Hoffman v. Secretary of Health and Human Services

Opinion

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 COMPENSATION 1

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 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 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 (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. 4 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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