Erica Fester v. HHS - MMRV, Autism Spectrum Disorder (ASD) (2016)
Case summary [AI summaries can sometimes make mistakes]
On April 15, 2010, Erica Fester, as the parent of B.A.B., a minor, filed a petition for compensation under the National Vaccine Injury Compensation Program. The petition alleged that the Proquad (MMRV) vaccine administered to B.A.B. on April 18, 2007, caused him to suffer encephalopathy, leading to developmental regression and delay.
Petitioner was initially pro se but obtained counsel, Peter Sarda, on April 17, 2014. Respondent is the Secretary of Health and Human Services.
The medical records and expert opinions submitted did not support the petitioner's claim. B.A.B. received the MMRV vaccine at his 12-month well-child visit.
Medical records indicated that B.A.B. met all developmental milestones at his nine, 12, and 15-month well-child visits. Following the vaccination, B.A.B. was diagnosed with Autism Spectrum Disorder (ASD) by several physicians, including Dr.
John Wilson, Dr. Lynn Wegner, and Dr.
Christine Hook. Petitioner's expert, Dr.
Karen Harum, a neurodevelopmental pediatrician, opined that B.A.B. suffered from "subclinical encephalopathy," which she defined as a subtle neurologic dysfunction manifesting as developmental regression, loss of language, and sensory processing deficits. Dr.
Harum's theory evolved, initially suggesting acute or delayed infectious encephalitis, and later proposing a multi-faceted framework involving a prior viral illness (roseola infantum), granulocytopenia, immune dysregulation, and the vaccine's components (aluminum, glutamate, formaldehyde) contributing to microglial activation and worsening encephalopathy. The Special Master found Dr.
Harum's theory lacked a sound medical basis and was not supported by the medical records or relevant literature. Specifically, the Special Master noted that B.A.B. was not diagnosed with encephalopathy or encephalitis, and his symptoms were more consistent with ASD.
The court also found that Dr. Harum's theory of causation was similar to theories previously rejected in the Omnibus Autism Proceeding (OAP).
Respondent's expert, Dr. Gregory Holmes, a pediatric neurologist, concluded that B.A.B. had ASD and that the MMRV vaccine had no bearing on his condition, stating there was no evidence of acute or subacute encephalopathy and that the MMR vaccine had no link to autism.
The Special Master, Chief Special Master Nora Beth Dorsey, determined that petitioner failed to prove causation under the three prongs of the Althen test. The decision found no reliable medical theory connecting the vaccine to encephalopathy, no logical sequence of cause and effect, and no proximate temporal relationship.
Consequently, the petition was dismissed for insufficient proof. Petitioner was represented by Peter Joseph Sarda, and respondent was represented by Voris Edward Johnson.
The decision was issued by Chief Special Master Nora Beth Dorsey on April 28, 2016.
Theory of causation
Petitioner alleged that the MMRV vaccine administered on April 18, 2007, caused B.A.B. to suffer encephalopathy, leading to developmental regression and delay, diagnosed as Autism Spectrum Disorder (ASD). Petitioner's expert, Dr. Karen Harum, opined that B.A.B. suffered from "subclinical encephalopathy" and proposed a multi-faceted theory involving a prior viral illness (roseola infantum), granulocytopenia, immune dysregulation, and vaccine components (aluminum, glutamate, formaldehyde) contributing to microglial activation and worsening encephalopathy. Respondent's expert, Dr. Gregory Holmes, concluded that B.A.B. had ASD and the vaccine was not a cause. Chief Special Master Nora Beth Dorsey found Dr. Harum's theory lacked a sound medical basis, was not supported by the medical records or literature, and was similar to previously rejected theories. The Special Master determined that petitioner failed to prove causation under the Althen test, finding no reliable medical theory, logical sequence of cause and effect, or proximate temporal relationship between the vaccine and the alleged injury. The petition was dismissed for insufficient proof. The theory was classified as Off-Table.
Source PDFs
USCOURTS-cofc-1_10-vv-00243