Triage, a medical device used to diagnose heart issues, didn't work -- and its maker, Alere, charged with selling it anyway, just settled with the U.S. Department of Justice for $33.2 million.
A diagnostic tool for myocardial infarction, congestive heart failure, heart failure, acute coronary syndrome and other cardiac conditions, Traige was discovered to be defective by FDA investigators in 2012 and recalled.
Former Alere senior quality control analyst Amanda Wu brought a whistleblower suit charging Alere under the False Claims Act with "knowingly selling materially unreliable point-of-care diagnostic testing devices" from 2006 to 2012. During that time "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," DOJ reports in a press release. Wu's suit was joined by the U.S. Justice Department. Her cut of the take as a qui tam relator will be about $5.6 million.
“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 M. Schenning, Acting U.S. Attorney for the District of Maryland, where the case had been filed. "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.”
Speaking of which: If you're wondering what to do if a patient comes into your practice claiming you treated them with a defective medical device such as an implant, here's a Part B News story on how to handle the situation.