Kelly v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 16-878V

(to be published)

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

DOUGLAS KELLY, *

* Chief Special Master Corcoran

*

*

Petitioner, * Filed: October 18, 2021

*

v. *

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

*

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

Renee Gentry, Vaccine Injury Litigation Clinic, George Washington University Law School,

Washington, DC, Petitioner.

Adriana Teitel, U.S. Dep’t of Justice, Washington, DC, Respondent.

ENTITLEMENT DECISION 1

On July 25, 2016, Douglas Kelly filed a petition seeking compensation under the National

Vaccine Injury Compensation Program (“Vaccine Program”), 2 alleging that his unilateral

sensorineural hearing loss (“SNHL”) was caused by an influenza (“flu”) vaccine received on

September 7, 2015. Petition (ECF No. 1) at 1. He has since refined his claim to allege that the

1

This Decision will 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 in its current form. Id.

2

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

100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012) (hereinafter “Vaccine Act” or “the Act”).

All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.

flu vaccine significantly aggravated a pre-existing condition (asymptomatic microvascular

angiopathy), which subsequently prompted his SNHL. Motion for Ruling on the Record at 20–

21 (ECF No. 58) (“Br.”).

The matter was reassigned to me in early 2021, after the special master formerly presiding

over it determined that the claim could be best resolved via ruling on the record. For the reasons

set forth below, and after review of the complete file and all briefs offered in the matter, I deny

entitlement. Petitioner has not established that he suffered from any preexisting condition that

the flu vaccine could aggravate, and his causation theory was not otherwise preponderantly

supported.

I. Factual Background

Vaccination and Acute Hearing Loss

Mr. Kelly (who was 63 years old as of the date of vaccination) had some earlier health

issues but no noted prior history of hearing loss. Thus, more than a year before the relevant

vaccination, at a May 1, 2014 annual exam, Petitioner’s primary care provider, Dr. Ronald Colson,

memorialized in the assessment section of exam record the existence of coronary artery disease

and mixed hyperlipidemia (high cholesterol), but opined that Petitioner’s receipt of statins and

other over-the-counter medications would be sufficient for treatment. Ex. 10 at 25. Otherwise,

there is nothing in the pre-vaccination medical record establishing that Petitioner was ever

diagnosed with any kind of angiopathy.

Petitioner received the flu vaccine around 2:00 p.m. on September 7, 2015. Ex. 1 at 1 (Rite

Aid prescription and receipt noting payment for the vaccine was processed at 2:11 p.m.). Later that

evening, he presented to the Rose Medical Center Emergency Room (“ER”). Ex. 2 at 18. There,

Mr. Kelly stated that “2 hours after [receiving his flu vaccine] he began having ringing in the left

ear associated with some lightheadedness,” and that he was now (seven hours later) “unable to

hear out of the left ear.” Id. Petitioner denied having confusion, headache, or any problem with his

other ear. Id.; Ex. 3 at 27, 31–32. Short onset of hearing loss was also confirmed in a letter

Petitioner wrote to a subsequent treater, otolaryngologist Dr. Owen Reichman, on December 9,

2015, stating that in fact the ringing in his left ear began 30 minutes after receiving the flu vaccine.

Ex. 4 at 12.

The ER treaters present at the time discussed Mr. Kelly’s symptoms with Dr. Judd Jensen,

the neurologist on call. Ex. 2 at 21. Dr. Jensen advised them to proceed with a head computed

tomography (“CT”) scan, and a CT angiogram (“CTA”) scan of Petitioner’s head and neck, to

2

rule-out a basilar artery infarct. 3 Id. at 21, 91–93. The head CT, however, revealed “no acute

intracranial abnormality,” and at most “a few areas of ill-defined low density in the left parietal

white matter [that] could represent small vessel ischemic changes of indeterminate age.” Id. at 16,

92. The head CTA revealed no occlusion, significant stenosis, nor aneurysmal dilation in either

the anterior or posterior circulation, and the neck CTA results also appeared normal. Id. Treaters

thus determined that Mr. Kelly should be discharged, with instructions to follow-up with an ear,

nose, and throat “(ENT”) specialist. Id. However, Petitioner proved “unable to ambulate

independently whatsoever secondary to lightheadedness,” so he was instead admitted to the

hospital for further evaluation, and it was recommended he receive a brain MRI to rule out a

cerebellar infarct. Id.

The MRI procedure was immediately initiated but was not completed because Petitioner

complained of difficulty breathing. Ex. 2 at 30. Nevertheless, the performing radiologist opined

that there appeared to be “no acute signs for ischemia,” although the use of contrast would have

been needed to confirm this impression. Id. The initial plan was to obtain a second MRI during the

morning of September 8, 2015, but then it was determined that a study with contrast was not

clinically warranted. Id. at 30, 35, 42. The final MRI report for what had been able to be completed

noted the result was normal, with no acute signs consistent with a stroke. Id. at 32, 89.

Mr. Kelly started steroids at the ER within hours of his hearing loss onset (Ex. 2 at 37), and

continued with oral prednisone after his discharge. Id. at 88, 182. Upon admission to the hospital

thereafter, Mr. Kelly was examined by hospitalist Dr. Hannah Lee in the early morning hours of

September 8, 2015. Id. at 30, 32. The record from this exam indicates that Petitioner was

“complaining of left-sided tinnitus and hearing loss with lightheadedness that occurred half an

hour after his flu shot.” Id. He denied having chest pain, shortness of breath, headache, or double

vision before his symptoms started, although he recalled having some lightheadedness, dizziness,

and loss of balance while in the ER. Id. Dr. Lee “suspect[ed] peripheral vertigo; Meniere[’s]

disease,” 4 but proposed that “to rule out cerebrovascular accident” a number of tests, including an

EKG, would have to be performed. Id. at 32.

Later that same morning, Petitioner was seen by Dr. Jensen and Neurology Department

Physician’s Assistant Kori Leman. Pet. Ex. 2 at 33. Petitioner relayed a history (and in particular

the hearing loss) consistent with what he had told prior treaters, and a physical exam revealed mild

3

The basilar artery supplies the brain and brainstem, and infarct is the stopping “of blood supply to the posterior

circulation or vertebrobasilar system of arteries to the brain.” Asad Ikram & Atif Zafar, BASILAR ARTERY INFARCT

(2012), https://www.ncbi nlm nih.gov/books/NBK551854/.

4

Meniere’s disease is also called endolymphatic hydrops, labyrinthine hydrops, and recurrent aural vertigo.

DORLAND’S ILLUSTRATED MEDICAL DICTIONARY 532 (33rd ed. 2020) (“DORLAND’S”). It includes hearing loss,

tinnitus, and vertigo resulting from non-suppurative disease of the labyrinth with edema. Id.

3

loss of balance with Romberg test. 5 Id. at 39. PA Leman assessed him with “hearing loss, tinnitus,

balance disturbance, without vertigo sensation, negative MRI for stroke, and normal vascular

workup leads to differential of viral labyrinthitis vs. Meniere’s,” with a “lean towards labyrinthitis

due to lack of vertigo.” Id. at 42. Steroidal medications were prescribed and administered on

September 8, 2015 at 12:30 p.m., and PA Leman proposed an audiology consult in a few weeks if

hearing loss persisted, but otherwise concluded that “no further brain imaging was required from

[a] neuro perspective.” Id. Dr. Jensen concurred, opining that Mr. Kelly’s symptoms were likely

due to “viral or post-viral labyrinthitis with the acoustic portion of the 8th nerve more involved

than the vestibular portion.” Id.

Petitioner was discharged the next day, on September 9, 2015. Ex. 2 at 12, 82. One

discharge summary form listed the following diagnoses or conditions: “1. Hearing Loss and

Dizziness 2. Hypokalemia 3. Hyperglycemia [and] 4. Hyperlipidemia.” Id. at 14. Other discharge

paperwork listed “Primary Diagnosis: vertigo likely benign Position vertigo or Labyrinthitis;

Secondary Diagnosis: Hearing loss.” Id. at 82, 168. Both discharge documents encouraged

Petitioner to pursue physical therapy and follow-up with audiology. Id. at 13, 82, 149, 175.

Confirmation of Hearing Loss

On September 10, 2015 (the day after discharge from the hospital), Mr. Kelly was seen by

otolaryngologist Dr. Reichman at ENT Denver, P.C. Ex. 4 at 12, 20. Audiologic testing revealed

mild sloping to profound SNHL in the left ear, and Dr. Reichman formally assessed Petitioner with

SNHL. Id. at 12, 20, 22–23. The impression section of the relevant record indicates that Dr.

Reichman informed Petitioner that sudden hearing loss is “usually autoimmune, viral or vascular

in origin.” Id. at 14, 22. He also stated that it was “not clear why this occurred after the flu shot

but may be related to activation of antibodies,” although in two-thirds of cases the loss would

resolve. Id. at 16 (emphasis added). But because Mr. Kelly had experienced vertigo along with his

hearing loss, Dr. Reichman predicted that he would likely not improve. Id.

Petitioner had a follow-up appointment with Dr. Reichman on September 24, 2015. Ex. 4

at 16. A repeat audiogram revealed some improvement, but in Dr. Reichman’s view “probably not

enough to make much of a difference,” and Petitioner also continued to have some balance issues.

Id. at 18–19, 21. Petitioner was encouraged to continue his walking program, taking care not to

overdo things, and Dr. Reichman opined that Petitioner would see improvement in everything

except for his hearing. Id. Mr. Kelly also saw Dr. Colson again on that same day. Ex. 10 at 16.

Physical exam revealed that Petitioner’s hearing was “intact to conversational voice both ears.” Id.

5

The Romberg Test has an individual stand with their feet close together and their eyes closed, where they are found

to sway the body or fall, as a result of affects in the posterior columns. DORLAND’S at 1686.

4

Petitioner was to call or return if his symptoms worsened or persisted. Id. at 17.

On November 30, 2015, Petitioner saw Dr. Reichman again and underwent a third

audiogram. Ex. 4 at 11, 13–15. Although it revealed no significant changes, Mr. Kelly did have

better speech reception when compared to his September 24, 2015 study. Id. He also reported that

his tinnitus and lightheadedness had improved, but he experienced periodic dizziness and

lightheadedness with quick motion. Id. at 11. Dr. Reichman proposed that Petitioner should

consider a hearing aid if he had “trouble with work as he starts to do more.” Id. 6

2016 Treatment and Beyond

On February 1, 2016, approximately five months after receiving the flu vaccine, Petitioner

was seen again by Dr. Reichman and underwent another audiogram that demonstrated stability in

his hearing loss. Ex. 4 at 3–4, 7. Dr. Reichman proposed several treatments to address the hearing

loss, including devices, but Petitioner requested the opportunity to consider them. Id. at 5. Several

months later, Mr. Kelly returned to Dr. Reichman in May 2016. Id. at 1. His audiogram was again

consistent with profound hearing loss in the left ear, but demonstrated a slight improvement from

the September 10, 2015 study, and Petitioner reported less vertigo. Id. The listed diagnoses for the

visit were “sensorineural hearing loss, unilateral, with unrestricted hearing on the contralateral

side” and “sudden idiopathic hearing loss, left ear.” Id. The final audiogram filed in this case is

from early 2017, and its findings were consistent with the prior results (e.g., showing stability in

loss. Ex. 13 at 1.

The sole additional record bearing on the claim and filed in the matter is from 2019 (after

the Petition’s initiation), when Mr. Kelly underwent a repeat MRI at Maui Diagnostic Imaging,

and it was interpreted by David Thoma, D.O. Ex. 35 at 1.7 The MRI revealed “moderate

periventricular and subcortical supratentorial variable white matter T2/FLAIR hyperintensities,”

and “normal flow voids in the major cerebral vessels and deep venous sinuses. Diffusion weighted

imaging appears within normal limits without evidence of ischemia or acute infarction.” Id. As a

result of these findings, impressions from it were listed as “1. Moderate, multifocal white matter

hyperintensities, probably small vessel ischemic changes; 2. Normal MR appearance of the

internal auditory canals. Specifically, the 7th and 8th cranial nerves are without focal enhancing

6

A month later, Petitioner corresponded with Dr. Reichman’s office, asking that the clinical summary contained in

his medical records be corrected to note that his hearing loss occurred the same day as vaccination rather than a week

later. Ex. 4 at 10. He noted in the letter that his desire to make this change related in part to his intent to bring a vaccine

injury claim. Id. Because, however, the medical record overall is consistent with Petitioner’s requested change, I do

not deem this otherwise litigation-oriented request to suggest anything improper about the change.

7

It appears that Petitioner’s primary causation expert, Dr. Carlo Tornatore, was the referring physician for the repeat

MRI, although the record does not reveal Dr. Tornatore to have treated Petitioner otherwise.

5

mass or abnormal morphology.” Id.

II. Expert and Treater Opinions

A. Carlo Tornatore, M.D.

Dr. Tornatore filed three reports in this matter on behalf of Mr. Kelly. Report, dated March

13, 2017, filed as Ex. 14 (ECF No. 22-2) (“First Tornatore Rep.”); Report, dated December 31,

2019, filed as Ex. 31 (ECF No. 47-2) (“Second Tornatore Rep.”); Report, dated July 26, 2020,

filed as Ex. 37 (ECF No. 54-2) (“Third Tornatore Rep.”). He also prepared a written response

to questions posed to the experts by the special master previously presiding over this case.

Response, dated October 19, 2020, filed as Ex. 40 (ECF No. 56-2) (“Tornatore Resp.”). His

opinion in this matter evolved somewhat over time, but he has ultimately opined that the flu

vaccine exacerbated Petitioner’s alleged pre-existing microvascular disease, resulting in a Type

I hypersensitivity reaction in Petitioner’s ear sufficient to cause his SNHL. Tornatore Resp. at

1.

Dr. Tornatore is a board-certified neurologist. See Ex. 15, dated March 13, 2017 (ECF

No. 22-3) (“Tornatore CV”). He graduated from Cornell University with a Bachelor of Arts in

Neurobiology, and attended Georgetown University Medical Center, where he received a Master

of Science in Physiology. Id. at 2. He subsequently graduated from medical school at

Georgetown University School of Medicine, completing a residency in the Department of

Neurology at Georgetown University Hospital. Id. He also completed a fellowship in molecular

virology at the National Institute of Health in Bethesda, Maryland. Id.

Dr. Tornatore has published multiple articles addressing cell biology and pathology of

demyelinating disorders. Tornatore CV at 7–14. Currently, he serves as Professor and Chairman

of the Department of Neurology at Georgetown University Medical Center, Chairman and

Neurologist-in-Chief of the Department of Neurology at Medstar Georgetown University

Hospital in Washington, D.C., and Executive Director of the Multiple Sclerosis Patient Centered

Specialty Home. Id. Dr. Tornatore possesses demonstrated expertise in the evaluation of

immunologic matters and their intersection with neurologic disease and injury, but is not an ear

specialist, and he has done only minimal research into the function of vaccines, publishing on

the rabies vaccine and an abstract on the human diploid cell vaccine and demyelination. Id. at 8,

13.

First Report

Dr. Tornatore’s initial report included a summary of Mr. Kelly’s medical history and

6

overall treatment for his hearing loss. See First Tornatore Rep. at 1–5. He particularly

highlighted Dr. Reichman’s speculation from September 2015 that “activation of antibodies”

attributable to vaccination might explain the SNHL. Id. at 5. Dr. Tornatore did not, however, go

into detail about Petitioner’s medical history or alleged susceptibility for this kind of injury

(although his initial opinion does point to Petitioner’s purported preexisting conditions as

helping to explain the injury, and so it does point toward where his expert opinion ultimately

ended up).

To ground his theory, Dr. Tornatore provided a brief overview of the inner ear’s anatomy

and function. First Tornatore Rep. at 5–6. He noted that two inner ear components critical to

hearing and balance (the cochlea 8 and the semicircular canals 9) “share the same blood supply,”

provided by the Labyrinthine artery—and thus any occlusion/blockage or other “vascular event”

impacting this artery could result in hearing loss or balance issues. Id. at 6. Indeed, Dr. Tornatore

maintained, acute hearing loss was understood to potentially possess a “vascular etiology,” and

was associated with a risk of stroke. Id.; H. Lee, Isolated Vascular Vertigo, 16 J. of Stroke 124–

30 (2014), filed as Ex. 43 on Oct. 19, 2020 (ECF No. 56-5) (“Lee”). Additional support for

hearing loss being the product of vascular/ischemic injury was also provided by migraine

research (although such research pertained to cerebral vessels rather than those in the ear). First

Tornatore Rep. at 6–7; E. Piovesan et al., Oscillucusis and Sudden Deafness in a Migraine

Patient¸ 61 Arq Neuropsiquiatr 848–50 (2003), filed as Ex. 16 on April 20, 2017 (ECF No. 25-

1) (“Piovesan”).

To explain how the flu vaccine might have caused sufficient vascular blockage/occluding

to produce hearing loss, Dr. Tornatore emphasized the fact that “atherosclerotic disease is an

inflammatory disorder of the vessel wall.” First Tornatore Rep. at 7. Vaccines inherently activate

the immune system, and in doing so can produce some initial inflammation. If that inflammation

impacted vessel walls in the ear already narrowed due to preexisting disease, acute ischemia

leading to hearing loss was likely, and could occur in reaction to a “relatively small

inflammatory response.” Id. Alternatively, the hearing loss could simply be due to some “non-

vascular mechanism” involving the cochlear cells, although Dr. Tornatore did not expand on

this possible mechanism. Id.

Dr. Tornatore offered no literature supporting this element of his opinion, however,

beyond a paper discussing a possible autoimmune etiology for SNHL. J. Berrocal & R. Ramírez-

8

The spirally wound tube, that resembles a snail shell that forms part of the internal ear. DORLAND’S at 373.

9

There are three long canals “of the bony labyrinth of the ear, forming loops and opening into the vestibule by five

openings; they lodge the semicircular ducts of the membranous labyrinth.” DORLAND’S at 275.

7

Camacho, Sudden Sensorineural Hearing Loss: Supporting the Immunologic Theory, 111

Annals of Otology, Rhinology & Laryngology 989–97 (2002), filed as Ex. 18 on April 20, 2017

(ECF No. 25-3). He also reasoned that because SNHL was “a very rare event,” the fact that this

case (plus another dismissed several years ago) 10 both involved acute onset of SNHL after the

flu vaccine could not be explained away as coincidence. First Tornatore Rep. at 7–8.

Mr. Kelly’s own medical work-up after onset of his SNHL, Dr. Tornatore maintained,

was consistent with the conclusion that the hearing loss occurred due to vascular injury. The CT

scan performed at the ER on September 7, 2015, for example, demonstrated “changes that were

consistent with small vessel stenosis/atherosclerosis from his history of hyperlipidemia.” First

Tornatore Rep. at 6. He also deemed the findings with respect to Petitioner’s white matter to be

likely consistent with what would have been seen “in the vasculature of the inner ear,” although

such scanning was not performed at the time of Petitioner’s ER visit (or even proposed by initial

treaters). Id.

Finally, Dr. Tornatore discussed Petitioner’s acute onset, defending it as reasonably

associated with vaccination only hours before. SNHL, he argued, could be mediated by a “Type

I hypersensitivity” reaction in which B cells are stimulated to produce IgE antibodies in a rapid

manner, usually in response to allergens (and hence associated with immediate reactions like

anaphylaxis or asthmatic attacks). First Tornatore Rep. at 7; J. Bellanti, Immunology IV: Clinical

Applications in Health and Disease 664–65 (4th ed. 2011), filed as Ex. 20 on April 20, 2017

(ECF No. 25-5). Type I hypersensitivity could further be divided into an immediate phase

(occurring “minutes after exposure”) versus a “late phase reaction” two to four hours post-

exposure, and involved the kind of cytokine release associated with the initial innate immune

response. Tornatore Rep. at 7.

Second Report

Dr. Tornatore’s second report was twice the length of the first (likely due, as he expressly

noted, to the fact that it had been determined by the prior special master presiding over this case

that the matter was going to be decided on the papers rather than at hearing). Status Report (ECF

No. 43). This report included an initial records review and personal credentials summary largely

identical to the first (Second Tornatore Rep. at 1–6), along with a far more detailed causation

opinion, aspects of which responded directly to points made by Respondent’s two experts.

After some additional reiteration of points made in the first report about the anatomy of

10

Park v. Sec’y of Health & Hum. Servs., No. 13-275V, 2014 WL 6435819 (Fed. Cl. Spec. Mstr. Oct. 28, 2014)

(dismissed on petitioner’s motion for failure to obtain expert).

8

the ear, Dr. Tornatore again proposed that a “vascular etiology” for SNHL existed, but he now

fleshed out in greater detail his prior contention that an “autoimmune event” could mediate the

vascular injury producing the hearing loss. Second Tornatore Rep. at 8–9. In support of this

concept, Dr. Tornatore cited an animal study that revealed how vaccination could induce an

autoimmune form of hearing loss. Id. at 9–10; C. Arturo Solares et al., Murine Autoimmune

Hearing Loss Mediated by CD4+ T Cells Specific for Inner Ear Peptides¸ 113 J. of Clinical

Investigation 1210–17 (2004), filed as Ex. 33 on December 31, 2019 (ECF No. 47-4) (“Solares”)

(researching whether “defined inner ear-specific proteins were capable of targeting T cell-

mediated autoimmune hearing loss in mice”). Dr. Tornatore also noted that electronic databases

confirmed amino acid sequence homology between components of the flu vaccine and peptides

in the cochlear structures in the ear. Second Tornatore Rep. at 10–11. This, he maintained,

established that molecular mimicry (the process of a vaccine or other chemical agent having

similar peptide chains causing an activation of autoreactive T or B cells) might plausibly explain

how the flu vaccine could precipitate the kind of injury necessary for an autoimmune form of

hearing loss. Id. at 11.

Dr. Tornatore took specific issue with arguments made by Respondent’s experts in their

reports. First, he maintained (in reaction to Dr. Phillips) that it did not matter that there was not

strong record evidence that Mr. Kelly had pre-vaccination vascular disease, since that condition

was understood to be asymptomatic frequently right up to the point of acute clinical presentation.

Second Tornatore Rep. at 12. He also defended the portion of his opinion proposing a

hypersensitivity reaction, noting that it was not undercut by an absence of evidence that

Petitioner had previously experienced no flu vaccine reaction, since it would be expected that

an “anamnestic immune response” 11 could present acutely. Id. at 13. The reliability of an IgE-

driven hypersensitivity reaction resulting in hearing loss was corroborated by Solares, which

also established that it could occur in the absence of proof of a systemic response (which

certainly did not occur in this case). Id. And the fact that treatments specific for allergic

reactions, like steroids or antihistamines, proved unavailing in ameliorating Petitioner’s

symptoms was not dispositive, since the irreversible character of the hearing loss meant that

inflammatory-limiting treatments could not be effective. Id; see also Third Tornatore Rep. at 3

(reiterating same point in reaction to Dr. Bigelow).

Dr. Bigelow’s criticisms were also deemed by Dr. Tornatore to miss their mark. The

possibility of a preexisting vessel occlusion was not in Dr. Tornatore’s view diminished by the

absence of other neurologic symptoms, since “the relevant inflammation is directly in the

11

Anamnestic refers to anamnesis, or aiding the memory. DORLAND’S at 73. When the term is employed in connection

with vaccination, it means “an acceleration of the immune attack due to sensitization,” typically from prior exposure

to the same vaccine or its antigenic components. Hargrove v. Sec’y of Health & Hum. Servs., No. 05-0694V, 2009

WL 1220986, at *7 (Fed. Cl. Spec. Mstr. April 14, 2009).

9

cochlea/vestibular apparatus,” and thus presumably confined there, with low likelihood of “other

neurologic findings.” Second Tornatore Rep. at 14. He reiterated the possibility of a fast

anamnestic hypersensitivity response, and also offered additional support for how SNHL could

be, as here, unilateral. Id; at 15; M. Kuhn et al., Sudden Sensorineural Hearing Loss: A Review

of Diagnosis, Treatment, and Prognosis, 15 Trends in Amplification 91–105 (2011), filed as Ex.

34 on December 31, 2019 (ECF No. 47-5).

Epidemiologic evidence offered to show the flu vaccine was not likely to produce hearing

loss was in Dr. Tornatore’s estimation useless, since it could not rule out truly rare events.

Second Tornatore Rep. at 14–15. And Dr. Tornatore deemed significant the fact that

Respondent’s experts had offered no other possible alternative explanation for Petitioner’s

injury, nor did the record itself suggest anything. Id. at 15.

Third Report

Dr. Tornatore’s third report responded to additional criticisms lodged against him by Dr.

Bigelow. He challenged Dr. Bigelow’s contention that SNHL is not particularly rare, observing

that literature filed by Dr. Bigelow undermined this suggestion. Third Tornatore Rep. at 1–2.

Dr. Tornatore also offered more literature to bulwark the association between SNHL and

vascular problems. Id. at 2; S. Merchant et al., Pathology and Pathophysiology of Idiopathic

Sudden Sensorineural Hearing Loss, 26 Otology & Neurotology 151–60 (2005), filed as Ex. 38

on July 26, 2020 (ECF No. 54-3) (arguing “the hypothesis that idiopathic sudden sensorineural

hearing loss may be the result of pathologic activation of cellular stress pathways involving

nuclear factor-KB within the cochlea”). And the hearing loss did not have to be complete to still

possess a vascular etiology. Third Tornatore Rep. at 2.

Next, Dr. Tornatore attacked Dr. Bigelow’s argument that the theory of a vascular

etiology was undercut by a June 2019 MRI that revealed no middle ear changes or occlusion. In

reaction, Dr. Tornatore proposed that it was uncommon for MRIs to detect these kind of ear

abnormalities in patients with SNHL. Third Tornatore Rep. at 2; K. Jeong et al., Abnormal

Magnetic Resonance Imaging Findings in Patients with Sudden Sensorineural Hearing Loss, 95

Medicine 1–5 (2016), filed on July 26, 2020 as Ex. 39 (ECF No. 54-4). And Dr. Tornatore again

denied that bilateral loss was required for there to be an autoimmune etiology, while observing

that Dr. Bigelow had seemed to concede that the speed of Mr. Kelly’s post-vaccination onset

was (all things being equal) consistent with the speed for a Type I hypersensitivity response

generally. Third Tornatore Rep. at 3.

Dr. Tornatore deemed the “fundamental issue” separating his opinion from Dr. Bigelow’s

was the latter’s failure to “follow simple rules of logic.” Third Tornatore Rep. at 3. Dr. Bigelow

10

was opining both that the true cause of Petitioner’s hearing loss was unknown—but also that the

vaccine could not have caused it. This, in Dr. Tornatore’s assessment, reflected an implicit bias

against the possibility of causation, especially since literature supported the conclusion that (a)

vascular events could explain SNHL, (b) favored treatments of it suggested it had some

inflammatory-related pathogenesis, and (c) “an autoimmune etiology to hearing loss is a viable

thesis,” as reflected in literature filed by Respondent. Id. at 2–3.

Response to Special Master Questions

The final written submission prepared by Dr. Tornatore usefully summarized his opinion

in this case, and provided some additional arguments relevant to it. He reiterated his opinion that

Mr. Kelly had a preexisting but asymptomatic microvascular disease, and an acute Type I

hypersensitivity reaction in the middle ear had caused “focal” injury to structures there located,

resulting in SNHL. Tornatore Resp. at 1, 4. Dr. Tornatore readily admitted that his opinion

required the determination that Petitioner first possessed this preexisting disease (specifically

“labyrinthine artery occlusion”), adding that the record supported his conclusion. Id. Although

the condition was not easily diagnosed (since Dr. Tornatore deemed it difficult to obtain MRI

imaging for inner ear vessels), the record showed that Petitioner had “all the hallmarks” of it,

given his age, the very fact of his acute hearing loss, and Dr. Reichman’s speculations about

vaccine causality. Id. at 4.

The proposed hypersensitivity reaction, moreover, was likely mediated by IgE—even

though there was no evidence of a localized reaction at the site of vaccination. Tornatore Resp.

at 1–3. To explain this disparity, Dr. Tornatore compared the injury in this case to Meniere’s

disease a/k/a “endolymatic hydrops,” a condition of the inner ear (importantly, not middle as is

contended here) that can produce hearing loss or dizziness/vertigo. An animal study had

confirmed that an inner ear allergic reaction (reflected as a Type 1 hypersensitivity reaction)

could be provoked with antigenic stimulation. Tornatore Resp. at 2; T. Takeda et al., Type 1

Allergy-Induced Endolymphatic Hydrops and the Suppressive Effect of Leukotriene Receptor

Antagonist, 33 Otology & Neurotology 886 (2012), filed as Ex. 41 on Oct. 19, 2020 (ECF No.

56-3) (studying the effect of the allergic reaction of DNP-As antigen on guinea pigs’ inner ear

and the inhibition effects of leukotriene receptor antagonist) (“Takeda”).

The same kind of provocation of Meniere’s had also been demonstrated to be possible in

humans via an allergic prick test, which resulted in acute symptoms manifestation of cochlear

disease not limited to the site of provocation. B. Topuz et al., Provocation of Endolymphatic

Hydrops with a Prick Test in Meniere’s Disease, 24 Advances in Therapy 819–25 (2007), filed

as Ex. 42 on Oct. 19, 2020 (ECF No. 56-4) (testing whether the antigenic challenge causing

allergic reaction is a stimulative factor for an episode of endolymphatic hydrops, specifically in

11

Meniere’s disease) (“Topuz”). Topuz, however, involved individuals with diagnosed or

suspected Meniere’s, who were moreover tested with skin pricks of allergens to which they had

been determined to be atopic/allergic. Topuz at 820-21. Here, Dr. Tornatore did not deem

absence of proof of a localized reaction to be especially significant, since the vaccine was

intramuscularly administered, making it difficult to “see” evidence of reaction. Tornatore Rep.

at 3.

Dr. Tornatore also again summarized his arguments for why treatment focused on the

allergic nature of the reaction (steroids or antihistamines) would be ineffective in addressing the

acute and largely-irreversible effects of the ischemic injury, which he noted would manifest in

minutes. Tornatore Rep. at 3. He maintained that onsets of 30 minutes (as some records

suggested had occurred) to one or two hours were all equally medically acceptable based on his

proposed mechanism. Id. And he repeated his contention that (effectively under the concept of

“challenge-rechallenge”) 12 the sensitivity reaction that his theory embraced would require a

first-time antigenic exposure, or “initial sensitization phase,” for the second allergic reaction to

occur as acutely and quickly as posited. Id. at 4.

B. Douglas Bigelow, M.D.

Dr. Bigelow, Respondent’s primary expert, offered two written reports, and (like Dr.

Tornatore) prepared answers to questions posed in this case by the prior special master presiding

over it. Report, dated May 8, 2019, filed as Ex. C (ECF No. 38-1) (“First Bigelow Rep.”);

Report, dated April 6, 2020, filed as Ex. E (ECF No. 51-1) (“Second Bigelow Rep.”); Response,

dated October 18, 2020, filed as Ex. F (ECF No. 57-1) (“Bigelow Resp.”). He disputed that the

flu vaccine was responsible for Mr. Kelly’s SNHL.

Dr. Bigelow is board-certified in otolaryngology and neurotology. See Ex. C, dated May

20, 2019 (ECF No. 38-1) (“Bigelow CV”). He graduated from Hamline University with a

Bachelor of Arts in Chemistry, and attended University of Minnesota School of Medicine. Id. at

1. He completed residency in Otolaryngology-Head and Neck Surgery at Washington

University, St. Louis. Id. He completed later programs at the Midwest Otologic Group in St.

Louis for Otology, Neurotology, Cranial Base Surgery, doing the same at the University of

Zurich. Id. Finally, a study of Gamma Knife Radiosurgery in Pittsburgh. Id. Currently, he serves

as an Associate Professor in the Department of Otorhinolaryngology: Head and Neck Surgery

at the University of Pennsylvania School of Medicine. Id. at 2. He also serves as the Director of

the Division of Otology/Neurotology at the University of Pennsylvania Medical Center. Id. Dr.

12

The “challenge-rechallenge” theory is a model where “a person (1) is exposed to one antigen, (2) reacts to that

antigen in a particular way, (3) is given the same antigen again, and (4) reacts to that antigen similarly.” Nussman v.

Sec’y of Health & Hum. Servs., No. 99-500V, 2008 WL 449656, at *9 (Fed. Cl. Spec. Mstr. Jan. 31, 2008).

12

Bigelow has given several presentations on otology and the causes there of. Id. at 5–11. Along

with that he has published several peer reviewed articles on otology and its presentation of

symptoms. Id. at 11–14. He also has non-peer reviewed articles, abstracts, editorials, reviews

and chapters published. Id. at 14–18. Dr. Bigelow has had many years treating and examining

otology and neurotology, but is not a vaccine specialist. See generally id.

First Report

Like Dr. Tornatore, Dr. Bigelow began his initial report with an in-depth evaluation of

the Petitioner’s medical history relevant to the case. See generally First Bigelow Rep. at 2–6.

He deemed Mr. Kelly’s onset (manifesting as left-sided tinnitus/hearing loss and

lightheadedness) to have occurred within a half-hour of the vaccination, based on representations

made at the ER by the Petitioner. Id. at 5, 9; Ex. 2 at 26, 32. Dr. Bigelow saw no evidence in the

record of other contemporaneous symptoms (not counting the nausea and dizziness Petitioner

displayed the next day, which Dr. Bigelow deemed consistent with Petitioner’s presentation).

First Bigelow Rep. at 5. Imaging results were inconclusive, and could not confirm or refute the

possibility that some brain problem explained the Petitioner’s symptoms. Id. at 5–6.

Based on the medical history, Dr. Bigelow accepted Petitioner’s diagnosis of left-sided

SNHL, noting that his course, treatment, and eventual progression toward an incomplete

recovery was consistent with it—although he deemed the cause of Petitioner’s injury to be

idiopathic. First Bigelow Rep. at 6. SNHL, he explained, is often idiopathic, with no causal

etiology ever obtained. Id. Petitioner’s injury was likely the same—and Dr. Bigelow proposed

this was largely the case because Mr. Kelly never received a full work-up that might explain the

original/underlying cause. The initial, incomplete MRI scan he had received, for example, was

in Dr. Bigelow’s view inadequate to rule out brain lesions as potentially causal. Id. Dr. Bigelow

also considered it significant that Petitioner’s hearing loss was not responsive to steroids when

they were administered promptly after the SNHL presented, noting this undercut any contention

that an autoimmune process explained Mr. Kelly’s injury. Id. at 8. The fact that his hearing loss

never became bilateral was also inconsistent with an autoimmune etiology. Id.

Dr. Bigelow next addressed some general points bearing on SNHL. Contrary to Dr.

Tornatore, Dr. Bigelow deemed sudden SNHL “a fairly common problem,” pointing out that

66,000 cases of SNHL occurred annually, and that he himself saw “a number of patients every

week” complaining of it. First Bigelow Rep. at 6; T. Alexander & J. Harris, Incidence of Sudden

Sensorineural Hearing Loss, 34 Otology & Neurotology 1586–89 (2013), filed as Ex. C-01 on

May 20, 2019 (ECF No. 39-1) (“Alexander & Harris”). Alexander and Harris observe that “the

majority of cases are idiopathic, with a specific cause identified in fewer than 30% of patients

presenting with SSNHL [sudden SNHL].” Alexander & Harris at 1586. Dr. Bigelow allowed

13

that SNHL could have a number of causes, including a vascular or autoimmune-driven source,

although he maintained that in most cases it was reasonably considered idiopathic. First Bigelow

Rep. at 7. He denied ever confronting a case in which a vaccine could explain the SNHL. Id. at

9.

Dr. Tornatore’s specific opinion—that Petitioner’s SNHL was due to preexisting vascular

harm to the “wall of the labyrinthine artery” exacerbated by the flu vaccine—was attacked by

Dr. Bigelow on several levels. For example, Dr. Bigelow questioned whether Petitioner had any

preexisting vascular problem in the first place, noting that the primary evidence of this—the CT

scan, which showed “some evidence of what is likely small vessel ischemic changes” in

Petitioner’s brain—was an “extremely common” imaging finding, especially as a patient ages,

but no scientific or medical studies linked this finding to atherosclerosis of the labyrinthine

artery. First Bigelow Rep. at 7. And the evidence Dr. Tornatore cited in this regard was in Dr.

Bigelow’s view unpersuasive. The Lee article dealt with hearing loss due to vertebrobasilar

ischemia, a condition associated with neurologic findings before or at the time of SNHL, and

often specifically attributable to blockage in the anterior inferior cerebellar artery (responsible

for directing blood to much of the brain), and of which the Labyrinthine artery was a branch.

Lee at 125; First Bigelow Rep. at 7. Thus, infarction/occlusion sufficient to produce hearing loss

would invariably also cause neurologic findings absent herein. Dr. Bigelow in fact deemed

Petitioner’s presentation more consistent with a viral-caused labyrinthitis or Meniere’s disease.

First Bigelow Rep. at 7.

Other literature cited by Dr. Tornatore was no more helpful to his theory, in Dr. Bigelow’s

assessment. One article acknowledged not only that the pathologic findings from patients with

SNHL were inconsistent with what was common in cases of arterial occlusion, but also that what

was seen when a person experienced Labyrinthine artery occlusion was “fibrosis and ossification

of the cochlea”—completely contrary to Petitioner’s presentation or course. First Bigelow Rep.

at 7; A. Belal, Jr., Pathology of Vascular Sensorineural Hearing Impairment, 90 The

Laryngoscope 1838 (1980), filed as Ex. 17 on April 20, 2017 (ECF No. 25-2) (“Belal”). And

findings relating to sudden hearing loss in a patient with migraines, like what was presented in

Piovesan, had no relevance to this case, since Petitioner had no comparable history, and since

the pathologic mechanism that led to hearing loss there was vasospasm 13 something not alleged

to have occurred herein. Piovesan at 1832–35.

Dr. Bigelow flatly denied that any reliable medical or scientific literature existed that

could link the flu vaccine to an inner ear vascular injury. First Bigelow Rep. at 8. Rather, he

noted the existence of reputable and reliable epidemiologic evidence specifically relevant to

13

Spasm of the blood vessels, resulting in vasoconstriction. DORLAND’S at 1997.

14

SNHL suggesting the contrary. Id. at 8–9; R. Baxter et al., Sudden-Onset Sensorineural Hearing

Loss after Immunization: A Case-Centered Analysis, 155 Otolaryngology-Head and Neck

Surgery 81–86 (2016), filed as Ex. C-04 on May 20, 2019 (ECF No. 39-4) (“Baxter”)

(researching connections between SNHL and vaccinations finding no evidence of increased

risk). At most, there was some limited case report evidence of a connection, but the particular

article identified by Dr. Bigelow was both distinguishable on the facts (it involved bilateral

hearing loss that proved responsive to steroids) and also expressly acknowledged that causation

could not be stated with certainty. H. Huang et al., Bilateral Sudden Deafness Following H1N1

Vaccination, 143 Otolaryngology-Head and Neck Surgery 849–50 (2010), filed as Ex. C-05 on

May 20, 2019 (ECF No. 39-5) (“Huang”) (subject’s bilateral hearing loss occurring 14 hours

after vaccination). Dr. Bigelow admitted the existence of some other case reports associating a

live attenuated MMR vaccine with hearing loss.

The exceedingly-short post-vaccination timeframe in which Petitioner’s SNHL

manifested was also, in Dr. Bigelow’s view, another factor eliminating the flu vaccine as

potentially causal. Again, Dr. Bigelow noted the absence in this time period of other

corroborative symptoms, like anaphylaxis, that would demonstrate the presence of an acute

inflammatory reaction in response to vaccination and manifesting as a hypersensitivity reaction.

First Bigelow Rep. at 8. The short timeframe was not consistent with an autoimmune reaction

either, since it would take more than a day for even the most immediately-produced class of

these autoantibodies, IgM, to appear. Id.

Second Report

Dr. Bigelow’s next report was a detailed response to Dr. Tornatore’s Second Report. He

began by defending his contention that SNHL was common, noting that the primary article he

offered to support this contention, Alexander and Harris, was a 2013 study, in comparison to the

paper cited by Dr. Tornatore from 1996 (which in turn relief on 1973 data to establish the

condition’s rarity). Second Bigelow Rep. at 1; G. Hughes et al., Sudden Sensorineural Hearing

Loss, 29 Otolaryngologic Clinics of North America 393–405 (1996), filed as Ex. 21 on April

20, 2017 (ECF No. 25-6) (“Hughes”); see also Kuhn at 91. Dr. Bigelow also opined that

Petitioner was in the high risk group for SNHL given his personal demographics (male in mid-

60s). Second Bigelow Rep. at 2.

Dr. Bigelow emphasized again his prior statements that SNHL was more often than not

deemed idiopathic, rather than (as Dr. Tornatore opined) likely attributable to vascular or

autoimmune injury (in the absence of proof structural defect to the ear). In so doing, he contested

the extent to which some of Dr. Tornatore’s literature actually supported his opinion, noting (for

example) that Hughes agreed that “definitive proof” connecting SNHL to vascular problems was

15

lacking (although it still deemed it a reasonable hypothesis). Second Bigelow Rep. at 2; Hughes

at 395. But a different article offered by Dr. Bigelow suggested that individuals diagnosed with

SNHL possessed evidence of ear lesions inconsistent with a vascular cause. H. Schuknecht &

E. Donovan, The Pathology of Idiopathic Sudden Sensorineural Hearing Loss, 243 Archives of

Otorhinolaryngology 1–15 (1986), filed as Ex. E-02 on April 7, 2020 (ECF No. 51-3)

(“Schuknecht & Donovan”). This article found that of the three most mentioned etiologies—

vascular lesions, membrane breaks and viral infection—the third cause was best-supported from

a scientific standpoint. Schuknecht & Donovan at 14.

Mr. Kelly’s own medical history remained, in Dr. Bigelow’s view, simply inconsistent

with his having experienced hearing loss due to vascular harm, preexisting or not. The fact that

his hearing loss was incomplete at all frequencies (being more severe in higher than low

frequencies, as evidenced by testing performed approximately a year and a half after the

vaccination) was not reflective of the degree of harm a vascular-caused injury would display,

since the literature filed in the case suggested it would progressively lead to increased “fibrosis

and ossification of the cochlea” over time. Second Bigelow Rep. at 3; Ex. 13 at 1.

Petitioner’s MRI scans similarly did not corroborate Dr. Tornatore’s contentions about a

vascular etiology. Dr. Bigelow stated that any patient evaluated for SNHL would undergo MRI

scanning, and in fact (and contrary to Dr. Tornatore’s assumptions) the scan would be able to

make out the cochlea and labyrinth in the ear, given the fluid found in each. Second Bigelow

Rep. at 3. 14 As a result, if fibrosis or ossification were present, “there is a loss of the T2 signal

in the cochlea on the MRI scan” and it would be readily ascertainable. Id. But the June 2019

MRI scan Petitioner underwent (and which Dr. Bigelow reviewed) revealed that Petitioner’s

“cochlea and labyrinth appeared perfectly normal,” with no evidence of fibrosis, ossification, or

other pathology (and none noted in the radiology report itself). Id. 15

More specifically, Dr. Bigelow argued that the literature filed in support of a vascular

etiology for SNHL in some cases only underscored why it was so unlikely given Petitioner’s

medical history. Although Lee did discuss sudden hearing loss in some individuals with

vertebrobasilar ischemia but without concurrent neurologic issues, such cases were more

commonly “associated with some neurologic findings”—findings completely absent here.

Second Bigelow Rep. at 2; Lee at 125. Belal was a case report of two patients, one of whom had

14

MRI or magnetic resonance imagining shows fluids by temporarily realigning water molecules in your body through

the magnetic field. MAYO CLINIC, https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768 (last visited

Sept. 26, 2021).

15

Dr. Bigelow also noted that the MRI revealed no brain or nerve lesion explanation for the SNHL, underscoring its

likely idiopathic nature. Second Bigelow Rep. at 4.

16

bilateral hearing loss while the other died of leukemia that was demonstrated to have infiltrated

the patient’s temporal bones—again, fact patterns easily distinguishable from Petitioner’s

history of unilateral hearing loss not accompanied by evidence of other illness. Second Bigelow

Rep. at 2; Belal at 1836. Moreover, the Belal subjects demonstrated cochlea ossification thought

to be the product of vascular occlusion, something not demonstrated herein. Second Bigelow

Rep. at 2–3; see also Schuknecht & Donovan at 14 (deeming finding of fibrous tissue and bone

in inner ear “presumptive evidence” that the hearing loss has a vascular etiology).

Dr. Bigelow also repeated his prior challenges to the contention that there could be an

autoimmune etiology for Petitioner’s SNHL. Individuals with SNHL caused by an autoimmune

process typically present with bilateral hearing loss (or loss in one ear followed by loss in the

other days to a few weeks later), but Mr. Kelly’s hearing loss was confined to his left ear, and

also did not feature the fluctuations common when the hearing loss was attributable to an

autoimmune process. Second Bigelow Rep. at 3–5. Literature cited by Dr. Tornatore to support

autoimmunity as a potential explanation was distinguishable, because the patients considered in

the case reports mentioned therein all had been diagnosed with a systemic autoimmune disease,

whereas Petitioner has never been. Id; B. Rossini et al., Sudden Sensorineural Hearing Loss and

Autoimmune Systemic Diseases, 21 International Archives of Otorhinolaryngology 213 (2017),

filed as Ex. 32 on Dec. 31, 2019 (ECF No. 47-3) (“Rossini”). Rossini purposefully looked at the

connections between patients with sudden SNHL and a systemic autoimmune disease,

specifically ruling out those without one, and thus clearly differentiating those circumstances

from the Petitioner’s. See id. Also, autoimmune-caused inner ear disease is typically responsive

to steroids—a fact confirmed by Rossini. Second Bigelow Rep. at 3; Rossini at 217. But the

record revealed that Petitioner had been given steroids within hours of his hearing loss and

before his hospital discharge—but without benefit. Second Bigelow Rep. at 4. And the speed of

Petitioner’s hearing loss—30 minutes to two hours after vaccination—was not consistent with

an autoimmune process, which would be dependent on a slower, adaptive immune response.

Second Bigelow Rep. at 5.

Dr. Bigelow ended his second report by revisiting the evidence he maintained closed the

door on the contention that the flu vaccine could precipitate SNHL, or did so here. Reliable

epidemiologic evidence existed to rebut Petitioner’s causation contentions. Baxter, for example,

involved almost nine million vaccinations over a seven-year period, but found no increased risk

in a case-controlled comparison. 16 Second Bigelow Rep. at 5; Baxter at 85. Moreover, had Mr.

Kelly possessed some preexisting propensity for a hypersensitivity reaction to the vaccine, there

would have been corroborative evidence of the reaction itself, in addition to the hearing loss.

16

Case-control studies “compare[] a group with a disease or condition to a control group without the condition.”

Snyder ex rel. Snyder v. Sec’y of Health & Hum. Servs., No. 01-162V, 2009 WL 332044, at *199 (Fed. Cl. Spec.

Mstr. Feb. 12, 2009).

17

Second Bigelow Rep. at 5. Nor was there trustworthy evidence of a “challenge-rechallenge,”

based on the fact that Petitioner had received the flu vaccine in the past (and therefore was more

susceptible to a rapid reaction in future encounters with it). Literature in fact supported the

conclusion that revaccination with the flu vaccine led to fewer, not more, reactions. Id; Baxter

at 85; J. Diez-Domingo et al., Safety and Tolerability of Cell Culture-Derived and Egg-Derived

Trivalent Influenza Vaccines in 3 to <18-year-old Children and Adolescents at Risk of Influenza-

Related Complications, 49 International J. of Infectious Diseases 174 (2016), filed as Ex. E-06

on April 7, 2020 (ECF No. 51-7).

Response to Special Master Questions

Dr. Bigelow’s two-page letter responding to questions posed to him by the special master

formerly presiding over this matter focused on a single issue: what other neurologic symptoms

would accompany an “occlusion event” impacting the blood supply to the inner or middle ear,

had Petitioner experienced one. Bigelow Resp. at 1. He noted several, including but not limited

to vertigo, hearing loss, tinnitus, and facial numbness, as well as facial palsy, Horner

syndrome 17, and hemiataxia. 18 Id. Mr. Kelly had displayed only the kinds of symptoms directly

associated with the hearing loss (like dizziness or tinnitus), but did not reveal the other “central

neurologic signs.” Id.

In addition, Dr. Bigelow reiterated his prior assertion that none of the imaging or scans

Petitioner had received—either at the time of the hearing loss or later—revealed brain lesions

that would be consistent with occlusion. Bigelow Resp. at 2. While he acknowledged that an

occlusion event isolated to the Labyrinthine artery (as somewhat alleged herein) would not

necessarily be directly visible in such imaging, such an injury (had it occurred) would have so

harmed both the relevant artery and cochlea more generally that the 2019 MRI Petitioner

received “would have demonstrated significant loss of the T2 signal of the inner ear”—and yet

it did not. Id; Ex. 35 at 1.

C. Michael Phillips, M.D.

Dr. Phillips, an allergist/immunologist, provided a single report for Respondent, although

it was not referenced in Respondent’s briefing. Report, dated August 12, 2017, filed as Ex. A

(ECF No. 31-1) (“Phillips Rep.”). Dr. Phillips opined that Petitioner’s SNHL could not be linked

17

Horner syndrome includes the symptoms of sinking of the eye and upper eyelid, elevation of the lower eyelid,

constriction of the pupil, anhidrosis and flushing of the affected side of the face and narrowing of the palpebral fissure

caused by a brainstem lesion. DORLAND’S at 1803.

18

Hemiataxia is ataxia affecting one side of the body only. DORLAND’S at 825.

18

persuasively to the flu vaccine.

Dr. Phillips is board-certified in internal medicine along with allergy and immunology.

Ex. A at 2, dated Jan. 2014 (ECF No. 31-2) (“Phillips CV”). He graduated with a Bachelor of

Science degree from the University of Wisconsin, continuing his education at the University of

Wisconsin School of Medicine. Id. at 1. Dr. Phillips completed a residency at the University of

Pennsylvania and was a research fellow at Harvard Medical School. Id. He also completed

research at the Walter Reed Army Institute of Research in the Immunology, Division of

Communicable Diseases and Immunology. Id. Currently, Dr. Phillips serves as a Professor of

Medicine in the Pulmonary Allergy Critical Care Division at the University of Pennsylvania

School of Medicine, and is a Lead Clinical Physician at the University of Pennsylvania,

Department of Medicine. Id. at 2. He is the Director of Allergy Services at the University of

Pennsylvania and consults for the Philadelphia Veterans Administration Hospital. Id. at 2–3. Dr.

Phillips has written over one hundred papers on subjects covering autoimmune reactions,

neurological diseases, vaccination, and others. Id. at 5–13. He has also published several

abstracts, editorials, reviews, chapters, and books on the same topics. Id. at 13–14. Dr. Phillips

has had numerous years studying and researching allergy and immunology issues. See generally

id.

Like the other experts, Dr. Phillips devoted part of his written report to a summary of Mr.

Kelly’s medical history, and it paralleled what Dr. Tornatore provided. Phillips Rep. at 4–6.

However, Dr. Phillips questioned whether Dr. Tornatore’s opinion was consistent with

immunologic or epidemiologic principles. Id. at 7. First, he maintained that evidence of a

preexisting vascular condition in Petitioner was absent. Any imaging evidence suggestive of

vascular disease was not in the region of the ear, and he had demonstrated no stroke-oriented

symptoms. Id. In addition, the statins he was taking for high cholesterol/hyperlipidemia seemed

to be working, and there was in any event no correlation between hyperlipidemia and ear-

oriented vascular disease. Id. Otherwise, the medical record showed nothing suggestive of an

immune-oriented cross-reaction having occurred in the ear, and no serologic testing or imaging

results supported such a conclusion either. Id. at 11.

Dr. Phillips next considered Dr. Tornatore’s argument that an allergic reaction mediated

by IgE could explain Petitioner’s SNHL. He noted the general unlikeliness of this possibility,

given that there was no evidence Petitioner had any preexisting allergy to the flu vaccine, and

the record did not establish any other manifestations of an allergic reaction (e.g., hives,

respiratory distress, edema, etc.). Phillips Rep. at 7. In addition, such a reaction would be

“reversible by antihistamines and steroids,” yet these treatments did not prove effective for Mr.

Kelly, and none of his treaters otherwise proposed this explained his SNHL. Id.

19

More specifically, an IgE-mediated allergic reaction would require “the interaction of

mast-cells 19 bearing IgE receptors for specific antigen,” but no such antigen had been identified.

Phillips Rep. at 7–8. And the reaction would inherently have a localized character before

becoming sufficiently systemic to impact the ear—but Petitioner demonstrated no reaction on

his arm or allergic-like injury there. Id. at 8. An IgE-mediated reaction would not otherwise

result in “vascular obstruction” distant from the locus of the vaccine’s administration. Id. at 8.

There were other possible, non-IgE-mediated allergic reactions (such as a “leukotriene mediated

delayed reaction”), but Dr. Phillips maintained they would take longer than thirty minutes to

two hours to produce vasculitic-associated symptoms, and thus were inconsistent with

Petitioner’s short onset. Id.

An autoimmune-mediated form of hearing loss attributed to the flu vaccine was also

rejected by Dr. Phillips. He allowed for the possibility of “reactions of the immune system to

specific antigens in the cochlea” resulting in sudden hearing loss, and admitted that an

autoimmune reaction resulting in “secondary vascular occlusion” produced by vasculitis was a

reliable explanation for some forms of SNHL. Phillips Rep. at 8–9. But Dr. Phillips argued there

was an absence of evidence that the flu vaccine could precipitate such a loss via molecular

mimicry and a cross-reaction. Phillips Rep. at 8. Since the vaccine is routinely administered to

millions of U.S. citizens each year, far more individuals should be experiencing hearing loss due

to the vaccine than are reported, yet epidemiologic evidence undercut this conclusion. Id. at 8–

9; Phillips Rep. at 9 (noting several studies that compared vaccinated versus un-vaccinated

populations with no statistical difference in autoimmune vasculitis, a theory of SNHL).

One study referenced by Dr. Phillips was specific to the question of the role vaccines

might play in causing SNHL. See Baxter (finding “no indication of an increased risk of

immunization with any vaccine prior to the development of [sudden SNHL]”); Phillips Rep. at

10. Dr. Phillips emphasized his opinion that Baxter had statistical significance, showing only

0.965 odds of SNHL after vaccination. Phillips Rep. at 10. Thus, Dr. Phillips concluded that the

existing epidemiologic evidence “clearly shows that there is no increased occurrence of

vasculitis” that might result in SNHL, and he otherwise discounted the causal value of case

reports. Phillips Rep. at 11.

III. Procedural History

After initiation of this claim in July 2016, Petitioner filed medical records through early

2017. Before then, Respondent filed a Rule 4(c) Report on October 11, 2016 (ECF No. 10),

19

A mast-cell is a “type of migrant connective tissue cell with basophilic, metachromatic, cytoplasmic granules that

contain histamine and heparin in humans and serotonin in species such as the rat and mouse.” DORLAND’S at 315.

20

contesting entitlement. Petitioner thereafter filed the first expert report from Dr. Tornatore in

March 2017, and Respondent in reaction filed Dr. Phillips’s expert report in August of that same

year. Additional rounds of expert reports were filed through the fall of 2020 (including the letter

responses to questions posed by the special master formerly presiding over this case).

Petitioner first expressed a willingness to resolve the case via Ruling on the Record in a

status report on August 5, 2019 (ECF No. 43). Petitioner then filed his Motion in December

2020, with Respondent opposing entitlement on March 9, 2021 (ECF No. 64) (“Opp.”). In the

intervening timeframe, the matter was reassigned to me. Petitioner completed briefing on the

matter with a Reply filed April 12, 2021 (ECF No. 65) (“Reply”).

IV. Parties’ Respective Arguments

Petitioner’s Brief

Petitioner argues that his preexisting, asymptomatic microvascular angiopathy was

worsened by receipt of the flu vaccine, resulting in sudden onset of SNHL. Br. at 20–21. Prior

to vaccination, he had risk factors for vascular disease from hyperlipidemia, taking medication

for this, and no prior history of any hearing-related issues. Ex. 3 at 27, 31. After vaccination,

however, he started experiencing severe tinnitus, imbalance with multiple falls, and

lightheadedness. Br. at 9. Thereafter he could not walk without issues, was unable to drive, and

ringing in his ears only stopped when he was asleep. Id.; Ex. 28 at 3. All of these health burdens

took a significant toll on his life, greatly limiting what he was able to do day-to-day. Br. at 10.

In defense of causation, Petitioner maintains that Dr. Tornatore has demonstrated how the

flu vaccine could provoke a Type 1 hypersensitivity reaction that significantly aggravated his

pre-existing asymptomatic condition. Br. at 16. The theory is supported by animal models and

human data collection demonstrating how an immune reaction or hypersensitivity may occur

upon introduction of an antigen. Br. at 12; Ex. 20 at 1–2; Ex. 41 at 4. Alternatively, Petitioner

identifies a vascular or autoimmune event as the cause. Id. at 11; Ex. 4 at 22; Ex. 14 at 5.

Numerous items of literature cited by Dr. Tornatore show how the inner ear works and how its

structures could have been restricted. Br. at 13–14. Dr. Tornatore also observed that while MRI

evidence did not reveal inner ear abnormalities or other findings consistent with his theory,

studies have shown that very few patients with SNHL show abnormalities in the first place. Id.

at 14; Ex. 39 at 1. Also significant was the fact that Petitioner’s treating physician, Dr. Reichman,

proposed the SNHL could have been caused by the vaccination. Br. at 16–17. Finally, Petitioner

maintains that the short onset (less than two hours) was consistent with filed literature and thus

medically acceptable. Br. at 16–17.

21

Respondent’s Opposition

Respondent argues for dismissal of the claim. Respondent accepts that Petitioner

experienced SNHL, but maintains that the record does not support the conclusion that Petitioner

had an asymptomatic microvascular disease. Opp. at 17–18. Even though Petitioner was

receiving medication for hyperlipidemia, the condition was under control, and thus provides

weak support for Petitioner’s contention that he had a preexisting medical issue. Id. at 17.

Otherwise, the medical records provide no evidence of any preexisting vascular condition, or an

autoimmune etiology for his SNHL. Id. at 32–33; Ex. C at 7; Ex. E at 3. And Dr. Reichman’s

speculation of a vaccine association was ultimately not corroborated by the entire record. Opp.

at 33; Ex. 4 at 22.

Respondent also notes that although Dr. Tornatore points to Petitioner’s CT scan as

evidencing “a few areas of ill-defined low density in the left parietal white matter [that] could

represent small vessel ischemic changes of indeterminate age,” this assertion lacks evidentiary

strength. Opp. at 18; Ex. 2 at 16, 92. In addition, Dr. Tornatore’s contention was not bulwarked

with literature support, and Dr. Bigelow did not also deem any diagnostic evidence from the

record as consistent with this conclusion. Response at 18; Ex. C at 6; Ex. E at 3.

More broadly, Respondent maintains that the claim of significant aggravation is

untenable, noting that Petitioner’s purported underlying vascular condition is incongruously

alleged to have “caused or primed him to suffer an entirely separate condition as a result of his

vaccine.” Opp. at 19. Indeed, since Petitioner had admitted that his hearing was normal pre-

vaccination, the onset of SNHL could inherently not have “aggravated” any absent preexisting

hearing problem. Id.

Respondent otherwise acknowledges that aspects of Dr. Tornatore’s causation theory

have scientific or medical reliability, but that its components do not add up to preponderant

evidence that the flu vaccine could cause SNHL under the facts of this case. Opp. at 22. For

example, Dr. Tornatore relies upon a study relating to individuals with Meniere’s disease, but

that illness is not a product of issues with the arterial system of the inner ear (which is the alleged

situs for injury in this case). Id. at 22–23. And two other studies he cites involved autoimmune-

mediated SNHL—a causal mechanism distinguishable from the vascular etiologies his theory

seemed to favor. Id. at 29. Respondent also noted the extent to which Dr. Tornatore’s causation

theories were inconsistently pursued, with him at some points claiming no Labyrinthine artery

infarction was causal, while saying the opposite elsewhere. Id. at 30; Ex. 40 at 1,3–4; Ex. 31 at

14. Dr. Bigelow, by contrast, located no literature support for an association between the flu

vaccine and SNHL. Opp. at 31–32; Ex. C at 8.

22

Petitioner’s Reply

On reply, Petitioner reiterates his assertion that his history of hyperlipidemia is a risk

factor for a vascular condition. Reply at 3; Ex. 31 at 8. Beyond that, Petitioner’s medical records

contain evidence that also establish the presence of a microvascular disease, like the CT scan

emphasized by Dr. Tornatore. Reply at 4; Ex. 3 at 31–32. Even the June 2019 MRI is supportive,

since, Petitioner argues, it reveals “probable small vessel ischemic changes.” Reply at 4; Ex. 35

at 1.

Petitioner also maintains that Dr. Tornatore’s theory was biologically plausible. Reply at

6; Ex. 40 at 2. Literature filed in support demonstrated that a “systemic immune challenge

resulted in a focal inner ear type I hypersensitivity reaction within 1 hour after the immune

challenge.” Reply at 7. And the possible injury mechanisms Dr. Tornatore proposed are generally

accepted in the medical community. Id. at 8. In effect, Petitioner maintains, Respondent is

demanding medical certainty for causation, even though that is not the proper evidentiary

standard. Id. at 9. Finally, Petitioner observed that there was no other possible cause for his SNHL

(and Respondent offered nothing in the alternative), and that he was able to demonstrate treater

support for causation. Reply at 10–11. Finally, the short onset timeframe (two to four hours) was

consistent with literature and otherwise medically acceptable. Id. at 12.

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 & Hum. Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano, 440

F.3d at 1320. 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.

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

23

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

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

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

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

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

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

Circuit in Althen v. Sec’y of Health and Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(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 & Hum. Servs., 35 F.3d

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

scientifically certain.” Id. at 549.

However, the Federal Circuit has repeatedly stated that the first prong requires a

preponderant evidentiary showing. See Boatmon v. Sec'y of Health & Hum. 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 & Hum. 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 & Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir.

2013) (citations omitted). If a claimant must overall meet the preponderance standard, it is logical

that they be required also to meet each individual prong with the same degree of evidentiary

showing (even if the type of evidence offered for each is different).

Petitioners may offer a variety of individual items of evidence in support of the first Althen

prong, and are not obligated to resort to medical literature, epidemiological studies, demonstration

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

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

24

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. Nevertheless, even though “scientific certainty” is not

required 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 & Hum. Servs., 956

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

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

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

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

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

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

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

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

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 & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is

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

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

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

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

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

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

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

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

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

mot. for review den'd, 100 Fed. Cl. 344, 356–57 (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

25

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

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

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

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

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 &

Hum. 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 & Hum. Servs., No. 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. Standards Applicable to Significant Aggravation Claim

Where a petitioner alleges significant aggravation of a preexisting condition, the Althen test is

expanded, and the petitioner has additional evidentiary burdens to satisfy. Loving v. Sec’y of Health

& Hum. Servs., 86 Fed. Cl. 135, 144 (2009). In Loving, the Court of Federal Claims combined the

Althen test with the test from Whitecotton v. Sec’y of Health & Hum. Servs., 81 F.3d 1099, 1107

(Fed. Cir. 1996), which related to on-Table significant aggravation cases. The resultant “significant

aggravation” test has six components, which require establishing:

(1) the person’s condition prior to administration of the vaccine, (2) the person’s current

condition (or the condition following the vaccination if that is also pertinent), (3) whether

the person’s current condition constitutes a “significant aggravation” of the person’s

condition prior to vaccination, (4) a medical theory causally connecting such a significantly

worsened condition to the vaccination, (5) a logical sequence of cause and effect showing

that the vaccination was the reason for the significant aggravation, and (6) a showing of a

proximate temporal relationship between the vaccination and the significant aggravation.

Loving, 86 Fed. Cl. at 144; see also W.C., 704 F.3d at 1357 (holding that “the Loving case provides

the correct framework for evaluating off-table significant aggravation claims”). In effect, the last

three prongs of the Loving test correspond to the three Althen prongs.

In Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072 (Fed. Cir. 2020), the Federal

Circuit further elaborated on the Loving framework. Under Prong (3) of the Loving test, the

Petitioner need not demonstrate an expected outcome, but merely that her current-post vaccination

condition was worse than pre-vaccination. Sharpe, 964 F.3d at 1081. And a claimant may make

out a prima facie case of significant aggravation overall without eliminating a preexisting condition

as the potential cause of her significantly aggravated injury (although the Circuit’s recasting of the

significant aggravation standard still permits Respondent to attempt to establish alternative cause,

26

where a petitioner’s showing is enough to make out a prima facie case and thereby shift the burden

of proof to Respondent). Id. at 1083.

C. 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 & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.

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

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

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

is evidenced by a rational determination).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

27

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

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

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

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

weight.”)).

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

records are automatically deemed accurate, or superior on their face to other forms of evidence.

Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly

situations in which compelling oral and written testimony may be more persuasive than records,

especially if the records are deemed to be incomplete or inaccurate. Campbell v. Sec'y of Health

& Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common sense and

experience, this rule should not be treated as an absolute and must yield where the factual

predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten

records which are, themselves, inconsistent, should be accorded less deference than those which

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

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

be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of Health & Hum. Servs., 991 F.2d 1570,

1575 (Fed. Cir. 1993).

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

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

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

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

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

explanations for inconsistencies between contemporaneously created medical records and later

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

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

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

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

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

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

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

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

D. Analysis of Expert Testimony

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

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

28

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

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

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

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

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

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

technique has been subjected to peer review and publication; (3) whether there is a known

or potential rate of error and whether there are standards for controlling the error; and (4)

whether the theory or technique enjoys general acceptance within a relevant scientific

community.

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

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

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

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

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

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

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

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

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

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

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

Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert's conclusion

“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too

great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743

(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec'y of Health & Hum.

Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for

review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. App’x. 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

29

must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26

(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);

see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court

has unambiguously explained that special masters are expected to consider the credibility of expert

witnesses in evaluating petitions for compensation under the Vaccine Act”).

E. Consideration of Medical Literature

Both parties filed medical and scientific literature in this case, but not all such items factor

into the outcome of this decision. While I have reviewed all the medical literature submitted in this

case, I discuss only those articles that are most relevant to my determination and/or are central to

Petitioners’ case—just as I have not exhaustively discussed every individual medical record filed.

Moriarty v. Sec'y of Health & Hum. Servs., No. 2015–5072, 2016 WL 1358616, at *5 (Fed. Cir.

Apr. 6, 2016) (“[w]e generally presume that a special master considered the relevant record

evidence even though he does not explicitly reference such evidence in his decision”) (citation

omitted); see also Paterek v. Sec'y of Health & Hum. Servs., 527 F. App’x 875, 884 (Fed. Cir.

2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the

conclusion that it was not considered”).

F. Disposition of Case Without Hearing

I am resolving this claim on the papers, rather than by holding a hearing. This is consistent

with the determination of the prior special master to whom the case was assigned, and the parties

have not in their filings opposed this mechanism for resolution. See Docket Entry, dated October

21, 2020. 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 (Ct.

Cl. Spec. Mstr. Apr. 19, 1991).

30

ANALYSIS

I. Treatment of Hearing Loss Claims in Vaccine Program

SNHL is a kind of acute hearing loss, and a symptom of a prior disease or pathologic

process. It therefore can have different potential etiologies, as both experts have acknowledged.

First Tornatore Report at 5–7; First Bigelow Report at 9.

Program claimants have frequently argued that SNHL was attributable to a vaccine—but

more often than not have not succeeded. 20 See, e.g., Inamdar v. Sec’y of Health & Hum. Servs.,

No. 15-1173V, 2019 WL1160341, at *16 (Fed. Cl. Spec. Mstr. Feb. 8, 2019) (referencing multiple

prior negative decisions involving SNHL or hearing loss); Donica v. Sec’y of Health and Hum.

Servs., No. 08-625V, 2010 WL 3735707, at *1, 10 (Fed. Cl. Spec. Mstr. Aug. 31, 2010) (flu

vaccine not demonstrated to cause adult hearing loss); Hopkins v. Sec’y of Health & Hum. Servs.

Nos. 00-745V & 00-746V, 2007 WL 2454038, at *13 (Fed. Cl. Spec. Mstr. Aug. 10, 2007)

(specific onset of hearing loss in child siblings after receipt of several vaccines could not be

established; criticizing Dr. Tornatore’s opinion as lacking foundation). In most such cases, the fact

of post-vaccination SNHL was not disputed, but the claimants could not demonstrate the vaccine

was causal.

In Inamdar, for example (a case I recently decided), a petitioner argued that the flu vaccine

had caused SNHL, with onset the following day, based on two theories. Inamdar, 2019

WL1160341, at *5. First, the claimant argued that the vaccine “could cause the production of

proinflammatory cytokines immediately upon vaccine administration.” Id. But I determined that

this argument relied too heavily on what was known about the wild virus rather than the vaccine.

Id. at *6. The second theory was that specific components of the vaccine “were structurally

homologous with ganglioside receptors on the neuronal myelin contained in the inner ear tissue,

and that antibodies generated in response to the vaccine could also cross-react with the self myelin,

resulting in tissue damage.” Id.

I found, however, that this contention misapplied mechanisms relevant in other contexts.

I also ruled that an alternative cause for the SNHL (the fact that the claimant was receiving

20

Decisions from different cases do not control the outcome herein, with only Federal Circuit decisions setting legal

standards to which new claims must adhere. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1358-59 (Fed.

Cir. 2019); Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (1998). Nevertheless, 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 thus be remiss in ignoring prior cases presenting similar theories or factual

circumstances, along with the reasoning employed in reaching such decisions.

31

antibiotics at the time) existed, as well as that the short onset was not preponderantly defended.

Inamdar, 2019 WL1160341, at *19. A too-short onset has been a notable obstacle to recovery in

other cases. See, e.g., Donica, 2010 WL 3735707, at *13 (two-hour post-vaccination onset of

SNHL not demonstrated to be medically acceptable).

A more recent case involving SNHL, by contrast, resulted in a determination favorable to

a petitioner, suggesting that there may well be reliable science (not previously considered or

proposed in older cases) to support the contention that a vaccine could cause this kind of abrupt

hearing loss. See Madigan v. Sec’y of Health & Hum. Servs., No. 14-1187V, 2021 WL 3046614,

at *1, 4 (Fed. Cl. Spec. Mstr. June 25, 2021) (flu vaccine caused adult petitioner’s SNHL). But

close consideration of the facts of that case reveals that Madigan is unhelpful to Petitioner herein.

In Madigan, the petitioner’s symptoms arose between three to four days post-vaccination.

Madigan, 2021 WL 3046614, at *4, 20. Thus (and putting aside the additional fact that the causal

theory offered therein is distinguishable from what was offered in this case), Madigan does not

counsel in favor of a finding of causation in a case presenting an extremely short onset—such as

the present matter.

II. Petitioner’s Significant Aggravation Claim Has Not been Preponderantly Established

It is undisputed that Mr. Kelly began to experience severe hearing loss in his left ear within

30 minutes to two hours of his receipt of the flu vaccine. Ex. 2 at 18; Ex. 4 at 12. Thus, the primary

question presented in this case is whether the flu vaccine could prompt such hearing loss—here,

by exaggerating a preexisting asymptomatic microvascular angiopathy. But that question

presupposes there was a preexisting condition subject to exaggeration—the first Loving prong.

Accordingly, a preliminary issue to resolve in this case is whether Mr. Kelly in fact suffered from

a preexisting but undiagnosed vascular condition.

A. Petitioner’s Argument that He Suffered from a Preexisting Condition is

Speculative and Unsupported by the Medical Record

The record does not preponderantly establish Petitioner’s contention that he suffered from

a preexisting microvascular angiopathy. Indeed, some of the evidence offered for this assertion

provides particularly weak support. For example, the fact that Mr. Kelly was receiving a statin

(a medication used prophylactically to arrest the development of hyperlipidemia) at the time of

vaccination is hardly evidence that he suffered from any pre-vaccination vascular problem. Nor

does the imaging evidence in this case corroborate Petitioner’s contention. The initial scanning

and imaging performed on Petitioner at the ER revealed little (beyond possible “small vessel

ischemic changes”) that could explain or undergird his hearing loss. Ex. 2 at 16, 30, 32, 89, 92.

This scanning evidence was not deemed significant by contemporaneous treaters. And the initial

32

MRI was also inconclusive (although it was not admittedly completed).

Then, a repeat MRI performed in 2019 (apparently in an effort to bulwark this claim)

revealed no more than “small ischemic changes,” that again were not characterized as significant

(or as evidence of a problem of the magnitude suggested by Petitioner). Ex. 35 at 1. In discussing

this kind of evidence, Dr. Bigelow (who was demonstrably more qualified to opine on the causes

and nature of hearing loss, given his actual medical focus and expertise, than Dr. Tornatore)

persuasively established that not only was Petitioner’s initial MRI incomplete (and thus could

not be cited to confirm Petitioner’s contention), but in fact the imaging and scanning overall did

not establish the presence of the degree of vascular problems argued by Dr. Tornatore. First

Bigelow Rep. at 5–7; Second Bigelow Rep. at 3. Dr. Bigelow also convincingly explained how

the imaging would either likely reveal the kinds of preexisting issues that Dr. Tornatore

maintained could not be displayed, or would at least have done so by the second time around

(i.e. the 2019 MRI), assuming that the initial hearing loss had been attributable to an arterial

occlusion in the ear. Second Bigelow Rep. at 3; Bigelow Resp. at 2.

Otherwise, Petitioner was never diagnosed with any vascular condition, there is no record

evidence that he had any such problems prior to vaccination, there were no neurologic findings

that would corroborate a vascular-oriented injury, and none of the post-vaccination records

suggested Petitioner’s SNHL had anything to do whatsoever with a preexisting vascular

condition. Articles like Belal or Lee helped identify the kinds of clinical findings that would be

consistent with preexisting arterial occlusion—but which are absent from this record. It simply

cannot be concluded on this record that the purported preexisting condition—the admitted

foundation for Dr. Tornatore’s opinion—has been preponderantly established.

B. Petitioner Cannot Meet the Other Loving Prongs 21

Respondent has questioned why Petitioner advances a significant aggravation claim, since

the “condition” Petitioner arguably suffered from was not itself directly made “worse,” but

21

Because a claimant must establish all prongs of either Althen or Loving to prevail, my determination that Petitioner

failed in so doing means I need not address each individual prong in my analysis. de Bazan, 539 F.3d at 1352. I will

note, however, that the record does not preponderantly establish that Petitioner’s SNHL was caused by the flu

vaccine—and hence he did not meet Althen prong two/Loving prong five. There is little to no treater support

associating the vaccine with Mr. Kelly’s hearing loss beyond some statements by Dr. Reichman—and those statements

need not be accepted at face value given their speculative character. Snyder, 88 Fed. Cl. at 746 n.67. The record

otherwise provides no corroborative evidence that Petitioner did experience a hypersensitivity reaction to the vaccine,

and testing and scanning/imaging performed on Petitioner did not produce results consistent with the proposed causal

theory. And I give some weight as well to Respondent’s contention that the alleged autoimmune mechanism of injury

is rebutted by the fact that Petitioner did not see improvement from the kinds of steroidal treatments usually effective

in addressing autoimmune illness, thus undermining the evidentiary support for that mechanism as an alternative.

33

instead was merely the purported causal foundation for the true injury of hearing loss. Opp. at

19. In Respondent’s view, Petitioner could just as easily have styled his claim as a regular non-

Table, causation-in-fact claim, alleging that the flu vaccine caused his SNHL (in the vascular-

Type I sensitivity manner alleged). There was no need to invoke Loving at all.

I am addressing the claim as pled, in acknowledgement of a petitioner’s right to define

the claim he wishes to assert. But I also note that since the Loving prongs incorporate the three

Althen prongs, my determination would be the same even if this case had more simply alleged

that the flu vaccine precipitated hearing loss by unmasking or negatively interacting with an

otherwise-benign and asymptomatic condition. Because whether the claim arises under Loving

or not, it founders on the first and third Althen prongs—Loving prongs four and six.

1. Petitioner’s Onset is Entirely Too Short (Loving Prong Six)

In addition to the fact that no preexisting vascular condition has been demonstrated on

this record, the claim also fails because Petitioner’s onset was entirely too short to be deemed

medically acceptable.

Although the Program recognizes that sensitivity/allergic reactions to vaccination exist,

and can manifest abruptly (with anaphylaxis being the best example 22), the evidence offered in

this case does not preponderantly support the conclusion that the flu vaccine could prompt acute

hearing loss so quickly, under the causal mechanism(s) proposed herein. Even if I accepted

Petitioner’s analogy of the hearing loss that occurred herein to Meniere’s, the evidence offered

relating to the latter in support of a short onset timeframe, like Takeda, distinguished the time

for reaction from the time of actual hearing loss, as Respondent has pointed out. Opp. at 25–26;

Takeda at 888–89.

Petitioner’s timing contentions otherwise raise far more questions than they persuasively

resolves. How would the introduction of antigens from the flu vaccine in a peripheral part of the

body cause an IgE allergic/hypersensitivity reaction within the ear less than two hours later—

and without evidence of a similar/related reaction spatially close to the situs of vaccination?

Comparisons to Meniere’s disease (which does not characterize what Petitioner experienced)

were not enough to preponderantly establish the point, especially since the nature of injury

alleged (vascular in origin) was distinguishable from what is known about how Meniere’s

occurs. The mere existence of other Type I hypersensitivity reactions in medicine, and the fact

that they can occur quickly, does not make it even barely plausible that SNHL due to vaccination

22

The Vaccine Injury Table recognizes anaphylaxis and anaphylactic shock for “[m]easles, mumps, rubella, or any

vaccine containing any of the forgoing as a component; DT; Td; or Tetanus Toxoid,” and “[i]nactivated polio vaccine,”

and requires a claimant to establish post-vaccination onset in four hours or less. 42 U.S.C. § 300aa-14.

34

could proceed in so swift a manner.

In addition, an autoimmune mechanism for injury in this case (which to some extent

stands as an alternative causation mechanism) would not likely occur in so fast a timeframe. If

Petitioner’s SNHL was autoimmune in nature, involving the production of IgE by B cells (as

Dr. Tornatore alleges (First Tornatore Rep. at 7)) how would an adaptive immune response

(which is what in most cases drives autoimmunity)—a process that the Program recognizes can

take days to unfold—occur so rapidly? Pelelo v. Sec’y of Health of Hum. Servs., No. 17-1485V,

2021 WL 4100312, at *20 (Fed. Cl. Spec. Mstr. Aug. 6, 2021) (discussing timeframe for

adaptive immune response in the context of peripheral neuropathy). It is true that the initial,

innate response to vaccination results in a comparatively-faster release of a variety of immune

cells, including cytokines—but an autoimmune response involving antibody production would

not occur in so short a timeframe. Even a case report filed by Dr. Bigelow, Huang, relating to

hearing loss after the flu vaccine involved a timeframe of no less than 14 hours. Huang at 850.

Dr. Tornatore endeavored to respond to these questions, but he did not do so in a manner

that exceeded a bare showing of plausibility. There is inadequate evidence in this record, or

contained in Dr. Torntore’s expert reports, that would permit me to conclude that (even assuming

the flu vaccine generally could cause SNHL in the manner alleged) onset of less than two or

even three hours is medically acceptable.

2. Petitioner has not Preponderantly Established the Flu Vaccine Could Cause

SNHL (Loving Prong Four)

The evidence offered for the “can cause” prong (evaluated by the same standard, whether

the claim is analyzed under Althen prong three or Loving prong four) also failed to clear the

preponderant line. Ultimately, Dr. Tornatore’s opinion unsuccessfully attempted to combine a

number of different components, not all of which meshed together, and which did not

collectively add up to a persuasive showing. 23

Of the mechanisms proposed as potentially causal, the one Dr. Tornatore seemed to end

up favoring was that Petitioner experienced a rapid Type I sensitivity reaction that could

exacerbate a vascular condition in Petitioner’s ear. Tornatore Rep. at 1, 4. There were individual

aspects of this theory that were reliable, such as the concept that vaccines can cause other

23

Although Dr. Tornatore’s theories were argued in the alternative, they were also somewhat inconsistent. Thus, the

idea that flu vaccine could cause an autoimmune response contradicted the concurrent argument that the flu vaccine

could prompt an allergic, Type I sensitivity reaction, since an autoimmune process could not be mediated in so short

a timeframe.

35

hypersensitivity reactions, or that distinguishable ear-oriented illnesses (like Meniere’s) can

result in hearing loss due to antigenic stimulation. See, e.g., Topuz. But the theory here not only

required a finding that Petitioner possessed a pre-existing vascular condition subject to

exacerbation (something I have not found was preponderantly demonstrated), but also that the

flu vaccine could worsen that condition by the same mechanism applicable to a different kind

of illness.

In addition, the evidence connecting the flu vaccine specifically to SNHL as a general

matter was limited to nonexistent. At most, Petitioner offered a few case reports—a kind of

evidence warranting low probative weight. R. V. v. Sec. of Health & Hum. Servs., No. 11-504V,

2016 WL 3882519, at *41 (Fed. Cl. Spec. Mstr. Feb. 19, 2016) (“individual patient case reports...

are not, in general strong evidence of causation” (internal quotation marks omitted)), mot. for

rev. denied, 127 Fed. Cl. 136 (2016). By contrast, reliable epidemiologic articles, like Baxter,

found no increased risk for post-flu vaccine SNHL. Baxter at 83, 85. As the Federal Circuit has

observed, although petitioners are never required to offer their own supportive epidemiologic

evidence to prevail, it can be evaluated and given weight when it exists—and it can undermine

a petitioner’s causation showing. D’Tiole v. Sec’y of Health & Hum. Servs., 726 F. App’x 809,

811–12 (Fed. Cir. 2018). 24 Otherwise, the potentiality for homology between amino acid

sequences in the vaccine’s antigens and tissues in the ear was not enough to show that the flu

vaccine (or the underlying wild virus it seeks to protect against) would likely cause a cross-

reaction in the ear, resulting in hearing loss.

The contention that SNHL could be driven by an autoimmune process, argued in the

alternative, was inconsistent with the timeframe in which Petitioner’s hearing loss actually

presented—as well as the fact that autoimmune-caused hearing loss would more likely present

bilaterally. Second Bigelow Rep. at 3–5. It was no answer to say that “sometimes” this was what

happened. Indeed, Dr. Bigelow persuasively established that hearing loss with a vascular origin

would similarly progress to a more complete loss. And an autoimmune origin would in most

24

Dr. Tornatore also attempted to drain Baxter of the weight I am giving it by maintaining that the “rare” nature of a

vaccine injury means that almost any large-scale epidemiologic study will be inadequately powered to detect the event.

See, e.g., Second Tornatore Rep. at 14–15. But this argument (ignoring the fact that it is contrary to the Federal

Circuit’s stated position on the relevance of this kind of evidence in Vaccine Program cases) is nonsensical. The fact

that a large-scale study can never with certainty disprove the possibility of causation by vaccine does not mean it lacks

evidentiary weight capable of undermining the petitioner’s showing (and of course it is the petitioner’s burden to

make that showing—not Respondent’s to prove a negative). A trustworthy epidemiologic study can undermine a

Petitioner’s case, even if it cannot make the causal claim impossible.

Moreover, it is logically inconsistent for petitioners to categorically dismiss the evidentiary import of contrary

epidemiologic evidence—but in the same breath tout the significance of case reports (which Program petitioners do

all the time). If case reports (usually involving only a handful of impacted/vaccinated individuals) have any evidentiary

value in proving a causal association, why would a study involving thousands if not millions of vaccine recipients not

also?

36

cases mean some other underlying systemic disease was occurring—again, absent from this

record

In reaching the conclusions I do on the insufficiencies in Petitioner’s causation theory, I

have overall given Dr. Tornatore’s opinion less weight than the rejoinder offered by Dr.

Bigelow. Dr. Tornatore was generally qualified to testify on many of the immunologic issues in

contention, and (as noted) individual aspects of his opinion made plausible contentions or had

some reliable scientific basis. But he plainly does not possess the otolaryngologic expertise of

Dr. Bigelow. Respondent’s expert simply displayed a better working understanding of the

foundations of hearing loss and its possible causes, he explained why the causation theories

offered were insufficient, and he more credibly interpreted the record in this case.

III. This Case was Properly Resolved Without a Trial

In ruling on the record, I am choosing not to hold a hearing. Determining how best to

resolve a case is a matter that lies generally within my discretion, and although the parties have

not objected to this method of adjudication, I shall explain why a hearing was not required.

Prior decisions have recognized that a special master’s discretion in deciding whether to

conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to “afford[] each

party a full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400–01 (citing Rule

3(b)). But that rule also includes the obligation of creation of a record “sufficient to allow review

of the special master’s decision.” Id. Thus, the fact that a claim is legitimately disputed, such that

the special master must exercise his intellectual faculties in order to decide a matter, is not itself

grounds for a trial (for if it were, trials would be required in every disputed case). Special masters

are expressly empowered to resolve fact disputes without a hearing—although they should only

so act if a party has been given the proper “full and fair” chance to prove their claim.

The present claim could be, and was, resolved fairly without the need for live testimony

from the experts. The SNHL injury was not disputed, nor the facts pertaining to its onset, leaving

only the causation theory and the alleged preexisting condition to be determined. The parties

engaged in several rounds of expert report submissions, allowing a fairly well-developed record

on the disputed issues—and both experts honed their opinions over time, as they reacted to

criticisms lodged by their counterpart or answered questions posed by the special master

previously presiding over this action. These reports, and the articles filed in support, provided me

with all that was required to ascertain entitlement in this case—live testimony from the experts

would not have altered the outcome, as I could understand the nature of the experts’ disagreement

based on the written record itself. Petitioner otherwise had ample opportunity to substantiate his

claim, as the number of reports filed herein establishes.

37

CONCLUSION

This claim is dismissed. In the absence of a timely-filed motion for review (see Appendix

B to the Rules of the Court), the Clerk shall enter judgment in accord with this decision. 25

IT IS SO ORDERED.

s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

25

Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their

right to seek review.

38