BioCentury
ARTICLE | Politics & Policy

Supreme Court hears vaccine arguments

October 13, 2010 11:36 PM UTC

The U.S. Supreme Court heard oral arguments Tuesday in Bruesewitz v. Wyeth to determine whether the National Childhood Vaccine Injury Act of 1986 preempts all design defect claims against the manufacturer of a vaccine, regardless of whether the vaccine's side effects were unavoidable. The petitioners, Russell and Robalee Bruesewitz, argued that courts should decide on a case-by-case basis whether such side effects are unavoidable. Wyeth argued that all design defect claims should be preempted, and that a ruling to the contrary could result in thousands of potential claimants in the state courts and drive manufacturers away from the market due to fear of liability, which is the scenario that the vaccine act was meant to prevent.

The Bruesewitzs originally filed a petition under the vaccine act in April 1995, alleging that their daughter's residual seizure disorder and developmental impairment was caused by Wyeth's Tri Immunol, a diphtheria-pertussis-tetanus (DTaP) vaccine. In 2002, the court established by the vaccine act dismissed the claim because March 1995 regulations had deleted residual seizure disorder from DTaP vaccines' injury table. The Bruesewitzs took their case to the state courts, claiming the side effects could have been avoided if the pharma had more aggressively developed an alternative to the whole-cell pertussis component of the vaccine. Last year, the U.S. Court of Appeals for the Third Circuit ruled that the defect claims were expressly preempted by the Act. ...