Medical device manufacturer Alere on Thursday agreed to pay the Justice Department $38.75 million to settle allegations that it knowingly sold defective blood monitoring test strips to Medicare beneficiaries.
Alere and its subsidiary Alere San Diego allegedly failed to inform the Food and Drug Administration, patients and providers of issues with its INRatio blood coagulation monitor’s test results. Many consumers billed Medicare to purchase the strips, which violates the False Claims Act.
“Medical device providers who cut corners or purposefully market defective tools put profit above patient health,” said George M. Crouch Jr., special agent in charge at the Federal Bureau of Investigations.
The FBI investigated the company for fraud following repeated warnings from Alere employees that the device was defective.
Patients, providers and insurers were not aware of any defects in the product, which remained on the market through 2016.
“In some cases (INRatio’s defect) has led to patient harm,” Alere said in the settlement brief.
The device has been linked to dozens of deaths and hundreds of injuries, including gastrointestinal bleeding and intracerebral hemorrhaging.
Alere initiated an investigation into the discrepancies in March 2008. The developer of the strips found INRatio’s algorithm couldn’t determine how long it takes blood to clot in certain patients, although the device is designed to monitor blood clotting in patients prescribed anticoagulants.
The device issues affected providers’ ability to prescribe appropriate anticoagulant doses to patients. Alere didn’t identify a solution nor alter the product, the settlement said.
Alere told the FDA that its internal investigation didn’t find any deficiencies with INRatio, according to the settlement. The company did not admit guilt as part of the deal.