NEW YORK (360Dx) – Abbott-owned company Alere and its subsidiary Alere San Diego will pay the US $33.2 million to settle allegations that it caused hospitals to submit false claims to federal healthcare programs by knowingly selling unreliable point-of-care diagnostic testing devices, the US Department of Justice announced on Friday.
The US had alleged that between January 2006 and March 2012, Alere sold rapid POC testing devices marketed under the brand name Triage. The devices were used to diagnose acute coronary syndromes, heart failure, drug overdose, and other conditions. Alere received customer complaints that the devices produced incorrect results, including false negative and false positive results, potentially putting patients at risk. The company, however, did not take proper corrective actions until inspections by the US Food and Drug Administration prompted a nationwide recall in 2012, the DOJ said.
"Physicians who work to treat patients with suspected myocardial infarctions rely upon devices such as Alere's Triage Cardiac products for quick and accurate readings," Acting US Attorney General for the District of Maryland Stephen Schenning said in a statement. "When manufacturers such as Alere make changes to the specifications that affect the product's reliability without informing physicians or the FDA, patient care is put at substantial risk."
The settlement deal resolves a whistleblower lawsuit filed by Amanda Wu, who was a senior quality control analyst at Alere. She will receive about $5.6 million as part of the settlement. Of the $33.2 million to be paid by Alere, more than $28 million will be returned to the federal government, which oversees the Medicare program, and almost $4 million will be returned to individual states, which jointly funded claims for Triage devices submitted to state Medicaid claims.