Using drugs in ways not approved by the U.S. Food & drug Administration (“FDA”) is called “off-label” use. Although it is generally legal for a doctor to prescribe a drug for an off-label use, it is illegal for drug manufacturers to promote off-label uses. Nevertheless, pharmaceutical companies have a stake in marketing off-label drug use, because off-label use means larger revenues from larger populations. Consequently, drug companies often covertly market drugs for off-label uses through schemes, such as decoy indications and kickbacks to physicians.

Under the federal False Claims Act, civil lawsuits may be brought by private individuals referred to as relators (i.e., “whistleblowers”) against drug companies that illegally market drugs for off-label uses. These lawsuits are called qui tam actions, and although they are brought to recover damages for the government, whistleblowers are allowed to keep between 15-30% of the damages recovered. The purpose of the qui tam provisions of the False Claims Act is to encourage private individuals who are aware of pharmaceutical off-label marketing fraud and other fraudulent activities being perpetrated against the government to bring such information forward.

Off-Label Whistleblower Lawsuit Recoveries

Whistleblowers have achieved huge recoveries on the government’s behalf in qui tam lawsuits brought against drug companies for off-label marketing. For example, in September 2008, four whistleblowers who brought off-label suits against drug manufacturer Cephalon were awarded $46.4 million to share in a global settlement. The whistleblower lawsuits accused Cephalon of marketing three of its drugs – Actiq, Gabitril and Provigil – for uses other than what the FDA had approved.

The four whistleblowers involved in the lawsuits included three former Cephalon representatives who said they were disturbed by Cephalon’s off-label marketing practices. All together, Cephalon agreed to pay $475 million in civil and criminal penalties to settle the off-label whistleblower lawsuits. Cephalon was also convicted of a misdemeanor.

Off-Label Drug Marketing Whistleblower Attorney

Our attorneys provide experienced legal representation to whistleblowers with information about off-label marketing by a drug company, pharmaceutical kickbacks, or other pharmaceutical fraud under the qui tam provisions of the False Claims Act. Contact us today for a free and confidential case evaluation.

Published November 17, 2011 by