ARTICLE | Politics, Policy & Law

Supreme Court may reset FDA-State power balance

How the Supreme Court may reset FDA preemption power

January 11, 2019 11:23 PM UTC

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. ...