Alere pays $33M to settle claim it knowingly sold unreliable devices

Alere is paying the U.S. $33.2 million to settle claims it knowingly sold unreliable point-of-care testing devices to emergency departments. The government alleges Alere continued to sell Triage devices in the years running up to a 2012 recall despite receiving reports of erroneous results.

Waltham, Massachusetts-based Alere recalled five products in its Triage range in 2012 in response to the reports of erroneous results. But the government sees that as a tardy response brought about by the findings of an FDA inspection. Alere is accused of failing to take corrective actions in response to reports of false results and of continuing to sell the Triage devices.

The false negatives and positives may have led patients with suspected heart failure, drug overdose, and other serious conditions to receive inappropriate clinical management. 

“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," Stephen Schenning, acting U.S. attorney for the District of Maryland, 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.”

That is what got the FDA involved in 2012. The financial settlement relates to the business side of Alere’s actions. The government alleges Alere’s Triage sales to Medicare, Medicaid, and other federal healthcare programs from January 2006 to March 2012 amount to false claims as it was “knowingly selling materially unreliable point-of-care diagnostic testing devices.”

To settle the allegations, Alere has agreed to pay $33.2 million. Around $28 million of the settlement will go to the federal government, with the remainder returning to individual U.S. states that jointly funded Medicaid Triage claims. Amanda Wu, an Alere senior quality analyst turned whistleblower, is receiving $5.6 million. Alere settled without admitting liability.

As reported by FierceMedTech 

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