Alere Settles Federal Complaint Over Testing Devices
Medical devicemaker Alere has agreed to pay $38.75 million to settle allegations that it sold defective rapid point-of-care testing devices.
The settlement resolves allegations that the company knowingly sold defective INRatio blood coagulation monitors that were used by Medicare beneficiaries taking anticoagulant drugs, such as warfarin.
The Department of Justice (DOJ) alleged that the company knew the software algorithm used in its INRatio monitors contained “a material defect.” Based on its own internal research, as well as external complaints, the company allegedly was aware that INRatio devices had a system limitation that “produced inaccurate and unreliable results for some patients,” the department said.
This resulted in more than a dozen deaths and hundreds of injuries, including intra-cerebral hemorrhaging and cardiovascular events following bleeding episodes, DOJ alleged.