Beckwith v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 21-1660V

*************************

*

DEBORAH BECKWITH, * Chief Special Master Corcoran

*

Petitioner, * Filed: August 29, 2025

*

v. *

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

*

Respondent. *

*

*************************

David J. Carney, Law Offices of Green & Schafle, LLC, Philadelphia, PA, for Petitioner.

Parisa Tabassian, U.S. Department of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION 1

On August 4, 2021, Deborah Beckwith filed a petition for compensation under the National

Vaccine Injury Compensation Program (the “Vaccine Program”). 2 Petitioner alleged initially that

she experienced Guillain-Barré syndrome (“GBS”) due to three separate doses of the influenza

(“flu”) vaccine received within two consecutive days (September 23 and 24, 2019). Petition (ECF

No. 1) at 2.

Earlier in the case’s life, a fact dispute arose regarding whether Petitioner could prove she

had received any of the alleged vaccine doses. Petitioner was, however, able to substantiate the

receipt of one dose of flu vaccine—in the early morning hours of September 24, 2019. See Order

Granting Second Motion for Reconsideration, dated July 26, 2023 (ECF No. 37) (“Fact Order”).

1

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

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

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

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

in its present form. Id.

2

The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,

100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”).

Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).

But this prevented Petitioner from arguing that the unique circumstances of receiving multiple

doses of the same vaccine in a short timeframe contributed to her injury. Fact Order at 2. And it

prevented her from succeeding on a Table flu vaccine-GBS claim as well, since her GBS onset

appeared to have occurred prior to the 3–42 day timeframe for such a claim. Id. at 2–3. This left

only a causation-in-fact claim to resolve.

After the parties filed some expert reports, I ordered Petitioner to show cause why I should

not dismiss the claim for failure to meet the third prong of the test for entitlement set forth in Althen

v. Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Both sides have now

briefed the issue. Petitioner’s Response to Show Cause Order, dated Dec. 2, 2024 (ECF No. 56)

(“Br.”); Respondent’s Show Cause Response, dated Jan. 29, 2025 (ECF No. 60) (“Opp.”);

Petitioner’s Reply, dated Mar. 13, 2025 (ECF No. 62) (“Reply”). Now, for the reasons set forth in

greater detail below, I deny entitlement. Petitioner has not demonstrated that her GBS onset

occurred in a medically-acceptable timeframe.

I. Brief Factual History

Petitioner’s pre-vaccination history includes gastroesophageal reflux disease,

cholecystectomy, alcohol dependence, chronic obstructive pulmonary disease, biliary duct

dilation, B12 deficiency, post-traumatic stress disorder, anxiety, and depression. Ex. 3 at 316, Ex.

5 at 14.

On September 23, 2019, Ms. Beckwith went to the Emergency Department at Robley Rex

Department of Veterans’ Affairs Medical Center in Louisville, KY, reporting abdominal pain that

had persisted for 11 days (and thus beginning well before the vaccination at issue). Ex. 3 at 319.

She reported vomiting after eating, with pain usually receding after vomiting, but added that the

vomiting was impacting her ability to eat. Id. Petitioner also noted that she was “recovering from

an [upper respiratory infection [“URI”]] that resolved a week ago before presentation w/ +

coughing, N/V/D, malaise, [and] chills.” Id. at 6. Shirley J. Cardona, M.D., diagnosed her with

“[s]epsis secondary to infection of the common bile duct,” and admitted Petitioner that same day

for further examination. Id. at 314, 322.

Records filed in this case establish that in the early morning of September 24, 2019,

Petitioner received a flu vaccine. Ex. 15 at 6. Admittedly, another, one-page record suggested

either that Petitioner received a dose the day before; later in the day on September 24 th; or even

three doses in that two-day period. See Ex. 1 at 3 (Immunizations summary record). But I have

found only that the dose administered in the morning of September 24 th has preponderant

evidentiary support. See Fact Order at 2.

There is no evidence of any immediate vaccine reaction. After vaccination and then during

the morning of September 24, 2019, Dr. Cardona examined Petitioner again. Ex. 3 at 314. Dr.

Cardona expressed the concern that Petitioner might be experiencing cholangitis due to her prior

2

gallbladder removal, as well as in light of her cholestatic pattern liver function tests, and therefore

referred her to gastroenterology. Id. She was subsequently examined by gastroenterologist Cristian

Riosperez, M.D. Id. at 316. Dr. Riosperez noted that Petitioner’s abdomen “showed [i]ntrinsic and

extrinsic biliary duct dilation similar to [her medical history] in 2018.” Id. Petitioner had a 1.2

centimeter filling defect with central gas seen in her distal common bile duct, and was reporting

nausea, diarrhea, and abdominal pain. Id. Dr. Riosperez recommended an endoscopic retrograde

cholangiopancreatography (“ERCP”) 3 under anesthesia to evaluate further the nature of

Petitioner’s symptoms. Id. The next morning (September 25, 2019), Petitioner awoke reporting

transient double vision, but no other neurologic symptoms. Ex. 3 at 297. She subsequently

underwent the proposed ERCP in the afternoon. Id. at 256.

It was after the performance of the ERCP that Ms. Beckwith first reported neurologic

symptoms that better reflected GBS onset. Thus, in a progress note from September 30, 2019,

neurologist Alexi Hernandez, M.D., stated as follows:

A few or several hours following the procedure, while the admitting team

was evaluating her, she noticed horizontal diplopia and, over the following

hours developed numbness in both hands as well as numbness in both feet,

which progressed and, at this point both her arms are entirely numb up to

the level of her shoulders and her legs are numb up to the level of the lower

i/3 of them .

Ex. 3 at 256 (emphasis added). Later (and now approximately 72 to 80 hours after the ERCP),

Petitioner stated she had difficulty swallowing, felt “wobbly” on her feet, had a numbness in her

jaw and neck, and had slurring speech. Id. at 256. Thus, Petitioner was experiencing clinically-

evident neurologic symptoms the evening of the ECRP procedure—which itself occurred less than

two days after vaccination.

Several days later, on September 30, 2019, and based on Petitioner’s presentation since the

diagnostic procedure, Dr. Hernandez’s assessment was GBS, Miller-Fisher variant (“MFS”), 4

noting “[a]cute progressive cerebellar syndrome, complete external ophthalmoplegia, areflexia

and distal sensory polyneuritic symptoms in an ascending fashion, after several days of abdominal

pain and several hours after undergoing ERCP [on September 25, 2019].” Id. at 264. Dr. Hernandez

recommended Petitioner be transferred to the intensive care unit with strict neurological

monitoring and a lumbar puncture evaluation. Id.

3

“Endoscopic Retrograde Cholangiopancreatography” is “a combination of retrograde and transhepatic

cholangiography, done to demonstrate all portion of the biliary tree; it is performed by cannulation of the bile duct

and pancreatic duct through the papilla of Vater using a flexible fiberoptic endoscope with retrograde injection of a

radiopaque medium.” Endoscopic Retrograde Cholangiopancreatography, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=65009 (last visited Aug. 29, 2025).

4

“Fisher Syndrome” is defined as a “variant of Guillain-Barré syndrome characterized by areflexia, ataxia, and

ophthalmoplegia” and is also known as Miller-Fisher syndrome. Fisher Syndrome, Dorlands, Medical Dictionary

Online, https://www.dorlandsonline.com/dorland/definition?id=110608 (last visited Aug. 29, 2025).

3

On October 1, 2019, Petitioner underwent a lumbar puncture with cerebrospinal fluid

(“CSF”) analysis. Ex. 3 at 244, Ex. 4 at 299. Dr. Hernandez noted that her CSF displayed an

elevated protein level of 65, supportive of a GBS diagnosis, although she was not also reporting

weakness. Ex. 3 at 244. Based on these findings, Dr. Hernandez recommended five rounds of

plasmapheresis treatments, which concluded on October 9, 2019. Id. at 121.

On October 16, 2019, Ms. Beckwith was discharged to inpatient rehabilitation. Ex. 3 at 36.

Petitioner still had transaminitis 5 due to acute choledocholithiasis and cholangitis. Id. at 121. She

remained an inpatient at Frazier Rehabilitation Institute through mid-November. Ex. 5 at 5.

Records from this time memorialize an onset of neurologic symptoms following the September

25, 2019, ERCP procedure, which included “ataxia, weakness, pain, areflexia, dysphagia,

dysarthria, hypophonia, tremors and sensory deficits in extremities.” Id. at 14.

Petitioner has filed additional medical records setting forth her treatment into 2020 and

beyond. But they do not shed light on the causation issues relevant to the disposition of this claim,

and I therefore do not include further evaluation of them.

II. Expert Opinions

The parties filed fairly extensive expert reports in support of their positions, and multiple

iterations of them as well. But because my analysis turns on only one Althen prong, in the interests

of brevity I discuss in detail herein only those portions of the reports bearing on the medical

acceptability of the timing of Petitioner’s onset.

A. Petitioner’s Experts

1. Dr. Joseph Jeret – Dr. Jeret is a neurologist. Although he filed other reports,6

only one is relevant to the prong three issue in dispute. See report, dated Sept. 5, 2023, filed as Ex.

16 (ECF No. 42-1) (“Jeret Rep.”).

5

“Transaminitis” is defined as “high levels of a particular type of enzyme in your blood, called a transaminase. The

most common ones are alanine transaminase (ALT) and aspartate transaminase (AST) (also called alanine transferase

and aspartate transferase). These enzymes are released into [the] blood by [the] liver. If a blood test show [one’s]

transaminases are elevated, it suggests that [the] live is under stress.” Transaminitis, Transaminitis, Cleveland Clinic,

https://my.clevelandclinic.org/health/symptoms/transaminitis (last visited Aug. 29, 2025).

6

Earlier in the case (and before the question of vaccination proof was resolved), Dr. Jeret offered a report presuming

that Petitioner had received three doses of flu vaccine, as originally alleged. See Report, dated October 19, 2022, filed

as Ex. 11 (ECF No. 24). But that factual premise has been undermined, and I disregard this earlier report in reaching

my conclusion in this case (and in any event Dr. Jeret recapitulated his arguments relevant to onset in his subsequent

reports). Dr. Jeret also prepared a second report after my vaccination administration ruling. Report, dated April 19,

2024, filed as Ex. 76 (ECF No. 53-1) (“Second Jeret Rep.”). This supplemental report only briefly addresses the

timing/onset issue. See Second Jeret Rep. at 3–4. And it repeats the same arguments, and references the same items

of literature, as contained in the first report pertaining to Althen prong three. It therefore merits no additional review

or comment.

4

Dr. Jeret received his undergraduate degree from CUNY Brooklyn College in Brooklyn,

New York in 1984, and his medical degree from SUNY Health Science Center at Brooklyn in

1988. See Curriculum Vitae, filed as Ex. 12 (ECF No. 24-2) (“Jeret CV”) at 1. Thereafter, he

completed a one-year general internal medicine preliminary year at Maimonides Medical Center,

followed by a three-year residency in Neurology and a one-year fellowship in Clinical

Neurophysiology at SUNY Downstate. Id. He is board certified in Neurology by the American

Board of Psychiatry and Neurology and is currently employed by Optum Health Care as an active

neurologist and is on staff at two community hospitals—South Nassau Community Hospital and

Mercy Medical Center. Id.; Jeret Rep. at 1. Dr. Jeret has published numerous articles in areas

related to neurology, reflecting his broad general practice. Id. at 2–7; Jeret Rep. at 1.

In his report, Dr. Jeret noted that some records filed in this case suggested Petitioner had

received three flu vaccine doses within 24 hours, but he seems to have accepted my fact finding

that only the dose recorded as having been administered the morning of September 24, 2019, was

likely received. Jeret Rep. at 4. He nevertheless opined that an onset of neurologic symptoms the

following day (which he concluded had occurred “approximately 36 hours later”) was medically

acceptable for flu vaccine-caused GBS. Id. at 10.

In support, Dr. Jeret offered several items of literature. One was a study relying on data

from South Korea. Y. Park et al., Clinical Features of Post-Vaccination Guillain-Barré Syndrome

(GBS) in Korea, J. Korean Med. Sci. 2017 Jul. 32(7):1154–59, filed as Ex. 45 (ECF No. 44-8)

(“Park”). Park’s authors relied on data derived from South Korea’s vaccine adverse event

compensation program, identifying 48 cases (over a 12-year period) in which individuals were

compensated for GBS post-vaccination injuries. Park at 1154–55. Park observed an onset of

neurological symptoms occurring within three weeks in 47 of 48 of the analyzed GBS cases, and

occurring within two days in a bit more than half. Park at 1156.

In another item referenced by Dr. Jeret (a retrospective study of passive surveillance data

derived from the Vaccine Safety Datalink), researchers observed evidence of “[o]nset as early as

1 day after flu vaccination.” Jeret Rep. at 10; S. Perez-Vilar et al., Guillain-Barré Syndrome After

High-Dose Influenza Vaccine Administration in the United States, 2018-2019 Season, 223 J. Infec.

Dis. 1:416 (2021), filed as Ex. 43 (ECF No. 44-6) (“Perez-Vilar”). Perez-Vilar’s authors employed

two post-vaccination risk periods, including a broader one of 1–42 days, and did observe cases

with onset in the one to seven-day range. Perez-Vilar at 421 (Figure 2) and 423 (Figure 3). But the

article makes no determination about the relative risk temporally from vaccination (beyond noting

a significant drop-off well past 42 days), and in fact determined that the risk was statistically

insignificant for a 1–42 day timeframe (and based on the season analyzed only), deeming their

findings “reassuring” as to the flu vaccine’s safety. Id. at 423.

A third article was similar, both in terms of its literal observations from data as well as their

meaningfulness when applied to this case. L. Polakowski et al., Chart-Confirmed Guillain-Barré

Syndrome After 2009 H1N1 Influenza Vaccination Among the Medicare Population, 2009-2010,

5

178 Am. J. Epidemiol. 6:962 (2013), filed as Ex. 42 (ECF No. 44-5) (“Polakowski”). Polakowski

relied on data from a pool of Medicare recipients (hence an elderly population), focusing on

instances of GBS arising temporally after receipt of the H1N1 flu vaccine—ultimately identifying

31 vaccinated individuals in a particular vaccination season (out of a total of approximately 3.4

million in the initial pool) who met the study’s diagnostic criteria for GBS, and who experienced

symptoms onset within 119 days of vaccination. Polakowski at 962–66. As with Perez-Vilar, some

of the final pool subjects had reported onset within a few days of vaccination. Id. at 967. However,

the relative risk for a more confined temporal period (8–42 days) was higher than for the broader,

1–42 period. Id. at 965–67, 969. Polakowski did not reach conclusions about more specific

questions of temporal risk, and noted further that although the risk associated with this particular

vaccination period was higher than when compared to controls, it was lower than with respect to

prior vaccination seasons. Id. at 971.

Dr. Jeret also offered some literature specific to the GBS variant Petitioner likely

experienced, Miller-Fisher. Jeret Rep. at 10. M. Kazi et al., Miller-Fisher Syndrome After

Vaccination in the United States: A Centers for Disease Control and Prevention/Food and Drug

Administration Vaccine Adverse Event Reporting System Study 1999-2017, 60 Musc. & Nerve

S1:534 (2019), filed as Ex. 13(f) (ECF No. 24-8) (“Kazi”). Kazi is a one-page abstract referencing

an observational study that relied on passive surveillance data derived from the Vaccine Adverse

Event Reporting System (“VAERS”). 7 Kazi at 534. Based on an 18-year period (and an

unspecified number of vaccines administered), its authors identified only 87 instances in which

Miller-Fisher syndrome was reported after receipt of several different vaccines (including flu

vaccine), finding no “increase in incidence of [Miller-Fisher syndrome] after vaccination as

compared to the general population. Id. But Dr. Jeret emphasized that of the instances of GBS

observed, “76% were reported within 6 weeks and 24% within 2 weeks,” along with an “increased

risk within the first 6 weeks,” and therefore (in Dr. Jeret’s estimation “onset after 2 days is

consistent with this review—arguably the largest study of post-vaccine MFS on record!” First Jeret

Rep. at 10.

2. Dr. Omid Akbari – Dr. Akbari is an academic immunologist, and he

prepared two lengthy written reports 8 on behalf of Petitioner. Report, dated Oct. 24, 2024, filed as

Ex. 18 (ECF No. 43-1) (“First Akbari Rep.”); Report, Apr. 23, 2024, filed as Ex. 77 (ECF No. 53-

2) (“Second Akbari Rep.”).

7

VAERS a database maintained by the Centers for Disease Control. VAERS collects information about adverse events

reported to have occurred after the administration of licensed vaccines in the U.S. See About VAERS, Vaccine Adverse

Event Reporting System (VAERS), https://vaers.hhs.gov/about.html (last visited Aug. 29, 2025).

8

Dr. Akbari’s two reports collectively total 67 pages—in a flu-GBS case that presents non-controversial issues about

general causation, and where it has been fairly self-evident for some time that only the third causation prong was in

dispute. This reflects a failure by counsel to avoid incurring unnecessary expert costs, and I will take into account that

failure when any fees award is issued in this case.

6

Dr. Akbari is a professor of allergy and immunology of Keck School of Medicine at the

University of Southern California. See Curriculum Vitae, filed as Ex. 19 (ECF No. 43-2) (“Akbari

CV”) at 2. He received his bachelor’s and master’s degrees from University College London in

1993 and 1995, respectively. Id. at 1. Thereafter, he received his Ph.D. in Cellular and Molecular

Immunology from the National Institute for Medical Research in London before completing a

post-doctoral fellowship at Stanford University. Id. Dr. Akbari has and continues to serve on the

editorial board of several journals, and he has numerous publications focused on the area of

immunology and allergy research. Id.; First Akbari Rep. at 2. He also has particular experience on

the subjects of “immune tolerance and how immune cells induce autoimmune and allergic

diseases.” First Akbari Rep. at 2. Dr. Akbari is not a medical doctor, however, and therefore he

does not diagnose or treat patients with neurological diseases in a clinical setting.

First Report

Dr. Akbari’s first report makes contentions relating to GBS onset parallel with what Dr.

Jeret offered, although he invokes more microbiologic and immunologic concepts in doing so. See

generally First Akbari Rep. at 10–12, 27.

Although prong one causation is not at issue in this case, a brief summary of Dr. Akbari’s

theory is still necessary, since it bears on whether Petitioner’s GBS began in a medically acceptable

timeframe. See generally First Akbari Rep. at 7–17. Dr. Akbari offered a sweeping, all-

encompassing theory, in which a vaccine (a) causes a local reaction, stimulating an immune

complex called the “inflammasome,” (b) encourages the production of cytokines as well as T

“helper cells” that are integral to the process of production of antibodies by B cells, (c) impacts

the function of immune regulatory cells that suppress aberrant immune responses, and (d)

eventually prompts the creation of antibodies in response. Id. at 7–8. Although these processes

bridge the initial, innate response (which is rapid) with the slower, secondary/adaptive response,

there is also a class of “innate like lymphocytes (“ILLs”) that act quickly, and are likely involved

“in the induction of demyelinating diseases such as GBS.” Id. at 10.

Dr. Akbari stated that molecular mimicry (between a vaccine or infectious antigens and a

self-tissue component) is accepted as a likely mechanism for GBS. First Akbari Rep. at 5. But he

applied an expansive definition of it, to mean not just cross-reactivity due to autoantibody attacks

driven by similarity between foreign antigens and self, but to include T cell reaction as well. Id. at

6. He also claimed that molecular mimicry was accepted despite the difficulty in ever showing an

actual mimic (a convenient assertion that largely excuses individuals who wish to invoke the

concept from having to substantiate it). Id. at 7. In addition, Dr. Akbari noted that GBS is likely

encouraged along by a particular type of T helper cell that causes production of proinflammatory

cytokines. Id. at 9.

Based on the foregoing, Dr. Akbari contended that “an early onset of GBS after flu

immunization” was medically acceptable. First Akbari Rep. at 10. (In support, he referenced the

7

same articles cited by Dr. Jeret, such as Park or Perez-Vilar). He observed studies where onset was

seen within three days of vaccination, like Park in particular. Id. at 11–12. He noted that the flu

vaccine’s initial stimulation of the inflammasome was also likely to encourage a faster immune

response, particularly by encouraging the production of proinflammatory cytokines. Id. at 13–17;

S. Crooke et al., Inflammasome Activity in Response to Influenza Vaccination is Maintained in

Monocyte-Derived Peripheral Blood Macrophages in Older Adults, 2 Frontiers in Aging, Art.

719103, filed as Ex. 46 (ECF No. 44-9) (“Crooke”), at 7–8 (inflammasome response to vaccination

in older population was consistent with younger groups, even though vaccination generally was

less immunogenic).

In addition, at least one study established that T cells could quickly impact the nervous

system “within the first few hours after being in the periphery,” and thereby cause (along with

ILLs) “injury and demyelination.” First Akbari Rep. at 27; R. Ransohoff et al., Three or More

Routes for Leukocyte Migration into the Central Nervous System, 3 Nat. Revs. Immunol. 569

(2003), filed as Ex. 72 (ECF No. 45-15) (“Ransohoff”). Ransohoff, however, focuses on the central

nervous system (the “CNS”), and movement of immune cells (including leukocytes) to and from

the periphery, and its authors emphasized how little remains known about this topic. Ransohoff at

578–79. More significantly, GBS is not a CNS disease, and so the speed with which a leukocyte

might be thought capable in some instances of moving into, or out of, the CNS does not suggest

GBS will occur as quickly as Dr. Akbari posits.

Second Report

Dr. Akbari’s second report mostly covered ground not directly pertinent to the

timeframe/onset dispute, but he did attempt to bulwark some of his points on this subject. See

generally Second Akbari Rep. at 27–30. For example, Dr. Akbari took issue with the argument of

Respondent’s immunologic expert (Dr. William Hawse) that not enough was known about ILLs

and their relationship with vaccination and GBS to deem them an explanation for a fast onset,

maintaining that ILLs were known to be fast-acting, could promote production of cytokines and T

helper cells, and likely played some role in encouraging “the development of demyelinating and

autoimmune disease,” including acute forms of GBS. Id. at 28. He also emphasized that “there are

no clear boundaries between innate and adaptive immunity” in any event (suggesting implicitly

that assumptions about the time it takes for adaptive responses to occur was unfounded). Id. at 27.

Dr. Akbari allowed, however, that there remains a “need for greater understanding of ILL function

in the hyper-acute phase of inflammation such as vaccination and adverse effects that may occur

within hours or few days”—and acknowledgement that the science on this subject is far less firm

than he implied. Id. at 28.9 Dr. Akbari nevertheless concluded that “the prompt response of [ILLs]

9

This section of Dr. Akbari’s report referenced (by my informal count) more than 15 individual items of literature.

See generally Second Akbari Rep. at 27–29, 35–36 (references 28 to 42). I have reviewed these articles—but none are

specific to the context of GBS onset occurring more rapidly than usual, due to suspected involvement of ILLs. Rather,

these items largely (like Dr. Akbari’s report overall—as well as the opinions he often provides in Vaccine Program

cases) make reliable scientific observations about immune system functioning in disparate contexts, but without

8

to flu immunization play a pivotal role in triggering an early-onset demyelination cascade.” Second

Akbari Rep. at 29. He deemed it likely the Petitioner “possessed a higher number of ILLs,”

assuming “genetic or environmental factors” relevant to her (although not substantiated in this

case) explained this. Id. 10

At bottom, Dr. Akbari maintained that a GBS onset within less than two days of vaccination

had been shown to be “plausible.” Second Akbari Rep. at 30. He emphasized that the 3–42 day

timeframe embraced by the Table version of the claim was “arbitrarily defined” by the “Vaccine

Court”—a wholly-erroneous contention, since Table claims are not established by OSM, but

instead reflect Respondent’s determinations, supported by applicable medical science. Id. Dr.

Akbari further contended that “we know” GBS can begin earlier or later after vaccination, given

personal genetics and individual immune variance. Id. And he added that “[i]f the Court never

accepted time frames outside of those on the Vaccine Injury Table, then there would not exist a

causation-in-fact case, which, to my understanding, is not the purpose, scope or intent of the

Vaccine Court.” Id.

B. Respondent’s Experts

1. Dr. Peter Kang – Dr. Kang, a neurologist, prepared one expert report on

Respondent’s behalf. Report, dated March 28, 2024, filed as Ex. C (ECF No. 50-1) (“Kang Rep.”).

Dr. Kang attended State University of New York (“SUNY”), for his undergraduate degree,

the University of Pittsburg School of Medicine for his medical degree, and Washington University

School of Medicine for his Master of Science in Clinical Investigation. See Curriculum Vitae, filed

Mar. 29, 2024 (ECF No. 50-14) (“Kang CV”) at 1. He then completed an internship in Preliminary

Internal Medicine, a residency in Neurology, and a fellowship in Neurocritical Care at Washington

University School of Medicine. Id. Dr. Kang is currently the Program Director for the Neurology

Residency Program at Washington University School of Medicine, as well as Teaching Faculty

and Attending Physician in the Neurointensive Care Unit, General Neurology Ward Service, and

Resident Continuity Clinic at Barnes-Jewish Hospital. Id. at 2. His clinical practice primarily

focuses on the care of individuals suffering neurologic conditions such as cognitive impairment,

disorders of consciousness, motor and sensory deficits, gait and balance disorder. Kang Rep. at 1.

Dr. Kang is board certified by the American Board of Psychiatry and Neurology in both Neurology

and Neurocritical Care. Kang CV at 3.

appreciably advancing the notion that the flu vaccine is likely to spur more quickly a pathogenic response leading to

GBS.

10

As additional support for his opinion, Dr. Akbari referenced a Program decision. Second Akbari Rep. at 29, citing

Harris v. Sec’y of Health & Hum. Servs., No. 18-944V, 2023 WL 2583393 (Fed. Cl. Spec. Mstr. Feb. 21, 2023)

(finding Tdap vaccine causal of GBS, with onset within one day). Putting aside the questionable value of a medical

expert making legal arguments about other Program decisions and their import, this case has no direct relevance, since

it involves a different vaccine, and since there is no analogous Table claim providing an onset timeframe that arguably

bears on the present circumstances.

9

With respect to the issue of onset and its medical acceptability, Dr. Kang noted that

Petitioner had received the flu vaccine on the morning of September 24, 2019, with onset of

neurologic, GBS-oriented symptoms later the next day. Kang Rep. at 16. But Dr. Kang maintained

that “no compelling evidence in the literature” supported the conclusion that the GBS variant

experienced by Petitioner could clinically manifest in such a short time frame “following an

immunogenic exposure.” Id.

In support, Dr. Kang stressed that “the adaptive immune response through development

and production of human immunoglobulins (first IgM then IgG or IgG) in response to exposure to

the influenza virus, for example, takes several days, peaking at about 7 days.” Kang Rep. at 16; F.

Krammer, The Human Antibody Response to Influenza A Virus Infection and Vaccination, 19 Nat.

Reviews – Immunol. 383 (June 2019), filed as Ex. C Tab 9 (ECF No. 50-10), at 383 Box 3. But

Petitioner had displayed GBS early symptoms (which would in theory be driven by the antibodies

produced in reaction to receipt of the flu vaccine) too soon after vaccination for the vaccine to have

been responsible for those antibodies. Kang Rep. at 16. As a result, “it is not plausible that the

vaccine is the cause of the MFS variant GBS.” Id.

2. Dr. William Hawse – Dr. Hawse is, like Dr. Akbari, an academic

immunologist, and he offered an expert report for Respondent. Report, dated February 6, 2024,

filed as Ex. A (ECF No. 49-1) (“Hawse Rep.”).

Dr. Hawse is an Assistant Professor in the Department of Immunology at the University of

Pittsburgh School of Medicine. See Curriculum Vitae, filed as Ex. B (ECF No. 49-16) (“Hawse

CV”) at 1. He earned his Ph.D. in Biophysical Chemistry at Johns Hopkins and currently runs a

laboratory studying CD4+ T-cell generation and immune tolerance to inform therapeutic strategies

for autoimmune diseases. Hawse Rep. at 1. Dr. Hawse has published multiple peer-reviewed

articles on the subject. He is not, however, a medical doctor or experimental clinician, and thus

does not offer commentary on diagnosis.

Much of Dr. Hawse’s report addressed issues of causation that do not impact this claim’s

resolution. But he also discussed Dr. Akbari’s contentions regarding Althen prong three. See

generally Hawse Rep. at 11. Dr. Hawse emphasized that the record established an onset within a

day of vaccination (not two days, as Dr. Akbari proposed). Id. at 11. He deemed it unlikely GBS

could manifest in so short a timeframe. He also observed that the record revealed that prior to

vaccination, Petitioner had both likely experienced a URI, and that she had been diagnosed with

an infection-associated sepsis—either of which could have triggered her subsequent GBS, and in

a timeframe more reasonable than the immediate one proposed for vaccine causation. Id.

Dr. Hawse also attempted to rebut some of Dr. Akbari’s specific contentions about points

in the human immunologic response that could have contributed to a short onset. ILLs, Dr. Hawse

maintained, could be quickly stimulated by vaccination. But the existing scientific and medical

literature on the topic was too sparse to conclude either that vaccines likely do stimulate these

10

immune cells, or (and more importantly) that they lead to GBS (and it was speculative for Dr.

Akbari to assume this explained instances in which individuals reported short onset of GBS after

vaccination). Id.

Similarly, Dr. Hawse noted that Dr. Akbari had shown (in citing articles like Crooke) only

that there is some inflammasome stimulation attributable to receipt of the flu vaccine—but not that

this stimulation would be sufficiently aberrant to cause a disease process leading to GBS. Hawse

Rep. at 4–5. In fact, literature suggested that vaccine-provoked inflammasome stimulation could

result in the production of inflammation-modulating cytokines. Id. at 5; S. Mohanty et al.,

Prologued Proinflammatory Cytokine Production in Monocytes Modulated by Interleukin 10 After

Influenza Vaccination in Older Adults, 211 J. Infect. Dis. 1174 (1 Apr. 2015), filed as Ex. A Tab

5 (ECF No. 49-6). And other studies observed that receipt of the flu vaccine suppressed some

innate responses that would be otherwise pro-inflammatory. Hawse Rep. at 5–6; F. Wimmers et

al., The Single-Cell Epigenomic and Transcriptional Landscape of Immunity to Influenza

Vaccination, 184 Cell 3915 (2021), filed as Ex. A Tab 6 (ECF No. 49-7).

III. Procedural History

This matter began approximately four years ago. After “pre-assignment review” (the

Program’s process for ensuring sufficient documents relevant to the claim have been filed for

analysis), the matter was assigned to the “Special Processing Unit” (“SPU”), since it alleged the

Table claim of GBS due to the flu vaccine—an oft-settled and common Vaccine Act claim.

However, Respondent’s June 2022 Rule 4(c) Report noted an issue with the claim—the fact that

the filed vaccination record (a facially-cursory document) suggested Petitioner had received three

vaccine doses in a short timeframe—one the night of September 23, 2019, and two more early the

next morning of the 24 th. Rule 4(c) Report (ECF No. 18) at 7; Ex. 1 at 3. And even if the latest

dose were deemed the sole vaccination event at issue, Petitioner’s onset of the evening of

September 25 th would still be too short, measured from vaccination, to meet the Table

requirements. Rule 4(c) Report at 7.

In reaction, I ordered Petitioner to show cause why the Table claim should not be

dismissed. Order, dated Jun 15, 2022 (ECF No. 19). Petitioner in reaction, however, maintained

that because it appeared she had received three doses of vaccine within 24 hours, a claim was still

viable (given the unusual circumstances—which might make a short onset medically

acceptable)—and based on that contention, I determined the matter would be transferred out of

SPU for expert input. Order, dated July 26, 2022 (ECF No. 22).

After several months of records filing and some initial expert input, Respondent raised

again the fact that it did not appear from the totality of the filed records (as of that time) that

Petitioner could corroborate receipt of any flu vaccine doses, let alone three. In reaction, I ordered

the parties to brief this issue. Order, dated February 9, 2023 (ECF No. 27). After the parties briefed

the question, it was my initial determination that the fact of vaccination had not been proven, and

11

I dismissed the claim on that basis in June 2023. Petitioner thereafter, however, moved twice for

reconsideration of my dismissal determination, and in the course of so doing was eventually able

to identify and offer a previously-unfiled document 11 confirming that she received one vaccine

dose at 2:20 a.m. on September 24, 2019. See Order Granting Second Motion for Reconsideration,

dated July 26, 2023 (ECF No. 37 (“Reconsideration Order”).

In my Reconsideration Order, however, I noted that despite due opportunity, Petitioner had

utterly failed to establish receipt of more than one dose of the flu vaccine. Reconsideration Order

at 2. I also found that the Table onset for a flu-GBS claim could be established, since Petitioner’s

onset seemed to have begun sooner than three days post-vaccination. Id. I otherwise ordered

Petitioner to file a revised expert report in light of my determination.

The parties thereafter filed the expert reports discussed above. Final reports were filed in

the summer of 2024, and in November of that same year I ordered Petitioner to show cause why

the claim should not be dismissed, for failure to meet prong three of the test set forth for causation-

in-fact claims by Althen. The parties filed the briefs cited above, completing the process in mid-

March 2025, and the matter is ripe for resolution.

IV. Parties’ Arguments

Petitioner

Petitioner maintains that the flu vaccine can cause GBS outside the 3–42-day timeframe—

first noting the importance of Dr. Akbari’s reliance on ILLs, and several newly identified cells

within this category: invariant natural killer cells (“iNKT”), innate like lymphoid cells, and gamma

delta T cells. Id. at 43, 46; Akbari First Rep. at 9. Dr. Akbari explained, “ILLs are fast-acting cells

and upon stimulation can produce cytokines and cause protection or cause pathologies (such as

adverse effects) within a few hours. Br. at 46–47; Akbari First Rep. at 9. Thus, he argued that ILLs

are understood to be “key participants in early response after immunization that would suggest the

involvement of these fast-acting immune cells in the induction of demyelinating diseases such as

GBS.” Id.; see also G. Borsellino et al., Phenotypic and Functional Properties of µδ T Cells from

Patients with Guillain Barré syndrome, 102 J. Neuroimmunology 199 (2000), filed as Ex. 38 (ECF

No. 44-1).

Similarly, according to Dr. Akbari, “ILCs have been shown to ‘exert a profound influence

in CNS inflammatory disease’ and [] these resident cells within the nervous system can be

activated early in disease to manifest disease-modifying cytokines and chemokines.” Br. at 47

(citing M. Brown & R. Weinberg, Mast Cells and Innate Lymphoid Cells: Underappreciated

Players in CNS Autoimmune Demyelinating Disease, 9 Frontiers Immunology 1 (2018), filed as

Ex. 39 (ECF No. 44-2). Lastly, Petitioner relies on an article to support the notion that iNKT cells

are “associated with GBS, [and] suggesting a central role of these fast-acting T cell types in

11

I note that this confirmation of vaccination was only discovered two years after the case’s filing.

12

inflammatory neuropathies varying between acute and chronic subtypes.” Br. at 48 (citing M.

Heming et al., Immune Cell Profiling of the Cerebrospinal Fluid Provides Pathogenetic Insights

into Inflammatory Neuropathies, 10 Frontier Immunology 1 (2019), filed as Ex. 41 (ECF No. 44-

4). Petitioner argues that these articles establish how these specific types of cells function within

the hyperacute phase of inflammation, and thus, can lead to an onset of injury within hours or a

few days. Br. at 48.

Here, Petitioner maintains that she began exhibiting symptoms of her GBS, Miller-Fisher

variant between 36- and 55-hours post-vaccination (based on the evidence establishing that she

received the vaccine in question on September 24, 2019, at 2:20 a.m.). Br. at 52, 53; Ex. 15 at 6;

Ex. 3 at 313–14. She further notes that she reported no prior neurological symptoms at the time

she was initially hospitalized for abdominal pain. Id. She underwent the ECRP at 2:40 p.m. and

was NPO for the following two hours. Br. at 53; Ex. 3 at 304. By 9:25 p.m. that evening, medical

records indicate that Petitioner was “resting comfortably at [the] time and [was] not disturbed.”

Ex. 3 at 307. Thus, she further maintains that her medical records would not document her

condition as such had she been experiencing weakness or neurological symptoms. Br. at 53.

Moreover, Petitioner notes that many of the reports following Petitioner’s ECRP do not mention

neurologic complaints until 9:30 a.m. the day after (meaning her onset would be longer than 48

hours post-vaccination). Ex. 3 at 289 (documenting complaint of fingertip numbing and dizziness

on September 26, 2019, at 9:30 a.m.); 256 (describing visit with Dr. Hernandez who noted

Petitioner’s progressing neurologic symptoms).

Accordingly, and relying on the above-mentioned studies, and other supported and well-

established medical literature, Petitioner contends that she has not only provided a sound and

reliable medical theory of causation, but that her experts, Drs. Akbari and Jeret, have

preponderantly proposed how the flu vaccine can trigger an earlier onset of GBS between one and

three days. Id. at 51.

Respondent

Respondent has offered a succinct brief in reaction to my Order to Show Cause,

maintaining that the case turns on Petitioner’s inability to show that a one-day post-vaccination

onset is medically acceptable. Opp. at 9–13. In so arguing, he notes my prior fact finding,

contrasting it with the view (reflected in Petitioner’s briefing) that her onset may have been closer

to three days post-vaccination. Id. at 10. But as Dr. Kang proposed, there is record evidence of an

onset as early as the morning of the ECRP procedure (which would make onset even closer-in-

time to vaccination). Id. at 11.

Dr. Kang, Respondent argues, has persuasively opined that the MFS GBS variant would

not be expected to begin within a day or two of a trigger like vaccination. Opp. at 11. In response,

Petitioner relies on case series like Kazi, which in fact do not establish the medical acceptability

13

of a short onset. Id. at 11–12. And case reports generally are low-value evidence of causation. Opp.

at 12 (citations omitted).

By contrast, Dr. Kang established that the production of autoantibodies that would likely

drive GBS would occur during the adaptive immune response, and would take days to a week or

so to occur—longer than the onset in this case. Opp. at 12. And that timeframe was more consistent

with the likelihood (corroborated by the record evidence of Petitioner’s pre-hospitalization

symptoms) that Petitioner had experienced an infection that resulted in her GBS. Id. at 12–13. Dr.

Akbari attempted to invoke ILLs as capable of causing GBS in a shorter timeframe, but the

independent support he offered for this contention was too general, and did not address the specific

issues in dispute relating to onset of GBS due to vaccination. Id. at 13. Thus, his opinion was

highly speculative.

V. Applicable Legal Standards

A. Petitioner’s Overall Burden in Vaccine Program Cases

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

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

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

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

Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §

11(c)(1)(C)(ii)(I); see also Moberly, 592 F.3d at 1321; Capizzano v. Sec’y of Health & Hum. Servs.,

440 F.3d 1317, 1320 (Fed. Cir. 2006). 12 There is a Table claim for GBS after receipt of the flu

vaccine, but (as discussed herein) it requires proof of an onset no sooner than three days post-

vaccination—and onsets too close-in-time to vaccination can be fatal even to non-Table claims

that the flu vaccine caused a person’s GBS.

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. Section 13(1)(a). That is, a petitioner must offer evidence that

leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence

before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s

existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v. United States, 6 Cl. Ct.

476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).

Proof of medical certainty is not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867,

873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not only

[the] but-for cause of the injury but also a substantial factor in bringing about the injury.” Moberly,

12

Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding

authority. Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings

concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Hum. Servs., 59 Fed. Cl. 121,

124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V,

2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

14

592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352–53

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

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

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

Section 13(a)(1).

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

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

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

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

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

injury.”

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

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

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

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

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

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

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

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

medical theory. Andreu, 569 F.3d at 1378–79 (citing Capizzano, 440 F.3d at 1325–26). Special

masters, despite their expertise, are not empowered by statute to conclusively resolve what are

essentially thorny scientific and medical questions, and thus scientific evidence offered to establish

Althen prong one is viewed “not through the lens of the laboratorian, but instead from the vantage

point of the Vaccine Act’s preponderant evidence standard.” Id. at 1380. Accordingly, special

masters must take care not to increase the burden placed on petitioners in offering a scientific

theory linking vaccine to injury. Contreras v. Sec'y of Health & Hum. Servs., 107 Fed. Cl. 280,

245 (2012).

In discussing the evidentiary standard applicable to the first Althen prong, the Federal

Circuit has consistently rejected the contention that it can be satisfied merely by establishing the

proposed causal theory’s scientific or medical plausibility. See Cerrone v. Sec’y of Health & Hum.

Servs., No. 24-1281, slip op. at 9 (Fed. Cir. July 29, 2025); Kalajdzic v. Sec’y of Health & Hum.

Servs., No. 2023-1321, 2024 WL 3064398, at *2 (Fed. Cir. June 20, 2024) (arguments “for a less

than preponderance standard” deemed “plainly inconsistent with our precedent” (citing Moberly,

592 F.3d at 1322)); Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir.

2019); see also Howard v. Sec'y of Health & Hum. Servs., 2023 WL 4117370, at *4 (Fed. Cl. May

18, 2023) (“[t]he standard has been preponderance for nearly four decades”), aff’d, 2024 WL

15

2873301 (Fed. Cir. June 7, 2024) (unpublished). And petitioners always have the ultimate burden

of establishing their overall Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of

Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United

States, 133 Fed. Cl. 782, 793 (2017) (noting that Moberly “addresses the petitioner’s overall

burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard).

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

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

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

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

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

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

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

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

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

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

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

Medical records and statements of a treating physician, however, do not per se bind the

special master to adopt the conclusions of such an individual, even if they must be considered and

carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,

test result, report, or summary shall not be binding on the special master or court”); Snyder v. Sec’y

of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that mandates

that the testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and

cannot be rebutted”). As with expert testimony offered to establish a theory of causation, the

opinions or diagnoses of treating physicians are only as trustworthy as the reasonableness of their

suppositions or bases. The views of treating physicians should be weighed against other, contrary

evidence also present in the record—including conflicting opinions among such individuals.

Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or capricious

for special master to weigh competing treating physicians’ conclusions against each other), aff’d,

698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,

2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed.

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

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

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

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

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

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

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

16

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

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

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

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

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

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

B. Legal Standards Governing Factual Determinations

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

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

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

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

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

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

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

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

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

1993) (determining that it is within the special master's discretion to determine whether to afford

greater weight to contemporaneous medical records than to other evidence, such as oral testimony

surrounding the events in question that was given at a later date, provided that such determination

is evidenced by a rational determination).

As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as

trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95

Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his

contemporaneous medical records, the special master's decision to rely on petitioner's medical

records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.

Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked

propositions explains why such records deserve some weight: (i) sick people visit medical

professionals; (ii) sick people attempt to honestly report their health problems to those

professionals; and (iii) medical professionals record what they are told or observe when examining

their patients in as accurate a manner as possible, so that they are aware of enough relevant facts

to make appropriate treatment decisions. Sanchez v. Sec'y of Health & Hum. Servs., No. 11–685V,

2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.

Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to

conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).

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

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

17

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

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

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

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

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

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

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

weight.”)).

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

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

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

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

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

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

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

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

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

deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)).

Ultimately, a determination regarding a witness's credibility is needed when determining the

weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of

Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent, and

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,

No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the

accuracy and completeness of medical records, the Court of Federal Claims has listed four possible

explanations for inconsistencies between contemporaneously created medical records and later

testimony: (1) a person's failure to recount to the medical professional everything that happened

during the relevant time period; (2) the medical professional's failure to document everything

reported to her or him; (3) a person's faulty recollection of the events when presenting testimony;

or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health

& Hum. Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir. 2014). In making

a determination regarding whether to afford greater weight to contemporaneous medical records

or other evidence, such as testimony at hearing, there must be evidence that this decision was the

result of a rational determination. Burns, 3 F.3d at 417.

18

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present

expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357,

1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to the

factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509

U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs., 617 F.3d 1328, 1339 (Fed.

Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).

Under Daubert, the factors for analyzing the reliability of testimony are:

(1) whether a theory or technique can be (and has been) tested; (2) whether the

theory or technique has been subjected to peer review and publication; (3) whether

there is a known or potential rate of error and whether there are standards for

controlling the error; and (4) whether the theory or technique enjoys general

acceptance within a relevant scientific community.

Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592–95).

In the Vaccine Program the Daubert factors play a slightly different role than they do when

applied in other federal judicial settings, like the district courts. Typically, Daubert factors are

employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence

that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are

used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &

Hum. Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the Daubert factors have been

employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of expert

testimony already admitted”). The flexible use of the Daubert factors to evaluate the

persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88

Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has not

been employed at the threshold, to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts in order to rebut a petitioner’s case.

Where both sides offer expert testimony, a special master's decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen, 618 F.3d at 1347 (citing Lampe, 219 F.3d at 1362). However, nothing requires the

acceptance of an expert's conclusion “connected to existing data only by the ipse dixit of the

expert,” especially if “there is simply too great an analytical gap between the data and the opinion

proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see

also Isaac v. Sec'y of Health & Hum. Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl.

Spec. Mstr. July 30, 2012), mot. for review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x.

19

999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of

competing expert testimony, based on a particular expert's credibility, is part of the overall

reliability analysis to which special masters must subject expert testimony in Vaccine Program

cases. Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often

turn on credibility determinations”); see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d

1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are

expected to consider the credibility of expert witnesses in evaluating petitions for compensation

under the Vaccine Act”).

D. Consideration of Medical Literature

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

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

literature submitted in this case, I discuss only those articles that are most relevant to my

determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed

every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072,

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

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

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

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

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

E. Determination to Resolve Case without a Hearing

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

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

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

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

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

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

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

& Human Servs., No. 02-472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19,

2016) (citing numerous cases where special masters decided on the papers in lieu of hearing and

that decision was upheld). I am simply not required to hold a hearing in every matter, no matter

the preferences of the parties. See Hovey v. Sec'y of Health & Human Servs., 38 Fed. Cl. 397, 402-

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

at 417.

20

ANALYSIS

The failure to establish even one of the three Althen prongs in the context of a causation-

in-fact claim is sufficient grounds for a claim’s dismissal (and therefore the three prongs need not

all be addressed in cases where a claimant clearly fails to satisfy at least one). Dobrydnev v. Sec’y

of Health & Hum. Servs., 566 Fed. App’x. 976, 980 (Fed. Cir. 2014). The primary deficiency in

Petitioner’s claim is her inability to satisfy the third Althen prong. Althen, 418 F.3d at 1281.

Petitioner has not preponderantly established that her GBS developed within a medically-

acceptable timeframe after receipt of the flu vaccine. 13

It is well understood in the Vaccine Program that the onset of an alleged vaccine injury is

marked by the “first symptom or manifestation of onset.” See Section 16(a)(2). As the Federal

Circuit makes clear in Markovich v. Sec'y of Health & Hum. Servs., 477 F.3d 1353, 1357 (Fed.

Cir. 2007), there is a difference between a “symptom” and “manifestation of onset”—but because

of the Act’s use of the disjunctive “or,” either can constitute the start of a disease process (even

though a symptom could be nonspecific, or hard to link to what was later viewed as a full disease).

Markovich, 477 F.3d at 1357–59. As a result, the date of official diagnosis, and/or when treaters

were able to reach a conclusion as to the proper diagnosis, does not mark the onset of an alleged

vaccine injury. Carson v. Sec'y of Health & Hum. Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013)

(stating that “it is the first symptom or manifestation of an alleged vaccine injury, not first date

when diagnosis would be possible, that triggers the statute of limitations under § 300aa–

16(a)(2).”). Nor is onset deemed the date an injured party recognizes the subsequent disease has

begun, or even understands the symptom to be concerning. See Markovich, 477 F.3d at 1357 (“[a]

symptom may be indicative of a variety of conditions or ailments, and it may be difficult for lay

persons to appreciate the medical significance of a symptom with regard to a particular injury”)

(emphasis added). Onset can predate the time when a disease could be accurately diagnosed. Id.14

As determined in my 2023 Fact Order, Petitioner’s GBS onset likely began in the evening

hours of September 25, 2019—most likely after her ECRP procedure, but not quite two days post-

vaccination. Fact Order at 2; Ex. 3 at 256; Br. at 56 (acknowledging that “Petitioner began

exhibiting symptoms of her GBS/Miller-Fisher variant between 36 and 55 hours after her flu

vaccination”). Thus, even though the parties may not precisely agree on when onset began, they

both accept a post-vaccination of less than three days—and the record preponderates in favor of

13

I do not deem it reasonably disputed that the flu vaccine could cause GBS (prong one)—based on the Table

presumption, as well as my familiarity with the ample medical science on the subject. I do not reach the second, “did

cause” prong, since all three prongs must be met to establish entitlement to damages—and in any event, an onset too

soon in time post-vaccination to be medically acceptable precludes a finding the flu vaccine “did cause” her GBS.

14

Although the injured child in Markovich was not diagnosed with a seizure disorder until August 2000, it was

determined in that case that the onset of the disease dated back a month earlier, when the child suffered from an eye-

blinking episode that was later determined to be the first symptom of her seizure disorder. Markovich, 477 F.3d at

1357, 1360.

21

an onset occurring sooner (35 to 40 hours post-vaccination). Accordingly, the Table elements for

a flu-GBS claim (3–42 days after vaccine administration) cannot be met. 42 C.F.R. § 100.3.

Petitioner could only succeed in her claim by showing that her less than two-day onset constituted

a medically-acceptable timeframe for vaccine-instigated GBS.

Petitioners alleging a non-Table, causation-in-fact flu vaccine-GBS claim are of course not

formally limited, in any “bright line” sense, by the Table’s timeframe element. They can always

attempt to prove that a shorter or longer onset is still medically acceptable, given the facts of the

case. Yet the medical science behind a Table claim—the raison d’etre for its existence—should

not be ignored simply because the claim can no longer succeed as a Table matter. That

medical/scientific foundation (which led the Government to presume causation when certain facts

are proven) remains meaningful, and should still be taken into account to some degree when

deciding claims that “fall out” of the Table.

Often, giving some regard to the elements of an analogous Table claim inures to a

claimant’s benefit, and avoids unnecessary expenditure of judicial resources and needless burdens

on the petitioner. It would, for example, be temporally wasteful and judicially picayune to demand

that a petitioner “prove” prong one causation in a flu vaccine-GBS case with the filing of opinions

and items of literature, just because he cannot meet Table timeframe onset. But Petitioner seems

to suggest this is exactly what should occur. Br. at 37–38.

So—should I simply don blinders, declare that the Table version of the flu vaccine-GBS

claim has no bearing herein, and proceed accordingly? Should I demand that Petitioner “prove”

the flu vaccine can cause GBS, as if I have no prior knowledge at all of the Table presumption of

causation? Should I require exhibits filed and hear expert testimony? And what if I were to find

that Petitioner in this case failed to prove an association? Should I issue decisions of that sort going

forward? Would every single non-Table case involving the flu vaccine and GBS come down to a

battle of the experts, with some petitioners prevailing because they made the effort, and others

losing when Respondent’s counsel goes to the “full nine yards,” as it were, to rebut causation?

To do so would be to open the door to a range of perverse outcomes contrary to the

Program’s goals of expedient case resolution. Were I to engage in such an overly rigid application

of prong one in failed flu vaccine-GBS Table claims, I would risk creating a “parallel universe” of

decisions in which petitioners had failed to prove something the Program otherwise presumes to

be so. 15 I reasonably hesitate to make such a world a reality.

15

Indeed (and as I have learned from other cases), there is ample evidence that the modern version of the flu vaccine

may not be reasonably associated with GBS, in comparison to the version administered during the swine flu epidemic

in the 1970s (the timeframe from which the most persuasive evidence of an association was generated). If Respondent

were allowed to litigate this issue without regard to the existence of the Table claim, inconsistent outcomes on such

claims would become common.

22

But “sauce for the goose is sauce for the gander,” as the adage goes—and this means that

if I am to give weight to some Table presumptions when evaluating a non-Table claim analog, I

should do the same with others. Here, that means that special masters should not disregard the

science behind the Table timeframe element. For that timeframe best captures the most likely

period in which flu vaccine-caused GBS would begin, based on the most persuasive and reliable

science available when the terms of the Table claim were struck. See Rowan v. Sec'y of Health &

Hum. Servs., No. 17-760V, 2020 WL 2954954, at *14–16 (Fed. Cl. Spec. Mstr. Apr. 28, 2020)

(discussing the relationship between Table requirements and non-Table claims in context of flu-

GBS claims). Otherwise, special masters risk stretching the Table’s timeframe period to fit a claim,

and on the mere say-so of an expert. Velasquez v. Sec’y of Health & Hum. Servs., No. 19-1703V,

2024 WL 829599, at n.13 (Fed. Cl. Spec. Mstr. Jan. 31, 2024). Failed Table claims would still

succeed if onset were “close” enough.

This does not mean that petitioners like Ms. Beckwith seeking to prove the medical

acceptability of a shorter (or longer) onset timeframe than what the Table allows for GBS are

doomed to failure. Rather, what they must do is establish (via evidence) what about the specific

facts of their medical history or personal circumstances suggests a faster onset due to vaccination

could occur. This has been done in prior cases, where petitioners were able to establish that some

synergistic combination of causes involving the vaccine and the claimant’s own preexisting health

likely resulted in a faster immune process. See, e.g., Lehrman v. Sec’y of Health & Hum. Servs.,

No. 13-901V, 2018 WL 1788477, at *16–19 (Fed. Cl. Spec. Mstr. Mar. 19, 2018) (finding a 24-

hour onset post-vaccination was medically acceptable because petitioner’s expert persuasively

explained how a preceding upper respiratory infection acted synergistically with the flu vaccine,

leading to a rapid onset of GBS).

Where that evidence is lacking, however, it is reasonable to find the third Althen prong has

not been satisfied. See, e.g., Orton v. Sec'y of Health & Hum. Servs., No. 13-631V, 2015 WL

1275459 (Fed. Spec. Mstr. Cl. Feb. 23, 2015) (dismissing claim where inadequate evidence

established the medical acceptability of a one-day onset of GBS); Rowan, 2020 WL 2954954, at

*19 (dismissing claim because it did not demonstrate that a 30–36-hour onset in elderly petitioner

was medically acceptable). And here, the kind of special/personal factors that would render a short

onset more acceptable are absent. The medical record in this case instead reveals no reaction to the

vaccination, and establishes merely onset of GBS-like neurologic symptoms after performance of

the ECRP. These facts do not suggest a faster aberrant immune response leading to GBS was more

likely in Petitioner’s case (no matter how plausible it might be), or did occur for the reasons

alleged. 16

16

The record evidence in this case actually provides other explanations for Petitioner’s close-in-time onset that are

more likely than vaccination to have impacted onset’s timing. For example, Petitioner was vaccinated after

experiencing a resolved URI—and in a timeframe that (if that infection was causal) would be consistent with a

medically-acceptable process instigated by infection that began more than a week before. There is also the possibility

that the ECRP was associated with Petitioner’s subsequent GBS—if the flu vaccine could cause GBS within two days,

23

None of the arguments of Petitioner’s experts have persuasively rebutted my finding that

onset of flu vaccine-caused GBS is unlikely to occur within two days of vaccination. Dr. Jeret, for

example, repeatedly identifies literature relying on passive surveillance reports of GBS beginning

in a comparably-short timeframe—but which do not opine as to the meaningfulness of these

occurrences, for purposes of causation. This is no different than relying on case reports—a kind of

evidence that takes note of a temporal association between an adverse event and vaccination, but

says very little about whether that relationship reflects more than mere chance. Campbell v. Sec’y

of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (2011) (stating that “[c]ase reports do not purport

to establish causation definitively, and this deficiency does indeed reduce their evidentiary value

compared particularly to formal epidemiological studies”).

More importantly, these independent items of literature do not provide any reliable basis

for concluding that the biologic process necessary to result in the production of antibodies capable

of causing the harm to myelin that characterizes GBS could occur in less than two days. The flu

vaccine is thought to be able to instigate GBS because it is believed to be capable of prompting,

via molecular mimicry, the creation of autoantibodies that (due to similarity with myelin self-

structures, like gangliosides) can cross-react, damaging the myelin as a result. That process of

antibody creation is not something that likely occurs within a day or two of vaccination. Rowan,

2020 WL 2954954, at * 17 (noting that antibodies are created during the adaptive immune process,

and that this phase is not likely to result in production of damaging antibodies within a few days—

even if the body “recognizes” foreign antigens, for purposes of generating antibodies against them,

in as little time as one day).

The specific items of literature referenced by Dr. Jeret are also worthy of little evidentiary

weight for other reasons. Park, for example, relies on outcomes from a foreign vaccine injury

compensation program, and thus could reflect a policy decision to resolve “close” cases. It

therefore does not stand for the proposition that an onset of less than two days has been found to

be medically acceptable, based on methodologically-sound research. I have for this reason rejected

Park when invoked in other cases to support a short onset comparable to what Ms. Beckwith

experienced. See, e.g., Flowers v. Sec'y of Health & Hum. Servs., No. 20-285V, 2024 WL 2828211

(Fed. Cl. Spec. Mstr. May 8, 2024), at *13, mot. for review den’d, 173 Fed. Cl. 613 (2024); Block

v. Sec’y of Health & Hum. Servs., No. 19-969V, 2021 WL 2182730 (Fed. Cl. Spec. Mstr. Apr. 26,

2021), at *5, 8–9. Relying on Park to prove the third Althen prong is little different from contending

that Vaccine Program damages decisions (particularly cases in which a short onset of GBS post-

vaccination occurred) substantiate the medical acceptability of the onset timeframe at issue. 17

why would a procedure performed hours prior to onset also not be potentially causal? (Admittedly, Petitioner has

specifically contested the latter speculation on my part; I reference it only to illustrate that the facts of this case provide

more alternative explanations for Petitioner’s GBS than they support the flu vaccine as causal).

Petitioners often attempt to do just that—offering in their briefing lengthy lists of cases in which compensation was

17

awarded in comparable cases as proof that they are entitled to compensation. See, e.g., Howard v. Sec’y of Heath &

Hum. Servs., No. 16-1592V, 2022 WL 4869354 (Fed. Cl. Spec. Mstr. Aug. 31, 2022), at *22–23, mot. for review

24

Other items are similarly distinguishable, or of limited probative value. Articles like

Polakowski and Vilar-Perez all rely on passive surveillance data (and thus are not robust evidence

of the degree of actual risk), and do not propose to evaluate the relative risk of vaccine-caused

GBS over timeframes comparable to this matter (say, two days versus a week), but instead merely

consider larger timeframes parallel to the flu vaccine-GBS Table period of 3–42 days. Moreover,

they either find no greater risk from vaccination, or limit their findings of risk to specific infectious

seasons and/or vaccine formulations then in use. All that I have been provided of Kazi is a

summary abstract, making it difficult to assess its actual findings—and while it seems to identify

a greater risk of the GBS variant at issue within the same timeframe applicable to a Table claim

(and arguably a meaningful risk within even two weeks of vaccination), it does not stand for the

proposition that onset within a day or two of vaccination is as likely as within a week or more.

Dr. Akbari’s science-heavy opinion proved no more persuasive on the disputed timeframe

question. To start, it reflects the same kind of overarching, generalized view that I have rejected

when encountering his expert opinions in other cases. See generally Efron v. Sec'y of Health &

Hum. Servs., No. 20-1405V, 2025 WL 408219, at *22 (Fed. Cl. Spec. Mstr. Jan. 2, 2025); Ampofo-

Addo v. Sec’y of Health & Hum. Servs., No. 21-1231V, 2025 WL 2463643 (Fed. Cl. Spec. Mstr.

July 31, 2025). In effect, Dr. Akbari offers a large-scale overview of the entirety of the immune

response, soup to nuts, proposing within it numerous points when vaccines could have a negative

impact. While this description may be biologically correct and/or supported by reliable

independent evidence in many respects, it founders in implicating vaccination as an “x factor”

leading to injury, and does not identify with enough reliable specific evidence where and how this

occurs. And it repeatedly speculates about certain aspects of the immune response that have not

been evaluated enough to deem those aspects of his opinion reliable.

Dr. Akbari’s specific arguments were also inadequately bulwarked with sufficient reliable

evidence. While he clearly offered numerous literature citations, and provided an explanation

about how different aspects of the immune response work (or are speculated to work in some faster

contexts—such as with ILLs), his opinion amounted to the contention that it was plausible that

GBS could be triggered in a shorter time than commonly understood. This is not equivalent to

evidence that GBS likely occurs in a day or two of vaccination—and the sheer amount of literature

he filed in connection with his reports does not constitute a preponderant showing on the timeframe

question. It simply remains more likely than not that it takes more than two days for flu vaccine-

caused GBS to produce autoantibodies sufficient to result in manifestation of outward, clinically-

observable symptoms.

Otherwise, Dr. Akbari mistakenly assumed the onset timeframe element of a Table flu

vaccine-GBS claim reflects legalistic presumptions of the special masters, when instead its terms

den’d, 2023 WL 4117370 (Fed. Cl. May 18, 2023), aff’d, 2024 WL 2873301 (Fed. Cir. June 7, 2024) (unpublished).

But only reasoned Program determinations—decisions explaining why a particular outcome was supported by the

evidence—have guidance value. Howard, 2022 WL 4869354, at *23. Determinations to settle claims say nothing at

all about the merits of the causation theory presented.

25

are the product of Respondent’s evaluation of the science. National Vaccine Injury Compensation

Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132-01 at 45144–45146 (July 29,

2015). That medical science suggests that it is unlikely, absent factors specific to a given claimant,

that vaccine-caused GBS will occur sooner than three days post-vaccination (since the

presumption of causation subsequently evaporates under such factual circumstances). And no

special factors have been proven that would explain why Petitioner in this case experienced a faster

onset. The circular logic that because the Petitioner’s onset did occur in short timeframe, some

unknown genetic or personal immunologic propensity exists that “explains” vaccine causation, is

nothing more than the kind of post hoc ergo propter hoc reasoning rejected by the Vaccine

Program.

Petitioner’s experts have unquestionably vouched for the medical acceptability of a one to

two-day onset of GBS post-vaccination, but I am not bound by their ipse dixit. I found the counter-

opinions of Drs. Kang and Hawse far more persuasive. Respondent’s experts relied on what is

known about GBS and its autoantibody propagation, and the fact (consistent with the Table

timeframe) that in most cases GBS will more likely than not take a few days to manifest clinically

after an environmental trigger (whether infection or vaccination), given the time it takes for the

body to manufacture the pathogenic, cross-reactive antibodies. Petitioner has otherwise not shown

than her personal health or other circumstances made a fast onset likely.

CONCLUSION

Vaccine Act claimants must carry their burden of proof to be entitled to damages. Because

Petitioner cannot show by preponderant evidence that her GBS began in a medically-acceptable

timeframe, I deny entitlement.

In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the

Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision. 18

IT IS SO ORDERED

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

18

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices

renouncing their right to seek review.

26