Medical device maker, Alere Inc. will pay $33.2 million to settle a whistleblower lawsuit which asserts that the company knowingly sold materially unreliable point-of-care diagnostic testing devices to hospitals. Alere will pay the federal government $33.2 million, of which $4.8 million will be paid to the participating states. Arkansas is set to receive $140,611.56. Alere is accused of selling its Triage devices to hospitals, which are used in emergency departments for the diagnosis of acute coronary syndromes, heart failure, drug overdose and other serious conditions, from 2006 through 2012. Alere received multiple complaints from providers that “put it on notice that certain devices it sold produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making.” Despite those warnings, Alere failed to take corrective action until the Food and Drug Administration issued a national product recall in 2012. Because of this conduct, the states allege that between January 1, 2006 and June 12, 2012, Alere knowingly submitted or caused the submission of false or fraudulent claims for the Triage devices to be submitted to, or caused purchases by, Medicaid.
“Alere not only cost government Medicaid programs money, the company put patients’ lives at risk by selling devices that gave false readings, despite receiving complaints about the accuracy of the equipment,” said Attorney General Rutledge. “These acts are not acceptable and will not be tolerated as long as I am Attorney General of Arkansas. Patient safety should always be health care providers’ number one concern.”