Photo of Andrew Tauber

A federal court has asked the supreme court of Washington to address the scope of that state’s learned-intermediary doctrine. In particular, it has asked whether Washington recognizes a “direct-to-consumer” exception to the doctrine.

Under the learned-intermediary doctrine, which has been adopted by every state other than West Virginia, a manufacturer of a prescription medical product satisfies its duty to warn of the risks associated with the product if it provides adequate warning to prescribing physicians. In short, manufacturers of prescription medical products must warn doctors, not patients.

The doctrine’s rationale is straightforward:  Medical products available only by prescription have complex risk-utility profiles that are difficult for lay persons to evaluate. Trained in medicine, familiar with the medical history of individual patients, and legally obligated to obtain informed consent before administering a treatment, doctors are best positioned to warn individual patients of the relevant risks in an intelligible manner.

Given that rationale, the doctrine is generally limited to prescription medical products—i.e., products that can be lawfully obtained only through a doctor. Accordingly, it typically does not apply to over-the-counter products.

Over the years, plaintiffs have sought to limit the doctrine even further, arguing that it should not apply when the manufacturer markets a prescription medical product directly to consumers. With the lone exception of New Jersey, no state that recognizes the doctrine has restricted it in that way. That makes sense. Even if a prescription product is advertised to potential patients, it still can be obtained only through physicians, who have the knowledge and duty to convey the relevant warnings to their patients.

Granting a plaintiff’s motion to certify the question, a federal district court has now asked the Washington supreme court whether that state’s learned-intermediary doctrine applies when a prescription medical product is marketed to potential patients. Although it recognized that “[t]he vast majority of state courts that have considered the issue have concluded that … the ‘learned intermediary’ doctrine should apply” in such situations, it concluded that the issue has sufficiently “far-reaching public policy and legal implications” to warrant certification of the question. Dearinger v. Eli Lilly & Co., 2021 WL 2805328 (W.D. Wash. 2021).

State supreme courts commonly agree to answer certified questions. It is not clear, however, whether Dearinger actually implicates the certified question. Although the drug at issue, Cialis, is marketed to consumers, the plaintiff is challenging the adequacy of its FDA-approved patient-information insert rather than the manufacturer’s consumer marketing. If the state supreme court accepts the certified question, we should know its answer later this year or early next.