Medical devices of all kinds – including pacemakers, hip implants, transvaginal mesh, and wheelchairs – are subject to federal safety requirements that vary depending on the class of the medical device. As a consumer product, medical devices may also be subject to state law product liability claims. In some cases, these state and federal claims are at odds with each other. When this is the case, the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act provides that state laws imposing requirements on manufacturers of class III medical devices that are different to or supplementary to federal law are preempted (or, in other words, prohibited) by federal law.
Moreover, in 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic, Inc. that the MDA preempted state law claims that would impose additional and/or different requirements, but it did not preempt parallel state law claims. In other words, Riegel held that a plaintiff could pursue state law claims if they were premised on federal law, including violations of FDA regulations.
A recent Ninth Circuit decision narrowed the scope of the Riegel decision in Stengel v. Medronic, Inc. In Stengel, the plaintiff was injured and paralyzed by a medical device. He sued the manufacturer of the medical device, asserting various claims, including state law claims for negligence and failure to warn. Although the district court dismissed the case, the Ninth Circuit Court of Appeals reversed the decision, holding that the plaintiff’s state law claims could proceed since they were parallel to federal law claims because they were based on violations of FDA regulations and did not seek to impose any obligations that were in addition to or different from federal law.
What This Means for You
Because this decision comes from the Ninth Circuit and not the Seventh Circuit, Illinois federal courts are not obligated to follow the ruling. Nonetheless, many commentators are lauding the decision as a victory for plaintiff’s rights since the Ninth Circuit joined the Fifth Circuit in narrowing the scope of the prior Supreme Court preemption rulings. Federal courts are still split on whether state law claims based on the failure to provide information to the FDA after pre-market approval are preempted by the MDA or not.
Because the issues of state law preemption are confusing and complex, you should consult with a skilled product liability attorney if you have been injured by a medical device. The Chicago product liability attorneys at Ankin Law Office, LLC focus on protecting the rights of the victims of dangerous and defective medical devices. Contact our office at (312) 600-0000 to schedule a free consultation with one of our knowledgeable Chicago product liability attorneys.