California Supreme Court Hears Argument On Learned Intermediary Doctrine

We observed oral argument the other day before the California Supreme Court in Himes v. Somatics, a case that places California’s learned intermediary doctrine squarely in the spotlight.  A learned intermediary case before the California Supreme Court?  For your ever-vigilant DDL bloggers, that is like Thanksgiving and Christmas wrapped into one! 

Who will be giving thanks after the California Supreme Court decides Himes?  We don’t know, but it sure was a good show.

To recap, Himes is before the California Supreme Court on a question certified from the Ninth Circuit.  As we detailed here, the issue is 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? 

Our initial take on these issues still applies: 

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. . . .

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.

An engaged California Supreme Court confronted the issues with aid of highly capable counsel, both of whom were swinging for the fences.  What do we mean by that?  Well, the questions certified to the California Supreme Court were couched in terms of the plaintiff’s causation burden.  So we were surprised when the plaintiff’s counsel spent most of his time arguing 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.    

That’s just crazy talk.  Plaintiffs in failure-to-warn cases always allege that the manufacturer’s warnings were not sufficient.  The plaintiff’s argument therefore would essentially read the learned intermediary doctrine out of the law.  Or, as the Ninth Circuit held when it certified the questions, “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.’” Himes v. Somatics, LLC, No. 21-55517, 2022 WL 989469, at *4 (9th Cir. Apr. 1, 2022) (quoting Sanchez v. Bos. Sci. Corp., 38 F. Supp. 3d 727, 734 (S.D. W. Va. 2014) (applying California law)).

That, however, is where counsel placed his marker, with emphasis on respecting and preserving patient autonomy.  Counsel even went so far as to assert that the California Supreme Court had endorsed this view in TH v. Novartis, the California case that adopted innovator liability.  Justice Kruger interrupted at this point to assert that TH v. Novartis did not really hold that and did not decide that issue.  She posited instead that there are different kinds of duties, and that a prescription medical product manufacturer can discharge its duty to warn by warning physicians—the learned intermediaries—who are best positioned to communicate warnings to patients.  Is there not an intermediate step that should consider what a reasonably prudent doctor would tell his or her patient? 

Counsel replied no, the consumer has the right to know the risks.  Justice Corrigan agreed, but asked how the Court should ensure as a matter of policy that the patient actually would know if not through a learned intermediary.  How would a duty running directly to the patient work?  Counsel replied that the manufacturer could fulfill its duty with direct-to-consumer advertising, which provoked some skepticism.  Justice Corrigan noted that the fulfillment of a medical product manufacturer’s duty to warn should not depend on what she watches on TV.  Justice Jenkins observed that counsel was suggesting a solution that was “antithetical” to the learned intermediary doctrine, which acknowledges that physicians are in the best position to advise their patients regarding the risks of treatment.  The plaintiff wanted the manufacturer to take on that duty.

Counsel argued that a manufacturer would take on that duty only if it were negligent in warning physicians.  There is that crazy talk again.  If a manufacturer provides adequate warnings, there is no liability and no need for any learned intermediary rule in the first place.  In other words, the plaintiff’s argument would render the learned intermediary rule superfluous—if the manufacturer failed to provide adequate warnings, it owes a duty directly to the patient; but if it gave adequate warnings, there is no need for the doctrine at all.  Either way, the learned intermediaries may as well go for a cup of coffee, because they don’t matter anymore.   

Justice Groban picked up on this apparent inconsistency:  The plaintiff was arguing that the physician should be part of the equation through informed consent, but that when it came to warnings causation, only the plaintiff’s decision-making process mattered.  Finally, we get to causation, and counsel argued that it was a decision for the jury.  The jury could hear from the physician and hear from the plaintiff, and then decide for itself whether the plaintiff would have consented to the treatment if the manufacturer had given the physician a stronger warning.  Justice Groban observed (as we have in multiple blogposts on this topic) that the plaintiff would win 100 percent of the time, because plaintiffs will always say that, “had they known” of the risk, they would not have granted consent. 

The balance of the plaintiff’s time was spent on whether the standard should be an objective standard or a subjective standard.  Should the plaintiff have to prove that a stronger warning would have altered the decision of a reasonably prudent patient under similar circumstances?  Or can plaintiffs meet their burden with their own subjective, 20/20 hindsight testimony that they would have declined treatment had the manufacturer provided a stronger warning? 

Counsel argued that the standard should always be subjective, subject only to the jury’s right to not believe the plaintiff.  Multiple justices tested this, asking for example whether an objective, reasonably prudent standard would adequately preserve the plaintiff’s remedy, as it does in medical malpractice cases.  Justice Evans asked how it would work with exceedingly rare side effects that physicians would not reasonably be expected to communicate to patients.  Counsel answered that it was all for the trier of fact, with the patient’s testimony subject to cross examination, just like in any other product liability case. 

That led to probably the most on-point observation of the day:  Justice Kruger noted that consumers purchasing the “average consumer product” are in a different position from patients seeking medical treatment from physicians—i.e., learned intermediaries. 

Defense counsel started by asking the Court to hold that a plaintiff in a failure-to-warn claim must offer evidence that a stronger warning would have altered the physician’s prescribing decision.  Remember how we said that both sides swung for the fences?  This is the defense version.  It is the traditional and most analytically sound restatement of the learned intermediary rule, under which the warnings causation inquiry begins and ends with the prescribing physician.  We happen to agree with this rule, since it is most faithful to how prescription medical care is actually provided, and it is the only way to invest responsibility for warning patients with the party in the best position (or even the only position) to do so—the prescribing physician.  It also happens to be the rule followed in the vast majority of jurisdictions. 

The California Supreme Court tested this argument, too.  Justice Kruger asked, in a couple of different ways, whether a rule that focuses on physicians needs also to leave room for patient autonomy.  Counsel acknowledged the importance of patient autonomy, but emphasized that there are multiple competing concerns.  These are prescription drugs that patients cannot decide to take on their own.  They need prescriptions, and physicians are not mere gatekeepers—they are learned intermediaries.  The warnings are directed to them, and they apply their experience and training to interpret those warnings for patients.  It would be speculation under these circumstances to allow patients to prove causation with their own subjective, hindsight testimony that they would not have consented to the treatment had they known all the risks.  Counsel also emphasized that the Court should presume that physicians will listen to their patients when making prescribing decisions, which further protects patient autonomy. 

The core of the defense argument was this:  Allowing plaintiffs to prove warnings causation with evidence of a stronger warning’s purported impact on patients, as opposed to physicians, comes at a cost.  Liability for prescription medical device manufacturers will be subject to significant hindsight bias, under which plaintiffs who have already suffered injuries will always say that they would not do it again.  Extending the duty to warn to patients, even indirectly, will also result in overwarning, which will not improve outcomes and threatens real harm to patients who will forego treatment.  Liability will rely on speculation—instead of looking at a prescribing physician’s actual practices, we will instead base liability on the speculative impact of a hypothetical stronger warning on a patient’s conduct years after the fact. 

Justice Corrigan noted that the Court understood all that, but would it not be sufficient to instruct a jury that it should decide causation under a reasonably prudent standard.  Counsel replied no, because that would build a house of cards.  The jury would have to consider what a reasonably prudent physician would have told a patient if the manufacturer had provided a stronger warning.  Then, it would have to consider the impact of that hypothetical conversation on the patient in a but for world.  And a jury is susceptible to same hindsight bias as the plaintiff.  The Court should instead do what other courts have done and look at what the prescribing physician actually did with knowledge of the risk.  That is not speculation. 

Justice Groban was struck by the parties’ stark positions.  The plaintiff was arguing that only the patient’s decision-making process mattered and that the learned intermediary rule should not apply at all.  The defendant was arguing that only the physician’s decision-making process mattered.  Both were degrading the notion of informed consent, which is a dialogue under which the patient makes a decision.  Was defendant presenting the “physician as god” and saying that the patient is irrelevant?  Counsel replied that the plaintiff’s argument was presenting the “lawyer as god” in a world where manufacturers would rarely, if ever, win summary judgment.  (Again, counsel for both sides were high quality, but we have to say, the “lawyer as god” retort was pretty good.) 

Multiple justices questioned counsel on whether they should be cutting the patient out of the equation and whether the traditional formulation of the learned intermediary rule would leave patients without a remedy.  Justice Kruger again came back to the objective standard:  Why is an objective standard not the solution to hindsight bias, as it is in medical malpractice cases?  Counsel replied that patients would still have sufficient remedies, including potentially against their physicians. And, we don’t need an objective standard because we can look at the actual conduct of prescribing physicians and whether they continued to prescribe the product to their patients, even when aware of the risk. 

Entertaining arguments all around, and we have a few observations with which to close.  First, we will say again (as Justice Groban observed) that counsel on both sides were going for the home run.  The Court was looking more for a double, a compromise position that would acknowledge meaningful roles for both the patient and the physician in the decision making process.  We imagine the Court’s draft opinion reflects this evident, even obvious desire for a middle ground, wherever that may lie. 

Second, we will not hazard a guess at the outcome, but we would be shocked if the Court were to hold that the learned intermediary doctrine evaporates when the manufacturer fails adequately to warn the physician.  The learned intermediary doctrine exists because plaintiffs allege that manufacturers have failed adequately to warn, and it sets the standard for proving causation where the warnings are directed to the learned intermediary, not the patient.  Crazy talk.  We do not think the Court is rethinking the learned intermediary doctrine on a fundamental level.  It will likely stick to the certified questions and tell us what to do with warnings causation. 

Third, we would also be surprised if the Court embraced a subjective standard, under which a plaintiff could get to a jury, in every case, with her own hindsight testimony that she would not have consented to treatment if she had known about a risk that she has already experienced.  The Ninth Circuit rejected that view when it certified the questions to the California Supreme Court, and the Court’s multiple acknowledgements that it understands hindsight bias and such suggest that it will reject a subjective standard, too. 

We expect an opinion within 90 days.  We will keep you posted.