Ralph Parmer v. HHS - Influenza, thrombotic thrombocytopenia purpura (2021)
Case summary [AI summaries can sometimes make mistakes]
On July 25, 2016, Ralph Parmer filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that an influenza vaccine administered on October 17, 2013, caused him to develop thrombotic thrombocytopenia purpura (TTP). Mr.
Parmer, then 37 years old, received the flu vaccine at Harmony Healthworks. Approximately seven days after vaccination, he began experiencing symptoms including fatigue, abdominal pain, shortness of breath, and dark urine.
His condition rapidly worsened, leading to hospitalization on October 27, 2013, where he was diagnosed with TTP, characterized by acute renal failure, thrombocytopenia, anemia, and schistocytes. His ADAMTS13 activity level was found to be 19% after initial treatment.
He was treated with plasmapheresis, rituximab, and prednisone, and discharged on November 15, 2013. His treating physicians noted a possible connection between his TTP and the flu shot, and subsequent medical records indicated an allergy or history of flu shot-induced TTP, advising against future flu vaccinations.
Mr. Parmer experienced a recurrence of TTP in September 2014.
The respondent, the Secretary of Health and Human Services, argued that the evidence did not support a causal link between the flu vaccine and TTP. An entitlement hearing was held on May 2, 2019.
Petitioner was represented by Isaiah Kalinowski, Esq., and respondent by Christine Becer, Esq. Special Master Mindy Michaels Roth presided.
The Special Master found that Mr. Parmer presented sufficient evidence to demonstrate that the flu vaccine more likely than not triggered his TTP and ruled that he was entitled to compensation, with the case to proceed to determine damages.
The decision was issued on April 19, 2021.
Theory of causation
Petitioner Ralph Parmer, age 37, received an influenza vaccine on October 17, 2013. He developed thrombotic thrombocytopenia purpura (TTP) with onset of symptoms approximately seven days post-vaccination, including fatigue, abdominal pain, shortness of breath, and dark urine, leading to hospitalization and diagnosis. Petitioner's expert, Dr. Philip Fireman, opined that the flu vaccine could trigger immune-mediated TTP through molecular mimicry, citing case reports associating flu infections and vaccines with TTP, and noting that TTP is an autoimmune disorder resulting from an immunologic trigger. Dr. Fireman acknowledged that the precise mechanism of antibody development against ADAMTS13 is unknown but found the case reports compelling. Respondent's expert, Dr. Lisa Baumann, argued that there was no evidence of a causal relationship between vaccines and TTP, no demonstrated homology between ADAMTS13 and the flu vaccine, and that large-scale epidemiological studies were lacking. Dr. Baumann emphasized the differences between TTP and other thrombotic microangiopathies like HUS and stated that ITP studies were not applicable to TTP. The Special Master found that petitioner presented a sound and reliable medical theory connecting the flu vaccine to TTP, supported by case reports and expert opinion, despite the lack of large-scale epidemiological studies, which are not required for off-Table injuries. The Special Master also found a logical sequence of cause and effect and a medically acceptable temporal relationship, noting that petitioner's treating physicians repeatedly associated his TTP with the flu vaccine and advised against future vaccinations. The Special Master concluded that petitioner met the Althen criteria and was entitled to compensation, with the burden shifting to the respondent to prove an alternative cause, which was not met. The decision was issued by Special Master Mindy Michaels Roth on April 19, 2021. This is an off-Table injury.
Source PDFs
USCOURTS-cofc-1_16-vv-00880