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Expert Analysis

The Growing Challenges To Drug Cos.' Preemption Defense

By Bryce Cooper, Sandra Edwards and Yarden Kakon (August 26, 2020, 5:20 PM EDT) -- In the wake of the U.S. Supreme Court's decisions in Wyeth v. Levine[1] and Merck Sharp & Dohme Corp. v. Albrecht,[2] drug manufacturers face challenges in establishing a preemption defense when they receive "newly acquired information" about a drug's side effects without clear evidence that the U.S. Food and Drug Administration would have rejected a label change adding a warning of the risk of harm....

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