Supreme Court to Hear Design Defect Preemption Case

Generic drug manufacturers were encouraged on Friday when the Supreme Court granted certiorari in the case of Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit, Bartlett v. Mutual Pham. Co., 678 F.3d 30 (1st Cir. 2012)). The petition asked the Supreme Court to determine the outer edges of what seemed clearly decided in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011): whether design defect claims against generic drug manufacturers are preempted by federal law. While Mensing held that failure to warn claims against generics are preempted because generic labeling must be identical to brand drug labeling, Bartlett concerns a design defect claim. Plaintiff alleged that even though the generic drug had to be the “same” as the branded drug, the manufacturer should have withdrawn the generic from the market.

The facts underlying the Bartlett case are undeniably tragic. The plaintiff, Karen Bartlett, was prescribed generic sulindac for shoulder pain and developed Steven-Johnson Syndrome/toxic epidermal necrolysis (SJS-TEN), which left her permanently injured and disfigured. Bartlett, 678 F.3d at 34. By the time of trial, the only remaining claim for the jury to decide was whether sulindac was defectively designed. Id. The jury awarded Bartlett $21.06 million in compensatory damages. Id.

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