The Qui Tam Blog

A federal judge in Brooklyn rejected a pharmaceutical sales representative’s defense of commercial free speech in responding to charges of criminal misbranding.   The Court found that the prohibition of off-label promotion of drugs is essential to maintaining the integrity of the FDA’s drug approval process,  The government used informants in investigating the case.   The case is United States v. Caronia, a court in Brooklyn, the Eastern District of N.Y.

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).

In a whistleblower cases against Caremark, Inc., a US District Judge in San Antonio, Texas, relying on a federal case in the Second Federal Circuit Court of Appeals, decided that the statute of limitations is not tolled for the government while it decides whether to intervene.  In other words, if the government takes several years to decide to join a case, it’s complaint in intervention does not relate back to the date of the original complaint filed by the whistleblower.  Why should the whistleblower and the government be penalized? The Court stated that the government should not have taken long to decide whether to intervene, and that Congress did not intend investigations to be protracted. The clear implication: several months is all that is required for a government investigation and evaluation. That is simply contrary to logic and Congressional intent. Congress did not impose any time limits on intervention.  Further, if a Court decides that the government has taken too long, it can deny further extensions of the seal. Do not penalize the whistleblower and the public. The message is clear. At least in the Western District of Texas, if the government is going to investigate and take several years, the whistleblower should implore the government to stay on the sidelines and not intervene.   The case is USA ex rel. Ramadoss v. Caremark, a court in the Western District of Texas, San Antonio.