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(not to be published)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Although this Decision has been formally designated “not to be published,” it will nevertheless be posted on the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).

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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