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Ending the Myth That Branded Drug Companies Cannot Benefit from Preemption
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.
The U.S. Supreme Court's Trilogy of Drug Preemption Cases
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Major Differences In UK, U.S. Copyright Laws
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