False Claims Act Case Brought by Patient Leads to $27 Million Settlement against Pacemaker Manufacturer St. Jude Medical

On July 8, 2021, the Department of Justice announced that pacemaker manufacturer St. Jude Medical (now owned by Abbott Laboratories) agreed to pay $27 million to resolve a False Claims Act qui tam action alleging that the company sold defective heart devices. Between 2014 and 2016, according to the government, St. Jude knowingly sold four models of implantable defibrillators with batteries that could deplete prematurely because “lithium clusters formed on the batteries of the devices, causing some of the batteries to short and, in turn, suffer a premature power drain.” The government further alleged that St. Jude had represented to the FDA in late 2014 that the battery depletion issue had not caused any serious injuries, when in fact St. Jude knew of “two reported serious injuries and one death associated with premature battery depletion” in the devices. By August 2016, there had been 729 premature battery depletion issues with the devices, and two deaths. Only in October 2016 did St. Jude announce a recall of the devices, which were implanted in patients’ bodies. The case was brought by Debbie Burke, a patient who received one of the devices that was subject to the recall, and she will receive a portion of the government’s recovery from St. Jude. Gregg Shapiro, a former federal prosecutor, represents whistleblowers in False Claims Act qui tam actions against medical device and pharmaceutical companies. He can be reached by telephone at 781-808-6789 or by e-mail at gshapiro@newmanshapiro.com.