The Ninth Circuit has certified a question to the California Supreme Court on the learned intermediary doctrine that immediately caught our attention:  In a failure-to-warn claim against a prescription medical product manufacturer, is the plaintiff required to show that a stronger warning would have altered the physician’s decision to prescribe the product?  Or can the plaintiff establish causation by showing that the physician would have informed the plaintiff of the stronger warning and that a prudent person in the patient’s position would have declined treatment?

It’s an important question.  Time and again, we have seen cases where there is no evidence that stronger warnings would have had any impact on the physician’s prescribing physician, which should be, and often is, the basis for summary judgment under the learned intermediary doctrine.  The essence of the doctrine is that a prescription medical product manufacturer’s duty to warn runs to the physician—the learned intermediary—not the patient.  Thus, if there is no evidence that stronger warnings would have had an impact on the physician, the plaintiff cannot prove that an alleged inadequacy in the warnings caused his or her injury.  We have written on this more times than we can count, including for example here, here, and here.

But what about cases where the plaintiff says, sure a stronger warning would not have influenced my doctor, but what about me?  If my doctor had informed me, I would not have consented to the treatment.

The Ninth Circuit recently confronted a version of this scenario in Himes v. Somatics, LLC, No. 21-55517, 2022 WL 983176 (9th Cir. Apr. 1, 2022) (to be published in F.4th), and Himes v. Somatics, LLC, No. 21-55517, 2022 WL 989469 (9th Cir. Apr. 1, 2022) (unpublished).  In Himes, two plaintiffs sued a manufacturer of electroconvulsive therapy devices, alleging that the defendants failed adequately to warn against risks like memory loss.  The district court granted summary judgment against both plaintiffs and ruled (1) that the learned intermediary rule applied and (2) absent evidence that stronger warnings would have affected the physicians’ decisions to prescribe the electroconvulsive therapy, the plaintiffs’ claims failed as a matter of law.  Himes v. Somatics, LLC, No. 21-55517, 2022 WL 989469, at *1.  These are tried-and-true applications of California’s learned intermediary rule.

On appeal, the Ninth Circuit had a slightly different take.  The court quickly rejected the plaintiffs’ contention that the learned intermediary doctrine does not apply when the manufacturer has not provided sufficient warnings to physicians.  Plaintiffs in failure-to-warn cases always allege that the manufacturer’s warnings were not sufficient, and the learned intermediary rule is designed to address exactly that situation.  The Ninth Circuit agreed with this and observed that the plaintiffs were essentially asking the court to write the learned intermediary rule out of California law.  Id. (“Because the adequacy of warnings is always challenged in failure-to-warn claims, ‘[i]f the learned intermediary rule became inapplicable when a plaintiff alleged that warnings were inadequate, the doctrine would never operate in California.’”) (quoting Sanchez v. Bos. Sci. Corp., 38 F. Supp. 3d 727, 734 (S.D. W. Va. 2014) (applying California law)).

Having ruled that the learned intermediary doctrine applied, the Ninth Circuit confronted the proper standard for warnings causation under California law, and on that point, the evidence for the two plaintiffs diverged.  For one plaintiff, the physician never reviewed the manufacturer’s warnings.  As a result, it was clear that the plaintiff could not prove that different or additional information would have affected the physician’s prescribing decision because “a reasonable jury could not find that [the] treating physician . . . would have known about any stronger warnings issued by [the defendant].”  Id. at *2.

For the second plaintiff, the physician testified that he paid attention to communications from manufacturers regarding safety risks and that he would include information about those risks in his patient consent process.  Id. at *2-*3.  Thus, even though there was no evidence that a stronger warning would have altered the physician’s prescribing decision, it was conceivable that a stronger warning might have influenced a patient’s decision to grant informed consent.  Is this enough to prove warnings causation?

The Ninth Circuit didn’t know:

The resolution of this appeal turns on the proper causation standard applied to [the plaintiff’s] claim.  If the district court and [the defendants] are correct that in failure-to-warn claims, a plaintiff must show that stronger manufacturer warnings would have altered the physician’s prescribing conduct, [the plaintiff’s] claims fail.  If, on the other hand, a plaintiff can establish causation by showing that a physician would have communicated the stronger warning to the patient and that a prudent person in the patient’s position would have declined the treatment after receiving the stronger warning, [the plaintiff’s] claims survive summary judgment.

Id. at *3.  The Ninth Circuit certified the issue to the California Supreme Court for determination in a separate, published order.  Himes v. Somatics, LLC, 2022 WL 983176.

We will see how the California Supreme Court rules, but one thing is for sure.  Plaintiffs cannot prove warnings causation with self-serving, after-the-fact declarations stating subjectively that they would not have consented to therapy “had they known” about purported additional risks.  The below quote from the Ninth Circuit is kind of long, but really important (even if buried in a footnote):

We disagree with the appellants’ [plaintiffs’] contention that in establishing causation through warnings, the effect of a stronger warning on a patient could be determined through the patient’s subjective post-hoc declaration.  As the Supreme Court of California has explained in the physician failure-to-inform context, “[s]ince at the time of trial the uncommunicated hazard has materialized, it would be surprising if the patient-plaintiff did not claim that had he been informed of the dangers he would have declined treatment.  Subjectively he may believe so, with the 20/20 vision of hindsight, but we doubt that justice will be served by placing the physician in jeopardy of the patient’s bitterness and disillusionment. . .  .”  We thus conclude that if it were possible to establish causation through warnings communicated to the patient by the physician, the effect on the patient must be determined based on what a prudent person in the patient’s position would have done with the benefit of stronger warnings.

2022 WL 989469, at *3 n.3 (emphasis added).  In other words, if the impact of additional warnings on a patient (as opposed to a physician) can form the basis for warnings causation, it could only be under an objective standard.  The key phrase is “prudent person in the patient’s position.”  Anyone who has experienced an alleged injury can convince himself or herself in retrospect that he or she would not have consented “had they known.”  If that statement could break the warnings causation chain, then that too would essentially write the learned intermediary doctrine out of California law.  The Ninth Circuit correctly did not bite, and neither should the California Supreme Court.  We will keep you posted.