Following oral arguments in Merck v. Albrecht on Jan. 7, the Supreme Court is pondering a decision that could reset the balance of power over drug label warnings between FDA and state courts. The outcome could have substantial financial implications for drug companies, either limiting or increasing their vulnerability to state tort litigation.
The court is being asked to decide if FDA’s denial of a proposed warning from Merck & Co. Inc. about a specific type of risk precluded the company from warning about a different risk.
More fundamentally, the case is about the roles of state courts and FDA in protecting the public from inaccurate or missing warnings on drug labels, and the Supreme Court is being asked to tell lower courts how they should determine if an FDA labeling decision preempts state law.
The underlying question is whether litigation in state courts supplements FDA vigilance, or if on the contrary, it undermines the agency’s authority and endangers public health by substituting an unpredictable hodgepodge of state court rulings for the judgment of a federal regulatory agency.
The comments and questions of Supreme Court justices outlined the contours of the controversy, but as always it is impossible to make confident predictions of their ruling based on