Supreme Court sets high bar for medical device lawsuits

Legal Compliance

The tiny balloon was supposed to stretch open a blocked artery on Charles Riegel's diseased heart. Instead, when the doctor inflated the balloon, it burst.

The patient went on life support but survived. His lawsuit against the manufacturer of that arterial balloon did not.

The U.S. Supreme Court ruled in favor of Medtronic, among the world's largest makers of medical devices, setting a precedent that has killed lawsuits involving some of the most sophisticated devices on the market.

The device that harmed Riegel had cleared the U.S. Food and Drug Administration's most rigorous review, known as "pre-market approval." To reach consumers, Medtronic provided regulators with documentation that the Evergreen Balloon Catheter would be safe and effective.

In Riegel v. Medtronic Inc., the justices grappled with whether Medtronic had any liability. They ruled that devices that have received pre-market approval are effectively immune from product liability lawsuits in state courts, where juries can award huge sums. The reasoning: Congress wrote that states couldn't add safety requirements beyond what the FDA imposes.

Since the Supreme Court ruling in 2008, rare is the case when a manufacturer must pay suffering, lost wages and other compensation to patients who claim they were injured by a pre-market approved device. Patients who believe they've been harmed can still sue device makers in federal court.

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