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Supreme Court Expands “Impossibility” Preemption to Design Defect Claims against Generic Drug Manufacturers
26 June 2013
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.
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
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.
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.
Mark P. Goodman
Maura Kathleen Monaghan
Kristin D. Kiehn
J. Robert Abraham
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