Court Opinion

ID: 4640397
Source: CourtListenerOpinion
Date Created: 2020-12-08 14:01:32.23191+00
Date Added: 2024-06-11T08:00:14.008527
License: Public Domain

In the United States Court of Federal Claims
                                             No. 16-1465V
                                   Filed Under Seal: October 29, 2020
                                      Reissued: December 7, 2020*

                                                     )
    GERALD TEMES,                                    )
                                                     )
                           Petitioner,               )
                                                     )        National Childhood Vaccine Injury Act,
    v.                                               )        42 U.S.C. § 300aa–1 to –34;
                                                     )        Influenza Vaccine; Pneumococcal
    SECRETARY OF HEALTH AND                          )        Vaccine; Cryoglobulinemia; Vasculitis.
    HUMAN SERVICES,                                  )
                                                     )
                           Respondent.               )
                                                     )
                                                     )

       Renee Gentry, Esq., Counsel of Record, Vaccine Injury Clinic, George Washington
University Law School, Washington, DC, for petitioner.

       Alexa Roggenkamp, Trial Attorney, Heather L. Pearlman, Assistant Director, Catharine
E. Reeves, Deputy Director, C. Salvatore D’Alessio, Acting Director, Ethan P. Davis, Acting
Assistant Attorney General, Torts Branch, Civil Division, United States Department of Justice,
Washington, DC, for respondent.

                             MEMORANDUM OPINION AND ORDER

GRIGGSBY, Judge

I.       INTRODUCTION

         Petitioner, Dr. Gerald Temes, seeks review of the May 12, 2020, Decision of the special
master denying his claim for compensation under the National Childhood Vaccine Injury Act
(“Vaccine Act”), 42 U.S.C. § 300aa–1 to –34. For the reasons set forth below, the Court

*
  This Memorandum Opinion and Order was originally filed under seal on October 29, 2020. ECF No.
65. The parties were given an opportunity to advise the Court of their views with respect to what
information, if any, should be redacted from the Memorandum Opinion and Order. On December 1,
2020, petitioner filed a joint status report on behalf of the parties stating that the parties had no redactions
to the Memorandum Opinion and Order. ECF No. 67. And so, the Court is reissuing its Memorandum
Opinion and Order, dated October 29, 2020, as the public opinion.
DENIES petitioner’s motion for review of the special master’s May 12, 2020, Decision and
SUSTAINS the decision of the special master.

II.     FACTUAL AND PROCEDURAL BACKGROUND1

        A.      Factual Background

        Dr. Temes is a retired thoracic surgeon who has been diagnosed with Type II
cryoglobulinemia—a blood disorder that can lead to vasculitis.2 Pet’r Pet. at 1. In this Vaccine
Act matter, Dr. Temes alleges that he developed cryoglobulinemia as a result of receiving the
influenza (“flu”) and pneumococcal (“Prevnar 13”) vaccines on October 19, 2015. Id.; see also
Pet’r Mot. for Rev. at 1. On May 12, 2020, the special master denied Dr. Temes’ claim for
compensation under the Vaccine Act. See generally May 12, 2020, Decision.

                1.        Dr. Temes’ Medical History

        Dr. Temes’ medical history is discussed in detail in the special master’s May 12, 2020,
Decision and is summarized here. May 12, 2020, Decision at 2-7.

        Dr. Temes received the flu and Prevnar 13 vaccines at issue on October 19, 2015. Pet’r
Ex. 8. During a subsequent consultation with Dr. Tuna Ozyurekoglu, a hand specialist, on
October 26, 2015, Dr. Temes reported experiencing symptoms of purple discoloration and
numbness in his hands, which improved in the clinic upon warming. Pet’r Ex. 3 at 6-7.

        During an appointment with his primary care physician, Matthew Rogers, M.D., on that
same day, Dr. Temes complained of a persistent high fever that started three days earlier, as well
as hand pain, myalgias in his legs, and dysuria. Pet’r Ex. 1 at 16, 21. At the time, Dr. Rogers
expressed concern that Dr. Temes was experiencing cryoglobulinemia and ordered Dr. Temes to
undergo further laboratory testing. Id. at 20-21.

1
  The facts recounted in this Memorandum Opinion and Order are taken from the petitioner’s petition
(“Pet’r Pet.”); petitioner’s motion for review (“Pet’r Mot. for Rev.”) and the memorandum in support
thereof (“Pet’r Mem.”); petitioner’s exhibits (“Pet’r Ex.”); the Secretary’s exhibits (“Resp’t Ex.”) and the
special master’s May 12, 2020, Decision (“May 12, 2020, Decision”). Except where otherwise noted, the
facts recited herein are undisputed.
2
 Cryoglobulinemia is a condition in which certain immunoglobulins found in the blood precipitate under
cool conditions. May 12, 2020, Decision at 1 n.3; Dorland’s Illustrated Medical Dictionary 438, 908
(33d ed. 2020).

                                                                                                           2
       On October 30, 2015, Dr. Temes presented to John Huber, M.D., for a consultation. Pet’r
Ex. 16 at 273. Dr. Huber reviewed Dr. Temes’ laboratory results and noted a slightly elevated
rheumatoid factor, depressed complement levels, and the absence of cold agglutinins. Id. Dr.
Temes’ cryoglobulin test results were still pending at that time. Id. at 277. A physical
examination revealed signs of ischemia in Dr. Temes’ fingers and toes. Id. at 276. Dr. Huber
concluded that Dr. Temes was likely experiencing mixed cryoglobulinemia as the result of
receiving the flu vaccine. Id. at 277. And so, Dr. Huber prescribed Dr. Temes prednisone and
directed him to follow-up after receiving the results of his cryoglobulin test. Id.

       After consulting with a dermatologist, Jeffrey Callen, M.D.—who noted that Dr. Temes’
cryoglobulinemia “is presumed to be due to a[ flu] vaccination[]”—Dr. Temes underwent
additional laboratory testing on November 17, 2015. Pet’r Ex. 2 at 9-10; see also Pet’r Ex. 1 at
183. Dr. Temes subsequently presented for a follow-up appointment on November 24, 2015,
with Dr. Huber, who noted that Dr. Temes’ rheumatoid factor was significantly elevated
compared to his prior test results. Pet’r Ex. 16 at 225. Although Dr. Temes reported improving
pain in his fingers and toes, a physical examination revealed worsening ischemia. Id. at 227.
And so, Dr. Huber ordered Dr. Temes to begin Rituxan treatments, the first of which Dr. Temes
received on December 1, 2015. Id. at 207, 230.

       Dr. Temes complained of necrosis in certain fingers and severe pain in his right foot at a
follow-up appointment with Dr. Huber on January 5, 2016. Id. at 161. Dr. Huber noted,
however, an overall improvement in Dr. Temes’ condition and recommended two additional
Rituxan treatments and a continued taper of Dr. Temes’ prednisone dosage from 20 to 10
milligrams per day. Id. at 164, 166-67. At his next appointment with Dr. Huber on January 19,
2016, Dr. Temes exhibited dramatic improvement and showed almost no signs of ischemic
changes in his hands or feet. Id. at 145. And so, Dr. Huber advised Dr. Temes to continue his
Rituxan treatments and to further taper his prednisone to five milligrams per day. Id. at 151.

       Throughout the remainder of 2016 and early 2017, Dr. Temes attended numerous follow-
up appointments with various medical providers and he reported considerable improvement of
his symptoms. See generally May 12, 2020, Decision at 5-6. Despite never achieving complete
remission, Dr. Temes was able to return to many of the activities that he had enjoyed prior to the
onset of his cryoglobulinemia, including playing golf. See, e.g., Pet’r Ex. 16 at 84.

                                                                                                    3
       Dr. Temes’ condition began to deteriorate again in May 2017, when he experienced
increased discomfort in his hands and feet, as well as pain precipitated by cold temperatures.
Pet’r Ex. 51 at 10. Dr. Huber recommended restarting Rituxan treatments, which Dr. Temes
began on May 18, 2017. Id. On May 30, 2017, Dr. Temes attended a follow-up with Dr. Huber
and complained of a rash on his bilateral feet. Id. A biopsy confirmed that Dr. Temes was
suffering from cutaneous vasculitis. Id.

       On June 28, 2017, John Lust, M.D., an expert in the study of cryoglobulinemia at the
Mayo Clinic, reviewed Dr. Temes’ medical history and outside laboratory results and concluded
that they evidenced a diagnosis of leukocytoclastic vasculitis. Pet’r Ex. 19 at 14, 17. Testing
conducted during Dr. Temes’ consultation with Dr. Lust “showed a trace [amount] of
cryoprecipitate and immunofixation[, which] demonstrated a Type II cryoglobulinemia
(monoclonal IgM kappa plus polyclonal IgG).” Pet’r Ex. 50. In his notes from that visit, Dr.
Lust also wrote that Dr. Temes’ “clinical diagnosis” was cryoglobulinemia that developed “in
response to [a flu] vaccination.” Pet’r Ex. 19 at 14. Dr. Lust recommended that Dr. Temes
continue with the two additional Rituxan treatments four weeks apart. Id. But, Dr. Temes
suffered a severe reaction to his Rituxan treatment on July 6, 2017. Pet’r Ex. 51 at 11. And so,
he began treatment with Cytoxan on July 11, 2017. Id.

       Dr. Temes continued to follow-up with Dr. Huber throughout the remainder of 2017 and
2018, and his condition remained stable with some slight fluctuations. See May 12, 2020,
Decision at 7. At a follow-up appointment on April 13, 2018, Dr. Huber wrote that Dr. Temes’
symptoms were “clinically . . . more consistent with a Type II cryoglobulinemia that we suspect
was induced by his [flu] vaccine.” Pet’r Ex. 51 at 12. Dr. Temes’ Cytoxan treatment was
discontinued on November 5, 2019. Pet’r Ex. 59 at 13. But, in February of 2020, Dr. Temes’
condition worsened, and his physicians discussed restarting Cytoxan. Id. at 2, 13.

               2.      Proceedings Before The Special Master

       Dr. Temes commenced this Vaccine Act case before the Office of Special Masters on
November 7, 2016. Pet. at 1. In support of his claim, Dr. Temes submitted fifty-seven exhibits
and two affidavits. See Pet’r Exs. 1-59. The special master held an entitlement hearing on
September 10, 2019. See generally Tr. Thereafter, the parties filed post-hearing briefs. See
Pet’r Post-Hr’g Br.; Resp’t Post-Hr’g Resp. Br.

                                                                                                   4
        During the entitlement hearing, Dr. Temes testified that he was in overall good health
before the vaccinations, and that he developed a high fever, muscle pain and aches, and
discoloration in one of his fingertips, within a week of his vaccinations. See generally Tr. 14:24-
15:1; Tr. 15:8-15:16. Dr. Temes also testified that he experienced a resurgence of his symptoms
in May 2017, and that he consulted with Dr. Lust at the Mayo Clinic, who expressed the opinion
that the vaccinations that Dr. Temes received may have played a role in the development of his
condition. Tr. 29:19-31:8.

        Joseph Bellanti, M.D., an immunologist, provided two expert reports and testimony in
support of Dr. Temes’ claim.3 See generally Pet’r Exs. 20, 52; Tr. 51:8-104:12. Dr. Bellanti
attributed Dr. Temes’ symptoms, which began within a week of vaccination, to an inflammatory
response and he concluded that Dr. Temes suffered from cryoglobulinemia. See Tr. 57:13-58:9.
But, Dr. Bellanti also acknowledged that many cases of cryoglobulinemia are “idiopathic,” or
without a known etiology. Tr. 86:15-86:17; 89:14-89:20.

        With regards to Dr. Temes’ theory of causation, Dr. Bellanti’s expert reports and
testimony generally relied upon the concept of epigenetics, which he described as the study of
environmental influence on gene expression. See Tr. at 65:6-66:8. Dr. Bellanti opined that the
vaccines Dr. Temes received triggered the expression of certain genes responsible for producing
cryoglobulins. Tr. 66:23-66:25. He also acknowledged, however, that other environmental
factors, such as changes in nutrition and certain viral infections, could provoke similar changes
in gene expression. Tr. 67:5-67:7.

        Dr. Bellanti’s causation theory also “assumed that an aberrant autoimmune response
could cause B cells to produce cryoglobulins essential to the development of cryoglobulinemia.”
May 12, 2020, Decision at 11; Tr. at 81:5-82:22; Pet’r Post-Hr’g Br. at 5. To support this aspect
of his expert opinion, Dr. Bellanti cited to the Catsoulis article—a study involving the effects of
hyper-immunizing rabbits with a pneumococcal vaccine. See Pet’r Ex. 22; E. A. Catsoulis et al.,
Cryoglobulinaemia in Rabbits Hyperimmunized with a Polyvalent Pneumococcal Vaccine, 9
Immunology 327, 327-31 (1965) (“Catsoulis”). This study found that administering the

3
 Dr. Bellanti serves as a professor emeritus in pediatrics and microbiology-immunology at the
Georgetown University School of Medicine. Pet’r Ex. 55 at 1.

                                                                                                      5
pneumococcal vaccine to rabbits every three days induced cryoglobulinemia within three to four
months. Catsoulis at 327. The study also found that when the rabbits were no longer vaccinated,
they recovered to baseline within five weeks. Id. at 330. When researchers re-initiated
vaccination, the rabbits suffered a recurrence of cryoglobulinemia, usually after three to five
weeks. Id. at 327. And so, the Catsoulis study concluded that intense pneumococcal
immunization can stimulate the production of cryoglobulins. Id. at 330.

        In addition, Dr. Bellanti proposed that molecular mimicry or bystander activation could
explain how vaccine-induced cryoglobulinemia, which is an acute condition, could persist after a
single vaccination. Tr. 101:12-101:17. In this regard, Dr. Bellanti relied upon several case
reports identifying instances of vasculitis, cold contact urticaria, and cryoglobulinemia following
vaccination. See Tr. at 74:16-78:12.4 First, the Tavadia case report describes four cases of
leucocytoclastic vasculitis following receipt of the flu vaccine. See Pet’r Ex. 23; S. Tavadia et
al., Leucocytoclastic Vasculitis and Influenza Vaccination, 28 Clinical and Experimental
Dermatology 154, 154-56 (2003) (“Tavadia”). Second, Dr. Bellanti relied upon the Iyngkaran
case report, which describes a patient who experienced the onset of cutaneous vasculitis and
exacerbation of pre-existing rheumatoid arthritis two weeks after receiving the flu vaccine. See
Pet’r Ex. 24; P. Iyngkaran et al., Rheumatoid Vasculitis Following Influenza Vaccination, 42
Rheumatology 907, 907-09 (2003) (“Iyngkaran”). Third, Dr. Bellanti cited to the Raison-Peyron

4
 Dr. Temes submitted the following medical literature in support of his claim: (1) E. A. Catsoulis et al.,
Cryoglobulinemia in Rabbits Hyperimmunized with a Polyvalent Pneumococcal Vaccine, 9 Immunology
327, 327-331 (1965); (2) S. Eid & J. Callen, Type II Cryoglobulinemia Following Influenza and
Pneumococcal Vaccine Administration, 5(11) JAAD Case Rep. 960, 961-62 (2019); (3) Patrizia Felicetti
et al., Spontaneous Reports of Vasculitis as an Adverse Event Following Immunization: A Descriptive
Analysis Across Three International Databases, Vaccine (2016); (4) B. Fox & A. Peterson,
Leukocytoclastic Vasculitis After Pneumococcal Vaccination, 26 AJIC 365, 365-66 (1998); (5) P.
Iyngkaran et al., Rheumatoid Vasculitis Following Influenza Vaccination, 42 Rheumatology 907, 907-909
(2003); (6) Po-Yu Liu et al., Cutaneous Vasculitis Following Influenza Vaccination, 49 Internal Medicine
2187, 2187-88 (2010); (7) Anne Lohse et al., Vascular Purpura and Cryoglobulinemia after Influenza
Vaccination, 66(6) Rev. Rheumatology 359, 359-62 (1999); (8) Seena Monjazeb et al., A Case of
Leukocytoclastic Vasculitis Following Influenza Vaccination, 2 JAAD Case Rep. 340, 340-42 (2016); (9)
Maria Inês Fernandes Pimentel et al., Henoch-Schönlein Purpura Following Influenza A H1N1
Vaccination, 44(4) Revista da Sociedade Brasileira de Medicina Tropical 531 (2011); (10) Nadia Raison-
Peyron et al., Cold Contact Urticaria Following Vaccination: Four Cases, 96 Acta Dermato-
Venereologica 852, 852-53 (2016); (11) S. Tavadia et al., Leukocytoclastic Vasculitis and Influenza
Vaccination, 28 Clinical and Experimental Dermatology 154, 154-56 (2003); (12) Ronni Wolf et al.,
Neutrophilic Dermatosis of the Hands After Influenza Vaccination, 48 Int’l J. of Dermatology 66, 66-68
(2009).

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case report, which documents the development of cold contact urticaria following vaccination.
See Pet’r Ex. 25; Nadia Raison-Peyron et al., Cold Contact Urticaria Following Vaccination:
Four Cases, 96 Acta Dermato-Venereologica 852, 852-53 (2016) (“Raison-Peyron”). Lastly,
Dr. Bellanti relied upon the Lohse case report, which involves a 68-year-old man who developed
Type II/mixed cryoglobulinemia two weeks after receiving the flu vaccine. See Pet’r Ex. 26;
Anne Lohse et al., Vascular Purpura and Cryoglobulinemia after Influenza Vaccination, 66(6)
Rev. Rhum. 359, 359-62 (1999) (“Lohse”).

       The Secretary relied upon two expert reports and testimony from Harry Schroeder, Jr.,
M.D., Ph.D. Resp’t Exs. A, G; Tr. 105:14-168:16. During the entitlement hearing, Dr.
Schroeder testified that Dr. Temes’ cryoglobulinemia was most likely unrelated to the vaccines
that he received. Tr. at 110:21-111:2. In this regard, Dr. Schroeder criticized Dr. Bellanti’s
causation theory regarding epigenetics, and he noted the absence of reliable scientific evidence to
suggest that the flu virus or flu vaccine could directly result in B cell mutations, which occurs
with cryoglobulinemia. Tr. 113:6-113:13; Tr. 116:12-116:18.

       Dr. Schroeder also testified that he rejected the probative value of the medical literature
offered by Dr. Temes. See Tr. 128:25-130:15. Specifically, Dr. Schroeder observed that the
Lohse case study authors avoided reaching a conclusion regarding vaccine causality. Tr. at
126:20-126:25 (citing Lohse at 359 (finding that a relationship between vaccination and
cryoglobulinemia could not be confirmed)). Dr. Schroeder also found the Catsoulis study to be
unpersuasive, because the effects of the hyperimmunization conducted in Catsoulis could not be
induced by the administration of a single high-dose flu vaccine, like the single dose received by
Dr. Temes. Tr. 111:12-111:23; 112:21-113:5. And so, Dr. Schroeder opined that the effects of
hyperimmunization observed in Catsoulis—the production of cryoglobulins—could not have
resulted from Dr. Temes’ single-dose of the flu vaccination. Tr. 122:1-122:7.

       With regards to the Tavadia and Iyngkaran case reports, Dr. Schroeder also opined that
these reports were not relevant, because they focused on diseases other than cryoglobulinemia.
Tr. 129:2-129:21. In addition, Dr. Schroeder observed that the other medical literature offered
by Dr. Temes to show that vaccines can cause vasculitis did not involve patients first suffering
from cryoglobulinemia—like Dr. Temes. Tr. 163:10-165:15 (citing Pet’r Ex. 56; S. Monjazeb et
al., A Case of Leukocytoclastic Vasculitis Following Influenza Vaccination, 2 JAAD Case

                                                                                                     7
Reports 340, 340-42 (2016) (“Monjazeb”); Pet’r Ex. 57; B. Fox & A. Peterson, Leukocytoclastic
Vasculitis After Pneumococcal Vaccination, 26(3) AJIC 365, 365-66 (1998) (“Fox”)). And so,
Dr. Schroeder concluded that the articles submitted by Dr. Temes did not support his contention
that the flu and/or Prevnar 13 vaccines can cause cryoglobulinemia.

       Lastly, Dr. Schroeder testified that the onset of Dr. Temes’ cryoglobulinemia, with
clinical evidence appearing within a week of vaccination, was too soon to establish a causal
relationship between the vaccinations that Dr. Temes received and his cryoglobulinemia. Tr.
122:24-123:7; 156:10-156:14. In this regard, Dr. Schroeder opined that it would take
approximately two to three weeks for an adequate concentration of immunoglobulins to build up
in the body before symptoms of cryoglobulinemia would manifest. Tr. 123:1-123:3. And so, he
concluded that the onset of symptoms following Dr. Temes’ vaccinations did not occur within a
medically acceptable time frame.5 Tr. 123:4-123:7.

               3.        The May 12, 2020, Decision

       On May 12, 2020, the special master issued a decision denying Dr. Temes’ Vaccine Act
claim. See generally May 12, 2020, Decision.

       In his May 12, 2020, Decision, the special master first addressed the characteristics of
cryoglobulinemia. See May 12, 2020, Decision at 23-24. In this regard, he observed that
“cryoglobulinemia is a condition in which particular serum antibodies called ‘cryoglobulins’
reversibly precipitate in the blood when cooled below 37 degrees Celsius (98.8 degrees
Fahrenheit).” Id. at 23 (citing J. Damoiseaux & J. Tervaert, Diagnostic and Treatment of
Cryoglobulinemia: It Takes Two to Tango, 47 Clinic. Rev. Allerg. Immunol. 299, 299 (2014)
(“Damoiseaux”)). The special master also observed that “Type II, or ‘mixed’ [cryoglobulinemia]
is thought to be caused by systemic autoimmune or infectious disease, . . . features monoclonal
IgM, polyclonal IgG, and rheumatoid factor activity[]” and is “particularly associated with a
hepatitis C infection.” Id. (citing Damoiseaux at 303).

5
 The special master observes in the May 12, 2020, Decision that there are several points on which Dr.
Bellanti and Dr. Schroeder agree—namely that: (1) Dr. Temes’ condition was properly diagnosed as
Type II mixed cryoglobulinemia; (2) several of Dr. Temes’ treating physicians expressed the opinion that
his condition was related to the vaccinations that he received in October 2015; and (3) Dr. Temes later
experienced leukocytoclastic vasculitis secondary to his cryoglobulinemia. May 12, 2020, Decision at 15;
Tr. 128:10-128:18; 147:18-147:23; 152:7-152:10.

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       The special master then determined, as an initial matter, that Dr. Temes had not offered a
scientifically-reliable causation theory under Althen Prong One, because there was sparse
evidentiary support that the flu and/or Prevnar 13 vaccines can cause cryoglobulinemia.6 See id.
at 25-28. Specifically, the special master found Dr. Bellanti “over-relie[d] on assumptions about
the interplay of vaccination with genetic susceptibility to cryoglobulinemia that the evidence
does not support.” Id. at 25. In this regard, the special master observed that, while Dr. Bellanti
proposed that vaccines could trigger a malfunction in the expression of genes responsible for
cryoglobulin production, he did not: (1) “identify the genes responsible for cryoglobulin
production[;]” (2) “discuss which vaccine components could trigger or silence gene
expression[;]” or (3) “offer persuasive evidence showing that any vaccines . . . have this
capacity.” Id. In addition, the special master found that “[n]one of the literature offered in this
case otherwise acknowledged epigenetics as a potential mechanism through which an individual
may develop cryoglobulinemia, regardless of [the] trigger.” Id. And so, the special master
found Dr. Temes’ arguments related to epigenetics to be unpersuasive. See id.

       The special master also rejected Dr. Temes’ theory that an immunocompromised state
resulting from epigenetic changes could allow a vaccination to initiate the abnormal production
of cryoglobulins. See id. at 25-26. In this regard, the special master observed that Dr. Temes
relied upon the Catsoulis study to support his theory that the Prevnar 13 vaccine can initiate the
production of cryoglobulins. Id. at 25. But, the special master determined that the Catsoulis
study had limited probative value, because the study only suggests that the Prevnar 13 vaccine
can cause cryoglobulin production after hyperimmunization over a prolonged time period. Id. at
25-26. Specifically, the special master found that the hyperimmunization that occurred in
Catsoulis was “not comparable to a single-instance receipt of the [Prevnar 13] vaccine” which
occurred in Dr. Temes’ case. Id. In addition, the special master determined that Dr. Temes’
proposition that the flu vaccine could similarly induce cryoglobulin production lacked
evidentiary support, because it “was not supported with more than conclusory statements . . . and
a single high dose flu vaccine is unlikely to produce results similar to those seen in Catsoulis,
which required roughly thirty to forty immunizations to induce cryoglobulinemia.” Id. (emphasis

6
 The special master also observed that Dr. Temes erroneously argued for an evidentiary standard of mere
plausibility in evaluating whether he can satisfy Althen Prong One. May 12, 2020, Decision at 25.

                                                                                                      9
in original); Catsoulis at 327. And so, the special master rejected Dr. Temes’ arguments that the
flu and/or Prevnar 13 vaccines can instigate the production of cryoglobulins necessary for the
development of cryoglobulinemia. See May 12, 2020, Decision at 26.

       The special master also determined that none of the case reports referenced by Dr. Temes
confirmed a causal relationship between the flu vaccine and the subsequent development of
leukocytoclastic vasculitis. Id. Specifically, the special master observed that, apart from the
Lohse study, “none of the cited case reports observing [a] temporal association between
leukocytoclastic vasculitis and vaccination mentioned cryoglobulinemia as occurring first.” Id.
at 26-27. The special master acknowledged that the Lohse study does “suggest[] that
cryoglobulinemia and . . . leukocytoclastic vasculitis may develop simultaneously[.]” Id. at 27.
But, he concluded that Lohse study “does not describe how an initial onset of cryoglobulinemia
can produce leukocytoclastic vasculitis years later, as occurred in Dr. Temes’[] case.” Id.

       The special master similarly found Dr. Temes’ arguments that molecular mimicry or
bystander activation could explain why he developed chronic cryoglobulinemia after a single
dose of the flu and/or Prevnar 13 vaccines to be scientifically unreliable. See id. at 27-28. First,
the special master found that, “beyond conclusory statements by Dr. Bellanti, no reliable
literature was offered to suggest that the relevant vaccines can trigger such a process in causing
persistent cryoglobulinemia.” Id. at 27. Second, the special master found that Dr. Bellanti’s
characterizations of bystander activation to explain the persistence of a vaccine-caused
cryoglobulinemia “were no better supported, and in fact were inconsistent.” Id. In this regard,
the special master observed that “Dr. Bellanti did not substantiate his contention [regarding
bystander activation] with either independent literature or his own personal experience and
research to show that cryoglobulinemia is known to become chronic in this manner.” Id. at 28.

       Lastly, the special master determined that, based upon Dr. Schroeder’s expert testimony,
“[o]nly ongoing exposure to an antagonizing antigen will perpetuate IgM production [resulting in
persistent cryoglobulinemia.]” Id. In this regard, the special master found that Dr. Temes “did
not offer any evidence to suggest that the antigenic components of the flu and/or [Prevnar 13]
vaccines remained present and active in the body for a sufficiently prolonged period to produce
the same chronic effects.” Id. Given this, the special master concluded that, “[Dr. Temes’]
theories were ultimately too conclusory and incomplete to be deemed preponderantly reliable.”

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Id. And so, the special master also concluded that “[t]he lack of credible and persuasive
evidence on the issue of causation leads [him] to conclude that [Dr. Temes] has not satisfied the
first Althen prong.” Id.

       Regarding Althen Prong Two—which requires that Dr. Temes establish that the flu
and/or Prevnar 13 vaccines did in fact cause his injury—the special master found that the
conclusions of Dr. Temes’ treating physicians, alone, were not enough to satisfy the burden of
proof under this prong. Id. at 28-29. In this regard, the special master determined that the
medical records did contain some favorable evidence for Dr. Temes, mainly in the form of
statements made by several of his treating physicians that his cryoglobulinemia was vaccine
induced. Id. But, the special master observed that he was “not bound by [these] treater opinions,
especially when other evidence rebuts or contradicts the grounds for such views.” Id. at 29
(citing Snyder ex rel. Snyder v. Sec’y of Health and Human Servs., 88 Fed. Cl. 706, 745 n.67
(2009)).

       The special master also determined that “none of the literature filed in this matter
supported a causal relationship between vaccination and the subsequent development of
cryoglobulinemia.” Id. Specifically, the special master observed that “Dr. Bellanti [failed to]
substantiate his opinions with reference to his own experience researching or studying the
condition or its relationship to vaccination.” Id. The special master also observed that Dr.
Callen’s case report, which focused on Dr. Temes’ clinical course, “conceded that ‘the
mechanisms of vasculitis and cryoglobulinemia induced by the [flu] and [Prevnar 13]
vaccination remain unknown’ and ‘it is not clear why cryoglobulins are produced as a response
to a viral antigen triggered in response to a vaccination.’” Id. (emphasis in original) (quoting
Pet’r Ex. 58; S. Eid & J. Callen, Type II Mixed Cryoglobulinemia Following Influenza and
Pneumococcal Vaccine Administration, 5(11) JAAD Case Reports 960, 961-62 (2019)). And so,
the special master concluded that, while “the treater views in this case do aid [Dr. Temes’]
showing, they ultimately relied too much on the obvious temporal relationship between
vaccination and injury to carry [Dr. Temes’] ‘did cause’ burden.” Id.

       The special master also determined that the evidence about Dr. Temes’ subsequent
development of vasculitis did not support the conclusion that his injuries were likely vaccine-
caused, because “the symptoms leading to that diagnosis did not manifest until a significant time

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after onset of his cryoglobulinemia in 2015.” Id. (emphasis in original). Given this, the special
master concluded that Dr. Temes’ vasculitis “so significantly post-dated vaccination that it is
difficult to associate the October 2015 vaccines with it[.]” Id. at 30.

        Lastly, regarding the onset of Dr. Temes’ cryoglobulinemia symptoms, the special master
determined that Dr. Temes failed establish a medically acceptable onset timeframe under his
causation theory. Id. Notably, the special master found that Dr. Temes’ showing with respect to
this prong “presents a similarly ‘mixed bag’ of evidence that in the end cannot satisfy this
element of his burden, largely due to his inability to persuasively establish the first prong [of
Althen].” Id. In this regard, the special master recognized that the evidentiary record
“establishes an obviously close temporal association (approximately five to seven days) between
the date of Dr. Temes’[] vaccinations and initial symptoms onset.” Id. But, he observed that Dr.
Schroeder testified that “it takes approximately five to seven days from the time of vaccination
for B cells to begin the production of plasma and memory cells” and “then takes up to three to
four weeks more for the body to produce enough IgM antibody to induce cryoglobulinemia.” Id.
(emphasis in original) (citing Tr. at 117:5-117:7).

        In addition, the special master observed that “the process of causing [the] appearance of
the cryoglobulins took several weeks (and only after repeated vaccination)[]” in the Catsoulis
study. Id. (citing Catsoulis at 328). Given this, the special master found that Dr. Schroeder’s
testimony and the Catsoulis article “cut[] against such a short turn-around from vaccination to
manifestation of the clinical symptoms [Dr. Temes] first reported[.]” Id. And so, the special
master concluded that Dr. Temes’ onset of cryoglobulinemia did not occur within a medically
acceptable timeframe under his proposed causation theory.7 Id.

        Because the special master determined that Dr. Temes did not successfully establish that
either the flu and/or Prevnar 13 vaccines “could cause cryoglobulinemia, and/or [did] so in a
timeframe of one week,” he concluded that the record evidence did not preponderate in a
favorable ruling. Id. at 31. And so, the special master denied entitlement in this case. Id.
        Dr. Temes, alleging error, seeks review of the special master’s decision.

7
  The special master also rejected the argument that Dr. Temes would have experienced a faster response
because he had developed immunologic memory from the flu vaccines that he received throughout his
life—a concept known as “re-challenge.” May 12, 2020, Decision at 30-31.

                                                                                                     12
       B.      Procedural Background

       On June 11, 2020, Dr. Temes filed a motion for review of the special master’s May 12,
2020, Decision. See generally Pet’r Mot. for Rev. On July 13, 2020, the Secretary filed a
response to Dr. Temes’ motion for review. See generally Resp’t Resp.

       The motion for review having been fully briefed, the Court resolves the pending motion.

III.   STANDARDS FOR DECISION

       A.      Vaccine Act Claims

       The United States Court of Federal Claims has jurisdiction to review the record of the
proceedings before a special master and, upon such review, 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).

       The special master’s determinations of law are reviewed de novo. Andreu ex rel. Andreu
v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1373 (Fed. Cir. 2009). The special master’s
findings of fact are reviewed for clear error. Id. (citation omitted); see also Broekelschen v.
Sec’y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (“We uphold the special
master’s findings of fact unless they are arbitrary or capricious.”). The special master’s
discretionary rulings are reviewed for abuse of discretion. Munn v. Sec’y of Dep’t of Health &
Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).

       In addition, a special master’s findings regarding the probative value of the evidence and
the credibility of witnesses will not be disturbed so long as they are “supported by substantial
evidence.” Doe v. Sec’y of Health & Human Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010)
(citation omitted); see also Burns v. Sec’y of Dep’t of Health & Human Servs., 3 F.3d 415, 417
(Fed. Cir. 1993) (holding that the decision of whether to afford greater weight to

                                                                                                   13
contemporaneous medical records or later given testimony is “uniquely within the purview of the
special master”); see also Hibbard v. Sec’y of Dep’t of Health & Human Servs., 698 F.3d 1355,
1363 (Fed. Cir. 2012) (citation omitted) (stating that there is no reversable error so long as the
special master considers relevant evidence, draws plausible inferences from said evidence, and
articulates a rational basis for his decision.). This “level of deference is especially apt in a case
in which the medical evidence of causation is in dispute.” Hodges v. Sec’y of Dep’t of Health &
Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). And so, the Court will not substitute its
judgment for that of the special master, “if the special master has considered all relevant factors,
and has made no clear error of judgment.” Lonergan v. Sec’y of Dep’t of Health & Human
Servs., 27 Fed. Cl. 579, 580 (1993).

       Under the Vaccine Act, the Court must award compensation if a petitioner proves, by a
preponderance of the evidence, all the elements set forth in in 42 U.S.C. § 300aa–11(c)(1), unless
there is a preponderance of evidence that the illness is due to factors unrelated to the
administration of the vaccine. 42 U.S.C. § 300aa–13(a)(1). A petitioner can recover either by
proving an injury listed on the Vaccine Injury Table (the “Table”), or by proving causation-in-
fact. See 42 U.S.C. §§ 300aa–11(c)(1)(C)(i)-(ii); Althen v. Sec’y of Health & Human Servs., 418
F.3d 1274, 1278 (Fed. Cir. 2005). And so, to receive compensation under the National Vaccine
Injury Compensation Program, a petitioner must prove either that: (1) the petitioner suffered a
“Table Injury” that corresponds to one of the vaccinations in question within a statutorily
prescribed period of time or, in the alternative, (2) petitioner’s injury was actually caused by a
vaccine. See 42 U.S.C. §§ 300aa–11(c)(1)(C)(i)-(ii), 300aa–14(a); see also Moberly v. Sec’y of
Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health &
Human Servs., 440 F.3d 1317, 1319-20 (Fed. Cir. 2006).

       In addition, in Table and non-Table cases, a petitioner bears “a preponderance of the
evidence” burden of proof. 42 U.S.C. § 300aa–13(a)(1)(A); Althen, 418 F.3d at 1278 (citing
Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)). And so,
a petitioner must offer evidence that leads the “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, 592 F.3d at 1322 n.2 (brackets
existing) (citations omitted); see also Snowbank Enters., Inc. v. United States, 6 Cl. Ct. 476, 486

                                                                                                     14
(1984) (holding that mere conjecture or speculation is insufficient under a preponderance
standard).

          In Althen, the Federal Circuit addressed the three elements to prove causation-in-fact.
Althen, 418 F.3d at 1278. The Federal Circuit has also held that all three elements “must
cumulatively show that the vaccination was a ‘but-for’ cause of the harm, rather than just an
insubstantial contributor in, or one among several possible causes of, the harm.” Pafford v. Sec’y
of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). Specifically, to establish a
prima facie case when proceeding on a causation-in-fact theory, a petitioner must “prove, by a
preponderance of the evidence, that the vaccine was not only a but-for cause of the injury but
also a substantial factor in bringing about the injury.” Shyface, 165 F.3d at 1352. In addition, a
petitioner must prove 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, 418 F.3d at 1278. While the Vaccine Act
does not require medical or scientific certainty, any theory posited must be “sound and reliable.”
Boatman v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019) (quoting
Knudsen by Knudsen v. Sec’y of Dep’t of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir.
1994)).

          The Federal Circuit has also recognized the probative value of the opinions of treating
physicians contained in contemporaneous medical records. Capizzano, 440 F.3d at 1326. Such
opinions and medical records are favored in Vaccine Act matters, because “treating physicians
are likely to be in the best position to determine whether ‘a logical sequence of cause and effect
show[s] that the vaccination was the reason for the injury.’” Id. (quoting Althen, 418 F.3d at
1280) (brackets existing). But, these opinions are not “binding on the special master or court.”
42 U.S.C. § 300aa–13(b)(1); see also Snyder ex rel. Snyder, 88 Fed. Cl. at 745 n.67 (citing
Andreu ex rel. Andreu, 569 F.3d at 1375) (“[T]here is nothing . . . that mandates that the
testimony of a treating physician is sacrosanct—that it must be accepted in its entirety and
cannot be rebutted.”). Rather, “the special master or court shall consider the entire record and
the course of the injury” when “evaluating the weight to be afforded to any such” opinion. 42
U.S.C. § 300aa–13(b)(1).

                                                                                                    15
       Lastly, if a petitioner establishes a prima facie case, the burden shifts to the respondent to
show, by a preponderance of the evidence, that the injury was caused by a factor unrelated to the
vaccine. See 42 U.S.C. § 300aa–13(a)(1)(B); see also Shalala v. Whitecotton, 514 U.S. 268,
270-71 (1995). But, regardless of whether the burden of proof shifts to the respondent, the
special master may consider the evidence presented by the respondent in determining whether
the petitioner has established a prima facie case. See Stone v. Sec’y of Health & Human Servs.,
676 F.3d 1373, 1379 (Fed. Cir. 2012) (“[E]vidence of other possible sources of injury can be
relevant not only to the ‘factors unrelated’ defense, but also to whether a prima facie showing
has been made that the vaccine was a substantial factor in causing the injury in question.”); de
Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The
government, like any defendant, is permitted to offer evidence to demonstrate the inadequacy of
the petitioner’s evidence on a requisite element of the petitioner’s case[-]in-chief.”).

IV.    LEGAL ANALYSIS

       In his motion for review, Dr. Temes raises three objections to the special master’s May
12, 2020, Decision. First, Dr. Temes argues that the special master impermissibly raised the
burden of proof under Althen Prong One, by requiring confirmation or certainty of the validity of
his theory of causation in the medical literature. Pet’r Mot. for Rev. at 10-17. Second, Dr.
Temes argues that the special master impermissibly raised the burden of proof under Althen
Prong Two, by requiring direct evidence and scientific confirmation of how the flu and/or
Prevnar 13 vaccines caused his cryoglobulinemia. Id. at 17-19. Lastly, Dr. Temes argues that
the special master erred in his analysis of Althen Prong Three, by finding that the timing of Dr.
Temes’ onset of cryoglobulinemia was not medically acceptable. Id. at 19-20.

       The Secretary counters that the special master reasonably concluded, after examining the
evidence, that Dr. Temes failed to establish by preponderant evidence that either the flu or
Prevnar 13 vaccines administered on October 19, 2015, can or did cause Dr. Temes to develop
cryoglobulinemia. Resp’t Resp. at 1, 9-19. The Secretary further argues that Dr. Temes has not
shown that the special master erred, or that the special master’s factual findings and legal
conclusions were arbitrary, capricious, an abuse of discretion or contrary to law. Id. at 1-2, 5-6,
17. And so, the Secretary requests that the Court deny Dr. Temes’ motion for review and sustain
the decision of the special master. Id. at 2, 19.

                                                                                                    16
          For the reasons discussed below, the evidentiary record before the Court shows that the
special master did not abuse his discretion, or act contrary to law, in reaching the decision to
deny Dr. Temes’ Vaccine Act claim. And so, the Court DENIES Dr. Temes’ motion for review
of the special master’s May 12, 2020, Decision and SUSTAINS the decision of the special
master.

          A.     The Special Master Reasonably Concluded
                 That Dr. Temes Did Not Satisfy Althen Prong One

          As an initial matter, the record evidence demonstrates that the special master applied the
correct legal standard to analyze Dr. Temes’ claim under Althen Prong One. In the May 12,
2020, Decision, the special master stated that the preponderant standard under the Vaccine Act
does not mandate medical certainty. May 12, 2020, Decision at 25. But, he also observed that
the preponderant standard does not permit recovery based upon the reasonable-sounding nature
of a particular theory. Id. It is well-established that the Vaccine Act does not require medical or
scientific certainty to establish causation, but a theory posited must be, nonetheless, “sound and
reliable.” Boatman v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019)
(quoting Knudsen by Knudsen v. Sec’y of Dep’t of Health & Human Servs., 35 F.3d 543, 548-49
(Fed. Cir. 1994)). In this case, the record evidence shows that the special master conducted his
analysis of Althen Prong One consistent with this standard. And so, the Court concludes that the
special master did not err in applying the law in this case. May 12, 2020, Decision at 25.

          The record evidence also shows that the special master reasonably considered and
weighed the opinions of Dr. Bellanti—and the scientific evidence—in determining that Dr.
Temes failed to meet his burden of proof under Althen Prong One. The Court will not disturb the
special master’s findings regarding the probative value of this evidence in this case, so long as
those findings are “supported by substantial evidence.” Doe, 601 F.3d at 1355.

                 1.      The Special Master Reasonably Weighed The
                         Expert Opinions And Evidence Regarding Epigenetics

          First, the substantial evidence in the record supports the special master’s determination
that Dr. Bellanti’s expert opinions regarding epigenetics were not adequately supported to meet
the requirements under Althen Prong One. In the May 12, 2020, Decision, the special master
found that Dr. Bellanti made certain assumptions about the interplay between a vaccination and

                                                                                                      17
changes in the genes responsible for cryoglobulin production (i.e. epigenetics) “that the evidence
does not support.” May 12, 2020, Decision at 25. Specifically, the special master observed that
Dr. Bellanti failed to: (1) “identify the genes responsible for cryoglobulin production[;]” (2)
“discuss which vaccine components could trigger or silence gene expression[;]” or (3) “offer
persuasive evidence showing that any vaccines, the specific [vaccines] at issue, or even the wild
virus or bacterial antigens underlying those vaccines have [the] capacity[]” to cause
cryoglobulinemia. Id. The special master also observed that Dr. Bellanti did not provide any
medical literature to support his views related to epigenetics. Id. And so, the special master
found Dr. Bellanti’s opinions related to the interplay of epigenetics and vaccination to be
unpersuasive. Id. at 25, 28.

       The special master’s decision to afford limited weight to Dr. Bellanti’s opinions
regarding epigenetics is supported by the substantial evidence. As the special master correctly
observes in the May 12, 2020, Decision, Dr. Bellanti failed to address which vaccine was
capable of stimulating genetic changes in this case; which vaccine components were responsible
for stimulating genetic changes; or which gene or genes were the target of these changes, during
the proceedings before the special master. See generally Pet’r Exs. 20, 52; Tr. 51:8-104:12. In
fact, as the special master also correctly observes, Dr. Bellanti failed to provide any evidentiary
support for the epigenetics portion of his causation theory. See May 12, 2020, Decision at 25;
see also id. A careful reading of the articles that Dr. Bellanti submitted with his expert reports
also reveals that none of these articles address epigenetics in relation to vaccines. See generally
Catsoulis; Fox; Iyngkaran; Lohse; Monjazeb; Raison-Peyron; Tavadia. Given this evidence, the
special master’s determination that Dr. Bellanti’s opinions regarding epigenetics were not
adequately supported is substantiated by the substantial evidence in this case.

               2.      The Special Master Reasonably Weighed The Evidence
                       Regarding Molecular Mimicry And Bystander Activation

       The substantial evidence also supports the special master’s determinations about the
probative value of Dr. Bellanti’s opinions regarding molecular mimicry and bystander activation.

       In the May 12, 2020, Decision, the special master found that Dr. Bellanti’s testimony
regarding how a single dose of the flu and/or Prevnar 13 vaccines could result in chronic
cryoglobulinemia to be “scientifically unreliable.” May 12, 2020, Decision at 27. Specifically,

                                                                                                     18
with regards to Dr. Bellanti’s opinions related to molecular mimicry, the special master found
that Dr. Bellanti did not support his views “beyond conclusory statements.” Id. The special
master also observed that Dr. Bellanti failed to provide any “reliable literature” to demonstrate
that the flu and/or Prevnar 13 vaccines “can trigger [molecular mimicry to] caus[e] persistent
cryoglobulinemia.” Id. With regards to Dr. Bellanti’s opinions on bystander activation, the
special master similarly found that “Dr. Bellanti did not substantiate his contention with either
independent literature or his own personal experience and research to show that
cryoglobulinemia is known to become chronic in this manner.” Id. at 28. And so, the special
master concluded that Dr. Bellanti’s opinions related to molecular mimicry and bystander
activation did not meet the preponderant standard under Althen Prong One.

       Again, the special master’s conclusions regarding the probative value of this evidence are
supported by the substantial evidence. The record evidence shows that Dr. Bellanti did not
provide any support—by way of medical literature or otherwise—for his opinion that either
molecular mimicry or bystander activation played a role in Dr. Temes’ case. See generally Pet’r
Exs. 20, 52; Tr. 51:8-104:12. Notably, Dr. Bellanti responded to a question from the special
master about how Dr. Temes’ cryoglobulinemia became chronic, by simply stating that “all I can
say is that I believe these bystander effects are the cause of perpetuating[ Dr. Temes’
condition].” Tr. 101:19-101:20. Given this evidence, the special master reasonably concluded
that Dr. Bellanti’s opinions regarding molecular mimicry and bystander activation should be
afforded limited weight.

               3.      The Special Master Reasonably Weighed
                       The Evidence Regarding Hyperimmunization

       The special master’s findings regarding the probative value of the Catsoulis article and
the issue of hyperimmunization were also reasonable in light of the record evidence in this case.
In the May 12, 2020, Decision, the special master found that Dr. Temes failed to provide
evidence that a single dose of the Prevnar 13 vaccine or flu vaccine could trigger
cryoglobulinemia. May 12, 2020, Decision at 26. In making this finding, the special master
observed that Dr. Temes received just a single dose of the Prevnar 13 and flu vaccines before the
onset of his symptoms. Id. Given this, the special master concluded that the “probative value”
of the Catsoulis article was limited, because the study in that article involved hyperimmunized

                                                                                                    19
rabbits that experienced cryoglobulinemia after approximately three to four months of repeatedly
receiving the pneumococcal vaccine. Id. at 25-26.

       The special master’s conclusion that the Catsoulis article has limited probative value in
this case is supported by the substantial evidence. As the special master correctly observes in the
May 12, 2020, Decision, the Catsoulis article is distinguishable from this case, because the
rabbits in Catsoulis were vaccinated with the pneumococcal vaccine every three days until they
developed cryoglobulinemia—which usually occurred after approximately three to four months
of repeated vaccinations. Catsoulis at 327. In contrast, it is undisputed that Dr. Temes received
a single dose of the Prevnar 13 and flu vaccines prior to the onset of his symptoms. See Pet’r Ex.
8. Given this, the special master’s determinations regarding the probative value of the Catsoulis
article and the issue of hyperimmunization were reasonable.

               4.      The Special Master Reasonably Considered Petitioner’s Case Reports

       Dr. Temes’ argument that the special master failed to adequately consider the case reports
that he submitted in this case is also unavailing. In his motion for review, Dr. Temes argues that
the special master erred, because “Dr. Bellanti’s theory of causation was certainly supported by
case reports.” Pet’r Mot. for Rev. at 13. As Dr. Temes correctly observes in his motion for
review, Dr. Bellanti submitted numerous case reports documenting either cryoglobulinemia or
forms of vasculitis following the administration of the flu or pneumococcal vaccines. See, e.g.,
Catsoulis; Tavadia; Iyngkaran; Monjazeb (documenting cases of vasculitis following flu
vaccination); Fox (documenting a case of leukocytoclastic vasculitis following pneumococcal
vaccination); Raison-Peyron (documenting cases of cold contact urticaria following flu
vaccination); Lohse (documenting a case of vascular purpura and cryoglobulinemia following flu
vaccination); Callen (a case report documenting Dr. Temes’ clinical course). But, the record
evidence also makes clear that the special master adequately considered these case reports and
reasonably determined that the reports were not probative evidence to show causation in this
case. May 12, 2020, Decision at 26.

       Notably, the special master correctly observes in the May 12, 2020, Decision that none of
the case reports that document leukocytoclastic vasculitis, or other forms of vasculitis, espouse a
causal connection between such diseases and the flu vaccine. Id. at 26; see, e.g., Lohse at 359
(noting that “in none of the reported cases [discussed in the article] was proof of a causal link

                                                                                                    20
with the [flu] vaccine obtained.”); Monjazeb at 341 (“The temporal nature of these cases of
vasculitis following vaccination suggests an immunopathogenic link that has yet to be
explained.”). The special master also correctly observes in his decision that, with the exception
of the Lohse case report, none of the submitted case reports involve an individual who developed
vasculitis after first suffering from cryoglobulinemia—which is what occurred to Dr. Temes in
this case. May 12, 2020, Decision at 26-27. In fact, the record evidence makes clear that Dr.
Temes did not show how these case reports—which mostly do not involve patients that are
similar to him in either demographic characteristics or symptom development—are analogous to
his own experience during the proceedings before the special master. And so, the special master
reasonably concluded that the case reports were insufficient to meet Dr. Temes’ burden under
Althen Prong One. Id. at 26-27.

               5.      The Special Master Reasonably Weighed The
                       Opinions Of Petitioner’s Treating Physician Opinions

       Lastly, the special master’s determinations regarding the probative value of the opinions
of Dr. Temes’ treating physicians were also reasonable and supported by the substantial evidence
in this case. Dr. Temes argues in his motion for review that the special master erred, because the
opinions of his treating physicians support a finding that he met his burden under the Althen
Prong One. Pet’r Mot. for Rev. at 17. But, again, the record evidence shows that the special
master appropriately weighed this evidence and reasonably concluded that the treating physician
evidence was not sufficient to meet Dr. Temes’ burden of proof.

       Specifically, in the May 12, 2020, Decision, the special master acknowledges that the
medical records “contain some favorable evidence” by way of “statements made by several of
Dr. Temes’[] treating physicians in which they expressed the opinion that his cryoglobulinemia
was the result of the vaccinations he received.” May 12, 2020, Decision at 28-29. The record
evidence also shows that all of Dr. Temes’ treating physicians concluded that Dr. Temes was
likely experiencing mixed cryoglobulinemia as the result of receiving the flu vaccine. See Pet’r
Ex. 1 at 20-21; Pet’r Ex. 2 at 2, 9; Pet’r Ex. 16 at 277; Pet’r Ex. 50 at 1. While there is no
dispute that Dr. Temes’ treating physicians agree that he is experiencing cryoglobulinemia as a
result of the flu vaccine, the special master decided to afford limited weight to these opinions,
because the opinions “relied too much on the obvious temporal relationship between vaccination
and injury[.]” May 12, 2020, Decision at 29.

                                                                                                    21
       The special master’s decision to afford limited weight to the views of Dr. Temes’ treating
physicians is supported by the substantial evidence. A careful review of the medical records
shows that the opinions of Dr. Temes’ treating physicians are based in large part upon the
temporal association between the date of his vaccinations and the onset of symptoms—
approximately five to seven days later. For example, one of Dr. Temes’ treating physicians, Dr.
Callen, observes in his medical notes that Dr. Temes developed symptoms of cryoglobulinemia
“[five] days after his flu shot.” Pet’r Ex. 2 at 9. The record evidence also shows that none of Dr.
Temes’ treating physicians espoused a causation theory to explain how the flu vaccine caused
Dr. Temes’ symptoms. See, e.g., id.; Pet’r Ex. 16 at 277; Pet’r Ex. 19 at 14, 17. In fact, Dr.
Callen acknowledges in his case report documenting Dr. Temes’ clinical course that “a causal
link with the [flu] vaccination cannot be proved by our observation[.]” Callen at 962; see also
Pet’r Ex. 16 at 16 (Dr. Huber noting that “[i]t was suspected that [Dr. Temes] had developed a
cryoglobulinemia induced by the [flu] vaccine[]” without providing a basis for that opinion,
aside from the timeline of Dr. Temes’ symptom development and subsequent laboratory testing).

       As the special master also correctly observes in the May 12, 2020, Decision, there is
other evidence in the record that contradicts the opinions of Dr. Temes’ treating physicians.
Specifically, none of the medical literature submitted in this case supports finding a causal
relationship between the flu and/or Prevnar 13 vaccines and cryoglobulinemia. See generally
Catsoulis; Fox; Iyngkaran; Lohse; Monjazeb; Raison-Peyron; Tavadia. In addition, as discussed
above, Dr. Bellanti did not substantiate his theory of causation with other scientific evidence
during the proceedings before the special master. May 12, 2020, Decision at 25-28. Given this,
the special master reasonably decided to afford limited weight to the opinions of Dr. Temes’
treating physicians. See Snyder ex rel. Snyder, 88 Fed. Cl. at 745 n.67.
       Because the evidentiary record makes clear that the special master appropriately
considered and weighed the expert opinions and reports of Dr. Bellanti—as well as the other
evidence submitted by both parties—in analyzing this case under Althen Prong One, Dr. Temes
has not shown that the special master erred by concluding that Dr. Temes failed to satisfy Althen
Prong One.

                                                                                                  22
       B.      The Special Master Reasonably Concluded
               That Dr. Temes Did Not Satisfy Althen Prong Two

       The record evidence also makes clear that the special master reasonably determined that
Dr. Temes failed to satisfy Althen Prong Two. In his motion for review, Dr. Temes argues that
the special master incorrectly focused his Althen Prong Two analysis on evidence that Dr. Temes
submitted under Althen Prong One. Pet’r Mot. for Rev. at 17. In this regard, Dr. Temes
correctly observes that the special master began his Althen Prong Two analysis by considering
the evidentiary concerns with Dr. Temes’ arguments regarding the theory of causation in this
case. May 12, 2020, Decision at 29 (noting that “none of the literature filed in this matter
supported a causal relationship between vaccination and the subsequent development of
cryoglobulinemia.”). But, the special master did not err in doing so, as Dr. Temes suggests.

       The Federal Circuit has long held that there is “no reason why evidence used to satisfy
one of the Althen . . . prongs cannot overlap to satisfy another prong.” Capizzano, 440 F.3d at
1326. And so, in this case, the special master appropriately considered the lack of evidentiary
support for Dr. Temes’ theory of causation to analyze whether there was sufficient evidence to
establish a logical sequence of a cause and effect showing that the vaccines at issue were the
reason for the Dr. Temes’ injury. May 12, 2020, Decision at 28-29.

       Dr. Temes also argues without persuasion that the special master erred in finding that the
treating physician evidence in this case failed to satisfy Althen Prong Two. Pet’r Mot. for Rev. at
22. As the special master correctly states in the May 12, 2020, Decision, special masters are not
bound by the opinions of treating physicians when there is conflicting evidence in the record.
Snyder ex rel. Snyder, 88 Fed. Cl. at 745 n.67 (citing Andreu ex rel. Andreu, 569 F.3d at 1375)
(stating that “there is nothing . . . that mandates that the testimony of a treating physician is
sacrosanct—that it must be accepted in its entirety and cannot be rebutted.”). As discussed
above, the special master found the views of the treating physicians in this case to be in stark
contrast with the submitted medical literature, which does not establish a definitive causal
relationship between the flu vaccine and cryoglobulinemia. May 12, 2020, Decision at 29. And
so, the special master reasonably concluded that the views of Dr. Temes’ treating physicians
were not sufficient to meet petitioner’s burden under Althen Prong Two. Id. at 30.

                                                                                                    23
        C.      The Special Master Reasonably Concluded That
                Petitioner Failed To Establish A Medically Acceptable Timeframe

        As a final matter, the record evidence also shows that the special master reasonably
concluded that Dr. Temes had not established a medically acceptable timeframe for the onset of
his symptoms. In his motion for review, Dr. Temes argues that the special master erred, because
the “record clearly shows that all treaters and Dr. Bellanti support the temporal association
between the October 19, 2015[,] vaccinations and the onset of Dr. Temes’ cryoglobulinemia as
being medically appropriate.” Pet’r Mot. for Rev. at 19-20. But, as the special master observes
in the May 12, 2020, Decision, Dr. Temes failed to establish what a medically acceptable onset
timeframe would be based upon his causation theory in this case. See May 12, 2020, Decision at
30. In fact, Dr. Temes did not put forward any evidence to show that the onset of his
symptoms—five to seven days after receiving the vaccinations—was medically acceptable,
during the proceedings before the special master. See generally Pet’r Exs. 20, 52.

        Rather, the evidence regarding the expected onset of cryoglobulinemia symptoms
contradicts Dr. Temes’ theory in this case. Notably, the Secretary’s expert, Dr. Schroeder,
testified that it takes up to three to four weeks after receiving a vaccination for the body to
produce enough IgM antibody to induce cryoglobulinemia. Tr. 116:19-117:17. Dr. Temes did
not rebut this testimony during the proceedings before the special master. See Pet’r Ex. 52 at 3
(failing to provide a detailed discussion of what an appropriate temporal relationship would be
under petitioner’s theory beyond noting that the onset that occurred in this case was appropriate).
Given this, the special master special master reasonably concluded that Dr. Temes failed to
satisfy his burden to establish a medically acceptable timeframe for the onset of his symptoms in
this case.

V.      CONCLUSION

        In sum, the evidentiary record in this Vaccine Act case shows that the special master did
not abuse his discretion, or act contrary to law, in finding that petitioner failed to establish that
the flu and/or Prevnar 13 vaccines can cause, or did in fact cause, his cryoglobulinemia. While
petitioner understandably disagrees with the special master’s May 12, 2020, Decision,
petitioner’s objection to the decision is, at bottom, a disagreement about the probative value of
the evidence submitted in this case. Because the record evidence shows that the special master

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considered relevant evidence—and that the special master’s determinations regarding the
probative value of that evidence are supported by substantial evidence—the Court will not
substitute its judgment for that of the special master.

       And so, for the forgoing reasons, the Court:

       1. DENIES petitioner’s motion for review of the special master’s May 12, 2020,
             Decision; and

       2. SUSTAINS the decision of the special master.

       The Clerk shall enter judgment accordingly.

       Some of the information contained in this Memorandum Opinion and Order may be
considered privileged, confidential or sensitive personally-identifiable information that should be
protected from disclosure. And so, this Memorandum Opinion and Order shall be FILED
UNDER SEAL. The parties shall review the Memorandum Opinion and Order to determine
whether, in their view, any information should be redacted prior to publication. The parties shall
also FILE, by December 1, 2020, a joint status report identifying the information, if any, that
they contend should be redacted, together with an explanation of the basis for each proposed
redaction.

       IT IS SO ORDERED.

                                                    s/Lydia Kay Griggsby
                                                    LYDIA KAY GRIGGSBY
                                                    Judge

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