The 2011 U.S. Supreme Court decision in PLIVA Inc. v. Mensing held that state law tort claims based on defective warning labels are preempted because generic drug manufacturers must use labels that are the “same” as the brand-name drugs’ labels. In Bartlett v. Mutual Pharmaceutical Co., Inc., the First Circuit held federal law did not preempt state tort law in design defect cases. Following PLIVA generic companies have argued the reasoning should extend to preemption to design defect claims because generic companies must use the same design, just as they must use the same labels. Mutual has filed a writ of certiorari with the U.S. Supreme Court, asking for summary reversal of Bartlett. This article analyzes the cases, and Mutual’s argument for pre-emption.
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