Vaccine Liability

The Supreme Court heard arguments last week in a dispute over whether a law designed to compensate families of children who have severe reactions to vaccine inoculations also shields drug manufacturers from most related product liability claims.

The justices are considering an appeal by the parents of a Pittsburgh woman who want to sue Pfizer’s Wyeth unit over the seizures and developmental disabilities their daughter suffered allegedly as a result of the company’s diphtheria, tetanus, and pertussis (DTP) vaccine, which she received as a six-month-old baby in 1992.

Robalee and Russell Bruesewitz initially sought compensation in 1995 but lost in a special court Congress set up to hear vaccine-injury claims under the National Childhood Vaccine Injury Act of 1986. That panel said the parents had failed to show that the seizures were caused by the vaccine.

The Bruesewitzes then filed a lawsuit against Wyeth based on Pennsylvania tort law. But in August 2007, the U.S. District Court for the Eastern District of Pennsylvania ruled that their claim was preempted by the 1986 law. In March 2009, the 3rd U.S. Circuit Court of Appeals in Philadelphia agreed.

To help ensure a stable vaccine supply, the statute protects manufacturers from most lawsuits over vaccine-related injuries or deaths. Legal action is preempted “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.”

David C. Frederick, a lawyer representing the Bruesewitz family, told the justices last week that the federal law does not bar all lawsuits, especially those filed when the harmful side effects were avoidable. He said a safer version of the vaccine existed, but Wyeth continued to market the riskier vaccine until 1998 because of costs.

Manufacturers have a duty to provide “the safest possible products in light of what the science holds,” Frederick said. Wyeth lawyer Kathleen Sullivan countered that Congress intended to preempt state-law claims because “the manufacturers were being driven out of the vaccine business, imperiling the nation’s vaccine supply.”

Chemical & Engineering News

ISSN 0009-2347

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