On June 2, the Washington Supreme Court in Dearinger v. Eli Lilly & Co. reaffirmed the learned intermediary doctrine as “a fixed part of Washington law” and refused to abandon or modify the doctrine when a drug manufacturer directly advertises to consumers. The decision came in response to a certified question from the United States District Court for the Western District of Washington. The plaintiff in Dearinger alleged that he suffered a hemorrhage leading to stroke that caused him permanent disabilities two hours after taking Cialis, a drug prescribed to treat hyperplasia, pulmonary arterial hypertension, and erectile dysfunction.

The “learned intermediary doctrine” provides that a pharmaceutical manufacturer satisfies its duty to warn patients of product risks by warning the prescribing physician, who then takes on the responsibility of communicating those warnings to the patient. The doctrine shifts the duty to warn of associated risks from the manufacturer to the doctor, “who is in a better position to communicate them to the patient.” “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration,” according to the Washington Supreme Court.

The Washington Supreme Court, “like many other courts,” rejected a direct-to-consumer advertising exception to the learned intermediary doctrine. The court said that the overarching policy behind the doctrine—i.e., the doctor being in the best place to understand both a drug and the patient’s medical history—is not altered by such advertising. Further, “physicians can give personally tailored warnings to patients in a way manufacturers cannot.”

Lastly, the court pointed out two relevant ways that Washington law regulates product warnings and prescription drug advertising. First, under the learned intermediary doctrine, “if the warning to the physician is inadequate, then the manufacturer is liable.” Second, if the manufacturer adequately warns the physician but the physician fails to communicate those risks to the patient, “then the physician is liable for breach of fiduciary duty” and “may be liable for medical malpractice….”

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