Supreme Court, PhRMA Present Arguments on Preemption

Washington, DC (Nov. 3)-Arguments in the Supreme Court case Wyeth v. Levine have concluded, leaving both sides to wait possibly until early 2009 for a decision in a preemption case involving the misadministration of Wyeth’s “Phenergan,” reported previously in PharmTech (see related ePT stories: Congress Holds FDA Preemption Hearings, and Wyeth Prepares for Supreme Court Preemption Case).

Diana Levine had to have her arm amputated after Phenergan was administered by a method known as an “i.v. push,” which caused gangrene. A Vermont jury awarded Levine $6.8 million, stating the drug’s label should have included a warning about the risks through intravenous injection. Wyeth contents that because the label was approved by the US Food and Drug Administration, the company cannot change its label to meet state demands. The federal requirements, argues the company, therefore preempts state regulation and the company should be immune to the state negligence lawsuit. 

Supreme Court justices argued whether FDA had a clear understanding of the risks of administering the drug via an i.v. push. According to an Associated Pressrelease, Justice Samuel Alito asked, “How could the FDA have concluded that i.v. push was safe and effective,” given that the drug is not a lifesaving drug and gangrene can result from improper administration? Justice Ruth Bader Ginsburg added, “No matter what benefit there was, how could the benefit outweigh that substantial risk?” The press release notes that Chief Justice John Roberts and Justice Antonin Scalia “seemed most receptive to Wyeth’s arguments, suggesting that FDA approval should protect Wyeth.”

Meanwhile, the Pharmaceutical Researchers and Manufacturers of America’s Senior Vice-President Ken Johnson issued a statement regarding federal preemption. The statement argues that federal preemption is “not about providing blanket immunity for America’s pharmaceutical research and biotechnology companies,” but instead it provides uniformity in scientifically based warnings. “One important point often remains silent in this debate. All medicines have some risks,” says Johnson. “Patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines.”