The Supreme Court ruled 6-3 in favor of Diana Levine in Wyeth v. Levine. Levine, a musician, had her arm amputated when an anti-nausea drug was improperly administered in her artery, and sued the manufacturer for failing to warn of the risks on the drug’s label. Wyeth claimed that her case was pre-empted by federal law.

Wyeth’s Phenergan is used to treat nausea and, according to its label, can be administered several different ways, including by IV push, in which the drug is injected directly into the vein. This carries the risk that the drug will instead be injected into an artery and cause gangrene, which is what happened here.

Levine argued that Phenergan’s label should have warned of this risk and prohibited IV push, instead suggesting less risky methods, such as an IV drip. Acting under Vermont law, the lower courts agreed.

Wyeth argued that because the FDA had approved Phenergan’s label, it had complied with all labeling requirements, and state law claims were pre-empted, despite subsequent information that IV push administration of Phenergan had caused gangrene in several cases. Even if it had wanted to include an IV push warning, Wyeth argued, it wouldn’t be able to because it would differ from the label the FDA had approved.

The Supreme Court disagreed. “The very idea that the FDA would bring an enforcement action against a manufacturer for strengthening a warning . . . is difficult to accept—neither Wyeth nor the United States has identified a case in which the FDA has done so.”

The decision is an important step in the fight against pre-emption, which, like binding mandatory arbitration, is designed to prevent injured consumers from getting their day in court. Although this decision bodes well for drug cases, the Supreme Court went the opposite way last year in Riegel v. Medtronic, which dealt with faulty medical devices. Congress introduced legislation last year that would forbid federal pre-emption of medical device cases, and the bill will likely be reintroduced soon.

Wyeth v. Levine [Supreme Court (PDF)]
(Photo: afagen)

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