Supreme Court to Consider Whether Federal Regulatory Approval Shields Medical Device Manufacturers from State Product Liability Suits

As reported in the Chicago Tribune, the U.S. Supreme Court agreed earlier this week to consider whether federal regulatory approval of medical devices shields manufacturers from most product liability lawsuits in state courts. In the underlying lawsuit at issue, a New York couple, Charles and Donna Riegel, sued Medtronic Inc. when its Evergreen balloon catheter burst during Charles Riegel’s angioplasty.

The growing consensus in federal appeals courts has been that the Food and Drug Administration’s regulation of medical devices, particularly the agency’s stringent pre-marketing approval process, generally does protect the companies from lawsuits.

Thanks to the Products Liability Prof blog for the tip.