Supreme Court hears preemption arguments

The U.S. Supreme Court heard oral arguments Monday in Wyeth v. Levine, a case involving FDA preemption of state product liability law. Wyeth is seeking to overturn a Vermont court decision to award Diana Levine $6.8 million in damages after she lost her forearm following an IV push injection of Wyeth's Phenergan to treat nausea associated with a migraine headache. The state courts decided that Phenergan's labeling, which includes warnings that inadvertent intra-arterial administration of the drug could cause gangrene resulting in amputation, was insufficient. The pharma argued that the FDA-approved labeling preempts state tort law because the state law could not be adhered to without violating the Food, Drug, and Cosmetic Act (FDCA), and because the state law frustrates FDA's congressionally mandated objective of balancing health risks and benefits (See BioCentury, Sep. 22, 2008). ...