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Supreme Court takes up drug warning labels

The case pits a Vermont musician who lost a limb against a pharmaceutical giant.

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The US Supreme Court is examining whether medical patients can sue a pharmaceutical manufacturer over the adequacy of a drug's warning label.

The issue arises in the case of a Vermont musician whose right arm had to be amputated after she experienced a negative reaction to an injected antinausea drug.

Diana Levine, a professional guitarist, sued drugmaker Wyeth, claiming that the company had given insufficient warning of the possible severe effects of its product. A Vermont jury awarded her $6.7 million in compensatory and punitive damages.

On Monday, the high court hears oral argument over whether Ms. Levine's suit was preempted by federal law and, thus, should have been thrown out of the Vermont courts before the trial even began.

The dispute is one of the closest-watched cases of the court's term. Forty-seven states and an array of consumer advocacy, medical, and other groups have filed friend of the court briefs supporting Levine. Wyeth has received supporting briefs from drug industry lobbyists, business groups, and the Bush administration.

The case pits two competing visions of how best to regulate the pharmaceutical industry. The industry favors centralized regulatory power wielded nationwide by the Food and Drug Administration (FDA). Consumer groups and trial lawyers prefer an overlapping system of national FDA regulations combined with the ability of injured patients to sue drug companies in state court for damages.


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