The Demise of Drug Design Litigation: Death by Federal Preemption

The Demise of Drug Design Litigation: Death by Federal Preemption

68 Am. U. L. Rev. 281 (2018).

*Irwin and Jill Cohen Professor of Law, Brooklyn Law School.  Special Counsel, Herzfeld and Rubin, P.C.

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 brand name drug.  In these cases, the Court made wide-ranging statements that are applicable to brand name drugs as well.  This Essay finds the Bartlett Court erred in having read New Hampshire law too narrowly.  At the same time, the Court’s reasoning has opened a debate as to the scope of federal preemption for brand name drugs.  This Essay argues that the sweeping language in these two cases leads to the conclusion that common law drug design cases involving brand name drugs will fall prey to federal preemption.