Medical device manufacturers Alere Inc. and Alere San Diego Inc. (collectively, Alere) have agreed to pay $38.75 million to resolve allegations that the companies violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices.
The settlement announced today resolves allegations that, from 2008 to 2016, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries taking anticoagulant drugs, such as warfarin. For those patients, blood coagulation monitoring is essential to determining a clinically appropriate and safe dosage for their medications. Too much of an anticoagulant drug can cause major bleeding, and too little of the drug can cause blood clots and strokes.
Since at least 2008, Alere allegedly knew that the software algorithm used in each version of its INRatio monitors contained a material defect. Based on its own internal research, as well as external complaints and warnings, Alere allegedly was aware that INRatio devices had a “system limitation” that produced inaccurate and unreliable results for some patients. The United States alleged that, despite awareness that INRatio systems were linked to over a dozen deaths and hundreds of injuries, including intra-cerebral hemorrhaging and cardiovascular events following bleeding episodes, Alere concealed the defect for years and billed Medicare for the use of defective INRatio devices. Alere allegedly failed to take appropriate corrective actions until 2016, when the devices were removed from the market following a nationwide Class I product recall undertaken at the request of the U.S. Food and Drug Administration (FDA).