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Robert B. Vogel, MD, JD
Retinal Ophthalmologist at Piedmont Eye Center, Lynchburg VA;
Attorney, Overbey Hawkins & Wright, PLLS, Lynchburg, VA;
Adjunct Professor, Humanities and Bioethics, Liberty University School of Medicine, Lynchburg, VA.
The medical device company Alere Inc. will pay the United States $33.2 million to resolve allegations brought against it under the federal False Claims Act (FCA). The complaint alleged that Alere knowingly submitted false claims to federal and state healthcare programs for unreliable point-of-care diagnostic testing devices, according to a U.S. Justice Department press release.
Alere marketed Triage, a point-of–care device intended to help emergency staff rapidly diagnose acute coronary syndromes (heart attacks), heart failure, drug overdose, and other emergency conditions. Alere allegedly had been put on notice by customer complaints that the devices produced erroneous results. This took the form of both false positive and false negative errors that had the potential to adversely affect clinical decision-making.
Alere failed to take corrective action until Food and Drug Administration (FDA) inspections revealed the high error rate, according to the Justice Department statement. There was a nationwide product recall in 2012. The FCA allegations spanned from January 2006 to March 2012.
The FCA case was filed in San Diego against Alere subsidiary Alere San Diego. Amanda Wu, a former senior quality control analyst at Alere, filed the case as a whistleblower. She will receive $5.6 million as part of the resolution.
Of the $33.2 million to be paid by Alere, approximately $28 million will go to the United States and $4 million will be returned to individual states whose Medicaid programs paid claims for the Triage device.
The claims resolved by this settlement are allegations only, and there has been no determination of liability. The Abbott Company bought Alere after these FCA allegations were settled; at press time, no mention of the FCA allegations or this settlement were found on its website.
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