Court Reverses Preemption of Medical Injury Suit

A California Appellate Court recently ruled in Coleman v. Medtronic, Inc. that state law tort claims against medical device manufacturers are not preempted by federal law. Medtronic manufactures and sells a medical device called Infuse that is used in spinal surgery. The U.S. Food and Drug Administration granted premarket approval of Infuse for use in certain types of spinal surgery where the incision is made on a patient’s abdomen, but did not approve the device for spinal surgeries where the incision is made on a patient’s back, which is considered “off label” – the use of a medical device for some other purpose than that for which it has been approved by the FDA. While there is nothing in the Medical Device Act that prevents a doctor from using a medical device in an off-label manner, the MDA restricts manufacturers from promoting use of a device in a manner inconsistent with premarket approval, and further requires manufacturers to report known dangers of the device use.

The plaintiff in Medtronic had undergone spinal surgery in which his surgeon used Infuse in an off-label manner. The plaintiff suffered numbness and pain following the surgery, which he alleged was caused by the off-label use. The plaintiff subsequently filed suit against Medtronic, in which he asserted a state law failure to warn and negligence causes of action based on a failure to report adverse information about the device in violation of federal regulations. Medtronic filed a demurrer, asserting that the state law causes of action were preempted by the federal Medical Device Act.

The trial court agreed with Medtronic and sustained the demurred as to the plaintiff’s state law tort claims. However, the California Appellate Court found that the state law torts did not come into conflict with the MDA. First, the court determined that the state law claims were not expressly preempted because they did not impose any requirements that relate to safety and effectiveness of the medical device that are different from or different to the requirements imposed under federal law, but instead paralleled federal law. Additionally, the court determined that the state law claims were not barred by implied preemption because the claims were based on traditional state tort law that existed independently from the MDA. The court thus allowed the plaintiff to pursue his state law claims that Medtronic failed to warn the FDA of potential dangers of its device and that Medtronic was negligent for promoting off-label uses of the device. Following Medtronic, manufacturers must be cautious to ensure that their promotion of a device is consistent with FDA approval and that potential complications with a device are documented. Failure to do so could lead to liability under both federal and state law.

Leave a Reply

Next ArticlePennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers