Hoffman has based part of his claim on a level of proof (plausibility) that is
lower than the required level of proof, which is preponderant evidence . . . [and u]nder the
correct burden of proof, Mr. Hoffman has failed to show how a flu vaccine can cause CIDP.
Thus, he is not entitled to compensation.” Id. at 2.
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Case 1:19-vv-00111-RTH Document 106 Filed 08/07/24 Page 5 of 21
In his decision, the Special Master presented a brief, undisputed account of petitioner’s
medical history. See SM Dec. at 2–5; id. at 2 n.2 (“[T]here are no disputes about what transpired
in Mr. Hoffman’s case.”). The Special Master explained:
Mr. Hoffman was diagnosed with low back pain on January 24, 2017. Exhibit 4 at
819, 862. This pain continued and Mr. Hoffman developed other problems for
which he was admitted to Riverside Methodist Hospital. In Riverside Methodist
Hospital, Mr. Hoffman underwent tests, including an EMG/NCS. Based upon the
results, Mr. Hoffman’s doctors diagnosed him with a neurologic disorder, Guillain-
Barré syndrome. Exhibit 7 at 261, 876-81.
Guillain-Barré syndrome is:
(i) … an acute monophasic peripheral neuropathy that encompasses a spectrum of
four clinicopathological subtypes described below. For each subtype of GBS, the
interval between the first appearance of symptoms and the nadir of weakness is
between 12 hours and 28 days. This is followed in all subtypes by a clinical plateau
with stabilization at the nadir of symptoms, or subsequent improvement without
significant relapse. Death may occur without a clinical plateau. Treatment related
fluctuations in all subtypes of GBS can occur within 9 weeks of GBS symptom
onset and recurrence of symptoms after this time-frame would not be consistent
with GBS.
(ii) The most common subtype in North America and Europe, comprising more
than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy
(AIDP), which has the pathologic and electrodiagnostic features of focal
demyelination of motor and sensory peripheral nerves and nerve roots. . . . AIDP
[is] typically characterized by symmetric motor flaccid weakness, sensory
abnormalities, and/or autonomic dysfunction caused by autoimmune damage to
peripheral nerves and nerve roots. The diagnosis of AIDP . . . requires:
(A) Bilateral flaccid limb weakness and decreased or absent deep tendon
reflexes in weak limbs;
(B) A monophasic illness pattern;
(C) An interval between onset and nadir of weakness between 12 hours and
28 days;
(D) Subsequent clinical plateau (the clinical plateau leads to either
stabilization at the nadir of symptoms, or subsequent improvement without
significant relapse; however, death may occur without a clinical plateau);
and,
(E) The absence of an identified more likely alternative diagnosis.
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Case 1:19-vv-00111-RTH Document 106 Filed 08/07/24 Page 6 of 21
. . .
(v) To qualify as any subtype of GBS, there must not be a more likely alternative
diagnosis for the weakness.
(vi) Exclusionary criteria for the diagnosis of all subtypes of GBS include the
ultimate diagnosis of any of the following conditions: chronic immune
demyelinating polyradiculopathy (CIDP) . . . 42 C.F.R. § 100.3(c)(15).
SM Dec. at 2–4. Special Master Moran next discussed petitioner’s change in diagnosis to CIDP.
Id. at 4–5. Acknowledging “the etiology of CIDP is ‘poorly understood,’” the Special Master
quoted petitioner’s expert Dr. Nadareishvili regarding “[a]n abundance of clinical and
experimental research [that] has led to the conclusion that CIDP is . . . an autoimmune disease.”
Id. at 5 (quoting ZN Report at 9). The Special Master then undertook a review of the evidence in
this case to determine whether petitioner had sufficiently alleged “the flu vaccine can provoke an
autoimmune attack, which leads to CIDP.” Id.
In his analysis, Special Master Moran acknowledged “Mr. Hoffman[] claims that a
vaccine caused an injury not listed on the Vaccine Injury Table” and outlined the Althen test for
off-table injuries: “A petitioner bears 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.’” Id. at 7 (quoting Althen v. Sec’y of Health & Hum
Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005)). Looking first to Althen prong one, the Special
Master began by “determin[ing] the level of proof” required for petitioner’s claim to succeed.
Id. at 7. In doing so, Special Master Moran explained, “Mr. Hoffman recognizes that his burden
of proof is preponderant evidence . . . [b]ut, Mr. Hoffman argues that a medical theory proposing
a causal connection between a vaccine and an injury needs to be only plausible.” Id. at 8 (citing
Mot. for Review at 8, 17–18). Looking at two recent cases from the Court of Federal Claims and
two from the Office of Special Masters, Special Master Moran concluded, “[a]n extensive
analysis of this issue is not required . . . because within the last two calendar years, judicial
officers have already held that the burden of proof for Althen prong one is persuasive [(i.e.,
preponderant)] evidence.” Id. at 8–9 (first citing Trollinger v. Sec’y of Health & Hum Servs.,
167 Fed. Cl. 127, 137 (2023); then citing Howard v. Sec’y of Health & Hum Servs., No. 16-
159V, 2023 WL 4117370, at *4–*5 (Fed. Cl. May 18, 2023); then citing Singleton v. Sec’y of
Health & Hum Servs., No. 17-1474V, 2023 WL 3595653, at *20 (Fed. Cl. Spec. Mstr. May 23,
2023); then citing J.D. v. Sec’y of Health & Hum Servs., No. 14-742V, 2022 WL 16543853, at
*27 (Fed. Cl. Spec. Mstr. Aug. 31, 2022)).
Applying the preponderant standard, Special Master Moran “evaluate[d] Mr. Hoffman’s
proposed theory” to determine whether “the evidence surpasse[d] the correct threshold.” Id. at 9.
The Special Master’s analysis of petitioner’s theory began with a review of “non-binding
precedents” providing guidance regarding “Mr. Hoffman[’s] advance[ment of] molecular
mimicry as a biologically plausible way that a flu vaccine can cause CIDP.” Id. at 9–10.
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Exploring decisions by the Federal Circuit, the Court of Federal Claims, and the Office of
Special Masters, Special Master Moran noted “authorities reviewing decisions involving
molecular mimicry have generally endorsed the approach of looking for some evidence that
persuasively shows that a portion of a vaccine resembles a portion of human tissue, which
contributes to causing the disease, and that the immune system will respond to the relevant
amino acid sequence.” See id. at 10 (first citing W.C. v. Sec’y of Health & Hum Servs., 704 F.3d
1352 (Fed. Cir. 2013); and then citing Caves v. Sec’y of Health & Hum Servs., 100 Fed. Cl. 119
(2011), aff’d sub nom., 463 Fed. App’x 932 (Fed. Cir. 2012); Tullio v. Sec’y of Health & Hum
Servs., No. 15-51V, 2019 WL 7580149, at *1214 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for
rev. denied, 149 Fed. Cl. 448 (2020)); id. at 12 (“In accordance with precedents such as W.C.,
Caves, [and] Tullio . . . the undersigned will look to see whether any evidence supports the
theory that flu vaccine can cause CIDP.”).
In reviewing petitioner’s proffered evidence, the Special Master stated the “lack of
understanding [regarding the cause of CIDP, which petitioner’s expert acknowledged,] does not
prevent Dr. Nadareishvili from proposing that the flu vaccine can cause CIDP via molecular
mimicry . . . [even though r]eferences postulating molecular mimicry as contributing to CIDP
appear scant in Mr. Hoffman’s case.” Id. at 14. The Special Master first discussed multiple
articles regarding the “body’s response to a malignant melanoma [and whether it] might lead to
CIDP through molecular mimicry.” Id. (first discussing M.D. Weiss et al., Molecular Mimicry in
Chronic Inflammatory Demyelinating Polyneuropathy and Melanoma, 51 NEUROLOGY 1738
(1998), ECF No. 48-2; and then discussing Marinos C. Dalakas, Pathogenesis of Immune-
Mediated Neuropathies, BIOCHIMICA ET BIPHYSICA ACT (17 June 2014), ECF No. 50-5; and
Angelika F. Hahn et al., Chronic Inflammatory Demyelinating Polyradiculoneuropathy, in
PERIPHERAL NEUROPATHY (Vol. 2) (2005), ECF No. 49-3). Special Master Moran likewise
highlighted the Hahn article, which, after “review[ing] four studies, of which one (McCombe)
was submitted as an exhibit here,” concluded “a direct or indirect relationship between CIDP and
[] preceding events remains to be established.” Id. at 15 (citing Hahn et al., at 2224). Reported
cases suggested the relation between immunization and CIDP is higher than chance, but the
study lacked a control group for comparison. Id. (citing Hahn et al., at 2224).
The Special Master then reviewed two articles, neither of which, according to the Special
Master, included reports of flu vaccines “preceding the onset of CIDP.” Id. (“[In the McCombe
study] no one reported receiving the flu vaccination . . . . Again, Bouchard did not report any
instances of any vaccination preceding the onset of CIDP.”). Indeed, in the Bouchard study,
sixteen out of one hundred patients reported an infectious event within six weeks of their
neurological symptoms, but none identified a vaccination as the event. Id. (citing C. Bouchard et
al., Clinicopathologic of Chronic Inflammatory Demyelinating Polyneuropathy 498, 499 (1999),
ECF No. 49-8. Dismissing a similar study in which “76 CIDP patients” completed a
“questionnaire on average approximately six years after the onset of their CIDP,” Special Master
Moran cited the authors’ concern regarding “draw[ing] firm conclusions from a questionnaire in
which patients report their recurrences after vaccinations themselves.” Id. at 15–16 (quoting
Krista Kuitwaard et al., Recurrences, Vaccinations, and Long-Term Symptoms in GBS and
CIDP, 14 J. OF PERIPHERAL NERVOUS SYSTEM 310, 312–15 (2009), ECF No. 50-3). Despite the
authors reporting some possible link between vaccines, including the flu vaccine, and CIDP
onset and symptoms, Special Master Moran noted “[t]he authors did not suggest any warnings
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Case 1:19-vv-00111-RTH Document 106 Filed 08/07/24 Page 8 of 21
about [flu] vaccinations,” leading the Special Master to conclude the “Kuitwaard [study] is an
article that collects numerous case reports into a series” so is of little persuasive value. Id. at 16.
Special Master Moran then dismissed another case report other researchers previously found to
“not contribute to the weight of mechanistic evidence,” id. at 17, especially as “case reports often
do not receive much consideration as evidence of causation.” Id. (citing 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)). In the report, a patient was diagnosed with CIDP after receiving a flu vaccination,
however, “the development of CIDP after influenza vaccination ha[d] not been previously
reported,” so the Special Master afforded the study little weight. Id. (citing J.M. Brostoff et al.,
Post-influenza vaccine chronic inflammatory demyelinating polyneuropathy at 229, (2008), ECF
No. 48-5). The Special Master further concluded “Dr. Nadareishvili does not add much on CIDP
. . . . [So a]t the end of the day, there is not sufficient evidence to support a finding that molecular
mimicry is a persuasive theory to explain how flu vaccines might cause CIDP.” Id. at 17–18
(emphasis added) (“Without having some well-informed ideas of the target antigen and how an
attack on the antigen leads to CIDP, it is difficult to accept, on a more likely than not basis, the
proposition that the flu vaccine contributes to a poorly understood process.”).
Turning briefly to petitioner’s analogization between CIDP and GBS, the Special Master
acknowledged “Mr. Hoffman’s attempted method of proof is legitimate . . . [as] [p]etitioners may
try to establish their cases through circumstantial evidence.” Id. at 19 (citing Capizzano v. Sec’y
of Health & Hum. Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006)). Special Master Moran likewise
recognized “GBS is both similar and different from CIDP.” Id. For instance, “both conditions
are believed to involve an attack on the myelin in the peripheral nerves,” but “GBS is a
monophasic disease and CIDP is a chronic disease.” Id. Further, according to Special Master
Moran, the “etiology of GBS is coming into focus,” including via “some epidemiological studies
. . . discover[ing] a slight increase in the incidence of GBS among people receiving a flu
vaccine.” Id. (citing 80 Fed. Reg. 45132, 45145–46 (July 29, 2015)); id. at 20 (“[T]he Secretary
[of Health and Human Services] found that the evidence and policy grounds support a proposal
to associate the flu vaccine with GBS on the Vaccine Injury Table.”). Per the Special Master,
however, “the data that allowed the Secretary [of Health and Human Services] to associate the
flu vaccine with GBS [for purposes of listing it on the Vaccine Injury Table] is lacking for CIDP
. . . [meaning] a finding that the flu vaccine can cause CIDP because [it] can cause GBS . . . is at
least one step too far to be persuasive.” Id. at 20 (“There is neither the quality nor the quantity of
evidence regarding any causes of CIDP.”). Thus, after evaluating recent similar cases in the
Office of Special Masters, Special Master Moran concluded, although “molecular mimicry . . .
may very well be . . . a biologically plausible theory to explain how the flu vaccine might cause
GBS,” “biological plausibility is not the evidentiary standard” under Althen prong one, meaning
“Mr. Hoffman’s evidence fails to measure up.” Id. at 23.
III. The Parties’ Expert Reports
A. Petitioner’s Expert Report from Dr. Zurab Nadareishvili
As noted supra, petitioner filed his expert report from Dr. Zurab Nadareishvili on 19 May
2021. See ZN Report. Dr. Nadareishvili is an Associate Professor of Neurology at George
Washington University School of Medicine and Health Sciences and serves as a Medical
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Director of the Stroke Program at Virginia Hospital Center. Curriculum Vitae of Dr.
Nadareishvili at 1, ECF No. 46-3. Dr. Nadareishvili treats between 3 and 5 CIDP patients a year
and treats approximately 1 GBS patient per month. ZN Report at 2.
In his report, Dr. Nadareishvili asserted, “[i]t is my opinion that, to a reasonable degree of
medical probability, [] Mr. Hoffman suffered from acute onset [CIDP], that he experienced the
onset of that condition about thirteen days from the date of vaccination, and that the vaccination
at issue was a substantial factor in the causation of Mr. Hoffman’s injured condition that has
persisted . . . to this day.” Id. at 1. Specifically, Dr. Nadareishvili stated, “CIDP is an immune-
mediated neuropathy. . . . In studying the potential immune mechanisms that trigger the
development of autoimmune responses to self, researchers focus on environmental triggers of
autoimmunity such as infections and vaccinations, and have developed a few different theoretical
mechanisms to understand this process.” Id. at 9–10. Dr. Nadareishvili then listed four ways a
vaccine can lead to an autoimmune response, each having been used to explain the pathogenesis
of GBS and CIDP. Id. at 10–11. He stated, “[r]esearch has most consistently supported
molecular mimicry as the dominant mechanistic model to explain the aberrant immune responses
that cause peripheral nerve injury like that seen in this case.” Id. at 11. Dr. Nadareishvili further
elaborated on molecular mimicry and how it specifically occurs in relation to vaccines:
Infectious agent[s] or vaccine[s] . . . may carry elements that are similar enough to
amino acid or glycan sequence[s] or structure[s] to self-antigens that the
pathogen[s] or vaccine[s] act[] as a self-‘mimic’. Termed ‘molecular mimicry’, T
or B cells that are activated in response to the . . . vaccine are also cross-reactive to
self and lead to direct damage and further activation of other arms of the immune
system.
Id. at 10. Dr. Nadareishvili then described how vaccine injury is linked to CIDP through
autoantibodies:
Research indicates that autoimmunity in CIDP is most likely mediated by
antibodies directed against myelin antigens, along with autoreactive T cells and
macrophages that invade the myelin sheath, axonal membranes and/or the nodes of
Ranvier. Antibodies against myelin . . . antigens have been found in the serum of
CIDP patients. Experimental models have shown that these autoantibodies from
CIDP patients directed against myelin . . . antigens can produce neuropathic
changes resembling CIDP in experimental animals.
Id. at 11–12. Dr. Nadareishvili stated as “proof of principle” of molecular mimicry in CIPD
cases, “[m]elanoma vaccines can express gangliosides . . . in the peripheral nerves and [] patients
with melanoma and CIDP also have anti-ganglioside antibodies against gangliosides expressed.”
Id. at 12. Conceding, “the precise pathogenesis of [CIDP] is not [] fully delineated,” Dr.
Nadarehivili stated, “there are data points that support the thesis of molecular mimicry causing
CIDP following an immune challenge.” Id. at 12. Finally, Dr. Nadareishvili discussed why GBS
is more frequently linked to vaccination than CIDP:
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It needs to be emphasized that A-CIDP diagnosis is always made in retrospect as
there are no clinical, electrodiagnostic, or biological markers that allow distinction
between A-CIDP and GBS in the acute phase. . . . Whereas GBS is frequently
linked to a preceding triggering event such as infection or vaccination, this
association is less apparent in CIDP due to the insidious onset and evolution of
CIDP and the common delay in making the diagnoses, which is on average 6-12
months from the onset of symptoms, so patients may no longer recall prodromal
events.
Id. at 8.
B. Respondent’s Expert Report from Dr. Michael Wilson
Respondent filed its expert report by Dr. Michael Wilson on 17 September 2021. See
Wilson Report. Dr. Wilson is an Associate Professor of Neurology at the University of
California, San Francisco. Curriculum Vitae of Dr. Wilson at 1, ECF No. 53-12. Dr. Wilson
“ha[s] a weekly clinic of 5–7 patients” and “AIDP and CIDP are frequently part of [his]
differential diagnoses.” Wilson Report at 1.
Dr. Wilson did not dispute “petitioner has CIDP that became symptomatic temporally
after his COPD exacerbation and administered vaccinations” but stated “there is very weak
evidence for any association between CIDP and influenza vaccinations” and “petitioner has pre-
existing [CLL] that puts him at significantly increased risk for CIDP.” Id. at 4. Specifically, Dr.
Wilson stated AIDP, which is a subtype of GBS, is most often triggered by viruses but noted
there are “vaccine-induced cases, most notably from the 1976 swine influenza vaccine.” Id. at 3.
He continued, CIDP sometimes “presents in a more insidious fashion than AIDP, but can also
have a more abrupt onset, as in the petitioner’s case, thus making it difficult to distinguish from
AIDP early on in the disease course.” Id. at 4 (citations omitted). Turning to CIDP in particular,
Dr. Wilson explained, the Institute of Medicine’s (IOM) 2012 report on the adverse effects of
vaccines assessed “the mechanistic evidence regarding an association between influenza vaccine
and CIDP as weak.” Id. (internal quotations omitted). Dr. Wilson noted the IOM’s 2012 report
concluded “the evidence is inadequate to accept or reject a causal relationship between influenza
vaccine and CIDP.” Id. (internal quotations omitted). Further, regarding petitioner’s medical
history, Dr. Wilson stated “much of the literature [Dr. Nadareishvili] cites posits a link between
anti-ganglioside bodies being cross-reactive against certain influenza antigens, and antigens
displayed on myelin surrounding peripheral nerves. However, petitioner was tested for the
presence of anti-ganglioside antibodies, and this testing was negative.” Id. at 4–5.
C. Expert Rebuttal and Supplemental Reports
In his Reply Report for petitioner filed 11 January 2022, Dr. Nadareishvili responded to
Dr. Wilson: “At no point did [Dr. Wilson] state that the theoretical explanation propounded in
my earlier report was unviable as a scientific explanation.” Reply of Dr. Nadareishvili (ZN
Reply) at 2, ECF No. 61-2. Dr. Nadareishvili likewise disputed Dr. Wilson’s remark CLL can
lead to CIDP:
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Dr. Wilson’s insinuation that petitioner’s co-morbid pre-existing conditions were
the cause of his CIDP is misleading, as no single study thus far has postulated a
causal relationship between CLL and CIDP. . . . His report did not cite to literature
that explained how CLL could cause, or even contribute to causing CIDP. . . . As
was already mentioned the Briani letter to the editor showed extremely low 0.37%
[] prevalence of CIDP in CLL, and no causality or even association between these
two conditions can be claimed based on this study as there was no control group
without CLL to compare with. Indeed, even the authors of [the] Briani [letter] []
declined to postulate a causal relationship between CLL and CIDP.
Id. at 5. Respondent filed its Supplemental Expert Report by Dr. Wilson on 13 March 2022, in
which Dr. Wilson emphasized “there is vanishing[ly] little evidence in the scientific and medical
literature and from the [petitioner’s] clinical test results . . . to undergird this speculation that
petitioner’s influenza vaccination actually did trigger his CIDP.” Michael R. Wilson Expert
Report (Suppl. Wilson Rep.) at 1, ECF No. 63-1.
IV. Petitioner’s Motion for Review and Respondent’s Arguments
On 9 February 2024, petitioner moved for review of the Special Master’s Decision
Denying Compensation. See Mot. for Rev. Disputing the level of proof of causation required by
the Special Master, petitioner asserts, “[b]inding Federal Circuit precedent is clear that
[p]etitioner was bound to provide, to a preponderance of the evidence in the individual case, a
reasoned, plausible explanation for how the vaccine at issue can cause [p]etitioner’s injury,
based on the scientific evidence that is available and filed into the record. . . . Here, the Special
Master evaluated the evidence based on a faulty standard of proof.” Id. at 12 (first emphasis
added). In other words, according to petitioner, “[t]he applicable law in the Vaccine Program
contemplates preponderant proof of biological plausibility as the sufficient proof for a medical
theory, not preponderant proof of the theory itself.” Id. at 10; see also Tr. at 18:14–18
(“[PETITIONER:] We would say that the distinction is what must be proved versus what is
necessary to prove it, that plausibility is what must be proved, that it must be proved through
preponderant evidence more likely than not that it is plausible.”). In response, respondent
argues, contrary to petitioner’s assertion, “the evidence must establish more likely than not that
the vaccine can cause an injury in general.” Resp’t’s Resp. at 3. After reviewing the parties’
arguments, the Court ordered supplemental briefing regarding the relationship between the
dispute in this case and the Court’s analysis in its previous decision, J. v. Sec’y of Health and
Hum Servs., 155 Fed. Cl. 20 (2021), on 18 March 2024. See 18 Mar. 2024 Order, ECF No. 94.
On 2 April 2024, respondent filed its Supplemental Brief, (Resp’t’s Suppl. Br., ECF No. 95), and
petitioner filed his Supplemental Brief the next day, see Pet’r’s Suppl. Br., ECF No. 96. The
Court held oral argument on Petitioner’s Motion for Review on 20 June 2024 in Washington,
DC. See 3 Apr. 2024 Order, ECF No. 97.
Specifically, in his Motion for Review, petitioner argues the Special Master erred in two
related ways: (1) “by applying incorrect legal standards to the evaluation of general causation,
requiring empirical evidence and scientific evidence . . . for a condition [for] which scientific
knowledge is limited[;]” and (2) “by applying an incorrect legal standard to the assessment of
[p]etitioner’s medical theory.” Mot. for Review at 1. In other words, petitioner accuses the
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Special Master of using “an incorrect analytical framework, which elevated the burden of proof
on general causation.” Id. at 3. At oral argument, the parties confirmed there are no factual
disputes at this stage of the litigation. See Tr. at 5:13–20 (“THE COURT: So before we get into
the agenda, can both parties [] confirm that at this stage in the petition for review [] there are no
factual issues that are in dispute? [PETITIONER:] None were raised in the Motion, Your
Honor. THE COURT: And the Respondent agrees? [RESPONDENT:] That is correct.”).
As to petitioner’s first allegation, petitioner explains “[t]he first prong of the Althen
standard is the element of general causation, which considers the more abstract, theoretical issue
of whether the vaccine can cause the particular injury alleged, by postulating a medical theory of
causation.” Mot. for Review at 4. Per petitioner, “[t]he law required [p]etitioner to prove by a
preponderance of the evidence filed in this case that his medical theory was biologically
plausible[] and reliable within the context of available medical knowledge. Instead, the Special
Master held [p]etitioner responsible to prove the theory with empirical evidence, and to explain
specific mechanisms . . . to prove precisely how the vaccination . . . damaged[] [p]etitioner’s
peripheral nervous system.” Id. at 4–5. Petitioner takes particular issue with the Special Master
determining “the lack of ‘definitiveness’” in petitioner’s theory required a denial of
compensation. Id. at 5. Petitioner argues he met his burden to show—either via direct or
circumstantial evidence—the “vaccination could cause [his] injury, and then explain how the
facts of” his “case aligns with that explanation.” Id. at 6, 13 (“The point of allowing
circumstantial evidence in the preponderance standard of proof is that, when taken together, the
various datapoints combine to support the medical theory.”). Citing multiple Federal Circuit
cases, see id. at 7–8 (citing, for example, Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274
(Fed. Cir. 2005); then citing Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1325
(Fed. Cir. 2006); and then citing Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009)), petitioner argues “the judges of the Court of Federal Claims have reversed
special master decisions which applied aberrant analysis that would require petitioners to provide
specific pathologic mechanisms or identification of antibody-epitope relationship.” Id. at 9
(citing Stitt v. Sec’y of HHS, 2013 U.S. Claims LEXIS 780, *30-31 (2013); then citing Patton v.
Sec’y of Health & Hum. Servs., 157 Fed. Cl. 159, 168 (2021)). Indeed, petitioner points to
Sharpe, in which the Federal Circuit explained, “the Special Master should not have been
concerned with what ‘future research’ may show but rather with the research presented in the
record” because “[t]he Vaccine Injury Program, after all, is designed to allow the finding of
causation in a field bereft of complete and direct proof of how vaccines affect the human body.”
Id. at 9 (quoting Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072, 1083 (Fed. Cir. 2020)
(internal quotations omitted)). Ultimately, according to petitioner, the “applicable law . . .
contemplates preponderant proof of biological plausibility as the sufficient proof for a medical
theory, not preponderant proof of the theory itself.” Id. at 10.
Regarding his related second allegation, Mr. Hoffman asserts a petitioner “satisfies the
‘can cause’ element by presenting a ‘medically plausible theory.’” Id. at 17. While
acknowledging certain recent “cases have seemed to diverge from this established plausibility
standard,” petitioner points to several Court of Federal Claims cases “harmoniz[ing the divergent
cases] with the longstanding [plausibility] precedent” and argues no recent decision has changed
the “nearly 30 years of Federal Circuit precedent on the standard for Althen’s prong 1.” Id. at
18–19. In his Supplemental Brief, petitioner reaffirms his argument, “it is a category error to
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conflate the general requirement for the quantity of evidence necessary to prove any component
of the prima facie case [(i.e., preponderant evidence)] with the qualitative metric for evaluating
the quality of a medical theory, which has remained biological plausibility.” Pet’r’s Suppl. Br. at
2. Petitioner continues, “[t]he can cause standard of biological plausibility is the correct legal
standard” for general causation, id., meaning the Court was correct in J. v. Sec’y of Health &
Hum. Servs., 155 Fed. Cl. 20 (2021) “that the first prong of Althen was satisfied . . . when
petitioner’s expert presented a ‘biologically plausible’ theory.” Id. at 3–4 (quoting J., 155 Fed.
Cl. at 42–43) (cleaned up).
Respondent disputes petitioner’s assertion Althen prong one is subject to a plausibility
standard. Specifically, respondent alleges “[t]he preponderance standard applies to each Althen
prong individually.” Resp’t’s Resp. at 3; see Tr. at 22:4–8 (“[RESPONDENT:] Petitioner’s
medical theory must be preponderantly supported or more likely than not based on persuasive
and reliable evidence. So the preponderant standard is a quantum of evidence. We typically
refer to it as 51 percent.”). According to respondent, “[t]he plausibility argument has been
repeatedly made on appeal by petitioners in recent years, and it has been repeatedly rejected by
both the Court of Federal Claims and the Federal Circuit.” Resp’t’s Resp. at 8 (citing LaLonde v.
Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014); then citing Boatmon v.
Sec’y of Health & Hum. Servs., 941 F.3d 1350, 1360 (Fed. Cir. 2019); and then citing W.C., 704
F.3d at 1356). Respondent reiterated its arguments in its Supplemental Brief, see Resp’t’s Suppl.
Br., in which it argues “the Federal Circuit has repeatedly stated . . . that the preponderant
evidence standard applies to each Althen prong individually.” Id. at 6. Indeed, in discussing the
Court’s previous decision in a similar case, J. v. Sec’y of Health & Hum. Servs., which
respondent acknowledges “suggested that biological plausibility was the appropriate evidentiary
standard . . . under Althen prong one,” see id. at 5 (citing J., 155 Fed. Cl. at 42–44), respondent
contends, “[i]f the Federal Circuit had intended that a petitioner could satisfy Althen prong one
by merely identifying a biologically plausible medical theory, it would have affirmatively
articulated such a standard.” Id. at 6. Thus, respondent alleges “the Court misread the vaccine
case law in” J. See Tr. at 8:3–11.
Further, in response to petitioner’s specific arguments, respondent argues the Special
Master correctly “required petitioner to provide preponderant evidence that his proffered medical
theory of molecular mimicry was sound and reliable in this case,” and petitioner failed to do so.
Resp’t’s Resp. at 11–12. Indeed, respondent contends “Dr. Nadareishvili was unable to offer
legally sufficient evidence,” “there is too little evidence to support a causal link between the flu
vaccine and CIDP,” and “[t]he Federal Circuit has previously rejected . . . molecular mimicry as
being too generic to be persuasive in a specific case.” Id. at 12 (citing W.C., 704 F.3d 1352).
Further, contrary to petitioner’s contention, respondent alleges “the Special Master correctly
evaluated the circumstantial evidence” and—similar to other recent Office of Special Master
cases—“concluded that CIDP and GBS are highly ‘distinguishable.’” Id. at 14–15.
V. Legal Standards
A. The Court’s Standard of Review of a Special Master’s Decision
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The Vaccine Act provides this court jurisdiction to review a Special Master’s decision
upon timely motion of either party. See 42 U.S.C. § 300aa-12(e)(1)–(2). In reviewing the record
of the proceedings before the Special Master, the Court may: (1) “uphold the findings of fact
and conclusions of law of the special master and sustain the special master’s decision;” (2) “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 (3) “remand the petition to the special master for
further action in accordance with the court’s direction.” Id. § 300aa-12(e)(2). “Fact findings are
reviewed . . . under the arbitrary and capricious standard; legal questions under the ‘not in
accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.”
Saunders v. Sec’y of Dept. of Health & Hum. Servs., 25 F.3d 1031, 1033 (Fed. Cir. 1994)
(quoting Munn v. Sec’y of Dept. of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.
1992)).
It is not the Court’s role “to reweigh the factual evidence, or to assess whether the special
master correctly evaluated the evidence.” Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d
1357, 1360 (Fed. Cir. 2000) (quoting Munn, 970 F.2d at 871). The Court also does “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.” Id. (quoting Munn, 970 F.2d at 871). “Reversal is
appropriate only when the special master’s decision is arbitrary, capricious, an abuse of
discretion, or not in accordance with the law.” Snyder ex rel. Snyder v. Sec’y of Health & Hum.
Servs., 88 Fed. Cl. 706, 718 (2009).
B. The Standard of Causation in Vaccine Cases
“A petitioner seeking compensation under the Vaccine Act must prove by a
preponderance of the evidence that the injury or death at issue was caused by a vaccine.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1341 (Fed. Cir. 2010) (citing 42
U.S.C. §§ 300aa-11(c)(1), -13(a)(1)). “A petitioner can show causation under the Vaccine Act in
one of two ways”: (1) “by showing that she sustained an injury in association with a vaccine
listed in the Vaccine Injury Table,” in which case “causation is presumed”; or (2) “if the
complained-of injury is not listed in the Vaccine Injury Table . . . the petitioner may seek
compensation by proving causation in fact.” Id. at 1341–42 (internal citations omitted). Vaccine
cases employ a burden shifting standard: “[o]nce the petitioner has demonstrated causation, she
is entitled to compensation unless the government can show by a preponderance of the evidence
that the injury is due to factors unrelated to the vaccine.” Id. at 1342 (citing Doe v. Sec’y of
Health & Hum. Servs., 601 F.3d 1349, 1351 (Fed. Cir. 2010); 42 U.S.C. § 300aa-13(a)(1)(B)).
“When a petitioner has suffered an off-Table injury . . . [the Federal Circuit] has
established the following test for showing causation in fact under the Vaccine Act:”
[The petitioner’s] burden is to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory causally connecting
the vaccination and the injury; (2) a logical sequence of cause and effect showing
that the vaccination was the reason for the injury; and (3) a showing of a proximate
temporal relationship between vaccination and injury.
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Broekelschen, 618 F.3d at 1345 (quoting Althen v. Sec’y of Health & Hum. Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005)). Under the first prong of Althen, “[a] petitioner must provide a
‘reputable medical or scientific explanation’ for its theory.” Boatmon v. Sec’y of Health & Hum.
Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019) (quoting Moberly ex rel. Moberly v. Sec’y of Health
& Hum. Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)). “While it does not require medical or
scientific certainty, [the explanation] must still be ‘sound and reliable.’” Id. (quoting Knudsen ex
rel. Knudsen v. Sec’y of Dept. of Health & Hum. Servs., 35 F.3d 543, 548–49 (Fed. Cir. 1994)).
Petitioners “need not produce medical literature or epidemiological evidence to establish
causation under the Vaccine Act.” Andreu ex rel. Andreu v. Sec’y of Dept. of Health & Hum.
Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009). Where such evidence is introduced, it must not be
viewed “through the lens of the laboratorian, but instead from the vantage point of the Vaccine
Act’s preponderant evidence standard.” Id. at 1380. For satisfying the second Althen prong,
“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.’” Capizzano v. Sec’y of
Health & Hum. Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (quoting Althen, 418 F.3d at 1280).
Lastly, “the proximate temporal relationship prong requires preponderant proof that the onset of
symptoms occurred within a timeframe for which, given the medical understanding of the
disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of
Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
VI. Whether the Special Master Erred in Requiring Persuasive Evidence of a
Persuasive Theory Under Althen Prong One
In rejecting petitioner’s proffered theory of causation, Special Master Moran concluded
“‘biological plausibility’ is not the evidentiary standard” under Althen prong one. SM Dec. at
23. Instead, the Special Master required “persuasive evidence,” id. at 8, of “a persuasive
theory.” Id. at 9; see id. at 8 (noting “persuasive” is higher on the “evidentiary scale” than
“plausible”). Respondent agrees, noting “both the Court of Federal Claims and the Federal
Circuit . . . ha[ve] made clear that ‘simply identifying a “plausible” theory of causation is
insufficient for a petitioner to meet [his] burden of proof.’” Resp’t’s Resp. at 8 (quoting
LaLonde v. Sec’y of Health & Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (additional
citations omitted)); see Tr. at 24:2–7 (“[RESPONDENT:] [If] all Petitioner had to provide was
preponderant evidence to satisfy a plausible theory . . . very likely it would be very general . . .
[s]o that’s why a plausible theory is not sufficient.”). In response, petitioner contends “the
Special Master erred by applying an incorrect legal standard to the assessment of [p]etitioner’s
medical theory.” Mot. for Review at 1. According to petitioner, he “must provide preponderant
proof of every component of . . . [his] case, including preponderant proof that the medical theory
relied upon to prove causation is plausible.” Id. at 15 (emphasis added); see Tr. at 18:8–14
(“THE COURT: So for Petitioner first . . . you argue on page 10 the first Althen prong
contemplates preponderant proof of biological plausibility as the sufficient proof for a medical
theory . . . is that correct? [PETITONER:] Yes, sir.”). The parties thus do not dispute
petitioners bear the burden of proving all Althen prongs, including prong one, by preponderant
evidence, see Tr. at 17:25–18:6 (“THE COURT: Do both parties then also agree that the test
requires preponderant evidence of a medical theory connecting the relevant vaccine to the kind
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of injury suffered? [PETITIONER:] Yes, sir. THE COURT: [Respondent?]
[RESPONDENT:] Agreed, Your Honor.”), but they disagree as to the required quality of
petitioners’ proffered medical theory. Tr. at 18:8–19:5 (petitioner agreeing “the first Althen
prong contemplates preponderant proof of biological plausibility”); Tr. at 8:8–11 (“THE
COURT: Does Respondent believe, then, as the Special Master put it in this case, Petitioner
must present a persuasive theory? [RESPONDENT:] That is correct.”); compare Resp’t’s
Suppl. Br. at 5 (“[The Federal Circuit’s] decision[s] cannot and should not be ready to endorse
the notion that the correct standard under Althen prong 1 is mere biological plausibility.”), with
Mot. for Review at 15 (stating petitioners must provide “preponderant proof that the[ir] medical
theory . . . is plausible”). While this dispute mirrors that of the parties in the Court’s previous J.
case, the Court revisits all relevant statutes and caselaw to determine the appropriate standard
under Althen prong one anew. See J. v. Sec’y of Health & Hum. Servs., 155 Fed. Cl. 20, 40–43
(2021); see also Tr. at 17:3–7 (“[THE COURT:] [D]oes Petitioner agree with the Court’s
holding in [J.] that Althen prong one requires a biologically plausible theory linking the vaccine
to the injury? [PETITIONER:] Yes, sir.”); see also Tr. at 12:18–14:5 (“[THE COURT:] So . . .
Respondent would agree that there’s no Federal Circuit precedential decision that has changed
any of the reasoning in [J.]? [RESPONDENT:] That is correct.”). Notably, at oral argument,
the parties agreed “if the Court were to hold . . . that the standard [under Althen prong one] is
plausibility,” the best path would be “to remand and [] allow a full reevaluation of all the record
evidence under this standard.” Tr. at 15:24–17:2; see also Tr. at 17:8–11 (“THE COURT: If the
holding [from J.] were to be applied in this case, does that warrant granting [p]etitioner’s motion
for review and then vacating and remanding? [PETITIONER:] Yes, sir.”).
The first prong of Althen requires a petitioner to provide “a medical theory causally
connecting the vaccination and the injury.” Althen v. Sec’y of Health & Hum. Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005) (citation omitted). The theory need not be corroborated by medical
literature or epidemiological evidence. See Capizzano v. Sec’y of Health & Hum. Servs., 440
F.3d 1317, 1325 (Fed. Cir. 2006); Andreu ex rel. Andreu v. Sec’y of Dept. of Health & Hum.
Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (“A trial court . . . [need] not [] evaluate whether an
expert witness’ medical theory is supported by the weight of epidemiological evidence.”).
Several Federal Circuit decisions have shed light on the meaning of this prong. In Andreu, for
example, the petitioners “argue[d] that they satisfied all three prongs of the Althen test by . . .
setting forth what even the government’s expert agreed was a ‘biologically plausible’ theory
explaining how toxins in the whole cell pertussis vaccine could cause seizures.” Andreu, 569
F.3d at 1375. Agreeing with the petitioners, the Federal Circuit stated the petitioners “met the
first . . . prong[] of the Althen test” because their expert “presented a ‘biologically plausible’
theory establishing that . . . [the] pertussis vaccine can cause seizures.” Id. In Andreu,
referencing Althen, the Federal Circuit accordingly cautioned against “impermissibly rais[ing] a
claimant’s burden under the Vaccine Act” as doing so would frustrate “the system created by
Congress, in which close calls regarding causation are resolved in favor of injured claimants.”
Id. at 1378 (quoting Capizzano, 440 F.3d at 1325–26) (internal quotations omitted); see Althen,
418 F.3d at 1280 (noting it is “the purpose of the Vaccine Act[]” to “allow the finding of
causation in a field bereft of complete and direct proof of how vaccines affect the human body”).
Although the Special Master in the instant case cited Andreu, see SM Dec. at 7, he did so for an
unrelated proposition. Respondent, on the other hand, conceded Andreu “does say that [prong
one] was met” by a plausible theory. See Tr. at 41:12–24.
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Similarly, in Kottenstette, the special master ruled in favor of the petitioner, finding
Althen prong one was satisfied as there was “a medical theory causally connecting the
vaccination and the injury.” Kottenstette v. Sec’y of Health & Hum. Servs., 861 Fed. App’x. 433,
437 (Fed. Cir. 2021) (internal quotations omitted). On appeal, the Federal Circuit held “the []
special master applied the correct legal standard.” Id. at 440. Indeed, the Federal Circuit stated
“[t]he [] special master’s statement that ‘medical probability means biological credibility rather
than specification of an exact biological mechanism . . . correctly recites this court’s statement in
several precedential cases that proof of causation does not ‘require identification and proof of
specifical biological mechanisms[.]’” Id. at 440–41 (quoting Knudsen v. Sec’y of Health & Hum.
Servs., 35 F.3d 543, 549 (Fed. Cir. 1994); then citing Simanski v. Sec’y of Health & Hum. Servs.,
671 F.3d 1368, 1384 (Fed. Cir. 2012)). The Federal Circuit therefore approved of the special
master’s application of a “biologic[al] credibility” standard to petitioner’s medical theory of
causation. Id. The Federal Circuit has thus said a biologically credible, or plausible, theory is
sufficient under Althen prong one. Id.; Andreu, 569 F.3d at 1375; see Plausible, WEBSTER’S
THIRD NEW INTERNATIONAL DICTIONARY (3rd ed. 2021) (“4a: superficially worthy of belief:
credible”); Credible, WEBSTER’S THIRD NEW INTERNATIONAL DICTIONARY (3rd ed. 2021) (“1:
capable of being credited or believed”).
In holding “the burden of proof for Althen prong one is persuasive evidence” of a
“persuasive theory,” rather than a biologically plausible theory, however, the Special Master
cited the Federal Circuit’s 2019 decision in Boatmon. See SM Dec. at 9 (citing Boatmon v. Sec’y
of Health & Hum. Servs., 941 F.3d 1351 (Fed. Cir. 2019)); see also Resp’t’s Resp. at 3 (noting
Boatmon reiterated “that ‘a “plausible” or “possible” causal theory does not satisfy the
standard”). In Boatmon, the Federal Circuit discussed “petitioners’ burden to prove actual
causation” in “off-Table cases.” Boatmon, 941 F.3d at 1359. In doing so, the Federal Circuit
noted the “burden to prove actual causation [is] . . . a preponderance of the evidence.” Id.
(citation omitted). This, according to the Federal Circuit, necessitates proffering a “sound and
reliable” theory of causation. Id. (quoting Knudsen, 35 F.3d at 548–49) (internal quotations
omitted). The Federal Circuit in Boatmon therefore took issue with the special master
“deviat[ing] from the correct ‘reputable,’ ‘sound and reliable’ standard and articulat[ing] a
‘reasonable’ standard.” Id. Thus, according to Boatmon, Althen prong one requires petitioners
“show by a preponderance of the evidence” their proposed “theory . . . is a sound and reliable
medical theory of causation.” Id. at 1362. To the extent the Boatmon court “reiterated that a
‘plausible’ . . . theory” is insufficient and discussed “prov[ing] all three Althen prongs by a
preponderance of the evidence,” id. at 1355, 1360, the Federal Circuit was “analyzing the overall
standards for ‘petitioners’ burden to prove actual causation[,’] not [the] standard for [petitioner’s
theory required by] Althen [prong] one.” J. v. Sec’y of Health and Hum Servs., 155 Fed. Cl. 20,
43 (2021) (quoting Boatmon, 941 F.3d at 1360). Indeed, as further explained by this Court in J.,
“[i]n the section of the Boatmon opinion where the Federal Circuit rejected a merely ‘plausible’
theory as sufficient to establish causation, the Federal Circuit was specifically analyzing the
overall standard for ‘petitioners’ burden to prove actual causation by a preponderance of the
evidence in off-table cases,’ not a standard for Althen element one . . . . The Boatmon court
reserved a separate section to discuss Althen element one, where the court used ‘a sound and
reliable medical theory of [causation]’ as the legal standard to review the special master’s
decision.” Id. (quoting Boatmon, 941 F.3d at 1360–62). In other words, Boatmon merely
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reiterated the familiar rule petitioners must present preponderant evidence of a “sound and
reliable medical theory,” Boatmon, 941 F.3d at 1360, which Andreu referred to as “a
‘biologically plausible’ theory.”2 Andreu, 569 F.3d at 1375; see also Olson v. Sec’y of Health &
Hum. Servs., 758 Fed. App’x. 919, 922 (Fed. Cir. 2018) (citing Oliver v. Sec’y of Health & Hum.
Servs., 900 F.3d 1357, 1361 (Fed. Cir. 2018) (requiring petitioners “show by preponderant
evidence each of the requirements set forth in Althen”) (cleaned up)). It did not, as
mischaracterized by the Special Master,3 impose a requirement petitioners must “present a
persuasive theory.” SM Dec. at 8.
Although respondent cites other Federal Circuit cases, such as Moberly and LaLonde, in
support of its argument “[t]he preponderance standard appl[ying] to each Althen prong
individually” means “it is insufficient for petitioner to posit a merely plausible theory,”
respondent misunderstands the rule set forth in these decisions. Resp’t’s Resp. at 3. In Moberly,
the petitioner—like petitioner here—argued “the special master imposed a heightened burden of
proof by requiring a showing of causation to the level of ‘scientific certainty’ rather than by a
preponderance of the evidence.” Moberly ex re. Moberly v. Sec’y of Health & Hum. Servs., 592
F.3d 1315, 1322 (Fed. Cir 2010). There, however, the petitioner contended the appropriate test
was “whether . . . [the] condition was ‘likely caused’” by the relevant vaccine. Id. The Federal
Circuit rejected this, stating the petitioner’s proposed test is “closer to proof of a ‘plausible’ or
‘possible’ causal link between the vaccine and the injury” than the appropriate “‘more likely than
not’ standard.” Id. Keying in its previous analysis of Althen prong one in Andreu, the Federal
Circuit then recognized a theory of general causation “should . . . be[] credited” when it is a
“biological[ly] plausibl[e] . . . theory.” Id. at 1325. In other words, as in Boatmon, Moberly
acknowledged petitioners can satisfy Althen prong one via a biologically plausible theory, so
long as they present preponderant evidence (i.e., satisfy the “more likely than not” standard) of
this theory. Id. Notably, respondent conceded at oral argument Moberly “seems to recognize . . .
that when there is a biologically plausible theory, it is proper for the Special Master to credit it as
sufficient for prong one.” See Tr. at 72:1–11 (the Court discussing Moberly with respondent).
Likewise, in LaLonde, the Federal Circuit stated petitioners must “demonstrate that the vaccine
more likely than not caused the condition alleged,” Lalonde v. Sec’y of Health & Hum. Servs.,
2 To the extent respondent alleged at oral argument the term “‘sound and reliable’ is the same as ‘persuasive,” see
Tr. at 62:4–63:7, there is no indication Boatmon intended to depart from previous Federal Circuit precedent, such as
Andreu, which required only a plausible medical theory. Indeed, respondent conceded there is no other “Federal
Circuit case law . . . clarify[ing] that . . . ‘persuasive’ is the same as ‘sound and reliable.’” See Tr. at 63:16–24; see
also Tr. at 63:9–15 (“[PETITIONER:] I disagree [‘sound and reliable’ means ‘persuasive.’]”).
3 In his decision, despite relying on Boatmon to conclude “[p]roof at merely a plausible level is insufficient as a
matter of law,” Special Master Moran failed to discuss the meaning of Boatmon’s “sound and reliable” terminology
and, indeed, did not even cite pages 1361 and 1362 of Boatmon, in which the Federal Circuit conducted its Althen
prong one analysis. See SM Dec. at 9, 21; Boatmon, 941 F.3d at 1360–62 (discussing whether the petitioners’
theory “is a sound and reliable medical theory as required by Althen prong one”). Respondent conceded this at oral
argument. See Tr. at 69:17–70:5 (“THE COURT: So did the Special Master in this case, in Hoffman, apply a sound
and reliable standard? [RESPONDENT:] Well, yes. THE COURT: And did Special Master Moran say that?
[RESPONDENT:] In those words specifically . . . maybe not.”); Tr. at 70:18–25 (“THE COURT: You would agree,
though, that [Special Master Moran] did not cite to 1362 of Boatmon? He cited to 1360. [RESPONDENT:] That
may, in fact, be the case, Your Honor. . . . THE COURT: I think it’s just 1360, which . . . seems to be not
necessarily related to prong one.”). Instead, Special Master Moran cited only to the Federal Circuit’s discussion of
“the petitioners’ burden to prove actual causation.” See SM Dec. at 9 (citing Boatmon, 941 F.3d at 1351, 1360)
(emphasis added).
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746 F.3d 1334, 1339 (Fed. Cir. 2014) (emphasis added), while also acknowledging Althen
requires “petitioner[s] to show . . . the medical plausibility of [their] theory of causation. . . .” Id.
at 1340 (citing Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 13555, 1365 (Fed. Cir.
2012)). Thus, the LaLonde court similarly distinguished between the burden of proof linking
vaccine to injury—preponderant evidence—from the standard of certainty required of
petitioner’s theory—plausibility. See id. Moberly and LaLonde, like Boatmon, therefore stand
for the proposition that to satisfy Althen prong one petitioners must provide preponderant
evidence linking the vaccine received to the injury suffered via a biologically plausible theory.
Moberly, 592 F.3d at 1322, 1325; see also Boatmon, 941 F.3d at 1359, 1362.4
The Federal Circuit’s caselaw from the last several decades thus makes clear a petitioner
can satisfy Althen prong one by “setting forth . . . a ‘biologically plausible’ theory” of general
causation. Andreu, 569 F.3d at 1375; see also Paluck v. Sec’y of Health & Hum. Servs., 786
F.3d 1373, 1380 (Fed. Cir. 2015) (describing medical plausibility as follows: the “vaccination
could . . . in theory” cause the injury); Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072,
1083 (Fed. Cir. 2020) (explaining a medically plausible theory must merely “demonstrat[e] that
[the] vaccine ‘can’ cause” the injury at issue)5; see also Tr. at 73:25–74:24 (“[THE COURT:]
Well, what precedential Federal Circuit decision directly addresses prong one . . . with a standard
different than plausibility[?] . . . [RESPONDENT:] Well, Althen . . . THE COURT: Any
other[s?] . . . [RESPONDENT:] [B]eyond that . . . I don’t know . . .”). The parties agree
petitioner must do so “by a preponderance of the evidence” as required by Boatmon, see supra;
see Olson, 758 Fed. App’x. at 922 (citing Oliver, 900 F.3d at 1361 (requiring petitioners “show
4 On 20 June 2024, minutes before oral argument in this case, the Federal Circuit issued its non-precedential
decision in Kalajdzic v. Sec’y of Health & Hum. Servs., No. 23-1321 (Fed. Cir. June 20, 2024). As the Court and
parties discussed this opinion at oral argument, see Tr. at 74:25–78:5 (discussing Kalajdzic), the Court takes judicial
notice of the decision. See Tr. at 77:10–79:19 (petitioner noting the Federal Circuit in Kalajdzic commits “a
category error” between “the level of evidence . . . needed to prove the medical theory . . . [and] what makes a
theory legitimate”); Tr. at 75:4–16 (respondent explaining Kalajdzic “affirmatively endorsed the preponderant
evidence standard under Althen prong one”). The government subsequently filed a notice of additional authority on
3 July 2024 to “bring the Court’s attention to specific aspects of the [Kalajdzic] opinion as they relate to the parties’
briefing,” ECF No. 100. In Kalajdzic, the parties—as here—“acknowledged . . . that Althen prong one requires
proof by a preponderance of the evidence,” however, the petitioner “appear[ed] to . . . argu[e] that the requirements
of the preponderance standard are more relaxed than what the law mandates.” Kalajdzic, No. 23-1321, slip. op at 5
(Fed. Cir. June 20, 2024). The Federal Circuit first explained Andreu’s “biological plausibility” language could not
“have endorsed a lower standard of proof than the preponderance standard” because “prong one was not disputed” in
that case. Id. (citing Andreu, 569 F.3d at 1375). Thus, after stating without explanation neither Kottenstette nor
Capizzano “undercut[] the requirement that a petitioner’s medical theory must be proven by preponderant evidence,”
id., the Federal Circuit concluded in Kalajdzic any standard for prong one “less than preponderance . . . is plainly
inconsistent with [Federal Circuit] precedent.” Id. The Court’s decision here requiring preponderant evidence, see
supra, to prove petitioner’s theory under Althen prong one is consistent with Kalajdzic. To the extent Kalajdzic
signaled a shift in Federal Circuit jurisprudence toward requiring preponderant evidence of a persuasive theory,
however, the Court is unable to reconcile this with the Circuit’s previous decisions in Moberly, LaLonde, and
Boatmon, see supra. Neither can the Court reconcile this decision with Kottenstette, in which the Federal Circuit
approved of “[t]he . . . special master’s statement that ‘medical probability means biological credibility[’]” and
stated, “biological credibility” “does not set a new lower . . . standard; it correctly recites [the Federal Circuit’s
statement in several precedential cases.” Kottenstette, 861 Fed. Appx. a 440–41. Kalajdzic therefore further
exemplifies the need for clarity related to Althen prong one, see infra n.7.
5 Paluck and Sharpe discuss plausibility with respect to the last three prongs of the Loving test for off-table
significant aggravation claims, see Loving ex rel. Loving v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 135 (2009),
which directly mirror the three-part Althen test. See Sharpe, 964 F.3d at 1083; Paluck, 786 F.3d at 1379–80.
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Case 1:19-vv-00111-RTH Document 106 Filed 08/07/24 Page 20 of 21
by preponderant evidence each of the requirements set forth in Althen”) (cleaned up)), but to the
extent the Special Master required petitioner to “present a persuasive theory,” the Special Master
improperly elevated petitioner’s burden under Althen prong one “not in accordance with [the]
law.” 42 U.S.C. § 300aa-12(e)(1)–(2); see Snyder ex rel. Snyder v. Sec’y of Health & Hum.
Servs., 88 Fed. Cl. 706, 718 (2009); SM Dec. at 8. Indeed, at least since Althen, the Federal
Circuit has recognized “requiring that the claimant provide proof of medical plausibility . . . is
merely a recitation of this court’s well-established precedent.” Althen, 418 F.3d at 1281; see Tr.
at 36:22–38:5 (petitioner explaining Althen “[a]t page 1281 . . . [said] there’s nothing wrong with
plausibility”). Were the Court to require “[p]etitioner[s] . . . [to] provide[] evidence that is both
persuasive and reliable” to prove persuasive theories in off-table cases as proposed by both
respondent and the Special Master, see, e.g., Tr. at 24:2–12, it would be virtually impossible to
make a “finding of causation in a field bereft of complete and direct proof.”6 Althen, 418 F.3d at
1280; see Tr. at 46:6–50:3 (“THE COURT: So in [Andreu,] . . . [the] Federal Circuit . . .
cautions requiring epidemiological studies or general acceptance in the scientific or medical
communities impermissibly raises a claimant’s burden . . . . What I’m wondering is how is it that
what the Government is articulating now for Althen prong one does not fall into that category
that the Federal Circuit seems to be directly cautioning against here? . . . [RESPONDENT:]
[Petitioners] are just required to provide convincing evidence to support that association between
the vaccine and the injury. . . THE COURT: But that sounds like epidemiological studies or
general acceptance in the scientific or medical communities, right? . . . What I’m asking is, is
the standard Respondent is articulating here, how is it not in those categories which the Federal
Circuit is cautioning against? . . . [I]t seems to me that this whole discussion here from the
Circuit is talking about a plausible theory and anything that would require something that would
automatically reject what just happens to be plausible, then, is something that Congress,
according to the Circuit, cautioned against because close calls regarding causation are resolved in
favor of injured claimants . . . [RESPONDENT:] This is true.”). Although the Court agrees with
respondent “science is evolving all the time,” see Tr. at 27:24–29:21, advances in immunology
cannot impact this Court’s application of the Vaccine Act. This case accordingly must be
remanded for the Special Master to consider whether petitioner presented preponderant evidence
“causally connecting the vaccination and the injury,” Althen F.3d at 1278, via a biologically
plausible theory, namely molecular mimicry, see SM Dec. at 6. Andreu, 569 F.3d at 1375
(holding petitioners “met the first . . . prong[] of the Althen test” because their expert “presented
a ‘biologically plausible’ theory” of general causation); see Tr. at 15:24–17:2. The Special
Master therefore should not require petitioner present “a persuasive theory to explain how a flu
vaccine could cause CIDP.” SM Dec. at 13. Rather, the Special Master must determine whether
petitioner has presented preponderant evidence linking the flu vaccine to CIDP via a biologically
plausible theory.7 Andreu, 569 F.3d at 1375; Althen, 418 F.3d at 1278 (requiring petitioners to
6 To the extent the Special Master rejected petitioner’s theory because petitioner did not present data that might
otherwise be sufficient to associate the flu vaccine with CIDP on the Vaccine Injury Table, see SM Dec. at 20, the
Court is wary of the impact of such a high burden on claimants’ ability to recover “in a field bereft of complete and
direct proof.” Althen, 418 F.3d at 1280. Indeed, at oral argument, respondent admitted it is “not sure” what “the
difference . . . in requirements [between off-table injuries and injuries placed on the table would be] if we[ were to]
look[] for preponderant evidence of a persuasive theory” for off-table cases. See Tr. at 27:6–16.
7 The Court notes many of the Federal Circuit cases interpreting Althen use similar yet divergent language when
discussing petitioner’s burden under Althen prong one, compare Althen, 418 F.3d at 1278 (requiring petitioners
“show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury . . .”), with Oliver, 900 F.3d at 1361 (requiring petitioners “show
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prove by a preponderance of the evidence the existence of a medical theory “causally connecting
the vaccination and the injury”).
VII. CONCLUSION
For the foregoing reasons, the Court VACATES the Special Master’s decision finding
petitioner did not meet his burden to demonstrate by a preponderance of the evidence a causal
connection between the flu vaccination and CIDP, ECF No. 89. The Court therefore GRANTS
petitioner’s Motion for Review, ECF No. 91, and REMANDS this case to the Special Master to
determine whether petitioner can satisfy the Althen test as explained in this Opinion and Order.
IT IS SO ORDERED.
s/ Ryan T. Holte
RYAN T. HOLTE
Judge
by preponderant evidence each of the requirements set forth in Althen”) (emphasis added) (internal quotations
omitted); compare also Andreu, 569 F.3d at 1375 (accepting a biologically plausible theory under Althen prong
one), with Kottenstette, 861 Fed. App’x. at 440–41 (accepting a biologically credible theory), and Boatmon, 941
F.3d at 1362 (requiring petitioners “show by a preponderance of the evidence” their proposed “theory . . . is a sound
and reliable theory” of causation.). The goal of the Vaccine Act and Vaccine Rules of the United States Court of
Federal Claims (VRCFC) “to decide . . . case[s] promptly and efficiently” would be best served by more clarity as to
what is required under Althen prong one. See VRCFC 1(b).
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================================================================================
DOCUMENT 3: USCOURTS-cofc-1_19-vv-00111-2
Date issued/filed: 2024-10-07
Pages: 37
Docket text: PUBLIC ORDER/RULING (Originally filed: 9/13/2024) regarding 109 Ruling on Entitlement, Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
--------------------------------------------------------------------------------
Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 1 of 37
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * *
DUANE HOFFMAN, *
* No. 19-111V
Petitioner, * Special Master Christian J. Moran
*
v. *
* Filed: September 13, 2024
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * *
Isaiah Kalinowski, Bosson Legal Group, P.C., Fairfax, VA, for petitioner;
Felicia D. Langel, United States Dep’t of Justice, Washington, DC, for respondent.
RULING FINDING ENTITLEMENT TO COMPENSATION1
Duane Hoffman alleges that an influenza (“flu”) vaccine caused him to
develop a neurologic problem, chronic inflammatory demyelinating
polyneuropathy (“CIDP”). Mr. Hoffman supported his claim with reports from a
neurologist retained for this litigation, Zurab Nadareishvili. The Secretary disputes
Mr. Hoffman’s claim that the flu vaccine injured him and has, likewise, supported
1 Because this Ruling 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 Ruling 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.
1

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 2 of 37
his position with reports from a neurologist the Secretary retained for this
litigation, Michael Wilson.
An Initial Entitlement Decision rejected Mr. Hoffman’s argument that he
was required to present a plausible theory of how the flu vaccine can cause CIDP.
Initial Entitlement Decision, issued Jan. 10, 2024, 2024 WL 402731. Mr. Hoffman
contested this determination. Pet’r’s Mot. for Rev., filed Feb. 9, 2024. The Court
agreed that the Initial Entitlement Decision erroneously elevated Mr. Hoffman’s
burden of proof. Opinion and Order, issued July 8, 2024, 2024 WL 3688477. The
Court remanded for further adjudication.
Upon remand, the parties filed supplemental briefs. An oral argument with
the undersigned was held on August 16, 2024.2 A review of the evidence under
the Court’s standards shows that Mr. Hoffman is entitled to compensation.
I. Background3
Mr. Hoffman was born in 1960. For many years, he worked as a
corrections officer, although he was not employed when he received the allegedly
causal flu vaccination in 2017. Exhibit 23 (affidavit regarding damages).
More than two years before the flu vaccination, Mr. Hoffman was diagnosed
with chronic lymphocytic leukemia (“CLL”). Exhibit 10 at 7 (Mar. 31. 2015).
The Secretary’s expert, Dr. Wilson, has proposed that the leukemia is associated
with an increased risk for CIDP. Exhibit A at 5.
In January 2017, Mr. Hoffman was hospitalized due to an exacerbation of
chronic obstructive pulmonary disease. Exhibit 4 at 657. While hospitalized, Mr.
Hoffman received the flu vaccine. Exhibit 1. (Mr. Hoffman also received a
pneumococcal vaccine but his claim rests upon the flu vaccine.)
2 As part of the motion for review, the Court heard oral argument. The transcript from
June 20, 2024 contains pages 1-86. The transcript from the August 16, 2024 argument contains
pages 101-199.
3 Events in Mr. Hoffman’s life were summarized in the Initial Entitlement Decision and
largely adopted in the Court’s Opinion and Order. The parties were satisfied with the recitation
of events. Tr. 111.
2

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 3 of 37
Mr. Hoffman was diagnosed with low back pain on January 24, 2017.
Exhibit 4 at 819, 862. This pain continued and Mr. Hoffman developed other
problems for which he was admitted to Riverside Methodist Hospital. In Riverside
Methodist Hospital, Mr. Hoffman underwent tests, including an EMG/NCS. Based
upon the results, Mr. Hoffman’s doctors diagnosed him with a neurologic disorder,
Guillain-Barré syndrome. Exhibit 7 at 261, 876-81.
Guillain-Barré syndrome is:
(i) … an acute monophasic peripheral neuropathy that encompasses a
spectrum of four clinicopathological subtypes described below. For each
subtype of GBS, the interval between the first appearance of symptoms and
the nadir of weakness is between 12 hours and 28 days. This is followed in
all subtypes by a clinical plateau with stabilization at the nadir of symptoms,
or subsequent improvement without significant relapse. Death may occur
without a clinical plateau. Treatment related fluctuations in all subtypes of
GBS can occur within 9 weeks of GBS symptom onset and recurrence of
symptoms after this time-frame would not be consistent with GBS.
(ii) The most common subtype in North America and Europe, comprising
more than 90 percent of cases, is acute inflammatory demyelinating
polyneuropathy (AIDP), which has the pathologic and electrodiagnostic
features of focal demyelination of motor and sensory peripheral nerves and
nerve roots. . . . AIDP [is] typically characterized by symmetric motor
flaccid weakness, sensory abnormalities, and/or autonomic dysfunction
caused by autoimmune damage to peripheral nerves and nerve roots. The
diagnosis of AIDP. . . requires:
(A) Bilateral flaccid limb weakness and decreased or absent deep
tendon reflexes in weak limbs;
(B) A monophasic illness pattern;
(C) An interval between onset and nadir of weakness between 12
hours and 28 days;
(D) Subsequent clinical plateau (the clinical plateau leads to either
stabilization at the nadir of symptoms, or subsequent improvement
without significant relapse; however, death may occur without a
clinical plateau); and,
3

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 4 of 37
(E) The absence of an identified more likely alternative diagnosis.
* * *
(v) To qualify as any subtype of GBS, there must not be a more likely
alternative diagnosis for the weakness.
(vi) Exclusionary criteria for the diagnosis of all subtypes of GBS include
the ultimate diagnosis of any of the following conditions: chronic immune
demyelinating polyradiculopathy (CIDP) . . .
42 C.F.R. § 100.3(c)(15).
Mr. Hoffman’s doctors prescribed a standard treatment for GBS, the
infusion of intravenous immunoglobulin (“IVIG”). In early 2017, when Mr.
Hoffman’s doctors were treating him for GBS, at least one doctor stated that the flu
vaccine caused Mr. Hoffman’s GBS. Exhibit 7 at 266; see also Exhibit 4 at 1053
(note, from an unknown source, that Mr. Hoffman’s allergies include the flu
vaccine).
Mr. Hoffman attempted rehabilitation for several months and sought care
from various doctors. One neurologist, Geoffrey Eubank, ordered a test for anti-
ganglioside antibodies. The results were negative. Exhibit 9 at 32.
Approximately eight months after the diagnosis of GBS, Mr. Hoffman saw
Dr. Eubank again. Exhibit 19 at 66 (Oct. 9, 2017). Dr. Eubank changed the
diagnosis to CIDP. He explained his rationale. Dr. Eubank
previously thought that [Mr. Hoffman] had Guillain
Barre syndrome but . . . [h]e continued to have some
worsening this summer and subsequently improved with
a course of IVIG for 5 days. This would not be typical for
Guillain Barre which should be more of a monophasic
illness.
Id.
Another neurologist, Timothy Rust, confirmed the diagnosis of CIDP.
Exhibit 19 at 58 (Dec. 13, 2017). Dr. Rust wrote that “CLL can be associated with
peripheral nervous system pathology similar to non-Hodgkin lymphoma, including
a relatively high rate of CIDP.” Id.
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The diagnosis of CIDP is accepted by the neurologists retained to provide
opinions. Exhibit 30 at 7; Exhibit A at 3-4.4 “CIDP” stands for “chronic
inflammatory demyelinating polyneuropathy,” which explains the basic
information about the disease. See Exhibit A at 4. Although most cases of CIDP
develop insidiously, CIDP can develop abruptly as in Mr. Hoffman’s case. Exhibit
30 at 7, Exhibit A at 4.
As discussed below, the etiology of CIDP is “poorly understood.” Exhibit A
at 5. According to Dr. Nadareishvili, “An abundance of clinical and experimental
research has led to the conclusion that CIDP is mediated by humoral and cellular
immunity against Schwann cell/myelin target antigens in the nerves, thus its
classification as an autoimmune disease.” Exhibit 30 at 9. A primary question in
this litigation is whether the flu vaccine can provoke an autoimmune attack, which
leads to CIDP.
II. Procedural History5
Initially, Mr. Hoffman alleged that the flu vaccine caused him to suffer GBS.
Pet., filed Jan. 22, 2019, ¶ 15. He sought compensation via the Vaccine Injury
Table and adjudication through the special processing unit of the Office of Special
Masters. Id. ¶ 20-21. The case was assigned to the special processing unit. Mr.
Hoffman periodically filed medical records.
The Secretary reviewed the evidence and recommended that compensation
be denied. Resp’t’s Rep., filed June 12, 2020. The Secretary maintained that
based upon the records from Dr. Eubank and Dr. Rust, Mr. Hoffman suffered from
4 In the Vaccine Program, petitioners often allege that a vaccine caused them to suffer
CIDP. Thus, special masters are generally familiar with CIDP. For some examples of recent
opinions about CIDP, see Radford v. Sec’y of Health & Hum. Servs., No. 18-704V, 2023 WL
2159306, at *7-12 (Fed. Cl. Spec. Mstr. Feb. 22, 2023); Berg v. Sec’y of Health & Hum. Servs.,
No. 16-650V, 2021 WL 6883495 at *24-37 (Fed. Cl. Spec. Mstr. Dec. 14, 2021); Tomsky v.
Sec’y of Health & Hum. Servs., No. 17-1132V, 2020 WL 5587365, at *8-18 (Fed. Cl. Spec.
Mstr. Aug. 24, 2020).
5 The Initial Entitlement Decision set forth the procedural history through the date it was
issued. 2024 WL 402731. The procedural history is repeated here because each decision is
evaluated separately. Cottingham v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1345 n.2
(Fed. Cir. 2020).
5

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 6 of 37
CIDP, not GBS. Id. at 8. Because resolution through the special processing unit
seemed infeasible, the case was reassigned. Notice, issued June 25, 2020.
Mr. Hoffman changed his claim. He alleged that the flu vaccine was the
cause-in-fact of his CIDP. Am. Pet., filed Sep. 17, 2020.
Mr. Hoffman supported his claim that the flu vaccine caused his CIDP with
a report from Dr. Nadareishvili. Exhibit 30. Dr. Nadareishvili stated that CIDP is
similar to GBS. He proposed that the flu vaccine can cause CIDP via molecular
mimicry. Id. at 7-16.
The Secretary countered by presenting a report from Dr. Wilson. Exhibit A.
Dr. Wilson disputed molecular mimicry as a theory to explain how a flu vaccine
might cause CIDP. Id. at 4-5. Dr. Wilson noted that to the extent that molecular
mimicry might predict an attack on gangliosides as causing CIDP, this theory
would not explain what happened to Mr. Hoffman because a test for anti-
ganglioside antibodies was negative. Id. at 5. Finally, Dr. Wilson suggested that
chronic lymphocytic leukemia is associated with CIDP. Id. at 5.
Dr. Nadareishvili responded to Dr. Wilson in a report filed on January 11,
2022. Exhibit 63. Dr. Nadareishvili contended that Dr. Wilson did not explain
how CLL can cause CIDP. Id. at 3.
Dr. Wilson replied that he did not say that CLL can cause CIDP because
“No one knows what triggers CIDP.” Exhibit C at 2 (filed Mar. 14, 2022). In an
ensuing status conference, the Secretary was asked how Mr. Hoffman’s chronic
lymphocytic leukemia affects the case given that Dr. Wilson has not presented any
mechanism by which CLL can cause CIDP. The Secretary stated that he might
obtain a report from a different expert and Mr. Hoffman objected to adding a new
expert on the ground that Mr. Hoffman’s CLL had been in the record. The
Secretary eventually reported that he was not interested in settlement and will
continue to defend the case. Resp’t’s Status Rep., filed Apr. 27, 2022.
The parties were directed to file briefs. Order, issued July 18, 2022. Mr.
Hoffman filed his primary brief on August 22, 2022 and his reply on October 5,
2022. In between, the Secretary filed his brief on September 21, 2022.
As noted previously, Mr. Hoffman was found not entitled to compensation.
Initial Entitlement Decision. 2024 WL 402731. The basis for denial was two-fold.
First, the appropriate burden of proof regarding Althen prong 1 is preponderant
6

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 7 of 37
evidence, not plausibility. Second, Mr. Hoffman failed to establish the
persuasiveness of the molecular mimicry theory in the context of a flu vaccine
causing CIDP. The Initial Entitlement Decision also commented, briefly, on
Althen prong 2 and Althen prong 3. The Initial Entitlement Decision found that
Mr. Hoffman had likely established Althen prong 3 because the interval between
the vaccination and the onset of his CIDP was appropriate for inferring causation.
However, the evidence regarding Althen prong 2 was less clear.
In granting Mr. Hoffman’s motion for review, the Court focused upon the
burden of proof for Althen prong 1. The Court instructed the undersigned to
determine whether Mr. Hoffman “has presented preponderant evidence linking the
flu vaccine to CIDP via a biologically plausible theory.” Opinion and Order, 2024
WL 3688477, at *14. Earlier, the Opinion and Order had defined “plausibility” as
“a qualitative inquiry into whether a fact is ‘[c]onceivably true.’” Id. at *2 n.1
(quoting Black’s Law Dictionary (11th ed. 2019)).
Following remand, the parties were directed to answer various questions and
they did. See Order, issued July 9, 2024; Pet’r’s Br. on Remand, filed July 24,
2024; Resp’t’s Br. on Remand, filed July 24, 2024. An oral argument was held on
August 16, 2024. With the oral argument, the case is again ready for adjudication.
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).
7

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 8 of 37
When a petitioner, like Mr. Hoffman, claims that a vaccine caused an injury
not listed on the Vaccine Injury Table, such as CIDP, the elements of a petitioner’s
case are well defined. A petitioner bears 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).
The contents of the Opinion and Order are binding in this case. Boatmon v.
Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1358 (Fed. Cir. 2019). In the
context of evaluating a district court's actions after a remand, the Federal Circuit
has stated that “the district court's actions on remand should not be inconsistent
with either the letter or the spirit of the mandate.” Laitram Corp. v. NEC Corp.,
115 F.3d 947, 951 (Fed. Cir. 1997).
IV. Analysis
The Secretary has not challenged prong three, which concerns timing. Tr.
112; Exhibit A at 5. Thus, the analysis concerns prongs one and two.
A. Althen Prong One
The Court’s Opinion and Order directed the undersigned to evaluate whether
Mr. Hoffman presented “preponderant evidence linking the flu vaccine to CIDP
via a biologically plausible theory.” The Court also defined “plausibility” in terms
of being “conceivably true.” The theory that Mr. Hoffman advances is molecular
mimicry. Thus, by substitution, the Court’s directive can be recast as requiring an
evaluation as to whether preponderant evidence supports a finding that it is
conceivably true that molecular mimicry can explain how the flu vaccine can cause
CIDP.6 The parties agreed that the Opinion and Order may reasonably be
6 Although the First Entitlement Decision cited a series of opinions from the Court of
Federal Claims about molecular mimicry as persuasive precedents, the Court’s Opinion and
Order did not cite to any of them. Similarly, although the First Entitlement Decision referenced
one case from the Federal Circuit about molecular mimicry, W.C. v. Sec’y of Health & Hum.
Servs., 704 F.3d 1352 (Fed. Cir. 2013), the Court’s Opinion and Order did not cite to W.C. See
8

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 9 of 37
interpreted as directing the undersigned to consider whether it is conceivable true
that molecular mimicry can explain how the flu vaccine can cause CIDP. Tr. 112-
15.
Through Dr. Nadareishvili, Mr. Hoffman advances molecular mimicry as a
biologically plausible way that a flu vaccine can cause CIDP. Pet’r’s Br. at 24-40;
see also Exhibit 30 at 11.7 Any vaccine is designed to engage people’s immune
systems. CIDP is considered an “immune-mediated neuropathy.” Exhibit 30 at 9.
This means that a person’s immune system attacks components of the nervous
system. A similar term is “autoimmune.” See Exhibit 32 (Lunn and Sheikh) at
768.8 Molecular mimicry is one of the most common theories offered by
petitioners to explain how a vaccine can cause a disease. See Tr. 123. A list of
more than 75 examples of cases with molecular mimicry is presented in the
appendices.
In simple terms, the theory of molecular mimicry is a vaccine -> (activates)
immune system -> (attacks) human tissue -> disease. Preponderant evidence
supports a finding that this proposition is conceivably true in the context of flu
vaccine and CIDP.
Evidence supporting the statement that it is conceivably true that molecular
mimicry explains how the flu vaccine can cause CIDP comes primarily from the
parties’ experts. Mr. Hoffman’s expert opined that “to a reasonable level of
scientific probability, this patient's seasonal influenza vaccination formed a
substantial factor in the development of inflammatory demyelinating
polyradiculopathy, which eventually became chronic (CIDP).” Exhibit 30 at 7.
Tr. 6 (identifying seven potentially relevant Federal Circuit precedential opinions). Under these
circumstances, review of those opinions would not be appropriate.
7 Although Mr. Hoffman alludes to “other pathologic mechanisms,” Pet.’r’s Br. at 24, he
has not developed any argument with regard to pathologic mechanisms except for molecular
mimicry. See Tr. 123.
8 Michael Lunn & Kazim Sheikh, Peripheral Neuropathies, 5 The Autoimmune Diseases
757 (2014). “Exhibit 31” is shown on the actual medical article; however, the comprehensive
exhibit list, submitted on April 1, 2023, indicates that this article is “Exhibit 32.” “Exhibit 31” is
shown on Dr. Nadareishvili’s curriculum vitae as well. The comprehensive exhibit list indicates
that Dr. Nadareishvili’s curriculum vitae is “Exhibit 31.” It appears that the Exhibit number on
the medical article is inaccurate. This decision will cite to this medical article as Exhibit 32.
9

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 10 of 37
The Secretary’s expert, Dr. Wilson, stated that “there is very weak evidence for
any association between CIDP and influenza vaccinations.” Exhibit A at 4. Dr.
Wilson did not opine that molecular mimicry is not conceivably true. Thus, to a
degree, Dr. Wilson’s opinion is not answering the question posed by the Court.
Beyond the opinion of Dr. Nadareishvili, relatively little evidence strongly
supports or strongly contradicts the proposition that it is conceivably true for
molecular mimicry to explain how flu vaccine can cause CIDP. For example, Dr.
Nadareishvili cited two articles in which the authors surveyed approximately 100
people who had CIDP to determine what were antecedent events. Exhibit 30 at 8
n.3. In one article, four people reported receiving vaccines but none reported the
flu vaccine. Exhibit 55 (McCombe) at 2622. 9 In the second article, none of the
people reported a vaccination within six weeks before the onset of their CIDP,
although 16 people reported an infection. Exhibit 56 (Bouchard) at 499.10 At oral
argument, Mr. Hoffman’s counsel maintained that McCombe was relevant because
the authors “include vaccines in their data set.” Tr. 146.11
It would be difficult to find that McCombe or Bouchard make it likely that
flu vaccination causes CIDP. See Howard v. Sec’y of Health & Hum. Servs., No.
16-1592V, 2022 WL 4869354, at *11, *24-25 (Fed. Cl. Spec. Mstr. Aug. 31, 2022)
(denying entitlement despite the presence of McCombe), mot. for rev. denied, 2023
WL 4117370, at *6 (Fed. Cl. 2023), aff’d without opinion, 2024 WL 2873301
(Fed. Cir. 2024). But, when the operative issue is whether it is conceivably true
that flu vaccination can cause CIDP via molecular mimicry, then McCombe and
Bouchard are supportive.
The same analysis also deepens the evidentiary value of a case report Dr.
Nadareishvili advanced. In this article, the authors described an instance in which
a 74-year-old man received a flu vaccination and, two days later, developed
9 P.A. McCombe et al., Chronic Inflammatory Demyelinating Polyradiculoneuropathy: A
Clinical And Electrophysiological Study of 92 Cases, 110 Brain 1617 (1987), filed as Exhibit 55.
10 C. Bouchard et al., Clinicopathologic findings and prognosis of chronic inflammatory
demyelinating polyneuropathy, 52 NEUROLOGY 498 (1999), filed as Exhibit 56.
11 At oral argument, Mr. Hoffman’s counsel was less familiar with the value of Bouchard.
See Tr. 1418-50.
10

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 11 of 37
weakness that led to a diagnosis of CIDP. Exhibit 44 (Brostoff) at 229. 12
Generally speaking, case reports provide little, if any, persuasive evidence that an
antecedent event (like a vaccination) caused the subsequence evident (like a
disease) because the case reports present sequences of events.13 See Tr. 152-54.
But, the present inquiry is different: does a case report enhance the biologic
plausibility of the proposition? It does. See J. v. Sec’y of Health & Hum. Servs.,
155 Fed. Cl. 20, 47 (2021) (characterizing the Agmon-Levin case reports as
“probative”); Bryan v. Sec’y of Health & Hum. Servs., No. 14-898V, 2020 WL
7089841, at *21 (Fed. Cl. Spec. Mstr. Oct. 9, 2020). The authors’ creation of a
case report supports the idea that it is “conceivably true” that the preceding event
caused the subsequent event. See Tr. 154.
Under the “biological plausibility” / “conceivably true” standard, Mr.
Hoffman has passed this threshold with Dr. Nadareishvili’s invocation of
molecular mimicry as a method to explain how flu vaccine can cause CIDP. It also
seems that almost every offering of molecular mimicry would be seen as
conceivably true. The appendices demonstrate the variety of vaccine-injury
combinations in which petitioners have proposed molecular mimicry. In a non-
binding opinion, a different judge recognized the molecular mimicry could
encompass almost anything:
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
12 J.M. Brostoff et al., Post-influenza vaccine chronic inflammatory demyelinating
polyneuropathy, 37 AGE AND AGEING 229 (2008), filed as Exhibit 44.
13 A few case reports, such as those presenting examples of challenge-rechallenge, might
be different. However, Mr. Hoffman conceded that Brostoff was not one of those special case
reports. Tr. 156.
11

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 12 of 37
matter which vaccine and which autoimmune disorder
are plugged in.
Dennington v. Sec’y of Health & Hum. Servs., 167 Fed. Cl. 640, 654 (2023),
appeal dismissed, No. 2024-1214 (Fed. Cir. Mar. 25, 2024) When asked at oral
argument what evidence would negate the plausibility of molecular mimicry, Mr.
Hoffman’s counsel struggled to articulate any. See Tr. 174. Mr. Hoffman’s
attorney argued that “there will never be a point where the – where the Special
Masters are in a position to negate molecular mimicry.” Tr. 167.14
The outcome of this ruling differs from the outcome in the First Entitlement
Decision because the burden of proof has changed. The First Entitlement Decision
found that Mr. Hoffman did not present a persuasive medical theory. However, for
the reasons explained above, Mr. Hoffman has presented a plausible medical
theory.
Accordingly, Mr. Hoffman has met the burden of proof as the Court has
defined it for Althen prong one.
B. Althen Prong Two
The second element of the causation-in-fact test is whether petitioner has
shown “a logical sequence of cause and effect showing that the vaccination was the
reason for the injury.” Althen, 418 F.3d at 1278. With respect to this prong, the
Federal Circuit has instructed special masters to consider carefully the views of a
treating doctor. Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326
(Fed. Cir. 2006).
Here, Mr. Hoffman draws support from Dr. Nadareishvili, who opined that
the vaccination was “a substantial factor in the causation of Mr. Hoffman’s injured
condition.” Exhibit 30 at 1. Dr. Nadareishvili appears to reach this conclusion
because (1) in his view, the flu vaccine can cause CIDP, (2) the CIDP presented in
an appropriate time after the flu vaccination (12 days), and (3) an elimination of
14 The fact that under the biologic plausibility standard, petitioners will almost
universally satisfy Althen prong one by presenting molecular mimicry does not affect the
outcome. Appellate authorities define the elements of petitioners’ cases and special masters
(attempt to) implement those standards. Althen, 418 F.3d at 1280 (a “special master’s role is to
apply the law”).
12

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 13 of 37
other potential causes. See id. at 18. Mr. Hoffman reasons this way as well.
Pet’r’s Br. at 41-43; Tr. 184-87.
Whether other causes of CIDP have been eliminated is debatable. The
Secretary’s expert, Dr. Wilson, stated that CLL has been associated with CIDP.
Exhibit A at 4. But, Dr. Wilson confirmed with admirable honesty and clarity in
his second report: “I did not provide a mechanistic explanation for what causes
CIDP; however, I intentionally did not use the words ‘cause’ or ‘causal’ when
discussing the association between hematologic malignancies and CIDP. No one
knows what triggers CIDP.” Exhibit C at 2. The Secretary similarly conceded that
the Secretary has not explained how a cancer can cause CIDP. Tr. 193-94.15 Thus,
Mr. Hoffman’s experience of CLL four years earlier still allows for a finding that
the flu vaccine caused his CIDP. See Pet’r’s Supp’l Br., filed July 24, 2024, at 7-
10.
At the end of the day, relatively little evidence supports or detracts on this
point. See Exhibit 30 at 18 (Dr. Nadareishvili: “Regarding the opinions of treating
physicians on etiology, the record in this case is relatively quiet”). The scarcity of
evidence does not prevent a finding in Mr. Hoffman’s favor as the proverbial
evidentiary scales need to tip only slightly. There is sufficient evidence for Mr.
Hoffman to meet his burden.
V. Conclusion
Under the standards set in the Court’s Opinion and Order, Mr. Hoffman has
shown that he is entitled to compensation. A separate damages order will issue
shortly.
15 The Secretary’s primary argument regarding prong two is that this element is irrelevant
because Mr. Hoffman’s case fails on prong one. Tr. 110, 188. However, for reasons explained
in the text, molecular mimicry is conceivably true.
13

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 14 of 37
The Clerk’s Office is directed to provide this Ruling to the assigned judge.
See Vaccine Rule 28.1(a).
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
14

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 15 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2019 WL rheumatoid
Parker Sanders, SM. 14‐979V 6/24/2019 flu accepted
3425297 arthritis
2019 WL
McKown Corcoran, SM. 15‐1451V 7/15/2019 HPV POTS rejected
4072113
2019 WL transverse
Pearson Dorsey, SM. 16‐9V 7/31/2019 flu rejected
3852633 myelitis
SM was not
arbitrary or
146 Fed. Cl. capricious in
Yalacki Firestone, J. 14‐278V 8/5/2019 hepatitis B POTS, CFS rejected
80 rejecting
molecular
mimicry
2019 WL small fiber
Swaiss Gowen, SM. 15‐286V 11/4/2019 Tdap accepted
6520791 GBS
MFR
denied,
2019 WL rheumatoid
Tullio Moran, SM. 15‐51V 12/19/2019 flu rejected 149 Fed.
7580149 arthritis
Cl. 448
(2020)
2020 WL multiple
Hitt Moran, SM. 15‐1283V 1/24/2020 flu accepted
831822 sclerosis
GBS as diagnosis
2020 WL
Sweeney Sanders, SM. 13‐392V 2/28/2020 flu GBS not evaluated was not
1844672
established
1

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 16 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
Respondent's
expert offered
MM to explain
para‐ how lung cancer
2020 WL
Sweeney Sanders, SM. 13‐392V 2/28/2020 flu neoplastic accepted could have
1844672
syndrome neurologic
complications.
SM seemed to
endorse.
2020 WL
Allard Roth, SM. 14‐442V 3/9/2020 HPV ITP rejected
1649669
2020 WL Timing was
Rowan Corcoran, SM. 17‐760V 4/28/2020 flu GBS not evaluated
2954954 wrong
MFR
denied,
2020 WL MMR and Onset was too
Castaneda Oler, SM. 15‐1066V 5/18/2020 PANS rejected 152
3833076 others quick
Fed.Cl.
576 (2020)
MFR
flu and/or denied,
2020 WL cryoglobuline
Temes Corcoran, SM. 16‐1465V 5/21/2020 pneumoco rejected 151 Fed.
4198036 mia
ccal Cl. 448
(2020)
2020 WL
Walls Olers, SM. 16‐557V 6/23/2020 childhood ITP accepted
13801342
2020 WL pneumoco
Deshler Corcoran, SM. 16‐1070V 7/1/2020 GBS rejected
4593162 ccal
2

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 17 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
MFR
denied,
2020 WL
Duncan Moran, SM. 16‐1367V 10/19/2020 HPV PANDAS rejected 153 Fed.
6738118
Cl. 642
(2021)
Petition filed
Soltero 2020 WL
Horner, SM. 16‐808V 10/20/2020 flu GBS accepted before Table
Arias 6706071
change
MFR
denied,
2020 WL
E.S. Corcoran, SM. 17‐480V 11/13/2020 HPV, flu narcolepsy rejected 154
9076620
Fed.Cl.
149 (2021)
MFR
denied,
2020 WL small fiber
E.S. Corcoran, SM. 17‐480V 11/13/2020 HPV, flu rejected 154
9076620 neuropathy
Fed.Cl.
149 (2021)
MFR
denied,
2020 WL
E.S. Corcoran, SM. 17‐480V 11/13/2020 HPV, flu CFS rejected 154
9076620
Fed.Cl.
149 (2021)
MFR
denied,
2020 WL
E.S. Corcoran, SM. 17‐480V 11/13/2020 HPV, flu POTS rejected 154
9076620
Fed.Cl.
149 (2021)
3

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 18 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2020 WL
Phillips Oler, SM. 16‐906V 11/23/2020 HPV ITP accepted
7767511
2020 WL
Phillips Oler, SM. 16‐906V 11/23/2020 live flu ITP rejected
7767511
Special master's
rejection of
flu and/or molecular
151 Fed. Cl. cryoglobuline
Temes Griggsby, J. 16‐1465V 12/7/2020 pneumoco rejected mimicry was
448 mia
ccal supported by
substantial
evidence.
2021 WL
Pickens Moran, SM. 17‐187V 1/22/2021 MMR SIDP rejected
615218
Special master
found that
2021 WL polyneuropat
Blender Dorsey, SM. 16‐1308V 2/26/2021 flu accepted pneumococcal
1096662 hy
vaccine played no
role
primary
2021 WL medistinal
Nifakos Oler, SM. 14‐236V 3/4/2021 HPV rejected
1345218 large B‐cell
lymphoma
Thrombotic
2021 WL
Parmer Roth, SM. 16‐880V 3/25/2021 flu Thrombo‐ accepted
1524512
cytopenia
2021 WL multiple
Robinson Oler, SM. 14‐952V 4/12/2021 flu accepted
2371721 sclerosis
4

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 19 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
SM was not
arbitrary or
153 Fed. Cl. capricious in
Duncan Davis, J. 16‐1367V 4/19/2021 HPV PANDAS rejected
642 rejecting
molecular
mimicry
vacated
On review, CFC and
found that remanded,
2021 WL brachial
Patton Horner, SM. 15‐1553V 5/17/2021 flu rejected molecular 157
2389835 neuritis
mimicry theory Fed.Cl.
satisfied Althen 1 159
(2021).
SM was not
MFR
arbitrary or
denied, affirmed,
2021 WL pneumoco capricious in
Loyd Corcoran, SM. 16‐811V 5/20/2021 ITP rejected not 2023 WL
2708941 ccal rejecting
available 1878572
molecular
on WL
mimicry
2021 WL small fiber
E.M. Sanders, SM. 14‐753V 7/9/2021 flu accepted
3477837 neuropathy
MFR
denied,
2021 WL
Caredio Corcoran, SM. 17‐79V 7/30/2021 flu epilepsy rejected 2021 WL
4100294
6058835
(2021)
5

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 20 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
Accepted theory
in ruling but later
dismissed for
insufficient
premature
2021 WL evidence that
Brayboy Sanders, SM. 15‐183V 8/30/2021 HPV ovarian accepted
4453146 Petitioner has
insufficiency
POI with
autoimmune
etiology, 2022
WL 1316235
2021 WL rheumatoid
Moran Oler, SM. 16‐538V 10/4/2021 flu rejected
4853544 arthritis
2021 WL pneumoco Miller‐Fisher
Koller Gowen, SM. 16‐439V 10/8/2021 accepted
5027947 ccal GBS
2021 WL
Andrews Oler, SM. 16‐196V 10/21/2021 flu SLE rejected
5755328
2021 WL peripheral
Haubner Sanders, SM. 16‐1426V 10/22/2021 flu rejected
5614942 neuropathy
Petitioner did not
2021 WL
Winkler Dorsey, SM. 18‐203V 12/10/2021 Tdap GBS not evaluated establish other
6276203
Althen prongs
2021 WL accepted in
Berg Oler, SM. 16‐650V 12/14/2021 flu CIDP
6883495 dicta
2022 WL transverse
I.J. Corcoran, SM. 16‐864V 1/4/2022 Tdap accepted Ruling on remand
277555 myelitis
juvenile
2022 WL
Putman Corcoran, SM. 19‐1921V 1/31/2022 MMR idiopathic rejected
600417
arthritis
2022 WL
Mason Corcoran, SM. 17‐1383V 2/4/2022 flu CIDP accepted
600415
6

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 21 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2022 WL
Clark Horner, SM. 18‐813V 2/7/2022 hepatitis B shoulder rejected
16635681
2022 WL
Sanchez Corcoran, SM. 18‐1012V 3/11/2022 Tdap CIDP rejected
1013264
2022 WL pneumoco
Maloney Dorsey, SM. 19‐1713V 3/17/2022 GBS accepted
1074087 ccal
2022 WL pneumoco transverse
Tracy Sanders, SM. 16‐213V 3/30/2022 accepted
1125281 ccal myelitis
MFR
denied, affirmed,
2022 WL
K.A. Corcoran, SM. 16‐989V 4/18/2022 Tdap GBS rejected 164 2024 WL
20213037
Fed.Cl. 98 2012526
(2022)
2022 WL pneumoco ulcerative
Gapen Moran, SM. 19‐422V 5/5/2022 rejected
1711616 ccal colitis
MMR,
2022 WL varicella,
Moses Moran, SM. 19‐739V 5/18/2022 sJIA rejected
2073346 pneumoco
ccal
MFR
Petitioner did not denied, affirmed,
2022 WL
Henkel Sanders, SM. 15‐1048V 8/31/2022 live flu narcolepsy accepted establish other 165 2024 WL
16557979
Althen prongs Fed.Cl. 3873569
153 (2023)
2022 WL small fiber
J.D. Sanders, SM. 14‐742V 8/31/2022 flu rejected
16543853 neuropathy
2022 WL pneumoco
Gross Dorsey, SM. 17‐1075V 9/22/2022 CIDP accepted
9669651 ccal
2023 WL
Mitchell Dorsey, SM. 19‐1534V 1/11/2023 flu ITP accepted
4483134
7

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 22 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2023 WL
C.F Horner, SM. 15‐731V 1/20/2023 HPV POTS rejected
2198809
2023 WL
E.A. Dorsey, SM. 18‐1587V 1/24/2023 flu Bell's palsy accepted
2640710
2023 WL
Bishara Moran, SM. 19‐115V 1/27/2023 Tdap scleroderma rejected
2799054
SM was not
arbitrary or
164 Fed. Cl. hepatitis B, capricious in affirmed
J.S. Meyers, J. 16‐1083V 2/13/2023 POTS rejected
314 HPV rejecting 9/5/24
molecular
mimicry
MFR
denied,
2023 WL pneumoco
Trollinger Corcoran, SM. 16‐473V 2/17/2023 GBS rejected 167
2521912 ccal
Fed.Cl.
127 (2023)
2023 WL
Radford Moran, SM. 18‐704V 2/22/2023 flu CIDP rejected
2159306
auto‐immune
2023 WL autonomic
Ambriz Sanders, SM. 15‐502V 2/27/2023 HPV rejected
2771037 ganglionopat
hy
MFR
premature Denied denied,
2023 WL
Bello Sanders, SM. 13‐349V 3/10/2023 HPV ovarian accepted entitlement on 167
2447497
failure other prongs Fed.Cl.
517 (2023)
8

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 23 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2023 WL transverse
Le Dorsey, SM. 16‐1078V 3/30/2023 Tdap accepted
3049203 myelitis
Giannanto 2023 WL
Moran, SM. 18‐497V 3/30/2023 varicella ADEM rejected
nio 2721387
2023 WL
J.G. Dorsey, SM. 20‐664V 4/3/2023 hepatitis A GBS accepted
2752634
2023 WL
Specks Sanders, SM. 15‐491V 4/14/2023 flu POTS rejected
2947619
2023 WL
DrummondSanders, SM. 16‐702V 4/21/2023 HPV POTS rejected
3035072
2023 WL myasthenia
Kelly Horner, SM. 16‐1548V 5/5/2023 flu rejected
3274159 gravis
2023 WL myasthenia
Smilo Dorsey, SM. 18‐1585V 5/15/2023 flu rejected
3918397 gravis
2023 WL multiple
Bravo Moran, SM. 17‐501V 5/31/2023 hepatitis B rejected
4147146 sclerosis
2023 WL
Hofer Gowen, SM. 18‐1752V 6/12/2023 flu MAID accepted
4397810
2023 WL rheumatoid
Clark Oler, SM. 17‐1553V 6/16/2023 flu rejected
4897284 arthritis
2023 WL dermato‐
McDaniel Dorsey, SM. 17‐1322V 6/26/2023 flu rejected
4678688 myositis
2023 WL small fiber
Schlusser Sanders, SM. 16‐901V 6/30/2023 flu rejected
4926908 neuropathy
2023 WL
Osso Dorsey, SM. 18‐575V 7/13/2023 hepatitis B GBS accepted
5016473
2023 WL hepatitis A multiple
Williams Roth, SM. 13‐471V 7/25/2023 accepted
4741993 & B sclerosis
2023 WL multiple
Mathis Moran, SM. 20‐431V 8/1/2023 flu rejected
5436135 sclerosis
2023 WL
Cobb Oler, SM. 17‐1123V 8/21/2023 HPV narcolepsy accepted
6457568
9

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 24 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
MFR
denied,
2023 WL multiple appeal
Townsend Dorsey, SM. 14‐266V 8/29/2023 flu rejected 170
6212496 sclerosis filed
Fed.Cl.
130 (2024)
2023 WL transverse
Bowling Moran, SM. 18‐109V 9/20/2023 flu rejected
6846491 myelitis
2023 WL alopecia
Farag Sanders, SM. 17‐714V 9/29/2023 HPV rejected
7203034 areata
167 Fed. Cl.
DenningtonSomers, J. 18‐1303V 10/6/2023 tetanus GBS rejected
640
chronic
2023 WL
Stoev Moran, SM. 19‐1434V 10/12/2023 HPV regional pain rejected
7297981
syndrome
Arredond 2023 WL
Dorsey, SM. 18‐1782V 10/31/2023 flu Bell's palsy accepted
o 8181138
2023 WL small fiber
Fiske Oler, SM. 17‐1378V 11/13/2023 flu accepted
8352761 neuropathy
2023 WL pneumoco
Sprenger Dorsey, SM. 18‐279V 11/14/2023 GBS accepted
8543435 ccal
2023 WL rheumatoid
Wilson Oler, SM. 17‐1264V 12/7/2023 flu rejected
9053671 arthritis
2024 WL small fiber
Greenhaw Moran, SM. 21‐2032V 1/2/2024 flu rejected
263123 neuropathy
mot. for
systemic rev.
2024 WL lupus denied,
Stricker Moran, SM. 18‐56V 1/2/2024 HPV rejected
263189 erthematosu 170
s (SLE) Fed.Cl.
701 (2024)
10

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 25 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2024 WL pneumoco
Anderson Dorsey, SM. 18‐484V 1/17/2024 GBS accepted
557052 ccal
2024 WL
Alsaadeh Dorsey, SM. 19‐1097V 1/23/2024 flu hearing loss rejected
694072
2024 WL
Rocha Moran, SM. 16‐241V 2/1/2024 hepatitis B vasculitis rejected
752787
MFR
denied,
Gamboa‐ 2023 WL pneumoco appeal
Tapp, J. 18‐925V 2/26/2024 GBS rejected 170
Avila 6536207 ccal filed
Fed.Cl.
441 (2024)
MFR
sensori‐
2024 WL denied,
Herms Dorsey, SM. 19‐70V 3/4/2024 DTaP neural rejected
1340669 2024 WL
hearing loss
3837327
2024 WL
Sparrow Moran, SM. 18‐295V 3/19/2024 MMR ADEM rejected MFR filed
1599165
Petitioner did not
2024 WL transverse
Brancheau Dorsey, SM. 21‐1209V 3/21/2024 flu not evaluated establish other
1619606 myelitis
Althen prongs
2024 WL GBS ‐ non‐
Lau Dorsey, SM. 19‐1956V 3/22/2024 flu accepted
1638367 Table
2024 WL Anti‐NMDAR
L.R. / BaxteOler, SM. 16‐922V 3/28/2024 various rejected
1912575 encephalitis
2024 WL small fiber
Coons Dorsey, SM. 20‐1067V 3/29/2024 Td accepted
1741619 neuropathy
2024 WL
Broussard Moran, SM. 18‐302V 4/4/2024 hepatitis B NMO rejected
1829210
11

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 26 of 37
Appendix 1:
Some Cases with Molecular Mimicry Sorted by Date
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
Petitioner did not
2024 WL neuroinflama have
M.M. Dorsey, SM. 18‐583V 7/18/2024 flu not evaluated
4164557 mation neuroinflammati
on
2024 WL pneumoco
Morrison Oler, SM. 18‐386V 7/18/2024 GBS rejected
3738934 ccal
12

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 27 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2020 WL
Walls Olers, SM. 16‐557V 6/23/2020 childhood ITP accepted
13801342
MFR
sensori‐
2024 WL denied,
Herms Dorsey, SM. 19‐70V 3/4/2024 DTaP neural rejected
1340669 2024 WL
hearing loss
3837327
2021 WL peripheral
Haubner Sanders, SM. 16‐1426V 10/22/2021 flu rejected
5614942 neuropathy
2023 WL
E.A. Dorsey, SM. 18‐1587V 1/24/2023 flu Bell's palsy accepted
2640710
Arredond 2023 WL
Dorsey, SM. 18‐1782V 10/31/2023 flu Bell's palsy accepted
o 8181138
vacated
On review, CFC and
found that remanded,
2021 WL brachial
Patton Horner, SM. 15‐1553V 5/17/2021 flu rejected molecular 157
2389835 neuritis
mimicry theory Fed.Cl.
satisfied Althen 1 159
(2021).
2021 WL accepted in
Berg Oler, SM. 16‐650V 12/14/2021 flu CIDP
6883495 dicta
2022 WL
Mason Corcoran, SM. 17‐1383V 2/4/2022 flu CIDP accepted
600415
2023 WL
Radford Moran, SM. 18‐704V 2/22/2023 flu CIDP rejected
2159306
2023 WL dermato‐
McDaniel Dorsey, SM. 17‐1322V 6/26/2023 flu rejected
4678688 myositis
MFR
denied,
2021 WL
Caredio Corcoran, SM. 17‐79V 7/30/2021 flu epilepsy rejected 2021 WL
4100294
6058835
(2021)
1

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 28 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
GBS as diagnosis
2020 WL
Sweeney Sanders, SM. 13‐392V 2/28/2020 flu GBS not evaluated was not
1844672
established
2020 WL Timing was
Rowan Corcoran, SM. 17‐760V 4/28/2020 flu GBS not evaluated
2954954 wrong
Petition filed
Soltero 2020 WL
Horner, SM. 16‐808V 10/20/2020 flu GBS accepted before Table
Arias 6706071
change
2024 WL GBS ‐ non‐
Lau Dorsey, SM. 19‐1956V 3/22/2024 flu accepted
1638367 Table
2024 WL
Alsaadeh Dorsey, SM. 19‐1097V 1/23/2024 flu hearing loss rejected
694072
2023 WL
Mitchell Dorsey, SM. 19‐1534V 1/11/2023 flu ITP accepted
4483134
2023 WL
Hofer Gowen, SM. 18‐1752V 6/12/2023 flu MAID accepted
4397810
2020 WL multiple
Hitt Moran, SM. 15‐1283V 1/24/2020 flu accepted
831822 sclerosis
2021 WL multiple
Robinson Oler, SM. 14‐952V 4/12/2021 flu accepted
2371721 sclerosis
2023 WL multiple
Mathis Moran, SM. 20‐431V 8/1/2023 flu rejected
5436135 sclerosis
MFR
denied,
2023 WL multiple appeal
Townsend Dorsey, SM. 14‐266V 8/29/2023 flu rejected 170
6212496 sclerosis filed
Fed.Cl.
130 (2024)
2023 WL myasthenia
Kelly Horner, SM. 16‐1548V 5/5/2023 flu rejected
3274159 gravis
2023 WL myasthenia
Smilo Dorsey, SM. 18‐1585V 5/15/2023 flu rejected
3918397 gravis
2

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 29 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
Petitioner did not
2024 WL neuroinflama have
M.M. Dorsey, SM. 18‐583V 7/18/2024 flu not evaluated
4164557 mation neuroinflammati
on
Respondent's
expert offered
MM to explain
para‐ how lung cancer
2020 WL
Sweeney Sanders, SM. 13‐392V 2/28/2020 flu neoplastic accepted could have
1844672
syndrome neurologic
complications.
SM seemed to
endorse.
Special master
found that
2021 WL polyneuropat
Blender Dorsey, SM. 16‐1308V 2/26/2021 flu accepted pneumococcal
1096662 hy
vaccine played no
role
2023 WL
Specks Sanders, SM. 15‐491V 4/14/2023 flu POTS rejected
2947619
2019 WL rheumatoid
Parker Sanders, SM. 14‐979V 6/24/2019 flu accepted
3425297 arthritis
MFR
denied,
2019 WL rheumatoid
Tullio Moran, SM. 15‐51V 12/19/2019 flu rejected 149 Fed.
7580149 arthritis
Cl. 448
(2020)
2021 WL rheumatoid
Moran Oler, SM. 16‐538V 10/4/2021 flu rejected
4853544 arthritis
2023 WL rheumatoid
Clark Oler, SM. 17‐1553V 6/16/2023 flu rejected
4897284 arthritis
3

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 30 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2023 WL rheumatoid
Wilson Oler, SM. 17‐1264V 12/7/2023 flu rejected
9053671 arthritis
2021 WL
Andrews Oler, SM. 16‐196V 10/21/2021 flu SLE rejected
5755328
2023 WL small fiber
Fiske Oler, SM. 17‐1378V 11/13/2023 flu accepted
8352761 neuropathy
2024 WL small fiber
Greenhaw Moran, SM. 21‐2032V 1/2/2024 flu rejected
263123 neuropathy
2021 WL small fiber
E.M. Sanders, SM. 14‐753V 7/9/2021 flu accepted
3477837 neuropathy
2022 WL small fiber
J.D. Sanders, SM. 14‐742V 8/31/2022 flu rejected
16543853 neuropathy
2023 WL small fiber
Schlusser Sanders, SM. 16‐901V 6/30/2023 flu rejected
4926908 neuropathy
Thrombotic
2021 WL
Parmer Roth, SM. 16‐880V 3/25/2021 flu Thrombo‐ accepted
1524512
cytopenia
2019 WL transverse
Pearson Dorsey, SM. 16‐9V 7/31/2019 flu rejected
3852633 myelitis
2023 WL transverse
Bowling Moran, SM. 18‐109V 9/20/2023 flu rejected
6846491 myelitis
Petitioner did not
2024 WL transverse
Brancheau Dorsey, SM. 21‐1209V 3/21/2024 flu not evaluated establish other
1619606 myelitis
Althen prongs
MFR
flu and/or denied,
2020 WL cryoglobuline
Temes Corcoran, SM. 16‐1465V 5/21/2020 pneumoco rejected 151 Fed.
4198036 mia
ccal Cl. 448
(2020)
4

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 31 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
Special master's
rejection of
flu and/or molecular
151 Fed. Cl. cryoglobuline
Temes Griggsby, J. 16‐1465V 12/7/2020 pneumoco rejected mimicry was
448 mia
ccal supported by
substantial
evidence.
2023 WL
J.G. Dorsey, SM. 20‐664V 4/3/2023 hepatitis A GBS accepted
2752634
2023 WL hepatitis A multiple
Williams Roth, SM. 13‐471V 7/25/2023 accepted
4741993 & B sclerosis
2023 WL
Osso Dorsey, SM. 18‐575V 7/13/2023 hepatitis B GBS accepted
5016473
2023 WL multiple
Bravo Moran, SM. 17‐501V 5/31/2023 hepatitis B rejected
4147146 sclerosis
2024 WL
Broussard Moran, SM. 18‐302V 4/4/2024 hepatitis B NMO rejected
1829210
SM was not
arbitrary or
146 Fed. Cl. capricious in
Yalacki Firestone, J. 14‐278V 8/5/2019 hepatitis B POTS, CFS rejected
80 rejecting
molecular
mimicry
2022 WL
Clark Horner, SM. 18‐813V 2/7/2022 hepatitis B shoulder rejected
16635681
2024 WL
Rocha Moran, SM. 16‐241V 2/1/2024 hepatitis B vasculitis rejected
752787
5

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 32 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
SM was not
arbitrary or
164 Fed. Cl. hepatitis B, capricious in affirmed
J.S. Meyers, J. 16‐1083V 2/13/2023 POTS rejected
314 HPV rejecting 9/5/24
molecular
mimicry
2023 WL alopecia
Farag Sanders, SM. 17‐714V 9/29/2023 HPV rejected
7203034 areata
auto‐immune
2023 WL autonomic
Ambriz Sanders, SM. 15‐502V 2/27/2023 HPV rejected
2771037 ganglionopat
hy
chronic
2023 WL
Stoev Moran, SM. 19‐1434V 10/12/2023 HPV regional pain rejected
7297981
syndrome
2020 WL
Allard Roth, SM. 14‐442V 3/9/2020 HPV ITP rejected
1649669
2020 WL
Phillips Oler, SM. 16‐906V 11/23/2020 HPV ITP accepted
7767511
2023 WL
Cobb Oler, SM. 17‐1123V 8/21/2023 HPV narcolepsy accepted
6457568
MFR
denied,
2020 WL
Duncan Moran, SM. 16‐1367V 10/19/2020 HPV PANDAS rejected 153 Fed.
6738118
Cl. 642
(2021)
6

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 33 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
SM was not
arbitrary or
153 Fed. Cl. capricious in
Duncan Davis, J. 16‐1367V 4/19/2021 HPV PANDAS rejected
642 rejecting
molecular
mimicry
2019 WL
McKown Corcoran, SM. 15‐1451V 7/15/2019 HPV POTS rejected
4072113
2023 WL
C.F Horner, SM. 15‐731V 1/20/2023 HPV POTS rejected
2198809
2023 WL
DrummondSanders, SM. 16‐702V 4/21/2023 HPV POTS rejected
3035072
MFR
premature Denied denied,
2023 WL
Bello Sanders, SM. 13‐349V 3/10/2023 HPV ovarian accepted entitlement on 167
2447497
failure other prongs Fed.Cl.
517 (2023)
Accepted theory
in ruling but later
dismissed for
insufficient
premature
2021 WL evidence that
Brayboy Sanders, SM. 15‐183V 8/30/2021 HPV ovarian accepted
4453146 Petitioner has
insufficiency
POI with
autoimmune
etiology, 2022
WL 1316235
primary
2021 WL medistinal
Nifakos Oler, SM. 14‐236V 3/4/2021 HPV rejected
1345218 large B‐cell
lymphoma
7

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 34 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
mot. for
systemic rev.
2024 WL lupus denied,
Stricker Moran, SM. 18‐56V 1/2/2024 HPV rejected
263189 erthematosu 170
s (SLE) Fed.Cl.
701 (2024)
MFR
denied,
2020 WL
E.S. Corcoran, SM. 17‐480V 11/13/2020 HPV, flu CFS rejected 154
9076620
Fed.Cl.
149 (2021)
MFR
denied,
2020 WL
E.S. Corcoran, SM. 17‐480V 11/13/2020 HPV, flu narcolepsy rejected 154
9076620
Fed.Cl.
149 (2021)
MFR
denied,
2020 WL
E.S. Corcoran, SM. 17‐480V 11/13/2020 HPV, flu POTS rejected 154
9076620
Fed.Cl.
149 (2021)
MFR
denied,
2020 WL small fiber
E.S. Corcoran, SM. 17‐480V 11/13/2020 HPV, flu rejected 154
9076620 neuropathy
Fed.Cl.
149 (2021)
8

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 35 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2020 WL
Phillips Oler, SM. 16‐906V 11/23/2020 live flu ITP rejected
7767511
MFR
Petitioner did not denied, affirmed,
2022 WL
Henkel Sanders, SM. 15‐1048V 8/31/2022 live flu narcolepsy accepted establish other 165 2024 WL
16557979
Althen prongs Fed.Cl. 3873569
153 (2023)
2024 WL
Sparrow Moran, SM. 18‐295V 3/19/2024 MMR ADEM rejected MFR filed
1599165
juvenile
2022 WL
Putman Corcoran, SM. 19‐1921V 1/31/2022 MMR idiopathic rejected
600417
arthritis
2021 WL
Pickens Moran, SM. 17‐187V 1/22/2021 MMR SIDP rejected
615218
MFR
denied,
2020 WL MMR and Onset was too
Castaneda Oler, SM. 15‐1066V 5/18/2020 PANS rejected 152
3833076 others quick
Fed.Cl.
576 (2020)
MMR,
2022 WL varicella,
Moses Moran, SM. 19‐739V 5/18/2022 sJIA rejected
2073346 pneumoco
ccal
2022 WL pneumoco
Gross Dorsey, SM. 17‐1075V 9/22/2022 CIDP accepted
9669651 ccal
2020 WL pneumoco
Deshler Corcoran, SM. 16‐1070V 7/1/2020 GBS rejected
4593162 ccal
2022 WL pneumoco
Maloney Dorsey, SM. 19‐1713V 3/17/2022 GBS accepted
1074087 ccal
9

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 36 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
MFR
denied,
2023 WL pneumoco
Trollinger Corcoran, SM. 16‐473V 2/17/2023 GBS rejected 167
2521912 ccal
Fed.Cl.
127 (2023)
2023 WL pneumoco
Sprenger Dorsey, SM. 18‐279V 11/14/2023 GBS accepted
8543435 ccal
2024 WL pneumoco
Anderson Dorsey, SM. 18‐484V 1/17/2024 GBS accepted
557052 ccal
MFR
denied,
Gamboa‐ 2023 WL pneumoco appeal
Tapp, J. 18‐925V 2/26/2024 GBS rejected 170
Avila 6536207 ccal filed
Fed.Cl.
441 (2024)
2024 WL pneumoco
Morrison Oler, SM. 18‐386V 7/18/2024 GBS rejected
3738934 ccal
SM was not
MFR
arbitrary or
denied, affirmed,
2021 WL pneumoco capricious in
Loyd Corcoran, SM. 16‐811V 5/20/2021 ITP rejected not 2023 WL
2708941 ccal rejecting
available 1878572
molecular
on WL
mimicry
2021 WL pneumoco Miller‐Fisher
Koller Gowen, SM. 16‐439V 10/8/2021 accepted
5027947 ccal GBS
2022 WL pneumoco transverse
Tracy Sanders, SM. 16‐213V 3/30/2022 accepted
1125281 ccal myelitis
2022 WL pneumoco ulcerative
Gapen Moran, SM. 19‐422V 5/5/2022 rejected
1711616 ccal colitis
2024 WL small fiber
Coons Dorsey, SM. 20‐1067V 3/29/2024 Td accepted
1741619 neuropathy
10

Case 1:19-vv-00111-RTH Document 112 Filed 10/07/24 Page 37 of 37
Appendix 2:
Some Cases with Molecular Mimicry Sorted by Vaccine and then Injury
CoFC Fed. Cir.
Title Judicial Officer Docket Date cite Vaccine Injury outcome notes
review review
2022 WL
Sanchez Corcoran, SM. 18‐1012V 3/11/2022 Tdap CIDP rejected
1013264
Petitioner did not
2021 WL
Winkler Dorsey, SM. 18‐203V 12/10/2021 Tdap GBS not evaluated establish other
6276203
Althen prongs
MFR
denied, affirmed,
2022 WL
K.A. Corcoran, SM. 16‐989V 4/18/2022 Tdap GBS rejected 164 2024 WL
20213037
Fed.Cl. 98 2012526
(2022)
2023 WL
Bishara Moran, SM. 19‐115V 1/27/2023 Tdap scleroderma rejected
2799054
2019 WL small fiber
Swaiss Gowen, SM. 15‐286V 11/4/2019 Tdap accepted
6520791 GBS
2022 WL transverse
I.J. Corcoran, SM. 16‐864V 1/4/2022 Tdap accepted Ruling on remand
277555 myelitis
2023 WL transverse
Le Dorsey, SM. 16‐1078V 3/30/2023 Tdap accepted
3049203 myelitis
167 Fed. Cl.
DenningtonSomers, J. 18‐1303V 10/6/2023 tetanus GBS rejected
640
Giannanto 2023 WL
Moran, SM. 18‐497V 3/30/2023 varicella ADEM rejected
nio 2721387
2024 WL Anti‐NMDAR
L.R. / BaxteOler, SM. 16‐922V 3/28/2024 various rejected
1912575 encephalitis
11