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Wednesday, March 30, 2011

Consumers’ Ability to Hold Drug Companies Accountable for Inadequate Warnings at Stake in Supreme Court

The Supreme Court will hear oral arguments today in the consolidated cases of PLIVA v. Mensing, Actavis Elizabeth, L.L.C. v. Mensing, and Actavis, Inc. v. Demahy. At stake is the ability of consumers to keep pharmaceutical companies honest about the potential danger their drugs pose. The Court must decide whether Hatch-Waxman Amendment provisions governing the labeling of generic prescription drugs preclude state claims against a pharmaceutical company for failing to adequately warn consumers about health risks.

Gladys Mensing sued PLIVA for failure to warn and misrepresentation in state court after a generic drug that PLIVA manufactured caused her to develop a severe and irreversible neurological movement disorder. Mensing claims that PLIVA failed to take steps to change the label warnings despite mounting evidence that the drug carried a far greater risk of the disorder than initially indicated.

PLIVA argues that federal law impliedly preempts Mensing's state claims. PLIVA claims that simultaneous adherence to state and federal law is impossible because federal law requires generic labels to be identical to labels approved for the name brand. As a result, PLIVA states that unilaterally strengthening the warning on the generic label to avoid state law liability would violate federal law. PLIVA also argues that state claims thwart the goal of the federal Hatch-Waxman Amendments to bring low cost generic drugs to market quickly.

Mensing argues that state law claims against a generic drug manufacturer are not preempted because the manufacturer could have proposed a label change for FDA to approve without making a unilateral change. In addition, the Hatch-Waxman Amendments must be read with other FDA statutes that are meant to ensure that drugs are safe for consumer use.

If the Supreme Court sides with drug companies, makers of generic pharmaceuticals will have less of an incentive to produce up-to-date label warnings for consumers.

Update (3/31): The New York Times reports on arguments in the case.

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