At the Court: Immunity for Child Vaccine Manufacturers

The Supreme Court will hear arguments today in Bruesewitz v. Wyeth, a case that will determine the extent to which pharmaceutical corporations are protected from lawsuits from those who are injured by their products.

Back in the 1980s, Congress passed the national Childhood Vaccine Injury Act to shield child vaccine manufacturers from certain types of state lawsuits. The law preempts certain design defect claims against the manufacturers 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." At issue is the term "unavoidable."

Hannah Bruesewitz's parents sued Wyeth when she suffered significant medical complications after receiving a vaccine manufactured by the drug manufacturer. Among other things, they argue that their lawsuit isn't preempted because the side effects were not unavoidable: A safer, alternative vaccine was available.

Wyeth argues that the federal law preempts all state design-defect claims, even if the manufacturer could have avoided the side effects by designing a different vaccine. They claim that the family's interpretation of the Vaccine Act undoes the statutory preemption intended by Congress, forcing vaccine manufacturers into state tort trials to determine if the side effects could have been avoided with a safer vaccine. In other words, you'd have a lawsuit to determine if the case should have been immune from lawsuit in the first place. Wyeth asserts that such an interpretation goes against Congressional intent to shield vaccine manufacturers from being forced to defend their vaccines in state courts on a case-by-case basis.

The Bruesewitz family cites Supreme Court precedent that, under constitutional principles of federalism, congressional intent to preempt traditional state powers must be "clear and manifest." In this case, they say, it isn't. Specifically, had Congress wanted to preempt all design defect claims, it would have simply written the statute without the "unavoidable" language: claims would be 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. " The family also argues that giving vaccine manufacturers an incentive to design better vaccines to avoid such lawsuits serves Congress's purpose of promoting vaccine safety.

Numerous organizations and individuals have submitted amicus briefs in favor of one party or the other. Not surprisingly, Wyeth is supported by pharmaceutical companies Glaxosmithkline, Merck, and Sanofi Pasteur. The American Association for Justice, Public Justice, and Public Citizen have submitted an amicus brief for the Bruesewitz family.

One of the amicus briefs is particularly interesting by virtue of the unusual pair of jurists who teamed up to submit it: progressive Erwin Chemerinsky and conservative Kenneth Starr, who argue in support of Hannah Bruesewitz and her parents.

PFAW