Harvey v. Secretary of Health and Human Services

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

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 BACKGROUND 2

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.

2

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

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

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

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

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.

7

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

8

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.”).

9

§ 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

10

(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.

11

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.

12

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)).

15

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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