Originally published in Bloomberg Law Reports, July 15, 2011.

As plaintiffs’ law firms and state and federal governments continue to scrutinize “off-label marketing,” drug manufacturers may become increasingly susceptible to a wide range of potential liability. Since May 2004, the country’s major drug manufacturers reportedly have paid billions of dollars in fines and penalties for allegedly marketing drugs for off-label use.1 Government law suits alone have cost manufacturers at least $1 billion in recent years.2

Off-label marketing is when drug companies advertise or promote their products for uses or in dosages other than those approved by the U.S. Food and Drug Administration (FDA). Although doctors often prescribe medications for off-label purposes and the federal government and some states even require health insurance plans to cover off-label prescriptions under some circumstances, the government and some plaintiffs have alleged that a company violates the law if it markets drugs for off-label use.

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