Court Opinion

ID: 6339891
Source: CourtListenerOpinion
Date Created: 2022-05-12 13:01:24.055917+00
Date Added: 2024-06-11T14:57:10.254189
License: Public Domain

In the United States Court of Federal Claims
                          OFFICE OF SPECIAL MASTERS

*************************
EDWARD MCCALL,           *
                         *                  No. 18-152V
             Petitioner, *                  Special Master Christian J. Moran
                         *
v.                       *                  Filed: April 19, 2022
                         *
SECRETARY OF HEALTH      *                  Entitlement; dismissal.
AND HUMAN SERVICES,      *
                         *
             Respondent. *
*************************
Andrew D. Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for petitioner;
Kyle E. Pozza, U.S. Dep’t of Justice, Washington, DC, for respondent.

           UNPUBLISHED DECISION DENYING COMPENSATION 1

       Edward McCall alleged that the Prevnar-13 and influenza (“flu”)
vaccinations he received on January 18, 2017, caused him to develop rheumatoid
arthritis. Pet., filed Jan. 31, 2018, at Preamble; ¶ 21. On March 30, 2022, Mr.
McCall moved for a decision dismissing his petition.

          I.   Procedural History

      Edward McCall filed a petition on January 31, 2018. After Mr. McCall filed
his medical records, the Secretary filed his Rule 4(c) report on November 15, 2018,
contesting entitlement. A status conference was then held on November 27, 2018,
during which an onset dispute was identified. The parties agreed to move forward
with expert reports. Instructions directed the experts to offer a medically

      1
       The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). 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.
acceptable timeframe to infer causation. Order, issued Dec. 21, 2018, at 5-6. The
experts were also instructed to explain when Mr. McCall’s onset of symptoms
began. Id. The parties were invited to comment on a draft version of the
Instructions, issued on November 30, 2018, but did not object. Final Instructions
were issued on December 21, 2018.

        After several motions for extensions of time, Mr. McCall filed a revised
expert report from Dr. Thomas Zizic on September 17, 2019. Exhibit 16. 2 In this
report, Dr. Zizic asserted that after receiving the flu vaccine on January 18, 2017,
Mr. McCall developed rheumatoid arthritis within approximately two months. See
id. at 42. However, he also noted that Mr. McCall began complaining of joint pain
and swelling by May 3, 2017. Id. at 33. Thus, Dr. Zizic acknowledges that Mr.
McCall did not complain of joint pain or swelling until approximately 15 weeks
post-vaccination. With respect to an appropriate temporal interval, Dr. Zizic stated
that “eight weeks is on the outer edge of an appropriate onset interval, but still
appropriate.” Id. at 42. Dr. Zizic did not provide a basis for this opinion.

       Dr. Zizic also maintained that “the vaccine triggered activation of B and/or T
lymphocytes through molecular mimicry, cross-priming, immune complex
formation or a combination of these.” Id. at 42. He further asserted that the
vaccine caused autoimmunity and triggered Mr. McCall’s rheumatoid arthritis due
to his genetic susceptibility. Id.

       In response, the Secretary filed an expert report from Dr. Chester Oddis on
January 29, 2020. Exhibit A. Dr. Oddis asserted that Dr. Zizic’s theory on timing
was “theoretical,” and noted that Dr. Zizic did not offer medical literature
supporting his proposed time interval. Id. at 6. He also opined that Dr. Zizic’s
causal theory was “largely hypothetical and could be applied to any external
antigenic stimulus including unknown environmental agents or undiagnosed or
clinically indolent infections.” Id. He emphasized that experts in autoimmunity
recommend patients with rheumatoid arthritis receive vaccinations. Id. at 5-6.

      In a status conference held on March 2, 2020, the undersigned referenced his
decision in Tullio v. Secretary of Health & Human Services, No. 15-51V, 2019
WL 7580149 (Fed. Cl. Spec. Mstr. Dec. 19, 2019), mot. for rev. denied, 149 Fed.
Cl. 448 (2020), which found that the petitioner did not meet his burden under the
2
 Dr. Zizic’s first attempt to express an opinion failed to comply with various
aspects of the Instructions. Thus, his first report, filed on April 26, 2019, was
struck and replaced with the revised report.
                                          2
first Althen prong to show that the flu vaccine can cause rheumatoid arthritis. In a
status report filed on April 1, 2020, Mr. McCall asserted that Tullio is
distinguishable from his case, and expressed interest in filing an additional expert
report from Dr. Zizic.

       On July 31, 2020, Mr. McCall filed a supplemental expert report from Dr.
Zizic. Exhibit 34. Dr. Zizic discussed the process of molecular mimicry generally,
providing summaries of multiple scientific articles. Dr. Zizic did not discuss the
onset of Mr. McCall’s rheumatoid arthritis specifically in this report.

       The Secretary filed a supplemental expert report from Dr. Oddis on March
10, 2021. Exhibit D. In this brief report, Dr. Oddis stated, “Dr. Zizic basically
reviews the concept of molecular mimicry from an immunological perspective. He
does not address the questions raised in my [report] and the bulk of his [report] is
irrelevant to the case of Mr. McCall.” Id. at 1. Dr. Oddis noted the limitations of
exhibit 63 (Wang), a study Dr. Zizic relied on to show an increased risk of
rheumatoid arthritis following the flu vaccine. Id. He stated that larger studies are
needed to support a causal connection between rheumatoid arthritis and the flu
vaccine. Id.

      Along with Dr. Oddis’s supplemental report, the Secretary filed expert
reports from Dr. J. Lindsay Whitton and Dr. Lawrence Moulton. Exhibits E and H.

       In Dr. Whitton’s report, he asserted that Dr. Zizic’s summary of Mr.
McCall’s medical history in his first report shows that Mr. McCall’s onset occurred
about 15 weeks following vaccination. Exhibit E at 4, citing exhibit 16 at 33-34.
Dr. Whitton argued that this medical history was inconsistent with Dr. Zizic’s
assertion that Mr. McCall developed rheumatoid arthritis about two months after
vaccination. Id. He added that Dr. Zizic did not provide any clarification on this
point in his second expert report (exhibit 34). Id. Dr. Whitton asserted that if Mr.
McCall’s symptoms began on May 3, 2017, 15 weeks post-vaccination, the
temporal relationship is not appropriate to infer causation. Id. at 5. He added that
“a vaccine-induced adaptive immune response (primary or memory) begins to
wane after ~3-4 weeks.” Id.

       Dr. Moulton agreed with Dr. Oddis and Dr. Whitton that Dr. Zizic’s second
report was “mainly composed of quotations from the biomedical literature
purporting to support his theories regarding biological links between
immunizations and [rheumatoid arthritis].” Exhibit H at 3. Dr. Moulton also
disputed the reliability of some of the literature on which Dr. Zizic relied. Like Dr.
                                          3
Oddis, Dr. Moulton noted methodological problems in the Wang article (exhibit
63). Id. at 4-9. Dr. Moulton concluded that there was no increased risk of
rheumatoid arthritis following the flu vaccine. Id. at 9.

       Mr. McCall filed a rebuttal expert report from Dr. Zizic on July 12, 2021.
Exhibit 64. Dr. Zizic stated, “The best documentation of the onset of Mr. McCall’s
[rheumatoid arthritis] in the contemporary medical records is from the office visit
with Dr. Ritu Sadhu on May 16, 2017 . . . .” Id. at 1. Dr. Zizic noted that during
this visit, Mr. McCall reported “joint pains over the last several months.” Id.,
citing exhibit 3 at 27-30. Dr. Zizic asserted that this indicates onset of “at least two
months” or “at least by March 16, 2017.” Id. at 2. Dr. Zizic therefore maintained
that the onset of Mr. McCall’s rheumatoid arthritis occurred within two months
after his vaccination. Id. He added that it is difficult for patients with rheumatoid
arthritis to “pinpoint” the date of onset, especially if the patient suffers from other
causes of joint disease, like Mr. McCall. Id.

     The Secretary then filed supplemental reports from Dr. Oddis, Dr. Moulton,
and Dr. Whitton on March 4, 2022. Exhibits J, K, and L.

       In Dr. Oddis’s report, he reiterated that “there is no epidemiological
evidence associating [the] influenza vaccination and [rheumatoid arthritis],” and
that experts recommend vaccinations for patients with rheumatoid arthritis.
Exhibit J at 1. With respect to onset, Dr. Oddis referenced five of Mr. McCall’s
visits with Dr. Sadhu in the ten weeks following his flu vaccination, during which
Mr. McCall only reported right shoulder pain, a preexisting condition. Id. at 2,
citing exhibit 3 at 3, 6, 9, 12, 16, 23. Dr. Oddis emphasized that Mr. McCall did
not report any other musculoskeletal complaints in the ten weeks following his
vaccination, and only reported a change in symptoms at his visit on May 16, 2017.
See id., citing exhibit 3 at 27. To Dr. Oddis, “it is difficult . . . to date the onset of
[Mr. McCall’s rheumatoid arthritis]” because Mr. McCall did not report a change
in his joint pain until May 16, 2017, despite several visits in the months prior. Id.

       Dr. Whitton reiterated his belief that Dr. Zizic’s first report places Mr.
McCall’s onset at 15 weeks post-vaccination. Exhibit K at 2, citing exhibit 16. He
added that Dr. Zizic’s second report did not clarify questions regarding his
assertion that Mr. McCall’s onset of rheumatoid arthritis occurred two months after
vaccination. Id. Dr. Whitton opined that an appropriate time interval for onset of
rheumatoid arthritis is six weeks and referenced the interval for Guillain-Barré
syndrome following the flu vaccine as support. Id. Therefore, Dr. Whitton argued,
both Dr. Zizic’s proposed interval of eight weeks and Mr. McCall’s likely onset of
                                            4
symptoms 15 weeks post-vaccination far exceed the appropriate temporal interval.
See id.

       In Dr. Moulton’s supplemental report, he repeated his criticism of the studies
and literature on which Dr. Zizic relied. See exhibit L. He reiterated that the
epidemiological data does not support Dr. Zizic’s assertion that vaccines increase
the risk of rheumatoid arthritis. Id. at 7. He added that the evidence does not
support a finding that the flu vaccine, more likely than not, caused Mr. McCall’s
rheumatoid arthritis. Id. at 7-8.

       A status conference was held on March 21, 2022, during which the
undersigned discussed the similarities between Mr. McCall’s case and Tullio in
that in both cases, petitioners’ experts proposed similarities between the
hemagglutinin portion of the flu vaccine and human collagen. The undersigned
also indicated that Dr. Zizic did not answer the questions regarding timing in his
last expert report. The undersigned raised concerns about the viability of Mr.
McCall’s case and reasonable basis. Mr. McCall pointed out that some evidence
differentiated Tullio from the present case, such as the participation of Dr. Zizic on
behalf of Mr. McCall. In light of continued discussions, Mr. McCall requested 30
days to determine how to proceed.

       On March 30, 2022, Mr. McCall moved to dismiss his case. Petitioner
stated that “it has become clear to [him] that he will be unable to prove that he is
entitled to compensation in the Vaccine Program.” Pet’r’s Mot., filed Mar. 30,
2022, at ¶ 1. Petitioner added that he intends to file a civil action. Id. at ¶ 5. The
Secretary did not file a response to this motion. This matter is now ready for
adjudication.

       II.   Analysis

       To receive compensation under the National Vaccine Injury Compensation
Program (hereinafter “the Program”), a petitioner must prove either 1) that the
vaccinee suffered a “Table Injury”—i.e., an injury falling within the Vaccine
Injury Table—corresponding to one of the vaccinations, or 2) that the vaccinee
suffered an injury that was actually caused by a vaccine. See §§ 300aa-13(a)(1)(A)
and 300aa-11(c)(1). Under the Act, a petitioner may not be given a Program award
based solely on the petitioner’s claims alone. Rather, the petition must be
supported by either medical records or by the opinion of a competent physician.
§ 300aa-13(a)(1).

                                           5
       In this case, Mr. McCall filed medical records and expert reports in support
of his claim, but nonetheless, wishes to have his claim dismissed and judgment
entered against him. Though Mr. McCall filed this motion pursuant to 42 U.S.C.
§ 300aa-21(a) (regarding voluntary dismissal), the undersigned will construe this
as a motion filed pursuant to 42 U.S.C. § 300aa-21(b) (regarding involuntary
dismissal), given Mr. McCall’s clear intent that a judgment issue in this case,
protecting his right to file a civil action in the future. See Pet’r’s Mot. at ¶ 5.

      To conform to section 12(d)(3), a decision must “include findings of fact and
conclusions of law.” Here, although the parties could have submitted briefs, Mr.
McCall conceded that “he will be unable to prove that he is entitled to
compensation.” Pet’r’s Mot. at ¶ 1. Therefore, Mr. McCall has elected to seek a
dismissal of his case. See Vaccine Rule 8(f).

       In any event, the evidence weighs against a finding that the flu vaccine
caused Mr. McCall’s rheumatoid arthritis, given the finding in Tullio that the
petitioner failed to establish that the flu vaccine can cause rheumatoid arthritis.
See Tullio, 2019 WL 7580149, at *27. The finding in Tullio provides greater
detail regarding the prong one aspect of this case—whether the flu vaccine can
cause rheumatoid arthritis. Mr. Tullio presented opinions from two experts, Dr.
Steinman and Dr. Utz, who are comparable to Dr. Zizic. After a robust
development of whether molecular mimicry between hemagglutinin and collagen
was a reliable theory, the undersigned found that Mr. Tullio had failed to meet his
burden of proof. See id. at *12-22. This finding considered large epidemiologic
studies that had failed to detect an increased incidence of rheumatoid arthritis
among people receiving the flu vaccine.

       Here, the evidence is similar. Importantly, the molecular composition of
hemagglutinin has not changed, and the molecular composition of collagen has not
changed. Although Mr. McCall and Dr. Zizic have been aware of the outcome of
Tullio for approximately two years, they have not persuasively argued that any
reliable evidence distinguishes Mr. McCall’s case from Tullio. At best, Dr. Zizic
may have raised some questions about one epidemiologic study, Ray (exhibit 62).
See exhibit 34 at 21-22. The authors in Ray initially found an increased risk of
rheumatoid arthritis following the flu vaccination in a cohort study but found no
increased risk in an extended case control analysis. Exhibit 62 (Paula Ray et al.,
Risk of Rheumatoid Arthritis Following Vaccination with Tetanus, Influenza and
Hepatitis B Vaccines Among Persons 15-59 Years of Age, 29 Vaccine 6592
(2011)). However, Dr. Zizic appears not to have any special training in
biostatistics. See exhibit 15 (curriculum vitae). Therefore, on this point, the
                                         6
opinion of Dr. Moulton, who has a Ph.D. in biostatistics, is more likely to be
persuasive. Exhibit I (curriculum vitae).

       While Mr. McCall’s evidence regarding prong one falls short of the
preponderance of the evidence standard, his case also suffers with respect to
Althen prong three. In Dr. Zizic’s opinion, the appropriate time for inferring that
the flu vaccine caused rheumatoid arthritis is eight weeks. Exhibit 16 at 42. He
did not provide support for this opinion. See id. Dr. Whitton disputed Dr. Zizic’s
assertion regarding an appropriate temporal interval. See exhibit K at 2 (opining
that six weeks is an appropriate timeframe for onset of symptoms). As for the
onset of Mr. McCall’s rheumatoid arthritis, Dr. Zizic’s opinion was deficient. Dr.
Zizic claimed that Mr. McCall’s onset of rheumatoid arthritis occurred within two
months following vaccination. Exhibit 16 at 42. However, the Secretary’s experts
persuasively argued that there is insufficient evidence to place Mr. McCall’s onset
at two months post-vaccination. See exhibit A (Dr. Oddis’s first report) at 2;
exhibit K (Dr. Whitton’s supplemental report) at 2.

       At the end of the day, despite able advocacy from Mr. Downing, Mr. McCall
did not proffer evidence of sufficient quality or quantity that would suggest that the
flu vaccine caused his rheumatoid arthritis. Thus, Mr. McCall’s choice to seek
dismissal voluntarily seems to be an appropriate conservation of resources.

      Thus, the Motion for Decision is GRANTED and this case is
DISMISSED WITH PREJUDICE for insufficient proof. The Clerk shall
enter judgment accordingly. See Vaccine Rule 21(b).

             IT IS SO ORDERED.

                                              s/Christian J. Moran
                                              Christian J. Moran
                                              Special Master

                                          7