In Himes v. Somatics, LLC, No. S273887, 2024 WL 3059637 (Cal. June 20, 2024), the Supreme Court of California delivered a win to the defense, upholding the learned intermediary doctrine in cases involving prescription drugs and medical devices. But the opinion also sets out a new causation standard that may prove to be difficult to apply in future cases. Below we provide a summary of the underlying opinions and the Court’s explanation of the new causation standard.
Case Background: The plaintiff in Himes alleged that Somatics, a medical device manufacturer, failed to adequately warn of the risk of permanent brain damage and memory loss associated with its electroconvulsive therapy (ECT) device. The Central District of California granted summary judgment in favor of Somatics, concluding that the learned intermediary rule applied and the plaintiff failed to provide adequate evidence to establish that stronger warnings would have changed the physician’s decision to prescribe ECT.
On appeal, the Ninth Circuit affirmed that the learned intermediary doctrine applied but held that the outcome of this case turned on the proper causation standard for the plaintiff’s claims. The Ninth Circuit then certified the following question to the Supreme Court of California to seek clarity on the causation standard:
[W]hether 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, slip op. at 2 (quoting Himes v. Somatics, LLC, 29 F.4th 1125, 1127 (9th Cir. 2022)).
The Supreme Court’s Opinion: The Court squarely upheld the learned intermediary doctrine in response to plaintiff’s attempt to sidestep the causation issue. At oral argument, plaintiff argued that if the manufacturer fails to provide adequate warnings to the physician, then the manufacturer’s duty runs directly to the patient. The Court disagreed, noting that plaintiff’s argument would have rendered the learned intermediary doctrine meaningless. The Court went on to explain that “the learned intermediary doctrine is neither a defense nor an exception to a traditional duty rule, and it does not cease to apply where a plaintiff alleges that a manufacturer failed to provide an adequate warning to the patient’s physician.” Id. at 10. Rather, in cases involving prescriptions drugs or medical devices, the learned intermediary doctrine dictates that a manufacturer’s duty to warn runs to the prescribing physician, not the patient.
On the issue of causation, the plaintiff focused on the plaintiff’s state of mind, while Somatics focused on the physician’s. In the plaintiff’s view, causation solely depends on the plaintiff’s subjective testimony as to whether they would have declined the treatment in the face of a stronger warning. On the other hand, Somatics argued that the causation analysis turns only on the prescribing physician’s decision whether to recommend the treatment.
The Court rejected both positions. For starters, the plaintiff’s subjective test was rife with issues:
If a subjective test were used, a plaintiff could simply offer self-serving testimony asserting that he or she would have declined the recommended treatment after being informed of the risks. Subjectively, the plaintiff may believe this to be true “with the 20/20 vision of hindsight, but we doubt that justice will be served by placing the [defendant] in jeopardy of the patient’s bitterness and disillusionment.”
Id. at 27 (internal citations omitted). But the Court also rejected Somatics’ argument, acknowledging the importance of the physician’s judgment and advice to the causation analysis but finding that the ultimate decision of whether to proceed with treatment lies with the patient.
Ultimately, the Supreme Court took a compromise position, emphasizing the importance of both the physician and the patient in medical treatment decisions:
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.
Id. at 2. Throughout the opinion, the Court continually highlighted the importance of the physician’s role as the learned intermediary to the patient, ultimately describing the causation standard as a two-step process:
The causation analysis should therefore begin by determining what, if anything, the patient’s physician would have communicated to the patient regarding the relative risks and benefits of the prescription drug or medical device in response to a stronger warning, and should then turn to whether an objectively prudent person in the patient’s position would have declined the treatment even where the evidence shows that the physician’s treatment recommendation would have been unchanged by the stronger warning.
Id. at 24. Perhaps recognizing the loose nature of this standard, the Court attempted to further guide the analysis by proposing six factors that lower courts should consider when determining whether an objectively prudent patient would have declined the physician’s recommended treatment:
- 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; and
- Personal characteristics of the patient or circumstances unique to the patient.
Id. at 25. The above list is not meant to be exhaustive; courts can consider other relevant factors.
[View source.]
