Home › Case briefs › Constitutional Law

Pliva, Inc. v. Mensing

Supreme Court of the United States · 2011 · Constitutional Law

Constitutional LawTortsFederal PreemptionPrescription Drug LabelingSupremacy Clauseimpossibility preemptiongeneric drugsfailure to warn

Facts

Mensing and Demahy were prescribed Reglan but received generic metoclopramide from their pharmacists, then developed tardive dyskinesia after taking the drug for several years. They alleged the generic manufacturers knew or should have known that long-term use carried a higher risk than the label disclosed and that the labels were therefore inadequate under state tort law. State law in Minnesota and Louisiana required manufacturers aware of product dangers to provide adequate warnings. Federal law, however, required generic manufacturers' labels to remain the same as the corresponding brand-name label, and the FDA interpreted its regulations to impose an ongoing duty of sameness.

Issue

Whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and therefore preempt, state-law failure-to-warn claims alleging that the manufacturers should have used stronger warning labels. More specifically, the question was whether it was impossible for generic manufacturers to comply with both federal labeling duties and the state tort duty to provide adequate warnings.

Rule

State law is preempted by federal law when it is impossible for a private party to comply with both state and federal requirements. For impossibility preemption, the question is whether the private party could independently do under federal law what state law requires; when federal law bars the party from taking the action state law demands, and compliance would require special permission and assistance from a federal agency, the state-law claim is preempted.

🔒

See the holding & full analysis

Create a free KwikCourt account to unlock the rest of this brief — and practice the case.

The court's holding and reasoning
Doctrine tests, pitfalls & exam hypotheticals
10 practice questions + 4 AI-graded essays on this case

Free sample · practice this case

Test yourself

One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Ohio, Lena Ortiz took a generic heartburn medication manufactured by Riverbend Labs. She later sued under Ohio tort law, alleging Riverbend knew of a serious long-term neurological risk and should have added a stronger warning to its label immediately, even though the brand-name version still used the older warning.

Is Lena's state failure-to-warn claim most likely preempted?

Explanation. The majority held that impossibility preemption applies when state law requires a generic manufacturer to strengthen its warning, but federal law requires the generic label to remain the same as the corresponding brand-name label. The key question is whether the private party could independently do under federal law what state law required. Here it could not, so the claim is preempted.