From the Desk of Gordon C. Klug:
The learned intermediary doctrine has been a part of Washington law since its adoption in 1978. This doctrine protects manufacturers of prescription drugs from liability as long as the manufacturers adequately warn the prescribing physician of the dangers and risks of the drug. Recently, the Washington Supreme Court was asked to recognize an exception to the learned intermediary doctrine that would expose a manufacturer to liability. No Washington court has considered this exception until now.
The Washington Supreme Court certified a question by Plaintiff asking whether Washington law recognizes an exception to the learned intermediary doctrine for drug manufacturers who advertise directly to consumers. In answering this question, the Court addressed whether the Washington Products Liability Act abrogated the learned intermediary doctrine and examined the policy reasons behind the doctrine.
Dearinger v. Eli Lilly & Co., 99956-2, 2022 WL 1788992 (Wash. June 2, 2022).
Plaintiff alleged that he suffered a hemorrhage that led to a stroke less than two hours after consuming Cialis, a drug manufactured by Defendant Eli Lilly and Co. to treat prostatic hyperplasia, pulmonary arterial hypertension, and erectile dysfunction. Plaintiff sued Defendant in federal court under the Washington Products Liability Act (WPLA) for negligent design, negligent failure to warn, and breach of warranty. Plaintiff claimed that Defendant knew or should have known of the risk of stroke Cialis presented to its consumers, and failed to adequately warn consumers of the risk.
Defendant moved to dismiss, claiming that it provided adequate warnings to Plaintiff’s prescribing physician under the learned intermediary doctrine. Plaintiff then moved for the US District Court to certify a question to the Washington Supreme Court asking whether Washington law recognizes an exception to the learned intermediary doctrine for drug manufacturers who advertise directly to consumers. The certified question presented to the Washington Supreme Court was: Does Washington law recognize an exception to the learned intermediary doctrine that requires prescription drug manufacturers to warn patients, not just prescribing physicians, when the manufacturer directly advertises to consumers?
Under the WPLA, a product manufacturer can be liable for failure to provide adequate warnings about a product if it harms the consumer. RCW 7.72.030(1). In the context of prescription drugs, the learned intermediary doctrine states that a manufacturer satisfies its duty to warn by properly warning the prescribing physician. Terhune v. A.H. Robins Co., 90 Wn.2d 9, 14, 577 P.2d 975 (1978). Thus, the manufacturer’s duty to warn is transferred to the doctor, who is in a better position to convey the information to the patient. Every state in the country has adopted some iteration of the learned intermediary doctrine, thus not only is it a fixed part of Washington law, but it is also universally followed across the country.
The Washington Supreme Court began its analysis of the question presented with Plaintiff’s contention that parts of the WPLA abrogates the doctrine. The Court addressed each provision cited by Plaintiff and determined that the WPLA does not abrogate the learned intermediary doctrine, nor does it provide for an exception.
The Court examined RCW 7.72.010(4), which states that a products liability claim includes claims for harm caused by “warnings” or “marketing”, among other things. The Court determined that this provision does not modify the doctrine, it just “tells us what we already know”. Next, the Court examined RCW 7.72.030(1)(b), which provides that a product is not reasonably safe if adequate warnings were not provided with the product. The Court found that this provision does not state that warnings must be given to directly to the user. But rather, it states that warnings must be provided with the product. The Court then turned to RCW 7.72.030(3), which lays out the consumer expectations test to determine whether a product is not reasonably safe. The Court stated that this provision merely addresses the standard for the adequacy of a warning and does not state who the manufacturer must warn. Lastly, the Court examined RCW 7.72.050(1), which permits a trier of facts to consider whether the product complied with legislative or administrative regulations.
The Court acknowledged that the U.S. Food and Drug Administration requires prescription drug manufacturers to directly warn consumers when advertising products but found that RCW 7.72.050(1) instructs the fact finder to consider FDA regulations to determine whether a manufacturer’s warning to the physician is adequate. The Court held that the learned intermediary doctrine and RCW 7.72.050(1) work together and are not in conflict.
After holding that nothing in the WPLA’s abrogates the learned intermediary doctrine, the Court turned to the underlying policies behind the learned intermediary doctrine. The Court stated that the overarching policy behind the learned intermediary doctrine is a patient’s reliance on a physician’s expertise and independent judgment. This policy is still as true today as it was when the doctrine was enacted in 1978. The Court also held that existing state laws sufficiently regulate product warnings so that no manufacturer could “abuse” the learned intermediary doctrine, as Plaintiff suggests in his argument. Under the doctrine itself, if the warning to the prescribing physician is inadequate, then the manufacturer is liable. RCW 7.72.030(1). Thus, the doctrine only has bearing on who a manufacturer must warn and is not an inquiry about the adequacy of the warning.
Additionally, the Court noted if the manufacturer adequately warns the physician, but the physician fails to communicate those warnings to the patient, then the physician is liable. Thus, consumers are not left without any redress if a drug manufacturer or physician provides inadequate warnings.
In sum, the Washington Supreme Court answered the certified question in the negative – Washington law does not recognize an advertising exception to the learned intermediary doctrine.
The Big Picture:
The learned intermediary doctrine is a fixed part of Washington’s law, and a Court is unlikely to find exceptions to the doctrine that expose a manufacturer to liability. A prescription drug manufacturer can still be protected under the learned intermediary doctrine even when they advertise directly to consumers, as long as they give adequate warnings to the prescribing physician.