VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00596
Package ID: USCOURTS-cofc-1_20-vv-00596
Petitioner: James Harvey, M.D.
Filed: 2020-05-13
Decided: 2025-09-16
Vaccine: influenza
Vaccination date: 2017-10-06
Condition: leukocytoclastic vasculitis and post-vaccine polyneuritis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Dr. James Harvey, a 76-year-old retired surgeon, filed a petition for compensation under the National Vaccine Injury Compensation Program on May 13, 2020. He alleged that an influenza vaccine administered on October 6, 2017, caused him to develop leukocytoclastic vasculitis (IgAV) and subsequently polyneuritis. Dr. Harvey had pre-existing conditions including asthma and diabetes. He reported experiencing a rash on his legs within hours of the vaccination. Six days later, on October 12, 2017, he was diagnosed with IgAV by a dermatologist, Dr. Kari Boucher, and was prescribed topical cream and prednisone. The rash persisted, and a subsequent biopsy confirmed IgAV. Dr. Harvey's IgAV symptoms subsided within a few weeks. Later, he experienced neuropathy. Dr. Harvey argued that the flu vaccine caused his IgAV, which in turn caused his neuropathy. The Secretary of Health and Human Services disputed Dr. Harvey's claim. Both parties submitted expert reports and legal arguments. Special Master Christian J. Moran issued a published decision on March 18, 2025, denying Dr. Harvey's petition. The Special Master found that Dr. Harvey failed to prove by a preponderance of the evidence that the flu vaccine was the cause-in-fact of his IgAV, specifically failing to meet the requirements of the Althen test. The Special Master found Dr. Harvey's medical theory connecting the vaccine to IgAV to be unpersuasive and lacking in detail, particularly regarding the role of cytokines, complement, and immune complexes in relation to defective IgA. Furthermore, the Special Master determined that the temporal relationship between the vaccination and the onset of IgAV was not within the medically acceptable timeframe, citing expert opinions that suggested a minimum of three days for IgAV onset following an exposure, whereas Dr. Harvey's symptoms appeared within 24 hours. The Special Master also found that the logical sequence of cause and effect was not established, partly due to the weaknesses in the other two prongs of the Althen test and the reliance on Dr. Harvey's own reports of vaccine association rather than independent physician opinions. The Special Master did not reach the issue of severity, as entitlement was not established. Dr. Harvey petitioned for review of the Special Master's decision. On October 6, 2025, Chief Judge Matthew H. Solomson of the U.S. Court of Federal Claims issued an opinion affirming the Special Master's decision. The Court found that the Special Master's analysis of the second Althen prong (logical sequence of cause and effect) was not arbitrary or capricious, noting that the Special Master carefully considered the views of treating physicians and provided a reasoned basis for weighing conflicting opinions, particularly favoring the opinion of immunologist Dr. David Lang over that of Dr. Rebecca Kuenzler regarding the timing of vaccine reactions. While the Court noted that the Special Master's reasoning for the first and third Althen prongs was less developed and potentially conclusory, it found that the strong reasoning for the second prong was sufficient to affirm the denial of compensation. The Court agreed that Dr. Harvey did not meet his burden to prove by a preponderance of the evidence that the flu vaccine was the cause-in-fact of his IgAV. Therefore, Dr. Harvey's petition for compensation was denied.

Theory of causation field:
Influenza vaccine on October 6, 2017, age 76, alleged to cause leukocytoclastic vasculitis and post-vaccine polyneuritis. DENIED. Petitioner James Harvey, M.D., advanced an off-Table theory tying flu vaccine immune activation to vasculitis and neuropathic symptoms. Respondent disputed causation, medical theory, and logical sequence. Special Master Gowen denied entitlement on March 18, 2025; Judge Stephen S. Schwartz affirmed in a public review opinion filed September 16, 2025. No injury compensation awarded.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-00596-1
Date issued/filed: 2025-04-14
Pages: 30
Docket text: PUBLIC DECISION (Originally filed: 03/18/2025) regarding 126 DECISION of Special Master. Signed by Special Master Christian J. Moran. (jjb) Service on parties made.
--------------------------------------------------------------------------------
Case 1:20-vv-00596-MHS Document 127 Filed 04/14/25 Page 1 of 30
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
JAMES HARVEY, M.D., *
* No. 20-596V
* Special Master Christian J. Moran
Petitioner, *
v. *
* Filed: March 18, 2025
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Jessica A. Wallace, Siri & Glimstad LLP, Aventura, FL, for Petitioner;
Ryan D. Pyles, United States Dep’t of Justice, Washington, D.C., for Respondent.
PUBLISHED DECISION DENYING COMPENSATION1
James Harvey alleges that an influenza (“flu”) vaccine caused him to suffer
leukocytoclastic vasculitis and post-vaccine polyneuritis. Pet., filed May 13, 2020.
The Secretary disputes Dr. Harvey’s entitlement to compensation. Both parties
have supported their positions with reports from expert witnesses and argued
through memorandum.
A review of the evidence and arguments shows that Dr. Harvey is not
entitled to compensation. This denial of entitlement is based upon a failure to
establish with preponderant evidence that the flu vaccine caused the vasculitis.
1 Because this decision contains a reasoned explanation for the action taken in this case, it
must be made publicly accessible and will be posted on the United States Court of Federal
Claims’ website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal
Management and Promotion of Electronic Government Services). This means the decision will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. Any changes will appear in the
document posted on the website.

Case 1:20-vv-00596-MHS Document 127 Filed 04/14/25 Page 2 of 30
Another challenging issue, which is not resolved, is whether the vasculitis caused a
polyneuropathy. The reasoning is set forth below.
I. Facts
A. Before Vaccination
Dr. Harvey was born in 1941. He had worked as a cardiothoracic surgeon
but had retired from practicing medicine before he received the allegedly causal flu
vaccination. Exhibit 1 (aff.) ¶ 4.
Decades before the vaccination, Dr. Harvey developed asthma. Exhibit 15
at 50 (Sep. 5, 2017 record stating that Dr. Harvey “had onset of his asthma when
he was 36 years old”); Exhibit 13 at 389 (Sep. 17, 2019 record stating that Dr.
Harvey “developed asthma 42 years ago”). Asthma is a recurring problem for Dr.
Harvey.
Around the age of 64 years old (or approximately 2005), Dr. Harvey was
diagnosed with diabetes. Exhibit 21 at 14-16 (July 7, 2015). In a July 7, 2015
appointment with an endocrinologist, Dr. Harvey denied numbness and tingling in
his feet. Id. In the next two years before the vaccination, Dr. Harvey had annual
appointments with his endocrinologist. Id. at 10-13 (Mar. 18, 2016) and 6 (Mar.
29, 2017).
In 2016, Dr. Harvey had a shunt placed to treat normal pressure
hydrocephalus (“NPH”). Exhibit 8 at 36. “Hydrocephalus” is “a condition marked
by dilation of the cerebral ventricles, most often occurring secondary to obstruction
of the cerebrospinal pathways . . . and accompanied by accumulation of
cerebrospinal fluid within the skull.” Dorland’s Illus. Med. Dictionary 867.
“Normal pressure hydrocephalus” often presents as “dementia, ataxia, and urinary
incontinence with hydrocephalus . . . occurring in middle-aged and older persons.
The cerebrospinal and spinal fluid pressures are at the upper end of normal, but
with excess spinal fluid volume, that pressure is actually abnormally high.” Id. At
the time of this examination (June 16, 2016), Dr. Harvey complained about
unsteady gait, forgetfulness, and urinary urgency/frequency. Exhibit 8 at 36. The
doctor noted that over the past year severe asthma attacks required Dr. Harvey to
take high dose steroids. Id.
In the months before the vaccination, Dr. Harvey’s asthma was worse than
normal. Exhibit 15 at 50 (Sep. 5, 2017). Dr. Harvey reported that although he had
required corticosteroids in the spring and fall, he had been off prednisone for six or
seven weeks. Id. A pulmonologist at Washington University in St. Louis, Mario
2

Case 1:20-vv-00596-MHS Document 127 Filed 04/14/25 Page 3 of 30
Castro, anticipated that Dr. Harvey would undergo a bronchial thermoplasty. Id.
A bronchial thermoplasty is “a procedure healthcare providers use to treat severe
asthma. A provider applies heat to the smooth muscles around [the] lungs to
shrink them.” CLEVELAND CLINIC, Bronchial Thermoplasty,
https://my.clevelandclinic.org/health/treatments/16811-bronchial-thermoplasty
(last visited March 3, 2025). In the three days leading to the bronchial
thermoplasty, Dr. Harvey was supposed to take 50 mg of prednisone and then taper
the prednisone. Exhibit 15 at 52.
A bronchial thermoplasty was performed on September 19, 2017. Exhibit
15 at 30-31. The taper of prednisone was finished on October 4, 2017. Exhibit 5
at 4.
B. Vaccination and Ensuing Six Months
Dr. Harvey received the allegedly causal flu vaccine on October 6, 2017.
Exhibit 3 at 25, 39. The pharmacy where Dr. Harvey received the flu vaccine was
in Delaware, near where he lived. Exhibit 1 (aff.) ¶ 6; Pet’r’s Br. at 41. Dr.
Harvey averred that “[w]ithin several hours after receiving the vaccine, [he]
developed a rash all over [his] legs and [he] began to feel down so [he] went to bed
and rested.” Exhibit 1 (aff.) ¶ 8.
Dr. Harvey’s testimony about the rapid onset of symptoms is consistent with
a contemporaneously created medical record. Dr. Harvey saw a dermatologist,
Kari Boucher, on October 12, 2017, which was six days after the vaccination.
Exhibit 5 at 4. Dr. Boucher memorialized a complaint from Dr. Harvey in which
Dr. Harvey stated that he had a painful, red, and burning rash for five days.
Exhibit 5 at 4. Dr. Boucher diagnosed Dr. Harvey with leukocytoclastic vasculitis.
Id. She prescribed a topical cream and prednisone. Id.
Leukocytoclastic Vasculitis
At a simple level, “vasculitis” means “inflammation of a blood or lymph
vessel.” Dorland’s at 1996. In this context, “leukocytoclastic vasculitis” is also
known as “hypersensitivity” vasculitis. Id. One type of hypersensitivity vasculitis
is known as Henoch-Schönlein purpura. Dorland’s at 1533; see also id. at 1996
3

Case 1:20-vv-00596-MHS Document 127 Filed 04/14/25 Page 4 of 30
(under “hypersensitivity vasculitis”); Exhibit 19, tab D (Meiller) at 273;2 Exhibit
19 at 6-7; Exhibit A at 2.
At a mechanistic level, Henoch-Schönlein purpura is mediated by a
component of the adaptive immune system known as immunoglobulin A (usually
abbreviated “IgA”).3 Exhibit 19, tab D (Meiller) at 274. Thus, Henoch-Schönlein
purpura is sometimes known as “IgA vasculitis.” People suffering from Henoch-
Schönlein purpura create abnormal IgA. Exhibit A, tab 1 (Oni) at 4.4
After the rash and pain persisted, Dr. Harvey sought a review by a second
dermatologist, Amy C. Musiek. Exhibit 6 at 10. In conjunction with undergoing a
punch biopsy, Dr. Harvey reported that he “received the flu shot on October 6th
and then experienced the rash on October 7th.” Exhibit 15 at 42 (report dated
October 17, 2017). The dermatopathology report from the punch biopsy showed
IgA, C3, and fibrinogen depositions “with blood vessel walls in the superficial
dermis.”5 Exhibit 15 at 24. Prednisone was continued “at 50mg daily until [Dr.
Harvey’s] paths/labs return.” Exhibit 15 at 43.
Dr. Harvey was hospitalized for a bronchial thermoplasty on October 18,
2017 at Barnes-Jewish Hospital in St. Louis. Exhibit 7 at 315; see also id. at 340
(discharge summary). In this context, an internist, David Pham, memorialized that
Dr. Harvey stated his vasculitis was “triggered [secondary to] flu shot, however
was only off prednisone for 2 days which appears atypical.” Id. at 354. By
discharge, Dr. Harvey reported that his “rash improved dramatically with
corticosteroids and only persist[ed] in his lower extremities. Id. at 340. Through
2 María José López Meiller et al., Henoch-Schönlein Purpura in adults, 63 CLINICS 273
(2008); filed as Exhibit 19, tab D.
3 “Immunoglobulins” “function as antibodies [and are] divided into five classes.”
Dorland’s at 908; accord Exhibit 19, tab B (Duarte) at 1. “IgA” contains two subtypes, known as
“IgA1” and “IgA2”. See Dorland’s at 908.
4 Louise Oni & Sunil Sampath, Childhood IgA Vasculitis (Henoch Schonlein Purpura) –
Advances and Knowledge Gaps, 7 FRONTIERS IN PEDIATRICS 4 (2019); filed as Exhibit A, tab 1.
5 In this context, “C3” refers to a type of complement. Complement refers to the process
by which the body destroys cells to which antibodies are attached. See Dorland’s at 387-89.
“Fibrinogen” is a substance that assists with coagulation. Dorland’s at 667 (under coagulation
factor I).
4

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his attorney of record, Dr. Harvey states that his “itchy, red, and burning purpuric
rash . . . subsided after a few weeks.” Pet’r’s Br., filed Apr. 6, 2024, at 54.6
Via telephone, Dr. Harvey and his wife consulted an internist at the
Cleveland Clinic, Stephen Hayden, M.D. on October 26, 2017. Exhibit 2 at 46. In
addition to noting that the punch biopsy showed IgA vasculitis, Dr. Hayden
memorialized a series of other problems: “Muscle weakness is a major problem.
He has had falls. Has NPH [normal pressure hydrocephalus]. He has not had his
shunt checked in a while. May also have neuropathy, steroid induced myopathy
etc. He says his renal function is getting worse. Anion gap. Glucose poorly
controlled.” Id.
A similar list of issues appeared in the October 31, 2017 record that Dr.
Hayden generated after an in-person visit at the Cleveland Clinic in Ohio. Exhibit
2 at 50. Dr. Hayden’s impressions included severe persistent asthma, IgA
mediated leukocytoclastic vasculitis, uncontrolled type 2 diabetes, and generalized
muscle weakness. Id. at 53. Dr. Hayden ordered a CT scan to check Dr. Harvey’s
normal pressure hydrocephalus. This CT scan showed that there was “no
significant change since 06/06/2016.” Exhibit 2 at 60 (Nov. 1, 2017).
For a check of his diabetes, Dr. Harvey saw an endocrinologist in the
Cleveland Clinic, Susan Williams, on November 1, 2017. Exhibit 2 at 68-80. A
review of systems included: “FEET: painful with neuropathy” and “NERVOUS
SYSTEM: feet are affected.” Id. at 69. Dr. Williams conducted a physical exam.
She inspected Dr. Harvey’s feet and he had “normal distal pulses.” Id. at 74. His
gait was “flat-footed and awkward [though] stable.” Id. She assessed Dr. Harvey
as having “Uncontrolled type 2 diabetes mellitus with complication, with long-
term current use of insulin.” Dr. Williams added that Dr. Harvey’s blood sugar
widely fluctuated “due to corticosteroids.” Id. Dr. Harvey maintains that Dr.
Williams did not diagnose him with diabetic neuropathy. See Pet’r’s Br. at 46.
Dr. Harvey had a follow up appointment with Dr. Hayden on November 2,
2017. Exhibit 2 at 86-88. Dr. Hayden directed Dr. Harvey to “[c]ontinue
prednisone taper. If muscle weakness improves, he may not need further
evaluation for that. If it does not improve, I [Dr. Hayden] recommend
Neurology/Neuromuscular evaluation with EMG.” Id. at 86-87. Dr. Hayden
6 Due to the resolution of the vasculitis within six months of the vaccination, Dr. Harvey
can fulfill the Vaccine Act’s severity requirement only if the vasculitis caused a neuropathy. See
Pet’r’s Br. at 20; Resp’t’s Br. at 33. The severity issue is discussed, but not resolved, in section
V below.
5

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memorialized that Dr. Harvey “would like to postpone further thermoplasty
procedures until diabetes is controlled. He has [to] take three days of prednisone 50
mg daily before the procedure, and has increased symptoms [from] the secretions
after the procedure, requiring high dose prednisone." Id. at 88.
After this appointment, there appears to be a three-month gap in in-person
medical appointments. However, between early November 2017 and early
February 2018, Dr. Harvey frequently communicated with doctors via patient
portals.
Using the patient portal, Dr. Harvey informed Dr. Hayden that he
“remain[ed] very weak” on November 8, 2017. Exhibit 2 at 96. Dr. Harvey was
concerned that he was experiencing a steroid myopathy. Accordingly, Dr. Hayden
advised that Dr. Harvey could stop prednisone. Id. at 87. A few days later, Dr.
Harvey stated that he was improved. Id. at 103 (Nov. 12, 2017). However, ankle
and foot pain prompted Dr. Harvey to cancel a third bronchial thermoplasty, which
had been scheduled for November 14, 2017. Exhibit 15 at 40.
By November 24, 2017, Dr. Harvey was still feeling weak and was having
trouble walking. Thus, he attempted to schedule an appointment with a neurologist
whom he had seen at the Cleveland Clinic, Joseph Rudolph, M.D. Exhibit 2 at
116. Due to the need to arrange to travel for this appointment, Dr. Harvey
proposed an appointment in February 2018. However, Dr. Rudolph was not
available. Id.; see also Exhibit 25 (Dr. Rudolph’s affidavit) ¶ 9.
About one week later, Dr. Harvey repeated his attempt to schedule an
appointment with Dr. Rudolph for “neuro evaluation, plus myopathy.” Exhibit 2 at
124 (Dec. 1, 2017). Yet, Dr. Rudolph remained unavailable. Dr. Harvey made a
third attempt but was not successful. Id. at 135 (Dec. 11, 2017).
Finally, Dr. Harvey requested an appointment with another neurologist with
expertise in movement disorders. Exhibit 2 at 137 (Dec. 14, 2017). Dr. Harvey
eventually saw Dr. Ilia Itin. See Exhibit 1 (aff.); Exhibit 2 at 174.
Before Dr. Harvey got to see Dr. Itin, Dr. Harvey communicated with his
primary care physician, Dr. Hayden, through the patient portal and raised the
possibility of an adverse reaction to the vaccine. Dr. Harvey wrote: “Might it be a
good idea for me to see somebody expert in vaccines? I find it difficult to attribute
this problem to prednisone, which I have endured for 40 years, often in higher and
lengthy doses? Would m[y] feather sensitivity have cross-over problems with egg
vaccines, etc?" Exhibit 2 at 169 (Feb. 8, 2018). Similarly, Dr. Harvey also asked:
6

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“my myopathy in temporal relationship to flu vaccine induced IgA vasculitis…I
have lost strength, balance, stamina… Is this a vaccine reaction complex?" Id. at
169 (Feb. 13, 2018).
Dr. Hayden suggested that Dr. Harvey see a doctor in “Neuromuscular
Medicine (Neurology) to assess the cause of the muscle weakness.” Exhibit 2 at
168. In this context, Dr. Hayden mentioned that he was uncertain whether the
weakness was induced by steroids and that Dr. Harvey “questions flu vaccine.” Id.
Dr. Harvey returned to his pulmonologist, Dr. Castro, on February 5, 2018.
The note from this record states that although Dr. Harvey had been scheduled for a
third thermoplasty on November 14, 2017, Dr. Harvey canceled the procedure due
to ankle and foot pain. Exhibit 15 at 40.
On February 20, 2018, Dr. Harvey went to the Cleveland Clinic for his
appointment with the neurologist, Ilia Itin. Dr. Itin’s note is relatively detailed.
With respect to events around the vaccination, Dr. Itin wrote:
Over time, on 10/5/2017 [sic] he had a flu shot. He was
weaning off oral steroids (he is asthmatic) when he broke
out in rash following flu shot. He was diagnosed with
IGA vasculitis which was treated with steroids. The
patient feels that his gait deteriorated from that point
on[.] [He] was on steroids until 11/2017[;] glucose was
elevated[.]"
Exhibit 2 at 174. With respect to more current problems, Dr. Itin stated:
He has trouble getting out of bed; standing up from the
toilet (proximal muscle weakness). The patient has no
stamina, he gives out and needs to rest. He is using
wheelchair more. He is [cautious] but he never fell. The
patient admits memory problems. . . . He admits
increased frequency of urination. The shunt was not
adjusted for past three years.
Id. at 175. Dr. Itin recommended physical therapy and prescribed a medication for
depression, escitalopram. Id. at 178.7
7 Dr. Itin also anticipated that “Dr. Nagel” would assess Dr. Harvey. However, the role
of Dr. Nagel is not readily apparent.
7

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An appointment with a physical therapist, Randy Karim, happened on
February 20, 2018. Exhibit 2 at 190-91. Dr. Harvey was described as having
decreased strength in his hips, decreased range of motion, decreased flexibility,
decreased balance, and problems in coordination. Id.
The next day, Dr. Harvey saw his endocrinologist, Dr. Williams. Exhibit 2
at 232 (Feb. 21, 2018). In the context of the history of present illness, Dr.
Williams wrote a complication was “peripheral neuropathy.” Id. The review of
systems stated: “FEET painful with neuropathy” and “NERVOUS SYSTEM: feet
are affected.” Id. at 233. On physical exam, Dr. Williams found “proximal
weakness persists.” Id. at 238. Dr. Harvey had a rash on his feet. Dr. Harvey’s
gait was flat-footed and awkward but stable. Id. at 74, 238. Dr. Harvey again
asserts that Dr. Williams did not diagnose him with a neuropathy. Pet’r’s Br. at 49.
For follow up of his normal pressure hydrocephalus and check of his shunt,
Dr. Harvey went to the University of Pennsylvania where he was seen by Dr.
Lucas on March 29, 2018. Exhibit 8 at 41-46. Dr. Lucas memorialized a
complaint that Dr. Harvey has “had a rocky year with myalgia, [and] reactions to
vaccines.” Exhibit 8 at 46. With respect to the shunt, Dr. Lucas examined it and
recommended Dr. Harvey return in one year. Id.
C. Remainder of 2018 and 2019
Dr. Harvey informed Dr. Hayden about a communication with Dr. Harvey’s
previous neurologist, Erwin Montgomery, M.D. Dr. Harvey recounted that Dr.
Montgomery
advised that I should see a neuromuscular neurologist
rather than a movement disorders one. Certainly, the guy
I saw last time was no help…doing what docs do when
they can’t help…make the patient a head case. I am NOT
depressed nor anxious, and if I were, I’d not hesitate to
seek help.
Exhibit 2 at 351 (July 3, 2018).
As to the anti-depressant medication, Dr. Harvey disagreed with this diagnosis and did
not fill the prescription. Exhibit 1 (aff.) ¶¶ 20-21; see also Exhibit 2 at 249 (Feb. 22, 2018 email
to Dr. Hayden in which Dr. Harvey wrote that he did not need “psych drugs”).
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A few days later, Dr. Harvey inquired through the patient portal about,
among other points, getting the shingles vaccine. Exhibit 2 at 358 (July 7, 2018).
Dr. Hayden’s response involved the flu vaccine:
I don’t think you should get egg based flu vaccine if that
is what caused the previous reaction.
Whether you can or should receive a different flu vaccine
is unclear to me. As the efficacy of flu vaccines is not
exactly stellar, the risk benefit ratio suggests to me that
maybe it is best to avoid them.
Shingrix is recombinant so there is no reason to suppose
it will cause a reaction.
Id. at 360.
Dr. Hayden expressed a similar concern about the flu vaccine after Dr.
Harvey inquired about getting a prescription for Tamiflu. In prescribing the
medication, Dr. Hayden stated: “[p]atient [is] unable to have influenza vaccine
because of prior severe reaction.” Id. at 387.
Dr. Harvey continued to press a question about the flu vaccine. He emailed
Dr. Hayden on October 5, 2018, writing:
I remain dissatisfied re[garding] my understanding of the
myopathy (or neuromuscular symptoms) temporally
related to my flu shot of October 5, 2017 [sic, actually
October 6, 2017]. I doubt the hypothesis of prednisone
related [because] neither dose nor duration were nearly as
high as in many intervals of my 41 year history. . . . Is
there anybody who can address my concern?
Exhibit 2 at 404. Dr. Hayden answered that he had reviewed case reports in
PubMed and stated that it is “plausible that something like myopathy could occur.”
Exhibit 2 at 403.
Based upon a referral from Dr. Hayden (Exhibit 2 at 416), Dr. Harvey
started physical therapy on November 14, 2018. Exhibit 9 at 3. The assessment
was “deconditioning after vasculitis/renal failure.”
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On February 13, 2019, Dr. Harvey sent a communication to Dr. Hayden
through the patient portal and again stated:
I am not satisfied with explanation (or non-explanation)
of my myoneural symptoms arising subsequent to flu
shot 10/5/17 [sic]. I remain lacking strength, stamina,
balance though I have been off prednisone almost a full
year. I am better than last year when you had to wheel
me around, but quite severely impaired compared to
10/4/17. I hope somebody can clarify what has happened
and what to [expect].
Exhibit 10 at 51. Dr. Harvey reiterated this belief that “my severe myopathy is flu
shot related,” and requested a recommendation for a specialist, such as a clinical
immunologist, who might help identify this issue. Id. at 57 (Feb. 25, 2019). Dr.
Hayden stated that he did not know how to prove whether the flu shot caused the
problem. Id. at 58.
On March 4, 2019, Dr. Harvey returned to the neurologist whom he had
previously seen, Dr. Rudolph. This history section reports that Dr. Harvey “cannot
walk very far. He has trouble getting up. This seems to have changed immediately
after receiving a flu shot – he seems to have developed a myopathy.” Exhibit 10 at
61-63. Dr. Rudolph advised that Dr. Harvey’s shunt for normal pressure
hydrocephalus should be evaluated. Dr. Rudolph also wrote that Dr. Harvey
“should be evaluated for post-inflammatory neuropathy or myopathy – this can
start with [an] EMG.” Id. at 63.
On the same day as the appointment with Dr. Rudolph, Dr. Harvey saw his
endocrinologist, Dr. Williams. She wrote that Dr. Harvey “[p]resents in annual
follow up for well controlled T2DM [type two diabetes mellitus] Off Steroids. Still
frustrated with neuro issues since his flu injection of 2017 with IgA vasculitis --
myopathy/neuropathy.” Exhibit 10 at 72. Dr. Williams listed “peripheral
neuropathy” as a “complication.” Id. at 72. Her assessment included “controlled
type 2 diabetes with complication.” Id. at 79.
The EMG, which Dr. Rudolph ordered, took place on April 15, 2019. The
results were:
1. A generalized sensorimotor polyneuropathy, which is
predominantly axonal in type, and mild to moderate in
10

Case 1:20-vv-00596-MHS Document 127 Filed 04/14/25 Page 11 of 30
degree electrically. There is no evidence of a
demyelinating polyneuropathy.
2. A right ulnar neuropathy, affecting predominantly the
sensory fibers, likely moderate in degree electrically.
3. There is no evidence of a generalized myopathy.
Exhibit 2 at 33.
With the EMG completed, Dr. Harvey saw two specialists in neuromuscular
disorders at the Cleveland Clinic, Monica Scarsella and Rebecca Kuenzler.
Exhibit 10 at 158-76. Part of this note recounts Dr. Harvey’s more remote history,
starting with the flu vaccination:
On Oct 5, 2017 [sic] patient got a [] flu shot. This was
followed by a rash on his bilateral lower extremities up to
his mid shins, as well as severe malaise causing him to be
bedbound for days though he denies signs/symptoms of
infection that he can recall. A skin biopsy showed IgA
vasculitis.
It is unclear when generalized weakness truly began but
thinks was sometime in close proximity to flu shot and
does not appear to be sudden onset or focal. He now
shows dogs as a hobby and used to be able to walk dogs
for long distances. Now can only walk few blocks and
very slowly.
Id. at 158.
Doctors Scarsella and Kuenzler memorialized Dr. Harvey’s current
problems:
He endorses the need to look at his feet while walking,
impaired balance, issues with fine motor movements
(picking up papers, buttoning his shirt,) memory
impairment although only retrieval which he attributes to
NPH.
Gets PT 3x/wk although hasn't improved in months.
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No sensory changes, pain, vision, dysphagia,
fasciculations, family history of similar problems,
myoclonus, triggers, clasp, SOB, CP, palpitations.
Id.
Dr. Scarsella stated that the “EMG today [is] notable for generalized
sensorimotor polyneuropathy, as well as right ulnar sensory neuropathy.” Id. at
166. She added that the “Time course for patient’s symptoms fits in correlation
with a post-vaccination polyneuropathy. There are rare reports of vasculitis
occurring after vaccination. Additionally, polyneuropathy can occur in correlation
with IgA vasculitis, although this is also rare.” Id. at 166. Dr. Kuenzler provided a
slightly different take. She wrote that the “time course [was] most compatible with
post-vaccine autoimmune response causing IgA-related changes in skin and
neuropathy.” Id. at 167.
The next day, Dr. Harvey saw another specialist in the Cleveland Clinic.
Exhibit 10 at 180-91 (Apr. 16, 2019). This time, the specialty was rheumatology.
The rheumatologist, Alexandra Villa Forte, M.D., obtained a history that is more or
less consistent with the above, including a notation that “Yesterday during
neurology appointment he was noted to have sensory changes. EMG consistent
with sensorimotor polyneuropathy.” Id. at 180.
Dr. Villa Forte’s assessment linked Dr. Harvey’s problems to the flu
vaccine. She wrote:
Although polyneuropathy can be seen in association with
IgA-vasculitis it is extremely rare and it is much more
likely that he had the neuropathy as a reaction to the flu
vaccine and not as part of a systemic vasculitic
syndrome.
The rash has not recurred and he has no other symptoms
or signs to suggest chronic or relapsing IgA vasculitis -
making it even more suggestive of a vaccine induced
reaction.
Id. at 184.
Dr. Villa Forte made several recommendations. She advised that
immunosuppressive therapy was not appropriate at this time and that before getting
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vaccines, Dr. Harvey should consider getting guidance from an allergist /
immunologist.
Via his patient portals, Dr. Harvey informed Dr. Hayden and Dr. Kuenzler
that he planned to contact an attorney about a potential vaccine injury. Id. at 200-
03 (Apr. 22, 2019). Similarly, on May 14, 2019, Dr. Harvey requested that his
neurologist, Dr. Rudolph, clarify the statement from Dr. Itin and state that Dr. Itin
reached an improper diagnosis. Id. at 216.
Dr. Rudolph responded, in part: “Both the Neuromuscular specialist and the
Rheumatologist that you saw here acknowledge the possibility of a vaccine-
induced response. So you have that evidence." Id. at 232. As for Dr. Rudolph’s
own knowledge, Dr. Rudolph told Dr. Harvey “as we have discussed, I don't know
much about vaccine induced anything, and neuropathy as well is not my area of
specialization. So I certainly am not aware of vaccine-induced-neuropathy studies,
sorry.” Exhibit 10 at 228.
Dr. Rudolph electronically signed a letter addressed to Attorney Wallace
regarding Dr. Harvey’s history. Dr. Rudolph wrote:
Dr. Harvey is a gentleman who developed Normal
Pressure Hydrocephalus a few years ago. It came to the
attention of the medical establishment in 2011-2012, and
he had a VP shunt placed in March 2012. This was
moderately successful.
Then, in 2017, after receiving a flu shot, he started to
decline in strength. This began to complicate his ability
to ambulate. On evaluation, it was realized that he has
sensory loss as well. Ultimately, after further evaluation,
it became clear that the new difficulty in walking (and
feeling) was due to a peripheral nerve problem. Electrical
testing supported this idea. He seems to have developed a
neuropathy as a consequence to the receiving the flu shot.
This idea is agreed to by a Neuropathy specialist and by a
Rheumatologist. This has caused a significant change to
his life - he has been unable to walk longer distances
including more than half of a block, and so he had to
move to a more accessible house (all on one story).
Exhibit 17.
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Dr. Harvey consulted an immunologist, David Lang, on September 19, 2019.
Exhibit 13 at 389-90. The purposes included to evaluate an adverse reaction to an
influenza vaccination in October 2017. Id. at 389. Dr. Lang noted that he did not
have the benefit of reviewing all outside records. Nevertheless, Dr. Lang set out a
lengthy history based, in part, on some records and on his interview with Dr.
Harvey. Dr. Lang stated that Dr. Harvey told him that the rash began 8-10 hours
after the vaccination. The remainder of Dr. Lang’s history is generally consistent
with the events described in medical records created contemporaneously with the
events. As part of the plan, Dr. Lang stated, “History furnished today of cutaneous
reaction beginning as early as 8 hours after administration of influenza vaccination
would be unusual for a vasculitic process.” Id. at 395.
Later that day, Dr. Harvey communicated with Dr. Lang via the patient
portal. Dr. Harvey asked whether Dr. Lang has experience in the National Vaccine
Injury Program. Id. at 418. Dr. Lang answered that he did “not have experience
with the National Vaccine Injury Program.” Exhibit 13 at 415. A few weeks later,
Dr. Harvey again inquired whether Dr. Lang knew “anybody to advise me upon flu
shot following polyneuropathy from vaccine reaction?” Id. at 533. A response
from someone apparently in Dr. Lang’s office was “Despite follow up we have not
obtained the records he requested to assist you with this issue.” Id.
D. 2020 and More Recently
Although Dr. Harvey submitted medical records created after 2019, (see
Exhibit 48), the parties did not refer to any of those medical records in their briefs
regarding entitlement. See Pet’r’s Br. at 5 (discussing Dr. Lang’s September 19,
2019 record); Resp’t’s Br. at 14 (discussing emails to and from Dr. Lang in
December 2019).
II. Procedural History
Represented by Attorney Jessica Wallace, Dr. Harvey sought compensation
through the Vaccine Program. Pet., filed Oct. 6, 2017. He periodically submitted
medical records and affidavits.
After reviewing this material, the Secretary argued that compensation was
not appropriate because Dr. Harvey had not established a prima facie case
establishing that his off-Table injuries were caused by the flu vaccine. Resp’t’s
Rep., filed Dec. 16, 2020, at 12-17. The Secretary has also argued the severity
requirement has not been established in this case. Id. at 14.
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To develop his case, Dr. Harvey retained Dr. M. Eric Gershwin and Dr.
Enrique Aradillas to provide expert opinions. Dr. Gershwin’s reports are exhibits
19, 22, 26, 27, and 28. Dr. Aradillas’s report is exhibit 23. In addition, Dr. Harvey
submitted a statement from his treating neurologist, Dr. Rudolph. Exhibit 25.8
To counter that evidence, the Secretary presented reports from Dr. Jonathan
Miner and Dr. Daniel Feinberg. Dr. Miner’s reports are Exhibits A, E, G, and H
and Dr. Feinberg’s reports are Exhibits C and F.
Once the parties completed the submission of reports, they were directed to
argue their cases through memorandum. Order, issued Dec. 21, 2023. As part of
that process, a status conference was held on January 17, 2024, to discuss
confusing aspects of Dr. Harvey’s case.
In due course, Dr. Harvey submitted his primary brief on April 6, 2024 and
his reply on September 4, 2024. In between, the Secretary filed his primary brief
on June 4, 2024 as well as a notice of supplemental authority on June 11, 2024. In
conjunction with these briefs, the parties filed supplemental reports from experts.
With the submission of Dr. Harvey’s reply, the case is ready for
adjudication. The case can be resolved on the papers without receiving oral
testimony. See Kreizenbeck v. Sec'y of Health & Hum. Servs., 945 F.3d 1362,
1365 (Fed. Cir. 2018). Dr. Harvey has enjoyed a full and fair opportunity to
present evidence and argument. See Pet’r’s Status Rep., filed July 3, 2023
(declining to present additional expert reports).
III. Standards for Adjudication
A petitioner is required to establish his case by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact's existence.” Moberly v. Sec’y of
Health & Hum. Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
8 Attorney Wallace spent approximately five hours writing Dr. Rudolph’s affidavit.
Pet’r’s Mot. for Interim Fees, filed July 16, 2022, Exhibit 1 (timesheets) at 22. Ms. Wallace also
spent multiple hours reviewing drafts of expert reports before they were filed.
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Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379-80 (Fed.
Cir. 2009) (reversing special master's decision that petitioners were not entitled to
compensation); see also Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357
(Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs., 9 F.3d 958, 961 (Fed.
Cir. 1993) (disagreeing with dissenting judge's contention that the special master
confused preponderance of the evidence with medical certainty).
The Vaccine Act requires that petitioners establish five elements. 42 U.S.C.
§ 300aa–11(c)(1)(A) through (E). Here, two items are disputed: whether Dr.
Harvey has established that the flu vaccine caused his vasculitis (causation
corresponds to paragraph (C)) and whether Dr. Harvey has established that the
vasculitis and any sequella lasted more than six months (severity corresponds to
paragraph (D)). These two issues are taken up in Section IV (causation) and
Section V (severity) below.
IV. First Issue: Causation
Because the Vaccine Injury Table does not associate the flu vaccine with
vasculitis, Dr. Harvey must pursue a claim that the flu vaccine was the cause-in-
fact of the vasculitis. See Pet’r’s Br. at 12. For causation-in-fact claims, a
petitioner bears a burden “to show by preponderant evidence that the vaccination
brought about [the vaccinee’s] injury by providing: (1) a medical theory causally
connecting the vaccination and the injury; (2) a logical sequence of cause and
effect showing that the vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination and injury.” Althen v.
Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
A. Althen Prong One – Medical Theory
The portion of Dr. Harvey’s brief discussing the medical theory or medical
theories to explain how the flu vaccine can cause vasculitis is not a model of
clarity. See Pet’r’s Br. at 20-26. This is disappointing as Dr. Harvey was given
notice that he needed to clarify his theories. The December 21, 2023 order for
briefs stated that a review of the expert reports suggested that theory or theories Dr.
Harvey was advancing were not explained well. Thus, Dr. Harvey was expected to
discuss at the January 17, 2024 status conference “the theory by which the flu
vaccine injured [Dr.] Harvey.” Order, issued Dec. 21, 2023. Similarly, the
briefing order attempted to impose some structure on the forthcoming briefs by
stating that “If Mr. Harvey chooses to set out different theories by which the flu
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vaccine can cause IgA vasculitis, Mr. Harvey is ordered to identify each theory by
number and devote a separate section of the brief to each theory individually."
Order, issued Dec. 21, 2023, at 5.
Despite these instructions, Dr. Harvey did not separately enumerate the
theory or theories he is advancing to connect the flu vaccine and vasculitis. See
Pet’r’s Br. at 20-26. To be clear, Dr. Harvey is not being penalized for how his
brief is formatted. The problem with Dr. Harvey’s brief is that it mentions
multiple concepts without really explaining why any of them are sound and
reliable. Such an approach is neither advisable nor persuasive. See Baron v. Sec’y
of Health & Human Servs., No. 14-341V, 2019 WL 2273484, at *17 (Fed. Cl.
Spec. Mstr. Mar. 18, 2019) (petitioners “need to propose something more than
taking a vague ‘kitchen sink’ approach and listing eleven mechanisms that have
been previously submitted in the Program for claims of vaccine-caused injury with
various degrees of success. Petitioners have listed many possibilities but have not
identified a sound and reliable explanation that can be applied to the vaccines and
injury in this case”).
A close reading of Dr. Harvey’s brief suggests that Dr. Harvey is advancing
the theory that the flu vaccine caused “abnormal immunological activation,”
possibly involving “cytokines” and the “complement system.” Pet’r’s Br. at 21-22.
Another idea that is mentioned is “immune complex deposition.” Id. at 22.
Neither Dr. Gershwin in his reports nor Dr. Harvey in his briefs have shown
why these theories are sound and reliable in the context of Dr. Harvey’s case. To
start, an assertion that the vaccine caused an “abnormal” activation of the immune
system does not meaningfully advance petitioner’s prong one burden. A premise
to the Vaccine Program is that vaccines are safe for the vast majority of people but
some people for unknown reasons experience an adverse reaction. Any adverse
reaction is “abnormal” in the sense that the normal response to a vaccination is not
adverse. So, an “abnormal immunological activation” does not constitute a
“theory” to satisfy prong one. Hennessey v. Sec’y of Health & Hum. Servs., 91
Fed Cl. 126, 135 (2010) (“Accordingly, one of the special master’s well-founded
concerns with [the expert’s] theory was its vagueness. . . . [The expert’s] theory is
so broad as to be meaningless. . . . Not only was petitioner’s medical theory vague,
it also lacked support. Understandably, it would be difficult for his theory to be
more specific given the paucity of any medical or scientific literature supporting a
link between the [] vaccine and [injury]”).
The other ideas, such as those involving cytokines, complement, and
immune complexes, are potentially valid theories for prong one as abstract
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Case 1:20-vv-00596-MHS Document 127 Filed 04/14/25 Page 18 of 30
propositions. However, Dr. Harvey has failed to connect these theories to what is
known about IgA vasculitis. See Broekelschen v. Sec’y of Health & Hum. Servs.,
618 F.3d 1339, 1345 (Fed. Cir. 2010) (“Because causation is relative to the injury,
a petitioner must provide a reputable medical or scientific explanation that pertains
specifically to the petitioner’s case"). Persuasive evidence shows that IgA
vasculitis is due, in part, to problems creating immunoglobulin A. See Exhibit A,
tab 1 (Oni) at 4. Dr. Harvey has not reliably linked cytokines, complement, and/or
immune complexes to defective IgA. Thus, Dr. Harvey has failed to carry his
burden regarding Althen prong one.
B. Althen Prong Three – Timing
Althen’s third prong requires “a showing of a proximate temporal
relationship between vaccination and injury.” 418 F.3d at 1278. The timing prong
actually contains two parts. A petitioner must show the “timeframe for which it is
medically acceptable to infer causation” and the onset of the disease occurred in
this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed. Cl. 532, 542-43
(2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012),
aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).
The medically acceptable timeframe depends, at least in part, on the theory
being offered. Langland v. Sec’y of Health & Hum. Servs., 109 Fed. Cl. 421, 443
(2013). Any theory that Dr. Harvey could propose is limited by the sequence of
events in that the vasculitis appeared within 24 hours of the flu vaccination. See
Pet’r’s Br. at 51 (acknowledging that “the onset of Dr. Harvey’s symptoms
occurred within twenty-four (24) hours of his Flu Vaccine”).
The rheumatologist whom the Secretary retained, Dr. Miner, persuasively
explained that the medically acceptable timeframe for IgA vasculitis exceeds one
day and is more likely at least three days. Exhibit G at 2.9 Dr. Miner based his
9 Dr. Miner appears to have a greater amount of experience in researching causes of
vasculitis than Dr. Gershwin. See Exhibit A at 1. Recognizing Dr. Miner’s greater amount of
experience is not the same as stating that Dr. Gershwin has no experience in the field. Although
Dr. Gershwin has worked as a rheumatologist for decades and, therefore, treated patients with
vasculitis, Dr. Gershwin’s interest in research appears to be on topics other than vasculitis. A
special master may consider differences in experience when evaluating the relative
persuasiveness of experts. See Depena v. Sec’y of Health & Hum. Servs., No. 13-675V, 2017
WL 1075101 (Fed. Cl. Spec. Mstr. Feb. 22, 2017), mot. for rev. denied, 133 Fed. Cl. 535, 547-48
(2017), aff'd without op., 730 Fed. App'x 938 (Fed. Cir. 2018); Copenhaver v. Sec’y of Health &
Hum. Servs., No. 13-1002V, 2016 WL 3456436 (Fed. Cl. Spec. Mstr. May 31, 2016), mot. for
rev. denied, 129 Fed. Cl. 176 (2016).
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opinion upon observations that that infections occur a few days before IgA
vasculitis. See Exhibit G, tab 3 (Bhimma) at 4 (noting that in at least half the
children with IgA vasculitis an upper respiratory tract infection preceded the onset
of the vasculitis “by 1-3 weeks”);10 Exhibit A, tab 3 (Hwang) at 2 (“HSP is known
to occur 3 to 10 days after a preceding infection”);11 Exhibit E, tab 1 (Fraticelli) at
834 (“Vasculitis tends to occur 7-10 days after exposure to a drug or infectious
trigger”).12 Dr. Miner’s opinion is consistent with the view of one doctor who
treated Dr. Harvey. In 2019, an immunologist, Dr. Lang, stated that a “cutaneous
reaction beginning as early as 8 hours after administration of influenza vaccination
would be unusual for a vasculitic process.” Exhibit 13 at 395. These articles, Dr.
Lang’s statement, and Dr. Miner’s opinion are a reliable basis for finding that the
medically appropriate interval is at least three days after exposure to the triggering
infection or agent.13
By way of contrast, Dr. Gershwin’s opinion that a flu vaccine can cause IgA
vasculitis to occur within one day lacks reliability, is poorly explained, and is not
persuasively supported by any medical or scientific articles. See Exhibit 19 at 5.
Dr. Gershwin appears to assume that before Dr. Harvey received the flu vaccine,
10 Rajendra Bhimma, IgA Vasculitis (Henoch-Schonlein Purpura), Medscape (June 28,
2023), https://emedicine.medscape.com/article/984105-overview?form=fpf; filed as Exhibit G,
tab 3.
11 Hyun Ho Hwang et al., Analysis of seasonal tendencies in pediatric Henöch-Schonlein
purpura and comparison with outbreak of infectious diseases, 97 MEDICINE 2 (2018); filed as
Exhibit A, tab 3.
12 Paolo Fraticelli et al., Diagnosis and management of leukocytoclastic vasculitis, 16
INTERNAL AND EMERGENCY MEDICINE 834 (2021); filed as Exhibit E, tab 1.
13 The Secretary also cites a case in which Dr. Gershwin relied upon an article stating,
“the temporal relationship between a vaccine and a ‘vaccine induced vasculitis is deemed to be
in the range of one to six weeks.’” Resp’t’s Br. at 21, quoting Van Dycke v. Sec’y of Health &
Hum. Servs., No. 18-106V, 2023 WL 4310701, at *16 (Fed. Cl. Spec. Mstr. Jun. 7, 2023). Dr.
Harvey attempts to distinguish that case because Dr. Gershwin made this statement in the context
of a different vasculitis, giant cell arteritis. Pet’r’s Reply at 6.
For the reasons explained in the text, the medical articles about IgA vasculitis provide a
persuasive basis for finding that a medically appropriate interval is at least three days. Thus,
resolving whether Dr. Gershwin is consistent in his opinions appears unnecessary. But see K.A.
v. Sec’y of Health & Hum. Servs., 164 Fed. Cl. 98, 116 (2022) (“Repeat experts who have
testified or submitted expert reports regularly in a particular field have to live with, or explain
away, their previous testimony and their previously filed expert reports"), aff’d without op., 2024
WL 2012526 (Fed. Cir. 2024).
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“IgA was already there.” Id.14 Dr. Gershwin has not justified this assumption. For
these reasons, Dr. Harvey has not met his burden of proof regarding Althen prong
three.15
C. Althen Prong Two – Logical Sequence
Given that Dr. Harvey did not present a persuasive medical theory
explaining how the flu vaccine can cause IgA vasculitis and given that he did not
establish that his vasculitis arose in a time suggestive of causation, it also follows
as a matter of logic that Dr. Harvey has not presented a logical sequence of cause
and effect. See Stricker, 170 Fed. Cl. 701, 721-22 (2024) (“there is no need to
address petitioner’s contention regarding the second Althen prong because it is not
logically possible to prevail if a claim is rejected on the first prong”); Caves v.
Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 145 (2011), aff’d without
opinion, 463 F. App’x 932 (Fed. Cir. 2012). However, this element is discussed
further for sake of completeness.
The remaining Althen prong requires a preponderant presentation of “a
logical sequence of cause and effect showing that the vaccination was the reason
for the injury.” Althen, 418 F.3d at 1278. With respect to this prong, the Federal
Circuit has instructed special masters to consider carefully the views of a treating
doctor. Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326 (Fed.
Cir. 2006).
Here, the bulk of Dr. Harvey’s argument under the prong 2 heading recites a
chronology of some of his medical appointments. See Pet’r’s Br. at 40-44.16 This
presentation is not necessarily wrong. It is just incomplete. As the Secretary
14 Also citing page 5 of Dr. Gershwin’s first report, Dr. Harvey asserts that “the
complement is already fixed to the blood vessel.” Pet’r’s Br. at 52. However, Dr. Gershwin did
not assert here that complement was already present.
15 Furthermore, if Dr. Harvey did have IgA attached to his blood vessels before the
vaccination, then, arguably, he was suffering from IgA vasculitis before the vaccination. In this
situation, Dr. Harvey could not prevail upon a theory that the vaccine caused the IgA vasculitis.
See Locane v. Sec’y of Health & Hum. Servs., 685 F.3d 1375, 1380-81 (Fed. Cir. 2012); Rocha
v. Sec’y of Health & Hum. Servs., No. 16-241V, 2024 WL 752787, at *33 (Fed. Cl. Spec. Mstr.
Feb. 1, 2024) (discussing that onset of a disease can precede detection of a disease and citing
cases).
16 A second portion addresses Dr. Harvey’s diabetes and the opinion of the Secretary’s
expert, Dr. Feinberg, that this pre-existing problem caused any neurologic problem. Pet’r’s Br.
at 44-51. How diabetes affected Dr. Harvey’s health is discussed in the context of severity.
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argues, a showing that a vaccine can cause a particular injury and the injury
developed within an appropriate time does not necessarily carry a petitioner’s
burden on prong two. Resp’t’s Br. at 28, citing Hibbard v. Sec’y of Health &
Hum. Servs., 698 F.3d 1355, 1366 (Fed. Cir. 2012), and Capizzano, 440 F.3d at
1326-27.
A stronger argument with respect to prong two might draw upon statements
from treating doctors. Of the various treaters, a few commented upon whether the
flu vaccine caused Dr. Harvey. These include the people listed in the following
chart.17
Date Doctor Notes Cite
10/12/2017 Dr. Kari Memorialized a complaint from Dr. Exhibit 5
Boucher Harvey that he had a painful, red, and at 4.
(dermatologist) burning rash for five days.
10/17/2017 Dr. Amy Reported that he received the flu shot Exhibit
Musiek and experienced a rash the next day. 15 at 42
(dermatologist) and 24.
10/18/2017 Dr. David Pham Memorialized that Dr. Harvey stated Exhibit 7
(internist) his vasculitis was triggered secondary at 315,
to flu shot; however, he was only off 340, and
prednisone for two days, which 354.
appeared atypical.
2/3/2018 Dr. Stephen Suggested Dr. Harvey see a Exhibit 2
Hayden neuromuscular medicine doctor at 168-
(primary care because Dr. Hayden was uncertain 169.
physician) whether weakness was induced by
steroids and that Dr. Harvey
“questions flu vaccine.”
2/20/2018 Dr. Ilia Itin Memorialized that after weaning off Ex 2 at
(neurologist) oral steroids, Dr. Harvey broke out in 174-175,
178.
17 The “Notes” column is intended to highlight key information. Additional context can
be found in recitation of facts.
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Date Doctor Notes Cite
a rash after the flu shot. He was
diagnosed with IgA vasculitis.
3/29/2018 Dr. Timothy Memorialized that Dr. Harvey “had a Exhibit 8
Harris Lucas rocky year with myalgia [and] at 46.
(neurosurgeon) reactions to vaccines.”
7/7/2018 Dr. Stephen After Dr. Harvey inquired about the Exhibit 2
Hayden shingles vaccine, Dr. Hayden at 360.
recommended that Dr. Harvey should
not “get egg based flu vaccine if that
is what caused the previous reaction.”
Dr. Hayden was unsure if Dr. Harvey
should receive a different flu vaccine.
9/6/2018 Dr. Stephen Prescribed Tamiflu to Dr. Harvey and Exhibit 2
Hayden stated that Dr. Harvey is “unable to at 387
have influenza vaccine because of
prior severe reaction.”
10/9/2018 Dr. Stephen Reviewed PubMed regarding flu Exhibit 2
Hayden vaccine and myopathy and stated that at 403.
“It seems plausible that something
like a myopathy could occur.” Note:
Dr. Harvey is not alleging the flu
vaccine caused a myopathy. See
Exhibit 23 at 1 (Dr. Aradillas
explaining that Dr. Harvey did not
suffer a myopathy).
2/27/2019 Dr. Stephen Stated that “I do not know how to Exhibit
Hayden prove the flu shot caused the 10 at 58.
problem.”
4/15/2019 Dr. Rebecca Memorialized that Dr. Harvey got a Exhibit
Kuenzler flu shot on October 5, 2017 [sic] and 10 at
(neuromuscular reported that it “is unclear when 158.
specialist) generalized weakness truly began but
22

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Date Doctor Notes Cite
thinks was sometime in close
proximity to flu shot”
4/15/2019 Dr. Monica Noted that the time “course for Exhibit
Scarsella patient’s symptoms fits in correlation 10 at
(vascular with a post-vaccination 166.
neurologist) polyneuropathy. There are rare
reports of vasculitis occurring after
vaccination. Additionally,
polyneuropathy can occur in
correlation with IgA vasculitis,
although this is also rare.”
4/16/2019 Dr. Alexandra Noted that although polyneuropathy Exhibit
Villa Forte can be seen in association with IgA- 10 at
(rheumatologist) vasculitis, it is extremely rare and 184.
much more likely that Dr. Harvey
had the neuropathy as a reaction to
the flu vaccine and not as part of a
systemic vasculitic syndrome. Note:
as explained below, Dr. Harvey is not
claiming that the flu vaccine directly
caused a neuropathy.
5/24/2019 Dr. Joseph Responded to Dr. Harvey’s inquiry Exhibit
Rudolph that “Both the Neuromuscular 10 at
(neurologist) specialist and the Rheumatologist . . . 232.
acknowledge the possibility of a
vaccine-induced response. So you
have that evidence.”
7/26/2019 Dr. Joseph Wrote a letter to Dr. Harvey’s Exhibit
Rudolph attorney that “He seems to have 17.
developed a neuropathy as a
consequence to the receiving the flu
shot.” Note: as explained below, Dr.
Harvey is not claiming that the flu
vaccine directly caused a neuropathy.
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Case 1:20-vv-00596-MHS Document 127 Filed 04/14/25 Page 24 of 30
Date Doctor Notes Cite
9/17/2019 Dr. David Lang Noted that “reaction beginning as Exhibit
(allergist and early as 8 hours after administration 13 at
immunologist) of influenza vaccination would be 395.
unusual for a vasculitic process.”
12/17/2019 Dr. David Responded to Dr. Harvey that Exhibit
Lang’s office “Despite follow up we have not 13 at
staff, Lisa obtained the records he requested to 533.
Krueger assist you with this issue.”
In reviewing the comments from treating doctors, it is important to
remember that Dr. Harvey is claiming that the flu vaccine caused him to suffer
vasculitis and a sequella to the vasculitis is neuropathy. See Pet’r’s Br. at 18
(introducing the argument how the flu vaccine can cause IgA vasculitis), 54
(discussing sequella); Pet’r’s Reply at 1 (arguing that preponderant evidence shows
the flu vaccine caused Dr. Harvey’s “injuries including IgA Vasculitis with
resulting polyneuropathy”). The arguments presented in Dr. Harvey’s memoranda
track the opinions presented by his primary expert, Dr. Gershwin. See Exhibit 19
at 4 (“At issue herein is whether an influenza vaccine . . . was a factor in the
development of his HSP variation of leukocytoclastic vasculitis that resulted in the
residual sequela of post-vaccine polyneuropathy”). Thus, statements that the flu
vaccine caused Dr. Harvey to suffer a neuropathy are off target.18
Another unusual aspect to the chronology of medical appointments is that
often the association between the flu vaccine and vasculitis was reported by Dr.
Harvey, and not independent opinions offered spontaneously by his treating
physicians. Dr. Harvey’s initiation of conversations about the potential for a
vaccine to have harmed him is especially apparent in communications with Dr.
Hayden.
18 The Secretary interpreted Dr. Harvey as presenting a claim that the flu vaccine caused
IgA vasculitis and the vasculitis caused the neuropathy. See Resp’t’s Br. at 23 (discussing
Althen prong one) and 33 (discussing sequella). Because Dr. Harvey did not assert the theory
that the flu vaccine directly caused a neuropathy, this decision does not address that question.
See Vaccine Rule 8(f)(1).
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In responding to Dr. Harvey’s questions about how the flu vaccine harmed
him, Dr. Hayden’s answers changed. At first, Dr. Hayden noted the question but
seemed not to answer it. Exhibit 2 at 168-69. Then, Dr. Hayden recommended
avoiding flu vaccines based on eggs but tolerating other flu vaccines. Id. at 358.
Around the same time, Dr. Hayden prescribed Tamiflu because Dr. Harvey’s
“prior severe reaction” prevented him from being vaccinated. Id. at 387-94.
Recommendations to avoid certain vaccines have been credited and have not been
credited as indications of a causal role for a vaccine. See, e.g., Compare Paterek v.
Sec’y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir. 2013) (stating
given the testimony of a treating doctor, “the decision to withhold future
administration of the pertussis vaccine provides little probative evidence of
causation”); Gramza v. Sec’y of Health & Hum. Servs., 139 Fed. Cl. 309, 335-36
(2018) (ruling that the special master was not arbitrary in refraining from giving
decisive weight to a note from a treating doctor advising “no future vaccination”
when the treater wrote the note three years after the incident); and Bangerter v.
Sec’y of Health & Hum. Servs., No. 14-1187V, 2022 WL 439535, at *29 (Fed. Cl.
Spec. Mstr. Jan. 18, 2022) (although a recommendation to avoid future
vaccinations has some value, this evidence does not carry petitioner’s burden on
prong two when petitioner failed to meet prongs one and three) With Andreu v.
Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1377 (Fed. Cir. 2008) (the opinion
of a treating doctor to withhold future vaccines can be quite probative); and
Robinson v. Sec’y of Health & Hum. Servs., No. 14-952V, 2021 WL 2371721,
*1376-77 (Fed. Cl. Spec. Mstr. Apr. 12, 2021) (evidence that treating doctor
withheld vaccines helps support prong two).
Whatever value Dr. Harvey might gain from these notes from Dr. Hayden---
and Dr. Harvey does not cite them in the context of his prong two argument---
seems tempered by Dr. Harvey’s later statement that he does not know how to
prove the flu vaccine caused a problem. Exhibit 10 at 58-60.
The treating doctor on whom Dr. Harvey relies most heavily is Dr. Kuenzler.
See Pet’r’s Br. at 43-44; Pet’r’s Reply at 3-4. Certainly, her statement “Time
course for patient’s symptoms fits in correlation with a postvaccination
polyneuropathy. There are rare reports of vasculitis occurring after vaccination.
Additionally, polyneuropathy can occur in correlation with IgA vasculitis, although
this is also rare" (Exhibit 10 at 166) provides some support for Dr. Harvey’s claim.
However, Dr. Kuenzler’s view is countered by the statement of Dr. Lang.
Dr. Lang wrote that: “History furnished today of cutaneous reaction beginning as
early as 8 hours after administration of influenza vaccination would be unusual for
a vasculitis process.” Exhibit 13 at 395. Given that Dr. Lang is an immunologist,
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his opinion regarding the time for an adverse reaction to a vaccine is more credible
than the opinion of someone, like Dr. Kuenzler, who appears not to specialize in
immunology.
Thus, when considered as a whole, the collection of statements from treating
doctors do not persuasively show that the flu vaccine caused Dr. Harvey’s
vasculitis. This finding is reached without considering two other arguments the
Secretary presented regarding Althen prong two.
The Secretary’s first counterargument seems to be that Dr. Harvey’s
discontinuance of prednisone two days before the flu vaccination, which is also
two days before the onset of the vasculitis, caused the vasculitis. See Resp’t’s Br.
at 29, citing Exhibit A (Dr. Miner’s report) at 5 and Exhibit E (Dr. Miner’s second
report) at 2. This proposition is intriguing but not adequately developed.
Moreover, because the Secretary does not bear a burden to explain what caused the
illness until a petitioner establishes a prima facie case, this point need not be
resolved conclusively.
The Secretary’s second counterargument regarding Althen prong two is
based upon (a lack of) challenge-rechallenge. In 2019, Dr. Harvey received the
“influenza vaccine but in 4 doses of ¼ usual dose each and without adverse effect.”
Exhibit 10 at 90. The Secretary reasons that the lack of reaction to a flu vaccine in
2019 suggests that Dr. Harvey did not have an adverse reaction in 2017. See
Resp’t’s Br. at 29-30; see also Locane v. Sec’y of Health & Hum. Servs., 685 F.3d
1375, 1381 (Fed. Cir. 2012) (ruling that the special master was not arbitrary in
rejecting causation when after receiving a second dose of the allegedly causative
vaccine, petitioner’s disease did not flare); Roshoven v. Sec’y of Health & Hum.
Servs., No. 14-439V, 2018 WL 1124737, at *21-22 (Fed. Cl. Spec. Mstr. Jan. 11,
2018) (finding that a lack of adverse reaction to a third dose of a vaccine
undermined petitioner’s claim that the earlier doses harmed her). Again, this
argument is intriguing. However, it is not readily apparent that four one-quarter
doses would be likely to cause the same adverse reaction as one full-strength dose.
This might be the case, but it would probably require testimony from an
immunologist, whom the Secretary did not present here.
Any deficiencies in the Secretary’s counterarguments do not enrich Dr.
Harvey’s evidence on Althen prong two. Neither the statements from treating
doctors nor the opinions from Dr. Gershwin are sufficient to meet Dr. Harvey’s
burden to show with preponderant evidence that the flu vaccine was the cause-in-
fact of his vasculitis.
26

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D. Summary regarding Causation
To establish the vaccine was the cause-in-fact of an injury, a petitioner must
establish three elements. In this case, Dr. Harvey’s evidence regarding the first
element, a theory, was particularly devoid of persuasiveness. His evidence
regarding the third element, an appropriate temporal relationship, was also very
weak. Although the evidence on the second element, a logical sequence of cause
and effect, was stronger, its comparative “strength” mostly derives from the
weakness of the evidence on the other two elements.
For these reasons, Dr. Harvey is not entitled to compensation. As such,
evaluating a different element of compensation, the severity of the injury, is not
required. However, for sake of completeness, this issue is taken up next.
V. Second Issue: Severity
The fourth statutory element concerns the severity of injury. 42 U.S.C.
§ 300aa–11(c)(1)(D). Petitioners may meet this element by establishing that their
injury lasted more than six months.19 The failure to establish six months of injury
results in a denial of compensation. See Starvridis v. Sec’y of Health & Hum.
Servs., No. 07–261V, 2009 WL 3837479, at *4 (Fed. Cl. Spec. Mstr. Oct. 29,
2009); Song v. Sec’y of Health & Hum. Servs., No. 92-279V, 1993 WL 534746
(Fed. Cl. Spec. Mstr. Dec. 15, 1993), mot. for rev. denied, 31 Fed. Cl. 61 (1994),
aff’d, 41 F.3d 1520 (Fed. Cir. 1994) (table).
Here, Dr. Harvey concedes that the condition he alleges the flu vaccine
caused, IgA vasculitis, did not last six months. Pet’r’s Br. at 20. Dr. Harvey,
therefore, proposes that he meets the six-month requirement because a sequella to
the IgA vasculitis, a peripheral neuropathy, continued beyond six months. Pet’r’s
Br. at 54. The Secretary does not contest that Dr. Harvey suffered a neuropathy.
However, the Secretary contends that the neuropathy was more likely due to
diabetes and not due to IgA vasculitis. Resp’t’s Br. at 34, citing Exhibit C (Dr.
Feinberg’s opinion) at 4.
Numerous problems prevent this issue from being resolved on the papers. If
determining whether Dr. Harvey met his burden on severity were needed to resolve
19 The Vaccine Act also allows a petitioner to receive compensation if either the vaccinee
died or the vaccinee underwent a surgical procedure. However, Dr. Harvey did not die and has
not undergone a surgery for his reaction to the vaccine.
27

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this case, then additional development, such as extra briefing and/or a hearing
would have been conducted. See Vaccine Rule 8(a) (authorizing special masters to
determine whether to hold a hearing).
A primary question is when Dr. Harvey’s neuropathy began. In this respect,
the Secretary’s apparent emphasis on the date of the EMG, which detected the
neuropathy, seems misplaced. See Resp’t’s Br. at 18, 36. Although the EMG was
conducted about 18 months after the vaccination, the date the polyneuropathy was
identified is not the date the polyneuropathy began. See Sparrow, 173 Fed. Cl.
177, 184, (2024) (“medical tests will generally come after symptoms first
develop”), appeal docketed, No. 25-1161 (Fed. Cir. Nov. 8, 2024); see also Exhibit
H at 2 (Dr. Miner’s report asserting that the date of infection, the date of
symptoms, and the date of diagnosis can be different in the context of an
infection).
While the April 15, 2019 EMG sets the latest date of Dr. Harvey’s
polyneuropathy, the earliest date is much less clear. The Secretary goes so far as to
suggest that Dr. Harvey’s complaint of weakness from before the vaccine could
have been a manifestation of the start of polyneuropathy. Resp’t’s Br. at 36.
Dr. Harvey’s answer is that the weakness he reported was due to the
preceding operation. Exhibit 23 (Dr. Aradillas’s report) at 4. But, except for this
episode, Dr. Harvey agrees that “weakness was Dr. Harvey’s main complaint with
regard to neuropathy.” Pet’r’s Br. at 50.
A further challenge to determining when Dr. Harvey’s polyneuropathy
began is the lack of findings in reports from doctors who examined Dr. Harvey
after the vaccination and before the EMG. For example, in mid-October 2017, Dr.
Harvey was hospitalized for a bronchial thermoplasty. Yet, during this stay, Dr.
Harvey affirmatively denied any weakness. Exhibit 7 at 456 (Oct. 18, 2017).
Nonetheless, about one week after discharge, Dr. Harvey told Dr. Hayden
over the telephone that “Muscle weakness is a major problem. He has had falls.”
Exhibit 2 at 46 (Oct. 26, 2017). When Dr. Harvey saw Dr. Hayden, Dr. Hayden
seemed more concerned about the shunt in Dr. Harvey’s brain. But, the CT scan
showed no significant change. Exhibit 2 at 60. Thus, the reason for Dr. Harvey’s
report of generalized muscle weakness appeared undetermined at the end of
October 2017.
The Secretary proposed that Dr. Harvey’s diabetes, which Dr. Hayden
characterized as “uncontrolled” (Exhibit 2 at 53), caused any peripheral
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neuropathy. Resp’t’s Br. at 6, 34. The potential persuasiveness of this argument is
diminished because the endocrinologist, Dr. Williams, did not diagnosis a diabetic
neuropathy on November 1, 2017. See Exhibit 2 at 68-80; see also Pet’r’s Br. at
46; Exhibit 23 at 3 (Dr. Aradillas’s report noting that Dr. Harvey was not
diagnosed with peripheral neuropathy); Exhibit 26 (Dr. Rudolph’s report) ¶ 16
(stating there was no diagnosis of peripheral neuropathy).20
Dr. Williams’s lack of assessment of a neuropathy, therefore, both helps and
hurts Dr. Harvey’s efforts to satisfy the six-month requirement. Dr. Williams
might undermine the argument that Dr. Harvey suffered from a diabetic
neuropathy. But, what does her note signify for any neuropathy? In Dr. Harvey’s
view, did Dr. Williams miss an opportunity to diagnose her patient with a (non-
diabetic) neuropathy?
Answers to these questions are far from clear. In this circumstance,
additional development in the form of oral testimony, particularly from Dr.
Williams, and/or argument would probably be appropriate. See Vaccine Rule 8(a)
(recognizing special master’s discretion to conduct hearings).
However, a hearing to determine whether Dr. Harvey satisfies severity
would waste scarce judicial resources as any determination in Dr. Harvey’s favor
would not change the outcome. Dr. Harvey’s case falters for failing to establish
with persuasive evidence that the flu vaccine was the cause-in-fact of vasculitis.
VI. Conclusion
As evident in medical records, Dr. Harvey has often wondered whether the
flu vaccination caused him to develop vasculitis. This potential connection is
understandable in the sense that the vasculitis was detected relatively soon after the
vaccination. However, a temporal sequence in which one event preceded a second
event does not mean that the first event caused the second event. When called
upon in this litigation to establish with preponderant evidence that the flu
vaccination was the cause-in-fact for his vasculitis, Dr. Harvey did not meet his
burden. Therefore, his claim for compensation is denied.
The Clerk's Office is instructed to enter judgment in accord with this
decision unless a motion for review is filed. Information about filing a motion for
20 Some of these assertions appear inconsistent with notations in Dr. Williams’s records
that a “complication” for Dr. Harvey was peripheral neuropathy. See, e.g., Exhibit 2 at 68, 232.
29

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review, including the deadline, can be found in the Vaccine Rules, which are
available on the website for the Court of Federal Claims.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
30

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_20-vv-00596-2
Date issued/filed: 2025-10-06
Pages: 18
Docket text: JUDGE VACCINE UNREPORTED OPINION (PUBLIC VERSION)(Originally filed September 16, 2025) reissuing 132 Judge Vaccine Order/Opinion, denying motion for review, and affirming the Special Master's decision. Signed by Chief Judge Matthew H. Solomson. (si) Service on parties made.
--------------------------------------------------------------------------------
Case 1:20-vv-00596-MHS Document 134 Filed 10/06/25 Page 1 of 18
In the United States Court of Federal Claims
No. 20-596V
(Filed Under Seal: September 16, 2025)
(Public Filing: October 6, 2025)
)
JAMES HARVEY, M.D., )
)
Petitioner, )
)
v.
)
)
SECRETARY OF HEALTH AND
)
HUMAN SERVICES,
)
)
Respondent.
)
)
Jessica Wallace, Siri & Glimstad, LLP, Aventura, FL, for Petitioner.
Ryan D. Pyles, Torts Branch, Civil Division, United States Department of Justice,
Washington, D.C., for Respondent. With him on the briefs were Yaakov M. Roth,
Acting Assistant Attorney General, C. Salvatore D’Alessio, Director, Heather L.
Pearlman, Deputy Director, and Voris E. Johnson Jr., Assistant Director.
OPINION AND ORDER
SOLOMSON, Chief Judge.
Petitioner, Dr. James Harvey, filed a claim for compensation against Respondent,
the Secretary of Health and Human Services, pursuant to the National Vaccine Injury
Compensation Program, 42 U.S.C. §§ 300aa-1 et seq. (the “Vaccine Act”). ECF No. 1. He
alleges that an influenza vaccination (the “Flu Vaccine”) caused him to suffer
leukocytoclastic vasculitis (“IgAV”), and, in turn, a neuropathy.1 Id. On March 18, 2025,
* This decision was initially issued under seal on September 16, 2025, in accordance with Rule
18(b) of the Vaccine Rules of the United States Court of Federal Claims, to permit Petitioner time

Case 1:20-vv-00596-MHS Document 134 Filed 10/06/25 Page 2 of 18
Special Master Moran denied Dr. Harvey’s petition for vaccine compensation.
ECF No. 126. The Special Master concluded that Dr. Harvey did not meet his burden to
prove, by a preponderance of evidence, that the Flu Vaccine was the cause-in-fact of
Dr. Harvey’s injury. Id. at 29. Dr. Harvey now petitions this Court for review of the
Special Master’s decision. ECF No. 128. For the reasons explained below, this Court
concludes that the Special Master’s decision in this case was not arbitrary or capricious.
Accordingly, the Special Master’s decision is AFFIRMED.
I. FACTUAL BACKGROUND2
Dr. Harvey received the Flu Vaccine on October 6, 2017. ECF No. 126 at 3. At the
time, he was 76 years old, a retired medical practitioner, and had relevant pre-existing
conditions, including severe asthma and diabetes. Id. at 2-3. Within several hours of
receiving the Flu Vaccine, Dr. Harvey developed a rash all over his legs and “began to
feel down.” Id. at 3.
On October 12, 2017 — six days after receiving the Flu Vaccine — Dr. Harvey saw
a dermatologist, Dr. Kari Boucher, to whom Dr. Harvey described the rash symptoms he
had experienced over the preceding five days. Dr. Boucher diagnosed Dr. Harvey with
IgAV, and prescribed both “a topical cream and prednisone.” ECF No. 126 at 3. On
October 17, 2017, as the pain and rash persisted, Dr. Harvey sought an opinion from a
second dermatologist, Dr. Amy C. Musiek. Id. at 4. Dr. Harvey again reported that he
received the Flu Vaccine on October 6, 2017, and developed a rash the following day. Id.
Dr. Musiek performed a punch biopsy, which confirmed that Dr. Harvey had IgAV. Id.
On October 18, 2017, Dr. Harvey was hospitalized for a planned bronchial
thermoplasty — a procedure used to treat severe asthma. ECF No. 126 at 3-4. During his
hospitalization, an internist “memorialized that Dr. Harvey stated his [IgAV] was
triggered [secondary to]” the Flu Vaccine. Id. at 4 (second alteration in original).
to propose redactions. Petitioner indicted that he requests no redactions. This public version also
reflects several typographical corrections.
1 IgAV symptoms often include, but are not limited to, severe rashes on the legs, and itchiness.
For additional information about IgAV, see the Special Master’s summary of the condition. ECF
No. 126 at 3-4.
2 Because the material facts are undisputed, this Court’s fact summary facts is largely drawn
from the Special Master’s decision. ECF No. 126.
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Dr. Harvey consulted over the phone with an internist at the Cleveland Clinic,
Dr. Stephen Hayden, on October 26, 2017. ECF No. 126 at 5. Dr. Hayden documented
that a recent punch biopsy showed Dr. Harvey had IgAV. Id. On October 31, 2017, during
Dr. Harvey’s first in-person visit with Dr. Hayden, Dr. Hayden memorialized his
impressions, including that Dr. Harvey suffered from IgAV. Id.
Dr. Harvey’s “rash . . . subsided after a few weeks.”3 ECF No. 126 at 4-5.
Thereafter, on November 1, 2017, an endocrinologist at the Cleveland Clinic,
Dr. Susan William, first diagnosed Dr. Harvey with a neuropathy. ECF No. 126 at 5. Over
the ensuing few months, Dr. Harvey met with Dr. Hayden and communicated with him
via a patient portal on several occasions. See Id. at 5-6. These communications centered
around Dr. Harvey’s neuropathy, including resulting neuromuscular issues. Id. During
this period, Dr. Harvey made no reference to his IgAV or the Flu Vaccine. Id.
On February 8, 2018, after Dr. Hayden suggested that Dr. Harvey see a neurologist
due to his ongoing neuropathy — more than four months after the Flu Vaccine, and long
after his IgAV symptoms had dissipated — Dr. Harvey for the first time, “raised the
possibility of an adverse reaction to the [Flu Vaccine].” ECF No. 126 at 6. Via the patient
portal, Dr. Harvey asked Dr. Hayden if it would “be a good idea [] to see somebody [who
3 To demonstrate entitlement to compensation pursuant to the Vaccine Act, a petitioner must
meet a “severity” requirement. 42 U.S.C. § 300aa–11(c)(1)(D) (providing, in relevant part, that a
petitioner must show he or she “suffered the residual effects or complications of [an alleged
vaccine-induced] illness . . . for more than 6 months after the administration of the vaccine”). In
this case, however, based on Dr. Harvey’s own account, his IgAV-related symptoms did not last
six months and subsided within six months of his receipt of the Flu Vaccine. Thus, in an attempt
to meet the severity requirement, Dr. Harvey maintains that the IgAV, in turn, caused a
neuropathy whose symptoms lingered well beyond the six-month period. ECF No. 126 at 5 n.6.
Relatedly, although Dr. Harvey’s medical record — as summarized in the Special Master’s
decision, discussed infra — contains an ample discussion supporting the possibility of the Flu
Vaccine’s having directly caused Dr. Harvey’s neuropathy, the Special Master found that
Dr. Harvey did not “assert that theory,” and thus the Special Master “[did] not address that
question.” Id. at 24 n.18. This Court similarly does not reach the issue because Dr. Harvey has
waived it — both before the Special Master and now before this Court. Indeed, Dr. Harvey
maintains only that the vaccine caused IgAV, which, in turn, caused a neuropathy. Furthermore,
because this Court affirms the Special Master’s reasonable conclusion that Dr. Harvey did not
prove, by preponderant evidence, that the Flu Vaccine caused IgAV, we do not need to reach his
neuropathy claim, in any event.
3

Case 1:20-vv-00596-MHS Document 134 Filed 10/06/25 Page 4 of 18
is an] expert in vaccines,” noting that Dr. Harvey found it difficult to attribute his then-
current problems related to his neuropathy to other life events. Id. A few days later, on
February 13, 2018, Dr. Harvey also questioned if the Flu Vaccine caused his IgAV. Id. at
7. Dr. Hayden, in his notes to a neurologist Dr. Harvey saw shortly thereafter,
memorialized that Dr. Harvey “questions flu vaccine [sic].” Id.
Dr. Ilia Itin — a neurologist Dr. Harvey visited on February 20, 2018 —
documented how Dr. Harvey “broke out in a rash following [his Flu Vaccine],” and “was
diagnosed with IgAV.” ECF No. 126 at 7. Dr. Itin further documented events and
symptoms related to Dr. Harvey’s neuropathy. Id.
On March 29, 2018, Dr. Timothy Harris Lucas, from the University of
Pennsylvania, memorialized a complaint from Dr. Harvey that he “had a rocky year with
. . . reactions to vaccines.” ECF No. 126 at 8. It is unclear from the record, however, if
Dr. Harvey, in his complaint to Dr. Lucas, was referring to his neuropathy — from which
he still suffered at the time — or also his IgAV, which had long since improved. As with
Dr. Hayden’s note to Dr. Harvey’s neurologist, however, Dr. Lucas was memorializing
Dr. Harvey’s reports regarding reactions to the Flu Vaccine, not Dr. Lucas’s own
independent conclusions.
On July 7, 2018, Dr. Harvey again communicated with Dr. Hayden via the patient
portal, this time inquiring if Dr. Harvey should get a shingles vaccine. ECF No. 126 at 9.
Dr. Hayden responded that he does not “think [Dr. Harvey] should get [an] egg-based
flu vaccine if that is what caused the previous reaction.” Id. (emphasis added). When
prescribing Tamiflu to Dr. Harvey, on another occasion, Dr. Hayden similarly noted that
Dr. Harvey is “unable to have influenza vaccine because of [a] prior severe reaction[.]”
Id. It is unclear, however, if Dr. Hayden’s reference to a “prior severe reaction,” was to
Dr. Harvey’s IgAV, neuropathy, or both.
On October 5, 2018, Dr. Harvey emailed Dr. Hayden. ECF No. 126 at 9. Dr. Harvey
indicated that he remained “dissatisfied” with his understanding of the “neuromuscular
symptoms” temporally related to his Flu Vaccine, and asked if “anybody could address
his concern.” Id. Dr. Harvey continued to press this concern with Dr. Hayden on
multiple occasions thereafter. Id. at 10. On February 25, 2019, in response to yet another
inquiry on the same subject, Dr. Hayden responded that “he did not know how to prove
4

Case 1:20-vv-00596-MHS Document 134 Filed 10/06/25 Page 5 of 18
whether the [Flu Vaccine] caused the problem. Id.4
Given that Dr. Harvey continued to experience neuromuscular symptoms despite
various treatments, Dr. Harvey, on April 15, 2019, saw two specialists in neuromuscular
disorders: Dr. Monica Scarsella and Dr. Rebecca Kuenzler.
Reviewing Dr. Harvey’s medical history, Dr. Scarsella concluded that the “[t]ime
course of [Dr. Harvey’s] symptoms fits in correlation with a post-vaccine
polyneuropathy.” ECF No. 126 at 12. As to whether the Flu Vaccine could have caused
IgAV, which in turn caused a neuropathy, Dr. Scarsella opined that “[t]here are rare
reports of [IgAV] occurring after vaccination. Additionally, polyneuropathy can occur in
correlation with IgAV, although this is also rare.” Id. Put simply, Dr. Scarsella believed
that Dr. Harvey’s neuropathy was a direct result of the Flu Vaccine, because the
alternative theory — which Dr. Harvey now presses — would assume a double rarity,
something which Dr. Scarsella would not do.
That same day, Dr. Kuenzler expressed her opinion that the “time course [of Dr.
Harvey’s symptoms was] most compatible with post-vaccine autoimmune response
causing [IgAV] and neuropathy.” ECF No. 126 at 12. (alteration in original) (emphasis
added). Thus, Dr. Kuenzler was the first doctor to opine, independently, that Dr.
Harvey’s IgAV was causally connected to the Flu Vaccine.
The next day, on April 16, 2019, Dr. Harvey saw a specialist in rheumatology,
Dr. Alexandra Villa Forte. ECF No. 126 at 12. Like Dr. Kuenzler, Dr. Forte opined that
Dr. Harvey’s IgAV was causally connected to the Flu Vaccine. First, in connection with
Dr. Harvey’s ongoing neuropathy, she opined that “[a]lthough polyneuropathy can be
seen in association with IgA[V,] it is extremely rare[,] and it is much more likely that
[Dr. Harvey] had the neuropathy as a [direct] reaction to the flu vaccine and not as part
of a systemic vasculitic syndrome.” Id. As to Dr. Harvey’s IgAV, she observed that “[t]he
rash has not recurred and he has no other symptoms or signs to suggest chronic or
relapsing IgA[V] — making it even more suggestive of a vaccine induced reaction.” Id.5
4 Here, Dr. Hayden’s reference to “the problem” is clearly to Dr. Harvey’s neuropathy-related
issues (and not IgAV).
5 Although Drs. Kuenzler and Forte support Dr. Harvey’s claim that the Flu Vaccine may have
caused his IgAV, they reject the idea that IgAV caused Dr. Harvey’s neuropathy. The problem
5

Case 1:20-vv-00596-MHS Document 134 Filed 10/06/25 Page 6 of 18
After deciding to file a vaccine compensation claim pursuant to the Vaccine Act in
this Court (but before doing so), Dr. Harvey saw an immunologist, Dr. David Lang, on
September 19, 2020. ECF No. 126 at 14. Dr. Lang documented the purpose of the visit:
“to evaluate an adverse reaction to an influenza vaccination in October 2017.” Id.
Dr. Lang noted that while “he did not have the benefit of reviewing all the outside
records,” he had some of the records, and he interviewed Dr. Harvey. Id. Dr. Lang
concluded that the “[h]istory furnished today of cutaneious reaction beginning as early
as 8 hours after administration of influenza vaccination would be unusual for a vasculitic
process.” Id. Put simply, Dr. Lang believed that it was unlikely the Flu Vaccine caused
IgAV, given the short period between when Dr. Harvey received the Flu Vaccine and the
onset of IgAV-related symptoms. Thus, Dr. Lang disagreed with Dr. Kuenzler and
Dr. Forte’s conclusion that the Flu Vaccine caused Dr. Harvey’s IgAV, and, instead,
agreed with Dr. Scarsella’s opinion — that such a cause-and-effect was unlikely.
II. PROCEDURAL HISTORY
On May 13, 2020, Dr. Harvey filed a petition for compensation pursuant to the
Vaccine Act. ECF No. 1. Dr. Harvey asserts that the Flu Vaccine caused him to suffer
from IgAV — and, as a consequence of the IgAV, from a neuropathy — and that he is
therefore entitled to compensation pursuant to the Vaccine Act. Id.; see ECF No. 126 at 5
n.6.
On May 16, 2020, this case was assigned to Chief Special Master Corcoran. That
same day, Dr. Harvey filed his medical records. ECF Nos. 7-9. On July 6, 2020, this case
was reassigned to Special Master Moran. ECF No. 15. Dr. Harvey retained
Dr. M. Eric Gershwin and Dr. Enrique Aradillas to present expert testimony. ECF No.
126 at 15. The government, in turn, presented testimony from Dr. Jonathan Miner and
Dr. Daniel Feinberg. Id.
After the case was briefed by both parties, on March 18, 2025, the Special Master
concluded that “[w]hen called upon in this litigation to establish with preponderant
for Dr. Harvey, however, is that he can only recover here — due to the severity requirement,
discussed supra — if he can prove that the neuropathy resulted from the IgAV. But, again, that
is a hypothesis both of these doctors reject. And while both doctors arguably support the idea that
Dr. Harvey’s neuropathy resulted directly from the vaccine — although not via the IgAV — Dr.
Harvey never argued before the Special Master or this Court that the Flu Vaccine directly caused
Dr. Harvey’s neuropathy. See supra note 3.
6

Case 1:20-vv-00596-MHS Document 134 Filed 10/06/25 Page 7 of 18
evidence that the [Flu Vaccine] was the cause-in-fact for his [IgAV], Dr. Harvey did not
meet his burden. Therefore, his claim for compensation is denied.” ECF No. 126 at 29.
On April 17, 2025, Dr. Harvey filed a motion for review of the Special Master’s
decision, ECF No. 128, and, with it, a memorandum in support of his motion, ECF No.
129. Dr. Harvey asks this Court to set aside the Special Master’s findings of fact that are
arbitrary and capricious, and conclusions of law that “are not in accordance with the
law,”6 and to “remand the case back to the Special Master with instructions to enter a
finding” that Dr. Harvey is entitled to compensation . . . .” Id. at 17. On May 15, 2025,
Respondent filed its response to Dr. Harvey’s motion for review, requesting that this
Court affirm the Special Master’s decision. ECF No. 131 at 20.
III. JURISDICTION
Pursuant to the Vaccine Act, this Court has jurisdiction to review a special
master’s decision upon the filing of a petition from either party within thirty days of that
decision. 42 U.S.C. § 300aa-12(e)(1). On review, this Court may:
(A) uphold the findings of fact and conclusions of law of the
special master and sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the
special master found to be arbitrary, capricious, an abuse
of discretion, or otherwise not in accordance with law
and issue its own findings of fact and conclusions of law,
or
(C) remand the petition to the special master for further
action in accordance with the court’s direction.
42 U.S.C. § 300aa-12(e)(2). No party disputes this Court’s jurisdiction.
IV. STANDARD OF REVIEW
“Under the Vaccine Act, the Court of Federal Claims reviews the Special Master’s
decision to determine if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with the law.’” Markovich v. Sec’y of Health & Hum. Servs., 477 F.3d 1353,
6 Dr. Harvey, in his brief, solely challenges the Special Master’s factual findings as arbitrary and
capricious, but does not argue that the Special Master misapplied the relevant law. See ECF No.
129.
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1355–56 (Fed. Cir. 2007) (quoting 42 U.S.C. § 300aa-12(e)(2)(B)). “Fact findings are
reviewed [by this Court] under the arbitrary and capricious standard.” Munn v. Sec’y of
Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). “‘Arbitrary and capricious’
is a highly deferential standard of review: ‘[i]f the special master has considered the
relevant evidence of record, drawn plausible inferences and articulated a rational basis
for the decision, reversible error will be extremely difficult to demonstrate.’” Rodriguez
v. Sec’y of Health & Hum. Servs., 632 F.3d 1381, 1384 (Fed. Cir. 2011) (quoting Hines on
Behalf of Sevier v. Sec’y of Health & Hum. Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
Our appellate court, the United States Court of Appeals for the Federal Circuit,
has thus explained that “the statute contemplates that fact finding will be done by the
special master.” Munn, 970 F.2d at 870. Indeed, Congress tasked the special masters
with the “unenviable job of sorting through these painful cases and, based upon their
accumulated expertise in the field, judging the merits of the individual claims.” Hodges
v. Sec’y of Dep’t of Health & Hum. Servs., 9 F.3d 958, 961 (Fed. Cir. 1993).
Therefore, on a petition for review, “[t]his court does not ‘reweigh the factual
evidence, or [] assess whether the special master correctly evaluated the evidence. And
of course we do not examine the probative value of the evidence or the credibility of the
witnesses. These are all matters within the purview of the fact finder.’” Broekelschen v.
Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1349 (Fed. Cir. 2010) (quoting Munn, 970 F.2d
at 871). “Rather, as long as a special master’s finding of fact is ‘based on evidence in the
record that [is] not wholly implausible, we are compelled to uphold that finding as not
being arbitrary or capricious.’” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d 1242, 1249
(Fed. Cir. 2011) (quoting Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1338 (Fed.
Cir. 2010)).
Put simply, “[t]he statute makes clear that, on review, the Court of Federal Claims
is not to second guess the Special Master[‘]s fact-intensive conclusions; the standard of
review is uniquely deferential for what is essentially a judicial process.” Hodges, 9 F.3d
at 961. “That level of deference is especially apt in a case in which the medical evidence of
causation is in dispute.” Id. (emphasis added).
While a special master’s overall conclusion is reviewed under the deferential
standard of review, a special master’s conclusions of law are reviewed de novo. Rodriguez,
632 F.3d at 1384 (citing Markovich, 477 F.3d at 1356); see also Munn, 970 F.2d at 870 n.10
(explaining that, unlike factual findings which are reviewed “under the arbitrary and
capricious standard[,]” legal questions are reviewed “under the ‘not accordance with the
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law’ standard” (quoting 42 U.S.C. § 300aa-12(e)(2)(B))).
In sum, a special master’s decision “is entitled to deference,” Morse v. Sec’y of Health
& Hum. Servs., 93 Fed. Cl. 780, 783 (2010), but this Court will find that a special master
has abused his or her discretion if the special master’s decision: “(1) is clearly
unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3)
rests on clearly erroneous fact findings; or (4) follows from a record that contains no
evidence on which the [special master] could rationally base [his] decision.” Wirtshafter
v. Sec’y of Health & Hum. Servs., 155 Fed. Cl. 665, 671 (2021) (quoting Ninestar Tech. Co. v.
Int’l Trade Comm’n, 667 F.3d 1373, 1379 (Fed. Cir. 2012)).7
V. DISCUSSION
A. Burden of Proof for Non-Table Claims
Pursuant to the Vaccine Act, a petitioner seeking compensation for an injury due
to a vaccine must assert that he or she: (a) received a vaccine specified in 42 U.S.C. § 300aa-
14 (the “Vaccine Injury Table” or “Table”); and (b) suffered either (1) an injury falling
within the Table in “association” with the vaccine, and which manifested within the time
period set forth in the Table (a “Table claim”), or (2) an injury not within the Table, but
which was “caused” by the vaccine (a “non-Table claim”), or (3) an injury falling within
the Table, that did not manifest within the time period set forth in the Table, and which
was “caused” by the vaccine (also a “non-Table claim”). Id. § 300aa–11(c)(1) (emphasis
added). To be awarded compensation, a petitioner must prove entitlement by a
preponderance of the evidence. Id. § 300aa–13(a)(1).
The salient difference between Table and non-Table claims is the quantum of
evidence required to prove causation. While the Vaccine Act “provides . . . a statutorily-
prescribed presumption of causation” for a Table claim, a petitioner must “prove[]
causation in fact” for a non-Table claim. Althen v. Sec’y of Health & Hum. Servs., 418 F.3d
1274, 1278 (Fed. Cir. 2005); see also Pafford v. Sec'y of Health & Hum. Servs., 451 F.3d 1352,
1355 (Fed. Cir. 2006) (noting that, given the “causal” language in § 300aa–11(c)(1) for non-
Table claims, “the petitioner in an off-table case has the burden to prove the vaccination
in question ‘caused’ the illness, disability, injury, or condition” pursuant to 42 U.S.C.
7 See also Spahn v. Sec’y of Health & Hum. Servs., 138 Fed. Cl. 252, 257 (2018) (“This Court will find
an abuse of discretion only where the special master’s decision is clearly unreasonable, based
upon an erroneous conclusion of law, rests on erroneous fact finding, or based on a record
without evidence to support the special master’s decision.”).
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§ 300aa–13(a)(1)).
In this case, Dr. Harvey asserts only a non-Table claim. Thus, Dr. Harvey was
required to “prove ‘actual causation’ or ‘causation in fact’ by a preponderance of the
evidence.” Moberly ex rel. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010) (citing cases). The Federal Circuit has succinctly articulated the burden to
prove causation-in-fact:
Concisely stated, [a petitioner’s] burden is to show by
preponderant evidence that the vaccination brought about
[petitioner’s] injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination
and injury.
Althen, 418 F.3d at 1278. These elements are often referred to as the “Althen Prongs” or
the “Althen Test.”
B. The Special Master’s Althen Prong 2 Analysis and Conclusion Were
Not Arbitrary or Capricious
The Special Master concluded that Dr. Harvey failed to prove causation-in-fact
because he did not prove all three Althen Prongs by the preponderance of the evidence.
ECF No. 126 at 27. Thus, the Special Master denied Dr. Harvey’s compensation claim
pursuant to the Vaccine Act. Id. This Court first addresses the Special Master’s Althen
Prong 2 analysis because it is ultimately dispositive of this case.
Althen Prong 2 requires a petitioner asserting a non-Table claim “to show by
preponderant evidence . . . a logical sequence of cause and effect showing that the
vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. As discussed further
below, this Court finds that the Special Master’s decision regarding Althen Prong 2 was
not arbitrary, capricious, or otherwise contrary to law. Accordingly, and on that basis
alone, this Court must uphold the Special Master’s decision. See, e.g., Greene v. Sec'y of
Health & Hum. Servs., 841 F. App'x 195, 201–03 (Fed. Cir. 2020) (discussing Althen Prong
3, “while noting that, in any event, the special master’s finding as to [Althen Prong 2]
independently supports affirmance” of the special master’s denial of compensation
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(internal citation omitted)).8
In evaluating whether a petitioner has met Althen Prong 2, the Federal Circuit has
instructed special masters to consider carefully the views of treating physicians.
“[M]edical records and medical opinion testimony are favored in vaccine cases, as
treating physicians are likely to be in the best position to determine whether ‘a logical
sequence of cause and effect show[s] that the vaccination was the reason for the injury.’”
Capizzano, 440 F.3d at 1326 (discussing Althen Prong 2) (alteration in original); see also
Simanski v. Dep't of Health & Hum. Servs., 601 F. App’x 982, 987–88 (Fed. Cir. 2015)
(“[M]edical records from treating physicians . . . can be ‘quite probative’ or ‘favored’
when considering issues relating to claims under the Vaccine Act.” (citing Capizzano, 440
F.3d at 1326)).
As a threshold matter, the Special Master correctly noted the Federal Circuit’s
preferred focus on treating physicians’ medical records when analyzing Althen Prong 2.
ECF No. 126 at 20. Ultimately, the Special Master concluded that “when considered as a
whole, the collection of statements from treating doctors do not persuasively show that
the [F]lu [V]accine caused Dr. Harvey’s [IgAV],” and therefore were insufficient “to meet
Dr. Harvey’s burden to show with preponderant evidence” a logical sequence of cause
and effect, demonstrating “that the flu vaccine was the cause . . . of his [IgAV].” Id. at 26.
In reaching that conclusion, the Special Master observed that the “bulk of
[Dr. Harvey’s] argument” regarding Althen Prong 2 involved “a chronology of some of
his medical appointments.” ECF No. 126 at 20. The Special Master aptly pointed out that
while that “presentation is not necessarily wrong . . . . [i]t is just incomplete[,]” and that
a “stronger argument with respect to [this prong] might draw upon statements from
8 In other words, even if a petitioner satisfies Althen Prongs 1 and 3, by proving “that a vaccine
can cause the injury at issue” (satisfying Althen Prong 1), and that “the injury was temporally
proximate to the vaccination” (satisfying Althen Prong 3), a petitioner must also show a “logical
sequence of cause and effect” connecting his injury to the vaccination. Capizzano v. Sec’y of Health
& Hum. Servs., 440 F.3d 1317, 1327 (Fed. Cir. 2006) (discussing Althen 418 F.3d at 1278). Simply
put, “[t]he second prong of the Althen[] Test is not without meaning.” Id. For example, “[a]
claimant could satisfy the first and third prongs without satisfying the second prong when
medical records and medical opinions do not suggest that the vaccine caused the injury.” Id. The
Special Master in this case — citing Capizzano and other instructive cases — correctly noted that
Dr. Harvey must satisfy Althen Prong 2 irrespective of whether he met his burden of proof as to
the other Althen Prongs. ECF No. 126 at 21.
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treating doctors.” Id. at 20-21. The Special Master thus took it upon himself to create a
comprehensive chart of potentially relevant opinions from various treating physicians.
Id. at 21-24.
Based on that chart, and after canvassing the entire medical record, the Special
Master made several important findings. First, the Special Master emphasized the
peculiar nature of Dr. Harvey’s claim — namely, that the Flu Vaccine directly caused
IgAV, but not the neuropathy, and that the neuropathy was a mere sequela to IgAV.
ECF No. 126 at 24. “Thus, [physician] statements that the [Flu Vaccine] caused Dr.
Harvey to suffer a neuropathy [were] off target,” given that was not even Dr. Harvey’s
claim. Id. (footnote omitted). Second, the Special Master highlighted another “aspect to
the chronology of medical appointments”: “often, the association between the Flu
Vaccine and [IgAV] was reported by Dr. Harvey,” but not by “independent opinions
offered spontaneously by his treating physicians.” Id. The Special Master cited
Dr. Harvey’s many communications with Dr. Hayden to demonstrate this pattern.
Id. at 24-25.
The Special Master then noted that Dr. Harvey, in his briefs, “relies most heavily,”
on the statement from Dr. Kuenzler to meet Dr. Harvey’s burden under Althen Prong 2.
ECF No. 126 at 25. In particular, Dr. Harvey relies on Dr. Kuenzler’s statement that the
“time course [of Dr. Harvey’s symptoms was] most compatible with post-vaccine
autoimmune response causing [IgAV] and neuropathy.” Id at 12.9 While acknowledging
that Dr. Kuenzler’s statement provides “some support” that the Flu Vaccine caused
Dr. Harvey’s IgAV, the Special Master pointed to Dr. Lang’s contrasting opinion. Id.
While visiting with Dr. Harvey, Dr. Lang noted that the “[h]istory furnished today of
9 The Special Master’s decision is particularly confusing on this issue because he mistakenly
attributes a quote from Dr. Scarsella’s medical records (that is unhelpful for Dr. Harvey) to
Dr. Kuenzler. ECF No. 126 at 25. While Dr. Kuenzler supports Dr. Harvey’s view that the Flu
Vaccine caused his IgAV, Dr. Scarsella rejected that conclusion. Id. at 12. Neither Dr. Harvey, in
his motion for review, nor the government, caught the mistaken quote in the Special Master’s
decision. See ECF No. 129 at 10-11; ECF No. 131 at 19. This error is immaterial, however, because
the Special Master correctly recognized that Dr. Kuenzler’s view supported Dr. Harvey’s claim.
In contrast, there is no indication that the Special Master believed that Dr. Scarsella supported
Dr. Harvey. Indeed, while Dr. Scarsella concluded that the Flu Vaccine directly caused
Dr. Harvey’s neuropathy, ECF No. 126 at 12, Dr. Scarsella rejected Dr. Harvey’s claim that the Flu
Vaccine caused the IgAV, which, in turn, caused the neuropathy. Id. At the end of the day, then,
the Special Master’s misquote was harmless.
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cutaneous reaction beginning as early as 8 hours after administration of influenza
vaccination would be unusual for a vasculitis process.” Id.
Weighing these conflicting physician statements, the Special Master gave more
weight to that of Dr. Lang, reasoning that he “is an immunologist” and, as such, “his
opinion regarding the time of an adverse reaction to a vaccine is more credible than the
opinion of someone, like Dr. Kuenzler, who appears not to specialize in immunology.”
ECF No 126 at 25-26.10 A special master may — and oftentimes must — weigh conflicting
treating physicians’ testimony; it is not error to conclude that one opinion is more
persuasive than another. See, e.g., Hibbard v. Sec’y of Health & Hum. Servs., 698 F.3d 1355,
1368 (Fed. Cir. 2012) (upholding special master’s Althen Prong 2 analysis where the
special master weighed an “array of different opinions among [] examining and treating
physicians as to the cause” of the alleged vaccine-induced illness — where some
physicians connected it to the vaccine and some did not — and ultimately determined
that the petitioner did not meet his burden).
In arguing that the Special Master’s analysis of Althen Prong 2 was arbitrary and
capricious, ECF No. 129 at 10-12, Dr. Harvey’s position boils down to a simple assertion:
the Special Master erroneously determined that Dr. Lang’s opinion was more credible
than Dr. Kuenzler’s. According to Dr. Harvey, “the special master left out critical facts
and statements from Dr. Lang[] . . . .,” which, taken together, effectively weakens Dr.
Lang’s overall conclusion. Id. at 11. In particular, Dr. Harvey notes that Dr. Lang made
his assessment without the benefit of having reviewed Dr. Harvey’s medical records from
two physicians he visited soon after taking the Flu Vaccine — Dr. Boucher and Dr. Musiek
—and that Dr. Lang admitted as much in his report. Id. at 11-12. Both Drs. Boucher and
Musiek diagnosed Dr. Harvey with IgAV, documenting his complaints about the
occurrence of severe rashes mere hours after taking the Flu Vaccine.
Nevertheless, Dr. Harvey’s argument is unpersuasive. Dr. Lang acknowledges, as
10 As discussed supra, two additional doctors expressed an opinion regarding whether the Flu
Vaccine likely caused Dr. Harvey’s IgAV: Dr. Scarsella and Dr. Forte. ECF No. 126 at 25-26.
Dr. Forte’s opinion supported the existence of such a causal relationship, while Dr. Scarsella’s
undermined it. Id. The Special Master, however, did not discuss either of those opinions in his
Althen Prong 2 analysis. See ECF No. 126 at 20-26. But, given that those opinions merely add an
additional treating physician’s support for each side, and because neither Dr. Scarsella nor Dr.
Forte is a neurologist, see id. at 12, such omission does not meaningfully alter the Special Master’s
analysis.
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a given, that Dr. Harvey suffered from IgAV soon after receiving the Flu Vaccine — that
fact is not contested now before this Court or previously before the Special Master. But
Dr. Lang simply opines that the Flu Vaccine was unlikely to have been the cause of
Dr. Harvey’s IgAV given the tight timeline between the Flu Vaccine and the onset of
IgAV symptoms. Furthermore, Drs. Boucher and Musiek did not themselves express an
opinion on whether the Flu Vaccine caused Dr. Harvey’s IgAV. Accordingly, this Court
cannot conclude that, had Dr. Lang reviewed the medical records from Dr. Harvey’s visits
with Drs. Boucher and Musiek, Dr. Lang might have reached a different causal
explanation. Regardless, the Special Master’s determination on this record is well within
his discretion. In sum, Dr. Harvey’s single grievance with respect to the Special Master’s
Althen Prong 2 analysis lacks merit.
More generally, however, this Court concludes that the Special Master correctly:
(1) articulated Dr. Harvey’s burden with respect to Althen Prong 2; (2) summarized the
pertinent facts and evidence; (3) arrived at conclusions of fact supported by the record;
and (4) weighed conflicting treating physician testimony, while expressing a reasoned
basis for the weight ultimately given to each. On that basis, the Special Master reasonably
held that Dr. Harvey did not meet his “burden to show with preponderant evidence that
the flu vaccine was the cause-in-fact of his [IgAV].” ECF No. 126 at 26. Because the
Special Master “considered the relevant evidence of record, [drew] plausible inferences
and articulated a rational basis for [his] decision,” Hines, 940 F.2d at 1528, this Court
cannot find that the Special Master’s determination, with respect to Althen Prong 2, is
“arbitrary, capricious an abuse of discretion, or otherwise not in accordance with the
law.” Markovich, 477 F.3d at 1355-56 (quoting 42 U.S.C. § 300aa–12(e)(2)(B)).11
C. The Special Master Did Not Articulate a Reasoned Basis for
Concluding that Petitioner Failed to Meet Althen Prongs 1 and 3
Although this Court affirms the Special Master’s overall denial of compensation
due to his well-reasoned decision regarding Althen Prong 2, we nevertheless address
Dr. Harvey’s critique of the Special Master’s conclusions regarding the other two Althen
Prongs. Althen Prong 1 requires a petitioner “to show by preponderant evidence . . . a
medical theory causally connecting the vaccination and the injury,” while Prong 3, in
11 This Court further notes, in support for the Special Master’s determination, that Dr. Harvey
only first raised the potential of his Flu Vaccine causally contributing to his IgAV well after his
IgAV-related symptoms had fully disappeared.
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turn, requires “a showing of a proximate temporal relationship between vaccination and
injury.” Althen, 418 F.3d at 1278. In that regard, Prongs 1 and 3 are somewhat related, as
a petitioner must demonstrate not only a “proximate temporal relationship” between the
vaccine and the injury, but also that the injury occurred in a medically acceptable
timeframe given the medical theory being offered. See Bazan v. Sec'y of Health & Hum.
Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).12
In contrast with the Special Master’s thorough Althen Prong 2 analysis, the Special
Master provided only a brief explanation in support of his conclusion that Dr. Harvey
failed to prove Althen Prongs 1 and 3 by preponderant evidence. ECF No. 126 at 18, 20.
With respect to Althen Prong 1, the Special Master — after documenting and
swiftly dismissing an insufficient theory put forward by Dr. Harvey in connection with
“abnormal immunological activation” — catalogued several other theories Dr. Harvey
posited. ECF No. 126 at 17-18. Specifically, the Special Master noted that Dr. Harvey
suggested that the Flu Vaccine caused “cytokines,” issues with the “complement system,”
or an “immune complex deposition.” Id. Then — absent any analysis as to what those
theories entail — the Special Master concluded that Dr. Harvey and his experts did not
explain “why [they] are sound and reliable,” and “failed to connect [those] theories to
what is known about [IgAV].” Id at 17-18. While acknowledging that “[p]ersuasive
evidence shows [IgAV] is due, in part,” to defective IgA, the Special Master concluded
that “Dr. Harvey [had] not reliably linked cytokines, complement, and/or immune
complexes to defective IgA.” Id. at 18.
With respect to Althen Prong 3, the Special Master first emphasized how “any
theory Dr. Harvey could propose[,] is limited by the sequence of events in that the [IgAV]
appeared within 24 hours of the [Flu Vaccine],” as Dr. Harvey admitted in his briefs.
12 As an illustration, even if symptoms of an injury occur within mere hours of a vaccine, a
petitioner will not meet his burden under Althen Prong 3 if the medical theory posits that the
vaccine caused an ailment for which the medically acceptable timeframe for post-exposure
symptoms is a few days. Bazan, 539 F.3d at 1352. Thus, in practice, Althen Prong 3 “can be
broken down into two steps.” Goodwin v. Sec’y of Health & Hum. Servs., 2024 WL 4758470, *2 (Fed.
Cl. Oct. 10, 2024). First, a petitioner must “establish the timeframe for which it is medically
acceptable to infer causation, that is, the timeframe in which symptoms would be expected to
arise if the [disorder] was caused by the vaccination.” Id. Second, the petitioner must “show that
the onset of [the disorder] occurred during this causation period.” Id. (alterations in original)
(quoting Shapiro v. Sec’y of Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011)).
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ECF No. 126 at 18. Thereafter, the Special Master sided with the government’s expert,
and concluded that there was a “reliable basis for finding that the medically appropriate
interval” for IgAV-related symptoms, was “at least three days after exposure to the
triggering infection or agent.” Id. at 18-19. As for Dr. Harvey’s opposing theory, the
Special Master addressed it with merely a single sentence: “By way of contrast,
Dr. Gershwin’s opinion that the flu vaccine can cause [IgAV] to occur within one day[,]
lacks reliability, is poorly explained, and is not persuasively supported by any medical
or scientific articles.” Id. at 19.
Dr. Harvey contends that the Special Master’s conclusions as to Althen Prongs 1
and 3 were arbitrary and capricious. ECF No. 129 at 6, 12. Dr. Harvey argues that, inter
alia, the Special Master did not sufficiently articulate relevant facts, evaluate the evidence
proffered, or provide a reasoned basis for his conclusions. Id. at 6-17.13 With respect to
Althen Prong 1, specifically, Dr. Harvey argues that the Special Master “did not provide
any substantive discussion regarding [Dr. Harvey’s] medical theory and medical
literature.” Id. at 9-10. Dr. Harvey primarily relies on this Court’s decision in Goodwin in
which the Court held that a special master’s “conclusory statements alone are
insufficient” to uphold a special master’s finding and that, instead, a “finding must be
supported by a reasoned explanation.” Goodwin, 2024 WL 4758470, at *3.14
In Goodwin, the sole issue before the Court was the special master’s analysis under
Althen Prong 3. Goodwin, 2024 WL 4758470, at *1. Judge Somers highlighted several
problems with the special master’s analysis of the petitioner’s proffered evidence,
including: (1) only two sentences of the fact section “arguably” related to Althen Prong
3; (2) in dismissing an expert opinion, the special master, “in [] conclusory fashion” —
and without identifying a single flaw — determined that the expert “had not
persuasively” supported his opinion; and (3) when analyzing a case study proffered by
the petitioner’s expert, the special master asked a “critical question” relating to the
study’s reliability, but “in what seem[d] to be a trend,” the Special Master did not answer
that question, and instead simply dismissed the study as unreliable. Id. at *3-4. Judge
Somers thus concluded that “although the result the special master reached . . . may
13 Dr. Harvey only raises this argument in connection with the Special Master’s Althen Prong 1
analysis. ECF No. 129 at 9-10.
14 Nor is it “adequate [for a special master] to summarize and reject arguments without explaining
why. . . .” Goodwin, 2024 WL 4758470, at *3 (quoting In re NuVasive, Inc., 842 F.3d 1376, 1383 (Fed.
Cir. 2016)).
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[have] ultimately be[en] correct, the Court simply [could] not sustain the result based on
the reasoning given.” Id. at *6. The Court, therefore, remanded the case to the special
master to “articulate a basis for his decision that the Court [could] consider under the
prescribed standard. . . .” Id.
There are remarkable similarities between this case and Goodwin with respect to
the Special Master’s analysis of Althen Prongs 1 and 3. For starters, the Special Master’s
fact section is virtually devoid of facts relating to Althen Prongs 1 and 3. See generally ECF
No. 126 at 1-14. Indeed, the Special Master’s fact section contains no details as to what
Dr. Harvey proffered to satisfy his burden pursuant to Althen Prongs 1 and 3. The Special
Master dismissed Dr. Harvey’s various medical theories under Althen Prong 1 “in
conclusory fashion,” Goodwin 2024 WL 4758470, at *3. Moreover, “in what seems to be a
trend,” Id. at *4, the Special Master dismissed Dr. Harvey’s expert’s opinion with respect
to Althen Prong 3 in a single conclusory sentence, noting that his opinion “lack[ed]
reliability, [was] poorly explained, and [was] not persuasively supported by any medical
or scientific articles.” ECF No. 126 at 19.
As such, just like in Goodwin, this Court is left with many unanswered questions.
For example, what are Dr. Harvey’s medical theories (other than that they involve
“cytokines,” issues with the “complement system,” or an “immune complex
deposition”)? Why are they not reliable? And, why did the Special Master conclude that
Dr. Harvey and his experts failed to connect those theories to IgAV? ECF No. 126 at 17-18.
While the Special Master notes “Dr. Harvey [had] not reliably linked cytokines,
complement, and/or immune complexes to defective IgA[,]” id. at 18, the Special Master
did not address either Dr. Harvey’s hypotheses regarding how the various mechanisms
caused defective IgA, or why those proposed links were not reliable. Similarly, the
Special Master’s single conclusory sentence, rejecting Dr. Gershwin’s opinion that the Flu
Vaccine can cause IgAV-related symptoms within one day of exposure, “leaves the
reviewing Court to ask,” Goodwin 2024 WL 4758470, at *3, why the opinion “lacks
reliability”? How is Dr. Harvey’s opinion “poorly explained”? What medical and
scientific articles, if any, support Dr. Harvey’s opinion? How is his opinion not
“persuasively supported” by those articles? ECF No. 126 at 19.
In sum, the Special Master’s conclusory statements regarding the alleged
shortcoming of the evidence Dr. Harvey proffered to satisfy his burden pursuant to
Althen Prongs 1 and 3 “do not give the Court a reasoned basis from which it can review
the special master’s determination[s].” Goodwin 2024 WL 4758470, at *3. The arbitrary
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and capricious standard “requires that the [special master] not only have reached a sound
decision, but have articulated the reasons for that decision.” Id. (emphasis added) (quoting
In re Sang Su Lee, 277 F.3d 1338, 1342 (Fed. Cir. 2002)). The Special Master has not done
so here.
Nevertheless, because this Court upholds the Special Master’s Althen Prong 2
analysis, as explained supra — and that provides a sufficient, independent basis to affirm
the Special Master’s overall conclusion, Greene, 841 F. App’x at 201–03 — this Court need
not remand this case to the Special Master for further analysis of Althen Prongs 1 and 3.
VI. CONCLUSION
Given the Special Master’s analysis and conclusion with respect to Althen Prong 2,
this Court finds that the Special Master’s overall decision regarding causation-in-fact was
not arbitrary, capricious, or otherwise contrary to law. Accordingly, this
Court AFFIRMS the Special Master’s decision. The Clerk shall enter JUDGMENT for
the Respondent, dismissing this petition.
IT IS SO ORDERED.
s/Matthew H. Solomson
Matthew H. Solomson
Chief Judge
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