Katherine Kelly v. HHS - Influenza, polymyalgia rheumatica (2022)

Katherine Kelly, a 73-year-old woman, filed a petition on October 10, 2017, alleging that an influenza vaccine received on September 30, 2016, caused her to develop polymyalgia rheumatica (PMR). Petitioner's initial symptoms of fever and joint pain appeared approximately two weeks after vaccination.

Her treating physician, Dr. Bransdorf, diagnosed her with PMR and noted improvement with prednisone.

The case proceeded as an off-Table claim, requiring Ms. Kelly to prove causation-in-fact.

Petitioner presented expert testimony from rheumatologist Thomas Zizic, M.D., who proposed molecular mimicry as a theory of causation, suggesting the flu vaccine's hemagglutinin could cross-react with self-antigens like collagen. Dr.

Zizic also noted similarities between PMR and giant cell arteritis (GCA) and cited case reports linking PMR and GCA to the flu vaccine. Respondent, the Secretary of Health and Human Services, presented expert testimony from immunologist and rheumatologist Mehrdad Matloubian, M.D., Ph.D.

Dr. Matloubian argued that the pathogenesis of PMR is unknown, no specific antigens have been identified, and molecular mimicry is speculative.

He critiqued the literature cited by Dr. Zizic, noting that collagen is not a recognized self-antigen in PMR and that the cited studies did not support molecular mimicry.

Dr. Matloubian also pointed out that PMR primarily affects the elderly due to aging immune systems and that the case reports cited by Dr.

Zizic were either irrelevant due to different types of vasculitis or showed only a temporal association without establishing causality. Special Master Daniel T.

Horner found that Ms. Kelly failed to establish a reputable medical theory of causation (Althen prong one), a logical sequence of cause and effect (Althen prong two), or a proximate temporal relationship (Althen prong three).

The Special Master concluded that Dr. Zizic's theory of molecular mimicry was not supported by sound and reliable scientific explanation, particularly regarding the link between the flu vaccine, collagen, and PMR, and that the case reports did not establish causality.

The Special Master also found that the treating physicians' initial notes suggesting a possible vaccine reaction did not establish causation for PMR, and that the temporal association between the vaccination and the onset of PMR symptoms was likely coincidental given the idiopathic nature of PMR and the petitioner's age. Consequently, the Special Master determined that Ms.

Kelly's PMR was idiopathic rather than vaccine-induced. The petition was denied and dismissed.