On June 2, 2022, the Washington State Supreme Court unanimously found that under Washington’s product liability law, a doctor who prescribes a drug acts as a “learned intermediary” between a patient and the drugmaker. This means that ultimately, regardless of whether a prescription drug manufacturer advertises its products directly to consumers, the manufacturer satisfies its duty to warn a patient when it adequately warns the prescribing physician of the drug’s risks and side effects.
While the learned intermediary doctrine has been a part of Washington state common law for a long time, David J. Dearinger v. Eli Lilly and Company was the first case in which the Supreme Court has considered whether state law requires drugmakers who participate in direct-to-consumer advertising need to share potential side effects directly with patients, in addition to prescribers.
In the case, Dearinger suffered a stroke that caused permanent disabilities less than two hours after taking Lilly’s drug, Cialis. Dearinger sued Lilly in federal court under the Washington products liability act, claiming that Lilly either knew or should have known Cialis presented a risk of stroke to its patients and did not adequately warn users of the risk.
Dearinger argued that with the increased frequency of direct-to-consumer advertising from pharmaceutical companies, the patient-doctor relationship has eroded and undermined patients’ reliance on doctors’ expertise. The court did not buy into the arguments, instead using the learned intermediary doctrine to rule in favor of Lilly, as mentioned above, “[i]n short, Washington law effectively creates a presumption that a physician will exercise independent judgment in prescribing medication to a patient. The existence of direct-to-consumer advertising does nothing to alter a physician’s duties. Thus, the first central premise of the learned intermediary doctrine remains intact.”
The Court also noted that a physician is “legally required to exercise independent judgment in determining whether to prescribe a drug” and that certain drugs are only obtainable through a prescription, such as Cialis. Therefore, patients rely on a physician’s independent judgment in obtaining prescription drugs, like Cialis, and the second rationale remains intact.
Dearinger cited statistics about how much money drug manufacturers spend on advertising, which Lilly does not dispute. Instead, Lilly argues that physicians remain in a better position to communicate prescription drug risks to patients than drug manufacturers, which the Court agrees with. For one, the Court noted that prescription drugs are “complex and carry significant risks” and the prescribers’ label of drugs contain 18 safety sections that they understand much easier than a lay person. Those warnings help to give physicians the ability to personally tailor warnings to patients in a way that manufacturers cannot – they can “personalize warnings to a patient based on that patient’s medical history and needs” but a manufacturer cannot create individual warnings because they do not know consumers’ medical information.
Ultimately, the Court found that Washington law does not recognize an advertising exception to the learned intermediary doctrine. Instead, a drug manufacturer is protected under the learned intermediary doctrine even when they advertise directly to consumers, so long as they give adequate warnings to prescribing physicians. The Court also noted that whether a warning is adequate remains a question of fact for a jury to decide.
Concurring Opinion
Two justices – including the Chief Justice – concurred with the majority opinion but wrote a concurring opinion voicing issues with “the majority’s unsupported assumptions that all physicians ‘comprehend … complex information’ better than all patients. And I cannot agree with the consequence of that assumption, that is, that it is better to withhold complex information from patients about their own medical condition than to reveal it to them in a commonsense, understandable way.” They cite “the explosion of websites devoted to public health, traditional medicine, alternative medicine, prescription drugs, etc.” as evidence of other ways to reveal complex information to the public. However, the “disagreement with the majority on this single policy matter does not change my conclusion about the importance of retaining the learned intermediary doctrine at this time.”