Alere, a medical device company acquired by Abbott in 2017, has agreed to pay $38.75 million to resolve allegations that it knowingly billed Medicare for defective testing devices, the U.S. Justice Department said July 8.
Alere allegedly knowingly sold defective blood coagulation monitors from 2008 to 2016. The monitors were used by Medicare beneficiaries taking anticoagulant drugs. Blood monitoring devices are essential for patients taking anticoagulants to determine safe dosages of the drugs, the Justice Department said. Taking too much of an anticoagulant drug can cause major bleeding, and taking too little can cause blood clots and strokes.
Alere allegedly knew that the software algorithm used in each version of the test contained a defect. Based on its own internal research and external complaints and warnings, Alere was allegedly aware that the devices had a "system limitation" that produced inaccurate and unreliable results for some patients.
Despite knowing that the devices were linked to more than a dozen deaths and hundreds of injuries, including intracerebral hemorrhaging and cardiovascular events following bleeding episodes, the U.S. alleged that Alere concealed the defect for years and billed Medicare for the use of the devices.
Alere allegedly failed to take corrective actions until 2016, when the FDA requested the company recall the devices.
Read the Justice Department's full news release here.