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November 1, 2000

Rethinking the Role of the Learned Intermediary: The Effect of Direct-to-Consumer Advertising on Litigation

Author Affiliations

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JAMA. 2000;284(17):2241. doi:10.1001/jama.284.17.2241-JMS1101-2-1

In a 5-2 decision issued in August 1999, which reversed the rulings of 2 lower courts, the New Jersey Supreme Court took a controversial stand challenging the foundation of pharmaceutical liability litigation. In Perez v Wyeth Laboratories Inc, the court argued that the "learned intermediary doctrine," which has historically shielded pharmaceutical companies from any obligation to warn patients directly about their prescription products, does not apply when companies engage in direct-to-consumer (DTC) advertising.1

The term "learned intermediary" originated in a 1966 liability suit brought against the producer of chloroquine phosphate for failing to warn physicians of its potential to cause irreversible retinopathy.2 The federal court in this case established a hierarchy of responsibility in which pharmaceutical companies have a duty to warn physicians directly about potential adverse effects caused by their products, while physicians must serve as "learned intermediaries" who interpret this information and advise patients appropriately. Under this rule, drug manufacturers have no legal obligation to ensure that warning information reaches the final consumer.

For more than 30 years, courts as well as legislative bodies have relied on this doctrine to define the legal boundaries of "failure to warn" suits brought against pharmaceutical manufacturers. As early as 1968, however, some legal exceptions to the learned intermediary doctrine were arising.3 In Davis v Wyeth Laboratories Inc, for example, it was determined that vaccine manufacturers had a specific duty to warn consumers directly of the dangers of immunizations, since they are often administered in a setting "without an individualized balancing by a physician of the risks involved."4 In 1985, the Massachusetts Supreme Court decided in MacDonald v Ortho Pharmaceutical Corp that in the case of oral contraceptive prescriptions, physicians are often "relegated to a relatively passive role," while the "young consumer of oral contraceptives is usually actively involved in the decision to use ‘the pill'"—thus putting the burden to warn the consumer directly upon the oral contraceptive producers.5

The Perez decision represents the first challenge to the applicability of the doctrine in the context of DTC advertising. Five New Jersey women (chosen to represent a larger group of similar plaintiffs) claimed that Wyeth Laboratories failed to provide adequate warnings about the adverse effects and surgical complications they later suffered using the heavily advertised Norplant contraceptive system. Both the trial court and New Jersey Appellate Division summarily dismissed the case in favor of Wyeth on the basis of the learned intermediary rule. Upon further appeal, however, the New Jersey Supreme Court agreed to hear this case as an opportunity "to resolve the threshold issue of whether the learned intermediary doctrine applies in the case of direct-to-consumer marketing of pharmaceutical goods."1

In its majority opinion, the court reevaluated the learned intermediary doctrine in terms of its historical context. It determined that the doctrine depended heavily on the premise that the patient-physician relationship is the focal point for all medical care, and that pharmaceutical companies are unable to communicate information about products directly to patients. In the current era of time-limited medical visits, appealing new "lifestyle" prescription drugs (for hair loss, impotence, etc), and widespread advertising opportunities, a physician's ability to influence the "preconceived expectations about treatment" was found to be significantly diminished.6 Arguing that these developments compromised the role of the learned intermediary, the court found that companies engaging in DTC marketing were legally responsible for providing adequate warnings to consumers about the potential dangers of their products.

Seemingly at odds with this decision, the facts presented in Perez actually contained no evidence that DTC advertising had influenced the plaintiffs. The dissenting justices contended that this decision did not address the particular case, but was intended purely to establish a legal precedent to be applied to all pharmaceutical products for which DTC advertising is used.1 Final judgment on whether Wyeth truly failed to warn the plaintiffs remains to be determined.

By creating a potentially explosive new basis for litigation against pharmaceutical companies, Perez raises important questions about the complex changes affecting our health care system. In addition to making pharmaceutical companies more accountable for the ways that they market products to consumers, the court's ruling also provides a reminder of the growing limitations physicians may face in informing the medical decisions of their patients. Although physicians may be elated at the prospect of sharing some of the legal burdens placed upon them, this landmark decision reflects the growing inability of physicians to serve as effective learned intermediaries in a health care system in which this function may be more necessary than ever.

Not Available, Perez v Wyeth Laboratories Inc, Supreme Court of NJ, No. A-16-98 (August 9, 1999).
Not Available, Sterling Drug Inc v Cornish, 370 F.2d 82, 85 (8th Cir 1966).
Hutton  MB Norplant litigation: creating an exception to the learned intermediary doctrine.  Trial. 1996;3274- 78Google Scholar
Not Available, Davis v Wyeth Laboratories, 399 F 2d 121 (9th Cir 1968).
Not Available, MacDonald v Ortho Pharmaceutical Corp, 475 N E 2d 65 (Mass), cert denied, 474 US 920 (1985).
Terzian  TV Direct-to-consumer prescription drug advertising.  Am J Law Med. 1999;25149- 167Google Scholar