Massachusetts-based medical device manufacturer Alere and its subsidiary Alere San Diego have agreed to pay the federal government $33.2 million to resolve allegations that Alere's faulty diagnostic devices misinformed clinicians and led to unnecessary medical care.
The Justice Department claims were that from 2006 to 2012, Alere, which was acquired by Abbott Laboratories last year, sold its Triage-branded devices to hospitals despite customer complaints warning of erroneous results. The devices were used in emergency departments to diagnose acute coronary syndromes, heart failure, drug overdoses and other serious conditions.
Alere allegedly didn't heed the warnings until U.S. Food and Drug Administration inspections prompted a nationwide product recall in 2012, the Justice Department said.
Of the $33.2 million to be paid by Alere for the alleged violation of the False Claims Act, about $28.4 million will be returned to the federal government and nearly $4.9 million will be returned to individual states that jointly funded claims for Triage devices submitted to state Medicaid programs.
Alere executives did not immediately return a request for comment.
"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," Stephen Schenning, acting attorney for the District of Maryland, said in a statement.
The lawsuit was filed by Amanda Wu, who formerly worked for Alere as a senior quality control analyst and will receive approximately $5.6 million.