The Learned Intermediary Doctrine Faces Unexpected Resistance by Federal District Court

Drug and medical device manufacturers sustained an unexpected blow last summer in Rimbert v. Eli Lilly and Company. In a decision handed down August 22, 2008, a federal court for the first time rejected the so-called "learned intermediary" doctrine in its entirety.

The learned intermediary doctrine grants drug and medical device manufacturers an exception to the traditional duty to warn. Whereas other companies must disclose the risks associated with their products directly to consumers, drug and device manufacturers need only warn the physicians that prescribe their products, who act as "learned intermediaries" between manufacturers and consumers.

The doctrine has been almost universally accepted across the United States. However, critics argue that recent changes in the medical and pharmaceutical industries—primarily the rise of managed care and direct-to-consumer advertising—have rendered the justifications underlying the doctrine obsolete. Rimbert was the second judicial opinion nationwide, and the first among federal courts, to reject the learned intermediary doctrine completely in light of these considerations.

The plaintiffs' bar may have scored an unexpected victory in Rimbert, but the impact of the decision on the continued viability of the doctrine remains to be seen. The decision is not binding on other courts, including those in New Mexico, where Rimbert was decided. Still, other federal courts may take a similarly aggressive stance against the doctrine where state law has not clearly adopted it, and state courts may follow the reasoning of Rimbert, leading both to an increase in litigation and an increase in the number of cases that survive summary judgment. In any event, Rimbert clearly signals the further development of opposition to the learned intermediary doctrine.

The Learned Intermediary Doctrine

The primary justification for the learned intermediary doctrine 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 consumers, mislead them, or discourage them from taking a medication that would in fact benefit them. 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.

Since the mid-20th century, the learned intermediary doctrine has been recognized or applied in 48 of the 50 states, as well as the District of Columbia. The highest courts of at least 31 states have either expressly applied the doctrine, approved it, or otherwise referred to it favorably. One other state, North Carolina, adopted it by statute, without comment by the state's highest court. In 16 of the remaining 18 states—including New Mexico—as well as the District of Columbia, the learned intermediary doctrine has either been applied or favorably recognized by the intermediate appellate courts and/or federal courts applying state law. Vermont is the only state that has not yet addressed the doctrine in any form. West Virginia is the only state whose highest court has rejected the doctrine in its entirety.

The Changed Landscape Underlying the Doctrine

Recent changes to the landscape underlying the learned intermediary doctrine have caused some to question its continued viability. The rise of managed care has forced primary care physicians to treat more patients per day and to spend less time with each one, thus weakening the position that doctors are best suited to communicate risk information to consumers. Meanwhile, due to the rise of the Internet and direct-to-consumer drug advertising, consumers have taken on a greater role in choosing their own treatments, often requesting desired prescription drugs by name. As a result, opponents of the doctrine liken the function of the modern-day doctor more to that of a professional prescription-dispenser than a "learned intermediary."

Few courts, though, have actually limited the learned intermediary doctrine in light of these perceived changes. In 1999, the Supreme Court of New Jersey, in Perez v. Wyeth, became the first court to do so, fashioning an exception to the doctrine in cases that involve drugs advertised directly to consumers. The Perez decision initially received substantial industry attention, as many thought the demise of the learned intermediary doctrine would be imminent in its wake. But the case in fact had surprisingly little impact outside of New Jersey: For eight years, not a single state or federal court adopted its reasoning.

Then, in June 2007, the Supreme Court of West Virginia did more than just adopt Perez. It banished the doctrine in its entirety in the landmark case, State ex rel. Johnson & Johnson Corp. v. Karl. The Karl decision marked the first time any court in the United States took such a strong position against the learned intermediary doctrine.

The Rimbert Decision

The Rimbert court was the first modern federal court to reject the learned intermediary doctrine, and significantly, it did so despite New Mexico state court precedent adopting the doctrine. In Rimbert, the decedent had committed a murder-suicide one month after commencing treatment with the prescription drug Prozac, which is manufactured by Eli Lilly and Company. The plaintiff alleged that the decedent's actions were caused by Lilly's failure to warn of the alleged association between Prozac and violent behavior. Lilly moved for summary judgment under the learned intermediary doctrine, claiming the decedent's prescribing physician had been adequately warned.

The United States District Court for the District of New Mexico, applying New Mexico law, denied Eli Lilly's motion to dismiss, and rejected the learned intermediary doctrine in its entirety. Recognizing that its duty was to predict how the Supreme Court of New Mexico would decide the issue, the court held that the justifications for the doctrine were no longer valid in light of the changed landscape of the pharmaceutical industry, and that the doctrine was "fundamentally inconsistent" with New Mexico's strict liability law. According to the court, the purpose of New Mexico's strict liability law, as pronounced by New Mexico's Supreme Court, is to "ensure that the risk of loss for injury resulting from defective products is borne by the suppliers." Because application of the learned intermediary doctrine would have placed the risk of loss on the physician and patient, the court would not allow it.

Significantly, Rimbert contravened three prior opinions issued by the New Mexico Court of Appeals, each of which adopted and applied the learned intermediary doctrine. A federal court is authorized to depart from appellate state court precedent only if there is convincing evidence that the state's highest court would do so as well. Accordingly, to justify its departure, the Rimbert court claimed that the outdated justifications for the learned intermediary doctrine, as well as the doctrine's fundamental inconsistency with New Mexico's strict liability law, constituted "convincing evidence" that the Supreme Court of New Mexico also would have disregarded the appellate court's prior adoption of the doctrine.

The Impact of Rimbert

Just how the Rimbert decision will affect drug and device litigation has yet to be seen. From one perspective, it seems insignificant, as the decision is not binding on any other federal or state jurisdiction, including the state courts of New Mexico. This view is amplified by the court's reversal of New Mexico state law, arguably an abuse of authority under the Erie doctrine, which requires federal judges to apply state substantive law when presiding over state law claims. From another angle, however, Rimbert could have a lasting impact on the viability of the learned intermediary doctrine. Not only was it the first federal court case to reject the doctrine, but it was also the first to do so in a state whose intermediate appellate courts had previously adopted the learned intermediary doctrine. Other federal district courts could take a similarly aggressive approach against the doctrine where state law has not indisputably adopted it, and state courts could be persuaded by the reasoning of the opinion. To the extent this is the case, manufacturers could face an increase both in the volume of litigation that is filed and litigation that survives summary judgment.

Even if Rimbert does not "open the floodgates," it still signifies the further development of opposition to the learned intermediary doctrine—an opposition that could be mobilizing faster than before. In the wake of Perez, it took eight years for another court to join in. After Karl, Rimbert was issued in a little more than a year.

Conclusion

Although the learned intermediary doctrine remains widely accepted in courts across the United States, critics argue that the justifications for the doctrine have been rendered obsolete by the rise of managed care and direct-to-consumer advertising. The movement against the doctrine started slowly, producing only two opinions from 1999 to 2007. However, the District of New Mexico's recent decision in Rimbert may signify that this movement is picking up steam. Rimbert was the first federal case to reject the learned intermediary doctrine, and it did so despite contrary precedent of the state intermediate appellate court. Although Rimbert may have been a victory for the plaintiffs' bar, one thing remains certain: The battle of the learned intermediary doctrine is far from over.