St. Jude Medical to Settle Federal Complaint Over Defective Heart Devices

July 13, 2021

St. Jude Medical has agreed to pay $27 million to settle allegations that it knowingly sold defective heart devices.

The Department of Justice (DOJ) alleged that between November 2014 and October 2016, the company sold defective heart devices to healthcare facilities that implanted the devices into patients insured by federal health care programs, leading to charges under the False Claims Act of defrauding the federal government.

The DOJ’s accusations centered around the company’s alleged failure to disclose serious adverse health events in connection with the premature depletion of the battery in certain models of its Fortify, Fortify Assura, Quadra and Unify devices, which are implantable defibrillators used in patients at risk of cardiac arrest due to an irregular heartbeat.

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