St. Jude Medical, Inc. reached a settlement agreement to pay $27 million in a government case that alleged the company knowingly sold defective heart devices to healthcare facilities between November 2014 and October 2016. These devices were implanted in patients who were insured by federal healthcare programs.
The case states that the company did not disclose serious adverse health events related to premature battery depletion of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators. These devices were used in patients at risk of cardiac arrest as a result of an irregular heartbeat. The government stated that St. Jude was aware that lithium clusters formed on the batteries, which resulted in the battery draining too early, by 2013.
“The government alleges that, in late 2014, St. Jude submitted a request to the Food and Drug Administration (FDA) to approve a change to prevent lithium clusters from draining the battery, and told the FDA, ‘no serious injury, permanent harm or deaths have been reported associated with this’ issue,” states a U.S. Department of Justice (DOJ) release. “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 DOJ also states that St. Jude Medical continued to distribute devices that were produced without the above-mentioned design change.
“The FDA regulates medical devices to assure that patient health is protected. Reporting information untruthfully to the agency about the safety of medical devices jeopardizes patients’ health and safety,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office. “We will continue to investigate and bring to justice those who place the public health at risk.”
Additional information about the case can be found on the DOJ website.