The Guide is an invaluable online tool for litigation and transactional attorneys. The Guide provides for more than 70 common law causes of action:

- Each action’s elements;
- The most recent state and federal cases that cite the actions’ elements;
- The applicable statute of limitations for each action; and
- Defenses to each cause of action.
- AND, The Guide is updated annually.

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Strict Liability Failure to Warn

1 Elements and Case Citations

1. The defendant manufactured/distributed/sold the product (was in the “chain of distribution”);

2. That the product had potential risks 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 the manufacture/distribution/sale;

3. That the potential risks 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;

5. That defendant failed to adequately warn of the potential risks;

6. That plaintiff was harmed while using the product as intended or in a reasonably foreseeable way; and

7. That lack of sufficient instructions or warnings was a substantial factor in causing plaintiff’s harm.

“[A] defendant involved in the marketing/distribution process has been held strictly liable if three factors are present:

(1) the defendant received a direct financial benefit from its activities and from the sale of the product;
(2) the defendant’s role was integral to the business enterprise such that the defendant’s conduct was a necessary factor in bringing the product to the initial consumer market; and
(3) the defendant had control over, or a substantial ability to influence, the manufacturing or distribution process.”

Bay Summit Community Ass’n v. Shell Oil Co., 51 Cal. App. 4th 762, 773 (1996).


California Supreme Court: O'Neil v. Crane Co., 53 Cal. 4th 335, 347-48 & 351-52 & 362-63 (2012); Johnson v. American Standard, Inc., 43 Cal. 4th 56, 64-65 (2008).

California 1st Dist.: Oxford v. Foster Wheeler LLC, 177 Cal. App. 4th 700, 717 (2009); Taylor v. Elliott Turbomachinery Co. Inc., 171 Cal. App. 4th 564, 575-77 (2009).

California 2d Dist.: Chavez v. Glock, Inc., 207 Cal. App. 4th 1283, 1304 (2012).

California 3d Dist.: Nelson v. Superior Court, 144 Cal. App. 4th 689, 695 (2006).

California 4th Dist.: Hufft v. Horowitz, 4 Cal. App. 4th 8, 13 (1992).

California 5th Dist.: McKenney v. Purepac Pharmaceutical Co., 167 Cal. App. 4th 72, 82-83 (2008) (drug and medical device manufacturer liability for failure to warn).

California 6th Dist.: County of Santa Clara v. Atlantic Richfield Co., 137 Cal. App. 4th 292, 318 (2006).


United States Court of Appeal for the 9th Circuit: Rosa v. TASER Int’l, Inc., 684 F.3d 941, 946 (9th Cir. 2012).

Central District: Michery v. Ford Motor Co., No. CV 12-04957 RSWL (FFMx), 2013 U.S. Dist. LEXIS 161445, at *19-20 (C.D. Cal. Nov. 12, 2013); Alarcon v. Organon U.S.A., Inc., No. CV 13-6337 PA (RZx), 2013 U.S. Dist. LEXIS 126556, at *8 (C.D. Cal. Sept. 4, 2013).

Eastern District: Waldo v. Eli Lilly & Co., No. CIV. S-13-0789 LKK/EFB, 2013 U.S. Dist. LEXIS 145772, at *11-12 (E.D. Cal. Oct. 8, 2013); Hatherley v. Pfizer, Inc., No. CIV. 2:13-00719 WBS CKD, 2013 U.S. Dist. LEXIS 93943, at *26 (E.D. Cal. July 3, 2013).

Northern District: Monigan v. National Presto Indus., No. C 12-3698 SI, 2013 U.S. Dist. LEXIS 177069, at *8-9 & 10-11 (N.D. Cal. Dec. 17, 2013); Tucker v. Wright Med. Tech., Inc., No. 11-cv-03086-YGR, 2013 U.S. Dist. LEXIS 38354, at *41-42 (N.D. Cal. Mar. 19, 2013).

Southern District: Cruz v. Sears, Sears’ Craftsman Tools, No. 12-CV-00623-H (BGS), 2012 U.S. Dist. LEXIS 99817, at *5 (S.D. Cal. July 18, 2012).

2 Defenses to Claim for Failure to Warn

(1) Cal. Code Civ. Proc. § 431.30(b)(2) (pleading affirmative defenses), and other standard defenses. See Chapter 1 for all defenses.

(2) Statute of Limitations: Cal. Code Civ. Proc § 335.1 (two years) if the plaintiff suffered personal injury. The statute of limitations is three years if the injury was to personal property Cal. Code Civ. Proc. § 338.

(3) The case law, with regard to element 2, holds 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.” Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d 987 (1991).

(4) FDA Preemption: Failure to warn cases are preempted in connection with pharmaceuticals where the warnings provided are those approved by the Federal Drug Administration. See, e.g., Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC(RNBx), 2013 U.S. Dist. LEXIS 169518, at *10-11 (S.D. Cal. Nov. 22, 2013) (citing 21 C.F.R. § 814.39(d)).

(5) Economic Loss: “[E]conomic loss alone, without physical injury, does not amount to the type of damage that will cause a negligence or strict liability cause of action to accrue. ‘In a strict liability or negligence case, the compensable injury must be physical harm to persons or property, not mere economic loss.’” County of Santa Clara v. Atlantic Richfield Co., 137 Cal. App. 4th 292, 318 (2006).

(6) Vaccine Act Preemption: “[M]anufacturers are generally immunized from liability for failure to warn if they have complied with regulatory requirements and have given the warning to the healthcare professional, the vaccine recipient, or the vaccine recipient’s legal representative.” Holmes v. Merck & Co., 697 F.3d 1080, 1085 (9th Cir. 2012) (citing the “National Childhood Vaccine Injury Act,” 42 U.S.C. § 300aa-22(e)).

(7) Reasonableness: Although the failure to warn elements contain language similar to the language used in negligence cases, “in strict liability, as opposed to negligence, the reasonableness of the defendant’s failure to warn is immaterial.” Carlin v. Superior Court, 13 Cal. 4th 1104, 1112 (1996). “[T]he fact that a manufacturer acted as a reasonably prudent manufacturer in deciding not to warn, while perhaps absolving the manufacturer of liability under the negligence theory, will not preclude liability under strict liability principles if the trier of fact concludes that, based on the information scientifically available to the manufacturer, the manufacturer's failure to warn rendered the product unsafe to its users.” Id. at 1113.

(8) Known Risks or Obvious Dangers: “There is no duty to warn of known risks or obvious dangers.” Chavez v. Glock, Inc., 207 Cal. App. 4th 1283, 1304 (2012).

(9) Sophisticated User: “Under the sophisticated user defense, sophisticated users need not be warned about dangers of which they are already aware or should be aware. . . . Because these sophisticated users are charged with knowing the particular product’s dangers, the failure to warn about those dangers is not the legal cause of any harm that product may cause.” Johnson v. American Standard, Inc., 43 Cal. 4th 56, 70-71 (2008).

(10) Lack of Causation: “[A] defendant is not liable to a plaintiff if the injury would have occurred even if the defendant had issued adequate warnings.” Chavez v. Glock, Inc., 207 Cal. App. 4th 1283, 1304 (2012).

(11) “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 reason that the product caused injury. . . Unforeseeable 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.” Perez v. VAS S.p.A., 188 Cal. App. 4th 658, 678 n.6 (2010).

(12) A superseding cause absolves a tortfeasor of liability, even though his or her conduct was a substantial contributing factor, when an independent event intervenes in the chain of causation, producing harm of a kind and degree so far beyond the risk the original tortfeasor should have foreseen that the law deems it unfair to hold him or her responsible. Collins v. Navistar, Inc., 214 Cal. App. 4th 1486, 1491 (2013). However, “[i]n California the doctrine requires more than mere negligence on the part of the intervening actor. ‘[T]he fact that an intervening act of a third person is done in a negligent manner does not make it a superseding cause if a reasonable man knowing the situation existing when the act of the third person is done would not regard it as highly extraordinary that the third person so acted or the act is a normal response to a situation created by the defendant's conduct and the manner in which the intervening act is done is not extraordinarily negligent.’” Doupnik v. General Motors Corp., 225 Cal. App. 3d 849, 863 (1990).

(12) Intervening Cause: “"[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., 161 Cal.App.4th 651, 661 (2008).

(13) Comparative negligence principles apply to actions founded on strict products liability. Aguirre v. Home Depot U.S.A., Inc., 1:10-cv-00311-LJO-GSA, 2012 U.S. Dist. LEXIS 119979 (E.D. Cal. Aug. 22, 2012).

(14) The defendant 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 in a failure to warn case. Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d 987 (1991).