On March 2, 2011, CAC filed an amicus curiae brief in the Supreme Court in PLIVA, Inc. v. Mensing. At issue in this case was whether state law claims against generic drug manufacturers for failing to properly warn consumers about dangerous risks associated with their products should be displaced by federal law. The PLIVA case was virtually identical to 2009’s Wyeth v. Levine, in which the Court held that state failure-to-warn claims against brand-name prescription drug manufacturers are not preempted by the Federal Food, Drug and Cosmetic Act (FDCA).

Gladys Mensing and Julie Demahy sued the generic manufacturers of the drug metoclopromide, which caused them to have serious adverse effects, alleging that they were injured because the drug manufacturers failed to adequately warn that long-term use of their generic drug could cause severe, harmful side effects. The generic drug manufacturers countered that, because federal law requires them to use the same label as the relevant brand-name drug, they cannot be held liable for the contents of the label. However, the U.S. Court of Appeals for the Eighth Circuit held that federal law provides for several mechanisms by which generic drug manufacturers can seek to change the label or otherwise warn consumers and physicians about risks, and therefore that state law liability can coexist with federal generic drug regulations.

CAC’s brief in PLIVA, like our brief in Wyeth, argued that state common law claims should be allowed to work in conjunction with FDA oversight, as neither the Constitution nor the principles behind it support displacing the States’ traditional role in protecting consumer safety and health in the absence of a direct conflict between state and federal law. In this case, there is nothing in the statutory text of the Hatch-Waxman Amendments to the FDCA, which encouraged the development of low-cost generic drugs, to suggest that the Amendments were intended to override the FDCA’s general preservation of state tort remedies as a complementary form of consumer protection.

The Court heard oral argument in PLIVA on March 30, 2011. CAC’s wrap-up of the oral argument is here.

On June 23, 2011, in an ideologically divided ruling, the Supreme Court held, 5-4, that generic drug manufacturers may not be sued under state failure-to-warn laws because it would be “impossible” for the generic drug manufacturers to comply with both state law and federal law. Read our statement decrying the ruling here. For an in-depth analysis of this decision, visit our blog Text & History.