Federal Preemption Developments Since PLIVA V. Mensing

Law360, New York (April 2, 2012, 12:27 PM EDT) -- Over the last eight months, a number of courts have been called upon to interpret and apply the United States Supreme Court's June 2011 holding in PLIVA Inc. v. Mensing[1] that federal preemption bars failure-to-warn claims against a generic drug manufacturer whose labeling mirrors the U.S. Food and Drug Administration (FDA)-approved labeling for the brand-name counterpart of the generic product.

While the law on the scope of Mensing will no doubt continue to evolve, three themes have emerged in the decisions to date.

First, most courts have held that, so long as the generic manufacturer scrupulously complies with its regulatory obligation...

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