Alere Settles Case About Point-of-Care Diagnostic Devices

According to the government's allegations, Alere received customer complaints 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, but the company failed to take appropriate corrective actions until FDA inspections prompted a nationwide product recall in 2012.

Alere, a Waltham, Massa.-based medical device manufacturer, and its subsidiary Alere San Diego have agreed to pay the United States $33.2 million to resolve allegations that Alere caused hospitals to submit false claims to Medicare, Medicaid, and other federal health care programs by knowingly selling materially unreliable point-of-care diagnostic testing devices, the Justice Department announced March 23.

"The United States is fortunate that innovative health care companies regularly develop medical devices that improve patients' lives, often in remarkable ways," said Chad A. Readler, acting assistant attorney general for the Justice Department's Civil Division. "But the department will hold medical device manufacturers accountable if they knowingly sell defective products that waste taxpayer dollars and adversely impact patient care."

The United States alleged that between January 2006 and March 2012, Alere knowingly sold materially unreliable rapid point-of-care testing devices marketed under the trade name Triage® for use in the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious conditions, and the devices were frequently used in emergency departments. According to the government's allegations, Alere received customer complaints 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, but the company failed to take appropriate corrective actions until FDA inspections prompted a nationwide product recall in 2012.

Of the $33.2 million to be paid by Alere, $28,378,893 will be returned to the federal government and a total of $4,860,779 will be returned to individual states, which jointly funded claims for Triage devices submitted to state Medicaid programs. The settlement with Alere resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and share in the government’s recovery. The civil lawsuit was filed by Amanda Wu, who formerly worked for Alere as a senior quality control analyst; she will receive approximately $5.6 million.

"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 U.S. 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."

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