Alan Archer v. HHS - Tdap, transverse myelitis (2021)

Alan Archer, a 55-year-old adult, filed a petition on June 24, 2015, alleging that the Tdap vaccine he received on August 7, 2012, caused him to develop transverse myelitis. The case was litigated as an "off-Table" claim, requiring Mr.

Archer to prove actual causation. The respondent was the Secretary of Health and Human Services.

Petitioner was represented by Diana L. Stadelnikas of Maglio Christopher & Toale, and respondent was represented by Sarah C.

Duncan of the U.S. Department of Justice.

Special Master Thomas L. Gowen presided over the case.

Mr. Archer's medical records indicated symptoms such as abdominal pain, urinary issues, and weakness beginning in late September or early October 2012, approximately 6-7 weeks after vaccination.

Medical professionals, including treating neurologists and specialists at the Mayo Clinic, diagnosed him with transverse myelitis, ruling out other potential causes like arteriovenous fistulas, tumors, or sarcoidosis. However, the court found that the timing of his symptom onset was too delayed to establish a medically acceptable causal link to the vaccination, a critical component of the Althen test for causation.

Experts suggested that symptoms typically appear within 2-3 weeks, or at most 4-6 weeks, after vaccination for transverse myelitis. While Mr.

Archer's experts, Dr. Agnes Jani-Acsadi and Dr.

Matthew Imperioli, argued for a broader interpretation of the onset timeframe, the court found the 6-7 week delay, or even a later September onset, to be outside the medically acceptable window for inferring causation. Respondent's expert, Dr.

Peter Donofrio, also argued against causation due to the delayed onset. Consequently, the Special Master denied Mr.

Archer's petition, finding he had not met his burden of proof regarding causation. The decision was issued on May 27, 2021.