Ruling could prevent whistleblower suits

Things may have just gotten tougher for potential pharma whistleblowers. Last Friday, the U.S. Court of Appeals for the Eleventh Circuit in Atlanta upheld a lower court's dismissal of a whistleblower case filed against Solvay Pharmaceuticals in 2004 by two former sales reps.

The reps say Solvay enacted a sophisticated off-label marketing plan to get doctors to prescribe Marinol, a drug that treats the side effects of chemotherapy, for unapproved uses. That, they claimed, "caused submission for reimbursement by Government Healthcare Programs of millions of dollars worth of prescriptions which were ineligible for such reimbursement," according to the filing. Secondly, the plaintiffs claim Solvay gave kickbacks to physicians and other healthcare providers to induce them to prescribe Marinol for off-label purposes.

The Court of Appeals ruled that the sales reps' claims did not meet False Claims Act rule 9b, which states that if a whistleblower accuses a company of submitting false claims for government payment, he or she must provide specific, detailed information about the incidents. "The complaint does not allege the existence of a single actual false claim," the Court observed in the ruling. "In fact, we are unable to discern from the complaint a specific person or entity that is alleged to have presented a claim of any kind, let alone a false or fraudulent claim."

As Pharmalot observes, in order to get that information, a sales rep would need to get from other parts of the company. That could be difficult to do, and without it a suit can succeed.

- see Pharmalot's blog entry
- check out the court ruling (.pdf)