The opinion
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.
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
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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
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Opinion of the Court by Groban, J.
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)
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Opinion of the Court by Groban, J.
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
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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
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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]
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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.
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(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
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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.
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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
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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
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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.
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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
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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
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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,
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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.
16
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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
17
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
“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
18
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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
19
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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
20
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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
21
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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
22
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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
23
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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.
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HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
(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.
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HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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
26
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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
27
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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.
28
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
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.
29
HIMES v. SOMATICS, LLC
Opinion of the Court by Groban, J.
GROBAN, J.
We Concur:
GUERRERO, C. J.
CORRIGAN, J.
LIU, J.
KRUGER, J.
JENKINS, J.
EVANS, J.
30
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