A federal judge has dismissed lawsuits that followed Medtronic's recall of its Sprint Fidelis leads, wires that connect an implantable defibrillator to the heart.

In an unrelated case, Riegel v. Medtronic, the Supreme Court held that federal law bars lawsuits "challenging the safety or effectiveness of a medical device," as long as the device is marketed in a form that received premarket approval from the FDA.

In this latest ruling, U.S. District Judge Richard H. Kyle suggested that the power to make it easier for injured patients to sue device makers lies not with the courts, but with Congress:

Congress has decided to limit medical-device manufacturers' liability in order to spur innovation, even though individuals are sometimes injured when using medical devices. Plaintiffs' remedy, therefore, lies with Congress, and not with this Court (or any other court), the judge ruled.

Last year, Democrats in the House and Senate introduced bills that would make it easier for plaintiffs to file liability lawsuits against device makers. Barack Obama was one of the co-sponsors of the Senate bill.

Read DOTmed's previous coverage at:
https://www.dotmed.com/news/story/6440/

More Industry Headlines