Supreme Court Expands “Impossibility” Preemption to Design Defect Claims against Generic Drug Manufacturers

26 June 2013
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  • On June 24, 2013, the U.S. Supreme Court issued an important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett, holding that state-law design-defect claims brought against a generic drug manufacturer are preempted by federal law where the claims seek to impose a duty to either change the drug’s design or alter its labeling.
  • The Bartlett decision builds on the Supreme Court’s decision in PLIVA, Inc. v. Mensing, extending the developing jurisprudence on impossibility preemption by clarifying that the preemptive reach of Mensing is not limited to failure-to-warn claims, but applies where a duty under state law would require a manufacturer to alter its labeling in a manner not permitted under federal law.
  • The Bartlett decision also vacates a controversial ruling by the First Circuit Court of Appeals, which held that a generic manufacturer could comply with conflicting duties under state and federal law by simply ceasing to sell the product in question.