MADISON, Wis. (Legal Newsline)-The Wisconsin Supreme Court has thrown out a case against Medtronic, Inc., ruling that federal law preempts state claims against approved medical devices.
The high court ruled that patients cannot sue manufacturers of medical devices approved by the U.S Food and Drug Administration.
Joseph Blunt Sr. sued Medtronic, Inc. after he had a Medtronic defibrillator removed after the company said the device's battery had a chance of failing.
Blunt's case centered on whether state negligence and product liability claims are pre-empted by federal law where a defective product received FDA approval.
Blunt had Medtronic's Marquis 7230 defibrillator implanted in his heart in 2004. A year later, Medtronic issued a warning that the devices' batteries could fail and result in death.
Blunt filed a lawsuit in Milwaukee County Circuit Court, alleging the company was negligent for continuing to sell an unsafe device. Blunt and his wife sued Medtronic, alleging negligence, strict product liability, and a loss of consortium and companionship.
At trial, Milwaukee Judge Richard Sankovitz ruled that the Minneapolis-based company was protected by federal law since the device was FDA-approved.
A state appeals court agreed the claim was pre-empted by federal law.
"The main basis for the Blunts' claim is that the original battery design was defective due to the potential shorting mechanism," the appeals court ruled. "If a jury found in favor of the Blunts on that claim, it would result in a state requirement different from the federal requirement. It would result in a jury finding that the FDA's approval of the design was erroneous."
In its ruling Tuesday, the state Supreme Court affirmed the earlier rulings. Among other industry groups, the Product Liability Advisory Council urged the justices to affirm the earlier rulings and dismiss the lawsuit.
The petition to bring the case before the Wisconsin Supreme Court was held in abeyance pending the U.S. Supreme Court's decision in Riegel v. Medtronic, Inc.
A decision in the case was issued Feb. 20. In its ruling, the high court held that the pre-emption clause of the Medical Device Amendments Act barred claims challenging the safety or effectiveness of a medical device marketed in a form that received pre-market approval.
From Legal Newsline: Reach staff reporter Chris Rizo at email@example.com.