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Ending the Myth That Branded Drug Companies Cannot Benefit from Preemption

By Victor E. Schwartz and Phil S.Goldberg
February 29, 2016

A myth has surfaced over the past few years that federal drug law preempts product liability suits against generic drug companies, but not brand-name manufacturers. This myth stems from an over-simplification of three U.S. Supreme Court cases. Put simply, preemption applies when it would be impossible for a prescription drug manufacturer to comply with both the FDA's requirements and what a plaintiff's lawyer alleges as its duty under tort law, here changing a drug's warnings or design to address a finding of defect in a given case. It does not matter whether the defendant made a generic or brand-name drug.

In December 2015, the United States Court of Appeals for the Sixth Circuit directly pierced this myth in Yates v. Ortho-McNeil-Janssen, No.15-31049 (6th Cir. Dec 11, 2015). The court issued a well-reasoned opinion applying the Supreme Court's doctrine of impossibility preemption to a design defect claim that the brand-name drug manufacturer should have changed the dosage of its drug's active ingredient. The Sixth Circuit held that impossibility preemption blocks any such design liability claim. The brand-name drug manufacturer could not abide by both FDA's approval for the specific design of that drug and sell an altered version of that drug.

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