Washington State Supreme Court Sides With Lilly Regarding Drug Warnings

Washington state’s Supreme Court agreed with Eli Lilly that prescription drug manufacturers are only required to warn the prescribing physician of a drug’s risks — not patients.

The ruling concluded a case against Lilly by an individual who alleged that he suffered a hemorrhage leading to a stroke less than two hours after taking the company’s erectile dysfunction drug Cialis (tadalafil), arguing that the company was negligent in not warning about the risk.

Lilly successfully argued that it had provided adequate warnings to the prescribing physician under the “learned intermediary doctrine,” whereby the manufacturer of a prescription medical product must warn doctors, not patients, of a product’s risks and doctors must then convey the warnings to patients. The doctrine has been adopted in most states.

The plaintiff claimed that companies who advertise directly to consumers are not protected by the doctrine. But the court ruled that there is no exception for direct-to-consumer advertising.