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DOJ: Alere Inc. knowingly sold unreliable diagnostic devices

A former Alere Inc. employee who blew the whistle on the medical device manufacturer will receive approximately $5.6 million as a reward. The former senior quality control analyst exposed millions of dollars in false claims against Medicare, Medicaid and other federal healthcare programs.

According to the Department of Justice, Alere Inc. and its subsidiary Alere San Diego have agreed to settle a False Claims Act lawsuit for $33.2 million. $28,378,893 of that total will be returned to the federal government, while $4,860,779 will be returned to various state Medicaid programs.

The allegations involve Alere's Triage brand diagnostic devices. These devices were meant to aid in the timely diagnosis of serious medical conditions in an emergency room setting. They gave information supposedly allowing quick diagnosis of heart failure, acute coronary syndromes, drug overdoses and other conditions.

According to the government, customers notified Alere that the devices created both false positives and false negatives, which adversely affected clinical decision making. Although aware of the problem, the government says, the company failed to take corrective action. Between January 2006 and March 2012, the government says, Alere knowingly continued to sell the unreliable devices. Ultimately, Food and Drug Administration inspections discovered the problem. That discovery prompted a nationwide recall of the Triage devices in 2012.

"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 the 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."

"Congress passed the False Claims Act on March 2, 1863 to protect taxpayer dollars from fraud and abuse and to allow private citizens to join the effort," said a special agent in charge for the U.S. Department of Health and Human Services Office of Inspector General in Philadelphia.

Indeed, the government relies on private citizens blowing the whistle on waste, fraud and abuse. If you work for an organization that provides services to the government, you may be in a position to help -- and you could be eligible for a substantial reward.

Before you blow the whistle, however, it's best to have your facts in order and a plan in place. We recommend working closely with a lawyer experienced in whistleblower law.

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