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The California Supreme Court issued its widely anticipated opinion on the learned intermediary rule the other day, and the opinion is worth the wait.  Based on the oral argument (which we reported on here), we did not expect the Supreme Court to enact a fundamental change to the learned intermediary doctrine, and the Court delivered.  The Court did not, for example, create any exceptions to the learned intermediary rule, nor did it alter the basic rule that a prescription medical product manufacturer’s duty to warn runs to prescribing physicians, and not directly to patients.  That’s the good news. 

The bad news is that the California Supreme Court’s unanimous opinion lowers the plaintiffs’ burden of proving warnings causation in a way that will only confuse things and lead to outright speculation. 

The issue before the Supreme Court in Himes v. Somatics, LLC, No. S273887, 2024 WL 3059637 (Cal. S. Ct. June 20, 2024) (to be published), was how plaintiffs in prescription medical product, failure-to-warn cases can meet their burden of proving warnings causation under California law.  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?  That is, whether said “prudent” person would have ignored his or her physician’s medical advice, given the stronger warning.

We won’t bury the lede.  Here is what the Supreme Court decided:

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. 

Himes, slip op. at 2.  Did you get that?  The question of whether inadequate warnings caused an injury still focuses on the warnings’ impact on the prescribing physician—the learned intermediary.  But the analysis does not begin and end there.  Now you need to go multiple steps further and ask whether the physician would have communicated a stronger warning to the patient, what form that communication would have taken, and whether that communication would have changed the patient’s decision to undergo treatment.

The causation inquiry therefore now involves hypothetical upon hypothetical and provides additional opportunities for plaintiffs to raise disputes of fact and for juries to speculate.  This is not a good development. 

To recap, the plaintiff in Himes alleged that the defendant medical device manufacturer did not adequately disclose to physicians that its electroconvulsive therapy device could cause various brain injuries.  Id. at 3.  A federal district court granted summary judgment because the prescribing physician had testified that a stronger warning from the manufacturer would not have altered his decision to prescribe the treatment.  Id. at 4.  The allegedly inadequate warning therefore did not cause the plaintiff’s alleged injury.  The Ninth Circuit approached it differently and found disputed facts on whether the prescribing physician would have passed along a stronger warning to the plaintiff.  Id. at 4-5.  Thus, in an opinion that we reported on here, the Ninth Circuit certified a question to the California Supreme Court asking for guidance on California’s warnings causation standard. 

Again, the California Supreme Court did not re-envision the learned intermediary rule.  Instead, the Court borrowed from the medical malpractice law and informed consent to acknowledge the patient in the decision-making process: 

Although we have long acknowledged that patients have “an abject dependence upon and trust in [their] physician[s] for the information upon which [they] rel[y],” we have also emphasized that “the decision whether or not to undertake treatment is vested in the party most directly affected: the patient.” . . .  Implicit in our informed consent rule is the recognition that patients will sometimes opt out of the medical treatments their physician recommend, as is their right.  If [the defendant] were correct that the physician’s prescribing decision is all that matters, . . . then there would be no need for the informed consent rule.

Id. at 14 (internal citations omitted).  The Court also emphasized, however, that physicians remain critical to the analysis:

That said, our holding does not remove the physician’s expertise from consideration in the causation analysis.  Instead, our holding takes into account the essential role of the physician’s recommendation in the patient’s treatment decision. . . .  The causation analysis must accordingly 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 and the treatment would still be in the patient’s best interests, notwithstanding the risks conveyed by a stronger warning. 

Id. at 16 (emphasis added).  The physician is not the sole consideration, but neither is the patient.  Because a patient cannot receive prescription treatment without a prescription, the physician will always serve to inform the patient and filter information that an ordinary patient would not understand, including a stronger warning.  The next block quote is kind of long, but it sums up the Supreme Court’s reasoning extremely well:

For this reason, the causation analysis cannot hinge solely on whether the risk conveyed in a hypothetical warning would have altered the physician’s assessment to such a degree that the physician would no longer recommend the treatment for the patient. But it also cannot turn solely on how the patient alone would have responded to the risk disclosed in the hypothetical stronger warning. This is because the risk of any hypothetical stronger warning would not have been conveyed directly to the patient. Instead, it would have been communicated to the patient by his or her physician who would have utilized his or her medical expertise to assess the risk and to recommend a course of treatment for the patient based on that assessed risk. . . . This is the physician’s function as an intermediary because, as the learned intermediary doctrine recognizes, if the warning were conveyed to the patient directly by the manufacturer, the patient might be inclined to reject even beneficial treatment.

Id. at 23-24.  The learned intermediary’s interaction with the patient is therefore built in: 

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.  We appreciate the Supreme Court’s reasoning, but we still think its new causation rule is off the mark.  The traditional formulation of the learned intermediary rule—under which causation turns on whether a stronger warning would have altered the physician’s prescribing decision—is both doctrinally sound and grounded in reality.  By comparison, the Supreme Court’s new rule relies on multiple hypotheticals and invites speculation on numerous levels.  We have always expected plaintiffs to articulate what the manufacturer’s stronger warning should have said.  But now we have to “determine” whether the physician would have passed on any part of the stronger warning, what he or she would have communicated, and whether and how that information would have affected the patient’s conduct. 

Spoiler alert:  Every plaintiff who has already experienced an alleged injury and is suing to collect money will say—always with 20/20 hindsight and often with a semblance of credibility—that he or she would have done something different or even declined treatment altogether.  Plaintiff lawyer minions whose job it is to defeat summary judgment are licking their chops. 

The California Supreme Court was clearly aware of this, so it listed (somewhat defensively) a series of factors relevant to whether an objectively prudent person would have declined physician-recommended treatment.  Those factors include, but are not 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; and the likelihood that the treatment would have resulted in more than marginal benefit to the patient.  [¶]  In addition, 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.

Id. at 25.  Listing these factors does not fix that the Court’s causation standard inevitably benefits the plaintiffs.  Worse yet, the rule encourages plaintiffs to claim that they would not have followed the medical advice they received, which can only erode the physician-patient relationship that the learned intermediary doctrine was created to preserve.  But at least we know where to start when drafting jury instructions.

There are many good points to emphasize from this opinion.  To start, the learned intermediary doctrine is alive and well in California, and it definitively applies to medical devices, if now subject to a squirrelly and over-engineered causation standard.  The plaintiffs in Himes trotted out the ridiculous argument that the learned intermediary doctrine should not apply at all and that the duty to warn should run to the patient—and only the patient—whenever the manufacturer has not provided sufficient warnings to physicians. 

The Supreme Court rejected this crazy talk as an “incorrect framing” of the issue, and it stated bluntly 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.”  Id. at 10.  This of course is the correct result.  If the learned intermediary rule evaporated whenever plaintiffs alleged inadequate warnings, it would never apply at all, since the plaintiffs in every failure-to-warn case allege that the warnings were inadequate.  We run into this argument fairly often, and having Himes’ persuasive and unanimous rejection of it will help, and not just in California.

Another positive is that the California Supreme Court erected an objective standard under which causation is measured by what an objectively prudent patient would do under the same circumstances.  The plaintiffs urged a subjective standard under which a patient could prove causation with his or own subjective testimony that he or she would have declined treatment in response to a stronger warning no matter what.  But the Supreme Court shot that down with equal bluntness:  “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.”  Id. at 27.  Of course, an objective standard is not the be-all and end-all that the Supreme Court makes it out to be.  Both subjective standards and objective standards are subject to severe hindsight bias.  The only difference is whose hindsight we’re talking about:  An allegedly injured plaintiff’s hindsight versus a jury’s hindsight in deciding what an objectively prudent person in the (injured) plaintiff’s position would have done upon receipt of medical advice weighing all the risks and benefits.  We are unsatisfied either way, but we will take the objective standard over the alternative.

The Supreme Court also recognized that prescription medical products are different from ordinary consumer products and rejected the plaintiffs’ argument that all products should be considered equal: 

[T]he learned intermediary doctrine recognizes that decision regarding whether to take a prescription drug or medical device are different from decision 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. 

Id. at 28.  Following oral argument, we noted that both sides were swinging for a home run, but that the Supreme Court was looking for a compromise double.  That is basically what they did.  Or maybe they just added extra bases to the playing field, while simultaneously making it easier for base runners to advance.  Whatever you call it, we will see how this plays out in practice.  We will still go through the ritual of asking physicians whether they read the warnings, whether they knew about the risks, and whether additional information about risks would have changed anything.  Our right honorable friends on the other side will still have their clients testify that they never would have used the drug or undergone the procedure “had they known” of the risks that allegedly befell them.  We will seek broader discovery into any other instances whether plaintiffs have ever rejected their physicians’ medical advice.  And we will still move for summary judgment.  More to come.