When You Don’t Have a Preemption Defense, What Then? Pick a Path or Your Poison

Favorable developments in the last two decades have made the legal doctrine of preemption a leading defense in pharmaceutical and medical device litigation involving products that have been approved by the Food and Drug Administration (FDA). See, e.g., Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019); Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013); PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). There is, however, a large category of medical devices that comes to market under the 510(k) premarket notification process whereby the FDA clears the device after finding it is as safe and effective as—i.e., substantially equivalent to—a legally marketed device. See 21 U.S.C. § 360c(i). The availability of “510(k) preemption” continues to be uncertain, although some conceptual legal inroads to establish impossibility preemption of state law tort claims based on 510(k) clearance have been made. Compare Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), with Sikkelee v. Precision Airmotive Corp., 822 F.3d 680 (3d Cir. 2016) (applying impossibility preemption recognized in Mensing and Bartlett to design defect claims in aircraft governed by Federal Aviation Act regulations), and Kelsey v. Alcon Labs., Inc., 2019 WL 1884225 (Utah Dist. Ct. Apr. 22, 2019) (finding state law manufacturing and design claims against 510(k)-cleared contact lens solution preempted). But even in the absence of a preemption defense, medical device manufacturers can attempt to take advantage of their compliance with federal regulations to defend against product liability claims.