Here are five insights.
1. The U.S. Justice Department accused Alere of selling its Triage point-of-care testing devices between January 2006 and March 2012 despite receiving customer complaints that some devices produced incorrect results for the diagnosis of acute coronary syndromes, heart failure and drug overdose.
2. The government alleges Alere failed to take proper corrective action until the FDA issued a nationwide product recall in 2012.
3. The federal government will receive $28,378,893 of the settlement, and $4,860,779 will be returned to individual states that jointly funded claims for Triage devices submitted to state Medicaid programs.
4. Amanda Wu, a former senior quality control analyst at Alere, filed the civil lawsuit and will receive about $5.6 million from the settlement.
5. “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 Stephen Schenning, Acting U.S. 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.”
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