# Johnson v. Secretary of Health and Human Services

> United States Court of Federal Claims · January 23, 2026

URL: https://www.frixlaw.com/law-library/cases/11245488

## Case

- **Court:** United States Court of Federal Claims
- **Decided:** January 23, 2026
- **Precedential status:** Unpublished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/11245488

## How later opinions describe it (automated extraction)

- noting that “close calls” are resolved in Petitioner’s favor
- noting that “close calls” are resolved in a 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”
- stating that an “expert opinion is no better than the soundness of the reasons supporting it” (citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980))

## Opinion text

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: December 23, 2025

*************************
ROBERTA JOHNSON, * PUBLISHED
*
Petitioner, * No. 22-107V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Ruling on Entitlement; Measles-Mumps-
AND HUMAN SERVICES, * Rubella (“MMR”) Vaccine;
* Sudden Onset Sensorineural Hearing
Respondent. * Loss (“SSNHL”); Autoimmune Inner Ear
* Disease (“AIED”).
*************************

Ronald Craig Homer, Conway, Homer, PC, Boston, MA, for Petitioner.
James Vincent Lopez, U.S. Department of Justice, Washington, DC, for Respondent.

RULING ON ENTITLEMENT 1

On February 2, 2022, Roberta Johnson (“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 a measles-mumps-rubella (“MMR”) vaccine
administered on April 19, 2019, caused her to develop bilateral sudden onset sensorineural

1
Because this Ruling 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 Ruling 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 Ruling to
individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa.

1
hearing loss (“SSNHL”) and autoimmune inner ear disease (“AIED”). 3 Petition at Preamble
(ECF No. 1). Respondent argued against compensation, stating “this case is not appropriate for
compensation under the Vaccine Act.” Respondent’s Report (“Resp. Rept.”) at 2 (ECF No. 22).

After carefully analyzing and weighing the evidence presented in accordance with the
applicable legal standards, 4 the undersigned finds Petitioner has provided preponderant evidence
that the MMR vaccine she received on April 19, 2019 caused her to develop AIED, satisfying
Petitioner’s burden of proof under Althen v. Secretary of Health & Human Services, 418 F.3d
1274, 1280 (Fed. Cir. 2005). Accordingly, Petitioner is entitled to compensation.

I. ISSUES TO BE DECIDED

The parties agree on Petitioner’s diagnosis of AIED. Joint Submission at 1.

The parties dispute all three Althen prongs. Joint Submission at 2. Specifically,
Respondent disputes that Petitioner has shown that “administration of an MMR can cause the
injuries alleged;” disputes that there is a “logical sequence of cause and effect between
[Petitioner’s] April 19, 2019 MMR vaccination and her subsequent injuries;” and disputes that
there is “an appropriate temporal relationship between [Petitioner’s] April 19, 2019 MMR
vaccination and the onset of her injuries.” Id.

II. BACKGROUND

A. Procedural History

On February 2, 2022, Petitioner filed a petition requesting compensation followed by
medical records and affidavits. 5 Petitioner’s Exhibits (“Pet. Exs.”) 1-7. The case was then
assigned to the undersigned. Notice of Assignment dated Apr. 26, 2022 (ECF No. 12).
Respondent filed a Rule 4(c) report on November 15, 2022, arguing against compensation.
Resp. Rept. at 1.

3
While the petition only alleges Petitioner developed SSNHL, subsequent filings specify that
Petitioner developed AIED. See, e.g., Joint Submission, filed Sept. 30, 2024, at 1 (ECF No. 70).
4
While the undersigned has reviewed all of the information filed in this case, only those filings
and records that are most relevant will be discussed. See Moriarty v. Sec’y of Health & Hum.
Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally presume that a special master
considered the relevant record evidence even though he does not explicitly reference such
evidence in his decision.”); see also Paterek v. Sec’y of Health & Hum. Servs., 527 F. App’x
875, 884 (Fed. Cir. 2013) (“Finding certain information not relevant does not lead to—and likely
undermines—the conclusion that it was not considered.”).
5
Petitioner continued to file medical records throughout litigation.

2
On June 29, 2023, Petitioner filed an expert report from Dr. Edwin M. Monsell. Pet. Ex.
11. On December 27, 2023 and January 26, 2024, Respondent filed expert reports from Dr.
Herman F. Staats and Dr. Yu-Lan Mary Ying. Resp. Exs. A, C.

The undersigned held a Rule 5 conference on March 21, 2024. Order dated Mar. 21,
2024 (ECF No. 55). She advised that parties that she had “adjudicated several SNHL cases and
has previously found it difficult for petitioners to show the hearing loss was autoimmune and that
it was caused by a vaccine.” Id. at 2. However, she explained the present case was “different
from past cases because the experts agreed Petitioner’s diagnosis is an autoimmune hearing loss
(AIED) and agreed as to Althen prong three.” Id. The undersigned noted the “case merits
consideration for settlement given that there is risk for both parties” and noted the case could be
resolved without an entitlement hearing. Id.

On July 24, 2024, Respondent filed a joint status report advising that he was not
amenable to settlement discussion in this case. Joint Status Rept., filed July 24, 2024 (ECF No.
66). The parties requested the undersigned set a briefing schedule for a ruling on the record. Id.

Petitioner filed his motion for a ruling on the record on September 30, 2024. Pet. Motion
for a Ruling on the Record (“Pet. Mot.”), filed Sept. 30, 2024 (ECF No. 73). Respondent filed
his responsive brief on January 21, 2025, and Petitioner filed a reply on March 5, 2025. Resp.
Response to Pet. Mot (“Resp. Response”), filed Jan. 21, 2025 (ECF No. 80); Pet. Reply to Resp.
Response (“Pet. Reply”), filed Mar. 5, 2025 (ECF No. 81).

This matter is now ripe for adjudication.

B. Medical Terminology

1. Autoimmune Inner Ear Disease

AIED is “a condition of a bilateral sensorineural hearing loss [(“SNHL”)], caused by an
‘uncontrolled’ immune system response.” Resp. Ex. C, Tab 18 at 1; 6 see also Resp. Ex. C, Tab
19 at 13 tbl.7, 16. 7 “AIED is considered to be responsible for [less than] 1% of all SNHL cases.”
Resp. Ex. C, Tab 18 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 []
steroid and immunosuppressive therapy.” Resp. Ex. C, Tab 18 at 1. Often only one ear is
affected in the early stage. Id. at 3. “The hearing deficit sometimes presents [with] threshold

6
Andrea Ciorba et al., Autoimmune Inner Ear Disease (AIED): A Diagnostic Challenge, 32 Int’l
J. Immunopathol. & Pharmacol. 1 (2018).
7
Sujana S. Chandrasekhar et al., Clinical Practice Guidelines: Sudden Hearing Loss (Update),
161 Otolaryngol. Head & Neck Surg. s1 (2019).

3
fluctuations.” Id. In 25-50% of cases, tinnitus 8 can be present. Id. 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, laboratory 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.

2. Sensorineural Hearing Loss

SNHL is “[h]earing loss resulting from abnormal function of the cochlea, auditory nerve,
or higher aspects of central auditory perception or processing.” Resp. Ex. C, Tab 19 at 4 tbl.1.
SNHL is “generally idiopathic,” but some cases are “associated with infections, vasculitides,
tumors, [] genetic conditions, and cardiovascular risk factors.” Resp. Ex. A, Tab 3 at 2. 9

SSNHL is a subset of SNHL that “occurs within a 72-hour window” and meets specific
audiometric criteria. Resp. Ex. C, Tab 19 at 3. “Possible etiologies of SSNHL include viral
infection, vascular compromise, autoimmune disease, inner ear pathology, and central nervous
system pathophysiology.” Id. at 16. Idiopathic SSNHL has “no identifiable cause despite
investigation” and accounts for “90% of patients with SSNHL.” Id. at 3.

C. Factual History

1. Summary of Medical Records 10

On March 15, 2019, Petitioner received an MMR vaccine at the Northwestern Medicine
(“NM”) employee health office in Winfield, Illinois. Pet. Ex. 1 at 1. Petitioner was employed as
an operating room nurse at NM Central DuPage Hospital. See, e.g., Pet. Ex. 2 at 1105. On April
19, 2019, 35 days later, Petitioner received a second dose of the MMR vaccine. Pet. Ex. 1 at 1.
She was sixty-five years old at the time of the vaccinations. Id. Petitioner’s medical history
prior to receiving the MMR vaccines was unremarkable. See, e.g., Pet. Ex. 2 at 1400-16, 1512-
30 (documenting routine annual visits).

On May 25, 2019, 36 days after receiving a second dose of MMR vaccine, Petitioner
presented to NM urgent care, reporting “bilateral ear fullness” beginning “[four to five] days

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 Dec. 17, 2025).
9
Roger Baxter et al., Sudden-Onset Sensorineural Hearing Loss After Immunization: A Case-
Centered Analysis, 155 Otolaryngol. Head & Neck Surg. 81 (2016).
10
This summary of medical records is taken from the parties’ briefs, with edits from the
undersigned, as the undersigned finds they provided an accurate representation of the records.
See Pet. Mot. at 4-30; Resp. Response at 3-9.

4
ago.” Pet. Ex. 2 at 1365. She reported she had “flown and been in [the] ocean [four] times over
the past ‘few weeks.’” Id. She reported taking decongestants without relief. Id. On
examination, her tympanic membranes 11 were “dull” bilaterally with no other significant
findings. Id. at 1367. She was diagnosed with bilateral acute serous otitis media, 12 prescribed
Flonase, and encouraged to continue taking decongestants. Id. at 1368.

On June 4, 2019, Petitioner underwent an audiogram at NM, which showed moderate
bilateral SNHL. Pet. Ex. 5 at 1. According to Petitioner’s declaration, the audiogram was
ordered by ear, nose, and throat specialist (“ENT”) Riddhi Patel, M.D., at NM. Pet. Ex. 6 at ¶ 4.
Petitioner states that she knew Dr. Patel from her work in the hospital and was also informally
examined by Dr. Patel on June 4, 2019; however, Dr. Patel’s examination was not formally
documented in the medical records. Id.; see also Pet. Mot. at 6 n.5.

On June 5, 2019, Petitioner saw neuro-ophthalmologist Jeffrey Haag, M.D., at the
Wheaton Eye Clinic, reporting the “sudden loss of hearing bilaterally [two] weeks ago [and]
trouble with balance.” Pet. Ex. 3 at 25. Petitioner reported that her symptoms “began after an
airplane flight.” Id. Dr. Haag noted Petitioner’s prior appointment with Dr. Patel, who found
bilateral hearing loss. Id. The eye examination showed mild nuclear sclerosis 13 bilaterally but
was otherwise normal. Id. at 26-27. Dr. Haag’s impression was “[d]izziness and decreased
hearing (bilateral, symmetrical), cause uncertain.” Id. at 25.

Dr. Haag later added an undated addendum to his chart note, indicating that he had
consulted with neurotologist Andrew Fishman, M.D., who reviewed Petitioner’s audiogram from
the day prior and believed it was consistent with bilateral SNHL. Pet. Ex. 3 at 25. Per Dr.
Fishman’s recommendation, Dr. Haag started Petitioner on prednisone 14 60 mg daily. Id.

11
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. 4, 2025).
12
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. 4,
2025). 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. 4, 2025).
13
Nuclear sclerosis, or nuclear cataract, refers to a congenital or degenerative opacity within the
central portion of the lens. Leila M. Khazaeni, Cataract, Merck Manual, https://www.merck
manuals.com/professional/eye-disorders/cataract/cataract (last visited Dec. 16, 2025). “The main
symptom is gradual, painless vision blurring.” Id.
14
Prednisone is “a synthetic glucocorticoid [i.e. steroid] . . . [administered] as an
antiinflammatory and immunosuppressant in a wide variety of disorders.” Prednisone, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=40742 (last
visited Nov. 4, 2025).

5
On June 12, 2019, Petitioner saw neurotologist Dr. Fishman at NM, reporting the onset of
bilateral hearing loss on May 22, 2019, associated with tinnitus, pressure in her ears, right ear
pain, dizziness, and headaches. Pet. Ex. 2 at 1340-41.

Also, on June 12, 2019, Petitioner underwent a second audiogram, which was unchanged
from the earlier study six days prior. Pet. Ex. 2 at 1331-32; Pet. Ex. 5 at 2. The audiologist
Krystine Mullins noted Petitioner had a family history of hearing loss, involving her father and
aunt. Pet. Ex. 2 at 1331-32.

On June 13, 2019, Petitioner underwent magnetic resonance imaging (“MRI”) of her
brain and internal auditory canals that showed a small meningioma 15 in the left occipital node
without any evidence of brain compression or mass effect. Pet. Ex. 2 at 1321-22.

On June 17, 2019, Petitioner saw ENT Seth Kay, M.D., for persistent vertigo. Pet. Ex. 2
at 1296. Dr. Kay noted Petitioner’s history of sudden onset bilateral SNHL and vertigo that
developed “[two] weeks ago after a flight.” Id. High-dose prednisone had improved Petitioner’s
hearing, but her vertigo persisted. Id. The ENT examination was normal. Id. at 1299. Dr. Kay
administered an intratympanic steroid injection in the right ear. Id. Dr. Kay’s diagnosis was
“[b]ilateral vertigo and hearing loss of unclear etiology.” Id. at 1300. The differential diagnoses
included bilateral Meniere’s disease, 16 bilateral labyrinthitis, 17 an autoimmune process, tumor, or
central nervous system process. Id. He referred Petitioner to a neurologist for further evaluation.
Id. Dr. Kay also noted Dr. Fishman “thought this was either bilateral Meniere’s or an
autoimmune process.” Id. at 1296.

On June 26, 2019, Petitioner underwent a third audiogram, which showed improved low
frequency hearing with otherwise moderate to severe bilateral SNHL. Pet. Ex. 2 at 1282; Pet.
Ex. 5 at 3. She was also evaluated again by Dr. Kay, complaining of right ear fullness that had
worsened when stopping diuretics for several days and improved after restarting them. Pet. Ex. 2
at 1268. Petitioner continued to report poor balance. Id. Dr. Kay favored a diagnosis of
Meniere’s disease given the improvement in her low frequency hearing, response to diuretics,
and minimal response to the middle ear steroid injection. Id. at 1272. Dr. Kay started to taper
Petitioner off prednisone and referred her to physical therapy (“PT”) for vestibular rehab. Id.

15
A meningioma is “a benign, slow-growing tumor of the meninges, usually next to the dura
mater.” Meningioma, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=30336 (last visited Nov. 4, 2025).
16
Meniere’s disease “is a clinical syndrome that consists of episodes of spontaneous vertigo
usually associated with unilateral fluctuating [SNHL], tinnitus, and aural fullness.” Pet. Ex. 39
at 2 (Jose A. Lopez‐Escamez et al., Diagnostic Criteria for Menière’s Disease, 25 J. Vestib.
Rsch. 1 (2015)).
17
Labyrinthitis is “inflammation of the internal ear; it may be accompanied by hearing loss or
vertigo.” Labyrinthitis, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=27360 (last visited Nov. 4, 2025).

6
On June 27, 2019, Petitioner had a PT evaluation for Meniere’s disease of both ears. Pet.
Ex. 2 at 1257. She reported a history that she “felt [her] ears were full as she came off a plane”
on May 22, 2019, with bilateral hearing loss that was worse on the right side. Id. Petitioner also
reported “[d]ifficult to tolerate busy visual stimulation” and dizziness. Id. Petitioner continued
to attend PT through November 26, 2019. Id. at 769-779, 816-26, 857-66, 918-48, 1039-41,
1052-60, 1084-91, 1152-77, 1247-63.

On July 10, 2019, Petitioner saw Dr. Fishman for a “follow up [regarding] [M]eniere’s
disease.” Pet. Ex. 2 at 1229. Petitioner reported that her vertigo had worsened since her last visit
and that she had obtained no relief from a right ear steroid injection. Id. She reported some
improvement of dizziness with PT. Id.

On July 11, 2019, Petitioner returned to Dr. Kay reporting worsening hearing since
stopping steroids. Pet. Ex. 2 at 1213. Dr. Kay noted that Dr. Fishman felt this was a progressive
autoimmune process. Id. The ENT examination was normal. Id. Dr. Kay diagnosed bilateral
hearing loss and vertigo of unclear etiology but “likely [AIED] given bilateral component and
only response to steroids.” Id. He restarted prednisone, continued vestibular rehab,
recommended hearing aids, and referred her to a rheumatologist. Id.

Also, on July 11, 2019, Petitioner underwent a fourth audiogram that showed a marked
decrease in hearing in the left ear. Pet. Ex. 2 at 1204; Pet. Ex. 5 at 5.

Petitioner next returned to Dr. Kay on July 25, 2019, and reported that she had obtained
hearing aids and her balance was slowly improving. Pet. Ex. 2 at 1134. Dr. Kay noted that
Petitioner had received MMR vaccines “[one to two] months before onset of symptoms” and that
there were “reports in the literature of similar vaccines causing hearing loss and vestibular
dysfunction.” Id. at 1134. He further stated that it was “unclear” whether the prior receipt of
MMR vaccine was “coincidental [versus] possible causation.” Id. at 1138. Dr. Kay’s
assessment remained “likely” AIED, and he noted Petitioner’s vertigo was severely limiting and
prevented her from returning to work. Id.

Later that day, Petitioner saw rheumatologist Brittany Panico, M.D., at NM, for an
evaluation of acute bilateral SNHL. Pet. Ex. 2 at 1104. Dr. Panico noted Petitioner’s vestibular
testing showed bilateral vestibular loss. Id. Petitioner continued “to have symptoms of
oscillopsia.” 18 Id. She continued to take prednisone, struggled with balance, and had
intermittent episodes of blurry vision. Id. In the history of the present illness, Dr. Panico noted
Petitioner “did receive MMR vaccine titers in March and April, approximately [one] month
before the onset of her hearing loss.” Id. at 1105. Further, Petitioner denied any rashes or skin
lesions or chemical exposure, nor recalled “any flulike symptoms, [upper respiratory infection]
symptoms[,] or recent infections.” Id. The physical examination was unremarkable besides a

18
Oscillopsia is “a symptom in which objects appear to wiggle, jerk, or move back and forth; it
sometimes accompanies nystagmus.” Oscillopsia, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=35681 (last visited Nov. 4, 2025).

7
positive Romberg’s sign. 19 Id. at 1107-08. Dr. Panico opined findings by “neuro-
ophthalmology, neurotology, [and] ENT” were “most consistent with autoimmune hearing loss”
but stated that Petitioner’s clinical features were “somewhat concerning for Cogan’s disease.” 20
Id. at 1110. Dr. Panico continued Petitioner’s prednisone taper and started her on methotrexate,
an immunosuppressive therapy. Id.

On August 1, 2019, Petitioner returned to neuro-ophthalmologist Dr. Haag, per a referral
from Dr. Panico, for an eye examination to rule out Cogan’s syndrome. Pet. Ex. 3 at 23.
Petitioner reported that her dizziness was worse since her last visit and that her “visual images
bounce a lot,” with intermittent vertical oscillopsia. Id. She had stopped driving in mid-June
2019. Id. The eye examination was normal and ruled out Cogan’s syndrome. Id. at 23-24. Dr.
Haag diagnosed Petitioner with “[v]estibular system dysfunction with bilateral hearing.” Id. at
23. He noted an “autoimmune etiology [was] suspected.” Id.

Petitioner had a follow up visit with Dr. Fishman on August 14, 2019. Pet. Ex. 2 at 1039.
Petitioner reported she was not sure if her dizziness was better and that she had periodic vision
changes. Id.

On August 27, 2019, Petitioner followed up with rheumatologist Dr. Panico for
autoimmune hearing loss. Pet. Ex. 2 at 994. Dr. Panico recommended Petitioner continue to
taper her prednisone. Id. at 1000. Her weekly methotrexate dosage was decreased due to
nausea. Id. The assessment remained SSNHL “concerning for autoimmune hearing loss.” Id.

On August 28, 2019, Petitioner saw neurosurgeon Andrew Chenelle, M.D., at NM, for
evaluation of the meningioma identified on her brain MRI. Pet. Ex. 2 at 978. Dr. Chenelle
believed the meningioma was an incidental finding unrelated to her current hearing loss and
balance problems. Id. at 981.

Later that day, Petitioner had a follow-up visit with Dr. Kay. Pet. Ex. 2 at 951. She
reported that her balance was slowly improving but she continued to have vertigo provoked by
visual and auditory stimuli. Id. Dr. Kay’s assessment remained “likely” AIED. Id. at 956.
Petitioner also underwent an audiogram. Id. at 968. Petitioner’s next follow-up with Dr. Kay
was October 2, 2019. Id. at 886-87. The assessment was unchanged. Id. at 899.

On October 3, 2019, Petitioner returned to Dr. Panico for follow-up of her autoimmune
hearing loss. Pet. Ex. 2 at 869. She advised Dr. Panico that she planned to resign from work “as

19
Romberg’s sign is the “swaying of the body or falling when standing with the feet close
together and the eyes closed.” Romberg Sign, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=106448 (last visited Nov. 4, 2025).
20
Cogan’s syndrome is “a rare autoimmune disease involving the eye and the inner ear.”
Vatinee Y. Bunya, Cogan Syndrome, Merck Manual, https://www.merckmanuals.com/
professional/eye-disorders/corneal-disorders/cogan-syndrome (last visited Nov. 5, 2025).

8
she feels this is the best decision for her.” 21 Id. She noted her father was also ill and receiving
hospice care and that she wanted to spend more time with him. Id. Petitioner reported that she
continued to experience vertigo in loud environments. Id. Dr. Panico’s assessment remained
SSNHL “concerning for autoimmune hearing loss.” Id. at 874.

On October 14, 2019, Petitioner saw optometrist Ann Clark, M.D., at Wheaton Eye
Clinic, complaining of blurry vision in her right eye along with “intermittent loss of vision, loss
of hearing, and loss of equilibrium.” Pet. Ex. 3 at 21. Petitioner reported she had to suppress her
right eye vision to see clearly. Id. at 21. Dr. Clark diagnosed diplopia (double vision). Id. at 22.

On November 6, 2019, Petitioner saw neurologist Timothy Hain, M.D., at Chicago
Dizziness and Hearing. Pet. Ex. 2 at 792. In the history of present illness, Petitioner reported
sudden onset of bilateral hearing loss on May 22, 2019, which worsened over the next two
weeks. Id. at 794. She said that her symptoms persisted despite treatment with prednisone and
methotrexate and that she had been unable to work as an operating room nurse since June 7,
2019. Id. Petitioner reported that she lost her balance easily in low light situations and that her
dizziness was triggered or worsened by rapid head movements, walking in poor lighting,
traveling in a car, and loud noises or bright lights. Id. She reported that her vertigo started
around June 5, 2019. Id. She had fallen three times due to her disequilibrium. Id. She also
reported that she had been diagnosed with oscillopsia and that her vision worsened around loud
noises. Id. On examination, Petitioner was unable to stand “in eyes closed tandem [R]omberg
for [six] seconds,” but her gait was otherwise unaffected. Id. at 804. She had “very slight
horizontal nystagmus.” 22 Id. Vestibulo-ocular reflex 23 “was very poor in all [three] directions.”
Id.

Dr. Hain diagnosed Petitioner with a “presumed” AIED (noting that “Cogan’s still seems
possible”), bilateral vestibular loss, and bilateral hearing reduction. Pet. Ex. 2 at 792. Dr. Hain
provided a detailed impression:

[Petitioner] is a very unusual patient with a recent onset of complete
vestibular loss and partial bilateral vestibular loss. Her presumptive diagnosis is
[AIED], although there has not been an autoimmune disease identified (as yet).

21
Petitioner resigned from her job at NM on October 19, 2019. Pet. Ex. 2 at 829.
22
Nystagmus is “involuntary, rapid, rhythmic movement of the eyeball.” Nystagmus, Dorland’s
Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=34565 (last
visited Nov. 4, 2025).
23
Vestibulo-ocular reflex is “nystagmus or deviation of the eyes in response to stimulation of the
vestibular system by angular acceleration or deceleration or when the caloric test is performed
(irrigation of the ears with warm or cool water or air).” Vestibuloocular Reflex, Dorland’s Med.
Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=103130 (last visited
Dec. 16, 2025).

9
The rarest aspect to her situation is her bilateral vestibular loss, which has
a prevalence of about 1/25,000 in the general population. . . . This combined with
bilateral sensorineural hearing loss is even more uncommon, and the only cases I
have seen in the last 30 years with a similar picture were again attributed to
[AIED]. [Petitioner] does not have a history of exposure to an ototoxic
medication such as an aminoglycoside.

[Petitioner] does not have Meniere’s disease—although her hearing
resembled Meniere’s at the beginning, Meniere’s does not have this pattern of
complete vestibular loss over a short time.

The associations of this syndrome with autoimmune disorders include
nearly [all] known autoimmune illness, but primarily there are reports in Cogan’s,
[ulcerative colitis (“UC”)], Wegener’s, Ankylosing spondylitis [(“AS”)],
relapsing polychondritis, [Rheumatoid Arthritis (“RA”)], and Scleroderma. Of
these, Cogan’s and Susac’s has been largely ruled out by a normal [ophthalmic]
exam although her inner ear MRI was not definitive . . . in ruling out Cogan’s.
Wegeners is unlikely due to her negative [antineutrophil cytoplasmic antibodies],
and RA is also unlikely. UC is unlikely due to lack of [gastrointestinal]
symptoms. AS and Scleroderma are very rare. Relapsing Polychondritis remains
a possibility, but it is difficult to rule out.

Regarding this picture arising post-vaccination (MMR), I have never
encountered this situation although I have seen about 300 patients with bilateral
loss in my career. It cannot be common.

Id. at 792-93. Dr. Hain suggested another ophthalmology evaluation to “be sure about Cogan’s.”
Id. at 793. Dr. Hain referred Petitioner to neurotologist Akihiro Matsuoka, M.D., who Dr. Hain
said had more experience with AIED than anyone he knew in the Chicago area. Id. at 794.

On December 2, 2019, Petitioner saw neurotologist Dr. Matsuoka at NM, for a second
opinion on AIED. Pet. Ex. 2 at 757-59. Dr. Matsuoka’s assessment was steroid-dependent
AIED, and he ordered additional work-up. Id. at 759. In his assessment, Dr. Matsuoka observed
Cogan’s and Susac’s syndromes had “notably” been “ruled out.” Id.

On December 9, 16, and 23, 2019, Petitioner was seen by Dr. Matsuoka and received
transtympanic steroid injections. Pet. Ex. 2 at 718, 739, 693.

On December 31, 2019, Petitioner was evaluated by rheumatologist Anisha Dua, M.D., at
NM, for SNHL and problems with balance and vision. Pet. Ex. 2 at 664. Dr. Dua opined that
Petitioner’s “clinical presentation and steroid responsiveness [were] consistent with AIED.” Id.
She opined the work-up showed no evidence of systemic autoimmune disease, and believed the

10
treatment needed to be more aggressive, including an increased dose of methotrexate and
Rituxan. 24 Id.

On January 3 and 17, 2020, Petitioner received additional transtympanic steroid
injections, administered by Dr. Matsuoka. Pet. Ex. 2 at 601, 628.

On February 26, 2020, Petitioner followed up with Dr. Dua after receiving two Rituxan
infusions that month. Pet. Ex. 2 at 483-87. Petitioner reported that her balance was possibly a
little bit better, and her hearing loss fluctuated with no major improvement or worsening. Id.

On March 13, 2020, Petitioner followed up with Dr. Matsuoka regarding her AIED. Pet.
Ex. 2 at 464. Dr. Matsuoka noted that an audiogram was unchanged since Petitioner’s last test.
Id. His assessment was AIED Type I with stable condition. Id.

The records filed show that Petitioner continued to follow up with Dr. Matsuoka for
treatment through 2021. See Pet. Ex. 2 at 74-308. She had tympanostomy tubes placed in her
right ear in July 2020 and left ear in November 2020. Id. at 197, 308. In December 2020 and
January 2021, Petitioner received additional transtympanic steroid injections. Id. at 125, 146,
156, 173. She remained on Rituxan and methotrexate for treatment of AIED. Id. at 94-103. An
audiogram on March 1, 2021 showed moderate to severe bilateral SNHL. Id. at 84.

On June 5, 2023, Petitioner underwent right cochlear implant 25 surgery. See Pet. Ex. 51
at 394-95. The following year, in June 2024, Petitioner underwent left cochlea implant surgery.
Pet. Mot. at 31.

2. Petitioner’s Declaration 26

At the time of vaccination, Petitioner was working as an operating room nurse at NM
Central DuPage Hospital. Pet. Ex. 6 at ¶ 1. An annual health screening done by her employer in
2019 found Petitioner had a negative mumps titer. Id. Petitioner’s employer then required her to

24
Rituxan, known generically as rituximab, is a “B cell-targeting [biologic agent] for the
treatment of immune-mediated diseases.” Pet. Ex. 35 at 1 (Celine Kaegi et al., Systematic
Review of Safety and Efficacy of Rituximab in Treating Immune-Mediated Disorders, 10
Frontiers Immunol. 1990 (2019)).
25
Cochlear Implant is a “a device consisting of a microphone, signal processor, external
transmitter, and implanted receiver; the receiver is surgically implanted under the skin near the
mastoid process above and behind the ear.” Cochlear Implant, Dorland’s Med. Dictionary
Online, https://www.dorlandsonline.com/dorland/definition?id=82067 (last visited Dec. 16,
2025).
26
Although titled an affidavit, it was not notarized. Therefore, it is referenced as a declaration.
Petitioner also submitted a declaration stating no prior civil action had been filed for her alleged
vaccine injury. See Pet. Ex. 7.

11
be vaccinated to protect against mumps. Id. She received the first dose of the MMR vaccine on
March 15, 2019, and her second dose on April 19, 2019. Id.

Petitioner averred that her hearing loss occurred 32 days after receiving the second dose
of the MMR vaccine. Pet. Ex. 6 at ¶ 3. In May 2019, Petitioner and her husband traveled to
Hawaii. Id. at ¶ 1. At the end of her trip, Petitioner noticed that her hearing was “muffled.” Id.
On May 25, 2019, three days after she returned home from Hawaii, Petitioner visited an urgent
care “to see if there was an obvious and fixable problem.” Id. At this visit, Petitioner’s problem
of “what felt like blocked ears” was “misdiagnosed” as fluid in the ears, and Petitioner was told
by the nurse practitioner “it would go away.” Id. at ¶ 3. “Over the following two and a half
weeks, [her] hearing loss, balance[,] and visual symptoms became more prominent and
debilitating.” Id. at ¶ 2. Petitioner explained that she began “using a wooden staff to walk,” she
could no longer navigate poorly lit spaces, and she had difficult driving. Id.

Petitioner consulted with Dr. Patel, an ENT surgeon that she worked with as an OR
nurse, regarding “how long [she] should wait for [her] ears to clear.” Pet. Ex. 6 at ¶ 4. Dr. Patel
offered to examine Petitioner. Id. On June 4, 2019, Petitioner went to Dr. Patel’s office. Id. Dr.
Patel found no fluid in Petitioner’s ears and had an audiologist run an audiogram. Id. The
audiogram showed significant bilateral, symmetrical SNHL. Id. “When Dr. Patel saw the
audiogram her response was essentially ‘how have you been able to hide this much hearing loss
at work?’” Id. Dr. Patel discussed next steps with Petitioner. Id. Petitioner made an
appointment the next morning, June 5, with a neuro-ophthalmologist. Id. The balance of
Petitioner’s declaration recounted her clinic course and her visits with various specialist as
documented in her medical records. Pet. Ex. 6 at ¶¶ 4-11.

Petitioner’s declaration also addressed the impact of her injury on her ability to work and
her quality of life. Due to her injury, Petitioner “had to leave a job that [she] loved and excelled
at.” Pet. Ex. 6 at ¶ 14. Petitioner was unable work in the OR due to her balance, hearing, and
visual symptoms. Id. at ¶ 6. Since leaving work, Petitioner is “longer able to plan for [an] active
retirement.” Id. at ¶ 14.

Petitioner averred that prior to her hearing loss, she was “a healthy and active adult.” Pet.
Ex. 6 at ¶ 1. As of the February 1, 2022 declaration, Petitioner relies on a “staff” when walking
around and continues to have difficulties driving. Id. at ¶ 12. She is unstable is “low light
surroundings” and unable “take a walk and casually look around because [she] lose[s] [her]
balance if [she] do[es] not concentrate.” Id. “Walking on uneven surfaces requires a great deal
of effort” and “[g]oing up or down stairs or escalators is frightening.” Id. Petitioner cannot hear
in noisy settings, even with her hearing aids in. Id. at ¶ 13. She is “no longer able to hear music
clearly; concerts and movies no longer are enjoyable.” Id. And she has difficulties
communicating with her family. Id. She concluded that it “has been stunning to go from being a
busy healthy person . . . to dealing with this much change and loss.” Id. at ¶ 16.

12
D. Expert Reports 27

1. Petitioner’s Expert, Edwin M. Monsell, M.D., Ph.D. 28

a. Background and Qualifications

Dr. Monsell is “board-certified by the American Board of Otolaryngology—Head and
Neck Surgery and hold[s] a Certificate of Added Qualifications from the same board in
Neurotology (diseases and surgery of the inner ear and related skull base).” Pet. Ex. 11 at 1; see
also Pet. Ex. 12 at 4. He obtained a Ph.D. in cell biology and neuroscience from Duke
University in 1977 and an M.D. from University of North Carolina School of Medicine in 1979.
Pet. Ex. 12 at 1. He then completed a surgical internship and a residency in the Otolaryngology-
Head and Neck Surgery department at Northwestern University, followed by a fellowship at the
House Ear Institute in Los Angeles, CA. Id. Since 1986, Dr. Monsell has held various hospital
or other professional appointments and since 2000, he has also held faculty appointments. Id. at
1-2. He currently holds two hospital appointments in Seattle, Washington and teaches in the
Otolaryngology-Head and Neck Surgery department at University of Washington in Seattle. Id.
He is a member and has held various positions for the American Academy of Otolaryngology-
Head and Neck Surgery, Association for Research in Otolaryngology, and other professional
societies. Id. at 2-3; Pet. Ex. 11 at 1. In 2003, Dr. Monsell “received the Harris P. Mosher
Award, the highest award for clinical and translational research in Otolaryngology by the
American Laryngological, Rhinological[,] and Otological Society (a/k/a the Triological Society)
for [his] research on mechanisms of hearing loss.” Pet. Ex. 11 at 1. Throughout his career, he
has published on the mechanisms of hearing loss, “treated many thousands of patients with
hearing loss[,] and performed over 3,500 major ear operations to remove tumors or infections
and restore hearing.” Id.; see also Pet. Ex. 12 at 10-18.

b. Opinion

Dr. Monsell opined that Petitioner suffered from AIED, a form of “fluctuating or rapidly
progressing sensorineural hearing loss that is responsive to immunosuppressive therapy.” Pet.
Ex. 11 at 13. Dr. Monsell opined that “more likely than not” Petitioner’s “MMR vaccination had
a substantial causal role in the development of her AIED.” Id. at 18.

i. Althen Prong One

Dr. Monsell’s causal theory focused on MMR vaccination as a live attenuated virus
vaccination. Pet. Ex. 11 at 14. Dr. Monsell proposed that live components of the MMR vaccine
can stimulate the immune system and lead to a vaccine-induced autoimmune response. Id. at 15.
He posited that the “many associations between the naturally occurring viruses, the attenuated

27
Although the undersigned has reviewed all of the expert reports and medical literature, for the
sake of brevity this Ruling does not include all details of the experts’ opinions. Instead, the
undersigned focuses on the experts’ material opinions, as they relate to the relevant issues.
28
Dr. Monsell submitted one expert report. Pet. Ex. 11.

13
viruses in the MMR vaccine, and hearing loss” explain “how the attenuated live viruses in the
MMR vaccine are likely responsible for developing autoimmune hearing loss and vestibular
disease in [Petitioner].” Id.

In support of his opinion, Dr. Monsell cited a publication from the U.S. Department of
Health and Human Services explaining that live attenuated virus vaccines “use a weakened (or
attenuated) form of the germ that causes a disease.” Pet. Ex. 31 at 2. 29 Live virus vaccines
include both measles and mumps. Id. at 3. Dr. Monsell explained that live attenuated viruses are
genetically altered to be less virulent than the live wild-type virus. Pet. Ex. 11 at 14. While less
virulent, “[a] live virus vaccine must infect cells in the recipient to stimulate an immune
response.” Id. He opined that evidence that measles, mumps, and/or rubella infections cause
hearing loss “suggests that live attenuated virus vaccination can cause hearing loss, at least in
rare instances.” Id.

Dr. Monsell noted there is “significant medical literature” discussing an increased
incidence of hearing loss after mumps and measles infections. Pet. Ex. 11 at 14; see, e.g., Pet.
Ex. 30 at 1 (describing profound hearing loss after mumps); 30 Pet. Ex. 40 at 1 (acknowledging “a
well established association between viral infection and sensorineural hearing loss” including
infections with measles and mumps); 31 Pet. Ex. 43 at 1 (describing measles-included hearing loss
in children); 32 Pet. Ex. 49 at 1 (noting mumps induced hearing loss “is not rare”). 33

For example, the study by Olajuyin et al. followed 112 children with measles-induced
hearing loss. Pet. Ex. 43 at 2. Seventy-two of these children had profound bilateral SNHL. Id.
at 3. In McKenna, the author explained measles infections accounted for five to 10 percent of all
cases of profound bilateral SNHL prior to the advent of vaccination. Pet. Ex. 40 at 3. McKenna
also noted that in “some individuals the attenuated [measles] virus [in vaccines] is pathogenic. . .
. Cases of unilateral and bilateral profound sudden deafness have been reported with the
administration of the vaccine.” Id. Further, the article noted that infection following the mumps

29
Vaccine Types, U.S. Dep’t Health & Hum. Servs., https://www.hhs.gov/immunization/basics/
types/index.html (last accessed June 21, 2023).
30
R. Hall & H. Richards, Hearing Loss Due to Mumps, 62 Arch. Dis. Child. 189 (1987). This
article was also filed as Resp. Ex. C, Tab 12.
31
Michael J. McKenna, Measles, Mumps, and Sensorineural Hearing Loss, 830 Ann. NY Acad.
Sci. 291 (1997). This article was also filed as Resp. Ex. C, Tab 6.
32
Oyebanji A. Olajuyin et al., Measles-Induced Hearing Loss: Pattern, Diagnosis, and
Prevention Among Children in Ekitis State, Southwest Nigeria, 23 Saudi J. Otorhinolaryngol.
Head & Neck Surg. 65 (2021).
33
Martti Vuori et al., Perceptive Deafness in Connection with Mumps: A Study of 298
Servicemen Suffering from Mumps, 55 Acta Otolaryngol. 231 (1962). This article was also filed
as Resp. Ex. C, Tab 8.

14
vaccination “is known to occur, and complications . . . including sudden unilateral and bilateral
hearing loss has been reported.” Id. at 5.

The study from Hall and Richards examined 33 children with unilateral SNHL hearing
loss and concluded “mumps could be a considered a cause in a third of the cases of hearing loss
studied.” Pet. Ex. 30 at 2-3. The authors explained hearing loss as a complication of mumps
infection is “characteristically unilateral and sensorineural in nature, and is thought to result from
endolymphatic labyrinthitis.” 34 Id. at 2. The authors also reported that “permanent hearing loss
can result from subclinical or unrecognized infections.” Id. at 4.

Next, Dr. Monsell discussed the pathogenesis of virus-induced SNHL. Pet. Ex. 11 at 15-
16. Relying on Cohen et al., 35 Dr. Monsell first explained that the mechanism of SNHL in
mumps included “atrophy of hair cells in the organ of Corti[36] and stria vascularis,[37] and
damage to the myelin sheath around the vestibulocochlear nerve.” 38 Id. at 15 (quoting Pet. Ex.
23 at 11); see also Pet. Ex. 40 (discussing mechanisms of SNHL). Dr. Monsell opined that
rubella, measles, and mumps virus infections produce a similar pathology. Pet. Ex. 11 at 15
(citing Pet. Ex. 24). 39 The viruses “are believed to infiltrate the stria vascularis of the cochlea

34
Endolymphatic labyrinthitis is “inflammation of the membranous labyrinth of the inner ear.”
Resp. Ex. C at 6; see also supra note 17.
35
Brandon E. Cohen et al., Viral Causes of Hearing Loss: A Review for Hearing Health
Professionals, 18 Trends Hear. 1 (2014). This article was also filed as Resp. Ex. C, Tab 5.
36
Organ of Corti is “the organ, resting on the basilar membrane of the cochlear duct, that
contains the auditory hair cells, special sensory receptors for hearing, as well as several types of
supporting cells.” Organum Spirale, Dorland’s Med. Dictionary Online, https://www.dorlands
online.com/dorland/definition?id=94965 (last visited Dec. 18, 2025).
37
Sria Vascularis is “a layer of vascular tissue consisting of epithelial cells, mesothelial cells,
and probably some neuroectoderm; it covers the outer wall of the cochlear duct and is thought to
secrete the endolymph.” Sria Vascularis Ductus Cochlearis, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=108900 (last visited Dec. 18, 2025).
38
Vestibulocochlear nerve is the “eighth cranial nerve; it . . . is connected with the brain by
corresponding roots, the vestibular and the cochlear roots.” Nervus Vestibulocochlearis,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/
definition?id=92439 (last visited Dec. 18, 2025).
39
A.D. Dunmade et al, Profound Bilateral Sensorineural Hearing Loss in Nigerian Children: Any
Shift in Etiology?, 12 J. Deaf Stud. Deaf Educ. 112 (2007).

15
during the viremic stage, and from there they either enter the endolymph[40] directly or damage
the metabolic functions of the stria vascularis in some way.” Pet. Ex. 24 at 6.

In Cohen et al., the authors noted the mechanisms involved in viral-induced SNHL “vary
greatly, ranging from direct damage to inner ear structures, including inner ear hair cells and
organ of Corti (as seen in some of the classically described causes of viral hearing loss such as
measles), to induction of host immune-mediated damage.” Pet. Ex. 23 at 1. The authors
specified that rubella- and mumps-induced SNHL was associated with direct damage to the inner
ear structures. Id. at 2 tbl.2. Measles-induced SNHL was associated with both direct damage as
well as an indirect etiology of “[d]ecreased immunity and secondary infection.” Id. The authors
furthered explained temporal bone studies of patients with measles-induced SNHL have “shown
degeneration of cochlear neurons most prominently in the basal turn, degeneration of the organ
of Corti and stria vascularis, and cellular infiltration of the cochlea.” Id. at 9. Of note, in their
discussion of measles-induced SNHL, Cohen et al. stated MMR vaccination was “rarely
associated with SNHL, with a time course of onset corresponding to incubation period of
measles infection and an incidence of [one] case per [six] to [eight] million vaccine doses.” Id.

The article from McKenna examined the histopathology of the temporal bones in patients
with measles- or mumps-induced SNHL. Pet. Ex. 40 at 3. The author noted “destruction or
degeneration of the organ of Corti, stria, and cochlear neurons is typical.” Id. “Of particular
significance is the presence of fibrous tissue in the scala of the basal turns, which is suggestive of
an associated inflammatory process (Fig. 1).” Id.

FIGURE 1. Case of profound bilateral hearing loss at
age four in association with measles. . . Pathologic
changes are similar in both ears. Predominant
histopathologic features include atrophy of the organ of

40
Endolymph is “the fluid contained in the membranous labyrinth of the ear; it is entirely
separate from the perilymph.” Endolympha, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=16333(last visited Dec. 18, 2025).

16
Corti and stria vascularis with degeneration of cochlear
neurons.

Id. at 4 fig. 1.

Moreover, Dr. Monsell explained infiltration of the inner ear with acute and chronic
inflammatory cells is a characteristic finding in animal models of experimental viral inner
infection. Pet. Ex. 11 at 16 (citing Pet. Ex. 41). 41 In Merchant et al., the authors opined that
evidence of a viral cause for sudden deafness is based on onset occurring in association with an
upper respiratory infection, positive serology studies supporting a systemic viral infection, and
histopathological findings similar to those seen after hearing loss associated with mumps or
rubella infections. Pet. Ex. 41 at 8. Dr. Monsell described an animal study by Fukuda et al. 42
that studied acute measles infection of the cochlea. Pet. Ex. 11 at 16 (citing Pet. Ex. 27).
“Positive immunofluorescence [indicating the presence of viral antigens] was observed in the
inflammatory cell infiltrates in the cochlear ducts and the lining of the perilymphatic structure.”
Id. (citing Pet. Ex. 27 at 2). The findings were consistent with endolymphatic labyrinthitis and
were consistent with prior studies of human temporal bone pathology caused by measles. Pet.
Ex. 27 at 1.

In humans, MRIs have shown signs of protein infiltrations of the inner ear during viral
infections. Pet. Ex. 11 at 16. In support, Dr. Monsell cited to an article by Otake et al. 43 who
reported on a case of profound unilateral SNHL following a case of subclinical mumps. Id.
(citing Pet. Ex. 45). A 3D-FLAIR MRI revealed an abnormal signal of the right cochlea and
vestibule indicating “hemorrhage or a high concentration of protein in the right ear” consistent
with labyrinthitis associated with “mumps deafness.” Pet. Ex. 45 at 1. Dr. Monsell explained
the MRI findings were due to an “intense local inflammatory reaction.” Pet. Ex. 11 at 16.
Another study, by Westmore et al., 44 found mumps virus in a perilymph sample (extracellular
fluid from the inner ear) collected five days after the onset of deafness. Id. (citing Pet. Ex. 50 at
1-2).

Next, Dr. Monsell opined that “the inner ear actively participates in inflammatory
processes.” Pet. Ex. 11 at 16. Dr. Monsell explained that “the inner ear is not an
immunologically privileged organ.” Id. Further, the inner ear is affected by systemic

41
Saumil N. Merchant et al., Pathology and Pathophysiology of Idiopathic Sudden Sensorineural
Hearing Loss, 26 Otol. Neurotol. 151 (2005).
42
Saroshi Fukuda et al., Acute Measles Infection in the Hamster Cochlea, 514 Acta Otolaryngol.
111 (1994).
43
Hironai Otake et al., 3D-FLAIR Magnetic Resonance Imaging in the Evaluation of Mumps
Deafness, 70 Int’l J. Pediatr. Otorhinolaryngol. 2115 (2006).
44
G.A. Westmore et al., Isolation of Mumps Virus from the Inner Ear After Sudden Deafness, 1
Brit. Med. J. 14 (1979). This article was also filed as Resp. Ex. C, Tab 9.

17
inflammatory events. Id. Dr. Monsell described an experiment by Adams et al. 45 where the
authors induced injury within mouse cochlea by injecting liposaccharides to induce systemic
inflammation. Id. (citing Pet. Ex. 13). Dr. Monsell explained “the inner ear responded by
transcribing and releasing [tumor necrosis factor], an important cytokine that promotes
inflammation.” Id. Additional medical literature explained it is “well accepted that the inner ear
is fully capable of generating an immune response and that this immune response can be
destructive to the delicate inner ear.” Pet. Ex. 29 at 3-4. 46

Dr. Monsell noted other ear diseases demonstrate autoimmunity in the inner ear. Pet. Ex.
11 at 14. Dr. Monsell explained that otosyphilis is clinically similar to AIED. Id.; see also Pet.
Ex. 29 at 6 (noting otosyphilis should be excluded by serum analysis prior to an AIED
diagnosis). Dr. Monsell explained otosyphilis has a disease mechanism that is “at least partly
inflammatory and thereby demonstrates the potential for infection to cause autoimmunity in the
inner ear.” Pet. Ex. 11 at 14.

Dr. Monsell opined that viruses “are common causes of autoimmune disease in general.”
Pet. Ex. 11 at 15. Further, Dr. Monsell noted that MMR vaccine induction of autoimmune
disease has been reported in other disease contexts with “autoimmune thrombocytopenia is the
most established of all vaccine‐related autoimmune disorders.” Id. at 17.

Turning to vaccination-induced hearing loss, Dr. Monsell relied on Agmon-Levin et al. 47
to explain the “proposed mechanism by which infectious agents, including live attenuated viral
vaccines, may induce autoimmunity.” Pet. Ex. 11 at 16 (citing Pet. Ex. 14). Agmon-Levin et al.
stated that “[i]nfectious agents are considered to be the most common triggers of autoimmunity,
and vaccines that contain antigens from infectious agents might induced autoimmunity by similar
mechanisms such as molecular mimicry, bystander activation, epitope spreading, and polyclonal
activation.” 48 Pet. Ex. 14 at 2. Dr. Monsell opined the mechanisms discussed in Agmon-Levin
et al. “are complex microbiological processes that could be subject to functionally different
genetic variants in vaccine recipients and idiosyncratic reactions leading to vaccine caused
AIED.” Pet. Ex. 11 at 16-17.

Additionally, Dr. Monsell opined medical literature supported an association between
MMR vaccination and hearing loss. Pet. Ex. 11 at 14. Dr. Monsell emphasized that the 2012

45
J.C. Adams et al., Selective Activation of Nuclear Factor Kappa B in the Cochlea by Sensory
and Inflammatory Stress, 160 Neuroscience 530 (2009).
46
Quinton Gopen & Jeffery P. Harris, Autoimmune Inner Ear Disease, in Head and Neck
Manifestations of Systemic Disease 53 (Jeffery P. Harris & Michael H. Weisman eds., 2007).
For a detailed description of the “basic steps” of the inner ear immune response, see Pet. Ex. 29
at 4.
47
Nancy Agmon-Levin et al., Vaccines and Autoimmunity, 5 Nat’l Rev. Rheumatol. 648 (2009).
48
These mechanisms are defined by Agmon-Levin et al. See Pet. Ex. 14 at 3 Box 2.

18
Institute of Medicine (“IOM”) committee 49 found an association between measles and mumps
vaccination and hearing loss, stating they “assesse[d] the mechanistic evidence regarding an
association between measles or mumps vaccine and hearing loss as low-intermediate[50] based on
knowledge about the natural infection, experimental evidence, and eight cases.” Id. at 15 (citing
Pet. Ex. 48 at 119). The eight cases 51 presented “clinical and experimental evidence suggestive
but not sufficient for the committee to conclude” that the MMR vaccine was a “contributing case
of hearing loss.” Pet. Ex. 48 at 119.

Dr. Monsell cited a review conducted by Asatryan et al., 52 which estimated hearing loss
after MMR vaccination occurred in one per six to eight million doses. Pet. Ex. 11 at 14 (citing
Pet. Ex. 16). Asatryan et al. conducted a review of VAERS 53 data and identified 44 cases of
“likely idiopathic” SNHL after MMR vaccination. Pet. Ex. 16 at 2. They also researched for
published case reports of SNHL and identified 11 cases following MMR vaccination. Id. at 2.
The authors noted the onset of hearing loss in the majority of these cases “was consistent with
the incubation periods of wild measles and mumps viruses.” Id. Asatryan et al. posited that as

49
Inst. of Med., Adverse Events Associated with Childhood Vaccines: Evidence and Causality
(Kathleen Stratton et al. eds., 2012). This was also filed as Resp. Ex. C, Tab 15.
50
The IOM committee developed four categories for mechanistic weight of the evidence
assessments: strong, intermediate, weak, and lacking. Inst. of Med., Adverse Events Associated
with Childhood Vaccines: Evidence and Causality 12-14 (Kathleen Stratton et al. eds., 2012)
[hereinafter 2012 IOM report]. An intermediate assessment is based on a “least two cases, taken
together, for which the committee concludes the vaccine may be a contributing cause of the
adverse event, based on an overall assessment of attribution in the available cases and clinical,
diagnostic, or experimental evidence consistent with relevant biological response to [the]
vaccine.” Id. at 14. Low-intermediate assessment is based on “at least two cases, that, taken
together, while suggestive, are nonetheless insufficient to conclude that the vaccine may be a
contributing case of the adverse event.” Id. Although the parties only filed Chapter 4 of the
2012 IOM report, the undersigned is familiar with the entirety of the 2012 IOM report. See Pet.
Ex. 48; Resp. Ex. C, Tab 15.
51
The eight cases include some cited by Dr. Monsell. For a full discussion of the cases
considered by the IOM, see Pet. Ex. 48 at 117-18.
52
Armenak Asatryan et al., Live Attenuated Measles and Mumps Viral Strain‐Containing
Vaccines and Hearing Loss: Vaccine Adverse Event Reporting System (VAERS), United States,
1990-2003, 26 Vaccine 1166 (2008).
53
VAERS, the Vaccine Adverse Event Reporting System, is “a national early warning system to
detect possible safety problems in U.S.-licensed vaccines. . . . VAERS is a passive reporting
system . . . [and] is not designed to determine if a vaccine caused a health problem, but is
especially useful for detecting unusual or unexpected patterns of adverse event reporting that
might indicate a possible safety problem with a vaccine.” About VAERS, U.S. Dep’t Health &
Hum. Servs., https://vaers.hhs.gov/about.html (last visited Dec. 16, 2025).

19
“vaccines against measles and mumps contain live attenuated viral strains, it is biologically
plausible” that individuals could develop hearing loss as a complication of MMR vaccination.
Id. at 1.

Of note, in the 14 cases described by Asatryan et al., many of the patients who reported
bilateral hearing loss after vaccination did not describe a history of fever or illness symptoms
prior to hearing loss. Pet. Ex. 16 at 3-5 (see Cases 1, 2, 9, 10, 11, 12, and 13).

Finally, Dr. Monsell provided several case reports of SNHL following vaccination for
measles, mumps, and/or rubella. 54 Pet. Ex. 11 at 15. In Hulbert et al., 55 the authors reported a
case of bilateral SNHL following a live measles-rubella vaccination. Pet. Ex. 32 at 1. The
patient, a 27-year-old woman, experienced hearing loss 22 days after receiving a live measles-
rubella vaccination. Id. Audiography taken 29 days after vaccination showed profound bilateral
SNHL. Id. She had generalized arthralgias three days after vaccination and developed a fever,
tinnitus, dizziness, vomiting, and gait unsteadiness shortly thereafter. Id. Serological tests for
syphilis, systemic lupus, Epstein-Barr virus, St. Louis encephalitis virus, and western equine and
eastern equine encephalomyelitis viruses were negative. Id. The patient had Immunoglobulin
(“Ig”) M antibodies for rubella. Id. The authors noted permanent bilateral hearing loss is “a
known but uncommon complication of measles, mumps, and rubella infections.” Id. “Severe
hearing loss has been reported as a complication of the mumps vaccine and of the measles-
mumps-rubella trivalent vaccine in children, usually in association with encephalitis.” Id.
Hulbert et al. concluded that “the patient’s symptoms and their temporal sequence after
vaccination, coupled with suspicious audiographic findings and serologic evidence of an acute
rubella infection, offer compelling evidence that her deafness was a complication of
vaccination.” Id.

Additional case reports described children with SNHL following measles, mumps, and/or
rubella vaccinations. A 1985 report from Brodsky and Stanievich 56 reported a case of a three-
year-old-child who developed a “encephalitis-like reaction” 10 days after receiving an MMR
vaccine. Pet. Ex. 21 at 2. Soon after, the child’s parents became concerned about hearing loss,
and the child was ultimately diagnosed with “severe to profound bilateral [SNHL].” Id. The
authors noted that the child’s hearing loss was “similar to the loss typically seen after infectious

54
In addition to the below discussed case reports, Dr. Monsell provided a case report from Koga
et al. that purported to report “a case of bilateral acute profound deafness most likely due to
MMR vaccination.” Pet. Ex. 38 at 1 (Keijiro Koga et al., Bilateral Acute Profound Deafness
After MMR Vaccination ‐ Report of a Case, 94 Nihon Jibiinkoka Gakkai Kaiho 1142 (1991)).
However, while a short abstract of the Koga et al. article is written in English, the case report is
written in Japanese.
55
Tim V. Hulbert et al., Bilateral Hearing Loss After Measles and Rubella Vaccination in an
Adult, 325 NEJM 134 (1991).
56
Lisa Brodsky & John Stanievich, Sensorineural Hearing Loss Following Live Measles Virus
Vaccination, 10 Int’l J. Pediatr. Otorhinolaryngol. 159 (1985).

20
measles.” Id. at 4. A 1995 case report from Jayarajan and Sedler 57 described the development of
unilateral SNHL in a 15-month-old child. Pet. Ex. 34 at 1. Twenty-four hours after measles
vaccination, she became unwell and began to stagger while walking, and two weeks later she
was admitted to the hospital with ataxia, drowsiness, and general irritability. Id. The child was
found to have profound left-sided hearing loss during routine screening when she was five years
old. Id. The authors noted measles infections account for five to 10 percent of SNHL in children
and noted incidence of neurological sequala following measles vaccination was one per 1.6
million doses of the vaccine. Id. Jayarajan and Sedler concluded the “sequence of events
suggests that a labyrinthitis which developed after measles vaccination may have resulted in
unilateral left sided hearing loss.” Id. at 1-2.

Stewart and Prabhu 58 reported nine cases of SNHL in children following MMR
vaccination. Pet. Ex. 47 at 1. In three cases, the deafness was found to be unrelated to the MMR
vaccine. Id. In six cases, the cause was unknown, but MMR vaccination 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.

A more recent case report, published in 2018, from Rikitake et al. 59 in Japan, reported
onset of bilateral hearing loss in a five-year old girl 18 days after receiving a mumps vaccine and
a measles-rubella vaccine. Pet. Ex. 46 at 2. Twelve days after vaccination the child had a fever
for one day, and vomited once the following day, before her symptoms remitted. Id. Eighteen
days after vaccination, the child was noted to have poor hearing and was brought to the hospital.
Id. She was examined by otorhinolaryngology and diagnosed with “bilateral acute [SNHL]
associated with a side reaction of the vaccination.” Id. The authors explained there was no other
finding or symptom to induce disease in this patient and concluded that SNHL about three weeks
after vaccination suggests the hearing loss was caused by vaccination. Id. at 3. Further, they
noted that unlike other case reports of SNHL, the child did not have encephalitis. Id. Rikitake et
al. explained the mumps vaccine is a live vaccine and noted that since the blood inner ear barrier
is immature in infants, “hearing loss may be easily caused by mumps virus.” Id. The authors
reported that incidence of hearing loss following natural mumps infection were 1/1,000-20,000
and the risk of hearing loss following mumps vaccination was reported to be about 1/6-8 million.
Id.

57
V. Jayarajan & P.A. Sedler, Hearing Loss Following Measles Vaccination, 30 J. Infect. 184
(1995).
58
Barbara J.A. Stewart & P. Umesh Prabhu, Reports of Sensorineural Deafness After Measles,
Mumps, and Rubella Immunization, 69 Arch. Dis. Child. 153 (1993).
59
Masahiro Rikitake et al., Bilateral Deafness as a Complication of the Vaccination - A Case
Report, 22 Int’l Tinnitus J. 19 (2018).

21
ii. Althen Prong Two

Dr. Monsell concluded that “more likely than not,” Petitioner’s MMR vaccination had a
“substantial causal role” in her development of AIED. Pet. Ex. 11 at 18. He opined that but for
this vaccination, Petitioner would not have developed AIED. Id.

Dr. Monsell opined that the evidence that Petitioner suffered an MMR vaccine injury was
“compelling.” Pet. Ex. 11 at 17. He summarized his opinion as follows.

First, as discussed above, there is an association between the MMR vaccine, clinical
measles, mumps, and rubella, and hearing loss. Pet. Ex. 11 at 17. Second, Petitioner was
“serologically negative, and thus immunologically naïve to mump antigens” when she received
the MMR vaccine. Id. Third, Dr. Monsell noted that the MMR vaccine “is not often
administered to adults, who may not have as a robust immune system as children.” Id. Next, Dr.
Monsell explained the MMR vaccine received by Petitioner contains three different live
attenuated viruses plus an adjuvant. Id.: see also Pet. Ex. 52 (vaccine package insert). 60 Dr.
Monsell explained that, theoretically, a vaccine with “more varied array of antigens,” was more
likely “to trigger an immune response that might eventually turn into autoimmune disease.” Id.
(quoting Pet. Ex. 14 at 2). Fifth, he noted that MMR vaccine induction of autoimmune disease
had been reported for other diseases such as autoimmune thrombocythemia. Id. Finally, Dr.
Monsell noted that Petitioner’s treating physicians agreed she suffered from AIED, an
autoimmune disease, with “no other autoimmune disease that her AIED could be secondary to.”
Id.

Additionally, Dr. Monsell opined that Petitioner’s clinical course was consistent with
AIED. Pet. Ex. 11 at 13-14. Dr. Monsell emphasized that Petitioner’s AIED was not associated
with any another autoimmune condition such as psoriasis, idiopathic thrombocytopenic purpura,
rheumatoid arthritis, primary biliary sclerosis, inflammatory bowel disease, connective tissue
diseases, or systemic autoimmune disease. Id. at 13, 17.

Moreover, Dr. Monsell ruled out several causes of SNHL such as age-related hearing
loss, toxic noise exposure, ototoxicity, Meniere’s disease, vestibular schwannoma, and stroke.
Pet. Ex. 11 at 12-13. He also ruled out eustachian tube dysfunction as a cause of Petitioner’s
hearing loss. Id. at 12. While eustachian tube dysfunction is associated with plane travel,
Petitioner’s clinical course was not consistent with eustachian tube dysfunction, and eustachian
tube dysfunction is not associated with SNHL. Id.

iii. Althen Prong Three

Dr. Monsell placed the onset of Petitioner’s symptoms associated with AIED as
approximately 30 days after receiving the second dose of her MMR vaccine. Pet. Ex. 11 at 17.
He opined Petitioner’s onset was “consistent with an immune‐mediated response following

60
Of note, the vaccine package insert identifies “[n]erve deafness” as an adverse reaction. Pet.
Ex. 52 at 4.

22
MMR vaccination.” Id. at 18. He further opined Petitioner’s onset was “within the timeframe
that [is] medically acceptable for autoimmune events following an antigenic trigger.” Id. at 17.

In support of this timeframe, Dr. Monsell noted that MMR vaccination has been
associated with autoimmune disease and explained that the autoimmune complication of
thrombocytopenia is included on the package insert for MMR vaccination. Pet. Ex. 11 at 17. Dr.
Monsell noted that package insert described “this autoimmune event following MMR
vaccination as occurring within [four to six] weeks after MMR vaccination.” Id.

In the summary of case reports of hearing loss after MMR vaccination from VAERS data
reviewed by Asatryan et al., onset (when reported) “ranged from [two] to 89 days following
vaccination, with a peak on days 10 through 14.” Pet. Ex. 16 at 3, 3 fig.1. Of the cases studied,
Asatryan et al. summarized 14 with detailed clinical data available. Id. at 3-5. In Case 1, onset
of hearing loss was noted the month after vaccination; in Case 6, hearing loss occurred within
one month (but “possibly” earlier); in Case 8, ataxia was noted one month after vaccination
followed by hearing loss four months after vaccination; in Case 9, hearing loss was noted two
months after vaccination; and in Case 13, tinnitus and hearing loss occurred one month after
vaccination. Id. at 3-5. Finally, in Case 14, the patient had her first MMR vaccination in August
2003 and the second vaccine in September 2003. Id. at 5. Two weeks following the second
vaccination she developed headaches, vertigo, and tinnitus, and a subsequent audiologic
evaluation in October showed bilateral hearing loss. Id.

2. Respondent’s Expert, Herman Staats, Ph.D. 61

a. Background and Qualifications

Dr. Staats obtained his B.S. in medical technology from Salisbury University in
Salisbury, Maryland and a Ph.D. in basic medical sciences (microbiology and immunology) from
the University of South Alabama in Mobile, Alabama. Resp. Ex. B at 1. He is a professor in the
Department of Pathology at Duke University School of Medicine and holds joint appointments
as an associate professor of immunology and associate professor of medicine. Id.; Resp. Ex. A at
1. He is also a member of the Duke Human Vaccine Institute. Resp. Ex. A at 1. Throughout his
career, Dr. Staats has been a member of and/or held positions with various organizations and
professional societies. Resp. Ex. B at 3-4. Dr. Staats “perform[s] research on the discovery and
evaluation of vaccine adjuvants.” Resp. Ex. A at 1. His bibliography consists of over 200
publications. Resp. Ex. B at 22-35.

b. Opinion

Dr. Staats opined “the medical record and the published literature do not support the
conclusion that [Petitioner’s AIED] and hearing loss was a result of the MMR vaccine.” Resp.
Ex. A at 13. He further opined there “no evidence” that the MMR vaccine caused Petitioner’s
AIED “via direct damage to the ear, inflammation, or molecular mimicry.” Id.

61
Dr. Staats submitted one expert report. Resp. Ex. A.

23
i. Althen Prong One

Dr. Staats summarized and responded to Dr. Monsell’s proposed causal mechanisms.
Resp. Ex. A at 4-5. He disagreed with Dr. Monsell’s conclusion that “the evidence of MMR
vaccine-induced injury” in Petitioner was “compelling.” Id. at 5.

Dr. Staats characterized Dr. Monsell’s causal theory as “vaccine viruses infecting the host
and causing hearing loss” due to the MMR vaccine containing live attenuated viruses. Resp. Ex.
A at 4. Dr. Staats described the distinctions in the immune response to a wild-type virus and a
live attenuated virus. Id. at 6. Relying on Lin et al., 62 Dr. Staats opined wild-type virus “results
in very different host exposure” compared to the live attenuated virus. Id. at 6-7 (citing Resp.
Ex. A, Tab 4).

Lin et al. examined the immune response of macaque monkeys to wild-type measles virus
and live attenuated measles virus. Resp. Ex. A, Tab 4 at 1. The route of administration was
through the respiratory tract. Id. at 2, 9. The authors found wild-type measles viruses
“replicated efficiently in B and T lymphocytes with spreading throughout lymphoid tissues
resulting in prolonged persistence of viral RNA” and live attenuated measles virus “replicated
efficiently in the respiratory tract but displayed limited spread to lymphoid tissue or peripheral
blood mononuclear cells.” Id. at 1. Three out of 12 macaques infected with the live attenuated
virus had detectable measles RNA in their peripheral blood mononuclear cells as compared to
the wild-type virus macaques, which all had detectable measles RNA after infection. Id. at 3.
None of the animals infected with the live attenuated measles virus had a rash in comparison to
those who received the wild-type virus, who all developed skin rashes. Id. Five of the 12
infected with the live attenuated measles virus had detectable measles RNA in their draining
lymph nodes. Id. The authors noted that a limitation of their study was that it did not address the
role of the subcutaneous immunization route and recommended further study of the effects of
route and dosing of live attenuated measles vaccines. Id. at 8.

Dr. Staats agreed “attenuated viruses in the vaccine are similar enough to the wild-type
virus to induce host immune response;” however, Dr. Staats asserted that the viral load of after
exposure to live attenuated virus is “much lower” than the viral load after exposure to wild-type
virus. Resp. Ex. A at 9. Dr. Staats further opined that “[c]onclusions based on infection with the
wild-type measles virus are not relevant to exposure to attenuated viruses used in the MMR
vaccine.” Id.

Dr. Staats disagreed the medical literature cited by Dr. Monsell discussing hearing loss
after wild-type measles, mumps, and/or rubella infections provided support for MMR vaccine-
induced hearing loss. Resp. Ex. A at 7-10. Dr. Staats noted that articles by Cohen et al.,
Dunmade et al., Fukada et al., and Olajuyin et al. all discussed wild-type infections and all
recommended MMR vaccinations. Id. at 8-9 (discussing Pet. Exs. 23, 24, 27, 43). Accordingly,
he opined that none of these articles provided support for or were relevant to Dr. Monsell’s

62
Wen-Hsuan W. Lin et al., A Durable Protective Immune Response to Wild-Type Measles
Virus Infection of Macaques Is Due to Viral Replication and Spread in Lymphoid Tissues, 12
Sci. Transl. Med. eaax7799 (2020).

24
theory. Id. Dr. Staats did not acknowledge that Cohen et al. discussed MMR vaccination as
“rarely associated with SNHL.” See id.; Pet. Ex. 23 at 9.

Responding to Dr. Monsell’s discussion of the inner ear inflammatory response, Dr.
Staats first criticized Dr. Monsell for not providing a “specific theory” that would “link the
MMR vaccination to inflammation in the inner ear and [Petitioner’s] hearing loss.” Resp. Ex. A
at 10. Next, Dr. Staats opined “vaccine-induced inflammation” causing hearing loss was not
supported by the results of Lin et al. Id. at 10, 11 fig.2 (citing Resp. Ex. A, Tab 4 at 7 fig.6). Dr.
Staats explained that while wild-type measles virus induced a “potent inflammatory response that
persists for days after infection,” the live attenuated virus exposure “does not induce robust
inflammation.” Id. at 10.

Addressing Dr. Monsell’s contention that the disease mechanism of syphilis-induced
SNHL (otosyphilis) demonstrated “the potential for infection to cause autoimmunity in the inner
ear with infection,” Dr. Staats acknowledged that syphilis infection “may induce an
inflammatory response to cause autoimmunity in the inner ear.” Resp. Ex. A at 11-12.
However, Dr. Staats again noted that the inflammatory response to live attenuated viruses found
in MMR vaccination “is very different to the host response to a live viral infection.” Id. at 12.
Accordingly, he opined the disease mechanism of otosyphilis did not support Dr. Monsell’s
theory of MMR-vaccine induced AIED. Id.

Moreover, Dr. Staats disagreed that Dr. Monsell or the medical literature provided
support for molecular mimicry as a mechanism for the MMR vaccine to cause AIED. Resp. Ex.
A at 12. Dr. Staats noted that molecular mimicry “is often discussed as a similarity in amino
acid sequence between a protein antigen in an infectious agent and a host protein that induces an
autoimmune disease.” Id. While Dr. Monsell invoked molecular mimicry in his report, he did
not identify “any regions of similarity between components of the MMR vaccine and host
antigens associated with [AIED].” Id. Dr. Staats cited a publication by Rojas et al. 63 that
identified structural homology for various viruses and autoimmune diseases. Id. (citing Resp.
Ex. A, Tab 6 at 4 tbl.1). Dr. Staats noted the authors did not identify “any antigens in measles,
mumps[,] or rubella that exhibit similarity to human antigens that would provide a basis for
molecular mimicry.” Id. Of note, Rojas et al. acknowledged that the generally referenced
criteria used to support molecular mimicry as a mechanism for a known pathogen are rarely
fulfilled. Resp. Ex. A, Tab 6 at 3 (“[Molecular mimicry] hypotheses are difficult to prove . . .
particularly for rare events/disease.”). Further, the authors list of infectious agents with
identified structural homology associated with a corresponding autoimmune disease is not
described as complete or exhaustive. See id. at 4 tbl.1.

Rojas et al. confirmed that molecular mimicry was “one of the likely mechanisms” for
the development of autoimmune disease and acknowledged that “environmental factors, such as .
. . vaccines, also have the potential to lead to autoimmunity not only via molecular mimicry but

63
Manuel Rojas et al., Molecular Mimicry and Autoimmunity in the Time of Covid-19, 139 J.
Autoimmun. 103070 (2023).

25
also by bystander activation, epitope-determinant spreading, and/or hapten carrier.” Resp. Ex. A,
Tab 6 at 2.

Next, Dr. Staats opined the “exact cause of hearing loss due to [AIED] has not yet been
determined.” Resp. Ex. A at 13. In support, Dr. Staats cited an article by Miwa and Okano 64
that described AIED as a “an idiopathic disorder characterized by unexpected hearing loss.” Id.
(quoting Resp. Ex. A, Tab 7 at 1). Miwa and Okano addressed the autoimmune nature of AIED,
noting that as “with most autoimmune diseases, it has been postulated that a misdirected assault
on the . . . inner ear proteins . . . activate[] the pro-inflammatory T-cell response and
autoantibody formation.” Resp. Ex. A, Tab 7 at 2. The authors explained that the inner ear is
“fully able to mount an immune response” to outside antigens. Id. at 6. The authors also noted
that AIED “represents much fewer than 1% of all cases of [SSNHL].” Id. at 1.

Turning to the medical literature on the association of MMR vaccination and hearing
loss, Dr. Staats observed that 2012 IOM report found “[t]he evidence inadequate to accept or
reject a causal relationship between MMR vaccine and hearing loss.” Resp. Ex. A at 5 (citing
Pet. Ex. 48 at 118). He further noted that the case reports discussed by the IOM had
symptomology of fever, rash, and nystagmus, which were not present in Petitioner. Id.
However, Petitioner’s medical records documented “very slight horizontal nystagmus” in
Petitioner. Pet. Ex. 2 at 794.

Dr. Staats opined that more recent vaccine safety reviews—by Maglione et al., 65 Gidengil
66
et al., and Baxter et al.—did not find an association between MMR vaccination and hearing
loss. Resp. Ex. A at 5-6 (citing Resp. Ex. A, Tab 1; Resp. Ex. A, Tab 2; Resp. Ex. A, Tab 3).

A 2014 safety review 67 by Maglione et al. sought to update the findings published in the
2012 IOM report. Resp. Ex. A, Tab 1 at 16. The authors, however, did not discuss hearing loss,
but instead addressed febrile seizures, thrombocytopenia, and other adverse effects. See id. at
126-27. The authors agreed with IOM conclusions that “evidence ‘convincingly’ supports a
causal relationship” between MMR vaccine and febrile seizures and that there is “moderate”

64
Toru Miwa & Takayuki Okano, Role of Inner Ear Macrophages and
Autoimmune/Autoinflammatory Mechanisms in the Pathophysiology of Inner Ear Disease, 13
Front. Neurol. 861992 (2022).
65
Margaret Maglione et al., Safety of Vaccines Used for Routine Immunization in the United
States, 215 Evid. Rep./Tech. Assess. 1 (2014).
66
Courtney Gidengil et al., Safety of Vaccines Used for Routine Immunization in the United
States: An Update, 244 Compar. Effectiveness Rev. 1 (2021).
67
This report was based on a systematic review of literature performed by the Southern
California Evidence-Based Practice Center (“EPC”) through a contract with the Agency for
Healthcare Research. See Resp. Ex. A, Tab 1 at 4, 8. The review by Gidengil et al. was also
prepared by the EPC. See Resp. Ex. A, Tab 2 at 3.

26
evidence to support an association between MMR vaccination and thrombocytopenic purpura in
children. Id. at 127. In his report, Dr. Staats acknowledged that Maglione et al. did not discuss
hearing loss. Resp. Ex. A at 5-6.

Gidengil et al. conducted a systematic of the literature on the safety of routine vaccines
administered in the United States with the goal of updating the 2014 report published by
Maglione et al. Resp. Ex. A, Tab 2 at 8. In their section on MMR vaccination, the authors
referenced the Baxter et al. study 68 noting it “detected no association between [SSNHL] and
MMR within one week of vaccination.” Id. at 11.

Baxter et al. analyzed seven years (2007 to 2013) of data from Kaiser Permanente
Northern California (“KPNC”) and identified 1,929 cases of SSNHL in the nine months
following any vaccine exposure and 57 cases of SSNHL within one week of vaccination. Resp.
Ex. A, Tab 3 at 1, 4. Using a case centered methodology, the authors did not find an association
between SSHL and any vaccination. Id. at 2. Specific to MMR, there were no cases of SSNHL
identified in the one-week risk interval after vaccination. Id. at 12 tbl.3. Relative to the
inactivated influenza vaccination, there were 167 cases in the risk interval of one to 28 days after
vaccination. Id. at 11 tbl. 2. The authors selected risk intervals of one to seven day, one to 14
days, one to 28 days, and 15 to 28 days. Id. at 4. They selected these intervals “through
literature and VAERS review as well as consultation with experts.” Id. at 6. They
acknowledged that a limitation of the study included the selection of risk intervals, “[i]f the
interval selected does not match the timing of increased risk an association may be missed.” Id.
For the MMR vaccine, the authors only included data from the one-week risk interval after
vaccination. Id. at 12 tbl. 3. Further, the number of cases of hearing loss following the MMR
vaccination occurring in day seven through 28 days is not known, because the supplemental
material was not filed with the article. See id. at 5. Additionally, the study design looked only at
diagnosis of SSNHL, and did not study SNHL or AIED following vaccination. Id. at 1-3.

Finally, Dr. Staats questioned the relevance of Dr. Monsell’s discussion of autoimmune
thrombocytopenia. Resp. Ex. A at 8. Dr. Staats noted Petitioner does not have autoimmune
thrombocytopenia and explained “the possible induction of one autoimmune condition
(autoimmune thrombocytopenia) does not equate to the induction of other autoimmune
diseases.” Id.

ii. Althen Prongs Two and Three

Dr. Staats opined “the medical record and the published literature do not support the
conclusion that [Petitioner’s AIED] and hearing loss was a result of the MMR vaccine.” Resp.
Ex. A at 13.

Addressing Dr. Monsell’s report, Dr. Staats argued there was “no discussion of a logical
sequence of cause and effect to support the theory that the MMR vaccine caused [Petitioner’s]

68
In his expert report, Dr. Staats explained that Baxter et al. was the study discussed by Gidengil
et al. in their vaccine safety review. Resp. Ex. A at 6. However, Respondent filed only an
excerpt of Gidengil et al. and the excerpt did not include the bibliography.

27
hearing loss.” Resp. Ex. A at 13. Dr. Staats also criticized the case reports provided by Dr.
Monsell as inconsistent with Petitioner’s clinical course in the present case. Id. at 7, 10, 12.

First, Dr. Staats noted that case report from Brodsky and Stanievich involved an
encephalitis-like reaction prior to the onset of SNHL. Resp. Ex. A at 7-8 (citing Pet. Ex. 21). As
Petitioner did not have any encephalitis-like symptoms after her MMR vaccine, Dr. Staats
opined this case report did not support the theory that the MMR vaccine caused Petitioner’s
hearing loss. Id. Of note, however, in their discussion of hearing loss cases following MMR
infection, Brodsky and Stanievich cite to literature describing “idiopathic” cases of severe
hearing loss where patients were noted to have an increased measles virus titer. Pet. Ex. 21 at 3.

Next, Dr. Staats distinguished Petitioner’s clinical course from the clinical course
reported in the Rikitake et al. child who developed bilateral acute hearing loss after mumps and
measles-rubella vaccination. Resp. Ex. A at 10 (citing Pet. Ex. 46). In Rikitake et al., 12 days
after vaccination, the patient experienced one day of fever, and the following day vomited once,
but then her symptoms abated. Pet. Ex. 46 at 2. Hearing loss was noted 18 days after
vaccination. Id. The authors concluded the vaccine “caused serious hearing loss in th[e] patient.”
Id. at 4. Dr. Staats noted Petitioner did not report fever or vomiting. Resp. Ex. A at 10.

Turning to the temporal association between the MMR vaccine and onset of Petitioner’s
AIED, Dr. Staats placed Petitioner’s onset as May 20 or 21, 2019 (approximately 30 days after
her second dose of MMR vaccine). Resp. Ex. A at 12. He did not rebut Dr. Monsell’s opinion
that this temporal association was appropriate given Petitioner’s proffered causal theory. Id. at
12-13.

3. Respondent’s Expert, Yu-Lan Mary Ying, M.D. 69

a. Background and Qualifications

Dr. Ying is “a fellowship trained otologist/neurotologist[] and [is] board certified in
otolaryngology and neurotology.” Resp. Ex. C at 1. After she obtained her M.D. in New York
from State University of New York (“SUNY”), Stony Brook School of Medicine, she completed
a general surgery internship and otolaryngology residency at the University of Pittsburgh
Medical Center. Resp. Ex. D at 1. Dr. Ying also completed a fellowship at the Howard Hughes
Medical Institute-National Institute of Health during medical school as well as a post-graduate
fellowship in otology/neurotology at Pittsburgh Ear Associates and a post-graduate fellowship in
neurotology at Baylor College of Medicine. Id. at 1-2. Since 2014, Dr. Ying has worked as an
assistant professor in the Otolaryngology-Head and Neck Surgery Department at Rutgers-New
Jersey Medical School. Id. at 2. She has also held various hospital appointments and
memberships in various professional societies, and she has served on several committees. Id. at
2-5. Dr. Ying has “a busy academic clinical practice treating many diverse patients with hearing,
balance[,] and lateral skull base disorders.” Resp. Ex. C at 1. She has co-authored over 30
publications throughout her career. Resp. Ex. D at 7-9.

69
Dr. Ying submitted one expert report. Resp. Ex. C.

28
b. Opinion

Dr. Ying agreed Petitioner’s bilateral SNHL was “most compatible with a diagnosis of
AIED.” Resp. Ex. C at 10. She disagreed, however, that there was sufficient evidence to
support Petitioner’s claim of “bilateral sudden SNHL, dizziness, and visual disturbances due to
an adverse reaction to MMR vaccination.” Id. at 8

i. Althen Prong One

Dr. Ying opined there was “insufficient scientific evidence indicating AIED is an adverse
event to MMR vaccination. There is no compelling evidence to establish causation between
MMR vaccination and AIED.” Resp. Ex. C at 10.

While Dr. Ying agreed measles and mumps infections can cause SNHL, Dr. Ying opined
AIED “has not been identified as a cause of SNHL after either measles or mumps infection.”
Resp. Ex. C at 6. Dr. Ying’s discussion of SNHL following natural measles and mumps
infection was largely consistent with Dr. Monsell’s description of SNHL following measles and
mumps infection. Id. at 5-6.

Dr. Ying agreed hearing loss was a common complication of measles infections. Resp.
Ex. C at 5. She noted measles-related hearing loss “is typically bilateral moderate to profound
SNHL and may follow measles encephalitis.” Id. Dr. Ying explained the pathogenesis of
measles encephalitis is “is due to the viral invasion of neurons resulting in inflammation of the
brain parenchyma.” Id. (citing Resp. Ex. C, Tab 7). 70 The Fisher et al. article cited by Dr. Ying
addressed the pathogenesis of measles encephalitis, explaining the virus is highly contagious and
usually spreads in the form of respiratory droplets, which infect cells in the alveoli of the
respiratory system. Resp. Ex. C, Tab 7 at 2-3. The infected cells drain into the lymph nodes,
and then the circulation, spreading to the skin, lung, liver, brain. Id. Hearing loss was not
specifically discussed.

After describing hearing loss caused by measles infection, Dr. Ying turned to mumps
infection. She opined that mumps “is the most common cause of acquired SNHL” and “has very
clearly been shown to be a cause of sudden SNHL.” Resp. Ex. C at 6 (citing Pet. Exs. 49-50).
She explained that SNHL “due to natural mumps infection results from endolymphatic
labyrinthitis, an inflammation of the membranous labyrinth of the inner ear as the primary route
of invasion of the virus is hematogenous.” 71 Id. (citing Resp. Ex. C, Tab 11). 72 In Mizushima

70
D.L. Fisher et al., Measles-Induced Encephalitis, 108 QJM 177 (2015).
71
Hematogenous means “disseminated by the circulation or through the bloodstream.”
Hematogenous, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=21756 (last visited Dec. 18, 2025).
72
Norio Mizushima & Yoshihiko Murakami, Deafness Following Mumps: The Possible
Pathogenesis and Incidence of Deafness, 13 Auris Nasus Larynx (Tokyo) S55 (1986).

29
and Murakami, the authors opined hematogenous infection was the “most probable” mechanism
of deafness due to mumps. Resp. Ex. C, Tab 11 at 2. The authors explained “the viremic state
due to mumps reaches the inner ear hematogenously, causes an inflammatory change in the stria
vascularis of the cochlea and then results in severe impairment of the endolymphatic system.”
Id. They also noted hearing loss in mumps was not associated with meningitis or
meningoencephalitis. Id.

Turning to the incubation period for these infections, Dr. Ying agreed the incubation
period of natural measles or rubella virus infection is about two weeks, and the incubation period
of mumps virus is about two to three weeks. Resp. Ex. C at 6. She explained in mumps-related
hearing loss, SNHL tends to occur four to five days after “onset of signs of infection such as flu-
like symptoms and parotitis.” 73 Id. (citing Pet. Ex. 30). Dr. Ying also acknowledged mumps-
induced SNHL can occur in asymptomatic cases of mumps. Id. (citing Resp. Ex. C, Tab 10). 74

Next, Dr. Ying reviewed the medical literature reporting an association between MMR
vaccination and SNHL. Resp. Ex. C at 6-7. Dr. Ying explained that the MMR vaccination
“includes live[]attenuated measles and mumps viruses.” Id. at 6. She acknowledged that
“[t]here are case reports that have associated MMR vaccination with SNHL in rare
circumstances.” Id. Cases of hearing loss associated with MMR vaccination vary in “severity,
can be bilateral or unilateral,” and have “been reported in both pediatric and adult patients.” Id.

Dr. Ying discussed case reports of bilateral acute SNHL occurring after the mumps and
MMR vaccinations. Resp. Ex. C at 7. Rikitake et al. reported bilateral acute hearing loss
approximately three weeks after receipt of the mumps vaccine. Id. (citing Pet. Ex. 46 at 3-4).
She emphasized that the “[m]umps vaccine was considered the cause based on the incubation
period.” Id. Next, Hulbert et al. described a patient who developed bilateral acute profound
hearing loss 22 days after MMR vaccination. Id. (citing Pet. Ex. 32). Finally, Stewart and
Prabhu reviewed nine cases of hearing loss after MMR vaccination, and in six they suggested
that vaccine causation was “one possibility.” Id. (citing Pet. Ex. 47 at 2). Dr. Ying emphasized
that “published case reports are only anecdotes and speculations of MMR vaccination resulting
in SNHL” and “might represent coincidental observations.” Id.

Additionally, Dr. Ying noted that both the 1994 and 2012 assessments by the IOM
committee found insufficient evidence to establish a causal relationship. Resp. Ex. C at 7 (citing

73
Parotitis is “inflammation of the parotid gland,” which is part of the salivary glands. Parotitis,
Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/dorland/definition?
id=37103 (last visited Dec. 19, 2025); Glandula Parotidea, Dorland’s Med. Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=78815 (last visited Dec. 19, 2025).
74
Hiromi Hashimoto et al., An Office-Based Prospective Study of Deafness in Mumps, 28
Pediatr. Infect. Dis. J. 173 (2009).

30
Resp. Ex. C, Tab 14; 75 Pet. Ex. 48). The 2012 IOM committee assessed the mechanistic
evidence regarding an association between measles or mumps vaccine and hearing loss as “low-
intermediate based on knowledge about the natural infection, experimental evidence, and eight
cases.” Id. (quoting Pet. Ex. 48 at 118). Regarding natural infection, the committee noted that
the wild-type mumps virus infection was associated with deafness and the wild-type measles
infection was associated with bilateral “hearing loss in [five to 10] percent of measles cases.”
Pet. Ex. 48 at 117. “The committee considers the effects of natural infection one type of
mechanistic evidence.” Id. Experimental evidence included the detection of anti-mumps
antibodies in patients who developed idiopathic SSNHL and the finding of measles antigen in
animal cochlear ducts. Id. at 118. These findings “suggested the involvement of measles and
mumps viruses in the pathogenesis of hearing loss.” Id. As Dr. Ying noted in her report, the
IOM committee ultimately determined the evidence was “inadequate to accept or reject a causal
relationship between MMR vaccine and hearing loss.” 76 Resp. Ex. C at 7 (quoting Pet. Ex. 48 at
118). Dr. Ying noted weaknesses in the evidence reviewed by the IOM committee were due to
“publications of a case report that did not provide evidence beyond temporality” and “long
latencies between vaccine administration and development of symptoms mak[ing] it impossible
to rule out other possible causes.” Id.

Dr. Ying provided medical literature that discussed the pathogenesis of AIED. See, e.g.,
Resp. Ex. C, Tab 16. 77 Vambutas and Pathak explained that “[a]s with most autoimmune
diseases, it has been postulated that a misdirected attack on self, in this case to inner ear proteins,
results in both proinflammatory T-cell responses and autoantibody formation, which represent
the basic features of AIED and other autoimmune diseases.” Id. at 2; see also Resp. Ex. C, Tab
17 at 3-4 (discussing the mechanisms of autoimmune process in the inner ear); 78 Resp. Ex. C,
Tab 18 at 2 (“An uncontrolled attack against inner ear antigens, resulting in both T-cell responses
and autoantibody development, has been proposed as the pathogenetic mechanism of AIED”).
In Ciorba et al., the authors noted this immunological process may result in cochlear and
vestibular damage with the most commonly reported damage being “cochlear vasculitis, atrophy

75
Kathleen Stratton et al., Adverse Events Associated with Childhood Vaccines Other Than
Pertussis and Rubella: Summary of a Report from the Institute of Medicine, 271 JAMA 1602
(1994).
76
The IOM committee defines this category of causation as evidence that “is not reasonably
convincing either in support of or against causality; evidence that is sparse, conflicting, of weak
quality, or merely suggestive—whether toward or away from causality falls in this category.”
2012 IOM report at 15, 23-24. Of note, the IOM committee determined that the “epidemiologic
evidence was insufficient or absent to assess an association between MMR vaccine and hearing
loss.” Pet. Ex. 48 at 115.
77
Andrea Vambutas & Shresh Pathak, AAO: Autoimmune and Autoinflammatory (Disease) in
Otology: What Is New in Immune-Mediated Hearing Loss, 1 Laryngoscope Investig.
Otolaryngol. 110 (2016).
78
R. Bovo et al., Immune-Mediated Inner Ear Disease, 126 Acta Otolaryngol. 1012 (2006).

31
of the organ of Corti, otic capsule otospongiosis,[79] endolymphatic hydrops[, 80] and spiral
ganglion degeneration.” 81 Resp. Ex. C, Tab 18 at 2.

Additionally, Vambutas and Pathak noted while the pathogenesis contemplates
autoantibody formation, no autoantibodies have been found specific to AIED. 82 Resp. Ex. C,
Tab 16 at 2. In a small group of patients, anti-cochlin antibodies have been reported that “would
represent a cochlear specific antibody response.” Id. Studies about AIED are difficult due to
limited access of the cochlea, that fact that peripheral blood immune markers may not reflect
inner ear immune reactions, and animal studies have been limited. Id.; see also Resp. Ex. C, Tab
18 at 2. Research also suggests that like other autoimmune diseases, AIED may be both an
autoimmune and an autoinflammatory disease. Resp. Ex. C, Tab 16 at 2.

Bovo et al. described the “three levels of proof” used in the diagnosis of an autoimmune
disease like AIED. Resp. Ex. C, Tab 17 at 1. The three levels of proof, in “descending order of
importance” are “(i) direct proof; (ii) indirect proof; and (iii) circumstantial evidence.” Id. The
authors explained that obtaining direct proof, through “the induction of disease in humans by
transferring autoantibodies or autoreactive T cells,” was ethically untenable. Id. Instead,
researchers must rely upon indirect proof, such as animal models, and circumstantial evidence.
Id. at 1-2. Looking at experimental models (a type of indirect proof), the authors explained a
“wide variety of antibodies against different ear tissues have been detected [in AIED],” and
“multiple antigens” have also been recognized, but none have been identified as “the specific
target.” Id. at 2. The authors concluded that based on available “clinical and experimental data
there is [] strong evidence of immune mechanisms in human inner ear disease.” Id. Bovo et al.
provided a detailed review of the immune system of the inner ear, noting there is “substantial
evidence of autoimmune mechanisms in . . . sudden deafness.” Id. at 3. Significantly, Bovo et
al. noted that the “‘cross-reactions’ theory is [] the most favored [mechanism]: antibodies or

79
Otospongiosis is “the formation of spongy bone in the bony labyrinth of the ear.”
Otospongiosis, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=35990 (last visited Dec. 19, 2025).
80
Endolymphatic hydrops is “an abnormal accumulation of endolymphatic fluid within the
membranous labyrinth of the inner ear.” Mickie Hamiter, Meniere Disease, Merck Manual,
https://www.merckmanuals.com/professional/ear-nose-and-throat-disorders/inner-ear-
disorders/meniere-disease (last visited Dec. 16, 2025).
81
The spiral ganglion is located within the cochlea and “consists of bipolar cells that send fibers
peripherally through the foramina nervosa to the spiral organ and centrally through the internal
acoustic meatus [auditory canal] to the cochlear nuclei of the brainstem.” See Ganglion
Cochleare, Dorland’s Med. Dictionary Online, https://www.dorlandsonline.com/
dorland/definition?id=78034 (last visited Dec. 19, 2025).
82
Bovo et al. explained clinical testing is not currently done to identify antibodies “to an inner
ear supporting cell antigen.” Resp. Ex. C, Tab 17 at 6.

32
rogue T cells cause accidental inner ear damages because the ear share common antigens with . .
. a virus . . . the body is fighting off.” Id. Other mechanisms were also discussed. 83 Id. at 3-4.

Additionally, Dr. Ying criticized several aspects of Dr. Monsell’s report. First, Dr. Ying
opined the mechanisms of vaccine-induced autoimmunity proposed by Agmon-Levin et al. “are
only just theories as there is still no published evidence demonstrating how MMR vaccine causes
AIED.” Resp. Ex. C at 9 (citing Pet. Ex. 14). Citing Agmon-Levin et al., Dr. Ying explained
“the role of other risk cofactors including environmental exposures [or] genetic susceptibility . . .
may affect the causal association between vaccination and autoimmunity.” Id. (citing Pet. Ex. 14
at 4). Dr. Ying observed that Dr. Monsell did not discuss the risk co-factors in Petitioner’s case.
Id. Although Dr. Ying described co-factors such as environmental exposures and genetic
susceptibility, she did not describe these in any detail or suggest that they independently can
cause AIED. Id.

Next, Dr. Ying faulted Dr. Monsell for not elaborating on his comment that “complex
microbiological processes that could be subject to functionally different genetic variants in
vaccine recipients and idiosyncratic reactions.” Resp. Ex. C at 9. Dr. Ying described this
statement as vague and noted it was unclear what “idiosyncratic reactions” Dr. Monsell was
referencing. Id.

Dr. Ying also criticized Dr. Monsell’s use of autoimmune thrombocytopenia as example
of MMR vaccination causing an autoimmune condition. Resp. Ex. C at 9. Dr. Ying opined “the
same process does not apply to hearing loss or inner ear.” Id. Dr. Ying did not provide further
explanation on the differences between autoimmune thrombocytopenia and AIED. Dr. Ying also
noted that there is no animal model for AIED to allow for “vaccine experiments.” Id.

Dr. Ying concluded “[i]n publications to date, there is insufficient scientific evidence
indicating AIED is an adverse event to MMR vaccination.” Resp. Ex. C at 10.

iii. Althen Prongs Two and Three

Dr. Ying opined there was “insufficient evidence” that Petitioner’s bilateral SNHL,
dizziness, and visual disturbances were an adverse reaction to the MMR vaccine. Resp. Ex. C at
8. Further, Dr. Ying disagreed that the onset of Petitioner’s AIED was “consistent with an
immune-mediated response following MMR vaccination.” Id. at 10.

First, Dr. Ying explained Petitioner’s clinical presentation was not consistent with
published case reports or the medical literature. Resp. Ex. C at 8. Petitioner did not experience
any adverse symptomatology such as fever or arthralgia after her MMR vaccination. Id. And, as
discussed further below, her hearing loss occurred outside the incubation period for mumps or
measles infection cited in the published case reports. Id. Dr. Ying further noted that Petitioner’s
serial MRIs were unremarkable and did not contain the high signal intensities in the cochlea
described by Otake et al. Id. (citing Pet. Ex. 45). However, Otake et al. noted the high signal

83
For another paper with a thorough discussion about the proposed mechanisms of AIED, see
Resp. Ex. C, Tab 18.

33
intensity present in the 3D-FLAIR imaging was not detected by T1 and T2 weighted MRIs taken
in the same patient. Pet. Ex. 45 at 2. Additionally, Dr. Ying opined Petitioner’s “subjective
visual complaints” were not commonly seen in measles, mumps, or rubella infection. Resp. Ex.
C at 8.

Next, Dr. Ying noted Petitioner did not report “any problem/side effects with the first
MMR vaccination administered on March 15, 2022.” Resp. Ex. C at 8. As Petitioner was
“already exposed to a first dose of MMR vaccine,” Dr. Ying opined the second dose of MMR
administered 30 days later “should not be so novel to trigger another autoimmune response.” Id.

Dr. Ying disagreed that Dr. Monsell’s comment that “MMR vaccine is not often
administered to adults, who may not have as robust an immune system as children” provided
support for vaccination causation in Petitioner. Resp. Ex. C at 9. She opined that if adults have
a less robust immune system, “then the incidence/occurrence of vaccine-induced autoimmunity
should be less in adults.” Id.

Additionally, Dr. Ying noted Petitioner’s hearing loss symptoms appeared “at the end of
her vacation in Hawaii.” Resp. Ex. C at 9. Dr. Ying opined “stressors from vacation/traveling
away from home could trigger immune responses.” Id. Dr. Ying noted “these stressors”
occurred closer in time to Petitioner’s hearing loss than her MMR vaccination. Id. Dr. Ying
suggested additional information regarding Petitioner’s “well-being” and symptoms at the end of
her vacation “could provide clues of other possible explanations.” Id.

Discussing the temporal relationship between Petitioner’s MMR vaccination and the
onset of her AIED, Dr. Ying explained Petitioner first reported muffled hearing/hearing loss 31
to 32 days after receiving her second dose of the MMR vaccine. Resp. Ex. C at 8. Dr. Ying
opined a 31/32-day onset is outside of the incubation period for measles and mumps infections.
Id. She reported the incubation for measles is 10 to 12 days “from exposure to prodrome” and
seven to 21 from exposure to rash. 84 Id. And Dr. Ying noted case reports that have associated
MMR vaccination with SNHL have a time course of onset corresponding to the incubation
period of measles infection. Id. at 6 (citing Pet. Ex. 23). Additionally, the case report from
Rikitake et al. described an onset of 18 days consistent with the incubation period of mumps. Id.
at 7 (citing Pet. Ex. 46). While the bilateral SNHL reported in Hulbert et al. had onset of 22
days, Dr. Ying noted the patient had “body reaction (arthralgias, fever, headaches, tinnitus,
dizziness) three days after she receive[d ]MMR vaccination.” Id. (citing Pet. Ex. 32).

Finally, Dr. Ying opined Petitioner’s theory that the onset of her AIED was “consistent
with an immune-mediated response following MMR vaccination” was “not based on a
reasonable degree of medical probability.” Resp. Ex. C at 10. As discussed above, Dr. Ying
disagreed that Dr. Monsell’s discussion MMR vaccine-induced thrombocytopenia was applicable
to AIED. Id. at 9. Dr. Ying did not discuss what a medically appropriate timeframe would be
for an immune‐mediated response following vaccination.

84
Dr. Ying cited Epidemiology and Prevention of Vaccine-Preventable Diseases (Elisha Hall et
al. eds., 14th ed. 2021) in support of the incubation period of measles infection; however, this
source was not filed as an exhibit by Respondent.

34
Dr. Ying concluded, “[m]ore than likely, [Petitioner] suffered ‘idiopathic’ AIED without
any association to her two doses of MMR vaccinations.” Resp. Ex. C at 10.

III. LEGAL FRAMEWORK

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 her burden by
presenting circumstantial evidence and reliable medical opinions. Id. at 1325-26.

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

35
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 her 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
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.

36
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 she
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that she received, or (2) that she 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 she suffered a Table Injury, she must prove a vaccine
actually caused her 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.

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 her 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 his 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

37
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. ANALYSIS

A. Althen Prong One

Under Althen prong one, Petitioner must set forth a medical theory explaining how the
received vaccine could have caused the sustained injury. Andreu, 569 F.3d at 1375; Pafford, 451
F.3d at 1355-56. Petitioner’s theory of causation need not be medically or scientifically certain,
but it must be informed by a “sound and reliable” medical or scientific explanation. Boatmon,
941 F.3d at 1359; see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs.,
98 Fed. Cl. 214, 257 (2011) (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”). If
Petitioner relies upon a medical opinion to support his theory, the basis for the opinion and the
reliability of that basis must be considered in the determination of how much weight to afford the
offered opinion. See Broekelschen, 618 F.3d at 1347 (“The special master’s decision often times
is based on the credibility of the experts and the relative persuasiveness of their competing
theories.”); Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994)
(stating that an “expert opinion is no better than the soundness of the reasons supporting it”
(citing Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980))).

The undersigned finds that Petitioner has provided preponderant evidence of a sound and
reliable causal mechanism as required under Althen prong one for the following reasons.

First, the parties’ experts agree that Petitioner’s diagnosis is AIED, autoimmune inner ear
disease. Thus, there is agreement that the diagnosis at issue here is autoimmune in nature.

Next, both parties’ experts and their referenced medical literature provide strong evidence
of the following foundational support: (1) The inner ear is not immunologically privileged, (2)
the inner ear has a robust immune system and can generate a destructive immune response, (3)
viruses are common causes of autoimmune conditions, (4) measles and mumps virus infections
are associated with SSNHL, and (5) MMR vaccines are associated with hearing loss as shown in
case reports.

While one case report may not provide persuasive evidence of causation, here there are
numerous cases of MMR vaccine associated hearing loss. While case reports are generally
insufficient to establish causation, they do provide some evidence in favor of causation. See,
e.g., Coleman v. Sec’y of Health & Hum. Servs., No. 18-352V, 2021 WL 1291677, at *13 (Fed.
Cl. Spec. Mstr. Feb. 16, 2021); Campbell v. Sec’y of Health & Hum. Servs., 97 Fed. Cl. 650, 668
(2011) (“[C]ase reports can by their nature only present indicia of causation but that does not
deprive them of all evidentiary weight.”). For rare conditions, case reports carry more weight
than would otherwise be afforded. Raymo v. Sec’y of Health & Hum. Servs., No. 11-0654V,

38
2014 WL 1092274, at *21 (Fed. Cl. Spec. Mstr. Feb. 24, 2014) (granting “more significance” to
case reports when the injury at issue was a “relatively rare condition” with “with only about 1400
new cases in the U.S. diagnosed annually”); see also Songero v. Sec’y of Health & Hum. Servs.,
No. 18-300V, 2025 WL 3013090, at *16 (Fed. Cl. Spec. Mstr. Oct. 3, 2025) (“In the context of
rare conditions, [] where epidemiologic studies are unavailable, [case reports] provide some
evidence of causation.”). Moreover, the IOM committee considered case reports in determining
their assessment as to a mechanistic theory. The committee identified specific publications,
including case reports, that provided “clinical, [or] diagnostic . . . evidence that contributed to the
weight of the mechanistic evidence.” Pet. Ex. 48 at 115.

Agmon-Levin et al. supports the third foundational tenet above and explains the nexus
with molecular mimicry. They state “[i]nfectious agents are considered to be the most common
triggers of autoimmunity, and vaccines that contain antigens from infectious agents might
induced autoimmunity by similar mechanisms such as molecular mimicry, bystander activation,
epitope spreading, and polyclonal activation.” Pet. Ex. 14 at 2. The MMR vaccine contains
antigens of the measles and mumps viruses and are infectious agents which historically are
known to induce autoimmune diseases by the mechanism of molecular mimicry.

Further, these foundational tenets formed the basis of the 2012 IOM assessment about the
mechanistic evidence related to hearing loss following measles or mumps vaccinations. The
IOM’s assessment of low-intermediate was “based on knowledge about the natural infection,
experimental cases[,] and eight [case reports].” Pet. Ex. 48 at 118. Although the parties here
disagree about the import of the assessment “low-intermediate,” the undersigned finds that since
the 2012 IOM report, the body of knowledge about hearing loss and AIED has grown. While no
specific vaccine antigens triggering AIED have been identified, and no specific autoantibodies
discovered to prove causation with certainty, molecular mimicry has emerged as the favored
causal theory. Due to the information described in the articles about AIED filed herein,
combined with knowledge about natural infections of measles and mumps and hearing loss, the
knowledge that viral infections cause autoimmune conditions, clinical a

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/11245488. Public record. Not legal advice.