Case Review: Ballard v. HHS
In Ballard v. Secretary of Health and Human Services, Special Master Mindy Michaels Roth issued a significant “Ruling on Entitlement,” finding that petitioner Kristine Ballard had proven her influenza vaccination caused her rare autoimmune condition, dermatomyositis (DM).
The case illustrates how the Vaccine Injury Compensation Program (VICP) applies scientific reasoning, legal precedent, and evidentiary standards—specifically the three-part Althen test—to determine vaccine causation for off-Table injuries.
Facts of the Case
Kristine Ballard, a healthy adult with no prior autoimmune disease, received a flu vaccine on November 3, 2018, and within two weeks developed a rash and muscle weakness later diagnosed as dermatomyositis. She filed a VICP claim in October 2019, alleging the flu shot was the triggering event. The government opposed, arguing her disease either predated the vaccine or was caused by sunlight exposure—a known DM trigger.
Dermatomyositis is a rare autoimmune disorder marked by inflammation of muscles and skin, most often seen in women between 40 and 60. Its causes are multifactorial—genetic, environmental, and immunologic—making direct causation complex to prove.
Ruling and Legal Reasoning
1. Medical Theory of Causation (First Althen Prong)
Petitioner’s expert, Dr. Eric Gershwin, presented a well-supported theory that the flu vaccine triggered an abnormal immune response leading to DM through interferon activation and immune dysregulation. He explained that vaccines mimic infections to train the immune system and, in genetically predisposed individuals, can mistakenly attack self-tissue.
Respondent’s expert, Dr. Emmanuel Maverakis, agreed with the general autoimmune mechanism but rejected a specific link between the flu vaccine and DM, calling it speculative.
Special Master Roth ruled for the petitioner, emphasizing that legal causation requires probability, not scientific certainty. She found Dr. Gershwin’s theory credible and consistent with medical literature on interferon involvement in DM and prior case reports of vaccine-triggered DM.
2. Logical Sequence of Cause and Effect (Second Althen Prong)
The government argued Ms. Ballard’s symptoms began before vaccination and that sunlight was the real cause. Special Master Roth rejected both claims.
Ms. Ballard’s pre-vaccine questionnaire showed no muscle weakness or numbness, disproving preexisting disease.
While sunlight can aggravate DM, there was no evidence of increased sun exposure, nor any reason why DM would suddenly develop after decades of consistent exposure.
Roth concluded the timing and pattern of onset strongly supported vaccination as the trigger, not sunlight.
3. Proximate Temporal Relationship (Third Althen Prong)
Both experts agreed a 2–3 week onset of autoimmune symptoms after vaccination was medically reasonable. Ms. Ballard’s rash appeared 15 days post-vaccine, a timeframe consistent with immune activation. This satisfied the third prong.
Conclusion
Special Master Roth found that Ms. Ballard met all three Althen criteria and that the government failed to prove an alternative cause. She ruled the flu vaccine triggered her dermatomyositis, entitling her to compensation under the Vaccine Act.
This decision reaffirms that in rare autoimmune cases, scientific uncertainty does not preclude legal causation. The VICP remains committed to fairly compensating individuals harmed by vaccines while recognizing that vaccine-related autoimmune diseases may not always be statistically visible but can still be biologically and legally valid.