Prosecutors claim that Alere continued to sell its Triage cardiac and drug test kids even as providers made it known that the device was faulty. The FDA recalled Triage in 2012.
Medical device maker Alere Inc. will pay the federal government $33.2 million to settle False Claims Act allegations that it knowingly sold “materially unreliable point-of-care diagnostic testing devices" to hospitals, the Department of Justice said.
Federal prosecutors allege that, from 2006 through 2012, Alere sold hospitals its Triage devices, which are used in emergency departments for the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious condition.
Alere continued to sell the product, prosecutors said, even as it 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, prosecutors said Alere failed to take corrective action until the Food and Drug Administration issued a national product recall in 2012.
Of the $33.2 million paid by Alere, $28.3 million will be returned to Medicare, and $4.8 million will be returned to states that paid for Triage devices with Medicaid.
HealthLeaders Media's requests for comment from Alere were not immediately returned on Friday afternoon.
"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," said Stephen M. Schenning, Acting United States Attorney for the District of Maryland.
"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," he said.
The settlement resolves a whistleblower lawsuit brought forward by Amanda Wu, a former senior quality analyst at Alere, who will receive $5.6 million of the settlement.
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.