St. Jude Medical will pay $27 million to settle false claims allegations that it knowingly sold defective heart devices that were later implanted into thousands of patients insured through Medicare and Medicaid, the Department of Justice said July 8.
“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” said Acting U.S. Attorney Jonathan Lenzner. “The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall."
Five details:
1. St. Jude allegedly failed to inform the FDA of serious adverse health events linked to premature battery depletion in certain models of its Fortify, Fortify Assura, Quadra and Unify devices — implantable defibrillators for patients at risk of cardiac arrest from an irregular heartbeat.
2. In 2014, St. Jude allegedly submitted a request to the FDA to approve a change to prevent the battery issue. At the time, the company told the FDA "no serious injury, permanent harm or deaths have been reported with this issue," though it was allegedly aware of two reported serious injuries and one death linked to the devices' premature battery depletion.
3. St. Jude allegedly continued distributing the defective devices through 2016. In August, it notified the FDA that the number of premature battery depletion events rose to 729, including two deaths and 29 events with loss of pacing.
4. St. Jude issued a medical advisory regarding the issue on Oct. 10, 2016. The FDA then issued a Class I recall, meaning there is a reasonable probability that "violative" products "will cause serious adverse health consequences including death."
5. While St. Jude stopped selling the devices after the recall, thousands of them were implanted between 2014 and 2016.