VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_15-vv-00051
Package ID: USCOURTS-cofc-1_15-vv-00051
Petitioner: Douglas Tullio
Filed: 2015-01-20
Decided: 2019-12-19
Vaccine: influenza
Vaccination date: 2012-09-29
Condition: rheumatoid arthritis
Outcome: denied
Award amount USD: 

AI-assisted case summary:
Douglas Tullio, a 69-year-old man, received a high-dose influenza vaccine on September 29, 2012. Approximately one week later, he began experiencing pain and weakness in his legs, which progressed to diffuse body pain. Initially, Guillain-Barré syndrome (GBS) was considered, and he was treated for it, but his condition did not improve significantly. A second opinion suggested he see a rheumatologist. He was eventually diagnosed with seronegative rheumatoid arthritis (RA) by Dr. Sheri Hsu. Mr. Tullio filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging the flu vaccine caused his RA. The case proceeded as an off-Table claim, meaning he had to prove causation. The court considered expert testimony and scientific literature regarding potential causal links, including epidemiology and the theory of molecular mimicry. The Special Master found that Mr. Tullio failed to establish a persuasive medical theory connecting the flu vaccine to his rheumatoid arthritis, noting that epidemiological studies did not show an increased risk of RA after flu vaccination and that the mechanistic evidence was insufficient. The court also found that Mr. Tullio did not establish a logical sequence of cause and effect. Although the temporal relationship between vaccination and symptom onset was within an acceptable window, the lack of a proven causal theory led to the denial of compensation. The decision was later reviewed by a judge, who upheld the Special Master's findings, concluding that the Special Master's decision was not arbitrary or capricious.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_15-vv-00051-0
Date issued/filed: 2020-01-14
Pages: 47
Docket text: PUBLIC DECISION (Originally filed: 12/19/2019) regarding 131 DECISION of Special Master. Signed by Special Master Christian J. Moran. (hh) Service on parties made.
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Case 1:15-vv-00051-MBH Document 132 Filed 01/14/20 Page 1 of 47
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * *
DOUGLAS TULLIO, * No. 15-51V
* Special Master Christian J. Moran
Petitioner, *
v. * Filed: December 19, 2019
*
SECRETARY OF HEALTH * Entitlement; flu vaccine; rheumatoid
AND HUMAN SERVICES, * arthritis; epidemiology; testability of
* molecular mimicry; tetramers
Respondent. *
* * * * * * * * * * * * * * * * * * * * *
Danielle Anne Strait, Maglio, Christopher & Toale (WA), Seattle, WA, for
petitioner;
Lisa Ann Watts, United States Dep’t of Justice, Washington, DC, for respondent.
PUBLISHED DECISION DENYING COMPENSATION1
Douglas Tullio claims that a flu vaccine he received on September 29, 2012,
caused him to develop rheumatoid arthritis (“RA”). He now seeks compensation
for his injuries under the Vaccine Act. The Act requires petitioners to provide
preponderant evidence that the vaccination caused the injuries they allege before
compensation can be awarded. Because the undersigned finds that Mr. Tullio has
not met this bar, Mr. Tullio is not entitled to compensation.
1 Because this decision contains a reasoned explanation for the action in this case, the
undersigned is required to post it on the United States Court of Federal Claims' website in
accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal
Management and Promotion of Electronic Government Services). This means the decision will
be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the
parties have 14 days to identify and move to redact medical or other information, the disclosure
of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned
agrees that the identified material fits within this definition, the undersigned will redact such
material before posting the decision.

Case 1:15-vv-00051-MBH Document 132 Filed 01/14/20 Page 2 of 47
I. Facts
A. Events in Mr. Tullio’s Life2
Until recently, Mr. Tullio has enjoyed a life of good health. At the time of
the vaccination in question, Mr. Tullio was 69 years old and was working nearly
full-time as the managing partner of a business owned with his wife. Tr. 13-14.
Mr. Tullio describes himself as living an active life and playing golf 2-3 times a
week prior to the onset of his rheumatoid arthritis. Tr. 12-13.
Mr. Tullio received a high-dose fluzone influenza vaccine on September 29,
2012. Exhibit 1. Approximately a week after the vaccination, Mr. Tullio began
“not moving real well” and began feeling a lot of pain in his lower legs and knees.
Tr. 15.
Mr. Tullio saw Dr. John Samples, an internist, twice in October 2012. At
the first visit, he complained that his legs had lately “[felt] weaker.” Exhibit 16 at
69 (October 12, 2012).3 At the time, Mr. Tullio ascribed the pain to a change in
dosage of his heart medication. Id.; see also Tr. 17-20, 35-37, 237, 415-17. Mr.
Tullio visited Dr. Samples again 13 days later, on October 25, 2012. This visit was
scheduled as a “urgent overbooked visit,” with Mr. Tullio complaining of “diffuse
body pain” that had been worse since the previous visit. Exhibit 16 at 62; see also
Tr. 20-21, 290. Bloodwork found high levels of C-reactive protein (“CRP”), a
marker for inflammation. Exhibit 6 at 246; see also Tr. 195, 198, 417-19.
Mr. Tullio continued to complain to multiple providers of pain and
weakness in his legs in November and December 2012. Exhibit 16 at 55; exhibit 3
at 20-21, 74; exhibit 4 at 7-9. During these visits, Guillain-Barré syndrome
(“GBS”) was considered as a possible diagnosis and Mr. Tullio was referred to a
neurologist, Dr. Brignoni. Exhibit 11 at 14. Also, during these visits, Mr. Tullio
ascribed the onset of his symptoms to his September 29, 2012 flu shot. Exhibit 3
at 7.
2 The facts of Mr. Tullio’s case are relatively straightforward and not in dispute.
3 The purpose of this visit was to establish care. The note that the visit was to establish
care was consistent with Mr. Tullio having recently moved to the Palm Springs area and
testimony by Dr. Utz that when a visit to establish care is made, it is often scheduled sooner than
other non-urgent visits may otherwise be scheduled. Tr. 235, 288.
2

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On December 4, 2012, he visited with neurologist Dr. Catherine Brignoni.
At this visit, he provided a chief complaint of “Possible GBS, diffuse weakness
and paresthesia after a flu vaccine.” Exhibit 11 at 14; see also Tr. 23-24. Mr.
Tullio had an abnormal neurological exam, with weakness, diminished reflexes,
and decreased sensation. Exhibit 11 at 15. Based on those observations and the
results of a nerve conduction study (“NCS”), Dr. Brignoni started Mr. Tullio on
treatment for GBS and ordered a cerebrospinal fluid (“CSF”) test to assist in the
diagnosis.
The results of the CSF test were very abnormal, showing a white blood cell
count of 2070 compared to a reference range of 0-5. Based on these results in
combination with other testing, Dr. Brignoni diagnosed Mr. Tullio with acute GBS
and ascribed the flu vaccine as the cause. Exhibit 16 at 48-51.
From mid-December 2012 to mid-January 2013, Mr. Tullio was treated
based on the diagnosis of GBS. However, his treatment was not very effective.
Mr. Tullio reported that the plasmapheresis treatments were providing “trace
minimal improvement in the pain” and that only epidurals provided relief. Exhibit
16 at 41; see also Tr. 25. Mr. Tullio described at the hearing how the uncertainty
regarding his diagnosis and the possibility that he had a proper GBS diagnosis
caused him substantial anxiety. Tr. 26.
In light of this uncertainty, Mr. Tullio arranged for a second opinion from
UCLA neurology, see Tr. 26, and was seen at UCLA on January 18, 2013, by Dr.
Shieh. See exhibit 17 at 10. At this visit, Mr. Tullio’s neurological workup was
nearly normal with the exception of his ankle reflexes. Id. at 11. Dr. Shieh
concluded that Mr. Tullio’s symptoms were not consistent with GBS and that the
CSF analysis was likely spurious. Id.; see also Tr. 314 (indicating the results of the
CSF analysis were not consistent with GBS). Dr. Shieh ordered a second CSF test,
and indeed the results of this test were normal. At that time, Dr. Shieh
recommended that Mr. Tullio see a rheumatologist for further evaluation. Exhibit
17 at 19; see also Tr. 26-27.
Mr. Tullio first saw the rheumatologist, Dr. Sheri Hsu, toward the end of
January 2013. Exhibit 4 at 11-15. Dr. Hsu was not immediately able to diagnosis
Mr. Tullio’s condition and expressed early concern that Mr. Tullio had a “pain
syndrome associated with his flu vaccine.” Id. at 14. Laboratory testing identified
elevated CRP and erythrocyte sedimentation rate (“ESR”), but returned normal
results for other inflammatory markers including cyclic citrullinated peptides
(“CCP”). Exhibit 6 at 20-32. Notably, Mr. Tullio was not suffering from joint
swelling (synovitis) at the time of the first visit. Id.; Tr. 27-28. Instead, his
symptoms were defined by joint pain (arthralgias).
3

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In February 2013, Mr. Tullio returned to Dr. Hsu, this time complaining of
joint swelling. Exhibit 4 at 23. Dr. Hsu now focused on the RA diagnosis. Id.; see
also Tr. 419. Further testing showed that Mr. Tullio was responding well to
prednisone, a steroid, and methotrexate, an immune system suppressant. Exhibit
10 at 13. He additionally was no longer showing elevated levels of CRP and ESR.
Exhibit 6 at 17, 19.
Mr. Tullio continues to see Dr. Hsu to this day. Tr. 28. He reports that his
RA is well-managed on various medications. Tr. 29-30. Mr. Tullio reports that he
continues to experience pain and swelling in his hands and wrists. Tr. 32.
Characteristically, he reports the symptoms are worst in the morning and when he
experiences flare-ups. Tr. 33, 40. Otherwise, Mr. Tullio reports that he is doing
well and is still able to live an active and fulfilling life. Tr. 40.
B. Mr. Tullio’s Illness: Rheumatoid Arthritis
Rheumatoid arthritis is ubiquitous. Its commonness distinguishes it from
most injuries that are claimed to be the result of vaccination in this Program. At
any given time, RA affects approximately one percent of the population. Exhibit
25 at 7; Tr. 63, 400, 631. However, the lifetime risk of RA is much higher.
Approximately 1 in 59 males in the American population will be diagnosed with
RA in his lifetime. Tr. 414, relying upon exhibit O (Crowson); Tr. 676.4
The underlying cause (or causes) of RA is (or are) unknown. Tr. 68, 219,
285, 401, 406, 508. There are known risk factors for the disease, including age,
female sex, genetics, and smoking. Tr. 69. The disease itself presents as an
autoimmune reaction wherein the body attacks its own tissue, specifically the
synovium—the membrane that lines the body’s joints.
The cellular components that are the target for the immune system’s attack
in RA are thought to be collagen, fibrinogen, enolase, and vimentin. Exhibit 40 at
8 (citing Trouw, exhibit 48); Tr. 94, 365. Each of these proteins is sometimes
modified by process known as citrullination. See Olson v. Sec'y of Health &
Human Servs., No. 13-439V, 2017 WL 3624085, at *5 (Fed. Cl. Spec. Mstr. July
14, 2017), mot. for rev. denied, 135 Fed. Cl. 670, 677 (2017), aff'd, 758 F. App'x
919 (Fed. Cir. 2018). Citrullination is the process of modifying the amino acid
arginine to a citrulline. One important feature of this modification is that a class of
antibodies, anti-citrullinated protein antibodies (“ACPA”), will attack proteins that
4 The bibliographic information for articles this decision cites can be found in the
appendix.
4

Case 1:15-vv-00051-MBH Document 132 Filed 01/14/20 Page 5 of 47
have been citrullinated. The presence of ACPA is a key indicator for RA and it
marks not only a diagnostic indicator of the disease but is thought to underlie the
pathology of the disease as well. When ACPAs are present in the blood of an RA
patient, the patients are classified as seropositive RA. Tr. 366, relying upon Trouw.
However, some people with rheumatoid arthritis do not have anti-
citrullinated protein antibodies or rheumatoid factor. Tr. 204; exhibit PP, tab 3
(Malmström). These people are classified as having seronegative RA.5 Scientists
know less about seronegative rheumatoid arthritis because, in part, these patients
are rare, making studies about them more difficult. Tr. 64-66, 404.
Regardless of the self-antigen attacked in rheumatoid arthritis, researchers
generally believe that T cells damage the synovium. Tr. 95, 105-06, 509. While
researchers have not determined why the T cells of some people turn against their
host, researchers have discovered that rheumatoid arthritis is more common in
people with a set of genes known as HLA-DR4.
The gene HLA-DR4 encodes a series of proteins that comprise part of the
major histocompatibility complex, typically abbreviated “MHC.” Tr. 113, 252.
MHC is a molecule that is expressed on the outside of an antigen presenting cell,
typically abbreviated “APC.” Tr. 111. A purpose of the MHC is to chop a larger
antigen into small pieces that it presents to a T cell. Tr. 111, 315. The process of
antigen presentation is discussed further in the context of molecular mimicry. See
section IV.B, below.
II. Procedural History
Mr. Tullio filed his petition on January 20, 2015. He periodically filed
medical records and then filed a statement of completion on April 7, 2015. The
Secretary evaluated this evidence and recommended that compensation be denied.
Resp’t’s Rep., filed June 17, 2015.
The parties then filed a series of reports from a total of four experts. Mr.
Tullio filed the first report, from Paul Utz, on February 29, 2016. Exhibit 25. Mr.
Tullio filed supplemental reports from Dr. Utz as exhibit 58 and exhibit 63. These
5 Mr. Tullio has seronegative RA. Exhibit 4 at 55 (listing diagnosis as “seronegative
RA”); exhibit 10 at 13 (describing Mr. Tullio as a “70 year old male with seronegative
arthritis”); exhibit 25 at 6 (“[Mr. Tullio’s] intake diagnosis was listed as ‘seronegative RA.’”);
Tr. 67.
5

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supplemental reports primarily responded to opinions that the Secretary’s expert,
Mehrdad Matloubian, presented in reports filed as exhibits E, PP, and SS.
Although Dr. Utz and Dr. Matloubian served as the primary experts, each
party retained a second expert. Mr. Tullio submitted a report from Dr. Steinman as
exhibit 40. The Secretary filed reports from Dr. Halsey as exhibits RR and TT.
As the process for obtaining expert reports appeared to be winding down, the
parties scheduled the case for a hearing from August 21 to August 23, 2018. In
anticipation of the hearing, the undersigned issued an order for submitting more
material, including briefs, before the hearing. Order, issued January 26, 2018. The
hearing could not happen in August 2018, because an expert developed an
unavoidable conflict. See Mot. to Amend Schedule, filed May 9, 2018; order,
issued May 14, 2018. The hearing was instead held on March 6-8, 2019, in San
Francisco, California.
Before the hearing and in accord with the January 26, 2018 order, Mr. Tullio
submitted a brief on January 4, 2019. However, Mr. Tullio’s brief did not
persuasively advocate his case, and he was instructed to file an amended brief.
Order, issued January 22, 2019. Mr. Tullio filed an amended and improved brief
on January 28, 2019. The Secretary filed a prehearing brief on February 19, 2019.
In addition to his brief, Mr. Tullio also sought access to the hearing
transcript from an assertedly similar case, Parker, No. 14-979V. In Parker,
petitioner alleged that the flu vaccine caused rheumatoid arthritis, and the experts
were Dr. Utz and Dr. Matloubian. The parties in the present case differed as to
whether a special master possessed the authority to order the release of a transcript
in one case to a petitioner in another case. See Pet’r’s Suppl. Br., filed February
15, 2019; Resp’t’s Resp., filed February 22, 2019. The parties further argued their
positions during the February 25, 2019 pre-trial conference. Ultimately, the
undersigned accepted the argument from the Secretary that the Vaccine Act
prevented special masters from ordering the release of a transcript to nonparties
without the consent of both parties. Order, issued Feb. 26, 2019, at 4, citing 42
U.S.C. § 300aa-12(d)(4)(A).
During the pre-trial conference, the undersigned also consulted the parties
about a proposed division of the three days of trial time. The undersigned
estimated that approximately 18 hours of testimony time was available and
suggested that nine hours should be allotted to Mr. Tullio, six hours allotted to the
Secretary, and three hours allotted to the undersigned. The parties agreed to this
proposal.
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As mentioned above, the hearing took place over three days. All
participants complied with the limits on testimonial time. Because the parties had
presented their arguments in the brief submitted before the hearing, the parties
were not instructed to submit briefs after the hearing. Instead, the case became
ready for adjudication upon delivery of the transcript.
III. Standards for Adjudication
A petitioner is required to establish his case 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). Proof of medical certainty is not required. Bunting v. Sec'y of Health &
Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1379-80
(Fed. Cir. 2009) (reversing special master's decision that petitioners were not
entitled to compensation); see also Lampe v. Sec'y of Health & Human Servs., 219
F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec'y of Health & Human Servs., 9 F.3d
958, 961 (Fed. Cir. 1993) (disagreeing with dissenting judge's contention that the
special master confused preponderance of the evidence with medical certainty).
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).
In this case, Mr. Tullio’s case largely falls for a failure to present a
persuasive medical theory explaining how the flu vaccine “can cause” rheumatoid
arthritis. This issue is extensively discussed in section IV, below. The lack of a
persuasive theory complicates the analysis of the appropriate temporal relationship,
which is prong 3. As explained in section V below, if Mr. Tullio had established
that molecular mimicry were a persuasive theory to explain a causal link between
flu vaccination and rheumatoid arthritis, then Mr. Tullio would have met his
burden regarding timing. But, any gains regarding prong 3 are relatively
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inconsequential as Mr. Tullio also has not established, by preponderant evidence, a
logical sequence of cause and effect. See section VI, below.
IV. Althen Prong 1: Theory
To restate, a petitioner must establish “a medical theory causally connecting
the vaccination and the injury.” Althen, 418 F.3d at 1278. This theory must be
persuasive. Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1356-57
(Fed. Cir. 2019). In assessing a theory, special masters may look for indicia of
reliability. See Moberly, 592 F.3d at 1324.
Evidence relevant to whether the flu vaccine can cause rheumatoid arthritis
falls into two broad categories: epidemiological studies and studies relating to the
molecular mimicry hypothesis. Due to the strength of the epidemiological studies,
these are discussed first in section A. Section B considers the studies the parties
put forward regarding molecular mimicry as a mechanistic theory to explain how
flu vaccination can cause RA. While sections A and B constitute the bulk of the
analysis, the analysis continues for two additional points. Section C highlights the
lack of studies directly testing the hypothesis that flu vaccination can cause RA via
molecular mimicry. Finally, section D comments upon Dr. Utz and Dr. Steinman
as expert witnesses.
A. Epidemiology Exploring Flu Vaccination
and Rheumatoid Arthritis
The topic of epidemiology presents two questions. The first is whether
special masters in the Vaccine Program should consider epidemiological studies?
Because the answer to that question is affirmative as explained in section 1, below,
the second question is what have epidemiological studies concerning the
association between flu vaccination and rheumatoid arthritis found? As discussed
in section 2, multiple epidemiological studies have not detected an increased
incidence of rheumatoid arthritis after flu vaccination or flu infection.
1. The Basis for Considering Epidemiological Studies
A lack of epidemiological studies supporting causation does not bar a
petitioner from receiving compensation. See Althen, 418 F.3d at 1278 (stating
that a petitioner may establish “a persuasive medical theory” through “‘reputable
medical or scientific explanation [,]’ i.e., ‘evidence in the form of scientific studies
or expert medical testimony’”) (quoting Grant v. Sec’y of Health & Human Servs.,
956 F.2d 1144, 1148 (Fed. Cir. 1992)). However, three reasons support
consideration of epidemiological findings when they exist. First and decisively,
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the Federal Circuit has endorsed special masters weighing epidemiological studies
that investigated whether a vaccination is associated with an increased incidence or
worsening of a disease. Second, outside of the Vaccine Program, other legal
authorities have also looked at epidemiological studies in analyzing causation
questions similar to the causation questions posed in the Vaccine Program. Third,
consideration of epidemiological studies is consistent with how researchers and
scientists investigate the difficult question of causation.
a) Vaccine Program Precedents Consider Epidemiological Studies
A review of caselaw from the Vaccine Program starts with opinions from the
Federal Circuit because opinions from that court establish binding precedent. In a
case early in the history of the Vaccine Program, the Federal Circuit determined:
“epidemiological studies are probative medical evidence relevant to causation” and
“considerable weight [is] due to epidemiological studies in the absence of direct
evidence of actual causation.” Grant, 956 F.2d at 1149.
This declaration remains binding because the Federal Circuit has not
overturned Grant in an en banc decision. However, a passage from Althen has led
to arguments that a consideration of epidemiologic studies implicitly and
impermissibly raised the burden of proof. See Althen, 418 F.3d at 1280. Yet, the
Federal Circuit has since rejected those arguments albeit in non-binding opinions.
See McCollum v. Sec'y of Health & Human Servs., 760 F. App'x 1003, 1009 (Fed.
Cir. 2019) (“[T]he special master’s consideration of Duffy [an epidemiologic
study] did not amount to a de facto requirement of epidemiological evidence to
find this prong met.”); D'Tiole v. Sec'y of Health & Human Servs., 726 F. App'x
809, 811 (Fed. Cir. 2018) (“Nothing in Althen or Capizzano requires the Special
Master to ignore probative epidemiological evidence that undermines petitioner’s
theory.”).
In addition to Grant, McCollum, and D’Tiole, the Federal Circuit has ruled
that special masters may weigh epidemiologic evidence. For example, when
determining whether the hepatitis B vaccine can cause multiple sclerosis, the
special master in W.C. analyzed three epidemiologic studies involving (a) 643
subjects, (b) 440 case subjects with 950 controls, and (c) 104 subjects in a double-
blind placebo-controlled study. W.C. v. Sec'y of Health & Human Servs., No. 07-
456V, 2011 WL 4537877, at *14-15 (Fed. Cl. Spec. Mstr. Feb. 22, 2011), mot. for
rev. denied, 100 Fed. Cl. 440 (2011), aff'd, 704 F.3d 1352 (Fed. Cir. 2013). The
special master found that these studies made the petitioner’s causation theory
“extremely unlikely.” Id. at *15. Upon appeal, the Federal Circuit cited those
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three studies and ruled that it “cannot say that the special master’s evaluation of the
expert testimony or weighing of the scientific evidence was arbitrary or
capricious.” W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1361 (Fed.
Cir. 2013).
Finally, the result of many epidemiological studies was one reason, although
not necessarily the primary reason, special masters overseeing the Omnibus
Autism Proceeding rejected the theory that vaccines can cause autism. See, e.g.,
Cedillo v. Sec'y of Health & Human Servs., No. 98–916V, 2009 WL 331968, at
*84-93 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot. for rev. denied, 89 Fed. Cl. 158
(2009), aff'd, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec'y of Health &
Human Servs., No. 03–654V, 2009 WL 332306, at *34–39 (Fed. Cl. Spec. Mstr.
Feb. 12, 2009), mot. for rev. denied, 88 Fed. Cl. 473 (2009), aff'd, 604 F.3d 1343
(Fed. Cir. 2010). Thus, special masters’ consideration of epidemiologic studies has
a long history that the Federal Circuit has endorsed.
b) Persuasive Authorities Outside of the Vaccine Program
Consider Epidemiologic Studies
While much of the procedure in Vaccine Program cases differs from the
procedures in traditional litigation, a critical evidentiary question is similar. State
and federal courts hear cases in which plaintiffs allege an exposure to a toxic
substance caused a harm. The question whether a substance can cause the alleged
harm resembles the question in off-Table Vaccine Program cases about whether a
vaccine can cause the alleged harm.6 The Federal Circuit has recognized this
similarity, stating for off-Table cases: “the petitioner is treated as the equivalent of
the tort plaintiff and the government is treated as the equivalent of the tort
defendant.” Walther v. Sec'y of Health & Human Servs., 485 F.3d 1146, 1151
(Fed. Cir. 2007). Likewise, the Federal Circuit has indicated that causation under
general tort law is useful in determining causation for off-Table Vaccine Program
claims. See Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322-23
(Fed. Cir. 2010); Shyface v. Sec'y, Health & Human Servs., 165 F.3d 1344, 1351
(Fed. Cir. 1999) (“The absence of elaboration of the law of causation in the
legislative history leads us to conclude that the Vaccine Act's requirement of
causation in non-Table cases was not viewed as distinct from causation in the tort
6 For on-Table cases, the analysis is much different because of the statutory presumption
of causation.
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Case 1:15-vv-00051-MBH Document 132 Filed 01/14/20 Page 11 of 47
law.”). Thus, consideration of how courts have considered epidemiologic studies
in analogous settings from tort law is informative.
In cases presenting the question of whether the exposure to some substance
has caused an injury, courts have allowed triers of fact to hear evidence based upon
epidemiologic studies. For a collection of cases, see David L. Faigan et al., 3 Mod.
Sci. Evidence § 23:4. These cases, in turn, are consistent with the guidance of the
Federal Judicial Center. The Federal Judicial Center has published a series of
guides designed “to assist judges . . . in reaching an informed and reasoned
assessment concerning the basis of expert evidence.” Jerome P. Kassirer and
Gladys Kessler, Reference Manual on Scientific Evidence, Preface, (3d ed. 2011).
According to the Federal Judicial Center, “[e]pidemiologic studies have been well
received by courts deciding cases involving toxic substances.” Michael D. Green
et al., Reference Manual on Scientific Evidence, Reference Guide on
Epidemiology, 549 n.2 (3d ed. 2011) (citing cases). “Epidemiologic evidence
identifies agents that are associated with an increased risk of disease in groups of
individuals, quantifies the amount of excess disease that is associated with an
agent, and provides a profile of the type of individual who is likely to contract a
disease after being exposed to an agent.” Id. at 552. The authors of this guide from
the Federal Judicial Center emphasize that “an association is not equivalent to
causation.” Id. “In evaluating epidemiologic evidence, the key questions, then, are
the extent to which a study's limitations compromise its findings and permit
inferences about causation.” Id. at 553.
c) Scientists Consider Epidemiology in Deciding Whether a
Substance Can Cause an Injury
One factor contributing to the reliability of an expert’s opinion is whether
the expert “employs in the courtroom the same level of intellectual rigor that
characterizes the practice of an expert in the relevant field.” Kumho Tire Co. v.
Carmichael, 526 U.S. 137, 152 (1999). Special masters may use this comparison
to evaluate opinion evidence presented in the Vaccine Program. Terran v. Sec'y of
Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999) (permitting special
masters to use Daubert factors); Davis v. Sec'y of Health & Human Servs., 94 Fed.
Cl. 53, 66 (2010) (“[U]niquely in this Circuit, the Daubert factors have been
employed also as an acceptable evidentiary-gauging tool with respect to
persuasiveness of expert testimony already admitted, at least in bench proceedings
conducted by special masters in vaccine cases.”), aff'd without op., 420 F. App'x
973 (Fed. Cir. 2011). But see Andreu v. Sec’y of Health & Human Servs., 569
F.3d 1367, 1379 (Fed. Cir. 2009) (“‘[I]n a field bereft of complete and direct proof
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of how vaccines affect the human body,’ a paucity of medical literature supporting
a particular theory of causation cannot serve as a bar to recovery.”) (quoting
Althen, 418 F.3d at 1280).
Here, the evidence shows that the medical community relies upon
epidemiology. A prominent example comes from Dr. Steinman’s experience. By
way of background, in 1998, to respond to claims that veterans from the Gulf War
incurred various diseases, Congress directed the Secretary of Veterans Affairs to
enter into an agreement with the National Academy of Sciences to “evaluate the
available scientific evidence regarding associations between illnesses and exposure
to toxic agents.” Omnibus Consolidated and Emergency Supplemental
Appropriations Act, 1999, Public Law 105-277, 112 Stat 2681, Section 1603.
Later, Congress further directed the relevant official within the Department of
Veterans Affairs to submit a report to Congress about epidemiological research on
this topic. Veterans Programs Enhancement Act of 1998, Public Law 105-368,
112 Stat 3315, Section 104. As a member of the National Academy of Sciences,
Dr. Steinman reviewed the findings before publication. Exhibit 41 (curriculum
vitae) at 3-4; Tr. 381-82. That report begins with an analysis of epidemiology.
See exhibit 43 at S-3 through S-7.7 Thus, this example demonstrates that the
process for determining whether the government should compensate veterans for
diseases possibly incurred during their service to their country considered
epidemiology.
Like Dr. Steinman, Dr. Utz has used epidemiology in his day-to-day affairs
outside of the courtroom. Dr. Utz led the Medical Scientist Training Program at
Stanford University for ten years. Exhibit 26 (curriculum vitae) at 2; Tr. 46. In
this capacity, Dr. Utz taught students pursuing a joint MD-PhD about the causes of
diseases. Dr. Utz testified that he taught students that epidemiology contributes to
the analysis of causation. Tr. 246.
A third example of how medical researchers use epidemiology in answering
questions about causation comes from Dr. Halsey. Due to his training and
experience, Dr. Halsey was recognized as an expert in the fields of vaccines,
vaccine safety, and epidemiology. Tr. 567. To assist doctors in determining
whether a vaccine adversely affected their patients, Dr. Halsey and colleagues
7 Although the researchers from the National Academy of Sciences attempted to use
epidemiological studies to determine whether veterans experienced higher incidence of various
illnesses, the researchers eventually determined that epidemiological studies were not useful
because they lacked a control group.
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developed an algorithm, which a peer-reviewed journal published. Exhibit QQ, tab
9 (Halsey), at 5794. In presenting to an audience of medical doctors, Dr. Halsey
and colleagues wrote: “Establishing general causation usually requires well-
designed epidemiologic studies demonstrating significantly increased risk of the
[adverse event] following the vaccine compared with unvaccinated individuals,
and/or mechanistic studies such as laboratory investigations implicating the
vaccine in affected individuals.” Id. at 5791.
The opinion that Dr. Halsey and colleagues presented here is similar to a
statement another researcher expressed. In trying to determine how to consider
whether viral vaccines cause autoimmune diseases, Ami Schnatter emphasized the
importance of controlled studies of vaccinated and unvaccinated subjects. Exhibit
EE (Schattner) at 3881-82; see also Tr. 542 (Dr. Matloubian’s testimony about this
article).
Thus, there is ample legal justification for considering epidemiological
studies in determining whether the flu vaccine can cause rheumatoid arthritis. Yet,
both Dr. Utz and Dr. Steinman opined that epidemiologic studies could provide no
information about what happened to Mr. Tullio because Mr. Tullio is a unique or
rare case. Dr. Utz disagreed with the idea that there must first be evidence of an
epidemiologic association between the vaccine and RA, and stated that “Mr. Tullio
unfortunately happens to be a rare person who developed this disorder.” Tr. 243.
Similarly, in Dr. Steinman’s view, a study on a population does not say anything
when the relevant dataset is composed of one person. Tr. 322.
Such opinions are unpersuasive in light of the existing law reviewed above.
According to Dr. Halsey, who possesses greater experience in epidemiology than
Dr. Steinman, Mr. Tullio’s uniqueness would not preclude drawing meaningful
conclusions from epidemiology. Tr. 600-01. As Dr. Halsey pointed out,
epidemiological studies have identified that the risk of developing Guillain-Barré
syndrome after flu vaccination is increased by one case or two cases per million
doses of vaccination. This example refutes a commonly offered argument that
epidemiological studies cannot detect rare events. Id.; see also Tr. 572; exhibit
QQ, tab 19 (Salmon). Finally, as discussed at length above, many cases have
supported weighing the results of epidemiological studies in determining
causation.
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2. Epidemiological Studies Investigating a Possible Association between
Flu Vaccine and Rheumatoid Arthritis Have Not Detected Any
Increased Risk
Through Dr. Halsey and Dr. Matloubian,8 the Secretary presented several
studies. While the details of the studies are set forth below, the bottom-line
conclusion of each study was that researchers did not find a statistically significant
increased risk of rheumatoid arthritis among people who received flu vaccine.
a) Ray
The subjects of this study were approximately one million members in
Kaiser Permanente Northern California from 1997 through 1999. Researchers
conducted two types of analyses, a cohort analysis and a case-control analysis.
Exhibit CC (Ray) at 6593. In a cohort analysis, individuals who are exposed to a
hypothetically causative agent are followed for a period of time to see whether they
develop a particular disease and their rate of disease is then compared to controls
who did not receive the same allegedly causal agent. See Carda on behalf of
G.J.C. v. Sec’y of Health & Human Servs., No. 14-191V, 2017 WL 6887368, at
*11 n.13 (Fed. Cl. Spec. Mstr. Nov. 16, 2017) (citing Reference Manual on
Scientific Evidence 621 (3rd ed. 2001)); Dwyer v. Sec’y of Health & Human
Servs., No. 03-1202V, 2010 WL 892250, at *66 (Fed. Cl. Spec. Mstr. Mar. 12,
2010). In a case-control analysis, researchers examine whether an exposure
increased the risk of a disease by looking retrospectively. Mead v. Sec’y of Health
& Human Servs., No. 03-215V, 2010 WL 892248, at *37 (Fed. Cl. Spec. Mstr.
Mar. 12, 2010).
In Ray, the cohort analysis found a potential increased risk for rheumatoid
arthritis in windows approximately six months and one year after flu vaccination.9
The relevant portion of table 3 presents this information:
8 In general, presentations about epidemiology should come from experts in
epidemiology.
9 Time periods beyond three months may not be relevant because Dr. Utz testified that a
biologically plausible interval between a flu vaccine and the onset of RA was six weeks. Tr.
200; see also Tr. 194 (Dr. Utz: two weeks or three weeks or four weeks is appropriate); Tr. 581
(Dr. Halsey commenting on Dr. Utz’s testimony).
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Exposure Vaccinated Crude R.R. Adjusted 95% CI p
Interval Individuals relative value
(days) with risk
rheumatoid
arthritis (n)
90 19 1.19 0.72 0.45, 1.14 0.16
180 62 2.24 1.36 1.03, 1.80 0.03
365 113 2.31 1.34 1.06, 1.69 0.01
The researchers in Ray then conducted a larger case-control study. The
case-control study showed that the flu vaccination did not increase the odds ratio in
a meaningful way. The relevant portions from table 4 are:
Exposure Exposed Exposed Crude Adjusted 95 CI p value
Interval cases, controls, O.R. O.R. %
(days) n (%) n (%)
90 21 (5.1) 85 (6.8) 0.7 0.7 0.4, 1.2 0.14
180 64 (15.4) 178 1.1 1.1 0.8, 1.6 0.57
(14.3)
365 113 (27.2) 309 1.1 1.1 0.9, 1.5 0.43
(24.8)
730 132 (31.8) 373 1.1 1.1 0.8, 1.4 0.59
(30.0)
The biggest limitation to this study, according to its authors, is that
determining the onset of rheumatoid arthritis is difficult. In addition, despite the
study’s sample size, “if a very small risk of [rheumatoid arthritis] in association
with vaccines does exist, a larger study would be needed to detect it.” Exhibit CC
at 6596.
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b) Bengtsson
In this study, these researchers “aimed to elucidate whether common
vaccinations given to adults were associated with an increased risk of [rheumatoid
arthritis] by using data from a large population-based case-control study on
incident cases of [rheumatoid arthritis].” Exhibit A (Bengtsson) at 1831. The
researchers used the following methodology. After people were diagnosed with
rheumatoid arthritis, researchers gave a questionnaire asking about environmental
exposures. The researchers also sent this questionnaire to a group of controls.
Overall, researchers identified 2,097 cases and 2,770 controls in total. Id. Of this
group, 272 cases received the flu vaccine and they were matched with 259
controls. The odds ratio was 1.1 with a 95% confidence interval of 0.9 to 1.3. Id.
at 1832 (figure 2). According to the authors: “Based on the results of our study
which comprised a large number of [rheumatoid arthritis] cases and controls (the
study has overall sufficient power (>80%) to detect a RR of 1.19), it is unlikely
that vaccinations in general should be considered as a major risk factor for
[rheumatoid arthritis].” Id. at 1833. According to Dr. Halsey, because the odds
ratio was 1.0, there was not even a hint that flu vaccine caused rheumatoid arthritis.
Tr. 581.
c) Bardage
These researchers studied 1.98 million people who lived in Stockholm
county (Sweden) from January 1, 1998, through at least October 1, 2009. The
researchers investigated whether a flu vaccination against H1N1, Pandemrix,
affected the risk of neurological and autoimmune disorders. Exhibit QQ, tab 4
(Bardage), at 2. The researchers looked for incidence of diseases within six weeks
of the vaccination and determined the hazard ratio under two different models. Id.
at 3.
For rheumatoid arthritis, table 2 shows:
Hazard ratio (95% CI)
Model 1 Model 2
All vaccinated 1.03 (0.89 to 1.19) 0.94 (0.81 to 1.09)
≤ 45 days 1.01 (0.86 to 1.20)
1.17 0.99 to 1.38)
> 45 days 0.86 (0.71 to 1.04) 0.84 (0.69 to 1.02)
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Based upon these findings, the researchers concluded the risk for rheumatoid
arthritis was “unchanged.” Id. at 1.
Each of these three studies found that flu vaccination did not increase the
risk of developing rheumatoid arthritis. Dr. Utz and Dr. Steinman acknowledged
as much. Tr. 99, 355.
While these studies directly investigated the precise question at hand, other
studies investigated a slightly different, but still related, question—whether people
who already have rheumatoid arthritis can receive a vaccination effectively and
safely? Tr. 420, 587. These studies did not detect any worsening of a person’s
rheumatoid arthritis after the person received a flu vaccination. Among these
studies, the most meaningful was written by Johanna Westra and others. The
Westra authors reported on six studies addressing the safety of flu vaccination in
patients with rheumatoid arthritis. They wrote: “In most of the latest studies of the
efficacy of influenza vaccination in patients with [rheumatoid arthritis], safety is
considered and yet no significant influence of vaccination on disease activity has
been reported. Also, in pre-post studies after influenza vaccination, patients with
[rheumatoid arthritis] did not experience increased disease activity.”10 Exhibit II
(Westra) at 140; accord Tr. 485 (Dr. Matloubian’s testimony about Westra). As
with the studies on whether flu vaccination can cause rheumatoid arthritis, Dr. Utz
and Dr. Steinman recognized that flu vaccination is not associated with a
worsening of rheumatoid arthritis. Tr. 217 (Dr. Utz); Tr. 364 (Dr. Steinman).
Dr. Halsey testified that a proper conclusion to draw from the epidemiologic
studies is the particular study did not detect an increased risk. Tr. 627. If another
study were done involving say, ten million people, that larger study may find a risk
that smaller studies have not. In other words, epidemiology cannot prove a
negative (meaning, epidemiology cannot establish that flu vaccine cannot cause
rheumatoid arthritis).
However, the Federal Circuit’s endorsement of special masters’
consideration of epidemiological evidence lends weight to the epidemiological
evidence offered here. Of the three most on-point studies, the smallest involved
more than two thousand cases of which 257 involved the flu vaccine plus more
10 Examples of pre and post studies in this record include Saad (exhibit QQ, tab 18)
(1,168 patients with RA) and Gabay (exhibit QQ, tab 7). See Tr. 587-92.
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than two thousand controls of which 297 matched the flu cases (Bengtsson). The
size of Bengtsson is similar in magnitude to the three studies about hepatitis B
vaccine and multiple sclerosis that the Federal Circuit reviewed in W.C. (In W.C.,
the number of participants ranged from 104 subjects to 643 subjects.) But,
Bengtsson was the smallest of the three key studies. The other two were larger by
orders of magnitude: one million people (Ray) and nearly two million people
almost equally divided between subjects and controls (Bardage).
In response to the epidemiology, Dr. Utz and Dr. Steinman had relatively
little to say. One of their arguments—that epidemiology is not relevant to
individual cases—has been rejected for being inconsistent with both law and
medicine. With respect to the specific studies discussed above, Dr. Steinman
added a critique that those studies were not relevant to Mr. Tullio’s situation
because none of those studies involved the exact vaccine that he received. Tr. 355,
363.
This criticism also misses its mark. The premise of Dr. Steinman’s
argument is that flu vaccines differ so greatly from year to year that a study about
one flu vaccine cannot be transferred to people receiving a flu vaccine in a
different year. Exhibit 40 (Dr. Steinman’s report) at 21. Each flu vaccine protects
against three strains of the flu virus and the strains typically change each year.
After Dr. Steinman disclosed this opinion in his report, Dr. Matloubian
tested the degree of difference among various iterations of flu vaccines. Using the
same methodology Dr. Steinman used to determine the degree of homology
between a component of the flu vaccine and a component of joint tissue, which is
discussed more extensively below, Dr. Matloubian found that the flu vaccines
retain at least 90 percent homology across the years. Exhibit PP (Dr. Matloubian’s
report) at 4-7. When asked about this approach, Dr. Steinman did not contest Dr.
Matloubian’s findings. Tr. 388-90.
While in this case Dr. Steinman opined that variations in flu vaccinations are
so great that one year’s flu vaccine is not relevant to analyzing the effects of
another year’s flu vaccine, in another case, Dr. Steinman took the opposite
position. There, the vaccinee developed neurologic symptoms within
approximately 24 hours of receiving a flu vaccination. To explain how a reaction
to the flu vaccination could occur so rapidly, Dr. Steinman relied upon a recall
response to a flu vaccine that the vaccinee had received years earlier. So, in that
case, the different years’ flu vaccinations were sufficiently similar that one could
serve as the recall response for the other. Forrest v. Sec’y of Health & Human
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Servs., No. 14-1046V, 2019 WL 925495, at *4, 6 (Fed. Cl. Spec. Mstr. Jan. 28,
2019); see also Tr. 390.
Thus, in this pair of cases, Dr. Steinman’s opinion as to whether flu vaccines
are similar or are different seemed to shift with the petitioner. When the
petitioner’s case advanced by having the flu vaccines be similar (Forrest), Dr.
Steinman said they are similar. When the petitioner’s case is improved by
differentiating different years’ flu vaccines, as in this case, Dr. Steinman offered an
opinion that the flu vaccines are different. Overall, this inconsistency reduces
confidence in Dr. Steinman’s credibility.
For these reasons, Dr. Steinman’s challenge to the usefulness of
epidemiologic studies not involving the 2015 flu vaccine that Mr. Tullio received
is not persuasive. Instead, the epidemiologic studies are persuasive. As such, the
epidemiological evidence weakens the reliability of opinions that the flu vaccine
can cause rheumatoid arthritis.
Nevertheless, it remains the case that, as Vaccine Program precedent
indicates, epidemiology is not dispositive. See, e.g., McCollum, 760 Fed. App’x at
1009 (noting that a special master may consider epidemiological evidence, but that
a claimant need not produce it). Thus, the evidence relevant to Mr. Tullio’s
hypothesis based upon molecular mimicry is also examined.
B. Molecular Mimicry as a Hypothesis to Explain how the Flu Vaccine
Can Cause Rheumatoid Arthritis
In lieu of epidemiology, Mr. Tullio presents the opinions of Dr. Utz and Dr.
Steinman that the flu vaccine can cause rheumatoid arthritis through a process
known as molecular mimicry. Molecular mimicry is one of the mechanistic
theories that petitioners in the Vaccine Program and their experts offer most
frequently. See, e.g., Forrest, 2019 WL 925495, at *1; Whelan v. Sec’y of Health
& Human Servs., No. 16-1174V, 2019 WL 1061473, at *3 (Fed. Cl. Spec. Mstr.
Jan. 28, 2019); B.A. v. Sec’y of Health & Human Servs., No. 11-51V, 2018 WL
6985218, at *1 (Fed. Cl. Spec. Mstr. Dec. 6, 2018); Morgan v. Sec’y of Health &
Human Servs., No. 12-77V, 2017 WL 6893079, at *6 (Fed. Cl. Spec. Mstr. Dec. 6,
2017); Smith v. Sec’y of Health & Human Servs., No. 08-864V, 2016 WL
2772194, at *19 (Fed. Cl. Spec. Mstr. April 18, 2016); Perez v. Sec’y of Health &
Human Servs., No. 10-659V, 2015 WL 9483680, at *4 (Fed. Cl. Spec. Mstr. Dec.
8, 2015).
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The starting point for understanding molecular mimicry is the immune
system. In response to encountering a foreign antigen (a vaccine), the body’s
immune system attempts to neutralize the antigen. This response proceeds through
a series of steps involving the innate immune system and (sometimes) the adaptive
immune system. The primary actors of the adaptive immune system, which is
implicated in the molecular mimicry hypothesis, are T cells and B cells. When the
adaptive immune system functions normally, the T cells or B cells proliferate,
destroy the antigen, and return to a quiet state. Tr. 76-77.
Unfortunately, in cases of autoimmune diseases, the adaptive immune
system goes awry. The body’s T cells and/or B cells turn against the constituent
host and damage not only the foreign invader but also the body’s own tissues.
Why autoimmune diseases arise is generally not known. However, molecular
mimicry has been suggested to explain the etiology of some autoimmune diseases.
The molecular mimicry hypothesis posits that autoimmune diseases arise
when the structure of the foreign invader resembles (or mimics) the structure of
cells in the body. This similarity confuses the adaptive immune system and leads
antibodies produced by B cells and/or T cells to attack the host, a process
sometimes known as “breaking tolerance.” In rheumatoid arthritis, the portion of
the body that is attacked is the synovium. A constituent part of the synovium is
collagen.
This explanation is the foundation for the theory that Dr. Utz and Dr.
Steinman offer. Dr. Utz presents a series of articles that, according to him, show
that 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. Dr.
Steinman supports Dr. Utz’s position by providing an opinion about the degree of
similarity required to make a cross-reaction possible. On the other hand, Dr.
Matloubian disagrees with both Dr. Utz and Dr. Steinman. Dr. Matloubian
maintains that the articles on which Dr. Utz has relied do not show similarity
between collagen and a portion of the flu vaccine. He also disputes the relevance
of Dr. Steinman’s opinion.
Weighing the relative persuasiveness of the opinions from experts Mr. Tullio
has retained and the expert from the Secretary takes place in the context of how
appellate authorities have considered molecular mimicry. These cases are outlined
in section 1 below. With this background, the evidence related to molecular
mimicry is examined in more detailed in section 2 below.
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1. Considerations of Molecular Mimicry by Appellate Authorities
in the Vaccine Program
Although special masters have often considered molecular mimicry in their
decisions, the number of opinions by appellate authorities on this topic is relatively
few. Of this group, the most important is W.C., a precedential opinion from the
Federal Circuit.
As discussed in the context of epidemiology, the petitioner in W.C. claimed
that the flu vaccine either caused or significantly aggravated his multiple sclerosis.
See W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352 (Fed. Cir. 2016). To
support this claim, the petitioner presented an opinion from a neurologist that
“through the process of molecular mimicry, the influenza vaccine triggered an
immune response which released T-cells that were cross-reactive with myelin. . . .
This induced an immune cascade, resulting in inflammation, demyelination, and
nerve damage characteristic of multiple sclerosis.” Id. at 1360. According to the
Federal Circuit, “The special master found that ‘[m]olecular mimicry is a well-
regarded theory in some contexts,’ . . . but correctly required additional evidence
showing that molecular mimicry can cause the influenza vaccine to significantly
aggravate multiple sclerosis.” Id. (citation omitted).11
The Federal Circuit’s statement that the special master “correctly required
additional evidence” concerning molecular mimicry is consistent with the
reasoning in Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119 (2011),
aff’d without op., 463 F. App’x 932 (Fed. Cir. 2012). In Caves, the petitioner
alleged that the flu vaccine caused her to develop transverse myelitis, and she
offered the theory of molecular mimicry. Id. at 128. In the underlying decision,
the special master found that while “the submitted articles supported the general
theory of molecular mimicry . . . the articles do not provide any support for the
more specific theory that the influenza vaccine can serve as the antigenic trigger
that sets the autoimmune process into motion.” Id. at 129. In resolving a motion
11 There are a handful of examples of established molecular mimicry. See Tr. 607 (Dr.
Halsey). Special masters have recognized two examples that do not involve vaccines: rheumatic
fever can lead to Sydeham’s chorea, McKown 2019 WL 4072113, at *16; W.C., 2011 WL
4537877, at *11, and c. jejuni infection can cause Guillain-Barré syndrome, Isaac v. Sec’y of
Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *4 (Fed. Cl. Spec. Mstr. July 30,
2012), mot. for rev. denied, 108 Fed. Cl. 743 (2013), aff’d without op., 540 Fed. App’x 999 (Fed
Cir. 2013).
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for review that challenged the special master’s decision, the Court of Federal
Claims upheld a method of examination that looks for evidence making the general
theory of molecular mimicry a reliable and persuasive explanation for the alleged
causal association between the vaccine and disease:
While there is significant support for the general theory, the special
master properly concluded that the more specific theory proposed by
[the petitioner’s expert] was not supported by any of the evidence
presented in this case. . . . The theory of molecular mimicry does not
apply specifically to petitioner's case; on the contrary, that general
theory could be used to demonstrate an association between virtually
any combination of antigens and autoimmune injuries. Without any
empirical evidence that the theory actually applies to the influenza
vaccine and [transverse myelitis], the first prong of Althen would be
rendered meaningless.
Id. at 135.12
Thus, according to W.C. and Caves, special masters “correctly” or
“properly” look at the evidence underlying the invocation of molecular mimicry.
Thus, this decision now turns to the evidence regarding molecular mimicry.
2. Evidence Relating to Molecular Mimicry as a Hypothesis to
Explain how the Flu Vaccine Can Cause Rheumatoid Arthritis
Through their experts, the parties submitted a great deal of evidence
regarding the reliability of opinions that the flu vaccine can cause rheumatoid
arthritis via molecular mimicry. The evidence falls within three broad themes: (a)
evidence regarding Blast searches, (b) evidence regarding experiments on the
hemagglutinin in flu virus and collagen, and (c) evidence regarding experiments on
tetramers.
12 Caves is not the only decision by the Court of Federal Claims regarding molecular
mimicry. However, Caves carries additional persuasive (although still not binding) force
because the Federal Circuit affirmed the judgment in Caves pursuant to Rule 36 of the Federal
Rules of Appellate Procedure.
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a) Blast Searches
In his first reports, Dr. Utz proposed that molecular mimicry explains how
flu vaccine can cause rheumatoid arthritis. Exhibit 25 at 9-10. After Dr.
Matloubian challenged this opinion, exhibit E at 8-13, Mr. Tullio presented a
report from Dr. Steinman generally supporting Dr. Utz’s opinion. See exhibit 40.
An analysis of Dr. Steinman’s opinion entails a further explanation of how T
cells respond to antigens. Some antigens, such as those in the flu vaccine, are
proteins, and proteins are composed of long strings of amino acids. There are 20
amino acids. When a foreign protein is introduced into the body, a part of the
immune system known as an antigen-presenting cell takes up the antigen. The
antigen-presenting cell chops up the complete protein into shorter segments,
usually comprised of 8-12 amino acids. (This shorter segment is known as a
peptide.) As discussed in more detail below, the antigen-presenting cell holds (or
binds) the peptide. The T cell, in turn, then sees (or reacts with) the peptide.
As it relates to molecular mimicry, Dr. Steinman’s opinion has two parts.
First, Dr. Steinman offers an opinion about the degree of similarity necessary to
permit a cross-reaction. Second, Dr. Steinman searched a computerized database
and found that hemagglutinin and collagen are sufficiently similar.
Based upon experiments in which Dr. Steinman participated, Dr. Steinman
opined that in a peptide of 12 amino acids, a cross-reaction can occur when the
same amino acid appears in five of the slots. Tr. 332. Dr. Steinman then used this
criterion to compare the molecular structures of hemagglutinin and collagen. Tr.
347-53. Despite respondent’s opposition, Dr. Steinman’s five out of 12 standard is
accepted for the sake of argument. But see exhibit QQ (expert report of Dr.
Halsey) at 6 (challenging Dr. Steinman’s findings); Tr. 612. Thus, the more
critical question is whether Dr. Steinman has shown that hemagglutinin and
collagen pass this standard.
The second part of Dr. Steinman’s work was to review the molecular
composition of hemagglutinin and collagen. Dr. Steinman accessed a resource
available through the National Institute of Health and entered the relevant proteins.
Tr. 388. Through an algorithm, the computer aligns the proteins so that amino
acids line up as frequently as possible. Tr. 347-48, 383-85, 388. From this
information, Dr. Steinman presented instances in which the homology met or
exceeded the 5/12 standard. See exhibit 40 at 7-20.
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Dr. Steinman described his work as an “experiment,” Tr. 326, although this
term seems to exaggerate his investigation. The database searches seemed to take
less than one hour. Tr. 388.
An issue with the theory of molecular mimicry is that because all proteins,
which have hundreds of amino acids, are built from the same 20 amino acids, it is
inevitable that some sequences of amino acids will repeat. For example, when
researchers looked for homology between bacteria and human proteins, they found
that at a level of seven amino acids, almost all (99.7%) human proteins overlap
with protein sequences found in bacteria. Exhibit TT, tab 6 (Trost); see also Tr.
604. Thus, the finding of sequence homology does not necessarily mean the
similarity has significance to the immune system. Tr. 370 (Dr. Steinman), 429 (Dr.
Matloubian), 515 (Dr. Matloubian); exhibit SS, tab 2 (IOM report). Dr. Utz, too,
questioned the reliance on an approach that involved simply searching for
sequence homologies. Tr. 272-73.
Dr. Matloubian, however, did investigate whether the peptides that Dr.
Steinman found were biologically relevant. Dr. Matloubian could take this
additional step because scientists extensively study the flu virus. In this work,
scientists have identified the portions of the flu virus that are peptides and created a
database of them. Dr. Matloubian queried the database to see whether the epitopes
that Dr. Steinman had identified appeared in the database. Dr. Matloubian
disclosed that he did not find any positive hits. Exhibit PP at 3-4, Tr. 483-88, Tr.
545.
When asked about Dr. Matloubian’s methodology of consulting other
databases, Dr. Steinman stated that he was aware of databases of known T cell
epitopes, Tr. 387, but did not otherwise respond to Dr. Matloubian’s critique of his
hypothesis. This lack of meaningful response from Dr. Steinman makes his
opinion regarding the usefulness of his Blast searches unpersuasive.
b) T cell Activity in the Molecular Mimicry Context
Apart from Dr. Steinman’s Blast searches, Dr. Utz based his theory of
molecular mimicry on four articles reporting on experiments involving
hemagglutinin and collagen. See exhibit 25 at 13; exhibit 34 at 8-11; see also
Pet’r’s Revised Preh’g Br., filed Jan. 29, 2019, at 15, 17 (identifying these
articles). However, before these articles are discussed, it is necessary to refine the
meaning of “molecular mimicry.”
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At a basic level, molecular mimicry attempts to explain how a T cell can
attack both a foreign substance (the hemagglutinin in flu vaccine) and host tissue
(the synovium). However, a T cell never sees its target in isolation. A T cell
recognizes its target only in the context of an antigen-presenting cell. See
Dorland’s Illustrated Medical Dictionary 315 (32d ed. 2012) (cell, antigen
presenting), 1512 (presentation, antigen). The antigen-presenting cell is like a
sausage bun and the peptide is a sausage. Exhibit 34 (Dr. Utz’s report) at 9. In the
continuation of this simile, the T cell is like mustard or relish that sits on top of the
sausage.
This model brings out the fact of two different sets of bonds. The first set of
bonds is between the antigen-presenting cell and the peptide. (This is sometimes
referred to as bonds on the bottom.) The second set of bonds is between the
peptide and the T cell. (This is sometimes referred to as bonds on the top.)
This image helps to visualize the two sets of bonds:
Exhibit SS, tab 1 (Abbas) at 118.
The difference in bonds underlies a dispute between Dr. Utz and Dr.
Matloubian about the meaning of molecular mimicry. In his report, Dr. Utz stated
that the process of molecular mimicry occurs when “an immune response to a
nonself antigen such as components of an influenza vaccine cross reacts with self
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molecules.” Exhibit 25 at 9; accord Tr. 124. His later reports and testimony
clarified that Dr. Utz included “bottom bonds,” meaning bonds between the
antigen-presenting cells and a peptide as fulfilling molecular mimicry.
Dr. Matloubian’s view of molecular mimicry was not as broad. He focused
on the T cell (or top) bond:
To an immunologist, [the] definition of molecular mimicry for T cells
is that the same T cell (via its unique T cell receptor) can recognize
two different antigens (peptides) and become activated by either one
of them . . . When two different antigens can be recognized by the
same T cell and lead to its activation, they are “molecular mimics” of
each other in the immunological sense.
Exhibit SS at 3; accord Tr. 423, 443. Dr. Matloubian’s focus on the T cells is
sensible because T cells cause damage in Dr. Utz’s explanation for rheumatoid
arthritis. Tr. 222 (Dr. Utz acknowledging T cell activation is part of molecular
mimicry), 427 (Dr. Matloubian’s explanation). In an article written for Scientific
American, Dr. Steinman illustrated molecular mimicry with a T cell reacting to
two antigens. Exhibit 40 at 23; see also Tr. 374-75 (Dr. Steinman testifying about
this article), Tr. 425 (Dr. Matloubian stating that his explanation of molecular
mimicry “is an agreement . . . with Dr. Steinman’s figure . . . which is in Exhibit 40
on page 23”). Even Dr. Utz agreed that to establish molecular mimicry to a level
of scientific certainty, the same T cell must recognize the two different antigens in
an antigen-presenting cell. Tr. 162.
However, Dr. Utz’s invocation of the term “scientific certainty” seems to
distract from the key issue. Given that the bottom bond is distinct from the top
bond, Dr. Utz has not provided any basis for evaluating molecular mimicry from
the standpoint of bonding between the antigen-presenting cell and a peptide from
the antigen.13 While Dr. Utz cited two articles that he claimed supported his
definition of molecular mimicry, the relevant passages are written with such
generality that they do not inform the question. See Tr. 132-33 (citing exhibit PP,
tab 3 (Malmström) at 4-5).
13 On a yet even deeper level of immunology, technically the tightness of the bond
between the antigen-presenting cell and the antigen affects the way the T cell can bind to the
antigen. See Tr. 267-68. However, this nuance does not lead to a different outcome.
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With an understanding that molecular mimicry requires the same T cell to
see two epitopes on antigen-presenting cells, a detailed discussion of the four
articles on which Dr. Utz relies becomes relatively unimportant. Listed in the
order of their publication, the four articles are exhibit 39 (Dessen), exhibit 35
(Hennecke and Wiley), exhibit 31 (Sun), and exhibit 37 (Li). Although the science
of these articles is complicated, they basically report on how an antigen-presenting
cell interacts with hemagglutinin and with collagen. In other words, the articles
discuss the bonds on the bottom. The articles do not discuss whether T cells bind
to the hemagglutinin and/or collagen as presented through the antigen-presenting
cell. For Dessen, see Tr. 227 (Dr. Utz), 453-54 (Dr. Matloubian). For Hennecke
and Wiley, see exhibit 34 (Dr. Utz report) at 11 (“this paper only demonstrates that
DR4 can bind an influenza or collagen peptide; it does not demonstrate that T cell
receptors . . . on human T cells can recognize collagen or influenza peptides), Tr.
228 (Dr. Utz), 454 (Dr. Matloubian). For Sun, see Tr. 156 (Dr. Utz), 522 (Dr.
Matloubian referencing Sun). For Li, see Tr. 154-55 (Dr. Utz discussing Li), 463
(Dr. Matloubian discussing Li).
In this context, Dr. Matloubian introduced a new comparison—one with
Lego figurines. He said that the bond between the antigen-presenting cell and the
antigen’s peptide is like a flat Lego board onto which a set of Lego figurine legs
can be placed. Tr. 443. Multiple legs can fit the Lego board. However, the type
of legs does not control whether the top part of the Lego figurine is a police officer,
a robber, or a stormtrooper. Tr. 443, 466-67. Because the articles on which Dr.
Utz was relying do not help with T cell binding on the top of the model, they do
not assist in supporting the theory of molecular mimicry.
After Dr. Matloubian had criticized Dr. Utz’s presentation of molecular
mimicry without any evidence showing T cell binding, see exhibit E at 12, Dr. Utz
took a different tact. In his first report, Dr. Utz had presented a view of how T
cells bind to peptides in an antigen presenting cell. Dr. Utz stated: the “T cell
repertoire . . . is composed of an estimated 1010 – 1014 different T [cells], each
specific for a single epitope.” Exhibit 25 at 9. One T cell sees one epitope. This
view appeared to be an orthodox view of immunologists. For example, a widely
used textbook for immunology states: “The antigen receptors of CD4+ and CD8+ T
cells are specific for peptide antigens that are displayed by MHC molecules (Fig.
6.1) . . . A single T cell can recognize a specific peptide displayed by only one of
the large number of different MHC molecules that exist.” Exhibit SS, tab 1
(Abbas) at 118-19.
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However, in a supplemental report written in response to an order to disclose
all opinions in advance of the hearing, Dr. Utz stated that “It is universally
accepted in immunology that T cells do not see one and only one peptide . . . In
fact, they almost certainly can recognize tens of thousands of peptides, and likely
over a million different peptides.” Exhibit 63 (Dr. Utz report) at 3. The concept
that T cells see multiple peptides is called “T cell degeneracy” and “T cell
flexibility.” See Tr. 98, 169. In support of T cell degeneracy, Dr. Utz cited three
papers—exhibit 68 (Birnbaum), exhibit 69 (Wooldridge), and exhibit 73
(Szomolay).
T cell degeneracy has been mentioned by special masters for more than a
decade. See Bubb v. Sec’y of Health & Human Servs., No. 01-721V, 2005 WL
1025707, at *11 (Fed. Cl. Spec. Mstr. April 29, 2005) (summarizing testimony
from Dr. Vera Byers and ultimately finding that the petitioner had failed to
establish molecular mimicry); see also Garcia v. Sec’y of Health & Human Servs.,
No. 05-720V, 2008 WL 5068934, at *3 (Fed. Cl. Spec. Mstr. Nov. 12, 2008)
(summarizing testimony from Dr. Derek Smith that research in the 1990’s showed
that the T cell response is “much more degenerate and less specific than we had
previously thought,” and ultimately finding the petitioner was entitled to
compensation).
Here, the evidence regarding T cell degeneracy is not robust. The two
witnesses who discussed T cell degeneracy are rheumatologists, not
immunologists. Although Dr. Utz and Dr. Matloubian possess the background,
training, and experience to present opinions about basic immunology, the question
of T cell degeneracy would be better informed by a doctor specializing in the more
relevant field of immunology. An immunologist would seem better qualified to
answer questions about T cell degeneracy, such as, if the research regarding T cell
degeneracy had been performed in the 1990’s as Dr. Smith’s testified in Garcia,
why does the Abbas textbook still indicate that one T cell recognizes only one
peptide on an antigen presenting cell? Under these circumstances, the undersigned
is reluctant to accept the reliability of T cell degeneracy. See McKown v. Sec’y of
Health & Human Servs., No. 15-1451V, 2019 WL 4072113, at *50 (Fed. Cl. Spec.
Mstr. July 15, 2019) (“Dr. Tornatore’s alternative T cell degeneracy mechanism
. . . fares no better.”).
Moreover, Mr. Tullio’s attorneys did not integrate the concept of T cell
degeneracy with the remainder of his case. The original brief did not cite
degeneracy or any of the three relevant articles at all. See Pet’r’s Preh’g Br., filed
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Jan. 4, 2019. After being instructed to develop his arguments in more detail, Mr.
Tullio’s explained why his experts cannot identify the exact self-antigen that
caused his rheumatoid arthritis, by citing to the trio of articles. Notably, the
Amended Brief did not use the specific term “degeneracy” at all. See Pet’r’s Am.
Preh’g Br. at 15.
It seems that the T cell degeneracy concept could be useful in the following
way. Under the old view, a T cell that recognized and attacked a protein in the
synovium, such as collagen, would recognize collagen and only collagen (or
something that closely mimicked its molecular structure). Thus, the likelihood of
this auto-reactive T cell also recognizing and responding to hemagglutinin would
be very unlikely. However, if T cells recognize and respond to millions of proteins
because T cells are degenerate, then the likelihood of a cross-reaction to another
protein is greatly enhanced.
But, even under the T cell degeneracy concept, it seems that all T cells do
not recognize all peptides. Whether any T cell that recognizes a protein associated
with rheumatoid arthritis can also recognize hemagglutinin is the next topic.14
c) Tetramers
Mr. Tullio’s last attempt to demonstrate molecular mimicry as a sound and
reliable hypothesis to explain how the flu vaccine can cause rheumatoid arthritis is
an argument based upon tetramers experiments. This contention lacks persuasive
value because Dr. Utz extends the studies beyond what the authors of those studies
reported.
Although Dr. Utz eventually came to see tetramers experiments as
supporting the molecular mimicry hypothesis, Dr. Matloubian actually introduced
a series of articles involving tetramers with his final supplemental report. Exhibit
SS. Dr. Matloubian wrote this report in response to Dr. Utz’s opinion regarding
the testability of molecular mimicry. Dr. Utz had contended that experiments to
detect whether a single T cell can bind to both hemagglutination and collagen were
expensive and technically challenging. Exhibit 63 at 6. Dr. Utz repeated this
14 Again, without the benefit of extensive development of the significance of T cell
degeneracy from the parties, the undersigned compares the situation to a lottery in which the
chances of winning are one in ten billion. Under the old view of a single T cell recognizing a
single antigen, a contestant in the lottery received one ticket. Under the T cell degeneracy
concept, the contestant receives a million tickets.
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opinion in his direct testimony. Tr. 188-89, 214. However, on cross-examination,
Dr. Utz seemed to shift, maintaining that articles that Dr. Matloubian had cited to
show tetramers experiments undermined molecular mimicry actually showed
molecular mimicry in operation. Tr. 240-41; see also Tr. 659-70 (rebuttal
testimony). Thus, a more extensive discussion of the tetramers experiments is
needed.
In introducing tetramers, Dr. Matloubian stated that tetramers are molecules
that “allow identification of T cells that recognize a specific MHC-peptide
complex.” Exhibit SS at 11. In this case, the relevant tetramers contain DR4 and
are loaded with either hemagglutination or collagen. Id.; Tr. 149 (Dr. Utz); see
also Tr. 472-73 (Dr. Matloubian). Using a diagram from the Stanford University
medical school website, Dr. Matloubian depicted how tetramers bind to a T-cell
receptor:
Exhibit SS at 11. This background about tetramers aids in understanding the four
papers about tetramers that the parties discussed.
Svendsen. Svendsen was written in 2004, and it appears, at that time, that
researchers were struggling to understand the pathology of rheumatoid arthritis.
(The pathology of rheumatoid arthritis is still not understood 15 years later.) One
issue was whether B cells or T cells initiated the disease. See Exhibit SS, tab 5
(Svendsen) at 7043. The Svendsen group investigated whether collagen-specific T
cells contributed to the initiation of rheumatoid arthritis by conducting at least
three experiments. Id. Each experiment involved tetramers for collagen and
tetramers for hemagglutinin.
In the first experiment, the researchers tested to see whether in a petri dish,
tetramers could stimulate T-cell hybridomas specifically. In immunology,
“specificity” refers to “the special affinity of antigen for corresponding antibody.”
Dorland’s at 1742. The results, presented in figure 1, show that DR4 tetramers for
hemagglutinin stimulated T-cell hybridomas for hemagglutinin but not T-cell
hybridomas for collagen. Panel a. Similarly, DR4 tetramers for collagen
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stimulated T-cell hybridomas for collagen, not T-cell hybridomas for
hemagglutinin. Panel b. The authors wrote: “When immobilized on microtiter
plates, the homologous, but not the heterologous, DR4 tetramers all stimulated
strong dose-dependent responses by the five different hybridomas specific for
[hemagglutinin] and the 15 for [collagen].” Exhibit SS, tab 5 (Svendsen) at 7039.
The authors added: “The DR4:HA tetramers bound strongly to the five HA(307-
319)-specific T-cell hybridomas, but not to any of the [collagen]-specific T cell
hybridomas . . . .” Id.
In Dr. Matloubian’s view, “none of their HA-specific hybridomas or
collagen-specific hybridomas showed cross-reactivity, meaning that they didn’t
recognize both collagen and hemagglutinin in the context of HLA-DR4.” Tr. 477;
accord Tr. 544-45. Dr. Utz agreed, stating: “[T]hese reagents look very clean.
They don’t seem to be cross-reacting for this one T cell receptor . . . .” Tr. 661.
The second experiment moves from the petri dish to living mice. Mice
genetically modified to develop arthritis were immunized with four substances:
collagen, hemagglutinin with a powerful adjuvant, the adjuvant alone, and saline.
Thirteen days after vaccination, the researchers obtained blood and the draining
lymph nodes from the mice. The researchers then stained with tetramers for either
collagen or hemagglutinin. Exhibit SS, tab 5 (Svendsen) at 7040. The researchers
determined the frequency of the targeted T cells, expressed as a percentage of T
cells.
The results appear in figure 3. When saline was used as the immunizing
agent, both collagen and hemagglutinin stimulated no response. The result was
0.00 percent. Panels g and h; see also Tr. 529, 662. When the adjuvant alone was
used, the result for collagen was 0.02 percent and the result for hemagglutinin was
0.01 percent. Panels e and f; see also Tr. 662-63.
The controversial part concerns immunization with hemagglutinin and the
results that appear in panels k and l. When the lymph nodes were later stained with
a hemagglutinin tetramer, the frequency was 0.86 percent. Panel l. The result in
panel l is not surprising. However, the arguably surprising result concerns what
happened when the lymph nodes, which were from hemagglutinin-immunized
mice, were stained with a collagen tetramer—the frequency was 0.08 percent.
Panel k.
In Dr. Utz’s view, 0.08 percent is enough to show some cross-reactivity
because 0.08 percent is self-evidently greater than zero. He testified that the 0.08
percent result “unequivocally demonstrates if a mouse is immunized with an HA
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peptide and then stained with a collagen tetramer, [then] that mouse has cross-
reactive T cells between HA and type II collagen.” Tr. 663. However, Dr.
Matloubian disagreed. In his view, because of the complexities of working with
tetramers and the nature of biologic systems, 0.08 percent was an artifact or
background result. Tr. 478-79, 532-34, 553.
On this point, Dr. Matloubian’s opinion is more persuasive.15 In
summarizing the findings of this experiment, the researchers wrote: “Notably,
cross-binding of either heterologous tetramer was minimal . . . i.e., not
significantly higher than in mice injected with [saline or adjuvant] alone . . . .”
Exhibit SS, tab 5 (Svendsen) at 7040. Moreover, the “minimal” cross binding
shown in figure 3 is consistent with the experiment shown in figure 1. And both
figure 1 and figure 3 are consistent with the caption to figure 4.
Figure 4 presents data for another experiment from the Svendsen paper. In
this experiment, the researchers extended the duration of the experiment in figure
3, which terminated on day 13, to at least 150 days. The purpose of this
experiment was to see how the frequency of collagen-specific T cells correlated to
the severity of arthritis in mice. While explaining their data in the caption to figure
4, the researchers wrote: “No DR4:HA(307-319) tetramer staining was detected
during the course of the experiments.” Exhibit SS, tab 5 (Svendsen) at 7041.
Although Dr. Matloubian mentioned this result in his testimony, Tr. 534, Dr. Utz
did not rebut it.
Thus, to summarize Svendsen, in two experiments the data shows no cross-
reactivity. Figures 1 and 4. In the third experiment, the degree of cross-reactivity
is “minimal” and “not significantly higher” than in controls. Figure 3. Thus, it
seems likely that Svendsen undermines the hypothesis that hemagglutinin and
collagen can induce the same reaction.
While the parties emphasized Svendsen among all the articles about
tetramers, the parties also discussed a few other articles. But, their discussion with
respect to these articles was much shorter.
Snir. In 2011, Omri Snir and colleagues, including Vivianne Malmström,
continued research into the cause of rheumatoid arthritis. They explored how T
cells could attack another protein found in the synovium, called vimentin. Exhibit
15 Both Dr. Utz and Dr. Matloubian possess a background to opine about tetramers. See
Tr. 188 (Dr. Utz), 535 (Dr. Matloubian), 658 (Dr. Utz).
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SS, tab 3 (Snir) at 2873. Vimentin can be citrullinated, meaning it can be found in
ACPA positive rheumatoid arthritis. Tr. 92.16
The researchers attempted to determine how modified sequences of amino
acids in the citrullinated form of vimentin compared to the unmodified sequence of
vimentin. While the specific results do not affect Mr. Tullio’s case, the relevant
point comes from how the researchers designed their experiment. In the
methodology for this experiment, a “hemagglutinin antigen tetramer was used as a
negative control.” Exhibit SS, tab 3 (Snir) at 2877 (figure 2 legend). Dr.
Matloubian interpreted this information as not supporting molecular mimicry. Tr.
482.
Dr. Utz’s interpretation, although presented somewhat cursorily, resembled
his view of the Svendsen paper. He identified data within figure 3 that showed the
percent of T cells responding to hemagglutinin was approximately 0.02 to 0.03
percent. Tr. 241-42; see also Exhibit SS, tab 3 (Snir) at 2878 (figure 3). However,
the measured levels are so tiny that, much like the Svendsen group, the Snir
researchers used hemagglutinin as a negative control. Apparently, they did not
find any response to hemagglutinin meaningful enough to warrant comment.
James. The last experiment involving tetramers for a protein connected to
rheumatoid arthritis and hemagglutinin is James.17 The group of researchers who
wrote the James article, published in 2014, included five people who co-authored
Snir, including Vivianne Malmström.
The researchers in James roughly followed the same methodology as in Snir.
For one experiment involving mice, the James researchers immunized genetically
modified mice with vimentin. After 14 days elapsed, the researchers removed the
mice’s spleens, stimulated the T cells in a petri dish with different substances, and
analyzed the results. See Tr. 547 (Dr. Matloubian summary). The researchers
were interested in assessing the recall response to “the citrullinated peptide,
unmodified peptide, or a control peptide.” Exhibit SS, tab 4 (James) at 1715. The
control peptide was hemagglutinin. For another experiment, which involved
humans, the author stated that using hemagglutinin as a positive control was
“important” because the researchers could see whether the changes in T cells were
16 Mr. Tullio is not ACPA positive.
17 Dr. Utz also discussed an article by Su, which Dr. Matloubian had submitted originally.
Tr. 670-72, 683. However, Dr. Utz's testimony was not persuasive.
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due to “[rheumatoid arthritis] itself or to the immunomodulatory therapy that the
patients receive.” Id. at 1717.
Malmström. In 2016, Dr. Malmström with Anca I. Catrina and Lars
Klareskog, a well-respected rheumatologist, wrote a review article about the
etiology of seropositive rheumatoid arthritis. Dr. Utz relied on this article to
explain basic concepts in rheumatoid arthritis. Tr. 113-16, 123, 132.
These authors stated that “molecular mimicry” was an attractive hypothesis
to explain how the body’s response to an infection of the gums can lead to an
attack on yet another protein in the synovium, enolase. Exhibit PP, tab 3
(Malmström) at 4; see also Tr. 131 (Dr. Utz), 514-15 (Dr. Matloubian). In
contrast, they described hemagglutinin as “an unrelated antigen.” Exhibit PP, tab 3
(Malmström) at 7, citing Snir and James. The view of these experts that
hemagglutinin is “unrelated” to various rheumatoid arthritis associated proteins
carries significant weight. See Tr. 411. Furthermore, Dr. Matloubian, in
presenting the work of the members of the Malmström and Klareskog group,
opined “this is the strongest evidence that there isn’t any [cross-reactivity].” Tr.
551.
When asked about this passage in the Malmström review article, Dr. Utz
replied that the Malmström and Klareskog group “are not studying mimicry . . . So
they are using this as a control for a totally different purpose.” Tr. 686. This
statement seems to confirm that the tetramer articles to which Dr. Utz belatedly
turned do not really support the proposition that hemagluttinin and collagen are
molecular mimics.
In sum, as discussed in section 1, above, pursuant to W.C., 704 F.3d at 1360,
and Caves, 100 Fed. Cl. at 135, petitioners must do more than simply proffer a
theory. Petitioners must offer a theory that is “persuasive.” See Boatmon, 941
F.3d at 1356-57.
Overall, the mechanistic evidence fell short of establishing the
persuasiveness of molecular mimicry as a theory to explain how flu vaccination
can cause rheumatoid arthritis. The Blast searches produced far too generalized
information and the results did not match the immunologically relevant portions of
the flu vaccine. The studies regarding hemagglutinin and collagen binding to
antigen-presenting cells did not show T cell binding. And, lastly, the studies using
tetramers tended to show that hemagglutinin and collagen are not molecular
mimics.
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The mechanistic evidence (section B) tends to align with the epidemiologic
evidence, which did not detect an increased incidence of rheumatoid arthritis
following flu vaccination (section A). Thus, exclusively for the reasons set forth in
sections A and B, Mr. Tullio has failed to carry his burden of presenting a reliable
and persuasive theory that the flu vaccine can cause rheumatoid arthritis. This
result appears consistent with the outcomes in two leading appellate cases to
discuss molecular mimicry, W.C., 704 F.3d at 1360, and Caves, 100 Fed. Cl. at
135, as discussed in section III.B.1, above.
C. Testability
Because the evidence in this case was insufficient to meet the burden
regarding a theory, the undersigned discusses what evidence could have been
supportive. In doing so, the undersigned recognizes that a petitioner’s burden is to
present a persuasive theory, not a scientifically certain theory. Bunting v. Sec'y of
Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Logically, the
following statements can be correct: (1) the evidence in this case did not meet the
petitioner’s burden to present a persuasive medical theory, (2) some quantum of
additional evidence could have been submitted that would have supported a finding
that petitioner met his burden, and (3) the quantum of evidence necessary to
change from (1) to (2) is less than the quantum of evidence required under a
scientific certainty standard. Here, Mr. Tullio could have presented evidence from
studies that directly tested the molecular mimicry hypothesis that Dr. Utz and Dr.
Steinman have proposed here.
As a matter of law, there seems to be no impediment for considering
whether a hypothesis is testable. In guiding trial court judges about the
admissibility of expert opinions, the Supreme Court’s list of authorized factors
begins with testability:
(1) whether a theory or technique can be (and has been) tested; (2)
whether the theory or technique has been subjected to peer review and
publication; (3) whether there is a known or potential rate of error and
whether there are standards for controlling the error; and, (4) whether
the theory or technique enjoys general acceptance within a relevant
scientific community.
Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 n. 2 (Fed. Cir.
1999) (citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 592-95 (1993)).
Special masters may use the Daubert factors in evaluating the persuasiveness of
expert testimony. Terran, 195 F.3d at 1316.
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Outside of litigation, testing of hypotheses places a critical role. Although
Henry Petroski was writing in the context of engineering, his comments describe a
process different disciplines use to advance knowledge.18 Petroski begins by
explaining how a theory is created:
The object of a science may be said to be to construct
theories about the behavior of whatever it is that the
science studies. Observation and experience, inspiration
and serendity, genius and just good guesses—by their
presence and absence, in pinches and dashes—all can
provide the recipe for a scientific theory. As with all
recipes, in which the cook is always the invisible
ingredient, the individuality of the scientist provides the
inexpressible human flavor. This aspect of science, the
concoction of theories, has no universal method.
Henry Petroski, To Engineer is Human: The Role of Failure in Successful Design
42 (1985). Petroski then describes the next step in the scientific process:
But once a theory has evolved, perhaps from a half-baked
idea to a precise and unambiguous statement of the
scientist’s entry in the great universal cook-off, the
scientific method may be used to judge the success or
failure of a given theory or the relative merits of
competing theories. Theories entered in the scientific
cooking contest are known as hypotheses and the process
of judging is known as the testing of hypotheses.
Id. Daubert’s endorsement of the testability of a theory seems to ratify the
scientific method Petroski captured. Because the legal foundation for considering
the testability of a hypothesis seems established, the next question is whether the
evidence in this case shows that the proposed hypothesis—that hemagglutinin and
collagen are molecular mimics—can be tested.
In this case, the evidence shows that researchers in laboratories have tested
the hypothesis that molecular mimicry plays a role in the pathogenesis of
rheumatoid arthritis. For example, in a review article about “research related to the
18 Petroski wrote the “Reference Guide on Engineering Practice and Methods” in the
2000 edition of the Federal Judicial Center’s Reference Manual on Scientific Evidence.
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associations between periodontal disease and rheumatoid arthritis,” the authors,
Clifton O. Bingham III and Malini Moni, described a study from 2011 by AJ
Kinloch and others.19 Exhibit 36 (Bingham) at 7. According to Bingham and
Moni, Kinloch tested whether peptides from the bacteria that cause gum infections
(Porphyromonas gingivalis) could participate in the development of arthritis. The
Kinoch group found supporting evidence. Id. at 7.20 Other support for the
molecular mimicry hypothesis as a link between P. gingivalis and enolase is found
in Lundberg. Exhibit 38 (Lundberg) at 2; see also Tr. 435 (Dr. Matloubian).
When asked whether these experiments could be done after substituting
hemagglutinin for P. gingivalis, Dr. Utz said the experiments could be done. Tr.
263. When asked whether the experiments had been done, Dr. Utz said he was not
aware of any. Tr. 265.21
Another example of testing molecular mimicry in the context of rheumatoid
arthritis comes from an older experiment. In 1998, researchers attempted to
determine whether a portion of the Epstein-Barr virus was similar to collagen by
testing the sera of patients with rheumatoid arthritis. They concluded: “Evidence
for molecular mimicry was not found.” Exhibit Y (Davies) at 53. When asked
about using the methodology in this paper to test hemagglutinin rather than
Epstein-Barr virus, Dr. Utz had difficulty answering the question initially.
However, he ultimately responded that the experiment would be difficult to
perform because hemagglutinin is a more challenging protein due to its “sugar
residues.” Tr. 261.
Dr. Steinman was direct in stating that molecular mimicry can be tested. Tr.
321-22; but see Tr. 385-86. He said that hemagglutinin could be put into
genetically engineered mice to see whether the animals developed rheumatoid
arthritis. Tr. 324, 334. On cross-examination, Dr. Steinman was asked whether he
could submit his theory for peer review. In answering, Dr. Steinman said: “I might
try to do the experiment[:] inducing disease in a humanized mouse with those
19 The underlying article by Kinloch is not part of this record.
20 The 2017 Malmström article states epidemiological data has not shown a clear
relationship between periodontitis and rheumatoid arthritis. Exhibit PP, tab 3 (Malmström) at 4-
5.
21 Later, in rebuttal testimony, Dr. Utz pointed to the tetramers experience, including
Svendsen, as experiments involving hemagglutinin that support cross-reactivity with collagen.
However, for the reasons explained above, Dr. Utz's opinion about the tetramers studies was not
persuasive.
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peptides.” Tr. 373. His answer here may reflect his earlier testimony on direct
examination that he is “not applying for a prize,” suggesting that his methods in
forming an opinion in a legal proceeding are less stringent than if he were
submitting his theory for peer review. Tr. 354. For example, when asked on cross-
examination about submitting his database search to a journal that publishes peer-
reviewed articles, Dr. Steinman stated that his work is sufficient for a court but not
for the broader community. Tr. 354 (“And that’s about the best I could do and
that’s the foundation of a theory for this Court. I’m not applying for a prize. I’m
just saying that this is where an experiment led me . . . .”). Dr. Steinman also
stated that if he were trying to publish a paper in a peer-reviewed journal, he would
do more, such as model his theory in mice. Tr. 373.
In short, Dr. Utz and Dr. Steinman have presented a hypothesis—
hemagglutinin and collagen are molecular mimics—that is testable, but has not
been tested directly. Why does this gap of knowledge and evidence exist?
Potentially contributing factors stem from the scientific and legal communities.
Regarding the scientific community, Dr. Matloubian stated that he analyzed
the evidence in the same way he approaches reviewing an application for a grant.
Tr. 432. Grant approval would be one practical way to fund an experiment. See
Tr. 373-74. However, according to Dr. Matloubian, people would determine
whether to fund the research after considering, among other factors, the data that
do and do not support the hypothesis. Tr. 432. The fact that epidemiology has not
detected a statistically significant increase in rheumatoid arthritis after flu
vaccination (or flu infection) and the fact that hemagglutinin is used as a control in
experiments testing reactivity of RA-proteins suggest that the medical community
would not want to devote scarce research dollars into investigating this hypothesis.
Tr. 606-09 (Dr. Halsey).
Regardless of the motivations of the broader medical and/or scientific
communities, the parties in this legal proceeding could have some interest in
testing the molecular mimicry hypothesis. See Sanne H. Knudsen, Adversarial
Science, 100 Iowa L. Rev. 1503 (2015); Samuel L. Tarry, Jr., Can Litigation-
Generated Science Promote Public Health?, 33 Am. J. Trial Advoc. 315 (2009);
William L. Anderson et al., Daubert’s Backwash: Litigation-Generated Science, 34
U. Mich. J.L. Reform 619 (2001). Although not a party-litigant, Dr. Utz expressed
frustration about resistance to acceptance of molecular mimicry as a theory. Tr.
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253.22 Dr. Utz’s dismay, in turn, seems to stem from a belief that he has done all
that is possible, except for conducting an unethical experiment to produce
rheumatoid arthritis in a healthy person. Exhibit 58 (Dr. Utz’s third report) at 4.
But, Dr. Utz seemed to overlook an intermediate step – mouse models. Tr. 269.
For rheumatoid arthritis, research by Svendsen, Snir, James, and Kinloch
suggest that one step would be to model people’s response to a vaccine with an
animal. The animal model would be a chance to examine whether a living
organism reacted in a way the molecular mimicry hypothesis predicts. See Tr. 273
(Dr. Utz’s testimony recommending studies involving living T cells); see also Tr.
270 (remarking about the Sun paper, “it is curious to me that they would, in fact,
go from a human experiment . . . backwards into a mouse experiment . . . [I]f one
were to do mouse experiments, they could look more at the mechanism where it
might work where the different cells might go, those sorts of things.”).
Dr. Steinman recognized that “[e]xperiments can settle the disagreement,”
Tr. 321, and that he could perform the perfect experiment in a mouse model. Tr.
334. But, in Dr. Steinman’s words, he did not have this responsibility when
presenting materials for a court. See Tr. 373; see also Tr. 334 (“[M]y job is to
make a theory, not to do the perfectly relevant experiment.”). With incentives
from the legal system, one party or both parties could investigate the
persuasiveness of molecular mimicry as a hypothesis to explain how a vaccine can
cause a disease. Of course, any study would require both time and resources.23
If Dr. Steinman or Dr. Utz had conducted experiments about molecular
mimicry, the results could have assisted Mr. Tullio in meeting his burden of proof.
Cf. Libas v. United States, 193 F.3d 1361, 1365-69 (Fed. Cir. 1999) (vacating
factual finding of the Court of International Trade that a certain fabric was power-
loomed because the record did not support the reliability of the test used to
22 In this context, Dr. Utz compares the process of determining a cause for rheumatoid
arthritis to the process of diagnosing and treating a patient with rheumatoid arthritis. This
comparison seems inapt as the patient might benefit from an unproven treatment that carries little
risk.
23 The Vaccine Program would seem to allow for time to seek approval from an
overseeing institution, to carry out the experiment, and to submit an article for peer review
because the pace of litigation has dramatically slowed. Mr. Tullio’s case came to hearing
approximately four years after it was filed and this time was relatively quick. Moreover, the
presence of approximately $4 billion in the Vaccine Injury Compensation Trust Fund suggests
that money is available to pay for experiments.
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distinguish hand-loomed and power-loomed fabrics); Pride v. BIC Corp., 218 F.3d
566, 578 (6th Cir. 2000) (“The failure of [the plaintiff’s] experts to test their
hypotheses in a timely and reliable manner or to validate their hypotheses by
reference to generally accepted scientific principles as applied to the facts of this
case renders their testimony on the cause and origin of the fire unreliable . . . .”).24
Testing the hypothesis could lead to information relevant to the other
Daubert factors. The results of an experiment using an animal model could, in
turn, be written in an article submitted for peer review. (Peer review is the second
Daubert factor.) When Dr. Utz presented his opinions at the hearing, he had not
written any articles proposing that the flu vaccine can cause rheumatoid arthritis.
Tr. 217-18. Likewise, Dr. Utz had not presented the hypothesis that flu vaccine
can cause rheumatoid arthritis to a national meeting. Tr. 219. Without this
foundational work, the specific theory does not enjoy general acceptance in the
medical community. Cf. Tr. 217 (Dr. Utz stating that none of the literature
identifies flu infection as a possible cause for rheumatoid arthritis), 363 (similar
testimony from Dr. Steinman). (General acceptance is the fourth Daubert factor.)
Thus, an experiment involving an animal model could advance a petitioner’s
attempt to satisfy the various Daubert factors.
In saying Mr. Tullio and his experts could have presented more evidence,
the undersigned might be perceived as demanding proof beyond a reasonable
doubt. The undersigned is aware that the standard is simple preponderance. See
Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961-62 (Fed. Cir. 1993)
(disagreeing with a dissent that opined the special master had imposed too high a
standard). But, even under the preponderance of evidence standard, a theory must
be “sound and reliable.” Boatmon, 941 F.3d at 1359 (quoting Knudsen v. Sec’y of
Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994)). As discussed in
sections A and B, the epidemiology and the mechanistic evidence do not support a
finding that the hypothesis of molecular mimicry between flu vaccine and
hemagglutinin is sound and reliable. Therefore, the lack of testing does not affect
24 Alternatively, special masters could expect that experts the Secretary retained (here,
Dr. Matloubian and Dr. Halsey) would experiment to test the hypothesis that petitioner’s experts
proposed. Some cases seem to place the burden of testing on the party opposing the proposed
theory. “Testability ‘assures the opponent of proffered evidence the possibility of meaningful
cross-examination (should he or someone else undertake the testing).’” City of Pomona v. SQM
North America Corp., 750 F.3d 1036, 1046 (9th Cir. 2014) (quoting United States v. Mitchell,
365 F.3d 215, 238 (3d Cir. 2004)) (reversing the district court’s exclusion of expert opinion
based on an erroneous application of the Daubert “testability” prong).
40

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the outcome of the case—if this section on testability were excised from the
decision, the undersigned still would have found that Mr. Tullio did not establish
prong 1.
D. Dr. Utz and Dr. Steinman as Experts
Lastly, a finding that the opinions of Dr. Utz and Dr. Steinman are not
persuasive in this case should not be construed as findings about Dr. Utz and Dr.
Steinman themselves. Both have accomplished much in their careers. They have
directly cared for patients and trained other medical professionals who have gone
on to care for other patients. They have researched treatments that have helped
countless people. Indeed, their professional achievements show that more is
possible in their work as experts.
If there is a flaw in Dr. Steinman’s presentation as an expert in this case, it is
that Dr. Steinman seemed to indicate that he expressed opinions, as an expert,
more readily than he would outside a legal proceeding. Tr. 373-74. Other special
masters have expressed similar concerns. See D.G. v. Sec'y of Health & Human
Servs., No. 11-577V, 2019 WL 2511769, at *182 (Fed. Cl. Spec. Mstr. May 24,
2019) (Dr. Steinman “flits back and forth from opinion to opinion to assist
petitioner in prevailing, even if he does not eventually believe what he wrote or
said. Dr. Steinman is the essence of a team player, in other words, an advocate.”);
Chinea v. Sec'y of Health & Human Servs., No. 15-095V, 2019 WL 1873322, at
*19 (Fed. Cl. Spec. Mstr. Mar. 15, 2019), mot. for rev. denied, 144 Fed. Cl. 378,
386-87 (2019). This dichotomy is inconsistent with the purpose of Daubert test as
“mak[ing] certain that an expert, whether basing testimony upon professional
studies or personal experience, employs in the courtroom the same level of
intellectual rigor that characterizes the practice of an expert in the relevant field.”
Kumho Tire, 526 U.S. at 152 (1999). It also appears that when Dr. Steinman is
appearing in a courtroom on behalf of Mr. Tullio, he is disclaiming a methodology
(epidemiology) that he supported when he was participating in the report for the
Persian Gulf veterans. See Tr. 381-83; see also exhibit 41 at 3-4; exhibit 43, tabs
1-3. However, Dr. Steinman’s approach might be consistent with a view that
distinguishes scientists from participants in the civil litigation. See Andreu, 569
F.3d at 1380 (“Medical literature and epidemiological evidence must be viewed,
however, not through the lens of the laboratorian, but instead from the vantage
point of the Vaccine Act’s preponderant evidence standard . . . .”).
To the extent that Dr. Steinman shaped his opinions due to the litigation
setting, the undersigned did not detect that Dr. Steinman was motivated because he
was being paid for his time. Dr. Utz and Dr. Steinman testified that they earn
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money outside the Vaccine Program, including work as experts. Tr. 53-58 (Dr.
Utz), 307 (Dr. Steinman), 359-61 (Dr. Steinman). This information suggested that
compensation through the Vaccine Program is less than the amounts received
elsewhere.25 While Dr. Steinman receives monetary compensation, he also stated
that participating in the Vaccine Program keeps him “sharp” thinking about
“fascinating” cases. Tr. 308; accord Tr. 357. It seems that these non-pecuniary
benefits also motivate Dr. Steinman’s participation in the Vaccine Program.
Regardless, this case does not turn on why experts presented the opinions
they presented. Instead, the case resolves on the (lack of) persuasiveness of the
theory that the flu vaccine can cause rheumatoid arthritis via molecular mimicry.
As discussed above, the powerful epidemiologic evidence does not support this
hypothesis. Dr. Matloubian easily refuted the usefulness of Dr. Steinman’s Blast
searches. Finally, the complicated tetramer studies contradict, rather than support,
the assertion that hemagglutinin mimics collagen in an immunologically
meaningful way. Consequently, Mr. Tullio did not meet his burden of proof for
Althen prong one. While the finding on prong one means that Mr. Tullio is not
entitled to compensation, the remaining two Althen prongs are reviewed for
completeness.
V. Althen Prong 3: Timing
The timing prong from Althen actually contains two parts. A petitioner must
show the “timeframe for which it is medically acceptable to infer causation” and
that the onset of the disease occurred in this period. Shapiro v. Secʼy of Health &
Human Servs., 101 Fed. Cl. 532, 542-43 (2011), recons. denied after remand on
other grounds, 105 Fed. Cl. 353 (2012), aff’d without op., 503 F. App’x 952 (Fed.
Cir. 2013).
A. Appropriate Temporal Interval
As discussed in section III.B above, Mr. Tullio and his experts advance the
theory of molecular mimicry. Dr. Utz explained that molecular mimicry would not
25 Although Dr. Utz and Dr. Steinman could earn more money working outside of the
Vaccine Program, Dr. Utz and Dr. Steinman receive compensation at a higher hourly rate than
Dr. Matloubian and Dr. Halsey. The hourly rates for Dr. Matloubian and Dr. Halsey are $300
per hour for most activities and $150 per hour for travel. Tr. 399, 497-98, 566. Furthermore, the
higher hourly rates for the petitioner's expert more than offset the delay in payment that the
petitioner's experts encounter.
42

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occur immediately because the immune system must ramp up before the immune
system would damage host cells. Tr. 193. Although Dr. Utz’s testimony was not
as clear as possible on this point, he seemed to indicate that the process of
molecular mimicry would take at least one week. Tr. 159, 193, 211.
As discussed above, Dr. Matloubian disagrees with the premise that
molecular mimicry can explain a relationship between flu vaccine and rheumatoid
arthritis. Dr. Matloubian pointed out that rheumatoid arthritis is not usually
considered a post-infectious disease and the triggers for the disease are not known.
Tr. 402, 407. One of the proposed triggers, smoking, could expose a person to
developing rheumatoid arthritis for years before the autoimmune attack on joints
begins. Tr. 407. Thus, to Dr. Matloubian, attempting to determine the appropriate
interval for an inference of causation is a non-sequitur because the pathogenesis of
rheumatoid arthritis is not known.
When asked about molecular mimicry more generally, Dr. Matloubian stated
that the process of molecular mimicry would take at least one week to begin. Tr.
431, 512. Dr. Matloubian also set an outer bound for the occurrence of molecular
mimicry at six weeks. Id.
If Mr. Tullio had established the persuasiveness of the molecular mimicry
theory to explain how flu vaccine can cause rheumatoid arthritis, then the
appropriate time period would be one to six weeks.
B. Onset of Mr. Tullio’s Rheumatoid Arthritis
Mr. Tullio received the flu vaccine on September 20, 2012. Exhibit 1.
According to his testimony, he began to experience pain in his legs, especially his
calves, about one week later. Tr. 15. Dr. Utz saw this calf pain as an unusual
manifestation of rheumatoid arthritis. Tr. 71, 192-93, 235.
Dr. Matloubian placed the onset of Mr. Tullio’s rheumatoid arthritis at about
a month later, on October 25, 2012. Tr. 512. On this date, Mr. Tullio complained
to Dr. Samples about “diffuse body pain,” exhibit 16 at 62, and lab work
uncovered high levels of C-reactive protein, exhibit 6 at 246.
Whether Mr. Tullio’s rheumatoid arthritis started on September 27, 2012, or
October 25, 2012, is not material. Both dates fit within the accepted temporal
interval of one to six weeks. Therefore, if Mr. Tullio had established prong one, he
would have also established prong three.
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VI. Althen Prong 2: Logical Sequence of Cause and Effect
The final prong from Althen is for a petitioner to demonstrate “a logical
sequence of cause and effect.” 418 F.3d at 1278. The Federal Circuit has
encouraged special masters to consider carefully the views of any treating doctor.
Here, no treating doctor has persuasively opined that the flu vaccination
caused Mr. Tullio’s rheumatoid arthritis. See Pet’r’s Am. Preh’g Br. at 20. The
potentially most supportive statement came from Dr. Hsu, who diagnosed Mr.
Tullio with rheumatoid arthritis and who has treated him. Relatively early in her
treatment of him, Dr. Hsu stated: “I am concerned about a pain syndrome
associated with his flu vaccine.” Exhibit 4 at 14 (report dated Jan. 30, 2013).
However, as the Secretary notes, Resp’t’s Preh’g Br. at 22, after Dr. Hsu diagnosed
Mr. Tullio with rheumatoid arthritis, she did not associate his disease with his flu
vaccination.
The lack of support from treating doctors is consistent with the lack of
information about the cause of rheumatoid arthritis. As explained much earlier in
section I.B of this decision, the cause of rheumatoid arthritis is not known.
Furthermore, when epidemiologic studies have explored a potential association,
they have not found an increased incidence of rheumatoid arthritis in people who
received the flu vaccine. Thus, given this information, it would be surprising for a
doctor to tell Mr. Tullio that the flu vaccination caused his rheumatoid arthritis.
See Tr. 219 (Dr. Utz stating that he has never told any of his rheumatoid arthritis
patients that flu vaccination caused their rheumatoid arthritis).
VII. Conclusion
For the foregoing reasons, Mr. Tullio has not presented sufficient evidence
to show that the flu vaccine caused him to develop rheumatoid arthritis.
Accordingly, his claim for compensation is DENIED.
The Clerk’s Office is instructed to enter judgment in accord with this
decision.
IT IS SO ORDERED.
s/ Christian J. Moran
Christian J. Moran
Special Master
44

Case 1:15-vv-00051-MBH Document 132 Filed 01/14/20 Page 45 of 47
Appendix of Articles Cited
A.K. Abbas et al., Antigen Presentation to T Lymphocytes and the Functions of Major
Histocompatibility Complex Molecules, in Cellular and Molecular Immunology 117
(2017), filed as exhibit SS, tab 1.
Carola Bardage et al., Neurological and autoimmune disorders after vaccination against
pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based
cohort study in Stockholm, Sweden, 343 BMJ d5956 (2011), filed as exhibit QQ, tab 4.
Camilla Bengtsson et al., Common vaccinations among adults do not increase the risk of
developing rheumatoid arthritis: results from the Swedish EIRA study, 69 Annals of the
Rheumatic Diseases 1831 (2010), filed as exhibit A.
Clifton O. Bingham III & Malini Moni, Periodontal disease and rheumatoid arthritis: the
evidence accumulates for complex pathobiologic interactions, 25 Current Opinion in
Rheumatology 345 (2013), filed as exhibit 36.
Michael E. Birnbaum et al., Deconstructing the peptide-MHC specificity of T cell recognition,
157 Cell 1073 (2014), filed as exhibit 68.
Deborah Cory-Slechta & Robert Wedge (editors), Committee on Gulf War and Health Volume
10: Update of Health Effects of Serving in the Gulf War, 10 Gulf War Health S-1 (2016),
filed as exhibit 43.
Cynthia C. Crowson et al., The Lifetime Risk of Adult-Onset Rheumatoid Arthritis and Other
Inflammatory Autoimmune Rheumatic Diseases, 63 Arthritis & Rheumatism 633 (2011),
filed as exhibit O.
J.M. Davies et al., Rheumatoid Arthritis Sera React with a Phage-Displayed Peptide Selected by
a Monoclonal Antibody to Type II Collagen that has Homology to EBNA-1, 30
Autoimmunity 53 (1999), filed as exhibit Y.
Andrea Dessen et al., X-Ray Crystal Structure of HLA-DR4 (DRA*0101, DRB1*0401)
Complexed with a Peptide from Human Collagen II, 7 Immunity 473 (1997), filed as
exhibit 39.
Cem Gabay et al., Impact of Synthetic and Biologic Disease-Modifying Antirheumatic Drugs on
Antibody Responses to the AS03-Adjuvanted Pandemic Influenza Vaccine, 63 Arthritis &
Rheumatology 1486 (2011), filed as exhibit QQ, tab 7.
Neal A. Halsey et al., Algorithm to assess causality after individual adverse events following
immunizations, 30 Vaccine 5791 (2012), filed as exhibit QQ, tab 9.
Jens Hennecke & Don C. Wiley, Structure of a Complex of the Human α/β T Cell Receptor
(TCR) HA1.7, Influenza Hemagglutinin Peptide, and Major Histocompatibility Complex
Class II Molecule, HLA-DR4 (DRA*0101 and DRB1*0401): Insight into TCR Cross-
Restriction and Alloreactivity, 195 J. Experimental Med. 571 (2002), filed as exhibit 35.
45

Case 1:15-vv-00051-MBH Document 132 Filed 01/14/20 Page 46 of 47
Eddie A. James et al., Citrulline-Specific Th1 Cells Are Increased in Rheumatoid Arthritis and
Their Frequency Is Influenced by Disease Duration and Therapy, 66 Arthritis &
Rheumatology 1712 (2014), filed as exhibit SS, tab 4.
X. Li et al., Influenza virus haemagglutinin-derived peptides inhibit T-cell activation induced by
HLA-DR4/1 specific peptides in rheumatoid arthritis, 24 Clinical & Experimental
Rheumatology 148 (2006), filed as exhibit 37.
Karen Lundberg et al., Periodontis in RA—the citrullinated enolase connection, 6 Nature
Reviews: Rheumatology 727 (2010), filed as exhibit 38.
Vivian Malmström et al., The immunopathogenesis of seropositive rheumatoid arthritis: from
triggering to targeting, 17 Nature Reviews: Immunology 1 (2016), filed as exhibit PP,
tab 3.
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), filed as
exhibit CC.
Carla G. S. Saad et al., Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1
vaccine in a large cohort of autoimmune rheumatic diseases, 70 Annals of the Rheumatic
Diseases 1068 (2011), filed as exhibit QQ, tab 18.
Daniel A. Salmon et al., Association between Guillain-Barré syndrome and influenza A (H1N1)
2009 monovalent inactivated vaccines in the USA: a meta-analysis, 381 Lancet 1461
(2013), filed as exhibit QQ, tab 19.
Ami Schattner, Consequence or coincidence? The occurrence, pathogenesis and significance of
autoimmune manifestations after viral vaccines, 23 Vaccine 3876 (2005), filed as exhibit
EE.
Omri Snir et al., Identification and Functional Characterization of T Cells Reactive to
Citrullinated Vimentin in HLA-DRB1*0401-Positive Humanized Mice and Rheumatoid
Arthritis Patients, 63 Arthritis & Rheumatism 2873 (2011), filed as exhibit SS, tab 3.
K. Stratton et al., IOM Committee Review Adverse Effects of Vaccines: Evidence and Causality,
National Academy of Sciences (2011), filed as exhibit SS, tab 2.
Jian Sun et al., Superior Molecularly Altered Influenza Virus Hemagglutinin Peptide 308-317
Inhibits Collagen-Induced Arthritis by Inducing CD4+ Treg Cell Expansion, 64 Arthritis
& Rheumatism 2158 (2012), filed as exhibit 31.
Pia Svendsen et al., Tracking of Proinflammatory Collagen-Specific T Cells in Early and Late
Collagen-Induced Arthritis in Humanized Mice, 173 J. Immunology 7037 (2004), filed as
exhibit SS, tab 5.
Barbara Szomolay et al., Identification of human viral protein-derived ligands recognized by
individual MHCI-restricted T-cell receptors, 94 Immunology & Cell Biology 573 (2016),
filed as exhibit 73.
Brett Trost et al., No human protein is exempt from bacterial motifs, not even one, 1 Self/Nonself
328 (2010), filed as exhibit TT, tab 6.
46

Case 1:15-vv-00051-MBH Document 132 Filed 01/14/20 Page 47 of 47
L.A. Trouw et al., Autoimmunity in rheumatoid arthritis: different antigens—common principles,
72 Annals of the Rheumatic Diseases ii132 (2013), filed as exhibit 48.
Johanna Westra et al., Vaccination of patients with autoimmune inflammatory rheumatic
diseases, 11 Nature Reviews: Rheumatology 135 (2015), filed as exhibit II.
Linda Wooldridge et al., A Single Autoimmune T Cell Receptor Recognizes More Than a
Million Different Peptides, 287 J. Biological Chemistry 1168 (2012), filed as exhibit 69.
47

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_15-vv-00051-1
Date issued/filed: 2020-07-22
Pages: 37
Docket text: JUDGE VACCINE REPORTED OPINION. Signed by Senior Judge Marian Blank Horn. (kee) Service on parties made.
--------------------------------------------------------------------------------
Case 1:15-vv-00051-MBH Document 146 Filed 07/22/20 Page 1 of 37
In the United States Court of Federal Claims
No. 15-51V
Filed: June 18, 20201
* * * * * * * * * * * * * * * * * *
*
*
DOUGLAS TULLIO,
*
Petitioner, * Vaccine Act; Motion for Review;
* Preponderance of the Evidence;
v.
* Expert Opinions; Influenza Vaccine;
SECRETARY OF HEALTH AND * Rheumatoid Arthritis; Epidemiology;
HUMAN SERVICES, * Application of Althen Test.
*
Respondent. *
*
* * * * * * * * * * * * * * * * * *
Jennifer Ann Gore Maglio, Maglio Christopher and Toale, P.A., Sarasota, FL, for
petitioner.
Dhairya D. Jani, Trial Attorney, Torts Branch, Civil Division, United States
Department of Justice, Washington, D.C., for respondent. With him were Heather L.
Pearlman, Assistant Director, Torts Branch, Civil Division, Catherine E. Reeves, Deputy
Director, Torts Branch, Civil Division, C. Salvatore D’Alessio, Acting Director, Torts
Branch, Civil Division, and Ethan P. Davis, Assistant Attorney General, Civil Division.
O P I N I O N
HORN, J.
On January 20, 2015, petitioner Douglas Tullio filed a petition for compensation
with the National Vaccine Injury Compensation Program (Vaccine Program), under the
National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1–300aa-34 (2012)
(Vaccine Act), for an off-Table injury. See 42 U.S.C. § 300aa-11(c)(1)(C)(ii) (2012).
Petitioner claimed that a September 29, 2012 fluzone high-dose influenza vaccination
caused him to develop “rheumatoid arthritis.” On December 19, 2019, Special Master
Christian J. Moran of the United States Court of Federal Claims denied petitioner’s claim
for an award of compensation, finding that petitioner had not shown, by a preponderance
of the evidence, that he is entitled to compensation under the Vaccine Act. See generally
Tullio v. Sec’y of Health & Human Servs., No. 15-51V, 2019 WL 7580149 (Spec. Mstr.
Fed. Cl. Dec. 19, 2019). On January 21, 2020, petitioner filed a motion for review in this
1 Reissued for Publication: July 22, 2020. This Opinion was issued under seal on June
18, 2020. The parties did not propose redactions to the June 18, 2020 Opinion, thus, the
court issues the decision without redactions for public distribution.

Case 1:15-vv-00051-MBH Document 146 Filed 07/22/20 Page 2 of 37
court of the Special Master’s decision denying his claim pursuant to Rule 23 of the
Vaccine Rules of the United States Court of Federal Claims (2019) (Vaccine Rules).
F I N D I N G S O F F A C T
The following summary of the relevant facts regarding petitioner’s medical history
are established in the record before the court, many of which are not in dispute. On
September 29, 2012, petitioner received a fluzone high-dose vaccination. According to
the record before the court, at the time he received the vaccination, petitioner was working
full-time with his wife, with whom he owned a business, and was sixty-nine years old. On
October 12, 2012, petitioner saw an internist, Dr. John Samples, for the first time, at which
time he complained that his legs “feel weaker.” Thirteen days later, on October 25, 2012,
petitioner once again visited Dr. Samples for an “[u]rgent overbooked visit,” because
petitioner complained of “diffuse body pain, worse since the last visit here 12 [sic] days
ago.” At that visit, petitioner had bloodwork done.
Throughout November and December of 2012, petitioner complained of pain and
weakness in his legs to multiple medical providers. A diagnosis of possible Guillain-Barré
syndrome (GBS) was considered, which led Dr. Mark Bouffard, a pain specialist, to refer
petitioner to a neurologist, Dr. Catherine Brignoni, on November 28, 2012. On December
4, 2012, petitioner visited Dr. Brignoni with the chief complaint of “[p]ossible GBS, diffuse
weakness and paresthesia after a flu vaccine.” Dr. Brignoni conducted a neurological
exam on petitioner, and based on the results, Dr. Brignoni began to treat petitioner for
GBS. While Dr. Brignoni was treating petitioner for GBS, she stated “[h]e should not
receive the flu vaccine any more [sic].” According to petitioner’s medical records, the
treatments to improve his pain from GBS “helped his bilateral shoulder pains and leg/thigh
pains” initially, but “the weakness has not changed.” This led petitioner to seek a second
opinion from Dr. Perry Shieh at the University of California, Los Angeles, neurology
department on January 18, 2013. Dr. Shieh recommended that petitioner see a
rheumatologist.
Petitioner initially saw a rheumatologist, Dr. Sheri Hsu on January 30, 2013. At the
first visit with Dr. Hsu, petitioner was not suffering from joint swelling, but was suffering
from joint pain. At the January 30, 2013 visit, Dr. Hsu made a note in petitioner’s medical
records, “I am concerned about a pain syndrome associated with his flu vaccine.” In
February 2013, petitioner did complain of joint swelling. While treating petitioner, Dr. Hsu
provided several different theories to explain petitioner’s pain, including all of the following
potential and distinct diagnoses: “seronegative RA [rheumatoid arthritis],” “Reactive
arthritis,” “Arthralgia,” “DDD [degenerative disc disease] lumbar spine,” and “Atrial
fibrillation.” (brackets added). By June 6, 2013, Dr. Hsu had diagnosed petitioner with
“seronegative RA [rheumatoid arthritis].”2 (capitalization in original) (brackets added).
2 One of petitioner’s experts Dr. Paul J. Utz testified at the hearing before Special Master
Moran, regarding the distinction between two types of rheumatoid arthritis, seropositive
and seronegative: “It is not a clean distinction. There is overlap between the two of them.”
Dr. Utz further testified that seronegative rheumatoid arthritis, “is more heterogenous in
2

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According to the most recent medical records dated December 11, 2018 from Dr. Hsu, as
well as petitioner’s testimony at the March 6 through 8, 2019 hearing, petitioner was still
suffering from rheumatoid arthritis.
On January 20, 2015, petitioner filed a petition within the statutory time period for
filing a petition for compensation with the Vaccine Program pursuant to the Vaccine Act.
In his petition, Mr. Tullio alleged, in relevant part:
6. To the current date, Petitioner continues to suffer from his
vaccine-induced injury.
7. Petitioner’s injuries are causally related to an adverse reaction
to a vaccination or vaccinations listed in 42 U.S.C. § 300aa-14.
8. Petitioner’s vaccine related injuries have lasted more than six
months. See, e.g., P Ex. 10 at 2-3.
Petitioner also stated in his petition that “his condition continued and subsequent
evaluation identified Petitioner’s condition as a rheumatological injury, most likely reactive
arthritis caused by his influenza vaccination. See, e.g., P Ex. 4 at 11-15; P Ex 17 at 18-
19.”3
On January 21, 2015, petitioner’s case was assigned to Special Master Christian
J. Moran. On January 22, 2015, petitioner filed eighteen exhibits, which included 1,257
terms of presentation and joint involvement and things like that. They tend to have less
severe disease.” Dr. Utz testified that generally seronegative rheumatoid arthritis is
determined by “the CCP test, which is just one test, is negative.” Dr. Utz also testified,
“CCP stands for cyclic citrullinated peptide.” Dr. Mehrdad Matloubian, respondent’s
expert, testified, “[a]s we have understood more about pathogenesis of seropositive
rheumatoid arthritis, this anti-citrullinated peptide antibody, ACPA, or anti-CCP is used to
distinguish between people who are seropositive and seronegative RA [rheumatoid
arthritis].” (brackets added). Respondent’s expert Dr. Matloubian also testified, when
asked “[d]oes seronegative RA [rheumatoid arthritis] in particular present
heterogeneously?” responded: “It can.” (brackets added).
3 By the time of the March 6-8, 2019 hearing before Special Master Moran, both parties
agreed that petitioner’s diagnosis is seronegative rheumatoid arthritis, not reactive
arthritis. At the hearing before Special Master Moran, petitioner’s counsel asked
petitioner’s expert, Dr. Utz, the following question, “hindsight being 20/20, what do you
believe that Mr. Tullio had after his September 2012 vaccination?” Dr. Utz responded, “I
think this was all seronegative rheumatoid arthritis from the beginning.” Respondent
agreed in its February 19, 2019 pre-hearing submission, stating, “petitioner was ultimately
diagnosed with seronegative RA [rheumatoid arthritis] by Dr. Hsu based on objective
findings of synovitis on examination. Pet. Ex. 4 at 23. The parties’ experts all agree with
this diagnosis.” (brackets added).
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pages of contemporaneous records from physicians’ offices and hospitals Mr. Tullio had
visited prior to filing his petition. On January 22, 2015, Special Master Moran issued an
Order which required petitioner to file a statement of completion once any “outstanding
medical records and affidavits” were filed. On April 7, 2015, petitioner filed his statement
of completion, after filing an affidavit by petitioner and additional medical records.
Throughout the proceedings before Special Master Moran, however, petitioner continued
to file updated medical records, with the last filing submitted to the court on March 7, 2019
during the hearing.
On June 17, 2015, respondent filed a Vaccine Rule 4c Report in which respondent
stated “[n]either RA [rheumatoid arthritis] nor reactive arthritis are presumptive injuries
following flu vaccine. Therefore, petitioner necessarily pursues a cause-in-fact claim.”
(brackets added). Respondent also contended in the Rule 4c Report, “[o]n the existing
record, petitioner has failed to provide preponderant evidence in support of the petition
for compensation.” Respondent further stated:
Without an expert opinion to support his claim, the sum total of petitioner’s
case is: that he received a flu vaccine on September 29, 2012; within three
weeks developed a rheumatologic condition (either reactive arthritis or RA
[rheumatoid arthritis]); and, no other cause for his condition has been
identified. However, as the Federal Circuit has cautioned, “neither a mere
showing of a proximate temporal relationship between vaccine and injury,
nor a simplistic elimination of other potential causes of the injury suffices,
without more, to meet the burden of showing actual causation.” Moberly[ ex
rel. Moberly v. Sec’y of Health & Human Servs.], 592 F.3d [1315,] 1323-24
[(Fed. Cir. 2010)]; citing Althen[ v. Sec’y of Health & Human Servs.], 418
F.3d [1274,] 1278 [(Fed. Cir. 2005)].
(brackets added).
During the proceedings before Special Master Moran, the parties in this case
called four experts, two for the petitioner and two for the respondent, who filed, in total,
ten expert reports. Petitioner’s experts were Dr. Paul J. Utz and Dr. Lawrence Steinman.
As of the most recent Curriculum Vitae filed on February 28, 2019, Dr. Utz is Board-
certified in rheumatology and completed a residency in immunology and rheumatology.
Dr. Utz also is the Director Emeritus of the Medical Scientist Training Program and
Associate Director for Education of the Institute for Immunity, Transplantation, and
Infection at Stanford University. In addition, Dr. Utz provides care at the Veterans Affairs
Palo Alto Health Care Hospital and Clinics. Dr. Utz introduced and relied on the Bingham
article and the Hennecke, Birnbaum, and Wooldridge papers. As of the most recent
Curriculum Vitae filed on February 28, 2019, Dr. Steinman is a Board-certified neurologist
and is a professor of neurology and neurological sciences at Stanford University. Dr.
Steinman offered Blast search testimony. Respondent’s experts were Dr. Mehrdad
Matloubian and Dr. Neal Halsey. As of the most recent Curriculum Vitae filed on February
28, 2019, Dr. Matloubian is a Board-certified rheumatologist who practices rheumatology.
Dr. Matloubian has a Ph.D. in virology. Dr. Matloubian is a Clinical Professor at University
4

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of California San Francisco. Dr. Matloubian introduced and relied on the Westra,
Malmström, Svendsen, James, and Snir studies. As of his most recent Curriculum Vitae
filed on February 28, 2019, Dr. Halsey is Board-certified in pediatrics and pediatric
infectious diseases. Dr. Halsey is the Director Emeritus of the Institute for Vaccine Safety
at the Johns Hopkins Bloomberg School of Public Health. Dr. Halsey introduced and
relied on the Bardage and Ray studies. The various articles, studies, and papers
introduced by the experts are discussed more fully below.
On January 4, 2019, petitioner submitted his pre-hearing brief to Special Master
Moran. The Special Master, however, indicated in an order on January 22, 2019 that “Mr.
Tullio’s brief did not persuasively advocate his case, and he was instructed to file an
amended brief.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *4. On
January 28, 2019, according to Special Master Moran, the petitioner “filed an amended
and improved brief.” Id. Petitioner’s January 28, 2019 pre-hearing brief alleged that “[t]he
primary issue in controversy in this case is Althen[ v. Secretary of Health & Human
Services] prong I, whether or not the influenza vaccination can cause RA [rheumatoid
arthritis].” (brackets and emphasis added). Petitioner also stated he is “not required to
introduce evidence of epidemiologic studies” because “[s]uch an approach would be
inconsistent with allowing ‘the use of circumstantial evidence envisioned by the
preponderance standard and negates the system created by Congress.’” (quoting Althen
v. Sec’y of Health & Human Servs., 418 F.3d at 1280). Regarding expert’s opinions that
are not directly supported by literature, petitioner stated the expert’s opinion “can also
surpass the threshold requirement for reliability, provided that the expert explains his
process at arriving at that opinion by scientific methodology.” (citing Daubert v. Merrell
Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1319 (9th Cir.), cert. denied, 516 U.S. 869
(1995)). Petitioner alleged “[t]hrough expert testimony consistent with his medical course,
Petitioner provides preponderant evidence that he suffered RA [rheumatoid arthritis] as
the result of an aberrant, individual immune response to what should have been a
beneficial influenza vaccination in 2012.” (brackets added). Petitioner also noted thirteen
cases in which a Special Master of the United States Court of Federal Claims has granted
compensation for a petitioner who developed rheumatoid arthritis after an influenza
vaccination.4
4 Petitioner’s statement in its January 28, 2019 pre-hearing brief is misleading. Although
the cases that petitioner cited granted compensation for petitioners who received
influenza vaccinations that the petitioners alleged led to rheumatoid arthritis, the
respective Special Masters did not find causation. The petitioners and respondents in
each of those cases stipulated that petitioners were entitled to compensation, but the
respondent denied the influenza vaccinations led to petitioners’ injuries. See Egan v.
Sec’y of Health & Human Servs., No. 15-976V; Zimmerman v. Sec’y of Health & Human
Servs., No. 14-323V; Walker v. Sec’y of Health & Human Servs., No. 14-921V; Ward v.
Sec’y of Health & Human Servs., No. 16-72V; Stolowski v. Sec’y of Health & Human
Servs., No. 12-635V; Miller v. Sec’y of Health & Human Servs., No. 13-837V; Hambleton
v. Sec’y of Health & Human Servs., No. 13-819V; Scales v. Sec’y of Health & Human
Servs., No. 13-501V; Habchy v. Sec’y of Health & Human Servs., No. 11-680V; Wallace
v. Sec’y of Health & Human Servs., No. 11-627V; DeMartini v. Sec’y of Health & Human
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Respondent filed its final pre-hearing submission on February 19, 2019, in which
respondent contended, “[i]n evaluating the reliability of petitioner’s expert’s opinion, a
special master ‘may conclude that there is simply too great an analytical gap between the
data and the opinion proffered.’” (quoting Cedillo v. Sec’y of Health & Human Servs., 617
F.3d 1328, 1339 (Fed. Cir. 2010)). Respondent stated, “[g]eneric theories of causation
are patently insufficient to meet petitioner’s burden of proof.” (citing Broekelschen v. Sec’y
of Health & Human Servs., 618 F.3d 1339, 1350-51 (Fed. Cir. 2010)). Respondent argued
that the absence of an association between the flu vaccine and rheumatoid arthritis “is
striking, given the high incidence of influenza infection globally and the numerous articles
that have been published on both influenza and RA [rheumatoid arthritis].” (brackets
added). Regarding the comment by Dr. Hsu, petitioner’s treating rheumatologist, at Mr.
Tullio’s first visit that stated “I am concerned about a pain syndrome associated with his
[petitioner’s] flu vaccine,” the respondent noted “it does not appear from her [Dr. Hsu’s]
later medical records that once she diagnosed petitioner with seronegative RA
[rheumatoid arthritis], that she ever mentioned the flu vaccine as a cause of his condition.”
(brackets added). Finally, respondent stated “[t]here is no ‘appropriate’ timeframe within
which medical science would expect RA [rheumatoid arthritis] to occur following the
administration of the flu vaccine, because the flu vaccine does not cause RA [rheumatoid
arthritis].” (brackets added).
From March 6, 2019 until March 8, 2019, Special Master Moran held an entitlement
hearing in San Francisco, California to determine whether petitioner should receive
compensation under the Vaccine Act, at which petitioner and all four experts testified. On
December 19, 2019, after describing the relevant medical events in petitioner’s history
and reviewing the evidence in the record before him, including the expert opinions offered
by both petitioner and respondent, Special Master Moran issued his decision denying
petitioner’s claim of entitlement to compensation. The Special Master found petitioner had
failed to carry his burden of proving how the flu vaccine had caused his rheumatoid
arthritis.
With regard to the first prong of the Althen test, described more fully below, “a
medical theory causally connecting the vaccination and the injury,” Althen v. Secretary of
Health & Human Services, 418 F.3d at 1278,5 Special Master Moran concluded that the
evidence presented by petitioner regarding molecular mimicry “fell short” of being
persuasive to establish petitioner’s case. See Tullio v. Sec’y of Health & Human Servs.,
2019 WL 7580149, at *22. The Special Master indicated that the epidemiological
evidence presented by respondent “weakens the reliability of opinions that the flu vaccine
Servs., No. 12-734V; Gifford v. Sec’y of Health & Human Servs., No. 10-325V; Merrill v.
Sec’y of Health & Human Servs., No. 7-278V.
5 The three prongs described in Althen v. Secretary of Health & Human Services, are: “(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 at 1278.
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can cause rheumatoid arthritis.” Id. at *11. Special Master Moran also wrote “there is
ample legal justification for considering epidemiological studies in determining whether
the flu vaccine can cause rheumatoid arthritis.” Id. at *8. Special Master Moran disputed
the proposition urged by petitioner – that petitioner’s T cell repertoire was so rare that it
would not have been detected by epidemiology. Special Master Moran stated: “As Dr.
Halsey pointed out, epidemiological studies have identified that the risk of developing
Guillain-Barré syndrome after flu vaccination is increased by one case or two cases per
million doses of vaccination. This example refutes a commonly offered argument that
epidemiological studies cannot detect rare events.” Id.
Despite finding that “Mr. Tullio did not meet his burden of proof for Althen prong
one,” Special Master Moran reviewed “the remaining two Althen prongs . . . for
completeness.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *27.
Special Master Moran reviewed petitioner’s claim under the second prong of the Althen
test, whether there exists a “logical sequence of cause and effect.” Althen v. Sec’y of
Health & Human Servs., 418 F.3d at 1278. Special Master Moran stated “[t]he lack of
support from treating doctors is consistent with the lack of information about the cause of
rheumatoid arthritis. As explained much earlier in section I.B of this decision, the cause
of rheumatoid arthritis is not known.” Tullio v. Sec’y of Health & Human Servs., 2019 WL
7580149, at *28. Special Master Moran stated, “given this information, it would be
surprising for a doctor to tell Mr. Tullio that the flu vaccination caused his rheumatoid
arthritis.” Id. The Special Master found “Mr. Tullio also has not established, by
preponderant evidence, a logical sequence of cause and effect.” Id. at *5.
In addition, Special Master Moran examined the case in the context of the third
prong of the Althen test, “a showing of a proximate temporal relationship between
vaccination and injury.” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278.
Based only on Dr. Utz’s testimony that molecular mimicry would take at least one week,
and Dr. Matloubian’s testimony that molecular mimicry would take between one and six
weeks, Special Master Moran made his finding that “the appropriate time period would be
one to six weeks.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *27.
As a result, because the petitioner had reported experiencing calf pain approximately one
week after receiving the flu vaccination and had complained to Dr. Samples of “diffuse
body pain” on October 25, 2012, about one month after the vaccination, Special Master
Moran concluded that “[b]oth dates fit within the accepted temporal interval of one to six
weeks. Therefore, if Mr. Tullio had established prong one, he would have also established
prong three.” Id. As a result of his review of the record before him Special Master Moran
denied petitioner’s claim for compensation. Thereafter, petitioner filed the motion for
review currently under consideration on January 21, 2020.6 The government responded
on February 19, 2020, and petitioner filed his reply on April 14, 2020. On April 28, 2020,
this court held a telephonic oral argument.
6 Mr. Tullio’s motion for review was filed within the statutory time period on Tuesday,
January 21, 2020 because Monday, January 20, 2020 was a federal holiday and this court
was closed.
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D I S C U S S I O N
When reviewing a Special Master’s decision, the assigned Judge of the United
States Court of Federal Claims shall:
(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 conclusions 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) (2018). The legislative history of the Vaccine Act states: “The
conferees have provided for a limited standard for appeal from the [special] master’s
decision and do not intend that this procedure be used frequently, but rather in those
cases in which a truly arbitrary decision has been made.” H.R. Rep. No. 101-386, at 517
(1989) (Conf. Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.
In Markovich v. Secretary of Health & Human Services, the United States Court of
Appeals for the Federal Circuit wrote, “[u]nder the Vaccine Act, the Court of Federal
Claims reviews the Chief Special Master’s decision to determine if it is ‘arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with the law.’ 42 U.S.C.
§ 300aa-12(e)(2)(B).” Markovich v. Sec’y of Health & Human Servs., 477 F.3d 1353,
1355-56 (Fed. Cir.), cert. denied, 552 U.S. 816 (2007); see also K.G. v. Sec’y of Health
& Human Servs., 951 F.3d 1374, 1379 (Fed. Cir. 2020); Oliver v. Sec’y of Health & Human
Servs., 900 F.3d 1357, 1360 (Fed. Cir. 2018) (citing Milik v. Sec’y of Health & Human
Servs., 822 F.3d 1367, 1375-76 (Fed. Cir. 2016)); Deribeaux ex rel. Deribeaux v. Sec’y
of Health & Human Servs., 717 F.3d 1363, 1366 (Fed. Cir.), reh’g and reh’g en banc
denied (Fed. Cir. 2013) (The United States Court of Appeals for the Federal Circuit stated
that “we ‘perform[ ] the same task as the Court of Federal Claims and determine[ ] anew
whether the special master’s findings were arbitrary or capricious.’” (brackets in original)
(quoting Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir.
2000))); W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1355 (Fed. Cir. 2013);
Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355, 1363 (Fed. Cir. 2012);
de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008);
Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343, 1347 (Fed. Cir.) (“Under the
Vaccine Act, we review a decision of the special master under the same standard as the
Court of Federal Claims and determine if it is ‘arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with law.’” (quoting 42 U.S.C. § 300aa-12(e)(2)(B))), reh’g
and reh’g en banc denied (Fed. Cir. 2008); Althen v. Sec’y of Health & Human Servs.,
418 F.3d at 1277; Faup v. Sec’y of Health & Human Servs., 147 Fed. Cl. 445, 458 (2019);
Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. 43, 47 (2013); Taylor v. Sec’y of
8

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Health & Human Servs., 108 Fed. Cl. 807, 817 (2013). The arbitrary and capricious
standard is “well understood to be the most deferential possible.” Munn v. Sec’y of Health
& Human Servs., 970 F.2d 863, 870 (Fed. Cir. 1992). The United States Court of Appeals
for the Federal Circuit has indicated that:
These standards vary in application as well as degree of deference. Each
standard applies to a different aspect of the judgment. Fact findings are
reviewed by us, as by the Claims Court judge, under the arbitrary and
capricious standard; legal questions under the “not in accordance with law”
standard . . . ; and discretionary rulings under the abuse of discretion
standard. The latter will rarely come into play except where the special
master excludes evidence.
Munn v. Sec’y of Health & Human Servs., 970 F.2d at 871 n.10; see also Carson ex rel.
Carson v. Sec’y of Health & Human Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013);
Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1366; W.C.
v. Sec’y of Health & Human Servs., 704 F.3d at 1355; Griglock v. Sec’y of Health &
Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012); Porter v. Sec’y of Health & Human
Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011) (citing Broekelschen v. Sec’y of Health &
Human Servs., 618 F.3d at 1345) (explaining that the reviewing court “do[es] not reweigh
the factual evidence, assess whether the special master correctly evaluated the evidence,
or examine the probative value of the evidence or the credibility of the witnesses—these
are all matters within the purview of the fact finder”) reh’g and reh’g en banc denied (Fed.
Cir. 2012); Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. at 56. “[T]he special
masters have broad discretion to weigh evidence and make factual determinations.”
Dougherty v. Sec’y of Health & Human Servs., 141 Fed. Cl. 223, 229 (2018).
With regard to both fact-findings and fact-based conclusions, the key
decision maker in the first instance is the special master. The Claims Court
owes these findings and conclusions by the special master great
deference – no change may be made absent first a determination that the
special master was “arbitrary and capricious.”
Munn v. Sec’y of Health & Human Servs., 970 F.2d at 870; see also 42 U.S.C. § 300aa-
12(e)(2)(B).
Generally, “if the special master ‘has considered the relevant evidence of record,
drawn plausible inferences and articulated a rational basis for the decision, reversible
error will be extremely difficult to demonstrate.’” Hibbard v. Sec’y of Health & Human
Servs., 698 F.3d at 1363 (quoting Hines v. Sec’y of Health & Human Servs., 940 F.2d
1518, 1528 (Fed. Cir. 1991)); see also Porter v. Sec’y of Health & Human Servs., 663
F.3d at 1253-54; Lampe v. Sec’y of Health & Human Servs., 219 F.3d at 1360; Avila ex
rel. Avila v. Sec’y of Health & Human Servs., 90 Fed. Cl. 590, 594 (2009); Dixon v. Sec’y
of Health & Human Servs., 61 Fed. Cl. 1, 8 (2004) (“The court’s inquiry in this regard must
therefore focus on whether the Special Master examined the ‘relevant data’ and
articulated a ‘satisfactory explanation for its action including a rational connection
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between the facts found and the choice made.’” (quoting Motor Vehicle Mfrs. Ass’n v.
State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (quoting Burlington Truck Lines,
Inc. v. United States, 371 U.S. 156, 168 (1962)))).
As noted by the United States Court of Appeals for the Federal Circuit:
Congress assigned to a group of specialists, the Special Masters within the
Court of Federal Claims, the unenviable job of sorting through these painful
cases and, based upon their accumulated expertise in the field, judging the
merits of the individual claims. The statute makes clear that, on review, the
Court of Federal Claims is not to second guess the Special Masters [sic]
fact-intensive conclusions; the standard of review is uniquely deferential for
what is essentially a judicial process. Our cases make clear that, on our
review . . . we remain equally deferential. That level of deference is
especially apt in a case in which the medical evidence of causation is in
dispute.
Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1366-67
(modification in original) (quoting Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958,
961 (Fed. Cir. 1993)); Hibbard v. Sec’y of Health & Human Servs., 698 F.3d at 1363;
Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1380 (Fed. Cir. 2012). The
United States Court of Appeals for the Federal Circuit has explained that the reviewing
courts “‘do not sit to reweigh the evidence. [If] the special master's conclusion [is] based
on evidence in the record that [is] not wholly implausible, we are compelled to uphold that
finding as not being arbitrary and capricious.’” Deribeaux ex rel. Deribeaux v. Sec’y of
Health & Human Servs., 717 F.3d at 1367 (modification in original) (quoting Lampe v.
Sec’y of Health & Human Servs., 219 F.3d at 1363); see also K.G. v. Sec’y of Health &
Human Servs., 951 F.3d at 1379 (“With respect to factual findings, however, we will
uphold the special master’s findings of fact unless they are clearly erroneous.” (citing
Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278)); Hibbard v. Sec’y of Health
& Human Servs., 698 F.3d at 1363 (citing Cedillo v. Sec’y of Health & Human Servs., 617
F.3d at 1338).
The United States Court of Appeals for the Federal Circuit has explained that:
A petitioner can establish causation in one of two ways. Id. [Broekelschen
v. Sec’y of Health & Human Servs., 618 F.3d at 1341] If the petitioner shows
that he or she received a vaccination listed on the Vaccine Injury Table, 42
U.S.C. § 300aa–14, and suffered an injury listed on that table within a
statutorily prescribed time period, then the Act presumes the vaccination
caused the injury. Andreu[ ex rel. Andreu] v. Sec’y of Health & Human
Servs., 569 F.3d 1367, 1374 (Fed. Cir. 2009). Where, as here, the injury is
not on the Vaccine Injury Table, the petitioner may seek compensation by
proving causation-in-fact.
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Milik v. Sec’y of Health & Human Servs., 822 F.3d at 1379 (citing Andreu ex rel. Andreu
v. Sec’y of Health & Human Servs., 569 F.3d at 1374); see also W.C. v. Sec’y of Health
& Human Servs., 704 F.3d at 1356; Broekelschen v. Sec’y of Health & Human Servs.,
618 F.3d at 1346; Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1356 (Fed.
Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2006), cert. denied, 551 U.S. 1102 (2007);
Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1147-48 (Fed. Cir. 1992); Faup
v. Sec’y of Health & Human Servs., 147 Fed. Cl. at 458; Dodd v. Sec’y of Health & Human
Servs., 114 Fed. Cl. at 50; Paluck v. Sec’y of Health & Human Servs., 104 Fed. Cl. 457,
467-68 (2012); Fesanco v. Sec’y of Health & Human Servs., 99 Fed. Cl. 28, 31 (2011).
For petitioner to establish a prima facie case in a vaccine case, decisions of the
Federal Circuit permit the use of circumstantial evidence, which the court described as
“envisioned by the preponderance standard” and by the vaccine system created by
Congress, in which “close calls regarding causation are resolved in favor of injured
claimants” without the need for medical certainty. See Althen v. Sec’y of Health & Human
Servs., 418 F.3d at 1280; see also Cloer v. Sec’y of Health & Human Servs., 654 F.3d
1322, 1332 n.4 (Fed. Cir. 2011), cert. denied, 566 U.S. 956 (2012); Andreu ex rel. Andreu
v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (“In Althen,
however, we expressly rejected the Stevens test, concluding that requiring ‘objective
confirmation’ in the medical literature prevents ‘the use of circumstantial evidence . . . and
negates the system created by Congress’ through the Vaccine Act.” (modification in
original)); La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 198 (2013)
(“Causation-in-fact can be established with circumstantial evidence, i.e., medical records
or medical opinion.”), aff’d, 746 F.3d 1344 (Fed. Cir. 2014). The Althen court further noted
that “the purpose of the Vaccine Act’s preponderance standard is to allow the finding of
causation in a field bereft of complete and direct proof of how vaccines affect the human
body.” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1280 (citing Knudsen ex
rel. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)); see
also W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1356.
When proving eligibility for compensation for a petitioner of an off-Table injury
under the Vaccine Act, such as the one filed by Mr. Tullio, petitioner may not rely on his
or her testimony alone. According to the Vaccine Act, “[t]he special master or court may
not make such a finding based on the claims of a petitioner alone, unsubstantiated by
medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1). A petitioner who
meets his or her burden is entitled to recovery under the Vaccine Act, unless the
respondent proves by preponderant evidence that the injury was caused by factors
unrelated to the vaccine. See Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373,
1379-80 (Fed. Cir. 2012); Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146,
1151 (Fed. Cir. 2007); see also Rus v. Sec’y of Health & Human Servs., 129 Fed. Cl. 672,
680 (2016) (citing 42 U.S.C. § 300aa-13(a)(1)(B); Shalala v. Whitecotton, 514 U.S. 268,
270-71 (1995)). “But, regardless of whether the burden of proof ever 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.” Rus v. Sec’y of
Health & Human Servs., 129 Fed. Cl. at 680 (citing Stone v. Sec’y of Health & Human
Servs., 676 F.3d at 1379; de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1353).
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Petitioner also must prove causation-in-fact in an off-Table injury. See Grant v.
Sec’y of Health & Human Servs., 956 F.2d at 1147-48. The United States Court of
Appeals for the Federal Circuit has held that causation-in-fact in the Vaccine Act context
is the same as the “legal cause” in the general torts context. See Shyface v. Sec’y of
Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). Therefore, drawing from
the Restatement (Second) of Torts, the vaccine is a cause-in-fact when it is “‘a substantial
factor in bringing about the harm.’” de Bazan v. Sec’y of Health & Human Servs., 539
F.3d at 1351 (quoting the Restatement (Second) of Torts § 431(a) (1965)); see also Oliver
v. Sec’y of Health & Human Servs., 900 F.3d at 1361 (citing Moberly ex rel. Moberly v.
Sec’y of Health & Human Servs., 592 F.3d at 1321); Deribeaux ex rel. Deribeaux v. Sec’y
of Health & Human Servs., 717 F.3d at 1367 (“To prove causation, a petitioner must show
that the vaccine was ‘not only a but-for cause of the injury but also a substantial factor in
bringing about the injury.’” (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d
at 1352–53)). A “‘substantial factor’ standard requires a greater showing than ‘but for’
causation.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1351 (citing Shyface
v. Sec’y of Health & Human Servs., 165 F.3d at 1352). “However, the petitioner need not
show that the vaccine was the sole or predominant cause of her injury, just that it was a
substantial factor.” Id. (citing Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146,
1150 (Fed. Cir. 2007)). A Judge of the United States Court of Federal Claims has
explained the relationship between “but-for” causation and “substantial factor” in
Deribeaux ex rel. Deribeaux v. Secretary of Health & Human Services:
The de Bazan [v. Sec’y of Health & Human Servs., 539 F.3d at 1351] court
defined but-for causation as requiring that “the harm be attributable to the
vaccine to some nonnegligible degree,” and noted that, although substantial
is somewhere beyond the low threshold of but-for causation, it does not
mean that a certain factor must be found to have definitively caused the
injury. Id. [de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1351]
Accordingly, a factor deemed to be substantial is one that falls somewhere
between causing the injury to a non-negligible degree and being the “sole
or predominant cause.” Id.
This definition of substantial—somewhere between non-negligible and
predominant—is applicable to respondent's burden to prove a sole
substantial factor unrelated to the vaccine. Accordingly, a respondent's
burden is to prove that a certain factor is the only substantial factor—one
somewhere between non-negligible and predominant—that caused the
injury.
Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 105 Fed. Cl. 583, 595
(2012), aff’d, 717 F.3d 1363 (Fed. Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2013)
(emphasis in original).
In order to recover under the Vaccine Act, a petitioner “must show, by a
preponderance of the evidence, ‘that the injury or death at issue was caused by a
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vaccine.’” Milik v. Sec’y of Health & Human Servs., 822 F.3d at 1379; (quoting
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d at 1341 (citing 42 U.S.C.
§§ 300aa–11(c)(1), –13(a)(1))); see also Oliver v. Sec’y of Health & Human Servs., 900
F.3d at 1361; W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1355-56 (“The Vaccine
Act created the National Vaccine Injury Compensation Program, which allows certain
petitioners to be compensated upon showing, among other things, that a person
‘sustained, or had significantly aggravated’ a vaccine-related ‘illness, disability, injury, or
condition.’” (quoting 42 U.S.C. § 300aa–11(c)(1)(C))); see also Boatmon v. Sec’y of
Health & Human Servs., 941 F.3d 1351, 1355, 1359 (Fed. Cir. 2019); Oliver v. Sec’y of
Health & Human Servs., 900 F.3d at 1360; La Londe v. Sec’y of Health & Human Servs.,
746 F.3d 1334, 1339 (Fed. Cir. 2014); Lombardi v. Sec’y of Health & Human Servs., 656
F.3d 1343, 1350 (Fed. Cir. 2011) (“A petitioner seeking compensation under the Vaccine
Act must prove by a preponderance of the evidence that the injury or death at issue was
caused by a vaccine.”); Faup v. Sec’y of Health & Human Servs., 147 Fed. Cl. at 458;
see also Shapiro v. Sec’y of Health & Human Servs., 105 Fed. Cl. 353, 358 (2012), aff’d,
503 F. App’x 952 (Fed. Cir. 2013); Jarvis v. Sec’y of Health & Human Servs., 99 Fed. Cl.
47, 54 (2011). “Nonetheless, the petitioner must do more than demonstrate a ‘plausible’
or ‘possible’ causal link between the vaccination and the injury; he must prove his case
by a preponderance of the evidence.” W.C. v. Sec’y of Health & Human Servs., 704 F.3d
at 1356 (quoting Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d at
1322); Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278; Hines v. Sec’y of
Health & Human Servs., 940 F.2d at 1525.
While scientific certainty is not required, the Special Master “is entitled to require
some indicia of reliability to support the assertion of the expert witness.” Moberly ex rel.
Moberly v. Sec’y of Health & Human Servs., 592 F.3d at 1324; see also Hazlehurst v.
Sec’y of Health & Human Servs., 88 Fed. Cl. 473, 439 (2009), aff’d, 604 F.3d 1343 (Fed.
Cir. 2010) (quoting Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d
at 1379). The United States Supreme Court has explained that:
Claimants who show that a listed injury first manifested itself at the
appropriate time are prima facie entitled to compensation. No showing of
causation is necessary; the Secretary bears the burden of disproving
causation. A claimant may also recover for unlisted side effects, and for
listed side effects that occur at times other than those specified in the Table,
but for those the claimant must prove causation.
Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228-29 (2011) (footnotes omitted); see also
Kennedy v. Sec’y of Health & Human Servs., 99 Fed. Cl. 535, 539 (2011), aff’d, 485 F.
App’x 435 (Fed. Cir. 2012).
The Federal Circuit in Althen v. Secretary of Health & Human Services defined a
three-prong test by which a petitioner can meet his or her burden to establish causation
in an off-Table injury case:
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To meet the preponderance standard, [petitioner] must “show a medical
theory causally connecting the vaccination and the injury.” Grant v. Sec’y of
Health & Humans Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (citations
omitted). A persuasive medical theory is demonstrated by “proof of a logical
sequence of cause and effect showing that the vaccination was the reason
for the injury[,]” the logical sequence being supported by “reputable medical
or scientific explanation[,]” i.e., “evidence in the form of scientific studies or
expert medical testimony[.]” Grant [v. Sec’y of Health & Human Servs.], 956
F.2d at 1148. [Petitioner] may recover if she shows “that the vaccine was
not only a but-for cause of the injury but also a substantial factor in bringing
about the injury.” Shyface[ v. Sec’y of Health & Human Servs.], 165 F.3d at
1352-53. Although probative, neither a mere showing of a proximate
temporal relationship between vaccination and injury, nor a simplistic
elimination of other potential causes of the injury suffices, without more, to
meet the burden of showing actual causation. See Grant[ v. Sec’y of Health
& Human Servs.], 956 F.2d at 1149. Concisely stated, [petitioner’s] burden
is to show by preponderant evidence that the vaccination brought about
[the] 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 at 1278 (first three sets of brackets
in original); see also Boatmon v. Sec’y of Health & Human Servs., 941 F.3d at 1354-55;
Oliver v. Sec’y of Health & Human Servs., 900 F.3d at 1361; Deribeaux ex rel. Deribeaux
v. Sec’y of Health & Human Servs., 717 F.3d at 1367; Porter v. Sec’y of Health & Human
Servs., 663 F.3d at 1249; Moberly ex rel. Moberly v. Sec’y of Health & Human Servs.,
592 F.3d at 1322; Pafford v. Sec’y of Health & Human Servs., 451 F.3d at 1355;
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006);
Faup v. Sec’y of Health & Human Servs., 147 Fed. Cl. at 458; C.K. v. Sec’y of Health &
Human Servs., 113 Fed. Cl. 757, 766 (2013).
With regard to the first Althen prong, “a medical theory causally connecting the
vaccination and the injury,” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278,
the Federal Circuit in Althen analyzed the preponderance of evidence requirement as
allowing medical opinion as proof, even without scientific studies in medical literature that
provide “objective confirmation” of medical plausibility. See id. at 1278, 1279-80; see also
Shapiro v. Sec’y of Health & Human Servs., 105 Fed. Cl. at 358. In rejecting a requirement
that a claimant under the Vaccine Act prove confirmation of medical plausibility from the
medical community and medical literature, the Althen court turned to the analysis
undertaken in Knudsen ex rel. Knudsen v. Secretary of Health & Human Services, 35
F.3d at 549. See Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1279-80. In
Knudsen ex rel. Knudsen v. Secretary of Health & Human Services, the United States
Court of Appeals for the Federal Circuit wrote, “to require identification and proof of
specific biological mechanisms would be inconsistent with the purpose and nature of the
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vaccine compensation program. The Vaccine Act does not contemplate full blown tort
litigation in the Court of Federal Claims.” Knudsen ex rel. Knudsen v. Sec’y of Health &
Human Servs., 35 F.3d at 549. The Federal Circuit in Knudsen stated further:
The Court of Federal Claims is therefore not to be seen as a vehicle for
ascertaining precisely how and why DTP [diphtheria-tetanus-pertussis
vaccine] and other vaccines sometimes destroy the health and lives of
certain children while safely immunizing most others. This research is for
scientists, engineers, and doctors working in hospitals, laboratories,
medical institutes, pharmaceutical companies, and government agencies.
The special masters are not “diagnosing” vaccine-related injuries. The sole
issues for the special master are, based on the record evidence as a whole
and the totality of the case, whether it has been shown by a preponderance
of the evidence that a vaccine caused the [petitioner’s] injury or that the
[petitioner’s] injury is a table injury, and whether it has not been shown by a
preponderance of the evidence that a factor unrelated to the vaccine caused
the child's injury. See 42 U.S.C. § 300aa-13(a)(1), (b)(1).
Id. (brackets added).
The Federal Circuit also has indicated that:
Although a finding of causation “must be supported by a sound and reliable
medical or scientific explanation,” causation “can be found in vaccine
cases . . . without detailed medical and scientific exposition on the biological
mechanisms.” Knudsen v. Sec’y of the Dep’t of Health & Human Servs., 35
F.3d 543, 548-49 (Fed. Cir. 1994). It is not necessary for a petitioner to point
to conclusive evidence in the medical literature linking a vaccine to the
petitioner's injury, as long as the petitioner can show by a preponderance
of the evidence that there is a causal relationship between the vaccine and
the injury, whatever the details of the mechanism may be.
Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1384 (Fed. Cir. 2012)
(omission in original).
Regarding the use of epidemiological evidence in a case in which causation is at
issue, the United States Court of Appeals for the Federal Circuit has found that a Special
Master may consider epidemiological evidence in determining causation. See Andreu ex
rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at 1379 (“Although Althen[ v.
Secretary of Health & Human Services,] and Capizzano[ v. Secretary of Health & Human
Services] make clear that a claimant need not produce medical literature or
epidemiological evidence to establish causation under the Vaccine Act, where such
evidence is submitted, the special master can consider it in reaching an informed
judgment as to whether a particular vaccination likely caused a particular injury.” (brackets
added)); see also Grant v. Sec’y of Health & Human Servs., 956 F.2d at 1149 (“These
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epidemiological studies are probative medical evidence relevant to causation.”); Althen v.
Sec’y of Health & Human Servs., 418 F.3d at 1280.
The second prong of the Althen test requires the petitioner to demonstrate “a
logical sequence of cause and effect, showing that the vaccination was the reason for the
injury” by a preponderance of the evidence. See Althen v. Sec’y of Health & Human
Servs., 418 F.3d at 1278; see also Pafford v. Sec’y of Health & Human Servs., 451 F.3d
at 1355. In order to prevail, the petitioner must show “that the vaccine was not only a but-
for cause of the injury but also a substantial factor in bringing about the injury.” Althen v.
Sec’y of Health & Human Servs., 418 F.3d at 1278 (quoting Shyface v. Sec’y of Health &
Human Servs., 165 F.3d at 1352). In Capizzano v. Secretary of Health & Human Services,
the Federal Circuit stated, “‘[a] logical sequence of cause and effect’ means what it
sounds like – the claimant’s theory of cause and effect must be logical. Congress required
that, to recover under the Vaccine Act, a claimant must prove by a preponderance of the
evidence that the vaccine caused his or her injury.” Capizzano v. Sec’y of Health & Human
Servs., 440 F.3d at 1326 (quoting 42 U.S.C. §§ 300aa-11(c)(1)-13(a)(1) (2006)); see also
Cozart v. Sec’y of Health & Human Servs., 126 Fed. Cl. 488, 498 (2016). The Federal
Circuit has found that treating physicians’ opinions can help satisfy the second prong of
the Althen test:
Such testimony is “quite probative” since “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.
[Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326] (citations
and internal quotation marks omitted); see also Althen[ v. Sec’y of Health &
Human Servs.], 418 F.3d at 1279–80 (noting that the Vaccine Act provides
for the use of “medical opinion as proof” of causation); Zatuchni v. Sec’y of
Health & Human Servs., 69 Fed. Cl. 612, 623 (Fed. Cl. 2006) (relying
heavily on the testimony of treating physicians in concluding that Vaccine
Act causation had been established).
Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at 1375 (first set of
brackets in original); see also Paluck v. Sec’y of Health & Human Servs., 786 F.3d at
1385 (finding “the special master erred in disregarding contemporaneous statements from
K.P.’s [petitioners’ minor child] treating physicians regarding the cause of his
neurodegeneration” and “[a]s we explained in Andreu, ‘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.’ [Andreu ex rel. Andreu v. Sec’y of
Health & Human Servs.,] 569 F.3d at 1375” (brackets added)).
The third prong of the Althen test requires the petitioner to demonstrate, by a
preponderance of evidence, “a proximate temporal relationship between vaccination and
injury.” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278. The United States
Court of Appeals for the Federal Circuit emphasized the importance of a temporal
relationship in Pafford v. Secretary of Health & Human Services, when the court noted
that “without some evidence of temporal linkage, the vaccination might receive blame for
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events that occur weeks, months, or years outside of the time in which scientific or
epidemiological evidence would expect an onset of harm.” Pafford v. Sec’y of Health &
Human Servs., 451 F.3d at 1358. Requiring evidence of strong temporal linkage is
consistent with the third requirement articulated in Althen because “[e]vidence
demonstrating petitioner’s injury occurred within a medically acceptable time frame
bolsters a link between the injury alleged and the vaccination at issue under the ‘but-for’
prong of the causation analysis.” Pafford v. Sec’y of Health & Human Servs., 451 F.3d at
1358 (citing Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326). The Pafford
court further explained,
[i]f, for example, symptoms normally first occur ten days after inoculation
but petitioner's symptoms first occur several weeks after inoculation, then it
is doubtful the vaccination is to blame. In contrast, if symptoms normally
first occur ten days after inoculation and petitioner's symptoms do, in fact,
occur within this period, then the likelihood increases that the vaccination is
at least a factor. Strong temporal evidence is even more important in cases
involving contemporaneous events other than the vaccination, because the
presence of multiple potential causative agents makes it difficult to attribute
"but-for" causation to the vaccination. After all, credible medical expertise
may postulate that any of the other contemporaneous events may have
been the sole cause of the injury.
Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within
a timeframe which, given the medical understanding of the disorder’s etiology, it is
medically acceptable to infer causation.” de Bazan v. Sec’y of Health & Human Servs.,
539 F.3d at 1352. Determining what constitutes a medically appropriate timeframe, thus,
is linked to the petitioner’s theory of how the vaccine can cause petitioner’s injury. See
id.; see also K.T. v. Sec’y of Health & Human Servs., 132 Fed. Cl. 175, 186 (2017);
Shapiro v. Sec’y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011).
According to the court in Capizzano v. Secretary of Health & Human Services,
evidence used to satisfy one of the Althen prongs may overlap with and be used to satisfy
another prong. See Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326 (“We
see no reason why evidence used to satisfy one of the Althen [v. Secretary of Health &
Human Services, 418 F.3d at 1278] prongs cannot overlap to satisfy another prong.”
(brackets added)). If a petitioner satisfies the Althen test, the petitioner prevails, “unless
the [government] shows, also by a preponderance of the evidence, that the injury was in
fact caused by factors unrelated to the vaccine.” Knudsen ex rel. Knudsen v. Sec’y of
Health & Human Servs., 35 F.3d at 547 (brackets in original; quotation omitted).
The Special Master has discretion to determine the relative weight of evidence
presented, including contemporaneous medical records and oral testimony. See Burns v.
Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (finding that the Special
Master had thoroughly considered evidence in record, had discretion not to hold an
additional evidentiary hearing); Hibbard v. Sec’y of Health & Human Servs., 698 F.3d at
1368 (finding it was not arbitrary or capricious for the Special Master to weigh diagnoses
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of different treating physicians against one another, including when their opinions
conflict).
“Clearly it is not then the role of this court to reweigh the factual evidence,
or to assess whether the special master correctly evaluated the evidence.
And of course we do not examine the probative value of the evidence or the
credibility of the witnesses. These are all matters within the purview of the
fact finder.”
Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. at 56 (quoting Munn v. Sec’y of
Health & Human Servs., 970 F.2d at 870 n.10); see also Rich v. Sec’y of Health & Human
Servs., 129 Fed. Cl. 642, 655 (2016); Paluck v. Sec’y of Health & Human Servs., 104
Fed. Cl. at 467 (“So long as those findings are ‘based on evidence in the record that [is]
not wholly implausible,’ they will be accepted by the court.” (quoting Lampe v. Sec’y of
Health & Human Servs., 219 F.3d at 1363 (alteration in original))). “Determinations
subject to review for abuse of discretion must be sustained unless ‘manifestly erroneous.’”
Heddens v. Sec’y of Health & Human Servs., 143 Fed. Cl. 193 (2019) (quoting Piscopo
v. Sec’y of Health & Human Servs., 66 Fed. Cl. 49, 53 (2005) (citations omitted)).
Additionally, a Special Master is “not required to discuss every piece of evidence
or testimony in [his or] her decision.” Snyder ex rel. Snyder v. Sec’y of Health & Human
Servs., 88 Fed. Cl. 706, 728 (2009) (brackets added); see also Paluck v. Sec’y of Health
& Human Servs., 104 Fed. Cl. at 467 (“[W]hile the special master need not address every
snippet of evidence adduced in the case, see id. [Doe v. Sec’y of Health & Human Servs.,
601 F.3d 1349, 1355 (Fed. Cir. 2010)], he [or she] cannot dismiss so much contrary
evidence that it appears that he ‘simply failed to consider genuinely the evidentiary record
before him.’” (brackets added) (quoting Campbell v. Sec’y of Health & Human Servs., 97
Fed. Cl. 650, 668 (2011))).
With regard to the Special Master’s weighing of evidence when testimony conflicts
with contemporaneous medical records, a Special Master generally should afford
contemporaneous medical records greater weight than conflicting testimony offered after
the fact. See Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991) (citing
United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“It has generally
been held that oral testimony which is in conflict with contemporaneous documents is
entitled to little evidentiary weight.”)), aff’d, 968 F.2d 1226 (Fed. Cir.) reh’g denied, (Fed.
Cir. 1992). This is because medical records, created contemporaneously with the events
they describe are presumed to be accurate and complete. See Cucuras v. Sec’y of Health
& Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
As discussed above, petitioner must prove by a preponderance of the evidence
that his rheumatoid arthritis was caused by the influenza vaccination he received. See 42
U.S.C. § 300aa-11(c)(1)(C)(ii)(I). If the Special Master’s decision was not arbitrary,
capricious, or not in accordance with the law, the reviewing court shall uphold that
decision. See 42 U.S.C. § 300aa-12(e)(2). Special Master Moran spent significant
amounts of time in his decision devoted to the details of the scientific and medical
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evidence, although often without offering definitions of the scientific and medical terms he
used in his decision. Also, given that the petitioner has the burden of proof, the Special
Master’s decision oddly starts his discussion of the experts’ opinions by first reviewing the
respondent’s experts, and then goes on to review the petitioner’s experts. Nonetheless
he did carefully try to review the record before him, including petitioner’s medical history,
the expert reports, and information provided to him at the hearing over which he presided.
As indicated above, petitioner submitted his medical records and offered two
experts, Dr. Paul J. Utz and Dr. Lawrence Steinman to support petitioner’s theory of
molecular mimicry and his theory of causation. At the oral argument before this court,
petitioner’s counsel indicated: “Dr. Steinman looked at the BLAST searches, Dr. Utz
looked at the articles on both, the HA collagen and how the T cells bond, but also on how
the tetramers, which are a portion that have the specific peptide complexes, how those
create these bonds.” (capitalization in original). Dr. Utz’s original expert report, submitted
on February 29, 2016, discussed petitioner’s theory of molecular mimicry, including
“[w]hen an immune response to a nonself antigen such as components of an influenza
vaccine cross reacts with self molecules, the process is termed ‘molecular mimicry.’” Dr.
Utz stated in his February 29, 2016 original expert report that the medical theory of
causation proffered by petitioner is that “the vaccine triggered activation of B and/or T
lymphocytes through molecular mimicry, formation of immune complexes, cross-priming,
or a combination of these.” Dr. Utz also stated in his February 29, 2016 original expert
report that “[m]any arthritides including systemic lupus erythematosus (SLE), rheumatoid
arthritis (RA), Lyme arthritis, serum sickness, and parvovirus infection are postulated to
be (SLE [systemic lupus erythematosus], RA [rheumatoid arthritis]) or known to be (the
remaining illnesses), caused by exposure to an infectious antigen or foreign antigen.”
(capitalization in original) (brackets added). Dr. Utz cited the Clifton O. Bingham III and
Malini Moni article (the Bingham article) in his November 7, 2016 first supplemental expert
report and stated “the Bingham article does not link influenza vaccination and RA
[rheumatoid arthritis]; however, it clearly shows that another expert considers molecular
mimicry to be a possible trigger in RA [rheumatoid arthritis], in contrast to the position
taken by Dr[.] Matloubian.” (brackets added). The Bingham article, titled, “Periodontal
disease and rheumatoid arthritis: the evidence accumulates for complex pathobiologic
interactions,” published in May 2013, examined “the associations between periodontal
disease and rheumatoid arthritis.” In the article, molecular mimicry is not mentioned by
name. The authors state that when other researchers “immunized” animals “using Pg-
enolase and human a-enolase” that “the study demonstrated that a Pg protein could
induce arthritis and propagate an immune response against citrullinated peptides.”
(emphasis in original). Regarding this statement in the Bingham article, Dr. Utz stated
“the authors clearly describe the ability of a bacterial protein to break tolerance and to
cause arthritis in an animal model, acting as a molecular mimic.”
In his November 7, 2016 first supplemental expert report, Dr. Utz also cited to the
Jens Hennecke and Don C. Wiley paper (the Hennecke paper), titled, “Structure of a
Complex of the Human α/β T Cell Receptor (TCR) HA1.7, Influenza Hemagglutinin
Peptide, and Major Histocompatibility Complex Class II Molecule, HLA-DR4 (DRA*0101
and DRB1*0401): Insight into TCR Cross-Restriction and Alloreactivity,” published
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February 25, 2002. (capitalization in original). Dr. Utz stated “the authors demonstrate
that a cross-reactive peptide (ie, [sic] a molecular mimic) derived from the hemagglutinin
molecule from influenza was able to bind the DR4 MHC molecule.” (capitalization in
original). The authors of the Hennecke paper described the findings of the study as: “This
structural study of TCR cross-reactivity emphasizes how MHC sequence differences can
affect TCR binding indirectly by moving peptide atoms.” (capitalization in original). Dr. Utz
stated, regarding the findings of this study, “this paper only demonstrates that DR4 can
bind an influenza or collagen peptide; it does not demonstrate that T cell receptors (TCRs)
on human T cells can recognize collagen or influenza peptides.” (capitalization in original).
Dr. Utz, in his September 4, 2018 third supplemental expert report also introduced the
Michael E. Birnbaum, Juan L. Mendoza, Dhruv K. Sethi, Shen Dong, Jacob Glanville,
Jessica Dobbins, Engin Özkan, Mark M. Davis, Kai W. Wucherpfennig, and K.
Christopher Garcia paper (the Birnbaum paper) as support for molecular mimicry and
stated “autoimmune T cells have the ability to be activated by immunogens encountered
in the environment, which may serve as the triggers for the initiation of autoimmunity.”
The Birnbaum paper, titled, “Deconstructing the peptide-MHC specificity of T cell
recognition,” published on May 22, 2014, examined “[d]econstructing the peptide-MHC
specificity of T cell recognition.” (capitalization in original). The Birnbaum paper stated:
While the naturally occurring peptides in this study were found as a proof of
principle for our methodology, they further support the hypothesis that
autoimmune T cells have the ability to be activated by immunogens
encountered in the environment, which may serve as the triggers for the
initiation of autoimmunity.
Dr. Utz in his September 4, 2018 third supplemental expert report also introduced the
Linda Wooldridge, Julia Ekeruche-Makinde, Hugo A. van den Berg, Anna Skowera, John
J. Miles, Mai Ping Tan, Garry Dolton, Mathew Clement, Sian Llewellyn-Lacey, David A.
Price, Mark Peakman, and Andrew K. Sewell paper (the Wooldridge paper), titled, “A
Single Autoimmune T Cell Receptor Recognizes More Than a Million Different Peptides,”
published November 18, 2011. (capitalization in original). The Wooldridge paper
researchers stated, “[a] single autoimmune T cell receptor recognizes more than a million
different peptides.”
In his June 8, 2017 second supplemental expert report, Dr. Utz also stated that the
evidence he provided should be sufficient to support molecular mimicry, but that he
cannot prove that molecular mimicry can occur without “culturing these autoreactive,
stimulated, expanded T cells and transferring them into an asymptomatic healthy human
subject to attempt to induce RA [rheumatoid arthritis] in fulfillment of Koch’s postulates,[7]
an experiment that would be completely unethical.” (emphasis in original) (brackets and
footnote added). Dr. Utz also admitted in his September 4, 2018 third supplemental expert
report, “I have not proven that the molecular mimic influenza peptides directly influence
the same T cells that are activated by collagen peptides.” (emphasis in original). Dr. Utz,
7 Dr. Utz does not define “Koch’s postulates” in his expert report.
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nonetheless, stated in his September 4, 2018 third supplemental expert report, “[i]n many
cases, I have successfully argued for molecular mimicry just by” “show[ing] sequence
homology between a vaccine component and a self molecule,” without citing to those
other cases.
In his November 7, 2016 first supplemental expert report, Dr. Utz indicated that
because rheumatoid arthritis is so heterogenous in its pathology it is difficult to determine
a cause. Dr. Utz then listed environmental factors that “the vast majority of
rheumatologists and immunologists would agree” contribute to rheumatoid arthritis. Dr.
Utz acknowledged environmental factors that contribute to rheumatoid arthritis in his
November 7, 2016 first supplemental expert report, such as use of “tobacco,” “age, sex,
family history, and gingivitis, among others.” Dr. Utz also stated in his February 29, 2016
original expert report, “my search identified no epidemiological link between RA
[rheumatoid arthritis] and influenza vaccination.” (brackets added). Dr. Utz, however,
stated in his February 29, 2016 original expert report that “many studies and textbooks
postulate that RA [rheumatoid arthritis] can be caused by viruses themselves, or by other
inflammatory triggers” without citing to the studies or textbooks to which he was referring.
(brackets added). Dr. Utz also stated in his February 29, 2016 original expert report that
petitioner’s T cell repertoire, which is the type of cell that would mistake a foreign antigen
for a self antigen to cause molecular mimicry, is so rare that “epidemiologic studies will
not have the power to capture rare, patient-specific events such as occurred in Mr[.]
Tullio’s case.”8
8 The court notes that Dr. Utz had been the retained expert in Parker v. Secretary of
Health & Human Services, No. 14-979V, 2019 WL 3425297 (Fed. Cl. Spec. Mstr. June
24, 2019). Because Dr. Utz was a retained expert in Parker v. Secretary of Health &
Human Services, petitioner had requested access to the hearing transcripts in the Parker
case, which was denied by the Special Master during the course of the proceedings
before him. In the motion for review to this court, petitioner also requested access to the
hearing transcripts in Forrest v. Secretary of Health & Human Services, No. 14-1046V,
2019 WL 925495 (Fed. Cl. Spec. Mstr. Jan. 28, 2019), in which Dr. Steinman was an
expert witness. To explain the issues petitioner raises, petitioner states in his motion for
review, “[i]t is erroneous and harmful to Petitioner to permit a credibility determination of
his expert based on extra-judicial information inaccessible to Petitioner.” Petitioner also
states: “This situation underscores the problems inherent in the Special Master’s pre-
hearing order denying Petitioner’s request for the transcript of a related proceeding.” It is
not apparent that the position taken by Dr. Steinman in Forrest v. Secretary of Health &
Human Services or by Dr. Utz in Parker v. Secretary of Health & Human Services would
have undermined the opinions as expressed in the instant case. The court believes that
the unavailability of the two hearing transcripts to petitioner would not have altered the
consideration given to the opinions offered by those two petitioner’s experts, impacted
concerns about Dr. Steinman’s credibility expressed by the Special Master in his decision,
or go to the credibility of Dr. Utz. This court, therefore, considers review by the petitioner
of the transcripts in Parker and Forrest not necessary nor of assistance to this court in its
review of the Special Master’s decision, and the Special Master did not err when he
denied petitioner’s request for the Parker transcript. Moreover, as discussed below, Mr.
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With respect to the “evidence regarding experiments on the hemagglutinin in flu
virus and collagen,” Special Master Moran found that the papers Dr. Utz relied upon to
assert the molecular mimicry theory to be “relatively unimportant” because the studies
“basically report on how an antigen-presenting cell interacts with hemagglutinin and with
collagen,” and not “whether T cells bind to the hemagglutinin and/or collagen as
presented through the antigen-presenting cell.” See Tullio v. Sec’y of Health & Human
Servs., 2019 WL 7580149, at *14, *16. Special Master Moran found that, without the
theory that hemagglutinin and collagen are molecular mimics having been tested, a “gap
of knowledge and evidence exist[s].” See id. at *24. During the course of the case before
the Special Master, respondent offered expert testimony to refute petitioner’s offers of
proof and to refute petitioner’s evidence. The respondent’s expert Dr. Matloubian agreed
with petitioner’s expert Dr. Utz in that the presentation of rheumatoid arthritis can be
heterogenous, however, Dr. Matloubian asserted in his June 10, 2016 original expert
report, “[f]or molecular mimicry to be relevant to an autoimmune disease and the vaccine
in question, the natural infection itself, i.e. with influenza virus in this case, should also
lead to development of that disease in some people.” (emphasis in original).
In his decision, Special Master Moran also relied on and discussed a number of
previously decided vaccine cases to bolster his conclusion to deny compensation to
petitioner, including W.C. v. Secretary of Health & Human Services and Caves v.
Secretary of Health & Human Services, as part of his analysis of petitioner’s theory of
molecular mimicry. See W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352 (Fed.
Cir. 2013); Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119, 135 (2011), aff’d,
463 F. App’x 932 (Fed. Cir. 2012). In W.C. v. Secretary of Health & Human Services,
petitioner alleged that his influenza vaccination caused aggravation to his multiple
sclerosis (MS) through the process of molecular mimicry. The United States Court of
Appeals for the Federal Circuit in W.C. v. Secretary of Health & Human Services
described the evidence presented by a petitioner:
The special master found that “[m]olecular mimicry is a well-regarded theory
in some contexts,” Special Masters Decision, 2011 WL 4537877, at *11, but
correctly required additional evidence showing that molecular mimicry can
cause the influenza vaccine to significantly aggravate multiple sclerosis,
see Broekelschen [v. Secretary of Health & Human Services], 618 F.3d at
1345 (holding “a petitioner must provide a reputable medical or scientific
explanation that pertains specifically to the petitioner's case”).
In support of his theory that molecular mimicry between the influenza virus
and myelin caused Petitioner's multiple sclerosis, Dr. Tornatore relied
primarily on an article by Wucherpfennig and Strominger at Harvard
University's Department of Molecular and Cellular Biology. Kai
Tullio failed to offer sufficient evidence to meet his burden of proving that his rheumatoid
arthritis was caused by the influenza vaccination petitioner received. See Tullio v. Sec’y
of Health & Human Servs., 2019 WL 7580149, at *28.
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Wucherpfennig & Jack L. Strominger, Molecular Mimicry in T Cell–Mediated
Autoimmunity: Viral Peptides Activate Human T Cell Clones Specific for
Myelin Basic Protein, 80 Cell 695 (1995). The Wucherpfennig article
showed that human myelin basic protein-specific T-cell clones derived from
the blood of multiple sclerosis patients were “cross-reactive” with one
peptide from a wild influenza Type A strain. Id. at 697. Dr. Tornatore testified
that this evidence, demonstrating that influenza proteins can stimulate
T-cells specific to myelin basic protein, makes it “beyond plausible” that the
influenza vaccine could stimulate the immune response that led Petitioner
to develop multiple sclerosis. J.A. 170.
W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1360. In W.C. v. Secretary of Health
& Human Services, the Federal Circuit outlined the reasons, which were also identified
by the Special Master, as to why the petitioner’s theory of molecular mimicry was
insufficient to prove petitioner’s case, finding, “Petitioner provided no evidence that the
portions of the influenza virus shown by Wucherpfennig [referred to in the quote
immediately above] to mimic myelin basic protein were present in the influenza vaccine
Petitioner received,” and “Petitioner also did not provide evidence that any peptide from
the influenza vaccine he received was cross-reactive with myelin basic protein-specific T-
cells.” Id. at 1360-61 (brackets added). The Federal Circuit in W.C. v. Secretary of Health
& Human Services also found that two studies which examined patients with MS relied
upon by the Special Master showed that MS was not exacerbated by the influenza
vaccination to be more persuasive than petitioner’s expert’s theory and affirmed the denial
of compensation by the Special Master. See id. at 1361.
The second case regarding molecular mimicry that Special Master Moran
discussed was Caves v. Secretary of Health & Human Services, a case also decided by
Special Master Moran, and which was then affirmed by Judge Bush of the United States
Court of Federal Claims. Subsequently, the United States Court of Appeals for the
Federal Circuit affirmed the Court of Federal Claims’ decision. See generally Caves v.
Sec’y of Health & Human Servs., 463 F. App’x 932 (Fed. Cir. 2012). In the Court of
Federal Claims decision, the Judge found:
The theory of molecular mimicry does not apply specifically to petitioner’s
case; on the contrary, that general theory could be used to demonstrate an
association between virtually any combination of antigens and autoimmune
injuries. Without any empirical evidence that the theory actually applies to
the influenza vaccine and TM [transverse myelitis], the first prong of Althen
would be rendered meaningless.
Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. at 135.
A case not relied upon or cited by the Special Master, but relevant to the instant
case, is a decision discussing molecular mimicry issued by United States Court of
Appeals for the Federal Circuit. See generally Broekelschen v. Sec’y of Health & Human
Servs., 618 F.3d 1339. The evidence the petitioner in Broekelschen v. Secretary of Health
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& Human Services offered to “connect[ ] the molecular mimicry theory to the flu vaccine”
was “a literature review based on two papers from the early 1950s, which in turn
considered vaccine cases between 1929 and 1952.” Id. at 1350. The Federal Circuit in
Broekelschen v. Secretary of Health & Human Services affirmed the Special Master’s
decision that petitioner “had not provided a ‘reliable medical or scientific explanation’
sufficient to prove by a preponderance of the evidence a medical theory linking the flu
vaccine to anterior spinal artery syndrome.” Id. at 1351 (quoting Knudsen ex rel. Knudsen
v. Sec’y of Health & Human Servs., 35 F.3d at 548). Although Mr. Tullio provided more
evidence than a literature review of two 1950s studies, Mr. Tullio failed to “provide
evidence that any peptide from the influenza vaccine he received was cross-reactive with”
the specific T cells. See W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1360–61;
see also Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d at 1351. When
arriving at his decision, Special Master Moran was justified in focusing on petitioner’s
expert Dr. Utz and respondent’s expert Dr. Matloubian, who shared concerns that the
cause of rheumatoid arthritis is unknown. The Special Master rationally could conclude
that that the influenza vaccination petitioner received was not the cause of Mr. Tullio’s
rheumatoid arthritis. As Dr. Utz testified at the hearing before Special Master Moran: “It is
currently not known what causes rheumatoid arthritis.” In response to the question from
respondent’s counsel at the hearing before Special Master Moran: “Does the medical
community know what causes rheumatoid arthritis?” Dr. Matloubian testified: “No.” As
discussed further below, based on a review of the record before the court, the Special
Master was justified to require more evidence than what was in the record to support
petitioner’s allegations that petitioner’s influenza vaccination caused the petitioner’s
rheumatoid arthritis. The Special Master’s conclusion was not arbitrary or capricious
based on his in-depth examination of the record before him. The Special Master also
stated:
The mechanistic evidence tends to align with the epidemiologic evidence,
which did not detect an increased incidence of rheumatoid arthritis following
flu vaccination. Thus, exclusively for the reasons set forth . . . Mr. Tullio has
failed to carry his burden of presenting a reliable and persuasive theory that
the flu vaccine can cause rheumatoid arthritis.
Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *22 (internal references
omitted). Special Master Moran, therefore, concluded that petitioner had not satisfied his
burden to prove by a preponderance of evidence that petitioner had presented a “logical
sequence of cause and effect,” and his conclusions were not arbitrary or capricious. See
Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278; see also Tullio v. Sec’y of
Health & Human Servs., 2019 WL 7580149, at *5.
At the oral argument before this court, petitioner’s counsel, however, stated that,
in addition to relying on the studies regarding hemagglutinin and collagen introduced by
Dr. Utz, petitioner also tried to rely on “how the tetramers, which are a portion that have
the specific peptide complexes, how those create these bonds.” Respondent’s expert Dr.
Matloubian had introduced the information regarding tetramers in his November 16, 2018
second supplemental expert report, in part in response to petitioner’s expert Dr. Utz
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indicating that testing his theory of molecular mimicry only would be possible through
unethical means.9 Dr. Matloubian also stated in his November 16, 2018 second
supplemental expert report, “[u]sing current immunological tools and techniques, such as
widely available tetramers, the question of whether the same T cell receptor can
recognize both collagen and HA peptides bound to the same HLA can be readily
addressed.” Dr. Matloubian described tetramers by stating, “these tools allow
identification of T cells that recognize a specific MHC-peptide complex (i.e., T cells that
are specific for HLA-DR4 containing the HA peptide or HLA-DR4 containing the collagen
II peptide).” (capitalization in original). Petitioner did not address the theory of tetramers
until petitioner’s expert Dr. Utz testified at the March 6-8, 2019 hearing before Special
Master Moran, in response to a question from petitioner’s counsel, “[h]ow would you go
about observing molecular mimicry in one of your patients in a clinical setting?”
Petitioner’s expert Dr. Utz replied:
In a clinical setting, to observe molecular mimicry or study it would be an
enormous challenge. So one of the things would be to identify collagen
antibodies. That would be one thing that would be supportive. Those assays
are not available in clinical labs to my knowledge. I have never ordered one.
They are only available in a research lab.
The second would be to create tetramers which Dr. Matloubian has
provided three [sic] exhibits on tetramers. Tetramers are MHC molecules
that are loaded in this case with DR4, loaded with collagen, or with HA.
The four studies on tetramers introduced by Dr. Matloubian in his first and second
supplemental reports were the Svendsen, Snir, James, and Malmström studies. Special
Master Moran evaluated the four studies regarding tetramer experiments introduced by
respondent. Special Master Moran found that the petitioner’s contention that tetramer
experiments can “explain how the flu vaccine can cause rheumatoid arthritis” “lacks
persuasive value because Dr. Utz extends the studies beyond what the authors of those
studies reported.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *18.
The Special Master evaluated the Pia Svendsen, Claus B. Andersen, Nick Willcox,
Anthony J. Coyle, Rikard Holmdahl, Thomas Kamradt, and Lars Fugger study (the
Svendsen study), titled, “Tracking of Proinflammatory Collagen-Specific T Cells in Early
and Late Collagen-Induced Arthritis in Humanized Mice” accepted for publication on
9 According to the Benaroya Institute, a source cited by Dr. Matloubian in his November
16, 2018 second supplemental expert report, tetramers are “are a multivalent synthetic
mimic of the peptide binding proteins found on the surface of antigen presenting cells.”
Scientists & Laboratories: Tetramer Core Laboratory, Benaroya Research Institute,
https://www.benaroyaresearch.org/what-is-bri/scientists-and-laboratories/core-
labs/tetramer -core-laboratory (last visited on June 18, 2020). Dr. Utz testified at the
hearing as to his definition of tetramers: “Tetramers are MHC molecules that are loaded
in this case with DR4, loaded with collagen, or with HA. Four of them tether together and
they have fluorophores on them so they glow. You can use those to look at antigen-
specific T cells.” (capitalization in original).
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August 10, 2004, which was introduced by Dr. Matloubian in his November 16, 2018
second supplemental expert report. The Special Master described three experiments
which took place to try to determine whether B or T cells “initiated the disease,” when
“struggling to understand the pathology of rheumatoid arthritis.” See id. In order to test
the theory, the researchers had used petri dishes and mice. One experiment referenced
in the Svendsen study involved mice being immunized with collagen, hemagglutinin with
an adjuvant, as well as an adjuvant, and saline. Blood was drawn from mice lymph nodes
thirteen days after immunization of collagen, hemagglutinin with an adjuvant, as well as
an adjuvant, and saline, and “researchers determined the frequency of the targeted T
cells, expressed as a percentage of T cells” that responded. See id. The frequency of the
T cells from the hemagglutinin-immunized mice that were stained with hemagglutinin
tetramer was 0.86 percent and with a collagen tetramer was 0.08 percent. Dr. Utz testified
that 0.08 demonstrates cross-reactivity between hemagglutinin and collagen. The Omri
Snir, Mary Rieck, John A. Gebe, Betty B. Yue, Crystal A. Rawlings, Gerald Nepom,
Vivianne Malmström, and Jane H. Buckner study (the Snir study), titled, “Identification
and Functional Characterization of T Cells Reactive to Citrullinated Vimentin in HLA–
DRB1*0401–Positive Humanized Mice and Rheumatoid Arthritis Patients,” which was
published in October 2011, was introduced by Dr. Matloubian in his November 16, 2018
second supplemental expert report. (capitalization in original). In the Snir study the
“hemagglutinin antigen tetramer was used as a negative control.” In addition in the Eddie
A. James, Mary Rieck, Jennifer Pieper, John A. Gebe, Betty B. Yue, Megan Tatum,
Melissa Peda, Charlotta Sandin, Lars Klareskog, Vivianne Malmström, and Jane H.
Buckner study (the James study), titled, “Citrulline-Specific Th1 Cells Are Increased in
Rheumatoid Arthritis and Their Frequency Is Influenced by Disease Duration and
Therapy,” published in July 2014, also introduced by Dr. Matloubian in his November 16,
2018 second supplemental expert report, the peptide control was again hemagglutinin.
(capitalization in original). In the Vivianne Malmström, Anca I. Catrina and Lars Klareskog
study (the Malmström study), titled, “The immunopathogenesis of seropositive
rheumatoid arthritis: from triggering to targeting,” published December 5, 2016, likewise
was introduced by Dr. Matloubian in his February 23, 2017 first supplemental expert
report. In the Malmström study, hemagglutinin from the influenza vaccination is described
as “an unrelated antigen” to the research regarding seropositive rheumatoid arthritis,
similar to how hemagglutinin was a control in the James study. When Special Master
Moran asked petitioner’s expert Dr. Utz at the hearing before him about the statement
that hemagglutinin is an unrelated antigen to seropositive rheumatoid arthritis, Dr. Utz
responded that “they are using these tetramers as a control. They are not studying
mimicry. They are not studying people like Mr. Tullio. So they are using this as a control
for a totally different purpose.”
At the oral argument before this court, petitioner’s counsel argued that, in addition
to the expert reports provided by Dr. Utz and the tetramer experiments introduced by
respondent, petitioner also relies on petitioner’s expert Dr. Lawrence Steinman’s “BLAST
searches.”10 (capitalization in original). Petitioner’s expert Dr. Steinman, in his November
10 At the hearing before Special Master Moran, Dr. Steinman described the Blast searches
as a computer program “aligning vast domains of these proteins and assigning weights
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7, 2016 original expert report, discussed the similarities between hemagglutinin, the
protein in the influenza vaccination, and that the “major proteins considered to be the
major targets of the response in RA [rheumatoid arthritis] are collagen, fibrinogen,
enolase and vimentin (8).” (brackets added). Dr. Steinman conducted what he called Blast
searches to determine “any relevant molecular mimics between” the proteins and the
components of the influenza vaccination the petitioner received by searching a National
Institute of Health database of amino acids. The enolase and hemagglutinin peptide
sequence homology11 was deemed “relevant” by Dr. Steinman because the “peptides of
enolase and the hemagglutinin from the 2012 vaccine have 5 of 12 or 4 of 11 identities
with 2 close matches within 12 amino acids, making it 7 of 12 positives.” The protein
vimentin also was deemed by Dr. Steinman to have relevant molecular mimics because
there were “4 of 12 identical, 5 of 12 positive, and 5 of 13 identical and 6 of 13 positive”
in the sequence homology Blast search. Regarding fibrinogen, Dr. Steinman stated there
was “a 4 of 7 identity and a 5 of 7 positivity” with hemagglutinin, which meant “this was
sufficient to induce clinical autoimmune disease.” Finally, in his November 7, 2016 original
expert report regarding collagen, Dr. Steinman stated, “[t]here were many molecular
mimics but these two above are stunning, including a 6 of 11 with four consecutive
IDENTICAL amino acids between collagen and the Hemagglutinin from Influenza Virus
A/Victoria/361/2011.” (capitalization in original). Dr. Steinman stated that “[s]trikingly,
there are extensive molecular mimics between the contents of the 2012 influenza vaccine
received by Petitioner and the critical antigens that are associated with rheumatoid
arthritis.” (emphasis in original omitted).
Regarding Dr. Steinman’s Blast searches, offered in support of petitioner’s case,
respondent’s expert Dr. Matloubian, in his June 10, 2016 original expert report, stated the
presence of linear sequence homology does not necessarily translate to
immunogenicity. Proteins consist of linear sequence of amino acids but fold
into complex three-dimensional structures. Therefore, the same sequence
of amino acids may be on the surface of one protein, and thus easily
accessible to antibodies, while in another protein the same sequence could
be buried inside the molecule and hidden from those antibodies.
Disputing petitioner’s theory of sequence homology, Dr. Matloubian also stated in his
February 23, 2017 first supplemental expert report:
and actually lining them up.” Regarding the Blast searches, which petitioner’s counsel
called the “Steinman study” at the oral argument, this court asked the petitioner’s counsel:
“You cannot tell me that Dr. Steinman’s experimentation had anything to do with either
high dose Fluzone influenza vaccine or rheumatoid arthritis. Is that correct?” Petitioner’s
counsel responded: “Yes, ma’am.”
11 Dr. Steinman, who performed the Blast searches, stated that sequence homology, in
his view, has an “operational definition that a sequence of 12 or fewer amino acids that
are identical at 4 positions.”
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Even though the same peptide sequence of 7-12 amino acids can occur in
two different proteins, its proper processing could be affected by the
surrounding amino acid sequences resulting in differences in the ability of
MHC molecules to present them to T cells. Because of these caveats, in
science, the standards of proof for molecular mimicry are quite high and
sequence homology itself is not sufficient evidence.
Moreover, Dr. Matloubian stated in his February 23, 2017 first supplemental expert report
that researchers generally focused much more heavily on studying the structure of
proteins, rather than on the sequence of proteins, because most algorithms regarding
sequence “have low accuracy for predicting MHC class II restricted epitopes,
underscoring the principle that just finding sequence homology in several proteins does
not imply antigenicity, let alone molecular mimicry.” (emphasis in original). In his
November 16, 2018 second supplemental expert report, Dr. Matloubian stated: “Just
because two peptides (small pieces of protein) may share similar sequences and even
bind to the same major histocompatibility complex (MHC/HLA) does not necessarily mean
that the same T cell can see them as similar (i.e. does not mean that they have the same
‘immunologic epitope’).” (capitalization in original) (emphasis omitted). In addition, Dr.
Matloubian stated in his November 16, 2018 second supplemental expert report that in
order for molecular mimicry to occur “at the T cell level, the same T cell must recognize
both the influenza peptide and the RA [rheumatoid arthritis] peptide associated with
MHC/HLA.” (capitalization in original) (emphasis omitted) (brackets added).
Regarding Dr. Steinman’s Blast searches, Special Master Moran wrote that
because all proteins “are built from the same 20 amino acids, it is inevitable that some
sequences of amino acids will repeat.” Tullio v. Sec’y of Health & Human Servs., 2019
WL 7580149, at *15. In this respect, Special Master Moran indicated that “the finding of
sequence homology does not necessarily mean the similarity has significance to the
immune system.” Id. Special Master Moran also noted that “scientists have identified the
portions of the flu virus that are peptides and created a database of them. Dr. Matloubian
queried the database to see whether the epitopes that Dr. Steinman had identified
appeared in the database. Dr. Matloubian disclosed that he did not find any positive hits.”
Id. After his review of the record before him, Special Master Moran found the Blast
research to be unpersuasive because of Dr. Steinman’s “lack of meaningful response”
when compared to respondent’s expert, Dr. Matloubian’s, conclusion, who searched the
influenza virus peptide database, as opposed to a more general database. See id.
After reviewing the record before him, Special Master Moran stated petitioner’s
expert Dr. Steinman “misses its mark” when Dr. Steinman “added a critique that those
studies[12] were not relevant to Mr. Tullio’s situation because none of those studies
12 Although not clear in the Special Master’s decision, based on the hearing transcript,
Dr. Steinman seemed to be referring to the Ray and Bardage studies discussed below.
The Bengtsson study, also discussed below, could also have been included because
petitioner argues that petitioner also would not have qualified for that vaccination. The
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involved the exact vaccine that he received.” Id. at *11 (footnote added). Dr. Steinman
testified at the hearing before Special Master Moran: “And again, I state in my report,
referring to Dr. Matloubian’s Exhibit CC [the Ray study] where he talks about vaccines
from the 1997 to 1999 season, that that epidemiology is totally irrelevant because those
vaccines didn’t have the 2009 A/California, the 2011 A/Victoria, the 2010 B/Wisconsin
because it was only 1999.” (brackets added). Dr. Steinman also testified: “Generally
speaking, there’s a whole problem with lumping all influenza vaccines into one boat
because, as I said this morning, they’re seasonal. The CDC [Center for Disease Control]
nominates well ahead of time the virus strains. The virus strains differ from year to year.
And we know, for instance, that one year a virus strain that was used with an adjuvant,
not here, but it led to an outbreak of narcolepsy.” (brackets added). Regarding this
argument offered by petitioner, Special Master Moran stated:
Dr. Matloubian tested the degree of difference among various iterations of
flu vaccines. Using the same methodology Dr. Steinman used to determine
the degree of homology between a component of the flu vaccine and a
component of joint tissue . . . Dr. Matloubian found that the flu vaccines
retain at least 90 percent homology across the years.[13] When asked about
this approach, Dr. Steinman did not contest Dr. Matloubian’s findings.
Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *11 (internal citations
omitted) (footnote added). The Special Master also concluded that “Dr. Steinman’s
challenge to the usefulness of epidemiologic studies not involving the 2015 [sic] flu
vaccine that Mr. Tullio received is not persuasive. Instead, the epidemiologic studies are
persuasive. As such, the epidemiological evidence weakens the reliability of opinions that
the flu vaccine can cause rheumatoid arthritis.” Id.
In Moberly ex rel. Moberly v. Secretary of Health & Human Services, the United
States Court of Appeals for the Federal Circuit found, “[a]s a general matter,
epidemiological studies are designed to reveal statistical trends only for a carefully
constructed test group. Such studies provide no evidence pertinent to persons not within
the parameters of the test group.” Moberly ex rel. Moberly v. Sec’y of Health & Human
Servs., 592 F.3d at 1324 (finding that because petitioner could not have belonged to a
test group that the study could not apply to petitioner). In Lampe v. Secretary of Health &
hearing transcript, however, cited by the Special Master cited only petitioner’s references
to the Ray and Bardage studies.
13 In this statement, Special Master Moran appears to be referring to a database
introduced and examined by respondent’s expert Dr. Matloubian. According to the Special
Master’s decision, “scientists have identified the portions of the flu virus that are peptides
and created a database of them. Dr. Matloubian queried the database to see whether the
epitopes that Dr. Steinman had identified appeared in the database. Dr. Matloubian
disclosed that he did not find any positive hits.” Tullio v. Sec’y of Health & Human Servs.,
2019 WL 7580149, at *15.
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Human Services, the United States Court of Appeals for the Federal Circuit also found
that because petitioner did not fit into the study’s “paradigm” that the study could not “shed
light on the issue of causation in her case.” Lampe v. Sec’y of Health & Human Servs.,
219 F.3d at 1366.14
In his decision, Special Master Moran criticized petitioner’s expert Dr. Steinman
for “suggesting that his methods in forming an opinion in a legal proceeding are less
stringent than if he were submitting his theory for peer review.” Tullio v. Sec’y of Health &
Human Servs., 2019 WL 7580149, at *24. Regarding Dr. Steinman, Special Master Moran
noted, “if he were trying to publish a paper in a peer-reviewed journal, he would do more,
such as model his theory in mice.” Id. Special Master Moran further wrote:
Dr. Steinman stated that his work is sufficient for a court but not for the
broader community. Tr. 354 (“And that’s about the best I could do and that’s
the foundation of a theory for this Court. I’m not applying for a prize. I’m just
saying that this is where an experiment led me [to that says could a vaccine
that has the components of Mr. Tullio’s that are shared with those antigens
that are imputed to be involved in the pathogenesis of rheumatoid arthritis,
could they have done it?]”).
Id. (brackets added). Special Master expressed concern that “Dr. Steinman seemed to
indicate that he expressed opinions, as an expert, more readily than he would outside a
legal proceeding” and that “[o]ther special masters have expressed similar concerns.” Id.
at *26 (citing D.G. v. Sec’y of Health & Human Servs., No. 11-577V, 2019 WL 2511769,
at *182 (Fed. Cl. Spec. Mstr. May 24, 2019); Chinea v. Sec’y of Health & Human Servs.,
No. 15-095V, 2019 WL 1873322, at *19 (Fed. Cl. Spec. Mstr. Mar. 15, 2019), aff’d, 144
Fed. Cl. 378, 386-87 (2019)). Special Master Moran wrote in his decision that Dr.
Steinman’s approach on behalf of the petitioner was inconsistent with the United States
14 The court notes that in an unpublished decision, McCollum v. Secretary of Health &
Human Services, the United States Court of Appeals for the Federal Circuit upheld a
Special Master’s determination that the studies regarding the adjuvanted H1N1
Pandemrix vaccination and narcolepsy were not persuasive to petitioner’s case because
petitioner in that case received the unadjuvanted influenza vaccination. See McCollum v.
Sec’y of Health & Human Servs., 760 F. App’x 1003, 1008-09 (Fed. Cir. 2019). In another
unpublished decision cited by petitioner, D’Toile v. Secretary of Health & Human
Services, the United States Court of Appeals for the Federal Circuit found appropriate the
lack of deference given to a study involving Pandemrix when the petitioner received a
different influenza vaccination than Pandemrix. See D’Tiole v. Sec’y of Health & Human
Servs., 726 F. App’x 809, 811 (Fed. Cir. 2018). Thereafter, in a decision issued by another
Judge of the United States Court of Federal Claims, Dougherty v. Secretary of Health &
Human Services, the Judge cited D’Tiole and found that the Special Master had
reasonably found insufficient evidence existed to support that the petitioner’s narcolepsy
was caused by the influenza vaccination because the vaccination was sufficiently different
from Pandemrix. See Dougherty v. Sec’y of Health & Human Servs., 141 Fed. Cl. at 229-
30.
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Supreme Court’s decision in Kumho Tires Co., Ltd. v. Carmichael, 526 U.S. 137 (1999),
because testimony in the courtroom should employ “‘the same level of intellectual rigor
that characterizes the practice of an expert in the relevant field.’” Tullio v. Sec’y of Health
& Human Servs., 2019 WL 7580149, at *26 (quoting Kumho Tires Co., Ltd. v. Carmichael,
526 U.S. at 152). In a somewhat contradictory statement, Special Master Moran also
wrote in his decision, “[h]owever, Dr. Steinman’s approach might be consistent with a
view that distinguishes scientists from participants in the civil litigation.” Id. (citing Andreu
ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at 1380).
Another of the petitioner’s arguments before this court is that the Special Master
erred because “[t]he weight placed on the epidemiological evidence herein influenced the
Decision’s entire causation analysis.” Petitioner argues that “the Special Master should
have rejected the epidemiology herein as not dispositive and of little persuasive value, as
opposed to finding it ‘powerful.’” (quoting Tullio v. Sec’y of Health & Human Servs., 2019
WL 7580149, at *11, *27). Although at the oral argument before this court, petitioner’s
counsel indicated that, in part, “Petitioners [sic] weren’t [sic] relying on epidemiological
studies in support of their [sic] position. Only Respondent was relying on them to counter
the Petitioner’s position,” petitioner also referred to some of the respondent’s evidence to
support his case, as described above regarding tetramers. Petitioner points to four studies
that the Special Master allegedly relied on too heavily: the Ray, Bengtsson, Bardage, and
Westra studies, each of which was introduced by the respondent. The Paula Ray, Steven
Black, Henry Shinefield, Aileen Dillon, Diane Carpenter, Edwin Lewis, Pat Ross, Robert
T. Chen, Nicola P. Klein, Roger Baxter study (the Ray study), titled, “Risk of rheumatoid
arthritis following vaccination with tetanus, influenza and hepatitis B vaccines among
persons 15-59 years of age,” published on July 16, 2011, introduced by Dr. Halsey in his
February 23, 2017 original expert report, examined influenza, hepatitis B, and tetanus
vaccinations from 1997 until 1999 in individuals from the ages of 15-59. To rebut Dr.
Steinman’s contention that the studies on influenza vaccinations from other years are
inapplicable, specifically the years covered in the Ray study, Dr. Matloubian stated in his
February 23, 2017 first supplemental expert report:
Two out of the four sequences are identical between the 1998-1999 strain
and the 2012-2013 one (Figure 3). The other two, only differ by one amino
acid between the two strains, resulting in 12 out of 13 in one case and 10
out of 11 in the other case of identical amino acids. This type of similarity is
what Dr. Steinman would term ‘stunning’ and is more remarkable than any
he has described in his report. (Ex. 40 at 20).
Petitioner claims in his motion for review that the Ray study raised by respondent should
not be dispositive, because “the high-dose influenza vaccine received by Petitioner was
not available during those years.” Petitioner also argues that petitioner would not have
qualified for the Ray study because “Petitioner was too old.”
The Camilla Bengtsson, Meliha C. Kepetanovic, and Henrik Källberg, et al. study
(the Bengtsson study), titled, “Common vaccinations among adults do not increase the
risk of developing rheumatoid arthritis: results from the Swedish EIRA study,” published
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on July 5, 2010, also introduced by respondent, although not through an expert, was
conducted from 1996-2006, and the class of people studied were from the ages of 18-70
living in Sweden. Additionally, the Bengtsson study noted that “[s]pecific vaccinations
studied were flu, tetanus, diphtheria, tickborne encephalitis, hepatitis (A, B, C), polio and
pneumococcus.” The Bengtsson study stated, “it is unlikely that vaccinations in general
should be considered as a major risk factor for RA [rheumatoid arthritis].” (brackets
added). Petitioner claims in his motion for review he would not have qualified for the
respondent-introduced Bengtsson study because “Respondent offered no evidence that
the influenza vaccination given in Sweden in 1998 was similar to the high-dose vaccine
given to Petitioner in 2012.”
The Carola Bardage, Ingemar Persson, Åke Örtqvist, Ulf Bergman, Jonas F
Ludvigsson, and Fredrik Granath study (the Bardage study), titled, “Neurological and
autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a
monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden,”
published in 2011, introduced by Dr. Halsey in his February 23, 2017 expert report, was
conducted with individuals who lived in Stockholm county, Sweden from January 1, 1998,
through at least October 1, 2009. These individuals received the H1N1 influenza
vaccination Pandemrix, and the researchers found that the risk for rheumatoid arthritis for
those who received the vaccination remained “unchanged.” Petitioner also argues that
the respondent-introduced Bardage study should not be heavily relied upon because,
“epidemiological and other evidence involving the Pandemrix vaccine have been
consistently rejected by special masters in decisions approved by this Court and the
Federal Circuit.”
The Johanna Westra, Christien Rondaan, Sander van Assen and Marc Bijl study
(the Westra study), titled, “Vaccination of patients with autoimmune inflammatory
rheumatic diseases,” published in March 2015, introduced by Dr. Matloubian in his June
10, 2016 original expert report stated:
In most of the latest studies of the efficacy of influenza vaccination in
patients with RA [rheumatoid arthritis], safety is considered and yet no
significant influence of vaccination on disease activity has been reported.
Also, in pre-post studies after influenza vaccination, patients with RA
[rheumatoid arthritis] did not experience increased disease activity.
(internal references omitted) (brackets added). According to the Westra study
researchers, corticosteroids, methotrexate, TNF inhibitor, and anti-IL-6-receptor antibody
have “no significant influence on influenza vaccination,” while the methotrexate plus TNF
inhibitor, anti-CD20 antibody, and abatacept “can cause a reduced immune response to
vaccination.” (capitalization in original). Using the Westra study as support in his February
23, 2017 first supplemental expert report, Dr. Matloubian stated that “even though it [the
influenza vaccination] elicits an immune response, the influenza vaccine does not
exacerbate the disease.” (brackets added). Dr. Matloubian, in his February 23, 2017 first
supplemental expert report described the results of the Westra study: “although these RA
[rheumatoid arthritis] patients were on immunosuppressive therapy, they still made an
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immune response to the influenza vaccine, but did not have an exacerbation of their RA
[rheumatoid arthritis].” (brackets added). Petitioner notes, however, that he “would not
have been included in” the respondent-introduced Westra study because “he was not
already suffering RA [rheumatoid arthritis] and receiving serious immune-modifying
medications at the time of vaccination.”15 (brackets added).
As noted above, the Special Master examined in detail the epidemiological studies
presented and wrote that the respondent’s epidemiological studies were “persuasive” and
“powerful.” See Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *11, *27.
Special Master Moran concluded his discussion of the first prong of the Althen test by
stating “the powerful epidemiologic evidence does not support this [petitioner’s]
hypothesis.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *27 (brackets
added); see also Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278. The Special
Master also stated, “[n]evertheless, it remains the case that, as Vaccine Program
precedent indicates, epidemiology is not dispositive.” Tullio v. Sec’y of Health & Human
Servs., 2019 WL 7580149, at *11. Special Master Moran also provided a cautionary note
to his findings by stating, “[r]egardless, this case does not turn on why experts presented
the opinions they presented. Instead, the case resolves on the (lack of) persuasiveness
of the theory that the flu vaccine can cause rheumatoid arthritis via molecular mimicry.”
See id. at *27. Although the Special Master in his decision appears to give more credence
to the respondent’s experts than to petitioner’s experts, he did carefully review all the
evidence before him in reaching his ultimate conclusion denying compensation and was
not arbitrary or capricious in doing so.
As also discussed above, the United States Court of Appeals for the Federal Circuit
has addressed the weight that epidemiological evidence should play in a Special Master’s
decision, for example, in Grant v. Secretary of Health & Human Services. See Grant v.
Sec’y of Health & Human Servs., 956 F.2d at 1145-49. In Grant v. Secretary of Health &
Human Services, the petitioner received the Quadrigen vaccination as an infant, to protect
petitioner from diphtheria, pertussis, tetanus, and polio, which petitioner alleged caused
his encephalopathies. See id. at 1145-46. The respondent in Grant introduced
epidemiological evidence which demonstrated that children who had received the
diphtheria, pertussis, and tetanus (DPT) vaccination, which is different than the
Quadrigen vaccination, experienced the same amount of infantile spasms as those who
did not receive the DPT vaccination. See id. at 1148-49. The Federal Circuit in Grant v.
Secretary of Health & Human Services approved the Special Master’s reliance on the
scientific evidence presented by the petitioner regarding the Quadrigen over the
respondent’s presentation of DPT epidemiology because “the epidemiological studies
cited by the Secretary in this appeal related to a general DPT vaccine, not the Quadrigen
vaccine,” and the epidemiology was “not dispositive of the actual causation question in
this case.” See id. at 1149. In Heddens v. Secretary of Health & Human Services, a
decision issued by a Judge of the United States Court of Federal Claims, a petitioner
15 In his decision, Special Master Moran did not indicate that the patients in the Westra
study were all taking immune-modifying medications.
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alleged that a human papillomavirus (HPV) vaccination caused her MS. See Heddens v.
Sec’y of Health & Human Servs., 143 Fed. Cl. at 195. In her motion for review, the
petitioner in Heddens v. Secretary of Health & Human Services argued that the Special
Master’s reliance on epidemiology which did not examine HPV and MS was appropriate.
See id. at 197-98. The Judge in Heddens v. Secretary of Health & Human Services found
that, because the Special Master “considered the epidemiological evidence presented by
respondent, but did not treat that evidence as weighing heavily against petitioner,” that
the Special Master did not abuse his discretion. See id. at 198. The Judge also stated
that because there was no indication that the Special Master “regarded the
epidemiological evidence with what petitioner calls ‘fervor,’” that the weight given to
epidemiological evidence did not heighten petitioner’s burden. See id. at 199.
Petitioner also appeals the Special Master’s finding that petitioner did not satisfy
the second prong of the Althen test, that there was a “logical sequence of cause and
effect” from the vaccine to petitioner’s injury. See Althen v. Sec’y of Health & Human
Servs., 418 F.3d at 1278. Petitioner argues in his motion for review, “[a]lthough it briefly
discussed Althen prong two, the decision failed to set forth whether this prong was
satisfied, likely as a result of its conclusion on prong one,” and petitioner, therefore,
requests “that any remand include an instruction to evaluate Petitioner’s evidence on
Althen prong two in accordance with Capizzano[ v. Secretary of Health & Human
Services, 440 F.3d at 1326].” (brackets added). Respondent argues, however, that the
Special Master made a proper finding that petitioner had not established a logical
sequence of cause and effect because the Special Master found that Dr. Hsu did not
associate petitioner’s rheumatoid arthritis with the flu vaccine in the petitioner’s medical
records once petitioner had received the rheumatoid arthritis diagnosis. Respondent also
argues that “the Special Master provided a sound reason, based on a contextual analysis
of the record as a whole, to conclude that no treating physician persuasively opined that
the flu vaccination caused petitioner’s RA [rheumatoid arthritis].” (brackets added).
Petitioner’s reply to respondent in this court concedes that Special Master Moran had
come to the conclusion that petitioner had not satisfied the second prong of Althen.
Petitioner, therefore changed his argument in this court to argue that “requiring multiple
treator attributions in order to reach an acceptable level of persuasiveness is not in
keeping with case law.” (citing Paluck v. Sec’y of Health & Human Servs., 786 F.3d at
1385-86). As stated above, the United States Court of Appeals for the Federal Circuit has
found that treating physician statements are considered “quite probative” 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.”
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326 (internal quotation marks
omitted); see also Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at
1375.
In Capizzano v. Secretary of Health & Human Services, the United States Court of
Appeals for the Federal Circuit found “[a]s far as the second prong is concerned, in our
view, the chief special master erred in not considering the opinions of the treating
physicians who concluded that the vaccine was the cause of Ms. Capizzano’s injury.”
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326. Regarding petitioner’s
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physicians, Special Master Moran noted petitioner’s visits to Dr. Samples, Dr. Bouffard,
Dr. Brignoni, and Dr. Shieh, before addressing the consultations with petitioner’s
rheumatologist, Dr. Hsu, including Dr. Hsu’s statement, that “I am concerned about a pain
syndrome associated with his flu vaccine.” Tullio v. Sec’y of Health & Human Servs., 2019
WL 7580149, at *28. The Special Master stated that “after Dr. Hsu diagnosed Mr. Tullio
with rheumatoid arthritis, she did not associate his disease with his flu vaccination.” Id.
As discussed above, the petitioner’s treating doctors were unable to diagnose petitioner’s
disease for months. Petitioner came to Dr. Hsu initially with an incorrect diagnosis of
Guillain-Barré syndrome, which has been recognized by the Secretary of Health and
Human Services to be associated with the influenza vaccination. See Vaccine Injury
Table, 42 C.F.R. § 100.3(a) (2019) (associating “Seasonal Influenza vaccines” with
“Guillain-Barré Syndrome” “3-42 days” after vaccine administration). After diagnosing
petitioner with rheumatoid arthritis, however, Dr. Hsu did not mention the influenza
vaccination in the medical records of when she saw petitioner. Therefore, Special Master
Moran did not discount the treating physician’s statement, but Special Master Moran took
the entire record into consideration when he found that the second prong of the Althen
test, “logical sequence of cause and effect,” was not satisfied because “no treating doctor
has persuasively opined that the flu vaccination caused Mr. Tullio’s rheumatoid arthritis.”
Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *28; see also Althen v.
Sec’y of Health & Human Servs., 418 F.3d at 1278.
Special Master Moran also stated that “[t]he lack of support from treating doctors
is consistent with the lack of information about the cause of rheumatoid arthritis” because
“the cause of rheumatoid arthritis is not known.” Tullio v. Sec’y of Health & Human Servs.,
2019 WL 7580149, at *28. According to Special Master Moran, “when epidemiologic
studies have explored a potential association, they have not found an increased incidence
of rheumatoid arthritis in people who received the flu vaccine.” Id. Also according to
Special Master Moran, “given this information, it would be surprising for a doctor to tell
Mr. Tullio that the flu vaccination caused his rheumatoid arthritis. See Tr. 219 (Dr. Utz
stating that he has never told any of his rheumatoid arthritis patients that flu vaccination
caused their rheumatoid arthritis).” Id.
The final, and most unusual, section in Special Master Moran’s decision is the
“Testability” section. See id. at *22-*26. Special Master Moran stated, “Dr. Utz and Dr.
Steinman have presented a hypothesis—hemagglutinin and collagen are molecular
mimics—that is testable, but has not been tested directly.” Id. at *24. Special Master
Moran also stated, “[i]f Dr. Steinman or Dr. Utz had conducted experiments about
molecular mimicry, the results could have assisted Mr. Tullio in meeting his burden of
proof.” Id. at *25. Special Master Moran goes so far as to state:
The Vaccine Program would seem to allow for time to seek approval from
an overseeing institution, to carry out the experiment, and to submit an
article for peer review because the pace of litigation has dramatically
slowed. Mr. Tullio’s case came to hearing approximately four years after it
was filed and this time was relatively quick. Moreover, the presence of
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approximately $4 billion in the Vaccine Injury Compensation Trust Fund
suggests that money is available to pay for experiments.
Id. at *25 n.23. Then, at the end of the section regarding testability, Special Master Moran
presented a caveat that applied to the entire section:
As discussed in sections A and B, the epidemiology and the mechanistic
evidence do not support a finding that the hypothesis of molecular mimicry
between flu vaccine and hemagglutinin is sound and reliable. Therefore, the
lack of testing does not affect the outcome of the case—if this section on
testability were excised from the decision, the undersigned still would have
found that Mr. Tullio did not establish prong 1 [of the Althen test].
Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *26 (brackets added).
This court notes that at the oral argument before this court, the petitioner explicitly
rejected the Special Master’s suggestion that petitioners in the Vaccine Program should
perform experiments to assist in providing proof for his or her case. In particular, the
petitioner’s attorney stated at the oral argument that the idea of testing “is not really a
practical approach,” because “it raises a lot of concerns for Petitioner, because as in this
case, first of all, I mean, who is going to do this research?” Further, petitioner argued at
the oral argument, that requiring testing “would not resolve their cases quickly” and “it
could be prohibitive, and if they [petitioners] were at a risk of losing the funds they put into
research, then it would, you know, be a reasonable basis type of analysis where they
would not be reimbursed their costs, then you have the -- it would be highly troubling.”
(brackets added). In addition, petitioner states in his motion for review that testing is
“impractical,” asking:
Would petitioners be expected to delay already crucially needed
compensation while their experts engage in testing? Would petitioners be
required to bear the cost of such testing unless and until it is reimbursed
through the granting of a motion for fees and costs? Would petitioners run
the risk of not being compensated for the costs of testing if their claims prove
unsuccessful and are challenged as not having a reasonable basis? What
is the practicality of finding expert researchers willing to sideline present
research and academic focus to run the experiments proposed in the
Decision?
Respondent stated in its response to petitioner’s motion for review in this court, regarding
the Special Master’s testability comments that “his discussion as to testability of
petitioner’s causation theory was clearly dicta.” Moreover, as noted above, the United
States Court of Appeals for the Federal Circuit in Knudsen ex rel. Knudsen v. Secretary
of Health & Human Services outlined the role of the United States Court of Federal Claims
in deciding cases in the Vaccine Injury Compensation Program:
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The Court of Federal Claims is therefore not to be seen as a vehicle for
ascertaining precisely how and why DTP and other vaccines sometimes
destroy the health and lives of certain children while safely immunizing most
others. This research is for scientists, engineers, and doctors working in
hospitals, laboratories, medical institutes, pharmaceutical companies, and
government agencies. The special masters are not “diagnosing” vaccine-
related injuries. The sole issues for the special master are, based on the
record evidence as a whole and the totality of the case, whether it has been
shown by a preponderance of the evidence that a vaccine caused the
[petitioner’s] injury or that the [petitioner’s] injury is a table injury, and
whether it has not been shown by a preponderance of the evidence that a
factor unrelated to the vaccine caused the child’s injury. See 42 U.S.C.
§ 300aa-13(a)(1), (b)(1).
Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d at 549 (brackets
added); see also Broekelschen v. Health & Human Servs., 618 F.3d at 1345; Andreu ex
rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at 1382.
In sum, after reviewing the evidence in the record before him, Special Master
Moran found that the petitioner had failed to meet his burden of proving “a medical theory
causally connecting the vaccination and the injury” with “some indicia of reliability to
support the assertion of the expert witness.” Althen v. Sec’y of Health & Human Servs.,
418 F.3d at 1278; Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d
at 1324.
C O N C L U S I O N
Upon review of the record before this court, including the medical records, the
expert reports, the testimony taken at the hearing before Special Master Moran, and
Special Master Moran’s decision, this court finds that Special Master Moran’s decision,
which concluded that the petitioner had failed to prove, by a preponderance of the
evidence, a medical theory of causation connecting the influenza vaccination to the
petitioner’s allegation that the vaccination caused his rheumatoid arthritis, was not
arbitrary or capricious. The Special Master’s ruling on entitlement denying compensation
to petitioner is AFFIRMED. The Clerk of the Court is instructed to enter JUDGMENT
consistent with this Opinion.
IT IS SO ORDERED.
s/Marian Blank Horn
MARIAN BLANK HORN
Judge
37