The U.S. Food and Drug Administration (FDA) regulates prescription drugs and medical devices. Physicians frequently prescribe approved drugs for uses that have not been approved by the FDA. This practice is referred to as off-label use. The FDA prohibits manufacturers from promoting off-label use. However, manufacturers indirectly promote the off-label use of their products in a variety of ways.
Physicians are making off-label use of an FDA-approved epilepsy drug in treating problems commonly found in people with diabetes. Another FDA-approved drug to help control epileptic seizures is being used as a treatment for bipolar disorder and pain although there is no research to support the drug’s use for such illnesses. A significant percentage of the sales of certain drugs result from off-label uses.
Duty to Warn
The manufacturer has a duty to warn the physician of any risks associated with the use of a drug or medical device that are known to the manufacturer. The manufacturer also has a duty to provide the physician with instructions for the use of its drugs and medical devices. The physician is responsible for advising the patient of the dangers associated with the use of a particular drug or medical device.
Manufacturer’s Liability for Off-Label Uses of Drug or Medical Device
The courts have not clearly established whether a manufacturer is liable for drug-related injuries resulting from off-label use. In some cases, the courts have held a manufacturer has no duty to warn of risks associated with the off-label use of a drug or medical device. Other cases have held that there is a duty to warn of the risks of an off-label use if the manufacturer knew of the off-label use.
Physician’s Liability for Off-Label Uses of Drug or Medical Device
The off-label use of a drug or medical device involves a medical judgment by the physician. The physician might be subjected to medical malpractice liability for his or her decision to use a drug or medical device in an off-label manner.