BioCentury
ARTICLE | Regulation

Narrowing down preemption

November 10, 2008 8:00 AM UTC

The oral arguments at the U.S. Supreme Court in Wyeth v. Levine last week suggest that the first decision in favor of FDA preemption of state tort laws in a prescription drug case is a very real possibility. But such a decision might be narrow, and not insulate drug manufacturers as much as they might hope.

Product liability suits against FDA-approved products are one of the largest generators of mass torts. The U.S. Supreme Court has taken an interest in whether FDA authority preempts state tort laws in such cases, having ruled in favor of preemption in a device case in February and then splitting 4-4 in a case that allowed Michigan state courts and juries to determine whether a company defrauded FDA...