Timothy Yannacone v. HHS - Influenza, primary cutaneous leiomyosarcoma (2024)

Timothy Yannacone, a 65-year-old man, filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that he developed primary cutaneous leiomyosarcoma after receiving an influenza vaccine on September 13, 2018. Mr.

Yannacone had a history of various medical conditions and skin lesions, including prior cancerous skin removals. Approximately one month after vaccination, he reported a pustule at the injection site, which was later diagnosed as a leiomyosarcoma.

Petitioner's expert, Dr. Kyle Amber, proposed that trauma from the vaccine injection, combined with local inflammatory responses and the petitioner's predisposition, could have triggered the cancer.

Respondent's experts, Drs. Emanual Maverakis and Stephen Hedrick, argued that the vaccine is administered into skeletal muscle, while leiomyosarcomas arise from smooth muscle, making a direct causal link unlikely.

They also contended that the inflammatory response from a vaccine is too transient to cause cancer and that the case reports cited by the petitioner were distinguishable. The court found that the petitioner failed to establish a medically acceptable theory of causation, a logical sequence of cause and effect, or a proximate temporal relationship.

The court noted that the evidence did not sufficiently support the theory that the flu vaccine could cause leiomyosarcoma, either through direct trauma or immune stimulation, and that the temporal proximity alone was insufficient. Therefore, Timothy Yannacone was denied entitlement to compensation.