May a defendant assert a preemption defense based on federal requirements it has not met? That question is being raised with increasing frequency in tort actions against the makers of medical devices and other products subject to preemptive federal regulation. Plaintiffs maintain that it disserves the overarching goal of enhancing safety to permit a defendant manufacturer who has not complied with federal safety standards to invoke the shield of preemption.
In Talbott v. C.R. Bard, Inc., 63 F.3d 25 (1995), the First Circuit recently refused to recognize a noncompliance exception to preemption under the Medical Device Amendments of 1976 (MDA) to the Food, Drug, and Cosmetic Act. In fact, the court of appeals rejected three variations of the noncompliance argument, including one advanced by the United States government in an amicus brief.
