Kristine Ballard v. HHS - Influenza, dermatomyositis (2025)

On October 15, 2019, Kristine Ballard filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that she developed dermatomyositis (DM) as a result of an influenza vaccine received on November 3, 2018. The respondent, the Secretary of Health and Human Services, argued that the case was not appropriate for compensation.

Petitioner submitted medical records and expert testimony from Dr. Eric Gershwin, while the respondent presented expert testimony from Dr.

Emmanuel Maverakis. Petitioner's counsel was David J.

Carney, Esq., and respondent's counsel was Parisa Tabassian, Esq. Special Master Mindy Michaels Roth presided over the case.

Petitioner Ballard, age 60, received an influenza vaccine on November 3, 2018. She reported that within approximately two weeks, she developed a rash and other symptoms consistent with DM.

Her medical records show a rash documented on November 18, 2018, and subsequent diagnoses of DM by various physicians, including the Arizona Arthritis Clinic and Dr. Mallace, a rheumatologist.

Petitioner's medical history prior to vaccination included asthma, kidney stones, stomach ulcers, allergic rhinitis, IBS, restless leg syndrome, and allergies. She had also received cosmetic treatments and presented with a growing papule on her nose in July 2018.

Dr. Gershwin opined that the flu vaccine acted as an environmental trigger, activating Ballard's immune system and leading to DM, particularly in a genetically predisposed individual.

He explained that DM involves hyperactivation of the innate immune system and dysregulation of the adaptive immune system, often involving interferon production and autoantibodies, creating a self-sustaining inflammatory loop. He cited studies and case reports suggesting that infections and vaccinations can trigger autoimmune responses through mechanisms like molecular mimicry or by exposing sequestered antigens.

Dr. Gershwin noted that while epidemiological studies have not shown a significant link between vaccines and DM, this is expected given the rarity of the disease and the challenges in detecting such associations.

He specifically disagreed with the respondent's expert regarding the timing of symptom onset and the role of sunlight. Respondent argued that the onset of Ballard's DM predated the vaccination and that sunlight exposure was a more likely cause.

Dr. Maverakis reviewed a questionnaire filled out by Ballard in January 2018 and concluded she had muscle symptoms prior to vaccination.

However, the Special Master found this interpretation of the questionnaire to be a misreading of the record, as Ballard had checked "No" to experiencing motor symptoms, radiating pain, or numbness/weakness. Dr.

Maverakis also pointed to the photo-distributed nature of Ballard's rash as evidence of sunlight triggering the DM, citing documentation of "photodermatitis." Dr. Gershwin countered that DM rashes are typically on photosensitive sites regardless of the cause, and there was no evidence of a change in Ballard's sun exposure prior to her symptom onset.

The Special Master noted that while sunlight can trigger or worsen DM, the medical records did not indicate that her providers opined sunlight caused her DM, and respondent did not provide evidence of a change in sun exposure or a timeframe for sunlight-induced DM. Dr.

Maverakis also argued that large-scale studies have not shown a link between flu vaccines and DM, and that flu vaccines are recommended for patients with DM. He conceded, however, that studying associations between vaccines and extremely rare diseases like DM is difficult, and that if an association exists, it would be hard to identify.

The Special Master applied the three-pronged Althen test for causation. For the first prong, the Special Master found Dr.

Gershwin's theory that the flu vaccine can trigger DM in a genetically predisposed individual, involving interferon activation and immune system dysregulation, to be sound and reliable, supported by medical literature and case reports, and not effectively rebutted by Dr. Maverakis.

For the second prong, the Special Master found that Ballard had demonstrated a logical sequence of cause and effect, as her symptoms began approximately two weeks after vaccination, consistent with Dr. Gershwin's proposed mechanisms, and that the respondent failed to prove an earlier onset or that sunlight was the sole cause.

For the third prong, the Special Master found a proximate temporal relationship, as Ballard's first documented symptom, a rash, appeared on November 18, 2018, about two weeks after her November 3, 2018 vaccination, which both experts agreed was a medically reasonable timeframe for symptom onset. Because Ballard established a prima facie case of causation, the burden shifted to the respondent to prove by a preponderance of the evidence that an unrelated factor was the sole substantial cause of her DM.

The Special Master found that the respondent failed to meet this burden, as the argument that sunlight was the cause was not sufficiently supported. Therefore, entitlement to compensation was granted, and the case proceeded to damages.