VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-01082
Package ID: USCOURTS-cofc-1_15-vv-01082
Petitioner: Alisha N. Pankiw
Filed: 2015-09-28
Decided: 2021-08-30
Vaccine: influenza
Vaccination date: 2012-09-28
Condition: inflammatory arthritis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Alisha Pankiw received an influenza vaccination on September 28, 2012. She alleged that this vaccine caused her to develop inflammatory arthritis. Twelve days later, she presented with joint pain and swelling, and was diagnosed with acute arthritis. Her primary care physician noted it was unlikely to be rheumatoid arthritis but possibly inflammatory arthritis related to her postpartum status. Over the following months, she saw multiple specialists, including a rheumatologist, who noted undifferentiated arthritis and considered the possibility of seronegative rheumatoid arthritis, but also noted her pregnancy could complicate diagnosis. Her condition was described as asymmetric inflammatory polyarthritis associated with a positive ANA, and her rheumatologist ultimately determined it resolved by September 5, 2013. The petitioner filed a petition for compensation, alleging the flu vaccine caused her arthritis. The Secretary contested the claim, arguing she failed to present a scientific theory linking the vaccine to arthritis, evidence that the vaccine caused her specific injury, and a proximate temporal relationship. The Special Master denied compensation, finding that Ms. Pankiw failed to prove she had rheumatoid arthritis and that her asserted medical theory of molecular mimicry, previously rejected in another case, was not persuasive for flu vaccine-induced arthritis. The Court of Federal Claims reviewed the Special Master's decision and found that the Special Master erred by failing to adequately consider Dr. Thornberry's diagnosis of inflammatory arthritis and the doctor's opinion attributing the condition to the flu vaccine. The court vacated the Special Master's decision and remanded the case for further proceedings, emphasizing the need for an accurate reflection of the record and the petitioner's specific diagnoses.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-01082-0
Date issued/filed: 2017-04-17
Pages: 7
Docket text: PUBLIC DECISION (Originally filed: 03/21/2017) regarding 53 Findings of Fact & Conclusions of Law. Signed by Special Master Christian J. Moran. (SP) Copy to parties.
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Case 1:15-vv-01082-EMR Document 56 Filed 04/17/17 Page 1 of 7
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
ALISHA N. PANKIW, *
* No. 15-1082V
Petitioner, * Special Master Christian J. Moran
*
v. * Filed: March 21, 2017
*
SECRETARY OF HEALTH * Findings of Fact, Onset of Joint
AND HUMAN SERVICES, * Pain.
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Ryan M. Spahr, Spahr Law Office, Indianapolis, IN, for petitioner;
Sarah Duncan, United States Dep’t of Justice, Washington, DC, for respondent.
FINDINGS OF FACT1
Alisha Pankiw alleges that an influenza (“flu”) vaccine caused her to suffer
joint pain. Although the parties agree about some aspects of her medical history,
the parties dispute when she began having joint pain. These Findings of Fact
attempt to resolve the outstanding factual disputes.
The parties agree that on March 20, 2012, Ms. Pankiw, who was working as
a nurse, gave birth to a daughter, K.P.2 Tr. 50, 271. On September 28, 2012, Ms.
Pankiw received a dose of flu vaccine. Exhibit 2 at 1. Ms. Pankiw saw Dr. Heisel
1 The E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17,
2002), requires that the Court post this ruling on its website. Pursuant to Vaccine Rule 18(b), the
parties have 14 days to file a motion proposing redaction of medical information or other
information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions ordered by the special
master will appear in the document posted on the website.
2 The girl’s name has been redacted to initials.

Case 1:15-vv-01082-EMR Document 56 Filed 04/17/17 Page 2 of 7
on October 10, 2012, during which she reported symptoms consistent with
arthritis.3 Exhibit 6 at 5.
The parties disagree about the onset of Ms. Pankiw’s knee/joint problems.
Ms. Pankiw contends that she first experienced these problems one to five days
post vaccination. Tr. 107-12; see also Tr. 307. The Secretary suggests that onset
was before the flu vaccine, possibly shortly after K.P. was born. The Secretary
relied upon histories Ms. Pankiw gave to doctors in the latter part of 2012,
especially Dr. Heisel.
A hearing was held to resolve this dispute. Witnesses were Ms. Pankiw, Ms.
Pankiw’s husband, Ms. Pankiw’s mother, and Ms. Pankiw’s friend. Their
testimony plus the information contained in all the documentary evidence is the
basis for the findings of fact made below.
Standards for Adjudication
The standards for resolving findings of fact are sufficiently established that
they need not be repeated here. For a detailed account, see Bayless v. Sec’y of
Health & Human Servs., No. 08-679V, 2015 WL 638197, at *2 (Fed. Cl. Spec.
Mstr. Jan. 15, 2015).
Analysis
The analysis begins with a short explanation of why the records from Dr.
Heisel do not persuasively establish an onset of Ms. Pankiw’s joint pain. The
remaining paragraphs discuss the more persuasive records and testimony.
The Secretary, in asserting that the onset of Ms. Pankiw’s joint problem is
unclear, primarily relies upon records from Dr. Heisel. Resp’t’s Rep. at 11-12.
But, with respect to Ms. Pankiw’s history, Dr. Heisel is not entirely consistent.
The history of present illness in Dr. Heisel’s first report from October 10, 2012
states: “Pain onset 4 mo ago 2 months post partum. Location is initially hands
back and feet. That went away. R ankle K [sic] knee L middle toe R index finger.
No other joints.” Exhibit 6 at 4. Dr. Heisel created his second report less than one
week later. In the October 15, 2012 report, he stated “Onset about a month ago.”
3 The parties seem to agree that medical records that memorialize Ms. Pankiw’s present
condition accurately state her health at the time the doctor created the record.
2

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Thus, it appears that Dr. Heisel suggests 3 different dates of onset.4 Id. at 22. The
inconsistency in histories Dr. Heisel recorded lessens the evidentiary value of these
reports.
Records created closer in time to the events that Ms. Pankiw is describing
appear more accurate. Following K.P.’s birth, Ms. Pankiw experienced swollen
hands and feet. Tr. 53. By Ms. Pankiw’s account, the duration was less than one
month and when Ms. Pankiw returned to her OB-GYN (Dr. Linn), she did not
report any swelling. Exhibit 15 at 76; Tr. 56, 304. Likewise, after giving birth,
Ms. Pankiw felt weak and Ms. Pankiw attributed this weakness to prolonged
bedrest during her pregnancy. Tr. 159; see also Tr. 36-38 (describing bed rest), 44
(same), 47 (same).
Also, within a month of K.P.’s birth, Ms. Pankiw sought attention from a
chiropractor at Apex Therapy Clinic. She reported low back pain that resolved
within two visits and mid back pain that did not immediately resolve. Exhibit 35
at 5.
Any lingering mid back pain did not last long. After the April 24, 2012
Apex Therapy visit, Ms. Pankiw did not return until October 22, 2012. Exhibit 35
at 6. Presumably, if Ms. Pankiw were hurting, she would have sought more
treatment. It is not likely that Ms. Pankiw was experiencing a significant amount
of pain because she increased her level of activity after April 2012. In May 2012,
her participation in a program to become a nurse practitioner rose from less than
half-time to more than half-time. Exhibit 32 at 1. She began her clinical
placements, working approximately 20 hours per week. Tr. 225; see also Tr. 61,
66.
In addition to her educational activities, Ms. Pankiw cared for K.P. and her
two stepchildren. Ms. Pankiw regularly walked around her neighborhood with
friends, went to the zoo, and brought her children to a swimming pool. Exhibits
23, 24, 26; Tr. 67-72, 249, 276. Her activity level suggests that she was not
experiencing any significant joint pain.
According to her husband, Ms. Pankiw’s state of general good health is
reflected in their decision to purchase plane tickets to attend a family member’s
4 First, the onset could be “four months” before the October 10, 2012 visit, which would
be June 10, 2012. Second, the onset could be “2 months postpartum,” which would be May 22,
2012. Third, the onset could be “about a month” before the October 15, 2012 visit, which would
be September 15, 2012.
3

Case 1:15-vv-01082-EMR Document 56 Filed 04/17/17 Page 4 of 7
wedding in Puerto Rico. A credit card invoice showed that the family purchased
the airfare on July 23, 2011. Exhibit 23. Mr. Pankiw persuasively explained that
his wife and he believed that they had adjusted to having K.P. and felt comfortable
planning a vacation that would include physical activities such as zip lining. Tr.
279, 289.
At the postpartum April 27, 2012 appointment, Dr. Linn had recommended
that Ms. Pankiw have her next appointment in three months. Exhibit 15 at 76.
This follow-up occurred on August 3, 2012. Exhibit 15 at 85; Tr. 82, 227. In Dr.
Linn’s review of symptoms, Dr. Linn recorded for musculoskeletal: “Negative for
myalgias and arthralgias.” Exhibit 15 at 85. Similarly, Dr. Linn’s physical exam
for musculoskeletal stated: “She exhibits no edema.” Id. at 87. Dr. Linn ordered a
routine set of labs that showed Ms. Pankiw’s TSH was low. Exhibit 15 at 92.
During her hearing testimony, Ms. Pankiw did not recall how Dr. Linn
responded to the lab results. Regardless, after these laboratory tests, Ms. Pankiw
saw Dr. Rogers on August 24, 2011 to establish care with a new primary care
physician. Exhibit 37 at 8; Tr. 96. In the review of symptoms that Dr. Rogers
created, the entry for musculoskeletal system states: “Negative for back pain and
arthralgias.” Exhibit 37 at 8. Dr. Rogers’s notes about her physical exam do not
contain any information about the musculoskeletal system.
Following the August 24, 2012 visit with Dr. Rogers, the picture of Ms.
Pankiw’s health becomes less clear. A record created in November 2012 states:
“In late August/early September she developed joint symptoms.” Exhibit 36 at 9.
Dr. Heisel’s second report, dated October 22, 2012, suggests a similar onset: “Pain
is increased in L knee… Also more swelling… Onset about a month ago.” Exhibit
6 at 22. A third doctor stated: “In September, she developed generalized
asymmetrical arthralgias. Over the next few weeks, the arthralgias turned to frank
arthritis of her left knee, right ankle, and wrist.” Exhibit 9 at 43 (Dr. Slama’s
December 18, 2012 report).
However, on September 17, 2012, Ms. Pankiw saw an endocrinologist,
Ernest O. Asamoah. Exhibit 16.1 at 7; Tr. 97. In the review of systems, the report
for musculoskeletal stated: “Negative for back pain, joint swelling and arthralgias.”
Id. at 8. Dr. Asamoah’s note from physical exam states “Normal range of motion”
in her musculoskeletal system. Id. at 9.
Besides the lack of a report of joint problems to Dr. Asamoah, other
evidence suggests that Ms. Pankiw was not having joint pain in September 2012.
4

Case 1:15-vv-01082-EMR Document 56 Filed 04/17/17 Page 5 of 7
She returned to working in a hospital as a floor nurse. Tr. 92, 230. Ms. Pankiw
brought K.P. to a play date with another infant. Exhibit 27; Tr. 15, 93.
In sum, before the flu vaccination, Ms. Pankiw was reasonably healthy and
was active. Any problems in her joints were not so pronounced that they interfered
with her typical duties.
On Friday, September 28, 2012, Ms. Pankiw received the flu vaccine.
Exhibit 21. There is no dispute about this event.
The time and attendance records Ms. Pankiw’s employer created show that
on the following day, Ms. Pankiw worked an extra shift. Exhibit 33 at 62. Ms.
Pankiw explained that her employer needed to maintain adequate nursing coverage
and, therefore, offered a very high hourly wage as an incentive for her to work
extra. If Ms. Pankiw were in pain, she would not have accepted this additional
assignment. Tr. 107-12, 308-10.
According to a calendar kept on Ms. Pankiw’s phone, she interviewed for a
job as a nurse practitioner on Wednesday, October 3, 2012. Ms. Pankiw credibly
testified that in preparing for his interview she was concerned about appearing
hobbled. Tr. 114-15, 211-12, 243-44, 308.
Two days later, on October 5, 2012, she had an interview for another job.
Ms. Pankiw again persuasively testified that by October 5, 2012, she could not
hide her limp. Id.
On October 10, 2012, she had her first of three appointments with Dr.
Heisel. As explained earlier, Dr. Heisel’s medical histories are not accurate with
respect to the history (onset of pain in her back and feet 4 months ago). However,
there is no reason to question the accuracy of Ms. Pankiw’s report to Dr. Heisel
about her condition on October 10, 2012. She was having sharp pain in her right
ankle and her left knee was swollen and achy. She felt stiff all day. Exhibit 6 at 4.
There is also no reason to question the accuracy of what Dr. Heisel reported
finding on his physical exam: “Patient exhibits no edema. I don’t appreciate any
warmth or effusion of the left knee. There is a little warmth at the right ankle. I
don’t appreciate any inflammation in her fingers or toes.” Id. at 5.
On Saturday, October 13, 2013, Ms. Pankiw’s family, including her mother,
visited a local orchard. (The date is recorded on a picture taken during the outing.)
During this trip, Ms. Pankiw had difficulty walking with the other members of her
group. Exhibit 29; Tr. 137, 209, 254, 288.
5

Case 1:15-vv-01082-EMR Document 56 Filed 04/17/17 Page 6 of 7
The next day, a Sunday, was the date of a birthday party for Ms. Pankiw’s
step-daughter. During this party, one of Ms. Pankiw’s friends noticed that she was
not moving very easily and offered her crutches. Mr. Pankiw recalled this birthday
party as a time when the extent of his wife’s joint problems was evident. Exhibit
25; Tr. 138, 282, 311.
Ms. Pankiw had her second visit with Dr. Heisel on Monday, October 15,
2012. Again, although Dr. Heisel’s history is not accurate, the information that he
recorded about Ms. Pankiw’s present condition is reliable. “Pain is increased in L
knee. . . . It has gotten worse recently.” Exhibit 6 at 22. Dr. Heisel also
commented: “Since she has more swelling and much more stiffness, requiring
walking on crutches, I suggested a steroid injection.” Id.
Other evidence also shows that Ms. Pankiw’s activity level changed. On
October 15, 2012, Ms. Pankiw canceled her shift as a nurse at the hospital. Tr.
117. The hospital’s time and attendance records show that Ms. Pankiw’s last shift
at the hospital was on October 23, 2012, when she attended an educational course.
Exhibit 31 at 1; Tr. 117.
Ms. Pankiw also attended two weddings on crutches. The first appears to
have been relatively close to her residence. See Tr. 141, 252. The other wedding
was in Puerto Rico. Exhibit 28; exhibit 30 (Facebook postings) at 3; Tr. 141, 252,
288.
Following these weddings, Ms. Pankiw saw a variety of doctors, including
her obstetrician for another pregnancy. It appears that the information about Ms.
Pankiw’s current condition as recorded in the records from these doctors is
accurate. The parties have not indicated that factual findings are needed for Ms.
Pankiw’s medical history after November 2012.
Conclusion
Ms. Pankiw has established that her joint pain began on approximately
October 1, 2012. This date is after she worked a double shift and before she had a
job interview on October 3, 2012.
The parties are ordered to provide these findings of fact to any expert whom
they retain to testify. Expert opinion inconsistent with these findings of fact is not
likely to be persuasive. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415,
417 (Fed. Cir. 1993) (holding that the special master did not abuse his discretion in
refraining from conducting a hearing when the petitioner’s expert “based his
opinion on facts not substantiated by the record”); Brooke Group Ltd. v. Brown &
6

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Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“When an expert opinion is
not supported by sufficient facts to validate it in the eyes of the law, or when
indisputable record facts contradict or otherwise render the opinion unreasonable,
it cannot support a jury’s verdict.”); Perreira v. Sec’y of Health & Human Servs.,
33 F.3d 1375, 1376 n.6 (Fed. Cir. 1994) (“An expert opinion is no better than the
soundness of the reasons supporting it.”); see also Bradley v. Sec’y of Health &
Human Servs., 991 F.2d 1570, 1574 (Fed. Cir. 1993) (the assumption of an expert
about the accuracy of a fact witness’s testimony does not “substantiate” the fact
witness’s testimony).
A status conference is set, sua sponte, for Tuesday, April 4, 2017 at 10:30
A.M. Eastern Time. The parties should be prepared to propose the next step in
this case.
Any questions may be directed to my law clerk, Shannon Proctor, at
(202) 357-6360.
IT IS SO ORDERED.
s/ Christian J. Moran
Christian J. Moran
Special Master
7

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DOCUMENT 2: USCOURTS-cofc-1_15-vv-01082-2
Date issued/filed: 2021-04-06
Pages: 10
Docket text: PUBLIC DECISION (Originally filed: 03/09/2021) regarding 116 DECISION of Special Master. Signed by Special Master Christian J. Moran. (hh) Service on parties made.
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Case 1:15-vv-01082-EMR Document 117 Filed 04/06/21 Page 1 of 10
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
ALISHA N. PANKIW, *
*
* No. 15-1082V
Petitioner, * Special Master Christian J. Moran
*
v. *
* Filed: March 9, 2021
SECRETARY OF HEALTH *
AND HUMAN SERVICES, * Entitlement; influenza (“flu”) vaccine;
* rheumatoid arthritis; diagnosis.
Respondent. *
* * * * * * * * * * * * * * * * * * * * * *
William E. Cochran, Jr., Black McLaren et al., P.C., Memphis, TN, for petitioner;
Sarah C. Duncan, United States Dep’t of Justice, Washington, DC, for respondent.
DECISION DENYING COMPENSATION1
Alisha Pankiw alleges that an influenza (“flu”) vaccination caused her to
suffer rheumatoid arthritis. She seeks compensation pursuant to the National
Childhood Vaccine Injury Compensation Program.
On December 21, 2020, Ms. Pankiw filed a motion for ruling on the record.
Respondent then filed his response to this motion on January 4, 2021, followed by
Ms. Pankiw’s reply, filed on January 11, 2021. Thus, Ms. Pankiw’s motion for
ruling on the record is now ripe for consideration. Ms. Pankiw has not
demonstrated: (1) a diagnosis of rheumatoid arthritis, or (2) that her alleged
1 The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), requires that the Court post this decision on its
website. This posting will make the decision available to anyone with the internet. Pursuant to
Vaccine Rule 18(b), the parties have 14 days to file a motion proposing redaction of medical
information or other information described in 42 U.S.C. § 300aa-12(d)(4). Any redactions
ordered by the special master will appear in the document posted on the website.

Case 1:15-vv-01082-EMR Document 117 Filed 04/06/21 Page 2 of 10
rheumatoid arthritis was caused by her flu vaccination. Thus, her petition is
dismissed.
I. Factual Background
Ms. Pankiw received her flu vaccination on September 28, 2012. Exhibit 2
at 1. She then presented to her primary care physician, Dr. Heisel, 12 days later on
October 10, 2012, complaining of “temporomandibular joint pain.” Exhibit 6 at 1.
Dr. Heisel characterized Ms. Pankiw’s reported joint pain as “sharp in ankle,”
“achy in knee,” “swollen knee,” and “most notable in the right ankle.” Id. at 5.
However, Dr. Heisel noted that, while Ms. Pankiw did “have some arthritis,” that
“[i]t is not a typical presentation for rheumatoid arthritis. It isn’t symmetric.” Id.
Additionally, a squeeze was performed, which was negative. Id. Dr. Heisel noted
a pain onset of “4 [months] ago 2 months postpartum.” Id. at 4. There are
discrepancies in the doctors’ records regarding reported onset of Ms. Pankiw’s
symptoms. However, the undersigned has found that her joint pain began on
approximately October 1, 2012. See Pankiw v. Sec’y of Health & Human Servs.,
No. 15-1082V, 2017 WL 1376435, at *4 (Fed. Cl. Spec. Mstr. Mar. 21, 2017).
At a follow-up visit on October 15, 2012, Ms. Pankiw reported a worsening
of her symptoms, which she characterized primarily as “stiffness.” Id. at 22. Dr.
Heisel again noted that Ms. Pankiw exhibited “acute arthritis,” but that it was
“[s]till not likely to be rheumatoid arthritis.” Id. at 23. He further noted that “[a]n
inflammatory arthritis is suggested by her postpartum status and the presence of
postpartum thyroiditis.” Id. Ms. Pankiw was put on prednisone at this visit.
On October 23, 2012, Ms. Pankiw reported to Dr. Heisel that her knee
stiffness/pain had improved but was worsening again, that her right ankle was
worse, and that there had been no change in the pain levels for her index finger and
left third toe. Id. at 27-31. A few weeks later, on November 12, 2012, Ms. Pankiw
visited her gynecologist for a prenatal visit, where she advised her gynecologist of
her potential rheumatological diagnosis and stated that, due to the prednisone, she
had experienced a “huge improvement in left knee stiffness.” Exhibit 8 at 8.
On December 4, 2012, Ms. Pankiw attended her first rheumatology visit
with Dr. Thomas. Exhibit 7 at 3. She presented with “undifferentiated arthritis”
and complained of pain in her left knee, right ankle, and right index finger. Id. Dr.
Thomas noted the possibility of “seronegative [rheumatoid arthritis]” and the
potential complicating diagnostic factor that Ms. Pankiw’s pregnancy presented.
Id.
2

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Between November 2012 and March 2013, Ms. Pankiw presented to
multiple medical providers consistently complaining of pain and/or stiffness in her
left knee, right ankle, wrist, and right index finger. These providers included
infectious disease specialist Dr. Slama, a chiropractor, rheumatologist Dr.
Thornberry, endocrinologist Dr. Asamoah, and OB/GYN Dr. Linn. See exhibit 9
at 20, 43-44 (Dr. Slama on December 18, 2012, and January 11, 2013); exhibit 11
at 5, 7 (chiropractor on January 4, 2013, and January 5, 2013); exhibit 9 at 16-19
(Dr. Thornberry on February 18, 2013); exhibit 16 at 21-24, 37-43 (Dr. Asamoah
on November 20, 2012, and February 20, 2013); exhibit 8 at 29 (Dr. Linn on
March 1, 2013).
During this time, Ms. Pankiw received various evaluations to determine
whether her symptoms represented an onset of lupus; however, a diagnosis of
rheumatoid arthritis was never made. On February 18, 2013, Dr. Thornberry
recorded her impression of Ms. Pankiw’s condition as “[a]symmetric inflammatory
polyarthritis associated with positive ANA.” Exhibit 9 at 18. She also noted that
“[t]he distribution of [Ms. Pankiw’s] articular disease is unusual for systemic lupus
erythematosus (SLE) and rheumatoid arthritis. However we must consider that
there is some influence upon her arthropathy by her pregnant state.” Id.
On February 20, 2013, Dr. Asamoah noted normal thyroid tests, despite Ms.
Pankiw’s consistent complaints of joint pain and stiffness. Exhibit 16 at 37-43.
On March 1, 2013, Dr. Linn characterized Ms. Pankiw’s condition as “[p]ossibly
arthritis/myalgias related to flu shot vs lupus.” Exhibit 8 at 29. Dr. Linn listed
systemic lupus erythematosus (SLE) as Ms. Pankiw’s diagnosis. Id. at 41.
By May 2013, Ms. Pankiw began reporting significant improvement in her
symptoms to her medical providers. In an appointment on September 5, 2013, Dr.
Thornberry noted that, based on her evaluation, Ms. Pankiw’s “pauciarticular
inflammatory arthritis associated with positive ANA [has] resolved.” Exhibit 9 at
9.2 Dr. Thornberry later maintained this as the date of resolution of Ms. Pankiw’s
arthritis symptoms in a letter to Ms. Pankiw’s attorney, stating that Dr. Thornberry
“felt that the arthritis had resolved when [she] examined her on 09/05/2013.”
Exhibit 10 at 28.
On December 13, 2013, Dr. Thornberry responded to a request from Ms.
Pankiw in which she asked for a note stating that she could not receive the flu
vaccination in the future, stating that Ms. Pankiw “had a significant adverse
reaction to an influenza vaccine administered in September, 2012, manifested by
2 Pauciarticular means “pertaining to or involving only a few joints.” Dorland’s Illus. Med. Dictionary
1378 (33d ed. 2020)
3

Case 1:15-vv-01082-EMR Document 117 Filed 04/06/21 Page 4 of 10
arthritis.” Exhibit 10 at 41. Over a year later, Ms. Pankiw presented to Dr.
Thornberry with joint pain. Dr. Thornberry characterized her condition as “joint
pain without evidence of inflammatory arthritis” and noted that she “suspect[ed]
that [Ms. Pankiw’s] discomfort [wa]s in part due to her deconditioned state and her
overweight status.” Id. at 16-17. Ms. Pankiw did not complain of joint pain at any
of her multiple subsequent medical appointments in 2015. In her letter to Ms.
Pankiw’s attorney on January 8, 2015, Dr. Thornberry stated that “[w]ith the
asymmetric and pauci-articular nature of her illness, consistent with viral
arthropathy or vaccine-induced arthropathy, it was felt that there was a reasonable
medical probability that her symptoms were caused by the influenza vaccination.”
Exhibit 10 at 28.
II. Procedural History
Ms. Pankiw filed her petition on September 28, 2015. She asserted that the
flu vaccination she received on September 28, 2012, caused her to suffer “arthritis
of the joints.” Pet. at Preamble, ¶¶ 2, 9. Ms. Pankiw filed medical records along
with her petition. She filed a statement of completion on December 18, 2015.
The Secretary filed his Rule 4(c) report on April 1, 2016, contesting Ms.
Pankiw’s claim based on his view that Ms. Pankiw failed to present: (1) a reputable
scientific or medical theory showing that the flu vaccine can cause arthritis (prong
1); (2) evidence showing that the flu vaccine actually caused arthritis of the joints
in Ms. Pankiw’s case; and (3) evidence establishing that the time frame between
Ms. Pankiw’s vaccination and onset of her injury fell within a medically acceptable
time frame. Resp’t’s Rep. at 11-12. Additionally, the Secretary argued that Ms.
Pankiw had not established a clear onset date for her arthritis and that she had
“ignored potential alternative causes of the arthritis in her joints,” specifically the
potential effects of her pregnancy on her joint pain. Id. at 12-13.
The parties discussed the factual issue of the onset of Ms. Pankiw’s joint
pain in a status conference held on April 12, 2016. Eventually, a fact hearing
regarding onset of Ms. Pankiw’s symptoms was set for October 18, 2016, in
Indianapolis, IN. The undersigned found that Ms. Pankiw’s joint pain began on
approximately October 1, 2012. See Pankiw v. Sec’y of Health & Human Servs.,
No. 15-1082V, 2017 WL 1376435, at *4 (Fed. Cl. Spec. Mstr. Mar. 21, 2017).
The parties then filed a succession of expert reports. Ms. Pankiw presented
reports from Dr. Utz and the Secretary presented reports from Dr. Matloubian and
Dr. Whitton. See exhibits 38-41, A, C-D, F-I. The Secretary filed the final expert
report on December 9, 2019. The opinions from Dr. Utz and Dr. Matloubian on
the topic of whether flu vaccine can cause rheumatoid arthritis largely matched the
4

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reports they authored in another case, Tullio v. Secretary of Health & Human
Services. Thus, at one point, the parties in Tullio and the parties in Pankiw
considered holding one hearing. See order, issued Dec. 10, 2018, CM/ECF No. 83.
However, the parties abandoned that effort largely due to the presence of experts
other than Dr. Utz and Dr. Matloubian.
Dr. Utz and Dr. Matloubian presented testimony as to whether the flu
vaccine can cause rheumatoid arthritis in a hearing held in Tullio on March 6-8,
2019. After considering this testimony as well as a series of medical articles
including epidemiologic studies, the undersigned found that the petitioner in Tullio
had not established that the flu vaccine can cause rheumatoid arthritis. Tullio v.
Secretary of Health & Human Services on this case. No. 15-51V, 2019 WL
7580149 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149 Fed. Cl.
448 (2020).
In a status conference held on February 18, 2020, the undersigned discussed
with Ms. Pankiw and the Secretary the likely effect of the decision in Tullio. Ms.
Pankiw’s attorney stated that he would consult with Dr. Utz regarding potentially
distinguishing factors between Ms. Pankiw’s case and that of the petitioner in
Tullio. He expressed a desire to wait on making any decisions about how to
proceed in Ms. Pankiw’s case until the Court of Federal Claims ruled on the
motion for review in Tullio. Order, CM/ECF No. 104, issued Feb. 18, 2020.
On June 18, 2020, the Court of Federal Claims issued a decision denying the
petitioner’s motion for review in Tullio. 149 Fed. Cl. 448 (2020). The petitioner
in Tullio did not appeal to the Federal Circuit.
After Ms. Pankiw’s attorney requested additional time to review the Court’s
Opinion denying the motion for review in Tullio and consult with Dr. Utz and Ms.
Pankiw, a status conference was held on September 29, 2020. Ms. Pankiw was
ordered to submit additional proof to support her case and/or submit the case for a
ruling on the record by October 29, 2020. Order, CM/ECF No. 111, issued Sept.
30, 2020. Ms. Pankiw filed additional medical literature on October 28, 2020, and
filed a motion for ruling on the record on December 21, 2020. Pet’r’s Mot.,
CM/ECF No. 113, filed Dec. 21, 2020. The Secretary filed a response on January
4, 2021, and Ms. Pankiw filed her reply on January 11, 2021. Resp’t’s Resp.,
CM/ECF No. 114, filed Jan. 4, 2021; Pet’r’s Reply, CM/ECF No. 115, filed Jan.
11, 2021. Thus, Ms. Pankiw’s reply makes the case ready for adjudication.
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III. Standards for Adjudication
Petitioners are required to establish their cases by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of
Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted).
To receive compensation, petitioners must establish five elements. 42
U.S.C. § 300aa–11(c)(1)(A) through (E); 42 U.S.C. § 300aa–13(a)(1)(A)
(authorizing special masters to award compensation when petitioners establish
items listed in section 11(c)(1)). To establish causation for off-Table injuries,
petitioners bear a burden “to show by preponderant evidence that the vaccination
brought about [the vaccinee’s] 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.” Althen v.
Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
The process for finding facts in the Vaccine Program begins with analyzing
the medical records, which are required to be filed with the petition. 42 U.S.C.
§ 300aa–11(c)(2). Medical records that are created contemporaneously with the
events they describe are presumed to be accurate. Cucuras v. Sec’y of Health &
Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
IV. Analysis
Here, Ms. Pankiw has failed to meet her burden with respect to two aspects
of her claims, which are dispositive. First, she has not shown by a preponderance
of the evidence that she suffered from rheumatoid arthritis (“RA”), the diagnosis of
which is the basis for Dr. Utz’s opinion supporting causation in her case. Second,
even assuming a diagnosis of RA, she has not presented a persuasive medical
theory to support that the flu vaccination can cause RA.
A. Diagnosis
A special master may make a preliminary determination regarding diagnosis
before reaching the issue of causation, as proving a relevant injury is necessary to
the success of a causation theory. See Broekelschen v. Sec’y of Health & Human
Servs., 618 F.3d 1339, 1345-46 (Fed. Cir. 2010). In his expert report, Dr. Utz
presents an opinion that is very similar to his opinion in Tullio with respect to how
6

Case 1:15-vv-01082-EMR Document 117 Filed 04/06/21 Page 7 of 10
an influenza vaccination can cause rheumatoid arthritis. However, Dr. Utz admits
that, while Ms. Pankiw did appear to suffer from arthritis, she definitively did not
suffer from rheumatoid arthritis. See exhibit 38 (Dr. Utz report) at 8.
Additionally, none of Ms. Pankiw’s medical providers diagnosed her with RA. In
fact, Dr. Heisel rejected a diagnosis of RA. See exhibit 6 at 1 (noting that Ms.
Pankiw did “have some arthritis,” but that “[i]t is not a typical presentation for
rheumatoid arthritis”); id. at 23 (noting that Ms. Pankiw exhibited “acute arthritis,”
but that it was “[s]till not likely to be rheumatoid arthritis”). Dr. Matloubian
further argued that Ms. Pankiw’s arthritis was a manifestation of her thyroiditis,
which existed pre-vaccination. Exhibit A at 23.
This conspicuous lack of a diagnosis or expert opinion identifying Ms.
Pankiw’s symptoms as manifestations of RA is significant because Dr. Utz’s
asserted medical theory relies on evidence produced to show that flu vaccinations
can cause rheumatoid arthritis. Additionally, even though Dr. Utz states in his
report that the flu vaccine can cause RA or inflammatory arthritis, see exhibit 38 at
17, Dr. Thornberry explicitly stated that Ms. Pankiw does not have inflammatory
arthritis either. Exhibit 10 at 16-17. It follows that, even if the undersigned were
to accept Dr. Utz’s medical theory, it is questionable how it would be applied to
Ms. Pankiw’s specific case, given that she did not suffer from RA and that there is
evidence against a diagnosis of inflammatory arthritis as well. Citing to studies
relevant to the flu vaccine-RA link, Dr. Utz states that “[i]t is plausible, and I
would argue very likely, that similar molecular mechanisms are at play in Ms.
Pankiw’s case . . . causing inflammatory arthritis.” Exhibit 38 at 11-12. However,
Dr. Thornberry stated that Ms. Pankiw did not suffer from inflammatory arthritis.
Exhibit 10 at 16-17. Dr. Utz goes on to analogize various causal relationships with
foreign antigens that involve conditions, none of which are Ms. Pankiw’s arthritis
condition. Essentially, Dr. Utz’s medical theory is premised on research and
medical literature involving RA. According to Dr. Utz and Ms. Pankiw’s medical
providers, Ms. Pankiw never suffered from RA. Therefore, the evidence presented
does not appear particularly informative, much less persuasive, with regard to Ms.
Pankiw’s particular circumstances. See Broekelschen, 618 F.3d at 1345 (“[A]
petitioner must provide a reputable medical or scientific explanation that pertains
specifically to the petitioner’s case[.]”).
B. Althen Prong 1
Even if a determination were made that Ms. Pankiw suffered from
rheumatoid arthritis or a condition sufficiently similar to make the asserted medical
theory applicable, Ms. Pankiw has failed to provide a persuasive medical theory
showing that a flu vaccination can cause arthritis. This finding is based primarily
on the fact that Ms. Pankiw advances a virtually identical theory as was advanced
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in Tullio, a case in which the undersigned rejected the molecular mimicry-based
theory of flu-RA causation.
The petitioner in Tullio advanced the theory of molecular mimicry.3 Dr. Utz
stated that “[i]n rheumatoid arthritis, the portion of the body that is attacked in the
synovium. A constituent part of the synovium is collagen. . . . [A] sufficient
degree of similarity between collagen and a portion of the flu vaccine such that T
cells attack not only the flu antigens but also collagen.” Tullio, 2019 WL 7580149,
at *12. In response, the Secretary’s expert Dr. Matloubian argued that the articles
presented by Dr. Utz to support his theory “do not show a similarity between
collagen and a portion of the flu vaccine.” Id.
Dr. Utz posits essentially the same theory of causation in this case. In his
report, Dr. Utz states that:
It is well accepted in the field of rheumatology that Type II collagen is
an autoantigen in RA. The Sun manuscript, as well as many other
manuscripts referenced in their paper, demonstrate that the influenza
antigen (HA) that is most important in generating an effective anti-
viral response contains linear epitope(s) that can trigger a strong
immune response that can cause inflammatory arthritis. Undoubtedly
other environmental (nonself) vaccine antigens can trigger immune
responses directed against self-molecules, leading to diseases, such as
inflammatory arthritis, RA, and MS.
Exhibit 38 at 17. In response, Dr. Matloubian argued that there is no “scientific
evidence to support molecular mimicry between influenza and collagen or other
RA associated antigens” – an argument substantially similar to that of his
responsive expert report in Tullio. Exhibit A at 22.
After the parties filed expert reports and the issue of Tullio’s probable effect
on this case was discussed, Ms. Pankiw filed one additional piece of evidence in
the form of a case report. See exhibit 52. The case report described a twelve-year-
old girl who developed transient oligoarthritis after suffering from the influenza B
infection. Id. at 1. As a preliminary matter, case reports hold relatively little
weight in vaccine cases. W.C. v. Sec’y of Health & Human Servs., No. 07-456V,
2011 WL 4537887, at *13 (Fed. Cl. Spec. Mstr. Feb. 22, 2011) (“[C]ase reports are
generally weak evidence of causation because [they] cannot distinguish a temporal
relationship from a causal relationship.”), mot. for rev. denied, 100 Fed. Cl. 440
3 For a detailed explanation of the molecular mimicry theory, see Tullio, 2019 WL
7580149, at *12.
8

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(2011), aff’d, 704 F.3d 1352 (Fed. Cir. 2013). Additionally, as the Secretary
points out in his response, there are key distinguishing factors in this case report
that make it unpersuasive for Ms. Pankiw’s case – namely, that it involved (1)
“possible” post-infectious arthritis, (2) an influenza infection, and (3) a child
subject. Exhibit 52 at 1; Resp’t’s Resp. at 3. Additionally, the case report itself
admits to a lack of reliability concerning causality. Exhibit 52 at 2. For these
reasons, the lone piece of additional evidence Ms. Pankiw offered in response to
concerns regarding the effect of the Tullio decision is unpersuasive as to the
question of causation.
The undersigned rejected the theory of molecular mimicry as applied in the
flu-RA context in Tullio, and does so here as well, given that there has been no
substantial departure in this case from the theory originally advanced by Dr. Utz.
See Tullio, 2019 WL 7580149, at *27. Furthermore, because Althen prong 1 is
dispositive in this case, the undersigned does not reach the issues of specific
causation or timing. It follows that, because the medical theory of causation is
unpersuasive, that the application to Ms. Pankiw’s circumstances would also be
unpersuasive. The lack of diagnosis and questionability of the RA-related aspects
of Ms. Pankiw’s condition would add to the lack of persuasiveness with respect to
specific causation or Althen prong 2.
C. Ruling on the Record is Appropriate
Special masters may rely on accumulated knowledge in the Vaccine
Program to make entitlement decisions on the papers. Thus, special masters,
“based upon their accumulated expertise in the field, judg[e] the merits of
individual claims.” Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d
1099, 1104 (Fed. Cir. 1996) (quoting Hodges v. Sec’y of Health & Human Servs.,
9 F.3d 958, 961 (Fed. Cir. 1993)). Additionally, special masters retain wide
discretion in determining whether an evidentiary hearing is necessary.
Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1365 (Fed. Cir.
2020) (citing 42 U.S.C. § 300aa-12(d)(3)(B)(v) (“In conducting a proceeding on a
petition a special master . . . may conduct such hearings as may be reasonable and
necessary.”)). The special master must only determine “that the record is
comprehensive and fully developed before ruling on the record.” Id. at 1366
(citing Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1385 (Fed.
Cir. 2012)).
The accumulated experience applied in this case includes the recent
consideration by the undersigned of the precise issue as to whether the flu vaccine
can cause rheumatoid arthritis. Ms. Pankiw submitted a motion for a ruling on the
record. She has had a full and fair opportunity to present her case, including a
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Case 1:15-vv-01082-EMR Document 117 Filed 04/06/21 Page 10 of 10
response to Tullio. Thus, a disposition on the papers is appropriate. See
Kreizenbeck, 945 F.3d at 1365.
V. Conclusion
For the foregoing reasons, the undersigned finds that Ms. Pankiw has not
met her burden to show by a preponderance of the evidence that the flu vaccination
caused her arthritis. Accordingly, the claim for compensation is DENIED.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
10

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_15-vv-01082-3
Date issued/filed: 2021-08-30
Pages: 23
Docket text: JUDGE VACCINE REPORTED OPINION re: Publicly available version of 121 Opinion and Order on Motion for Review. Signed by Judge Eleni M. Roumel. (ls) Service on parties made.
--------------------------------------------------------------------------------
Case 1:15-vv-01082-EMR Document 123 Filed 08/30/21 Page 1 of 23
In the United States Court of Federal Claims
ALISHA N. PANKIW,
Petitioner, No. 15-vv-1082
v. Filed: August 13, 20211
SECRETARY OF HEALTH Reissued for Public Availability:
AND HUMAN SERVICES, August 30, 2021
Respondent.
William E. Cochran, Jr., Black McLaren Jones Ryland & Griffee, PC., Memphis, Tennessee for
Petitioner.
Sarah C. Duncan, United States Department of Justice, Civil Division, Torts Branch,
Washington, D.C. for Respondent.
OPINION AND ORDER
On September 28, 2015, Petitioner Alisha N. Pankiw filed a Petition for compensation with
the National Vaccine Injury Compensation Program, under the National Childhood Vaccine Injury
Act of 1986, 42 U.S.C. §§ 300aa-1–300aa-34 (2012) (Vaccine Act), for an off-table injury.
Petition ¶ 1 (ECF No. 1). Specifically, Petitioner alleged that the flu vaccination administered on
September 28, 2012 resulted in her developing inflammatory arthritis,2 a condition that was
1 Pursuant to the United States Court of Federal Claims Vaccine Rule 18(b), the Court filed this
Opinion and Order on August 13, 2021, and provided the parties fourteen (14) days to propose
redactions. The parties did not propose redactions. Accordingly, the Court is publicly reissuing
its Opinion and Order in its original form for publication.
2 Inflammatory arthritis is characterized by morning stiffness lasting more than an hour, “gelling”
phenomena in which extended immobility such as from a car ride or getting out of a chair or tub
leads to profound stiffness, fatigue, and elevated inflammatory markers. Pet’r Ex. 38 (ECF No.
64-2) (Dr. Utz’s First Report) at 6.

Case 1:15-vv-01082-EMR Document 123 Filed 08/30/21 Page 2 of 23
resolved by September 5, 2013. See Petitioner’s Motion for Review of Special Master’s March 9,
2021 Decision Denying Compensation (ECF No. 118) (Pet’r Br.) at 6. Petitioner filed various
medical records3 and expert reports4 to support her position. Respondent filed competing expert
opinions5 to support its position that Petitioner’s joint pain was caused by postpartum autoimmune
thyroiditis and not her September 28, 2012 flu vaccine.
On March 9, 2021, Special Master Christian J. Moran issued a decision concluding that
Petitioner is not entitled to an award of compensation. See Pankiw v. HHS, No. 15-1082V, slip
op. (Fed. Cl. Spec. Mstr. March 9, 2021) (ECF No. 116) (Dec. or Decision). The Petitioner seeks
review of the Decision, contending that the Special Master erred in determining that Petitioner
did not meet her burden of demonstrating causation under Althen prong one. Petitioner’s Motion
for a Ruling on the Record (ECF No. 113); see also Pet’r Br. Specifically, Petitioner alleges that
the Special Master conducted his analysis under Althen prong one under the inaccurate premise
that Petitioner was never diagnosed with inflammatory arthritis. Pet’r Br. at 6.
Respondent requests this Court affirm the Special Master’s decision. Respondent’s
Response to Petitioner’s Motion for Review (ECF No. 120) (Resp’t Br.). Respondent argues the
Special Master’s findings regarding Petitioner’s diagnosis are immaterial and that the Decision
should be affirmed because Petitioner allegedly failed to provide a reliable medical theory causally
3 Petitioner initially filed medical records marked as Exhibits 2-11 (ECF Nos. 9-10). She later
filed additional medical records marked as Exhibits 15-18 (ECF No. 13) and expanded medical
records marked as Exhibits 35-37 (ECF Nos. 42-43).
4 Petitioner filed expert reports by Dr. Paul Utz (ECF Nos. 64, 74, 85, 95).
5 Respondent filed reports by two experts: Dr. Mehrdad Matloubian (ECF Nos. 67, 78, 87, 102)
and Dr. J. Lindsay Whitton (ECF No. 78-6).
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connecting her flu vaccination to inflammatory arthritis or rheumatoid arthritis (RA). Resp’t Br.
at 13-16.
For the reasons stated below, Petitioner's Motion for Review is SUSTAINED. The Special
Master’s Decision denying entitlement is VACATED, and the case is REMANDED for further
proceedings consistent with this Opinion and Order.
BACKGROUND
I. Petitioner’s Medical Records
Petitioner is a 31-year-old female with a medical history that includes hyperthyroidism,
thyroiditis, and significant back pain. Pet’r Ex. 16-1 (ECF No. 13-4) at 8-11; Pet’r Ex. 35 (ECF
No. 42-2) at 5-10.6 After giving birth in March 2012, Petitioner was diagnosed with low thyroid
stimulating hormone (TSH). Pet’r Ex. 15 (ECF No. 13-3) at 86-87, 90-92; Pet’r Ex. 37 (ECF No.
43-3) at 5, 11. Additionally, Petitioner experienced lower and mid back pain, and ankle pain at
least as early as March 2012. See generally Pet’r Ex. at 15 (chronicling “problems” of “low back
pain syndrome” and “ankle pain”); Pet’r Ex. 35 at 5-8. On September 17, 2012, Petitioner visited
Dr. Ernest Asamoah, an endocrinologist, regarding her low TSH. Pet’r Ex. 16-1 at 4. Dr. Asamoah
found Petitioner’s condition was “classic for post partum thyroiditis,” and should be monitored to
prevent the risk of hypothyroidism. Pet’r Ex. 16-1 at 9-10.
On September 28, 2012, Petitioner received the flu vaccine under the Fluarix brand. Pet’r
Ex. 2 (ECF No. 9-1). Twelve days later, on October 10, 2012, Petitioner visited her primary care
physician, Dr. William A. Heisel, and complained of “sharp” joint pain in her right ankle, a
“swollen” left knee, and pain in her left middle toe and right index finger. Pet’r Ex. 6 (ECF No.
6 This Court refers to the page numbers that CM/ECF automatically generates at the top of each
page when referencing Petitioner’s exhibits.
3

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9-5) at 1, 4-5. During the examination, Dr. Heisel found “some arthritis” in Petitioner’s right ankle
but concluded that this was “not a typical presentation for rheumatoid arthritis,” because her
arthritis was not “symmetric.” Id. at 5. On October 15, 2012, Petitioner revisited Dr. Heisel for
swelling in her left knee that she characterized as “stiffness,” which, she reported, had begun a
month earlier and had recently worsened. Id. at 22. Dr. Heisel diagnosed Petitioner with acute
arthritis. Id. at 23. Dr. Heisel noted that it was unlikely Petitioner’s symptoms were caused by
rheumatoid arthritis and that her post-partum status indicated that her symptoms were more likely
the result of inflammatory arthritis. Id. Dr. Heisel treated Petitioner’s symptoms with a steroid
injection in her left knee. Id. at 22. On October 23, 2012, Petitioner attended a third appointment
with Dr. Heisel, during which Petitioner reported reduced pain in her left knee, worsening pain in
her right ankle, and no change in pain from her index finger and left third toe. Id. at 27-31. Dr.
Heisel noted that RA was still “fairly unlikely.” Id. at 31.
In early November of 2012, Petitioner discovered she was pregnant. Pet’r Ex. 12 at 1
(¶ 11). Petitioner subsequently visited several doctors complaining of joint pain. On November
8, 2012, Petitioner met with Dr. Kathleen Thomas, a rheumatologist, who noted that Petitioner
recently had postpartum thyroiditis in early August 2012 and had developed joint symptoms soon
thereafter. Pet’r Ex. 36 (ECF No. 43-2) at 9. Dr. Thomas reported that Petitioner had “unspecified
inflammatory polyarthropathy” consistent with her thyroid disease and prescribed prednisone for
symptomatic relief. Id. at 11-12. On November 12, 2012, Petitioner visited Dr. Cady Linn, an
obstetrician-gynecologist, for prenatal treatment. Pet’r Ex. 8 (ECF No. 10-1) at 8. Dr. Linn noted
that Petitioner was undergoing diagnosis for a possible rheumatologic condition. Id. Dr. Linn also
noted that Petitioner had a “huge improvement in her left knee stiffness” since taking prednisone.
Id.
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On November 20, 2012, Dr. Asamoah increased Petitioner’s Synthroid dose to treat her
thyroiditis. Pet’r Ex. 16-1 at 21-27. On December 4, 2012, Petitioner followed up with Dr.
Thomas for undifferentiated arthritis—complaining of joint pain in her left knee, right ankle, and
right index finger. Pet’r Ex. 7 (ECF No. 9-6) at 3. During this visit, Dr. Thomas found that
Petitioner’s symptoms may be indicative of “early seronegative [rheumatoid arthritis]” but
suggested Petitioner’s ongoing pregnancy could complicate a diagnosis due to an “immunologic
shift.” Id. Dr. Thomas suggested Petitioner reduce her prednisone dosage over time and transition
to Plaquenil in her third trimester. Id.
Dr. Linn referred Petitioner to Dr. Thomas Slama, an infectious disease specialist whom
Petitioner visited on December 18, 2012. Pet’r Ex. 9 (ECF No. 10-2) at 43-44. During this visit,
Dr. Slama observed that Petitioner had a “hot, swollen right ankle and left knee in addition to
arthralgia of her left wrist.” Id. On January 11, 2013, Dr. Slama referred Petitioner to Dr. Denise
Thornberry. Id. at 20. In his referral letter, Dr. Slama stated that he had evaluated Petitioner’s
condition and found that Petitioner’s active arthritis from the initial visit to be nearly resolved but
stated that “[a]t the present time, all I can say is that [Petitioner] has an active synovitis that is not
likely bacterial in etiology.” Id.
On February 18, 2013, Petitioner visited Dr. Denise Thornberry, a rheumatologist, on
referral from Dr. Slama. Pet’r Ex. 10 (ECF No. 10-3) at 27. In summarizing parts of Petitioner’s
medical history, Dr. Thornberry noted the pain and swelling Petitioner had experienced in her left
knee, right ankle, left third toe, and right index finger. Id. While Petitioner’s left toe pain was
resolved, she still experienced pain in her right index finger Proximal interPhalangeal (PIP) joint,
right ankle, and left knee. Id. at 50. Dr. Thornberry diagnosed Petitioner’s condition as
“[a]symmetric inflammatory polyarthritis associated with a positive ANA.” Id. at 51.
5

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Additionally, Dr. Thornberry noted “the distribution of [Ms. Pankiw’s] articular disease is unusual
for systemic lupus erythematosus (SLE) and rheumatoid arthritis.” Id. Dr. Thornberry considered
that Petitioner’s ongoing pregnancy might have some influence on arthropathy levels. Id.
Petitioner reported improvements throughout her subsequent appointments with Dr.
Thornberry. Petitioner returned to Dr. Thornberry on May 7, 2013 for a follow-up appointment
regarding Petitioner’s asymmetric pauciarticular inflammatory arthritis. Id. at 45. Petitioner
complained of persistent swelling at her right ankle that was not painful. Id. She denied
experiencing early morning stiffness. Id. Dr. Thornberry noted there was “slight swelling” of the
right Achilles tendon; accordingly, he decreased her prednisone prescription to every other day for
six weeks at the same dose of 2.5 mg. Id.
By September 5, 2013, Dr. Thornberry had determined that Petitioner’s “[p]auciarticular
inflammatory arthritis associated with positive ANA [was] resolved.” Pet’r Ex. 10 at 42. On
December 13, 2013, Petitioner called Dr. Thornberry requesting a written statement that Petitioner
could not receive the flu vaccination due to her past symptoms of joint pain. Id. at 81. On January
20, 2014, Dr. Thornberry provided the requested letter, which stated that Petitioner “had a
significant adverse reaction to an influenza vaccine administered in September 2012, manifested
by arthritis.” Id. at 41. On January 8, 2015, Petitioner returned to Dr. Thornberry and complained
of continued joint pain during exercise. Id. at 16-17. Dr. Thornberry noted Petitioner had “joint
pain without evidence of inflammatory arthritis” and the joint pain could be due, in part, to her
“deconditioned state and overweight status.” Id. at 17.
On May 29, 2015, in response to a request from Petitioner’s attorney, Dr. Thornberry
provided a summation of her treatment. Id. at 27-30. Dr. Thornberry identified Petitioner’s
diagnosis as “inflammatory arthritis associated with a positive ANA,” that was resolved on
6

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September 5, 2013. Id. at 28. Dr. Thornberry ultimately found that “[w]ith the asymmetric and
pauci-articular nature of her illness, consistent with viral arthropathy or a vaccine-induced
arthropathy, it was felt that there was reasonable medical probability that her symptoms were
caused by the influenza vaccination.” Id.
II. Expert Opinions
In addition to the referenced medical records, the Special Master reviewed eleven expert
reports filed by three different experts. See generally Pet’r Ex. 38 (ECF. No. 64-2) (Dr Utz’s First
Report); Resp’t Ex. A (ECF No. 67-1) (Dr. Matloubian’s First Report); Pet’r Ex. 39 (ECF No.
74-2) (Dr. Utz’s Second Report); Resp’t Ex. C (ECF No. 78-1) (Dr. Matloubian’s Second Report);
Resp’t Ex. D (ECF No. 78-6) (Dr. Whitton’s First Report); Pet’r Ex. 39 (ECF No. 85-2) (Dr. Utz’s
Third Report); Resp’t Ex. F (ECF No. 87-1) (Dr. Matloubian’s Third Report); Pet’r Ex. 41 (ECF
No. 95-1) (Dr. Utz’s Fourth Report); Resp’t Ex. G (ECF No. 87-7) (Dr. Whitton’s Second Report);
Resp’t Ex. H (ECF No. 102-1) (Dr. Matloubian’s Fourth Report); Resp’t Ex. I (ECF No. 102-7)
(Dr. Whitton’s Third Report). These expert reports are discussed in more detail below.
A. Petitioner’s Expert Reports
Petitioner retained Dr. Paul Utz, who serves as the Acting Chief of Rheumatology at
Stanford University and who owns a lab that receives funding from the National Institute of Health
to study influenza infection and vaccination. Pet’r Ex. 38 (Dr. Utz’s First Report) (ECF. No. 64-
2) at 1-2. Dr. Utz filed four reports.
On November 3, 2017, Petitioner filed her first expert report from Dr. Utz, who concluded
that Petitioner had developed inflammatory arthritis as a “direct result” of her influenza
vaccination. Pet’r Ex. 38 at 25. Dr. Utz theorized that it is “plausible” that the influenza vaccine
can cause inflammatory arthritis when “influenza antigen(s) in the vaccine are delivered to the
7

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immune system, leading to cross reactivity and molecular mimicry to self-antigens that then break
tolerance to self, causing inflammatory arthritis.” Id. at 11-12. Specifically, Dr. Utz described
how hemagglutinin (HA), an antigen found in influenza vaccines, and Type II collagen, a
prominent rheumatoid arthritis (RA) autoantigen, can lead to the development of B and T cell
autoreactivity associated with inflammation. Id. at 16-17. According to Dr. Utz, an influenza
peptide and a Type II collagen peptide bind to MHC/HLA class II molecule HLA-DR4 which
affect T cell binding indirectly. Id. at 18-19. However, the studies used to support his research
did not involve inflammatory arthritis and did not demonstrate that T cells recognize collagen or
influenza peptides. Id. at 19-20. Still, Dr. Utz asserted that these studies suggest that such
molecular processes can be generalizable to inflammatory arthritis and many of Petitioner’s
symptoms. Id. at 23-25.
On May 21, 2018, Dr. Utz defended his theory of molecular mimicry as a valid hypothesis
noting that molecular mimicry is broadly accepted as a mechanism that leads to autoimmunity.
Pet’r Ex. 39 (Dr. Utz’s Second Report) (ECF No. 74-2) at 6. Dr. Utz reiterated that influenza HA
and collagen antigens can bind to an MHC DR4 molecule and, as a result, share a similar
composition and are molecular mimics of one another. Id. Dr. Utz emphasized that Petitioner’s
own rheumatologist, Dr. Thornberry, found Petitioner’s symptoms “consistent with viral
arthropathy or a vaccine-induced arthropathy, [and] . . . that there was a reasonable medical
probability that her symptoms were caused by the influenza vaccination.” Id. at 5 (quoting Pet’r
Ex. 10 at 27-28).
On December 10, 2018, the Special Master issued an order for submissions in preparation
for a hearing. In that order the Special Master stated, inter alia:
Here, the parties agree that Ms. Pankiw’s condition does not meet the
generally-accepted criteria for rheumatoid arthritis (“RA”). Exhibit 38 at 8; exhibit
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A at 10. Nonetheless, Dr. Utz notes that Ms. Pankiw’s inflammatory arthritis
resembles many features of RA even if it does not meet the formal classification.
Furthermore, Dr. Utz often uses RA and Ms. Pankiw’s form of arthritis
interchangeably in his argument that Ms. Pankiw has a vaccine-induced arthritic
condition. In their responsive reports, Drs. Matloubian and Whitton appear to
accept the premise that RA is, for the purposes of Ms. Pankiw’s case, sufficiently
similar to Ms. Pankiw’s condition that it can be used interchangeably for the
purposes of examining whether the flu vaccine can cause her current arthritic
condition. Accordingly, there appears to be little dispute about the fact that Ms.
Pankiw suffers from arthritis and that while her condition is not RA, RA is
sufficiently similar to be used as a model for her condition.
Spec. Mstr. December 10, 2018 Order for Submissions in Preparation of the Hearing (ECF No.
84) (December 10, 2018 Order) at 4. In a footnote, the Special Master added, “[i]f the undersigned
is incorrect in his conclusion that the parties agree that RA is a useful model for understanding Ms.
Pankiw’s current condition, they should explicitly address this mischaracterization in their briefs.”
Id. at 4 n.2.
On January 3, 2019, Dr. Utz filed a third expert report, which did not respond to the
question the Special Master posed in his December 10, 2018 Order, but instead reiterated that an
individual T cell receptor recognizes more than one peptide and that Petitioner’s “abnormal”
immune system was “primed” for molecular mimicry. Pet’r Ex. 40 (ECF No. 85-2) (Dr. Utz’s
Third Report) at 3-6.
Dr. Utz responded to the December 10, 2018 Order in his fourth and final response by
noting that while Petitioner does not have RA, “the bystander activation and molecular mimicry
models . . . apply broadly to other inflammatory arthritides.” Pet’r Ex. 41 (Dr. Utz’s Fourth Report)
(ECF No. 95-1) at 13. Therefore, Dr. Utz concluded “to a reasonable degree of medical and
scientific certainty that [Petitioner had] developed new onset inflammatory arthritis as a direct
causative result of her influenza vaccination.” Dr. Utz’s Fourth Report at 21.
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B. Respondent’s Expert Reports
1. Dr. Matloubian’s Reports
Respondent retained Dr. Mehrdad Matloubian, an Associate Professor at the University of
California San Francisco and a board-certified rheumatologist who has been engaged in
virology/immunology research for more than 20 years. Resp’t Ex. A (ECF No. 67-1) (Dr.
Matloubian’s First Report) at 1. On February 5, 2018, Respondent filed an expert report by Dr.
Matloubian, who opined that Petitioner’s inflammatory arthritis was caused by her postpartum
autoimmune thyroiditis, unrelated to the flu vaccine. Dr. Matloubian’s First Report at 10, 23. Dr.
Matloubian disagreed with Dr. Utz’s medical theory based on molecular mimicry on the basis that
(1) there are differences between the pathogenesis of RA and Petitioner’s inflammatory arthritis,
and (2) even if RA was sufficiently similar to Petitioner’s inflammatory arthritis there was still no
support for Dr. Utz’s molecular mimicry theory linking the influenza vaccine and RA or any
another type of inflammatory arthritis. Id. at 21-22.
On September 21, 2018, Dr. Matloubian submitted a second report maintaining that no
evidence supported Dr. Utz’s molecular mimicry theory. Resp’t Ex. C (ECF No. 78-1) (Dr.
Matloubian’s Second Report) at 1. Notably, Dr. Matloubian stressed that a medical theory of
causation based on molecular mimicry requires more than simply showing that two molecules are
similar. Id. at 3. According to Dr. Matloubian, in the immunologic sense, molecular mimicry
must show that two sperate antigens are activated by the same T cell. Id. Dr. Matloubian, criticized
Dr. Utz’s theory because, according to Dr. Matloubian, Dr. Utz purportedly failed to provide any
support for the proposition that influenza HA and collagen can be recognized by the same T cell.
Id. at 5.
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On April 5, 2019, Dr. Matloubian again refuted Dr. Utz’s molecular mimicry theory,
stating that Dr. Utz has not shown that (1) collagen is an acceptable antigen in types of
inflammatory arthritis other than RA, (2) T cells are generally able to recognize multiple peptides,
and (3) influenza HA and collagen are similar enough to be cross-reactive. Resp’t Ex. F (ECF No.
87-1) (Dr. Matloubian’s Third Report) at 5-7.
On December 9, 2019, Dr. Matloubian filed his final response, which addressed the
questions in the Special Master’s December 10, 2018 Order. Resp’t Ex. H (ECF No. 102-1) (Dr.
Matloubian’s Fourth Report) at 1. Dr. Matloubian stated there is no molecular mimicry between
collagen, an RA-associated antigen, and influenza HA. Id. at 12. Dr. Matloubian argued that the
expert reports offered by Dr. Utz do not demonstrate that “HA peptides can activate T cells that
can cause arthritis.” Id. at 13. Dr. Matloubian further criticized Dr. Utz’s focus on HLA-DR4, “a
molecule strongly associated with anti-CCP positive RA, but not with other forms of autoimmune
arthritis.” Id. at 19.
Therefore, Dr. Matloubian ultimately concluded that:
In my professional duties, I would not interpret the papers provided by Dr. Utz on
the altered peptide ligand as indicative of molecular mimicry between influenza
HA and collagen, nor would I equate the complex pathogenesis of HLA-DR4-
associated CCP positive RA to that of HLA-B27-associated spondyloarthropathies
or all other types of inflammatory arthritis.
Dr. Matloubian’s Fourth Report at 19.
2. Dr. Whitton’s Reports
Respondent also offered three reports from Dr. J. Lindsay Whitton, a Professor at Scripps
Research Institute who studies viral pathogenesis and the immune responses to virus infections
and vaccines. Resp’t Ex. E (ECF No. 78-7) (Dr. Whitton’s curriculum vitae). Dr. Whitton agreed
with Dr. Matloubian that Petitioner’s inflammatory arthritis was not caused by her influenza
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vaccination. See generally Resp’t Ex. D (ECF No. 78-6) (Dr. Whitton’s First Report); Resp’t Ex.
G (ECF No. 87-7) (Dr. Whitton’s Second Report); Resp’t Ex. I (ECF No. 102-7) (Dr. Whitton’s
Third Report). Dr. Whitton opined that Dr. Utz had not demonstrated that flu and collagen peptides
are molecular mimics because he could not show that such peptides activate the same T cells. Dr.
Whitton’s First Report at 12. In his second report, Dr. Whitton acknowledged that T cells can
recognize multiple antigens, but that this capability of recognizing multiple antigens was not as
widespread as Dr. Utz’s report implied. ECF No. 87-7 at 4-7. Dr. Whitton’s third report was
especially critical of Dr. Utz’s purportedly selective reliance on certain studies and his allegedly
shifting theory of molecular mechanisms, which he contended led to Petitioner’s inflammatory
arthritis. Dr. Whitton’s Third Report at 1-2.
In each of his three expert reports, Dr. Whitton concluded that the evidence supporting Dr.
Utz’s theory that molecular mimicry was responsible for Petitioner’s arthritis was “extremely
weak.” Id. at 14-15.
III. Tullio v. Secretary of Health and Human Services, 15-vv-15
On December 7, 2018, the Special Master held a status conference to discuss the possibility
of holding a coordinated hearing with the petitioner in Tullio v. Secretary of Health & Human
Services, 15-vv-15, an action that also involved a medical theory of causation premised on
molecular mimicry. See December 10, 2018 Order. The record does not reflect that a joint hearing
ever occurred.
On December 19, 2019, the Special Master issued a decision denying the Tullio petitioner’s
claim of entitlement to compensation. Tullio v. Sec’y of Health & Hum. Servs., 149 Fed. Cl. 448,
454-55 (2020). Subsequently, the Special Master held a status conference in the present action to
determine whether Petitioner’s case involved factors that would distinguish it from Tullio. On
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April 20, 2020, Petitioner filed a status report urging the Special Master to wait for a decision from
the United States Court of Federal Claims in Tullio before considering next steps in her case. (ECF
No. 105.)
On June 18, 2020, the Honorable Marian Blank Horn issued a decision in Tullio affirming
the Special Master’s ruling on entitlement and denying compensation to the petitioner in that case.
Tullio, 149 Fed. Cl. at 478. After reviewing Judge Horn’s opinion denying the motion for review
in Tullio, Petitioner informed the Special Master that she would likely seek a ruling on the record
from the Special Master and requested additional time to determine whether she would file any
additional proof in support of her Petition. (ECF No. 110.)
On October 28, 2020, Petitioner submitted additional evidence concerning how the
influenza virus could lead to arthritis. (ECF No. 112.) Specifically, Petitioner filed a case report
entitled “Transient oligoarthritic of the lower extremity following influenza B virus infection: Case
report.” Pet’r Ex. 52 (ECF No. 112-1) (Bruck et al., Transient Oligoarthritic of the Lower
Extremity Following Influenza B Virus Infection: Case Report, 8 PEDIATRIC RHEUMATOLOGY 4
(2010)). The case report stated:
A 12-year-old girl developed influenza B virus infection proven by typical
symptoms and detection of the virus in a nasopharyngeal swab by culture and PCR.
Two weeks later she developed an otherwise unexplained transient oligoarthritis of
small joints of the left foot. Influenza viruses may be a hitherto underappreciated
cause of a post-infectious arthritis.
Id. at 1.
III. The Special Master’s Decision
On December 21, 2020, Petitioner moved for a ruling on the record, arguing that she had
proven all three Althen prongs and relying heavily on Dr. Thornberry’s statements that “there was
a reasonable medical probability that [Petitioner’s] symptoms were caused by the influenza
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vaccination.” Petitioner’s Motion for a Ruling on the Record (ECF No. 113) at 1 (quoting Pet’r
Ex. 10 at 27-28).
Respondent countered, arguing that Petitioner had not met the Althen prongs because she
did not offer a reliable medical theory establishing that her flu vaccine caused her inflammatory
arthritis. Respondent’s Response to Petitioner’s Motion for a Ruling on the Record (ECF No. 114)
at 1-2. Respondent further contended that Petitioner’s medical theory was unreliable because
Petitioner’s expert had premised his medical theory on RA, which Petitioner conceded she did not
have. Id. at 2 Moreover, Respondent noted that the Special Master recently had rejected Dr. Utz’s
molecular mimicry theory in Tullio, and that Petitioner failed to provide sufficient evidence
demonstrating that her medical theory was reliable. Id. at 3. In a footnote, Respondent
acknowledged that Dr. Thornberry attributed Petitioner’s inflammatory arthritis to the flu vaccine
but argued that the Special Master was not bound by Dr. Thornberry’s statements, especially where
Dr. Thornberry allegedly did not provide a medical theory, explain the logical sequence of
causation, or address the temporal relationship between Petitioner’s vaccine and her injury. Id. at
4 n.6.
On March 9, 2021, the Special Master issued a Decision denying compensation. See
Decision. First, the Special Master found that Petitioner failed to show, by a preponderance of the
evidence, that she suffered from RA. Dec. at 6. Specifically, the Special Master’s decision states:
This conspicuous lack of a diagnosis or expert opinion identifying Ms. Pankiw’s
symptoms as manifestations of RA is significant because Dr. Utz’s asserted medical
theory relies on evidence produced to show that flu vaccinations can cause
rheumatoid arthritis. Additionally, even though Dr. Utz states in his report that the
flu vaccine can cause RA or inflammatory arthritis, see exhibit 38 at 17, Dr.
Thornberry explicitly stated that Ms. Pankiw does not have inflammatory arthritis
either. Exhibit 10 at 16-17. It follows that, even if the undersigned were to accept
Dr. Utz’s medical theory, it is questionable how it would be applied to Ms.
Pankiw’s specific case, given that she did not suffer from RA and that there is
evidence against a diagnosis of inflammatory arthritis as well. Citing to studies
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relevant to the flu vaccine-RA link, Dr. Utz states that “[i]t is plausible, and I would
argue very likely, that similar molecular mechanisms are at play in Ms. Pankiw’s
case . . . causing inflammatory arthritis.” Exhibit 38 at 11-12. However, Dr.
Thornberry stated that Ms. Pankiw did not suffer from inflammatory arthritis.
Exhibit 10 at 16-17. Dr. Utz goes on to analogize various causal relationships with
foreign antigens that involve conditions, none of which are Ms. Pankiw’s arthritis
condition. Essentially, Dr. Utz’s medical theory is premised on research and
medical literature involving RA. According to Dr. Utz and Ms. Pankiw’s medical
providers, Ms. Pankiw never suffered from RA. Therefore, the evidence presented
does not appear particularly informative, much less persuasive, with regard to Ms.
Pankiw’s particular circumstances. See Broekelschen, 618 F.3d at 1345 (“[A]
petitioner must provide a reputable medical or scientific explanation that pertains
specifically to the petitioner’s case[.]”).
Dec. at 7 (brackets in original) (emphasis added).
Second, the Special Master determined that, even if Petitioner could show she had RA, she
nevertheless failed to meet the requirements under Althen prong one because she could not provide
a plausible medical theory causally connecting receipt of the influenza vaccination to RA. Id. at
7-9. Relying on Tullio, the Special Master highlighted that an identical medical theory based on
molecular mimicry associated with RA was rejected. Id. Based on the expert opinions, the Special
Master found “no substantial departure” from Tullio. Id. at 9. The Special Master found that
Althen prong one was dispositive and that he therefore did not need to reach Althen prongs two or
three. Id.
On April 7, 2021, Petitioner filed a Motion for Review of the Special Master’s Decision
denying her claim pursuant to Rule 23 of the Vaccine Rules of the United States Court of Federal
Claims (Vaccine Rules). See Pet’r Br. at 1. Petitioner argues that the Special Master’s
determination that Petitioner had not demonstrated a diagnosis and had not met her burden of proof
under Althen prong one were arbitrary and capricious. Id. at 4. To support these assertions,
Petitioner highlights the Special Master’s failure to consider: (1) Dr. Thornberry’s diagnosis of
inflammatory arthritis, a condition Dr. Thornberry stated was resolved by 2013, and (2) Dr.
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Thornberry’s statements that, in his opinion, Petitioner’s flu vaccine caused her inflammatory
arthritis. Id. at 6-9.
APPLICABLE STANDARD OF REVIEW
The National Childhood Vaccine Injury Act of 1986 (Vaccine Act) created the National
Vaccine Injury Compensation Program, 42 U.S.C. § 300aa–10 et seq., to provide compensation to
people found to be injured by certain vaccines. Congress established the Vaccine Act after lawsuits
against vaccine manufacturers and healthcare providers threatened to cause vaccine shortages and
reduce vaccination rates. See Bruesewitz v. Wyeth LLC, 562 U.S. 223, 227-28 (2011). Petitions
alleging injuries caused by a vaccine must be filed in the United States Court of Federal Claims,
where a Special Master initially reviews and issues an initial decision on the petition. Id. at 228
(citing 42 U.S.C. § 300aa–11(a)(1)).
Under the Vaccine Act, the United States Court of Federal Claims reviews the Special
Master’s decision upon the filing of a Motion for Review of Decision of Special Master. 42 U.S.C.
§ 300aa–12(e). Upon such a review, the Court may:
(A) uphold the findings of fact and conclusions of law of the special master and
sustain the special master’s decision;
(B) set aside any findings of fact or conclusion of law of the special master found
to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law and issue its own findings of fact and conclusions of law; or
(C) remand the petition to the special master for further action in accordance with
the court's direction.
42 U.S.C. § 300aa-12(e)(2); accord Vaccine Rule 27(c). The standards set forth in 42 U.S.C.
§ 300aa-12(e)(2)(B), “vary in application as well as degree of deference” as each “standard applies
to a different aspect of the judgment.” Munn v. Sec'y of Health & Human Servs., 970 F.2d 863,
870 n.10 (Fed. Cir. 1992). “Thus, the [United States Court of Federal Claims] judge reviews the
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special master's decision essentially for legal error or factual arbitrariness.” Bradley v. Sec'y of
Health & Human Servs., 991 F.2d 1570, 1574 (Fed. Cir. 1993).
DISCUSSION
Under the Vaccine Act, Petitioner may demonstrate eligibility for an award in two ways.
See Munn, 970 F.2d at 865. Petitioner may either show that she suffered an injury listed on the
Vaccine Injury Table within the requisite time period, in which causation is presumed (table
injury), or she may demonstrate that her condition was caused-in-fact by the flu vaccine (off-table
injury). Capizzano v. Sec’y of Health & Human Serv., 440 F.3d 1317, 1320-21 (Fed. Cir. 2006)
(citing Munn, 970 F.2d at 865; 42 U.S.C. §§ 300aa-13(a)(1), 300aa-11(c)(1)(C)(ii)(I)). As
Petitioner alleges an off-table injury here, she must prove by a preponderance of the evidence that
her vaccine was “not only a but-for cause of the injury but also a substantial factor in bringing
about the injury.” Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir.
1999). In showing “that the vaccination brought about her injury,” Petitioner must satisfy the three
Althen prongs. Petitioner must show by a preponderance of the evidence:
(1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was the
reason for the injury; and
(3) a showing of a proximate temporal relationship between vaccination and
injury.
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278; see also Boatmon v. Sec’y of
Health & Human Servs., 941 F.3d 1351, 1354-55 (Fed. Cir. 2019).
A special master’s factual findings are reviewed under the arbitrary and capricious standard
of review. Althen, 418 F.3d at 1278. The scope of this review is limited and is highly deferential.
Lampe v. Sec'y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000). Factual findings
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of a special master must reflect a consideration of the relevant evidence of record, not be wholly
implausible, and articulate a rational basis for the conclusion reached. See, e.g., Cedillo v. Sec’y
of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010); Hines ex. rel. Sevier v. Sec’y of
the Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991).
Nonetheless, a deferential standard of review “is not a rubber stamp.” Porter v. Sec’y of
Health & Human Servs., 663 F.3d 1242, 1256 (Fed. Cir. 2011) (O’Malley, J., concurring-in-part,
dissenting-in-part). A special master must “consider[ ] the relevant evidence of record, draw[ ]
plausible inferences and articulate[ ] a rational basis for [his] decision . . . .” Hines, 940 F.2d at
1528); see 42 U.S.C. § 300aa–13(b)(1). The special master’s findings of fact also must be
“supported by substantial evidence.” Doe v. Secretary of Health & Human Servs., 601 F.3d 1349,
1355 (Fed. Cir. 2010) (citing Whitecotton by Whitecotton v. Sec’y of Health & Human Servs., 81
F.3d 1099, 1105 (Fed. Cir. 1996), on remand from Shalala v. Whitecotton, 514 U.S. 268 (1995)).
“[A] finder of fact generally is not required to itemize every piece of evidence on an issue and
adopt or reject it. Shapiro v. Sec’y of Health & Human Servs., 101 Fed. Cl. 532, 540 (2011)
(citations omitted). However, the special master cannot dismiss so much contrary evidence that it
appears that the special master “simply failed to consider genuinely the evidentiary record . . . .”
Campbell v. Sec’y of Health & Human Servs., 97 Fed. Cl. 650, 668 (2011).
While Petitioner claims she suffered inflammatory arthritis based on Dr. Thornberry’s
diagnosis, Pet’r Br. at 8-9, the Special Master began his Decision by incorrectly stating that
Petitioner alleged she had RA. Dec. at 1. Further, the Special Master incorrectly stated in his
Decision that “even though Dr. Utz states in his report that the flu vaccine can cause RA or
inflammatory arthritis . . . , Dr. Thornberry explicitly stated that [Petitioner] does not have
inflammatory arthritis.” Dec. at 7 (citations omitted). However, the record reflects that Dr.
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Thornberry actually did diagnose Petitioner with “asymmetric inflammatory polyarthritis
associated with a positive ANA.” Pet’r Ex. 10 at 51; see also id. at 27, 28, 29, 30, 42, 45. Dr.
Thornberry explained:
[Petitioner’s] history at the initial visit on 02/18/2013 was that she had received an
influenza vaccine on 09/28/2012. She developed pain and swelling of the left knee
and her right ankle of such significance that by 10/14/2012, she had to ambulate
with crutches. She had additional symptoms involving the left 3rd toe and the right
index finger. Joint examination on that date was abnormal for painful motion at
the index finger PIP joint on the right hand and restriction of motion at the left knee,
and swelling at the right ankle. Review of evaluation which had been accomplished
prior to the time of my initial evaluation was remarkable for a positive ANA and
elevation of CRP. Fluid obtained from the left knee on 12/18/2012 was abnormal
with a white cell count of 2583, indicating the presence of inflammation. Tests for
rheumatoid arthritis were negative. I did perform additional laboratory studies
including CBC, creatinine, C3, C4, anti-double stranded DNA antibodies, and
antiphospholipid antibodies. Those studies returned with normal or negative
findings. She was treated initially with prednisone 20 mg daily, which was able to
be tapered and discontinued in 06/2013. I saw her on 09/05/2014, and her
examination then was without evidence of inflammatory arthritis. It was felt that
she had recovered from the inflammatory arthritis. Repeat testing of ANA
antibody, which may be observed in patients with SLE or as a consequence of
nonspecific stimulation of the immune system, was negative on 12/09/2013.
Pet’r Ex. 10 at 27 (emphasis added). In other words, reading Dr. Thornberry’s statement in context
demonstrates that Dr. Thornberry found that Petitioner had suffered and then recovered from
inflammatory arthritis. Because the Special Master omitted this critical evidence, this Court is left
with no choice but to find that the Special Master abused his discretion See Mockzek v. Sec’y of
Health and Human Servs., 776 F. App’x. 671 (Fed. Cir. 2019) (reversing and remanding special
master’s “harsh result” in dismissing the plaintiff’s petition under the Vaccine Act and holding the
special master abused his discretion because petitioner’s expert testimony and additional evidence
were not facially insufficient for purposes of summary judgment); J.H. v. Sec’y of Health and
Human Servs., 123 Fed. Cl. 206 (2015) (vacating and remanding the action to the special master
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holding special master abused his discretion where he failed to consider all medical records and
mischaracterized the considered records).
Respondent argues that, even if the Special Master erred in concluding that Petitioner did
not suffer from inflammatory arthritis, the error is harmless because the Special Master explicitly
found that Petitioner’s evidence failed to meet the Althen’s first prong. Resp’t Br. at 13-14.
Specifically, the Special Master stated, “[e]ven if a determination were made that [Petitioner]
suffered from rheumatoid arthritis or a condition sufficiently similar to the asserted medical theory
applicable, [Petitioner] has failed to provide a persuasive medical theory showing that a flu
vaccination can cause arthritis.” Dec. at 7.
The problem with this argument is that the Court cannot determine on the record currently
before it whether the Special Master accurately addressed Petitioner’s particular circumstances.
Though the Special Master broadly states that Petitioner’s asserted medical theory fails to
demonstrate how “flu vaccine can cause arthritis,” the record reflects that the Special Master failed
to acknowledge Dr. Thornberry’s statements that Petitioner suffered from inflammatory arthritis.
Moreover, the Special Master heavily relies on his previous decision in Tullio, without addressing
the specific facts of Petitioner’s case. Tullio involved a petitioner with a different diagnosis who
received a different vaccine. See Tullio, 149 Fed. Cl. at 451. More importantly, in Tullio, none of
the petitioner’s treating physicians ever attributed the petitioner’s diagnosis with the petitioner’s
vaccine. Id. at 476. Conversely, here, the record reflects evidence that Dr. Thornberry, Petitioner’s
treating physician, attributed Petitioner’s alleged inflammatory arthritis to Petitioner’s flu vaccine.
Specifically, Dr Thornberry stated that Petitioner’s inflammatory arthritis was “consistent with
viral arthropathy or a vaccine-induced arthropathy,” and that “it was felt that there was reasonable
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medical probability that her symptoms were caused by the influenza vaccination.” Pet’r Ex. 10 at
27-30.
The Court recognizes that there is evidence on the record that may ultimately support the
Special Master’s conclusion that Petitioner’s condition was not caused by Petitioner’s influenza
vaccine. See e.g., Dr. Matloubian’s Fourth Report at 19; Dr. Whitton’s Third Report at 1-2. The
Court further recognizes that the Special Master is not bound by Dr. Thornberry’s diagnosis and
may very well reach the same conclusion on remand. See 42 U.S.C. § 300aa-13(b) (“Any such
diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special
master or court.”). This Court, however, cannot sustain the Special Master’s Decision as is where
it failed reflect and address the particular facts of Petitioner’s case. See Shapiro, 101 Fed. Cl. at
540 (2011) (remanding case to special master where special master’s factual finding was based on
a “selective reading” of petitioner’s medical records); cf. Dobrydnev v. Sec’y of Health & Human
Servs., 566 F. App’x 976, 982 (2014) (affirming special master’s causation findings where special
master “explicitly acknowledged” favorable evidence to petitioner but nonetheless concluded the
evidence was “outweighed” by other record evidence).
Nor can this Court conclude at this stage that the Decision’s failure to accurately address
Dr. Thornberry’s diagnosis was harmless error. It is unclear whether the Special Master’s Althen
prong one analysis was premised on the assumption that Petitioner did not suffer from
inflammatory arthritis. Dec. at 7. Though the Decision at times broadly references Petitioner’s
medical theory for “arthritis” or “a condition sufficiently similar to RA,” the Court is unable to
determine on the current record whether the Special Master’s determination under Althen prong
one would be different had he considered the full context of Dr. Thornberry’s diagnosis. Id.
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Finally, fundamental fairness forecloses this Court from affirming the Decision where it
lacks sufficient analysis particular to this Petitioner’s case. See 42 U.S.C. § 300aa-13(b)(1)(A)
(“In determining whether to award compensation to a petitioner under the Program, the special
master or court shall consider, in addition to all other relevant medical and scientific evidence
contained in the record . . . 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 . . . .”); Vaccine Rule 8(b)(1) (“In
receiving evidence, the special master will not be bound by common law or statutory rules of
evidence but must consider all relevant and reliable evidence governed by principles of
fundamental fairness to both parties.”).
While the Decision’s failure to adequately address Dr. Thornberry’s statements in context
may have ultimately result in harmless error, this Court strongly believes that Plaintiff is entitled
to a decision based on an accurate reflection of the record and her own medical diagnoses. The
Court cannot sufficiently conduct its review without the Special Master’s analysis in this regard.
Cf. Tadlock v. McDonough, 5 F.4th 1327 (Fed. Cir. 2021) (finding, in the context of the United
States Court of Appeals for Veterans Claims jurisdiction, a remand is the proper course of action
where the fact finder fails to adequately consider evidence in the first instance). Accordingly, this
Court remands this action to the Special Master to determine whether the Althen prongs are
satisfied bearing in mind Dr. Thornberry’s statements and diagnosis in their full context.
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CONCLUSION
For the reasons stated above, Petitioner’s Motion for Review (ECF No. 118) is
SUSTAINED. The Special Master’s Decision denying entitlement (ECF No. 116) is VACATED,
and this case is REMANDED for further proceedings consistent with this Opinion and Order.
IT IS SO ORDERED.
s/Eleni M. Roumel
ELENI M. ROUMEL
Judge
August 13, 2021
Washington, D.C.
Reissued for Public Availability: August 30, 2021
23