Supreme Court sets high bar for medical device lawsuits

Legal Analysis

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.

Related listings

  • Court: Reds exempt from tax on promotional bobbleheads

    Court: Reds exempt from tax on promotional bobbleheads

    Legal Analysis 12/01/2018

    Quoting the Cincinnati Reds’ long-time play-by-play announcer, the Ohio Supreme Court declared Tuesday that “this one belongs to the Reds.”The state’s high court ruled 5-2 that the Major League Baseball franchise is exempt fro...

  • Arkansas Supreme Court disqualifies term limits proposal

    Arkansas Supreme Court disqualifies term limits proposal

    Legal Analysis 10/15/2018

    The Arkansas Supreme Court on Friday ordered election officials to not count votes cast for a ballot measure that would have imposed the strictest term limits in the country on state legislators.In a 4-3 ruling disqualifying the proposed initiative, ...

  • Senate begins final day of Supreme Court nominee hearings

    Senate begins final day of Supreme Court nominee hearings

    Legal Analysis 09/05/2018

    Senators began the fourth and final day of hearings for Supreme Court nominee Brett Kavanaugh on Friday, but with the nominee finished answering questions the day they seemed unlikely to alter his path to confirmation.Senate Democrats worked into the...

New Rochelle, New York Personal Injury Lawyers

If you or a loved one has been injured in an accident, contact Kommer, Bave & Ollman, LLP, in New Rochelle, New York, immediately. We can answer all your questions and work with you to determine if you have the grounds for a personal injury lawsuit. The attorneys at our firm are determined to resolve even the most difficult of cases. We will work closely with you to determine the best course of action to get your claim or case resolved in the most efficient way possible. We will fight for your right to compensation! No one should have to suffer a financial burden from the result of another person’s carelessness. The attorneys at Kommer, Bave & Ollman, LLP will aggressively fight to ensure that justice is served on your behalf.