Renewed look at the duty to warn and affirmative defenses.

• Author: Richmond, Douglas R.

Duty to warn allegations are easy to make, and the cases are proliferating, making it time to sharpen up on the affirmative defenses

THE DUTY to warn is the most widely employed claim or theory in products liability litigation today.(1) Almost all products liability actions include allegations that the manufacturer failed to warn the plaintiff or a decedent of product dangers.

Duty to warn cases have proliferated for several reasons. First, failure to warn claims are not technical and are relatively inexpensive to prosecute, unlike traditional design defect cases.(2) Second, almost all products capable of causing harm could be made less hazardous by effectively warning users.(3) Third, manufacturers may be held liable for their failure to warn of product dangers, or for providing inadequate warnings, under negligence, strict liability and warranty theories.(4) In other words, plaintiffs have some theoretical flexibility in prosecuting their claims.

This article discusses generally manufacturers' liability for the failure to warn consumers of product dangers, a duty that may be subdivided into the duty to instruct or provide directions for safe and a duty to warn against inherent dangers.(5) It then addresses the theories under or pursuant to which liability for a failure to warn is most frequently imposed and finally discusses affirmative defenses to failure to warn claims.

The Duty to Warn

1. Negligence

   The general rule regarding a manufacturer's duty to warn consumers of product dangers is embodied in Section 388 of the Restatement (Second) of Torts:

   One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier

   (a) knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and

   (b) has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and

   (c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.(6)

   All three of Section 388's criteria must be satisfied for liability to attach.(7)

   A manufacturer must warn of product risks when it knows or should know that, without warnings, its product is likely dangerous for the use for which it is supplied.(8) The duty to warn is triggered where the danger, absent warnings, is "significant" or "sufficiently serious."(9) In the distribution chain, only the manufacturer is charged with the "knows or has reason to know" standard. The manufacturer's higher standard is grounded in its presumed superior knowledge of the product and its hazards.(10) The information a manufacturer should know includes that obtainable from a reasonable inquiry of experts and a reasonable search of scientific literature.(11)

   When negligence is alleged, the duty to warn turns on whether the subject injury was reasonably foreseeable by the manufacturer.(12) Foreseeability is twice an issue. First, was the product use foreseeable? Phrased differently, was the product used as the manufacturer might have reasonably anticipated? Second, was the injury itself reasonably foreseeable? Regardless of whether foreseeability relates to a manufacturer's duty or to proximate cause, it is impossible to characterize particular events as foreseeable. Foreseeability is thus a fact issue generally left to the common sense of juries.(13)

   The landmark foreseeability case is Hubbard-Hall Chemical Co. v. Silverman.(14) Hubbard-Hall sold bags of the insecticide Parathion to a farmer. The bags were labeled with explicit warnings in English identifying Parathion as a poison. The warnings did not include hazard symbols, such as the traditional "skull and bones." Two Puerto Rican laborers, only one of whom could read limited English, ingested the Parathion while dusting crops and died. The laborers' survivors sued the manufacturer, alleging that it inadequately warned farm laborers of Parathion's hazards. The trial judge quoted Section 388 in the instructions, and the jury returned a verdict for the plaintiffs.

   Affirming, the First Circuit Court of Appeals was "of the opinion that the jury could reasonably have believed that defendant should have foreseen that its admittedly dangerous product would be used by ... persons like plaintiffs' intestates, who were farm labors, of limited education and reading ability." Because the manufacturer's warnings lacked the "skull and bones or other comparable symbols," the court said, the jury reasonably found them to be inadequate.

   The need to warn in languages other than English is a current issue. In Ramirez v. Plough Inc.(15) an infant contracted Reye's Syndrome after being given the product named St. Joseph Aspirin for Children. While the packaging in which the aspirin was sold warned in English of the dangers of Reye's Syndrome, the child's grandmother, who administered the aspirin, read and spoke only Spanish. The trial court granted the manufacturer's motion for summary judgment, holding that there was no duty to warn in foreign languages.

   The California Court of Appeal reversed. It noted that the manufacturer's own evidence showed that more than 23 million Americans speak languages other than English at home. The plaintiff submitted evidence that the defendant knew that Hispanics were an important part of the children's aspirin market and that they often maintained their first language instead of learning English. Indeed, the manufacturer advertised its children's aspirin in the Spanish media. The court concluded that the foreseeability of purchase by a Hispanic not literate in English and the reasonableness of not giving a Spanish-language warning were jury issues.

   The California Supreme Court in turn reversed.(16) It reasoned that because state and federal law regulating non-prescription drugs require only English warnings, "the prudent course [was] to adopt for tort purposes the existing legislative and administrative standard of care," and the manufacturer owed no duty to warn in languages other than English. As a rule, however, manufacturers have a duty to warn in another language, commonly Spanish, when the use of their products by non-English speakers is known or intended.(17) This is especially true if manufacturers advertise in alternative language media.

   Foreseeability also may be an issue when a product is not used as the manufacturer intended. In High v. Westinghouse Electric Corp.(18) the plaintiff was allegedly exposed to harmful PCB's when scrapping oil-filled transformers. The Florida Supreme Court held that manufacturers have a duty to warn of dangers inherent even in the disposal of their products.

   A manufacturer's duty to warn under negligence principles also is gauged by cost-benefit analysis, or risk-utility balancing. Relevant factors to be balanced include (1) the probability of danger, (2) the magnitude of the danger and (3) the burden on the manufacturer.(19) Courts and juries often regard adding or improving warnings as a modest-even insignificant-financial burden.(20) Therefore, risk-utility analysis generally disfavors manufacturers.

2. Strict Liability

   Distinguishing between failure to warn claims grounded in negligence and those based on strict liability is often difficult. Theoretical distinctions are largely unimportant, however, because ultimate liability is similarly analyzed, regardless of the chosen cause of action. In the warnings context, negligence and strict liability have converged.(21)

   Strict products liability flows from Section 402A of the Restatement and its comments:

   (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if

   (a) the seller is engaged in the business of selling such a product, and

   (b) it is expected to and does reach the user or consumer without a substantial change in the condition in which it is sold.

   (2) The rule stated in Subsection (1) applies although

   (a) the seller has exercised all possible care in the preparation and sale of his product, and

   (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.(22)

   While the text of Section 402A does not discuss warnings, comments h, j and k make clear its intended application of warnings.(23)

   Courts attempt to distinguish between a manufacturer's negligence or strict liability for its failure to warn on a product-versus-conduct basis. In other words, the latter theory is tied to product condition or quality, while the former focuses on the defendant's conduct.(24) The product-conduct approach lacks analytical value. The difference between strict liability and negligence in warnings cases is basic: in strict liability cases, manufacturers' knowledge of product dangers is assumed or imputed; plaintiffs alleging negligence must prove that manufacturers knew or should have known of dangers.(25) Indeed, the development of strict liability can be linked to the widespread recognition that "the circumstances behind some injuries would make negligence practically impossible for an injured plaintiff to prove."(26)

   Like negligence, strict liability for a failure to warn includes an element of foreseeability.(27) Comment j to Restatement Section 402A states that a manufacturer has a duty to warn "if [it] has knowledge, or by the application of reasonable skill and foresight should have knowledge, of the presence ... of the danger" of hazards associated with the product's use. If a manufacturer could not reasonably have foreseen dangers inherent in a...