On June 23, 2011, the U.S. Supreme Court issued a 5-4 decision in PLIVA v. Mensing, 131 S.Ct. 2567, 564 U.S. (2011), which effectively bars claims against generic pharmaceutical manufacturers for state failure-to-warn claims, as being preempted under federal law. Currently, brand-name manufacturers have a continuing responsibility “for the accuracy and adequacy” of labeling and are specifically permitted to “change their labels” to add additional warnings. Id. at 2574. Generic manufacturers, on the other hand, “have an ongoing federal duty of ‘sameness.’” Id. at 2575.
Deferring to the Food and Drug Administration’s interpretation of its own regulations, the high court concluded that federal law did not permit generic manufacturers to unilaterally strengthen its warning labels. Id. In particular, the court held that generic pharmaceutical manufacturers are prohibited from using the FDA’s “Changes Being Effected” (CBE) process to unilaterally strengthen their labels with new safety information, and are also prohibited from sending “Dear Doctor” letters to warn physicians of risks that are not contained in the FDA-approved labeling of the brand name drug. Id.
