As we reported in April, the United States Court of Appeals for the Ninth Circuit certified a question on California’s Learned Intermediary Doctrine in Himes v. Somatics, LLC, 2022 WL 989469 (9th Cir. Apr. 1, 2022). The California Supreme Court has now decided the issue in a way that walks the middle ground. On the one hand, the court rejected plaintiff’s call for recognizing an exception to the learned intermediary rule and reaffirmed the basic rule that a manufacturer’s duty to warn runs to the prescribing physician. On the other hand, the court ultimately lowered plaintiff’s burden of providing warnings causation. The opinion has clear ramifications not only on dispositive motion and trial practice, but on discovery strategies in prescription drug and medical device cases.

The question before the court was whether a plaintiff is “required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product,” or whether a 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, 16 Cal.5th 209 (2024).)

The California Supreme Court answered by holding that “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.”

In deciding this, the court held that the causation analysis must take into consideration whether the physician would still recommend the prescription drug or medical device for the patient, even in the face of the stronger 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 also 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.

Recognizing that every plaintiff would likely argue that they would have declined treatment had they received the stronger warning, the California Supreme Court provided a series of factors relevant to whether an objectively prudent person would have declined the physician recommended treatment. The relevant factors include, but are not necessarily limited to:

• Whether the physician weighed and assessed the risks and benefits of the treatment and, after discussing those risks and benefits with the patient, continued to recommend the treatment
• Whether the treatment was novel or was instead an established method for addressing the patient’s condition
• The availability and utility of alternative treatments and the degree to which they have previously been tried in an effort to address the patient’s condition
• The severity of the patient’s condition
• The likelihood that the treatment would have resulted in more than marginal benefits to the patient

However, the court allowed some subjective factors to bled into the “objectively prudent person standard,” holding “personal characteristics of the patient or circumstances unique to the patient should be taken into account when applying the objectively prudent person in the patient’s position standard.”

Although this new standard may encourage plaintiffs to claim they would not have followed the advice of their physician, there are positive outcomes from this decision. First, it concretely applies the learned intermediary doctrine to medical devices. Second, the decision rejected the plaintiff’s request that, in the face of an inadequate warning, the manufacturer should warn the patient directly, thereby attempting to eliminate the learned intermediary doctrine. The court also rejected plaintiff’s proposal for a subjective causation standard and instituted an objective standard. Finally, the court recognized that prescription medical products are different from ordinary consumer products:

The learned intermediary doctrine recognizes that decisions regarding whether to take a prescription drug or medical device are different from decisions regarding whether to buy or use a consumer product. Consumers may reasonably expect consumer products to be safe when used as intended, but ‘a patient’s expectations regarding the effects of [a prescription] drug [or medical device] are those related to him [or her] by his [or her] physician.’ In addition, whereas consumer products are generally used for personal convenience or pleasure, prescription drugs and medical devices are often necessary to ensure the health of the patient. Physicians accordingly do not discuss the risks of treatment in isolation, but rather discuss them alongside the benefits of treatment as well as the risks of foregoing treatment altogether.

Both prescription drug and medical device manufacturers can continue to cite the learned intermediary doctrine confidently when defending against failure to warn claims. However, defendants should expand their discovery focus to include not only whether a physician would have chosen to pass on the specific warning urged by a plaintiff but also whether an “objectively prudent person” would have declined the recommended treatment if given that warning, being mindful of the factors that the court cited in Himes. Defendants should also be mindful of evidence in a plaintiff’s medical history that could affect the objective standard, such as prior examples of plaintiff ignoring physicians’ recommended treatment and prior treatment history.