Faulkenberry v. Secretary of Health and Human Services

In the United States Court of Federal Claims

No. 19-238V

Filed: May 14, 2025 †

AMY FAULKENBERRY, on behalf of her

minor son, WCF,

Petitioner,

v.

THE SECRETARY OF HEALTH AND

HUMAN SERVICES,

Respondent.

Milton Clay Ragsdale, IV, Ragsdale LLC, Birmingham, AL, for Petitioner.

Madelyn E. Weeks, Trial Attorney, Alexis B. Babcock, Assistant Director, Heather L. Pearlman,

Deputy Director, C. Salvatore D’Alessio, Director, Brian M. Boynton, Principal Deputy Assistant

Attorney General, Torts Branch, Civil Division, U.S. Department of Justice, Washington, D.C.,

for Respondent.

MEMORANDUM OPINION AND ORDER

TAPP, Judge.

Petitioner, Amy Faulkenberry (“Ms. Faulkenberry”), on behalf of her minor son

(“WCF”), petitioned for compensation, alleging that WCF suffered from anti-NMDAR

encephalitis after receiving the hepatitis A vaccine and/or influenza (“flu”) vaccine. 1 (Pet., ECF

†

This Order was originally filed under seal on April 24, 2025. (ECF No. 101). The Court

provided parties the opportunity to review this opinion for any proprietary, confidential, or other

protected information and submit proposed redactions no later than May 8, 2025. The parties

filed a Joint Status Report indicating that they did not seek any redactions. (ECF No. 104). Thus,

the sealed and public versions of this Order are identical, except for the publication date and this

footnote.

1

The Special Master included a brief description of anti-NMDAR encephalitis. See

Faulkenberry on behalf of WCF v. Sec’y of Health & Hum. Servs., No. 19-238V, 2024 WL

4892507, at *2 (Fed. Cl. Spec. Mstr. Nov. 1, 2024); (Decision, ECF No. 95). For approximately

70% of patients, initial symptoms include headache, fever, nausea, vomiting, diarrhea, and some

psychiatric symptoms. See id. (citing Josep Dalmau et al., Clinical experience and laboratory

investigations in patients with anti-NMDAR encephalitis, 10 LANCET NEUROL. 63 (2011); filed

as Spec. Mstr. Ex. A-2.). For children, initial symptoms include seizures and status epilepticus,

No. 1). The Special Master concluded that Ms. Faulkenberry “failed to show how either a

hepatitis A vaccine or a flu vaccine can cause anti-NMDAR encephalitis.” Faulkenberry on

behalf of WCF v. Sec’y of Health & Hum. Servs., No. 19-238V, 2024 WL 4892507, at *1 (Fed.

Cl. Spec. Mstr. Nov. 1, 2024); (Decision, ECF No. 95). The Special Master denied compensation

because Ms. Faulkenberry failed to present a medical theory supporting causation between the

vaccine and anti-NMDAR encephalitis. See id at *6.

Ms. Faulkenberry seeks review, (ECF No. 97), arguing the Special Master used incorrect

legal standards when analyzing evidence of general causation and assessing her medical theory.

(Mem. Mot. for Rev. (“Pet’r’s Mem.”), ECF No. 97-1). The Court DENIES Ms. Faulkenberry’s

Motion for Review and AFFIRMS the Special Master’s decision.

I. Background

WCF’s diagnosis was preceded by multiple episodes of respiratory syncytial virus

(“RSV”), bronchiolitis, and an upper respiratory infection (“URI”). Faulkenberry, 2024 WL

4892507 at *1 (citing Pet’r’s Ex. 4 at 3–6, ECF No. 9). At his eighteen-month checkup, WCF’s

physician administered the hepatitis A and flu vaccines. Id. WCF’s respiratory difficulties

continued with new symptoms manifesting. See id. Following receipt of the vaccines, doctors

again treated WCF for URI, vomiting, and on a separate occasion, convulsions. Id. at *1–2. In

the following weeks, multiple pediatricians and neurologists examined WCF, and he tested

positive for NMDA antibodies. Id. at *2.

Ms. Faulkenberry petitioned for vaccine compensation on February 12, 2019. (See

generally Pet.). Using a preponderance of the evidence standard, the Special Master found Ms.

Faulkenberry had failed to present persuasive evidence that the hepatitis A vaccine and/or flu

vaccine could cause anti-NMDAR encephalitis. See generally Faulkenberry, 2024 WL 4892507.

The Special Master’s findings chiefly relied on a review of scientific literature and testimony

from admitted experts Dr. Lydia Marcus (“Dr. Marcus”), 2 retained by Ms. Faulkenberry, and Dr.

Eric Lancaster (“Dr. Lancaster”), 3 retained by the Secretary of Health and Human Services (“the

Secretary”). See id. at *3 (citing Ex. 23, ECF No. 40; Ex. B, ECF No. 46).

Both parties’ experts agree that WCF’s diagnosis is anti-NMDAR encephalitis; however,

they differ on whether WCF’s diagnosis should be attributed to the vaccine. See generally

Faulkenberry, 2024 WL 4892507 at *3–5. The experts primarily disagreed on three aspects of

which is followed by “decreased responsiveness, alternating between agitation and catatonia, and

marked by abnormal movements and autonomic instability.” Id. The Special Master noted that

approximately 75% of patients recover or experience mild complications; however, some will be

hospitalized for several months and need physical and behavioral rehabilitation. See id.

2

Dr. Marcus is a board-certified pediatric neurologist and author of a pending article on anti-

NMDAR encephalitis. See Faulkenberry, 2024 WL 4892507, at *3 (citing Ex. 22, ECF No. 40).

3

Dr. Lancaster is a board-certified neurologist with “expertise in antibody-mediated neurologic

disorders” and has treated adult patients with anti-NMDAR encephalitis. See Faulkenberry on

behalf of WCF, 2024 WL 4892507, at *3 (citing Ex. A, B, ECF No. 46).

2

this case: (1) whether there is a theory by which vaccines can cause anti-NMDAR encephalitis;

(2) when WCF first manifested symptoms of his anti-NMDAR encephalitis; and (3) whether an

infection, and not the vaccines, could have caused the anti-NMDAR encephalitis. Id.

In support of Ms. Faulkenberry’s argument, Dr. Marcus recited several medical theories

explaining how anti-NMDAR encephalitis can be induced; however, she appeared to focus on

molecular mimicry 4 as a “plausible mechanism[.]” Faulkenberry, 2024 WL 4892507 at *3

(citing Pet’r’s Ex. 22 at 3). Dr. Lancaster disputed this theory, arguing that the “key phenomenon

which absolutely must occur for anti-NMDAR encephalitis to develop is the creation of specific

antibodies that target a specific 3-dimensional epitope on the GluN1 receptor subunit[.]” Id.

Additionally, Dr. Lancaster concluded it was highly improbable “that a denatured vaccine

protein” would strongly resemble this structure. 5 Id. (citing Resp’t Ex. A at 4, ECF No. 46). Dr.

Lancaster also noted that Dr. Marcus failed to specify which vaccine would carry the NMDAR

mimic or which protein was the mimic. See id. (citing Resp’t Ex. A at 5). To this, Dr. Marcus

countered that only a “plausible biologic theory” was required rather than an exact mechanism or

evidence of a causal link. Id. (citing Pet’r’s Ex. 54 at 3).

Dr. Lancaster also discussed WCF’s medical history to show viable alternative causes for

his anti-NMDAR encephalitis. See Faulkenberry, 2024 WL 4892507 at *4. (citing Resp’t Ex. A

at 5). WCF had a history of periodic upper respiratory infections and otitis media throughout

early childhood; he would later present symptoms associated with acute gastrointestinal infection

and was later diagnosed with maxillary sinusitis “when he presented with the first definite

symptoms of anti-NMDAR encephalitis.” See id. Dr. Lancaster noted that these were active

infections preceding the onset of encephalitis, and any one of these causes could have led to

WCF’s anti-NMDAR. See id. Thus, Dr. Lancaster determined it to be more likely that infection

was the cause of WCF’s anti-NMDAR encephalitis as opposed to the receipt of vaccinations. Id.

Dr. Marcus disagreed with Dr. Lancaster’s opinion. Id. (arguing that even if the infection theory

was accepted, the vaccinations received must be considered a “necessary and substantial

cause.”).

Under the National Childhood Vaccine Injury Act of 1986 (“the Vaccine Act”),

petitioners must either establish: (1) an injury listed on the Vaccine Injury Table occurred within

the requisite period, or (2) an unlisted injury was caused-in-fact by a vaccine listed on the Table.

See 42 C.F.R. § 100.3; 42 U.S.C. § 300aa-11(c)(1)(C). Here, Ms. Faulkenberry petitioned for an

4

The molecular mimicry theory begins when a person’s immune system attempts to neutralize a

foreign antigen (a vaccine). Tullio v. Sec'y of Health & Hum. Servs., No. 15-51V, 2019 WL

7580149, at *12–14 (Fed. Cl. Spec. Mstr. Dec. 19, 2019). In autoimmune diseases, the immune

response goes awry attacking not only the foreign antigen but also the body’s own tissues. Id. at

12. Molecular mimicry posits this malfunction occurs when the “structure of the foreign invader

resembles (or mimics) the structure of cells in the body[,]” confusing the immune system, which

in turn attacks the host. Id. (“[A] process sometimes known as “breaking tolerance.”).

5

Denatured means to modify the molecular structure of something such as a protein or DNA.

Denatured, Merriam-Webster’s Dictionary, https://www.merriam-

webster.com/dictionary/denatured (last visited Apr. 19, 2025).

3

unlisted injury; thus, she was required to establish causation. To demonstrate actual causation,

Ms. Faulkenberry was required to show by preponderant evidence: “(1) a medical theory

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

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

between vaccination and injury.” Althen v. Sec’y of Health & Hum. Servs., 418 F. 3d 1274, 1278

(Fed. Cir. 2005) (the Althen test).

The Special Master explained that to prevail, Ms. Faulkenberry must establish her case

by a preponderance of the evidence for each Althen prong. Faulkenberry, 2024 WL 4892507, at

*6 (citing Althen, 418 F.3d at 1278). He also emphasized the importance of distinguishing

between “preponderant evidence” and “medical certainty,” stating that while preponderant

evidence is required, proof of medical certainty is not. Id. In accordance with this standard, the

Special Master rejected Ms. Faulkenberry’s broad argument that she must merely establish a

plausible medical theory of causal connection. See id. at *7. Despite finding that Ms.

Faulkenberry improperly argued that a plausible theory was sufficient, the Special Master went

on to evaluate the evidence she provided to see if it met the preponderance standard. See id. 8–

14.

The Special Master found that the epidemiologic evidence relied upon by Ms.

Faulkenberry was not persuasive. See Faulkenberry, 2024 WL 4892507, at *8 (noting that

Plaintiff’s expert relied on an abstract 6 more than three years old and not cited by any special

master). He also required full versions of medical articles rather than abstracts. Id. (holding

abstracts lack the benefit of peer reviews or scrutiny from the scientific community). Further

still, the Special Master identified the limited information in the abstract Dr. Marcus used as a

“methodological flaw.” Id. (finding the abstract relied on the Vaccine Adverse Event Reporting

System (“VAERS”) database, which is not a reliable source) (citing Hazlehurst v. Sec’y of

Health & Hum. Servs., 88 Fed. Cl. 473, 488 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010);

Hennessey v. Sec’y of Health & Hum. Servs., No. 01-190V, 2009 WL 1709053, at *33 (Fed. Cl.

Spec. Mstr. May 29, 2009)).

Moreover, the Special Master also found the four case reports Dr. Marcus submitted to be

unsubstantiated. Faulkenberry, 2024 WL 4892507, at *8. “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.” Id. at *9 (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)). Apart from this, he determined that the case reports also lacked merit.

See id. Among those case reports, one was an abstract, 7 two discussed vaccines other than the

6

Nour Jedidi, et al., Encephalitis after Influenza Vaccination in the United States: A CDC/FDA

Vaccine Adverse Event Reporting System Study, 1990–2018 (3052). 19 NEUROLOGY, supplement

15 (2021); (Ex. 50, ECF No. 70).

7

Teodora Cartisano and Jennifer Kicker, Anti-N-methyl-D-Aspartate Receptor Encephalitis in 7-

Month Old Infant Following Influenza Vaccination (P5.136), 86 NEUROLOGY, supplement 16

(2016); (Ex. 51, ECF No. 70).

4

hepatitis A and flu vaccines, 8 and the fourth discussed a disease other than anti-NMDAR

encephalitis. 9 See id. Thus, the Special Master concluded that the expert’s extrapolations from

these case reports were unpersuasive. See id.

As for disclosing medical theories, the Special Master noted the lack of explanation

linking either vaccine received by WCF to anti-NMDAR encephalitis. See Faulkenberry, 2024

WL 4892507, at *9. The Special Master criticized Dr. Marcus and Ms. Faulkenberry for listing

multiple mechanisms and/or theories but failing to meaningfully engage with the theories. Id. at

*10. Since both Ms. Faulkenberry and Dr. Marcus primarily focused on molecular mimicry, the

Special Master centered his analysis on case law analyzing this medical theory. See id. at *10–

11. The Special Master found that Dr. Marcus did not “persuasively establish the reliability of

the molecular mimicry theory in the context of anti-NMDAR encephalitis.” Id. at *12. The

Special Master determined that Dr. Marcus’s opinion included many generalities, lacked

explanations for the methodology or results of cited studies, and mentioned no hypothesis of how

the vaccines could lead to the “creation of antibodies to the specific protein that causes anti-

NMDAR encephalitis.” Id. at *12–14. Accordingly, the Special Master determined that Ms.

Faulkenberry failed to meet prong one of the Althen test. See id. at *15.

II. Analysis

Ms. Faulkenberry asks the Court find that the Special Master applied the incorrect

standard to analyze whether the vaccine caused WCF’s injuries. (See generally Pet’r’s Mem.).

When reviewing a special master’s decision, the Court must determine if the decision is

“arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law[.]” 42

U.S.C. § 300aa-12(e)(2)(B). Accordingly, the Court applies this arbitrary and capricious standard

to factual findings and de novo to legal conclusions. See Munn v. Sec’y of Health & Hum. Servs.,

970 F.2d 863, 870 (Fed. Cir. 1992).

With a mixed question of law and fact, “the standard of review . . . depends on whether

answering it entails primarily legal or factual work.” Echols v. Sec’y of Health & Hum. Servs.,

165 Fed. Cl. 9, 16 (2023) (citations omitted). In vaccine cases, the Court does not “reweigh”

factual evidence, question whether the special master correctly evaluated the evidence, or re-

examine the probative value of the evidence. Porter v. Sec’y of Health & Hum. Servs., 663 F.3d

1242, 1249 (Fed. Cir. 2011); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,

1360 (Fed. Cir. 2000). Neither does the Court “examine the probative value of the evidence or

the credibility of the witnesses.” Porter, 663 F.3d at 1249.

8

Dominique Endres, Psychiatric Presentation of Anti-NMDA Receptor Encephalitis, 10 FRONT.

NEUROL. 1086 (2019); filed as Exhibit 52. Caroline Hofmann et al., Anti-NMDA receptor

encephalitis after TdaP-IPV booster vaccination: cause or coincidence?, 258 J. NEUROL. 500

(2010); (Ex. 30, ECF No. 40).

9

Isabella Van Ussel et al., Encephalitis related to a H1N1 vaccination: case report and review of

the literature, 124 CLIN. NEUROL. NEUROSURG. 8 (2014); (Ex. 36, ECF No. 41).

5

Rather, the Court upholds the special master’s decision if they “considered the relevant

evidence of record, dr[ew] plausible inferences and articulated a rational basis for the

decision[.]” Hines on behalf of Sevier v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528

(Fed. Cir. 1991) (holding that “reversible error [is] extremely difficult to demonstrate”). The

standard of review is “highly deferential.” Cucuras v. Sec’y of Health & Hum. Servs., 26 Cl. Ct.

537, 541 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993). The Court cannot “substitute its

judgment for that of the special master merely because it might have reached a different

conclusion.” Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 718 (2009). So long as

the special master’s factual determination is “based on evidence in the record that is not wholly

implausible, we are compelled to uphold that finding as not being arbitrary or capricious.”

Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010).

As previously stated, special masters and this Court apply the Althen test to show actual

causation. Althen, 418 F.3d at 1278. Under this test, petitioners must show by preponderant

evidence a medical theory causally connecting the vaccination and the injury, a logical sequence

of cause and effect showing that the vaccination was the reason for the injury, and a showing of a

proximate temporal relationship between vaccination and injury. Id. The parties do not dispute

that it is the petitioner’s burden to establish its case by a preponderance. (Pet’r’s Mem. at 15;

Def.’s Resp. at 6, ECF No. 100). The preponderance standard of proof is a statutory requirement

and applies to each individual prong of the Althen test. See Olson v. Sec'y of Health & Hum.

Servs., 758 F. App'x 919, 922 (Fed. Cir. 2018) (citing Oliver v. Sec'y of Health & Hum. Servs.,

900 F.3d 1357, 1361 (Fed. Cir. 2018)); 42 U.S.C. § 300aa-13(a)(1)(A). A petitioner must satisfy

all three prongs to demonstrate causation. See Althen, 418 F.3d at 1274.

Althen prong one requires the petitioner to show “a medical theory causally connecting

the vaccination and the injury.” Althen, 418 F.3d at 1278. The Federal Circuit has interpreted

prong one of the Althen test and the Vaccine Act to find that causation must be proven by a

preponderance of the evidence. See 42 U.S.C. § 300aa-13(a)(1)(A); Boatmon v. Sec’y of Health

& Hum. Servs., 941 F.3d 1351, 1355 (Fed. Cir. 2019); LaLonde v. Sec’y of Health & Hum.

Servs., 746 F.3d 1334, 1341 (Fed. Cir. 2014). The Federal Circuit and this Court have clarified

the preponderance standard requires “the trier of fact to believe that the existence of a fact is

more probable than its nonexistence[.]” LaLonde, 746 F.3d at 1338–39. Precisely, “simply

identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of

proof.” Id. at 1341 (citing Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1332 (Fed.

Cir. 2010).

The petitioner must provide a “reputable medical theory” that the vaccine can cause the

alleged type of injury. Althen, 418 F.3d at 1278; see also Pafford v. Sec’y of Health & Hum.

Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006) (holding the vaccination must be “a substantial

factor in causing the illness, disability, injury or condition and that the harm would not have

occurred in the absence of the vaccination.”). Ultimately, a special master must determine

whether the medical theory advanced by the petitioner and their expert is “more probable than

not[.]” Althen, 418 F.3d at 1279–80 (citing Hellebrand v. Sec’y of Health & Hum. Servs., 999

F.2d 1565, 1572–73 (Fed. Cir. 1993)).

A special master must review record evidence to assess the preponderance standard but is

at liberty to determine the weight of each piece of evidence. See generally Knudsen v. Sec’y of

6

Health & Hum. Servs., 35 F.3d 543, 549 (Fed. Cir. 1994); Hodge v. Sec’y of Health & Hum.

Servs., 164 Fed. Cl. 633, 641–42 (2023). Furthermore, when evaluating expert testimony, a

special master “may conclude that there is simply too great an analytical gap between the data

and the opinion proffered.” Cedillo, 617 F.3d at 1339 (quoting Gen. Elec. Co. v. Joiner, 522 U.S.

136, 146 (1997)); LaLonde, 746 F.3d at 1341 (affirming the special master’s findings that the

expert’s reliance on a theory that is “unsupported by literature” insufficiently proves causation).

A special master is also not obligated to accept an “expert[s] opinion testimony that is connected

to the existing data or methodology ‘only by the ipse dixit of the expert[.]’” Jarvis v. Sec'y of

Health & Human Servs., 99 Fed. Cl. 47, 61 (quoting Cedillo, 617 F.3d at 1339 (internal citations

omitted).

Here, Ms. Faulkenberry raises two main objections to the Special Master’s decision. (See

Pet’r’s Mem. at 3). First, Ms. Faulkenberry claims the Special Master heightened Petitioner’s

burden by requiring direct proof of how anti-NMDAR encephalitis is caused. (See generally id.

at 4–14). Second, Ms. Faulkenberry argues the Special Master required her to “present a

persuasive theory” which improperly elevated her burden under prong one of the Althen Test.

(See generally id. at 14–20). The Court disagrees with both of Ms. Faulkenberry’s arguments and

finds that the Special Master did not impermissibly raise the burden of proof and used the correct

standard when evaluating her medical theory.

First, Ms. Faulkenberry contends that the Special Master erred by requiring direct proof

of causation, thereby raising the burden of proof. (See Pet’r’s Mem. at 4–14). Essentially, Ms.

Faulkenberry’s disagreement pertains to the sufficiency of her evidence. Ms. Faulkenberry seems

to take issue with the outcome of the Special Master’s decision and the weighing of the evidence;

however, she couches her argument as a legal dispute by discussing the standard of proof

required for causation. (Pet’r’s Mem. at 5 (arguing she was only required to show “by a

preponderance of evidence . . . that her medical theory was biologically plausible and reliable

within the context of available medical knowledge.”)). 10 She contends that in the absence of

direct proof, as exists here, circumstantial evidence may be sufficient to establish causation. (Id.

at 4). While the Court agrees with this in principle, the Court agrees with the Special Master that

the gaps in Ms. Faulkenberry’s proof do not surpass the requirement of preponderant evidence.

Ms. Faulkenberry claims the Special Master required direct proof of causation by

analyzing each piece of medical literature in isolation rather than considering them as a

10

(See Pet’r’s Mem. at 3–4 (“[i]nstead of weighing whether Petitioner’s evidence in this case

met the preponderance standard, he held Petitioner to a level of proof that may be available for

some other conditions, but is scientifically unknown for anti-NMDAR encephalitis”), 5

(“[i]nstead of weighing Petitioner’s evidence with this in mind, the Special Master found that a

‘gap in Dr. Marcus’s opinion . . . deprive[d] [it] of sufficient evidentiary weight to be reliable’”),

6 (“[i]nstead of weighing this testimony, the Special Master ignored the evidence and concluded

that this ‘gap’ should drive the outcome of the case”), 6 (“instead of weighing the evidence in

this case to determine whether it meets petitioner’s burden, the Special Master compared this

case to other cases evoking the same medical theory of molecular mimicry”), 8 (“the law is clear

that special masters must weigh a petitioner’s proof by a preponderance of the proof in that

individual case”), 12 (“[t]he law required the Special Master to weigh the available evidence for

how the vaccination could have caused [WCF’s] anti-NMDAR encephalitis”)).

7

collective to support her medical theory. (Pet’r’s Mem. at 13). This assertion is unsupported. The

Special Master reviewed and determined that Ms. Faulkenberry’s epidemiological study was

unreliable, her case reports were problematic, and that her expert struggled to present a theory

explaining how vaccinations can cause anti-NMDAR encephalitis. Faulkenberry, 2024 WL

4892507, at *8–15. From this collective assessment, the Special Master determined that Ms.

Faulkenberry had failed to meet her burden. Id. at *15. Rather than evaluate Ms. Faulkenberry’s

medical literature “by itself,” as Ms. Faulkenberry suggests, the record demonstrates that the

Special Master evaluated the entirety of her evidence.

Ms. Faulkenberry also alleges the Special Master raised the burden of proof when he

“required empirical confirmation or other direct proof that the vaccine at issue does cause the

injury alleged[.]” (Pet’r’s Mem. at 13). Specifically, Ms. Faulkenberry states the Special Master

improperly “demanded direct evidence” demonstrating how either the Hepatitis A or flu vaccines

“led to the creation of antibodies to the specific protein that causes anti-NMDAR encephalitis.”

(Id. at 13–14). Ms. Faulkenberry argues that her expert is permitted to synthesize a medical

theory by “combined references to circumstantial evidence of biologic plausibility in medical

literature.” (Id.). Dr. Marcus’s theory primarily advanced a theory of molecular mimicry. 11

The Special Master explained that the Federal Circuit and this Court consistently require

a petitioner to present at least some persuasive or reliable evidence to support such a theory.

Faulkenberry, 2024 WL 4892507, at *10 (citing 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 review.

denied, 149 Fed. Cl. 448 (2020)). The Special Master also articulated that requiring such

evidence, when evaluating the theory of molecular mimicry, does “not elevate the petitioner’s

burden of proof.” Id. at *11 (citing 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 755 (Fed. Cir. 2021)).

Faulkenberry, 2024 WL 4892507, at *10. Here, the Secretary highlighted that Ms.

Faulkenberry’s molecular mimicry theory contained a “foundational deficit” in that it was

unclear whether Dr. Marcus believed that the alleged mimic resided in the flu vaccine, Hep A

vaccine, or some combination. Id. at 12 (citing Resp’t’s Br. at 24–25, ECF No 88). Further still,

the Secretary argued that Dr. Marcus utilized the generalized term “autoimmune encephalitis”

which made it unclear “whether the percentages she cites apply to WCF's specific condition of

anti-NMDAR encephalitis or other types of encephalitis.” Id. The Special Master agreed with the

Secretary’s arguments.

Dr. Marcus opined that “molecular mimicry, acting possibly in combination with other

mechanisms,” is a reliable theory amongst the medical community to explain vaccine-induced

autoimmunity. Faulkenberry, 2024 WL 4892507, at *13. However, the Special Master found

that this statement was overly generalized:

11

Dr. Marcus raised several other theories including “host infection, occult neoplasm,”

“polyclonal lymphocyte activation, epitope spreading, . . . and antigen complementarity.”

Faulkenberry, 2024 WL 4892507, at *14. Dr. Marcus failed to engage with the alternate theories

“in a meaningful way.” Id. at 10. Therefore, the Special Master determined reliance on these

alternate theories to be non-persuasive. Id. at 14 (citing Baron v. Sec'y of Health & Human

Servs., No. 14-341V, 2019 WL 2273484, at *17 (Fed. Cl. Spec. Mstr. Mar. 18, 2019)).

8

This statement conflates a very general biological fact, namely that molecular

mimicry has been proven to occur in very rare cases for specific diseases with

specific triggers, with the question of whether molecular mimicry actually

occurs for this specific disease with this specific mimic. Dr. Marcus does not

provide any reliable evidence that molecular mimicry occurs for the specific

vaccine in question to cause antiNMDAR encephalitis. It is entirely

insufficient for Dr. Marcus to just assert that molecular mimicry exists in

general, and therefore we must consider this the likely disease mechanism in

this case. If we accept Dr. Marcus's reasoning, then we would have to

conclude that any vaccination can cause every autoimmune disease simply

because molecular mimicry has been shown with other stimuli and other

diseases.

Id. (citations omitted).

Both Dr. Lancaster and Dr. Marcus agreed that the creation of auto-antibodies was an

essential event that must occur for anti-NMDAR encephalitis to develop. Faulkenberry, 2024

WL 4892507, at *13. However, the Special Master found that Dr. Marcus failed to “hypothesize

any way that the hepatitis A vaccine and/or the flu vaccine [could] lead[] to the creation of

antibodies to the specific protein that causes anti-NMDAR encephalitis.” Id. The Special Master

determined that this lack of hypothesis was fatal to the believability of Dr. Marcus’s opinion. Id.

(“This leaves a gap in Dr. Marcus's opinion regarding molecular mimicry and deprives Dr.

Marcus's opinion of sufficient evidentiary weight to be reliable.”).

Additionally, the Special Master found Dr. Marcus’s reliance on two articles to be of

little value. Faulkenberry, 2024 WL 4892507, at *13–14. One article explored potential links

between vaccines and anti-NMDAR encephalitis using analysis across six vaccines including the

H1N1 influenza vaccine. Id. at *14 (noting the article excluded the hepatitis A vaccine). The

Special Master criticized the article for failing to discuss any connection between its findings and

found its conclusion was limited. Id. Ultimately, the Special Master noted that Dr. Marcus "did

little" to explain the study’s methodology or results in support of her opinion. Id. (finding Dr.

Marcus had not proposed that the articles use of “phylogenetic analysis” could “serve as a proxy

for a showing of some homology.”). Similarly, Dr. Marcus relied upon a second article to assert

that “a study of almost 3,000 patients tested for anti-NMDAR antibodies found [a] higher

prevalence of anti-NMDAR antibodies in patients with anti-influenza A IgG.” Id. However, Dr.

Lancaster noted that this article did not study patients with anti-NMDAR encephalitis, and Dr.

Marcus failed to elaborate. Id. The Special Master found the article unhelpful. Id. (“Dr.

Lancaster’s criticism seems well-founded.”). Other than her expert’s assertions, Ms.

Faulkenberry’s theory lacked the support necessary to reach the asserted conclusions. Such a

mere theory is insufficient to meet Althen’s first prong.

Ms. Faulkenberry’s related second argument claims the Special Master employed the

incorrect evidentiary standard when evaluating the validity of her expert’s medical theory

regarding how the vaccines WCF received can cause anti-NMDAR encephalitis. (Pet’r’s Mem.

at 14). She argues the Special Master erred by “confusing petitioner’s burden of proof

(probability) with the element of causation petitioner must prove (a plausible medical theory).”

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(Id.). Stated differently, Ms. Faulkenberry’s objects not to the specific evidentiary standard of

proof for Althen prong one, but rather to what she was required to prove and how she could

prove it. (Id. at 15 (“Petitioner carries a burden to prove causation by a preponderance of

evidence, but preponderance is not the metric the Federal Circuit has adopted to evaluate the

validity of Petitioner’s medical theory.”)). Ms. Faulkenberry argues the validity of her medical

theory can be satisfied “by setting forth a ‘biologically plausible’ theory of general causation”

and the Special Master improperly elevated her burden by requiring a “persuasive theory[.]” (Id.

at 14–15).

The Special Master properly identified that Ms. Faulkenberry was required to “do more

than demonstrate a ‘plausible’ or ‘possible’ causal link between the vaccination and the injury;

[she] must prove his case by a preponderance of the evidence.” Faulkenberry, 2024 WL

4892507, at *7 (citing W.C. v. Sec'y of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir.

2013)). After specifying that the preponderance standard applies to prong one, the Special

Master also explained that determining whether the theory met that standard requires an

evaluation of the evidence Ms. Faulkenberry supplied. Id. at *8 (“[I]t is conceivable that the

evidence surpasses the correct threshold . . . . [f]or this reason and to demonstrate that all

evidence relevant to Althen prong one has been considered, the undersigned will next evaluate

Ms. Faulkenberry's proposed theories”).

The Special Master articulated that the evidence supplied must be of a persuasive nature.

Faulkenberry, 2024 WL 4892507, at *7 (“the Court of Federal Claims [has generally] held that

the burden of proof for Althen prong one is persuasive evidence.”). This requirement is

consistent throughout the case law from the Federal Circuit. See Hodges v. Sec’y of Health &

Hum. Servs., 9 F.3d 958, 967 (“[T]he factfinder must decide the reliability, consistency, and

probative value of the scientific evidence, with the guidance of scientific opinion.”); Kirby v.

Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1384 (Fed. Cir. 2021) (affirming the special

master’s standard in requiring a “reputable medical theory . . . based on a sound and reliable

medical or scientific explanation.”); Kottenstette v. Secretary of Health and Human Services, 861

F. App’x 433, 440–41 (Fed. Cir. 2021) (holding proof of causation “does not ‘require

identification and proof of specific biological mechanisms[,]” but must be supported by a sound

and reliable medical or scientific explanation) (internal citations omitted); Knudsen, 35 F.3d at

548–49; See Nunez v. Sec’y of Health & Hum. Servs., 825 F. App’x 816, 819 (Fed. Cir. 2020)

(determining whether the evidence “so persuasively” establishes the reliability of a medical

theory); Orloski v. Sec’y of Health & Hum. Servs., 839 Fed. App’x 538, 541 (Fed. Cir. 2021).

Failure to present reliable evidence will necessarily fail to meet muster.

The Court has already determined that the Special Master devoted substantial analysis to

the evidence provided by Ms. Faulkenberry in support of her case. See generally Faulkenberry,

2024 WL 4892507, at *8–15. However, for the variety of reasons previously highlighted, the

Special Master found her evidence to be deficient which is within his purview as the fact finder.

Althen, 418 F.3d at 1278 (“[a] persuasive medical theory is demonstrated by ‘proof of a logical

sequence of cause and effect showing that the vaccination was the reason for the injury[,]’ the

logical sequence being supported by ‘reputable medical or scientific explanation[.]’”); Knudsen,

35 F.3d at 548; Nunez, 825 F. App’x at 819. These deficiencies highlight the unreliability of Ms.

Faulkenberry’s evidence and undermines her medical theory.

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Because the Special Master acted within his discretion, Ms. Faulkenberry’s arguments

fail. Porter, 663 F.3d at 1249 (“as long as a special master's finding of fact is ‘based on evidence

in the record that [is] not wholly implausible, we are compelled to uphold that finding as not

being arbitrary or capricious.’”) (internal citations omitted). The Court finds the Special Master’s

analysis is well-reasoned and thorough. Accordingly, the Special Master did not arbitrarily

evaluate the evidence or impermissibly raise Ms. Faulkenberry’s burden of proof for establishing

causation.

III. Conclusion

For the stated reasons, the Court hereby DENIES Ms. Faulkenberry’s Motion for Review,

(ECF No. 97), and AFFIRMS the Special Master’s November 1, 2024, decision. The Clerk is

directed to enter judgment accordingly.

The Court has filed this ruling under seal. The parties shall confer to determine proposed

redactions to which all parties agree. Per Vaccine Rule 18(b), no later than May 8, 2025, the parties

shall file a joint status report indicating their agreement with the proposed redactions, attaching a

copy of those pages of the Court’s ruling containing proposed redactions, with all proposed

redactions clearly indicated.

IT IS SO ORDERED.

s/ David A. Tapp

DAVID A. TAPP, Judge

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