PLIVA, Inc. v. Mensing

Background

Two women who took generic metoclopramide for years developed a severe movement disorder called tardive dyskinesia and sued the generic drug makers under Minnesota and Louisiana law for failing to provide adequate warnings. The brand-name drug (Reglan) and generics have a long regulatory history of label changes, including a 12-week warning and a 2009 FDA black-box warning.

Reasoning

The Court asked whether federal drug rules for generic makers conflict with state tort duties to change a label. It deferred to the FDA’s view that generics must keep the same label text as the brand-name drug and cannot unilaterally strengthen warnings through the usual change process or by sending separate warning letters. Because state law effectively required the generic makers to use a different, stronger label but federal rules required “sameness,” the Court concluded it was impossible for the companies to obey both laws and therefore state-law claims are overridden.

Real world impact

The ruling removes the possibility of state failure-to-warn lawsuits against the generic manufacturers in these cases, shifts the practical power to the FDA and the brand-name maker to change labels, and leaves injured patients with fewer state-law remedies when a generic is substituted. The Court noted Congress or the FDA could change the rules going forward.

Dissents or concurrances

A dissent argued the impossibility test should be stricter: generic makers could have asked the FDA to change labels, and denying state suits now leaves injured people worse off and may harm incentives to monitor drug safety.