Design Defect Claim That Generic Drug Caused Stevens-Johnson Syndrome Not Preempted by Federal Food, Drug, and Cosmetic Act

A patient who was prescribed a non-steroidal anti-inflammatory drug (“NSAID”) called Sulindac brought a product liability claim against the manufacturer. The plaintiff’s physician prescribed the name brand of the medication; her pharmacy dispensed a generic version. As a result of taking the medication, the plaintiff contracted Stevens–Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN), a hypersensitivity condition characterized by necrosis of the skin and mucous membranes, and often causing blindness or death. Sixty to sixty-five percent of the outer skin layer on the plaintiff’s total body surface area deteriorated, burned, or turned into an open wound and her eyesight was almost completely destroyed. SJS/TEN is a rare but known possible side effect of Sulindac.


The plaintiff brought a multi-claim action in state court against the manufacturer of the generic Sulindac, including claims for breach of warranty, fraud, and negligence, as well as design defect, failure to warn, and manufacturing defect. After the defendant removed the case to federal court on diversity grounds, all claims, except for the design defect claim, were dismissed by the district court on summary judgment or voluntarily by the plaintiff.


At trial, the theory of the plaintiff’s case was that Sulindac's risks outweighed its benefits making it unreasonably dangerous to consumers, despite the FDA having never withdrawn its statutory “safe and effective” designation that the original manufacturer had secured and on which the defendant was entitled to piggyback under federal law. A jury found for the plaintiff and awarded her $21.06 million.


On appeal, the defendant argued that the Federal Food, Drug and Cosmetic Act (FDCA) preempted state law design defect claims against generic drug manufacturers. Although the U.S. Supreme Court has held that that the FDCA does not preempt state law failure-to-warn claims (and by implication, design defect claims) against drug manufacturers, it has also carved out an exception to the general rule for failure-to-warn cases against manufacturers of generic medications. The defendant urged the court to extend the rationale of that case to design defect claims against generic manufacturers. The court of appeals declined to do so, stating that such a far-reaching rule must be made by Congress or the Supreme Court.


The court of appeals also denied the defendant’s argument that state law required the plaintiff to show not only that the product was unreasonably dangerous, which she did, but also that a safer alternative existed.


The defendant raised several other issues on appeal, including that the verdict was excessive. All were denied, and the verdict was affirmed.


See: Bartlett v. Mutual Pharmaceutical Co., Inc., 2012 WL 1522004 (1st Cir. (N.H.) May 02, 2012) (not designated for publication).