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The generic drug industry suffered a disappointment when the 1st Circuit recently held federal law did not preempt state tort law in design defect cases. 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. Since PLIVA v. Mensing was decided, generic companies have argued this reasoning should extend preemption to design defect claims because generic companies must use the same design, just as they must use the same labels. Several district courts had endorsed this reasoning in other circuits. The 1st Circuit held in Bartlett v. Mutual Pharmaceutical Co., Inc., however, that PLIVA did not extend to design-defect claims against Mutual Pharmaceutical Company. On July 31, Mutual filed a writ of certiorari with the U.S. Supreme Court, asking for summary reversal of Bartlett because the “sameness” rationale supporting preemption in Mensing should also apply to the design of the drug product.

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