Off Label Promotion

WJA handles numerous cases from employees in the pharmaceutical and medical device industry, as well as claims by physicians, lab technicians and nurses.

It is illegal for pharmaceutical or medical device companies to promote their products for uses not approved by the Food and Drug Administration (FDA). It is also illegal for corporations to market drugs for off-label indications. This may include a medical device which is approved by the FDA for some procedures or body parts, but not others. For example, a medical device salesman cannot promote a sale of an artery wire that is approved by the FDA for leg artery but not for the heart artery for heart surgeons to use in heart artery procedures.

Knowing some of the forms that off-label promotion can take can make it easier to recognize this unlawful practice. Most common examples include paying incentives to sales representatives for making sales of off-label devices or drugs and paying kickbacks to doctors to prescribe drugs or use medical devices for off-label use. Off label promotion may take many forms. For example, a medical device company may not ask sales-representatives to market an off-label device to doctors for a certain procedure not approved by the FDA. A careful review by a WJA attorney may help you understand whether your company is violating off-label or kickback laws.

The most critical component, however, is for you to draft a well-articulated complaint to either a government agency or your employer, explaining how the company practices violate FDA, kickback or off-label laws. Under California law – you do not need to specify a particular law or the statute, as long as it is clear that you are complaining about an illegal conduct. You are also not required to be 100% accurate whether the company is in fact violating the law. If you reasonably believe this is the case, then it is sufficient. If you are terminated or have significant negative changes in your employment after your complaint, you may have a case for whistleblower retaliation. It is critical that you consult with a WJA whistleblower attorney to assist you with your case.