State supreme court rules in favor of Eli Lilly in case over warning patients of risks when DTC ads are in play
In a contentious case centering on product liability, Washington state’s top court recently ruled that Eli Lilly and other drugmakers do not need to provide specific warnings to patients, in addition to the warnings they provide to prescribing physicians regarding the side effects of drugs, even if a drug is advertised directly to patients.
The suit in question involved David Dearinger, who suffered a stroke that caused him permanent disabilities less than two hours after taking Lilly’s erectile dysfunction drug Cialis. Dearinger sued Lilly in federal court under the Washington products liability act, claiming Lilly knew or should have known Cialis presented a risk of stroke to its users and failed to adequately warn users of this risk.
Part of Dearinger’s argument is that over time, the increased use of direct-to-consumer advertising from pharma companies has eroded the typical patient-doctor relationship, and undermined patients’ reliance on doctors’ expertise.
But the Washington Supreme Court didn’t seem fazed by the argument and stood behind what’s known as the “learned intermediary doctrine,” which has been around since 1978 and is used in every state and Washington, D.C. The doctrine provides that drugmakers satisfy their duty to warn patients of the risks of their products if companies properly warn the prescribing physicians.
“In 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,” the ruling said. “By legal design, a physician must exercise independent judgment in prescribing medication, and a consumer must rely on this judgment in obtaining a prescription for a drug like Cialis.”
On the question of whether Washington state law recognizes an exception to the learned intermediary doctrine that requires prescription drug manufacturers to warn patients, not just prescribing physicians, when the manufacturer directly advertises to consumers, the court called Dearinger’s claims “largely unsubstantiated,” saying some of the articles and studies he cites “offer weak support to justify an exception other courts have flatly rejected.”
“Washington law does not recognize an advertising exception to the learned intermediary doctrine,” the ruling supported by 7 members of the court said. “Rather, a drug manufacturer is protected under the learned intermediary doctrine even when they advertise directly to consumers, provided they give adequate warnings to the prescribing physician. Of course, whether a warning is adequate remains a question of fact for a jury to decide.”
But two other judges, who also concurred, on the whole, took issue 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.”