Friday, December 10, 2010

Supreme Court agrees to review one more very important torts case - duty to warn by manufaturers of generic drugs

The Supreme Court announced today it has agreed to review three consolidated cases that will clarify the legal duty of makers of generic medicines to change their labels to warn consumers of a new threat of harmful side effects, and to decide whether state court lawsuits may be filed for failure to do so. The Court consolidated three separate cases on the issue: PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501). The cases involved two women who developed tardive dyskinesia, a serious condition affecting neurological movement, after taking a generic version of the brand-name drug Reglan. (Reglan was manufactured by Wyeth.) The generic manufacturers involved in the new cases argued in their appeals that Congress did not intend for state court lawsuits to impede the marketing of generic drugs, as cheaper versions of brand-name drugs, and that should make a difference from the situation with a brand-name manufacturer like Wyeth. The Court granted review of the issue even though the Solicitor General argued it should deny review in Mensing. On that, go here. For details, including the lower court opinions and briefs, on PLIVA Inc. v. Mensing go here. For Actavis v. Mensing, go here and for Actavis v. Demahy, go here. For more on the story go to here. Here are some links to some of my previous entries on this blog related to this issue: Preemption debate regarding generic drugs (6/11/10) Video on preemption issues in generic drug cases and question about inadequate warnings (11/2/10) Solicitor General files brief on preemption debate regarding generic drugs (11/3/10)

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