Off-label prescribing

September 1, 2007

Dr. Label is well known for his innovative off-label use of a variety of medications for bullous diseases.

Dr. Label is well known for his innovative off-label use of a variety of medications for bullous diseases.

Three years, ago he prescribed such a medication to a patient with pemphigus vulgaris. In fact, the patient asked about the medication because she had seen it advertised on television as being popular and safe to use for a variety of rheumatologic disorders.

It should be noted that the Food and Drug Administration (FDA) does not regulate the practice of medicine and physicians are never liable solely on the basis of their off-label use of a medication.

Conversely, physicians are by no means exempt from the risk of liability arising from off-label prescribing.

What is clear is that in tort law, if a patient is injured by a medication and then files a product liability claim, the "learned intermediary doctrine" can affect the apportionment of liability between the drug manufacturer and the prescribing physician. This doctrine is based on the presumption that physicians, as learned intermediaries between drug manufacturers and patients, are responsible for warning patients of potential hazards associated with prescribed medications. A manufacturer is therefore excused from warning each patient who receives the medication so long as the manufacturer properly warns the prescribing physician of the product's dangers.

Drug manufacturers typically use the learned intermediary doctrine as an affirmative defense against liability, to shift blame for patient injuries to the prescribing physician, in cases where warnings were not reasonably passed on to patients. The apportionment of liability under the doctrine generally hinges on whether the risk of harm was foreseeable by the manufacturer or whether off-label use constituted the standard of care in the medical community.

Thus, while physicians are clearly not required to disclose to patients that a drug is being prescribed for off-label use, physicians can make an effort to reduce liability by doing so.

Sharing the responsibility

While the learned intermediary doctrine may be invoked each time a prescription is written, the practical strength of the doctrine may have diminished over recent years, as physicians tend to stand less as intermediaries between their patients and the various drug manufacturers.

In cases of off-label prescribing, manufacturers have attempted to benefit from the doctrine's protection by claiming that the absence of appropriate labeling constituted an appropriate warning against a drug's off-label use. Recently this approach has met only limited success as direct-to-consumer marketing has become popular. A minority of courts have now reasoned that because drug manufacturers now generate a sense of product quality through mass advertising and marketing practices, they are reasonably subject to the duty to directly warn the consumer.

Thus, although historically a drug manufacturer could move all liability onto Dr. Label, today's manufacturer-to-consumer direct marketing may, at the very least, allow Dr. Label to share liability with the drug manufacturer.

Dr. Goldberg is the director of SkinLaser & Surgery Specialists of New York and New Jersey; director of Mohs surgery and laser research, Mount Sinai School of Medicine; and adjunct professor of law, Fordham Law School.