When PMA Preemption Stops at the Operating Room Door

In Miller v. Rush University Medical Center, plaintiff’s alleged that Scott Miller suffered a spinal cord contusion during a cervical disc replacement surgery performed at Rush University Medical Center. The procedure involved implantation of the Mobi-C cervical disc system, a Class III medical device that received FDA premarket approval (PMA). Plaintiff alleges that the device was implanted too deeply because the depth-stop mechanism on the inserter instrument failed. Plaintiff brought suit against multiple defendants, including the hospital and treating physicians for medical negligence, the device manufacturers for product liability, and the distributor and its on-site sales representatives for product liability and negligence. In the subject decision, the court addressed motions to dismiss directed at the Third Amended Complaint.

Relying on well-established Supreme Court precedent under Riegel v Medtronic, the court held that the Medical Device Amendments (MDA) expressly preempted the plaintiffs’ state-law product-liability claims against the manufacturers. Because the Mobi-C system underwent the FDA’s rigorous PMA process, its design, labeling, and warnings constituted federal requirements. Any state-law claim seeking to impose requirements different from or in addition to those federal standards—such as design-defect or failure-to-warn theories—was therefore barred. The plaintiffs attempted to avoid preemption by arguing that the inserter instrument was a separate device not covered by PMA approval. The court rejected that characterization, concluding that the inserter was a component of the PMA-approved system and had been subject to PMA supplements. As a result, it enjoyed the same preemptive protection as the implant itself.

Apart from federal preemption, the distributor was entitled to dismissal of the product-liability claims under Illinois’s Distributor Statute (735 ILCS 5/2-621). That statute generally requires dismissal of non-manufacturing sellers once the manufacturer is properly joined, unless the plaintiff can show the distributor exercised control over the design, knew of the defect, or created the defect. The court found that no allegations were made that the distributor designed or manufactured the device, showing distributor had knowledge of the defect, nor any facts that showed distributor failed to pass along FDA-mandated warnings. Accordingly, all product-liability claims against the distributor were dismissed, independently of federal preemption.

The court then addressed the negligence claims against the distributor’s sales representatives who were present during the surgery. The plaintiffs alleged that the representatives assisted in assembling or loading the inserter, failed to verify that it was properly assembled, and undertook responsibilities on which the surgical team relied. While the court acknowledged that FDA regulations do not assign sales representatives any formal role in surgery, it held that Illinois voluntary-undertaking principles governed the analysis. Under Illinois law, a party who affirmatively undertakes to perform a task may assume a duty to perform that task with reasonable care. At the pleading stage, the court found it plausible that the sales representatives had voluntarily assumed duties during the surgery and that their alleged negligence could have contributed to the plaintiff’s injury. The negligence claims against the individual representatives were therefore permitted to proceed.

The decision reinforces several important principles. First, PMA preemption remains a powerful defense against product-liability claims involving Class III medical devices, and Illinois’s Distributor Statute continues to provide meaningful protection for non-manufacturing sellers when the manufacturer is properly before the court. At the same time, federal preemption does not extend to human conduct that falls outside the FDA’s regulatory framework. Individuals who actively participate in surgical procedures may face personal negligence exposure, regardless of the regulatory status of the device at issue.