Walter Eisner • Fri, January 16th, 2015
If a device manufacturer is accused of lying to the FDA about complying with their regulations and then asks Medicare for reimbursement, a whistleblower is likely to sue the manufacturer under the False Claims Act (FCA). If the whistleblower makes a good case, the government is likely to join in.
That’s been the basis of many lawsuits, including lawsuits against soon-to-be-Irish-based Medtronic plc and its Infuse product. In that case the whistleblowers say the company cooked the scientific evidence books by paying physicians to say things about the product that weren’t true, and then asking for reimbursement. Even a private insurer jumped on that bandwagon and sued the company. The company vehemently denies the accusations.
But according to John Fleder, writing on the FDA Law Blog on January 14, 2015, that could all change soon. On January 7, 2015, a judge in California issued a decision, that Fleder says, “May put to rest plaintiffs’ efforts to use the FDC (Food, Drug and Cosmetic) Act to support an FCA case.”
Campie v Gilead Sciences, Inc.
Here is what happened.