A prescription drug maker has done its legal duty by warning prescribing physicians of a drug’s risks in accordance with Washington law even when the drugs are advertised directly to consumers, the state’s Supreme Court ruled.
The ruling may have upheld the status quo, but it addresses a legal challenge that sought to shift the duty to inform consumers of side effects to the drug makers to keep up with changes to healthcare and increased direct-to-consumer advertising.
The U.S. District Court for the Western District of Washington asked the high court to rule whether there’s a direct-to-consumer advertising exception in a learned intermediary case involving a man who reportedly suffered a stroke and permanent disabilities after taking the erectile dysfunction drug Cialis.
The Supreme Court issued its ruling late last week.
“The policies underlying the learned intermediary doctrine remain intact even in the direct-to- consumer advertising context,” the court’s ruling states. “Further, existing state law sufficiently regulates product warnings and prescription drug advertising. Accordingly, we hold regardless of whether a prescription drug manufacturer advertises its products directly to consumers, the manufacturer satisfies its duty to warn a patient when it adequately warns the prescribing physician of the drug’s risks and side effects.”
The case is Dearinger et al v. Eli Lilly. In the lawsuit, plaintiff David Dearinger alleges that two hours after taking the prescription drug made by Eli Lilly and Co. to treat hyperplasia, pulmonary arterial hypertension, and erectile dysfunction, he suffered a hemorrhage that lead to a stroke.
The suit was filed in federal court under Washington’s Products Liability Act and it charges negligence, and claims Lilly knew or should have known Cialis presented a risk of stroke and failed to warn users of this risk.
Lilly moved to dismiss the complaint arguing it provided adequate warnings to Dearninger’s prescribing physician, pointing out that it was in accordance with the learned intermediary doctrine, a policy adopted by most states that places the responsibility of warning patients of the risks of prescribed medicines on prescribing physicians.
Dearinger countered an exception to this doctrine should be considered for drug makers who advertise directly to consumers. Since no Washington court had considered this exception, Dearinger moved for the U.S. District Court to certify a question to the high court asking if state law recognizes such an exception.
The Washington State Association for Justice Foundation filed an amicus curiae brief supporting Dearinger, and the Pharmaceutical Research and Manufacturers of America and the Washington Defense Trial Lawyers submitted briefs supporting Lilly.
The case centers on product liability, which is governed under the Washington Products Liability Act. The court in its ruling cited two past applicable decisions from 2017 and 1978 upholding the learned intermediary doctrine.
The act holds manufacturers liable for failing to provide warnings about a product if it harms a user, but this duty to provide warnings to patients under the learned intermediary doctrine is transferred to the doctor, “who is in a better position to communicate then to the patient,” according to the ruling.
“Courts applying the learned intermediary doctrine have done so without recognizing an exception,” the ruling states.
Dearninger has been reached out to for comment.
A Lilly spokesperson responded to a request for comment via email with the following statement:
“Lilly strongly believes the Court arrived at the correct decision by rejecting the plaintiffs’ request to recognize an exception to the learned intermediary doctrine in Washington. Physicians and other prescribers will continue to play a crucial role in and are responsible for ensuring that patients understand the risks and benefits of medications.”
Dearinger and the other interested parties in the case also argued that changes to healthcare and increased direct-to-consumer advertising should necessitate an exception to the learned intermediary doctrine.
The high court in its consideration of that argument referred to rationale in state law that physicians exercise independent judgment, patients primarily rely on this judgement, physicians decide what facts should be told to the patient and it’s difficult for drug makers to communicate directly with the consumer.
“By legal design, a physician must exercise independent judgement in prescribing medication, and a consumer must rely on this judgement in obtaining a prescription like Cialis,” the ruling states.
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