A new court ruling may have a significant impact on whisteblower lawsuits that focus on off-label marketing. Last Friday, the US Court of Appeals for the Eleventh Circuit in Atlanta upheld a dismissal of a 2004 lawsuit filed by two Solvay Pharmaceuticals sales reps, who alleged the drugmaker caused the federal government to overpay by promoting off-label use of itsMarinol treatment for chemotherapy patients ( background).
Specifically, the court ruled the reps' lawsuit was lacking because they failed to offer specific examples showing Solvay actually caused the federal government's Medicaid program to overpay by millions of dollars based on an alleged off-label marketing. Instead, the reps argued there was an obvious increase in Marinol scrips and a subsequent rise in federal government payments for the drug (here is the ruling).
At issue was the need to clear a legal hurdle known as rule 9b, a controversial provision of the False Claims Act, which requires a whistleblower to provide specific info about false claims submitted to the government for payment. The level of detail might include amounts charged, drugs prescribed, patient diagnosis and individuals involved in billing. The bottom line: sales reps filing whistleblower suits will likely be required to gain access to info from other parts of their company to succeed.