R.G. v. HHS - DTaP, epilepsy (2022)

On November 7, 2016, Stacy and Jennifer Ginn, parents of R.G., filed a petition under the National Vaccine Injury Compensation Program alleging that their minor son, R.G., developed epilepsy as a result of receiving multiple vaccines on November 15, 2013. The vaccines administered were diphtheria-tetanus-acellular-pertussis (DTaP), inactivated polio (IPV), haemophilus influenzae type b (Hib), measles-mumps-rubella (MMR), and influenza (flu).

R.G. was four years old at the time of vaccination. Petitioners alleged that the vaccines triggered a febrile seizure which caused or contributed to R.G.'s epilepsy.

The respondent, the Secretary of Health and Human Services, argued against compensation, stating that the petitioners had not provided preponderant evidence. In a Ruling on Entitlement issued on March 26, 2021, Special Master Nora Beth Dorsey found that the petitioners had provided preponderant evidence that the vaccines triggered a febrile seizure which caused or contributed to R.G.'s epilepsy, satisfying the burden of proof under the Althen standard.

The Special Master determined that while most febrile seizures are benign, in rare cases, a vaccine-triggered febrile seizure can initiate the process leading to epilepsy, especially if it is a complex or focal seizure. The Special Master found no alternative cause for R.G.'s epilepsy and established a proximate temporal relationship between the vaccinations and the injury.

Petitioners' expert, Dr. Mahbubul Huq, a pediatric neurologist, opined that R.G. had epilepsy.

Respondent's expert, Dr. Shlomo Shinnar, initially opined that R.G. had a mild seizure disorder but later agreed that R.G. had epilepsy after reviewing additional medical records.

The Special Master deferred to the diagnosis of R.G.'s treating physician, Dr. Wilfred Castro-Reyes, who diagnosed epilepsy on February 24, 2014.

The Special Master found that the vaccinations likely caused R.G.'s initial seizure, and that this seizure, in turn, caused or contributed to the development of his epilepsy. The public decision does not describe the specific symptoms of the initial seizure beyond R.G. shaking, being unresponsive, and having blue lips, nor does it detail the specific mechanism of epileptogenesis beyond the general role of pro-inflammatory cytokines and potential blood-brain barrier disruption.

A subsequent Ruling Awarding Damages was issued on December 6, 2022, by Special Master Nora Beth Dorsey. The parties agreed to a total compensation award of $282,086.95.

This award was structured as a lump sum payment of $260,014.62 for life care expenses for the first year and pain and suffering, and a lump sum payment of $22,072.33 for past unreimbursable expenses. An additional amount was allocated to purchase an annuity for future life care expenses, with specific growth rates for medical and non-medical items.

The total award included $243,258.39 for pain and suffering (past and future, with future pain and suffering converted to net present value) and $22,072.33 for past unreimbursable expenses. The annuity payments were to be made for R.G.'s lifetime, contingent on his survival.

Petitioners were represented by Ronald C. Homer of Conway Homer, P.C., and respondent was represented by Terrence K.

Mangan and later Felicia Langel of the U.S. Department of Justice.