MADISON, Wis. (Legal Newsline)-The Wisconsin Supreme Court has decided to hear a case considering whether state negligence and product liability claims are pre-empted by federal law where a defective product received FDA approval.

The case involves Joseph Blunt Sr., who had a defibrillator manufactured by Medtronic Inc. implanted in May of 2004.

Minneapolis-based Medtronic, a year later, advised physicians of a possible battery shorting problem in the device, the Marquis 7230.

So, as a precautionary measure, Blunt and his physician decided to remove the device and replace it with an improved Medtronic model.

At the time Blunt received his defibrillator, both the original and the model with the improved battery were available for implantation, and the FDA had placed no restrictions on selling devices with the original design.

After the surgery, Blunt and his wife sued Medtronic, alleging negligence, strict product liability, and a loss of consortium and companionship.

The sole issue in the case is whether the Blunts' tort claims are pre-empted by federal law.

A Milwaukee County court sided with Medtronic, which argued that because the defibrillator had been approved by the FDA's extensive pre-market approval process, the claim was pre-empted by federal law.

The Court of Appeals affirmed the lower court's decision.

"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."

The July-issued ruling continued, "It would usurp the power Congress gave to the FDA, and thus must be pre-empted."

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 reporter Chris Rizo by e-mail at

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