Photo: AP/ Jose Luis Magan.
Photo: AP/ Jose Luis Magan.
Updated: July 09, 2021 01:22 PM
Created: July 09, 2021 12:51 PM
On Thursday, St. Jude Medical, Inc., has agreed to pay $27 million to settle allegations under the False Claims Act that the company knowingly sold defective heart devices to health care facilities between November 2014 and October 2016, according to the U.S. Department of Justice.
Workers at the health care facilities then implanted the devices into patients insured by federal health programs.
"To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents," said Acting U.S. Assistant Attorney General Brian M. Boynton of the Justice Department's Civil Division. "We will hold accountable those companies whose conduct violates the law and puts patients' health at risk."
The government alleges that St. Jude failed to disclose serious adverse health events in connection with the premature depletion of battery in certain models of its Fortify, Fortify Assura, Quadra and Unify devices, which are implantable defibrillators used in patients at a risk of cardiac arrest due to an irregular heartbeat. According to the DOJ, the devices are surgically implanted into patients' chests, and when the devices detect an irregular heartbeat, they send an electrical pulse to the heart to "shock" it back to its normal rhythm.
The government alleged by 2013, St. Jude knew that lithium clusters formed on the batteries of the devices, causing some batteries to short and, in turn, suffer a premature power drain.
In late 2014, 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, the DOJ alleges. 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.
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. About two months later, St. Jude issued a recall on the devices, making it so they were no longer sold. However, thousands of the devices had been implanted into patients between Nov. 20, 2014 and Oct. 10, 2016.
"Ensuring patient safety is our number one priority," said Special Agent in Charge Maureen R. Dixon of the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG). "HHS-OIG will continue to work with our law enforcement partners to investigate and hold accountable medical companies who put profits over people and ensure the integrity of the Medicare and Medicaid programs."
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