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PLIVA, INC. v. MENSING

Docket No.: 09-993
Certiorari Granted: 12/10/2010
Argued: March 30, 2011
Decided: June 23, 2011
Consolidated with: 09-1501, Actavis, Inc. v. Julie Demahy 09-1039, Actavis Elizabeth, LLC v. Gladys Mensing

Topics:

EPA, Medicaid, Medicare, Supremacy Clause, patent, pre-emption clause, preemption

PartyNames: PLIVA, Inc., et al. v. Gladys Mensing
Petitioner: PLIVA, Inc., et al.
Respondent: Gladys Mensing

Court Below: United States Court of Appeals for the Eighth Circuit
Citation: 588 F.3d 603

PLIVA, Inc., et al.
v.
Gladys Mensing
Background:

The Drug Price Competition and Patent Term Restoration Act (the "Hatch-Waxman Amendments"), which amended the federal Food, Drug, and Cosmetic Act ("FDCA") allow for the approval of low- cost generic versions of previously approved drug products through an abbreviated application process.

Question Presented:

Whether the Eighth Circuit abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act's requirement that a generic drug's labeling be the same as the FDA-approved labeling for the listed (or branded) drug.

Question:

Can generic drug makers be sued for not warning about potentially dangerous side effects on their drug labels even when they follow federal rules that only require their labels to match those of their brand-name equivalents?

PLIVA, INC. v. MENSING
ORAL ARGUMENT

March 30, 2011

Listen to Oral Argument in PLIVA, INC. v. MENSING
Holding: reversed and remanded
Vote: 5-4
Opinion By: Justice Clarence Thomas
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