Tuesday, February 22, 2011

Vaccine makers shielded from suits says Supreme Court

In a 6-2 vote, the Supreme Court today ruled that vaccine makers cannot be sued outside of a specially designated "vaccine court," created by National Childhood Vaccine Injury Act of 1986.

The justices apparently struggled with some ambiguities in the law, with Justice Scalia writing that the "lack of guidance for design defects [in the drugs] combined with the extensive guidance for the grounds of liability specifically mentioned in the act strongly suggests that design defects were not mentioned because they are not a basis for liability."

However, Justice Sotomayer (with Justice Ginsburg) dissented, saying that
to "pre-empt all design defect claims against vaccine manufacturers for covered vaccines, the majority’s decision leaves a regulatory vacuum in which no one—neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements.

This concern is especially acute with respect to vaccines that have already been released and marketed to the public. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins. Nothing in the text, structure, or legislative history remotely suggests that Congress intended that result."

Links to the Supreme Court decision can be found: here.

The ruling was in response to a case brought by the Bruesewitz family, against Wyeth (now owned by Pfizer, Inc), in which the Breusewitz's claimed that their infant daughter was harmed by toxins in a booster shot.

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