The Demise of Drug Design Litigation: Death by Federal Preemption

Abstract

For over half a century courts and commentators have disagreed as to the standards governing liability for drug design cases. In the last several years the United States Supreme Court decided two cases that will have a profound effect on whether drug design defect cases, in general, are federally preempted. In PLIVA v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, the Court preempted product liability actions for failure to warn and design defect against the manufacturers of generic drugs that met the FDA standard for the name-brand drug. In these cases the court made wide ranging statements that are applicable to name-brand drugs as well. This essay finds the Court’s reasoning in Bartlett erred in having misread New Hampshire law. At the same time its reasoning has opened a debate as to the scope of federal preemption for name-brand drugs. This essay argues that the sweeping language in these two cases leads to the conclusion that common law drug design cases in name-brand drugs will fall prey to federal preemption.

Keywords: drugs; pharmaceutical; drug design; product liability