Preemption is the first fight in any device case
Before a jury ever hears about a failed implant, the defense moves to dismiss on preemption. In medical device litigation, that motion is not a formality. It disposes of more cases than any Daubert challenge. Whether a claim survives turns on two questions decided at the pleading stage: how the device reached the market, and whether the state-law duty you are asserting mirrors a federal one. Getting both right at the complaint stage is the difference between a case and a dismissal with prejudice.
PMA versus 510(k): the pathway decides the doctrine
The Medical Device Amendments of 1976 added an express preemption clause, 21 U.S.C. § 360k(a), barring states from imposing requirements different from, or in addition to, federal ones. How much force that clause carries depends entirely on the approval pathway.
In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court held that a device approved through the rigorous premarket approval process, known as PMA, carries device-specific federal requirements, so most common-law claims against a PMA device are expressly preempted. Design-defect and failure-to-warn theories that would second-guess the FDA's approved design and labeling are gone.
The 510(k) pathway is the opposite. In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Court held that 510(k) clearance, which turns on substantial equivalence to a predicate device rather than an independent safety review, imposes no device-specific requirement and therefore does not preempt state tort claims. The first thing to establish in any device file is which pathway applies. It dictates everything that follows.
The parallel-claim exception is the whole ballgame for PMA devices
Riegel left a door open, and plaintiffs have spent more than a decade walking through it. Section 360k(a) preempts only state duties that are different from, or in addition to, federal ones. A claim that a manufacturer violated a federal requirement, and that the same conduct breached a genuine state-law duty, is not preempted, because it imposes nothing additional. That is the parallel claim.
The Ninth Circuit's en banc decision in Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013), is the template. The court let a failure-to-warn claim proceed where the theory was that the manufacturer failed to report adverse events to the FDA as federal regulation required, and that a parallel state duty ran to the patient. The Fifth Circuit reached a comparable result in Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011). The through-line: plead the violation of a specific federal requirement, then anchor it to an existing state cause of action.
Buckman and the narrow lane between the two
The parallel claim has to thread a needle. In Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), the Court held that a claim existing solely because of an alleged fraud on the FDA is impliedly preempted, because policing the agency's own processes is a federal function. So the claim cannot be too different from federal law, which triggers express preemption under Riegel, and cannot exist only because of federal law, which triggers implied preemption under Buckman. It has to rest on a traditional state duty that happens to run parallel to a federal one. Courts call this the narrow gap, and pleading into it is a drafting exercise, not an afterthought.
How to plead the surviving claim
- Identify the exact federal requirement. Cite the specific PMA condition, the applicable Current Good Manufacturing Practice regulation, or the adverse-event reporting rule under 21 C.F.R. Part 803. Generic references to FDA regulations get dismissed as conclusory.
- Match it to a recognized state duty. Manufacturing-defect and failure-to-warn theories parallel most cleanly, while design claims against a PMA device rarely survive.
- Plead the manufacturing deviation with facts. A claim that the specific unit departed from the FDA-approved specifications is not second-guessing the design, so it stays outside Riegel.
- Keep the FDA out of the injury narrative. If the harm is framed as flowing from deceived regulators rather than from a defective device that hurt your client, Buckman swallows the claim.
Discovery once you survive the motion
Surviving preemption reorients discovery around the federal requirement you pleaded. The manufacturer's adverse-event files, its complaint-handling records, FDA Form 483 inspection observations, and warning letters become the core of the case, because they show whether the company met the very federal duty your parallel claim rests on. The failed unit still matters, and the chain-of-custody discipline that governs any defect case applies, a subject we cover across our product liability reporting. But the documentary center of gravity shifts to the regulatory file.
Why this matters for case selection
Preemption should shape intake, not just motion practice. A catastrophic injury from a PMA device with no identifiable federal violation is a hard case, however sympathetic the client. A comparable injury from a 510(k) device, or from a PMA device with a documented reporting failure or manufacturing deviation, is a materially stronger file. Building that assessment into screening protects the firm's capital, the same triage discipline we apply to lien-heavy and expert-intensive matters in our practice operations coverage. The device that hurt your client is only half the question. The other half is how it reached the market and what the manufacturer told the government along the way. For related rulings, see our case law coverage.