The United States Department of Justice announced that Alere Inc. and its subsidiary, Alere San Diego, reached a settlement agreement with the United States government for $33.2 million over allegations that Alere had violated the False Claims Act. According to Healthcare Finance, the settlement did not include any admission of actual liability on Alere’s part.
The False Claims Act was passed “to protect taxpayer dollars from fraud and abuse and to allow private citizens to join the effort,” according to Maureen R. Dixon, Special Agent in Charge for the U.S. Department of Health and Human Services Office of Inspector General in Philadelphia. The lawsuit alleged that, between January 2006 and March 2012, 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 under the trade name Triage®.
According to a press release, the devices, which were generally used in time-sensitive emergency room settings, produced erroneous results and had the potential to create false positives and false negatives. Alere allegedly became aware of the erroneous results through customer complaints but failed to take appropriate action until the Food and Drug Administration prompted a product recall in 2012.
As a result of the settlement, the federal government will receive $28,378,893, and individual states will receive $4,860,779. Amanda Wu, a former senior quality control analyst for Alere, filed the current lawsuit on behalf of the United States under the whistle blower provision of the False Claims Act and will receive approximately $5.6 million, per the provisions of the False Claims Act.