St. Jude Medical to pay $27M in DOJ settlement on heart devices
The U.S. Department of Justice says that St. Jude Medical has agreed to pay $27 million to settle allegations that the company knowingly sold defective heart devices used from 2014 to 2016 in patients insured by federal health care programs.
The medical device manufacturer, which was based in Little Canada prior to being acquired by Abbott Laboratories in 2017, is not admitting liability, according to settlement terms released Thursday, nor is the government conceding that its claims are not well founded.
The government alleged that St. Jude failed to disclose serious adverse health events, including patient deaths, connected to the premature depletion of batteries in certain implantable defibrillators, which are devices that can shock hearts back into rhythm. The allegations were raised in a whistleblower lawsuit filed by a patient who received one of the heart devices.
"Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration (FDA), and the U.S. government will not pay for devices that are unsafe and risk injury or death," Acting U.S. Attorney Jonathan F. Lenzner for the District of Maryland said in a news release."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."
A spokesperson for Illinois-based Abbott said : "This relates to a matter that took place prior to Abbott's acquisition of St. Jude Medical." St. Jude denies the allegations in the case. Abbott announced it would buy St. Jude Medical in April 2016. The deal closed Jan. 4, 2017.
The government alleged that St. Jude knew by 2013 that lithium clusters formed on the batteries of the devices, causing some to short and then suffer a premature power drain. When St. Jude asked the government to approve a change that would address the problem, the company told regulators that no serious injury, permanent harm or deaths had been reported associated with the issue, according to the government's allegations in the case.
"However, according to the government's allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with premature battery depletion (PBD) induced by lithium clusters," the Justice Department said in a news release. "St. Jude continued to distribute devices that had been manufactured without the new design."
"In August 2016, St. Jude contacted the FDA and informed it that the number of PBD events had increased to 729, including two deaths and 29 events associated with loss of pacing," the Justice Department said. "On Oct. 10, 2016, St. Jude issued a medical advisory regarding the PBD caused by lithium cluster shorts, which FDA classified as a Class I recall."
"After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between Nov. 20, 2014, and Oct. 10, 2016," the government said.
