John C. Maloney Jr. and Clara Son | New Jersey Law Journal

Courts have relied on the differences in the regulations of the Food and Drug Administration (FDA) governing the labeling of brand-name and generic prescription drugs to justify the differences in the courts’ application of preemption and, in a few jurisdictions, the merits of the controversial innovator liability doctrine in duty-to-warn cases. Now, in response, the FDA has proposed a rule amending its regulations governing generic drug labeling that, if approved and implemented, would significantly alter the scope of potential tort liability of brand-name and generic drug manufacturers. The proposed FDA rule would also dramatically change the drug-labeling process and the duties and responsibilities of generic drug manufacturers.

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