Key takeaways

• On February 20th, the U.S. Court of Appeals for the First Circuit held that state-law claims asserting that a branded drug label is false or misleading are impliedly preempted by the Federal Food, Drug, and Cosmetic Act.
• The First Circuit recognized that, under federal law, branded drug manufacturers may only make unilateral changes to drug labeling in limited circumstances based on information not previously known to the FDA. Where plaintiffs seek to impose labeling changes based on information that was available to the FDA when it approved a drug label, the claims are preempted.
• The court’s decision makes clear that preemption is a viable defense not only for generic drug manufacturers, but also for branded drug manufacturers faced with state-law claims challenging the adequacy of drug labeling.