CACI No. 1222. Negligence - Manufacturer or Supplier - Duty to Warn - Essential Factual Elements

Judicial Council of California Civil Jury Instructions (2023 edition)

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1222.Negligence - Manufacturer or Supplier - Duty to
Warn - Essential Factual Elements
[Name of plaintiff] claims that [name of defendant] was negligent by not
using reasonable care to warn [or instruct] about the [product]’s
dangerous condition or about facts that made the [product] likely to be
dangerous. To establish this claim, [name of plaintiff] must prove all of
the following:
1. That [name of defendant] [manufactured/distributed/sold] the
2. That [name of defendant] knew or reasonably should have known
that the [product] was dangerous or was likely to be dangerous
when used or misused in a reasonably foreseeable manner;
3. That [name of defendant] knew or reasonably should have known
that users would not realize the danger;
4. That [name of defendant] failed to adequately warn of the danger
[or instruct on the safe use of the [product]];
5. That a reasonable [manufacturer/distributor/seller] under the
same or similar circumstances would have warned of the danger
[or instructed on the safe use of the [product]];
6. That [name of plaintiff] was harmed; and
7. That [name of defendant]’s failure to warn [or instruct] was a
substantial factor in causing [name of plaintiff]’s harm.
[The warning must be given to the prescribing physician and must
include the potential risks or side effects that may follow the foreseeable
use of the product. [Name of defendant] had a continuing duty to warn
physicians as long as the product was in use.]
New September 2003; Revised June 2011, December 2012, May 2020
Directions for Use
Give this instruction in a case involving product liability in which a claim for
failure to warn is included under a negligence theory. For an instruction on failure
to warn under strict liability and for additional sources and authority, see CACI No.
1205, Strict Liability - Failure to Warn - Essential Factual Elements. For instructions
on design and manufacturing defect under a negligence theory, see CACI No. 1220,
Negligence - Essential Factual Elements, and CACI No. 1221, Negligence - Basic
Standard of Care.
To make a prima facie case, the plaintiff has the initial burden of producing
evidence that the plaintiff was injured while the product was being used in an
intended or reasonably foreseeable manner. If this prima facie burden is met, the
burden of proof shifts to the defendant to prove that the plaintiff’s injury resulted
from a misuse of the product. (See Perez v. VAS S.p.A. (2010) 188 Cal.App.4th 658,
678 [115 Cal.Rptr.3d 590] [strict liability design defect risk-benefit case].) See also
CACI No. 1245, Affırmative Defense - Product Misuse or Modification. Product
misuse is a complete defense to strict products liability if the defendant proves that
an unforeseeable abuse or alteration of the product after it left the manufacturers
hands was the sole cause of the plaintiff’s injury. (Campbell v. Southern Pacific Co.
(1978) 22 Cal.3d 51, 56 [148 Cal.Rptr. 596, 583 P.2d 121]; see CACI No. 1245.)
Misuse or modification that was a substantial factor in, but not the sole cause of,
plaintiff’s harm may also be considered in determining the comparative fault of the
plaintiff or of third persons. See CACI No. 1207A, Strict Liability - Comparative
Fault of Plaintiff, and CACI No. 1207B, Strict Liability - Comparative Fault of
Third Person.
The last bracketed paragraph is to be used in prescription drug cases only.
Sources and Authority
“[T]he manufacturer has a duty to use reasonable care to give warning of the
dangerous condition of the product or of facts which make it likely to be
dangerous to those whom he should expect to use the product or be endangered
by its probable use, if the manufacturer has reason to believe that they will not
realize its dangerous condition.” (Putensen v. Clay Adams, Inc. (1970) 12
Cal.App.3d 1062, 1076-1077 [91 Cal.Rptr. 319].)
“Under California law, a manufacturer generally has no duty to warn of risks
from another manufacturers product, and is typically liable only for harm
caused by its own product.” (Johnson & Johnson Talcum Powder Cases (2019)
37 Cal.App.5th 292, 315 [249 Cal.Rptr.3d 642].)
“Negligence law in a failure-to-warn case requires a plaintiff to prove that a
manufacturer or distributor did not warn of a particular risk for reasons which
fell below the acceptable standard of care, i.e., what a reasonably prudent
manufacturer would have known and warned about.” (Chavez v. Glock, Inc.
(2012) 207 Cal.App.4th 1283, 1305 [144 Cal.Rptr.3d 326], internal citation
“Thus, the question defendants wanted included in the special verdict
form - whether a reasonable manufacturer under the same or similar
circumstances would have given a warning - is an essential inquiry in the
negligent failure to warn claim.” (Trejo v. Johnson & Johnson (2017) 13
Cal.App.5th 110, 137 [220 Cal.Rptr.3d 127] [citing this instruction].)
“Negligence and strict products liability are separate and distinct bases for
liability that do not automatically collapse into each other because the plaintiff
might allege both when a product warning contributes to her injury.” (Conte v.
Wyeth, Inc. (2008) 168 Cal.App.4th 89, 101 [85 Cal.Rptr.3d 299].)
“The ‘known or knowable’ standard arguably derives from negligence principles,
and failure to warn claims are generally “rooted in negligence” to a greater
extent than’ manufacturing or design defect claims. Unlike those other defects, a
“warning defect” relates to a failure extraneous to the product itself and can
only be assessed by examining the manufacturers conduct. These principles
notwithstanding, California law recognizes separate failure to warn claims under
both strict liability and negligence theories. In general, a product seller will be
strictly liable for failure to warn if a warning was feasible and the absence of a
warning caused the plaintiff’s injury. Reasonableness of the sellers failure to
warn is immaterial in the strict liability context. Conversely, to prevail on a
claim for negligent failure to warn, the plaintiff must prove that the sellers
conduct fell below the standard of care. If a prudent seller would have acted
reasonably in not giving a warning, the seller will not have been negligent.”
(Webb v. Special Electric Co., Inc. (2016) 63 Cal.4th 167, 181 [202 Cal.Rptr.3d
460, 370 P.3d 1022], footnote and internal citations omitted.)
“It is true that the two types of failure to warn claims are not necessarily
exclusive: ‘No valid reason appears to require a plaintiff to elect whether to
proceed on the theory of strict liability in tort or on the theory of
negligence. . . . [¶] Nor does it appear that instructions on the two theories will
be confusing to the jury. There is nothing inconsistent in instructions on the two
theories and to a large extent the two theories parallel and supplement each
other.’ Despite the often significant overlap between the theories of negligence
and strict liability based on a product defect, a plaintiff is entitled to instructions
on both theories if both are supported by the evidence.” (Oxford v. Foster
Wheeler LLC (2009) 177 Cal.App.4th 700, 717 [99 Cal.Rptr.3d 418].)
“(1) [T]he strict liability instructions ‘more than subsumed the elements of duty
to warn set forth in the negligence instructions’; (2) under the instructions, there
is no ‘real difference between a warning to ordinary users about a product use
that involves a substantial danger, and a warning about a product that is
dangerous or likely to be dangerous for its intended use’; (3) [defendant]’s duty
under the strict liability instructions ‘to warn of potential risks and side effects
envelope[d] a broader set of risk factors than the duty, [under the] negligence
instructions, to warn of facts which make the product “likely to be dangerous”
for its intended use’; (4) the reference in the strict liability instructions here to
‘potential risks . . . that were known or knowable through the use of scientific
knowledge’ encompasses the concept in the negligence instructions of risks
[defendant] ‘knew or reasonably should have known’; and (5) for all these
reasons, the jury’s finding that [defendant] was not liable under a strict liability
theory ‘disposed of any liability for failure to warn’ on a negligence theory.”
(Trejo, supra, 13 Cal.App.5th at pp. 132-133, original italics, internal citations
“In the context of prescription drugs, a manufacturers duty is to warn physicians
about the risks known or reasonably known to the manufacturer. The
manufacturer has no duty to warn of risks that are ‘merely speculative or
conjectural, or so remote and insignificant as to be negligible.’ If the
manufacturer provides an adequate warning to the prescribing physician, the
manufacturer need not communicate a warning directly to the patient who uses
the drug.” (T.H. v. Novartis Pharmaceuticals Corp. (2017) 4 Cal.5th 145, 164
[226 Cal.Rptr.3d 336, 407 P.3d 18], internal citations omitted.)
“Because the same warning label must appear on the brand-name drug as well as
its generic bioequivalent, a brand-name drug manufacturer owes a duty of
reasonable care in ensuring that the label includes appropriate warnings,
regardless of whether the end user has been dispensed the brand-name drug or
its generic bioequivalent. If the person exposed to the generic drug can
reasonably allege that the brand-name drug manufacturers failure to update its
warning label foreseeably and proximately caused physical injury, then the
brand-name manufacturers liability for its own negligence does not
automatically terminate merely because the brand-name manufacturer transferred
its rights in the brand-name drug to a successor manufacturer.” (T.H.,supra, 4
Cal.5th at p. 156.)
Secondary Sources
6 Witkin, Summary of California Law (11th ed. 2017) Torts, §§ 1317-1321
Haning et al., California Practice Guide: Personal Injury, Ch. 2(II)-D, Strict Liability
For Defective Products, ¶¶ 2:1271, 2:1295 (The Rutter Group)
California Products Liability Actions, Ch. 2, Liability for Defective Products, § 2.21,
Ch. 7, Proof, § 7.05 (Matthew Bender)
40 California Forms of Pleading and Practice, Ch. 460, Products Liability, § 460.11
(Matthew Bender)
19 California Points and Authorities, Ch. 190, Products Liability, § 190.165 et seq.
(Matthew Bender)

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