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June 10, 2022

Washington State Supreme Court Says Drug Manufacturers Have No Duty to Warn Patients

The Washington State Supreme Court ruled on June 2 that drug manufacturers have satisfied their responsibility to patients by warning prescribing physicians of a drug’s risks in accordance with Washington law, even when they advertise directly to consumers.

The U.S. District Court for the Western District of Washington certified a question to the Washington Supreme Court on whether a direct-to-consumer advertising exception exists in a “learned intermediary” case involving a man who reportedly suffered a stroke after taking the erectile dysfunction drug Cialis, made by Eli Lilly.

Under the “learned intermediary doctrine,” which has long been part of the state’s common law, the manufacturer of a prescription medical product must warn doctors, not patients, of the risks associated with the product. In this case of first impression, the plaintiff unsuccessfully argued that there should be an exception to this doctrine when the manufacturer mass markets its product directly to consumers, and a patient’s reliance on doctors’ expertise is undermined by the mass direct-to-consumer drug advertising.

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