Michael McCollum v. HHS - Influenza, narcolepsy with cataplexy (2017)

Michael McCollum, a 51-year-old adult, filed a petition alleging that he developed narcolepsy with cataplexy as a result of receiving an influenza vaccine in the fall of 2011. He did not have direct proof of vaccination but presented circumstantial evidence, including a Walgreens purchase on October 18, 2011, and testimony from himself and his wife.

Mr. McCollum had a significant pre-existing medical history, including obstructive sleep apnea, hypertension, and attention deficit disorder, which presented sleep-related issues prior to the alleged vaccination.

His alleged symptoms of narcolepsy and cataplexy began around December 2011, approximately two months after the vaccination. Petitioner's expert, Dr.

Marcel Kinsbourne, proposed a theory of molecular mimicry, suggesting the H1N1 vaccine components could trigger an autoimmune response leading to narcolepsy. Respondent's expert, Dr.

Maryanne Deak, opined that the vaccine-related evidence was weak and that Mr. McCollum's symptoms did not meet the criteria for narcolepsy, also pointing to his pre-existing conditions.

The Special Master denied entitlement, finding that Petitioner failed to establish a reliable causation theory under the Althen prongs. Specifically, the court found that the scientific literature linking the specific type of unadjuvanted H1N1 vaccine administered in the U.S. to narcolepsy was insufficient, and that epidemiological evidence contradicted a causal link.

The court also found that Petitioner's challenge-rechallenge argument was waived and lacked direct proof. The decision was later affirmed on review by the Court of Federal Claims.