Court Opinion

ID: 4675064
Source: CourtListenerOpinion
Date Created: 2021-04-06 20:02:05.257153+00
Date Added: 2024-06-11T08:03:23.936127
License: Public Domain

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.
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
       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
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
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.

                                            5
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
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
                                              7
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
(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
                                              9
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

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