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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.

By Staff writer of The Christian Science Monitor / November 4, 2008


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

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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.

"Patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines," says Ken Johnson, senior vice president with the industry trade group Pharmaceutical Research and Manufacturers of America.

Critics say FDA protects drug companies

Levine disagrees. She says the FDA is protecting the drug companies from lawsuits, rather than protecting consumers from dangerous drugs. "I had no idea what the risks were," she says of her ordeal with the Wyeth-produced antinausea drug.

Lawyers for Wyeth say Levine's lawsuit is preempted by federal law and federal regulations. They say the antinausea drug, Phenergan, is approved by the FDA and that the agency authorized the content of the company's warning about the possible negative effects of the drug. The warning label said that if the drug was improperly injected it could lead to the onset of gangrene and the necessary amputation of a limb.

"FDA concluded that Phenergan was safe and effective for use under the conditions described in the approved labeling," writes Washington lawyer Seth Waxman in Wyeth's brief to the court. "That labeling included specific cautionary language" related to the intravenous injection of the drug.

Levine's lawyers say the FDA approved a general warning for Phenergan, but did not conduct a detailed assessment of the dangers and benefits of the intravenous injection of Phenergan.

The Vermont jury found that Wyeth had violated state law by failing to adequately warn of the dangers of intravenous injection.