Drug & Device News

In Bruesewitz v. Wyeth, L.L.C., No. 09-152, the U.S. Supreme Court in February held that the National Childhood Vaccine Injury Act of 1986 (NCVIA) pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine's side effects. The plaintiffs had sought compensation for their daughter, who suffered complications following the administration of a diphtheria, tetanus, and pertussis (DTP) vaccine. After they were denied compensation by the Court of Federal Claims they brought suit for tort damages in Pennsylvania. Wyeth removed the suit to the Federal District Court, which granted Wyeth summary judgment, holding that the Pennsylvania law the plaintiffs brought suit under was pre-empted by 42 U.S.C. ' 300aa-22(b)(1), which provides that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after Oct. 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” The Third Circuit affirmed, as did the Supreme Court.