California Supreme Court Watch

#22-157 Himes v. Somatics, LLC, S273887. (9th Cir. No. 21-55517; 29 F.4th 1125; Central District of California; D.C. No. 2:17-cv-06686-RGK-JC.) Request under California Rules of Court, rule 8.548, that this court decide questions of California law presented in a matter pending in the United States Court of Appeals for the Ninth Circuit. The questions presented are: “Under California law, in a claim against a manufacturer of a medical product for a failure to warn of a risk, is the plaintiff required to show that a stronger risk 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 risk warnings to the plaintiff, either in [] patient consent disclosures or otherwise, and a prudent person in the patient’s position would have declined the treatment after receiving the stronger risk warning?”

Request for certification granted: 6/15/2022

Case fully briefed: 10/20/2022

Cause argued and submitted: 4/03/2024

Opinion published: 6/20/2024

See the Order Certifying Question to the Supreme Court of California.

See the Oral Argument.

See the California Supreme Court Opinion.  (Himes v. Somatics, LLC (2024) 16 Cal.5th 209.)

“This case involves a question not of duty, but of causation: If a prescription drug or medical device manufacturer has breached its duty under the learned intermediary doctrine to provide an adequate warning (or any warning at all) to the physician, how must the plaintiff prove that the failure to warn caused his or her injury? We granted a request from the United States Court of Appeals for the Ninth Circuit to determine whether the plaintiff is ‘required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product,’ or whether the plaintiff may instead establish causation ‘by showing that the physician would have communicated the stronger risk warning[] to the plaintiff, either in their patient consent disclosures or otherwise, and a prudent person in the patient’s position would have declined the treatment after receiving the stronger risk warning.’ (Himes v. Somatics, LLC (9th Cir. 2022) 29 F.4th 1125, 1127 (Himes).)

We answer these questions as follows: A plaintiff is not required to show that a stronger warning would have altered the physician’s decision to prescribe the product to establish causation. Instead, a plaintiff may establish causation by showing that the physician would have communicated the stronger warning to the patient and an objectively prudent person in the patient’s position would have thereafter declined the treatment. The causation analysis, however, must take into consideration whether the physician would still recommend the prescription drug or medical device for the patient, even in the face of a more adequate warning. In other words, where the evidence shows that the physician would have continued to recommend the treatment notwithstanding the stronger warning, the plaintiff must prove that an objectively prudent person in the patient’s position would have declined treatment despite the physician’s assessment that the benefits of the treatment for the patient would still outweigh any risks disclosed by a stronger warning. As in the informed consent context, the test is what an objectively prudent person in the patient’s position would have done in light of all the information presented and is not determined by the plaintiff’s subjective belief as to what he or she might have done with the benefit of hindsight. (See Cobbs v. Grant (1972) 8 Cal.3d 229, 245 (Cobbs).)

…

We therefore conclude that the Ninth Circuit was right to adopt the objectively prudent person in the patient’s position test set forth in Cobbs.”

Justice Groban authored the opinion of the Court, in which Chief Justice Guerrero and Justices Corrigan, Liu, Kruger, Jenkins, and Evans concurred.

In the news: Pierson, Doctor’s recommendation does not bar patient’s lawsuit over device -California top court, Reuters (June 21, 2024).