The Wisconsin Supreme Court has thrown out a case against Medtronic, Inc. (Medtronic), ruling that federal law preempts state claims against approved medical devices. The high court ruled that patients cannot sue makers of medical devices approved by the US Food and Drug Administration (FDA). The court ruled against a Wisconsin man who had surgery to remove a defibrillator after the manufacturer, Medtronic warned that its battery had a chance of failing.
The ruling is a victory for Medtronic and other manufacturers who want to limit product liability.
But two justices warned the decision leaves Wisconsin residents at the mercy of the FDA, which has a poor track record of ensuring the safety of medical devices.
“The result may be no meaningful protection for Wisconsin patients,” Justice Ann Walsh Bradley wrote.
At issue was whether patients could sue in state court over medical equipments that received market approval from the FDA. Under a 1976 federal law, companies must prove the safety and effectiveness of such devices to the FDA before they can enter the marketplace.
Joseph Blunt, Sr., 63, of St. Francis, had a Medtronic Marquis 7230 defibrillator implanted in 2004 to try to prevent his heart from failing.
The company warned the following year the devices’ batteries might fail in one out of 10,000 patients, which could lead to a potentially fatal loss of power. Many patients, including Blunt, had surgery to remove the devices.
The company knew of the problem over 2 years earlier but kept selling the product. The FDA did not order a recall or withdraw its 2002 approval. In the meantime, Medtronic obtained approval from the FDA in 2003 to also sell an identical device with fixed batteries.
Blunt filed a lawsuit in Milwaukee County Circuit Court against Medtronic after his surgery, alleging the company was negligent for continuing to sell an unsafe medical device. A judge and an appeals court both ruled the lawsuit was not allowed under federal law.
The US Supreme Court ruled last year that state lawsuits were barred in a similar case involving a malfunctioning heart catheter sold by Medtronic.