The Learned Intermediary Doctrine and Beyond: Exploring Direct-to-Consumer Drug Advertising Liability in the New Millennium

By Hill, Jaclyn Carole | Defense Counsel Journal, October 2005 | Go to article overview

The Learned Intermediary Doctrine and Beyond: Exploring Direct-to-Consumer Drug Advertising Liability in the New Millennium


Hill, Jaclyn Carole, Defense Counsel Journal


DURING the late 1990s, Americans began to experience a dramatic increase in prescription drug advertising created for and directed specifically at consumers. (1) For the first time in history, television and magazine advertisements offered possible solutions to chronic conditions such as allergies, diabetes, and arthritis, as well as more sensitive afflictions like impotence and depression. Today, an estimated 8.5 million consumers annually "ask their doctor" for a specific drug by name after viewing a prescription drug advertisement. This promotion of prescription drugs by pharmaceutical companies directly to consumers via broadcast or print media is commonly referred to as direct-to-consumer ("DTC") advertising.

The proliferation of DTC prescription drug advertisements in the late 1990s reflected regulatory changes effectuated by the Food and Drug Administration ("FDA"). Although the FDA had permitted drug manufacturers to advertise directly to consumers since the early 1980s, compliance with FDA disclosure requirements made advertising to consumers cost-prohibitive and burdensome. To address the cumbersome and costly requirements of advertising, the FDA issued a directive in 1997 which provided the pharmaceutical industry with a cost-efficient method of compliance. (2) By alleviating the costs of compliance, the FDA provided the impetus for drug manufacturers to launch full-scale advertising programs directed at consumers in the late 1990s.

As a consequence of increased DTC advertising, consumers have begun to seek recourse against pharmaceutical manufacturers for aggressively advertising and over-promoting their prescription drugs directly to consumers. (3) Initially, plaintiffs asserted these claims in conjunction with lawsuits brought against manufacturers for failure to provide adequate warnings to consumers regarding the drugs' side effects. (4) In defense, drug manufacturers invariably argued that they were shielded from liability under the learned intermediary doctrine, because the physician, not the manufacturer, had the duty to warn the patient of any risks associated with the prescriptive drug.

To circumvent the legal obstacle created by the learned intermediary doctrine, consumers are now trying to use other areas of state law, such as consumer protection statutes and fraudulent and negligent misrepresentation, to support claims against pharmaceutical manufacturers for overzealous DTC advertising campaigns. Despite these efforts, the limited authority on DTC advertising liability illustrates that the threshold issue in consumer actions will still be whether the learned intermediary doctrine applies to absolve the drug manufacturer from liability.

I. Background

A. FDA Regulation of Direct-to-Consumer Drug Advertising

In 1937, Congress promulgated the Food, Drug, and Cosmetic Act ("FDCA") to limit interstate commerce in drugs to those that are both safe and effective. (5) Under the FDCA, the Food and Drug Administration ("FDA") was also established within the Department of Health and Human Services ("DHHS") to regulate the importation, manufacture, distribution, and sale of drugs in the United States.

Congress then enacted the Kefauver-Harris Amendments to the FDCA in 1962 requiring drug manufacturers to test new drugs for both effectiveness and safety before they could be marketed. (6) In addition to heightened testing standards, section 502(n) of the amendments gave the FDA the power to regulate prescription drug advertising. (7) Prior to 1962, the Federal Trade Commission ("FTC"), not the FDA, had jurisdiction to regulate drug advertisements in general. (8) Today, the FTC still retains authority to regulate the advertising of over-the-counter ("OTC") drugs.

While it is clear that section 502(n) gave the FDA the authority to regulate advertisements of prescription drugs, it is not so clear that Congress intended this authority to extend to DTC advertising. …

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