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: November 2, 2021
SECRETARY OF HEALTH *
AND HUMAN SERVICES, * Entitlement; influenza (“flu”) vaccine;
* inflammatory arthritis; remand.
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 ON REMAND DENYING COMPENSATION 1
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.
A March 9, 2021 decision found that Ms. Pankiw did not establish that she
was entitled to compensation. Pankiw v. Sec’y of Health & Hum. Servs., No. 15-
1082V, 2021 WL 1264559 (Fed. Cl. Spec. Mstr. Mar. 9, 2021). The two bases
were that Ms. Pankiw did not establish that she suffered from rheumatoid arthritis
and she did not establish that the flu vaccine can cause rheumatoid arthritis.
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.
Ms. Pankiw challenged this decision. Pet’r’s Mot. for Rev., filed Apr. 7,
2021. The Court granted this motion for review, vacated the March 9, 2021
decision, and remanded for additional consideration. The Court specifically
directed the undersigned to analyze Ms. Pankiw’s claim based upon a premise that
she suffered from inflammatory arthritis (not rheumatoid arthritis). In this regard,
the Court also instructed the undersigned to consider the opinion from a doctor
who treated Ms. Pankiw, Dr. Thornberry.
The different posture does not change the result. As confirmed on remand,
the theory by which a flu vaccine can cause inflammatory arthritis is the same as
the previously considered theory by which a flu vaccine can cause rheumatoid
arthritis. Thus, the value of that theory does not change. Moreover, although Dr.
Thornberry’s opinion adds some weight to Ms. Pankiw’s evidence, Dr.
Thornberry’s opinion is not sufficiently persuasive to tip the scales in Ms.
Pankiw’s favor. Accordingly, Ms. Pankiw has not met her burden of proof.
I. Factual Background
Ms. Pankiw was born in 1980. Exhibit 1. By 2012, Ms. Pankiw had been
diagnosed with hyperthyroidism, thyroiditis, and back pain. Exhibit 15 at 8-11;
exhibit 35 at 5-10. After giving birth, Ms. Pankiw was diagnosed with low thyroid
stimulating hormone. Exhibit 15 at 86-92; exhibit 37 at 5, 11. On September 17,
2012, an endocrinologist, Ernest Asamoah, stated that Ms. Pankiw’s condition was
“classic for post partum thyroiditis.” Exhibit 16 at 9-10.
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 test 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 & Hum. 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
2
“[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 received a steroid injection in her left
knee and 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. Dr. Heisel determined that rheumatoid arthritis was
“fairly unlikely.” Id. at 31.
A few weeks later, on November 12, 2012, after learning she was pregnant,
Ms. Pankiw visited her gynecologist for a prenatal visit. Ms. Pankiw 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. Dr. Thomas indicated that Ms. Pankiw suffered from an “unspecified
inflammatory polyarthropathy” consistent with her thyroid disease. Dr. Thomas
prescribed prednisone. Id.
Ms. Pankiw returned to her endocrinologist, Dr. Asamoah, on November 20,
2012. Dr. Asamoah increased her dose of Synthroid to treat her thyroiditis.
Exhibit 16 at 21-27.
Between November 2012 and February 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. For example, during a
December 4, 2012 visit, Dr. Thomas (a rheumatologist) stated that Ms. Pankiw
might be suffering from “early seronegative [rheumatoid arthritis],” but also noted
that Ms. Pankiw’s pregnancy could complicate a diagnosis. Exhibit 7 at 3.
Ms. Pankiw saw a specialist in infectious diseases, Thomas Slama, on
December 18, 2012. Dr. Slama observed that Ms. Pankiw had a “hot, swollen right
ankle and left knee in addition to arthraligia of her left wrist.” Exhibit 9 at 33-34.
Dr. Slama determined that Ms. Pankiw “has an active synovitis that is not likely
3
bacterial in etiology” and referred her to another rheumatologist, Denise
Thornberry. Id. at 20.
The appointment with Dr. Thornberry took place on February 18, 2013. In
the history, Dr. Thornberry stated Ms. Pankiw “received an influenza vaccine on
09/29/2012, and by 10/14/2012 she had to walk with crutches secondary to pain
and swelling of the left knee and her right ankle. She also developed pain and
swelling at the left 3rd toe and at the right index finger.” Exhibit 10 at 49.
Presently, Ms. Pankiw was having pain in her right index finger, right ankle, and
left knee. 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. Ms. Pankiw told Dr. Thornberry that the
persistent swelling in her right ankle was not painful. Exhibit 10 at 45. Dr.
Thornberry decreased the amount of prednisone Ms. Pankiw was prescribed.
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 January 20, 2014, Dr. Thornberry responded to a request made by Ms.
Pankiw on December 13, 2013, 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 arthritis.” Exhibit 10 at 41, 81.
2
Pauciarticular means “pertaining to or involving only a few joints.” Dorland’s Illus. Med. Dictionary
1378 (33d ed. 2020)
4
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 (Jan. 8, 2015). Dr. Thornberry noted that Ms. Pankiw “has been
talking with an attorney about compensation from a national vaccination fund in
order to cover her medical expenses relative to her reaction to the influenza
vaccine.” Id. at 17. Dr. Thornberry’s impression included “History of a reaction
to influenza vaccine.” Id.
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 May 29,
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 30.
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, 2017 WL 1376435, at *4.
5
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 the flu vaccine can cause rheumatoid arthritis largely matched
the 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. 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.
Sec’y of Health & Hum. Servs., 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 potential
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, 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, issued Sept. 30, 2020. Ms.
Pankiw filed additional medical literature on October 28, 2020. See exhibit 52
(Normi Bruck et al., Transient Oligoarthritic of the Lower Extremity Following
Influenza B Virus Infection: Case Report, 8 Ped. Rheu. 4 (2010)).
Ms. Pankiw argued for a ruling on the record in her favor through a motion,
which was three paragraphs. Pet’r’s Mot., filed Dec. 21, 2020. The Secretary
6
argued that Ms. Pankiw was not entitled to compensation through a response,
which was essentially five pages. The Secretary argued that “Dr. Utz’s evidence
under Althen prong one that was previously deemed unreliable and unpersuasive in
Tullio, should be rejected here as well.” Resp’t’s Resp., filed Jan. 4, 2021, at 3.
Although in reply Ms. Pankiw did not address Tullio, she cited other decisions in
which special masters found a flu vaccine can cause rheumatoid arthritis. Pet’r’s
Reply, filed Jan. 11, 2021.
As noted in the introduction, the March 9, 2021 Decision found that Ms.
Pankiw was not entitled to compensation. The undersigned found that Ms.
Pankiw’s expert, Dr. Utz, had proffered a theory explaining how flu vaccine can
cause rheumatoid arthritis, but Ms. Pankiw did not establish that she suffered from
rheumatoid arthritis. In addition, the undersigned found that Dr. Utz’s theory for
how flu vaccine can cause rheumatoid arthritis was sufficiently similar to the
theory evaluated in Tullio that the same result was warranted. Thus, the
undersigned found that Ms. Pankiw had failed to establish the first Althen prong.
Ms. Pankiw challenged the March 9, 2021 Decision. Ms. Pankiw raised two
objections. First, the undersigned “erred in determining petitioner has not met her
burden of demonstrating a diagnosis of rheumatoid arthritis, when petitioner never
alleged she had rheumatoid arthritis.” Pet’r’s Mot. for Rev., filed Apr. 7, 2021, at
6. Second, Ms. Pankiw maintained the undersigned “erred in determining
petitioner has not met her burden of demonstrating that her flu vaccine caused her
inflammatory arthritis.” Id. at 7. In this section, Ms. Pankiw did not discuss
Tullio.
The Secretary supported the March 9, 2021 Decision. According to the
Secretary, any criticisms regarding “diagnosis are immaterial.” Resp’t’s Resp. to
Mot. for Rev., filed May 7, 2021, at 13. The Secretary further argued that the
undersigned’s “finding that petitioner did not satisfy her burden on Althen prong
one is supported by the record.” Id. at 14. In this section, the Secretary discussed
Tullio.
As mentioned, the Court granted the motion for review. The Court ordered
a consideration of Ms. Pankiw’s theory of how the flu vaccine can cause
inflammatory arthritis, particularly in light of Dr. Thornberry’s opinions.
On remand, the undersigned inquired whether the theory Dr. Utz proposed in
Ms. Pankiw’s case differed from the theory that he proposed in Tullio. In
response, Dr. Utz confirmed that “There are no material differences between my
opinion as to how the flu vaccine cause inflammatory arthritis (as expressed in
7
Pankiw) and my opinion as to how the flu vaccine can cause rheumatoid arthritis
(as expressed in Tullio).” Exhibit 53 (Dr. Utz’s letter, dated Sept. 2, 2021).
Following this submission, the undersigned conferred with the parties
regarding potential next steps in a status conference held on September 14, 2021.
The parties stated that they did not have any additional evidence or arguments to
offer, making the decision on remand ready for adjudication.
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 & Hum. 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 & Hum. 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 &
Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
IV. Analysis
While the March 9, 2021 Decision incorrectly asserted that Ms. Pankiw was
alleging that the flu vaccine caused her to suffer rheumatoid arthritis, the Court has
stated that Ms. Pankiw’s claim was that the flu vaccine caused her to suffer
inflammatory arthritis. In this regard, the Court emphasized a May 29, 2015
statement from Dr. Thornberry that Ms. Pankiw “had recovered from inflammatory
arthritis.” Pankiw v. Sec’y of Health & Hum. Servs., No. 15-1082V, 2021 WL
8
3855768, at *10 (Fed. Cl. Aug. 13, 2021) (quoting exhibit 10 at 27). Once the
question of diagnosis is resolved, a critical question is whether Ms. Pankiw has
established, by preponderant evidence, “a medical theory causally connecting the
[flu] vaccination and the injury [inflammatory arthritis].” Althen, 418 F.3d at
1278.
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 in Tullio, a case
in which the undersigned rejected the molecular mimicry-based theory to explain
how a flu vaccine can cause rheumatoid arthritis. In Dr. Utz’s recent letter, he
agreed that “There are no material differences.” Exhibit 53.
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.
3
For a detailed explanation of the molecular mimicry theory, see Tullio, 2019 WL
7580149, at *12.
9
In Tullio, Dr. Utz and Dr. Matloubian had an opportunity to explain the
bases for their opinions and the undersigned evaluated that testimony.4 The
undersigned found that the epidemiological evidence strongly weighed against a
finding that the flu vaccine can cause rheumatoid arthritis. Tullio, 2019 WL
7580149, at *27. The undersigned also found that Dr. Utz’s theory of molecular
mimicry did not establish a likely homology between a component of the flu
vaccine and a body part impaired in rheumatoid arthritis. Id. at *22. As noted
previously, the Court ruled that these findings were not arbitrary. 149 Fed. Cl. at
468.5
Given the high degree of similarity between Dr. Utz’s opinion in Tullio and
in Ms. Pankiw’s case, should Dr. Utz’s opinion be treated the same? Afterall, Dr.
Utz has confirmed on remand that his opinions are materially the same. Exhibit
53. In addition, one of the experts who addressed Dr. Utz’s opinion in this case
(Dr. Matloubian) has offered virtually the same opinion contesting Dr. Utz’s
opinion as he did in Tullio.
There appears to be no principled reason for weighing Dr. Utz’s opinion
differently in Ms. Pankiw’s case than how it was weighed in Tullio. Ms. Pankiw’s
three briefs have failed to discuss Tullio in any respect. See Pet’r’s Mot. for
Ruling on the Record, filed Dec. 21, 2020; Pet’r’s Reply in Support of a Ruling on
the Record, filed Jan. 4, 2021; Pet’r’s Mot. for Rev., filed Apr. 7, 2021. If
anything, the Secretary’s submission of reports from a second expert, Dr. Whitton,
further undermine Dr. Utz’s opinion that a flu vaccine can cause inflammatory
arthritis. Exhibit I (Dr. Whitton’s report, dated Dec. 3, 2019).
However, Ms. Pankiw’s evidence consists of more than just Dr. Utz’s
opinion. Two potentially distinguishing factors are an additional piece of medical
literature and Dr. Thornberry’s opinions.
The additional article contributes very little. The March 9, 2021 Decision
explained why this article was not valuable:
The case report described a twelve-year-old girl who developed
transient oligoarthritis after suffering from the influenza B
infection. [Exhibit 52] at 1. As a preliminary matter, case
reports hold relatively little weight in vaccine cases. W.C. v.
4
Each party in Tullio called one additional witness. However, the primary witnesses were Dr. Utz and Dr.
Steinman.
5
Another special master rejected molecular mimicry as a way to explain how the flu vaccine can cause
rheumatoid arthritis in a case not involving Dr. Utz. Moran v. Sec’y of Health & Hum. Servs., No. 16-538V, 2021
WL 4853544, at *24-28 (Fed. Cl. Spec. Mstr. Oct. 4, 2021).
10
Sec’y of Health & Hum. 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 (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.
2021 WL 1264559, at *5.
Ms. Pankiw did not challenge this assessment. See Pet’r’s Mot. for Rev.,
filed Apr. 7, 2021. In its Opinion, the Court did not suggest that this evaluation
required reassessment in any respect. Thus, the undersigned, again, declines to
give the case report any significant weight.
The more meaningful evidence, the one about which the Court directed
further consideration, is the set of opinions from Dr. Thornberry. “Specifically, Dr
Thornberry stated that [Ms. Pankiw’s] inflammatory arthritis was ‘consistent with
viral arthropathy or a vaccine-induced arthropathy,’ and that ‘it was felt that there
was reasonable medical probability that her symptoms were caused by the
influenza vaccination.’” 2021 WL 3855768, at *3 (quoting exhibit 10 at 27-30).
As a statement from a doctor who treated Ms. Pankiw, Dr. Thornberry’s
opinion that the flu vaccination caused her symptoms warrants careful
consideration. Cappizano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1326
(Fed. Cir. 2006). However, as the Court recognized Dr. Thornberry’s opinion is
not binding. 2021 WL 3855768, at *11 (citing 42 U.S.C. § 300aa–13(b)); see also
Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 745 n.67 (2009).
Dr. Thornberry’s statement that the flu vaccine did cause an injury to Ms.
Pankiw implies that the flu vaccine can cause that injury. See Cappizano, 440 F.3d
at 1326 (recognizing that evidence relevant to one Althen prong may be relevant to
another Althen prong); Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119,
145 (2011) (“[A]s noted by the special master, a statement that a vaccine did in
fact cause an injury presupposes that the vaccine is capable of causing that
injury.”), aff’d, 463 Fed. App’x 932 (Fed. Cir. 2012) (per curiam). But, the
11
undersigned declines to give Dr. Thornberry’s statements regarding causation
substantial weight.
The main weakness in Dr. Thornberry’s statement is the lack of explanation.
In terms of causation, the entirety of Dr. Thornberry’s letter to Ms. Pankiw’s
attorney is: “With the asymmetric and pauci-articular nature of her illness,
consistent with viral arthropathy or a 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. Dr. Thornberry provides no basis
explaining how a flu vaccine can induce an arthropathy. Dr. Thornberry does not
indicate that she consulted any medical textbooks, and she does not indicate that
she researched a potential causal connection by looking to online sources. Dr.
Thornberry’s conclusion that the flu vaccine caused Ms. Pankiw’s symptoms
seems to be just that – a conclusion. Without any elucidation from Dr. Thornberry
about why she feels that the influenza vaccine harmed Ms. Pankiw, crediting this
opinion is difficult.
Special masters are not obligated to accept all causal statements from
treating doctors and may consider whether the treating doctor’s causal opinion
contains some explanation. See Langland v. Sec’y of Health & Hum. Servs., 109
Fed. Cl. 421, 438-40 (2013); Ruiz v. Sec’y of Health & Hum. Servs., No. 02-156V,
2007 WL 5161754, at *14 (Fed. Cl. Oct. 15, 2007) (“[T]he record as a whole
makes clear that none of those experts was able to develop a medical theory to
explain how petitioner's psychological disorder came about, whether as a direct
result of the vaccination, her physical condition, or otherwise.”).
One opinion that directs special masters not to expect much detail from a
treating doctor, Campbell v. Sec’y of Health & Hum. Servs., 97 Fed. Cl. 650, 667
(2011), is distinguishable. There, a treating doctor offered an opinion that an
influenza vaccine caused petitioner’s rheumatoid arthritis during the course of
treatment. Id. at 654.
In contrast, Dr. Thornberry presented her opinion to the attorney
representing Ms. Pankiw. This chronology is a second, although less important,
reason for giving Dr. Thornberry’s statements relatively little weight. When Dr.
Thornberry first saw Ms. Pankiw in February 2013, Dr. Thornberry knew that Ms.
Pankiw received the flu vaccine and then developed joint pain approximately two
weeks later. Exhibit 10 at 49.6 Yet, Dr. Thornberry did not causally connect the
6
The chronology Dr. Thornberry received does not match the undersigned’s finding of fact. See Pankiw v.
Sec’y of Health & Hum. Servs., No. 15-1082V, 2017 WL 1376435, at *4 (Fed. Cl. Spec. Mstr. Mar. 21, 2017)
(finding her joint pain began on approximately October 1, 2012). When an expert assumes a set of facts not
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two events. This omission tends to weaken Dr. Thornberry’s later-expressed
opinion slightly. See Duncan v. Sec’y of Health & Hum. Servs., 153 Fed. Cl. 642,
663 (2021) (noting that a special master may consider, among other factors, when a
treating doctor first opined that the vaccine caused the injury).
Dr. Thornberry’s opinion about the causal role of the vaccine appears to
have evolved. At the beginning, Dr. Thornberry did not attribute Ms. Pankiw’s
symptoms to the flu vaccination. In the next two visits, Dr. Thornberry did not
express an opinion that the flu vaccine harmed Ms. Pankiw. Exhibit 10 at 45 (May
7, 2013); id. at 42 (Sept. 5, 2013).7
Then, in response to Ms. Pankiw’s request, Dr. Thornberry authored a letter
to exempt her from future vaccinations. Exhibit 10 at 41, 81. This type of letter
carries a varying amount of weight. See Gramza v. Sec’y of Health & Hum.
Servs., 139 Fed. Cl. 309, 335-36 (2018); Langland, 109 Fed. Cl. at 440.
Finally, Dr. Thornberry wrote the January 20, 2014 letter to Ms. Pankiw’s
attorney. Unlike the treating doctor’s statement in Campbell that was created
during treatment, Dr. Thornberry appears to have had enough time to present a
reasoned explanation for her conclusion that the vaccine caused Ms. Pankiw’s
symptoms. The lack of support for this conclusion means that it carries relatively
little weight. See Caves, 100 Fed. Cl. at 134 (“[A] scientific theory that lacks any
empirical support will have limited persuasive force.”).
In short, in accord with the Court’s instruction on remand, the undersigned
has reconsidered Dr. Thornberry’s opinion. To the undersigned, Dr. Thornberry’s
opinion is less valuable than the more developed opinions from Dr. Matloubian
and Dr. Whitton that the flu vaccine did not harm Ms. Pankiw. See Whitecotton v.
Sec’y of Health & Hum. Servs., 81 F.3d 1099, 1108 (Fed. Cir. 1996) (indicating
that special masters enjoy discretion in how to weigh evidence).
Accordingly, Ms. Pankiw has not demonstrated with preponderant evidence
that the flu vaccine can cause inflammatory arthritis. The theory Dr. Utz presented
is nearly identical to the theory he presented in Tullio and there is no reason for
crediting that theory in this case after it was rejected in Tullio. Ms. Pankiw’s
reliance on one case report involving a different disease adds very little to her case.
supported by preponderant evidence, a special master may reject that expert’s opinion. Burns v. Sec’y of Health &
Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993).
7
In the October 18, 2016 hearing, Ms. Pankiw testified that Dr. Thornberry had said that the vaccine
caused her problems before Ms. Pankiw requested a letter exempting her from vaccinations. Tr. 239. But, Dr.
Thornberry did not memorialize this opinion in any of the records created while treating Ms. Pankiw.
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Finally, Dr. Thornberry’s opinion, although carrying some value, is not sufficiently
persuasive to overcome the strength of the Secretary’s opposition.
Furthermore, because Ms. Pankiw’s case falls short in terms of Althen prong
one, consideration of the two remaining Althen prongs is not necessary. Likewise,
because Ms. Pankiw has not met her burden of proof, Dr. Matloubian’s suggestion
that Ms. Pankiw’s pre-existing thyroid problem caused her joint problems, see
exhibit A at 23, need not be evaluated.
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.
The Clerk’s Office is directed to enter judgment in accord with this decision
unless a motion for review is filed. Information about filing a motion for review,
including the deadline for filing a motion for review, can be found in the Vaccine
Rules, which are posted on the Court’s webpage. The Clerk’s Office is also
directed to provide this decision to the assigned judge pursuant to Vaccine Rule
28.1(a).
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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