Himes v. Somatics

322 Cal.Rptr.3d 1

549 P.3d 916

Michelle HIMES, Plaintiff and Appellant,

v.SOMATICS, LLC, Defendant and Respondent.

S273887

Supreme Court of California.

June 20, 2024

Ninth Circuit, 21-55517, Central District of California, 2:17-cv-06686-RGK-JC

Baum, Hedlund, Aristei & Goldman, Wisner Baum, Bijan Esfandiari, Los Angeles, Monique Alarcon, Santa Monica, and R. Brent Wisner, Los Angeles, for Plaintiffs and Appellants,

Poole Shaffery & Koegle, Jason A. Benkner, David S. Poole, Santa Clarita, Samuel Roy Weldon Price; Wiggin and Dana, Jonathan M, Freiman and Ariela C. Anhalt for Defendant and Respondent.

Cole Pedroza, Curtis A. Cole and Cassidy C. Davenport, San Marino, for California Medical Association, California Dental Association and California Hospital Association as Amici Curiae on behalf of Defendant and Respondent.

Gonzalez Government Consulting, Cher Gonzalez and David Gonzalez, Santa Ana, for California Life Sciences as Amicus Curiae on behalf of Defendant and Respondent.

Covington & Burling, Ashley M. Simonsen, Los Angeles, Michael X. Imbroscio, Paul W. Schmidt and Gregory L. Halperin for Pharmaceutical Research and Manufacturers of America as Amicus Curiae on behalf of Defendant and Respondent.

Faegre Drinker Biddle & Reath and Alan Lazarus for The Product Liability Advisory Council, Inc., as Amicus Curiae on behalf of Defendant and Respondent.

Fred J. Hiestand for The Civil Justice Association of California as Amicus Curiae on behalf of Defendant and Respondent.

Kellogg, Hansen, Todd, Figel & Frederick, Reid M. Figel, Aaron M. Panner, Mark. P. Hirschboeck and E. Perot Bissell for American Psychiatric Association as Amicus Curiae.

Opinion of the Court by Groban, J.

In a typical products liability case, a manufacturer owes a duty to warn the end user "about the hazards inherent in their products." (Johnson v. American Standard, Inc. (2008) 43 Cal.4th 56, 64, 74 Cal.Rptr.3d 108, 179 P.3d 905.) For manufacturers of prescription drugs and many medical devices, however, the "duty to warn runs to the physician, not to the patient," (Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1116, 56 Cal.Rptr.2d 162, 920 P.2d 1347, italics omitted (Carlin); accord, T.H. v. Novartis Pharmaceuticals Corp. (2017) 4 Cal.5th 145, 164, 226 Cal. Rptr.3d 336, 407 P.3d 18 (T.H.).) Thus, these manufacturers have a duty to warn physicians of the risks associated with their products but need not warn the patient regarding those same risks. The primary rationale for this rule, called the "learned intermediary doctrine," is that physicians, not their patients, are best positioned to understand "the relevant benefits and risks associated with various prescription drugs and medical devices." (Rest.3d Torts, Products Liability, § 6, com. d, p. 147.) Once a manufacturer has fulfilled its duty to warn the physician, "[t]he duty then devolves on the healthcare provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy." (Id., com. b, p. 146.)

This case involves a question not of duty, but of causation: If a prescription drug or medical device manufacturer has breached its duty under the learned intermediary doctrine to provide an adequate warning (or any warning at all) to the physician, how must the plaintiff prove that the failure to warn caused his or her injury? We granted a request from the United States Court of Appeals for the Ninth Circuit to determine whether 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 v. Somatics, LLC (9th Cir. 2022) 29 F.4th 1125, 1127 (Himes).)

[1–4] We answer these questions as follows: 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. The causation analysis, however, must take into consideration whether the physician would still recommend the prescription drug or medical device for the patient, even in the face of a more adequate warning. In other words, where the evidence shows that the physician would have continued to recommend the treatment notwithstanding the stronger warning, the plaintiff must prove that an objectively prudent person in the patient’s 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. As in the informed consent context, the test is what an objectively prudent person in the patient’s position would have done in light of all the information presented and is not determined by the plaintiffs subjective belief as to what he or she might have done with the benefit of hindsight. (See Cobbs v. Grant (1972) 8 Cal.3d 229, 245, 104 Cal. Rptr. 505, 502 P.2d 1 (Cobbs).)

I. BACKGROUND

Plaintiff Michelle Himes sued defendant Somatics, LLC, for negligence, strict liability, and loss of consortium, alleging that Somatics failed to provide an adequate warning regarding certain risks associated with undergoing electroshock or electroconvulsive therapy (ECT). An ECT device "is a prescription device … used for treating severe psychiatric disturbances by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient’s head." (21 C.F.R. § 882.5940(a) (2018).) ECT has been used for decades in severe cases of depression. Prior to prescribing ECT, Himes’s physicians prescribed at least nine different antipsychotics and antidepressants to treat her depression, but her condition worsened. She was hospitalized several times for severe depression or suicidal ideation. Eventually, Himes enrolled in an inpatient program where Dr. Raymond Fidaleo determined ECT was appropriate for her and administered it to her on 26 different occasions. Himes asserts that she was warned only that ECT could cause shortterm memory loss, and that Somatics failed to disclose to her physician that its ECT device could cause "permanent brain damage, severe permanent retrograde and anterograde amnesia, and acute and/or chronic organic brain syndrome." She further avers that Somatics’s failure to warn caused her to suffer these injuries.

Somatics moved for summary judgment, assuming for the purpose of its motion that even if Himes could establish that (1) ECT is capable of causing permanent brain damage and memory loss in patients; (2) Himes’s ECT treatments caused her to suffer permanent brain damage and memory loss; and (3) Somatics failed to adequately warn Dr. Fidaleo of the risk of permanent brain damage and memory loss, then Himes would still be unable to "establish a causal link between [her] purported injuries" and Somatics’s alleged failure to warn. More specifically, Somatics argued that, under the learned intermediary doctrine, a plaintiff "cannot survive summary judgment if stronger warnings would not have altered the physician’s decision to prescribe the treatment at issue" and "Dr. Fidaleo’s deposition testimony makes it clear that he still would have recommended ECT even if he had been informed of" the risk of permanent brain damage and memory loss. The district court agreed with Somatics, finding that Himes must prove "that the non-disclosed risks" regarding Somatics’s ECT device must be " ‘sufficiently high that it would have changed the treating physician’s decision to prescribe the product.’ " (Riera v. Mecta Corporation (C.D.Cal., May 14, 2021, No. 2:17-CV-06686-RGK-JC) 2021 WL 2024688, p. *5.) Because Himes failed to present evidence showing "that a more detailed warning as to the risks" would have changed Dr. Fidaleo’s decision "to administer ECT" to her, the district court granted summary judgment. (Ibid.)

On appeal, the Ninth Circuit agreed with the district court that Himes failed to present evidence tending to show Dr. Fidaleo would have altered his decision to prescribe ECT to Himes if Somatics had issued a stronger warning about its ECT device. (Himes, supra, 29 F.4th at p. 1126.) There was, however, a genuine dispute of material fact as to whether Dr. Fidaleo would have been alerted to a stronger warning and would have passed along the warning to Himes. (Ibid.) The Ninth Circuit accordingly concluded that the disposition of this appeal "hinges on the resolution of the causation standard." (Ibid.) Specifically, if "a plaintiff must show that stronger manufacturer warnings would have altered the physician’s prescribing conduct, Himes’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, Himes’s claims survive summary judgment." (Ibid.) We granted the Ninth Circuit’s request to answer state law questions regarding the proper causation standard. (Cal. Rules of Court, rule 8.548(a).)

II. DISCUSSION

A. The Learned Intermediary Doctrine

[5–8] The learned intermediary doctrine provides that manufacturers have a duty to warn physicians, but not the physi- cians’ patients, about certain risks accompanying use of their prescription drugs and many medical devices. (T.H., supra, 4 Cal.5th at p. 164, 226 Cal.Rptr.3d 886, 407 P.3d 18, accord, Rest.3d ...