# Alsaadeh v. Secretary of Health and Human Services

> United States Court of Federal Claims · February 20, 2024

URL: https://www.frixlaw.com/law-library/cases/10736168

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** February 20, 2024
- **Precedential status:** Unpublished
- **Opinion:** Opinion
- **Judges:** Nora Beth Dorsey
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10736168

## How later opinions describe it (automated extraction)

- explaining that a “temporal relationship alone will not demonstrate the requisite causal link and that petitioner must posit a medical theory causally connecting the vaccine and injury.”
- noting that “close calls” are resolved in Petitioner’s favor
- noting that special masters are bound by both § 13(b)(1) and Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: January 23, 2024

* * * * * * * * * * * * * * *
BASEM ALSAADEH, * PUBLISHED
*
Petitioner, * No. 19-1097V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Dismissal; Pneumococcal Conjugate
AND HUMAN SERVICES, * (“Prevnar 13”) Vaccine; Influenza (“Flu”)
* Vaccine; Hearing Loss; Autoimmune Inner
Respondent. * Ear Disease (“AIED”); Sensorineural
* Hearing Loss (“SNHL”).
* * * * * * * * * * * * * * *

Brian L. Cinelli, Schiffmacher Cinelli Adoff LLP, Buffalo, NY, for Petitioner.
Neil Bhargava, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION1

On July 30, 2019, Basem Alsaadeh (“Petitioner”) filed a petition for compensation under
the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2018),2 alleging that he suffered from hearing loss as a result of
receiving an influenza (“flu”) vaccine and a pneumococcal conjugate (“Prevnar 13”) vaccine on
October 22, 2016. Petition at ¶ 1 (ECF No. 1). Respondent argued against compensation, stating
“this case is not appropriate for compensation under the terms of the Act.” Respondent’s Report
(“Resp. Rept.”) at 2 (ECF No. 25).

1
Because this Decision contains a reasoned explanation for the action in this case, the
undersigned is required to post it on the United States Court of Federal Claims’ website and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of
Electronic Government Services). This means the Decision will be available to anyone with
access to the Internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to
identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material from
public access.
2
The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2018) (“Vaccine Act” or “the Act”). All citations in this Decision
to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa.

1
After carefully analyzing and weighing the evidence presented in accordance with the
applicable legal standards, the undersigned finds Petitioner has failed to provide preponderant
evidence that the flu and/or Prevnar 13 vaccines he received caused his hearing loss. Thus,
Petitioner has failed to satisfy his burden of proof under Althen v. Secretary of Health & Human
Services, 418 F.3d 1274, 1280 (Fed. Cir. 2005). Accordingly, the petition must be dismissed.

I. ISSUES TO BE DECIDED

“The parties do not dispute that Petitioner suffered hearing loss.” Joint Submission, filed
Dec. 5, 2022, at 2 (ECF No. 66). However, Respondent questions whether the diagnosis is
autoimmune inner ear disease (“AIED”), as suggested by Petitioner’s expert. Resp. Brief on
Entitlement (“Resp. Br.”), filed Mar. 22, 2023, at 11-12 (ECF No. 72).

The parties dispute causation. Particularly, “[t]he parties dispute whether Petitioner’s
hearing loss was caused by the subject vaccinations and whether Petitioner has satisfied the
Althen prongs.” Joint Submission at 2. Petitioner contends he has met his burden under the
Althen criteria. Petitioner’s (“Pet.”) Br., filed Dec. 5, 2022, at 14-25 (ECF No. 65). Respondent
disagrees and argues Petitioner failed to preponderantly establish that his hearing loss was
caused-in-fact by his vaccinations. Resp. Br. at 14.

II. BACKGROUND

A. Medical Terminology

AIED is an “autoimmune process that leads to the dysfunction of the inner ear, resulting
in fluctuating, audiovestibular symptoms.” Pet. Exhibit (“Ex.”) 19-5 at 1.3 AIED is associated
with sensorineural hearing loss (“SNHL”).4 See Pet. Ex. 18-4 at 13 tbl.7, 16.5 “AIED is
considered to be responsible for [less than] 1% of all SNHL cases.” Pet. Ex. 18-9 at 1.6

“The clinical expression of AIED is a progressive bilateral and not always symmetric
SNHL, progressively developing between [three] and 90 days, which typically benefits from []
steroid and immunosuppressive therapy.” Pet. Ex. 18-9 at 1. Often only one ear is affected in

3
Hitomi Sakano & Jeffrey P. Harris, Emerging Options in Immune-Mediated Hearing Loss, 4
Laryngoscope Investigative Otolaryngology 102 (2019). This is also cited as Resp. Ex. A, Tab
5.
4
SNHL is defined below. See infra page 3.
5
Sujana S. Chandrasekhar et al., Clinical Practice Guidelines: Sudden Hearing Loss (Update),
161 Otolaryngology Head & Neck Surgery s1 (2019).
6
Andrea Ciorba et al., Autoimmune Inner Ear Disease (AIED): A Diagnostic Challenge, 32 Int’l
J. Immunopathology & Pharmacology 1 (2018).

2
the early stage. Id. at 3. “The hearing deficit sometimes presents threshold fluctuations.” Id.
“[T]he presence of bilateral SNHL of 30dB or more at any frequency with evidence of
progression in at least one ear on two serial audiograms performed less that [three] months apart”
is the presentation often used for diagnosis. Pet. Ex. 18-11 at 2.7 In 25-50% of cases, tinnitus8
can be present. Pet. Ex. 18-9 at 3. Importantly, “there are no standardized diagnostic criteria or
reliable diagnostic tests for the diagnosis of AIED.” Id. at 1. As such, the diagnosis of
“immune-mediated cochleovestibular disorders” is based on clinical symptoms, lab tests
(“demonstrating the presence in the serum of antibodies or activated T cells against inner ear
antigens”), and on the response to immunosuppressive treatment. Id. at 3. “Essentially, AIED is
a diagnosis of exclusion, suspected in case of a documented progressive SNHL, when other
etiologic causes have been ruled out.” Id.

SNHL is “hearing loss due to a lesion in either the cochlea (sensory mechanism of the
ear), the vestibulocochlear nerve, the central neural pathways, or a combination of these
structures.” Sensorineural Hearing Loss, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=80207 (last visited Nov. 17, 2023). It
results from either damage to the cochlea or “disruption of the electrical conduction pathway
from the inner ear to the brain. Thus, injury to hair cells, supporting cells, auditory neurons, or
the central auditory pathway can cause [SNHL].” Anil K. Lalwani, Disorders of Hearing, in 1
Harrison’s Principles of Internal Medicine 238, 240 (Joseph Loscalzo et al. eds., 21st ed. 2022).
Damage to the hair cells may be caused by intense noise, viral infections, Meniere’s disease,9 or
aging. Id.

Conductive hearing loss is “hearing loss due to a defect of the sound-conducting
apparatus, i.e., of the external auditory canal[10] or middle ear.”11 Conduction Hearing Loss,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=

7
Tamara Mijovic et al., Autoimmune Sensorineural Hearing Loss: The Otology-Rheumatology
Interface, 52 Rheumatology 780 (2013).
8
Tinnitus is “a noise in the ears, such as ringing, buzzing, roaring, or clicking. It is usually
subjective in type.” Tinnitus, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=50114 (last visited Nov. 17, 2023).
9
Meniere’s disease is “hearing loss, tinnitus, and vertigo resulting from nonsuppurative disease
of the labyrinth with edema.” Meniere Disease, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=70588 (last visited Nov. 17, 2023).
10
The external auditory canal is “the passage of the external ear leading to the tympanic
membrane, divided into an outer cartilaginous meatus and an inner bony meatus.” Meatus
Acusticus Externus, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=88271 (last visited Nov. 17, 2023).
11
The middle ear is “the cavity in the temporal bone comprising the cavitas tympani, auditory
ossicles, and tuba auditiva.” Auris Media, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=59682 (last visited Nov. 17, 2023).
3
80188 (last visited Nov. 17, 2023). “Factors that obstruct the transmission of sound or dampen
the acoustic energy result in conductive hearing loss.” Lalwani, supra, at 239. Conductive
hearing loss can occur from obstruction of the external auditory canal by earwax, debris, and
foreign bodies; swelling or narrowing of the lining of the canal; neoplasms of the canal;
perforations of the tympanic membrane;12 disruption of the vibration transmissions by trauma or
infection; or fluid, scarring, or neoplasms in the middle ear. Id.

B. Procedural History

Petitioner filed his petition on July 30, 2019. Petition. That same day, Petitioner filed
medical records,13 medical literature, an affidavit, and a declaration14 by his treating ear nose and
throat (“ENT”) physician, Dr. Deborshi Roy. Pet. Exs. 1-12. Respondent filed his Rule 4(c)
Report arguing against compensation on August 10, 2020. Resp. Rept. at 1.

On April 30, 2021, Petitioner filed an expert report from Dr. Richard Beck. Pet. Ex. 18.
On August 27, 2021, Respondent filed expert reports from Dr. J. Lindsay Whitton and Dr.
Douglas C. Bigelow. Resp. Exs. A, C. Petitioner filed a supplemental expert report from Dr.
Beck on December 29, 2021, and Respondent filed supplemental expert reports from Dr.
Whitton and Dr. Bigelow on April 29, 2022. Pet. Ex. 19; Resp. Exs. E-F.

The undersigned held a Rule 5 conference on June 2, 2022. Order dated June 2, 2022
(ECF No. 48). However, the undersigned was unable to give her preliminary findings and
opinions “due to the complexities regarding the alleged mechanism of causation and the factual
issues of onset and type of hearing loss.” Id. at 1. Given the risk to both sides, the parties were
encouraged to initiate settlement negotiations. Id. Petitioner provided a demand to Respondent,
but upon review, Respondent elected to continue to defend the case. Pet. Status Rept., filed July
18, 2022 (ECF No. 49); Joint Status Rept., filed Sept. 20, 2022 (ECF No. 58). The parties agreed
to resolve entitlement through a ruling on the record. Joint Status Rept., filed Sept. 20, 2022.

On December 5, 2022, Petitioner filed his brief for a ruling on the record. Pet. Br.
Respondent filed his brief on March 22, 2023. Resp. Br. On April 24, 2023, Petitioner filed a
reply. Pet. Reply to Resp. Br. (“Pet. Reply”), filed Apr. 24, 2023 (ECF No. 73).

This matter is now ripe for adjudication.

C. Factual History

12
The tympanic membrane, also called the eardrum, is “the obliquely placed, thin membranous
partition between the external acoustic meatus and the tympanic cavity.” Membrana Tympanica,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=
88565 (last visited Nov. 17, 2023).
13
Petitioner continued to file medical records throughout the course of litigation.
14
This is exhibit is titled “Affidavit,” but it is not notarized, and therefore the undersigned
references it as a declaration.

4
1. Stipulated Facts

The parties agreed to the following stipulated facts as set forth in their Joint Submission.
See Joint Submission at 1-2.

Petitioner was born on August 1, 1958. Joint Submission at 1 (citing Pet. Ex. 1 at ¶ 2).
He received his medical degree in his native country of Jordan, and trained in internal medicine,
hematology, oncology, and hyperbaric medicine. Id. (citing Pet. Ex. 1 at ¶ 2). He subsequently
moved to the United States and currently resides in California. Id. (citing Pet. Ex. 1 at ¶ 3).

On October 22, 2016, Petitioner received the quadrivalent flu vaccination and Prevnar 13
vaccination intramuscularly in his left deltoid. Joint Submission at 1 (citing Pet. Ex. 2 at 1).

About one week later, Petitioner developed symptoms similar to an upper respiratory
infection (“URI”) and then noticed problems hearing. Joint Submission at 2 (citing Pet. Ex. 1 at
¶ 7). In November 2016, Petitioner began taking a 10-day course of amoxicillin and a three-day
course of Zithromax,15 two antibiotics which he had in his possession and took at his own
direction as a physician. Id. (citing Pet. Ex. 1 at ¶ 7). Petitioner’s “symptoms continued to
progress over the following weeks and at the end of December 2016, he began taking a course of
the antibiotic [levofloxacin].”16 Id. (citing Pet. Ex. 1 at ¶ 8).

On March 2, 2017, Petitioner presented to Redlands Community Hospital and saw
Lauren Lo, nurse practitioner (“NP”). Joint Submission at 2 (citing Pet. Ex. 3 at 38). Petitioner
“reported his symptoms and asked to have his testosterone checked because he was feeling
fatigue[d].” Id. (citing Pet. Ex. 3 at 38).

2. Summary of Medical Records

15
Zithromax is trademark for azithromycin. Zithromax, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=54062 (last visited Nov. 17, 2023).
Azithromycin is “an azalide antibiotic . . . that inhibits bacterial protein synthesis, effective
against a wide range of gram-positive, gram-negative, and anaerobic bacteria; used in the
treatment of mild to moderate infections caused by susceptible organisms.” Azithromycin,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=5244
(last visited Nov. 17, 2023).
16
Levofloxacin is “a broad-spectrum fluoroquinolone antibacterial agent used in the treatment of
infection by susceptible organisms, including bronchitis, community-acquired pneumonia,
pyelonephritis, urinary tract infections, acute maxillary sinusitis, and skin and soft tissue
infections.” Levofloxacin, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=28157 (last visited Nov. 17, 2023).

5
In addition to the facts stipulated to by the parties, the following summary of medical
records provides additional relevant information.

Prior to the vaccinations at issue, Petitioner had a history of type II diabetes mellitus,
vitamin D deficiency, hypertension, hyperlipidemia, and coronary artery disease. Pet. Ex. 3 at 1-
3, 32. At an appointment with his primary care physician (“PCP”) on September 29, 2016, three
weeks prior to the vaccinations at issue, there were no complaints of respiratory illness or
hearing loss. See id. at 32-34. On October 22, 2016, at 58 years old, Petitioner received the flu
vaccine and Prevnar 13 vaccine in his left deltoid. Pet. Ex. 2 at 1.

On March 2, 2017, Petitioner presented to his PCP at Redlands Community Hospital and
saw Nurse Lo. Pet. Ex. 3 at 38. Petitioner complained of fatigue and requested his testosterone
be checked. Id. Petitioner also reported that “since having flu shot[,] [he] had upper respiratory
symptoms of cough, cold[,] [] congestion[,] and wheezing.” Id. It was noted that Petitioner
“continue[d] to smoke daily.” Id. Physical examination showed bilateral bulging of the
tympanic membranes, fluid behind the tympanic membranes, and erythema. Id. The assessment
was URI and bilateral effusion.17 Id. at 39. Petitioner was prescribed antibiotics and an inhaler.
Id. Blood work drawn on March 3, 2017 revealed his hemoglobin A1c (“HbA1c)18 was high at
9.3 (normal range 4.8-5.6). Id. at 42.

Petitioner returned to Nurse Lo on March 15, 2017. Pet. Ex. 3 at 44. He complained of
“continue[d] . . . persistent fatigue” and attributed it to low testosterone levels. Id. His
testosterone was low at 335 (normal range 348-1197 ng/dL). Id. at 42. Due to his recently
elevated HbA1c of 9.3, Petitioner’s diabetes medication was changed to Invokana 100 mg, one
tab per day. Id. at 44. Petitioner was also educated on continuing his metformin and Lantus
insulin for his diabetes. Id.

On March 29, Petitioner called his PCP’s office complaining of “bilateral hearing loss”
and “persistent hearing changes.” Pet. Ex. 3 at 37. Petitioner requested a referral to an ENT
specialist. Id. An ENT referral was submitted. Id.

On April 12, 2017, Petitioner presented to ENT specialist, Dr. Roy. Pet. Ex. 4 at 1.
History indicated that Petitioner “developed the flu and a severe URI in December and ever since
then[,] [Petitioner] had bilateral ear pain and hearing loss.[19] [Petitioner] took [antibiotics] and
got a little better and then last week he developed worsening symptoms along with constant

17
Effusion is “the escape of fluid into a part or tissue.” Effusion, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=15649 (last visited Nov. 17,
2023).
18
HbA1c is a type of glycated hemoglobin; “its levels are increased in persons with poorly
controlled diabetes mellitus.” Hemoglobin A1c, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=80470 (last visited Dec. 5, 2023).
19
This appears to be the first report by Petitioner of the history of his hearing loss and he relates
the onset to “severe URI in December.” Pet. Ex. 4 at 1.

6
tinnitus in both ears.” Id. The family history included “Hearing Loss: Brother * Meniere’s
Disease.” Id. Review of symptoms noted hearing loss, ringing in ears, and ear pain, as well as
difficulty breathing, postnasal drip, snoring, sore throat, and cough. Id. at 2. Physical
examination revealed the right tympanic membrane was clear and intact “but retracted with fluid
in the middle ear.” Id. The left tympanic membrane was “clear and severely scarred, with fluid
in the middle ear.” Id. Both external auditory canals (“EAC”) were clear. Id. Dr. Roy
diagnosed Petitioner with bilateral chronic mucoid otitis media,20 bilateral tinnitus, and bilateral
unspecified hearing loss. Id. Dr. Roy wrote that Petitioner had “bilateral mucoid otitis media
after the flu.” Id. at 3. He prescribed Petitioner antibiotics (Levaquin) and steroids (Medrol
Dosepak). Id.

A hearing evaluation was conducted on April 14, 2017. Pet. Ex. 5 at 1; Pet. Ex. 13 at 1.
There is no interpretation of this evaluation in the medical records.21 An audiogram was
performed on April 24, 2017. Pet. Ex. 4 at 4. The audiogram was interpreted by Dr. Roy as
showing “bilateral, mild to moderate, predominantly conductive hearing loss across all
frequencies.” Id. at 6. Dr. Roy’s interpretation did not mention SNHL. See id. Dr. Roy’s
assessment was bilateral “chronic mucoid otitis media,” “tinnitus,” and “conductive hearing
loss.” Id. at 6.

At the visit on April 24, Petitioner reported that he took antibiotics and steroids, but his
symptoms had not improved. Pet. Ex. 4 at 5. Examination again revealed that the right
tympanic membrane was clear and intact “but retracted with fluid in the middle ear,” and the left
tympanic membrane was “clear and severely scarred, with fluid in the middle ear.” Id. at 6. Dr.
Roy wrote that Petitioner had “chronic tinnitus and conductive hearing loss after developing an

20
Otitis media is “inflammation of the middle ear.” Otitis Media, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=95455 (last visited Nov. 17,
2023). Mucoid (resembling mucus) otitis media is “serious otitis media in which the secretion is
particularly viscous.” Otitis Media, Mucoid, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=95459 (last visited Nov. 17, 2023);
Mucoid, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=32378 (last visited Nov. 17, 2023). Serous otitis media is “chronic otitis media
marked by serous effusion into the middle ear.” Otitis Media, Serous, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=95462 (last visited
Nov. 17, 2023).
21
The records are somewhat confusing in that audiograms from 2017 and 2019 are contained in
the same exhibits, so care must be taken to determine the date of testing.

7
illness after a flu and [Prevnar 13] vaccine.” Id. He recommended bilateral tympanostomy
tubes.22 Id.

On April 27, 2017, Petitioner underwent bilateral myringotomy with tube placement.
Pet. Ex. 4 at 9. History indicated Petitioner’s “ear symptoms [had] not changed since his last
visit.” Id. at 8. The procedure confirmed “[t]hick mucoid fluid was in [his] middle ear space
bilat[erally], which was removed with suction.” Id. at 9. The assessment remained bilateral
chronic mucoid otitis media and bilateral conductive hearing loss. Id.

Petitioner followed up with his PCP on May 10, 2017. Pet. Ex. 3 at 48. History
indicated that Petitioner had tubes placed bilaterally in his ears but that he “continue[d] to have
tinnitus.” Id. Petitioner reported that an audiogram was done and that he was “diagnosed with
bilateral conductive hearing loss.” Id. He also reported that he was “currently in an open case
due to side effects of vaccines from flu shot” and requested lab results for antibodies. Id. Nurse
Lo ordered labs for immunoglobulin (“Ig”) A, IgM, IgG, pneumococcal antibodies, and mumps
antibodies to assess “[p]otential side effect of vaccination.”23 Id. at 49. The labs obtained on
May 12 showed that 23 serotypes of pneumococcal antibody were tested (including a number of
serotypes not included in Prevnar 13 vaccine). Id. at 51-52. Antibodies for seven stereotypes
were low, but the other 15 were in the normal reference range. Id. at 51-52. IgA, IgM, and IgG
were all within the normal reference range. Id. at 53. Mumps IgG was positive, indicating past
exposure to the virus or vaccination. Id. at 54. HbA1c was high at 8.7 (normal range 4.8-5.6).
Id. at 53.

On June 6, 2017, Petitioner returned to Dr. Roy and reported that his hearing was “slowly
getting better.” Pet. Ex. 4 at 11. “He ha[d] no pain or drainage from the ears, but [did] have
intermittent popping and crackling sounds.” Id. Dr. Roy listed bilateral conductive hearing loss
as one of Petitioner’s current problems. Id. It was also noted that a sleep study performed on
May 14, 2017 determined he had sleep apnea. Id. at 10-11. Examination revealed the tubes in

22
A tympanostomy tube is “a tube inserted after myringotomy in chronic cases of middle ear
effusion, such as in secretory or mucoid otitis media; it provides ventilation and drainage for the
middle ear during healing.” Ventilation Tube, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=115337 (last visited Nov. 17, 2023).
Myringotomy, also called tympanostomy, is “the creation of a hole in the tympanic membrane.”
Myringotomy, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=32972 (last visited Nov. 17, 2023).
23
It does not appear that tests were done for antibodies against inner ear antigens. For
description of inner ear antigens, see Pet. Ex. 18-9 at 2-3.

8
his ears were in place and dry. Id. at 13. A nasopharyngoscopy revealed collapsed
oropharyngeal airway and sluggish mobility of the right cords.24 Id.

From September 2017 to August 2018, Petitioner saw his PCP for treatment of his other
medical conditions such as diabetes myelitis, coronary artery disease, allergic rhinitis, and
postnasal drip. See Pet. Ex. 3 at 68-69, 74-75, 77-78, 87-88, 91-92; Pet. Ex. 15 at 4. Petitioner
did not mention issues with his hearing at these appointments. See Pet. Ex. 3 at 68-69, 74-75,
77-78, 87-88, 91-92; Pet. Ex. 15 at 4.

On November 27, 2018, Petitioner saw Anita Adorador, NP, at his PCP office for a
follow-up. Pet. Ex 16 at 2. Nurse Adorador noted hearing loss and “[p]er [Petitioner], [it was]
secondary to flu vaccine given several years ago.” Id. at 3. Petitioner requested a referral to
ENT. Id.

An audiogram was conducted on March 26, 2019 at Miracle Ear, and the handwritten
note on the study stated “mild to moderate sensory neural deafness[,] moderate for high
frequency (sensory neural)[,] [n]o conductive hearing loss.” Pet. Ex. 5 at 3. It appears only the
right ear was tested on this date. See id. Another audiogram performed on April 9, again at
Miracle Ear, remarked “[r]ight ear mild to moderate sensorineural loss. Left ear severe
sensorineural loss.” Id. at 4.

Throughout 2021, Petitioner presented to Progressive Neurology & Sleep Medicine
Associates for his sleep apnea and a stroke he had in September 2020. See Pet. Ex. 20 at 3-32.
On October 5, 2021, Petitioner had a follow-up there with neurologist Dr. LeAnn Hoang. Pet.
Ex. 20 at 17. Dr. Hoang documented that Petitioner asked

if MRI/[magnetic resonance angiography (“MRA”)][25] identified a cause for
[SNHL]. [Petitioner] [r]eport[ed] he had a recent audiogram this year that
showed mild-moderate [right] [SNHL] and moderate-severe [left] [SNHL].
[Petitioner] [r]eport[ed] he had hearing loss that started after [flu] and [Prevnar
13] vaccine in 2016. It was initially thought to be conductive, as there were air
fluid levels behind ear drums, but that was removed and he had some
improvement, but then progressive bilateral hearing loss restarted. He [] filed a
lawsuit regarding his [SNHL], which he attribute[d] to the vaccine.

Id. Dr. Hoang’s impression was that Petitioner’s hearing loss was not due to a vascular problem.
Id. at 18. Dr. Hoang wrote a letter that same day stating that Petitioner’s brain MRI and head

24
Petitioner was assessed with paralysis of vocal cords and larynx. Pet. Ex. 4 at 13. Given the
upper airway obstruction, vocal fold motion impairment, and sleep apnea, a magnetic resonance
imaging (“MRI”) and computed tomography (“CT”) scan were ordered. Id. at 15. A June 19,
2017 chest CT scan noted a few pulmonary micronodules that were most likely post-
infectious/inflammatory. Pet. Ex. 3 at 64-65.
25
The MRI and MRA were done on October 8, 2020. Pet. Ex. 19 at 27-28. It appears this
imaging was done in relation to Petitioner’s stroke, not for his hearing loss. See id.
9
MRA from October 2020 were reviewed and that “clinical history and neuroimaging do not
support a vascular etiology.” Id. at 33.

On February 11, 2022, Petitioner underwent an audiogram which showed “bilateral mild
SNHL rising to normal with bilateral mild high frequency SNHL.” Pet. Ex. 21 at 1. Impression
was “mild SNHL.” Id. On February 16, Petitioner was seen by Dr. Johnny Arruda who
diagnosed Petitioner with SNHL. Id. at 6. Dr. Arruda’s history indicated Petitioner reported
bilateral hearing loss for the past five years, had bilateral tubes placed in 2017, that his last
hearing test was in 2019, and that he had a history of chronic ear infections. Id. Dr. Arruda
wrote “[t]he issue with infection and hearing loss apparently related to a flu vaccine and [Prevnar
13] vaccine.” Id. Dr. Arruda’s diagnosis was hearing loss and history of acute otitis media. Id.
at 8.

No other relevant medical records were filed.

3. Affidavit of Petitioner

On July 24, 2019, Petitioner executed an affidavit. Pet. Ex. 1 at 4. He attended Army
Medical College in Islamabad, Pakistan on a full scholarship from the Jordan government. Id. at
¶ 2. Thereafter, he served as a physician in the Jordan Army for 23 years, retiring with the rank
of Brigadier General. Id. Upon retirement, he opened a private clinic in Jordan where he
practiced medicine until 2015, when he moved to the United States. Id. At that time, his
position was Senior Medical Consultant, “the highest attainable by medical doctors in Jordan.”
Id. He holds specializations in internal medicine, hematology, and oncology from the Jordan
Medical Board. Id. He has also received medical training in the United States; however,
Petitioner is not licensed to practice medicine in the United States. Id.; Pet. Ex. 19 at 7, 9.
Petitioner’s wife was also a physician in the Jordan Army. Pet. Ex. 1 at ¶ 3. At the time
Petitioner executed his affidavit, Petitioner was an instructor with Key Medical Resources where
he taught a variety of medical subjects to healthcare professionals and was the primary instructor
for nurses seeking specialized certifications. Id.

Prior to the vaccinations at issue, Petitioner recalled not having hearing problems or
problems with his ears. Pet. Ex. 1 at ¶ 4. He “never experienced any symptoms of any ear
disease such as tinnitus or vertigo and did not experience any other hearing disturbances.” Id.

On October 22, 2016, Petitioner received the flu vaccine and the Prevnar 13 vaccine. Pet.
Ex. 1 at ¶ 5. This was the first flu vaccine he had ever received. Id.

Approximately one week later, Petitioner recounted “experiencing symptoms that
resembled a[] [URI] and then later started noticing issues with [his] ears and hearing.” Pet. Ex. 1
at ¶ 7. Petitioner prescribed himself a 10-day course of amoxicillin, a three-day course of
Zithromax, and an antihistamine. Id. He averred “[t]his would be a typical course of treatment
for the symptoms [he] was experiencing.” Id. Over the following weeks, he did not see any
improvement. Id. at ¶ 8. Towards the end of December, he prescribed himself a second course
of antibiotics, levofloxacin, “a very strong antibiotic.” Id.

10
By January 2017, Petitioner was still experiencing symptoms. Pet. Ex. 1 at ¶ 9. He did
not seek emergent treatment then because in his experience as a physician, “there was not really
anything else that [he] believed they would prescribe for [him] other than what [he] had already
been taking. All of the steps [Petitioner] followed would have been part of the standard course
of treatment for [his] symptoms.” Id. Instead, he called his PCP to schedule an appointment and
was interested in seeking a referral to an ENT. Id.

Petitioner saw his PCP on March 2, 2017 “as [his] condition had begun to deteriorate
further despite multiple courses of antibiotics.” Pet. Ex. 1 at ¶ 10. He was diagnosed with a URI
and bilateral effusion and prescribed more antibiotics. Id. Petitioner returned to his PCP on
March 15 for a previously scheduled well visit. Id. at ¶ 11. He stated that “[a]lthough the report
from that date mentions [his] continued fatigue, [he] also raised the issue of his continued
hearing problems at this appointment as well.” Id. But upon reviewing the report, however, it
did “not appear [to Petitioner] that this was noted by [his] physician.” Id. By the end of March,
Petitioner’s hearing loss was “increasing in both ears” and he did not see improvement with
medications. Id. at ¶ 12. He again called his PCP and requested a formal referral to an ENT. Id.

In April 2017, Petitioner saw Dr. Roy and was diagnosed with otitis media, bilateral
tinnitus, and bilateral hearing loss. Pet. Ex. 1 at ¶ 13. Petitioner also recalled Dr. Roy noting a
collection of fluid behind his eardrum. Id. at ¶¶ 13-14. A subsequent audiogram showed
moderate to severe hearing impairments. Id. Dr. Roy prescribed antibiotics and steroids but
again, Petitioner saw no improvement. Id. at ¶ 13.

Petitioner ultimately underwent a bilateral tympanostomy, a surgery recommended by Dr.
Roy in which “tubes were placed to remove fluid from the middle ear.” Pet. Ex. 1 at ¶ 17. After
the surgery, Petitioner averred that his “condition improved somewhat and while [he] was able to
hear better than before the surgery, some residual hearing loss remained.” Id. at ¶ 19. Petitioner
opined that in April 2019, an audiogram confirmed he has SNHL “with severe to profound
impairments in [his] left ear and mild to moderate hearing loss in [his] right ear.” Id. at ¶ 20.

Finally, Petitioner concluded that as a physician, he knew that “in certain rare cases[,]
vaccinations may disturb the immune system in a way that can result in serious medical
problems. Such problems may be transient or permanent.” Pet. Ex. 1 at ¶ 21. Thus, Petitioner
“believe[d] that [he] suffered severe transient immune deficiency in reacting to the flu shot. As
[his] immune system could not fight off the [URI], [he] suffered significant symptoms and the
vaccination interacted with the [URI] to create an enhanced adverse reaction resulting in [his]
hearing loss.” Id.

4. Email from Dr. Mansour Karadsheh

After receiving the May 12, 2017 lab results, Petitioner sent them to Dr. Karadsheh, “an
immunologist that [he] kn[e]w from his native country of Jordan, for a consultation.”26 Pet. Ex.

26
The correspondence sent to Dr. Karadsheh from Petitioner was not filed.

11
1 at ¶ 15. Dr. Karadsheh is a consultant physician in allergy and immunology.27 Pet. Ex. 6 at 1.
On July 7, 2017, Dr. Karadsheh emailed “Dr. Hatter” stating,

[i]t is known that the simultaneous administration of [flu] and [Prevnar 13]
vaccine may induce a state of immunodeficiency[28] in a previously healthy
subject[]. In [Petitioner’s] case, the infection was severe enough to cause the
complications of native diseases, that [his] immune system could not control.
This is shown by the normal immunoglobulins, with poor response to the antigens
in the vaccine constituents.

Id. Petitioner averred that Dr. Karadsheh reviewed the results and emailed him back “verifying
his belief that the administration of the vaccinations caused [Petitioner] to develop an
immunodeficiency which prevented [his] body from fighting off the [URI].” Pet. Ex. 1 at ¶ 15.

5. Declaration of Dr. Deborshi Roy

Dr. Roy was Petitioner’s treating ENT physician in 2017.29 Pet. Ex. 7 at 2. In June 2018,
he executed a declaration. Id. Dr. Roy is a licensed and board-certified otolaryngologist. Id. at
¶ 1. At the time of his declaration, he practiced at the ENT & Sinus Center in California and
stated that on April 12, 2017, Petitioner “presented to [him] with complaints of bilateral ear pain,
tinnitus, and hearing loss.” Id. at ¶ 2.

Dr. Roy recalled Petitioner reporting that “he started developing [] symptomology after
receiving a[] [flu] vaccination and [Prevnar 13] vaccination several months previously.” Pet. Ex.
7 at ¶ 3. Dr. Roy wrote that Petitioner “stated that he started developing symptoms consistent
with a[] [URI] and he indicated that he prescribed himself two rounds of antibiotics over the

27
Petitioner did not file a curriculum vitae or other evidence of Dr. Karadsheh’s education,
medical training, or licensure. The information about his specialty is based on the copy of the
emailed that was filed. Pet. Ex. 6 at 1.
28
Immunodeficiency is “a deficiency of immune response or a disorder characterized by
deficient immune response; classified as antibody (B cell), cellular (T cell), or combined
immunodeficiency, or phagocytic dysfunction disorders.” Immunodeficiency, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=24872 (last visited
Dec. 21, 2023). It is a “failure in humoral antibody or cell-mediated limbs of the immune
response. If attributable to intrinsic defects in T and/or B lymphocytes, the condition is termed
primary []. If the defect results from loss of antibody and/or lymphocytes, the condition is
secondary [].” Immunodeficiency, Illustrated Dictionary of Immunology 362 (Julius M. Cruse &
Robert E. Lewis eds., 3d ed. 2009). That is, it “can be primary (due to a defect in the immune
mechanism itself) or secondary (dependent on another disease process).” Immunodeficiency,
Stedman’s Medical Dictionary 952 (28th ed. 2006).
29
The medical records filed by Petitioner show that he saw Dr. Roy from April 12, 2017 until
June 6, 2017. See Pet. Ex. 4. Based on the medical records filed, it does not appear Petitioner
has seen Dr. Roy since June 6, 2017.

12
ensuing months.” Id. at ¶ 4. After Petitioner’s condition did not improve, he came under Dr.
Roy’s care. Id. at ¶ 5. Dr. Roy placed him on antibiotics and steroids, but when audiogram and
examination indicated Petitioner’s symptoms did not improve on the medications, he
recommended and performed a bilateral tympanostomy tube placement procedure on April 27,
2017. Id.

Dr. Roy opined, to a reasonable degree of medical certainty, that the vaccines Petitioner
received “were a substantial factor in causing an immune deficiency that resulted in the upper
respiratory symptoms and consequential bilateral ear pain, tinnitus, otitis media, and hearing loss
and that these conditions necessitated [his] treatment and the resulting surgery.” Pet. Ex. 7 at ¶
6. Dr. Roy’s declaration did not reference SNHL or AIED.

D. Medical Literature Submitted with Petition

Along with the petition, Petitioner filed medical literature to support his claim. Pet. Exs.
8-12. This literature was not discussed by Petitioner’s expert.

The first piece of medical literature was from the Institute of Medicine (“IOM”)30 which
acknowledged a “biologic plausibility that mumps vaccine could cause sensorineural deafness”
and, to a lesser extent, that the measles vaccine “could cause sensorineural deafness.” Pet. Ex. 8
at 31. However, they concluded “[t]he evidence [was] inadequate to accept or reject a causal
relation between measles or mumps vaccines and sensorineural deafness.” Id. Moreover,
Petitioner did not receive the measles or mumps vaccines.

The second was a case report of a 33-year-old man who developed hearing loss within 24
hours of receiving the meningococcal and tetanus-diphtheria vaccines. Pet. Ex. 9 at 1.31
Functional recovery was achieved after about six months. Id. at 4. Despite investigations
excluding possible related pathologies, the cause of the patient’s hearing loss remained unknown.
Id. Accordingly, the authors wrote that a “post-vaccinal correlation seem[ed] possible.” Id. at 3.
“The short period of time between the vaccinations and the onset of the hearing loss suggest[ed] .
. . that it may be the result of an adverse reaction to vaccines.” Id. at 4.

The third was a case report of an 11-year-old with sudden hearing loss after receiving a
rabies immunization two days prior. Pet. Ex. 10 at 1.32 The authors noted that side effects after
immunization can include sudden hearing loss, “although this is rarely observed.” Id.

30
Inst. of Med., Measles and Mumps Vaccines, in Adverse Events Associated with Childhood
Vaccines: Evidence Bearing on Causality 118 (Kathleen Stratton et al. eds., 1994). The IOM is
now the National Academy of Medicine.
31
Federica De Marco et al., Post Vaccinal Temporary Sensorineural Hearing Loss, 15 Int’l J.
Env’t Rsch. & Pub. Health 1780 (2018)
32
Oğuz Güçlü & Fevzi Sefa Dereköy, Sudden Hearing Loss After Rabies Vaccination, 30
Balkan Med. J. 327 (2013).
13
The fourth piece of medical literature filed discussed nine reports of children with SNHL
after measles, mumps, and rubella (“MMR”) vaccinations. Pet. Ex. 11 at 1.33 In three cases, the
deafness was found to be unrelated to the MMR vaccine. Id. In six cases, the cause was
unknown, but MMR remained a possible etiology. Id. The authors concluded “[a]ny risk of
deafness after MMR [immunization] is small and must be weighed against the risks of the
natural diseases.” Id. at 2.

Lastly, Petitioner filed a document that purports to show there have been approximately
280 Vaccine Adverse Event Reporting System (“VAERS”) reports filed alleging the
development of hearing loss after vaccination. See Pet. Ex. 12; Pet. Br. at 19, ¶ 81. There is no
identification on this document about where the information came from, who obtained it, or what
it applies to.

E. Expert Reports

1. Petitioner’s Expert, Dr. Richard A. Beck34

a. Background and Qualifications

Dr. Beck is a practicing, board-certified otolaryngologist-head and neck surgeon. Pet.
Ex. 18 at 1. He received his M.D. at the University of Miami in Florida, and completed an
otolaryngology-head and neck surgery residency at Madigan Army Medical Center. Id.; Pet. Ex.
18-1 at 1. Dr. Beck served in the United States Army for nine years during which he was Chief
of otolaryngology-head and neck surgery at Eisenhower Army Medical Center. Pet. Ex. 18 at 1.
Dr. Beck has been in private practice since his honorable discharge in 1993. Id. In his practice,
he routinely evaluates, diagnoses, and treats individuals with ear problems including AIED,
SNHL, and tinnitus. Id.

b. Diagnosis Opinion

Dr. Beck opined that Petitioner has AIED. Pet. Ex. 18 at 10; see also Pet. Ex. 19 at 7.
Specifically, he opined “the fluctuating nature and bilateral sudden [SNHL] following the
administration of [the Prevnar 13 and flu] vaccinations . . . are responsible for [AIED].” Pet. Ex.
18 at 6-7; see also Pet. Ex. 19 at 4. But see Pet. Ex. 19 at 15, ¶ 17 (opining Petitioner
“experienced AIED which caused bilateral asymmetric sudden [SNHL]”). According to Dr.
Beck, Petitioner’s AIED “manifested in the SNHL which [was] asymmetric and [] fluctuated
since onset.” Pet. Ex. 18 at 10.

33
Barbara J.A. Stewart & P. Umesh Prabhu, Reports of Sensorineural Deafness After Measles,
Mumps, and Rubella Immunisation, 69 Archives Disease Childhood 153 (1993).
34
Petitioner filed two expert reports from Dr. Beck. Pet. Exs. 18-19.

14
Citing medical literature, he posited the “[d]iagnosis of AIED is accepted when the
clinical condition manifests progressive bilateral, fluctuating, [SNHL] over a period of weeks to
months.” Pet. Ex. 18 at 11 (citing Pet. Ex. 18-7 at 1 (“AIED hearing loss is usually rapid,
bilateral, and progressive . . . .”); Pet. Ex. 18-8 at 1 (“[P]atient[s] usually present[] with bilateral,
asymmetric, progressive hearing loss over a course of days to months.”);35 Pet. Ex. 18-9 at 1
(“The clinical expression of AIED is a progressive bilateral and not always symmetric SNHL,
progressively developing between [three] and 90 days, which typically benefits from a steroid
and immunosuppressive therapy.”); Pet. Ex. 18-10 at 1 (“The hallmark of this clinically
diagnosed condition is the presence of a rapidly progressive, often fluctuating, bilateral [SNHL]
over a period of weeks to months.”)).36 Dr. Beck did not specifically discuss any of this medical
literature.

As applied to Petitioner, Dr. Beck posited the “fluctuating nature and bilateral
asymmetric sudden [SNHL] defines [AIED] which [] resulted in bilateral asymmetric sudden
[SNHL] of a severe to profound degree in [Petitioner’s] left ear and a moderate to severe degree
in [Petitioner’s] right ear as documented by audiometric testing in April 2019.” Pet. Ex. 19 at 7.
Dr. Beck did not further interpret any of Petitioner’s audiograms. Dr. Beck averred that
Petitioner’s SNHL “on audiometric testing has shown fluctuance and asymmetry on serial
examination as expected for AIED which is progressive[37] and further impairment is expected.”
Id. at 22.

One of the references cited by Dr. Beck stated that because “there are no standardized
diagnostic criteria or reliable diagnostic tests for the diagnosis of AIED,” the diagnosis of
“immune-mediated cochleovestibular disorders” is based on clinical symptoms, lab tests
(“demonstrating the presence in the serum of antibodies or activated T cells against inner ear
antigens”), and on the response to immunosuppressive treatment. Pet. Ex. 18-9 at 1, 3 (“[O]nly a
small percentage of patients (14%) is steroids responsive.”); see also Pet. Ex. 18-10 at 6 (“[N]ot

35
Andrew J. Griffith, Biological and Clinical Aspects of Autoimmune Inner Ear Disease, 65
Yale J. Biology & Med. 17 (1992).
36
R. Bovo et al., Immune-Mediated Inner Ear Disease, 126 Acta Oto-Laryngologica 1012
(2006).
37
In addition to Dr. Beck characterizing Petitioner’s hearing loss as progressive, he also
characterized it as sudden. Dr. Beck opined the medical records, Petitioner’s affidavit, and a
phone call with Petitioner on December 3, 2021 indicated that prior to vaccination, Petitioner did
not have hearing problems or any issues with his ears and “clearly document[ed] the sudden
bilateral onset of otologic symptoms within one week postvaccination.” Pet. Ex. 19 at 18.

15
all patients respond to []steroid therapy in the same manner . . . .”). The authors recommended
that serologic tests38 be conducted in all patients with suspected AIED. Id. at 3.

Similarly, Sakano and Harris suggested “the presence of additional systemic autoimmune
findings, diagnosis of autoimmune disorder,[39] or laboratory findings of autoimmune markers
may aid in the diagnosis.” Pet. Ex. 19-5 at 1; see also Pet. Ex. 18-4 at 16 (suggesting evidence of
an association between autoimmune disease and sudden SNHL); Pet. Ex. 18-6 at 3 (finding that
sudden SNHL is sometimes associated with systematic immune-mediated diseases and that
patients can have “evidence of T-cell and antibody recognition of inner ear antigens”).40

Dr. Beck did not discuss the lack of systemic autoimmune findings or inflammatory
markers as suggested by the medical literature. See Pet. Ex. 18-9 at 3, 4 tbl.2; Pet. Ex. 19-5 at 1.
He did not address the fact that Petitioner never underwent testing suggested by Ciorba et al. or
that Petitioner was not diagnosed with AIED. Dr. Beck did not respond to Respondent’s expert’s
(Dr. Bigelow) position that Petitioner does not meet the diagnostic criteria for AIED or that
Petitioner did not have sudden bilateral asymmetric SNHL.

c. Causation Opinion

i. Althen Prong One

Dr. Beck opined the Prevnar 13 and flu vaccinations administered on October 22, 2016
are responsible for causing Petitioner’s AIED. Pet. Ex. 19 at 7. Dr. Beck’s proposed theory is

38
Some of the tests recommended by Ciorba et al. include erythrocyte sedimentation rate
(“ESR”), C-reactive protein, antinuclear antibody (“ANA”), antineutrophil cytoplasmic antibody
(“ANCA”), and human leukocyte antigen (“HLA”). Pet. Ex. 18-9 at 4 tbl.2.
39
An autoimmune disorder is “a disorder caused by an immune response directed against self
antigens. The usual characteristics are demonstrable circulating autoantibodies or cell-mediated
immunity against autoantigens, inflammatory lesions caused by immunologically competent
cells or immune complexes in tissues containing the autoantigens, and clinical or experimental
evidence that the autoimmune process is pathogenic and not secondary to other tissue damage.”
Autoimmune Disease, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=70076 (last visited Dec. 7, 2023). They include “diseases such as systemic
lupus erythematosus and rheumatoid arthritis in which cells of the adaptive immune system such
as autoreactive T and B cells become overreactive and produce self-reactive T-cell and antibody
responses.” Barton F. Haynes et al., The Immune System in Health and Disease, in 2 Harrison’s
Principles of Internal Medicine 2671 (Joseph Loscalzo et al. eds., 21st ed. 2022).
40
Benjamin E. Schreiber et al., Sudden Sensorineural Hearing Loss, 375 Lancet 1203 (2010).

16
that “[i]mmune-mediated mechanisms activate the innate immune system[41] within the inner ear
and thereby produce antigens[42] which are known to cause damage to the cochleovestibular
structures.” Pet. Ex. 18 at 11. Dr. Beck did not explain this theory further.

Notably, Dr. Beck conceded that it is not known what triggers the autoimmune response
in the pathophysiology of AIED. Pet. Ex. 19 at 15 (citing Pet. Ex. 19-5 at 2). But he stated
“[t]here are some studies that suggest that autoantibodies are produced against inner ear protein
through molecular mimicry in response to viral or bacterial infection.” Id. (quoting Pet. Ex. 19-5
at 2). Dr. Beck did not discuss molecular mimicry any further. And he did not explain how this
statement about viral and bacterial infection related to his opinion that the flu and Prevnar 13
vaccines could cause AIED. But Dr. Beck did opine that URIs are typically viral and do “not
result in immune-mediated mechanisms activating the innate immune system within the inner
ear, thereby producing antigens which are known to cause damage to the cochleovestibular
structures.” Pet. Ex. 18 at 13 (emphasis omitted).

1. Medical Literature

Dr. Beck cited medical literature, but he did not discuss any of it in his expert reports to
support his opinions.43 Nonetheless, the literature referenced by Dr. Beck was helpful in
understanding what is or what is not known about the cause of AIED.

Ciorba et al. acknowledged that “the pathogenetic mechanisms of AIED remain unclear.”
Pet. Ex. 18-9 at 1, 5 (“The inflammatory and the immune-mediated pathogenetic mechanisms are
still not completely known . . . .”). The authors suggested a number of different mechanisms
including, “(1) deposition of circulating immune complexes . . . ; (2) vestibule-cochlear
autoantibodies . . . ; (3) vasculitis; (4) micro-thrombosis[;] and (5) electrochemical alterations.”
Id. at 2-3. “Many antigens in the inner ear and possibly the endolymphatic sac have been
recognized as possible AIED targets.” Id. at 2. The authors explained that activation of the

41
The innate immune system is an “ancient immune recognition system of host cells bearing
germline-encoded pattern receptors [] that recognize pathogens and trigger a variety of
mechanisms of pathogen elimination.” Haynes et al., supra note 39, at 2671. In contrast, the
adaptive immune system is a “recently evolved system of immune responses mediated by T and
B lymphocytes. Immune responses by these cells are based on specific antigen recognition . . . .”
Id. The adaptive immune system is “characterized by antigen-specific responses to a foreign
antigen or pathogen.” Id. at 2689. “[F]ollowing the initial contact with antigen . . . , subsequent
antigen exposure leads to more rapid and vigorous immune responses (immunologic memory).”
Id.
42
An antigen is “any substance capable, under appropriate conditions, of inducing a specific
immune response and of reacting with the products of that response, that is, with specific
antibody or specifically sensitized T lymphocytes, or both.” Antigen, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=3334 (last visited Dec. 22, 2023).
43
In his second report, Dr. Beck does discuss medical literature cited by Respondent’s experts;
however, it is not supportive of his proposed causal mechanism.
17
immune system involves “the release of interleukin (IL)-1β,” and that “immunoglobulins can
target, by chemotaxis, the inner ear in response to antigenic stimuli.” Id. In summary, Ciorba et
al. summarized a number of leading theories, but did not reach a conclusion about the
mechanism of pathogenesis.

Similarly, Sakano and Harris did not identify the pathogenesis of AIED. Pet. Ex. 19-5 at
2. They noted that studies suggest “antibody concentration within the inner ear,” but they did not
identify any probable mechanism. Id. They concluded that “[w]hatever the initial insult or
trigger may be, the autoimmune process leads to destructive changes in the inner ear and
ultimately neural degeneration and hearing loss.” Id. at 6.

Mijovic et al. explained that the “strongest pathogenic evidence is that of an immune-
mediated disease. The inner ear . . . may mount an immune response against foreign and self-
antigens damaging sensory structures within it.” Pet. Ex. 18-11 at 2. “Both humoral and cell-
mediated mechanisms are involved in the autoimmune injury to the inner ear.” Id. “Cochlear
innate immunity has been proposed to contribute to the initiation of a local adaptive immune
response following antigen challenge.” Id. “[A]s a consequence of a yet identified trigger (i.e.
antibody cross-reactivity, viral injury, trauma, vascular insult, surgical damage and others)
damaging the inner ear, lymphocytes from the systemic circulation are exposed to proteins of the
cochlea.” Id. Thus, the authors concluded the trigger is not yet identified. See id.

Schreiber et al. wrote that sudden SNHL is sometimes associated with systematic
immune-mediated diseases and that patients can have “evidence of T-cell and antibody
recognition of inner ear antigens. However, the role of tissue-specific immune-responses is
poorly defined.” Pet. Ex. 18-6 at 3.

Huang et al.44 is a case report of a 17-year-old girl who developed bilateral sudden
deafness (moderate SNHL) 14 hours after receiving an H1N1 vaccination. Pet. Ex. 18-2 at 1.
The authors stated that “acute loss of cochlear function” following vaccination is a rare event and
thought to be associated with an antigen-antibody reaction. Id. at 1-2. They discussed hearing
loss following other vaccines, including live virus vaccines, where the “causative factors of
deafness were considered to be the viral components of the vaccines . . . or the latent
autoimmune response to the vaccine contents.” Id. at 2. But the authors acknowledged “the
mechanism of bilateral sudden hearing loss induced by H1N1 vaccine is unknown.” Id.

Chen et al.45 discussed three potential mechanisms proposed to explain how a viral
infection can cause sudden SNHL. Pet. Ex. 18-3 at 2. However, the authors concluded that
while studies show viral infection is one etiology of sudden SNHL, “there is little research
proving or clearly indicating the pathogenesis of this disease” and “further research is needed.”
Id. at 5.

44
Hsueh-Hsin Huang et al., Bilateral Sudden Deafness Following H1N1 Vaccination, 143
Otolaryngology Head & Neck Surgery 849 (2010).
45
Xin Chen et al., Role of Viral Infection in Sudden Hearing Loss, 47 J. Int’l Med. Rsch. 2865
(2019).

18
Regarding diagnostic testing, Dr. Beck averred that “[d]iagnostic testing, including
serologic assessment, immunologic testing, and medical imaging, is limited in proving the
etiology” of sudden SNHL. Pet. Ex. 18 at 11. For example, Chen et al. discussed limitations to
studies. Pet. Ex. 18-3 at 5. The authors wrote that “an indirect diagnosis [of sudden hearing
loss] can often be obtained by detecting class antibodies to identify primary infection, which is
most frequently responsible for overt disease. However, pathology can be induced by an
endogenous reinfection that, in most cases, would not give rise to IgM.” Id. “This in turn can
lead to underestimation in the role of viruses as etiological agents in sudden hearing loss.” Id.
Nonetheless, Dr. Beck opined that “histopathologic studies . . . indicate the changes commonly
found are consistent with viral infection and immunologic injury.” Pet. Ex. 18 at 11 (citing Pet.
Ex. 18-5 at 4 (finding “[t]he parallel incidence of [idiopathic sudden hearing loss] and positive
viral seroconversion suggests that the two are closely related and that viral infection is a major
cause of idiopathic sudden hearing loss]”)). But see Pet. Ex. 18-6 at 2 (concluding that while
“many viruses have been postulated as possible causes of sudden [SNHL], [] serological,
epidemiological, and histopathological data are not conclusive”).

Dr. Beck averred that none of the medical literature cited by Respondent’s experts is
applicable here because it was not about the “dual simultaneous vaccination” of Prevnar 13 and
flu. Pet. Ex. 19 at 11. However, Dr. Beck discussed an article relied on by Dr. Bigelow that
analyzed the concomitant administration of vaccines. Id. at 21 (citing Resp. Ex. C, Tab 4).46 Dr.
Beck quoted Frenck et al. for the proposition that “[m]ore systemic adverse events were seen
with the concomitant administration of [Prevnar 13] and [trivalent inactivated flu vaccine] than
with the single administration of either vaccine.” Id. (quoting Resp. Ex. C, Tab 4 at 7). Notably,
Dr. Beck left out the remainder of the paragraph which states that “[g]iven that the two vaccines
were administered concomitantly, the higher rate of systemic events does not appear to be
unusual and is not considered clinically meaningful.” Resp. Ex. C, Tab 4 at 7. Moreover, this
specific part of the article was discussing local site reactions, not URI, otitis media, or SNHL.
Id. at 6 tbl.7, 7.

ii. Althen Prong Two

Dr. Beck then veered from his immune-mediated mechanism and adopted a theory based
on “immunodeficiency.” Pet. Ex. 18 at 11-12. He wrote that Petitioner’s “simultaneous
administration of [flu] and [Prevnar 13] vaccines [were] the reason for inducing a state of
immunodeficiency.” Id. at 12. However, Dr. Beck did not explain the definition of
immunodeficiency or how it caused AIED. He also did not explain how the administration of
vaccines causes immunodeficiency.

46
Robert W. Frenck et al., Randomized, Controlled Trial of a 13-Valent Pneumococcal
Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults,
19 Clinical & Vaccine Immunology 1296 (2012). This is also cited as Pet. Ex. 19-14.
19
According to Dr. Beck, the testing done on Petitioner on May 12, 2017 “showed an
abnormal immune response.”47 Pet. Ex. 18 at 9. Petitioner’s results showed that seven serotypes
of pneumococcal antibodies were low, but the other 15 were in the normal reference range. Pet.
Ex. 3 at 51-52. IgA, IgM, and IgG were normal. Id. Dr. Beck opined the results “indicated a
marked abnormal immune system response as multiple pneumococcal antibody subtypes were
abnormally low despite the previous administration of Prevnar 13 vaccination on [October 22,
2016].” Pet. Ex. 18 at 6. Dr. Beck averred “[o]bjective laboratory data clearly demonstrate[]
[Petitioner’s] abnormal immunologic responses as he showed low antibody titers to many strains
of pneumococcus including several which were included in the Prevnar 13 vaccine.” Id. at 9, 12
(“The pneumococcal antibody results were markedly abnormal with low antibody titers to
numerous serotypes of Streptococcus pneumoniae [(“S. pneumoniae”)], including several of the
serotypes included in the Prevnar 13 vaccine.”).

Dr. Beck conceded that “to assess an individual’s response to vaccination requires
comparison” to baseline testing and “there are no prevaccination serologic test results for
comparison.” Pet. Ex. 19 at 10. Regardless, he maintained that “there is no data in the medical
record to disprove the abnormal immunologic response which [Petitioner] demonstrated in test
results following the administration of Prevnar 13 and [flu] vaccinations on [October 22, 2016].”
Id. Dr. Beck did not explain or provide any references to support his opinion that the test results
represent an immunodeficiency or an abnormal immune response to vaccination or how it could
lead to AIED.

Dr. Beck quoted Dr. Karadsheh who wrote “[i]t is known that the simultaneous
administration of [flu] and [Prevnar 13] vaccine may induce a state of immunodeficiency in a
previously health subject[].” Pet. Ex. 18 at 6 (quoting Pet. Ex. 6 at 1).

He also relied on Dr. Roy’s declaration where he opined the vaccinations “were a
substantial factor in causing an immune deficiency that resulted in upper respiratory symptoms
and consequential bilateral ear pain, tinnitus, otitis media, and hearing loss.” Pet. Ex. 18 at 9
(quoting Pet. Ex. 7 at ¶ 6). Dr. Beck believed this was consistent with his own opinion that
Petitioner had “an abnormal immune-mediated response which [] result[ed] in damage from

47
Dr. Beck appeared to use “abnormal immune response” and “immunodeficiency”
interchangeably. See, e.g., Pet. Ex. 18 at 10 (opining Petitioner had an “abnormal immunologic
response following the administration of Prevnar 13 and [flu] vaccinations on [October 22,
2016], [that] resulted in the development of [AIED]”), 12 (opining Petitioner’s “simultaneous
administration of [flu] and [Prevnar 13] vaccines [were] the reason for inducing a state of
immunodeficiency”).

20
[AIED].” Pet. Ex. 19 at 19 (emphasis omitted).48 He did not explain how the vaccines caused
Petitioner’s upper respiratory symptoms, or how that would have led to AIED.

As for alternative causes, Dr. Beck opined that “[b]ecause the incidence of bilateral
sudden hearing loss is rare[,] the possibility of [] neoplastic, age-related [], or idiopathic cause is
extremely improbable.” Pet. Ex. 18 at 11. Furthermore, he averred that Petitioner’s other
medical conditions “would not produce asymmetric [SNHL] as in the case for [Petitioner], and
thus are not medically reasonable alternative explanations.” Id. at 13 (emphasis omitted).

As discussed in more detail above under prong one, Dr. Beck opined it would be “highly
improbable for a simple/uncomplicated URI . . . to result in sudden [SNHL] bilaterally.” Pet. Ex.
18 at 13.

Regarding Petitioner’s history of diabetes and coronary artery disease, Dr. Beck also
opined that it would be “highly improbable” for diabetes or vascular disease “to result in sudden
[SNHL] bilaterally.” Pet. Ex. 18 at 13. He noted Petitioner “had diabetes mellitus for years and
alleged cardiovascular disease for years without any incidence or complaints of hearing loss or
ear problems. It was only after receiving the vaccinations . . . that [Petitioner] suddenly
experienced [] otologic symptoms.” Pet. Ex. 19 at 12.

Moreover, Dr. Beck posited that Petitioner’s treating physicians “did not consider
diabetes mellitus as a risk factor for hearing loss”49 nor did they “request audiometric testing be
performed, even with the known medical history of diabetes.” Pet. Ex. 19 at 13. Dr. Beck
opined “[t]hese practices [were] in keeping with American Diabetes association [] clinical
guidelines recommendations” because “a hearing evaluation is not included in the advocated
end-organ assessment” for diabetics. Id. (quoting Pet. Ex. 19-1 at 2).50 However, as Dr. Beck
recognized, Baiduc and Helzner wrote that persons with diabetes also suffer from SNHL and that
“hearing loss is a possible consequence of [diabetes mellitus].” Id. (quoting Pet. Ex. 19-1 at 2).

48
Because Dr. Beck opined that URIs do “not result in immune-mediated mechanisms activating
the innate immune system within the inner ear, thereby producing antigens which are known to
cause damage to the cochleovestibular structures,” it appears Dr. Beck did not believe the URI
was a contributing factor to the cause of Petitioner’s hearing loss. Pet. Ex. 18 at 13 (emphasis
omitted). Thus, this statement seems inconsistent with Dr. Beck’s reliance on Dr. Roy’s
statement that Petitioner’s vaccines “were a substantial factor in causing an immune deficiency
that resulted in the upper respiratory symptoms and consequential . . . hearing loss.” Pet. Ex. 7 at
¶ 6.
49
Dr. Beck also quoted Dr. Hoang who, after reviewing Petitioner’s MRI and MRA, wrote that
Petitioner’s “clinical history and neuroimaging do not support a vascular etiology as the cause
for his [SNHL].” Pet. Ex. 19 at 20.
50
Rachel R. Baiduc & Elizabeth P. Helzner, Epidemiology of Diabetes and Hearing Loss, 40
Seminars Hearings 281 (2019). This is also cited as Resp. Ex. A, Tab 1.

21
Whether Petitioner’s diabetes was controlled, an issue raised by Respondent’s experts,
Dr. Beck averred that there is an “ongoing debate about the ‘optimal’ HbA1c” level and that
“glycemic targets must be individualized.” Pet. Ex. 19 at 14 (quoting Pet. Ex. 19-3 at 1).51 Klein
and Buse discussed the various results of trials analyzing microvascular risk and HbA1c levels.
Pet. Ex. 19-3 at 5. Current guidelines “recommend that individualized HbA1c targets be
established based on the patient’s age, life expectancy, comorbidities[,] and risk of
hypoglycaemia.” Id. According to Dr. Beck’s phone interview with Petitioner on December 3,
2021, “[Petitioner’s] current endocrinologist has achieved improvement in diabetes control by
implementing this approach.” Pet. Ex. 19 at 14. Klein and Buse summarized, based on current
guidelines and trials, that the “overarching goal” should be an HbA1c less than or equal to 7.5.
Pet. Ex. 19-3 at 11. Petitioner’s HbA1c level prior to vaccination was elevated at 8.4. Pet. Ex. 3
at 32. Petitioner’s HbA1c level after vaccination continued to be high at 9.3 (March 3, 2017) and
8.7 (May 12, 2017). Id. at 42, 53.

Dr. Beck opined that medical literature regarding diabetes and hearing loss cited by
Respondent’s expert, Dr. Whitton, does not apply because Petitioner had sudden SNHL,52
whereas Srinivas et al.53 stated that hearing loss in patients with diabetes mellitus is “usually
gradually progressive.” Pet. Ex. 19 at 14 (citing Pet. Ex. 19-4 at 1). Further, he quoted the
authors for the proposition that “[t]he pathophysiology of diabetes related hearing loss is
speculative.” Id. (quoting Pet. Ex. 19-4 at 1).

iii. Althen Prong Three

Dr. Beck opined “the abnormal immune-mediated response that [Petitioner] experienced
affected both ears one week postvaccination.” Pet. Ex. 19 at 19. He averred “[t]he clinical
manifestation of bilateral [SNHL] caused by uncontrolled immune system response is
progressive and often asymmetric, developing between [three] and 90 days.” Pet. Ex. 18 at 12
(citing Pet. Exs. 18-4, 18-7, 18-9). Dr. Beck relied on Petitioner’s affidavit for the basis for his
opinion that onset was one week after vaccination. Id.

Dr. Beck posited that patients with sudden SNHL often delay seeking medical attention
and that Petitioner instead instituted “self-directed interventions.” Pet. Ex. 18 at 8; see also Pet.
Ex. 18-6 at 1. “[W]ithin one [] week following the combined vaccinations[,] [Petitioner] began

51
Klara R. Klein & John B. Buse, The Trials and Tribulations of Determining HbA1c Targets for
Diabetes Mellitus, 16 Nature Revs. Endocrinology 717 (2020). This is also cited as Resp. Ex. A,
Tab 3.
52
Again, the undersigned notes that Dr. Beck classified Petitioner’s SNHL as sudden as
evidenced here, and as progressive as discussed in the diagnosis section above.
53
C.V. Srinivas et al., Clinical Study to Evaluate the Association Between Sensorineural Hearing
Loss and Diabetes Mellitus in Poorly Controlled Patients Whose HbA1c >8, 68 Indian J.
Otolaryngology Head & Neck Surgery 191 (2016). This is also cited as Resp. Ex. A, Tab 4.

22
to experience what resembled a[] [URI] and bilateral ear (otologic) symptoms including changes
of his hearing in both ears.” Pet. Ex. 19 at 6. Dr. Beck opined “[t]his sudden onset of ear
(otologic) symptoms meets the definition of sudden [SNHL] although [Petitioner] did not
recognize the severity of the problem and did not seek immediate medical attention.” Id.

Dr. Beck criticized Dr. Whitton’s use of calculating the incidence rate of SNHL to
support the temporal association as coincidental because the literature he referenced, Black et
al.54 and Alexander and Harris,55 “fails to meet his own . . . requirements.”56 Pet. Ex. 19 at 17
(citing Resp. Ex. A, Tabs 9-10). Dr. Beck opined “the data used by [Dr.] Whitton to ‘calculate
the incidence of SNHL’ which estimates ‘unilateral loss of hearing’ is not applicable and results
in an erroneous conclusion which does not apply to [Petitioner’s] bilateral asymmetric sudden
[SNHL].” Id. (emphasis omitted).

In summary, Dr. Beck opined the “proximate temporal relationship of onset of symptoms
considering the etiology of [AIED] occurring as it does in this case within days to months[,] it is
medically acceptable to infer causation-in-fact.” Pet. Ex. 18 at 13.

2. Respondent’s Expert, Dr. Douglas C. Bigelow57

a. Background and Qualifications

Dr. Bigelow is board certified in otolaryngology head and neck surgery, with a
subspecialty of neurotology.58 Resp. Ex. C at 2. He received his M.D. from the University of
Minnesota School of Medicine, and completed an otolaryngology-head and neck surgery

54
Steven Black et al., Importance of Background Rates of Disease in Assessment of Vaccine
Safety During Mass Immunisation with Pandemic H1N1 Influenza Vaccines, 374 Pub. Health
2115 (2009). This is also cited as Pet. Ex. 19-9.
55
Thomas H. Alexander & Jeffrey P. Harris, Incidence of Sudden Sensorineural Hearing Loss,
34 Otology & Neurotology 1586 (2013). This is also cited as Pet. Ex. 19-10.
56
Dr. Whitton relied on Black et al. for calculating the frequency in which a disease will occur
after vaccination. Resp. Ex. A at 10-11. The authors warned about the uncertainty in the
estimates when considering rare events and miscoding of events. Resp. Ex. A, Tab 9 at 6-7. Dr.
Whitton relied on Alexander and Harris to obtain data regarding the incidence of SNHL. Resp.
Ex. A at 10-11. Dr. Beck stated that Alexander and Harris incorrectly described sudden SNHL
as unilateral hearing loss. Pet. Ex. 19 at 17 (citing Resp. Ex. A, Tab 10 at 1). Importantly, the
data collected was derived from the coding for this diagnosis. Id. (citing Resp. Ex. A, Tab 10 at
2).
57
Respondent filed two expert reports from Dr. Bigelow. Resp. Exs. C, F.

Neurotology is the “neurological study of the ear.” Neurotology, Merriam-Webster Dictionary
58

Online, https://www.merriam-webster.com/medical/neuro-otology (last visited Jan. 2, 2024).

23
residency at Washington University, St. Louis. Resp. Ex. D at 1. He is currently an Associate
Professor in the Department of Otorhinolaryngology: Head and Neck Surgery at the University
of Pennsylvania School of Medicine. Id. He is also the Director of the Division of
Otology/Neurotology at the University of Pennsylvania Medical Center in Philadelphia. Id. at 2.
Dr. Bigelow has “over thirty years of experience as an attending physician managing patients
with otology problems, hearing loss, sudden hearing loss, chronic otitis, otitis media with
effusion, dizziness, tinnitus, vestibular migraine, acoustic neuromas etc. in a university tertiary
care setting.” Resp. Ex. C at 2.

b. Diagnosis Opinion

Dr. Bigelow disagreed that Petitioner’s diagnosis is AIED. Resp. Ex. F at 3, 8. He
explained that “AIED is a bilateral condition that usually begins with sudden SNHL in one ear
with involvement of the other ear usually within days to weeks after onset.” Id. at 3. He also
acknowledged the definition and criteria described by Ciorba et al., discussed above. Id. at 2-3;
see also Resp. Ex. C at 13-14. He noted several characteristics were inconsistent with a
diagnosis of AIED—primarily that Petitioner’s initial hearing loss was mainly conductive, not
sudden, and the subsequent SNHL likely developed progressively. Resp. Ex. F at 2-4; Resp. Ex.
C at 13. He analyzed Petitioner’s audiograms to explain his reasons.

i. 2017 Audiograms

First, Dr. Bigelow opined that “the vast majority of Petitioner’s hearing loss, when he
was first evaluated, was conductive[59] and was due to [otitis media with effusion].” Resp. Ex. F
at 3-4; see also Resp. Ex. C at 14. He opined that Petitioner’s 2017 audiograms “demonstrated a
predominately conductive hearing loss that would be consistent with the mucoid fluid in the
middle ear.” Resp. Ex. C at 11. Specifically, he noted that the audiogram from Dr. Roy’s office,
on April 24, 2017, “demonstrated a bilateral symmetric mostly conductive hearing loss due to the
fluid present in [Petitioner’s] middle ear.” Id. at 12 (citing Pet. Ex. 4 at 4); see also Resp. Ex. F
at 3 (“[U]pon reviewing the audiogram, it is clear that the vast majority of the hearing loss
present at that time was a conductive hearing loss [], not a [SNHL].”).

Dr. Bigelow explained “[f]luid in the middle ear, also known as otitis media with effusion
[] causes a conductive hearing loss, fullness/pressure in the ear and commonly tinnitus.” Resp.
Ex. C at 12 (citing Resp. Ex. C, Tab 1).60 It is “a condition in which there is fluid in the middle

The April 24, 2017 audiogram was interpreted by Dr. Roy as showing “bilateral, mild to
59

moderate, predominately conductive hearing loss.” Pet. Ex. 4 at 6. Diagnosis was “chronic
mucoid otitis media, bilateral, tinnitus, bilateral, and conductive hearing loss, bilateral.” Id.
60
Fredrick T. Searight et al., Otitis Media with Effusion, StatPearls [Internet],
https://www.ncbi.nlm.nih.gov/books/NBK538293/ (last updated Aug. 11, 2021). This is also
cited as Pet. Ex. 19-11.

24
ear, but no signs of acute infection.” Resp. Ex. C, Tab 1 at 2. “As fluid builds up in the middle
ear and [e]ustachian tube, it places pressure on the tympanic membrane. The pressure prevents
the tympanic membrane from vibrating properly, decreases sound conduction, and therefore
results in a decrease in patient hearing.” Id.

Otitis media with effusion is usually due to eustachian tube dysfunction and is often
associated with a URI.61 Resp. Ex. C at 12 (citing Resp. Ex. C, Tab 1 at 3; Resp. Ex. C, Tab 2).62
Dr. Bigelow averred nasal pathology can contribute to eustachian tube dysfunction. Id.
Additionally, “[s]moking has been shown to be associated with reduced ciliary beat frequency in
samples of middle-ear mucosa taken from adults with [otitis media with effusion].” Resp. Ex. C,
Tab 2 at 3. Dr. Bigelow averred that “AIED does not cause conductive hearing loss or [otitis
media with effusion],” and Dr. Bigelow’s research did not “state[] or infer[] that vaccinations are
the cause of [otitis media with effusion].” Resp. Ex. F at 3, 6-7.

Dr. Bigelow opined that Petitioner’s “multiple underlying conditions,” “persistent URI
symptoms,” and smoking habits, “especially when they are all occurring together,” could
contribute to eustachian tube dysfunction and otitis media with effusion. Resp. Ex. C at 12; see
also Resp. Ex. F at 6. He noted Petitioner “was a smoker and continued to smoke while he had
the URI symptoms.” Resp. Ex. C at 12. The chest CT scan from June 19, 2017 “identified
diffuse bronchial wall thickening suggestive of smoking related bronchitis, which would suggest
reactive airway disease from smoking.” Id. Moreover, he pointed out that “Dr. Roy identified a
deviated septum and enlarged turbinates in the nose as well as obstructive sleep apnea,
oropharyngeal airway narrowing due to redundant tissue and a complete collapse of the
oropharyngeal airway” on June 6, 2017. Id. (citing Pet. Ex. 4 at 10-15).

Next, Dr. Bigelow explained that in 2017, while Petitioner’s primary diagnosis was
conductive hearing loss, Petitioner also had some symmetrical, normal to mild SNHL. Resp. Ex.
C at 11; Resp. Ex. F at 3. However, Dr. Bigelow attributed this to Petitioner’s age and medical
history. Resp. Ex. C at 11; Resp. Ex. F at 3. He opined “[t]he measurement of [P]etitioner’s
sensorineural reserve (inner ear function) revealed symmetric sensorineural hearing that was in
the normal to mild hearing loss range in both ears with thresholds that were between 10 dB and
40 dB (normal is considered to be from 20 to 25 dB and less).” Resp. Ex. F at 3. Dr. Bigelow
opined the minimal amount of SNHL demonstrated in the audiograms “is often seen in someone
of [Petitioner’s] age, with a family history of hearing loss and multiple medical and vascular
conditions.” Resp. Ex. C at 11; see also Resp. Ex. F at 3.

Moreover, Dr. Bigelow opined the records do not show that Petitioner “experienced a
bilateral sudden hearing loss.” Resp. Ex. C at 11. “The first notation in the medical record of

61
Otitis media with effusion is also often unilateral. Resp. Ex. C, Tab 1 at 3.
62
R. Mills & I. Hathorn, Aetiology and Pathology of Otitis Media with Effusion in Adult Life,
130 J. Laryngology & Otology 418 (2016). This is also cited as Pet. Ex. 19-12.

25
hearing loss was on [March 29, 2017] when [Nurse] Lo recorded that ‘[Petitioner] called,
report[ed] bilateral hearing loss with persistent hearing changes.’” Id. (quoting Pet. Ex. 3 at 37).
Petitioner stated that “the URI symptoms began approximately [one] week after the vaccination
and ‘then [he] later started noticing issues with [his] ears and hearing.’” Id. (quoting Pet. Ex. 1 at
¶ 7). Dr. Bigelow noted that Dr. Roy’s records from April 12, 2017 report that “[Petitioner]
developed the flu and a severe URI in December and ever since then he’s had bilateral ear pain
and hearing loss. He took a Z-pack and got a little better and then last week developed
worsening symptoms along with constant tinnitus in both ears.” Id. (quoting Pet. Ex. 4 at 1). Dr.
Bigelow opined that “[d]epending on when in December the symptoms began[,] this would be
between [six] and 10 weeks after the vaccinations,” which is “well past the [three] to 90 day time
period after vaccinations that the Ciorba [et al.] article describes.” Id. at 11, 14; see also Resp.
Ex. F at 3.

In summary, Dr. Bigelow opined the 2017 audiograms showed predominantly conductive
hearing loss and not SNHL characteristic of AIED. Further, if the vaccinations had caused
AIED he posited there would have been a sudden, asymmetric bilateral SNHL “readily apparent”
on the April 14 and April 24, 2017 audiograms. Resp. Ex. F at 3. However, neither of those
audiograms showed “asymmetric or significant SNHL.” Id.

ii. 2019 Audiograms

Dr. Bigelow noted that Petitioner’s conductive hearing loss improved after the placement
of ventilation tubes. Resp. Ex. F at 3. This is evidenced by the March 26, 2019 and April 9,
2019 audiograms which did not show any conductive hearing loss. Id. (citing Pet. Ex. 5 at 3-4).

The March 26, 2019 audiogram was only of the right ear. Resp. Ex. C at 13 (citing Pet.
Ex. 5 at 3). Dr. Bigelow opined it demonstrated improvement from 2017 as there was no
conductive hearing loss, and that the sensorineural hearing level in Petitioner’s right ear was
unchanged compared to the 2017 audiograms. Resp. Ex. F at 3; Resp. Ex. C at 13 (opining the
sensorineural reserve from the March 26, 2019 audiogram “was the same (within 5 dB, which is
test-retest variability) to improved when compared to the April 2017 hearing test”). Dr. Bigelow
opined this does not support a diagnosis of AIED because Petitioner’s right-sided hearing was
“unchanged, not fluctuating or progressive, so there [was] not bilateral involvement which is a
key component of AIED.” Resp. Ex. F at 3; see also Resp. Ex. C at 13 (“The fact that the right
ear was unchanged since 2017 would [] not corroborate Dr. Beck’s statement that the hearing
loss was fluctuating.”).

On April 9, 2019, an audiogram was performed on both ears. Resp. Ex. C at 13 (citing
Pet. Ex. 5 at 4). Dr. Bigelow opined the right ear was unchanged, and the left ear “demonstrated
a moderately severe to severe [SNHL] across all frequencies with no residual conductive hearing
loss.” Id. Although the 2019 audiogram showed the “[SNHL] in the left ear was significantly
worse when compared to the April 24, 2017 audiogram,” Dr. Bigelow opined “it is not known

26
when that worsening occurred since there were no audiograms provided between April 2017 and
March 2019 or after April 2019 to determine how his hearing [] changed overtime.” Id.

Based on the evidence, Dr. Bigelow opined it was “likely the hearing loss on the left was
a progressive loss over time as neither the medical records nor [Petitioner’s] affidavit suggest
there was a sudden loss of hearing after the April 2017 evaluations.” Resp. Ex. C at 13. “If there
was a sudden loss of hearing on the left, [Dr. Bigelow] would have expected [Petitioner] to have
contacted his medical providers.” Id. He added that because “a progressive loss occurs slowly
over time, most patients will not notice the change until significant hearing loss has occurred
which may be why [Petitioner] did not obtain another audiogram for [two] years after his April
2017 test.” Id.

In summary, Dr. Bigelow opined that Petitioner did not have symptoms consistent with
AIED. Resp. Ex. C at 15; Resp. Ex. F at 2. Specifically, Petitioner “did not have bilateral
fluctuating sensorineural hearing loss as neither the medical records, audiograms nor
[Petitioner’s] affidavit document or suggest a fluctuating hearing loss or sudden SNHL.” Resp.
Ex. C at 15; see also Resp. Ex. F at 4. Therefore, he concluded Petitioner “would not meet the
criteria to diagnose AIED.” Resp. Ex. C at 14, 16.

c. Causation Opinion

i. Althen Prong One

In response to Petitioner’s theory based on immunodeficiency, Dr. Bigelow opined that
“[i]f there is a reduced immune response, then that would make it less likely that an adverse
event would occur. You would be more likely to experience an immune mediated adverse event
if there was a hyperactive immune response, not a reduced immune response.” Resp. Ex. F at 7.

Regarding immunodeficiency following vaccination, Dr. Bigelow cited the Centers for
Disease Control and Prevention (“CDC”)63 which stated that “studies demonstrate concomitant
administration of [Prevnar 13 vaccine] and [trivalent inactivated flu vaccine] is immunogenic
and safe.” Resp. Ex. C at 15 (quoting Resp. Ex. C, Tab 5 at 3).

Frenck et al. conducted a randomized double-blind study to evaluate the immunogenicity
and tolerability of a Prevnar 13 vaccine co-administered with the trivalent flu vaccination. Resp.
Ex. C, Tab 4 at 1. “Immunogenicity results show[ed] that immune responses for [trivalent
inactivated flu vaccine] antigens after the concomitant administration of [Prevnar 13] and
[trivalent inactivated flu vaccine] to healthy adults aged 50 to 59 years [were] robust and
noninferior to immune responses after [trivalent inactivated flu vaccine] given separately.” Id. at
7. “[A]ntipneumococcal IgG responses were lower for all serotypes and statistically
significantly lower for [eight] of 13 serotypes after concomitant administration of [Prevnar 13]

63
Administering Pneumococcal Vaccines, Ctrs. for Disease Control & Prevention,
https://www.cdc.gov/vaccines/vpd/pneumo/hcp/administering-vaccine.html (last reviewed Nov.
21, 2019). This is also cited as Pet. Ex. 19-15.
27
and [trivalent inactivated flu vaccine] compared with administration of [Prevnar 13] alone.” Id.
However, the authors posited “it is likely that [Prevnar 13] establishes immunologic memory, a
common characteristic of conjugated polysaccharide vaccines that is not seen with purified
polysaccharide vaccines.” Id. Thus, “[o]verall, the concomitant administration of [Prevnar 13]
and [trivalent inactivated flu vaccine] was demonstrated to be immunogenic and well tolerated.”
Id.

Dr. Bigelow cited Baxter et al.,64 which analyzed the association between vaccinations
and sudden SNHL. Resp. Ex. C, Tab 6 at 1. Baxter et al. indicated that “[i]n all risk intervals
prior to the onset of [sudden SNHL], [the authors] found no evidence of increased risk of
immunization compared with matched controls.” Resp. Ex. C at 17 (quoting Resp. Ex. C, Tab 6
at 1). “Review of the 13 VAERS reports of [sudden SNHL] following [trivalent inactivated flu
vaccine] seemed to indicate the possibility of clustering in time of [sudden SNHL] with respect
to the [trivalent inactivated flu vaccine] vaccination; however, temporal association does not
prove causation when assessing the association of vaccine adverse events.” Id. (quoting Resp.
Ex. A, Tab 8 at 3). Dr. Bigelow opined “[t]his is a very powerful study with a massive data base
that specifically looked at and did not find an association with vaccination and sudden SNHL.”
Resp. Ex. F at 5.

Moreover, Dr. Bigelow noted that while Dr. Beck quoted Dr. Karadsheh who stated “[i]t
is known that the simultaneous administration of [flu] and pneumococcal vaccine may induce a
state of immunodeficiency in a previously healthy subject[],” Dr. Karadsheh “[did] not provide
any studies to back up his statement and opinion.” Resp. Ex. C at 15 (first quoting Pet. Ex. 18 at
9; and then quoting Pet. Ex. 6 at 1).

ii. Althen Prong Two

1. No Abnormal Immune Response

Dr. Bigelow opined there is no evidence of an abnormal immune response. Regarding
Petitioner’s laboratory results, Dr. Bigelow noted all but two of the serotypes in Prevnar 13 were
in the normal range. Resp. Ex. C at 15. He opined “[t]his would not confirm a significantly
abnormal response.” Id.

Dr. Bigelow disagreed with Dr. Roy “that the vaccine caused immunodeficiency that
resulted in the URI, ear pain, tinnitus, otitis media, and hearing loss.” Resp. Ex. C at 15. He
averred that even Dr. Beck contradicted this statement by opining that a URI would not result in

64
Roger Baxter et al., Sudden-Onset Sensorineural Hearing Loss After Immunization: A Case-
Centered Analysis, 155 Otolaryngology Head & Neck Surgery 81 (2016). This is also cited as
Resp. Ex. A, Tab 8; Pet. Ex. 19-8.

28
AIED.65 Id.; see also Pet. Ex. 18 at 13. Dr. Bigelow agreed with Dr. Beck “that the URI
[Petitioner] had in late 2016 and 2017 did not cause any immune related ear problems or hearing
loss.” Resp. Ex. C at 15.

2. Progression of Hearing Loss

Dr. Bigelow opined Petitioner developed “bilateral [otitis media with effusion] which
caused a significant conductive hearing loss that was initially diagnosed in March 2017,
objectively measured with an audiogram in April 2017 and definitively treated with bilateral
ventilation tube placement in April 2017.” Resp. Ex. C at 14.

The first notation of hearing loss in the medical records was on March 29, 2017, more
than five months after the vaccinations. Resp. Ex. C at 9, 11 (citing Pet. Ex. 3 at 37). Petitioner
had audiograms done in April 2017 which Dr. Bigelow opined showed “predominately
conductive hearing loss that would be consistent with the mucoid fluid in the middle ear with a
sensorineural reserve (inner ear function) that was in the normal to mild hearing loss range
bilaterally.” Res. Ex. C at 11. Petitioner’s conductive hearing loss improved after the placement
of ventilation tubes on April 27, 2017. Id. at 13; Resp. Ex. F at 3; Pet. Ex. 4 at 9. The next
audiogram was not until March 2019 and showed no conductive hearing loss and Petitioner’s
right-sided SNHL was the same as in 2017. Resp. Ex. C at 13; Resp. Ex. F at 3; Pet. Ex. 5 at 3.
Another audiogram in April 2019 showed “a moderately severe to severe [SNHL] across all
frequencies [in the left ear] with no residual conductive hearing loss” in either ear. Resp. Ex. C
at 13 (citing Pet. Ex. 5 at 3).

Dr. Bigelow opined Petitioner’s otitis media with effusion caused his conductive hearing
loss shown in the 2017 audiograms, but “it did not cause his asymmetric SNHL” as shown on
the April 9, 2019 audiogram. Resp. Ex. F at 6. He also stated that the vaccinations did not
cause the otitis media with effusion. Id. at 7.

He averred the “etiology of [Petitioner’s] left sided asymmetric SNHL is not known.”
Resp. Ex. C at 14. But “in the majority of cases of sudden or progressive SNHL, a specific
cause is never identified.” Id. According to Dr. Bigelow, Petitioner’s “left sided SNHL that
occurred after the April 2017 audiogram was most likely progressive, but if there was a sudden
left sided SNHL that occurred after April 2017, it would have occurred somewhere between
[six] months and [two-and-one-half] years after the vaccinations and would not have had any
association or relationship to the vaccinations.” Resp. Ex. F at 6.

Dr. Bigelow added that “[a]nyone with a unilateral hearing loss needs to have an MRI
scan that adequately covers the internal auditory canals and cerebellopontine angles to rule out
any lesions such as an acoustic neuroma that can cause unilateral hearing loss.” Resp. Ex. C at
14. If contrast is not utilized then, at a minimum, “high resolution T2 images through the

65
Dr. Beck opined URIs are typically viral and do “not result in immune-mediated mechanisms
activating the innate immune system within the inner ear, thereby producing antigens which are
known to cause damage to the cochleovestibular structures.” Pet. Ex. 18 at 13 (emphasis
omitted).
29
internal auditory canals” would be necessary. Id. “If a lesion was identified on the MRI scan
that would certainly account for the asymmetric SNHL.” Id. (citing Resp. Ex. C, Tab 3).66

Upon reviewing Petitioner’s MRI, Dr. Bigelow noted that it was “done to evaluate
symptoms of ataxia, not asymmetric SNHL, so it was done without contrast.” Resp. Ex. F at 3.
He said it was “good that the radiologist noted that the seventh and eighth nerve bundles were
normal,” however, “[w]ithout contrast, small lesions that could cause SNHL can sometimes be
missed, especially if the scan was not tailored to evaluate the internal auditory canals as would
typically be done if it was obtained to evaluate for causes of asymmetric SNHL.” Id. at 3-5.
“Thus, while [P]etitioner’s non-contrast MRI would certainly rule out any larger lesions, it may
not capture smaller lesions capable of causing [P]etitioner’s asymmetric SNHL.” Id. at 5.

3. Alternate Causes/Other Conditions

Next, Dr. Bigelow reasoned that Petitioner had multiple chronic medical issues “which
would have made him more susceptible for chronic airway disease and [eustachian tube
dysfunction] and contribute to [otitis media with effusion].” Resp. Ex. C at 15. “However, once
the mucoid fluid was removed and the ventilation tubes were placed, the conductive hearing loss
resolved completely and did not cause any long-term or permanent problems or hearing loss.”
Id. Again, he added that “[t]he [otitis media with effusion] would not cause [Petitioner’s]
SNHL.” Id.

One of the chronic illnesses raised by Dr. Bigelow was diabetes. See Resp. Ex. F at 6.
He stated that diabetes is a “well-known risk factor for SNHL.” Id. Dr. Bigelow emphasized
that “Petitioner had a medical history significant for coronary artery disease with [five] stents, as
well as peripheral arterial disease with bilateral femoral stents and hypertension in addition to his
diabetes mellitus on insulin and oral medications.” Id. According to him, “these factors place
[P]etitioner at a much higher risk for developing SNHL.” Id.

iii. Althen Prong Three

Dr. Bigelow found Dr. Beck’s opinion—that onset of Petitioner’s AIED symptoms began
within days to months following vaccination—to be unsubstantiated by the evidence. Resp. Ex.
C at 16.

He noted that Petitioner’s affidavit indicated “that his URI symptoms started
approximately [one] week following the vaccinations and that the ear symptoms and hearing
loss started sometime later.” Resp. Ex. C at 16. Dr. Bigelow stated that Dr. Roy’s medical
records suggest that Petitioner’s “ear symptoms and hearing loss began sometime in December

66
Samantha M. Baird et al., Inner Ear and Retrocochlear Pathology on Magnetic Resonance
Imaging for Sudden and Progressive Asymmetrical Sensorineural Hearing Loss, 89 ANZ J.
Surgery 738 (2019). This is also cited as Pet. Ex. 19-13.

30
2016[67] which would be somewhere between [six] and 10 weeks after the vaccination.” Id. In
March 2017 Petitioner was diagnosed with bilateral middle ear effusion and the “audiograms
obtained in April 2017, [six] months after the vaccinations, demonstrated a predominantly
conductive hearing loss due to the fluid in the middle ear.” Id.

As stated above, Dr. Bigelow opined “[t]he etiology for the deterioration of the left-sided
hearing is unknown, but it occurred sometime after the April 2017 audiograms, which were
obtained [six] months after the vaccinations. This would be well outside the window of any
[effect] from the October 2016 vaccinations.” Resp. Ex. F at 3, 6; see also Resp. Ex. C at 16
(“Given that the deterioration of the left sided SNHL occurred between [one] and [three] years
after the vaccinations there is no temporal relationship between the vaccinations and the
SNHL.”).

3. Respondent’s Expert, Dr. J. Lindsay Whitton68

a. Background and Qualifications

Dr. Whitton received his B.Sc. in molecular biology, his M.B., Ch.B. in medicine, and his
Ph.D. in herpesvirus transcription from the University of Glasgow in Scotland. Resp. Ex. A at 1.
He also completed internships in medicine and surgery and has held various professor positions
since 1986. Id.; Resp. Ex. B at 1. At the time Dr. Whitton authored his reports, he was a
professor in the Department of Immunology and Microbiology at the Scripps Research Institute
in California, where he was previously involved in research. Resp. Ex. A at 1-3; Resp. Ex. B at
1. Dr. Whitton is a member of various professional societies and editorial boards and has
authored or co-authored almost 200 publications. Resp. Ex. B at 1-15. Dr. Whitton does not
provide patient care, diagnose, or treat patients as he is not licensed as a medical doctor. Resp.
Ex. A at 3.

b. Diagnosis Opinion

Dr. Whitton deferred to Dr. Bigelow on the issue of diagnosis. Resp. Ex. A at 3; Resp.
Ex. E at 2.69 However, Dr. Whitton did note that Dr. Beck’s diagnosis of AIED was not reached
by Petitioner’s treating physicians. Resp. Ex. E at 2. As a preface to his opinions about
causation, Dr. Whitton explained that in order to critique Petitioner’s theory of causation, he

67
Dr. Roy’s history notes from April 12, 2017 document that Petitioner “developed the flu and a
severe URI in December and ever since then[,] [Petitioner] had bilateral ear pain and hearing
loss.” Pet. Ex. 4 at 1.
68
Respondent filed two expert reports from Dr. Whitton. Resp. Exs. A, E.
69
Dr. Whitton commented on the difference between the diagnosis as alleged by Dr. Beck and
the diagnosis in the petition and by Petitioner’s treating physicians. See Resp. Ex. E at 1-2.
Because Dr. Whitton is not qualified to opine on diagnosis, the undersigned will not discuss this
part of his expert report.

31
relied on the diagnosis of AIED. Resp. Ex. A at 3. But he emphasized that by doing so, he did
not concede that Petitioner has AIED. Id.

c. Causation Opinion

i. Althen Prong One

Dr. Whitton first pointed out some contradictions between Petitioner’s allegations and
Dr. Beck’s opinions and conclusions as to the proposed mechanism. Resp. Ex. A at 3. Dr.
Whitton stated,

the primary allegation, and theory of causation, made in the [p]etition, and in
[P]etitioner’s affidavit, is that the vaccines caused an immunodeficiency, which
resulted in an infection, which caused tinnitus and hearing loss that was, at first,
mainly conductive, but which became sensorineural, with increasing severity;
however, Dr. Beck—although accepting the presence of immunodeficiency—
argues that the vaccines caused a disease called autoimmune inner ear disease
(AIED) thereby causing tinnitus and [SNHL].

Id.

Dr. Whitton understood Dr. Beck’s alleged mechanism of causation to be that the
vaccinations caused an immunodeficiency which, led to a URI that “caused [P]etitioner’s hearing
loss and tinnitus.” Resp. Ex. A at 6. Dr. Whitton emphasized that it is “not clear” how
autoimmune hearing loss fits with the immunodeficiency theory. Id. Moreover, he is “not aware
of any credible evidence that these vaccines, individually, or together, are known to cause
‘immunodeficiency.’” Id. at 8; Resp. Ex. E at 3.

In response to Dr. Beck’s assertion that vaccines can cause SNHL and AIED, Dr.
Whitton referenced literature to show there is “no causal association between vaccination and
SNHL.” Resp. Ex. A at 10 (emphasis omitted).

Like Dr. Bigelow, Dr. Whitton also cited Baxter et al., a study on sudden onset SNHL in
“recipients of [more than] 23 million doses of various vaccines, including [more than] 8 million
doses of flu vaccine[] and [more than] 650,000 doses of Prevnar 13 vaccine.” Resp. Ex. A at 10
(citing Resp. Ex. C, Tab 6 at 3 tbl.1). They “found no indication of an increased risk of
immunization with any vaccine prior to the development of [sudden SNHL].” Resp. Ex. C, Tab
6 at 9. Baxter et al. concluded their “large-scale analysis applying a case-centered method did
not detect any association between [sudden SNHL] and previous receipt of [flu] or other
vaccines.” Id. at 1.

In response to Dr. Beck who posited that none of the literature reports on the dual
simultaneous vaccination with Prevnar 13 and flu vaccination, Dr. Whitton opined the “fact that
a hypothesis (in this case, that Prevnar 13 [and] flu vaccine can cause [sudden SNHL]) has not

32
been disproven does not mean that we can safely assume that it must be true.” Resp. Ex. E at 6
(emphasis omitted).

ii. Althen Prong Two

Dr. Whitton opined “[t]here is absolutely no evidence” that Petitioner had an
“immunodeficiency.” Resp. Ex. A at 9. First, he opined that Petitioner’s bloodwork “most
certainly does not show ‘immunodeficiency.’” Id. at 8 (emphasis omitted). He noted
Petitioner’s IgG, IgA, and IgM were all within normal limits and his mumps antibodies were
consistent with having either a previous mumps infection or a mumps vaccine. Id. at 8.

Regarding the pneumococcal antibodies, Dr. Whitton opined that the pneumococcal
antibodies test Petitioner received “evaluates the levels of antibodies against all 23 of the
bacterial polysaccharides that are present in Pneumovax 23 [], an S. pneumoniae vaccine that
[P]etitioner did not receive.” Resp. Ex. A at 8. Instead, Petitioner received Prevnar 13, which
contains polysaccharides from the following 13 strains of S. pneumoniae: 1, 3, 4, 5, 6A, 6B, 7F,
9V, 14, 18C, 19A, 19F, and 23F. Id. Dr. Whitton explained that Pneumovax 23 contains 12 of
those 13 bacterial polysaccharides but also additional serotypes not present in Prevnar 13. Id.;
see also Resp. Ex. A, Tab 6 (Prevnar 13 package insert). Therefore, Dr. Whitton explained that
when evaluating Petitioner’s laboratory studies, one must review the 12 antibodies specific to the
12 polysaccharides contained in Prevnar 13. Resp. Ex. A at 8. The other levels of antibodies are
not relevant to the Prevnar 13 vaccination. Id.

He explained the goal of Prevnar 13 vaccination is “to induce protective levels of
antibody against all 13 strains.” Resp. Ex. A at 8. However, “it is common for individuals to fail
to respond to one or more of the included polysaccharides” but in practice, it does not mean it
was ineffective. Id. at 8-9. Instead, the threshold for an adequate vaccine response is an
antibody titer great than 1.3 μg/ml for over 70% of the serotypes. Id. at 9 (citing Resp. Ex. A,
Tab 7 at 1).70 Dr. Whitton charted the different strains of S. pneumoniae, indicated which are in
Prevnar 13, and compared with Petitioner’s results ranked in descending order. Id. “Petitioner
had antibody levels well above the 1.3 μg/ml threshold for 10 of the 12 antibodies that are
relevant to Prevnar 13.[71] This is an 83.3% response, well above both of the thresholds
described above.” Id. Thus, Dr. Whitton concluded, “that [P]etitioner mounted [an] appropriate
immune responses to the Prevnar 13 vaccine.” Id. (emphasis omitted); see also Resp. Ex. E at 4.

70
Thomas M. Daly et al., Multilaboratory Assessment of Threshold Versus Fold-Change
Algorithms for Minimizing Analytical Variability in Multiplexed Pneumococcal IgG
Measurements, 21 Clinical & Vaccine Immunology 982 (2014). This is also cited as Pet. Ex. 19-
7.
71
The 6A serotype was not tested. See Pet. Ex. 3 at 51-52. Dr. Whitton explained this was
because “the assay that was used was designed to test for antibody responses to a different
pneumococcal vaccine, Pneumovax 23, [which] lacks the 6A serotype polysaccharide.” Resp.
Ex. E at 3-4.

33
Further, Petitioner’s top 10 antibody levels were specific for polysaccharides in Prevnar
13. Resp. Ex. A at 9. The “antibody titers to polysaccharides that are in Pneumovax 23, but are
not in Prevnar 13, [were] much lower.” Resp. Ex. E at 4 (emphasis omitted). Dr. Whitton
opined that “the very low titers of antibodies to the polysaccharides that are present only in
Pneumovax 23 serve as internal negative controls, against which the antibody titers to the
Prevnar 13 polysaccharides can be compared, thereby providing additional evidence that
[P]etitioner mounted an appropriate immune response to Prevnar 13.” Id. at 5. In conclusion,
Petitioner’s blood work relative to pneumococcal antibodies showed that Petitioner had a normal
immune response to the Prevnar 13 vaccination and did not show immunodeficiency. Id.

Second, Dr. Whitton noted that the allegations of immunodeficiency in the petition,
Petitioner’s affidavit, and Dr. Roy’s declaration appeared to come from Dr. Karadsheh. Resp.
Ex. A at 6-7. Dr. Whitton stated “that the allegation of immunodeficiency comes from a single
source[,] Dr. [] Karadsheh,” and it was adopted by Petitioner, Dr. Roy, and Dr. Beck. Id. at 8.

Regarding an alternative cause for Petitioner’s hearing loss, Dr. Whitton pointed out that
Petitioner suffered two ailments prior to vaccination that are relevant: “poorly-controlled
diabetes mellitus[] and [] cardiovascular disease, both of which markedly increase the risk of
developing SNHL.” Resp. Ex. A at 4, 12.

Dr. Whitton explained that “[d]iabetes is a risk factor for developing hearing loss.” Resp.
Ex. A at 4 (citing Resp. Ex. A, Tab 2 at 1 (“Diabetes can contribute to hearing loss . . . through
numerous mechanisms, including microangiopathy, mitochondrial dysfunction, advance
glycation end products/inflammation, and glutamate excitotoxicity.”));72 see also Pet. Ex. 19-4 at
2 (“One of the known complications of [diabetes mellitus] is hearing impairment, especially
hearing loss . . . .”). Baiduc and Helzner discussed the high prevalence of hearing loss in persons
with diabetes and examined studies suggesting a higher incidence of hearing loss in persons with
diabetes compared to those without diabetes. Pet. Ex. 19-1 at 1. They found the
“epidemiological data support[ed] an association between [diabetes mellitus] and hearing loss.”
Id. at 6. Additionally, studies showed the risk of developing sudden SNHL was significantly
higher in diabetic groups compared with nondiabetic groups, including in the 50-64 year age
group. Id. at 14; see also Resp. Ex. A, Tab 4 at 1 (discussing the significant association between
older age groups with diabetes and SNHL).

Moreover, “in diabetic patients, the prevalence of hearing loss is higher in those with
poorly-controlled disease, as reflected by the blood level of HbA1c, a key indicator of blood
glucose control in diabetes.” Resp. Ex. A at 4 (citing Pet. Ex. 19-3). In Srinivas et al., “30.8%
of people with well-controlled disease (HbA1c [less than] 7) had SNHL, but SNHL was present
in 85.7% of those with poorly-controlled diabetes (HbA1c [greater than] 8).” Id. (citing Resp.
Ex. A, Tab 4). Petitioner had bloodwork done on April 7, 2016, prior to his vaccinations, and his
HbA1c level was flagged as “high” at 8.3. Id. (citing Pet. Ex. 3 at 12). The associated notes
indicated that “in adults with diabetes, adequate glycemic control would be indicated by a
HbA1c level [less than] 7.0.” Id. (citing Pet. Ex. 3 at 12). According to Dr. Whitton, Petitioner’s

72
Christopher Spankovich & Krishna Yerraguntia, Evaluation and Management of Patients with
Diabetes and Hearing Loss, 40 Seminars Hearing 308 (2019). This is also cited as Pet. Ex. 19-2.

34
diabetes was poorly-controlled months prior to the vaccinations at issue. Id. On March 3, 2017,
five months post-vaccination, Petitioner’s HbA1c was still high at 9.3. Id. (citing Pet. Ex. 3 at
42). Dr. Whitton referenced several other lab results with elevated HbA1c levels showing that
“[t]here is little doubt that Petitioner had, and has, [] poorly-controlled diabetes,” which
increased the risk of hearing loss. Id. at 5.

Additionally, Dr. Whitton opined “Petitioner also has coronary artery disease and, in
persons with diabetes, individuals with coronary heart disease are more likely to develop hearing
loss than those without heart disease.” Resp. Ex. A at 4 (citing Pet. Ex. 19-1 at 7). Baiduc and
Helzner stated, “[i]n addition to age, sex, noise exposure, and genetic predisposition,
cardiovascular disease and its antecedents may precipitate hearing loss.” Pet. Ex. 19-1 at 1.

iii. Althen Prong Three

Dr. Whitton opined that “coincidental temporal associations are inevitable, and often are
quite common.” Resp. Ex. A at 10. He explained that the frequency in which a disease will
occur after vaccination can be calculated using (1) the annual incidence of the disease, (2) the
number of vaccine doses administered annually, and (3) the time interval between the
vaccination and disease onset. Id. He cited Black et al. as an example of applying this by
“evaluat[ing] the likelihood of coincidental occurrence between flu vaccination and several
neurological diseases including [Guillain-Barré Syndrome (“GBS”)], and found that, for every
10 million vaccinees, [approximately] 21 cases of GBS would occur within [six] weeks of
vaccination, purely by chance.” Id. (citing Resp. Ex. A, Tab 9). Thus, Dr. Whitton believed any
temporal association between vaccination and Petitioner’s hearing loss was coincidental.

III. DISCUSSION

A. Standards for Adjudication

The Vaccine Act was established to compensate vaccine-related injuries and deaths. §
10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as
a simple, fair and expeditious means for compensating vaccine-related injured persons. The
Program was established to award ‘vaccine-injured persons quickly, easily, and with certainty
and generosity.’” Rooks v. Sec’y of Health & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting
H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).

Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health
& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Petitioner need not make a specific type of
evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological
markers or genetic predisposition, or general acceptance in the scientific or medical communities
to establish a logical sequence of cause and effect.” Capizzano v. Sec’y of Health & Hum.
Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead, Petitioner may satisfy his burden by
presenting circumstantial evidence and reliable medical opinions. Id. at 1325-26.

35
In particular, a petitioner must prove 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));
see also Pafford v. Sec’y of Health & Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The
received vaccine, however, need not be the predominant cause of the injury. Shyface, 165 F.3d
at 1351. A petitioner who satisfies this burden is entitled to compensation unless Respondent
can prove, by a preponderance of the evidence, that the vaccinee’s injury is “due to factors
unrelated to the administration of the vaccine.” § 13(a)(1)(B). However, if a petitioner fails to
establish a prima facie case, the burden does not shift. Bradley v. Sec’y of Health & Hum.
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

“Regardless of whether the burden ever shifts to the [R]espondent, the special master
may consider the evidence presented by the [R]espondent in determining whether the [P]etitioner
has established a prima facie case.” Flores v. Sec’y of Health & Hum. Servs., 115 Fed. Cl. 157,
162-63 (2014); see also Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379 (Fed. Cir.
2012) (“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors
unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine
was a substantial factor in causing the injury in question.”); de Bazan v. Sec’y of Health & Hum.
Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is permitted
to offer evidence to demonstrate the inadequacy of the [P]etitioner’s evidence on a requisite
element of the [P]etitioner’s case-in-chief.”); Pafford, 451 F.3d at 1358-59 (“[T]he presence of
multiple potential causative agents makes it difficult to attribute ‘but for’ causation to the
vaccination. . . . [T]he Special Master properly introduced the presence of the other unrelated
contemporaneous events as just as likely to have been the triggering event as the vaccinations.”).

B. Factual Issues

Petitioner must prove, by a preponderance of the evidence, the factual circumstances
surrounding his claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh
the evidence presented, which may include contemporaneous medical records and testimony.
See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a
special master must decide what weight to give evidence including oral testimony and
contemporaneous medical records).

Medical records, specifically contemporaneous medical records, are presumed to be
accurate and generally “warrant consideration as trustworthy evidence.” Cucuras v. Sec’y of
Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). But see Kirby v. Sec’y of Health
& Hum. Servs., 997 F.3d 1378, 1382 (Fed. Cir. 2021) (rejecting the presumption that “medical
records are accurate and complete as to all the patient’s physical conditions”); Shapiro v. Sec’y
of Health & Hum. Servs., 101 Fed. Cl. 532, 538 (2011) (“[T]he absence of a reference to a
condition or circumstance is much less significant than a reference which negates the existence
of the condition or circumstance.” (quoting 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))), recons. den’d after remand,
105 Fed. Cl. 353 (2012), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013). The weight afforded to
contemporaneous records is due to the fact that they “contain information supplied to or by

36
health professionals to facilitate diagnosis and treatment of medical conditions. With proper
treatment hanging in the balance, accuracy has an extra premium.” Id. To overcome the
presumptive accuracy of medical records, a petitioner may present testimony which is
“consistent, clear, cogent, and compelling.” Sanchez v. Sec’y of Health & Hum. Servs., No. 11-
685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of
Health & Hum. Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30,
1998)), mot. for rev. den’d, 142 Fed. Cl. 247 (2019), vacated on other grounds & remanded, 809
F. App’x 843 (Fed Cir. 2020).

There are situations in which compelling testimony may be more persuasive than written
records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of
Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“[L]ike 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 v. Sec’y of Health & Hum.
Servs., No. 03-1585V, 2005 WL 6117475, at *19 (Fed. Cl. Spec. Mstr. Dec. 12, 2005)
(“[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 v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379
(Fed. Cir. 2009); Bradley, 991 F.2d at 1575.

Despite the weight afforded medical records, special masters are not bound rigidly by
those records in determining onset of a petitioner’s symptoms. Valenzuela v. Sec’y of Health &
Hum. Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991); see
also Eng v. Sec’y of Health & Hum. Servs., No. 90-1754V, 1994 WL 67704, at *3 (Fed. Cl.
Spec. Mstr. Feb. 18, 1994) (Section 13(b)(2) “must be construed so as to give effect also to §
13(b)(1) which directs the special master or court to consider the medical records (reports,
diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special
master or court to be bound by them”).

C. Causation

To receive compensation through the Program, Petitioner must prove either (1) that he
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that he received, or (2) that he suffered an injury that was actually caused by a
vaccination. See §§ 11(c)(1), 13(a)(1)(A); Capizzano, 440 F.3d at 1319-20. Petitioner must
show that the vaccine was “not only a but-for cause of the injury but also a substantial factor in
bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352-53).

Because Petitioner does not allege he suffered a Table Injury, he must prove a vaccine he
received actually caused his injury. To do so, Petitioner must establish, by preponderant
evidence: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a
showing of a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d
at 1278.

37
The causation theory must relate to the injury alleged. Petitioner must provide a sound
and reliable medical or scientific explanation that pertains specifically to this case, although the
explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v.
Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner cannot
establish entitlement to compensation based solely on his assertions; rather, a vaccine claim must
be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In
determining whether Petitioner is entitled to compensation, the special master shall consider all
material in the record, including “any . . . conclusion, [or] medical judgment . . . which is
contained in the record regarding . . . causation.” § 13(b)(1)(A). The special master must weigh
the submitted evidence and the testimony of the parties’ proffered experts and rule in Petitioner’s
favor when the evidence weighs in her favor. See Moberly, 592 F.3d at 1325-26 (“Finders of
fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence
presented to them and, if appropriate, as to the credibility of the persons presenting that
evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in Petitioner’s
favor).

Testimony that merely expresses the possibility—not the probability—is insufficient, by
itself, to substantiate a claim that such an injury occurred. See Waterman v. Sec’y of Health &
Hum. Servs., 123 Fed. Cl. 564, 573-74 (2015) (denying Petitioner’s motion for review and
noting that a possible causal link was not sufficient to meet the preponderance standard). The
Federal Circuit has made clear that the mere possibility of a link between a vaccination and a
petitioner’s injury is not sufficient to satisfy the preponderance standard. Moberly, 592 F.3d at
1322 (emphasizing that “proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and
the injury” does not equate to proof of causation by a preponderance of the evidence); Boatmon
v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359-60 (Fed. Cir. 2019). While certainty is
by no means required, a possible mechanism does not rise to the level of preponderance.
Moberly, 592 F.3d at 1322; see also de Bazan, 539 F.3d at 1351.

IV. DIAGNOSIS ANALYSIS

As Federal Circuit precedent establishes, in certain cases it is appropriate to determine the
nature of an injury before engaging in the Althen analysis. Broekelschen v. Sec’y of Health &
Hum. Servs., 618 F.3d 1339, 1346 (Fed. Cir. 2010). Since “each prong of the Althen test is
decided relative to the injury[,]” determining facts relating to the claimed injury can be
significant. Id.

In his petition, Petitioner requests compensation for “bilateral ear pain, tinnitus[,] and
hearing loss.” Petition at ¶ 3; Pet. Br. at 1-2. In their joint submission, the parties do not dispute
that Petitioner has suffered hearing loss, but they dispute the diagnosis of AIED. Petitioner’s
expert, Dr. Beck, opines that Petitioner has AIED. Dr. Beck’s opinions are somewhat confusing
and sometimes contradictory. Respondent’s expert, Dr. Bigelow, disagrees and opines Petitioner
does not meet the criteria for AIED. Based upon a review of all of the evidence, the undersigned
finds that Petitioner does not have AIED for the following reasons.

AIED is characterized by a “a progressive bilateral and asymmetric SNHL profile, which
typically benefits from a steroid and immunosuppressive therapy.” Pet. Ex. 18-9 at 1. The

38
illness progresses over a period of three and 90 days. Although there are no standardized
diagnostic criteria for AIED, the medical literature consistently reports that AIED is
predominantly sensorineural, not conductive, hearing loss. See e.g., Pet. Ex. 18-8 at 7; Pet. Ex.
18-9 at 1; Pet. Ex. 18-10 at 5.

A. There Is No Diagnosis by Treating Physicians in the Contemporaneous
Medical Records

The first reason that the undersigned finds that Petitioner did not have AIED is that his
post-vaccination hearing loss was not diagnosed as SNHL, and thus, it was not consistent with
AIED. Moreover, none of Petitioner’s treating physicians diagnosed him with AIED.

Petitioner’s audiogram on April 24, 2017 was interpreted by Dr. Roy to show “bilateral,
mild to moderate, predominantly conductive hearing loss across all frequencies.” Pet. Ex. 4 at 6.
Dr. Roy did not diagnose SNHL. Further, Dr. Bigelow opined that the 2017 audiograms showed
primarily a conductive hearing loss. This opinion is consistent with Dr. Roy’s documented
contemporaneous diagnosis. Therefore, the earliest in time diagnostic audiogram shows that
Petitioner had conductive hearing loss, and he was not diagnosed with SNHL or AIED.

Petitioner did not have another audiogram until 2019, when an April 9, 2019 audiogram
showed severe SNHL in the left ear. Dr. Bigelow explains that Petitioner’s SNHL in the left ear
was “significantly worse” compared to the April 24, 2017 audiogram. Resp. Ex. C at 13. Still,
he was not diagnosed with AIED. Since no audiograms were done between April 2017 and
April 2019, it is not possible to determine when or how Petitioner’s hearing loss changed over
that two-year period of time. Thus, Dr. Bigelow agrees Petitioner had SNHL, but not until 2019,
more than two years after Petitioner’s vaccinations. The undersigned finds that SNHL that
presents two years after vaccination is not temporally associated with vaccination. See Section
V.B.

B. There Is a Lack of Findings Consistent with Autoimmune Hearing Loss

Next, AIED is thought to be autoimmune in nature, and Petitioner did not have
characteristics of an autoimmune condition. One indication of an autoimmune cause of hearing
loss described by Ciorba et al. is responsiveness to steroid treatment. Petitioner was prescribed
systemic steroids (Medrol Dosepak) by Dr. Roy on April 12, 2017. When Petitioner returned to
see Dr. Roy on April 24, Petitioner reported that he took the antibiotics and steroids but they did
not improve his symptoms. While Ciorba et al. suggests that only 14% of patients with AIED
are responsive to steroids, Petitioner’s failure to improve on steroids weighs against finding that
his hearing loss was autoimmune in nature. Pet. Ex. 18-9 at 3; see also Pet. Ex. 18-11 at 1
(“AIED is one of the few forms of sensorineural deafness that can potentially be treated.”); Pet.
Ex. 18-8 at 8 (“A positive response to []steroid therapy is the third criterion for the diagnosis of
[AIED].”).

None of Petitioner’s records in 2017 reference any autoimmune hearing loss. None of
Petitioner’s treating physicians suggest that the hearing loss was autoimmune in nature. Great
weight is afforded to contemporaneous records is due to the fact that they “contain information

39
supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions.
With proper treatment hanging in the balance, accuracy has an extra premium.” Cucuras, 993
F.2d at 1528; see also Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326.

While Dr. Karadsheh and Dr. Roy later opined Petitioner experienced some kind of
abnormal immune response, the undersigned finds these opinions less persuasive for two main
reasons. First, Dr. Roy’s opinions were not made contemporaneously. See Zumwalt v. Sec’y of
Health & Hum. Servs., No. 16-994V, 2019 WL 1953739, at *19 (Fed. Cl. Spec. Mstr. Mar. 21,
2019) (rejecting opinion from a treating provider when he presented an opinion two-and-one-half
years after treatment and after litigation was initiated), mot. for review den’d, 146 Fed. Cl. 525

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10736168. Public record. Not legal advice.