Supreme Court Lets Stand Ninth Circuit Decision on Defective Medical Devices
Earlier this summer, the U.S. Supreme Court declined to hear an appeal in Stengel v. Medtronic, Inc. This means the 2013 decision of the Ninth Circuit Court of Appeals will stand. That decision allowed product liability claims against a medical device manufacturer on the basis of a “failure to warn” product defect to proceed in state court, even though medical devices are normally regulated at the federal level. Usually, if state law in any way conflicts with federal law, the federal law prevails. Here, however, the court held that the state law was merely “parallel” to the federal law, so the state law was not preempted by the federal law, and the products liability lawsuit could proceed in state court.
That law at issue was the Medical Device Amendments of the Food, Drug and Cosmetic Act. This law prohibits states from establishing their own rules which are different from federal law regarding the safety or effectiveness of Class III medical devices, such as artificial hip replacements and pain infusion pumps. The plaintiff in this case had been rendered paraplegic due to a defective pump and catheter which had been surgically implanted in his abdomen to deliver pain medicine directly to his spine.
Apparently, the device maker Medtronic was aware of risks like Mr. Stengel suffered before his injury occurred, but the company failed to inform the FDA as required. The injury victim sued the catheter maker under Arizona negligence law for failing to report adverse events to the FDA as required by federal law.
Federal laws governing claims against defective medical devices are complicated. Whether claims can be brought in state court depends on the class of device and whether it went through Pre-Market Approval with the FDA for safety and effectiveness or if it got to market without being evaluated by the FDA because it was “substantially equivalent” to another device already on the market (a process known as 510(k) clearance).
The federal district court held that Stengel’s negligence claim was preempted by the federal law, and this decision was upheld on appeal by a panel of Ninth Circuit judges. However, the full bench of all the judges on the Ninth Circuit reheard the case and reversed the district court, holding that the duty of care under Arizona state negligence law paralleled the duty of device makers under the federal law, so the state claim was not preempted.