Sylvester Williams v. HHS - Hepatitis B, autoimmune hepatitis (2023)

Sylvester Williams, a 34-year-old adult, received a Recombivax hepatitis B vaccine on June 30, 2015. He alleged that this vaccine caused him to develop autoimmune hepatitis (AIH).

The case proceeded as an "off-Table" claim, meaning Mr. Williams had to prove that the vaccine caused his injury.

He presented expert opinions from an immunologist, Dr. Gershwin, and a hepatologist, Dr.

Gish, who theorized that the hepatitis B vaccine could trigger AIH through mechanisms like molecular mimicry or by exacerbating a pre-existing condition. They pointed to the temporal proximity between his vaccination and the onset of symptoms, approximately one month later, as evidence.

Respondent, the Secretary of Health and Human Services, presented expert opinions from an immunologist, Dr. MacGinnitie, and a hepatologist, Dr.

Lammert. They argued that there was insufficient scientific evidence to support a causal link between the hepatitis B vaccine and AIH.

They also presented evidence suggesting that Mr. Williams' AIH was likely chronic and predated his vaccination, citing his prior non-specific symptoms and an elevated ALT level four months before the vaccine.

Furthermore, his treating hepatologist, Dr. Shiffman, indicated that vaccination against hepatitis B is an appropriate treatment for AIH patients.

The Special Master found that Mr. Williams failed to establish a reputable medical theory connecting the vaccine to AIH (Althen prong one) and did not prove a logical sequence of cause and effect (Althen prong two).

The court also noted that while symptoms appeared about 30 days post-vaccination, this was not definitively the onset, and the proposed mechanism of causation did not align with an immediate immune response. Consequently, the petition was dismissed for failure to prove causation.