Who Do Drug Manufacturers Need to Warn? Washington Supreme Court Weighs In

Author: Shivani Bommakanty

Guest Editor: Grace Shuman

Related Articles: Product Liability, Washington

View More: Search articles by topic

July 12, 2022 12:54pm

 

The Washington Supreme Court recently held[1] the duty to warn requirements under the Washington Product Liability Act[2] (“WPLA”) are satisfied when drug manufacturers provide adequate warnings about the risks and side effects of a given drug to the prescribing physician, even if they also directly advertise to the consumer.  This decision was in response to a plaintiff’s request to certify a question to the Washington Supreme Court on whether Washington recognized an exception to the learned intermediary doctrine.

The court upheld the common law doctrine of the learned intermediary doctrine, which states a manufacturer satisfies their duty to warn when they provide warnings of a drug’s risks and side effects to the physician.  The Court agreed with the doctrine’s reasoning that due to their expertise and independent judgment, physicians are better suited to communicate warnings to patients when prescribing medicine, a physician has a direct relationship with the patient facilitating communication regarding the safety and risks of using a drug, and there are sufficient regulations related to product warnings and prescription drug regulations.  The court held that if adequate warnings are provided to physicians by the manufacturer, the duty to warn requirement under the WPLA is met, even when the manufacturer also advertises directly to consumers.

 

The Underlying Case

The case, Dearinger v. Eli Lilly,[3] involved a suit against Eli Lilly (“Lilly”), the manufacturer of Cialis.  Cialis is a drug used to treat prostate hyperplasia, erectile dysfunction, and pulmonary arterial hypertension.  The plaintiff sued Lilly under the WPLA for negligent design, negligent failure to warn, and a breach of warranty.   Specifically, plaintiff alleged Lilly failed to adequately warn of the risk of paralytic stroke in its direct advertisements to consumers.  After taking the drug, plaintiff suffered a paralytic stroke, causing him severe and permanent disabilities.

 

Duty to Warn

Under the learned intermediary doctrine, a manufacturer satisfies their duty to warn of the risks and side effects of a drug when they provide adequate warnings to physicians who are in a better position to convey the risks and benefits of a drug to their patients.  Plaintiff argued there is an exception to the learned intermediary doctrine, however, when the manufacturer directly advertises to consumers.  The court found there is no such exception in Washington reasoning the WPLA does not specify who should be warned by the manufacturer – it only creates a duty to warn.  Under common law, the learned intermediary doctrine allows the manufacturer to satisfy this duty if it has provided adequate warnings to the physician.  The Court found the WPLA did not abrogate or conflict with this common law doctrine, which is still valid.

 

The Holding

The court held whether adequate warnings were provided is a question of fact that must be determined by a jury.  FDA regulations address the adequacy of warnings on medical products which can be relied on by the jury to evaluate the adequacy of a given warning on a medical product.

 

Takeaway

Drug manufacturers can satisfy their duty to warn under the WPLA if they provide adequate warnings to physicians.  Physicians are the natural gatekeepers to consumers for prescription medication and obtain informed consent from their patients.  The practice of medicine and the distribution of prescription drugs are sufficiently regulated and designed to protect consumers of prescription drugs.  However, whether warnings provided to physicians are adequate is a question of fact to be considered by a jury.  Juries can rely on FDA regulations related to warnings in determining the adequacy of such warnings.

 

 

 


[1] Dearinger v. Eli Lilly, P.3d, 2022 WL178992 (Wash. June 2, 2022)

[2] RCW 7.72

[3] Dearinger v. Eli Lilly & Co., 2021 WL 2805328 (W.D. Wash. 2021)

Copyright © 2001–2022 Tyson & Mendes LLP. All Rights Reserved. Website by Big Behavior.