Does Rx Advertising to Consumers Create an Exception to the Learned Intermediary Doctrine?

Under the learned intermediary doctrine, a prescription drug manufacturer satisfies its duty to warn patients of a medicine’s risks when it adequately warns the prescribing doctor. In this case the Supreme Court of Washington State was asked to decide whether state law recognizes an exception to the learned intermediary doctrine if the manufacturer advertises its prescription drug directly to consumers.

Just the Facts: The patient alleged that he suffered a hemorrhage leading to a stroke causing permanent disabilities within two hours of taking Cialis, which its manufacturer, Eli Lilly and Co. had been advertising to consumers. The patient sued the manufacturer claiming that Lilly knew the risk of stroke and failed to adequately warn users of the risk. The manufacturer moved to dismiss, claiming that it provided adequate warnings to the patient’s prescribing physician under the learned intermediary doctrine. In response, the patient claimed that there is an exception to the learned intermediary doctrine for prescription drug manufacturers who advertise direct to consumers. The court agreed to consider this issue.

The Court Decides: The court noted that the learned intermediary doctrine has been part of Washington law since 1978, and an exception to it has never been recognized. The court noted that it has consistently reiterated the “central principle that a manufacturer satisfies its duty to warn patients of product risks by warning the prescribing physician, who then takes on the responsibility of communicating those warning to the patient.” The court declined the patient’s request to carve out an exception to the learned intermediary rule. It offered a 4-part rationale for this decision: “1) physicians exercise independent judgment, 2) patients primarily rely on a physician’s independent judgment, 3) the physician decides what facts should be told to the patient, and 4) it is difficult for a manufacturer to communicate directly with the consumer.” The court concluded that “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.”

The Take Away: Be aware that every state in the country (plus the District of Columbia and Puerto Rico) has adopted the learned intermediary doctrine in some form, putting the onus on doctors to convey medication warnings. Most courts have held that the learned intermediary doctrine also protects pharmacists and pharmacies, but some courts have held that pharmacists have a duty to warn in certain circumstances, such as known contraindications, or clear errors on the face of the prescription.

Source: Certification From the United States Dist. Court v. Eli Lilly & Co. 510 P.3d 326 (Wash. 2022) - https://casetext.com/case/certification-from-the-united-states-dist-court-v-eli-lilly-co