Common defenses. Product‑liability defenses are fact‑intensive and include misuse, substantial alteration, assumption of risk, comparative fault, and evidence of compliance. In the drug/device space, federal preemption is frequently decisive.
Regulatory framework. The Food, Drug, and Cosmetic Act (FDCA) establishes a comprehensive federal scheme for medical products. The Medical Device Amendments (MDA) added classification, registration, manufacturing‑practice, labeling, and premarket pathways. Devices fall into Class I (general controls), Class II (special controls), and Class III (highest risk). Class III devices typically require Premarket Approval (PMA), a rigorous, evidence‑heavy process showing a “reasonable assurance of safety and effectiveness.” Other devices often proceed via 510(k) substantial‑equivalence notification. 21 U.S.C. §§ 360c–360e; 21 C.F.R. pts. 807, 814.
Preemption doctrines. The MDA contains an express preemption clause prohibiting state requirements “different from, or in addition to,” federal requirements for devices. 21 U.S.C. § 360k(a). There is also implied preemption: private litigants may not pursue claims that exist solely by virtue of the FDCA or that would usurp FDA’s enforcement role. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).
Supreme Court guidance. For PMA devices, state‑law claims imposing duties different from, or in addition to, PMA requirements are generally preempted. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). By contrast, 510(k) devices typically receive less preemption because 510(k) clears devices as “substantially equivalent,” not via a de novo safety‑and‑effectiveness review. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Parallel claims—state‑law duties that genuinely mirror specific federal requirements and are causally tied to the injury—may survive, but artful attempts to enforce the FDCA indirectly are barred by Buckman. (See Riegel, Lohr, Buckman).
Practical effect. PMA devices face robust preemption, often narrowing viable theories to truly parallel claims; 510(k) devices are less protected by preemption, but plaintiffs still must avoid implied‑preemption pitfalls. Knowing the device’s regulatory pathway is therefore central to evaluating exposures and defenses.
