The Wisconsin Supreme Court has thrown out a case against Medtronic, ruling that federal law preempts state claims against FDA-approved medical devices.
The state's high court ruled that patients cannot sue manufacturers of medical devices approved by the FDA, based on the Supreme Court's decision in Riegel v. Medtronic in February 2008.
In January, the U.S. District Court for the District of Minnesota dismissed with prejudice a group of class-action lawsuits filed against Medtronic regarding its faulty Sprint Fidelis defibrillator leads on grounds of federal preemption.
In the Wisconsin case, Joseph Blunt, Sr., sued the Minneapolis-based company after he had a Medtronic defibrillator removed due to a company warning regarding the potential for device's battery to fail. Blunt's case centered on whether state negligence and product liability claims are preempted by federal law where a defective product received FDA approval.
Blunt had Medtronic's Marquis 7230 defibrillator implanted in his heart in 2004; in 2005 Medtronic issued a warning that the devices' batteries could fail and result in death.
"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, 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. In its ruling, the Wisconsin high court held that the preemption 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.