E.M. v. HHS - Influenza, small fiber neuropathy (2024)
Case summary [AI summaries can sometimes make mistakes]
E.M., a 24-year-old adult, filed a petition on August 19, 2014, alleging that the influenza vaccine administered on August 23, 2011, caused her to develop small fiber neuropathy. Petitioner's treating physicians, including Dr.
Traci Purath, Dr. Jorge Marquez de Leon, and Dr.
Alexandru C. Barboi, diagnosed her with small fiber neuropathy and, in some cases, opined that the flu vaccine was the cause.
Petitioner's expert, Dr. Lawrence Steinman, also concluded that the flu vaccine caused her small fiber neuropathy, theorizing a mechanism of molecular mimicry and recall response.
Respondent's expert, Dr. Peter D.
Donofrio, initially contested the diagnosis and causation, but later conceded that Petitioner suffered from small fiber neuropathy based on biopsy results, though he questioned the link to the vaccine due to the timing and Petitioner's symptom presentation. Special Master Herbrina Sanders issued a ruling on entitlement on July 9, 2021, finding that Petitioner had provided preponderant evidence that the flu vaccine was the cause-in-fact of her small fiber neuropathy.
Following this entitlement ruling, the parties stipulated to damages. On February 28, 2024, Special Master Sanders awarded E.M. $245,126.01, comprising a $225,000.00 lump sum for pain and suffering, $10,126.01 for past unreimbursed expenses, and $10,000.00 for future unreimbursable medical expenses.
Petitioner was represented by Scott B. Taylor of Urban & Taylor, S.C., and Respondent was represented by Voris E.
Johnson of the U.S. Department of Justice.
Theory of causation
Petitioner E.M. received an influenza vaccine on August 23, 2011. She alleged this caused small fiber neuropathy. Petitioner's expert, Dr. Lawrence Steinman, theorized that components in the 2011 Fluarix vaccine mimicked the alpha 3 nicotinic acetylcholine receptor (ɑ3-nAChR) present in prior flu vaccines, triggering a 'recall response' and an autoimmune reaction to ɑ3-nAChR, leading to small fiber neuropathy. Dr. Steinman's theory involved molecular mimicry and was supported by BLAST searches identifying sequence homologies between vaccine components and ɑ3-nAChR, as well as animal studies showing such homologies can cause neuroinflammation. He also argued that Petitioner's prior flu vaccinations created immunological memory, allowing for a rapid reaction within hours of the 2011 vaccine. Special Master Herbrina Sanders found Dr. Steinman's theory biologically plausible and accepted the 'recall response' and molecular mimicry mechanism, concluding that the flu vaccine caused Petitioner's small fiber neuropathy. Respondent's expert, Dr. Peter D. Donofrio, initially disputed the diagnosis and causation but later conceded the presence of small fiber neuropathy based on biopsy results, though he questioned the vaccine's role. The Special Master found Dr. Steinman's expert opinion more persuasive. Petitioner was awarded $245,126.01 in compensation. Attorneys for Petitioner were Scott B. Taylor and for Respondent was Voris E. Johnson. The decision date was February 28, 2024.