Alere Settles False Claims Suit for $33.2 Million
Massachusetts-based medical device manufacturer Alere and its subsidiary Alere San Diego agreed to pay more than $33 million to resolve False Claims Act allegations that Alere knowingly sold unreliable point-of-care diagnostic testing devices to hospitals.
According to lawyers for the Department of Justice, Alere sold the Triage testing devices between 2006 and 2012 despite customer complaints that the devices produced erroneous results. The devices were frequently used by emergency departments to conduct blood and urine tests to aid in the diagnosis of acute coronary syndromes, heart failure and drug overdose.
The DOJ contended that Alere knew some of its devices produced faulty results, adversely affecting clinical decision making and leading to unnecessary medical interventions.