M.S.M. v. HHS - DTaP, febrile status epilepticus and encephalopathy (2020)
Case summary [AI summaries can sometimes make mistakes]
Ermerita Morales, on behalf of her infant son M.S.M., filed a petition for compensation under the National Vaccine Injury Compensation Program on December 10, 2014. M.S.M. received vaccinations for diphtheria-tetanus-acellular pertussis (DTaP), Haemophilus Influenzae Type B (Hib), Inactivated Polio (IPV), Pneumococcal Conjugate (PCV), Hepatitis B (Hep B), and Rotavirus on March 11, 2013.
Within approximately 16 hours, M.S.M. developed a fever and experienced status epilepticus. On December 26, 2013, M.S.M. received DTaP, Hib, and PCV vaccinations again and subsequently developed fever and status epilepticus within a similar timeframe.
M.S.M. did not have developmental delay prior to the initial seizure activity but developed it afterward and continues to have seizure activity. Genetic testing was negative for known pathogenic mutations.
Petitioner alleged that the vaccines caused an acquired epileptic encephalopathy. The respondent recommended against compensation.
Following an entitlement hearing, Special Master Thomas L. Gowen issued a ruling on July 30, 2019, finding that M.S.M.'s vaccinations caused an encephalopathy responsible for sequelae including developmental delay and continued seizure activity, and thus M.S.M. was entitled to compensation.
On October 5, 2020, a decision was issued regarding damages. Midland Trust Company, as guardian of M.S.M.'s property, was substituted as petitioner.
The final award included a lump sum payment of $1,239,414.94 for life care expenses, lost future earnings, and pain and suffering. An additional lump sum of $32,036.18 was awarded to satisfy a Medicaid lien.
Compensation for future life care expenses was to be provided through an annuity contract. The total award amount was $1,271,451.12.
Theory of causation
Petitioner alleged that M.S.M.'s vaccines caused an acquired epileptic encephalopathy. Petitioner's experts, Dr. Shafrir and Dr. Bellanti, opined that the vaccines activated an innate immune response involving pro-inflammatory cytokines, which can cause fever and status epilepticus, leading to encephalopathy and subsequent developmental delay and seizure activity. Respondent's experts, Dr. Wiznitzer and Dr. Lobo, conceded that the vaccines caused fever and status epilepticus in M.S.M. The public decision does not detail the specific mechanism of how the innate immune response leads to encephalopathy or further seizure activity beyond fever induction. The public decision notes that M.S.M. experienced challenge-rechallenge, having similar events after receiving the same vaccines on two separate occasions. Genetic testing for SCN1A mutations and other genes associated with seizure disorders was negative. Special Master Thomas L. Gowen found that petitioner proved by a preponderance of the evidence that the vaccines caused an encephalopathy responsible for M.S.M.'s developmental delay and continued seizure activity. The decision awarded $1,271,451.12 in total compensation, including a lump sum of $1,239,414.94 and $32,036.18 for a Medicaid lien, with future life care expenses to be covered by an annuity. The decision was issued on July 30, 2019 (entitlement) and October 5, 2020 (damages). Attorneys for petitioner included Clifford J. Shoemaker and Renee J. Gentry. Attorney for respondent was Christine M. Becer.
Source PDFs
USCOURTS-cofc-1_14-vv-01186