Monica v. HHS - Hepatitis B, cerebral edema and death (2008)

On July 31, 2008, the United States Court of Federal Claims reviewed a Special Master's decision that denied compensation to the petitioners for the death of their infant daughter, Monica. Monica, who was seven weeks old, received her second hepatitis B vaccination on December 21, 1994.

Approximately four-and-a-half hours later, she was found unresponsive and later pronounced dead. The petitioners alleged that the hepatitis B vaccine caused a "cytokine storm," leading to cerebral edema and Monica's death.

The Special Master had determined that the petitioners failed to establish a prima facie case that the vaccine caused the death, concluding instead that Monica died from Sudden Infant Death Syndrome (SIDS), which the Special Master deemed an unrelated factor. The Court of Federal Claims vacated this decision, finding that the Special Master had misallocated the burden of proof by requiring the petitioners to disprove SIDS as part of their prima facie case.

The court noted that SIDS, being an idiopathic condition, cannot serve as an unrelated factor under the Vaccine Act. Furthermore, the court found that the Special Master applied an overly stringent burden of proof regarding the "can cause" prong of the Althen test and failed to consider the totality of the evidence regarding Monica's brain weight.

The case was remanded for a new causation determination, with instructions to apply the correct legal standards, including proper burden allocation and reevaluation of evidence on brain weight and temporal proximity. The Special Master was also directed to clarify the specific unrelated factor, if any, that caused Monica's death and assess if it fits the Act's prohibition against idiopathic causes.

The court emphasized that SIDS is an idiopathic, unexplained diagnosis and cannot defeat a petitioner's established case. The Special Master's reliance on SIDS as an unrelated factor was deemed contrary to law.

The court also found that the Special Master's assessment of Monica's brain weight was flawed, as it relied on inapposite studies and failed to consider other evidence suggesting the brain was heavy. The court directed the Special Master to reevaluate the evidence on brain weight.

The decision was vacated and remanded for further proceedings consistent with the court's opinion. The Special Master was instructed to apply the correct legal standards for burden of proof, assess biological plausibility for the "can cause" prong, clarify the unrelated factor and its idiopathic nature, and consider the totality of evidence regarding brain weight and temporal proximity.

The remand proceedings were to be completed within 90 days. The court noted that the Special Master's decision was filed under seal and subject to public disclosure objections.

The factual background was derived from the Special Master's decision, joint stipulations, exhibits, and hearing transcripts. The hepatitis B vaccine is described as a noninfectious viral vaccine derived by recombination from hepatitis B surface antigen and cloned in yeast cells, administered intramuscularly.

Petitioners' experts included Dr. Alan S.

Levin, M.D., J.D., an immunologist, and Dr. John J.

Shane, M.D., a neuropathologist. Respondent's experts included Dr.

Christine McCusker, M.D., a pediatric immunologist, and Dr. Enid Gilbert-Barness, M.D., a pediatric neuropathologist.

The Special Master's decision was vacated and remanded for further proceedings.