In a front-page New York Times article on September 19 about the Supreme Court's current interest in clarifying the role of federal preemption in product liability law, Professor Catherine Sharkey commented on the pressing legal debate, which she deemed a "muddled area of law."
In Wyeth v. Levine, the Court will consider the case of a Vermont woman who lost part of her right arm due to the administration of an anti-nausea drug via a method whose risks, the plaintiff says, should have caused the pharmaceutical company to include a warning against using the drug in that manner. While a Vermont jury awarded the plaintiff $6 million, the manufacturer argues that it was restricted by federal law to using the existing FDA-approved warning label--an instance of federal preemption. The other side claims that the law sets only a minimum federal labeling standard, and that states are free to make drug warnings more stringent.
This past February, in Riegel v. Medtronic, the Supreme Court ruled that federal preemption applies to injuries caused by medical devices that have been approved by the FDA, meaning that manufacturers cannot be held liable. Sharkey, whose article on FDA regulatory preemption in pharmaceutical cases was cited in Justice Ruth Bader Ginsburg's Riegel dissent, observed in the Times that the earlier case "boiled down to statutory interpretation. Levine challenges the court to define the parameters of preemption outside the safe confines of the legislators’ text.”