A Drug Manufacturer's Liability for Off-Label Use

Injuries Resulting from Off-Label Use

It is legal and common for physicians to make off-label uses of drugs and medical devices. Off-label use refers to the use of drugs and medical devices for purposes not mentioned on the manufacturer's labels. Off-label applications of drugs are common in the treatment of cancer and heart disease. If a drug or medical device is legally sold for a particular purpose, doctors have professional discretion to use that drug or device for other conditions in treating their patients. The U.S. Food and Drug Administration (FDA) prohibits manufacturers from promoting off-label use. However, manufacturers indirectly promote their products in a variety of ways, including the funding of research into off-label uses.

Duty to Warn

As a general rule, a manufacturer is liable for drug-related injuries only if the manufacturer knew or should have known of a particular risk and failed to adequately warn of the risk. The manufacturer's duty is to warn the prescribing physician, not the patient. In turn, the physician has a duty to inform the patient of the risks associated with the use of a certain drug or medical device.

Liability for Failing to Warn of Off-Label Risks

It is not clearly established whether a manufacturer can be held liable for drug-related injuries resulting from off-label use. One approach by the courts has been to hold that a manufacturer has no duty to warn of risks unique to the off-label use of its drugs. In one particular case, the manufacturer was not held liable for injuries sustained by a patient who took a drug to treat sinusitis. The FDA had not approved the drug to treat upper respiratory tract infections.

In another approach, a court held that the manufacturer has to warn of risks associated with any use of a drug, whether it is an approved use or an off-label use. In one specific case, a patient sustained injuries after a contraceptive drug was injected into his spine to relieve back pain. The manufacturer was aware of the off-label use but failed to warn physicians that injecting the drug could cause scarring of the nerves in the lower back.

A third approach has been to hold a manufacture liable for failing to warn of the risks of an off-label drug use. The court found that a manufacturer knew or should have known of the off-label use of its drug, which amounted to a large portion of the sales of the drug.

Still another approach has been to hold drug manufacturers liable for failing to warn of risks associated with foreseeable off-label drug uses. Physicians were prescribing a drug to prevent miscarriages, an off-label use of the drug. The court upheld a verdict for the plaintiff, who was injured by the drug. The court found evidence that the manufacturer knew that physicians were prescribing the drug to prevent miscarriages.

Copyright 2010 LexisNexis, a division of Reed Elsevier Inc.