The Third Circuit ruled last week that children who allege injuries caused by vaccines can't pursue design defect claims, since Congress explicitly prohibited such suits in an attempt to shield manufacturers from liability. The decision, announced in Bruesewitz v. Wyeth Home Products Corp., is at odds with a previous state court decision, signaling that the issue may eventually find itself before the Supreme Court.

The court granted summary judgment to defendant Wyeth laboratories, ruling that the immunity written into the National Childhood Vaccine Injury Act preempts all design defect claims. Essentially, the court held that Congress's pronouncement, as federal law, bars state suits predicated on defective design.

In October 2008, however, the Georgia Supreme Court ruled that manufacturers are only immune from design liability if the vaccine is shown to be "unavoidably unsafe." That case, American Home Products Corp. v. Ferrari, said that design defect cases would thus require individual hearings to determine if the injury could have been prevented.

The Vaccine Act provides that manufacturers are immune from suits dealing with "side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." The problem, according to Third Circuit Judge D. Brooks Smith, is that "unavoidable," the key word in this phrase, is not defined anywhere in the Act.

Looking to Congressional intent, Judge Smith pointed out that under the Ferrari analysis, all design defect claims will be entitled to an initial hearing on whether the problem was "unavoidable." According to Smith, this "construction is contrary to the structure of the Act because it does not bar any design defect claims," and could not have been what Congress intended when it wrote the Act.

Last month, in a similar case, the Supreme Court held that suits alleging that manufacturers failed to warn of possible dangers were not preempted. However, Smith distinguished that case on the grounds that it dealt with "implied" preemption, whereas the Bruesewitz case examines an explicit instruction from Congress regarding manufacturers' immunity from design defect suits.

The Third Circuit decision affirmed the district court's dismissal of Bruesewitz's suit, in which District Court Judge Michael Baylson held that the Vaccine Act "represents part of a comprehensive statutory scheme which pre-empts all design defect claims brought under state tort law."

The suit was brought by the parents of 17-year-old Hannah Bruesewitz, who alleged that DPT shots were responsible for her residual seizure disorder and serious developmental delay. DPT is a combination of three vaccines used to inoculate against whooping cough, tetanus, and diphtheria, an upper respiratory tract illness. Bruesewitz received three DPT shots within six months of her birth, and subsequently suffered a string of seizures.

A British study commissioned in the 1980s showed that 1 in 140,000 doses of DPT lead to neurological problems including seizures, decreased consciousness, or brain disease. In serious cases, the reactions can be fatal. Bruesewitz's parents alleged that a Congressional report discovered two deaths and 66 serious injuries resulting from the vaccine.

The Ferrari case is currently before the Supreme Court on certiorari, and a direct circuit split may offer the high court sufficient incentive to hear it. If that happens, the Third Circuit view will have plenty of precedent on its side. Before the Ferrari decision, a number of state and federal courts agreed that all design defect claims are preempted under the Vaccine Act.