July 8, 2021

Alere Inc. and Alere San Diego Inc. have agreed to pay nearly $39 million to settle allegations of knowingly selling defective blood coagulation monitors, which are used to determine safe dosages of anticoagulant drugs, to Medicare beneficiaries.  Too much anticoagulant could result in massive bleeding, while too little can result in blood clots and strokes.  By 2008, Alere had allegedly become aware of the fact that the software used in its INRatio monitors contained a material defect that caused some patients to see inaccurate results.  Although the company was also aware of dozens of deaths and hundreds of injuries associated with the devices, it failed to take them off the market and even continued to bill Medicare for them, in violation of the False Claims Act, until the FDA requested a Class I recall in 2016.  USAO NJ

Tagged in: Defective Products, FCA Federal, Healthcare Fraud, Medical Devices and DME, Medicare,