Disputed claims for pertussis vaccine injuries under the National Vaccine Injury Compensation Program.

ABSTRACT

BACKGROUND: The National Vaccine Injury Compensation Program (NVICP) provides no-fault compensation to victims of serious untoward vaccine reactions under the supervision of the Department of Health and Human Services (HHS). Special Masters of the Court of Federal Claims settle compensation disputes that arise between applicants and program administrators. The majority of published NVICP claim decisions concern disputes over the cause of neurologic illness or unexpected infant death following pertussis vaccination. METHODS: Information was collected from the published decisions to determine the medical characteristics of cases in which injuries were legally attributed to pertussis vaccination. Because of practical and statutory restrictions on the application process and the evolving nature of HHS claim denials, vaccinees in the disputed cases are not representative of all vaccine casualties, or of all NVICP applicants. RESULTS: Injuries were blamed on pertussis vaccine in 542 claims disputed by HHS. Claims asserted that pertussis vaccine caused seizure disorders (333 claims, 189 were awarded compensation), anaphylaxis (7 claims, 6 awards), hypotonic/hyporesponsive episodes or other injuries leading to early death (107 claims, 73 awards), and long-term neurologic disease (51 claims, 18 awards). CONCLUSIONS: Assertions that pertussis vaccine caused unexpected infant death (other than anaphylaxis), seizure disorders, and long-term neurologic damage are inconsistent with epidemiological research. Findings of legal causation may contribute to popular perceptions that pertussis vaccine is a dangerous biological product. By providing compensation for these claimants, however, the NVICP may reduce the number of successful civil suits and thus protect the nation's vaccine supply.