Off-Label Marketing

Drug and medical device company marketing is governed by many laws and regulations. Drugs and medical devices are generally approved by the U.S. Food and Drug Administration for specific uses based on a rigorous analysis of clinical data regarding the safety and efficacy of the drug or device for those specific uses. Companies are generally forbidden from marketing their drugs and devices for uses other than those specifically approved by the FDA. This is because the efficacy and safety of the drug or device has not been properly tested for the unapproved use.

Drug and medical device companies nevertheless often violate these laws and market their products to physicians for unapproved and unproven uses, putting the health and safety of patients at risk. The U.S. Department of Justice and Department of Health and Human Services have aggressively prosecuted off-label marketing violations against drug and medical device companies, obtaining billions of dollars in recoveries since 2004. Whistleblowers were responsible for the majority of these prosecutions. There are, however, many nuances to off-label marketing cases, which have been complicated by some recent case law. So if you have evidence of off-label marketing it is essential to speak to a qualified whistleblower attorney.