Direct-to-Consumer Advertising of Prescription Drugs

What is the learned intermediary doctrine?

As a general rule, prescription drug manufacturers have no duty to warn consumers of the risks associated with taking prescription drugs. Under the learned intermediary doctrine, the drug manufacturers are only required to inform doctors of such risks. The doctrine presumes that the doctor is in a better position than the manufacturer to discuss with the consumer the benefits, risks, and side effects of a drug. Under the learned intermediary doctrine, drug manufacturers are relieved of any liability if they adequately warns doctor of drug risks and side effects.

Who regulates direct-to-consumer advertising?

The U.S. Food and Drug Administration (FDA) regulates prescription drug advertising. In 1997, the FDA adopted special guidelines for advertising prescription drugs through broadcast media. These regulations were not as restrictive as past ones. Drug manufacturers began advertising in television, radio and print.
Is there an exception to the learned intermediary doctrine for direct-to-consumer advertising?

Direct-to-consumer advertising by prescription drug companies has prompted some courts to reevaluate the learned intermediary doctrine. In 1992, a federal district court in Massachusetts stated that direct-to-consumer advertising of a prescription drug might give rise to an exception to the learned intermediary rule. The same year, an Alaska court questioned whether marketing a prescription drug directly to the public could give rise to a duty to warn consumers.

In 1997, the Oklahoma Supreme Court held that the learned intermediary doctrine did not apply in a lawsuit filed by a nicotine patch user who had sued the drug manufacturer for its failure to warn of side effects. The court held that FDA regulations required manufacturers of nicotine patches to provide certain warnings directly to patch users.

In 1999, the New Jersey Supreme Court held that the learned intermediary doctrine does not apply in cases where drug companies have directly marketed to consumers.

Although there appears to be a trend toward an exception to the learned intermediary doctrine for direct-to-consumer advertising, the majority of courts do not recognize such an exception. The majority holds that prescription drug manufacturers have no duty to warn consumers directly of the risks associated with taking prescription drugs.

Copyright 2012 LexisNexis, a division of Reed Elsevier Inc.