Ulysse v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 15-451V

(not to be published)

************************* Chief Special Master Corcoran

GERDA ULYSSE, *

* Filed: May 19, 2022

Petitioner, *

v. *

*

SECRETARY OF HEALTH *

AND HUMAN SERVICES, *

*

Respondent. *

*

*************************

Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for Petitioner.

Mark Kim Hellie, U.S. Dep’t of Justice, Washington, DC, for Respondent.

RULING ON ENTITLEMENT 1

On May 4, 2015, Gerda Ulysse filed a petition for compensation pursuant to the National

Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 to -34 (2012) (the “Vaccine

Program”). 2 Petition, dated May 4, 2015 (ECF No. 1) (“Pet.”); Amended Petition, dated Dec. 7,

2015 (ECF No. 17) (“Amend. Pet.”). Petitioner alleges that as a result of receiving a seasonal

influenza (“flu”) vaccine on October 16, 2013, she suffered a rheumatological injury. Pet. at 1.

Petitioner later specified her injury to be dermatomyositis (“DM”). Amend. Pet. at 1.

1

This Ruling shall 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 Ruling will be available to anyone with access to the internet.

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 “of 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 Ruling will

be available to the public. Id.

2

The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,

100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through -34 (2012) [hereinafter “Vaccine Act” or “the

Act”]. Individual section references hereafter will be to Section 300aa of the Act (but will omit the statutory prefix).

1

An entitlement hearing was held on December 6, 2021, in Washington, D.C., with the parties

appearing remotely. The parties have now submitted post hearing briefs, 3 and the matter is ripe for

resolution.

For the reasons set forth below, I find entitlement for the Petitioner.

I. Factual Background

Prior Medical History

Ms. Ulysse (born on August 28, 1962) was at the time of vaccination a licensed practical

nurse who worked as a dialysis technician. Ex. 2 at 7; Ex. 13 at 237. Her pre-vaccination history

is uneventful—with one relevant exception. Three weeks prior to vaccination (on September 24,

2013), Petitioner saw orthopedist Dr. Eric Freeman for treatment of a history of left knee pain after

being referred by her primary care physician, Dr. Howard Grill. Ex. 2 at 9. Dr. Freeman noted that

Petitioner’s pain was “ongoing progressively.” Id. Petitioner was positive for possible crepitus, 4

mild effusion (or fluid in the relevant knee), 5 and an x-ray was negative for acute bony

abnormality, although she revealed some patellofemoral symptoms. Id. In addition, she revealed

positive results on a “McMurray Test,” 6 performed to evaluate the presence of a meniscal tear. 7

Id.

Dr. Freeman opined, based on Petitioner’s presentation and exam, that she was suffering

from “left knee possible internal derangement. I am going to recommend that we get her into a

course of physiotherapy for strengthening exercises.” Ex. 2 at 9. He also proposed her use of a

slide-on brace and recommended an MRI if her symptoms did not improve. Id.

See Petitioner Post Hearing Brief, dated Feb. 14, 2022 (ECF No. 111) (“Petitioner Brief”); Respondent Post Hearing

3

Brief, dated Feb. 14, 2022 (ECF No. 110) (“Respondent Brief”).

4

Crepitus, according to Respondent’s expert, Dr. Robert Lightfoot, is “crackling or creakiness when a joint is moved.”

Tr. at 137.

5

Effusion is “the escape of fluid into a part or tissue, as an exudation or a transudation.” Effusion, Dorland’s Medical

Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=15649&searchterm=effusion (last visited

May 9, 2022).

6

As explained by Petitioner’s expert, Dr. Tassiulas, the McMurray Test is “to detect ligamentous instability or potential

meniscal injury, like a mechanical type of problem in the knee.” Tr. at 73. Respondent’s expert, Dr. Lightfoot,

characterized it as a “maneuver when one has a knee condition that is difficult to diagnose or to nail down as to

diagnosis that is done to see if possibly there might be an internal derangement, which would be a piece of torn

cartilage or a piece of torn ligament.” Id. at 135.

7

A meniscal tear, or torn meniscus is a common knee injury where an individual “forcefully twist[s] or roate[s] [their]

knee.” Torn Meniscus, Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/torn-meniscus/symptoms-

causes/syc-20354818 (last visited May 9, 2022). The meniscus is a cartilage in the knee that cushions between the

shinbone and thighbone, when torn is causes pain, swelling, popping, locking up of the knee and other issues. Id.

2

Vaccination and Subsequent Medical Issues

Petitioner received the flu vaccine on October 16, 2013, at her workplace. Ex. 1 at 2.

Almost two weeks later, on October 29, 2013, she saw Dr. Grill, reporting that she had felt “blah”

after the shot. Ex. 2 at 2; Ex. 21 at 2. Dr. Grill observed no temperature or other outward issues,

or any other concerning symptoms, but allowed for the possibility of a post-vaccinal reaction,

recommending that Petitioner contact him again if she experienced no change. Ex. 2 at 2.

Ms. Ulysse went back to Dr. Grill in early November, reporting more joint stiffness and

aches. Ex. 21 at 2. Blood work performed around this time was negative for liver-related issues or

rheumatoid factor (which would have suggested a clear rheumatic explanation for Petitioner’s joint

complaints). Ex. 2 at 26–27.

Petitioner was subsequently referred to Dr. Benjamin Levine, a rheumatologist, and saw

him on November 11, 2013, complaining of bilateral wrist aches for two weeks, worsening with

use and associated with swelling. Ex. 11 at 118. She also reported bilateral knee pain for a few

months (which if correct would predate the mid-October vaccination) that worsened with use. Id.

Otherwise, she informed Dr. Levine that a week after vaccination, she had developed a rash on her

fingers, palms, and elbows along with throat pain, odynophagia and oral ulcers, and later

polyarthralgias, with some medications helping the rash but not the joint pain. Id.

Exam at the time of this visit with Dr. Levine revealed no fever or upper respiratory-

associated symptoms. Ex. 11 at 118–19. Dr. Levine observed ulcers on Ms. Ulysse’s cheeks, with

full range of motion in her shoulders, with some mild discomfort, tenderness and swelling in her

wrists, tender hyper-pigmented lesions of the palms and fingers with cracked skin, minimal

hyperpigmentation of the extensor aspect of the elbows, and normal range of motion in the knees

with pain and crepitus. Id. at 119–21. Her bilateral upper extremity (“BUE”) strength was 5/5. Id.

at 120. Dr. Levine’s assessment included acute onset polyarthralgias and inflammatory arthritis,

along with a possible “serum sickness-like reaction” that might be vaccine-related. Id. at 121. He

also performed additional blood and urinalysis tests at this time, that later showed Petitioner’s AST

at 20, ALT at 19, and the SED rate at 21 mm—all deemed within normal ranges. 8 Ex. 11 at 124–

25.

8

AST stands for aspartate transaminase, “an enzyme of the transverse class that catalyzes the reversible transfer of an

amino group from aspartate to α-ketoglutarate to form glutamate and oxaloacetate, with pyridoxal phosphate required

as a cofactor.” Aspartate Transaminase, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=4466 (last visited May 2, 2022). ALT means alanine

transaminase, “an enzyme of the transferase class that catalyzes the reversible transfer of an amino group from alanine

to α-ketoglutarate to form glutamate and pyruvate, with pyridoxal phosphate as a cofactor.” Alanine Transaminase,

Dorland’s Medical Dictionary Online, https://www.dorlandsonline.com/dorland/definition?id=1509 (last visited May

2, 2022). SED is shortened for “skin erythema dose.” SED, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=45211&searchterm=SED (last visited May 2, 2022).

3

Identification of DM as Diagnosis

Dr. Levine referred Ms. Ulysse for a dermatologic consult, and she saw Dr. Eve

Lowenstein for that purpose on November 15, 2013. Ex. 5 at 2. Petitioner again stated that she first

began experiencing symptoms within two weeks of receipt of the flu vaccine. Id. She reported a

variety of symptoms at this time: arthralgias at almost all her joints but ankles; swelling of her

hands; headache; plus, shoulders and wrists aching, and some pain with swallowing. Id. On exam,

she displayed a psoriaform rash on her elbows and knuckles, with patchy erythema on her face. Id.

DM was included in the differential diagnosis, along with connective tissue lupus, or some kind

of drug reaction.

Dr. Lowenstein asked to review Petitioner’s prior blood work, and also performed skin

biopsies from her elbow, forearm, and left lower and upper thigh. Ex. 5 at 5–6. The lab interpreted

the results to reveal “patchy interface dermatitis,” among other things, deeming the biopsies to

present “unusual” findings that likely represented “a drug eruption with features of connective

tissue disease.” Id. at 5. The lab technician opined (based solely on the arm biopsies) that the

diagnostic differential should include lupus, DM, and “the drug-induced forms of these diseases.”

Id. New labs performed to test for other possible explanations (including certain autoantibodies,

inflammatory biomarkers, and tests to identify other rheumatic-associated immune disorders, like

Sjogren’s syndrome) produced negative results. Id. at 4.

The requested blood work largely was, in Dr. Lowenstein’s words, “normal and negative”

of any causal etiologies (other than evidence of a resolved parvovirus infection). Ex. 5 at 7. She

proposed that Petitioner’s clinical presentation was still “consistent with dermatomyositis”—

although this raised the possibility of the need for a paraneoplastic evaluation, to rule out some

other, more serious but undiagnosed condition like lymphoma. Id. After consideration of the

biopsy results, however, Dr. Lowenstein proposed that Petitioner’s symptoms were “most likely

consistent with either connective tissue disease or erythema multiforme related to a drug.” Ex. 5

at 7.

Before this dermatologic consult was completed, Ms. Ulysse went to the South Nassau

Community Hospital (“SNCH”) Emergency Department on November 18, 2013, with complaints

of joint pain and rash for the last three weeks. Ex. 13 at 216. She now reported that the day after

her flu shot, she had developed 7/10 aching joint pain and stiffness, with a painful rash on her

hands and elbows. Id. Exam showed moderate edema of the bilateral hands and wrists, with severe

pain on movement but no erythema. Id. at 218. She ended up being admitted to the hospital until

December 6, 2013, due to her inability to ambulate and lack of improvement from pain relievers.

Id. at 221; 490–92.

4

Petitioner subsequently underwent several other evaluations at SNCH that same month.

Thus, on November 19, 2013, she had a rheumatology consultation with Dr. Joseph Cohn. Ex. 13

at 172. The history from this visit (which occurred prior to receipt of the skin biopsy results) reveals

Petitioner’s admission that she had while running injured her left knee a year earlier. Id. Otherwise,

she again reported that two weeks after the October vaccination she developed a skin rash

involving her metacarpophalangeal joints and fingertips, elbow, and thighs that had not resolved,

followed by joint pain and swelling of her hands, elbows, shoulders, and knees. Id. Dr. Cohn

conducted a complete exam, and reviewed Petitioner’s prior blood work. Ex. 13 at 173. He

expressed concern with Ms. Ulysse’s low white blood cell count as possibly reflective of a “diffuse

viral eruption” or even an HIV infection but based on the available data proposed a differential

that included reactive arthritis and Behcet’s syndrome. 9 Id.

Ms. Ulysse also had a neurology consultation the same day, at which time she complained

of difficulty walking due to pain. Ex. 13 at 236. A peripheral neuropathy was deemed possible due

to her reflexes, strength, and sensation, but the performed motor exam was “somewhat limited

secondary to pain.” Ex. 9 at 57; Ex. 13 at 236. She met with treaters in the hematology/oncology

department. She described symptoms comparable to what she had previously reported to other

doctors, and it was observed that a progressive drop in her white blood cell count was likely

attributable to a reaction to an unidentified acute illness (although other blood testing again

produced normal results). Id. at 167–70, 261, 265, 270. Proposed diagnoses included some

unspecified viral illness, Stevens-Johnson’s syndrome, 10 and syphilis. Id. at 253.

While hospitalized, Petitioner complained of pain when swallowing. Ex. 13 at 351. In the

course of treatment, a flexible laryngoscopy found several white patchy ulcerations in her lower

pharynx deemed consistent with thrush versus immune-related inflammation, leading Petitioner to

be prescribed anti-fungal medication. Id. at 330–31. During this period, evidence of

dermatomyositis was noted (in particular via skin lesions), along with joint pain and swelling, but

no tenderness or weakness Id. at 367. Upon discharge, her diagnoses included dysphagia, 11

polyarthralgia, and herpes lesions. Id. at 490.

On December 10, 2013, Petitioner had a follow-up visit with Dr. Lowenstein, at which

time she complained of weakness and thrush (deemed attributable to the steroid medications she

9

Behcet’s syndrome or Behcet’s disease is a rare disorder that causes systemic blood vessel inflammation. Behcet’s

Disease, Mayo Clinic, https://www mayoclinic.org/diseases-conditions/behcets-disease/symptoms-causes/syc-

20351326 (last visited May 2, 2022).

10

Stevens-Johnson syndrome is “traditionally considered to be a severe form of erythema multiforme.” Stevens-

Johnson Syndrome, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=111447 (last visited May 2, 2022). The syndrome shows

“respiratory prodrome precedes a characteristic mucocutaneous lesions and other symptoms.” Id.

11

Dysphagia is difficulty when swallowing. Dysphagia, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=15265&searchterm=dysphagia (last visited May 3, 2022).

5

had been taking) leading to difficulty swallowing. Ex. 5 at 9. Skin biopsies taken from her thighs

were consistent with different kinds of dermatitis. Id. Dr. Lowenstein again proposed (consistent

with her November treatment of Petitioner) that Ms. Ulysse was experiencing paraneoplastic or

drug-related DM. Id. at 9. Later that same December, Petitioner followed up with Dr. Levine, who

noted that the rash on Petitioner’s hands had not improved, and that she was now reporting severe

shoulder, wrist, and knee pain with morning stiffness that lasted more than an hour. Ex. 11 at 135.

Her labs were largely negative, except for some evidence of inflammation biomarkers. Id. at 135,

140–41. She had no facial rashes or lesions, no liver enlargement, her hyper-pigmented lesions

had improved on her palms and fingers, there was hyper-pigmentations over the bilateral MCPs

with skin breakdown, and both knees had normal range of motion with discomfort and crepitus.

Id. at 137–38. Based upon these observations, Drs. Lowenstein and Levine concurred that

Petitioner should undergo a muscle MRI. Ex. 5 at 8.

Before the end of December 2013, Ms. Ulysse had a neurology consultation at SNCH with

Dr. Joshua Kugler. Ex. 9 at 20. The exam showed normal strength, and although she displayed

ulcers on her hands and buttocks and some inflammatory biomarkers, she now revealed normal

white blood cell levels, and other test results they were improved from November. Id. at 21–25.

Dr. Kugler concluded that there was “[n]o laboratory abnormalities of acute significance, except

elevated [liver function tests].” Id. at 24.

Treatment in 2014 and Beyond

Ms. Ulysse continued to experience a variety of symptoms and conditions, some of which

are associated with her DM, but the subsequent record does not shed significant light on the

question of vaccine causation. Thus, as of January 22, 2014, at a follow-up visit with Dr. Levine,

Ms. Ulysse’s arthralgias and myalgias were improving with medication, but she was showing

prominent oral and skin ulcers, the etiology of such was unclear to Dr. Levine since DM would

not usually produce this kind of symptom. Ex. 11 at 144, 146, 148. She also continued to obtain

treatment for throat and mouth ulcer complaints. See e.g., Ex. 6 at 8; Ex. 7 at 1. Intravenous

immunoglobulin (“IVIG”) treatment Petitioner was receiving was improving her rash, and her

various other symptoms also had diminished, although she complained of tingling and numbness

of the left fingertips, with decreased sensation in the first to fourth fingertips and the second right

fingertip, that led to a proposed neurologic consultation. Ex. 11 at 17–22.

To that end, Petitioner saw neurologist Dr. Jeffrey Behar on March 18, 2014. Ex. 9 at 17.

Her history stated, “likely inflammatory arthropathy, possibly post vaccinal, though unclear,

clinically improving.” Id. The exam had severe local pain to palpation of the wrists, along with the

EMG/NCS of the BUE being consistent with carpal tunnel syndrome. Id. at 18. A brain MRI

showed non-enhancing increased signal intensity in the periventricular white matter in both

hemispheres. Id. at 11–12, 14. This pattern was not associated with demyelinating disease. Id. at

6

11.

By April, Petitioner’s persistent joint pain and recurring lesions led her to again seek

emergency treatment, and after another rheumatologic workup she was diagnosed with amyopathic

DM versus mixed connective tissue disease. Ex. 15 at 68–69, 87. She sought emergency care on

other occasions due to her arthralgias and associated symptoms. Ex. 3 at 28, 323. On May 5, 2014,

Petitioner had a follow-up appointment with Dr. Levine for her amyotrophic DM, focusing on the

rash proposed to have begun after receipt of the flu vaccine. Ex. 11 at 69–73.

Petitioner has since continued to treat for the same overall constellation of issues,

informing treaters of the temporal relationship between vaccination at onset of symptoms in the

fall of 2013. Because these later medical records do not shed substantial light on the issue of

causation, they are not further discussed.

II. Witness Testimony

A. Petitioner’s Expert: Ioannis Tassiulas, M.D., Ph.D.

Dr. Tassiulas, a rheumatologist, testified at the hearing and prepared a single, relatively-

short expert report. Report, dated, July 29, 2016, filed as Ex. 27 (ECF No. 38-1) (“Tassiulas Rep.”).

He opined that the flu vaccine could cause DM and did so to Petitioner.

Dr. Tassiulas attended the Aristotle University of Thesaloniki School of Medicine in

Greece. Ex. 28 at 2, filed on Aug. 1, 2106 (ECF No. 40-1) (“Tassiulas CV”). He thereafter “joined

the NIH for a research fellowship in immunology and rheumatology, where [he] spent 2 ½ years

working mainly on projects related to systemic lupus erythematosus and rheumatoid arthritis.” Tr.

at 5. He later did three years of research doing cytokine signaling for autoimmune diseases at

Cornell University, followed by five years of teaching back in Greece on rheumatology. Id. at 6.

He subsequently returned to the United States, where he was an associate professor at West Chester

Medical Center for four years. Id.

Dr. Tassiulas then went to Mount Sinai Hospital, where he presently works as an “associate

professor of medicine, rheumatology attending, associate program director, and medical director

of the Rheumatology Faculty Practice.” Tr. at 5. He spends approximately 70 percent of his time

on clinical treatment of patients, with the remaining 30 percent on education, clinical trials, and

rheumatology fellowship program. Id. His clinical practice specifically includes general

rheumatology, lung disease, and systemic autoimmune diseases, including DM. Id. at 8. He

estimates seeing about 30 to 50 patients in a year. Id. at 9. In discussing his peer-reviewed articles,

books, and other authorship, Dr. Tassiulas stated he has researched or written on “the regulation

of autoimmunity and inflammation through cytokines and other immune cell receptors.” Id. at 7.

7

He is currently involved in a clinical trial evaluating a cytokine receptor inhibitor as a treatment

for lung disease associated with autoimmune processes. Id. at 8. He also addressed these topics in

books, reviews, lectures, presentations, and abstracts. Tassiulas CV at 8–12.

Dr. Tassiulas began his testimony with a general explanation of autoimmune disease. The

immune system “consists of different cells that can recognize invaders, and they can recognize

them as nonself and, you know, fight them off or can recognize transformed cells and kill them.”

Tr. at 41. Autoimmune diseases occur when the immune system aberrantly responds to self

proteins instead of recognizing them. Id. at 42. This causes “the development of inflammation

driven by different mechanisms, driven by autoantibodies, driven by inflammatory cells, by

lymphocytes, and the development of inflammation in different organs.” Id. ‘

DM, Dr. Tassiulas explained, is believed to be the product of autoimmune-mediated

inflammation occurring in the muscles and the skin (sometimes also involving the lungs), and can

be the result of a combination of environmental factors, a genetic predisposition, and some specific

pathologic process. Tr. at 42–43; Tassiulas Rep. at 1. Dr. Tassiulas gave a list of the common

classifications used to determine DM, including muscle weakness and cutaneous manifestations,

adding that a muscle biopsy or EMG testing 12 can confirm the diagnosis (although Petitioner’s

case was here not confirmed in this manner). Tassiulas Rep. at 2; Tr. at 14.

Onset of DM is usually acute and “characterized by malaise, fatigue, and not so much

muscle pain, but muscle weakness, and especially proximal muscle weakness.” Tr. at 12. There

are different forms of DM depending on its presentation or evolution. Tr. at 47 (discussing M.

Dalakas, Inflammatory Muscle Diseases, 372 New England J. Medicine 1734, 1735 (2015), filed

as Ex. 27, Tab A (ECF No. 38-1) (“Dalakas”)). In its early stages, individuals experience myalgias

and muscle tenderness (except in the case of “amyopathic” DM), but often little muscle weakness.

Tassiulas Rep. at 2; Tr. at 49. DM affects the joints of the wrists, knees, and hands, with symptoms

characterized by arthralgias and arthritis, but can have an impact on the lungs as well. Tr. at 48–

50; Dalakas at 1734. It can result in “Gottron papules” (which he defined as “violaceous flat-

topped papules and plaques located over the dorsal aspect of interphalangeal or

metacarpophalangeal joints”), eyelid rashes, cutaneous vasculitis causing digital ulcerations, and

other skin rashes that cause puffy hands and ulcers. Id.; Tr. at 13; Dalakas at 1735. It peaks among

the general population two times: in childhood (when it is referred to as juvenile dermatomyositis

(JDM”)), and when individuals are in their 40s and 50s. Tr. at 26–27.

12

EMG testing is also called electromyography which is a technique that records “the extracellular activity (action

potentials and evoked potentials) of skeletal muscles at rest, during voluntary contractions, and during electrical

stimulation.” Electromyography, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=15854&searchterm=electromyography (last visited May 9,

2022). These tests may be done by “surface electrodes, needle electrodes, and devices for amplifying, transmitting,

electromyograph.” Id.

8

Dr. Tassiulas admitted that generally the cause of DM is unknown (except when it is

attributable to malignancies, specifically cancer). Tr. at 81–82. But he also proposed a number of

possible environmental triggers for DM. Certain kinds of UV light, for example, are “known to

drive inflammation in the skin in patients with lupus or with dermatomyositis.” Id. at 44. In

addition, DM can be caused by infections, smoking, certain medications, and vaccines. Id. at 20,

44; H. Orbach & A. Tanay, Vaccines as a Trigger for Myopathies, 18 Lupus 1213, 1213 (2009),

filed as Ex. 27, Tab B (ECF No. 38-1) (“Orbach”). Orbach specifically identified “hepatitis B

vaccine and the BCG vaccination against tuberculosis . . . [with] sporadic cases after vaccination

against tetanus, diphtheria,” along with a single case of flu vaccine-caused DM. Tr. at 50; Orbach

at 1214. 13 In regard to Petitioner’s case, the only possible environmental factors (besides the flu

vaccine) possibly relevant were sun exposure and infections. Id. at 45.

Ms. Ulysse, Dr. Tassiulas proposed, was properly diagnosed with DM, although he allowed

there was some ambiguity as to the exact subtype involved. Her primary complaints initially

included joint paint, fatigue, skin rashes, and oral ulcers. Tr. at 79. Muscle weakness, by contrast,

was not a predominant symptom, and testing even revealed only minor elevations of certain

enzymes associated with the problem—but in Dr. Tassiulas’s view “the primary thing with

dermatomyositis are the skin findings, and this is her case.” Id.; see also Tr. at 13. Ms. Ulysse was

also suffering from Gottron’s papules and heliotrope rashes, which Dr. Tassiulas deemed more

supportive of an amyopathic dermatomyositis diagnosis. Id. at 17. In the end, he agreed the medical

record included this as the specific diagnosis, although he observed that Petitioner also displayed

some muscle inflammation and dysphasia. Id. at 18–19.

DM has been proposed to be autoimmune in nature, and Dr. Tassiulas commented on the

evidence from Petitioner’s history that was consistent with her experiencing an autoimmune

process. It is well-understood in medical science that a number of infectious processes could later

cause the rise of a secondary autoimmune disease, such as rheumatic fever occurring in the wake

of a streptococcal pharyngeal infection, as the immune system (in fighting the infection) aberrantly

causes a cross-reaction. Tr. at 28–29. The same could be true of DM. There are also some

autoantibodies thought to be potentially associated with DM (and thus might be driving the disease

process), although their absence is not exclusionary for the diagnosis, and can in fact be detected

only 40 to 60 percent of the time. Tr. at 14, 22–23. In Petitioner’s specific case, one such

autoantibody was identified in testing, but only “a couple years after her presentation.” Id. at 14.

In addition, a lower extremity MRI performed on Petitioner did show inflammation (Id.), and she

displayed a decreased white blood cell count that Dr. Tassiulas deemed “not uncommon to see in

different autoimmune—systemic autoimmune syndromes.” Id. at 17–18. However, he

acknowledged that this finding was likely explained by her underlying illness rather than standing

13

The one case report involving the flu vaccine referenced in Orbach is the same case report relied on by Petitioner in

this case. See F. Jani et al., Influenza Vaccine and Dermatomyositis, 12 Vaccine 1484 (1994), filed as Ex. 27, Tab G

(ECF No. 38-1).

9

as evidence of an autoimmune process. Id. at 18.

Dr. Tassiulas next put forth some specific mechanistic theories for how an autoimmune

process might later manifest as DM. In particular, he mentioned three mechanisms: molecular

mimicry, production of interferons (a cytokine that serves a messenger function in immune

responses), 14 and wild infection. Tr. at 31. He later admitted that some of them could be connected;

for example, a pathologic disease process could feature both a molecular mimicry-driven cross-

reaction and cytokine upregulation, depending on the process’s stage. Id. at 59. He maintained that

medical literature existed to provide reliable support for each. Id. at 31.

Molecular mimicry can occur when amino acid sequences are homologous between a

vaccine’s components and structures in the human tissue. Antibodies produced by the immune

system in reaction to the vaccine may then erroneously identify comparable self structures as

foreign, attacking them in the process. Tassiulas Rep. at 2. In the context of DM, molecular

mimicry would involve homology between foreign antigenic proteins and tobramycin, a muscle

protein, or keratin, a protein in epidermis produced by keratinocytes. Tr. at 31; E. Walker & P.

Jeffrey, Polymyositis and Molecular Mimicry, A Mechanism of Autoimmunity, The Lancet 605,

606–607 (1986), filed as Ex. 27, Tab E (ECF No. 38-1) (“Walker”). Walker is a review article

looking at polymyositis, and found “significant homology between the hemagglutinin, that it’s part

of the influenza Type A, and between the hemagglutinin and the keratin and tobramycin of human

origin.” Tr. at 33. Walker was also focused on wild infections as causing autoimmunity rather than

vaccination, but Dr. Tassiulas noted that the flu vaccine also includes hemagglutinin in a purified

form. Id. at 35, 93–94. Dr. Tassiulas’s opinion did not, however, provide a proposed homologous

amino acid sequence, nor did he provide literature more specific to how DM might unfold due to

the mechanism of molecular mimicry.

Dr. Tassiulas also explained how cytokine production stimulated by vaccination could lead

to a pathologic process. Tr. at 37. He maintained that cells infected with the wild flu virus are

known to produce interferon alpha, a cytokine that has been observed to be overexpressed in DM

patients. Tassiulas Rep. at 2; Tr. at 40–41. This overexpression is not exclusive to DM, but instead

is common in individuals experiencing a variety of autoimmune diseases. Tr. at 38. Such cytokine

upregulation provoked by vaccination in turn has the capacity to stimulate dendritic cells in the

body. Id. at 39. The cytokines thus lead “not only to break in tolerance but also help[] the activation

14

An interferon can be one of many types “of glycoproteins that exert virus-nonspecific but host-specific antiviral

activity by inducing the transcription of cellular genes coding for antiviral proteins that selectively inhibit the synthesis

of viral RNA and proteins.” Interferon, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=25558&searchterm=interferon (last visited May 10, 2022).

These interferons have immunoregulatory functions that “can be stimulated by viral infection.” Id. Based upon the

different types of interferons they are “divided into three distinct types (α, β, and γ) associated with specific producer

cells and functions, but all animal cells are able to produce interferons, and certain producer cells (leukocytes and

fibroblasts) produce more than one type (both interferon-α and interferon-β).” Id.

10

of lymphocytes, and also [are] one of the major factors in driving production of autoantibodies by

B cells.” Tr. at 57. Thus, the stimulation of these cytokines could theoretically provoke an

autoimmune response.

To support this contention, Dr. Tassiulas stated that research has found that “the trivalent

[vaccine] was the one that was causing this increased interferon production,” compared to the

monovalent vaccine. Tr. at 40. He also highlighted an article that he maintained showed the

purported impact of such cytokine upregulation on individuals who had a genetic susceptibility for

autoimmune disease. Tr. at 56; A. Theofilopoulos et al., Type I Interferons (α/β) in Immunity and

Autoimmunity, 23 Ann. Rev. Immunology 307 (2005), filed as Ex. 27, Tab D (ECF No. 38-1)

(“Theofilopoulos”). Theofilopoulos looked at the interferons as a type of cytokine that are crucial

in the adaptive and innate immune process. See Theofilopoulos at 308–11. It also addresses the

“potential drivers of increased Type I interferon production in diseases like lupus and what are the

main mechanisms that increase Type I interferon production that can lead to autoimmune disease

by breaking immune tolerance.” Tr. at 56; Theofilopoulos at 310–11, 316. But as it was noted on

cross-examination, Theofilopoulos does not address vaccines or vaccinations as capable of

initiating this cytokine production in amounts sufficient to cause disease. Tr. at 92. Indeed, it more

generally observes that this class of cytokine can both promote or inhibit the immune response, in

positive or negative ways, with more questions than answers raised about how specifically this

occurs. Theofilopoulos at 325–26.

Post-trial, Petitioner filed an additional item of literature that Dr. Tassiulas referenced in

his testimony. See S. Athale et al., Influenza Vaccines Differentially Regulate the Interferon

Response in Human Dendritic Cell Subsets, 22 Sci. Transl. Med. 1 (2017), filed as Ex. 45 (ECF

No. 105-1) (“Athale”). Athale’s authors noted the significance of dendritic cells in promoting an

adaptive response to the flu vaccine and performed an experiment to compare vaccine

effectiveness of two flu vaccines (the trivalent, non-adjuvanted Fluzone vaccine and the

monovalent, non-adjuvanted H1N1 vaccine) in their ability to activate dendritic cells. Athale at 2–

3. Athale demonstrated the Fluzone version was more effective and did so using the vaccines’

ability to stimulate cytokine upregulation as a comparative measurement. Id. at 2, 7–8. Thus,

although Athale does not say anything about DM, it is consistent with Dr. Tassiulas’s argument

about the significance of cytokine stimulation in immunogenicity.

Dr. Tassiulas offered other evidence to connect vaccination with autoimmune diseases like

DM. Tr. at 60; R. Chen et al., Epidemiology of Autoimmune Reactions Induced by Vaccination, 16

J. Autoimmunity 309 (2001), filed as Ex. 27, Tab F (ECF No. 38-1) (“Chen”). Chen’s authors

looked at how autoimmune diseases could be triggered, with a focus on a number of different

vaccines that have been associated (to varying degrees of reliability) with autoimmune conditions.

See Chen at 310. But Chen makes no specific mention of authorities suggesting the flu vaccine is

related to DM, or any arguably-comparable rheumatic condition for that matter (and in fact does

11

not at all discuss the flu vaccine’s purported association with autoimmune conditions).

Another article observed that 9.7 percent (20 of 206) of a pool of patients experiencing

some form of myopathy had previously been vaccinated, supporting a theory that the preceding

vaccination could be causal. Tr. at 64; V. Limaye et al, Infections and Vaccinations as Possible

Triggers of Inflammatory Myopathies, Muscle & Nerve 987 (2017), filed as Ex. 43 (ECF No. 101-

1) (“Limaye”). Limaye considered the frequency of idiopathic inflammatory myopathies post-

vaccination generally, but also considered sub-variants like DM, and found that “DM was

overrepresented in those with preceding vaccination,” although DM was the diagnosed subtype

only in 6 of the 20 relevant cases considered. Limaye at 988. In addition, 15 of the 20 vaccinations

at issue were for the flu vaccine, with a median post-vaccination onset of 10 weeks. Id. But

Limaye’s findings do not associate the flu vaccine specifically with DM, but instead only observed

more broadly instances of myopathy after “vaccination”—without breaking down the data by

specific vaccine. Id. 15

The only other evidence offered by Dr. Tassiulas directly addressing an association

between the flu vaccine and DM came in the form of a case report of a “68-year-old woman,

apparently previously healthy, [who] after an influenza vaccination . . . developed [] basically

inflammation in the muscles, at the site of vaccination, two weeks after she had the vaccine.” Tr.

at 62; F. Jani et al., Influenza Vaccine and Dermatomyositis, 12 Vaccine 1484 (1994), filed as Ex.

27, Tab G (ECF No. 38-1) (“Jani”). The woman in Jani was diagnosed with DM, and it appeared

her symptoms began at the vaccination site. Jani at 1484. On cross-examination, however,

Respondent observed that this was inconsistent with the more commonly-symmetrical presentation

of DM. Tr. at 85, 86. Dr. Tassiulas nevertheless emphasized that Ms. Ulysse’s initial presentation

was consistent with the Jani case subject, although the case report (which was three paragraphs

long in total) was rather lacking in detail to support the claim—and even noted specifically that

“[e]pidemiological study has failed to find an association between [DM] and influenza vaccine.

Jani at 1484; Tr. at 100.

Dr. Tassiulas’s opinion about causation did rely to some extent on Petitioner’s presentation,

and he noted that she had been basically healthy pre-vaccination. Tr. at 68–69. Her workup for

other potential causes was thorough as well, and looked for “evidence of recent viral infections by

serological methods,” but antiviral and antibiotic treatments were ineffective. Id. at 69–70.

Ultimately, different infections were considered but nothing was deemed conclusive. Id. at 28. She

also had workups “for occult malignancies, including mammograms, transvaginal ultrasounds . . .

15

Limaye also noted the occurrence of a specific antibody in patients also seen in Petitioner, which Dr. Tassiulas states

“is not considered to be myositis-specific antibody, but definitely it’s a myositis-associated antibody.” Tr. at 64

(emphasis added). Importantly, however, this antibody was only detected in Ms. Ulysse (by Dr. Tassiulas’s admission)

“actually a couple of years after her presentation [in the fall 2013],” making it exceedingly difficult to conclude she

likely possessed it from the outset. Tr. at 14; see also Ex. 23 at 1–3 (February 2016 rheumatology work-up).

12

CP cancer test of her chest, abdomen and pelvis,” but no such testing hinted at an etiology. Id. at

70. And she displayed no other relevant risk factors. Id. at 70–71.

Other alternative explanations that the record suggested were not deemed by Dr. Tassiulas

to merit weight. A positive parvovirus infection test result, for example, was more likely proof of

a resolved prior exposure in his view than a causal explanation. Tr. at 71. As to Ms. Ulysse’s

bilateral knee pain, Dr. Tassiulas noted that it was not accompanied by any description of

inflammatory arthritis. Id. at 72. Her x-ray was also normal. And her orthopedic evaluation

concluded her symptoms were likely a mechanical issue, as evidenced by the McMurray test

results, which better supported a mechanical injury, despite the evidence of fluid/swelling (which

he did not deem inconsistent with a non-inflammatory joint problem). Id. at 72–73; Ex. 10 at 1.

Dr. Tassiulas also denied that systemic inflammatory arthritis could begin in one joint, but instead

more commonly displayed in several joints at once—further undermining the likelihood that

Petitioner’s DM preceded vaccination. Tr. at 73.

On cross-examination, Dr. Tassiulas agreed that he had offered no epidemiological studies

showing an association between the flu vaccine and DM—a fact that literature he filed

acknowledged. Tr. at 83, 87; Orbach at 1215 (“there is no evidence in the literature that vaccines

preceded IM or that IM incidence followed vaccination campaigns increased.”). But because DM

was a rare condition, “it’s hard to have good, large epidemiological studies, and for the same

reason, you know, it’s hard to have good clinical therapeutic studies or control studies as well.”

Id. at 52. Instead, case reports or studies, along with retrospective studies, were in Dr. Tassiulas’s

estimation the best available evidence to determine potential causality. Id. at 53.

Finally, Dr. Tassiulas concluded that the temporal relationship between Petitioner’s

vaccination and onset was medically appropriate. Tr. at 76. Ms. Ulysse received the flu vaccine

about two weeks before her symptoms manifested. Some of Petitioner’s treaters mentioned the

temporal relationship between her illness and DM, highlighting a potential association. Id. at 71.

An onset of “weeks to some months” post-vaccination would be, in Dr. Tassiulas’s estimation,

medically reasonable in light of relevant authority. Id. at 76. Dr. Tassiulas’s report referenced a

case report study in which twelve cases of DM were observed to have occurred between five hours

and five weeks of vaccination. Tassiulas Rep. at 5; See N. Agmon-Levin et al., Vaccines and

Autoimmunity, 5 Nat. Rev. Rheumatology 648 (2009), filed as Ex. 27, Tab H (ECF No. 38-1)

(“Agmon-Levin”). Agmon-Levin in fact makes no mention at all of DM (suggesting that this

citation was in error). Agmon-Levin at 648–49. But a different item of literature, Orbach,

referenced (in addition to the two-week timeframe for onset in Jani) JDM occurring after a variety

of other vaccines, and in a timeframe of between five hours and six weeks. Orbach at 1214.

B. Respondent’s Expert: Robert W. Lightfoot, Jr., M.D.

13

Dr. Lightfoot testified at the hearing and submitted one expert report addressing in writing

his theory that Petitioner suffered from an atypical form of DM not caused by vaccination, and

that more likely began pre-vaccination. See Report, filed as Ex. A on Jan. 23, 2017 (ECF No. 47-

1) (“Lightfoot Rep.”).

Dr. Lightfoot received his B.A. and MD. from Vanderbilt University in Nashville,

Tennessee. Tr. at 111. He then did an internship at Columbia Presbyterian Medical Center,

residency at Columbia Presbyterian and Vanderbilt University Hospital, finally a fellowship in

rheumatology at the Columbia University College of Physicians and Surgeons. Ex. B at 1, filed

on Feb. 20, 2020 (ECF No. 79-1) (“Lightfoot CV”). Dr. Lightfoot was part of the junior faculty

at Cornell Medical Center for six years before becoming director of the Division of

Rheumatology at the Medical College of Wisconsin. Tr. at 112.

Dr. Lightfoot is board certified in internal medicine and rheumatology. Tr. at 112;

Lightfoot CV at 1. He is currently working at the University of Kentucky as a professor of

medicine emeritus. Tr. at 112. He also practices rheumatology privately at his clinic and at a

fellow’s clinic. Id. Dr. Lightfoot is an active medical staff at the Albert B. Chandler Medical

Center. Id. at 113. Dr. Lightfoot estimates he sees about 24 patients a week, along with inpatient

consultation in rotation, seeing about 30 to 40 DM patients a year. Id. at 113–14. Further, he is a

member of several professional societies. Lightfoot CV at 3–5. Dr. Lightfoot has taught and

lectured on the subjects of rheumatic diseases, vasculitis, internal medicine, lupus, and other

similar courses. Id. at 7–11. He is also published on the same topics in peer-reviewed journals,

book chapters, and abstracts. Id. at 17–26.

Dr. Lightfoot agreed that Petitioner was properly diagnosed with DM. Tr. at 119. Based

on his review of the medical record, he deemed it an atypical case, in both timing and intensity.

Lightfoot Rep. at 3. He emphasized that her presentation from the start did not include the

complaints of muscle weakness he would associate with DM—instead featuring pain reports and

the skin-related presentation characteristic of the condition. Id. at 3–4. Along with this he noted

that Petitioner’s “serum muscle enzymes were only mildly elevated for her degree of rash and

discomfort,” which he also considered atypical. Id. at 3. Usually these would reach hundreds to

thousands, but Dr. Lightfoot noted, Petitioner’s “were many times in the normal range, once

reaching >300, but no higher.” Id. at 3.

Dr. Lightfoot could not identify the cause of Petitioner’s DM, noting that in his experience

DM’s cause was more often than not unknown. Id. at 116. He accepted that testing evidence from

the medical record did not reveal an underlying malignancy that could explain Ms. Ulysse’s DM.

Id. at 145. But he disputed that the flu vaccine could be causal, arguing that Dr. Tassiulas’s

evidence for this contention was unpersuasive or unsupportive. Id. at 121–22. Dalakas, for

example, stated expressly that the etiologic explanations for inflammatory diseases remain mostly

14

unknown. Dalakas at 1742. Further, other studies have not found an increased risk of autoimmune

diseases after vaccination. See, e.g., Orbach at 1215. He also disagreed with the Orbach article’s

listing of vaccines as an environmental factor that could cause DM, noting it included other

factors that he did not find credible, like silicon implants or collagen injection. Id. at 143–44.

Notably, Dr. Lightfoot referenced no literature in support of his own contentions, and only

attempted to show that the literature affirmatively offered by Petitioner was unsupportive of her

causation theory.

Dr. Lightfoot also took issue with Dr. Tassiulas’s contention about the likely autoimmune

nature of DM, denying that medical science had settled on an agreed autoimmune pathway to

explain DM’s pathologic process. Tr. at 122. Thus, while cytokine levels or certain autoantibodies

could be measured in association with DM, there was no proven pathophysiology of DM that

relied on either to instigate the condition. Id. In so proposing, Dr. Lightfoot referenced serologic

testing from Petitioner’s medical history, noting that her labs were almost all negative for such

allegedly-causal immune cells, with the exception of one instance of an elevated autoantibody—

a finding Dr. Lightfoot deemed likely to be “a spurious false positive test,” given the amount of

testing she underwent and its consistently negative character. Lightfoot Rep. at 4–5. There was,

in his view, inadequate evidence that in this case Petitioner’s DM was driven by cross-reactive

antibodies. Id. at 5. Other abnormal testing results, like high liver enzymes, were results that were

simply consistent with DM and thus did not corroborate the presence of an autoimmune process.

Tr. at 123, 125.

It can be difficult, Dr. Lightfoot proposed, to identify onset of DM, since antibodies

associated with it (which may be inadvertently observed after serologic testing) can long predate

symptoms onset. Tr. at 119. Here, he opined that Petitioner’s symptoms began at least a week

prior to vaccination and possibly earlier. Lightfoot Rep. at 6. Thus, the flu vaccine could not be

causal (whether or not it had that capacity).

To support this aspect of his opinion, Dr. Lightfoot pointed to Petitioner’s medical history.

Central to his determination was Petitioner’s pre-vaccination orthopedic visit on September 24,

2013, when she complained of left knee problems. Tr. at 119–20; Ex. 10 at 1. The record from

this visit characterized her complaints as ongoing and progressive, which in Dr. Lightfoot’s view

was more likely consistent with some underlying developing and chronic condition, despite other

aspects of this record supporting a mechanical explanation. Tr. at 120. The x-ray on her knee was

also a major factor in support of his conclusion; it was not consistent with a mechanical problem,

while effusion was already detectable. Lightfoot Rep. at 6. Thereafter, and within a few weeks,

this initial, arthritic presentation become more systemic, as Petitioner began experiencing

symptoms in her “small joints and large joints, both right side and left side.” Tr. at 120. Although

he agreed that an asymmetrical presentation for DM onset was uncommon, it did not in his view

rule out the likelihood that these knee symptoms established onset, since sometimes arthritis is a

15

major component of DM. Id. at 120–21, 147. He gave little weight to the evidence of crepitations

as undermining his onset opinion. Id. at 148.

Dr. Lightfoot admitted that Ms. Ulysse’s treaters had found significant the post-vaccinal

nature of her injury, and in some cases proposed a connection, but he disputed whether doctors

lacking expertise in immunology or rheumatology were well-suited to reliably opine on the

subject. Tr. at 129. He also noted, however, that it appeared from the record that most of Ms.

Ulysse’s treaters (other than Dr. Levine) seemed unaware of her previous knee pain, undermining

their conclusion that the vaccine was causal (since such speculation did not take into account the

entire record). Id. at 134. Dr. Lightfoot accepted the accuracy of the McMurray test (which might

corroborate a limited and mechanical problem) but noted that quickly thereafter “things got out

of hand at any rate,” and thus the overall findings from the September 2013 orthopedic visit were

consistent with his onset opinion. Id. at 137. And no follow-up MRI was ever performed to

confirm the possibility of a limited mechanical problem (something that in his view would have

been performed by most orthopedists if they suspected that was the actual nature of the problem.

Id. at 149.

III. Procedural History

This case was initiated in May 2015, with medical records being filed a month later,

followed by an amended petition in December 2015. ECF No. 17. After expert reports were filed,

a hearing had been scheduled (before the special master to whom the case had been assigned) for

April 22–23, 2020, but was cancelled. Scheduling Order, dated Mar. 23, 2020 (Docket Entry).

The matter was reassigned to me in January 2021 (ECF No. 94), and I reset the hearing for

December 6, 2021. Prehearing Order, dated Feb. 16, 2021 (ECF No. 97). The matter proceeded

as scheduled and is now ripe for resolution.

IV. Applicable Legal Standards

A. Petitioner’s 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 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §

11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321 (Fed.

Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006). 16

In this case, Petitioner does not assert a Table claim.

16

Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding

authority. Hanlon v. Sec’y of Health & Hum. 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 & Hum. Servs., 59 Fed. Cl. 121,

16

For both Table and Non-Table claims, Vaccine Program petitioners bear a “preponderance

of the evidence” burden of proof. Section 13(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 Enter. 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 & Hum. 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 & Hum. Servs., 165 F.3d 1344,

1352–53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum. 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

Circuit in Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(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.”

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 & Hum. 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 & Hum. 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

124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V,

2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).

17

placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras, 121 Fed.

Cl. at 245.

In discussing the evidentiary standard applicable to the first Althen prong, the Federal

Circuit has consistently rejected the contention that it can be satisfied merely by establishing the

proposed causal theory’s scientific or medical plausibility. See Boatmon v. Sec’y of Health & Hum.

Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also LaLonde v. Sec’y of Health & Hum. Servs.,

746 F.3d 1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply

identifying a ‘plausible’ theory of causation is insufficient for a petitioner to meet her burden of

proof” (citing Moberly, 592 F.3d at 1322)). And petitioners always have the ultimate burden of

establishing their overall Vaccine Act claim with preponderant evidence. W.C. v. Sec’y of Health

& Hum. Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted); Tarsell v. United States,

133 Fed. Cl. 782, 793 (2017) (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 & Hum. Servs., 956

F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” 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 & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

Medical records and statements of a treating physician, however, 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 & Hum. 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 be weighed against other, contrary

evidence also present in the record—including conflicting opinions among such individuals.

Hibbard v. Sec’y of Health & Hum. 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); Veryzer v. Sec’y of Dept. of Health & Hum. Servs., No. 06-522V,

18

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 opinion, 475 F. Appx. 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 & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what

is a medically acceptable timeframe must align with the theory of how the relevant vaccine can

cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health & Hum.

Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012), aff’d

mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs., No. 11-355V,

2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denied (Fed. Cl. Dec. 3,

2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Legal Standards Governing Factual Determinations

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 & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir.

1993) (determining that it is within the special master's discretion to determine whether to afford

greater weight to contemporaneous medical records than to other evidence, such as oral testimony

surrounding the events in question that was given at a later date, provided that such determination

is evidenced by a rational determination).

As noted by the Federal Circuit, “[m]edical records, in general, warrant consideration as

trustworthy evidence.” Cucuras, 993 F.2d at 1528; Doe/70 v. Sec'y of Health & Hum. Servs., 95

Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner's testimony and his

contemporaneous medical records, the special master's decision to rely on petitioner's medical

records was rational and consistent with applicable law”), aff'd, Rickett v. Sec'y of Health & Hum.

Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). A series of linked

propositions explains why such records deserve some weight: (i) sick people visit medical

professionals; (ii) sick people attempt to honestly report their health problems to those

professionals; and (iii) medical professionals record what they are told or observe when examining

19

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 & Hum. Servs., No. 11–685V,

2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Hum.

Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993 F.2d at 1525 (Fed. Cir. 1993) (“[i]t strains reason to

conclude that petitioners would fail to accurately report the onset of their daughter's symptoms”).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec'y of Health & Hum. Servs., No. 03–1585V, 2005 WL

6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical records

are often 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 & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d

1226 (Fed. Cir. 1992), cert. den'd, 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.”)).

However, the Federal Circuit has also noted that there is no formal “presumption” that

records are accurate or superior on their face to other forms of evidence. Kirby v. Sec’y of Health

& Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). There are certainly situations in which

compelling oral or written testimony (provided in the form of an affidavit or declaration) may be

more persuasive than written records, such as where records are deemed to be incomplete or

inaccurate. Campbell v. Sec'y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any

norm based upon common sense and experience, this rule should not be treated as an absolute and

must yield where the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL

6117475, at *19 (“[w]ritten records which are, themselves, inconsistent, should be accorded less

deference than those which are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)).

Ultimately, a determination regarding a witness's credibility is needed when determining the

weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec'y of

Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to

contemporaneous medical records, such testimony must be “consistent, clear, cogent, and

compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec'y of Health & Hum. Servs.,

No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). 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;

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or (4) a person's purposeful recounting of symptoms that did not exist. La Londe v. Sec'y of Health

& Hum. 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, such as testimony at hearing, there must be evidence that this decision was the

result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present

expert testimony in support of his claim. Lampe v. Sec’y of Health & Hum. 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 & Hum. Servs., 617 F.3d 1328, 1339 (Fed.

Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999).

Under Daubert, the 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).

In the Vaccine Program the Daubert factors play a slightly different role than they do when

applied in other federal judicial settings, like the district courts. Typically, Daubert factors are

employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence

that is unreliable or could confuse a jury. By contrast, in Vaccine Program cases these factors are

used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec'y of Health &

Hum. 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 not

been employed at the threshold, to determine what evidence should be admitted, but instead to

determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts in order to rebut a petitioner’s case.

Where both sides offer expert testimony, a special master's decision may be “based on the

credibility of the experts and the relative persuasiveness of their competing theories.”

Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing

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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 & Hum.

Servs., No. 08–601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for

review den'd, 108 Fed. Cl. 743 (2013), aff'd, 540 F. 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 & Hum. 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 numerous items of medical and scientific literature in this case, but not

all such items factor into the outcome of this decision. While I have reviewed all the medical

literature submitted in this case, I discuss only those articles that are most relevant to my

determination and/or are central to Petitioner’s case—just as I have not exhaustively discussed

every individual medical record filed. Moriarty v. Sec’y of Health & Hum. Servs., No. 2015–5072,

2016 WL 1358616, at *5 (Fed. Cir. Apr. 6, 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 & Hum. 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”).

ANALYSIS

I. Overview of Alleged Injury

DM is characterized as a type of myositis, or an “inflammation of a voluntary muscle.”

Myositis, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=32923 (last visited May 3, 2022). DM in

particular features “inflammatory skin changes, including the Gottron sign (discolored papules,

especially on extensor surfaces such as the knees, elbows, and knuckles); poikiloderma; discolored

eyelids and edema of the eyelids and periorbital tissue; and an erythematous rash on the forehead,

neck, trunk, and arms.” Dermatomyositis, Dorland’s Medical Dictionary Online,

https://www.dorlandsonline.com/dorland/definition?id=32923 (last visited May 3, 2022). Muscle

weakness is a common feature of DM. See Dalakas at 1735; Orbach at 1213; Jani at 1484; Limaye

at 988. Focal muscle pain, by contrast (and distinguished from aches), is somewhat less common,

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and in some cases is associated more with the injection situs rather than becoming a generalized

symptom. Orbach at 1215.

Although there are very few identifiable Program decisions involving DM as an alleged flu

vaccine injury, I have had occasion to consider the precise issue at least once before. Whelan v.

Sec’y of Health & Hum. Servs., No. 16-1174V, 2019 WL 1061473 (Fed. Cl. Spec. Mstr. Jan. 28,

2019) (denying entitlement). The Whelan petitioner did not go to a doctor until two months later

for a dermatologist appointment, at which time she noted left shoulder pain and “frozen shoulder.”

Id. at *1. She subsequently showed signs (similar to Ms. Ulysse) of rash, Gottron’s papule, and

weakness in her extremities (although the Whelan petitioner also displayed a potential breast

tumor—and hence possible evidence of malignancy). Id. at *1–2. The Whelan Petitioner’s expert

generally invoked the theory of molecular mimicry, along with other such as helper and suppressor

T-cells, B-cell activation post-vaccination, aluminum adjuvants, and modification of antigens. Id.

at *3. Respondent’s expert, by contrast, argued that the wild flu virus had not been shown to cause

DM, which should occur for the vaccine do then do such. Id. at *5.

I ultimately denied entitlement, but mostly due to the fact that the claimant’s onset had

occurred several months post-vaccination, and hence far longer than the relevant timeframe herein.

Whelan, 2019 WL 1061473, at *13–14. I also noted that the petitioner’s expert relied too heavily

on a single case report—the same one as offered herein, Jani—and did not offer enough additional

reliable evidence to associate the flu vaccine with DM. Id. at *15. Respondent’s expert, by contrast,

offered compelling reasons to doubt a vaccine association. And the “did cause” element was also

unsatisfied, given (a) evidence of a potential malignant alternative cause, plus (b) reasons to

question the DM diagnosis.

A different prior case resulted in a favorable determination for the petitioner—although it

involved a distinguishable condition, JDM, as well as different vaccines. Rodriguez v. Sec’y of

Health & Hum. Servs., No. 13-253V, 2017 WL 5563419, at *1 (Fed. Cl. Spec. Mstr. Oct. 26, 2017)

(granting entitlement based on Diphtheria-Tetanus-acellular Pertussis (“DTaP”), Measles-Mumps-

Rubella (“MMR”), Polio, and Varicella vaccines given to a minor child). Id. The petitioners in

Rodriguez put forth a theory of cytokine overproduction after administration of the vaccines, where

a “pro-inflammatory interferon signature could likely cause several changes within cells, including

in the endoplasmic reticulum,” thereafter encouraging adaptive immune responses that would

promulgate disease. Id. at *11. After that the adaptive immune system causes the continued

responses in the body. Id.

In finding for petitioners, the Rodriguez special master was persuaded by the fact that JDM

was deemed by both experts to be mediated by a combination of innate and adaptive immune

responses, but with cytokines especially significant to the process. Rodriguez, 2017 WL 5563419,

at *12. And the injured child had been exposed to several different vaccines at once (unlike the

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present case), increasing the likelihood that an aberrant reaction would occur. In addition, the rarity

of JDM suggested to the special master that epidemiologic studies could not shed light on

causation. Id. In the end, both experts seemed to agree enough on the broad strokes of the theory

for the special master to find that causation was preponderantly established.

II. Petitioner Has Carried her Burden of Proof

The parties do not dispute Petitioner’s DM diagnosis in this case—leaving only the

question of whether the flu vaccine she received likely caused it. The evidence in this case is hardly

robust—but the overall mix of proof offered by Petitioner, which included reliable items of

literature plus persuasive testimony by Dr. Tassiulas, crossed the preponderant line, and that

showing was not rebutted by Respondent.

First, Petitioner’s “can cause” showing was just adequate enough to establish

preponderance. The most compelling aspect of Petitioner’s theory was that cytokine upregulation

attributable to vaccination could result in DM, given what is known about the role cytokines might

play in DM’s pathogenesis plus DM’s likely autoimmune character. I am generally unpersuaded

by arguments that attempt to turn around what is known about a vaccine’s intended effects (and

here specifically, how a vaccine may upregulate cytokines close-in-time to vaccination). Cordova

v. Sec’y of Health & Hum. Servs., No. 17-1282V, 2021 WL 3285367 at *17 (Fed. Cl. Spec. Mstr.

June 23, 2021) (“Evidence that a vaccine causes an immune response—the intended function of

any vaccine—does not amount to a showing that this response is, or can become, pathologic, absent

additional proof linking to evidence of the vaccine’s otherwise-intended response.”). But in this

case, Petitioner’s showing (provided by a qualified expert, with specific demonstrated knowledge

on both DM and the theory at issue) was supported by a reasonable mix of reliable literature and

at least one on-point case study (an admittedly weak kind of evidence, but one that still requires

some consideration when offered). Limaye was especially helpful to Petitioner, even though the

study did not fully link the flu vaccine to DM, since it provided additional corroboration to the Jani

single case report of observed instances in which DM occurred post-vaccination. 17

17

Dr. Tassiulas did not offer any epidemiologic evidence, although Petitioners can prevail in the Program without

doing so (and indeed are never obligated to offer this kind of evidence in the first place). I do not, however, accept

Dr. Tassiulas’s argument that epidemiologic studies cannot meaningfully be taken into account when considering

causation, given rarity of the relevant disease (and concomitantly the rarity of a vaccine-caused injury). Tr. at 52–53.

That argument conflates the preponderant standard, which applies herein, with scientific certainty, which does not.

Petitioners are never required to prove with certainty that a vaccine “can cause” an injury—but Respondent is also not

burdened with proving the opposite. Thus, large scale and otherwise-reliable epidemiologic studies should not be

thrown out because they cannot disprove causation—to require that they do so involves application of a certainty

standard on only one party to a Vaccine Act claim.

The rarity of a vaccine injury is also no reason to ignore otherwise-pertinent epidemiologic proof. In effect, the

argument asks the special master to give great weight to the fact that a person experienced an uncommon illness after

vaccination—to imbue the temporal association with significance, because the fact that few get the illness in the first

place means the known factor of vaccination likely caused it. Yet controlling Program law prohibits doing just that.

McGrail v. Sec’y of Health & Hum. Servs., No. 17-926V, 2021 WL 1728706 at *26 (Fed. Cl. Spec. Mstr. Apr. 23,

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Respondent’s rebuttal showing, by contrast, was far more conclusory and piecemeal. Dr.

Lightfoot was certainly qualified to opine on the injury at issue, but he mostly limited his argument

to attempting to show that Petitioner’s DM likely predated vaccination (which, as discussed below,

was ultimately not persuasive). He did successfully identify qualifications in the literature

Petitioner filed, in which various authors noted the lack of full evidence either associating

vaccination with DM or corroborating Petitioner’s theory. But he offered not a single item of

literature—epidemiologic studies or otherwise—to defend his contentions, preferring instead

simply to maintain that the items offered by Petitioner were inadequate. 18

This was an ineffective defense against Petitioner’s showing. While no party to a Vaccine

Act case is required to offer any particular kind of evidence, when a petitioner offers numerous

items of proof in support of the first Althen prong, Respondent “rolls the dice” by simply trying to

poke holes in the petitioner’s evidence, without filing his own evidence that adds rebutting detail

to the overall causation “picture.” I must ultimately weigh the evidence before me—not what could

have been offered in a more fully-litigated matter. 19 Thus, the fact that Respondent need not offer

any counter-evidence does not mean that the failure to do so is not always significant. Petitioners

cannot effectively rebut Respondent’s employ of reliable epidemiologic evidence that undermines

causation by arguing that such evidence does not “count” or need not be filed. The opposite is true

as well: Respondent’s failure to file his own rebuttal proof is not to be overlooked simply because

he need not do so procedurally.

In the end, Petitioner’s causation showing was better substantiated with a number of items

of reliable scientific/medical proof, and it outweighed Respondent’s more cursory rebuttal. Of

course, my finding does not mean that Petitioner’s showing was particularly persuasive—on the

contrary, I deem it barely preponderant enough to meet her burden of proof. I make this finding

despite reasoned, lingering doubt that the evidence offered in this case proves the flu vaccine “can

cause” DM—but preponderance does not mean scientific certainty, so doubt can remain even in

cases where a petitioner’s showing is minimally adequate.

2021) (“disregarding large-scale evaluations of vaccination outcomes due to the rarity of vaccine injuries” is not

reasonable). Relevant epidemiologic evidence can greatly undercut a petitioner’s showing, and should be evaluated

when offered, as the Circuit has noted. See, e.g., D’Tiole v. Sec’y of Health & Hum. Servs., 726 Fed. App’x. 809 (Fed.

Cir. 2018).

18

Except in a few cases where Respondent opted not to offer his own expert in reaction to Petitioner’s filing of an

expert report, I can think of no other cases I have adjudicated where Respondent chose not to file a single item of

literature.

19

For this reason, I do not find that my prior decision in Whelan counsels against the finding in this case—putting

aside the fact that no prior decisions ever compel a ruling one way or another, except in rare cases where a particular

injury has been litigated so often, and so extensively, that judicial economy does not favor reconsideration (e.g., claims

involving autism as the alleged vaccine injury). Not only did Whelan involve a number of distinguishable facts (a

lengthy onset in particular) that made a favorable finding impossible, but Respondent’s expert showing therein was

far more persuasive.

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Second, I find that Petitioner has demonstrated preponderantly that the flu vaccine likely

“did cause” her DM. As with her first prong showing, the evidence is not strongly in Petitioner’s

favor, but it is sufficient. Thus, the record in this case establishes that Petitioner complained, close-

in-time to vaccination, of a malaise-like reaction (which would be consistent with the

cytokine/interferon-oriented causation theory), with symptoms presentation beginning within two

weeks. Although no serologic testing corroborates her causation theory, several treaters opined a

vaccine association, and those opinions deserve some weight even if, as Dr. Lightfoot noted, they

are not immunologic specialists. Ex. 2 at 20 (Dr. Grill, Mar. 18, 2014), 33 (Dr. Levine, Nov. 11,

2013); Ex. 5 at 2 (Dr. Lowenstein, Nov. 15, 2013); Ex. 9 at 18 (Dr. Behar, Mar. 18, 2014); Ex. 11

at 71 (Dr. Levine, May 5, 2014); Ex. 13 at 174 (Dr. Cohn, Nov. 19, 2013), 227 (Dr. Grill, Nov.

19, 2013). This also is not a case in which there is substantial evidence of a potential alternative

explanation, given the negative testing results for other infectious or malignant etiologies.

The issue of onset of Petitioner’s DM is admittedly problematic. The record in this case

does contain evidence supporting the conclusion that Petitioner’s joint issues may have begun

three weeks before vaccination. Certainly Dr. Lightfoot made reasonable points about Ms.

Ulysse’s presentation at that time, and it could be inferred from it that this reflected the beginning

of what later was diagnosed (and after additional manifestations) as DM. At the same time,

however, the record of this pre-vaccination visit is consistent with a purely mechanical complaint,

distinguishable from the joint pain, muscle weakness, or skin symptoms that would be consistent

with DM. Those kinds of symptoms (in particular, skin rash) only manifested after vaccination,

and Respondent did not persuasively establish that Petitioner’s complaint of knee pain prior to

vaccination was more likely than not the first onset of DM-related symptoms. Thus (and despite

the fact that both experts seemed to agree Ms. Ulysse’s presentation was somewhat atypical), I do

not find on this record that “more likely than not” her DM preceded vaccination.

Finally, the timeframe in which Petitioner’s post-vaccination symptoms manifested is

consistent with her expert’s theory and the support offered for it. The Jani case report and Limaye

(in conjunction with evidence offered about the timeframe for cytokine upregulation, and the role

those kinds of immune cells theoretically play in driving DM) all suggest that a two-week, post-

vaccination onset is medically reasonable. And Dr. Lightfoot did not specifically offer testimony

or written opinion establishing how or why this period of time might be too long or too short for

the proposed aberrant immune reaction. Thus (and not unlike Petitioner’s causation proof more

generally), this aspect of Petitioner’s claim was unrebutted.

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CONCLUSION

As noted above, Petitioner’s overall showing was not notably persuasive or strong. In a

different case, with a more substantive opposition marshaled by Respondent, the outcome would

likely have been different. But the evidence offered in this case was overall quite limited, 20 and

constitutes (with the medical record evidence) the record before me. Based on that record, I find

that Petitioner has carried her burden of proof, and therefore is entitled to an award of damages.

In order to guide the parties through the damages phase of the action, a separate damages

order will issue.

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

Each side offered a single expert report, and neither exceeded six pages in length. Respondent offered no literature.

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And the trial was concluded in approximately a half of a day.

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