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

Petitioner Alan Archer, age 55, received a Tdap vaccine on August 7, 2012, and subsequently developed symptoms consistent with transverse myelitis. The claim was litigated as an "off-Table" injury, requiring proof of actual causation under the Althen standard. Petitioner's experts, Dr. Agnes Jani-Acsadi and Dr. Matthew Imperioli, proposed a theory of causation involving molecular mimicry, epitope spreading, or bystander activation, arguing that the Tdap vaccine induced transverse myelitis. They contended that petitioner's condition met the diagnostic criteria for transverse myelitis, despite a longer-than-typical progression to nadir. Respondent's expert, Dr. Peter Donofrio, disputed the diagnosis of transverse myelitis, suggesting a syrinx or tumor as the cause, and importantly, argued that the temporal relationship between the vaccination and symptom onset was not proximate. Petitioner's alleged symptom onset was in late September or early October 2012, approximately 6-7 weeks post-vaccination. Petitioner's experts suggested a medically acceptable timeframe of up to 4-6 weeks for symptom onset. Respondent's experts and the court found this timeframe to be too delayed, citing that immune responses typically occur within 7-10 days, or at most 2-3 weeks, with some literature suggesting up to 4-6 weeks. The court found that the onset of symptoms, even when viewed most favorably to the petitioner (late September, approximately 54 days post-vaccination), fell outside the medically acceptable window of 42 days (6 weeks) for inferring causation. Therefore, the petition was denied due to failure to establish a proximate temporal relationship, a key prong of the Althen test. Petitioner was represented by Diana L. Stadelnikas and respondent by Sarah C. Duncan. Special Master Thomas L. Gowen issued the decision on June 29, 2021.