A victory for generics suppliers

In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we predicted, the Court reversed the First Circuit’s decision and held that “(s)tate-law design defect claims that turn on the adequacy of a drug’s warnings are preempted by federal law under PLIVA [Inc. v. Mensing].”

Bartlett’s background -

Bartlett’s facts are undeniably tragic. The plaintiff, Karen Bartlett, took generic sulindac (manufactured by Mutual) for shoulder pain. She developed Stevens-Johnson syndrome/ toxic epidermal necrolysis (SJS/ TEN) and suffered permanent injury and disfigurement. By the time of trial, the only remaining claim for the jury to decide was whether sulindac was defectively designed. The jury found in Bartlett’s favor and awarded her $21.06 million in compensatory damages.

Originally published in Chain Drug Review on 8/5/2013.

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