Carol Wilkinson v. HHS - Influenza, polymyalgia rheumatica (2024)

Carol Wilkinson, a 74-year-old woman, filed a petition alleging that an influenza vaccine she received on December 1, 2015, caused her to develop polymyalgia rheumatica (PMR). She had a history of various medical conditions, including migraines, GERD, hyperlipidemia, depression, anxiety, hypothyroidism, IBS, cervical osteoarthritis, kidney stones, osteopenia, and hoarseness.

Approximately one week after her flu vaccination, she began experiencing pain in her hips, shoulders, and thighs, and later developed swelling and pain in her right hand. She was diagnosed with PMR by a rheumatologist, who prescribed prednisone and administered a steroid injection.

Petitioner's symptoms improved with prednisone but recurred when she attempted to reduce the dosage. She also experienced side effects from the prednisone, such as swelling and elevated calcium levels, and was later diagnosed with hyperparathyroidism and deep vein thrombosis (DVT).

Petitioner's expert, Dr. Petros Efthimiou, opined that the flu vaccine caused an aberrant activation of her immune system, potentially through molecular mimicry or cytokine-induced inflammation, leading to PMR.

Respondent's expert, Dr. Christopher A.

Mecoli, disagreed, stating that the proposed mechanisms were too nonspecific and lacked foundational support, and that the etiology of PMR is largely unknown. The court found that Petitioner failed to establish a sound and reliable medical theory connecting the flu vaccine to her PMR, thus failing the first prong of the Althen test for causation.

Although a temporal relationship existed, the court found it insufficient on its own to prove causation, especially given the lack of a proven mechanism. Consequently, the petition was denied and dismissed.