VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01553
Package ID: USCOURTS-cofc-1_17-vv-01553
Petitioner: Elaine Clark
Filed: 2017-10-18
Decided: 2023-08-01
Vaccine: influenza
Vaccination date: 2015-12-06
Condition: rheumatoid arthritis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Elaine Clark, a 74-year-old woman, filed a petition alleging that the influenza vaccine she received on December 6, 2015, caused her to develop rheumatoid arthritis (RA). She also initially alleged aggravation of arthritis, small fiber neuropathy, carpal tunnel syndrome, and a shoulder injury, but later clarified that her primary claim was RA. The court reviewed extensive medical records, expert reports from rheumatologists Dr. Arthur Brawer for the petitioner and Dr. Merhdad Matloubian for the respondent, and testimony from the petitioner and both experts. Petitioner's expert, Dr. Brawer, proposed a "perfect storm" theory involving molecular mimicry, chemical toxicity, and other factors, suggesting the vaccine triggered an immediate inflammatory response that led to RA. Respondent's expert, Dr. Matloubian, argued that RA has a long pre-clinical phase, often years before symptoms appear, and that the petitioner's RA likely predated the vaccination, evidenced by synovitis and erosion found during her knee replacement surgery a month prior. Dr. Matloubian also cited numerous studies indicating no causal link between the flu vaccine and RA, and highlighted that smoking and being female are known risk factors for RA, which the petitioner possessed. The court found Dr. Brawer's "perfect storm" theory lacked specificity and scientific validation, and that the weight of the evidence, particularly epidemiological studies and the understanding of RA's long development period, did not support a causal connection. The court also noted that some treating physicians considered the vaccine link unlikely. Ultimately, the court concluded that Ms. Clark failed to prove by a preponderance of the evidence that the flu vaccine caused her RA, and therefore, her petition was denied.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_17-vv-01553-1
Date issued/filed: 2023-08-01
Pages: 43
Docket text: PUBLIC DECISION (Originally filed: 6/16/2023) regarding 101 DECISION of Special Master. Signed by Special Master Katherine E. Oler. (emh) Service on parties made.
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Case 1:17-vv-01553-UNJ Document 104 Filed 08/01/23 Page 1 of 43
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1553V
Filed: June 16, 2023
* * * * * * * * * * * * * * * * * * * * * * * * * *
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ELAINE CLARK,
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Petitioner, *
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v.
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SECRETARY OF HEALTH AND *
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HUMAN SERVICES,
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Respondent. *
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Phyllis Widman, Widman Law Firm, LLC, Northfield, NJ, for Petitioner
Ryan Pyles, U.S. Department of Justice, Washington, DC, for Respondent
DECISION ON ENTITLEMENT1
Oler, Special Master:
On October 18, 2017, Elaine Clark (“Petitioner”) filed a petition for compensation under
the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine
Act” or “Program”). The petition alleges that Petitioner developed “significant
aggravation/exacerbation of arthritis, rheumatoid arthritis with associated polyneuropathy/small
fiber neuropathy, exacerbation of carpal tunnel syndrome, and a left shoulder injury” as a result of
the influenza (“flu”) vaccine she received on December 6, 2015. Pet. at 1, ECF No. 1. Petitioner
1 Because this Decision contains a reasoned explanation for the action in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government
Services). This means the Decision will be available to anyone with access to the internet. In accordance
with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information,
the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that
the identified material fits within this definition, I will redact such material from public access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).
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later clarified that she was alleging the flu vaccine caused her to develop rheumatoid arthritis
(“RA”). ECF No. 41.
Upon review of the evidence in this case, I find that Petitioner has failed to preponderantly
demonstrate that the flu vaccine can cause RA or that it did so in this case. The petition is
accordingly dismissed.
I. Procedural History
Petitioner filed her petition on October 18, 2017. Pet. at 1. She filed medical records in
support of her petition on November 1, 2017 (Exs. 1, 3-9), November 8, 2017 (Ex. 10), November
22, 2017 (Ex. 11), January 31, 2018 (Exs. 12-14), and April 11, 2018 (Exs. 15-18).
Respondent filed his Rule 4(c) report on July 6, 2018, recommending that entitlement be
denied. ECF No. 26 (“Resp’t’s Rep.”) at 1.
After that, the parties each filed an expert report from a rheumatologist; Petitioner filed a
report from Dr. Arthur Brawer and Respondent filed a report from Dr. Merhdad Matloubian. Ex.
19; Ex. A.
I held a status conference on September 5, 2019. During my discussion with the parties, I
confirmed with Petitioner’s counsel that Petitioner’s alleged injury is RA. Counsel indicated that
this was the case.3 See ECF No. 41. I also informed Petitioner’s counsel that it will be “difficult
for Petitioner to succeed under the current theory presented by Dr. Brawer. Specifically, I am not
convinced Petitioner can establish that an onset of RA within 24 hours following vaccination
represents a medically feasible time frame.” Id. I ordered Petitioner to file a responsive expert
report both responding to Respondent’s expert and addressing this issue. Id.
Petitioner filed a second expert report from Dr. Brawer on September 18, 2019. Ex. 20.
I held a status conference on November 20, 2019. During that conference, I told Petitioner’s
counsel that
Dr. Brawer’s latest expert report did not fully address my question regarding how
rheumatoid arthritis (“RA”) can develop within 24 hours of vaccination. Dr. Brawer
proposed a theory of molecular mimicry in his prior expert report to explain why
vaccines have caused a wide variety of autoimmune diseases. In this case, Dr.
Brawer did not address medical feasibility of onset of RA within 24 hours of the
flu vaccination under his molecular mimicry theory, as it relates to Althen prong 3.
Specifically, he did not explain how it is medically plausible for the immune
response, that is a central component of the autoimmune process that causes RA, to
occur so quickly.
3 Based on this assertion, I have not analyzed whether the flu vaccine caused Petitioner to develop any
injury other than RA.
2

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ECF No. 43.
Petitioner filed three individual expert reports from Dr. Brawer on January 29, 2020. Exs.
21, 22, 23. Respondent filed a responsive report from Dr. Matloubian on March 30, 2020. Ex. C.
Petitioner filed a sixth expert report from Dr. Brawer on April 22, 2020. Ex. 27.
I held a status conference on April 24, 2020. I spoke with the parties about scheduling an
entitlement hearing and asked them to submit their availability to chambers. ECF No. 53. Based
on the parties’ submissions, I scheduled an entitlement hearing for August 24, 2021. See
Scheduling Order dated 5/1/2020.
The parties filed prehearing briefs on July 27 and August 9, 2021. ECF Nos. 62, 66.
I conducted an entitlement hearing via Zoom on August 24, 2021. Petitioner presented
testimony from herself and Dr. Brawer. Respondent presented testimony from Dr. Matloubian.
After the hearing, the parties each filed a supplemental expert report and additional medical
literature addressing an issue raised at the entitlement hearing (whether synovitis and erosion are
common findings in end-state osteoarthritis). Exs. 37-53; Ex. D; Ex. D, Tab 1.
Subsequently, the parties submitted post-hearing briefs. ECF Nos. 92, 93, 94. Both
Petitioner and Respondent indicated that the record was complete on June 21, 2022. ECF No. 95.
This matter is now ripe for an adjudication.
II. Medical Records
A. Relevant Pre-Vaccination History
On June 6, 2013, Petitioner saw orthopedist Thomas E. Hoerner, MD, for an evaluation of
left knee pain that occasionally radiated up to her hip and down to her ankle. Ex. 4 at 71-72.
Petitioner also reported muscle aches, muscle weakness, arthralgias, and joint pain. Ex. 6 at 50.
Petitioner had been on “long-time chiropractic manipulation” and Dr. Hoerner’s impression was
of “calcifying tendinitis of shoulder” (location not specified), joint pain in the pelvic area and
thigh, and “disorders of bursae and tendons in shoulder region, unspecified.” Ex. 4 at 72. Petitioner
reported that she was considering surgery for her left knee arthritis the following September. Id.
On November 4, 2013, Petitioner saw her primary care provider, Joseph Gurka, DO, for a
follow-up to her right knee replacement surgery. Ex. 4 at 6. Petitioner reported that her left knee
might also need surgery soon. Id.
On August 6, 2015, Petitioner saw Dr. Hoerner to schedule her left knee replacement
surgery. Ex. 4 at 86-87. Dr. Hoerner’s impression was of hip and knee pain, “bursitis of shoulder,”
and “calcific tendinitis of shoulder.” Id. at 87. On November 4, 2015, Petitioner underwent left
knee replacement surgery. Ex. 6 at 5. Dr. Hoerner’s notes on the knee replacement procedure
reflect “significant bone loss and erosion in the lateral tibial plateau.” Ex. 11 at 45. The post-
operative pathology report notes that the bone and tissue sample collected during the procedure
3

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contained “[b]ony and cartilaginous fragments with degenerative change, synovial fragments with
proliferative synovitis.”4 Id. at 47. During a follow-up appointment with Dr. Gurka on November
24, 2015, Petitioner exhibited mild swelling in her left ankle. Ex. 4 at 15.
B. Post-Vaccination History
On December 6, 2015, Petitioner, then 74 years of age, received the allegedly causal flu
vaccination in her left arm. Ex. 1 at 1-2.
On December 15, 2015, Petitioner saw Dr. Hoerner for a follow-up to her left knee
replacement. Ex. 6 at 43-46. He noted that Petitioner’s knee was doing well, but that “her chief
complaint is really her ankle and foot pain” Id. at 45. In addition, he noted that she “had to get off
the walker because of bilateral shoulder pain” and that “she has difficulty elevating the left more
than the right.” Id. There was no documentation of wrist or hand pain by Dr. Hoerner at this visit.
Dr. Hoerner also did not mention her flu vaccination. He suspected possible polymyalgia
rheumatica (PMR) and ordered blood tests. Id. The results showed a normal inflammatory marker
and erythrocyte sedimentation rate (“ESR”)5 of 10 on December 15, 2015, making PMR less
likely. Ex. 6 at 87.
At her first physical therapy (“PT”) appointment on December 12, 2015, Petitioner
complained of “increased sh[oulder] & wrist pain.” Ex. 5 at 7.
On December 28, 2015, Dr. Gurka evaluated Petitioner for “bilateral shoulder, wrist, and
pain [sic] since she has stopped using her crutches since her knee surgery.” Ex. 4 at 16. He noted
that Petitioner had a mechanical fall on her left side the previous week and that x-rays had shown
no fractures. Ex. 4 at 16. On physical exam, he noted reduced range of motion in her shoulders as
well as “edema”6 on bilateral “upper extremities.” Id. at 17. His assessment was pain in Petitioner’s
shoulders and left knee, and he recommended follow up with orthopedics. Id. at 16.
4 Synovitis is “inflammation of a synovial membrane [of a joint]; it is usually painful, particularly on
motion, and is characterized by a fluctuating swelling due to effusion within a synovial sac.” DORLAND’S
MEDICAL DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=48576 (last
visited on Apr. 25, 2023) (hereinafter “DORLAND’S”).
5 Erythrocyte sedimentation rate is “the rate at which [red blood cells] precipitate out from a well-mixed
specimen of venous blood…[A]n increase in rate is usually due to elevated levels of plasma proteins,
especially fibrinogen and immunoglobulins...It is increased in monoclonal gammopathy,
hypergammaglobulinemia due to inflammatory disease, hyperfibrinogenemia, active inflammatory disease,
and anemia.” DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=102146 (last visited on
Apr. 24, 2013).
6 Edema is “the presence of abnormally large amounts of fluid in the intercellular tissue spaces of the body,
usually referring to subcutaneous tissues. It may be localized (as from venous obstruction, lymphatic
obstruction, or increased vascular permeability) or systemic (as from heart failure or renal disease).”
DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=15589 (last visited on June 2, 2023).
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On January 6, 2016, Petitioner saw Peter Shoukimas, PA-C, for an orthopedics follow-up.
Ex. 6 at 39-43. He noted that Petitioner complained of “pain in the shoulders with limited range of
motion due to discomfort and numbness and tingling in the ulnar nerve distribution of both hands.”
Id. at 41. PA Shoukimas added that “the patient has found that since her surgery for total knee
replacement on the left and the use of crutches that this is when the pain occurred and has become
somewhat worse.” Id. His impression was of bursitis of shoulder, calcific tendinitis of shoulder,
and PMR. Id. at 42.
On January 14, 2016, Petitioner returned to Dr. Hoerner. Ex. 6 at 38. Petitioner stated that
she had experienced “sudden onset of right upper extremity pain” on December 6, 2015, the day
she received the flu vaccine. Id. She stated that her shoulder pain was disrupting her sleep and that
“any attempt to elevate the shoulder” would cause pain. Id. Petitioner also complained of
numbness in the ring and little fingers of her right hand. Id.
On January 21, 2016, Petitioner began attending physical therapy for bilateral bursitis and
bilateral shoulder pain. Ex. 5 at 32. On January 27, 2016, Petitioner underwent nerve conduction
velocity testing via electromyography (“EMG”). Ex. 4 at 51-54. The results were abnormal,
showing bilateral median mononeuropathy at the wrists (Carpal Tunnel syndrome) and mild, right
ulnar mononeuropathy at the ulnar groove (Cubital Tunnel). Id. at 54. The study showed no
evidence of bilateral cervical radiculopathy. Id.
On January 29, 2016, Petitioner was evaluated by Joshua Philbrick, MD, an associate of
Dr. Hoerner, for “bilateral shoulder pain and bilateral hand numbness and tingling.” Ex. 6 at 31-
35. He noted that Petitioner’s pain had begun on December 6, 2015, and that Petitioner
“attribute[d] her shoulder pain to the flu shot and the crutches” that she used after her knee
replacement surgery. Id. at 34. On physical exam of Petitioner’s hands, Dr. Philbrick noted some
evidence of osteoarthritis in multiple small joints of both of her hands but did not document any
joint swelling or hand edema. Id. His impression, based on EMG findings was “bilateral carpal
tunnel, moderate on the right, mild on the left” as well as “right mild cubital tunnel” in addition to
“bilateral shoulder impingement and rotator cuff tendinitis.” Id.
On physical examination on February 27, 2016, Dr. Gurka noted that Petitioner had
bilateral edema of the hands and feet. Ex. 11 at 36. Blood tests performed on February 29, 2016,
showed an elevated ESR of 41 (normal <30) and a negative anti-nuclear antibody (“ANA”).7 Id.
at 21, 23.
On March 11, 2016, Petitioner underwent additional blood tests. Ex. 6 at 85-86. The results
showed elevated inflammatory markers, including an ESR of 67 (normal <40), and C-reactive
protein (“CRP”) of 22.9 (normal <4.9), as well as a positive rheumatoid factor of 42.4 and a
7 Antinuclear antibodies are “antibodies directed against nuclear antigens; ones against a variety of different
antigens are almost invariably found in systemic lupus erythematosus and are frequently found in
rheumatoid arthritis, scleroderma (systemic sclerosis), Sjögren syndrome, and mixed connective tissue
disease.” DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=56804 (last visited on Apr.
24, 2023).
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negative ANA. Id. An MRI of Petitioner’s left shoulder on March 22, 2016, showed a rotator cuff
tear as well as tendinitis, bursitis, and a large cystic ganglion. Id. at 64-65.
Petitioner also returned to Dr. Philbrick on March 11, 2016. Ex. 4 at 102-04. She
complained of continuing tingling and numbness in her hands. Id. at 103. Dr. Philbrick noted
Petitioner’s history of bilateral shoulder impingement, bilateral carpal tunnel syndrome, left side
cubital tunnel syndrome, and a recent hospitalization for fainting spells. Id. Petitioner’s history
also included edema in all four extremities and right foot pain that had lasted a few weeks with no
traumatic cause. Id. Dr. Philbrick noted that Petitioner attributed her orthopedic issues to the flu
vaccine she received on December 6, 2015. Id. The diagnosis was bilateral carpal tunnel syndrome,
right shoulder bursitis, lesion of right ulnar nerve, right foot pain, bilateral hand pain, and
osteoarthritis of the carpometacarpal joint of both thumbs. Id. at 103-04.
On March 22, 2016, Petitioner underwent an MRI of her left shoulder. Ex. 4 at 62-63. The
results were suggestive of “a pinpoint full thickness tear” of the supraspinatus tendon. Id. at 63.
The results also included biceps tendinosis, mild to moderate acromioclavicular joint degenerative
changes, small glenohumeral joint diffusion, trace subacromial-subdeltoid bursitis, and possible
focal nondetached tear along the posterior labrum. Id.
On March 24, 2016, Petitioner saw her pulmonologist, Daniel Coleman, MD, FCCP, for
chronic obstructive pulmonary disease (“COPD”). Ex. 8 at 7-9. He reviewed Petitioner’s
musculoskeletal symptoms, including right shoulder pain and bilateral wrist and forearm pain, and
noted that she “believes that the flu shot was the reason for those symptoms (which seems unlikely
. . .).” Id. at 7 (ellipsis in original).
On March 31, 2016, Petitioner saw rheumatologist Menachem Kohen, MD. Ex. 7 at 10-11.
He noted that Petitioner started to “experience left shoulder discomfort” on the night of her
December 6, 2015, flu vaccination, “which after a few days involved also her right shoulder.” Id.
at 10. Dr. Kohen noted that Petitioner had active synovitis in her hands and wrists and bilateral leg
edema. Id. He diagnosed Petitioner with seropositive RA and started treatment with Plaquenil
(hydroxychloroquine) and prednisone. Id. at 11. Dr. Kohen noted that “[t]here are descriptions in
the literature of new onset inflammatory arthropathies after vaccinations, and since [Petitioner’s]
symptoms started after the flu vaccination, the vaccination could have been a contributory factor
to the onset of her disease.” Id.
On June 9, 2016, Petitioner saw Dr. Kohen for a follow-up. Ex. 7 at 8-9. He noted that
Petitioner experienced “intense hand arthralgias” after discontinuing prednisone and restarted
Petitioner on a lower dose. Id. Petitioner reported ongoing left shoulder pain which had been
temporarily alleviated after a cyst in her left shoulder was drained. Id. at 8.
On June 15, 2016, Petitioner saw orthopedist Eric Arvidson, MD, complaining of
worsening intermittent left shoulder pain that would sometimes disappear completely. Ex. 4 at
121-22. Dr. Arvidson reviewed Petitioner’s spinal x-ray and noted “[c]onsiderable loss of the
neural foramen where the C6 nerve root would exit” and “[s]ignificant discogenic disease
throughout the spine, however the vertebral body heights are well maintained.” Id. at 122. Dr.
Arvidson thought that Petitioner’s symptoms were the result of her cervical pathology, and
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pending an MRI, Petitioner’s physical therapy was “converted” from shoulder therapy to neck
therapy. Id. at 122. Petitioner underwent an MRI on July 1, 2016, which showed mild stenosis8 at
C5-6; moderate foraminal narrowing on the right and severe foraminal narrowing on the left;
multilevel mild annular disc bulges; and a small central disc protrusion at C3-4. Ex. 4 at 67.
On July 11, 2016, Petitioner returned to Dr. Arvidson complaining of persistent neck pain,
especially on the left side. Ex. 4 at 123-24. Dr. Arvidson recommended continuing PT and traction,
saying that if invasive treatment was needed, Petitioner would be referred elsewhere. Id. at 124.
On August 23, 2016, Petitioner returned to Dr. Kohen for a follow-up for her RA. Ex. 7 at
6-7. Petitioner reported that in general, she felt much better than she had at the beginning of 2016,
but that her pain had increased in the prior 24 hours. Id. at 6. Dr. Arvidson noted that Petitioner
had some relief from her neck and left shoulder discomfort with injections to her cervical spine.
Id. At a later RA follow-up, Petitioner reported that hand arthralgias were rare and that she was
generally feeling better than she had in the past. Ex. 4 at 127.
On November 22, 2016, Petitioner saw Erica Balfour, MS, PAC, at the pain clinic at Holy
Family Hospital. Ex. 11 at 110-12. Petitioner’s chief complaint was neck pain and she also reported
“chronic widespread pain (shoulder, neck, hands) which is associated with [a diagnosis] of
‘explosive RA’ episode [status post] flu shot in Dec[ember] 2015.” Id. at 110. Ms. Balfour’s
assessment was myalgia, cervical radiculopathy, shoulder pain, chronic pain, hand pain, and
neuropathy. Id. at 111.
On March 4, 2017, Petitioner saw neurologist Marcelo Matiello, MD, for “chronic
multifocal pain.” Ex. 3 at 2-7. He noted that Petitioner began to experience burning left shoulder
pain and then bilateral shoulder pain after her December 2015 influenza vaccination and that the
burning pain spread to both of her hands three to four days later. Id. at 2. Dr. Matiello suspected
sensory polyneuropathy secondary to RA. Id. at 6. EMG performed on March 27, 2017,
“suggest[ed] the presence of a mild right median sensory neuropathy at the wrist, as may be seen
in carpal tunnel syndrome,” as well as mild, non-localized right ulnar sensory neuropathy. Id. at
10.9
On June 27, 2017, Petitioner returned to Dr. Matiello and reported that gabapentin had been
helping with her pain. Ex. 3 at 17-22. Dr. Matiello noted that Petitioner’s EMG “did not show
evidence of sensory polyneuropathy.” Id. at 21. His impression was a possible small fiber
neuropathy and recommended a skin biopsy to confirm. Id. A July 5, 2017 skin biopsy was
considered diagnostic for a small fiber axonopathy. Ex. 10 at 8.
8 Stenosis is “an abnormal narrowing of a duct or canal.” DORLAND’S, https://www.dorlandsonline.com
/dorland/definition?id=47090 (last visited on Apr. 25, 2023).
9 In his review of the EMG results, Dr. Matiello also noted that “[v]arious pathological processes have been
proposed for vaccine-associated polyneuropathies, with some theories describing immune mediated
hypersensitivity to the solvent/adjuvants and/or invasion of nervous system through a prolonged, less
virulent infection.” Ex. 16 at 5. It is not clear whether Dr. Matiello was aware that Petitioner had received
an inactivated, non-adjuvanted component influenza vaccine that is not capable of replication or of causing
an infection.
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On November 1, 2017, Petitioner saw Dr. Matiello. Ex. 10 at 2-7. His impression was that
[Petitioner] developed rheumatoid arthritis after a flu vaccination in December
2015. On her neuro exam again today she has diminished pinprick, touch,
temperature and vibration, with normal segment position sensation, on both arms
and feet. EMG did not show evidence of sensory polyneuropathy. Her skin biopsy
shows evidence of small fiber neuropathy. Literature review includes case studies
of small fiber neuropathy post flu vaccination. Various pathological processes have
been proposed for vaccine associated polyneuropathies, with some theories
describing immune-mediated hypersensitivity to the solvents/adjuvants and/or
invasion of nervous system through a prolonged, less virulent infection. I
recommend that she does not take the flu vaccine this year and continues
gabapentin. I will also send her for PT to help with gait and fall precaution. Her
symptoms started before she got treatment for her rheumatoid arthritis, so
likelihood of her small fiber neuropathy being secondary to methotrexate is small.
Id. at 6.
On March 20, 2018, Petitioner returned to Dr. Kohen for a follow-up for her RA. Ex. 15 at
1-2. Petitioner denied flareup of hands or feet and arthralgias. Id. at 1. Petitioner reported mild
intermittent hand joint and feet metatarsalgias with morning stiffness, neck pain, and mild bilateral
finger paresthesias. Id.
On September 4, 2018, Petitioner saw rheumatologist Saba Beg, MD. Ex. 33 at 1322. In a
follow-up appointment on November 14, 2019, Dr. Beg described Petitioner’s condition as
morning stiffness in her hands, no joint pain, and occasional swelling in her hands. Id. at 372.
Petitioner reported that she was able to do most of the things that she used to do. Id.
In her most recent rheumatology appointment with Mazen Nazrallah, MD, Petitioner was
reported to be doing well on medication, especially Plaquenil. Ex. 33 at 8-10.
III. Petitioner’s Affidavit and Testimony
A. Petitioner’s Affidavit
Petitioner signed her affidavit on May 7, 2017. Ex. 2 at 2. In it, she stated that she received
the flu vaccine in her left arm on December 6, 2015, and that by that same evening, she was unable
to lie on her left side due to intense shoulder pain. Id. at 1. Petitioner stated that she visited various
doctors, and then was treated by Dr. Kohen, a rheumatologist. Id. Petitioner averred that Dr. Kohen
told her she had an explosive case of RA most likely triggered by the flu vaccine. Id.
B. Petitioner’s Testimony
Petitioner testified at the entitlement hearing on August 24, 2021. Tr. at 5-40. Petitioner
testified that she had knee replacement surgery in November 2015 and that she received the
8

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allegedly causal flu vaccination on December 6, 2015, at the age of 74. Id. at 11-12. Petitioner
testified that she received the flu vaccine in her left arm. Id. at 13. She stated that she had received
flu vaccinations beginning five or six years prior to December 2015 at the recommendation of her
pulmonologist. Id.
Petitioner testified that she was unable to sleep on her left side the night she received the
flu vaccine because of pain in her left shoulder. Tr. at 13. When she woke up on December 7,
2015, the pain had spread to both shoulders and both arms. Id. The pain, which Petitioner described
as a burning sensation, persisted during the following days. Id. at 14. Petitioner went to her pre-
scheduled appointment with Dr. Hoerner, her orthopedist, to follow up on her knee replacement a
few weeks later. Id. at 14-15. She described her shoulder and foot pain, and Dr. Hoerner suggested
that the crutches Petitioner was using post-surgery might be causing her shoulder pain .10 Id. at 16.
Petitioner was unconvinced by this explanation because she “didn’t use the crutches faithfully”
while recovering from surgery. Id.
Due to Medicare coverage issues, Petitioner had to wait to start shoulder PT until her post-
surgical knee PT was complete. Tr. at 17-18. Petitioner underwent PT and occupational therapy
(“OT”) for her shoulders simultaneously. Id. at 18.
Petitioner went on to describe her daily life in the first few months after receiving the flu
vaccine. Tr. at 18. She was unable to hold a glass of water without dropping it and could not lift a
pot off the stove. Id. She had difficulty getting dressed and taking a shower. Id. at 18-19. She found
it difficult to use the stairs in her home due to fatigue and balance issues. Id. at 19.
Petitioner testified that, in February 2016, she was sitting on the couch with her son when
suddenly “everything went black, and [she] just fell over.” Tr. at 20. Petitioner’s son took her to
the hospital, where Petitioner received a diagnosis of syncope of unknown origin. Id. Her hands
were swollen such that she was unable to peel the lids off of paper cups during breakfast the next
day. Id. at 21; Ex. 35 at 1-2 (photo). Her regular physician, Dr. Gurka, saw her in the hospital and
ordered IV Lasix to control the swelling in her hands. Id. Petitioner reported that this helped for a
while, but that the swelling returned. Id.
Petitioner testified that, at Dr. Gurka’s recommendation, Petitioner began seeing a
rheumatologist, Dr. Kohen, in March 2016. Tr. at 23. She reported she did not feel that her other
orthopedist, Dr. Philbrick, had been listening to her about the seriousness of her pain. Id. Dr.
Philbrick ordered testing that showed a cyst in Petitioner’s shoulder. Id. at 24. Dr. Kohen also
reviewed the results of Petitioner’s blood tests and diagnosed her with RA. Id. at 25. Dr. Kohen
told Petitioner that the flu vaccine could have triggered the explosive onset of her RA, and that he
had other patients who had experienced this. Id. at 26.
Petitioner testified that Dr. Kohen prescribed prednisone, which did lessen her pain and
enable her to sleep better than she had been. Tr. at 26. She reported that “the pain came back with
a vengeance” when she stopped taking prednisone. Id. at 27. Petitioner began seeing a pain
10 During her testimony, Petitioner did not recall whether Dr. Hoerner himself or his assistant said this. Tr.
at 16.
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management specialist on the advice of her orthopedist. Id. She began receiving regular cortisone
shots. Id. at 27-28.
Petitioner testified that, prior to her knee replacement in November 2015, Petitioner had
worked as a nurse and victim advocate. Tr. at 10. She was unable to return to work after receiving
the flu vaccine because she no longer had the necessary energy or stamina. Id. at 28.
Petitioner testified that, in the fall of 2016, she was feeling better except for the burning
sensation in her hands. Tr. at 30. Dr. Kohen recommended that she see a neurologist, and Petitioner
began seeing Dr. Matiello in early 2017. Id. at 30-31. After nerve conduction studies and a skin
biopsy, Dr. Matiello diagnosed Petitioner with small axon neuropathy and prescribed gabapentin.
Id. at 31. In 2017, Petitioner’s condition had improved. Id. at 32.
Petitioner testified that, the summer before she received the flu vaccine, she had generally
felt well. Tr. at 34-35. She was able to get up and leave the house for work between 7:15 and 8:00
a.m. Id. at 35. Her work involved attending proceedings in two different courts, completing
paperwork, and answering the phone. Id. She occasionally went out in the evening after work. Id.
After the vaccination, she felt she had “hit a wall.” Id. at 36. She described serious fatigue and
difficulty performing everyday tasks. Id. She testified that she believes that the flu vaccine she
received on December 6, 2015, caused her injury. Id. at 37-38.
IV. Expert Opinions and Qualifications
A. Expert Qualifications
1. Petitioner’s Expert: Arthur E. Brawer, MD
Dr. Brawer received his medical degree from Boston University in 1972. Ex. 36 (“Brawer
CV”) at 3. After his internship and residency, he completed a fellowship in arthritis at Boston
University Medical Center in 1976. Id. Since 1976, he has been in private practice, serving as the
Director of Rheumatology and Director of the Arthritis Clinic at Monmouth Medical Center in
Long Branch, New Jersey. Id. In his practice, Dr. Brawer has seen roughly 25,000 patients, of
whom about 10,000 were RA patients. Tr. at 76.
Dr. Brawer is board certified in rheumatology and internal medicine. Brawer CV at 4. He
is the author of 41 peer-reviewed publications. Id. at 4-10. He has also held teaching positions at
Drexel University in Philadelphia and at the Robert Wood Johnson School of Medicine in New
Brunswick, New Jersey. Id. at 1. I recognized him as an expert in rheumatology and internal
medicine. Tr. at 45.
2. Respondent’s Expert: Merhdad Matloubian, MD, PhD
Dr. Matloubian received his bachelor’s, master’s and doctoral degrees (specializing in
immunology and virology) from the University of California, Los Angeles. Ex. B at 1,
(“Matloubian CV”); First Matloubian Rep. at 1. He completed his residency at the University of
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California, San Francisco (“UCSF”), followed by a fellowship in rheumatology, also at UCSF.
Matloubian CV at 1. He is board certified in internal medicine and rheumatology. Id. at 1-2.
Dr. Matloubian’s practice involves a combination of research and patient care. He has
served as an associate professor of Medicine at UCSF since 2001. Matloubian CV at 2. In his
research, Dr. Matloubian focuses on innate and adaptive immune responses to viral infections, and
he has published numerous articles in reputable medical journals on issues in this field. Id. at 7–8,
10–14; In addition to teaching and research work, he also serves as associate director of the UCSF
Molecular Medicine Consult Service, which is a hospital service involving both clinicians and
research scientists, who work together to treat patients with a variety of unusual disorders.
Matloubian CV at 3. Additionally, Dr. Matloubian has spent one month per year as an attending
physician on the UCSF Inpatient Rheumatology Consult Service since 2001. Id. I recognized him
as an expert in immunology and rheumatology. Tr. at 117.
B. Pre-Hearing Expert Reports
Prior to the entitlement hearing, Dr. Brawer submitted six expert reports. Exs. 19-23, 27.
Dr. Matloubian submitted two expert reports. Exs. A, C.
1. Dr. Brawer: First Expert Report
Dr. Brawer began his first expert report by reviewing Petitioner’s medical conditions prior
to her December 6, 2015, flu vaccination. Ex. 19 (“First Brawer Rep.”) at 1. These included, but
were not limited to, COPD, leg edema, calcific tendinitis and rotator cuff damage, and
osteoarthritis. Id. Dr. Brawer noted that Petitioner began experiencing pain and swelling in her left
hand and wrist three days after vaccination which affected her metacarpophalangeal (knuckle)
joints and proximal interphalangeal joints in her fingers, “areas completely different from her prior
osteoarthritic involvement at the base of the thumb.” Id. at 1-2. He opined that “the additive
polyarthritis subsequent to December 6, 2015 was chronic, intractable, and unremitting on a daily
basis.” Id. at 2. He opined that Petitioner’s “clinical picture was highly suggestive of [RA] that had
been directly initiated by the influenza vaccination on December 6, 2015.” Id.
Dr. Brawer criticized Respondent’s Rule 4(c) report as having “failed to appreciate the
distinction between [Petitioner’s] age related osteoarthritic joint involvement from the
superimposed systemic inflammatory process of [RA].” First Brawer Rep. at 2. He opined that the
mechanism by which the flu vaccine caused Petitioner’s RA was “cross reactivity between
routinely used vaccine materials and self-antigens in the body.” Id. He explained that “antigens of
infectious agents can cross react with self-antigens present on a variety of body cells, including
immunocompetent cells, thereby triggering systemic inflammatory reactions,” otherwise known
as molecular mimicry. Id. at 2-3. In support of this opinion, Dr. Brawer cited medical literature
that was never filed. Id. Dr. Brawer noted that several medical conditions, including RA, have
been linked in the literature with vaccine-induced molecular mimicry. Id. at 3.
Dr. Brawer also opined that molecular mimicry is not the only mechanism by which
vaccines can trigger autoimmunity, stating that “[a]dverse effects on immunoregulatory cells by
vaccines can alter the balance between helper and suppressor T-cells.” First Brawer Rep. at 3-4.
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He also opined that “[p]olyclonal B-cell activation, a phenomenon routinely present in [RA]
patients, can also occur following vaccination.” Id. at 4.
As to the logical sequence of cause and effect leading to Petitioner’s RA, Dr. Brawer
opined that Petitioner did not suffer from systemic inflammatory arthritis prior to receiving the flu
vaccine. First Brawer Rep. at 4. He further opined that Petitioner’s RA “cannot be attributed to
any other well defined clinical entity or inflection that could have triggered this condition.” Id. He
added that Petitioner’s chronic inflammatory condition began within 24 hours of her flu
vaccination “and continued to exist indefinitely.” Id. He concluded by opining that the there was
a temporal relationship between receipt of the flu vaccine and the development of Petitioner’s RA.
Id.
2. Dr. Matloubian: First Expert Report
In his first expert report, Dr. Matloubian began his analysis by stating that he agreed that
seropositive RA was the correct diagnosis for Petitioner based on her medical records. Ex. A
(“First Matloubian Rep.”) at 6. He noted that Petitioner suffered from other non-inflammatory
causes of musculoskeletal pain, including osteoarthritis and small fiber neuropathy. Id.
Dr. Matloubian provided a detailed description of RA. First Matloubian Rep. at 6-9. He
explained that RA is “a systemic inflammatory disease” manifesting in “peripheral arthritis, mainly
in the small joints of the hands and feet.” Id. at 6. Without treatment, RA can cause “deformity
and destruction of joints” that are visible on x-ray as “bony erosions.” Id. Dr. Matloubian explained
that RA affects about 1% of Caucasian people and that women are two to three times more likely
to develop it, with peak onset occurring between ages 50 and 75. Id. at 7.
Dr. Matloubian opined that RA can be difficult to diagnose and that it usually presents with
“insidious onset of pain, stiffness, and swelling in multiple joints over the course of weeks to
months.” First Matloubian Rep. at 7. The American College of Rheumatology and the European
League Against Rheumatism developed classification criteria for RA based on four domains: (1)
number and site of joints involved; (2) serological abnormalities; (3) elevated ESR and CRP; and
(4) symptoms lasting longer than six weeks. Id. Dr. Matloubian noted that Petitioner’s clinical
presentation included shoulder pain, synovitis in the small joints of her hands and her wrists,
elevated ESR and CRP, positive rheumatoid factor, and anti-CCP antibodies. Id.
Dr. Matloubian opined that the pathogenesis of RA is not well understood, but that genetic
and environmental factors are thought to play a role. First Matloubian Rep. at 7. He also opined
that, in RA, the breakdown in immune tolerance and development of autoantibodies such as
rheumatoid factor and anti-CCP antibodies “precede clinically apparent symptoms by several
years.” Id.
Dr. Matloubian opined that the erosion and synovitis in Petitioner’s left knee at the time of
her knee replacement in November 2015 “raise[] the likelihood of ongoing asymptomatic RA
related synovitis in the petitioner’s joints prior to her vaccination, which would be consistent with
the current multi-step models of pathogenesis of RA.” First Matloubian Rep. at 8. Dr. Matloubian
opined that medical literature supports the idea that the RA disease course is divisible into multiple
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phases. Id. One such model proposes six phases: (1) genetic risk factors; (2) environmental risk
factors (e.g., smoking, antibiotics); (3) systemic autoimmunity; (4) clinical symptoms; (5)
unclassified arthritis; and (6) RA. Id. (citing van Steenbergen, et al., The Preclinical Phase of
Rheumatoid Arthritis: What is Acknowledged and What Needs to Be Assessed?, 65(9) ARTHRITIS
& RHEUMATISM 2219-32 (2013) (filed as Ex. A, Tab 11)). Dr. Matloubian opined that factors such
as infections, toxins, drugs, and radiation may impact this progression in a particular patient, but
that the long lag time between development of autoantibodies and clinical disease makes causation
very difficult to establish. Id. at 9. Dr. Matloubian also opined that the apparent complexity of the
pathogenesis of RA makes “simplistic explanations, such as molecular mimicry,” less likely. Id.
Dr. Matloubian next turned to Petitioner’s case. First Matloubian Rep. at 9. He criticized
Dr. Brawer’s expert report, opining that Dr. Brawer ignored significant evidence in the literature
in which researchers have found no evidence of a causal link between vaccines and RA. Id. at 9-
10 (citing Ray, et al., Risk of rheumatoid arthritis following vaccination with tetanus, influenza
and hepatitis B vaccines among persons 15-59 years of age, 29 VACCINE 6592-97 (2011) (filed as
Ex. A, Tab 17) (“Ray”); Fomin, et al., Vaccination against influenza in rheumatoid arthritis: the
effect of disease modifying drugs, including TNFα blockers, 65 ANNALS OF RHEUMATIC DISEASES
191-94 (2006) (filed as Ex. A, Tab 18) (“Fomin”); Bengtsson, et al., Common vaccinations among
adults do not increase the risk of developing rheumatoid arthritis: results from the Swedish EIRA
study, 69 ANNALS OF RHEUMATIC DISEASES 1831-33 (2010) (filed as Ex. A, Tab 19) (“Bengtsson”).
He also disagreed with Dr. Brawer’s reliance on case reports because they lack control groups and
only show “temporal associations of two events in a few individuals.” Id. at 10. Dr. Matloubian
also pointed out that “the American College of Rheumatology recommends influenza
immunization of individuals with autoimmune diseases, including RA,” and that “despite millions
of people being vaccinated each year with influenza virus, reports of temporally related onset of
arthritis is quite rare.” Id. at 11-12.
Dr. Matloubian disagreed with Dr. Brawer’s theory of molecular mimicry as the
mechanism by which the flu vaccine can cause RA. First Matloubian Rep. at 12. He opined that,
with the exception of streptococcal bacterial infection causing rheumatic fever, molecular mimicry
“has rarely been persuasively demonstrated as the cause of autoimmunity in humans.” Id. He
further opined that in order for molecular mimicry to be relevant here, the natural flu infection
should also cause RA in some patients, but it does not. Id. He criticized Dr. Brawer’s bystander
activation hypothesis, opining that because natural flu infection elicits a stronger immune response
than the flu vaccine does, we would expect to see RA caused by flu infections more often than by
the vaccine. Id.
Dr. Matloubian next questioned Dr. Brawer’s reliance on an unfiled article by Kanduc, et
al. to support his claims about peptide sequence homology between the flu vaccine and self-
antigens in the body, calling a simple sequence homology “meaningless.” First Matloubian Rep.
at 12 (citing First Brawer Rep. at 3). He cited medical literature stating that “‘[m]any such
homologies exist, and the vast majority of these are not associated with biologically relevant
autoimmune phenomena or actual human disease.’” Id. at 12-13 (citing INSTITUTE OF MEDICINE,
Adverse Effects of Vaccines: Evidence and Causality (2012) (filed as Ex. A, Tab 25)). He opined
that, in any case, there is strong indication in the medical literature that there is no molecular
mimicry between the flu virus and self-antigens associated with RA. Id. at 13.
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Dr. Matloubian also disagreed with Dr. Brawer’s opinion that the flu vaccine caused
Petitioner’s RA because symptom onset was too close in time to her flu vaccination. First
Matloubian Rep. at 13. He noted that “the autoimmune process that leads to development of this
disease begins years before the disease becomes clinically apparent.” Id. Therefore, he opined that
“it would be virtually impossible for an immune response to be initiated and cause symptoms
within 24 hours and lead to all of her symptoms within 3-4 days as alleged by Dr. Brawer.” Id. He
opined that the B and T cell response needed to cause inflammation would have taken seven to 14
days to reach its peak, plus additional time for those cells to travel to the affected joints. Id.
Dr. Matloubian stressed that the cause of RA in a particular case, including Petitioner’s, is
not ascertainable. First Matloubian Rep. at 13. He pointed out that Dr. Brawer is the author of a
paper finding a link between traumatic injury and development of RA. Id. (citing Brawer & Goel,
The onset of rheumatoid arthritis following trauma, 8 OPEN ACCESS RHEUMATOLOGY: RES. &
REVS. 77-80 (2016) (filed as Ex. A, Tab 29) (“Brawer & Goel”)). Dr. Matloubian opined that Dr.
Brawer’s own research supports the contention that Petitioner’s knee replacement surgery in
November 2015 was “an example of direct joint trauma.” Id. at 14. He posited that “[a]n invasive
procedure such as joint replacement provides an ideal opportunity for the joint related self-antigens
to be released into the blood stream and initiate an autoimmune response.” Id. He also argued that
the timing of onset after surgery (roughly one month) is consistent with the findings in Dr.
Brawer’s article. Id.
Finally, Dr. Matloubian disagreed with Dr. Brawer’s reliance on Petitioner’s symptoms
having begun on the day of her vaccination. First Matloubian Rep. at 14. He opined that this could
have been a coincidence, citing medical literature that calculated the likelihood of coincidental RA
onset after vaccination. Id. (citing Ahmed, et al., Assessing the safety of adjuvanted vaccines, 3(93)
SCI. TRANSLATIONAL MED. 1-10 (2011) (filed as Ex. A, Tab 30) (“Ahmed”). The authors found
that, based on the statistical likelihood of developing RA and the number of vaccine doses
administered, we have a 90% chance of seeing one case of RA onset coinciding with vaccination
for every 10,000 vaccine doses administered. Ahmed at 7. Dr. Matloubian opined that, “[t]aking
into account that 150 million people are annually immunized with influenza in the U.S., we would
expect then that 15,000 individuals would develop RA after such vaccination due to coincidence
alone.” Id. He concluded that, a woman’s lifetime risk of developing RA being one in 28,
Petitioner’s RA was more likely that not unrelated to her flu vaccination. Id.
3. Dr. Brawer: Second Expert Report
In his second expert report, Dr. Brawer criticized Dr. Matloubian as being “first and
foremost a researcher” with limited clinical experience. Ex. 20 (“Second Brawer Rep.”) at 1. In
fact, he spent a significant portion of the report levelling personal attacks against Dr. Matloubian.
Dr. Brawer wrote that Dr. Matloubian had “a cookie cutter one size fits all approach to [RA] that
is untempered by clinical reality.” Id. Later in his report, he referred to Dr. Matloubian’s analysis
as “feeble”, described his opinions as the “epidemiologic ramblings of a research scientist”, and
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stated that the “usefulness and validity” of his expert report was “inversely related to its length.”
Id. at 2-3.11
Dr. Brawer went on to opine that RA is a complex disease with “numerous predisposing
factors other than genetic predisposition and HLA susceptibility,” including, but not limited to,
physical injury, infection, smoking, hormonal imbalance, and vaccinations. Second Brawer Rep.
at 1. He opined that the initial inflammatory events in the early days and weeks of RA in patients
whose disease is triggered by one of these predisposing factors is different from those in a case of
“classical spontaneous” development of RA. Id. He added that laboratory testing can be confusing
or misleading in cases where RA develops due to one of the above triggers because the typical
blood markers may be absent even when a patient meets all of the diagnostic criteria for RA. Id.
4. Dr. Brawer: Third, Fourth, and Fifth Expert Reports
Petitioner next filed three supplemental expert reports from Dr. Brawer on the same day.
Dr. Brawer began his third expert report by opining that the “immunologic landscape in
[RA] encompasses an extraordinary collection of complex phenomena.” Ex. 21 (“Third Brawer
Rep.”) at 1. Dr. Brawer described research into the “spontaneous, chronological pre-clinical
immunologic events preceding the onset of [RA] symptoms and signs,” such as those listed in his
second expert report. Id. He opined that such immunologic triggers for RA are relevant in about
25% of cases. Id. He opined that these triggers initiate “cascades of inflammation” that lead to the
11 Dr. Brawer’s use of personal insults and disparaging language against Dr. Matloubian was such that I
twice addressed the issue with Petitioner’s counsel during status conferences. ECF Nos. 43, 53. I informed
counsel that such conduct is unhelpful and detracts from Dr. Brawer’s medical opinion. ECF No. 53. I
further note that my colleagues have previously remarked upon Dr. Brawer’s use of language identical to
that employed in Petitioner’s case. McDonald v. Sec’y of Health & Hum. Servs., No. 15-612V, 2023 WL
2387844, at *6 (Fed. Cl. Spec. Mstr. Mar. 7, 2023) (noting that Dr. Brawer engaged in unnecessary personal
criticism of Respondent’s expert when he stated that Dr. Wallace’s expert report “manifests a ‘cookie cutter’
view of neurological fatiguing syndromes … untampered [sic] by clinical reality.”); Whelan v. Sec’y of
Health & Hum. Servs., No. 16-1174V, 2019 WL 1061473, at *4 fn. 10 (Fed. Cl. Spec. Mstr. Jan. 28, 2019)
(stating “Dr. Brawer also dedicates a sizable portion of his supplemental report to criticizing Dr.
Matloubian’s report, largely by way of ad hominem attacks on Dr. Matloubian himself,…characterizing
Dr. Matloubian as … having ‘a cookie-cutter, one-size fits all approach to inflammatory systemic
connective tissue diseases that is untampered [sic] by clinical reality,’…and asserting that ‘the usefulness
and validity of Dr. Matloubian’s report of November 28, 2017 is inversely related to its length’)”); Braun
v. Sec’y of Health & Hum. Servs., No. 16-1098V, 2018 WL 2375751, at *15 (Fed. Cl. Spec. Mstr. Apr. 24,
2018) (noting Dr. Brawer’s remark that “‘Dr. Matloubian has a cookie cutter, one size fits all approach to
[systemic lupus erythematosus] that is untampered [sic] by clinical reality.’”). It is, of course, well within
the purview of an expert witness to express disagreement with the opinion of another expert witness.
However, I find that Dr. Brawer’s continued disparaging remarks about Dr. Matloubian’s opinion,
experience, and character went beyond professional disagreement and were both unnecessary and
unhelpful.
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development of RA. Id. He stated that traditional, “‘classical’” models of RA do not take this into
account. Id.
Dr. Brawer went on to opine that the theories discussed in his first expert report may not
be the exclusive cause of RA. Third Brawer Rep. at 1. Rather, they “may eventually wind up being
secondary amplification loops that confer chronicity to [RA] once it has been acutely triggered”
by vaccine-induced inflammatory cascades. Id. He opined that assigning a precise timeline to
vaccine-induced RA onset is difficult, stating that “chronological parameters are not compatible
with the broad spectrum of medical realities.” Id. at 1-2.
Dr. Brawer began his fourth expert report by stating that “[t]he discrepancies and confusion
in this case can essentially be distilled down to one simple fact: immunological disturbances in the
human body are not synonymous with inflammatory disturbances in the human body.” Ex. 22
(“Fourth Brawer Rep.”) at 1. He added that immune dysregulation can cause chronic inflammation,
but that it does not always, and that, likewise, acute inflammation can cause local immunologic
disturbance that then disseminates to other parts of the body. Id.
Dr. Brawer reiterated his list of triggers that can initiate systemic inflammatory processes.
Fourth Brawer Rep. at 1. He opined that each trigger can initiate acute inflammation that can lead
to “the local appearance of immunocompetent cells,” which in turn can lead to widespread
inflammatory conditions such as RA. Id. He noted that, while diagnosis of RA requires at least six
weeks of continuous polyarthritis, in about 10 percent of cases of idiopathic RA, onset begins in a
single joint and does not spread to other joints for five years. Id. He opined that this fact “implies
that diverse disjointed mechanisms of disease progression are operative.” Id.
Dr. Brawer discussed the example of mono- or polyarthritis caused by viral infection.
Fourth Brawer Rep. at 1-2. He explained that infection-associated arthritis can persist after the
resolution of other symptoms and eventually evolve into RA. Id. He stressed the heterogeneity of
laboratory findings in such cases, especially the white cell counts in synovial fluid, and argued that
this is evidence that “multiple mechanisms of disease causation are operative.” Id. at 2.
Dr. Brawer stated that recent medical literature supports an increased risk of developing
RA and systemic lupus erythematosus “following severe emotional upset.” Fourth Brawer Rep. at
2. He noted that there is evidence that severe childhood trauma (e.g., the loss of a parent) is
associated with increased risk of developing RA as an adult. Id. He also described cases he has
seen in his clinical practice wherein severe temperature exposure triggers acute onset of RA. Id.
Dr. Brawer concluded by reiterating his opinion that the timeline of onset of RA after a
triggering event is highly variable, from 24 hours to three weeks. Fourth Brawer Rep. at 2. He also
reiterated his opinion that theories pertaining to idiopathic RA do not pertain to cases of RA
triggered by the events he has described. Id.
In his fifth expert report, Dr. Brawer opined that Petitioner’s flu vaccination “triggered an
immediate and brisk inflammatory response,” the persistence of which “implies that
immunocompetent cells had joined the reaction.” Ex. 23 (“Fifth Brawer Rep.”) at 1. He further
opined that Petitioner’s immunologic response spread to other parts of her body by means of
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“cellular proliferation and migration,” resulting in autoimmunity and RA. Id. He argued that
vaccine-induced disease mechanisms “become accompanied by multiple slowly escalating
amplification loops comprising other adverse immunologic responses.” Id.
Dr. Brawer opined that it is likely that multiple mechanisms of vaccine-induced disease
operate at the same time, but that their effects are not necessary felt simultaneously. Fifth Brawer
Rep. at 1. He reiterated his opinion that an onset window of 24 hours to several weeks was
plausible. Id.
5. Dr. Matloubian: Second Expert Report
In his second expert report, Dr. Matloubian responded to Dr. Brawer’s second, third, fourth,
and fifth expert reports. Ex. C (“Second Matloubian Rep.”) at 1. Dr. Matloubian opined that Dr.
Brawer’s theory of causation in this case “is entirely based on a temporal relationship between two
events: vaccination and development of disease.” Id. He criticized Dr. Brawer’s reliance on case
reports and anecdotes from his clinical practice and his lack of consideration for peer-reviewed
literature. Id.
Dr. Matloubian reiterated his opinion that the timing of symptom onset in Petitioner’s case
cuts against vaccine causation because “RA begins years before the affected individual becomes
symptomatic.” Second Matloubian Rep. at 2.
Dr. Matloubian disagreed with Dr. Brawer’s list of environmental triggers for RA because
some of them “have not been substantiated by careful and controlled research, whose goal is to
distinguish coincidence from causation.” Second Matloubian Rep. at 2. He opined that evidence
in the literature that vaccines can trigger RA is based on case reports only and that only female sex
and a history of smoking have been consistently shown to raise the risk of developing RA. Id. He
also opined that environmental factors that influence the transition from pre-clinical to clinical RA
would not act within 24 hours as Dr. Brawer contends. Id.
Dr. Matloubian also explained in greater detail his critique of Dr. Brawer’s reliance on case
reports. Second Matloubian Rep. at 3. He reiterated his opinion that coincidence cannot be ruled
out without a control group. Id. He also opined that a serious problem with case reports is that the
author does not discuss the entire medical record, but rather the selections from it that he or she
deems relevant. Id. at 4. The issue with this, Dr. Matloubian argues, is that there may be parts of
the medical record that are arguably relevant to causation that are left out of the case report. Id. As
an example, Dr. Matloubian stated that he served as Respondent’s expert in one of the cases in the
article by Brawer & Koyoda that was litigated in the Vaccine Program, and thus had access to the
entire medical record. Id. He took issue with the decision in Brawer & Koyoda not to discuss the
patient’s case of GBS four months after vaccination as being relevant to their conclusion that her
vaccination may have caused her to develop lupus erythematosus. Id. (citing Brawer & Koyoda,
The onset of rheumatoid arthritis and systemic lupus erythematosus following influenza
vaccination: Report of three cases, 4:3 CLIN. MICROBIOL. & INFECTIOUS DISEASE 1-3 (2019) (filed
as Ex. 25) (“Brawer & Koyoda”)). Dr. Matloubian opined that the increased muscle enzymes that
Dr. Brawer attributed to her lupus may actually have been related to her GBS, and used this case
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to illustrate his opinion that case reports are not good evidence of causal relationships because
parts of the medical record may be left out. Id.
Dr. Matloubian concluded by distinguishing his analysis from Dr. Brawer’s, stating that
his opinion was based “not on [his] personal experience, but on what the experts have published
in the literature based on their analysis of carefully done controlled studies.” Second Matloubian
Rep. at 4.
6. Dr. Brawer: Sixth Expert Report
Dr. Brawer began his sixth expert report by criticizing Dr. Matloubian for having “once
again redundantly regurgitated the mechanisms of [RA] beginning spontaneously.” Ex. 27 (“Sixth
Brawer Rep.”) at 1. He reiterated his opinion that the mechanisms of idiopathic RA differ from
those in cases of vaccine-induced RA. Id. Dr. Brawer also took issue with Dr. Matloubian’s
critique of Dr. Brawer’s recent publication. Id. (citing Brawer & Koyoda). He opined that Dr.
Matloubian “obviously prefers that one unilaterally and compartmentally evaluate any medical
case solely by perusal of statements in a single hospital chart” and that Dr. Matloubian’s remarks
on the case in Brawer & Koyoda “should, without reservation, be completely disregarded.” Id. at
2. He referred to Dr. Matloubian’s remarks as “callous” and suggested that they “are more likely
to adversely reflect on his own flippant integrity and truncated clinical experience.” Id.
C. Expert Testimony
1. Dr. Brawer
At the entitlement hearing, Dr. Brawer stated that, prior to her December 6, 2015, flu
vaccination, Petitioner suffered from COPD, atrial fibrillation, leg edema, allergic rhinitis,
gastroesophageal reflux, penicillin allergy, hemorrhoids, calcific tendinitis and rotator cuff damage
in her shoulders, and degenerative joint disease, also known as osteoarthritis, in her knees, spine,
and some small joints in her hands. Tr. at 46-47. Dr. Brawer explained that osteoarthritis is the
kind of arthritis that frequently happens in old age. Id. at 47. He explained that osteoarthritis has a
typical distribution in the body and that it “differs significantly from inflammatory conditions such
as [RA].” Id.
Dr. Brawer testified that he had reviewed the lab work ordered by Dr. Hoerner and
explained that the ESR “is essentially a blood test for inflammation.” Tr. at 48. He opined that a
normal result for a person of Petitioner’s age would be 30 or less. Id. He noted that Petitioner’s
ESR was normal just before her knee replacement surgery in November 2015 while she was
already suffering from osteoarthritis. Id. at 48-49. Dr. Brawer went on to explain that the
rheumatoid factor is a test “that is usually positive in about 80% of patients with [RA],” and that
it is not typically tested unless RA is suspected. Id. at 50. He opined that Petitioner’s rheumatoid
factor after vaccination was “markedly positive.” Id. He opined that osteoarthritis does not evolve
into RA because osteoarthritis is not a systemic inflammatory autoimmune disease. Id. at 51.
Dr. Brawer testified that there is evidence in the medical literature to suggest that RA may
be a syndrome rather than a disease, and that chronic inflammation can lead to systemic
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autoimmune diseases such as RA. Tr. at 52. He referred to a study conducted in Scandinavia in the
1970’s that examined cases of RA following skiing injuries. Id. at 53. The authors found that the
rates of positive ANA among subjects was 10 to 12 percent within one week of injury, 14 percent
within two weeks, and 20 percent within three weeks. Id. (citing Julkunen, et al., Severe trauma
as an etiologic factor in rheumatoid arthritis, 3 SCANDINAVIAN J. RHEUMATOLOGY 97-102 (1974)
(filed as Ex. 42) (“Julkunen”)). Dr. Brawer testified that the findings of this study led to further
research into “how physical injuries could initiate chronic inflammation at the site of the injuries
and then lead to the spread of that inflammation to multiple other joints…and eventually morph
into [RA].” Tr. at 55. This research suggests that chronic inflammation, regardless of how it is
initiated, if unchecked, can trigger a systemic immunologic reaction that can lead to chronic
disease, including RA. Id. at 55-56.
Dr. Brawer testified that it is not possible for a total knee replacement to trigger RA because
the procedure involves the removal of the entire synovium, which is the source of inflammation
and joint destruction in RA. Tr. at 56. Accordingly, he opined that Petitioner’s knee replacement
surgery was not relevant to the cause of her RA. Id. at 57.
Dr. Brawer testified that, in Petitioner’s case, three questions must be asked: (1) what
condition Petitioner has; (2) how Petitioner got it; and (3) why, or by what mechanism, Petitioner
got it. Tr. at 57. He added that he finds theories of molecular mimicry problematic because they
do not explain why a variety of vaccines can cause the same condition, or why one vaccine can
cause a variety of conditions. Id. at 58.
Dr. Brawer testified that at least half a dozen mechanisms can participate in the production
of vaccine-induced autoimmunity. Tr. at 59. He stated that “multiple mechanisms may be triggered
on day one of the vaccination, [but] they are not necessarily all clinically relevant on day one of
the vaccination.” Id. He opined that what is required is “a perfect storm,” which is to say that “half
a dozen things need to come together to produce vaccine toxicity, and molecular mimicry is only
one part of that.” Id. at 60.
Dr. Brawer explained his theory of causation as follows:
[I]f you have localized inflammation set up in a certain area from the vaccine and
it doesn’t quiet down, that inflammation is capable of recruiting immunocompetent
cells. That inflammation is capable of then having that inflammation travel to
distant areas by various mechanisms…if it goes on for six weeks or longer in
multiple joints, then you have to decide whether indeed the [RA] was indeed
triggered by the vaccination.
Tr. at 60.
Dr. Brawer noted that the vast majority of people tolerate vaccines well and opined that
only in cases of “the perfect storm” will a vaccine cause autoimmune disease. Tr. at 60. He opined
that “the perfect storm” requires involvement of regulatory T cells, the cells responsible for
regulating and shutting down the immune response that occurs upon vaccination. Id. at 61. Dr.
Brawer posited that the failure of regulatory T cells to shut down the immune response is partly to
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blame for the overactive immune response leading to autoimmunity. Id. Dr. Brawer went on to
opine that channelopathies12 are relevant to regulatory T cells, as well as to other
immunocompetent cells. Id. at 62. Dr. Brawer explained that, of the roughly 400 known
channelopathies, over 300 do not have any clinical consequence without a triggering event (e.g., a
febrile seizure). Id.
Dr. Brawer opined that several factors are required to create “the perfect storm” and lead
to autoimmunity, including “regulatory T cell dysfunction, chemical toxicity, channelopathies,
mitochondrial dysfunction, and what we call DAMPs, or damage-associated pathogens, molecular
pathogens.” Tr. at 63. He went on to opine that this heterogeneity may explain why one vaccine
can cause several different autoimmune problems and why the same autoimmune problem can be
caused by several different vaccines, as well as the diversity in timing of disease onset. Id. at 64.
Dr. Brawer testified that he cannot explain why a patient experiences “the perfect storm”
and autoimmunity upon receiving a vaccine when the same patient received previous vaccines
without incident. Tr. at 64. He added that he has seen this happen in his practice. Id.
Dr. Brawer opined that Petitioner had chronic inflammation at the vaccination site that
spread from one shoulder to the other, and then to her wrists and hands. Tr. at 65-66. He noted that
these are not the joints normally affected by osteoarthritis. Id. at 66. He posited that Petitioner’s
condition was “an additive polyarthritis that then [became] chronic.” Id.
Dr. Brawer next addressed Petitioner’s testimony that she suffered from neuropathy. Tr. at
67. He opined that Petitioner had “several types of neuropathies. I think she had some entrapment
phenomenon at her wrists that produced carpal tunnel syndrome.” Id. He explained that swelling
in the wrists can compress the nerves that lead to the fingers, causing pins-and-needles sensations
and pain in the fingers and hands. Id. He testified that neuropathies are among the extra-articular
manifestations of RA, along with “rheumatoid nodules…Sjogren’s syndrome, dryness in the
eyes.” Id. at 68.
Dr. Brawer testified that RA is a complex disease with “numerous predisposing factors
other than genetic predisposition and HLA susceptibility.” Tr. at 69. These include, but are not
limited to, physical injuries, infections, severe emotional upset, exposure to chemicals such as
pesticides, smoking, hypoxia, hormonal imbalance, prolonged exposure to unusual temperature
changes, and vaccinations. Id. at 69-70. Dr. Brawer opined that these triggers “actually account
for the vast majority of cases as opposed to the traditional concepts…that this is an immunologic
12 Dr. Brawer alluded to his own research on channelopathies, which explains that “[s]odium, potassium,
and other ions routinely fluctuate in and out of cells through pores (channels) in cell membranes.
Channelopathies are diseases caused by disturbed function of ion channel components and/or the proteins
that regulate them. These diseases are either congenital (i.e., from a mutation in one or more genes encoding
the proteins) or acquired. Examples of the latter can occur from autoimmune attack on ion channel proteins,
ligand anomalies, or from chemical toxicity.” Arthur Brawer, Vaccination Induced Diseases and their
Relationship to Neurologic Fatiguing Syndromes, Channelopathies, Breast Implant Illness, and
Autoimmunity via Molecular Mimicry, 4 INT’L J. VACCINES & IMMUNIZATION 1-5, at 2 (2020) (filed as Ex.
31) (“Brawer”).
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problem that begins decades or several months or several years before the actual joint inflammation
itself occurs.” Id. at 70. He opined that RA “is getting more perplexing, not less perplexing.” Id.
Dr. Brawer gave three reasons for his opinion that the flu vaccine caused Petitioner’s RA.
Tr. at 71. First, Petitioner did not have RA prior to vaccination on December 6, 2015. Id. Second,
“the chronological sequence of events is very classical for vaccine-induced toxicity producing an
autoimmune problem.” Id. Finally, he opined that, but for the flu vaccine, Petitioner likely would
not be suffering from RA. Id.
Dr. Brawer testified that he bases his theories in this case on his 46 years as a clinician. Tr.
at 72. He acknowledged that his theories still require verification or refutation in a research setting.
Id. He reiterated his opinion that vaccine-induced toxicity is the result of many factors and opined
that molecular mimicry alone is not enough. Id. at 72-73.
Dr. Brawer responded to Dr. Matloubian’s reliance on medical literature in his expert
reports, opining that “you can’t force fit the patients into the research. The researchers have to
explain what we see at the bedside.” Tr. at 75. Dr. Brawer opined that the onset of Petitioner’s RA
occurred very soon after she received the vaccine because of the inflammatory response, which
precedes the immunologic response. Id. at 77.
On cross examination, Dr. Brawer testified that, while he is not certified to practice
alternative medicine, he has written a book on the subject and “do[es] apply alternative medicine
disciplines” to some patients. Id. at 81.
Dr. Brawer testified that, in one of his articles, he discusses three cases of post-vaccination
injury, each of which was litigated in the Vaccine Program. Tr. at 82-83 (citing Brawer & Koyoda).
He conceded that he served as petitioner’s expert witness in each of the three cases, but he opined
that there was no conflict of interest in doing so because he evaluated each case on its merits. Id.
at 86. Dr. Brawer agreed with the statement that temporal association between vaccination and
autoimmunity is not enough to establish causation. Id. at 89.
Dr. Brawer testified that, in his practice, he has known infections to be causally related to
seropositive RA. Tr. at 89. He added that he has seen patients present with a viral infection and
abnormal liver function in whom the arthritis persists after the other symptoms resolve. Id. at 90-
91. He declined to state that any vaccination can cause RA, but opined that both the hepatitis B
and measles, mumps, and rubella (“MMR”) vaccines can. Id. at 91, 93.
Dr. Brawer opined that it is highly probable that, in Petitioner’s case, components of the
flu vaccine played a role in influencing epigenetics, leading to Petitioner’s injury. Tr. at 98. He
explained that vaccine additives can alter gene expression (i.e., “genes may turn off that should be
turned on, or genes that turn on that should be turned off.”). Id. at 97-98.
Dr. Brawer opined that Petitioner’s initial inflammation was in her left shoulder. Tr. at 99.
He added that this was in the context of her chronic illness but was only diagnosable as RA after
it had persisted for six weeks. Id. at 99-100. Dr. Brawer maintained that it is clear that Petitioner’s
RA began within 24 hours of receiving the flu vaccine. Id. at 102-03.
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I asked Dr. Brawer to succinctly summarize his theory of causation under prong one of
Althen. Tr. at 102. He replied that “there are essentially roughly half a dozen different elements
participating in the production of vaccine toxicity that can then trigger a systemic autoimmune
condition.” Id. at 103. He added that “these entities may not necessarily all be clinically relevant
on day one or day two of the vaccination process.” Id. He opined that “molecular mimicry has
some role in this, but it certainly cannot possibly exist by itself, and probably doesn’t become
clinically relevant until three or four weeks after the initial vaccination.” Id. He opined that
“chemicals in the vaccine are capable of initiating acute inflammation,” and that “in the presence
of certain chemicals, these ion channels become dysfunctional,” leading to channelopathy. Id. at
104. He continued, stating that “there are ion channels in immunocompetent cells, including
regulatory T cells and including macrophages and dendritic cells and polymorphoneuclear
leukocytes.” Id. He opined that channel dysfunction of immunocompetent cells is “part of this
augmentation-amplification loop causing dysfunction that can become self-perpetuating.” Id. He
added that dysfunctional mitochondria within cells “are capable of initiating both
autoinflammatory and autoimmune processes.” Id. He emphasized that the “incredible diversity
and heterogeneity [of] vaccine toxicity” is evidence that [t]here has to be more than just one
component.” Id. at 106.
Dr. Brawer concluded by opining that a flu infection can cause RA, but that it is “very
rare.” Tr. at 107.
On redirect examination, Dr. Brawer testified that osteoarthritis causes inflammation and
synovitis in the joints, but that these processes are different from the inflammation and synovitis
caused by RA. Tr. at 186. He opined that, while the pathology report on Petitioner’s knee at the
time of her replacement surgery found synovitis, bone resorption, and erosion, “these are common
findings in end-stage osteoarthritis” and do not indicate that Petitioner had RA. Id. Dr. Brawer
disagreed with Dr. Matloubian, saying that “it’s simply preposterous to assume that [Petitioner]
had [RA] in her knee superimposed on her osteoarthritis just because a pathologist described
synovitis and bone erosion and loss of cartilage.” Id. at 187.
Dr. Brawer opined that RA most often occurs in women younger than Petitioner (i.e.,
between the ages of 30 and 50). Tr. at 187. He also criticized Dr. Matloubian’s testimony that
Petitioner had nonerosive RA because an x-ray would be needed to make this determination. Id.
at 188. He opined that this claim was inconsistent with Dr. Matloubian’s other contention that
Petitioner’s knee pathology showed erosions and bone loss. Id.
Dr. Brawer testified that patients with osteoarthritis frequently develop calcium deposits
in the synovium and surrounding tissues. Tr. at 197. He opined that these deposits can cause the
pathological features of osteoarthritis to take on the appearance of RA, and that accompanying
synovitis can resemble RA inflammation because inflammatory and immunocompetent cells are
present in the synovium and bone erosion occurs. Id. He reiterated his opinion that Petitioner did
not have RA prior to receiving the flu vaccine on December 6, 2015. Id. at 198.
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2. Dr. Matloubian
Dr. Matloubian also testified at the entitlement hearing. Tr. at 110-85. He began by
explaining that RA is “a chronic autoimmune inflammatory arthritis” affecting the joints, as well
as other organs. Tr. at 117-18. He testified that RA affects about 1% of the Caucasian population
and is about three times more common in women than in men. Id. at 118. He added that peak onset
is during the ages of 50 to 75, but onset can occur at any age. Id. Dr. Matloubian explained that in
RA, B lymphocytes and T cells begin to attack parts of the body, causing chronic inflammation
and damage. Id. at 118-19. There are two types: seropositive RA, which is associated with anti-
CCP13 positivity; and seronegative RA, in which the patient exhibits clinical symptoms of RA, but
is negative for anti-CCP antibodies. Id.
Dr. Matloubian opined that HLA, or human leukocyte antigen, alleles are thought to play
a role in RA. Tr. at 120, 122.
Dr. Matloubian testified that diagnosis of RA begins with a clinical diagnosis of
inflammatory arthritis consistent with RA, which involves a physical exam and taking of the
patient’s medical history, and a finding of active joint inflammation or synovitis. Tr. at 120-21.
The clinical diagnosis is then confirmed with x-rays and blood tests. Id. at 121. A positive test for
anti-CCP antibodies will lead to a diagnosis of seropositive RA. Id. Dr. Matloubian reiterated his
opinion that Petitioner has seropositive nonerosive RA. Id. at 122.
Dr. Matloubian opined that the pre-clinical phase of Petitioner’s RA began prior to her
December 6, 2015, flu vaccination. Tr. at 122. He also opined that the pre-clinical phase of RA
can last for many years, and on average lasts three to five years. Id. He cited the synovitis and
erosion in Petitioner’s left knee at the time of her knee replacement in November 2015 as evidence
that she already had RA at that time. Id. at 123. Dr. Matloubian explained that synovitis is the
proliferation of the synovium, the layer that lines the joint capsule. Id. at 123. Ordinarily, the
synovium is only one cell thick, and synovitis results in a mass of cells rather than a thin layer. Id.
Dr. Matloubian explained that osteoarthritis is different from RA in that it is a degenerative
bone disease resulting from normal wear and tear on joints as the body ages. Tr. at 124. He opined
that osteoarthritis is characterized by loss of cartilage and consequent growing of additional bone
material, and thus is not consistent with erosion. Id. He opined that synovitis accompanied by
erosion is not typically associated with osteoarthritis either. Id. He explained that erosion is the
invasion of bone by the proliferating synovial cells. Id. He cited medical literature supporting the
contention that synovitis can be present in a joint before the patient feels symptoms of RA. Id. at
125-26 (citing Kraan, et al., Asymptomatic synovitis precedes clinically manifest arthritis, 41(8)
ARTHRITIS & RHEUMATISM 1481-88 (1998) (filed as Ex. A, Tab 9) (“Kraan”) (reporting that biopsy
showed evidence of synovitis in asymptomatic joints in RA patients)). Dr. Matloubian opined that
it is more likely than not that Petitioner had anti-CCP antibodies and positive rheumatoid factor
prior to vaccination based on the predominant view in the field of seropositive RA. Id. at 128-29.
13 Dr. Matloubian testified that “anti-CCP” refers to antibodies that attack cyclic citrullinated peptides.
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Dr. Matloubian expressed the opinion that it is more likely than not that the flu vaccine
played no role in her RA. Tr. at 129. He noted that Petitioner is female and a former smoker, both
of which are risk factors for developing RA. Id. at 130. He also noted that her disease onset
occurred during the typical age range. Id.
Dr. Matloubian opined that there is no association between the flu vaccine and
development of RA. Tr. at 130. In support of this opinion, he noted that the current guidance in
the medical community is to recommend annual flu vaccination to patients with RA. Id. He opined
that the medical literature indicates that RA patients respond to the flu vaccine itself, but that it
does not lead to disease flares in RA patients. Id. He denied that there is any evidence of molecular
mimicry between components of the flu vaccine and antigens known to be involved in RA
development. Id. at 131.
Dr. Matloubian next elaborated on his opinion that a history of smoking increases the risk
of developing RA. Tr. at 131. He cited medical literature positing a link between smoking and
citrullinated peptides that bind to HLAs and elevate the risk of RA. Id. at 131-32 (citing
Malmström, et al., The immunopathogenesis of seropositive rheumatoid arthritis: from triggering
to targeting, NATURE REVS.: IMMUNOLOGY 1-16 (2016) (filed as Ex. A, Tab 4)). He noted that
Petitioner had smoked roughly half a pack of cigarettes per day for four years prior to 1979. Id. at
132. He declined to say for certain that smoking caused Petitioner to develop RA.14 Id.
Dr. Matloubian opined that some literature suggests that the elevated risk of RA from
smoking may have to do with up-regulation of certain enzymes in the mucosa of the lungs, leading
to production of citrullinated peptides. Tr. at 133. He opined that these citrullinated peptides break
down immune tolerance in people with HLA-based susceptibility. Id. For this same reason, he
opined, the literature suggests that there may be a link between periodontal disease and RA by way
of the mucosa in the mouth. Id. at 134. He added that a third theory is that changes in the
microbiome of the gut can also contribute to RA, but that more research is needed in this area. Id.
at 135.
Dr. Matloubian opined that influenza virus is not considered to be a cause of RA. Tr. at
136. He added that influenza can cause inflammation in the lungs, but that this inflammation does
not apparently lead to breakdown of immune tolerance. Id. at 137.
Dr. Matloubian next took issue with several of the environmental triggers that Dr. Brawer
opined can lead to the development of RA. Tr. at 137. He opined that he was unaware of any link
between severe emotional upset, pesticides and insecticides, hypoxia, hormonal imbalances, or
prolonged exposure to unusual temperature changes and RA. Id. at 137-38. He agreed that there is
a known link between streptococcal infections and rheumatic fever, as well as between
campylobacter jejuni infection and Guillain-Barré syndrome. Id. at 138. He also opined that
reactive arthritis can occur after chlamydia, urethritis, or infection with salmonella or shigella, but
14 When asked to opine on Petitioner’s smoking history as having been roughly half a pack per week rather
than per day, Dr. Matloubian declined to say that this would have decreased or eliminated her risk of
developing RA. Tr. at 171-72. He opined that there is a risk of developing RA even many years after a
person stops smoking but conceded that the risk does decrease with time. Id. at 172.
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opined that RA is not a post-infectious autoimmune disease. Id. Dr. Matloubian testified that, while
certain infections, such as hepatitis B and C, are associated with inflammatory polyarthritis, this
most often resolves within two to four weeks. Id. at 139. A diagnosis of RA, by contrast, requires
six weeks of continuous symptoms. Id. He opined that influenza has not been associated with even
transient inflammatory polyarthritis. Id.
Dr. Matloubian disagreed with Dr. Brawer’s “perfect storm” theory of causation, opining
that many of the factors Dr. Brawer pointed to, such as channelopathies, mitochondrial
dysfunction, and toxins, have not been validated in the literature. Tr. at 141. He opined that this
theory was “speculative and not established and not reliable.” Id. He opined that, at any rate, there
has been no evidence presented that Petitioner suffers from a channelopathy or mitochondrial
dysfunction. Id. at 142.
Dr. Matloubian next gave his definition for molecular mimicry as the reaction of T and B
cells to self-antigens as though they were foreign antigens. Tr. at 143. He opined that peptide
sequence homology between self-antigens and foreign antigens is quite common, but that not all
such homologies are biologically relevant. Id. That is to say, he opined, that not every instance of
molecular mimicry causes disease. Id. Dr. Matloubian testified that “there’s no evidence in the
medical or scientific literature that there is molecular mimicry between influenza vaccine or virus-
associated antigens and those antigens that are found to be associated with seropositive [RA].” Id.
at 144. As support for this opinion, Dr. Matloubian added that researchers who study the
pathogenesis of RA “use antigens derived from influenza virus as a negative control.” Id. at 145.
Dr. Matloubian opined that, if molecular mimicry were to cause RA, that he would expect
the time between exposure to the antigen and clinical symptoms would be about a week. Tr. at
145. This accounts for the time needed to produce a robust T and B cell response and for the T and
B cells to travel to the site of inflammation. Id. at 145-46. He cited medical literature that argues
that, if a vaccine can trigger an autoimmune condition via molecular mimicry, then the natural
infection should be able to trigger that autoimmune condition as well. Id. at 147-48 (citing Ami
Schattner, Consequence or coincidence? The occurrence, pathogenesis, and significance of
autoimmune manifestations after viral vaccines, 23 VACCINE 3876-86 (2005) (filed as Ex. A, Tab
24) (“Schattner”)). Dr. Matloubian argued that this phenomenon would need to be demonstrated
by studies, not by case reports, in order to be credible. Id. at 148.
Dr. Matloubian reiterated his opinion that, based on the literature, there is no link between
viral vaccines and autoimmunity. Tr. at 149. He also reiterated his point that the flu vaccine is
recommended for patients with RA. Id. He explained that this is so because RA patients are
frequently prescribed immunosuppressant medications, making flu infection more dangerous, and
because “there’s no risk to vaccines.” Id.
Upon questioning by the Court, Dr. Matloubian opined that it is more likely than not that
the synovitis and erosion noted prior to Petitioner’s knee replacement surgery in November 2015
constituted the pre-clinical phase of her RA. Tr. at 180. He explained this by opining that
osteoarthritis is a “bone-forming disease,” meaning that, as cartilage wears away with age,
osteoarthritis causes the bones to grow together. Id. at 180-81. By contrast, he continued, RA is a
“bone-destroying disease” in which the profusion of profusion of the synovium erodes the bone.
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Id. at 181. Dr. Matloubian testified that it is possible for a patient to have both osteoarthritis and
RA at the same time. Id.
Dr. Matloubian opined that it is difficult to draw conclusions about the length of the lag
time between onset of pre-clinical RA and clinical symptoms because it is rare for a patient to
undergo blood testing for RA markers until symptoms of RA begin to appear. Tr. at 182. He
testified that one exception was a study of military recruits who gave blood samples at multiple
points over the course of their service. Id. Close relatives of patients known to have RA have also
been tested and found to develop RA within three to five years of testing positive for anti-CCP
antibodies. Id. at 183.
D. Post-Hearing Expert Reports
At the conclusion of the entitlement hearing, I requested an additional supplemental expert
report from each party addressing synovitis and erosion and whether they are common findings in
cases of osteoarthritis. Tr. at 202.
1. Dr. Brawer
In his seventh expert report, Dr. Brawer responded to my question, saying that the medical
literature demonstrates that erosive changes occasionally occur in cases of osteoarthritis, but that
this is not frequent. Ex. 53 (“Seventh Brawer Rep.”) at 1. He opined that “[i]t is much more
common for end stage Osteoarthritis to demonstrate synovitis,” and noted that this is consistent
with the November 5, 2015, pathology report of Petitioner’s knee just before her knee replacement
surgery. Id. He disagreed with Dr. Matloubian’s testimony that Petitioner was suffering from
seronegative15 erosive RA in her knee prior to the flu vaccine, citing this same pathology report.
Id. Dr. Brawer concluded by reiterating his opinion that Petitioner did not clinically manifest RA
prior to her vaccination. Id.
2. Dr. Matloubian
In his third expert report, Dr. Matloubian responded to my question above. Ex. D (“Third
Matloubian Rep.”) at 1. He cited medical literature supporting the idea that erosion can occur in
osteoarthritis, but that this is rare and restricted to the small joints of the hands. Id. (citing Doherty
& Abhishek, Clinical manifestations and diagnosis of osteoarthritis, UP TO DATE (2021) (filed as
Ex. D, Tab 1)). Dr. Matloubian opined that the medical literature does not support the occurrence
of erosion in osteoarthritis of the knee. Id.
Dr. Matloubian concluded that Petitioner’s medical literature also provides support for his
previous hypothesis that Petitioner’s knee replacement surgery may have been a physical trauma
that triggered her RA. Id. (citing Julkunen; Al-Allaf, et al., A case-control study examining the
15 Dr. Matloubian did not opine that Petitioner suffered from seronegative RA. Tr. at 122-23; First
Matloubian Rep. at 7. Instead, Dr. Matloubian’s opinion is that Petitioner developed RA prior to
vaccination, and prior to her bloodwork that established her disease was seropositive.
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role of physical trauma on the onset of rheumatoid arthritis, 40 RHEUMATOLOGY 262-66 (2001)
(filed as Ex. 43) (“Al-Allaf”)).
V. Applicable Law
A. Petitioner’s Burden in Vaccine Program Cases
Under the Vaccine Act, when a petitioner suffers an alleged injury that is not listed in the
Vaccine Injury Table, a petitioner may demonstrate that she suffered an “off-Table” injury.
§ 11(c)(1)(C)(ii).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
off-Table claim, a petitioner must satisfy all three of the elements established by the Federal Circuit
in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen requires that
petitioner establish by preponderant evidence that the vaccination she received caused her injury
“by providing: (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.” Id. at 1278.
Under the first prong of Althen, petitioners must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at
1355-56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound
and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d
543, 548 (Fed. Cir. 1994). Proof that the proffered medical theory is reasonable, plausible, or
possible does not satisfy a petitioner’s burden. Boatmon v. Sec’y of Health & Hum. Servs., 941
F.3d 1351, 1359-60 (Fed. Cir. 2019).
Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). However, special masters are “entitled to require some indicia
of reliability to support the assertion of the expert witness.” Boatmon, 941 F.3d at 1360, quoting
Moberly, 592 F.3d at 1324. Special Masters, despite their expertise, are not empowered by statute
to conclusively resolve what are complex scientific and medical questions, and thus scientific
evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian,
but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at
1380. Accordingly, special masters must take care not to increase the burden placed on petitioners
in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of Health & Hum.
Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017);
see also Hock v. Sec’y of Health & Hum. Servs., No. 17-168V, 2020 U.S. Claims LEXIS 2202 at
*52 (Fed. Cl. Spec. Mstr. Sept. 30, 2020).
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion
testimony are favored in vaccine cases, as treating physicians are likely to be in the best position
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to determine whether a ‘logical sequence of cause-and-effect show[s] that the vaccination was the
reason for the injury’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed
as particularly trustworthy evidence, since they are created contemporaneously with the treatment
of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”). As with expert testimony offered to establish a theory of causation, the opinions or
diagnoses of treating physicians are only as trustworthy as the reasonableness of their suppositions
or bases. The views of treating physicians should also be weighed against other, contrary evidence
also present in the record. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742, 749 (2011),
aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health & Hum. Servs., No. 06-522V, 2011
WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344,
356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed. Cir. 2012).
The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to
the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant
proof that the onset of symptoms occurred within a timeframe which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012),
aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-
355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl.
Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Law Governing Analysis of Fact Evidence
The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).
The special master is required to consider “all [] relevant medical and scientific evidence contained
in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s
report which is contained in the record regarding the nature, causation, and aggravation of the
petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic
or evaluative test which are contained in the record and the summaries and conclusions.” Section
13(b)(1)(A). The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3
F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to
afford greater weight to contemporaneous medical records than to other evidence, such as oral
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testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).
Medical records created contemporaneously with the events they describe are generally
trustworthy because they “contain information supplied to or by health professionals to facilitate
diagnosis and treatment of medical conditions,” where “accuracy has an extra premium.” Kirby v.
Sec’y of Health & Hum. Servs., 997 F.3d 1378 (Fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528.
This presumption is based on the linked proposition that (i) sick people visit medical professionals;
(ii) sick people honestly report their health problems to those professionals; and (iii) medical
professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions. Sanchez v. Sec’y of Health & Hum. Servs., No. 11-685V, 2013 WL 1880825 at *2 (Fed.
Cl. Spec. Mstr. Apr. 10, 2013).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005 WL
6117475 at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records
are generally found to be deserving of greater evidentiary weight than oral testimony -- especially
where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528; see also
Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam, 968 F.2d
1226 (Fed. Cir. 1992), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States
v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral testimony
which is in conflict with contemporaneous documents is entitled to little evidentiary weight.”)).
However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475 at *19 (“[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent and
compelling.” Sanchez, 2013 WL 1880825 at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
No. 90-2808V, 1998 WL 408611 at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
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a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.
C. Analysis of Expert Testimony
Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of her claim. Lampe v. Sec’y of Health
& Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually
evaluated according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell
Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum. Servs.,
617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d
1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony are:
(1) whether a theory or technique can be (and has been) tested; (2) whether the theory or technique
has been subjected to peer review and publication; (3) whether there is a known or potential rate
of error and whether there are standards for controlling the error; and (4) whether the theory or
technique enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at
1316 n.2 (citing Daubert, 509 U.S. at 592-95).
The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora. Daubert factors are employed by judges to exclude
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”).
Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a
particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”).
D. Consideration of Medical Literature
Although this decision discusses some but not all of the medical literature in detail, I
reviewed and considered all of the medical records and literature submitted in this matter. See
Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally
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presume that a special master considered the relevant record evidence even though [s]he does not
explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health & Hum. Servs.,
115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every piece of
evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed. Cir.
2015).
V. Analysis
Because Petitioner does not allege an injury listed on the Vaccine Injury Table, her claim
is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, Petitioner must
prove by preponderant evidence that she suffered an injury and that this injury was caused by the
vaccination at issue. See Capizzano, 440 F.3d at 1320.
A. Causation in Fact/Significant Aggravation
Although Petitioner claimed in her petition that the flu vaccine significantly aggravated her
condition, she did not pursue this argument in her pre-hearing or post-hearing briefs, or at the
entitlement hearing. See Pet’r’s Pre-Hearing Brief at 4 (“Elaine Clark asserts that the flu vaccine
caused her Rheumatoid arthritis.”); Pet’r’s Post Hearing Brief at 3 (“Petitioner provided reputable
medical and scientific explanation demonstrating that the flu vaccine caused her injuries.”).
Furthermore, Dr. Brawer testified multiple times that Petitioner did not have RA prior to receiving
the flu vaccine. See e.g., Tr. at 71, 101-02, 198. Accordingly, I have not analyzed Petitioner’s case
as a significant aggravation claim, and instead have considered it pursuant to Althen v. Sec’y of
Health & Hum. Servs., 418 F.3d 1274.16
B. Rheumatoid Arthritis Generally
RA is a chronic inflammatory disease characterized by inflammation of the synovium in
multiple joints, leading to joint pain. Kraan at 1481. Without treatment, RA may lead to joint
deformity and destruction. McInnes & Schett, The Pathogenesis of Rheumatoid Arthritis, 365 N.
ENGL. J. MED. 2205-19, 2205 (2011) (filed as Ex. A, Tab 1) (“McInnes & Schett”). Its pathogenesis
is not well understood, but genetic and environmental factors are thought to play a role. Id. at 2205-
06. The two primary immune features of RA are rheumatoid factor and citrullinated autoantigens
(“anti-CCP antibodies”). Malmström at 1. Patients with clinical symptoms of RA who test positive
for both of these are diagnosed with seropositive RA, while those who suffer clinical symptoms
of RA and test negative for these are diagnosed with seronegative RA. Id.
16 Assuming Petitioner had advanced a significant aggravation theory, I find that theory would have been
unpersuasive for the reasons articulated in this Decision. Namely, any significant aggravation theory would
have necessarily relied on the same unpersuasive causal mechanism articulated in Petitioner’s causation-
in-fact claim. If Petitioner had pursued a significant aggravation claim further, it would be appropriate to
discuss the legal standards for such a claim articulated in Loving ex rel. Loving v. Sec’y of Health & Hum.
Servs., 86 Fed. Cl. 135, 144 (2009). Because Petitioner abandoned this argument by not discussing
significant aggravation in her briefs and because it is clear such as claim would fail, I have not analyzed
this issue further.
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RA is common, affecting about 1% of Caucasians. First Matloubian Rep. at 7. Women are
about three times more likely than men to develop RA. Id. The parties agree that Petitioner was
correctly diagnosed with seropositive RA. First Brawer Rep. at 2; First Matloubian Rep. at 6.
C. Persuasiveness of the Experts
While Dr. Brawer is qualified to offer his opinion as a rheumatology expert in this matter,
several components of both his written expert reports and his testimony merit discussion.
Several times during his testimony, Dr. Brawer stated his opinion in sweeping terms
without providing explanation or support. For example, he enumerated several factors in his
“perfect storm” theory by saying
It’s clear that molecular mimicry may indeed be playing a role. It’s clear that if you
have a problem with a channelopathy, which I can explain, that may indeed factor
in. It’s clear that if you have a problem with regulatory T cells, that may also indeed
factor in. And it’s also clear that there’s some participation by mitochondria in this
process.
Tr. at 59-60.
In another example of this trend, Dr. Brawer opined that “[y]ou need a half a dozen things
to come together to produce vaccine toxicity, and molecular mimicry is only one part of that.
That’s obvious to anyone who understands the diversity and heterogeneity of the vaccine toxicity
as I’ve explained it.” Tr. at 60. Dr. Brawer’s repeated insistence on how “obvious” or “clear” his
theory of causation was combined with his failure to fully explain that theory diminish the
persuasiveness of his opinion.
In addition to overstating certain elements of his opinion, Dr. Brawer also misstated the
age at which RA typically manifests. Dr. Matloubian testified that RA is a disease of older age,
which typically peaks between the ages of 50 and 75. Tr. at 118. Dr. Brawer testified on redirect
examination to rebut several of Dr. Matloubian’s assertions; one of them concerned the age at
which RA typically manifests. Dr. Brawer testified that: “Rheumatoid arthritis is a disease of
young women, twenties, thirties, forties. Certainly we can see it in older age, but the peak incidence
is in younger women.” Id. at 187.
The medical literature supports Dr. Matloubian’s testimony. See, e.g. Scott at 1097
(“Prevalence rises with age and is highest in women older than 65 years…”); Stanich at 181 (“RA
can occur in individuals of virtually every age group, although the age of onset for a majority of
the population is between 40–70 years. A US National Health Examination Survey (1960–1962)
performed by Engel and colleagues showed the incidence of RA to be only 0.3% in adults younger
than 35 years.”); Crowson et al., The Lifetime Risk of Adult-Onset Rheumatoid Arthritis and Other
Inflammatory Autoimmune Rheumatic Diseases, 63 ARTHRITIS & RHEUMATISM 3, 633-39 (2011)
(filed as Ex. A, Tab 2) (“The cumulative risk was ˂1% before age 50 years, reflecting the small
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incidence of RA at those ages. The cumulative risk of RA increased steeply in both sexes at ~60
years of age, where the incidence of RA was highest, and flattened after age 80 years.”).
When asked twice on cross-examination whether he agreed with the statement from
Crowson that the incidence of RA is highest at age 60, Dr. Brawer declined to answer the question.
See Tr. at 189-92.17 Dr. Brawer’s testimony regarding this matter in conjunction with his broad
statements regarding “clear” vaccination causation that were not further explained caused me to
afford his opinion less weight than that of Dr. Matloubian.
D. Althen Prong One
In the context of the Program, “to establish causation, the standard of proof is
preponderance of evidence, not scientific certainty.” Langland v. Sec’y of Health & Hum. Serv.,
109 Fed. Cl. 421, 441 (2013). Petitioner’s burden under Althen’s first prong is to provide a medical
theory causally connecting the vaccination and the injury. Id. This theory must be sound and
reliable. Boatmon, 941 F.3d at 1359.
Petitioner is not the first to assert a causal relationship between the flu vaccine and RA in
the Vaccine Program. My colleagues and I have consistently found that petitioners have failed to
produce preponderant evidence that the flu vaccine can cause RA. See Moran v. Sec’y of Health
& Hum. Servs., No. 16-538V, 2021 WL 4853544 (Fed. Cl. Spec. Mstr. Oct. 4, 2021); Hock v.
Sec’y of Health & Hum. Servs., No. 17-168V, 2020 WL 6392770 (Fed. Cl. Spec. Mstr. Sept. 30,
2020); Tullio v. Sec’y of Health & Hum. Servs., No. 15-51V, 2019 WL 7580149 (Fed. Cl. Spec.
Mstr. Dec. 19, 2019), aff’d 149 Fed. Cl. 448 (2020).
Petitioner initially contended that the flu vaccine caused Petitioner’s RA because
ingredients in the vaccine cross-reacted with self-antigens in her body, the phenomenon known as
molecular mimicry. First Brawer Rep. at 2-3. While Dr. Brawer mentioned other possible
mechanisms for how the flu vaccine could cause RA, his first expert report focused on molecular
mimicry as a stand-alone theory. See First Brawer Rep. After I asked how molecular mimicry
could begin within 24 hours of vaccine administration, Dr. Brawer then asserted that Petitioner’s
vaccination “triggered an immediate and brisk inflammatory response, manifested clinically by
joint pain and stiffness.” Fifth Brawer Rep. at 1. Dr. Brawer later elaborated on this theory, stating
that molecular mimicry would not be enough on its own to cause Petitioner’s RA. Tr. at 72-73. He
theorized that several factors must co-occur, creating a “perfect storm” that enables a vaccine to
cause autoimmune disease. Id. at 60. These factors include “regulatory T cell dysfunction,
17 Dr. Brawer testified as follows: “You know, I’m glad you brought that question up because in order for
you to understand current literature, you need to understand the old literature. And I understand the old
literature because I lived through it, was trained through it, and I know it thoroughly. And I’m going to give
a specific example and then I’m going to tie it to this case. I’ll give two specific examples, but I’ll be brief,
Your Honor. The first has to do with drug-induced lupus, which appeared as a clinical entity in the early to
mid-1970s. And if you look at textbooks from 45 years ago, you will find the statement by the person who
was editing that particular chapter that most of the time systemic lupus that’s drug-induced resolves when
the drug is stopped, but not all the time. Sometimes the lupus persists. …” Tr. at 189-90. Although Dr.
Brawer testified further along these same lines, he did not answer the question posed.
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chemical toxicity, channelopathies, mitochondrial dysfunction, and what we call DAMPs, or
damage-associated pathogens, molecular pathogens.” Id. at 63.
According to Dr. Brawer, Petitioner experienced this inflammatory response on the same
day as her vaccination. Fifth Brawer Rep. at 1. Dr. Brawer contended that this immunologic
response became more widespread via “cellular proliferation and migration.” Id. He added that
“[s]ome of these vaccine-induced mechanisms may present themselves with acute arthritic
phenomena within 24 hours. These phenomena then become accompanied by multiple slowly
escalating amplification loops comprising other adverse immunologic responses that were also
initiated on day one by the vaccination but did not become paramount and self-sustaining until
several weeks later.” Id.
For the reasons described below, I find that Petitioner has not provided a sound and reliable
medical theory causally connecting the flu vaccine and RA.
1. Petitioner’s “Perfect Storm” Theory Lacks Persuasiveness
I find that the “perfect storm” theory of causation articulated by Dr. Brawer at the
entitlement hearing lacks persuasiveness.
The literature filed by both parties is all but unanimous in the conclusion that RA is a
complex disease whose etiology remains unclear. See, e.g., McInnes & Schett at 2205; Malmström
at 14; Julkunen at 97; Brawer & Goel at 77. In his fifth expert report, Dr. Brawer opined that it is
likely that multiple mechanisms of vaccine-induced disease operate at the same time, but that their
effects are not necessary felt simultaneously. Fifth Brawer Rep. at 1. He elaborated on this thought
at the entitlement hearing, when he testified regarding his theory of the “perfect storm,” meaning
that in order for a vaccine to trigger autoimmune disease, a host of different factors must also co-
occur, including “regulatory T cell dysfunction, chemical toxicity, channelopathies, mitochondrial
dysfunction, and what we call DAMPs, or damage-associated pathogens, molecular pathogens.”
Tr. at 63. He testified that the various factors result in “amplification loops” and that it may be the
case that not all factors have equal clinical relevance at the start of the process. Id. at 64.
Dr. Brawer did not cite to any medical literature in his fifth expert report. During the
hearing, he referred briefly to his own research and to his experience as a clinician to support the
“perfect storm” theory. Tr. at 62, 64. He also conceded that this theory still needs to be validated
in a research context. Tr. at 72.
In short, Dr. Brawer did little more than list a series of occurrences and mechanisms that
he opines contribute to the “perfect storm.” He did not describe how each event leads to the
development or RA or how these events follow as a consequence of the flu vaccine. Dr. Matloubian
testified that Dr. Brawer’s theories are “quite speculative … and not reliable.” Tr. at 141. I find
that the lack of specificity as to each of the factors Dr. Brawer described undermine its
persuasiveness.
According to Dr. Brawer, molecular mimicry plays a role in the induction of RA by the flu
vaccine and is part of the “perfect storm.” (See Tr. at 60, “You need a half a dozen things to come
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together to produce vaccine toxicity, and molecular mimicry is only one part of that.”). As with
the other elements of the “perfect storm”, Dr. Brawer did not further explain how the flu vaccine
caused molecular mimicry resulting in RA.
It is well established in the Vaccine Program that, while the theory of molecular mimicry
is generally considered to have some validity, a Petitioner must do more than invoke “the magic
words ‘molecular mimicry’” in order to satisfy the requirements of Althen prong one. McGuinness
v. Sec’y of Health & Hum. Servs., No. 17-0954V, 2021 WL 5292343, at *17 (Fed. Cl. Spec. Mstr.
Oct. 20, 2021) (citing McKown v. Sec’y of Health & Hum. Servs., No 15-1451V, 2019 WL
4072113, at *50 (Fed. Cl. Spec. Mstr. July 15, 2019)). Here, Dr. Brawer mentions molecular
mimicry as a component of his theory of the “perfect storm,” but he provides no further
explanation. I recognize that petitioners are not required to demonstrate a specific biologic
mechanism which caused their disease, nor are they required to present medical literature or
epidemiological studies in support of their theory. See Kottenstette, 861 Fed. Appx. 433 (Fed. Cir.
June 15, 2021) (citing Knudsen, 35 F.3d at 549) (reaffirming the principle that “proof of causation
does not ‘require identification and proof of specific biological mechanisms[.]’”); Andreu, 569
F.3d at 1378-79. However, a petitioner’s prong one theory must be reliable. The mere mention of
molecular mimicry, without more, does not constitute a reliable or persuasive prong one theory.
I note that in Moran v. Secretary of Health and Human Services, I previously considered
whether the flu vaccine can cause RA via the theory of molecular mimicry. Moran v. Sec’y of
Health & Hum. Servs., No. 16-538V, 2021 WL 4853544 (Fed. Cl. Spec. Mstr. Oct. 4, 2021). I did
not find that theory persuasive in Moran, and similarly do not find it to be so here.
In addition to the fact that Dr. Brawer has not done more than invoke the words “molecular
mimicry”, other evidence suggests that the flu vaccine does not cause RA via molecular mimicry.
First, as Dr. Matloubian noted, evidence does not support that the flu virus causes RA. Tr. at 136.
The medical literature supports this opinion. Stanich noted that “in no case has any single organism
or group of organisms been demonstrated to be causative for RA.” Stanich at 184. Schattner opines
that in order for a viral vaccine to be established as a cause of autoimmunity, the viral infection
should also be liked to autoimmunity. Schattner at 3881; see also, Noel R. Rose, Negative
selection, epitope mimicry and autoimmunity, 49 CURRENT OPINION IN IMMUNOLOGY 51-55 (2017)
(filed as Ex. A, Tab 27). According to Dr. Matloubian, “[t]he absence of a causal association
between natural influenza virus infection and development of RA argues strongly against the
possibility of molecular mimicry or bystander activation as a plausible biologic explanation.” First
Matloubian Rep. at 15. Dr. Brawer did not explain why the flu vaccine would cause RA but the
flu virus has not been shown to do so. Instead, he opined that he has seen anecdotal situations
where this has occurred. Tr. at 107.
Additionally, the Malmström article, which discusses the pathogenesis of RA, describes
antigens from influenza virus as an “unrelated antigen” and use it as a negative control in their
study. Malmström at 7. Dr. Matloubian described this as “a strong indicator that the general
medical and research communities that study pathogenesis of RA do not recognize any relationship
between RA associated antigens and those of influenza virus.” First Matloubian Rep. at 13. I
further note that in Tullio, the special master found this point to be a compelling argument against
the applicability of molecular mimicry in a flu vaccine-RA case. He stated: “The view of these
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experts that hemagglutinin is ‘unrelated’ to various rheumatoid arthritis associated proteins carries
significant weight.” Tullio, 2019 WL 7580149, at *21. I agree, and find this point is persuasive
evidence which further undermines Petitioner’s position that the flu vaccine caused Petitioner to
develop RA via molecular mimicry.
2. The Majority of Persuasive Studies do not Support a Connection between Flu
Vaccine and RA
Respondent sited several studies in support of his position that the flu vaccine does not
cause RA. The overwhelming majority of the epidemiological evidence does not support a causal
link.
Epidemiologic evidence is relevant with respect to Althen prong one. See, e.g., D’Tiole v.
Sec’y of Health & Hum. Servs., 2016 WL 7664475 (Fed. Cl. Spec. Mstr. Nov. 28, 2016), mot. for
review den’d, 132 Fed. Cl. 421 (2017); Blackburn v. Sec’y of Health & Hum. Servs., No. 10–410V,
2015 WL 425935, at *28–30 (Fed. Cl. Spec. Mstr. Jan. 9, 2015). However, this type of evidence
is not required in order for a petitioner to establish that a vaccine can cause an injury. A vaccine
injury is a rare event that cannot be disproved because a vaccinee did not experience a response
consistent with that of the general population. See Harris v. Sec’y of Health & Hum. Servs., No.
10–322V, 2014 WL 3159377, at *11 (Fed. Cl. Spec. Mstr. June 10, 2014) (finding that
epidemiologic studies cannot absolutely refute causal connections, because it is possible that a
larger study could always detect an increased risk), mot. for review dismissed, 2015 U.S. App.
LEXIS 7921 (Fed. Cir. 2015).
In support of his position that Petitioner’s RA was not caused by the flu vaccine, Dr.
Matloubian cited Ray. First Matloubian Rep. at 10. This study involved a medical chart review of
approximately one million patients in the Kaiser Permanente system from 1997 through 1999 and
included both a cohort analysis and a case-control analysis. Ray at 6592. In Ray, the cohort analysis
found a possible association between the flu vaccine and RA in windows approximately six months
and one year after flu vaccination. Id. at 6596. The researchers in Ray then increased the power of
the study and conducted a larger case-control analysis which concluded that there was no
additional risk of developing RA after flu vaccination. Id. I find that the Ray study provides strong
evidence that there is no association between flu vaccine and RA.
Dr. Matloubian also referred to the Bengtsson case-control study. First Matloubian Rep. at
10 (citing Bengtsson). This study followed 1998 cases of RA and 2252 controls for five years after
vaccination. Bengtsson at 1831. Bengtsson found no association between the development of RA
and prior vaccine exposure. Id. at 1832. Significantly, Bengtsson also found no increased risk of
developing RA after vaccination in subjects who were smokers or who were carriers of HLA-
DRB1 SE, the two best known risk factors for RA. Id. I find that this study also provides persuasive
evidence that flu vaccine is not associated with RA.
Dr. Matloubian also cited Fomin, which assessed the safety of the flu vaccine in patients
already diagnosed with RA based on data from 82 RA patients and 30 healthy controls. Fomin at
191. The authors of this study concluded that “[v]accination against influenza was not associated
with a significant worsening of any clinical or laboratory index of disease activity.” Fomin at 193.
36

Case 1:17-vv-01553-UNJ Document 104 Filed 08/01/23 Page 37 of 43
I find that the absence of evidence that flu vaccination exacerbates pre-existing RA supports
Respondent’s position that the flu vaccine does not cause RA. The authors of the Westra article
came to the same conclusion in their review of the literature. Westra, et al., Vaccination of patients
with autoimmune inflammatory rheumatic diseases, 11 Nature Revs. Rheumatology 135-45 (2015)
(filed as Ex. A, Tab 21) (“Westra”). This literature review reported on six studies which addressed
the safety of the flu vaccine in patients with autoimmune rheumatic diseases, including RA. Westra
at 140. The authors stated that “no significant influence of vaccination on disease activity has been
reported.” Id. at 140. Schattner came to the same conclusion in her literature review. Schattner at
3876 (“whenever controlled studies of autoimmunity following viral vaccines were undertaken,
no evidence of an association was found.”).
In addition, Dr. Matloubian cited Singh. Singh et al., 2015 American College of
Rheumatology Guideline for the Treatment of Rheumatoid Arthritis, ARTHRITIS &
RHEUMATOLOGY, 1-25, 2015, (filed as Ex A Tab 22) (hereinafter “Singh”). Dr. Matloubian
testified that the American College of Rheumatology concluded that the flu vaccine is
recommended for people with RA. Tr. at 170; Singh at 17.
The totality of the literature submitted by Respondent persuasively demonstrates that there
is not an association between the flu vaccine and RA.
Dr. Brawer submitted several medical articles in support of his position that the flu vaccine
can cause RA. In contrast to Dr. Matloubian’s references, Dr. Brawer relied primarily on case
reports to support his theory. Brawer & Koyoda reported two cases in which patients experienced
the onset of symptoms later diagnosed as RA within 24 hours of flu vaccination. Brawer & Koyoda
at 1. Dr. Brawer also submitted Older, et al., which reports five cases of lupus erythematosus after
various vaccinations. Older, et al., Can Immunization Precipitate Connective Tissue Disease?
Report of Five Cases of Systemic Lupus Erythematosus and Review of the Literature, 23(3)
SEMINARS IN ARTHRITIS & RHEUMATISM 131-39, 131 (1999) (filed as Ex. 29) (“Older”). Petitioner
does not provide epidemiological evidence to support her contention that the flu vaccine can cause
RA, and Dr. Brawer acknowledged that his theories still require validation in a research setting.
Tr. at 72.
It is well established in the Vaccine Program that a petitioner is not required to provide
epidemiological studies in order to satisfy prong one of the Althen analysis. Capizzano, 440 F.3d
at 1325. Case reports can provide some limited support for a petitioner’s theory of causation.
Campbell v. Sec’y of Health & Hum. Servs., 97 Fed. Cl. 650, 668 (2011) (“Case reports do not
purport to establish causation definitively, and this deficiency does indeed reduce their evidentiary
value compared particularly to formal epidemiological studies. Nonetheless, the fact that case
reports can by their nature only present indicia of causation does not deprive them of all evidentiary
weight.”). Accordingly, I conclude that the case reports Petitioner filed do provide some support
for her claim that the flu vaccine caused her RA. However, I find the epidemiological studies filed
by Respondent more persuasive. I find that the weight of the evidence suggests that there is no
association between the flu vaccine and RA.
37

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Considering the totality of the evidence discussed above, I find that Petitioner has not
presented a sound and reliable theory that preponderantly shows that the flu vaccine can cause RA.
Petitioner has not satisfied the first Althen prong.
E. Althen Prong Two
Under Althen’s second prong, a petitioner must “prove a logical sequence of cause and
effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The
sequence of cause and effect must be “‘logical’ and legally probable, not medically or scientifically
certain.” Id. A petitioner is not required to show “epidemiologic studies, rechallenge, the presence
of pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect.” Id. (internal citations omitted).
Capizzano v. Sec'y of Health & Hum. Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead,
circumstantial evidence and reliable medical opinions may be sufficient to satisfy the second
Althen prong. Isaac v. Sec’y of Health & Hum. Servs., No. 08-601V, 2012 WL 3609993, at *16
(Fed. Cl. Spec. Mstr. July 30, 2012), aff’d 108 Fed. Cl. 743 (2013).
For the reasons outlined below, I find that Petitioner has not met her burden under Althen
prong two.
1. Synovitis and Erosion
Of consequence to Petitioner’s claim is the presence of synovitis and erosion in her left
knee at the time of her knee replacement in November 2015. Ex. 11 at 45, 47. At the entitlement
hearing, Dr. Brawer opined that these were the result of Petitioner’s osteoarthritis and they do not
indicate that she had RA prior to her flu vaccination on December 6, 2015. Tr. at 186. Dr. Brawer
also opined that both synovitis and erosion occur in osteoarthritis, but that the latter is uncommon.
Seventh Brawer Rep. at 1. Petitioner filed medical literature supporting this opinion. Mathiessen
& Conaghan, Synovitis in osteoarthritis: current understanding with therapeutic implications,
19(18) ARTHRITIS RES. & THERAPY 1-9, 8 (2017) (filed as Ex. 40) (“Mathiessen & Conaghan”)
(stating that synovitis is commonly observed in osteoarthritic joints); Anandarajah, et al., Patients
with Erosive Osteoarthritis have Less Extensive Synovitis than Patients with Rheumatoid Arthritis
on Histopathology, Abstract No. 1112, ACR/ARHP Annual Meeting (2012) (filed as Ex. 38)
(“Anandarajah”) (concluding that synovitis occurs in both osteoarthritis and RA, but to a lesser
extent in the former than in the latter); Punzi, et al., Time to redefine erosive osteoarthritis, 1
RHEUMATIC & MUSCULOSKELETAL DISEASES 1-2, 1 (2015) (filed as Ex. 37) (“Punzi”) (showing
that erosion is sometimes seen in cases of osteoarthritis, but only in the joints of the hands and
spine).
Dr. Matloubian opined that synovitis and erosion are evidence that Petitioner had RA prior
to receiving the flu vaccine. Tr. at 123. He testified that synovitis does occur in osteoarthritis,
although less frequently than in RA, but that he would not expect to see erosion in osteoarthritis.
Id. Dr. Matloubian also noted that none of Petitioner’s literature mentions the “presence of erosive
changes in knees of individuals with OA, which was the joint where Dr. Hoerner observed erosions
intraoperatively in petitioner.” Third Matloubian Rep. at 2.
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Although the literature shows that synovitis and erosion can occur in osteoarthritic joints,
Petitioner has not presented evidence that OA patients can experience erosions in joints other than
the hands or spine. Because of this, the weight of the evidence supports the conclusion that it is
more likely than not that Petitioner’s synovitis and erosion resulted from her RA than from
osteoarthritis. Thus, it follows that Petitioner’s RA already existed at the time of her knee
replacement roughly one month prior to receiving the flu vaccine. This finding is consistent with
the extensive body of literature which describes a lag between the development of autoantibodies
and the development of disease in RA patients. A petitioner cannot succeed on a claim of
causation-in-fact where the alleged condition preexisted the vaccination. See W.C. v. Sec'y of
Health & Hum. Servs., 704 F.3d 1352, 1354–55 (Fed. Cir. 2013) (affirming the special master’s
denial of compensation on claim of causation-in-fact because “[i]f a petitioner has a disorder before
being vaccinated, the vaccine logically cannot have caused the disorder”). In this case, the medical
records demonstrate that Petitioner was, more likely than not, experiencing symptoms consistent
with RA at the time of her knee replacement surgery.
2. Lack of Evidence for the “Perfect Storm”
As discussed in the previous section, Dr. Brawer testified that vaccination can trigger
autoimmunity leading to RA only when several factors coincide in what he referred to as a “perfect
storm.” Tr. at 62. These factors are molecular mimicry, “regulatory T cell dysfunction, chemical
toxicity, channelopathies, mitochondrial dysfunction, and what we call DAMPs, or damage-
associated pathogens, molecular pathogens.” Id. Petitioner has not provided evidence that any of
these factors were present at or before the onset of her RA.
3. Coincidental RA Onset After Vaccination
Dr. Matloubian opined that RA affects roughly 1% of the Caucasian population, with an
incidence rate of roughly 40 for every 100,000 people. First Matloubian Rep. at 7. Respondent’s
medical literature supports the notion that RA is not a rare condition. Deane, et al., Genetic and
environmental risk factors for rheumatoid arthritis, 31 BEST PRACTICE & RES. CLINICAL
RHEUMATOLOGY 3-18, 4 (2017) (filed as Ex. C, Tab 2) (“Deane”) (stating that RA affects 0.5% to
1% of the overall population); McInnes & Schett at 2205 (“[RA] is a common autoimmune
disease.”). Dr. Matloubian opined that the onset of Petitioner’s RA shortly after vaccination is
most likely a coincidence. First Matloubian Rep. at 14-15. In Ahmed, the authors found that, based
on the general statistical likelihood of developing RA and the number of vaccine doses
administered, there is a 90% chance of seeing one case of RA onset coinciding with vaccination
for every 10,000 vaccine doses administered. Ahmed at 7. Dr. Matloubian opined that, “[t]aking
into account that 150 million people are annually immunized with influenza in the U.S., we would
expect then that 15,000 individuals would develop RA after such vaccination due to coincidence
alone.” Id. He concluded that, a woman’s lifetime risk of developing RA being one in 28,
Petitioner’s RA was more likely that not unrelated to her flu vaccination. Id.
In the Vaccine Program, temporal association alone does not suffice to demonstrate
causation. See, e.g., Zumwalt v. Sec’y of Health & Hum. Servs., No. 16-994V, 2019 WL 1953739
at *20 (Fed. Cl. Spec. Mstr. Mar. 21, 2019), aff’d, 146 Fed. Cl. 525 (2019). The demonstrable
39

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likelihood of symptom onset occurring after vaccination purely by coincidence cuts against
Petitioner’s argument.
4. Risk Factors for RA
It is relevant that the record shows that Petitioner had an elevated risk of developing RA
due to factors unrelated to the flu vaccine.
First, Petitioner is a woman. Dr. Matloubian opined that RA is two to three times more
common among women than men. First Matloubian Rep. at 7. Dr. Brawer did not refute this
testimony.
Second, the record reflects that Petitioner smoked cigarettes for a period in the 1970s. Tr.
at 132. The medical literature filed by both parties establishes that smoking is a known risk factor
for RA. See Malmström at 2 (noting that smoking has a large impact on ACPA-positive patients);
McInnes & Schett at 2011 (stating that “[s]moking and other forms of bronchial stress (e.g.,
exposure to silica) increase the risk of rheumatoid arthritis among persons with susceptibility
HLA–DR4 alleles”); Hunt & Emery, Defining populations at risk of rheumatoid arthritis: the first
steps to prevention, RHEUMATOLOGY, Vol. 10, 521-30, 2014 (filed as Ex. A, Tab 6) (observing
that smoking is a risk factor for seropositive RA); Stanich at 187.
The strength of evidence that female sex and a history of smoking are known to elevate the
risk of developing RA reduces the persuasiveness of Petitioner’s argument that her RA was caused
by the flu vaccine.
5. Treating Physicians
In weighing evidence, special masters are expected to consider the views of treating
doctors. Cappizano, 440 F.3d at 1326. The views of treating doctors about the appropriate
diagnosis are often persuasive because the doctors have direct experience with the patient whom
they are diagnosing. See McCulloch v. Sec’y of Health & Human Servs., No. 09-293V, 2015 WL
3640610, at *20 (Fed. Cl. Spec. Mstr. May 22, 2015).
Reviewing the medical record, I find some evidence that treating physicians may have
attributed Petitioner’s RA to the flu vaccine. Dr. Kohen, Petitioner’s rheumatologist, noted on
March 31, 2016, that “[t]here are descriptions in the literature of new onset inflammatory
arthropathies after vaccinations, and since [Petitioner’s] symptoms started after the flu vaccination,
the vaccination could have been a contributory factor to the onset of her disease.” Ex. 7 at 11. Dr.
Matiello, Petitioner’s neurologist, noted on November 1, 2017, that the medical literature contains
case studies of small fiber neuropathy after flu vaccination and recommended that Petitioner not
receive the flu vaccine that year. Ex. 10 at 6. In several years of medical appointments, suggestions
by Petitioner’s treating physicians that the flu vaccine may have caused her RA were rare and
brief. Furthermore, neither medical provider described a mechanism for how the flu vaccine caused
or contributed to Petitioner’s condition.
The record also contains evidence that treating physicians did not attribute Petitioner’s RA
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to the flu vaccine. On March 24, 2016, Petitioner’s pulmonologist, Dr. Coleman, stated that
Petitioner “believes that the flu shot was the reason for those symptoms (which seems unlikely...).”
Ex. 8 at 7 (ellipsis in original). Petitioner also had numerous appointments with providers who
never noted any potential link between the vaccine and her RA. See, e.g., Ex. 4 at 16 (appointment
with regular physician, Dr. Gurka, on December 28, 2015); Ex. 6 at 39-43 (orthopedic follow-up
on January 6, 2016).
Although I have considered them, treating physician statements that the flu vaccine “could
have” been a contributory factor in the onset of Petitioner’s RA, or that case studies show small
fiber neuropathy can occur after the flu vaccine thus Petitioner should not receive her flu vaccine
that year, do not constitute evidence sufficient for Petitioner to meet her burden. This is particularly
true when viewed alongside her one treater who specifically described Petitioner’s theory that the
flu vaccine harmed her to be “unlikely”. Accordingly, while I find that there is some support for
Petitioner’s claim in the opinions of her treating providers, I conclude that Petitioner has failed to
preponderantly demonstrate that her flu vaccination was the cause in fact of her RA. Accordingly,
she has not met her burden under prong two of Althen.
F. Althen Prong Three
The timing prong contains two parts. First, a petitioner must establish the “timeframe for
which it is medically acceptable to infer causation” and second, he must demonstrate that the onset
of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed. Cl. 532,
542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012), aff’d
without op., 503 F. App’x 952 (Fed. Cir. 2013).
As to the medically appropriate timeframe, Dr. Brawer opined that Petitioner did not have
RA prior to receiving the flu vaccine. Tr. at 71, 102-03. He opined that vaccine-induced RA may
begin within 24 hours of vaccination but may take as long as three weeks to manifest. Fourth
Brawer Rep. at 2. He added that “[t]rying to extend theories encompassing the idiopathic
spontaneous onset of rheumatoid arthritis to its onset induced by varied environmental exposures
is an exercise in futility.” Id.
On the other hand, Dr. Matloubian opined that “it would be virtually impossible for an
immune response to be initiated and cause symptoms within 24 hours and lead to all of her
symptoms within 3-4 days as alleged by Dr. Brawer.” First Matloubian Rep. at 13. He also testified
that patients test positive for anti-CCP antibodies for up to 10 years prior to clinical onset, and
three to five years on average. Tr. at 122 (“[S]eropositive RA…just doesn’t start overnight…it’s
been going on for years before it becomes clinically apparent.”).
The record contains significant evidence supporting the contention that RA develops over
a much longer period of time than 24 hours to several days. Respondent presented evidence that
the autoantibodies associated with RA are detectable in the blood up to several years before the
disease is clinically apparent. Malmström at 2; Hazes & Luime, The epidemiology of early
inflammatory arthritis, 7 NATURE REVS. RHEUMATOLOGY 381-90, 381 (2011) (filed as Ex. A, Tab
5); Hunt & Emery, Defining populations at risk of rheumatoid arthritis: the first steps to
prevention, 10 NATURE REVS. RHEUMATOLOGY 521-30, 522 (2014) (filed as Ex. A, Tab 6); Nielen,
41

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et al., Specific Autoantibodies Precede the Symptoms of Rheumatoid Arthritis: A Study of Serial
Measurements in Blood Donors, 50(2) ARTHRITIS & RHEUMATISM, 380-86, 380 (2004) (filed as
Ex. A, Tab 7); Kevin D. Deane, Autoantibodies, citrullinated histones and initiation of synovitis,
NATURE REVS. RHEUMATOLOGY ONLINE (2015) (filed as Ex. A, Tab 13); Deane & Holers, The
Natural History of Rheumatoid Arthritis, 41(7) CLINICAL THERAPEUTICS 1256-69 (2019) (filed as
Ex. C, Tab 1) (“Deane & Holers”).
Deane & Holers explain that, in light of the evidence that autoimmunity begins long before
clinical symptoms of RA appear, “it is therefore highly likely that factors that trigger and propagate
RA-related autoimmunity as well as drive the transition from pre-RA to [inflammatory arthritis]
are acting years before a diagnosis.” Deane & Holers at 1262. Deane & Holers do note that “not
all individuals who develop [inflammatory arthritis] have detectable seropositivity for
autoantibodies preceding their arthritis.” Id. at 1265. They do state, however, that “existing studies
suggest that a high percentage of individuals who develop [seropositive] RA will have
seropositivity for these antibodies” before the onset of symptoms. Id.
I have already found that the synovitis and erosion present in Petitioner’s left knee one
month prior to vaccination were more likely due to ongoing RA than to osteoarthritis. Section
(V)(E)(1), supra. Further, I have previously agreed with the reasoning of Chief Special Master
Corcoran that
given what is known about RA (and in particular the fact that the presence of the
antibodies closely associated with it often long precede onset of RA symptoms), it
is highly unlikely a vaccine could either cause these autoantibodies to develop in a
medically-reasonable timeframe, or spark an autoimmune process dependent upon
them, such that a vaccine administered close in time to appearance
of RA symptoms could be deemed causal.
Moran, 2021 WL 4853544, at *35 (quoting Monzon v. Sec’y of Health & Hum. Servs., No. 17-
1055V, 2021 WL 2711289, at *19 (Fed. Cl. Spec. Mstr. June 2, 2021)). My opinion on this point
has not changed. Petitioner has not presented preponderant evidence that 24 hours to several days
is a medically acceptable timeframe for the onset of RA after flu vaccine, and thus has not
established the third Althen prong.
VI. Conclusion
Upon careful evaluation of all the evidence submitted in this matter, including the medical
records, the affidavits and testimony, as well as the experts’ opinions and medical literature, I
conclude that Petitioner has not shown by preponderant evidence that she is entitled to
compensation under the Vaccine Act. Her petition is therefore DISMISSED. The clerk shall
enter judgment accordingly.18
IT IS SO ORDERED.
18 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly
or separately) a notice renouncing their right to seek review.
42

Case 1:17-vv-01553-UNJ Document 104 Filed 08/01/23 Page 43 of 43
s/ Katherine E. Oler
Katherine E. Oler
Special Master
43

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_17-vv-01553-cl-extra-10735659
Date issued/filed: 2024-04-12
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10269069
--------------------------------------------------------------------------------
    In the United States Court of Federal Claims
                                OFFICE OF SPECIAL MASTERS
                                    Filed: February 15, 2024

* * * * * * * * * * * * * *                                UNPUBLISHED
ELAINE CLARK,              *
                           *
         Petitioner,       *                               No. 17-1553V
                           *                               Special Master Oler
v.                         *
                           *                               Attorneys’ Fees and Costs
SECRETARY OF HEALTH        *
AND HUMAN SERVICES,        *
                           *
         Respondent.       *
* * * * * * * * * * * * * *
Phyllis Widman, Widman Law Firm, LLC, Linwood, NJ, for Petitioner.
Ryan D. Pyles, United States Department of Justice, Washington, DC, for Respondent.

                       DECISION ON ATTORNEYS’ FEES AND COSTS1

        On October 18, 2017, Elaine Clark (“Petitioner”) filed a petition for compensation under
the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine
Act” or “Program”). The petition alleges that Petitioner developed “significant
aggravation/exacerbation of arthritis, rheumatoid arthritis with associated polyneuropathy/small
fiber neuropathy, exacerbation of carpal tunnel syndrome, and a left shoulder injury” as a result of
the influenza (“flu”) vaccine she received on December 6, 2015. Pet. at 1 (ECF No. 1). Petitioner
later clarified that she was alleging the flu vaccine caused her to develop rheumatoid arthritis
(“RA”) (ECF No. 41). On June 16, 2023, the undersigned issued her decision dismissing the
petition. (ECF No. 101).

       On December 19, 2023, Petitioner filed an application for final attorneys’ fees and costs.
(ECF No. 105). (“Fees App.”). Petitioner requests total attorneys’ fees and costs in the amount of
$3,819.07, representing $3,770.00 in attorneys’ fees and $49.07 in attorneys’ costs. Fees App. at
1
  The undersigned intends to post this Ruling on the United States Court of Federal Claims' website. 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. Because this unpublished 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 in accordance
with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion
of Electronic Government Services).
3. Pursuant to General Order No. 9, counsel for petitioner represents that petitioner personally
incurred costs in the amount of $833.07. Id. Respondent responded to the motion on December 19,
2023, stating that “Respondent is satisfied the statutory requirements for an award of attorneys’
fees and costs are met in this case” and requesting that the undersigned “exercise her discretion
and determine a reasonable award for attorneys’ fees and costs.” Resp’t’s Resp. at 2. (ECF No.
106). Petitioner did not file a reply thereafter.

       This matter is now ripe for consideration.

I.     Reasonable Attorneys’ Fees and Costs

        Section 15(e) (1) of the Vaccine Act allows for the Special Master to award “reasonable
attorneys' fees, and other costs.” § 300aa–15(e)(1)(A)–(B). Petitioners are entitled to an award of
reasonable attorneys' fees and costs if they are entitled to compensation under the Vaccine Act, or,
even if they are unsuccessful, they are eligible so long as the Special Master finds that the petition
was filed in good faith and with a reasonable basis. Avera v. Sec'y of Health & Human Servs., 515
F.3d 1343, 1352 (Fed. Cir. 2008). Here, although the petition was eventually dismissed, the
undersigned finds that the claim possessed good faith and reasonable basis while it was pending
before the Court and notes that Respondent has also indicated in his response that he is satisfied
both have been met as well. Accordingly, Petitioner is entitled to a final award of reasonable
attorneys’ fees and costs.

        It is “well within the special master's discretion” to determine the reasonableness of fees.
Saxton v. Sec'y of Health & Human Servs., 3 F.3d 1517, 1521–22 (Fed. Cir. 1993); see also Hines
v. Sec'y of Health & Human Servs., 22 Cl. Ct. 750, 753 (1991). (“[T]he reviewing court must grant
the special master wide latitude in determining the reasonableness of both attorneys' fees and
costs.”). Applications for attorneys' fees must include contemporaneous and specific billing
records that indicate the work performed and the number of hours spent on said work. See Savin
v. Sec'y of Health & Human Servs., 85 Fed. Cl. 313, 316–18 (2008).

        Reasonable hourly rates are determined by looking at the “prevailing market rate” in the
relevant community. See Blum v. Stenson, 465 U.S. 886, 895 (1984). The “prevailing market rate”
is akin to the rate “in the community for similar services by lawyers of reasonably comparable
skill, experience and reputation.” Id. at 895, n.11. The petitioner bears the burden of providing
adequate evidence to prove that the requested hourly rate is reasonable. Id.

       a. Reasonable Hourly Rates

       Petitioner requests the following hourly rates for the work of her counsel, Ms. Phyllis
Widman, $400.00 per hour for work performed in 2022 and $480.00 per hour for work performed
in 2023. Although the requested rate for 2022 is reasonable, the requested rate for 2023 is
excessive. Previously, Ms. Widman has been awarded the rate of $420.00 for work performed in
2023. See McDonald v. Sec’y of Health & Human Servs., No. 15-612V, 2023 WL 6620307, (Fed.
Cl. Spec. Mstr. Sept. 12, 2023); Elder v. Sec’y of Health & Human Servs., No. 21-0028V, 2023
WL 4196770 (Fed. Cl. Spec. Mstr. May 26, 2023). Petitioner has provided no argument as to why
the undersigned should depart from the previously awarded rate for 2023 and the reduced rate shall


                                                  2
be applied herein to her work in this case. This reduces petitioner’s request for attorney’s fees in
the amount of $462.00.

       b. Reasonable Hours Expended

         Attorneys' fees are awarded for the “number of hours reasonably expended on the
litigation.” Avera, 515 F.3d at 1348. Counsel should not include in their fee requests hours that are
“excessive, redundant, or otherwise unnecessary.” Saxton, 3 F.3d at 1521 (quoting Hensley v.
Eckerhart, 461 U.S. 424, 434 (1983)). Additionally, it is well-established that billing for
administrative/clerical tasks is not permitted in the Vaccine Program. Rochester v. United States,
18 Cl. Ct. 379, 387 (1989); Arranga v. Sec’y of Health & Human Servs., No. 02-1616V, 2018 WL
2224959, at *3 (Fed. Cl. Spec. Mstr. Apr. 12, 2018).

         The overall hours spent on this matter appear to be reasonable. The undersigned has
reviewed the billing entries and finds that they adequately describe the work done on the case and
the amount of time spent on that work. None of the entries appear objectionable, nor has
Respondent identified any entries as objectionable. Accordingly, Petitioner is awarded final
attorneys’ fees in the amount of $3,308.00.

       c. Attorneys’ Costs

        Like attorneys’ fees, a request for reimbursement of attorneys’ costs must be reasonable.
Perreira v. Sec’y of Health & Human Servs., 27 Fed. Cl. 29, 34 (Fed. Cl. 1992). Petitioner requests
a total of $49.07 in attorneys’ costs for postage. Petitioner has provided adequate documentation
supporting this cost and it shall be fully reimbursed.

       d. Petitioner’s Costs

        Pursuant to General Order No. 9, Petitioner has indicated that she has personally incurred
costs totaling $833.07 in pursuit of her petition for compensation. This amount is comprised of
postage, acquiring medical records, and a supplemental report from Dr. Brawer. These costs are
reasonable and shall be fully reimbursed.

II.    Conclusion

        In accordance with the Vaccine Act, 42 U.S.C. § 300aa-15(e) (2012), the undersigned has
reviewed the billing records and costs in this case and finds that Petitioner’s request for fees and
costs, other than the reductions delineated above, is reasonable. The undersigned finds that it is
reasonable to compensate Petitioner and her counsel as follows:

 Attorneys’ Fees Requested                                            $3,770.00
 (Reduction to Fees)                                                 - ($462.00)
 Total Attorneys’ Fees Awarded                                        $3,308.00

 Attorneys’ Costs Requested                                             $49.07
 (Reduction to Costs)                                                     -

                                                 3
    Total Attorneys’ Costs Awarded                                          $49.07

    Total Attorneys’ Fees and Costs                                       $3,357.07

    Petitioner’s Costs Awarded                                             $833.07

    Total Amount Awarded                                                  $4,190.14

         Accordingly, the undersigned awards the following:

      1) a lump sum in the amount of $3,357.07, representing reimbursement for Petitioner’s
         attorneys’ fees and costs, in the form of a check payable jointly to Petitioner and
         Petitioner’s counsel of record, Ms. Phyllis Widman; and

      2) a lump sum in the amount of $833.07, representing reimbursement for Petitioner’s
         out of pocket costs, in the form of a check payable to Petitioner.

        In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the
court shall enter judgment in accordance herewith.2

         IT IS SO ORDERED.

                                                 s/ Katherine E. Oler
                                                 Katherine E. Oler
                                                 Special Master




2
 Entry of judgment can be expedited by each party’s filing of a notice renouncing the right to seek review.
Vaccine Rule 11(a).

                                                    4