The Learned Intermediary Doctrine
In the context of prescription drugs, the learned intermediary doctrine provides that the drug manufacturer satisfies its duty to warn the patient of the risks of its product where it properly warns the prescribing physician. In other words, the manufacturer’s duty to provide warnings to patients transfers to the doctor, who is in a better position to communicate them to the patient.
The Washington Supreme Court explained: “Under the learned intermediary doctrine, a prescription drug manufacturer satisfies its duty to warn patients of a drug’s risks when it adequately warns the prescribing physician. The United States District Court for the Western District of Washington ask[ed] us via certified question whether Washington law recognizes an exception to the learned intermediary doctrine when a prescription drug manufacturer advertises its product directly to consumers. We answer this question in the negative: there is no direct-to-consumer advertising exception. The policies underlying the learned intermediary doctrine remain intact even in the direct-to-consumer advertising context. 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 Underlying Facts
Plaintiff David Dearinger alleged that he suffered a hemorrhage leading to a stroke that caused him permanent disabilities less than two hours after consuming Cialis. Cialis is a prescription drug manufactured by defendant Eli Lilly and Co. (Lilly) to treat prostatic hyperplasia, pulmonary arterial hypertension, and erectile dysfunction. Dearinger sued Lilly in federal court under the Washington products liability act (WPLA), chapter 7.72 RCW, for negligent design, negligent failure to warn, and breach of warranty. The theory central to Dearinger’s claims is that Lilly knew or should have known Cialis presented a risk of stroke to its users and failed to adequately warn users of this risk. Ganna Dearinger, Dearinger’s wife, also brought a claim for loss of consortium.
Lilly moved to dismiss the complaint, claiming it provided adequate warnings to Dearinger’s prescribing physician under the learned intermediary doctrine. In response, Dearinger claimed there is an exception to the learned intermediary doctrine for drug manufacturers who advertise directly to consumers. Since no Washington court had considered this exception, Dearinger moved for the United States District Court to certify a question to the Washington Supreme Court asking whether Washington law recognizes such an exception, which the court granted.
Source Dearinger v. Eli Lilly and Company, No. 99956-2.
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