Alere pays $33.2 million for false claims caused by defective diagnostic equipments

by Ben Vernia | April 3rd, 2018

On March 22, the Department of Justice announced that Massachusetts-based diagnostic equipment company Alere, Inc., had agreed to pay $33.2 million to settle allegations, originally brought by a whistleblower, that the company’s faulty diagnostic equipment led health care providers to submit false claims to federal healthcare programs. According to DOJ’s press release:

Massachusetts-based medical device manufacturer Alere Inc. and its subsidiary Alere San Diego (Alere) 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 healthcare programs by knowingly selling materially unreliable point-of-care diagnostic testing devices, the Justice Department announced today.

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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®.  The Triage® devices aided in the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious conditions, and the devices were frequently used in emergency departments where timely decisions are critical to ensuring proper patient care.  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.  Nonetheless, 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.

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The government announced that the whistleblower will receive $5.6 million (19.7% of the federal share of the settlement).

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