Whistleblowers Beware: Pleading with High Level of Specificity Required in 11th Circuit

In a whistleblower case, a Magistrate Judge, following the law from the Eleventh Federal Circuit Court of Appeals, decided that in order for a whistleblower to properly plead a qui tam case, he must plead with particularity the actual submission of false or fraudulent claims to the government. In other words, it was not enough for the whistleblower to allege that there were illegal off-label marketing campaigns causing the submission of hundreds of thousands of false claims for prescriptions. The whistleblower was also required to include specific allegations of an actual false claim that was submitted to the government. The obvious inference was insufficient. The message from the 11th Circuit Court is simple. If you are going to prevail in our circuit, you must be prepared to have as clients or witnesses everyone in the chain of alleged misconduct, especially people in the billing department to prove that the time and effort devoted toward a scheme culminated in an actual billing. The message is clear.  Do not file off-label marketing cases in this federal circuit, or for that matter any other claims that require specific billing information.  The case is USA ex rel. Hopper v. Solvay Pharmaceuticals, a court in the Middle District of Florida (Tampa).

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