The learned intermediary doctrine and beyond: exploring direct-to-consumer drug advertising liability in the new millennium.

• Author: Hill, Jaclyn Carole

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.

1. Background

   1. 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. As the legislative history reflects, the purpose of the bill was to "provide physicians with better and more adequate information about drugs and correlatively to reduce the dissemination of information which is false and misleading...." (9) Congress was primarily concerned with the regulation of prescription drug advertising to physicians, not consumers. The legislative history is void of any discussion concerning DTC advertising. (10) As a result, the FDA interpreted the FDCA in 1962 to permit drug manufacturers to advertise prescription drugs only to healthcare providers.

      Prior to 1983, DTC advertising had occurred on a limited scale, but during the early 1980s, pharmaceutical companies were preparing to launch DTC advertising campaigns directed at consumers. (11) In response, the FDA requested that a two-year voluntary moratorium be placed on DTC advertising so that the FDA could investigate the effects of such advertising on consumers and the efficacy of then-existing FDA regulations. (12) At the end of this two-year moratorium, the FDA concluded that the existing regulations adequately addressed any legal issues involving DTC advertising that might arise in the future. (13) In effect, drug manufacturers could advertise prescription drugs directly to consumers pursuant to already existing FDA regulations.

      The regulatory progeny of the FDCA have historically distinguished print advertising from broadcast advertising. (14) Print advertisements for prescription drugs must include a "brief summary" containing the products' side effects, contraindications, (15) and effectiveness. (16) Drug manufacturers can easily satisfy this requirement by placing the warning language found on the labels of FDA-approved drugs in the advertisements. (17)

      In contrast, broadcast advertising, which includes radio, television, and the Internet, must contain a brief summary and a "major statement" disclosing the product's major side effects and contraindications in the audio or audio-visual portion of the advertisement. (18) This dual requirement of a brief summary and a major statement in broadcast advertising made DTC advertising cost-prohibitive for drug manufacturers due to the lack of time available in a commercial to fulfill these requirements.

      To address these cumbersome and costly requirements, the FDA issued a draft guidance in 1997 for DTC broadcast advertisements, which was, for all intents and purposes, a "how to" guide for advertising pharmaceutical products on television and radio. (19) In its guidance, the FDA suggested that, in lieu of a brief summary, a pharmaceutical company substitute an "adequate provision," along with a major statement, to comply with FDA regulations.

      As specified by the FDA, an adequate provision must contain four elements: 1) a toll-free telephone number for consumers to obtain product information, 2) the identification of a current publication that contains a summary of FDA-approved labeling for the product, 3) a statement advising consumers to consult with their health-care provider, and 4) an Internet web site address that contains product information. The adequate provision provides consumers with various resources to which they can refer to for information that is required in the brief summary and major statement.

      By complying with the adequate provision prong of the FDA's guidance, drug manufacturers essentially satisfied the brief summary requirement of the FDA regulation in a cost-effective manner. In effect, the adequate provision allowed manufacturers the opportunity to provide consumers with an alternative means of accessing their product's labeling information without having to include the entire label's information specifically in the broadcast advertisement. As a result, the adequate provision provided the impetus for drug manufacturers to launch full-scale DTC advertising programs in broadcast media. (20)

      In addition to the brief summary and major statement requirements, a prescription drug advertisement is also subject to the "true statement" requirement. (21) An advertisement is not a true statement if it is false or misleading with respect to side effects, contraindications, or effectiveness; if it does not "fairly balance" side effect and contraindication information against claims of effectiveness; or if it promotes a particular use and does not reveal possible consequences associated with that recommended use. Additionally, any part of the advertisement that is untrue or misleading cannot be remedied by reference to or inclusion of corrective true information in another part of the advertisement. (22) Potentially misleading statements without qualifying language must be followed by immediate reference to qualifying information.

      To ensure that drug manufacturers comply with DTC advertising requirements, the FDA established the Division of Drug Marketing, Advertising, and Communications ("DDMAC"). The DDMAC reviews advertisements submitted by manufacturers, competing manufacturers, consumers, and physicians. (23) The DDMAC focuses primarily on drug advertisements that will receive the greatest exposure or will have the greatest potential to impart misleading impressions.

      Under FDA regulations, pharmaceutical companies are required to submit all drug advertisements to the DDMAC when they are initially disseminated to the public. (24) At that time, pharmaceutical companies may request that the DDMAC issue advisory comments regarding their advertisements. (25) Absent exceptional circumstances, however, the DDMAC cannot require pre-approval of advertising materials. (26)

      After the dissemination of an advertisement, if a manufacturer fails to comply with federal statutes and regulations in the broadcast or publication of its advertisement, then the DDMAC may sanction the manufacturer. These sanctions range from subtle to drastic, beginning with an untitled letter from the agency setting forth objections to the advertisement. (27) If the objections in the untitled letter are not remedied, then the...