Catch of the Week: Medical Device Companies to Pay $38.75M Over Defective Coagulation Monitor Allegations Linked to Patient Deaths, Injuries
Medical device manufacturers Alere Inc. and Alere San Diego Inc. will pay nearly $40 million to resolve allegations that they knowingly sold defective blood coagulation monitors used by Medicare beneficiaries and falsely billed Medicare for the devices. The monitors are supposed to ensure that patients taking anticoagulant drugs receive a safe dosage to avoid life-threatening consequences from too much or too little medication, including major bleeding, blood clotting, and strokes. Alere’s InRatio devices allegedly used software algorithms that produced inaccurate and unreliable readings for some patients. The Justice Department accused Alere of concealing the dangerous, and sometimes deadly, defect for years, resulting in a False Claims Act settlement announced yesterday.
Devices Linked to Over a Dozen Deaths, Hundreds of Injuries
According to the United States, Alere continued to sell its InRatio devices and hide the defect long after it discovered the monitors had been linked to numerous deaths and injuries. The company allegedly knew InRatio devices produced inaccurate readings since at least 2008 but failed to remove them from the market until 2016, after the FDA requested a product recall. Prior to the recall, Alere received external warnings and complaints and conducted its own internal research but was not forthcoming with the FDA, the government said.
In a press release announcing the settlement, the government vowed to fight healthcare fraud schemes that place patients at risk. “Medical device providers who cut corners or purposefully market defective tools put profit above patient health,” said FBI Special Agent in Charge George M. Crouch Jr. “The FBI will not sit idly by when people’s lives are at risk.”
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