Product Liability Law

Riegel Will Affect Many—But Not All—Medical Device Suits

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Lawyers representing plaintiffs in lawsuits alleging injuries for medical devices were bracing for waves of dismissal motions after a U.S. Supreme Court ruling Wednesday.

The court ruled in Riegel v. Medtronic that manufacturers of medical devices winning a rigorous pre-market approval from the Food and Drug Administration cannot be sued for injuries caused by the devices. The case involved a balloon catheter that burst in a patient’s coronary artery.

Hours after the decision, a Florida judge sent lawyers in a pending heart-stent lawsuit against Johnson & Johnson an e-mail asking them to submit briefs on whether the action should be dismissed, the New York Times reports.

New York lawyer Hunter Shkolnik represents more than 600 plaintiffs in suits against Medtronic alleging harm from faulty heart defibrillator wires. He told the newspaper he is ready for a fight. “Medtronic probably already has summary judgment motions ready to go, and I expect to see them filed in the next few days,” he said.

The ruling may also affect lawsuits over a recalled heart valve, spinal disks, artificial hip parts and a hearing aid.

But plaintiffs lawyers do not see the ruling as a bar to all lawsuits over faulty medical devices that went through the extensive Food and Drug Administration approval process mandated by a 1976 law. New suits will focus on whether companies making faulty devices followed safety standards required by the FDA or whether the manufacturers held back information from the agency.

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