A Bad Fit: Qui Tam Actions and Off-Label Use Allegations

Over the past decade, there has been a rise in the number of whistleblower lawsuits filed under the federal False Claims Act in the health care arena. Companies which have allegedly marketed an approved drug product for a use that FDA has not approved have been a major target in a number of these cases. However, as explained in John R. Fleder’s recent article in FDLI Update , there has a clear trend by the courts to dismiss these actions. As a result, there is great doubt that persons filing these cases can ever muster the evidence necessary to bring such a case, let alone prevail.