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Legally Adequate Warning Labels: A Conundrum for Every Manufacturer

A traditional axiom of products liability law is that a manufacturer or supplier of goods has a duty to warn of any danger from the intended or unintended but reasonably foreseeable use of its products. This duty extends to those using or purchasing the product, as well as to those who could reasonably be expected to be harmed by its use. While there are many ways in which to warn, warning labels attached to the product are a traditional method of fulfilling this duty. However, merely warning of the danger may not be enough. Even where a warning is provided, a manufacturer may still be liable if the warning is not deemed to be legally "adequate."

Under current products liability law, a determination of adequacy is a highly subjective and fact-intensive evaluation. As such, defining a step-by-step procedure for creating unassailably adequate warning labels is impossible. Nonetheless, an examination of current statutes and case law, voluntary consensus standards, and the new Restatement (Third) of the Law of Torts: Products Liability (hereinafter Third Restatement) does provide substantial insight into what information a court may consider when evaluating the adequacy of a warning.

This article will examine the law and standards and how they apply when a court is making a determination of legal sufficiency. With a clear understanding of this information, a manufacturer will be better able to develop warning labels that will satisfy the adequacy requirement.

Duty to Warn

Generally, the manufacturer has a duty to warn where:

  1. the product supplied is dangerous;
  2. the danger is or should be known by the manufacturer;
  3. the danger is present when the product is used in the usual and expected manner; and
  4. the danger is not obvious or well known to the user. See Billiar v. Minnesota Mining and Manufacturing Co., 623 F.2d 240, 243 (2d Cir. 1980).

Once a duty to warn arises, the manufacturer who has provided a warning may still be liable for harm if the warning provided is inadequate. That is, even if the manufacturer has provided a warning, a qualitative evaluation may result in a finding that the warning did not sufficiently warn of the product's potential dangers. "Providing an inadequate warning is no better than providing no warning at all." American Law of Products Liability 3d, §33:1.

The difficulty for manufacturers is, therefore, to prospectively determine what may be considered an "adequate" warning for each foreseeable risk. A lack of objective criteria makes this determination difficult. Third Restatement §2, comment i. The problem is compounded by the fact that adequacy determination is a factual issue most often left to the fact finder. A fact finder often concludes that, if the plaintiff was injured, the warning must be per se inadequate. See Victor E. Schwartz & Russell W. Driver, "Warnings in The Workplace: The Need For a Synthesis of Law And Communication Theory," 52 U.Cin.L.Rev. 38, 54 (1983). These problems have made it difficult for even the most well intentioned manufacturers to ensure that they can successfully defend against a claim of inadequacy.

What then should a manufacturer do to ensure that its warning labels are legally adequate? To better answer that question, it is helpful to understand the social policy justification for imposing liability on manufacturers.

The Requirement of Adequacy. The policy justification for the duty to warn is rooted in the notion that product manufacturers are better able to anticipate what dangers are inherent during the use of their products. The manufacturer then is in a better position to warn of these dangers. It would be fundamentally wrong to permit an exploitative manufacturer to profit from the sale of a product it knows or should know to be dangerous. By allocating the burden in this way, manufacturers are additionally provided an incentive to "achieve optimal levels of safety in designing and marketing products." Third Restatement §2, comment a. This is not to say that, as a society, we believe a manufacturer should be absolutely liable for its products. Society does not benefit from "excessively safe" products that overly sacrifice utility any more than it benefits from unreasonably risky products. Rather, we are interested in encouraging the optimal balance of product safety and utility . Thus, the duty to warn enhances society's goal of risk reduction without eliminating the manufacturer's incentive to produce useful goods.

Warning defects include:

  • failure to warn;
  • failure to provide an adequate warning; and
  • failure to adequately instruct.

Adequacy differs from failure to warn in that adequacy addresses the qualitative characteristics of a warning while failure to warn addresses the quantitative aspects (i.e., failure to warn asks: "is there a warning at all?" while adequacy asks "was the warning provided adequate?"). Adequacy of warnings may also be distinguished from adequacy of instructions. The fact that adequate instructions are provided that assist the operator in the correct operation of the product does not necessarily discharge the duty to provide an adequate warning. A warning may still be required to call attention to the dangers of using the product.

While not the exclusive method of providing a warning, labels are one of the most effective in communicating danger. This is especially true where the warning label is attached directly to the product. One reason for this increased effectiveness is that a warning label affixed directly to the product stays with the product even after transfer to subsequent users. This assures that the subsequent users are also warned. Additionally, warning labels attached to the product may improve effectiveness by warning non-users of the potential dangers. As discussed below, this is critical in some instances as a manufacturer may be liable for warning others in addition to the product user.

Who Must Be Warned. Generally, one who supplies a product directly or through a third party is subject to liability to those whom the manufacturer should expect to use the product or to be endangered by its probable use. Restatement (Second) of Torts §388 (1965). This may include not only the party to whom the product is given, but also friends or employees of the purchaser. While there is little doubt that a purchaser or known user should be warned, more difficult questions arise when a third party not in the chain of title alleges a warning defect.

Many courts have, in accordance with section 388, held that a manufacturer or distributor is required to warn only those that it could "reasonably foresee would be likely to use its product or who are likely to come into contact with the danger, if any, inherent in the use of its product." Am.Law Prod.Liab.3d §33:15. The warning given must be adequate to protect any and all foreseeable users from hidden dangers. While this duty may also extend to bystanders, warnings need not be given to the general public. See, e.g., Harrison v. McDonough Power Equipment Inc., 381 F.Supp. 926, 929 (S.D.Fla.1974) (the distributor of an inherently dangerous product must take reasonable precautions to avoid injuries to users and bystanders); Eagle-Picher Industries, Inc. v. Balbos, 84 Md.App.10, 578 A.2d 228, 251 (1990) ("[t]here is no longer any doubt that negligence liability extends to any lawful use of the thing supplied, as well as to a mere bystander...")

There are also exceptions when certain intermediaries are involved. For example, where the user is not sufficiently sophisticated to evaluate the warning or when directly warning the user is not feasible, a warning may, in some circumstances, be given to an intermediary. This is a common occurrence with medical devices and pharmaceutical products. Under the "learned intermediary" doctrine, a drug manufacturer may typically rely on the doctor to provide the warnings to the patient. See Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548-549 (Ind.App. 1979). However, the drug manufacturer may not always discharge his duty by warning the intermediary. The sufficiency of a warning to third parties is evaluated using a reasonableness standard. See generally Second Restatement §388, comment n.

A manufacturer may also be relieved of his duty to warn under the "sophisticated user" doctrine. As previously discussed, the duty to warn arises because it is assumed the manufacturer knows more about the product's dangers than the user. However, where the user is sophisticated (i.e., the dangers of the product are known to the user), there is no duty to warn. See White v. Amoco Oil Co., 835 F.2d 1113, 1118 (5th Cir. 1988). Similarly, "[t]he manufacturer . . . need not warn of dangers that users know or should know or of dangers that are or should be obvious to ordinary users." Id. at 1118. Finally, courts have generally found that a manufacturer is not liable for warning of an "open and obvious" danger. "It is . . . well settled that a manufacturer is under no duty to warn a user of every danger which may exist during the use of the product, especially when such danger is open and obvious." Gurley v. American Honda Motor Co. , 505 So.2d 358, 361 (Ala. 1987).

Accordingly, the duty to warn extends to others besides the user/purchaser. Determining whether a warning will be considered adequate to all reasonably foreseeable parties is therefore a complex task. A manufacturer must be constantly aware of those affected by the use of its product and take reasonable steps to warn that audience. This burden can appear daunting, especially where a potential cause of action is brought under strict liability. However, modern courts have applied a more relaxed interpretation of strict liability to warning defect cases.

Strict Liability Or Negligence. As it pertains to warning defects, a claim under strict liability would presume a defendant has constructive knowledge of all product dangers, known and unknown, related to the use of its products and must warn accordingly. Not only is holding a manufacturer to have knowledge not yet in existence unreasonable, enforcement of such a standard hinders innovation.

However, the modern view in warnings cases has been to hold defendants responsible for only what knowledge they had or should reasonably have had when they sold the product (ignoring for the moment any post-sale duty to warn). This effectively applies negligence principles to what is considered strict liability. Most courts have reasoned that under either strict liability or negligence, the standard applied is the same.

Consequently, the current trend is to analyze warning defects under a reasonableness standard regardless of whether the claim is brought in strict liability, negligence or contract/warranty. Reasonableness does not mean that the warning has to be the best possible, but rather requires that it be one that a reasonably prudent manufacturer would provide under similar circumstances. Gurley v. Honda, supra, 505 So.2d at 361.

Elements of an Adequate Warning

What, then, constitutes an adequate warning? The Third Restatement, at §2(c), states that:

"a product . . . is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe."

While this reiterates the aspects of foreseeability and reasonableness already discussed, it does little to objectively define adequacy beyond these general concepts. Case law, however, does discuss the factual analysis required in making a determination of legal adequacy.


It is critical that a manufacturer develop adequate warning labels to protect itself from product liability claims. Warning defect claims are often added as a matter of course to products liability suits. With more manufacturers aware of the warning issue and thus providing more warnings, modern warning defect claims often allege inadequacy instead of failure to warn.

Unfortunately, adequacy of warnings is often overlooked during warning label design and the unfortunate manufacturer is left fighting to prove retrospectively that it took all reasonable steps to ensure the allegedly defective label was adequate. It is often too late at this point. By instituting a procedure that analyzes the questions and factors listed herein, a manufacturer stands a substantially greater chance of prevailing during a subsequent determination of adequacy.

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