CACI 1222 Negligence—Manufacturer or Supplier—Duty to Warn—Essential Factual Elements
California Civil Jury Instructions CACI
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 [product];
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, 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.
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 manufacturer’s 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 omitted.)
•“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 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], 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 omitted.)
•“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.’ 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 manufacturer’s failure to update its warning label foreseeably and proximately caused physical injury, then the brand-name manufacturer’s 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.)