K.J.D. v. HHS - MMR, autism spectrum disorder (ASD), complex epilepsy, epileptic encephalopathy, and developmental regression (2017)
Case summary [AI summaries can sometimes make mistakes]
On February 23, 2017, Brian and Claire Dempsey, parents of K.J.D., filed a petition for compensation under the National Vaccine Injury Compensation Program. They alleged that the measles-mumps-rubella (MMR) vaccine administered to their son on October 25, 1999, caused him to develop complex epilepsy, epileptic encephalopathy, developmental regression, and autism spectrum disorder (ASD).
The respondent, the Secretary of Health and Human Services, contested the claim. The case was initially part of the Omnibus Autism Proceeding (OAP) and later reframed under a mitochondrial-dysfunction theory.
Special Master George L. Hastings issued a decision on March 21, 2017, denying entitlement.
Petitioners' expert, Dr. Richard Boles, a clinical geneticist, opined that the MMR vaccine caused K.J.D.'s neurological deterioration.
He based this opinion on a close temporal relationship between vaccination and symptom onset, K.J.D.'s genetic variant in the CACNA1H gene, and alleged mitochondrial dysfunction. Respondent's expert, Dr.
Gerald Raymond, a clinical/biochemical geneticist, disagreed, stating there was no contemporaneous medical evidence of acute encephalopathy or other adverse events around the time of immunization, that K.J.D.'s records did not support the alleged timeline of deterioration, and that diagnostic criteria for mitochondrial disorder were not met. Special Master Hastings found Dr.
Boles's opinion unpersuasive, noting it was based on incorrect factual assumptions about K.J.D.'s medical history, specifically the claimed sudden and dramatic neurological deterioration shortly after vaccination, which was contradicted by contemporaneous records. The Special Master also found that the CACNA1H genetic variant did not independently support vaccine causation and that there was insufficient evidence of mitochondrial dysfunction.
Petitioners failed all three prongs of the Althen test for causation-in-fact. The petition was denied.
Theory of causation
Petitioners alleged that the MMR vaccine administered on October 25, 1999, caused K.J.D.'s neurological deterioration, including complex epilepsy, epileptic encephalopathy, developmental regression, and autism spectrum disorder (ASD). Petitioners' expert, Dr. Richard Boles, opined that the MMR vaccine caused these conditions due to a close temporal relationship between vaccination and symptom onset, K.J.D.'s CACNA1H gene variant, and alleged mitochondrial dysfunction. Respondent's expert, Dr. Gerald Raymond, disputed these claims, finding no evidence of acute adverse events post-vaccination and noting that K.J.D.'s medical records did not support the alleged timeline of deterioration or meet the criteria for mitochondrial disorder. Special Master George L. Hastings denied entitlement, finding Dr. Boles's opinion unpersuasive due to factual inaccuracies regarding the timing and severity of K.J.D.'s alleged post-vaccination deterioration and lack of evidence for mitochondrial dysfunction. The Special Master concluded that Petitioners failed to establish causation-in-fact under the Althen test. The petition was denied.
Source PDFs
USCOURTS-cofc-1_04-vv-00394