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Phenergan Causes Gangrene, & the FDA’s Cool with it – a Huge Preemption Case for the Supreme Court.

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Today, the US Supreme Court will begin hearing Wyeth v. Levine, the Court’s third preemption case in less than a year.

At issue in the case is one woman’s horrific experience with the Wyeth drug Phenergan, an FDA-approved drug to treat migraines. When in April of 2000, Diana Levine went to her local health center seeking migraine treatment, a physician’s assistant administered Phenergan intravenously. But because the syringe missed Levine’s vein, the arm became gangrenous in a couple of weeks, and ultimately had to be amputated.

The FDA first approved Phenergan for intravenous use in 1995, but follow-up studies led it to mandate a warning label indicating the risks (including gangrene) of using it intravenously. Despite the gangrene risk, the FDA has never seriously considered taking Phenergan off the shelves.

Levine initially filed suit against Wyeth in Vermont state court, arguing that the warning label does not adequately address or prevent the risks associated with IV use of Phenergan. The state’s jury agreed with Levine, awarding her $7.4 million in damages. The Vermont Supreme Court upheld the decision, concluding that no conflict exists between the interests of the federal and state governments. The "FDA and the state share the purpose of encouraging pharmaceutical companies to alter their drug labels when they are inadequate to protect consumers," it wrote.

In today’s case, Wyeth will argue that only the FDA can properly decide how to label drugs, and that Congress has always intended for the FDA to have the final say on drug labeling—preempting (i.e. prohibiting) consumer claims against drug manufacturers when FDA labels result in tragedies like Levine’s. In turn, Levine will argue that Congress intended for the FDA’s powers to be checked by state governments.

Thus far, out of the thirty briefs submitted to the Court, only eight of them support Wyeth. Not too surprisingly, supporters include the United States Chamber of Commerce and the Bush Administration. Support for Diana Levine has come from AARP, the editors of the New England Journal of Medicine, and 47 states.

A win for the FDA and preemption would put one more nail in the coffin of consumer rights.