St. Jude Medical, Alere Pay Combined $65M to Settle DOJ Claims They Knowingly Sold Defective Devices Fierce Biotech
The U.S. Department of Justice (DOJ) announced recently that two medical device makers had agreed to separate settlements after the government alleged they sold defective products for years, even after receiving reports of related injuries and deaths. St. Jude Medical agree to pay $27 million, and Alere said it would pay $38.75 million; however, neither company admitted wrongdoing. In the case of St. Jude Medical, which was acquired by Abbott in 2017, lithium clusters formed on the batteries on several models of its implantable defibrillators, putting the batteries at risk of shorting out and losing power. The DOJ alleged that St. Jude knew about the issue as early as 2013. In 2014, the company requested that the U.S. Food and Drug Administration (FDA) clear an update to the defibrillators that would resolve the battery problem, and it said the issue had not caused any serious injuries or deaths at that time. According to DOJ, St. Jude had already been informed about two injuries and one death associated with the lithium clusters.
In August 2016, the company reported more than 700 instances of premature battery depletion to the FDA, which were linked to two additional deaths, and by October, St. Judge had recalled the devices, with FDA labeling the recall as Class I, its most serious type of recall. Meanwhile, Alere allegedly sold its INRatio blood coagulation monitors for years after learning of a defect in the device's software that could provide inaccurate results for some individuals. DOJ said the company continued to sell the products for several more years without reporting the issue to patients or regulators. The defects reportedly were associated with more than 12 deaths and hundreds of injuries, including intra-cerebral hemorrhaging and cardiovascular events caused by major bleeding episodes. Alere took the products off the market in 2016, following a Class I recall requested by the FDA. Both cases, which were brought under the False Claims Act, arise from charges that, in continuing to sell the potentially dangerous products to healthcare facilities, where they were used for individuals enrolled in federal healthcare programs, the companies received government payments for products they knew had issues.
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