When a plaintiff is injured by a Class III medical device, the first motion they will face is a preemption motion arguing that all state tort claims are expressly preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Under the Supreme Court's 2008 decision in Riegel v. Medtronic, Inc., 552 U.S. 312, state tort law requirements that are different from or in addition to federal requirements imposed through the PMA process are preempted. If the plaintiff cannot plead around preemption, the case is gone at the motion-to-dismiss stage before discovery begins.
The parallel claim exception is the doctrine that keeps state-law claims alive in Class III device litigation. It is the central issue in medical device products liability pleading, and it requires more precision than most products liability complaints provide by default. The discussion below addresses the framework, the specific pleading requirements, and the discovery approach for medical device product liability cases where preemption is contested.
The Riegel Framework
Riegel involved a Medtronic balloon catheter that ruptured during an angioplasty procedure. The device had received premarket approval (PMA) from the FDA, the most rigorous regulatory pathway for medical devices. The Court held that PMA imposes device-specific requirements and that state tort law claims that would impose different or additional requirements on the device are expressly preempted under 21 U.S.C. § 360k(a).
The preemption analysis is a two-step inquiry. First: has the federal government established requirements applicable to the device through the PMA process? For Class III devices that have received PMA approval, the answer is yes. Second: would the state law claim impose requirements that are different from or in addition to those federal requirements? A negligence or strict liability design defect claim based on a theory that the device should have been designed differently than its PMA-approved design imposes a different design requirement, and is preempted. A claim that the manufacturer violated the requirements the FDA already approved is not preempted because it runs parallel to, rather than against, the federal requirements.
Class I and Class II Devices: A Different Analysis
Riegel's express preemption defense applies only to PMA-approved Class III devices. Class II devices cleared through the 510(k) substantial equivalence pathway are not subject to the same express preemption analysis because 510(k) clearance does not impose device-specific requirements in the way PMA does. The Supreme Court confirmed this in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). State tort claims against Class I and 510(k)-cleared Class II devices face implied preemption analysis but not Riegel express preemption, which gives plaintiffs substantially more room to operate.
Before drafting the complaint, confirm which regulatory pathway the device at issue went through. PMA approval letters and the complete PMA file are publicly available on the FDA's 510(k) and PMA databases, and the regulatory history will determine the entire preemption strategy.
The Parallel Claim: Pleading Requirements
The parallel claim exception requires pleading that the manufacturer violated specific, identified federal requirements imposed through the PMA process, and that those violations caused the plaintiff's specific injury. Courts have consistently dismissed parallel claims pleaded in conclusory terms. The complaint must identify: (1) the specific PMA-approved specification or manufacturing requirement the defendant violated; (2) how the defendant's conduct deviated from that specific requirement; and (3) how that specific deviation caused the injury the plaintiff suffered.
Courts that have sustained parallel claims over preemption motions typically involve situations where post-approval manufacturing inspections revealed deviations from approved manufacturing processes, where the defendant implemented unauthorized design changes without PMA supplement approval, where labeling was changed without FDA approval, or where the device was manufactured outside the approved facility or using unapproved components. Each of those scenarios involves conduct that violated the federal requirements rather than conduct that merely failed to meet some higher state standard.
FDA Enforcement Records as Pleading Material
The FDA's publicly available enforcement databases are critical pre-complaint research tools in parallel claim cases. Warning letters issued to the manufacturer, Form 483 inspection observations, mandatory recall notices, medical device reports (MDRs) filed under 21 C.F.R. Part 803, and adverse event data available through the MAUDE database all provide factual detail about the specific deviations from PMA requirements that are the foundation of a viable parallel claim.
A manufacturer that received a warning letter citing failure to follow device history record requirements, that issued a voluntary recall of devices manufactured during a specific period, or that has a pattern of MDRs showing the same failure mode as the plaintiff's injury is a manufacturer against whom a parallel claim can be specifically pleaded. The FOIA process can be used to request the complete PMA file, inspection records, and correspondence between the manufacturer and the FDA before the complaint is finalized.
Discovery Strategy in Parallel Claim Cases
If the parallel claim survives the motion to dismiss, discovery in preemption-adjacent medical device cases is heavily focused on the manufacturing and quality records. The corrective action and preventive action (CAPA) files document instances where the manufacturer identified manufacturing or design deviations and the actions taken to correct them. The complaint handling system captures adverse event reports received by the manufacturer before the plaintiff's injury. Device history records document each unit's production sequence against the approved manufacturing process.
These records are expensive to obtain and analyze, but they are the evidentiary foundation for both the parallel claim and the design defect theory. A metallurgical or biomedical engineering expert who can review the device history records and opine on whether the specific unit that injured the plaintiff was manufactured in compliance with the PMA-approved process is required for the expert phase.
Implied Preemption Under Buckman
Even when express preemption does not apply, defendants in medical device cases may argue implied preemption under Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), which preempted fraud-on-the-FDA claims. Courts have interpreted Buckman broadly in some circuits to preempt any state claim that rests on the theory that the FDA was deceived during the approval process. Structure parallel claims around violations of approved requirements rather than fraud-on-the-FDA to avoid Buckman's reach.
For medical device product liability cases generally, preemption is the first and most consequential motion, and surviving it requires complaint precision that most standard products liability forms do not provide. Invest in the FDA regulatory research before the complaint is filed, not afterward.