Ninth Circuit Asks California Supreme Court to Clarify the Causation Standard Applicable When the Learned Intermediary Doctrine Applies

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How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff required to show that the stronger warning would have altered the physician’s decision to prescribe the product? Or may the plaintiff establish causation by showing that the physician would have communicated the stronger warnings to the patient and that a prudent person in the patient’s position would have declined the treatment as a result?

The Ninth Circuit isolated this undefined causation standard in Himes v. Somatics, LLC, and certified the question to the California Supreme Court. After confirming that the learned intermediary doctrine is alive and well in California and that a failure to warn claim cannot survive when the learned intermediary does not read the warnings at all, the Ninth Circuit stopped short of defining the causation standard that applies when a learned intermediary does read the warnings.

These questions arose in a two-plaintiff case involving an electroconvulsive therapy (ECT) product. See Himes v. Somatics, LLC, 2022 WL 989469 (9th Cir. Apr. 1, 2022). The plaintiffs alleged that the manufacturer failed to warn about the risks of permanent memory loss, inability to formulate new memories, and brain damage. One plaintiff’s claim clearly failed for lack of causation because his treating physician testified that he did not pay attention to information or warnings provided by the manufacturer. When the learned intermediary does not read the warnings, there can be no causal nexus between the allegedly inadequate warning and the plaintiff’s injury.

But the treating physician for the other plaintiff, Michelle Himes, testified that he did pay attention to information from manufacturers and that he included warnings from manufacturers in his patient consent forms and discussed manufacturers’ disclosed risks with patients. Importantly, Himes’s treating physician testified that although more stringent warnings would not have altered his prescribing practices, he would have passed them along to his patients. Himes argued on appeal that if this treating physician had received a stronger warning and passed it on to her, she would not have undergone ECT and that, because no prudent person in her position — without the benefit of hindsight— would disagree, summary judgment should be denied.

No California court has articulated the contours of the causation standard under similar facts — where the treating physician would have learned about the stronger warning from the manufacturer and passed them along to the patient without changing his treatment decision, but the plaintiff claims that the stronger warning would have changed a prudent patient’s treatment decision. The Ninth Circuit recognized this issue implicated important policy concerns and certified the issue to the California Supreme Court. Himes v. Somatics, LLC, 2022 WL 983176 (9th Cir. Apr. 1, 2022).

The California Supreme Court now has discretion to accept the question as written, restate it, or deny the request. We will continue to follow this, and if the California Supreme Court weighs in, you can read about it here.

About the Author: Adrienne Franco Busby

Adrienne Franco Busby puts science and strategy to work for companies facing product liability litigation. She is an experienced litigator in product liability, commercial, employment, class action and mass tort matters.

About the Author: Stephanie A. Koltookian

Stephanie A. Koltookian is a Products Liability associate residing in our Des Moines, Iowa office. Stephanie focuses on medical device products liability defense.