Title: Himes v. Somatics, LLC
Citation: N/A
Docket Number: S273887
State: California
Issuer: California Supreme Court
Date: June 20, 2024

IN THE SUPREME COURT OF 
CALIFORNIA 
 
MICHELLE HIMES, 
Plaintiff and Appellant, 
v. 
SOMATICS, LLC, 
Defendant and Respondent. 
 
S273887 
 
Ninth Circuit 
21-55517 
 
Central District of California 
2:17-cv-06686-RGK-JC  
 
 
June 20, 2024 
 
Justice Groban authored the opinion of the Court, in which 
Chief Justice Guerrero and Justices Corrigan, Liu, Kruger, 
Jenkins, and Evans concurred. 
 
1 
HIMES v. SOMATICS, LLC 
S273887 
 
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.)  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, italics omitted (Carlin); accord, T.H. v. 
Novartis Pharmaceuticals Corp. (2017) 4 Cal.5th 145, 164 
(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 health-care 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 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
2 
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).)  
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 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
3 
patient’s position would have done in light of all the information 
presented and is not determined by the plaintiff’s 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 
(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 short-term 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) 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
4 
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 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
5 
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 
The 
learned 
intermediary 
doctrine 
provides 
that 
manufacturers have a duty to warn physicians, but not the 
physicians’ patients, about certain risks accompanying use of 
their prescription drugs and many medical devices.  (T.H., 
supra, 4 Cal.5th at p. 164, accord, Rest.3d Torts, Products 
Liability, § 6, subd. (d).)  The manufacturer need not “warn of 
risks that are ‘merely speculative or conjectural, or so remote 
and insignificant as to be negligible.’ ”  (T.H., at p. 164, quoting 
Carlin, supra, 13 Cal.4th at p. 1116.)  Nor must the 
manufacturer warn of risks that are already known to the 
medical community.  (Carlin, at p. 1116; Gall v. Smith & 
Nephew, Inc. (2021) 71 Cal.App.5th 117, 122 (Gall); Plenger v. 
Alza Corp. (1992) 11 Cal.App.4th 349, 362 (Plenger).)  But the 
manufacturer is required to warn physicians of any non-
negligible risks that are generally unknown to the medical 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
6 
community, as this will “allow the health-care provider, and 
thereby the patient, to make an informed choice whether to 
utilize the drug or medical device.”  (Rest.3d Torts, Products 
Liability, § 6, com. d, p. 148.)          
Once the manufacturer has fulfilled its duty to warn the 
physician of non-negligible risks, “[t]he duty then devolves on 
the health-care 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.”  
(Rest.3d Torts, Products Liability, § 6, com. b, p. 146; see also 
Cobbs, supra, 8 Cal.3d at p. 245 [physicians must divulge to 
patients “whatever information is material” to the treatment 
decision].)  The patient cannot sue the manufacturer for failing 
to warn him or her directly:  As long as the manufacturer has 
adequately warned the patient’s physician of the non-negligible 
risks of its prescription drug or medical device, the 
manufacturer has fulfilled its duty to warn.  (T.H., supra, 
4 Cal.5th at p. 164; Brown v. Superior Court (1988) 44 Cal.3d 
1049, 1062, fn. 9 (Brown).)  Moreover, “[t]he manufacturer 
cannot be held liable if it has provided appropriate warnings and 
the doctor fails in his [or her] duty to transmit these warnings 
to the patient.”  (Brown, at p. 1062.)  In such circumstances, “the 
patient has a claim against the doctor, but not against the 
manufacturer.”  (2 Dobbs, The Law of Torts (2d ed. 2011) § 466, 
p. 959 (Dobbs on Torts).)    
The learned intermediary doctrine recognizes that, 
“[w]hile the ‘ordinary consumer’ may have a reasonable 
expectation that a product such as a machine he [or she] 
purchases will operate safely when used as intended, 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] 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
7 
physician, to whom the manufacturer directs the warnings 
regarding the drug’s [or medical device’s] properties.”  (Brown, 
supra, 44 Cal.3d at pp. 1061–1062.)  “[P]atients are generally 
persons unlearned in the medical sciences” and, therefore, have 
“an abject dependence upon and trust in [their] physician[s] for 
the information upon which [they] rel[y]” when deciding on a 
particular course of treatment.  (Cobbs, supra, 8 Cal.3d at 
p. 242.)  Unlike the patient, the physician has medical expertise 
which enables him or her to “understand the significance of the 
risks involved and to assess the relative advantages and 
disadvantages” of a particular treatment.  (Rest.3d Torts, 
Products Liability, § 6, com. b, p. 146.)  The physician thus acts 
as a learned intermediary between the manufacturer and the 
patient by recommending a course of treatment based not only 
on the warnings relayed by the manufacturer, but also on the 
physician’s own medical training and experience as well as the 
patient’s particular needs and risk factors.  (Ibid.)   
The doctrine does not create an immunity from a 
prescription drug or medical device manufacturer’s general duty 
of care owed to patients, however.  Pursuant to the doctrine, the 
manufacturer fulfills its general duty of care owed to the patient 
by providing an adequate warning to the patient’s physician.  If 
the manufacturer fails to provide an adequate warning to the 
patient’s physician, then the patient may sue asserting 
negligence for breach of its general duty of care or asserting 
strict liability for marketing a product that has been rendered 
defective due to the inadequate warning.  (See Brown, supra, 
44 Cal.3d at p. 1069, fn. 12; accord, Dobbs on Torts, § 466, 
p. 959.)  To succeed on a negligent failure-to-warn claim, the 
plaintiff has the burden to prove that “a reasonably prudent 
manufacturer would have known and warned about” the risk.  
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
8 
(Carlin, supra, 13 Cal.4th at p. 1112.)  To succeed on a strict 
liability failure-to-warn claim, the plaintiff need only prove that 
the manufacturer “did not adequately warn of a particular risk 
that was known or knowable in light of the generally recognized 
and prevailing best scientific and medical knowledge available 
at the time of manufacture and distribution.”  (Ibid.)  Whether 
asserting a negligent or a strict liability failure-to-warn claim, 
the plaintiff must also establish that the manufacturer’s failure 
to warn “[was] a substantial factor in causing [the plaintiff’s] 
injury.”  (Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 69 
(Stevens); accord, Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 
479.)  Subsumed within the causation analysis are a number of 
inquiries, including whether the prescription drug or medical 
device is capable of causing the injury in anyone; whether the 
prescription drug or medical device caused the patient’s injury 
in particular; and whether the manufacturer’s failure to warn 
caused the patient to use the product.  (See Onglyza Product 
Cases (2023) 90 Cal.App.5th 776, 781, fn. 3, 791; see also Carlin, 
at p. 1116; Gall, supra, 71 Cal.App.5th at p. 122; Plenger, supra, 
11 Cal.App.4th at p. 362.)   
In this case, Somatics assumed, solely for the purpose of 
its summary judgment motion, that Himes will be able to show 
that its ECT device caused the complained-of injury and that 
Somatics inadequately informed Himes’s physician of the risk of 
this injury.  In addition, the Ninth Circuit already determined 
that “no reasonable juror could find that [Himes’s] physician 
would have altered his decision to prescribe the treatment.”  
(Himes, supra, 29 F.4th at p. 1126.)  The Ninth Circuit, 
however, found that there is a genuine dispute of material fact 
as to whether Himes’s physician “would have learned of stronger 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
9 
warnings and communicated them to Himes.”  (Ibid.)1  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.  We do not decide whether a plaintiff may establish 
causation through other means or based on circumstances not 
encompassed within the Ninth Circuit’s certified question.  We 
also note that, regardless of how we resolve the causation 
question at issue here, Himes will still need to prove that 
Somatics’s ECT device caused her injury and that Somatics was 
required to and failed to adequately inform Himes’s physician of 
the risk of this injury to prevail on her failure-to-warn claim. 
 
Himes attempts to bypass the causation question at issue 
by incorrectly framing the learned intermediary doctrine as 
either a defense or an exception to a manufacturer’s usual duty 
to warn the end user directly of the risks involved in using 
 
1  
At oral argument, Somatics’s counsel asserted that the 
Ninth Circuit erred on this point, claiming that the undisputed 
facts show that Himes’s physician never read any of the 
informational materials Somatics sent to him.  Counsel further 
argued that, where the evidence shows that a physician would 
not have read a stronger manufacturer warning, this breaks the 
causal chain.  It is not our role, however, to resolve issues of fact 
upon review of a certified question of law.  (Vu v. Prudential 
Property & Casualty Ins. Co. (2001) 26 Cal.4th 1142, 1153 (Vu).)  
Moreover, the legal question of whether the causal chain is 
broken where a physician testifies that he or she would not have 
read or otherwise been alerted to a stronger warning is outside 
of the scope of the certified question before us. 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
10 
consumer products.  In doing so, Himes claims that if a 
manufacturer fails to provide an adequate warning to the 
physician, then the doctrine is rendered inapplicable, and the 
manufacturer must warn the patient directly.  Himes further 
asserts that because Somatics failed to warn her physician, 
Somatics should have warned her directly of the risks of ECT 
and she need not prove that the failure to warn her physician 
caused her injury.   
The Ninth Circuit rightly rejected this argument in its 
unpublished memorandum accompanying its certification order.  
(Himes v. Somatics, LLC (9th Cir., Mar. 7, 2022, No. 21-55517) 
2022 WL 989469, p. *1.)  As the recent appellate court decision 
in Amiodarone Cases (2022) 84 Cal.App.5th 1091 correctly held, 
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 to the patient’s physician.  (Id. at 
1104–1106.)  It instead “defines the scope of a manufacturer’s 
duty to warn in context of prescription drugs” or medical devices 
(id. at p. 1104) by providing that the manufacturer’s “duty to 
warn runs to the physician, not to the patient” (Carlin, supra, 
13 Cal.4th at p. 1116).  If the manufacturer fails in its duty to 
adequately warn a physician of the non-negligible risks 
associated with its prescription drugs or medical devices, the 
manufacturer’s duty to warn the physician does not transform, 
retroactively, into a duty to warn the patient.  (Amiodarone 
Cases, at p. 1106.)  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.  The patient may seek to hold the 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
11 
manufacturer liable by showing that the breach caused the 
patient’s injury.  (Brown, supra, 44 Cal.3d at p. 1069, fn. 12; 
accord, Dobbs on Torts, § 466, p. 959.)   
Himes’s assertion that, absent a warning to her physician, 
Somatics had a duty to warn her directly of the risks of ECT is 
inconsistent with a fundamental principle underlying the 
learned intermediary doctrine.  As the Courts of Appeal have 
repeatedly recognized, an ordinary patient like Himes has “ ‘no 
way to evaluate’ ” the “ ‘highly technical information’ ” provided by 
the manufacturer, and her unmediated response to such 
information may “ ‘jeopardiz[e] [her] life.’ ”  (Carmichael v. Reitz 
(1971) 17 Cal.App.3d 958, 989 (Carmichael); accord, Bigler-Engler 
v. Breg, Inc. (2017) 7 Cal.App.5th 276, 319; Plenger, supra, 
11 Cal.App.4th at p. 362, fn. 6; Fogo v. Cutter Laboratories, Inc. 
(1977) 68 Cal.App.3d 744, 754.)  For this reason, “[t]he law and 
medical ethics both demand that doctors, for their patients’ 
benefit, evaluate scientific information about prescription drugs 
and [many medical devices]” (Gall, supra, 71 Cal.App.5th at 
p. 122) and relay any material information to their patients 
(Cobbs, supra, 8 Cal.3d at p. 245).  Thus, the “absence of an 
adequate warning about a prescription drug [or medical device] to 
a physician” does not “result in a duty to provide a warning to the 
patient.”  (Amiodarone Cases, supra, 84 Cal.App.5th at p. 1106.)  
 
The cases on which Himes relies do not hold otherwise.  
Most of the decisions Himes cites stand for the unremarkable 
principle that, where a manufacturer gives adequate warnings 
to a physician, it fulfills its duty to warn and does not need to 
ensure that the warning reaches the patient.  (Carlin, supra, 
13 Cal.4th at p. 1116; Stevens, supra, 9 Cal.3d at p. 65; Brown, 
supra, 44 Cal.3d at p. 1062; Carmichael, supra, 17 Cal.App.3d 
at p. 994; Love v. Wolf (1964) 226 Cal.App.2d 378, 395.)  And 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
12 
while the court in Hill v. Novartis Pharmaceuticals Corp. 
(E.D.Cal. 2013) 944 F.Supp.2d 943 claimed that the learned 
intermediary doctrine “ ‘applies only if a manufacturer provided 
adequate warnings to the intermediary’ ” (id. at p. 953), it 
quoted Stewart v. Union Carbide Corp. (2010) 190 Cal.App.4th 
23 for this principle — a decision involving the distinct 
sophisticated intermediary doctrine and which we disapproved 
of on this very point.  (Webb v. Special Electric Co., Inc. (2016) 
63 Cal.4th 167, 188.)  
We accordingly reject Himes’s assertion that Somatics had 
a duty to warn her directly of the risks of ECT and turn to the 
Ninth Circuit’s certified question regarding causation.   
B. 
Causation  
It is well settled that a plaintiff must prove the failure to 
warn was a substantial factor in causing the injury.  (Stevens, 
supra, 9 Cal.3d at p. 69.)  The substantial factor causation 
standard “ ‘subsumes the “but for” test,’ ” under which “the 
plaintiff must prove that, but for the alleged negligence, the 
harm would not have happened.”  (Viner v. Sweet (2003) 
30 Cal.4th 1232, 1239.)  But it also “reach[es] beyond” the “ ‘but 
for’ test . . . to satisfactorily address other situations, such as 
those involving independent or concurrent causes in fact.”  
(Rutherford v. Owens-Illinois, Inc. (1997) 16 Cal.4th 953, 969.)  
It is a “relatively broad” standard, “requiring only that the 
contribution of the individual cause be more than negligible or 
theoretical.”  (Id. at p. 978.)  The question posed by the Ninth 
Circuit does not involve any alleged independent or concurrent 
causes of Himes’s injury, and so we focus on how Himes may be 
able to prove that, but for Somatics’s failure to warn her 
physician, Himes would not have been injured. 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
13 
The Ninth Circuit asks whether Himes is required “to 
show that a stronger risk warning would have altered the 
physician’s decision to prescribe the product,” or whether she 
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, supra, 29 F.4th at p. 1127.)  We hold that 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 notwithstanding 
the physician’s continued recommendation of the treatment.  
Somatics argues that a plaintiff must show that the 
patient’s physician would have changed his or her prescribing 
decision to establish causation.  In Somatics’s view, the patient’s 
own decision as to whether to accept the recommended 
treatment is irrelevant, meaning that if the patient’s physician 
testifies that he or she would not have changed his or her 
prescribing decision, then there can be no liability.  Somatics 
believes its view of causation best aligns with the learned 
intermediary doctrine given the doctrine’s recognition that 
patients generally rely on their physicians’ medical expertise 
when deciding on a particular course of treatment.  (Gall, supra, 
71 Cal.App.5th at p. 122; see also Cobbs, supra, 8 Cal.3d at 
p. 242.)  According to Somatics, the doctrine assumes patients’ 
reliance on physicians because a patient has no way to evaluate 
“highly technical information” on the risks associated with 
drugs or medical devices and “might actually object” to using a 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
14 
drug or medical device even where the patient’s life is in danger.  
(Carmichael, supra, 17 Cal.App.3d at p. 989.)   
We cannot wholly discount the essential role of patient 
choice in medical treatment decisions, however.  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]” (Cobbs, supra, 8 Cal.3d at 
p. 242), we have also emphasized that “the decision whether or 
not to undertake treatment is vested in the party most directly 
affected: the patient” (id. at p. 244).  Our informed consent rule 
thus requires physicians to disclose to their patients “the risks 
inherent in the procedure [they are] prescribing, the risks of a 
decision not to undergo the treatment, and the probability of a 
successful outcome of the treatment.”  (Id. at p. 243.)  But once 
the physician discloses this information, it is “reserved to the 
patient alone” to weigh the disclosed risks against the patient’s 
own “fears and hopes” in deciding whether to undergo the 
recommended treatment.  (Ibid.)  Implicit in our informed 
consent rule is the recognition that patients will sometimes opt 
out of the medical treatments their physicians recommend, as is 
their right.  (See id. at p. 245 [casual connection between 
physician’s failure to obtain informed consent and injury arises 
“if it is established that had revelation been made consent to 
treatment would not have been given”].)  If Somatics were 
correct that the physician’s prescribing decision is all that 
matters, and the patient’s own decision as to whether to undergo 
the treatment after having learned of the risks is irrelevant, 
then there would be no need for the informed consent rule.         
Like our informed consent jurisprudence, the learned 
intermediary doctrine affirms patient autonomy in medical 
treatment decisions.  The doctrine’s rationale is that warnings 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
15 
pertaining to prescription drugs and medical devices should be 
relayed to patients by their physicians — rather than by the 
manufacturer — because physicians are in a better position to 
assist patients in deciphering and evaluating the warnings.  
(Rest.3d Torts, Products Liability, § 6, com. b, p. 146.)  The 
underlying goal is to adequately inform patients of material 
risks so that they can make “an informed choice as to therapy.”  
(Ibid.)  Stated differently, by ensuring that physicians will assist 
patients in understanding manufacturer warnings relating to 
material risks and in balancing those risks against the benefits 
of treatment, the doctrine enables patients to make intelligent 
treatment decisions.   
We have previously indicated that the patient’s role in 
deciding his or her own course of treatment does not disappear 
in the context of the learned intermediary doctrine.  Specifically, 
in Finn v. G. D. Searle & Co. (1984) 35 Cal.3d 691, we suggested 
that a jury might be able to find causation in the context of a 
manufacturer’s failure to warn the plaintiff’s physician of the 
dangers of a certain drug if the jury determined that, had the 
physician been warned, the physician “would have (or should 
have) refrained from prescribing the drug, or th[e] plaintiff 
would have refrained from taking it.”  (Id. at p. 702, italics 
added.)  While not binding on us, we also find persuasive other 
courts’ observations that the learned intermediary doctrine does 
not “allow health care professionals to substitute their judgment 
for 
that 
of 
their 
patients.” 
 
(Gilliland 
v. 
Novartis 
Pharmaceuticals Corp. (S.D. Iowa 2014) 34 F.Supp.3d 960, 972 
(Gilliland).)  Nor does it “assume[] that a doctor will issue a 
prescription” to “an informed patient who is unwilling to risk a 
medical product’s side effects.”  (Hrymoc v. Ethicon, Inc. 
(Super.Ct.App.Div. 2021) 467 N.J.Super. 42, 90 [249 A.3d 191, 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
16 
220], affd. as mod. (2023) 254 N.J. 446 [297 A.3d 1245] 
(Hrymoc).)  Thus, the doctrine does not “obviate the need to 
consider whether the plaintiff-patient’s decision concerning her 
recommended course of treatment would have been different, 
assuming that the warning at issue had been more adequate” 
and was deemed material enough to be passed along to the 
patient by the physician.  (Gilliland, at p. 972.)2  
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 learned intermediary doctrine recognizes that patients are 
often 
influenced 
by 
their 
physician’s 
treatment 
recommendations and that a physician may be able to assuage 
a patient’s fears or persuade the patient that the benefits of 
treatment outweigh any risks.  (See Brown, supra, 44 Cal.3d at 
p. 1061.)  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 that the treatment 
would still be in the patient’s best interests, notwithstanding 
the risks conveyed by a stronger warning.  Because our holding 
acknowledges the role of both the physician and the patient in 
medical treatment decisions, it comports with the learned 
intermediary doctrine’s recognition that treatment decisions are 
 
2  
We caution that other states’ requirements for proving a 
failure-to-warn claim in the context of the learned intermediary 
doctrine may differ from California law, and our citation to extra 
jurisdictional cases or secondary sources in this opinion does not 
constitute an endorsement of all statements of law set forth in 
those authorities.     
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
17 
made collaboratively by patients and their physicians, and the 
physician acts as an “intermediary” who helps the patient in 
appreciating and weighing the benefits and risks of treatment.    
Indeed, the very premise of the doctrine is that the physician 
will assist the patient in understanding material information 
conveyed by the warning “so that the patient can make an 
informed choice as to therapy.”  (Rest.3d Torts, Products 
Liability, § 6, com. b, p. 146.)   
But as another court aptly observed, “no one disputes that 
it is up to the individual patient to decide whether to undergo a 
given treatment therapy” (Gilliland, supra, 34 F.Supp.3d at 
p. 972, fn. 21), and we therefore cannot presume that an 
objectively prudent person in the patient’s position will follow 
the 
physician’s 
treatment 
recommendations 
in 
all 
circumstances.  (See also Payne, supra, 767 F.3d at p. 532 
[causation in both informed consent and failure-to-warn cases 
“ultimately rests with the patient’s decision to take or reject the 
medication”]; Hrymoc, supra, 249 A.3d at p. 220 [“[T]he 
‘prescribing decision’ . . . logically entails . . . a patient’s assent 
to follow that recommendation” and “it should not be assumed 
that a doctor will issue a prescription [to] an informed patient 
who is unwilling to risk a medical product’s side effects”].)  
Although the learned intermediary doctrine provides that a 
manufacturer has no duty to warn the patient directly of the 
risks inherent to its prescription drugs or medical devices, it 
does so with the understanding that the physician is best 
positioned to communicate any material risks conveyed by the 
warning to the patient.  The doctrine does not stand for the 
principle that, once the manufacturer breaches its duty to warn 
the physician, the patient’s medical treatment decisions become 
irrelevant to the causation analysis.  To conclude otherwise 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
18 
“would frustrate the purpose of the learned intermediary rule, 
which is to enable patients to make informed and intelligent 
decisions whether to undergo a recommended therapy by 
balancing the probable risks against the probable benefits of the 
course of treatment proposed by their physicians.”  (Gilliland, 
at p. 972.)  In sum, under the learned intermediary doctrine, the 
physician’s judgment and advice remains central to the 
causation analysis, but the ultimate decision of whether to go 
forward with the treatment resides with the patient. 
Somatics contends that “a vast body” of out-of-state 
decisions hold that a plaintiff may prove causation only by 
showing that an adequate warning would have altered the 
physician’s decision to prescribe the prescription drug or 
medical device.  While we rely in this opinion on several non-
California decisions, the analysis of which we find to be 
persuasive (see T.H., supra, 4 Cal.5th at p. 175), we disagree 
with Somatics that there exists a “near unanimity of agreement” 
regarding the particular issue before us (Moradi-Shalal v. 
Fireman’s Fund Ins. Companies (1988) 46 Cal.3d 287, 298).  A 
few decisions from other states’ supreme courts suggest that a 
plaintiff must prove that an adequate warning would have 
altered the physician’s prescribing decision, but none of these 
decisions expressly considered Himes’s theory of causation.  
(Janssen Pharmaceutica, Inc. v. Bailey (Miss. 2004) 878 So.2d 
31, 58; Strumph v. Schering Corp. (N.J. 1993) 626 A.2d 1090, 
adopting dissent issued in Strumph v. Schering Corp. 
(N.J.App.Div. 1992) 606 A.2d 1140, 1148 (dis. opn. of Skillman, 
J.); Seley v. G. D. Searle & Co. (1981) 67 Ohio St.2d 192, 201 
[423 N.E.2d 831, 838–839].)  Other state supreme court 
decisions appear to suggest that the causation question is not 
limited to determining whether the warning would have altered 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
19 
the physician’s prescribing decision.  For example, Somatics 
relies on Centocor, Inc. v. Hamilton (Tex. 2012) 372 S.W.3d 140, 
but this decision could be read as supporting Himes’s view.  In 
Centocor, the Texas Supreme Court found causation lacking 
both because there was “no evidence that [the patient’s] 
prescribing physicians or [the patient] would have acted 
differently had [the manufacturer] provided a different 
warning.”  (Id. at p. 171, italics added.)  The court explained that 
the patient’s actions indicated “she would likely have continued” 
treatments even if she had been warned of the risk.  (Id. at 
p. 173.)  The court in Centocor also cited approvingly to McNeil 
v. Wyeth (5th Cir. 2006) 462 F.3d 364, wherein the Fifth Circuit 
held that, “[w]here the physician would have adequately 
informed a plaintiff of the risks of a disease, had the label been 
sufficient, but fails to do so on that account, and where the 
plaintiff would have rejected the drug if informed, the 
inadequate labeling could be a ‘producing’ cause of the injury, 
because 
it 
effectively 
sabotages 
the 
function 
of 
the 
intermediary.”  (Id. at p. 373, italics added; see also Centocor, at 
p. 170.)  This suggests that the Texas Supreme Court considered 
the patient’s decision as to whether to undergo the 
recommended treatment to be relevant to the causation 
analysis.  The Utah Supreme Court’s decision in Barson v. E.R. 
Squibb & Sons, Inc. (Utah 1984) 682 P.2d 832 similarly suggests 
that causation may not be limited to the prescribing doctor’s 
decision.  There, the court found sufficient evidence for a “jury 
to conclude that had [a] . . . proper warning been given” the 
plaintiff would not have injected the drug, based in part on the 
plaintiff’s testimony that “she had expressed strong concern 
over taking any drugs during her pregnancy, but allowed the 
[drug] injections after being assured by [her doctor] that they 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
20 
were safe.”  (Id. at p. 836.)  The remaining states’ supreme 
courts have simply not had occasion to consider the causation 
question before us.    
Somatics fares no better by pointing to federal decisions 
applying state law.  Somatics relies, for example, on Odom v. 
G.D. Searle & Co. (4th Cir. 1992) 979 F.2d 1001, but in Odom 
causation was lacking because the physician had independent 
knowledge of the risk, such that a stronger manufacturer 
warning regarding the risk would not have changed the 
physician’s conduct in any manner — not even by motivating 
the physician to pass along the warning to the patient.  (Id. at 
p. 1003.)  Somatics additionally relies on Sager v. Hoffman-La 
Roche, Inc. (N.J.Super.Ct.App.Div., Aug. 7, 2012, No. A-3427-
09T4) 2012 WL 3166630, but the court in Sager seems to have 
misinterpreted a Florida appellate court decision in determining 
that causation is established only by showing an adequate 
warning would have changed the physician’s prescribing 
decision.  (See id. at pp. *16–*17.)  The case on which Sager 
relied, Hoffmann-La Roche Inc. v. Mason (Fla.Dist.Ct.App. 
2009) 27 So.3d 75, in fact found that the inadequate warning 
could not be a cause of the patient’s injuries because the 
physician was already aware of the risk.  (Id. at p. 77.)  Thus, 
“the question of whether a different warning could have 
prevented the plaintiff’s injury in some manner other than by 
changing the physician’s decision to prescribe — e.g., by 
prompting the physician to pass along a more detailed warning, 
or to reduce the dosage — was not before the Mason court.”  
(Guenther v. Novartis Pharmaceutical Corp. (M.D.Fla. 2014) 
990 F.Supp.2d 1299, 1304.)  Finally, while several federal court 
decisions on which Somatics relies seem to focus on the 
physician’s prescribing decision, most do not consider whether 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
21 
causation may also be established by showing a physician would 
have passed along a manufacturer’s warning to the plaintiff and 
that an objectively prudent person in patient’s position would 
have rejected the treatment based on the relayed warning.  In 
Wendell v. GlaxoSmithKline LLC (9th Cir. 2017) 858 F.3d 1227, 
for example, the Ninth Circuit found evidence that a stronger 
warning would have influenced the physician’s prescribing 
practices, and therefore had no need to consider an alternative 
theory of causation.  (Id. at pp. 1238–1239.)     
Indeed, only a few cases expressly reject Himes’s theory of 
causation.  Most of these decisions do not explain why causation 
must be limited to proving that the physician would have 
changed his or her prescribing decision in view of the stronger 
warning.  (See, e.g., Munoz v. American Medical Systems, Inc. 
(C.D.Cal., Mar. 30, 2021, No. 220CV01640ODWJPRX) 2021 WL 
1200038, p. *4; Carnes v. Eli Lilly and Co. (D.S.C., Dec. 16, 2013, 
No. CA 0:13-591-CMC) 2013 WL 6622915, p. *5; Allain v. Wyeth 
Pharmaceuticals, Inc. (N.D.Ala., Jan. 14, 2015, No. 2:14-CV-
00280-KOB) 2015 WL 178038, p. *6.)  The court in Garrison v. 
Novartis Pharmaceuticals Corp. (M.D.Ala. 2014) 30 F.Supp.3d 
1325, for example, concluded without further elaboration that 
the physician’s testimony that he would have passed a stronger 
warning along to the patient was irrelevant because the 
physician testified that he still would have prescribed the 
treatment notwithstanding the stronger warning.  (Id. at 
p. 1336.)  As another example, the court in Stewart v. Boston 
Scientific Corp. (S.D.W.Va., Oct. 6, 2015, No. 2:12-CV-03686) 
2015 WL 5842762 reasoned that a plaintiff must prove the 
physician would have changed his or her prescribing decision 
because “ ‘[i]t is the physician who is best situated to weigh the 
potential risks associated with a [product] against the possible 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
22 
benefits of the [product] and the unique needs and 
susceptibilities of each patient.’ ”  (Id. at p. *6.)  This reasoning, 
however, merely restates the rationale underpinning the 
learned intermediary doctrine’s rule that the manufacturer’s 
duty to warn runs only to the physician.  It does not explain why 
proof of causation must hinge on the physician’s prescribing 
decision to the exclusion of the patient’s own independent 
decision regarding whether to consent to the recommended 
treatment.  We find more persuasive the out-of-state authority 
that takes into consideration, at least in some manner, the role 
of the patient in the medical treatment decision.  (See, e.g., 
Thacker v. Ethicon, Inc. (6th Cir. 2022) 47 F.4th 451, 461; Payne, 
supra, 767 F.3d at pp. 531–532; In re Prempro Products 
Liability Litigation (8th Cir. 2009) 586 F.3d 547, 569–570; Toole 
v. McClintock (11th Cir. 1993) 999 F.2d 1430, 1433; Gilliland, 
supra, 34 F.Supp.3d at p. 972; Mongeon v. Ethicon, Inc. (D.Mass. 
2020) 456 F.Supp.3d 298, 303; Fields v. Eli Lilly and Co. 
(M.D.Ala. 2015) 116 F.Supp.3d 1295, 1308–1309.)  We 
accordingly reject Somatics’s assertion that “causation turns 
only on the physician’s prescription decision.”     
At the same time, we recognize that patients often rely on 
their physician’s expertise and judgment in making medical 
treatment decisions, and so the causation analysis should take 
into consideration any evidence about what the physician would 
have communicated to the patient regarding the treatment and 
the allegedly undisclosed risks, including any evidence that the 
patient’s physician would have still recommended the treatment 
even if the manufacturer had provided an adequate warning of 
the alleged risks.  As amici curiae California Medical 
Association, California Dental Association, and California 
Hospital Association observe, medical treatment decisions are 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
23 
made jointly by the physician and the patient after together 
discussing and weighing the relevant risks and benefits of 
treatment.  The learned intermediary doctrine itself recognizes 
that patients are often influenced by their physician’s treatment 
recommendations and that a physician may be able to assuage 
a patient’s fears or persuade the patient that the benefits of 
treatment outweigh any risks.  (See Brown, supra, 44 Cal.3d at 
p. 1061.)  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.  When discussing the recommended 
treatment, physicians assist the patient by contextualizing any 
risks based on the patient’s medical circumstances and needs; 
trying to alleviate the patient’s fears regarding the risks; 
describing the risks and benefits of other possible treatments; 
distilling any studies and medical literature related to the 
treatment decision; and explaining the reasons why the 
physician believes the recommended treatment is the best 
option for the patient despite the risks.  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 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
24 
be inclined to reject even beneficial treatment.  (Carmichael, 
supra, 17 Cal.App.3d at p. 989.)  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.  In other words, 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.3       
Somatics asks us to find “as a matter of law” that “an 
objectively prudent person would not refuse last-resort, life-
saving treatment because of a small risk of side effects.”  
Somatics explains that Himes suffered from severe depression 
and suicidal ideation, her physicians had previously prescribed 
nine different antipsychotics and antidepressants that failed to 
alleviate her depression, and Dr. Fidaleo prescribed ECT — a 
“long-established medical procedure used at the nation’s top 
hospitals to treat serious mental health issues” — in a “last 
resort” effort “to save [her] life.”  Somatics further asserts that 
“[n]o objectively prudent person would refuse a prescribed 
treatment where (1) the patient is facing a serious risk of death, 
 
3  
We do not address how a physician’s negligence in reading 
the manufacturer’s warnings, communicating the risks, or 
prescribing the treatment to a patient might affect this analysis. 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
25 
(2) all other treatment options have failed, and (3) a physician 
prescribes and urges the use of a medical treatment to save the 
patient’s life.”  It is not for us to decide, however, whether 
Somatics’s view of the facts is correct or whether an objectively 
prudent person in the patient’s position might reasonably 
decline the recommended treatment under such circumstances.  
“Our role here is limited to setting out general principles of 
California law for the assistance of the Ninth Circuit.  The 
application of these principles of law to the specific facts of [the] 
case is a matter for the federal judiciary.”  (Vu, supra, 26 Cal.4th 
at p. 1153.)  Nevertheless, for the purpose of providing guidance, 
we observe that the facts Somatics raises, if true, will certainly 
be relevant to the causation analysis.  That is, relevant factors 
that should be considered in determining whether an objectively 
prudent patient would have declined physician-recommended 
treatment include, but are not necessarily 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 benefits 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.  Informed consent cases illustrate 
how such characteristics or circumstances might be considered.  
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
26 
In Wilson v. Merritt (2006) 142 Cal.App.4th 1125, for example, 
the plaintiff was a paraplegic “who had been largely paralyzed 
by a prior surgery and was dependent upon the use of his arms 
and shoulders for any mobility at all, and who, at that point, had 
already achieved about a 20 percent improvement . . . based on 
physical therapy alone.”  (Id. at p. 1139.)  Given the plaintiff’s 
unique medical circumstances and prior treatment history, the 
court found that there was sufficient evidence for a jury to 
conclude that an objectively prudent person in the patient’s 
position would have declined the recommended procedure — 
manipulation of his shoulder under anesthesia — if the patient 
had known it could result in a torn rotator cuff and a fractured 
bone.  (Ibid.)  As another example, in Daum v. SpineCare 
Medical Group, Inc. (1997) 52 Cal.App.4th 1285 there was 
sufficient evidence for a jury to find that an objectively prudent 
person in the patient’s position would have declined an 
experimental surgery had the patient been warned of the risks, 
particularly given that the plaintiff had previously taken a 
conservative approach to surgery and other treatment options 
were available.  (Id. at p. 1312.)  Ultimately, we recognize that 
it may well be a rare case in which an objectively prudent person 
in the patient’s position would decline treatment even when the 
physician recommends it and believes it to be a last resort 
treatment necessary to save the patient’s life.  Nevertheless, we 
do not decide whether this matter presents such a rare case, as 
this is an issue for the federal courts to resolve.  
Himes asserts that causation in this context should not be 
determined by how an objectively prudent person in the 
patient’s position would have reacted to a stronger warning 
communicated by patient’s physician, and that we should 
instead find that causation is established by the patient’s 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
27 
subjective testimony that he or she would have declined the 
treatment in response to the warning.  The Ninth Circuit 
correctly rejected this argument.  (Himes v. Somatics, LLC, 
supra, 2022 WL 989469, at p. *3, fn. 3.)  As the Ninth Circuit 
observed, we held in Cobbs that “an objective test” — measured 
by “what would a prudent person in the patient’s position have 
decided if adequately informed of all significant perils” — “is 
preferable” in the context of medical treatment decisions 
because by “the time of trial the uncommunicated hazard has 
materialized.”  (Cobbs, supra, 8 Cal.3d at p. 245.)  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.  
(Ibid.)  Subjectively, the plaintiff may believe this to be true 
“with the 20/20 vision of hindsight, but we doubt that justice will 
be served by placing the [defendant] in jeopardy of the patient’s 
bitterness and disillusionment.”  (Ibid.) 
Himes urges us to limit the objective standard to medical 
malpractice claims against patients’ physicians, and to not 
extend it to failure-to-warn claims against prescription drug or 
medical device manufacturers.  We decline to limit the objective 
standard in the way Himes suggests.  Our observation in Cobbs 
that a subjective standard is prone to hindsight bias applies in 
failure-to-warn claims against manufacturers of prescription 
drugs or medical devices, just as it does in informed consent 
cases against physicians.  (See Cobbs, supra, 8 Cal.3d at p. 245.)  
The court in Canterbury v. Spence (D.C. Cir. 1972) 464 F.2d 772, 
which we relied on in Cobbs in adopting the objective standard, 
explained that a subjective standard “places the factfinder in the 
position of deciding whether a speculative answer to a 
hypothetical question is to be credited” and “calls for a subjective 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
28 
determination solely on testimony of a patient-witness 
shadowed by the occurrence of the undisclosed risk.”  (Id. at 
p. 791.)  An objective standard is preferable because, though the 
plaintiff’s testimony would remain relevant, “it would not 
threaten to dominate the findings” and would “be appraised 
congruently with the factfinder’s belief in its reasonableness.”  
(Ibid.)  The objective standard thereby “ease[s] the fact-finding 
process and better assure[s] the truth as its product.”  (Ibid.)  An 
objective standard is particularly useful in cases in which the 
plaintiff is unable to testify, perhaps because the patient has 
passed away or is incompetent. 
Moreover, even assuming, as Himes asserts, that a 
subjective standard of causation applies in other failure-to-warn 
cases involving consumer products,4 the learned intermediary 
doctrine recognizes that decisions regarding whether to take a 
prescription drug or medical device are different from decisions 
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.”  (Brown, supra, 
44 Cal.3d at p. 1061.)  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.  Physicians accordingly do not 
discuss the risks of treatment in isolation, but rather discuss 
them alongside the benefits of treatment as well as the risks of 
 
4  
We herein adopt an objective causation standard only in 
the context of failure-to-warn claims involving prescription 
drugs or medical devices, and we express no view on whether it 
might apply to other failure-to-warn claims.   
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
29 
foregoing treatment altogether.  A subjective standard that 
relies on the plaintiff’s postinjury assessment regarding how he 
or she would have reacted to the warning in isolation would not 
only be prone to hindsight bias, it would also fail to take into 
account the context in which the risks of prescription drugs and 
medical devices are discussed with patients as well as patients’ 
general reliance on the treatment recommendations of their 
physicians.  The objective standard incorporates the physician’s 
role in the treatment decision by asking not whether the 
plaintiff subjectively believes, in hindsight, that he or she would 
have declined to use the drug or medical device in light of a 
stronger warning, but rather whether an objectively prudent 
person in the patient’s position would have refused the 
treatment even though his or her physician would have still 
recommended the treatment.  We therefore conclude that the 
Ninth Circuit was right to adopt the objectively prudent person 
in the patient’s position test set forth in Cobbs.  
III.  CONCLUSION 
In conclusion, we answer the Ninth Circuit’s certified 
question 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.  A plaintiff may 
instead 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 
notwithstanding 
the 
physician’s continued recommendation of the treatment. 
 
 
 
 
 
 
 
 
 
 
HIMES v. SOMATICS, LLC 
Opinion of the Court by Groban, J. 
 
30 
GROBAN, J. 
We Concur: 
GUERRERO, C. J. 
CORRIGAN, J. 
LIU, J. 
KRUGER, J. 
JENKINS, J. 
EVANS, J. 
 
 
See next page for addresses and telephone numbers for counsel who 
argued in Supreme Court. 
 
Name of Opinion  Himes v. Somatics, LLC 
__________________________________________________________  
 
Procedural Posture (see XX below) 
Original Appeal  
Original Proceeding  XX on request by 9th Circuit (Cal. Rules of 
Court, rule 8.548) 
Review Granted (published) 
Review Granted (unpublished)  
Rehearing Granted 
__________________________________________________________  
 
Opinion No. S273887 
Date Filed:  June 20, 2024 
__________________________________________________________  
 
Court:   
County:   
Judge:   
__________________________________________________________   
 
Counsel: 
 
Baum, Hedlund, Aristei & Goldman, Wisner Baum, Bijan Esfandiari, 
Monique Alarcon and R. Brent Wisner for Plaintiffs and Appellants. 
 
Poole Shaffery & Koegle, Jason A. Benkner, David S. Poole, 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 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 
for California Life Sciences as Amicus Curiae on behalf of Defendant 
and Respondent. 
 
 
 
Covington & Burling, Ashley M. Simonsen, 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. 
 
 
Counsel who argued in Supreme Court (not intended for 
publication with opinion): 
 
Bijan Esfandiari 
Wisner Baum, LLP 
11111 Santa Monica Boulevard, Suite 1750 
Los Angeles, CA 90025 
(310) 207-3233 
 
Jonathan M. Freiman 
Wiggin and Dana LLP 
One Century Tower 
265 Church Street 
New Haven, CT 06510 
(203) 498-4584