Whelan v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-1174V
(not to be published)

* * * * * * * * * * * * * * **
MERRY WHELAN, * Special Master Corcoran
*
Petitioner, * Filed: January 28, 2019
*
v. * Influenza (“flu”) vaccine;
* Dermatomyositis (“DM”);
SECRETARY OF HEALTH * Althen Prong Three.
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * ***

Martin J. Rubenstein, Martin Rubenstein, Staten Island, NY, for Petitioner.

Sarah C. Duncan, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION DENYING ENTITLEMENT1

On September 21, 2016, Merry Whelan filed a petition seeking compensation under the
National Vaccine Injury Compensation Program (“Vaccine Program”). 2 Ms. Whelan alleged that
her October 4, 2013 influenza (“flu”) vaccine caused dermatomyositis (“DM”). Pet. at 1 (ECF
No. 1).

Once the medical records, statement of completion, Respondent’s Rule 4(c) Report, and
expert reports were filed, I conducted a status conference, during which I recommended that this

1
Although this Decision has been formally designated “not to be published,” it will nevertheless be posted on the
Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This
means that the Decision will be available to anyone with Internet access. As provided by 42 U.S.C. § 300aa-
12(d)(4)(B), however, the parties may object to the Decision’s inclusion of certain kinds of confidential information.
Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “pf any
information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged
or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly
unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole Decision will be available to the public
in its current form. Id.

2
The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-
10–34 (2012) (hereinafter “Vaccine Act” or “the Act”). Individual section references hereafter shall refer to §300aa
of the Act.
case be resolved without hearing. See Minute Entry, May 9, 2018. The parties agreed to this
proposition, and Petitioner filed a brief in support of her claim on July 31, 2018. See Pet’r’s Pre-
Hr’g Mem. (ECF No. 30-1) (“Pet’r Br.”). Respondent subsequently filed a brief arguing for
dismissal of Petitioner’s claim. See Resp’t’s Response to Pet’r’s Br. in Support of her Claim, filed
Sept. 21, 2018 (ECF No. 33) (“Resp. Br.”). Petitioner filed a Reply on October 4, 2018 (ECF
No. 34).

Having completed my review of the evidentiary record and the parties’ filings, I hereby
DISMISS Petitioner’s claim, for the reasons stated below.

I. Factual Background

Before receiving the flu vaccine at issue, Ms. Whelan’s medical history was largely
unremarkable. She did, however, have polymorphic light eruption (“PMLE”)3 from ages thirteen
to fifty, as well as a family history of cancer. Ex. 10 at 2 (ECF No. 6-10).

On October 4, 2013, Petitioner, then age fifty-four, received the Fluvirin flu vaccine at a
Walgreens in Cherry Hill, New Jersey. Ex. 1 at 3 (ECF No. 6-1). There is some dispute about the
situs of the vaccine’s administration: the vaccination record states that she received it in her left
shoulder (id.), but Petitioner later reported that she received the shot in her right shoulder. Ex. 15
at 2 (Expert Report of Dr. Arthur Brawer), filed July 5, 2017 (ECF No. 12-1) (“Brawer Rep.”).

There are no medical records relevant to Petitioner’s claim for the next two months. Then,
on December 13, 2013, Petitioner saw her dermatologist, Emily Miller, M.D., for a mole check.
Ex. 3 at 21–22 (ECF No. 6-3). Notes from that visit do not reflect concern about any muscle pain
or a rash. See id. At a January 22, 2014 annual check-up with a gynecologist,4 however, Petitioner
was now noted (for the first time in the medical records in this case) to have left shoulder pain and
a history of “frozen shoulder.” Ex. 17 at 11–12 (ECF No. 13-2). This record does not specify when
such pain began. See id.

On March 25, 2014, Petitioner returned to Dr. Miller with complaints of an itchy rash on
her face and hands, which she stated had been present for approximately two months (meaning it
began in late January). Ex. 3 at 19–20. She connected the start of her rash to a trip to Puerto Rico.
Id. at 20. At this same visit, she denied muscle pain and weakness. Id. Dr. Miller noted that the
rash could be evidence of PMLE, DM, or SCLE [subacute cutaneous lupus erythematous]. Id. At

3
PMLE is skin rash resulting from exposure to sunlight. Dorland’s Illustrated Medical Dictionary 642, 1538 (32nd
ed. 2012) (hereinafter “Dorland’s”).

4
Notes from this visit do not identify which physician Ms. Whelan saw. See Ex. 17 at 11–13.

2
a follow-up appointment with Dr. Miller on April 1st, examination revealed a worsening rash as
well as a Gottron’s papule5 on Ms. Whelan’s right hand. Id. at 10–11. Dr. Miller then ruled out
PMLE and SCLE, diagnosing Petitioner with DM. Id. at 10.

Ms. Whelan’s rash thereafter continued to spread, and she saw Dr. Miller for two additional
follow-up visits in April 2014. Ex. 3 at 4–5, 8–9. Petitioner consulted with two rheumatologists
and another dermatologist the following month: an in-person visit with rheumatologist Brian
Grimmett, M.D., on May 5th; a telephone consultation with rheumatologist Preethi Thomas, M.D.,
on May 9th; and an in-person visit with dermatologist Victoria Werth, M.D., on May 13th. Ex. 9
at 4–5 (ECF No. 6-9); Ex. 10 at 2–3; Ex. 29b at 204–08 (ECF No. 20-2).

At her visit with Dr. Grimmett, Petitioner reported that she had started experiencing
weakness in her legs at least four months earlier (or January), with weakness in her arms and neck
developing sometime thereafter. Ex. 9 at 4. During her telephone consultation with Dr. Thomas,
by contrast, Petitioner stated that her symptoms began in December 2013 with left shoulder pain.
Ex. 29b at 204. Ms. Whelan reiterated her belief that her rash began during a February 2014
vacation in Puerto Rico at these visits. Ex. 10 at 29; Ex. 29b at 204. All three physicians confirmed
that Petitioner suffered from DM, noting a serious rash and weakness in multiple extremities that
made even simple tasks difficult. Ex. 9 at 5; Ex. 10 at 30; Ex. 29b at 204. Furthermore, Dr. Thomas
noted that many DM cases are indicative of the presence of cancer, and she accordingly
recommended several cancer screenings. Ex. 29b at 208.

On June 12, 2014, Petitioner saw Allan Magaziner, D.O., at the Magaziner Center for
Wellness. Ex. 2 at 10–11 (ECF No. 6-2). At this visit, she now informed Dr. Magaziner of her
suspicions (for the first time in this medical record) that her symptoms “actually began in October
2013 when she felt she may have had a frozen shoulder as she had some discomfort in that area.”
Id. at 10. But this record makes no mention of the flu vaccine. See id. at 10–11. Ms. Whelan then
underwent a colonoscopy on July 16, 2014, which was normal except for a finding of non-bleeding
internal hemorrhoids. Ex. 5 at 5–6 (ECF No. 6-5). The colonoscopy was ordered due to treater
concern that her DM diagnosis could be secondary to an “occult malignancy.” Id. at 9.

Six months later, Petitioner experienced a DM flare-up in January and February of 2015.
Ex. 10 at 14, 19–20. The record is otherwise silent as to any other subsequent flare-ups or DM
symptom recurrence. In addition, nearly three years after her October 2013 flu vaccination,
Petitioner was treated for breast cancer. An August 16, 2016 mammogram revealed a small mass
in her right breast, and a September 1st biopsy confirmed the presence of a ductal carcinoma in
situ (“DCIS”).6 Ex. 27 at 3 (ECF No. 19-4). The small tumor was removed on October 13th, after

5
Gottron’s papules are small, flat-topped, and discolored raised areas on the knuckles characteristic of DM. Dorland’s
at 1373.
6
A DCIS is a malignant growth in a mammary duct that has not spread elsewhere in the body. Dorland’s at 291, 569,

3
which Ms. Whelan underwent radiation therapy. Id. at 3, 12. She successfully completed radiation
treatment on December 28, 2016. Id. at 12.

At a September 18, 2017 visit with Dr. Thomas, Petitioner was reported to have no
weakness and that her rash was better. Ex. 29a at 4 (ECF No. 20-1).

II. Witness Statements

Only one statement7 was filed in this case, from Petitioner’s close friend, Gail Parker Krol.
See Ex. 40, filed July 31, 2018 (ECF No. 30-2). In it, Ms. Krol stated that Ms. Whelan had
complained to her of pain and weakness in her right upper arm in mid-October 2013. Id. at 2. Ms.
Krol believed this to be “frozen shoulder,” which she herself had previously experienced. Id. After
Petitioner was diagnosed with DM, Ms. Krol conducted independent research that led her to
believe that Ms. Whelan’s condition may have resulted from her flu vaccine. Id. at 3–4. Ms. Krol’s
affidavit also provides corroboration for several points that are well-substantiated in Petitioner’s
medical record, including the fact that Petitioner developed a rash after her trip to Puerto Rico and
had a small tumor removed from her breast in September 2016. Id. at 2–3.

III. Expert Reports

A. Dr. Arthur Brawer

Arthur Brawer, M.D., filed two reports on Petitioner’s behalf. See generally Brawer Rep.;
Ex. 38, filed Apr. 26, 2018 (ECF No. 27-1) (“Brawer Supp. Rep.”). Petitioner did not file a
curriculum vitae (“CV”) for Dr. Brawer, but his letterhead indicates that he is a rheumatologist
and serves as a diplomate to both the American Board of Internal Medicine and the American
Board of Rheumatology.8 Brawer Rep. at 1. Dr. Brawer opined that the flu vaccine caused
Petitioner’s DM through molecular mimicry.

i. Dr. Brawer’s First Expert Report

571, 944.
7
Contrary to Vaccine Act requirements, Petitioner did not file a sworn statement of her own to accompany her Petition.
See Section 11(c)(1).

8
Dr. Brawer has testified previously in the Vaccine Program. See, e.g., Cabrera v. Sec’y of Health & Human Servs.,
No. 13-598V, 2017 WL 510466, at *4 (Fed. Cl. Spec. Mstr. Jan. 12, 2017). As noted in Cabrera, he received his M.D.
from Boston University, then completed a residency in internal medicine and a fellowship in arthritis. Id. As of early
2017, he was board-certified in internal medicine and rheumatology. Id. At that time, he served as an associate clinical
professor at Hahnemann/Drexel University School of Medicine in Philadelphia, as well as an assistant clinical
professor of medicine at Robert Wood Johnson University School of Medicine in New Brunswick, New Jersey. Id.

4
 Dr. Brawer begins his six-page report by noting that he performed an in-person evaluation
of Ms. Whelan, in addition to a review of her medical records. Brawer Rep. at 1. He provides an
overview of Petitioner’s medical history, noting that she received the October 4, 2013 flu vaccine
in her right arm—contrary to what the vaccination record and other medical records state, although
he asserts that such records are “in error.” Id. at 1–2. Dr. Brawer describes Petitioner’s post-
vaccination course, stating that she began experiencing severe pain in her right shoulder one week
after vaccination, which developed into progressive weakness in both upper extremities, a feeling
of heaviness in her legs, and frequent fatigue. Id. He notes further that, in early 2014, she developed
a rash on her forehead, followed by a generalized full-body rash. Id. With no specific reference to
Petitioner’s February 2014 trip to Puerto Rico, Dr. Brawer asserts that “[n]one of this rash was
precipitated by sun exposure.” Id. Dr. Brawer does not address the fact that Ms. Whelan’s medical
records are silent as to her claimed soreness, weakness, and fatigue in the final months of 2013.
He next describes the results of his physical examination of her, concluding that she suffers from
DM “directly initiated by and related to the influenza vaccination administered on October 4,
2013.” Id. at 3.

Dr. Brawer then turns to his explanation of how the flu vaccine caused Petitioner’s DM.
Brawer Rep. at 4–5. He describes the theory of molecular mimicry, in which “antigens of infectious
agents can cross react with self-antigens on a variety of body cells, including immunocompetent
cells, thereby triggering systemic inflammatory reactions.” Id. at 4. He alludes to “numerous
reports” that purportedly provide support for the theory of molecular mimicry in general (though
he specifically cites to only one item of medical literature), then proceeds to identity six scientific
articles that ostensibly speak to the theory’s applicability to DM. Id. at 5.

In the alternative, Dr. Brawer briefly touches on other theories of causation. Brawer Rep.
at 5. In particular, he notes that vaccines can “alter the balance between helper and suppressor T-
cells,” and that “[p]olyclonal B-cell activation . . . can also occur following vaccination.” Id.
Furthermore, he alludes to “additional deleterious mechanisms of vaccine induced autoimmune
diseases, including adjuvants such as aluminum, modification of surface antigens, induction of
novel antigens, and exposure of sequestered antigens.” Id. Dr. Brawer does not discuss any of these
alternative theories in detail, however, nor does he discuss their applicability to the flu vaccine and
DM.

Dr. Brawer turns next to the questions of whether there was a logical sequence of cause
and effect and reasonable temporal relationship linking Petitioner’s DM to the flu vaccine. Brawer
Rep. at 5–6. Noting that Ms. Whelan did not experience other conditions likely to trigger DM prior
to her diagnosis (such as systemic inflammatory arthritis), Dr. Brawer concludes that the sequence
of cause and effect is logical. Id. He finds “complete concordance” between Petitioner’s medical

5
records and her self-reported history, and based on this concludes with “an emphatic yes” that the
October 4, 2013 flu vaccine is temporally related to Ms. Whelan’s development of DM. Id. at 6.

ii. Dr. Brawer’s Second Expert Report

Dr. Brawer’s supplemental report was filed in response to the report from Respondent’s
expert (which is discussed below). Brawer Supp. Rep. at 2. He examined Ms. Whelan for a second
time on April 11, 2018, and he begins his second report by providing an update on her condition.
Id. at 1. He asserts that she experienced a DM flare-up in late fall of 2017, but does not identify
medical records supporting this.9 Id.

Dr. Brawer then responds to Dr. Matloubian’s report. He discusses Petitioner’s September
2016 lumpectomy in relation to her DM, noting that the almost three-year gap between her flu
vaccine and lumpectomy makes it “far outside the realm of probability” that her carcinoma was
present when her DM first began. Brawer Supp. Rep. at 3. However, he provides no explanation
of what would constitute a reasonable time lapse in order for there to be a causal link between the
cancer and the preceding DM, nor does he cite medical literature in support of his statements on
this topic. Id. at 3–4. Finally, Dr. Brawer reiterates his conclusions from his first report and
provides a brief rebuttal to criticisms raised by Dr. Matloubian, emphasizing the varied causes,
presentations, and courses of inflammatory systemic connective tissue diseases.10 Id. at 2.

B. Dr. Mehrdad Matloubian

Mehrdad Matloubian, M.D., Ph.D., provided one report on behalf of Respondent. See
Ex. A, filed Dec. 1, 2017 (ECF No. 22-1) (“Matloubian Rep.”). As reflected in his CV, Dr.
Matloubian received his B.S., M.D., and Ph.D. (specializing in immunology and virology) from
the University of California, Los Angeles. Ex. B at 1, filed Dec. 1, 2017 (ECF No. 23-6)
(“Matloubian CV”); Matloubian Rep. at 1. He completed a residency in Medicine at the University
of California, San Francisco (“UCSF”), followed by a fellowship in rheumatology at the same
facility. Matloubian CV at 1.

Dr. Matloubian’s practice involves a combination of research and patient care. He has
served as an associate professor of Medicine at UCSF since 2001. Matloubian CV at 2. In his
research, Dr. Matloubian focuses on innate and adaptive immune responses to viral infections, and

9
Petitioner has not otherwise filed medical records substantiating or providing details about this alleged DM flare-up.

10
Dr. Brawer also dedicates a sizable portion of his supplemental report to criticizing Dr. Matloubian’s report, largely
by way of ad hominem attacks on Dr. Matloubian himself. See Brawer Supp. Rep. at 2–4 (characterizing Dr.
Matloubian as having “little appreciation for the fact that the complexity of nature far transcends man’s ingenuity,”
having “a cookie-cutter, one-size fits all approach to inflammatory systemic connective tissue diseases that is
untampered by clinical reality,” and having an “obsession with the deficiencies of molecular mimicry;” and asserting
that “the usefulness and validity of Dr. Matloubian’s report of November 28, 2017 is inversely related to its length”).

6
he has published numerous articles in reputable medical journals on issues in this field. Id. at 7–8,
10–14; Matloubian Rep. at 1. In addition to teaching and research work, he also serves as associate
director of the UCSF Molecular Medicine Consult Service, which is a recently-established hospital
service involving both clinicians and research scientists, who work together to treat patients with
a variety of unusual disorders. Matloubian CV at 3. Additionally, Dr. Matloubian has spent one
month per year as an attending physician on the UCSF Inpatient Rheumatology Consult Service
since 2001. Id.

In his fifteen-page report, Dr. Matloubian discusses Petitioner’s medical history, opines
that the flu vaccine played no role in her development of DM, and offers an alternative theory of
causation. See generally Matloubian Rep. Unlike Dr. Brawer, Dr. Matloubian did not personally
examine Ms. Whelan, but he provides a detailed review of her medical history. Id. at 1–3. In his
view, no causal link exists between the flu vaccine and DM, and he discusses the weaknesses in
Dr. Brawer’s theory at length. See id. at 7–12.

DM, Dr. Matloubian explains, is one of the idiopathic inflammatory myopathies—a group
of heterogeneous autoimmune diseases of unknown cause that affect both the skin and muscle
function. Matloubian Rep. at 4. It presents with a rash (often in a specific pattern) after extensive
sun exposure, as well as muscle weakness in the neck, shoulders, upper arms, and thighs. Id. The
effects on the muscles are symmetric, meaning that both sides of the body are affected equally. Id.

Dr. Matloubian criticizes Dr. Brawer’s assertion that the flu vaccine can cause DM through
molecular mimicry. Matloubian Rep. at 7–12 (discussing Brawer Rep. at 4–5). He provides an
overview of how molecular mimicry works, explaining that, regardless of whether a disease is
mediated by B cells or T cells, the specific antibodies produced (whether in response to an infection
or vaccination, as alleged here) to fight a particular pathogen must detect parallel structures to that
pathogen in self-cells in order for molecular mimicry to occur. Id. at 8. Accordingly, in order for
a vaccine to cause an autoimmune disease (such as DM), the pathogen from which the vaccine is
derived must, in his opinion, be associated with the autoimmune disease in question. Id. at 8, 10.
This means, he argues, that the wild virus (which the vaccine immunizes against) should also
plausibly cause the same autoimmune disease in some individuals. Id. Against this backdrop, Dr.
Matloubian proceeds to assess whether the wild flu virus has been shown to cause DM. Id. at 10.
His research revealed no studies linking the two, which he finds particularly compelling given the
high incidence of wild flu infections worldwide. Id. at 10–11.

Dr. Matloubian next considers the medical literature cited by Dr. Brawer in support of his
assertion that the flu vaccine is associated with DM. Matloubian Rep. at 11–12. He discusses five
of the six items of literature cited by Dr. Brawer (see Brawer Rep. at 5) in turn. Matloubian Rep.
at 11–12. One was a letter to the editors of medical journal The Lancet aiming to correct the
mistaken view that the flu vaccine and DM were associated. Id. at 11 (citing Richard K.

7
Winkelmann, Influenza Vaccine and Dermatomyositis, 320 The Lancet 495 (1982), filed as Ex. 20
(ECF No. 16-1) (“Winkelmann”)). Another was a case report linking the Hepatitis B vaccine—
which is entirely unrelated to the flu vaccine—to DM. Id. (citing Arie Altman et al., HBV Vaccine
and Dermatomyositis: Is There an Association?, 28 Rheumatology Int’l 609 (2007), filed as Ex.
21 (ECF No. 16-2) (“Altman”)). Collectively, three others referenced the same case report of a
patient who experienced DM following a flu vaccination. Id. at 11–12 (citing F.M. Jani et al.,
Influenza Vaccine and Dermatomyositis, 12 Vaccine 1484 (1994), filed as Ex. 28 (ECF No. 19-5)
(“Jani”) (one flu-DM case report); Joerg-Patrick Stügben, A Review on the Association Between
Inflammatory Myopathies and Vaccination, 13 Autoimmunity Rev. 31 (2013), filed as Ex. 23 (ECF
No. 16-4) (“Stügben”) (listing one flu-DM case report, which is the Jani report)11; H. Orbach &
A. Tanay, Vaccines as a Trigger for Myopathies, 18 Lupus 1213 (2009), filed as Ex. 25 (ECF
No. 19-2) (discussing one flu-DM report, which is the Jani report)). Furthermore, Dr. Matloubian
opines that it would be improper to rely on case reports alone to support a theory of causation
between the flu vaccine and DM, as they do not discuss the subjects’ prior or subsequent medical
history, and “provide no mechanistic evidence for causation and may simply reflect coincidental
temporal association.” Id. at 12. He also calls into question the accuracy of the DM diagnosis made
in the Jani case report.12

Dr. Matloubian also responds to one of Dr. Brawer’s alternative theories of causation.
Matloubian Rep. at 12 (discussing Brawer Rep. at 5). He notes that, while Dr. Brawer theorizes
that adjuvants may play a role in vaccine-related harms, the flu vaccine received by Ms. Whelan
(Fluvirin) contains no adjuvants. Id.13

Dr. Matloubian also discusses onset and the timing of Ms. Whelan’s first DM-related
symptoms. When an injury is driven by molecular mimicry, Dr. Matloubian noted, onset would be
expected to occur within one to three weeks after vaccination. Matloubian Rep. at 14. He explained
that this is the case because B- and T-cell responses peak ten to fourteen days after immunization.
Id. at 13. In his view, however, the record establishes that Petitioner’s DM symptoms did not begin
until December of 2013, when she first experienced “musculoskeletal symptoms,” more than eight
weeks after immunization, making vaccine causation impossible even under Petitioner’s proffered
theory. See id.

11
Dr. Matloubian states that Stügben contains “a handful” of flu-DM cases, but in my own review of the article I
found only one listed. Matloubian Rep. at 11; Stügben at 33.
12
Dr. Matloubian does not discuss the final item of medical literature cited by Dr. Brawer in his first report, “an article
in 1979 in the Scandinavian Journal of Rheumatology by E. Kass, entitled ‘Dermatomyositis associated with BCG
vaccination’” (“Kass”). Brawer Rep. at 5. That article does not appear to have been filed in this case. Regardless,
based on its title, it appears to discuss the bacille Calmette-Guérin vaccine, which immunizes against tuberculosis and
is thus not relevant to this claim. Dorland’s at 2015.

13
See Package Insert—Fluvirin at 8, available at U.S. Food & Drug Admin., Fluvirin,
https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm112852.htm.

8
 In addition to offering criticism of Dr. Brawer’s theories of causation, Dr. Matloubian also
puts forth an alternative theory linking Petitioner’s DM to her subsequent breast cancer.
Matloubian Rep. at 4–6. He cites epidemiologic studies in support of his position that DM is
associated with cancer, even when the cancer is diagnosed for up to five years after the DM. Id. at
4–5. He explains how immune responses to cancer cells may also attack normal tissue, causing
autoimmune diseases such as DM. Id. at 5. While he concedes that the link between cancer and
DM is still not fully understood, Dr. Matloubian opines that it is likely a correct hypothesis, and
that is accurately describes Petitioner’s clinical course. Id. at 6. Noting that her carcinoma was
detected approximately two years after her DM diagnosis, he finds it likely that her 2014-
diagnosed DM was related to her then-likely subclinical breast cancer. Id. at 5–6.

IV. Procedural History

As noted above, Ms. Whelan filed her Petition on September 21, 2016. Respondent filed
his Rule 4(c) Report on April 3, 2017. ECF No. 9. Petitioner’s medical records were submitted
sporadically over the course of many months, the last of which were filed on October 23, 2017.
Dr. Brawer’s initial expert report was filed in July 2017, followed by supporting medical literature
two months later. Respondent filed Dr. Matloubian’s report and accompanying medical literature
in December 2017, and Petitioner filed Dr. Brawer’s responsive report in April 2018. The parties
submitted their respective briefs in the summer and fall of 2018. This case is now ripe for decision.

V. Parties’ Respective Arguments

A. Petitioner’s Memorandum

Petitioner asserts that she has satisfied all three prongs (discussed in detail below) of the
Federal Circuit’s test for determining Vaccine Act entitlement stated in Althen v. Secretary of
Health & Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005), and has thus demonstrated
entitlement to an award of compensation on a theory of causation-in-fact. See Pet’r Br. at 1.
Emphasizing that Dr. Brawer met with Ms. Whelan twice in person and has extensive clinical
experience, she urges me to adopt his conclusion about the flu vaccine’s causal role in her
development of DM. Id. at 4–5.

Ms. Whelan contends that she has provided a theory of general causation through Dr.
Brawer’s explanation of molecular mimicry. Pet’r Br. at 2. She highlights a quotation from the
Jani case study, whose authors opined that the patient’s onset of DM shortly after vaccination and
the disease’s similar presentation to other vaccine-associated DM cases “do suggest a causal
relationship” linking the flu vaccine and DM. Id. at 8 (citing Jani at 1484).

9
 Petitioner notes further that Dr. Brawer discusses alternative theories of vaccine-induced
injury, including an altered balance between helper and suppressor T cells, “polyclonal T cell
activation,” the role of adjuvants, “modification of surface antigens,” “induction of noval [sic]
antigens and exposure of sequestered antigens.” Pet’r Br. at 2. Petitioner does not identify which,
if any, of these concepts applies specifically to her case, however, nor does she provide further
detail or scientific support regarding any of their mechanisms of causation. See id.

Turning next to the question of whether Petitioner’s flu vaccine is connected to her
subsequent DM onset by a logical sequence of cause and effect, Petitioner cites to Dr. Brawer’s
conclusion that her DM cannot be attributed to other causes. Pet’r Br. at 3. In particular, she notes
that she did not experience systematic inflammatory arthritis prior to developing DM. Id. She
argues further that the close temporal nexus between her vaccination and DM onset, as well as the
indefinite continued existence of her condition, illustrate the vaccine’s causal role. Id.

Petitioner briefly discusses the temporal connection between the flu vaccination and her
development of DM. Pet’r Br. at 3. Though she does not specify when her DM onset began, she
restates Dr. Brawer’s conclusion that her self-reported medical history at her in-person
consultations with him is in “complete concordance” with her medical records. Id.

After laying out her case for compensation, Petitioner proceeds to criticize the alternative
theory of causation put forth by Dr. Matloubian: that her DM could be linked to her 2016 breast
cancer. Pet’r Br. at 4–5; 9–12. Ms. Whelan notes that her DCIS was “not a full blown disease
process but a strictly localized process, which in any event was likely not present in the Fall of
2013.” Id. at 4–5. She also asserts that her DM was not alleviated after the DCIS was excised. Id.
at 12.

Petitioner also discusses evidence cited by Dr. Matloubian in support of his cancer-
causation theory. Pet’r Br. at 9–12. She notes that Dr. Matloubian quotes a finding that between
nine and thirty-two percent of DM cases are associated with cancer, which means that sixty-eight
to ninety-one percent of DM cases are not cancer-associated. Id. at 9. With regard to the literature
cited by Dr. Matloubian in support of his conclusions, Petitioner asserts that “[w]hile Dr.
Matloubian refers to an extensive body of literature supporting an association between [DM] and
cancer, only a minority of patients with [DM] have cancer diagnosed.” Id. at 11–12. She criticizes
the inadequacy of his discussion of DM and cancer, stating that he had failed to explain whether
cancer causes DM, vice versa, or whether some additional factor plays a causal role in both
conditions. Id. at 9. Finally, she criticizes his overall logical framework, arguing that his opinion
that there is no cross-reactivity between the flu vaccine and relevant self-cells should undermine
his conclusion that such cross-reactivity exists between tumor-specific immune cells and relevant
self-cells. Id. at 12.

10
 B. Respondent’s Response

Respondent counters Petitioner’s claim for entitlement, asserting that Petitioner has not
satisfied any of the three Althen prongs. Resp. Br. at 1.

First, Respondent contends that Petitioner has failed to provide a sound and reliable theory
of causation linking the flu vaccine to DM. Resp. Br. at 10. He urges me not to accept the theory
of molecular mimicry without concrete support for a link between the specific vaccine and illness
at issue, citing a previous Vaccine Program decision in which I stated that petitioners “cannot
simply invoke the concept of molecular mimicry and call it a day.” Id. at 10 (quoting Johnson v.
Sec’y of Health & Human Servs., No. 14-254V, 2018 WL 2051760, at *26 (Fed. Cl. Spec. Mstr.
Mar. 23, 2018)). He notes that the literature cited by Dr. Brawer in support of his molecular
mimicry theory largely does not actually support his conclusions. Id. at 10–11. Respondent notes
that Dr. Matloubian’s research revealed no association between the wild flu virus and DM, which
he stated would be necessary in order for molecular mimicry to apply. Id. at 12.

Respondent also addresses the alternative theories of causation proffered by Petitioner.
Resp. Br. at 10 n.8. He notes that Dr. Brawer’s discussion of the adjuvant has no applicability to
this case, as the flu vaccine Ms. Whelan received contains no adjuvant. Id. All other theories
alluded to by Dr. Brawer and Petitioner should similarly be discounted, he asserts, due to
Petitioner’s failure to provide any additional explanation or supporting literature. Id.

Respondent criticizes Petitioner’s proffered logical sequence of cause and effect,
characterizing it as impermissible post hoc ergo propter hoc reasoning. Resp. Br. at 13–14. He
asserts that Petitioner cannot simply rely on temporal proximity and elimination of other possible
causes in order to show that the flu vaccine caused her injury. Id. Furthermore, he takes issue with
Petitioner’s failure to satisfactorily address the potential causal role of breast cancer. Id. at 14–15.

Finally, Respondent addresses the issue of timing, both with regard to the onset of Ms.
Whelan’s DM and what would constitute a medically-acceptable onset of an injury under a theory
of molecular mimicry. Resp. Br. at 16–19. He contends that Petitioner’s claimed DM onset in
October 2013 is unsupported by contemporaneous medical records, and that the first recorded
symptoms in fact occurred no less than eight weeks after vaccination. Id. Citing Dr. Matloubian’s
statement than a molecular mimicry-induced injury would occur within one to three weeks,
Respondent contends that even if I find Petitioner’s theory of causation credible, onset occurred
too long after vaccination to find causation here. Id. at 19.

C. Petitioner’s Reply

In a short Reply (just over one page in length), Petitioner reiterates that Dr. Brawer’s
conclusions are based on his in-person interactions with Petitioner, as well as on his extensive

11
clinical experience. Reply at 1. For this reason, Petitioner asks me to find his opinions more
persuasive than those of Dr. Matloubian, which she contends are based “on speculation.” Id.

VI. Applicable Legal Standards

A. Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 11(c)(1), 13(a)(1)(A), 14(a); see also Moberly v. Sec’y of Health & Human
Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440
F.3d 1317, 1320 (Fed. Cir. 2006).14 In this case, Petitioner does not assert a Table claim.
Furthermore, a petitioner must show that he has “suffered the residual effects or complications of
such illness, disability, injury, or condition for more than 6 months after the administration of the
vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered such illness, disability,
injury, or condition from the vaccine which resulted in inpatient hospitalization and surgical
intervention.” Section 11(c)(1)(D).

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. Section 13(a)(1)(a). That is, a petitioner must offer evidence that
leads the “trier of fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge of the fact’s
existence.” Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enters. v. United States, 6 Cl. Ct.
476, 486 (1984) (mere conjecture or speculation is insufficient under a preponderance standard).
Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate that the vaccine was “not
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006). A petitioner may not receive a Vaccine Program award based solely on his assertions;
rather, the petition must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal

14
Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. App’x 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

12
Circuit in Althen: “(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 proximate temporal relationship between vaccination and injury.” Althen,
418 F.3d at 1278.

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355–56 (citations omitted). To satisfy this prong, a
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549.

Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378–79 (Fed. Cir. 2009)
(citing Capizzano, 440 F.3d at 1325–26). Special masters, despite their expertise, are not
empowered by statute to conclusively resolve what are essentially thorny scientific and medical
questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through
the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant
evidence standard.” Id. at 1380. Accordingly, special masters must take care not to increase the
burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v.
Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844
F.3d 1363 (Fed. Cir. 2017).

In discussing the evidentiary standard applicable to the first Althen prong, many decisions
of the Court of Federal Claims and Federal Circuit have emphasized that petitioners need only
establish a causation theory’s biological plausibility (and thus need not do so with preponderant
proof). Tarsell v. United States, 133 Fed. Cl. 782, 792–93 (2017) (special master committed legal
error by requiring petitioner to establish first Althen prong by preponderance; that standard applied
only to second prong and petitioner’s overall burden); Contreras, 121 Fed. Cl. at 245
(“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis in
original)); see also Andreu, 569 F.3d at 1375. At the same time, there is contrary authority from
the Federal Circuit suggesting that the same preponderance standard used overall in evaluating a
claimant’s success in a Vaccine Act claim is also applied specifically to the first Althen prong. See,
e.g., Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed. Cir. 2010)
(affirming special master’s determination that expert “had not provided a ‘reliable medical or
scientific explanation’ sufficient to prove by a preponderance of the evidence a medical theory
linking the [relevant vaccine to relevant injury]”) (emphasis added). Regardless, petitioners always
have the ultimate burden of establishing their Vaccine Act claim overall with preponderant
evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations

13
omitted); Tarsell, 133 Fed. Cl. at 793 (noting that Moberly “addresses the petitioner’s overall
burden of proving causation-in-fact under the Vaccine Act” by a preponderance standard).

The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” an injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as 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’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence present in the record—including conflicting opinions
among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011)
(not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions
against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Dept. of Health &
Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review denied, 100 Fed. Cl. 344, 356 (2011), aff’d without op., 475 Fed. App’x 765 (Fed. Cir.
2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” 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 1347, 1352 (Fed. Cir. 2008). The explanation for
what is a medically acceptable timeframe must also align with the theory of how the relevant
vaccine can cause the injury in question. Id. at 1352; Shapiro v. Sec’y of Health & Human Servs.,
101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d mem.,

14
2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human Servs., No. 11-355V,
2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review denied (Fed. Cl. Dec. 3,
2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Analysis of Fact Evidence

The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as the “results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, provided that such determination is
evidenced by a rational determination).

Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528. This presumption is based on the linked propositions
that (i) sick people visit medical professionals; (ii) sick people honestly report their health
problems to those professionals; and (iii) medical professionals record what they are told or
observe when examining their patients in as accurate a manner as possible, so that they are aware
of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health &
Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013);
Cucuras v. Sec’y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d at 1525
(Fed. Cir. 1993).

Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony—
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992), cert. denied sub. nom. Murphy v. Sullivan, 506 U.S. 974 (1992)
(citing United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally
been held that oral testimony which is in conflict with contemporaneous documents is entitled to
little evidentiary weight”)).

15
 In determining the accuracy and completeness of medical records, the Court of Federal
Claims has listed four possible explanations for inconsistencies between contemporaneously
created medical records and later testimony: (1) a person’s failure to recount to the medical
professional everything that happened during the relevant time period; (2) the medical
professional’s failure to document everything reported to her or him; (3) a person’s faulty
recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of
symptoms that did not exist. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203–
04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making a determination regarding whether to
afford greater weight to contemporaneous medical records or other evidence, there must be
evidence that this decision was the result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Reports

Establishing a sound and reliable medical theory often requires a petitioner to present
statements from medical experts in support of his claim. Lampe v. Sec’y of Health & Human Servs.,
219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated
according to the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow
Pharm., Inc., 509 U.S. 579, 594–96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617
F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d
1302, 1316 (Fed. Cir. 1999)). “The Daubert factors for analyzing the reliability of testimony are:
(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, 195 F.3d at
1316 n.2 (citing Daubert, 509 U.S. at 592–95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
& Human Servs., 94 Fed. Cl. 53, 66–67 (2010) (“uniquely 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”). The flexible use of the Daubert factors to evaluate the
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 742–45. In this matter (as in numerous other Vaccine Program cases), Daubert has been
employed to determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert reports, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”

16
Broekelschen, 618 F.3d at 1347 (citing Lampe, 219 F.3d at 1362). However, nothing requires the
acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the
expert,” especially if “there is simply too great an analytical gap between the data and the opinion
proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see
also Isaac v. Sec’y of Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl.
Spec. Mstr. July 30, 2012), mot. for review denied, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. App’x
999 (Fed. Cir. 2013) (citing Cedillo, 617 F.3d at 1339). Weighing the relative persuasiveness of
competing expert testimony, based on a particular expert’s credibility, is part of the overall
reliability analysis to which special masters must subject expert testimony in Vaccine Program
cases. Moberly, 592 F.3d at 1325–26 (“[a]ssessments as to the reliability of expert testimony often
turn on credibility determinations”); see also Porter v. Sec’y of Health & Human Servs., 663 F.3d
1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously explained that special masters are
expected to consider the credibility of expert witnesses in evaluating petitions for compensation
under the Vaccine Act”).

D. Consideration of Medical Literature

Both parties filed medical and scientific literature in this case, but not every filed item
factors into the outcome of this decision. While I have reviewed all of the medical literature
submitted in this case, I discuss only those articles that are most relevant to my determination or
are central to Petitioner’s case. Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1328
(Fed. Cir. 2016) (“[w]e generally presume that a special master considered the relevant record
evidence even though he does not explicitly reference such evidence in his decision”) (citation
omitted); see also Paterek v. Sec’y of Health & Human Servs., 527 F. App’x 875, 884 (Fed. Cir.
2013) (“[f]inding certain information not relevant does not lead to—and likely undermines—the
conclusion that it was not considered”).

E. Determination to Resolve Case Without Hearing

I have opted (without objection by either side) to decide entitlement in this case based on
written submissions and evidentiary filings, including the expert reports, rather than after a
hearing. The Vaccine Act and Rules not only contemplate but encourage special masters to decide
petitions on the papers when, in the exercise of their discretion, they conclude that such a means
of adjudication will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d).
The choice to do so has been affirmed on appeal. See D’Tiole v. Sec’y of Health & Human Servs.,
726 F. App’x 809, 812 (Fed. Cir. 2018); Hooker v. Sec’y of Health & Human Servs., No. 02-472V,
2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases where
special masters decided on the papers in lieu of hearing and that decision was upheld). I am simply
not required to hold a hearing in every matter, no matter the preferences of the parties. Hovey v.
Sec’y of Health & Human Servs., 38 Fed. Cl. 397, 402–03 (1997) (special master acted within his

17
discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy v. Sec’y of Health &
Human Servs., No. 90-882V, 1991 WL 71500, at *2 (Ct. Cl. Spec. Mstr. Apr. 19, 1991).

ANALYSIS

For the reasons set forth below, I find that Petitioner has failed to satisfy all three prongs
of a causation-in-fact claim under Althen. I discuss each prong below in order of its significance
to my determination.

A. Althen Prong Three

Even assuming that the flu vaccine could cause DM, Petitioner has failed to show that her
injury occurred within a medically-acceptable time frame after vaccination. Petitioner’s expert,
Dr. Brawer, offers no opinion on the question of how long after vaccination one would expect DM
to develop if caused through molecular mimicry. Rather, he states in conclusory fashion that there
is “complete concordance” between Petitioner’s contemporaneous medical records and her later-
reported recollections that her symptoms began earlier than such records reflect. Brawer Rep. at 6.
This assertion does not address the more fundamental question of when onset would be expected
under Petitioner’s proffered theory, and thus does not gain evidentiary weight simply from Dr.
Brawer’s pronouncement.

In addition, Petitioner’s timing argument is contrary to the evidence offered in this case
about what the reasonable timeframe for a vaccine-induced autoimmune reaction resulting in DM.
In her brief, Petitioner asks me to adopt Dr. Matloubian’s view that molecular mimicry-driven
onset would occur one to three weeks after vaccination. Pet’r Br. at 14. This time period is
consistent with the post-vaccination DM noted in the Jani case study. Jani at 1484 (DM began two
weeks after vaccination).

But this onset is not reflected in Petitioner’s medical record, which does not support the
conclusion that Petitioner’s DM began so quickly after vaccination. Neither her rash nor muscle
pain clearly associated with DM was noted until three months after vaccination, in February 2014.
This is consistent with other medical records. At all other visits with physicians in the intervening
eight months, Petitioner consistently placed the onset of her rash as during her February 2014
vacation to Puerto Rico. See, e.g., Ex. 3 at 20. Ms. Whelan’s first statement to a treater indicating
that her symptoms may have began closer in time to vaccination was not until her visit with Dr.
Magaziner in June 2014. And Dr. Matloubian at best allowed for onset in December 2013—still
too long after the October 4th vaccination to constitute a reasonable timeframe under Petitioner’s
causation theory.

In addition, it is unclear whether muscle pain or weakness that she may have experienced
prior to this can fairly be attributed to her DM. Petitioner repeatedly denied muscle pain and

18
weakness at doctor’s visits until long after vaccination. See, e.g., Ex. 3 at 19–20 (denying muscle
pain and weakness at March 25, 2014 visit with Dr. Miller). And while her later-in-time statements
to treaters suggested that she began experiencing pain in one shoulder sometime around October
or December 2013 (see, e.g., Ex. 2 at 10–11 (stating to Dr. Magaziner at June 2014 visit that
symptoms began with frozen shoulder in October 2013); Ex. 29b at 204 (informing Dr. Thomas
during May 2014 conversation that symptoms began in December 2013 with left shoulder pain)),
pain in one shoulder was not likely a symptom of DM, as Dr. Matloubian noted that DM-related
muscle weakness is symmetric—that is, it presents on both sides of the body. Matloubian Rep.
at 4.

Petitioner was unsuccessful in varying these medical records. She offered no witness
statement of her own, and Ms. Krol’s statement contradicts the existing record (like Ms. Whelan’s
after-the-fact statements to treaters) without corroboration. It is well-established Vaccine Program
law that contemporaneous medical records are presumed accurate, meaning that later-in-time
statements at odds with such records may be given very little weight. See, e.g., Burns, F.3d at 417.

Accordingly, I cannot conclude that Petitioner’s symptoms began within three weeks after
vaccination. Because the record for onset is inconsistent with Petitioner’s causation theory, and
because Petitioner has otherwise established that a longer time period would be medically
appropriate for vaccine-induced DM, she has failed to satisfy the third Althen prong.

B. Althen Prong Two

In addition to failing to explain how the flu vaccine could cause DM (as discussed below),
Petitioner has failed to show that it did so in her case. There is significant disagreement in the
record as to when Petitioner’s DM began, but even if I assume for the sake of argument that it
began the week after vaccination as alleged, it is well-established in the Vaccine Program that
mere temporal proximity between vaccination and onset of injury does not suffice to demonstrate
causation-in-fact. See McCarren v. Sec’y of Health & Human Servs., 40 Fed. Cl. 142, 147 (1997).

As noted above, the evidence supporting the idea that Petitioner developed pain in one
shoulder in late 2013 (consisting largely of later-in-time statements to treaters and Mr. Krol’s
affidavit, not contemporaneous medical records) does not actually support a diagnosis of DM, as
Dr. Matloubian persuasively established that DM presents with symmetrical muscle weakness. The
symptoms more clearly associated with DM—a rash and symmetrical weakness—were not present
until late January or early February 2014, approximately three months after vaccination. Petitioner
has not demonstrated a logical sequence of cause and effect explaining how a process of molecular
mimicry could cause onset so long after vaccination, and no other signs or symptoms of an
autoimmune process were visible in the intervening months between vaccination and DM onset.
Indeed, the record is wholly silent on whether Petitioner experienced any symptoms between

19
October 2013 and the end of that year. Nor did any treater propose the flu vaccine was causal of
her DM.

Additionally, Petitioner did not fully succeed in rebutting Respondent’s argument that her
subsequently-diagnosed breast cancer may have been associated with her DM. Dr. Brawer made
the argument that the timeframe was entirely too long to link the cancer to the prior DM, but neither
provided evidence in support of his conclusions nor addressed the literature offered by Dr.
Matloubian. For example, Dr. Brawer disputed Dr. Matloubian’s statement that cancer related to
DM could present up to five years after DM diagnosis (Brawer Supp. Rep. at 3, discussing
Matloubian Rep. at 5), but failed to address an article cited by Dr. Matloubian finding that “DM
patients remain at increased [cancer] risk for at least 5 years after their initial diagnosis of
myositis.” Ex. A Tab 2 at 11 (ECF No. 22-3) (emphasis added). In response, Petitioner has simply
asserted that Dr. Matloubian failed to substantiate the causal role and sequence of events
connecting DM and cancer (Pet’r Br. at 9), ignoring Dr. Matloubian’s explanation of these very
issues. See Matloubian Rep. at 5–6. While I cannot on this record determine what the evidence
suggests the true cause of Petitioner’s DM was, this argument further undermined the sufficiency
of Petitioner’s “did cause” showing.

C. Althen Prong One

Dr. Brawer reasonably invoked molecular mimicry as a mechanism explaining the
pathogenesis of autoimmune conditions like DM, but he did not in the first instance adequately
establish that the flu vaccine itself (or the more potent wild virus) has been associated with DM.
The literature he cited in support of that contention either directly undermines the conclusion or
provides only tenuous, indirect support. Winkelmann, for example, states that there is no
association between the flu vaccine and DM, while Altman and Kass discuss different vaccines.
In addition, the remaining three items of literature cited by Dr. Brawer all involved the same
individual case report of DM following flu vaccine. As Dr. Matloubian noted, however, the
association proposed therein should be viewed with skepticism due to its questionably accurate
diagnosis. Moreover, case reports are themselves not deemed robust evidence of causation in the
Vaccine Program, a precept recognized Stügben’s authors. Stügben at 33 (“case reports . . .
provide[] only limited potential to establish causal effects” and thus “should not be interpreted as
proof of cause”); see also Crutchfield v. Sec’y of Health & Human Services, No. 09-0039V, 2014
WL 1665227, at *19 (Fed. Cl. Spec. Mstr. Apr. 7, 2014). Otherwise, there were too many ways in
which this causation theory wills its sub-components to be true without substantiating them with
reliable evidence, or evidence pertaining to this case. See Brawer Rep. at 5 (discussing potential
causal role of adjuvant, but failing to note that relevant formulation of flu vaccine in this case is
unadjuvanted).

20
 CONCLUSION

Having reviewed the medical records, expert reports, medical literature, and arguments put
forth by the parties, I do not find that Petitioner has established with sufficient preponderant
evidence that the flu vaccine she received on October 4, 2013, could have caused, or did cause,
her DM. Accordingly, she has not established entitlement to a damages award and I must
DISMISS her claim.

In the absence of a timely-filed motion for review (see Appendix B to the Rules of the
Court), the Clerk SHALL ENTER JUDGMENT in accordance with this decision.15

IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Special Master

15
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing
their right to seek review.

21