Hyman Phelps and McNamara
Developments in the Law

A Bad Fit: Qui Tam Actions and Off-Label Use Allegations
November 2008

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.

Click here to view the full FDLI Article

If you have any questions regarding the above information, please contact:
John R. Fleder (202) 737-4580 jfleder@hpm.com