March 23, 2018
Massachusetts-based medical device manufacturer Alere Inc.
agreed to pay $33.2 million to resolve allegations that Alere violated the False Claims Act by causing hospitals to submit false claims to Medicare, Medicaid, and other federal healthcare programs by knowingly selling unreliable point-of-care diagnostic testing devices marketed under the trade name Triage. According to the government, 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. The allegations originated in a whistleblower lawsuit filed under the qui tam
provisions of the False Claims Act by Amanda Wu, who formerly worked for Alere as a senior quality control analyst. She will receive a whistleblower award of roughly $5.6 million from the proceeds of the government's recovery. DOJ