Qui Tam lawsuits are what we also refer to as whistleblower suits, whereby a private individual assists the government with the prosecution of illegal activities and can receive all or part of any penalty imposed.

In healthcare, these usually involve False Claims Act (FCA) allegations directly against a provider. But the provider is not always at the center of these types of Qui Tam suits. One of the longest running Qui Tam cases that still lurks in the federal court system, initially filed in 2003 against a pharmaceutical company is United States ex rel. King v. Solvay Pharmaceuticals, Inc.

In this case, two former Solvay employees alleged that Solvay had been engaging in misleading marketing ploys to encourage providers to prescribe their drugs for off-label use. Off-label use means that the FDA has not approved the drug for a prescribed diagnosis, and submission of a claim for this drug would violate the FCA. Solvay spent millions to promote these drugs for off-label uses. Salespersons visited doctors, urging them to consider Solvay’s drugs for off-label indications. Solvay also paid physicians to attend lavish dinners and speaker events about its drugs, and paid physicians who prescribed its drugs, which in turn could implicate the Anti-Kickback Statute (AKS). The final outcome of this case is still pending as there have been a series of appeals that are still ongoing.

Are providers insulated in these type of cases where inducement is involved? Not so much. Of particular significance is that providers have a responsibility in the pharma-physician relationship to recognize when they are at risk of a violation of the AKS. A Qui Tam case against a manufacturer could give rise to an FCA action, placing the provider front and center under the microscope.

For more information on Qui Tam or whistleblower situations, please contact Linda Mancini at 781-272-8001.