U.S. Court of Appeals Ruling Protects Marketing of Off-Label Uses of Pharmaceuticals

The Food and Drug Administration (FDA) has consistently warned of the dangers of using pharmaceuticals for off-label purposes. Using a drug for off-label purposes means using it for purposes for which it has not specifically been approved by the FDA. Unfortunately, however, off-label use of drugs still accounts for 80% of prescriptions of antipsychotic drugs in nursing homes. Recently, there have been several lawsuits questioning the legality of pharmaceutical companies marketing their drugs for off-label uses.

Just recently, pharmaceutical sales representative Alfred Caronia was charged with promoting a drug for off-label purposes. Caronia argued that the FDA’s regulations prohibiting of the marketing of drugs for off-label purposes violated his rights under the First Amendment. The U.S. Court of Appeals accepted this argument, overturned his conviction, and ruled that “the government cannot prosecute pharmaceutical manufacturers and their representatives…for speech promoting the lawful, off-label use of an FDA-approved drug.” Nevertheless, the FDA maintains that off-label marketing of drugs should be considered “misbranding,” especially given the dangerous risks associated with the off-label use of pharmaceuticals. You can read more about this case in the article “Off-Label Marketing and the First Amendment” published in the New England Journal of Medicine.

In nursing homes, antipsychotic medications, which are intended to treat schizophrenia and bipolar disorder, are frequently used for the off-label purpose of treating dementia. These drugs have become popular in skilled nursing facilities because of their sedative effects. Patients with dementia often suffer from agitation and can sometimes become combative. Although numerous studies have concluded that the most effective treatments for dementia-related agitation are behavioral, understaffed nursing homes do not employ sufficient staff to carry out such therapies. Non-pharmacological alternatives, which include recreational activities, take up much more time than simply administering a pill.

Consequently, inadequately staffed nursing homes frequently resort to chemically restraining their patients. However, it is important for you to know that the use of chemical restraints, which often derives from the off-label use of antipsychotic medications, violates your loved one’s Patients’ Rights. Moreover, the use of antipsychotic drugs has deadly side effects, including an increased risk of strokes, falls, and mortality. This dangerous practice is so prevalent in nursing homes, in fact, that the Center for Medicare and Medicaid Services has adopted an initiative to reduce the use of antipsychotics for off-label purposes.


If you feel that your loved one is being chemically restrained, please take action immediately. With years of experience and numerous favorable judgments for our clients, the nursing home neglect specialists at the Law Offices of Ben Yeroushalmi can help you obtain the rights to which your loved one is entitled. Contact us today for a free consultation.