(WFRV) – St. Jude Medical Inc. is paying over $20 million to settle allegations that it knowingly sold defective heart devices to health care facilities that, in turn, implanted the devices into patients insured by federal health care programs.
The United States Department of Justice announced on July 8, that between November 2014 and October 2016, St. Jude allegedly failed to disclose serious adverse health impacts in connection with certain models of its Fortify, Fortify Assura, Quadra, and Unify 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,” said Acting U.S. Attorney Jonathan F. Lenzner for the District of Maryland. “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. The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so strengthen patient safety.”
The heart devices, which are surgically implanted into patients’ chests and are used to send an electrical pulse to the heart to “shock” it back to its normal rhythm when the devices detect an irregular heartbeat. However, the government alleges that, by 2013, St. Jude knew that lithium clusters formed on the batteries of the devices, causing some of the batteries to short and, in turn, suffer a premature power drain preventing them from regulating the heartbeat.
In late 2014, the government alleges that St. Jude submitted a request to the 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. 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.
While fully aware of the defect in the heart devices, the government reports St. Jude continued to distribute devices that had been manufactured without the new design. In August 2016, St. Jude reportedly 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, according to the U.S. Department of Justice.
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. A Class I recall is where there is a reasonable probability that “violative” products “will cause serious adverse health consequences, including death.” After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 20, 2014, and October 10, 2016.
“The Defense Criminal Investigative Service (DCIS) and its law enforcement partners will aggressively investigate fraud that puts the health of our military members and their families at risk,” said Special Agent in Charge Christopher W. Dillard of the DCIS Mid-Atlantic Field Office. “We hope this settlement sends a clear warning to medical corporations that choose profit over patient care.”