CACI 1205 Strict Liability—Failure to Warn—Essential Factual Elements

California Civil Jury Instructions CACI

1205 Strict Liability—Failure to Warn—Essential Factual Elements

[Name of plaintiff] claims that the [product] lacked sufficient [instructions] [or] [warning of potential [risks/side effects/allergic reactions]]. To establish this claim, [name of plaintiff] must prove all of the following:

1.That [name of defendant] [manufactured/distributed/sold] the [product];

2.That the [product] had potential [risks/side effects/allergic reactions] that were [known/ [or] knowable in light of the [scientific/ [and] medical] knowledge that was generally accepted in the scientific community] at the time of [manufacture/distribution/sale];

3.That the potential [risks/side effects/allergic reactions] presented a substantial danger when the [product] is used or misused in an intended or reasonably foreseeable way;

4.That ordinary consumers would not have recognized the potential [risks/side effects/allergic reactions];

5.That [name of defendant] failed to adequately warn [or instruct] of the potential [risks/side effects/allergic reactions];

6.That [name of plaintiff] was harmed; and

7.That the lack of sufficient [instructions] [or] [warnings] 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, side effects, or allergic reactions 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 April 2009, December 2009, June 2011, December 2011, May 2020

Crowdsource Lawyers

Directions for Use

With regard to element 2, it has been often stated in the case law that a manufacturer is liable for failure to warn of a risk that is “knowable in light of generally recognized and prevailing best scientific and medical knowledge available.” (See, e.g., Anderson v. Owens-Corning Fiberglas Corp. (1991) 53 Cal.3d 987, 1002 [281 Cal.Rptr. 528, 810 P.2d 549]; Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1112 [56 Cal.Rptr.2d 162, 920 P.2d 1347]; Saller v. Crown Cork & Seal Company (2010) 187 Cal.App.4th 1220, 1239 [115 Cal.Rptr.3d 151]; Rosa v. City of Seaside (N.D. Cal. 2009) 675 F.Supp.2d 1006, 1012.) The advisory committee believes that this standard is captured by the phrase “generally accepted in the scientific community.” A risk may be “generally recognized” as a view (knowledge) advanced by one body of scientific thought and experiment, but it may not be the “prevailing” or “best” scientific view; that is, it may be a minority view. The committee believes that when a risk is (1) generally recognized (2) as prevailing in the relevant scientific community, and (3) represents the best scholarship available, it is sufficient to say that the risk is knowable in light of “the generally accepted” scientific knowledge.

The last bracketed paragraph should be read only in prescription product cases: In the case of prescription drugs and implants, the physician stands in the shoes of the ordinary user because it is through the physician that a patient learns of the properties and proper use of the drug or implant. Thus, the duty to warn in these cases runs to the physician, not the patient. (Bigler-Engler v. Breg, Inc. (2017) 7 Cal.App 5th 276, 319 [213 Cal.Rptr.3d 82], original italics.)

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] [risk-benefit design defect case].) See also CACI No. 1245, Affirmative 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 manufacturer’s 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.

Sources and Authority

“Our law recognizes that even ‘ “a product flawlessly designed and produced may nevertheless possess such risks to the user without a suitable warning that it becomes ‘defective’ simply by the absence of a warning.” …’ Thus, manufacturers have a duty to warn consumers about the hazards inherent in their products. The purpose of requiring adequate warnings is to inform consumers about a product’s hazards and faults of which they are unaware, so that the consumer may then either refrain from using the product altogether or avoid the danger by careful use.” (Taylor v. Elliott Turbomachinery Co., Inc. (2009) 171 Cal.App.4th 564, 577 [90 Cal.Rptr.3d 414], internal citations and footnote omitted.)

“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 manufacturer’s 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 seller’s 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 seller’s 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], original italics, 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].)

“The actual knowledge of the individual manufacturer, even if reasonably prudent, is not the issue. We view the standard to require that the manufacturer is held to the knowledge and skill of an expert in the field; it is obliged to keep abreast of any scientific discoveries and is presumed to know the results of all such advances.” (Carlin, supra, 13 Cal.4th at p. 1113, fn. 3.)

“[A] defendant in a strict products liability action based upon an alleged failure to warn of a risk of harm may present evidence of the state of the art, i.e., evidence that the particular risk was neither known nor knowable by the application of scientific knowledge available at the time of manufacture and/or distribution.” (Anderson, supra, 53 Cal.3d at p. 1004.)

“[T]here can be no liability for failure to warn where the instructions or warnings sufficiently alert the user to the possibility of danger.” (Aguayo v. Crompton & Knowles Corp. (1986) 183 Cal.App.3d 1032, 1042 [228 Cal.Rptr. 768], internal citation omitted.)

“A duty to warn or disclose danger arises when an article is or should be known to be dangerous for its intended use, either inherently or because of defects.” (DeLeon v. Commercial Manufacturing and Supply Co. (1983) 148 Cal.App.3d 336, 343 [195 Cal.Rptr. 867], internal citation omitted.)

“California is well settled into the majority view that knowledge, actual or constructive, is a requisite for strict liability for failure to warn  … .” (Anderson, supra, 53 Cal.3d at p. 1000.)

“[T]he duty to warn is not conditioned upon [actual or constructive] knowledge [of a danger] where the defectiveness of a product depends on the adequacy of instructions furnished by the supplier which are essential to the assembly and use of its product.” (Midgley v. S. S. Kresge Co. (1976) 55 Cal.App.3d 67, 74 [127 Cal.Rptr. 217].)

Under Cronin, plaintiffs in cases involving manufacturing and design defects do not have to prove that a defect made a product unreasonably dangerous; however, that case “did not preclude weighing the degree of dangerousness in the failure to warn cases.” (Cavers v. Cushman Motor Sales, Inc. (1979) 95 Cal.App.3d 338, 343 [157 Cal.Rptr. 142].)

“Two types of warnings may be given. If the product’s dangers may be avoided or mitigated by proper use of the product, ‘the manufacturer may be required adequately to instruct the consumer as to how the product should be used.’ If the risks involved in the use of the product are unavoidable, as in the case of potential side effects of prescription drugs, the supplier must give an adequate warning to enable the potential user to make an informed choice whether to use the product or abstain.” (Buckner v. Milwaukee Electric Tool Corp. (2013) 222 Cal.App.4th 522, 532 [166 Cal.Rptr.3d 202], internal citation omitted.)

“[T]he warning requirement is not limited to unreasonably or unavoidably dangerous products. Rather, directions or warnings are in order where reasonably required to prevent the use of a product from becoming unreasonably dangerous. It is the lack of such a warning which renders a product unreasonably dangerous and therefore defective.” (Gonzales v. Carmenita Ford Truck Sales, Inc. (1987) 192 Cal.App.3d 1143, 1151 [238 Cal.Rptr. 18], original italics.)

“In most cases, … the adequacy of a warning is a question of fact for the jury.” (Jackson v. Deft, Inc. (1990) 223 Cal.App.3d 1305, 1320 [273 Cal.Rptr. 214].)

“There is no duty to warn of known risks or obvious dangers.” (Chavez v. Glock, Inc. (2012) 207 Cal.App.4th 1283, 1304 [144 Cal.Rptr.3d 326].)

“In the context of prescription drugs, a manufacturer’s 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.’ ” (T.H. v. Novartis Pharmaceuticals Corp. (2017) 4 Cal.5th 145, 164 [226 Cal.Rptr.3d 336, 407 P.3d 18], internal citations omitted.)

“[A] pharmaceutical manufacturer may not be required to provide warning of a risk known to the medical community.” (Carlin, supra, 13 Cal.4th at p. 1116.)

“To prevail on her failure-to-warn claims, [plaintiff] ‘ “will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [her] doctors in time to prevent [her] injuries.’ [Citation.]” But at this stage, [plaintiff] need only allege ‘ “a causal connection” ’ between [defendant’s] failure to report and her injuries.” (Mize v. Mentor Worldwide LLC (2020) 51 Cal.App.5th 850, 863–864 [265 Cal.Rptr.3d 468], internal citation omitted.)

“To be liable in California, even under a strict liability theory, the plaintiff must prove that the defendant’s failure to warn was a substantial factor in causing his or her injury. (CACI No. 1205.) The natural corollary to this requirement is that a defendant is not liable to a plaintiff if the injury would have occurred even if the defendant had issued adequate warnings.” (Huitt v. Southern California Gas Co. (2010) 188 Cal.App.4th 1586, 1604 [116 Cal.Rptr.3d 453].)

“When a manufacturer or distributor has no effective way to convey a product warning to the ultimate consumer, the manufacturer should be permitted to rely on downstream suppliers to provide the warning. ‘Modern life would be intolerable unless one were permitted to rely to a certain extent on others doing what they normally do, particularly if it is their duty to do so.’ ” (Persons v. Salomon N. Am. (1990) 217 Cal.App.3d 168, 178 [265 Cal.Rptr. 773], internal citation omitted.)

“[A] manufacturer’s liability to the ultimate consumer may be extinguished by ‘intervening cause’ where the manufacturer either provides adequate warnings to a middleman or the middleman alters the product before passing it to the final consumer.” (Garza v. Asbestos Corp., Ltd. (2008) 161 Cal.App.4th 651, 661 [74 Cal.Rptr.3d 359].)

“ ‘A manufacturer’s duty to warn is a continuous duty which lasts as long as the product is in use.’ [¶] … [T]he manufacturer must continue to provide physicians with warnings, at least so long as it is manufacturing and distributing the product.” (Valentine v. Baxter Healthcare Corp. (1999) 68 Cal.App.4th 1467, 1482 [81 Cal.Rptr.2d 252].)

“ ‘[T]he law now requires a manufacturer to foresee some degree of misuse and abuse of his product, either by the user or by third parties, and to take reasonable precautions to minimize the harm that may result from misuse and abuse. … [T]he extent to which designers and manufacturers of dangerous machinery are required to anticipate safety neglect presents an issue of fact. … [A] manufacturer owes a foreseeable user of its product a duty to warn of risks of using the product.’ ” (Wright v. Stang Manufacturing Co. (1997) 54 Cal.App.4th 1218, 1235 [63 Cal.Rptr.2d 422].)

“California law does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together.” (O’Neil v. Crane Co. (2012) 53 Cal.4th 335, 361 [135 Cal.Rptr.3d 288, 266 P.3d 987].)

“The O’Neil [supra] court concluded that Tellez-Cordova [Tellez-Cordova v. Campbell-Hausfeld/Scott Fetzger Co. (2004) 129 Cal.App.4th 577] marked an exception to the general rule barring imposition of strict liability on a manufacturer for harm caused by another manufacturer’s product. That exception is applicable when ‘the defendant’s own product contributed substantially to the harm … .’ In expounding the exception, the court rejected the notion that imposition of strict liability on manufacturers is appropriate when it is merely foreseeable that their products will be used in conjunction with products made or sold by others. The O’Neil court further explained: ‘Recognizing a duty to warn was appropriate in Tellez-Cordova because there the defendant’s product was intended to be used with another product for the very activity that created a hazardous situation. Where the intended use of a product inevitably creates a hazardous situation, it is reasonable to expect the manufacturer to give warnings. Conversely, where the hazard arises entirely from another product, and the defendant’s product does not create or contribute to that hazard, liability is not appropriate.’ ” (Sherman v. Hennessy Industries, Inc. (2015) 237 Cal.App.4th 1133, 1142 [188 Cal.Rptr.3d 769], original italics, internal citations omitted; see also Hetzel v. Hennessy Industries, Inc. (2016) 247 Cal.App.4th 521, 529 [202 Cal.Rptr.3d 310] [O’Neil does not require evidence of exclusive use, but rather requires a showing of inevitable use]; Rondon v. Hennessy Industries, Inc. (2016) 247 Cal.App.4th 1367, 1379 [202 Cal.Rptr.3d 773] [same].)

“[L]ike a manufacturer, a raw material supplier has a duty to warn about product risks that are known or knowable in light of available medical and scientific knowledge.” (Webb, supra, 63 Cal.4th at p. 181.)

“[T]he duty of a component manufacturer or supplier to warn about the hazards of its products is not unlimited. … ‘Making suppliers of inherently safe raw materials and component parts pay for the mistakes of the finished product manufacturer would not only be unfair, but it also would impose and intolerable burden on the business world … . Suppliers of versatile materials like chains, valves, sand gravel, etc., cannot be expected to become experts in the infinite number of finished products that might conceivably incorporate their multi-use raw materials or components.’ Thus, cases have subjected claims made against component suppliers to two related doctrines, the ‘raw material supplier defense’ and ‘the bulk sales/sophisticated purchaser rule.’ Although the doctrines are distinct, their application oftentimes overlaps and together they present factors which should be carefully considered in evaluating the liability of component suppliers. Those factors include whether the raw materials or components are inherently dangerous, whether the materials are significantly altered before integration into an end product, whether the supplier was involved in designing the end-product and whether the manufacturer of the end product was in a position to discover and disclose hazards.” (Artiglio v. General Electric Co. (1998) 61 Cal.App.4th 830, 837 [71 Cal.Rptr.2d 817].)

Secondary Sources

6 Witkin, Summary of California Law (11th ed. 2017) Torts, §§ 1631–1643
Haning et al., California Practice Guide: Personal Injury, Ch. 2(II)-D, Strict Liability for Defective Products, ¶¶ 2:1275–2:1276 (The Rutter Group)
California Products Liability Actions, Ch. 2, Liability for Defective Products, § 2.11[4]; Ch. 7, Proof, § 7.05 (Matthew Bender)
40 California Forms of Pleading and Practice, Ch. 460, Products Liability, §§ 460.11, 460.164 (Matthew Bender)
19 California Points and Authorities, Ch. 190, Products Liability, §§ 190.193–190.194 (Matthew Bender)