“The doctrine of strict products liability imposes strict liability in tort on the manufacturer of a defective product and others in the product’s chain of distribution.” Garrett v. Howmedica Osteonics Corp. (2013) 214 Cal.App.4th 173, 181-82. In a products liability case, a plaintiff may seek recovery on a theory of strict liability or negligence. Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 478.

“‘The elements of a strict products liability cause of action are

1. a defect in the manufacture or design of the product or a failure to warn,
2. causation, and
3. injury.’”

Nelson v. Super. Ct. (2006)144 Cal.App.4th 689, 695 citing County of Santa Clara v. Atlantic Richfield Co. (2006) 137 Cal.App.4th 292, 318.

Three Types of Product Defects

“[T]here are three ways to hold a manufacturer strictly liable for injuries caused by its product:

1. if the product is defectively manufactured;
2. if it is defectively designed; or
3. if it is distributed without sufficient warnings or instructions about its potential for harm.”

Karlsson v. Ford Motor Co. (2006) 140 Cal.App.4th 1202, 1208.

Manufacturing Defects

Manufacturing defects arise where a flaw in the manufacturing process creates a product that differs from what the manufacturer intended. Brown v. Superior Court (1988) 44 Cal.3d 1049, 1057; Garrett v. Howmedica Osteonics Corp. (2013) 214 Cal.App.4th 173, 190 (“a product has a manufacturing defect if the product as manufactured does not conform to the manufacturer’s design.”).

The elements of a products liability claim based on a manufacturing defect are:

1. defendant manufactured, distributed, and/or sold the product;
2. the product contained a manufacturing defect when it left name of defendant’s possession;
3. plaintiff used the product in a reasonably foreseeable way;
4. causation;
5. damages.

See CACI 1201.

Design Defects - Two Tests

A manufacturing defect is the legal cause of injury only if the defect was a substantial factor in producing the injury. Soule v. General Motors Corp. (1994) 8 Cal.4th 548, 572.

“A product is defective in design if:

1. the benefits of the design do not outweigh the risk of danger inherent in the design (risk-benefit test), or
2. if the product fails to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner (consumer expectations test).”

Garrett, supra, 214 Cal.App.4th at 182.

The elements of a products liability claim based on design defect are:

1. defendant manufactured, distributed, and/or sold the product;
2. the product did not perform as safely as an ordinary consumer would have expected at the time of use;
3. plaintiff used the product in a reasonably foreseeable way;
4. causation;
5. damages.

See CACI 1203.

Prescription Drugs

A manufacturer of prescription drugs cannot be strictly liable for a design defect and that the appropriate test for determining a prescription drug manufacturer’s liability for a design defect involves an application of the ordinary negligence standard. Brown v. Super. Ct. (1988) 44 Cal.3d 1049, 1061, 1069. Under the negligence standard as reflected in comment k to section 402A on page 353 of the Restatement Second of Torts, adopted in Brown, a manufacturer is liable for a design defect only if it failed to warn of a defect that it either knew or should have known existed. Brown, supra, at 1059.

Brown explained that the consumer expectations test is inappropriate for prescription drugs because an ordinary consumer would have no safety expectations with respect to a prescription drug apart from the information provided by his or her physician. Brown, supra, 44 Cal.3d at 1061-1062. A prescription drug manufacturer that has provided appropriate warnings to the physician cannot be liable for the physician’s failure to convey those warnings to the patient, and cannot be liable if the patient relies on information provided by others as to the side effects of the drug. Id. at 1062.

Warning of Defects

“The duty to warn is measured by what is generally known or should have been known to the class of sophisticated users, rather than by the individual plaintiff’s subjective knowledge.” Johnson v. Amer. Standard, Inc. (2008) 43 Cal.4th 56, 65-66. “California law... recognizes the obvious danger rule, which provides that there is no need to warn of known risks under either a negligence or strict liability theory.” Id. at 67.

A product may be dangerous where it lacks adequate warnings or instructions. Brown, supra, at 1057. Generally, manufacturers have a duty to warn consumers of the hazards inherent in the products of which consumers are unaware. Id. In California, liability for failure to warn is conditioned on the manufacturer’s actual or constructive knowledge of the risk. Anderson v. Owens-Cornring Fiberglas Corp. (1991) 53 Cal.3d 987, 1000. The duty to warn applies to all entities in a product’s chain of distribution. Taylor v. Elliott Turbomachinery Co. Inc. (2009) 171 Cal.App.4th 564, 575.

The elements of a products liability claim based on failure to warn are:

1. defendant manufactured, distributed, and/or sold the product;
2. the product had potential risks, side effects, and/or allergic reactions that were known at the time of manufacture, distribution, and/or sale;
3. the potential risks, side effects, and/or allergic reactions presented a substantial danger to users of the product;
4. ordinary consumers would not have recognized the potential risks, side effects, allergic reactions;
5. defendant failed to adequately warn or instruct of the potential risks, side effects, and/or allergic reactions;
6. plaintiff used the product in a reasonably foreseeable way;
7. the lack of sufficient instructions or warnings was a substantial factor in causing name of plaintiff’s harm.

CACI 1205.

Affirmative Defenses

Product Misuse

Product misuse, an affirmative defense, is a superseding cause of injury that absolves a tortfeasor of his or her own wrongful conduct only when the misuse was “so highly extraordinary as to be unforeseeable.” Perez v. VAS S.p.A. (2010) 188 Cal.App.4th 658, 685, 115; Bunch v. Hoffinger Industries, Inc. (2004) 123 Cal.App.4th 1278, 1302; see generally CACI No. 1245.

Because it is an affirmative defense, it is incumbent upon the defendant to present evidence supporting each essential element thereof. Huynh v. Ingersoll-Rand (1993) 16 Cal.App.4th 825, 830-32. To establish this particular affirmative defense, a defendant must first present evidence showing the plaintiff or a third party misused the product in an unforeseeable manner. Huynh, supra, 16 Cal.App.4th at 832-33. The defendant must also show the misuse caused the plaintiff’s injury. Id.

“Foreseeability is a question for the jury unless undisputed facts leave no room for a reasonable difference of opinion.” Torres v. Xomox Corp. (1996) 49 Cal.App.4th 1, 19, 56; Chavez v. Glock, Inc. (2012) 207 Cal. App. 4th 1283, 1308.

Obvious Danger Rule

“California law... recognizes the obvious danger rule, which provides that there is no need to warn of known risks under either a negligence or strict liability theory.” Johnson v. Amer. Standard, Inc. (2008) 43 Cal.4th 56, 67.

Sophisticated User — Specific Defense to Failure to Warn

The sophisticated user defense exempts manufacturers from their typical obligation to provide product users with warnings about the products’ potential hazards. Johnson v. American Standard, Inc. (2008) 43 Cal. 4th 56, 65 citing In re Asbestos, 543 F.Supp. at 1151. The defense is considered an exception to the manufacturer’s general duty to warn consumers, and therefore, in most jurisdictions, if successfully argued, acts as an affirmative defense to negate the manufacturer’s duty to warn. Id.