Eli Lilly wins key dispute over patient warnings in era of DTC advertising

Pharma has notched a legal win in a Washington state product liability case. The state’s highest court has ruled that drug companies are obligated to warn doctors, but not patients, about potential risks of their medicines, even if the drugmaker advertises directly to consumers.

The decision (PDF) stems from a lawsuit filed against drugmaker Eli Lilly by a patient in 2021 who said he suffered a stroke within hours of taking Lilly’s Cialis, which treats erectile dysfunction and a condition that causes an enlarged prostate.

The patient, David Dearinger, sued Lilly in federal court, arguing that the company knew or should have known that Cialis presented a risk of stroke and failed to adequately warn users of the drug about the risk. 

Lilly sought to have the case dismissed, claiming the company provided adequate warning to Dearinger’s prescribing doctor under the “learned intermediary doctrine.” Under the long-standing doctrine, drug companies are considered to have met their obligation to warn patients about the risks of a drug as long as they have adequately warned their physicians. 

But Dearinger, who represented himself, asked the court to carve out an exception for companies that advertise their drugs to consumers. The rise in DTC drug ads has “eroded the patient-doctor relationship,” he argued, since patients no longer rely solely on the doctor’s expertise when deciding to take a drug.

The court, however, sided with Lilly, ruling that DTC advertising does not negate the doctrine, which has been part of Washington law since 1978 and has been adopted in some form in every state. 

“The policies underlying the learned intermediary doctrine remain intact even in the direct-to-consumer advertising context,” Justice Susan Owens wrote in the unanimous June 2 decision. “Further, existing state law sufficiently regulates product warnings and prescription drug advertising.”

The court agreed with the doctrine's premise that doctors are better equipped to communicate risks to patients than drug manufacturers are. Doctors must exercise independent judgment in prescribing medication, and their role as a “gatekeeper” to prescription drugs prevents people from relying solely on advertising, the ruling said.

The court also pointed out that FDA guidelines require drug warnings to physicians to contain 18 safety sections, ranging from storage and handling to adverse reactions and overdoses. Doctors can “comprehend this complex information in a way the average lay person cannot” and can also personalize warnings based on a patient’s medical history and needs, the ruling said.

“Of course, whether a warning [given to doctors] is adequate remains a question of fact for a jury to decide,” the ruling said.