Generic Drug Preemption Scorecard

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We’ve decided that, since PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), product liability preemption in the context of generic drugs has come into its own and should no longer be lumped in with the overall topic of drug/vaccine preemption. Thus we’re bestowing a new scorecard on post-Mensing generic drug preemption decisions. We’ll start with Mensing itself and go from there:

1.PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. June 23, 2011) (metoclopramide). Hatch Waxman Act's requirement that generic drug labeling must stay the same as branded labeling preempts failure to warn claims against generic drug makers. Generic drug manufacturers cannot change their labels without prior FDA approval. Dear Doctor/DHCP letters cannot vary from generic drug labeling. The bare chance that the FDA, if approached, might agree to change both the generic and branded labels simultaneously, is insufficient to prevent preemption...

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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