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Expert Analysis

How Recent Pro-Preemption Wave May Lift Brand-Name Drugs

Law360, New York (November 16, 2015, 3:51 PM EST) -- Recent and upcoming cases show the pharmaceutical preemption defense to be alive and well. In Wyeth v. Levine, the U.S. Supreme Court held that preemption for branded manufacturers hinged on their ability to show "clear evidence" that the U.S. Food and Drug Administration would have rejected the substance of the labeling change at issue in the lawsuit. 555 U.S. 555, 571 (2009). In the aftermath of Wyeth, many courts routinely denied preemption motions brought by branded manufacturers, even in compelling situations, without deep consideration of Wyeth's "clear evidence" standard....

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