USA – A news report on kstp.com states that St. Jude Medical, Inc., will pay $27 million to settle accusations made under the U. S. False Claims Act. The U.S. Department of Justice filed a lawsuit against St. Jude Medical, Inc., alleging the medical device manufacturer deliberately sold defective heart devices to medical care facilities from November 2014 to October 2016. The health care professionals at the medical facilities implanted the defective heart devices into patients insured by federal health programs.
Acting U.S. Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division stated that the lawsuit helps ensure the safety and of patients, and implantable cardiac device manufacturers must be transparent when corresponding with the U. S. government about safety concerns and incidents. Attorney Boynton also stated that the Attorney General’s Office would hold accountable those companies whose conduct violates the law and puts patients’ health at risk.”
The U.S. Department of Justice alleges that St. Jude failed to disclose severe adverse health issues concerning “depletion of battery” issues in certain models of its Fortify Assura, Fortify, Quadra, and Unify heart devices which are implantable defibrillators. Implantable defibrillators are placed in patients who have an irregular heartbeat that increases their risk of suffering cardiac arrest. According to the U.S. Department of Justice, these cardiac defibrillators are implanted into the patients’ chests, and if the devices detect an irregular heartbeat, the devices send an electrical pulse to the heart. The electrical pulse “shocks” the patient’s heart back into normal rhythm.
The government complaint alleged that St. Jude Medical was aware of the defect back in 2013. The problem concerning the devices is that lithium clusters formed on the batteries inside the devices. These lithium clusters would cause the affected batteries to “short,” causing the batteries to drain their power prematurely.
The U.S. Department of Justice also alleges that back in 2014, St. Jude Medical petitioned the FDA to approve a modification that prevents lithium clusters from draining the defibrillator batteries. At that time, St. Jude Medical informed the FDA that “no serious injury, permanent harm or deaths have been reported associated with this” issue. According to the government’s assertions, St. Jude Medical was knowledgeable of two serious injuries and one death connected to the premature battery depletion (PBD) issue caused by lithium clusters.
St. Jude Medical then continued to market the implantable cardiac defibrillators as if the devices had been manufactured without the new design changes. The U.S. Department of Justice also stated that back in August 2016, St. Jude notified the FDA that the number of premature battery depletion events had risen to 729 cases, including 29 events connected with “loss of pacing” and two deaths. Approximately two months later, St. Jude Medical issued a voluntary recall on the devices. At this point, thousands of their implantable defibrillator devices had been inserted into patients from November 20, 2014, to October 10, 2016.
Maureen R. Dixon, Special Agent in Charge with the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG), stated that her agency’s number one priority is patient safety. Ms. Dixon stated that the HHS-OIG will work with law enforcement to investigate and hold medical companies accountable when they put profits over people. and ensure the integrity of the Medicare and Medicaid programs.”
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