Will the FDA's Proposed DTC Ad Rule Further Erode the Learned Intermediary Doctrine?

On March 29, 2010, the Food and Drug Administration (FDA) issued proposed amendments to its regulations concerning direct-to-consumer (DTC) television and radio ads for prescription drugs. The proposed rule set standards for determining whether DTC ads present warnings in a "clear, conspicuous, and neutral manner." The new standards are highly subjective, and would require interpretation and application to each unique DTC ad. Thus, the new standards could create challenges for pharmaceutical companies in how they develop and approve DTC ads.

Aside from the costs to bring an ad to market, the new standards raise the question of how these newly judged "clear, conspicuous, and neutral" ads will impact products liability litigation. Specifically, if approved, will the new standards accelerate the spark created by Perez v. Wyeth and challenge the continued viability of the learned intermediary doctrine? Or will courts continue to recognize the doctrine based on the important role physicians play in helping patients make proper healthcare choices? The answer is unclear. Yet, the new standards under the proposed rule could provide the plaintiffs' bar with another source to further its opposition to the learned intermediary doctrine.

FDA Regulation of DTC Ads

FDA regulation of DTC ads is not new. Current regulations require that DTC ads include "information relating to the major side effects and contraindications of the advertised drugs…." These regulations fail, however, in detailing how DTC ads must be formatted in their presentation of potential safety issues. As a result, critics argue that consumers are presented with safety warnings that are accompanied by quick scene changes showing comforting visual images of patients benefiting from the advertised drug, or loud, upbeat music. These distractions allegedly prevent consumers from understanding, or even hearing, the warnings. Even when the consumer can hear or read the warnings without distraction, critics argue that confusing terminology and statistical information keeps the consumer from digesting the warning. Consequently, after viewing the ads, consumers must still rely on information from their physicians to fully comprehend the benefits and safety risks of the drugs.

Congress responded to the critics by passing the Food and Drug Administration Amendments Act of 2007 (FDAAA). The FDAAA amended section 502(n) of the Federal Food, Drug, and Cosmetic Act by requiring that safety warnings in DTC ads be presented in "a clear, conspicuous, and neutral manner." The proposed rule is the FDA's interpretation of this section. Consequently, to avoid misbranding, DTC ads would have to be formatted to comply with the proposed rule.

The proposed rule will regard a DTC ad in compliance if it meets the following standards:

1. Information is presented in language that is readily understandable by consumers;
2. Audio information is understandable in terms of the volume, articulation, and pacing used;
3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.

These proposed standards are consistent with the FDA's May 2009 draft guidance for the industry entitled Presenting Risk Information in Prescription Drug and Medical Device Promotion.

Standard No. 1 judges whether the DTC ad utilizes everyday words or terms to describe risks. For example medical jargon such as the word ‘syncope' should be replaced with the term ‘fainting' to be more understandable to the average consumer. Standard No. 2 assesses the potential for audio distractions that effect consumer understanding. Volume consistency, articulation of speech, and pacing of speech would all be judged. For example, risk information cannot be rattled off at the end of an add, but must instead be delivered at a pace that allows the consumer "to hear and process it." Standard No. 3 addresses written text presented with audio and visual components, and judges whether the text can be easily processed by the consumer.

Finally, Standard No. 4 is a catch-all provision that assesses whether the ad as a whole includes distractions that draw attention away during presentation of a major statement. The FDA is particularly concerned if "distracting elements convey additional benefit information" during a portion of the ad that should be dedicated to a neutral risk presentation.

Clearly, the proposed rule could have a considerable impact on the way prescription drug ads are currently developed and approved. For example, the standards would require close attention to pace of speech and harmonization of visual safety warnings with concurrent audio statements. In analyzing a DTC ad under the new standards, the FDA's focus would be on the ad's cognitive load – the mental effort required of the consumer to understand the various components of the ad, without being diverted from the risks and warnings by graphics, images, or other aspects. Further, close attention would also have to be paid to the complexity of the terminology used to convey the risks and warnings. This could lead pharmaceutical companies to staffing social science or psychology consultants to gauge the consumer's perception and digestion of DTC ads. While focus groups are commonly utilized in ad development, their import may also increase under the new standards. Even after careful development, there are sure to be requests by the FDA after submission for costly re-formatting.

The new challenges in development and approval would be costly and would impact a large number of DTC ads. The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) examined a randomly selected sample of 35 DTC ads disseminated in 2008, and found that approximately one-third of the reviewed ads could be judged in violation of a "clear, conspicuous, and neutral standard." There would be a costly transition period while the FDA attempts to bring DTC ads in compliance and to achieve its stated goal of "ads that effectively communicate the risk information needed for consumers to receive a fair and accurate impression of the prescription drug product being promoted."

The FDA has a worthy goal in attempting to "improve the communication of risk information, thereby resulting in an audience receiving a more accurate net impression of the product's benefits and risks." However, if the proposed rule successfully transforms DTC ads, how will the plaintiffs' bar attempt to utilize this new tool in prescription drug liability litigation?

The Learned Intermediary Doctrine and Perez v. Wyeth

The learned intermediary doctrine is an exception to the general rule that manufacturers must warn consumers directly of the risks associated with a product. Instead, manufacturers of prescription drugs are required to provide adequate warnings only to the health-care community. The primary justification is that prescribing physicians, as opposed to manufacturers, are in the best position to convey risk information to consumers in a meaningful way. Under state law, physicians are already obligated to know the complex risk information of the treatments they prescribe; to assess that information in light of the needs and susceptibilities of each patient; and to make independent, professional determinations as to what treatment is appropriate. Consumers rely on their physicians' judgment and, in fact, cannot obtain prescription products without them. Manufacturers, unlike physicians, lack the means to effectively communicate the risks of their products to consumers. Were manufacturers to disseminate highly technical risk information to consumers, they could potentially confuse and mislead the consumers. Accordingly, the learned intermediary doctrine requires manufacturers only to provide warnings to physicians, who are then expected to relay the pertinent risk information to their patients in an understandable manner.

Eleven years ago—in Perez v. Wyeth—the New Jersey Supreme Court cast doubt on the continued viability of the learned intermediary doctrine. Perez held that prescription drug manufacturers that market their products directly to consumers should be subject to claims by consumers if their advertising fails to provide adequate warning of the product's dangerous propensities. In so holding, the Perez court found that modern medical practice undermines the pillars of the learned intermediary doctrine. In particular, Perez found that prescription drug manufacturers, as evidenced by the large expenditures they spend on marketing, no longer "lack effective means to communicate directly with patients."

The deterioration of the patient-physician relationship was also critical to the Perez holding. Stating that the "'Norman Rockwell' image of the family doctor no longer exists," the New Jersey Supreme Court found that busy physicians have considerably less time to inform patients of the risks and benefits of a drug. This, coupled with the increased ability of drug manufacturers to communicate directly with their consumers, led the Perez court to find that patients are relying on the DTC ads for information regarding the benefits and potential side effects of prescription drugs. Accordingly, while Perez did not discard the learned intermediary doctrine in its entirety, it did find an exception to the doctrine for prescription drug manufacturers who choose to advertise directly to consumers. As a result, in order to avoid liability, prescription drug manufacturers must make their safety warnings in DTC ads adequate.

Perez initially received substantial industry attention, as many believed it was the beginning of the demise of the learned intermediary doctrine. For eight years, however, not a single state or federal court adopted its reasoning. See Vitanza v. UpJohn Co., 778 A.2d 829 (Conn. 2001); Colacicco v. Apotex, Inc., 432 F.Supp.2d 514 (E.D. Pa. 2006); Beal v. Biomet, Inc., 492 F.Supp.2d 1360 (S.D. Fla. 2007). None of these decisions, however, include a thorough analysis of the reasoning of Perez. Instead, they reject the DTC ad exception because of poor factual scenarios or because no other state courts have followed the New Jersey Supreme Court.

In 2007, Perez began to regain momentum. In State ex rel. Johnson & Johnson Corp. v. Karl, the West Virginia Supreme Court adopted the reasoning of Perez, and went one step further and rejected the learned intermediary doctrine in its entirety. The United States District Court for the District of New Mexico, in Rimbert v. Eli Lilly and Company, soon followed suit. And, in March 2010, the Court of Appeals of Texas, in Centocor, Inc. v. Hamilton, cited Perez in finding an exception to the learned intermediary doctrine for prescription drug manufacturers who advertise directly to consumers.

Because the FDA's proposed rule for DTC ads regulates the adequacy of warnings and is targeted to ensure that consumers "receive a fair and accurate impression of the prescription drug product being promoted" from DTC ads, the new standards may add to the momentum of the Perez opposition to the learned intermediary doctrine.

Impact of the Proposed Rule on the Learned Intermediary Doctrine

In partial support of the proposed rule, the FDA cites a large survey that found that 60 percent of responding physicians believed DTC ads for prescription drugs provided patients with little or no understanding about the risks and negative effects of the products, and 65 percent of these physicians observed that DTC ads may lead patients to confuse the relative risks and benefits of advertised drugs. Aikin, K., J. Swasy, and A. Braman,‘‘Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs—Summary of FDA Survey Research Results, Final Report,'' November 19, 2004. This illustrates the continued importantance of the physician's role, even in this age of DTC ads, in presenting the risk-benefit profile of a prescription drug to the patient.

However, the proposed rule is arguably designed, to some extent, to reduce the necessity for the physician. The FDA hopes to achieve an audience that notices, attends to, and comprehends the risk information presented in DTC ads. If this lofty goal can be adequately met, a physician's role in relaying risk information arguably becomes less significant. This may result in courts beginning to question what role physicians play when prescriptions are advertised directly to consumers. If the physicians' role is partially replaced, that could have a lasting impact on how courts view the learned intermediary doctrine.

Opposition to the learned intermediary doctrine also appears to be fashionable. While it was eight years before another court followed Perez, in the last three years, three courts in, Karl, Rimbert, and Hamilton, have relied on Perez in finding a DTC ad exception to the learned intermediary doctrine. Now, the plaintiffs' bar would have a federal statute and corresponding FDA rule which arguably codify the holding of Perez. While the proposed rule does not create a duty for prescription drug manufacturers to provide safety warnings directly to consumers, it does require that if DTC ads are used, they must provide warnings that are comprehensible to the average consumer. This could be a useful tool to the plaintiffs' bar in persuading other courts to adopt the reasoning of Perez. To the extent this is the case, prescription drug manufacturers could face an increase both in the volume of litigation that is filed and litigation that survives summary judgment on learned intermediary grounds.

From another perspective, the proposed rule may seem less significant. Several courts have rejected a Perez exception to the learned intermediary doctrine. See Vitanza, 778 A.2d at 829; Beal, 492 F.Supp.2d at 1360; Colacicco, 432 F.Supp.2d at 514. These rejections signal a reluctance by the courts to remove the physician from the patient's prescription drug decision making process. Even in the face of the proposed rule, the physician remains critical, because the proposed rule merely requires that DTC ads convey adequate warnings in a format that a "reasonable consumer" can understand. The reasonable consumer is not a physician and does not have the training and expertise that a physician utilizes in tailoring risk information for a prescription drug to a particular patient, taking into account that particular patient's medical history and the potential risks and benefits of the drug for that particular patient. Therefore, even if a DTC ad adequately warns the reasonable consumer, that should remain the first step in the prescription drug decision making process, and the patient still must seek out and rely upon the learned expertise of a personal physician to fully process the risks and benefits of the drug for the patient's own intended use.

Conclusion

The learned intermediary doctrine remains almost universally accepted across the United States. Its critics, however, point to the significant changes in the health-care industry since its inception, including, the deterioration of the physician-patient relationship and a dramatic increase in DTC ads. Thus far, a few courts have been willing to acknowledge that these changes justify a departure from the traditional defense. The FDA's proposed rule is designed to improve consumer understanding of safety information conveyed by DTC ads, and may result in plaintiffs arguing further deterioration of a physician's role in a patient's prescription drug decision making. However, before courts accept such arguments, they should weigh carefully what a reasonable consumer is capable of understanding against what an experienced physician adds to a patient's decision-making process.