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 by the use of scientific knowledge available] at the time of [manufacture/ distribution/sale];

3. That the potential [risks/side effects/allergic reactions] presented a substantial danger to users of the [product];

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 the [product] was used [or misused] in a way that was reasonably foreseeable to [name of defendant];

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

8. That 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.]

Directions for Use

A fuller definition of "scientific knowledge" may be appropriate in certain cases. Such a definition would advise that the defendant did not adequately arn of a potential risk, side effect, or allergic reaction that was "knowable in light of the generally recognized and prevailing best scientific and medical knowledge available." (Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1112 [56 Cal.Rptr.2d 162, 920 P.2d 1347].)

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." (Valentine v. Baxter Healthcare Corp. (1999) 68 Cal.App.4th 1467, 1483 [81 Cal.Rptr.2d 252].)

Some cases state that product misuse must be pleaded as an affirmative defense. (See, e.g., Williams v. Beechnut Nutrition Corp. (1986) 185 Cal.App.3d 135, 141 [229 Cal.Rptr. 605].) However, the advisory committee feels that absence of unforeseeable misuse is an element of plaintiff's claim and that foreseeable misuse is more properly asserted by defendant in support of a claim of contributory negligence. But see below:

"[P]roduct misuse [is] a defense to strict products liability only when the defendant prove[s] that an unforeseeable abuse or alteration of the product after it left the manufacturer's hands was the sole reason that the product caused injury." (Campbell v. Southern Pacific Co. (1978) 22 Cal.3d 51, 56 [148 Cal.Rptr. 596, 583 P.2d 121], internal citations omitted.)

" 'Misuse' is a defense only when that misuse is the actual cause of the plaintiff's injury, not when some other defect produces the harm. This causation is one of the elements of the 'misuse' affirmative defense and thus the burden falls on the defendant to prove it." (Huynh v. Ingersoll-Rand (1993) 16 Cal.App.4th 825, 831 [20 Cal.Rptr.2d 296], internal citation omitted.)

Sources and Authority

"[A] manufacturer or a supplier of a product is required to give warnings of any dangerous propensities in the product, or in its use, of which he knows, or should know, and which the user of the product would not ordinarily discover." (Groll v. Shell Oil Co. (1983) 148 Cal.App.3d 444, 448 [196 Cal.Rptr. 52], internal citations omitted.)

"Even though the product is flawlessly designed and manufactured, it may be found defective within the general strict liability rule and its anufacturer or supplier held strictly liable because of the failure to provide an adequate warning." (Persons v. Salomon North America, Inc. (1990) 217 Cal.App.3d 168, 174 [265 Cal.Rptr. 773], internal citations omitted.)

"Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer's conduct. The rules of strict liability require a plaintiff to prove only that the defendant 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. . . . [T]he manufacturer is liable if it failed to give warning of dangers that were known to the scientific community at the time it manufactured or distributed the product." (Anderson v. Owens-Corning Fiberglas Corp. (1991) 53 Cal.3d 987, 1002-1003 [281 Cal.Rptr. 528, 810 P.2d 549].)

"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 v. Superior Court (1996) 13 Cal.4th 1104, 1113, fn. 3 [56 Cal.Rptr.2d 162, 920 P.2d 1347].)

"[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].)

"[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], italics in original.)

"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].)

"[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.)

"We are aware of no authority which requires a manufacturer to warn of a risk which is readily known and apparent to the consumer, in this case the physician." (Plenger v. Alza Corp. (1992) 11 Cal.App.4th 349, 362 [13 Cal.Rptr.2d 811].)

" '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." (Self v. General Motors Corp. (1974) 42 Cal.App.3d 1, 7 [116 Cal.Rptr. 575], disapproved and overruled on nother issue in Soule v. General Motors Corp. (1994) 8 Cal.4th 548, 580 [34 Cal.Rptr.2d 607, 822 P.2d 298].)

Secondary Sources

6 Witkin, Summary of California Law (9th ed. 1988) Torts, §§ 1265- 1271D

California Products Liability Actions, Ch. 2, Liability for Defective Products, § 2.11, 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 (Matthew Bender)

(New September 2003)