By RYAN J. FOLEY
February 17, 2009
The court ruled against a Wisconsin man who had surgery to remove a defibrillator after the manufacturer, Medtronic, Inc., warned its battery had a chance of failing. The ruling is a victory for Minneapolis-based Medtronic and other manufacturers who want to limit product liability.
But two justices warned the decision leaves Wisconsin residents at the mercy of the U.S. Food and Drug Administration, 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 devices that received market approval from the U.S. Food and Drug Administration. 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 more than two 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 device. A judge and an appeals court both ruled the lawsuit was not allowed under federal law.
The U.S. Supreme Court ruled last year that state lawsuits were barred in a similar case involving a malfunctioning heart catheter sold by Medtronic.
All seven Wisconsin justices agreed that ruling meant Blunt's case must be dismissed. In the majority opinion, Justice Patience Roggensack said the FDA's approval of the defibrillator with the fixed battery did not affect the approval of the original.
"It's a sorry day when the law of the land is that a medical device manufacturer is free to sell less-safe, obsolete medical devices to clear out its inventory after having received FDA approval for a safer device," said Blunt's lawyer, John Cabaniss.
Two concurring justices - Walsh Bradley and Chief Justice Shirley Abrahamson - criticized the U.S. Supreme Court decision but said they must follow it. The decision leaves Wisconsin residents' safety in the hands of the flawed FDA, Walsh Bradley wrote.
She cited a letter from FDA scientists released last month that charged "the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."
"It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices," Walsh Bradley wrote.
Wisconsin Manufacturers & Commerce, the state's powerful business lobby, and the Product Liability Advisory Council had urged the court to dismiss the lawsuit.
The council, a national group whose members include auto, pharmaceutical, chemical and electronics makers, said allowing the lawsuit would drive up the costs of lifesaving medical devices and hamper product innovations.
But the Wisconsin Association of Justice, which represents trial lawyers, said dismissing it would shield companies from being held accountable for marketing dangerous products.