{"id":43322,"date":"2021-07-08T16:25:33","date_gmt":"2021-07-08T23:25:33","guid":{"rendered":"https:\/\/cjnotebook.com\/?p=43322"},"modified":"2021-07-08T16:25:33","modified_gmt":"2021-07-08T23:25:33","slug":"st-jude-agrees-to-pay-27-million-for-allegedly-selling-defective-heart-devices","status":"publish","type":"post","link":"https:\/\/cjnotebook.com\/?p=43322","title":{"rendered":"St. Jude Agrees to Pay $27 Million for Allegedly Selling Defective Heart Devices"},"content":{"rendered":"

MARYLAND<\/strong><\/span><\/p>\n

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St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, it knowingly sold defective heart devices to health care facilities, according to authorities.<\/span><\/p>\n

\"\"<\/a><\/p>\n

The devices were implanted into patients insured by federal health care programs. St. Jude was acquired by Abbott Laboratories in January 2017, officials stated.<\/span><\/p>\n

\u201cTo 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,\u201d said Acting Assistant Attorney General Brian M. Boynton of the Justice Department\u2019s Civil Division. \u201cWe will hold accountable those companies whose conduct violates the law and puts patients\u2019 health at risk.\u201d<\/span><\/p>\n

\u201cMedical 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,\u201d said Acting U.S. Attorney Jonathan F. Lenzner for the District of Maryland. \u201cThe 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\u2019s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so strengthen patient safety.\u201d<\/span><\/p>\n

\"\"The government alleges that St. Jude failed to disclose serious adverse health events in connection with the premature depletion of the battery in certain models of its Fortify, Fortify Assura, Quadra and Unify devices, which are implantable defibrillators used in patients at risk of cardiac arrest due to an irregular heartbeat. <\/span><\/p>\n

The devices are surgically implanted into patients\u2019 chests, and when the devices detect an irregular heartbeat, they send an electrical pulse to the heart to \u201cshock\u201d it back to its normal rhythm. <\/span><\/p>\n

The government alleged 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.\u00a0<\/span><\/p>\n

\"shallow<\/a>The government alleges that, 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, \u201cno serious injury, permanent harm or deaths have been reported associated with this\u201d issue.<\/span><\/p>\n

However, according to the government\u2019s 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.<\/span><\/p>\n

St. Jude continued to distribute devices that had been manufactured without the new design.<\/span><\/p>\n

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. <\/span><\/p>\n

\"\"<\/a>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. <\/span><\/p>\n

A Class I recall is where there is a reasonable probability that \u201cviolative\u201d products \u201cwill cause serious adverse health consequences, including death.\u201d <\/span><\/p>\n

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.\u00a0<\/span><\/p>\n

\u201cEnsuring patient safety is our number one priority,\u201d 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). \u201cHHS-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.\u201d<\/span><\/p>\n

\u201cThe FDA regulates medical devices to assure that patient health is protected,\u201d said Special Agent in Charge Mark S. McCormack of the FDA Office of Criminal Investigations, Metro Washington Field Office. \u201cReporting information untruthfully to the agency about the safety of medical devices jeopardizes patients\u2019 health and safety. We will continue to investigate and bring to justice those who place the public health at risk.\u201d<\/span><\/p>\n

The civil settlement includes the resolution of claims brought under the\u00a0qui tam<\/em>\u00a0or whistleblower provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall. The\u00a0qui tam<\/em>\u00a0case is captioned\u00a0United States ex rel. Debbie Burke v. St. Jude Medical, Inc.<\/em>, No. 16-cv-3611 (D. Md.).<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

MARYLAND St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, it knowingly sold defective…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-43322","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"yoast_head":"\nSt. Jude Agrees to Pay $27 Million for Allegedly Selling Defective Heart Devices<\/title>\n<meta name=\"description\" content=\"MARYLAND St. Jude Medical Inc. 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