Pelelo v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 17-1485V

(to be published)

***************************** Chief Special Master Corcoran

*

THOMAS PELELO, *

* Filed: August 6, 2021

Petitioner, *

*

v. *

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

*

Respondent. *

*

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

James Cook, Dutton, Daniels, Hines, Kalkhoff, Cook & Swanson, PLC, Waterloo, IA, for

Petitioner.

Catherine Stolar, U.S. Dep’t of Justice, Washington, DC, for Respondent.

ENTITLEMENT DECISION 1

On October 10, 2017, Ann Pelelo, mother of Thomas Pelelo, filed a petition on his behalf

for compensation under the National Vaccine and Injury Compensation Program (the “Vaccine

Program”). 2 (ECF No. 1) (“Petition”). The Petition alleged that Mr. Pelelo experienced Parsonage-

Turner syndrome, a/k/a brachial neuritis, after receipt of a human papillomavirus (“HPV”) vaccine

on December 29, 2015. Petition at 1. The caption was changed once Mr. Pelelo became 18 years

1

This Decision shall be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of

2002, 44 U.S.C. § 3501 (2012)). This means that the Decision will be available to anyone with access to the

internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion

of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days

within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial

or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the

disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the

whole Decision will be available to the public. Id.

2

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

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

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

old, and hence the proper petitioner/party in interest. Order, dated September 19, 2019 (ECF No.

44).

I determined that this matter could be most efficiently resolved via ruling on the record.

Based on that record and the parties’ other written submissions, I find that Petitioner has not carried

his evidentiary burden. Insufficient evidence supports the conclusion that the HPV vaccine can

cause brachial neuritis, or did so to Petitioner in this case.

I. Factual Background

Mr. Pelelo was born on August 6, 2001. Ex. 2 at 1. His prior medical history included

lumbar, right foot, and left lower extremity pain. Ex. 6 at 1-2 (December 2015 appointments with

chiropractor for lumbar and right foot pain); see also Ex. 15 at 191, 193. Petitioner received his

first dose of HPV vaccine on October 16, 2015, in his left deltoid. Ex. 2 at 1. The record does not

reveal he experienced any reaction to it, and sets forth no symptoms associated with this claim

before the next dose he received.

Vaccination and Initial Symptoms

Petitioner received his second HPV vaccine dose on December 29, 2015, again in his left

deltoid. Ex. 2 at 1; Petition at 1. Petitioner has reported awakening the morning after he received

this dose, with numbness and disability of the left arm. Id. Petitioner has also stated in another

declaration that he “attended swim practice the day after” receiving his second HPV vaccination,

but at that time “had great difficult[y] moving [his] left shoulder.” Letter, filed as Ex. 32 on Sept.

1, 2020 (ECF No. 56-1), at 1.

Less than two weeks later, on January 11, 2016, Mr. Pelelo presented to his existing

chiropractor. Ex. 6 at 3. At this time, Petitioner appears to have complained of tightness between

his shoulder blades, worse on the left side, with the “date of the condition” identified as “1/8/16 –

swim.” Id. He was referred to his pediatrician for follow-up. Id. Later that same day, Ann Pelelo

phoned Petitioner’s pediatrician’s office (as reflected in a note of the call memorialized in the

record), stating that her son could not move his arm, and was self-treating with ibuprofen but

without relief. Ex. 3 at 25-26. She also reported that Petitioner had been “evaluated by [a] swim

coach and [an] athletic trainer as well as a chiropractor and felt there was nerve damage” relating

to Petitioner’s December 29, 2015 HPV vaccine dose. Id. Petitioner was now referred to an

orthopedist. Id. at 26.

On January 12, 2016, Mr. Pelelo underwent an orthopedic assessment with Dr. Steven

Rock to evaluate his left shoulder pain, which was reported to have begun “shortly after receiving

his HPV vaccine on December 29, 201[5].” Ex. 3 at 15. The history of present illness noted that

Petitioner’s pain was “more periscapular and in the area of the upper trapezius,” with weakness

and associated difficulty “forward flexing or abducting the shoulder.” Id. The pain associated with

his symptoms made it difficult to for him to swim competitively. Id.

2

Upon examination, Petitioner displayed tenderness “over the supraspinatus, infraspinatus

and upper trapezius on the left,” with mild tenderness in the deltoid area and reduced left upper

extremity strength. Ex. 3 at 16. Dr. Rock opined that “[p]resumptively,” Petitioner had Parsonage-

Turner syndrome, “which [was] felt to be a potential autoimmune response or inflammatory

disorder [that] can occur post immunization, post illness or sometimes after injury.” Id. Dr. Rock

added, however, that specific testing—an electromyography (“EMG”) and/or nerve conduction

study (“NCS”)—could help “solidify the diagnosis.” Id. Dr. Rock prescribed a Medrol Dosepak

and ordered physical therapy. Id.

On January 19, 2016, Mr. Pelelo went back to Dr. Rock, now reporting that his pain had

not improved. Ex. 3 at 14. On exam, he revealed “no obvious scapular winging, although there

[wa]s potentially some subtle winging on the left developing.” Id. Dr. Rock referred Petitioner to

a neurologist to obtain a definitive diagnosis, and to “evaluate for any other potential possibilities.”

Id. at 15. A week later (January 28th), Mr. Pelelo saw neurologist Dr. Marsha Horwitz. Id at 8. The

history from this visit reports that Petitioner was experiencing “left shoulder numbness, pain and

unable to l[i]ft arm since 2 weeks after HPV injection,” although it also stated he has felt “a feeling

of tightness in his left shoulder the following day” after vaccination. Id. On exam, Petitioner’s left

upper extremity weakness was confirmed. Id. at 9. Dr. Horwitz’s diagnosis was “[l]eft brachial

plexopathy, autoimmune, consistent with [PTS].” Id. at 10.

Subsequent Treatment and Evaluation

On February 24, 2016, Mr. Pelelo was evaluated at the University of Iowa’s Sports

Medicine Clinic (the “Sports Medicine Clinic”). Ex. 3 at 40. The history of present illness section

of the record from this visit is consistent with Petitioner’s initial witness statement, both of which

report a reaction within a day of vaccination. Thus, this record’s history states that after the HPV

vaccine dose at issue, Petitioner had “proceeded to swim practice that night with no problems,”

but awoke the next day with numbness, and could not thereafter swim. Id. The history also noted,

however, that Petitioner’s PTS initial diagnosis had been arrived at “without an EMG.” Id. His

examination showed “severe scapular winging during forward flexion and extension indicating

serratus anterior dysfunction.” Id. at 42. He also had “[m]ild sensation loss of [his] dorsal hand

and fingers” on the left. Id.

EMG and NCS studies were performed at the Sports Medicine Clinic (now approximately

eight weeks post-vaccination), but they did not corroborate the brachial neuritis diagnosis. Rather,

they showed “no electrophysiologic evidence of either left brachial plexopathy, long thoracic

neuropathy, or other neuropathy typically involved in scapular winging.” Ex. 4 at 129. In

particular, Petitioner’s needle EMG was deemed “essentially normal.” Id. By contrast, his “left

median distal latencies were slightly prolonged” in the NCS, leading to an “incidental finding of

very mild median neuropathy at the wrist,” but his median motor and sensory studies were

otherwise normal. Id. The EMG/NCS was signed by neurologist Dr. Heather Bingham, who

certified that she was “present during the examination and concur[ed] with the findings and

interpretation of th[e] report.” Id.

3

In the subsequent months, Mr. Pelelo was extensively treated for his presumed brachial

neuritis. In March 2016, he began receiving intravenous immunoglobulin (“IVIG”) therapy, after

failing to improve with physical therapy. Ex. 3 at 47. The admission note indicated that Petitioner

had received an HPV vaccine dose on December 29, 2015, and “[t]hat night, he attended swim

practice and noted mild discomfort and weakness.” Id. Petitioner reported that “his pain gradually

ended but that he continues to have intermittent decreased sensation and tingling down his arm

and to his central three fingers.” Id. Petitioner’s treating physicians had expressed confidence in

the brachial neuritis diagnosis, even though their notes specifically acknowledged that on EMG

Petitioner had displayed “no electrophysiologic findings for left brachial plexopathy, long thoracic

neuropathy, or other neuropathy.” Id. at 47-48. Petitioner received two IVIG infusions that month.

Id. at 45.

By the end of March 2016, it appeared Mr. Pelelo had largely recovered, with resolution

of his pain and a return to his former strength. Ex. 3 at 35. At most, he displayed “slightly

diminished muscle bulk” of his left shoulder, as compared to his right, and mild scapular winging.

Id. He was now able to return to swimming, and although he continued to pursue physical therapy,

he could pursue athletic activities without pain. Ex. 5 at 4-5. As of May 2016, however, Petitioner

reported a plateauing in his recovery, with “decreased ROM and more weakness with manual

muscle testing.” Id. at 5. To gain a better understanding of the presentation, Dr. Andrew Peterson

at the Sports Medicine Clinic ordered an MRI, but the results were deemed normal. Ex. 3 at 30,

33.

Into the summer of 2016, Petitioner continued to pursue competitive sports without pain,

“but fe[lt] limited in some of the movements.” Ex. 5 at 3. Then, on July 14, 2016, Mr. Pelelo

informed his physical therapist that his left shoulder pain had worsened “over the past 7-10 days,”

although his physical therapist associated it with over-exertion and effort rather than related to

Petitioner’s earlier brachial neuritis diagnosis. Id. By the fall of 2016, Petitioner’s physical therapy

was discontinued. Id. at 2.

Subsequent evaluations revealed some persistent/lingering left shoulder pain, confirming

the sense that Mr. Pelelo’s overall condition had plateaued since May, although his range of motion

was near normal. Ex. 3 at 117-18. By early November 2016, Petitioner received a release from his

pediatrician to return to “swim team and swimming in P.E.” See Ex. 3 at 112. Thereafter, Mr.

Pelelo continued to report left shoulder pain that he said interfered with his athletic pursuits, and

he pursued chiropractic treatment from 2017 to 2019. Ex. 6 at 15 (December 23, 2016 appointment

with chiropractor reporting radiating pain from thoracic region into left shoulder); see also Ex. 19.

Records from his more recent medical history do not shed light on the claims asserted herein.

4

II. Expert Reports

A. Petitioner’s expert: Alan J. Fink, M.D.

Dr. Fink, a neurologist, filed three reports. Report, dated August 14, 2018, filed as Ex.

9 (ECF No. 22-1) (“First Fink Rep.”); Report, dated December 13, 2019, filed as Ex. 22 (ECF

No. 46-1) (“Second Fink Rep.”); Report, dated August 16, 2020, filed as Ex. 36 (ECF No. 36-

001) (“Third Fink Rep.”). Dr. Fink endorsed brachial neuritis as the proper diagnosis for

Petitioner’s injury, and that the HPV vaccine had likely caused it. First Fink Rep. at 3-5.

Dr. Fink is a neurologist in private practice in Greenville, Delaware, and an examiner

for the Social Security Administration. See Ex. 10 (ECF No. 22-2) (Dr. Fink’s Curriculum

Vitae (“CV”)) at 2. He received his medical degree in 1970 from State University of New York

– Buffalo School of Medicine, and did a residency in medicine at Nassau County Medical

Center, followed by a neurology residency at Yale-New Haven Hospital. CV at 1-2. He also

held MRI-related fellowships thirty-plus years ago. Id. at 1. He has received several “best

doctor-neurology” awards from a Delaware regional magazine, and is board certified in

neurology. Id. at 2-3. He holds the position of Clinical Assistant Professor of Neurology at

Thomas Jefferson Medical College in Philadelphia, Pennsylvania. Id. at 3. Over his 47 years

of practice, Dr. Fink recalls encountering “the neurological complications of vaccines”

presenting as brachial neuritis twice, although he also treated the same condition twice where

it did not arise in connection with vaccination. First Fink Rep. at 1.

First Report

Dr. Fink began his first report with a brief review of Mr. Pelelo’s medical history

consistent with the medical record, beginning well prior to vaccination. First Fink Rep. at 1-3.

He specifically accepted the conclusion that Petitioner’s onset occurred within 24 hours of his

receipt of a second HPV vaccine dose. Id. at 3.

Dr. Fink then characterized brachial neuritis as “a condition that causes pain and

weakness of the shoulder girdle muscles and/or of the upper extremity muscles.” First Fink

Rep. at 3. He noted that “[a]utoimmune and immunizations” are an understood cause for

brachial neuritis, and maintained it was reasonable to view it as immune-mediated. J. Van Eijk

et al., Neuralgic Amyotrophy: An Update on Diagnosis, Pathophysiology, and Treatment, 53

Muscle Nerve 337-50 (2016), filed as Ex. 25 on Dec. 16, 2019 (ECF No. 46-4) (“Van Eijk”),

at 339-40. Another article Dr. Fink had offered showed that between 30 to 85 percent of all

case involving assumed immune-mediated responses occurred three to fourteen days after

vaccination, and thus somewhat acutely (although obviously less so than Petitioner avers

occurred in his case). First Fink Rep. at 3; P. Debeer et al., Brachial Plexus Neuritis Following

HPV Vaccination, 26 Vaccine 4417-19, 4418 (2008), filed as Ex. 11 on Aug. 28, 2018 (ECF

No. 22-3) (“Debeer”) (describing brachial neuritis as presenting with “sudden severe pain”).

Debeer, however, is a single-subject case report, observing one case of brachial neuritis in a

5

19 year-old woman that manifested one month after the second HPV dose—not one day.

Debeer at 4417.

Regarding causation, Dr. Fink observed that post-vaccination brachial neuritis had

been observed in connection with a number of vaccines, and specifically noted that case reports

existed suggesting the HPV vaccine was associated with 16 incidents of brachial neuritis

(although Dr. Fink’s report provides no citation for this assertion). First Fink Rep. at 4. 3 He

proposed, however, that these occurrences were likely under-reported, since “neuritic pain is

often related to a shoulder joint problem.” Id He provided no other explanation in this report

for how the HPV vaccine might trigger or cause brachial neuritis.

Dr. Fink also provided some examples from the medical record that he maintained

supported his opinion that the HPV vaccine caused Mr. Pelelo’s brachial neuritis. He observed

that Petitioner’s treaters had made the diagnosis based on the evidence of “sudden and severe

pain followed by atrophic weakness of the shoulder muscles and dyskinesia.” First Fink Rep.

at 4-5. Mr. Pelelo also did not see a return to normal muscle function, which Dr. Fink said is

characteristic in more than half of all brachial neuritis cases. Id. at 4. And Petitioner had

experienced some recurrence as well, which also was not unusual. Id.; Van Eijk at 339.

Dr. Fink admitted that some important diagnostic criteria—in particular, Petitioner’s

MRI or EMG results—did not confirm the brachial neuritis diagnosis. First Fink Rep. at 4.

However, he discounted the importance of such findings, arguing that this was not an unusual

outcome and did not per se rule out the diagnosis. Id.

Second Fink Report

Dr. Fink’s second report responded both to challenges raised in the report of Respondent’s

expert, as well as questions posed to him directly by the special master previously presiding over

the case. First, Dr. Fink noted other aspects of the medical record that he maintained supported the

brachial neuritis diagnosis. In particular, scapular winging (which he deemed a potential result of

brachial neuritis) was observed at a May 2016 exam conducted by the University of Iowa Sports

Clinic. Second Fink Rep. at 1. Mr. Pelelo’s lack of complete recovery even as late as the fall of

2016 was also consistent with the diagnosis. Id. at 1, 4. And the kind of ongoing “prolonged

weakness” Petitioner had experienced was seen in at least a quarter of brachial neuritis cases. Id.

at 3.

More of Dr. Fink’s second report was devoted to explaining why he did not consider the

normal MRI and EMG results to be inconsistent with a brachial neuritis diagnosis. He noted

literature stating that only about six percent of brachial neuritis cases featured abnormal MRI

3

At most, one of the case reports filed in the matter states that 17 instances of “brachial plexopathy” were reported by

passive surveillance systems of reported adverse effects after the HPV vaccine. Taras et al., Brachial Neuritis

Following Quadrivalent Human Papilloma Virus (HPV) Vaccination, 6 Hand 454-456 (2011), filed as Ex. 12 on Aug.

28, 2018 (ECF No. 22-4) at 456. As discussed herein, however, that kind of data does not receive significant weight

in Program cases.

6

results. Second Fink Rep. at 2; Van Eijk at 339. The same was generally true of EMGs, even

though they admittedly were often relied upon by neurologists to confirm the diagnosis. Second

Fink Rep. at 2; Van Eijk at 343. EMGs were in fact often “fraught with sampling error,” and thus

might well fail to demonstrate abnormalities demonstrated in clinical evidence, and thus optimally

two should be performed (although that did not occur here). Second Fink Rep. at 2, 3; Van Eijk at

342 (“[a] normal motor nerve conduction study examination does not exclude brachial plexitis as

a diagnosis”). Dr. Fink also observed that in Petitioner’s case, it appeared the EMG/NCS was

performed not by a neurologist but by a technician less skilled at the task. Second Fink Rep. at 3.

In response to questions raised by the special master about the likely pathophysiology of

Petitioner’s injury attributable to vaccination—a matter not explored in any detail in his the first

report—Dr. Fink proposed a multi-factored process. A genetic predisposition carried by the injured

party would, in his view, likely interact with (a) a mechanical injury to a nerve (in this case, Mr.

Pelelo swimming the day after receipt of the second HPV dose), and (b) a vaccine-instigated

immune system reaction, producing an autoimmune process. Second Fink Rep. at 3; N. van Alfen

et al., Treatment for Idiopathic and Hereditary Neuralgic Amyotrophy (Brachial Neuritis)

(Review), (3) Cochrane Database of Systematic Reviews, Art. No.: CD006976, 1-6 (2009), filed

as Ex. 28 on Dec. 16, 2019 (ECF No. 46-7) (“van Alfen I”); M. Martinez-Lavin, Hypothesis:

Human Papillomavirus Vaccination Syndrome—Small Fiber Neuropathy and Dysautonomia

Could be its Underlying Pathogenesis, 34 Clin. Rheumatol. 1165-69 (2015), flied as Ex. 26 on

Dec. 16, 2019 (ECF No. 46-5) (“Martinez-Lavin”).

Martinez-Lavin does not specifically address brachial neuritis. Rather, it puts forth the

hypothesis that small fiber neuropathy and dysautonomia (both of which it deems manifestations

of “[s]ympathetic nervous system dysfunction”) could constitute the underlying pathogenesis for

a group of rare overlapping reactions (complex regional pain syndrome, postural orthostatic

tachycardia syndrome, etc.), that often are reported in passive surveillance as adverse responses to

receipt of the HPV vaccine. Martinez-Lavin at 1165. Indeed, Martinez-Lavin notes that adverse

reactions appear to be more frequent after HPV vaccination when compared to other types of

immunizations, although the article does not flesh out a causal relationship. Id. Brachial neuritis

could, therefore, in Dr. Fink’s view plausibly reflect the same kind of “HPV syndrome.” Evidence

that the process causing brachial neuritis was likely immune-mediated was also provided by other

literature suggesting “[t]he presence of multimodal mononuclear infiltrates . . . and antiganglioside

antibodies” in the blood serum of patients with the condition. Second Fink Rep. at 3. 4

Third Fink Report

4

Dr. Fink’s report cites a particular article for this assertion. Z. Simmons, Electrodiagnosis of Brachial Plexopathies

and Proximal Upper Extremity Neuropathies, 24 Phys. Med. Rehabil. Clin. N. Am. 1-20 (2013), filed as Ex. 29 on

Dec. 16, 2019 (ECF No. 46-8) (“Simmons”). Respondent filed the same article. See Ex. C. However, I cannot locate

in Simmons where the autoimmune nature of brachial neuritis is discussed. The sections of Simmons highlighted by

Petitioner do not at all deal with the subject, and the more general focus of Simmons is on the utility of the use of

EMG and NCS testing.

7

Dr. Fink’s final report, the longest of the three, endeavored to answer several additional

questions posed by the special master formerly presiding over the matter about Petitioner’s

causation theory. First, Dr. Fink discussed what he would deem a “medically acceptable” onset for

HPV vaccine-caused brachial neuritis. Third Fink Rep. at 2. Dr. Fink noted that some literature

supported an onset of 3-14 days, and hence a timeframe longer than what Petitioner alleges to have

experienced, but added that the “consensus current working opinion” is that onset occurs “acutely”

—which, in his view, supported a single-day onset. Id; M. Bromberg, Brachial Plexus Syndromes

– UpToDate (Aug. 8, 2018), https:www.uptodate.com/contents/brachial-plexus-

syndromes/print?search=…, filed as Ex. 14 on Aug. 28, 2018 (ECF No. 22-6) (“Bromberg”).

Bromberg briefly reviews the underlying anatomy, pathogenesis, and general clinical features of

brachial plexopathies, and discusses a number of specific plexopathies classified by clinical

setting. Bromberg at 1. Bromberg distinguishes between acute and insidious onset of symptoms

from brachial plexopathies. Id. at 3. However, no actual timeframe (measuring from trigger to

symptoms manifestation of brachial neuritis) is discussed in this article. Acute and insidious onset

are distinguished in terms of pain occurring in the shoulder or upper arm, versus progressive pain

and evolving weakness. Id. It is thus not self-evident from Bromberg that “acute” can be

interpreted as Dr. Fink proposes, since the term’s usage seems intended to describe degree and

temporal intensity of pain (i.e. coming on unexpectedly and severely), rather than the timeframe

from trigger to symptoms.

Second, Dr. Fink disputed that certain sports activities relevant in this case could be the

cause of brachial neuritis independent of vaccination. He felt instead that “thoracic outlet

syndrome” would be the proper diagnostic descriptor for such a sports-related injury arising from

Petitioner’s pursuits (swimming and baseball). Third Fink Rep. at 3. But in any such case, the

symptoms would be “significantly different” from what Petitioner experienced. Id. Brachial plexus

injuries do not appear associated with swimming or baseball, but instead with other kinds of

contact sports (football, rugby) or biking. Id. And they would feature secondary clinical indicia

reflective of their severity (broken bones, collapsed lungs). Id. At bottom, the kind of neurologic

symptoms characterizing Mr. Pelelo’s injury were not akin to the orthopedic-in-nature symptoms

common to a swimming injury. Id.

Dr. Fink also provided further explanation for the biological process through which he

contended the HPV vaccine would theoretically cause brachial neuritis. Third Fink Rep. at 4. He

proposed it would occur either via “direct antigenic attack” on brachial plexus nerves, or through

“focal inflammation of vessels of the nerve” resulting in axonal damage. Id; G. Chavada & H.

Willison, Autoantibodies in Immune-Mediated Neuropathies, 25(5) Current Opinions –

Neurology, 550-55, 555 (Oct. 2012), filed as Ex. 30 on Dec. 16, 2019 (ECF No. 46-9). The fact

that Petitioner had already received the HPV vaccine (two months before) had effectively “primed”

his immune system to respond more quickly after a second dose. Third Fink Rep. at 4.

Besides the above, Dr. Fink repeated his prior contentions that the absence of EMG

abnormalities in Petitioner’s case was not significant, especially since the test appeared not to have

8

been performed by a physician capable of performing the test or interpreting the results properly.

Third Fink Rep. at 4-5, 7. He also again referenced medical record evidence supporting his view

that Petitioner’s condition had persisted (despite some contrary evidence suggesting

improvement). Id. at 5-7.

B. Respondent’s expert: Peter Donofrio, M.D.

Dr. Donofrio acted as Respondent’s expert and filed three written reports. Report, dated

June 11, 2019, filed as Ex. A (ECF No. 34-1) (“First Donofrio Rep.”); Report, dated April 23,

2020, filed as Ex. L (ECF No. 51-1)(“Second Donofrio Rep.”); Report, dated December 17, 2020,

filed as Ex. P (ECF No. 60-1)(“Third Donofrio Rep.”). He contested the accuracy of Petitioner’s

diagnosis, and otherwise disputed the assertion that the HPV vaccine can cause brachial neuritis.

Dr. Donofrio is a professor of neurology and director of the MDA and ALS clinics at the

Vanderbilt University Medical Center. First Donofrio Rep. at 1; See Ex. B (ECF No. 34-2) (Dr.

Donofrio’s Curriculum Vitae (“Donofrio CV”)) at 2. He received his B.S. at the University of

Notre Dame, and then attended the Ohio State University School of Medicine for his M.D.

Donofrio CV at 2. He is board certified in neurology, internal medicine, electrodiagnostic

medicine, and neuromuscular disorders. Id. Dr. Donofrio is experienced in treating peripheral

neuropathies like GBS and CIDP, as well as brachial neuritis, and is a member of organizations

focusing on these kinds of neuropathic conditions. First Donofrio Rep. at 1. Among his

publications is a textbook on the specific topic of peripheral neuropathy. Donofrio CV at 21. He

is not an immunologist—although neither is Dr. Fink.

First Report

Dr. Donofrio’s initial report included a detailed review of Mr. Pelelo’s medical history.

First Donofrio Rep. at 1-5. He then provided an overview of brachial neuritis, deeming it an

“inflammatory condition of the nerves within the brachial plexus.” First Donofrio Rep. at 6. The

brachial plexus 5 is a “clustering of nerve fibers” whose branches form the primary nerves for the

shoulder, arms, and hands. First Donofrio Rep. at 6; Z. Simmons, Plexopathies and Proximal

Upper Extremity Neuropathies, 24 Phys. Med. Rehabil. Clin. N. Am. 1-20 (2013), filed as Ex. C

on July 23, 2019 (ECF No. 39-1) (“Simmons”). Injuries to the brachial plexus will, therefore,

inherently “produce weakness, sensory changes and commonly deep tendon reflex abnormalities.”

First Donofrio Rep. at 6. And the fact that the brachial plexus is comprised of nerve fibers also

means that injuries to it will be detectible through EMG/NCS testing. Id. This kind of condition

should also be visible to an extent on MRI, since brachial neuritis will usually lead to “neurogenic

atrophy” of the muscles served by the brachial plexus. Id.

5

Dr. Donofrio thus distinguished brachial neuritis from injuries to peripheral nerves connected to, but distal from, the

plexus. First Donofrio Rep. at 6.

9

Brachial neuritis is understood in some cases to have an infectious origin or trauma

(whether from surgical interventions or some external accident), but is also commonly idiopathic,

meaning no triggering explanation can be identified. First Donofrio Rep. at 6, 8. Although Dr.

Donofrio admitted that case reports exist purporting to observe an association between some

vaccines and brachial neuritis, he opined that there was no reliable scientific/medical proof

connecting the two. Id. He noted in particular that the Institute on Medicine’s report regarding

proposed adverse effects of various vaccines had found no reliable link between the HPV vaccine

and brachial neuritis. Id. at 8; Institute of Medicine of the National Academies, Adverse Effects of

Vaccines: Evidence and Causality, Chronic Inflammatory Disseminated Polyneuropathy, 512-13

(Kathleen Stratton, et al.), filed as Ex. D on July 23, 2019 (ECF No. 39-2) (the “IOM Report I”).

Based on his overall review of the record, Dr. Donofrio concluded that Mr. Pelelo likely

had not experienced brachial neuritis. First Donofrio Rep. at 9. He based this conclusion on a

number of different factors. He allowed for the fact that Petitioner’s presentation, from the late

December 2015 vaccination until February 2016, was at least “suggestive of a brachial plexus

process.” First Donofrio Rep. at 6. But Dr. Donofrio deemed the negative/normal EMG and NCS

results almost dispositive of the issue, since the timing of the performance of this testing

(approximately two months after alleged onset in late December) meant they should have detected

“even subtle neurogenic abnormalities” by that time, if in fact injury to the brachial plexus had

previously occurred. Id. Indeed, Dr. Donofrio questioned later treater support for the brachial

neuritis diagnosis in the face of these normal results. Id. at 7 (discussing Ex. 3 at 47).

In highlighting the normal EMG/NCS results, Dr. Donofrio stressed his disagreement with

Dr. Fink that brachial neuritis could exist even without confirmation by such nerve testing. First

Donofrio Rep. at 7-8. He noted that medical literature filed in the case (by both sides) strongly

supported the conclusion that EMG/NCS testing were understood as critical to the diagnosis. Id.

at 8; J. Aymond et al., Neuralgic Amyotrophy, 28(12) Orthopaedic Rev. 1275-1279 (1989), filed

as Ex. F on July 23, 2019 (ECF No. 39-4); Bromberg at 3. Indeed, the more reputable studies

focusing on persons with brachial neuritis all involved individuals whose diagnosis had been

confirmed via EMG/NCS testing. See, e.g., A. Martinez-Salio et al., Neuralgia Amiotrofica:

Revision de 37 Casos, 27(159) Rev. Neurol. 823-826 (1998) (original in Spanish), filed as Ex. G

on July 23, 2019 (ECF No. 39-5). This was also true of many of the case reports filed by Petitioner

that purported to associate the HPV vaccine with brachial neuritis. See, e.g., Debeer at 4418; J.

Taras et al., Brachial Neuritis Following Quadrivalent Human Papilloma Virus (HPV)

Vaccination, 6 Hand 454-456 (2011), filed as Ex. 12 on Aug. 28, 2018 (ECF No. 22-4) (“Taras”)

at 455 (female subject’s brachial neuritis began three days after receipt of second HPV vaccine

dose; diagnosis confirmed by EMG/NCS results, although initial results were normal).

10

Other facts gleaned from the medical record persuaded Dr. Donofrio that Petitioner’s

brachial neuritis diagnosis was not tenable. The May 2016 MRI scan of Mr. Pelelo’s left shoulder,

for example, produced normal results, and thus did not reveal the kind of denervation-related

muscle atrophy that should have been present. First Donofrio Rep. at 7; citing Ex. 3 at 32. Scapular

winging was not observed in January 2016, although it should have in Dr. Donofrio’s opinion been

evident in a case of brachial neuritis that began in late December. First Donofrio Rep. at 9.

Petitioner also showed marked improvement after treatment with IVIG and steroids (contrary to

assertions in Dr. Fink’s report), and seemed largely recovered by the end of March. First Donofrio

Rep. at 7, 9. And Dr. Donofrio noted a number of factual inconsistencies about Petitioner’s

treatment progress, noting instances where improvement of symptoms was not acknowledged in

certain records. First Donofrio Rep. at 7, citing Ex. 3 at 17-18, 30. Dr. Donofrio overall seemed to

find (although his report did not say so directly) that the totality of Petitioner’s treatment course—

looking at the record between early December 2015 (before the second HPV vaccine dose was

administered) and August 2017—revealed he suffered from a host of “musculoskeletal symptoms”

that might better explain the symptoms complained of in this case. First Donofrio Rep. at 9.

Second Report

Dr. Donofrio’s next report endeavored to answer Dr. Fink’s attacks on his initial opinion.

Dr. Donofrio devoted considerable attention to the importance of the EMG/NCS testing results.

Second Donofrio Rep. at 1-3. First, he defended the results obtained for Petitioner as trustworthy,

over Dr. Fink’s objections that a physician had not literally performed the tests on Petitioner,

emphasizing that Dr. Bingham (the neurologist who approved the results) would have well-

understood how to perform such testing and whether the results were reliable, and thus her

endorsement of the results was reasonable even if a technician had been actually responsible for

the tests. Id. at 1. Dr. Donofrio’s review of the specific records pertaining to the testing underscored

for him the reliability of the results, since the testing was thorough and involved the muscles most

likely to be abnormal in cases of scapular winging (and thus essentially undercut conclusions by

treaters about the significance of the presence of scapular winging). Id. at 1, 2-3.

Second, Dr. Donofrio reiterated points in his first report supporting the overall importance

of EMG/NCS results in diagnosing brachial neuritis. He noted that literature filed in the case stood

directly for the proposition that such testing was virtually required to confirm the diagnosis.

Second Donofrio Rep. at 2-3; Simmons at 10-11; N. van Alfen, et al., Sensory Nerve Conduction

Studies in Neuralgic Amyotrophy, 88 Am. J. Phys. Med. Rehabil. 941-946, 942 (2009), filed as

Ex. N on Apr. 28, 2020 (ECF No. 51-3) (“van Alfen II”). In response to Dr. Fink’s arguments that

literature like Van Eijk acknowledged that the diagnosis was tenable without an abnormal EMG

result, Dr. Donofrio attempted to clarify EMG as a term, noting that it “is often used to describe

only the needle examination whereas other health care providers use the term EMG to describe all

parts of the electrodiagnostic exam,” including the NCS component. Second Donofrio Rep. at 2.

11

Applying the broader understanding of the term (which Dr. Donofrio appeared to endorse), it could

not be said that a normal EMG result was common to brachial neuritis. Id. 6 In fact the relevant

literature did not actually consider in studied brachial neuritis cases whether full EMG diagnostic

tests had been performed. Id.; van Alfen II at 942.

Dr. Donofrio also defended certain record evidence as supportive of his diagnostic

contentions. He continued to embrace Petitioner’s MRI results as inconsistent with brachial

neuritis, although he agreed that an additional MRI, performed with gadolinium contrast,7 would

have helped confirm the significance of the initial findings. Second Donofrio Rep. at 3. He disputed

the importance of the fact that Petitioner had been treated with steroids or IVIG, maintaining that

their use was commonplace when neurologic injury was suspected, and hence such treatments did

not particularly corroborate the diagnosis. Id. Indeed, he deemed their alleged effectiveness as

further undermining the diagnosis, since such immunomodulating treatments are not understood

to have such a positive impact on brachial neuritis. Id. at 3-4. And he identified numerous other

discrepancies in the record that he felt did not corroborate the diagnosis, such as inconsistency in

observing scapular winging over the course of Petitioner’s treatment. Id. at 4-5.

Regarding Petitioner’s onset, Dr. Donofrio took issue with Dr. Fink’s contention that a 2-

20 day onset was reasonable, observing that (a) one of the very case reports relied upon for an

HPV vaccine-brachial neuritis association observed that this timeframe had not been confirmed

for the HPV vaccine, and (b) it was not consistent otherwise with Petitioner’s one-day onset, which

had not itself been substantiated by any reliable evidence. Second Donofrio Rep. at 5. In fact, the

timeframe for onset of any form of brachial neuritis was not in Dr. Donofrio’s view likely to be so

short, given what was known about how long it would take for an immune response to occur after

antigenic exposure. Id; Institute of Medicine of the National Academies, Adverse Effects of

Vaccines: Evidence and Causality, Evaluating Biological Mechanisms of Adverse Events, 57-58,

58 (Kathleen Stratton, et al.), filed as Ex. O on April 28, 2020 (ECF No. 51-4) (the “IOM Report

II”). Indeed, even re-exposure to the same antigen (which would inherently be faster, as was

arguably the case here, since Petitioner’s second HPV dose is alleged causal of his injury) would

not produce an immune reaction sooner than three to five days post-vaccination. Id.

6In so asserting, Dr. Donofrio also noted that Van Eijk relied on an earlier item of literature for the conclusion that an

EMG could be normal and not preclude a brachial neuritis diagnosis, but that this earlier-published item did not

consider the combination of nerve testing that Dr. Donofrio deemed to be included under the EMG heading. Second

Donofrio Rep. at 2; van Alfen at 7.

7

In some cases, a contrast material (typically gadolinium) will be injected through an intravenous line during an MRI

scan. Mayo Clinic, MRI Overview, https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768 (last visited

July 20, 2021). The contrast material enhances certain details in the imaging, and in particular can reveal the existence

of ongoing or present inflammation. Id.

12

Third Report

Dr. Donofrio’s final report reacted to some of Dr. Fink’s responses (in his own third report)

to the special master’s questions, although he limited his commentary to diagnostic issues. He first

discussed whether it was accurate to characterize the onset of brachial neuritis after vaccination as

“acute,” questioning the reliability of one of the items of medical literature supported in behalf of

this assertion. Third Donofrio Rep. at 1. Dr. Donofrio then noted that to the extent “acute” was

meant to support the medical acceptability of a one-day onset, this contention was not consistent

with other medical literature filed by Petitioner, which supported only a longer onset timeframe.

Id; Taras at 454 (stating that in 30-85% of the cases, an antecedent event can be found 3-14 days

before the initial onset of pain). He also deemed such a short onset “highly unusual for an

immunological vaccine reaction,” adding that three days or more for a reaction was far better

supported by medical science. Third Donofrio Rep. at 4.

Next, Dr. Donofrio reviewed the distinction he drew between literature pertaining to the

common clinical features of brachial neuritis and what a young athletic person like Mr. Pelelo

might experience. Third Donofrio Rep. at 1. Although he disclaimed specialized expertise in sports

injuries, Dr. Donofrio did identify (based on some literature research he performed to respond to

the issue) a small study of 22 swimmers that did not reveal brachial plexopathy, or some other

neurologic source, to be the cause of their shoulder complaints. S. Rupp et al., Shoulder Problems

in High Level Swimmers – Impingement, Anterior Instability, Muscular Imbalance?, 16(8) J.

Sports Med. 557-565 (1995), filed as Ex. Q on Dec. 17, 2020 (ECF No. 60-2) (“Rupp”). He added

that scapular winging was not itself specific to brachial neuritis, despite Dr. Fink’s suggestions to

the contrary. Third Donofrio Rep. at 1.

Dr. Donofrio’s third report also spent additional time arguing with Dr. Fink about the

legitimacy/adequacy of Petitioner’s February 2016 EMG testing, and whether its findings were

trustworthy, as well as the greater question of whether a “normal” EMG test result was consistent

with brachial neuritis. Third Donofrio at 2. And he commented on several exhibits that (at the time

of the preparation of this final report) had been recently filed. Many of these newly-filed exhibits

were simply additional medical records or witness statements, although Dr. Donofrio did highlight

one—a case report purportedly linking the HPV vaccine to brachial neuritis—that he found

involved a different injury (proximal median nerve palsy), and that moreover had been confirmed

by an abnormal EMG. Id. at 3; Taras at 455.

III. Procedural History

After filing this action in October 2017, Petitioner began gathering documents relevant to

his claim and filing them into the record, completing the process the same month as filing. The

petition was initially assigned to the Special Processing Unit of the Office of Special Masters (the

“SPU”) based on the supposition that it might be readily settled. However, after Respondent’s Rule

4(c) Report (filed June 2018 (ECF No. 17)) revealed the intent to defend the claim, Petitioner filed

13

Dr. Fink’s first expert report that August, prompting a responsive report from Dr. Donofrio in June

2019. The matter was thereafter transferred out of SPU. ECF No. 36.

Additional expert reports were filed by both sides thereafter, with the matter subsequently

being reassigned to me in the summer of 2020. ECF No. 55. I allowed a final round of additional

expert reports to be filed, and then informed the parties of my view that the case could properly be

resolved on the papers. Petitioner’s Motion for Ruling on the Record was filed in January 2021

(ECF No. 61) (“Mot.”), and Respondent’s Opposition filed in March 2021 (ECF No. 63) (“Opp.”).

No reply was filed, and the claim is now ripe for resolution.

IV. Parties’ Respective Arguments

Petitioner offered a succinct brief arguing in favor of entitlement in this case, addressing

in succession each of the three causation prongs from Althen v. Sec’y of Health and Hum. Servs.,

418 F.3d 1274, 1278 (Fed. Cir. 2005). First, he noted the other kinds of vaccines that have been

associated with brachial neuritis, adding that case reports (some of which were filed in this matter)

have also linked the HPV vaccine to the injury. Mot. at 1. He further reiterated the potential

mechanisms outlined by Dr. Fink for how the vaccine could initiate the injury—either “direct

antigenic attack” on the brachial plexus nerves, or “a focal inflammation of vessels of the nerves”

that indirectly would cause nerve damage. Id. at 2. The fact that Petitioner had received one dose

of the HPV vaccine already also impacted his exaggerated immune reaction to the second dose.

Id.

Second, Petitioner endeavored to demonstrate how his medical history was consistent with

the vaccine causing his brachial neuritis. He recalled the one-day onset of pain and weakness,

observing this was consistent with the sudden/acute nature of brachial neuritis onset, as well as his

subsequent course. Mot. at 2-4. Finally, Petitioner devoted the remainder of his brief to defending

the time in which his onset began as medically acceptable, although in so doing he revisited Dr.

Fink’s attacks on the legitimacy of the normal EMG findings. Id. at 5-6. He otherwise maintained

that the course of his injury reflected brachial neuritis despite some evidence of improvement, and

disputed Dr. Donofrio’s points that Petitioner’s athletic endeavors could have played a role in

causation. Id. at 7-9.

Respondent’s brief was considerably longer, and included a more detailed overview of Mr.

Pelelo’s medical history. Opp. at 4-11. After a recitation of the legal standards governing a non-

Table causation claim, Respondent attempted to demonstrate why Petitioner had not carried his

burden of proof. As a general matter, Respondent contested that Petitioner had in fact been

properly diagnosed with brachial neuritis, noting that the EMG testing did not corroborate the

treaters’ clinical symptom-oriented diagnosis, and arguing that Dr. Fink’s assertion that brachial

neuritis could exist even with negative EMG findings was unreliable, especially when contrasted

with Dr. Donofrio’s more well-founded contentions. Id. at 15-20. Respondent also maintained that

14

Petitioner’s clinical course did not reflect how brachial neuritis would commonly unfold,

especially since Petitioner seemed at times to recover. Id. at 20-21.

Respondent next proposed that the three Althen prongs were unmet. Dr. Fink had not

established a reliable and reputable theory regarding the HPV vaccine’s propensity to cause

brachial neuritis, relying on limited items of literature that revealed how little was still known

about the pathogenesis of brachial neuritis. Opp. at 21-23, 26-27. Dr. Fink otherwise relied too

much on case reports or VAERS data 8 that only established a temporal relationship between the

HPV vaccine and brachial neuritis. Id. at 23-25. Petitioner also could not prove the HPV vaccine

“did cause” his brachial neuritis, relying too heavily on the temporal association alone, without

offering evidence of treater views as to vaccine causation. Id. at 27-29. And there were unrebutted

alternative explanations for Petitioner’s injury, attributable to his physical activities as a swimmer

and baseball player. Id. at 30. Finally, Respondent maintained that a 24-hour onset of vaccine-

caused brachial neuritis was not medically acceptable, noting in particular that even the

Petitioner’s most-helpful literature and case reports filed in the matter supported only an onset

more than a few days—not less than one. Id. at 31-32.

V. Applicable Law

A. Standards for Vaccine Claims

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

suffered an injury falling within the Vaccine Injury Table (i.e., a “Table Injury”); or (2) they

suffered an injury actually caused by a vaccine (i.e., a “Non-Table Injury.) See Sections

13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; § 11(c)(1)(C)(ii)(I); see also

Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v.

Sec'y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). In this case, Petitioner

does not assert a Table claim.

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

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

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

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

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

8

“VAERS,” or the Vaccine Adverse Event Reporting System, is a passive surveillance system maintained by the

Center for Disease Control, in which anyone may file a report alleging that a vaccine caused a particular injury, illness,

or death. As discussed by other special masters, the data provided by VAERS does not illustrate a causal connection;

rather, VAERS exists to prompt further scientific investigation into potentially dangerous vaccines. See, e.g.,

Tompkins v. Sec'y of Health & Human Servs., No. 10-261V, 2013 WL 3498652, at *9 n.25 (Fed. Cl. Spec. Mstr. June

21, 2013), mot. for review denied, 117 Fed. Cl. 713 (2014). VAERS reports are informal and unverified, and should

not be confused with formal case reports in medical literature. Tompkins, 2013 WL 3498652, at *9 n.26. For these

reasons, other special masters have consistently declined to rely on VAERS data as probative with regard to vaccine

causation. See, e.g., Analla v. Sec'y of Health & Human Servs., 70 Fed. Cl. 552, 558 (2006); Ryman v. Sec'y of Health

& Human Servs., 65 Fed. Cl. 35, 39–40 (2005).

15

476, 486 (1984) (explaining that mere conjecture or speculation is insufficient under a

preponderance standard). On one hand, proof of medical certainty is not required. Bunting v. Sec'y

of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). But on the other hand, a petitioner

must demonstrate that the vaccine was “not only [the] but-for cause of the injury but also a

substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v.

Sec'y of Health & Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)); Pafford v. Sec'y of

Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a

Vaccine Program award based solely on his assertions; rather, the petition must be supported by

either medical records or by the opinion of a competent physician. Section 13(a)(1).

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

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

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

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

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

injury.” Each Althen prong requires a different showing and is discussed in turn along with the

parties’ arguments and my findings.

Under Althen prong one, petitioners must provide a “reputable medical theory,”

demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at

1355–56 (citations omitted). To satisfy this prong, a petitioner's theory must be based on a “sound

and reliable medical or scientific explanation.” Knudsen v. Sec'y of Health & Human Servs., 35

F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or

scientifically certain.” Id. at 549. However, the Federal Circuit has repeatedly stated that the first

prong requires a preponderant evidentiary showing. See Boatmon v. Sec'y of Health & Human

Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019) (“[w]e have consistently rejected theories that the

vaccine only “likely caused” the injury and reiterated that a “plausible” or “possible” causal theory

does not satisfy the standard”); see also Moberly v. Sec'y of Health & Hum. Servs., 592 F.3d 1315,

1321 (Fed. Cir. 2010); Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1350

(Fed. Cir. 2010). This is consistent with the petitioner's ultimate burden to establish his overall

entitlement to damages by preponderant evidence. W.C. v. Sec'y of Health & Human Servs., 704

F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted).

Petitioners may offer individual items of evidence pertaining to the first Althen prong

without resort to medical literature, epidemiological studies, demonstration of a specific

mechanism, or a generally accepted medical theory. Andreu v. Sec'y of Health & Human Servs.,

569 F.3d 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano, 440 F.3d at 1325–26). No one “type”

of evidence is required. Special masters, despite their expertise, are not empowered by statute to

conclusively resolve what are essentially thorny scientific and medical questions, and thus

scientific evidence offered to establish Althen prong one is viewed “not through the lens of the

laboratorian, but instead from the vantage point of the Vaccine Act's preponderant evidence

standard.” Andreu, 569 F.3d at 1380. However, even though “scientific certainty” is not required

16

to prevail, the individual items of proof offered for the “can cause” prong must each reflect or arise

from “reputable” or “sound and reliable” medical science. Boatmon, 941 F.3d at 1359-60.

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

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

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

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

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

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

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

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

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

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

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

However, medical records and/or statements of a treating physician's views do not per se

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

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

conclusion, judgment, test result, report, or summary shall not be binding on the special master or

court”); Snyder v. Sec'y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is

nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be

accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a

theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the

reasonableness of their suppositions or bases. The views of treating physicians should also be

weighed against other, contrary evidence also present in the record—including conflicting

opinions among such individuals. Hibbard v. Sec'y of Health & Human Servs., 100 Fed. Cl. 742,

749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians'

conclusions against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec'y of Dept. of

Health & Human Servs., No. 06–522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29,

2011), mot. for review den'd, 100 Fed. Cl. 344, 356–57 (2011), aff'd without opinion, 475 F. App’x.

765 (Fed. Cir. 2012).

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

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

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

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

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

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

is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine

can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of Health &

Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105 Fed. Cl. 353 (2012),

aff'd mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No.

17

11–355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den'd (Fed. Cl.

Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

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

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

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

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

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

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

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

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

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

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

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

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

is evidenced by a rational determination).

Medical records that are created contemporaneously with the events they describe are

presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient's

health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Human Servs., 95 Fed.

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

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

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

Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based

on the linked propositions that (i) sick people visit medical professionals; (ii) sick people honestly

report their health problems to those professionals; and (iii) medical professionals record what they

are told or observe when examining their patients in as accurate a manner as possible, so that they

are aware of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec'y of

Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10,

2013); Cucuras v. Sec'y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at

1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately

report the onset of their daughter's symptoms.”).

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

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

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

records are generally found to be deserving of greater evidentiary weight than oral testimony—

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

see also Murphy v. Sec'y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam,

968 F.2d 1226 (Fed. Cir. 1992), cert. den'd, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United

18

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

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

weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive

than written records, such as where records are deemed to be incomplete or inaccurate. Campbell

v. Sec'y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon

common sense and experience, this rule should not be treated as an absolute and must yield where

the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19

(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than

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

determination regarding a witness's credibility is needed when determining the weight that such

testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Human

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

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

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

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

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

determining the accuracy and completeness of medical records, the Court of Federal Claims has

listed four possible explanations for inconsistencies between contemporaneously created medical

records and later testimony: (1) a person's failure to recount to the medical professional everything

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

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

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

Sec'y of Health & Human Servs., 110 Fed. Cl. 184, 203–04 (2013), aff'd, 746 F.3d 1334 (Fed. Cir.

2014). In making a determination regarding whether to afford greater weight to contemporaneous

medical records or other evidence, such as testimony at hearing, there must be evidence that this

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

C. Analysis of Expert Testimony

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

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

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

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

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

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

1999). Under Daubert, the factors for analyzing the reliability of testimony are:

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

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

19

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

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

acceptance within a relevant scientific community.

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

However, in the Vaccine Program the Daubert factors play a slightly different role than

they do when applied in other federal judicial settings—e.g., the district courts. Typically, Daubert

factors are employed by judges (in the performance of their evidentiary gatekeeper roles) to

exclude evidence that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases

these factors are used in the weighing of the reliability of scientific evidence proffered. Davis v.

Sec'y of Health & Human Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely in this Circuit, the

Daubert factors have been employed also as an acceptable evidentiary-gauging tool with respect

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

to evaluate the persuasiveness and reliability of expert testimony has routinely been upheld. See,

e.g., Snyder, 88 Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases),

Daubert has not been employed at the threshold, to determine what evidence should be admitted,

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

Respondent frequently offers one or more experts of his own in order to rebut a petitioner's

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

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

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

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

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

proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 91997));

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

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

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

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

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

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

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

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

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

under the Vaccine Act”).

D. Consideration of Medical Literature

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

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

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

20

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

every individual medical record filed. Moriarty v. Sec'y of Health & Human Servs., No. 2015–

5072, 2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 2016) (“[w]e generally presume that a special

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

evidence in his decision”) (citation omitted); see also Paterek v. Sec'y of Health & Human Servs.,

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

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

E. Standards for Ruling on the Record

I am resolving Petitioner’s claim on the papers rather than via hearing (and the parties have

not objected in their filings that I do so). The Vaccine Act and Rules not only contemplate but

encourage special masters to decide petitions on the papers where (in the exercise of their

discretion) they conclude that doing so will properly and fairly resolve the case. Section

12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of hearing has been

affirmed on appeal. Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed. Cir.

2020); see also Hooker v. Sec’y of Health & Hum. Servs., No. 02-472V, 2016 WL 3456435, at *21

n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where special masters decided

case on the papers in lieu of hearing and that decision was upheld). I am simply not required to

hold a hearing in every matter, no matter the preferences of the parties. Hovey v. Sec’y of Health

& Hum. Servs., 38 Fed. Cl. 397, 402–03 (1997) (determining that special master acted within his

discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health &

Hum. Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr. 19, 1991).

ANALYSIS

I. Overview of Brachial Neuritis

The experts in this case agree that Parsonage-Turner syndrome and brachial neuritis

interchangeably describe the same condition. See, e.g., Second Fink Rep. at 1; First Donofrio Rep.

at 6. 9 The brachial plexus is located between the spinal nerve roots and the nerves of the arm, and

is a bundle of nerves that relates to the sensory and motor function of the upper extremities.

Dorland’s Medical Dictionary 1440 (33 rd ed. 2020). It can be injured in many ways, including

trauma or infection, and such injury often leads to weakness or numbness. Donofrio First Rep. at

6. Brachial plexitis is the general term for injury to the plexus due to inflammation, while any other

kind of unexplained plexitis is commonly called PTS or brachial neuritis. Id. Brachial neuritis

often involves a finding of winged scapula due to involvement of the long thoracic nerve, and it

9 Literature filed in this case also refers to brachial neuritis as “neuralgic amyotrophy,” but recognizes the overlap in

terminology. See, e.g., Van Eijk at 337.

21

also generally involves selective weakness of the muscles of the anterior interosseous nerve. Id. It

is characterized by severe pain, muscle weakness, and atrophy. Id.

Although this case does not allege a Table claim, the requirements for the sole Table-

recognized brachial neuritis injury (after receipt of vaccines containing a tetanus component)

provide some useful insight into the contours of a vaccine-caused brachial neuritis injury. Under

the Table (42 C.F.R. § 100.3(a)(I)(B)), causation for vaccine-caused brachial neuritis is presumed

when symptoms begin within 2-28 days of the vaccination. The Table also requires corroboration

from “[n]erve conduction studies (NCS) and electromyographic (EMG) studies localizing the

injury to the brachial plexus . . . before the diagnosis can be made if weakness is limited to muscles

supplied by a single peripheral nerve…” 42 C.F.R. § 100.3(c)(6)(i-iii). Of course, a non-Table

claim is not subject to the same restrictions.

There are ample prior non-Table decisions associating vaccines containing a tetanus

component with brachial neuritis. 10 See, e.g., Devonshire v. Sec’y of Health & Human Servs., No.

99-031V, 2006 WL 2970418, at *15 (Fed. Cl. Spec. Mstr. Sept. 28, 2006) (stating that it is well

known that brachial neuritis can occur following a tetanus vaccination), aff’d, 76 Fed. Cl. 452

(2007); DeGrandchamp v. Sec’y of Health & Human Servs., No. 01-413V, 2003 WL 21439670,

at *7 (Fed. Cl. Spec. Mstr. May 15, 2003) (relying on IOM publications to find that in theory, the

tetanus toxoid in Td vaccine can cause brachial neuritis). Literature offered in this case also

supports this determination. See, e.g., J. Miller et al., Acute Brachial Plexus Neuritis: An

Uncommon Cause of Shoulder Pain, 62(9) Am. Fam. Physician. 2067-2017, 2068 (Nov. 2000),

filed as Ex. H on July 23, 2019 (ECF No. 39-6). However, I have identified no reasoned decisions

finding that the HPV vaccine specifically can cause brachial neuritis. 11

I have previously decided two non-Table cases alleging different vaccines caused brachial

neuritis, denying compensation in both—but in both instances because the claimant could not

establish onset occurred in a medically acceptable timeframe. See, e.g., Greene v. Sec’y of Health

10 Prior decisions from different cases do not control the outcome herein. Boatmon, 941 F.3d at 1358–59; Hanlon v.

Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). But special masters reasonably draw upon their experience

in resolving Vaccine Act claims. Doe v. Sec’y of Health & Hum. Servs., 76 Fed. Cl. 328, 338–39 (2007) (“[o]ne reason

that proceedings are more expeditious in the hands of special masters is that the special masters have the expertise and

experience to know the type of information that is most probative of a claim”) (emphasis added). They would therefore

be remiss in ignoring prior cases presenting similar theories or factual circumstances, along with the reasoning

employed in reaching such decisions. I therefore include this brief discussion to illustrate the framework for my

determination—which in the end arises from a balancing of the evidence offered in this case.

11 Some cases involving the HPV vaccine and brachial neuritis have resulted in settlement. See, e.g., Hessel v. Sec’y

of Health & Hum. Servs., No. 11-412V, 2012 WL 3140357 (Fed. Cl. Spec. Mstr. July 9, 2012). But they are of little

guidance herein, because settled matters are not only non-precedential but do not contained reasoned evaluations of

the science involving the capacity of the HPV vaccine to cause brachial neuritis. See Randazzo v. Sec’y of Health &

Hum. Servs., No. 18-1513V, 2021 WL 829572, at *4 (Fed. Cl. Spec. Mstr. Feb. 1, 2021) (discussing low relevance of

settled SIRVA claims in comparison to reasoned decisions).

22

& Hum. Servs., No. 11-631V, 2019 WL 4072110 (Fed. Cl. Spec. Mstr. Aug. 2, 2019) (41-day

onset after tetanus vaccine too long to be causal), mot. for rev. den’d, 146 Fed. Cl. 655 (Fed. Cl.

2020), aff’d, 841 Fed. App’x. 195 (Fed. Cir. 2020). Admittedly, Greene is mostly distinguishable,

since not only did it involve a vaccine closely associated with brachial neuritis, but an onset far

longer than relevant herein. But it stands for the proposition that even otherwise-causal vaccines

may not be found to cause injuries that occur in an unacceptable timeframe post-vaccination—

whether too short or long. See Aguayo v. Sec’y of Health & Hum. Servs., No. 12-563V, 2013 WL

441013, at *4 (Fed. Cl. Spec. Mstr. Jan. 15, 2013) (onset of GBS fourteen weeks after flu vaccine

too long to satisfy Althen prong three).

In an earlier decision—Garner v. Sec’y of Health & Human Servs., No. 15-063V, 2017

WL 1713184 (Fed. Cl. Mar. 24, 2017), mot. for review den’d, 2017 WL 3483352 (Fed. Cl. July

31, 2017)—I considered a claim that the Hepatitis A and B vaccines caused brachial neuritis. The

earliest onset possible in Garner was even longer than Greene—45 days after vaccination, based

on the first record documentation of any complaints by petitioner about arm or shoulder pain.

Garner, 2017 WL 1713184, at *1. Respondent’s expert, however, argued that the outer limit for

latency after vaccination was four weeks. Id. at *8. I found this point to be dispositive, even though

the claimant’s Althen prong one showing was persuasive. Id. at *16.

II. Petitioner Has Not Carried His Althen Burden

The experts in this case hotly contest whether Mr. Pelelo in fact likely suffered from

brachial neuritis. On this matter, there is evidence on both sides. Petitioner can point to consistent

treater support for the diagnosis, as well as symptoms that reflect the alleged injury, such as pain

and weakness of the left should and arm. See Ex. 3 at 8, 15, 40.

Respondent, however, has noted that EMG/NCS testing did not corroborate the diagnosis,

and that these results are very reliable. Dr. Fink did credibly establish that brachial neuritis could

be present even in the absence of such abnormal test results, and he offered reliable literature to

support his contention. See, e.g., Van Eijk at 339, 343-44. He also cited a case report that featured

an initially-normal EMG result before a brachial neuritis diagnosis was obtained. Taras at 454-55.

However, equally-reliable evidence suggests that the condition generally is less likely if the

diagnostic testing outcome is normal. Dr. Donofrio persuasively established (over Dr. Fink’s more

scattershot objections) that these results should be paid heed—and they undermine the diagnosis

substantially.

The context in which Petitioner experienced the injury also bears on the diagnosis. His age

and background as an athlete might provide some factual bases for his injury independent of

vaccination. Also, the course of his injury, which seemed to improve then worsen (but after a time

when his athletic pursuits intensified) provides a tantalizing suggestion for an alternative basis for

his injuries. Petitioner’s expert, Dr. Fink, stated in his second report that “a mechanical injury

(swimming) of different nerve elements,” may cause an injury of the brachial plexus. Second Fink

23

Rep. at 3. Dr. Fink backed away from this concession in his final report, however, instead asserting

that “[w]ithout specific trauma to the brachial plexus it is not possible to invoke [] repetitive motion

of the arm resulting in injury to the brachial plexus.” Third Fink Rep. at 3. Dr. Fink also noted as

an example that certain aspects of the injury such as “winging of the scapula” were “unique to

brachial plexitis.” Id. However, Dr. Donofrio rebutted this assertion and cited an article from the

International Journal of Sports Medicine where five of twenty-two swimmers with shoulder

problems had scapular winging and, in each of these instances, brachial plexopathy was “not

thought to be the cause.” Third Donofrio Rep. at 1 (citing Rupp at 1).

In many cases, evaluating the evidence offered in support of, or against, the preferred

diagnosis, in order to determine how that evidence preponderates, is critical to the case’s

resolution. Broekelshen, 618 F.3d at 1346. Here, however, I need not do so despite the attention

the issue was given by the experts—for it is clear from the record and filed submissions that two

of the three Althen prongs have not been met, even if there was not dispute as to diagnosis. I will

thus assume for sake of argument that the brachial neuritis diagnosis has preponderant support,

despite the persuasive points made by Dr. Donofrio about the reliability of this conclusion. I

address the prongs in order of their significance to my determination.

A. Althen Prong One

Petitioner’s showing on the “can cause” prong did not preponderantly support his

allegations. Indeed, it was the weakest element of his overall case, and thus is grounds for dismissal

regardless of how the other prongs are resolved. 12

It is unquestionably true that other vaccines are associated with brachial neuritis—with one

(tetanus) so persuasively linked that the Government has added a tetanus-brachial neuritis claim

to the Table. But it is an axiomatic principle in the Program that petitioners do not prevail simply

by analogizing their case to what is known about other vaccines; they must instead prove the

vaccine at issue is causal. Monzon v. Sec’y of Health & Hum. Servs., No. 17-1055V, 2021 WL

2711289, at *21 (Fed. Cl. Spec. Mstr. June 2, 2021). They also cannot bulwark a non-Table claim

by noting how close they come to meeting a comparable Table claim’s requirements. W.C. v. Sec’y

of Health & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013); Tarsell v. United States, 133 Fed.

Cl. 782, 793 (2017). And this case does not involve a tetanus-containing vaccine in any event.

To establish that the HPV vaccine specifically can cause brachial neuritis, Petitioner mostly

relied on case reports, a type of evidence recognized in the Program to offer faint causation support.

See, e.g., Campbell v. Sec’y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (Fed. Cl. 2011) (case

reports “do not purport to establish causation definitively, and this deficiency does indeed reduce

12

Because Petitioner must meet all three Althen prongs to prevail, I need not address Petitioner’s success in

establishing the “did cause”/second prong of the Althen test. Contreras v. Sec'y of Health & Human Servs., No. 05–

626V, 2012 WL 1441315, at *1 (Fed. Cl. Spec. Mstr. Apr. 5, 2012), rev’d on other grounds, 107 Fed. Cl. 280 (Fed.

Cl. 2012).

24

their evidentiary value”). Case reports are not without any evidentiary value, but they are weak

proof of causation—a fact that is often readily acknowledged by their authors, as is true here. See,

e.g., Debeer at 4419.

Dr. Fink’s reports could not make up for the deficiency in reputable scientific or medical

support offered for the “can cause” prong. He provided no reliable scientific or medical evidence

showing that the antigens of the HPV vaccine (or for that matter the underlying wild virus it

provides immunity against) could be reliably linked to brachial neuritis, and referenced no other

medical research showing a connection. In addition, he personally possessed no demonstrated

immunologic expertise that could shed light on the issue (as reflected in the fact that most of his

expert contentions went to diagnosis rather than the crucial issue of causation). His reports

otherwise were too general in their causal assertions.

Dr. Fink also did not provide a reliable biologic mechanism for how the vaccine would

cause this injury. Although unquestionably petitioners need not prove a mechanism to prevail, it

is fair for a special master to evaluate the claimant’s success in so showing when an attempt to do

so is ventured—as here. Morgan v. Sec’y of Health & Hum. Servs., 148 Fed. Cl. 454 (Fed. Cl.

2020). But Dr. Fink’s proposed mechanisms were highly speculative. He concedes in his reports

that “the cause of post-vaccinial [sic] brachial plexitis is theoretical.” Third Fink Rep. at 4.

Nevertheless, Dr. Fink asserts that vaccinations may cause brachial neuritis “if not [through] a

direct antigenic attack by attenuated virus on brachial plexus nerves, then, a focal inflammation of

vessels of the nerve [that] causes axonal damage, with unequal severity from one nerve to another.”

Id. He goes on to suggest that autoantibodies may be involved because “autoantibodies… directed

against peripheral nerve[s] can produce a polyneuropathy.” Id. Dr. Fink’s main support for these

theories come from a single review article, however, which acknowledges its own tentative nature.

P. Seror, Neuralgic Amyotrophy. An Update, 84 Joint Bone Spine 153-58, at 156 (2017), filed as

Ex. 24 on Dec. 16, 2019 (ECF No. 46-3) (“[t]he pathophysiology of [brachial neuritis] remains

uncertain,” and mechanistic proposals for how it advances (which include an autoimmune

hypothesis) remain until now simple presumptions,” despite some evidence supporting immune-

mediation).

The proposal that brachial neuritis’s pathophysiology occurs via a generalized, innate

response to vaccination is also not helpful in this case in demonstrating causation. In some

circumstances, it may be true that a petitioner can experience a transient reaction to a vaccination,

like malaise or situs pain. But general responses that resolve short of the six-month period required

to establish the severity requirement in Program cases, and that cannot otherwise be tied to the

alleged injury, do not satisfy a petitioner’s burden. Monzon, 2021 WL 1736816 at *20. And here,

insufficient evidence has been presented that would allow me to conclude that the mere triggering

of an innate response to the HPV vaccine would be enough to evolve into brachial neuritis, absent

connective evidence providing insight into how this might occur. It cannot be assumed that the

HPV vaccine could cause brachial neuritis simply because it is a vaccine, administered prior to

injury. Speculative literature like Martinez-Lavin, that considered whether other neuropathic

25

injuries might reflect some kind of “HPV vaccine syndrome,” do not say enough about brachial

neuritis to be given significant weight.

Overall, Petitioner’s case seems mostly to rely on the fact that other vaccines have been

deemed in the Program to cause the same injury. If other vaccines can cause brachial neuritis, Dr.

Fink reasons, why not HPV as well? But the association between other vaccines, such as those

containing a tetanus component, and brachial neuritis appear more attributable to aberrant

reactions imposed by that specific component—not the general impact of vaccination. For

example, a case report cited by Dr. Fink observes that, unlike case reports of brachial neuritis

following the tetanus toxoid, “the HPV vaccine… does not contain a toxoid so it remains unclear

how it could have given rise to a neuritis[.]” Debeer at 4418 (emphasis added). Vaccines are

formulated differently to provide immunologic protections against different pathogens, so their

components usually cannot be theorized to have a “one size fits all” impact. While there are a few

injuries, like shoulder injury related to vaccine administration, or “SIRVA,” that may be caused

by a number of vaccines interchangeably, the same has not been found to be true for brachial

neuritis. 13

In this case, neither expert possessed specific immunologic expertise to “overpower” the

other simply based on personal credentials and established, well-grounded subject-matter

familiarity with the functioning of the immune system and its bearing on this kind of neurologic

injury. And I do not find this is a case where this particular issue goes against Petitioner because

of the overall strength of Respondent’s expert’s showing (although on matters relating to brachial

neuritis more generally, I do find that Dr. Donofrio’s opinion arose from more demonstrated

expertise and reliable science than Dr. Fink’s). But Dr. Fink himself lacked the kind of specific

immunologic expertise needed to breathe life into his causation theory, and his absence of

professional expertise in the topic was damaging to the theory on its own (especially since

petitioners bear the ultimate burden of proof in vaccine cases in any event). Petitioner did not carry

his burden of proof on this first prong, and that assessment can be reached simply by looking at

the evidence Dr. Fink did offer—it did not rise to a preponderant showing.

B. Althen Prong Three

Another deficiency in the evidence offered to substantiate the claim is the exceedingly

short timeframe in which Petitioner’s post-vaccination symptoms onset occurred. The record

13

Indeed, a glance at the Table illustrates the problem of broad assumptions about the scope of vaccine-associated

adverse events. For example, the Table allows claimants to seek recovery for SIRVA based on twelve different kinds

of vaccines, including HPV. See generally Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3;

§ 11(c)(1)(C)(ii)(I). But the Table includes brachial neuritis only after receipt of tetanus-containing vaccines. 42 C.F.R.

§ 100.3(a)(I)(B). This reflects Respondent’s determination that medical science supports the conclusion that many

vaccines can cause SIRVA, likely due to the common impetus for the injury (injection of antigen into the bursa

sufficient to cause localized inflammation), which is independent of their varying contents. The same has not been

found to be true of brachial neuritis.

26

establishes that Mr. Pelelo first experienced pain within 24 hours of vaccination. See, e.g., Ex. 6

at 3; Pelelo Aff. at 1. But this is far too soon for an immune-mediated case of brachial neuritis,

which the literature suggests would take several days to manifest, since the injury requires some

degree of inflammation to develop before it is felt symptomatically. See IOM Report II.

Dr. Fink maintained in response that other literature suggested that brachial neuritis onset

is felt “acutely,” but that term seems to have been employed in the relevant literature to mean

“unexpected and severe,” rather than to describe a timeframe for onset. Bromberg at 3. Indeed, the

case reports Petitioner places so much reliance upon all involve onset of more than 24 hours post-

vaccination. See, e.g., Debeer at 4417 (case report of brachial neuritis with onset one month after

second HPV vaccination); Taras at 454 (case reported of alleged brachial neuritis with onset three

days after second HPV vaccination). Thus, even if I had found that the HPV vaccine can cause

brachial neuritis, the evidence does not preponderate in favor of the determination that it would

likely manifest as quickly as it did so for Petitioner. This is especially so since Petitioner’s theory

depends on a determination that the vaccine triggered an autoimmune process, which would most

likely require some kind of adaptive immune response. Second Fink Rep. at 3. That kind of

adaptive process is understood to take several days. See Block v. Sec’y of Health & Hum. Servs.,

No. 19-969V, 2021 WL 2182730, at *1 (Fed. Cl. Spec. Mstr. Apr. 26, 2021) (time for antibody-

driven peripheral neuropathy in question takes more than three days to begin). Dr. Donofrio

credibly and persuasively established in his reports that even in the event of a speedier immune

response attributable to a prior exposure to the HPV vaccine, onset for an immune-mediated,

adaptive response (through the production of antibodies) would take more than even two days.

Donofrio Second Rep. at 5.

As noted above, Vaccine Act cases involving brachial neuritis have been dismissed where

onset was not demonstrated to be medically reasonable—most often because it was too long after

vaccination. See, e.g., Greene, 2019 WL 4072110 (41 day onset too long); Garner, 2017 WL

1713184 (45 day onset too long). Here, onset is too soon—but this equally is a basis for the

determination that the claim cannot succeed. de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d

1347, 1352 (Fed. Cir. 2008) (“we see no reason to distinguish between cases in which onset is too

soon and cases in which onset is too late; in either case, the temporal relationship is not such that

it is medically acceptable to conclude that the vaccination and the injury are causally linked”).

CONCLUSION

Other vaccines have preponderantly been demonstrated in the Vaccine Program to be

associated with the capacity to trigger brachial neuritis, and it is conceivable that science may

eventually expand that list to include the HPV vaccine. But not nearly enough was demonstrated

in this case to conclude that the HPV vaccine could also cause brachial neuritis, or in the very

27

short timeframe at issue. Accordingly, Petitioner has not met his burden of proof, and I am

compelled to dismiss this claim.

In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the

court SHALL ENTER JUDGMENT in accordance with the terms of this decision.14

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

14

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices

renouncing their right to seek review.

28