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