Pankiw v. Secretary of Health and Human Services

In the United States Court of Federal Claims
ALISHA N. PANKIW,
Petitioner, No. 15-vv-1082
v. Filed: August 13, 2021 1
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.
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 records 3 and expert reports 4 to support her position. Respondent filed competing expert
opinions 5 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).
2
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
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.
4
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
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
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
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
8
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.
9
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.
10
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
11
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
12
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
13
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
14
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.
15
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
16
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
17
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.
18
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
19
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
20
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.
21
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.
22
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