In October 2016, St. Jude Medical (now Abbott) issued an advisory on a family of ICD and CRT-D devices that may develop Lithium deposits within the battery leading to a short circuit and result in premature and potentially rapid battery depletion. However, according to the DOJ, St. Jude was already aware of the issue by 2013. In 2014 St Jude asked the FDA to approve an update to the devices to mitigate the battery issue. In its request, St. Jude claimed that the issue had not caused any serious injuries or deaths, but the DOJ claimed that the company had been informed of two injuries and one death caused by the issue.
The lawsuit covers the period between November 2014 and October 2016, during which the DOJ claims St. Jude was fully aware of the device’s issues but continued selling thousands of devices. By August 2016, St. Jude reported to FDA two more deaths linked to this issue, and over 700 cases of premature battery depletion.
The federal case was brought under the False Claims Act based on the allegation that by continuing to sell the potentially harmful products to healthcare facilities and implanted in patients enrolled in Medicare and Medicaid, St. Jude played a role in securing government payments for devices that they knew were defective. It was announced on July 8, 2021 that St. Jude Medical agreed to pay $27 million to settle this case.