Courts across the country have long recognized the learned intermediary doctrine, which holds that a manufacturer of a prescription medication or medical device discharges its duty to warn by providing an adequate warning to the doctor. The doctor, in turn, has a separate duty to weigh the risks and benefits of a particular treatment and convey the appropriate risk information to the patient.
Under the learned intermediary doctrine, to succeed on a failure-to-warn claim, the plaintiff is typically required to come forward with affirmative testimony from the prescribing physician that the physician would have made a different treatment decision had she been provided with a different warning. While plaintiffs often argue that the plaintiff would have made a different treatment decision, most courts have held that this is irrelevant to the learned intermediary analysis. In Himes v. Somatics, LLC, 549 P.3d 916, 921 (Cal. 2024), the California Supreme Court may have just opened the door to this argument.
Background
The plaintiff in Himes filed claims against Somatics, LLC, the manufacturer of an electroconvulsive therapy (ECT) device, alleging that the company failed to adequately warn about the risks of permanent brain damage and memory loss associated with the use of its product. Somatics filed a motion for summary judgment based on the learned intermediary doctrine, arguing that plaintiff's claims must be dismissed because her prescribing physician's testimony made clear that he would not have changed his treatment decision based on additional risk information.1 The plaintiff made two arguments in response: First, she argued that the doctrine did not apply at all because the warnings to the doctor were inadequate.2 Second, she argued that even if the doctrine did apply, her claims survive summary judgment because, even though he still would have recommended the treatment, her doctor testified that he would have relayed a more detailed warning to his patients, and had he done so she would not have consented to treatment.3 The district court rejected both of the plaintiff's arguments, and granted Somatics' motion.4
On appeal, the Ninth Circuit likewise rejected the plaintiff's argument that the learned intermediary doctrine did not apply. But the court found that it was an open question under California law whether evidence that a warning would have triggered a different consent process can defeat summary judgment on the basis of that doctrine. In 2022, the Ninth Circuit certified the following question to the California Supreme Court:
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 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?5
California Supreme Court's Decision
This June, the California Supreme Court answered that question. The court held 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."6
The court based its decision in part on its informed consent case law, explaining that "the learned intermediary doctrine," like "[its] informed consent jurisprudence . . . affirms patient autonomy in medical treatment decisions," and a warnings causation standard that turned solely on the doctor's prescribing behavior would "wholly discount [that] essential role of patient choice."7 So while the court recognized the "essential role of the physician's recommendation," it concluded that it could not entirely discount the role of the patient either.8
Recognizing that plaintiffs will likely always contend that had the stronger warning been communicated to them, they would have refused treatment, the court adopted an "objective, prudent person" standard: "the test . . . is not determined by the plaintiff's subjective belief as to what he or she might have done with the benefit of hindsight" (emphasis added).9 To meet their causation burden on this new theory, then, a plaintiff must demonstrate that an objectively prudent person in their position would have declined treatment despite the physician's assessment that the benefits of treatment for the patient would outweigh the risks.
To guide this inquiry, the court provided a non-exhaustive list of factors to be considered, including:
- 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
- the personal characteristics of the patient or circumstances unique to the patient.10
Implications
Manufacturers no doubt may be concerned that California just eviscerated the learned intermediary doctrine. What plaintiff, after all, won't say with hindsight bias that she would have made a different decision? While this decision does provide plaintiffs asserting failure-to-warn claims based on prescription drugs or devices with an additional way to prove warnings causation, the learned intermediary doctrine remains alive and well in California. Of course, the extent to which this decision impacts a manufacturer's litigation risk depends on how it is interpreted and applied by lower courts, but there are several aspects of the Himes decision that limit its impact.
First, the California Supreme Court expressly endorsed the learned intermediary doctrine and its application to both prescription drugs and medical devices. The decision also reaffirmed the central role of the physician's treatment recommendation in any learned intermediary analysis. Indeed, to win, the plaintiff must produce evidence that an objectively prudent person would have rejected the treatment recommendation of her prescribing physician.
Second, the decision leaves intact other arguments available to defendants for challenging causation. For example, a plaintiff cannot defeat summary judgment based on this new theory if the doctor's decision to use the product was based on his or her independent knowledge of the risks at issue.11 Likewise, a defendant is still entitled to summary judgment if the doctor never read the warning, in which case a different warning wouldn't have made a difference.12
Third, the court addressed—and squarely rejected—an argument often urged by plaintiffs in failure-to-warn product liability cases involving prescription products: that the doctrine is inapplicable where the manufacturer fails to adequately warn the physician.13 The court rightly recognized that this would bypass the causation question by conflating the elements of causation and duty. As the court explained: "If the manufacturer fails in its duty to adequately warn a physician ... [that duty] does not transform, retroactively, into a duty to warn the patient. Instead, the manufacturer's failure to warn the patient's physician results in a breach of its general duty of care to the patient under negligence principles or a breach of its obligation to market a product free from defects under strict liability principles."14 But to prevail on their claims, plaintiffs must still prove that this breach caused their claimed injuries.15
Fourth, the issue addressed and decided by the California Supreme Court was a narrow one: whether a plaintiff can meet her causation burden based on affirmative evidence that:
- the doctor would have received a stronger warning,
- the doctor would have communicated that warning to the plaintiff, and
- that additional hypothetical risk information would have led an objectively prudent patient in plaintiff's position to decline treatment against the advice of their doctor.
In other words, because the plaintiff in Himes had elicited testimony from her prescribing doctor that he would have changed his consent processes based on Somatics' disclosure of additional risk information, the California Supreme Court did not have occasion to consider whether the plaintiff could have prevailed in the absence of such affirmative testimony.16 That said, the court clearly embraced that it is plaintiff's burden to prove causation, strongly suggesting that plaintiffs must adduce some affirmative testimony that their prescribing doctors would have altered their consent processes in order to avail themselves of this new theory: "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, and should then turn to whether an objectively prudent person in the patient's position would have declined the treatment ... In other words, the plaintiff must prove that an objectively prudent person in [their] 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."17
Finally, the court was careful to reject any suggestion that a plaintiff can defeat summary judgment simply by proffering a self-serving affidavit. Instead, the court adopted an objective standard: "The causation analysis must [ ] consider whether an objectively prudent person in the patient's position would have declined the treatment even where his or her physician would have advised the patient that the treatment would still be in the patient's best interest, notwithstanding the risks conveyed by a stronger warning."18 Accordingly, then, even if the prescribing physician would have changed her consent process based on a hypothetically stronger warning, if she would nonetheless have continued to recommend the treatment to the plaintiff, defendants may still argue that no objectively prudent patient would have declined treatment under the circumstances.
It remains to be seen how the court will apply the California Supreme Court's decision on remand. While it is hard to imagine that an "objectively prudent person" would ignore their physician's recommended course of treatment, it may be that courts become reluctant to weigh in at the summary judgment stage, making early case disposition more difficult to obtain.
Footnotes
1. Riera v. Mecta Corp., No. 2:17-CV-06686-RGK-JC, 2021 WL 2024688, at *3-5 (C.D. Cal. May 14, 2021).
2. Id. at *5.
3. Id.
4. Id. at *5-6.
5. Himes v. Somatics, LLC, 29 F.4th 1125, 1127 (9th Cir. 2022).
6. Himes v. Somatics, LLC, 549 P.3d 916, 921 (Cal. 2024).
7. Id. at 926.
8. Id. at 927.
9. Id. at 921
10. Id. at 931.
11. See id. at 929.
12. See id. at 924 & n.1.
13. See id. at 924-25.
14. Id. (citations omitted).
15. See id.
16. See id. at 924 ("The Ninth Circuit [ ] found that there is a genuine dispute of material fact as to whether Himes's physician 'would have learned of stronger warnings and communicated them to [her]. We therefore address here only whether a plaintiff may establish causation by showing that, had the manufacturer provided an adequate warning to the patient's physician, the physician would have relayed the warning to the patient and an objectively prudent person in the patient's position would have rejected the treatment, notwithstanding the fact that the patient's physician still would have recommended the treatment." (internal citation omitted; emphasis added).
17. Id. at 930 (first emphasis added).
18. Id. at 927
Originally published by Pharmaceutical Online
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