Supreme Court delivers big win to generic-drug makers

The high court's Pliva v. Mensing decision shields generic-medication companies from failure-to-warn claims.

Gladys Mensing and Julie Demahy didn’t know that the simple act of filling their prescriptions would eventually lead to litigation in the Supreme Court. Both women were prescribed Reglan, a brand-name heartburn drug made by Wyeth Pharmaceuticals, and their pharmacists filled their prescriptions with the drug’s generic versions. After taking the drugs for several years, Mensing and Demahy developed the same serious neurological disorder that causes involuntary muscle movements.

The women sued the generic-medication makers—Pliva Inc. and Actavis Inc.—because the drugs’ labels didn’t contain warnings about the possibility of developing the disorder. Mensing and Demahy also said the companies should have updated the labels as they uncovered previously unknown risks.

Contentious Decision 

On June 23, the Supreme Court decided 5-4 in favor of the generic-drug manufacturers, marking a departure from Levine. The narrow ruling was politically divided, with liberal Justices Stephen Breyer, Ruth Bader Ginsburg, Elena Kagan and Sonia Sotomayor dissenting. 

Label Litigation

While failure-to-warn lawsuits against generic-drug companies will soon fall by the wayside in light of Mensing, the litigation landscape could hold some surprises for brand-name manufacturers. Consumers who experience side effects from a generic drug could theoretically sue the brand-name equivalent’s manufacturer.

Ashley Post

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