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Failure to Warn Cases - A Major Threat

Date: Feb 13, 1998


Failure to warn cases continue to be a major factor in product liability litigation. Studies show that as many as 80 percent of all product liability suits involve a failure to warn claim. Failure to warn claims are often successful for plaintiffs because they may be easier for juries to understand than technical issues surrounding a determination about whether a product was defectively designed or manufactured. Certainly, when warnings are absent, juries may conclude that the cost and feasibility of providing warning labels or cautionary instructions is minor compared to the possibility of injury or death. Manufacturers have been found liable for failure to warn even in cases where the danger of a particular product was open and obvious. And, the adequacy of warnings may also be an issue. Consequently, a comprehensive program for informing customers of the risks associated with a product is essential.

To minimize the likelihood of injury, and the corresponding risk of a liability suit, companies should take an analytical approach in developing adequate warning labels and operating instructions on consumer products, particularly if they are not selling to a "sophisticated user." Manufacturers should:

  • Find out if government or other standards apply.
  • Evaluate the types of warnings provided on the same or similar products.
  • Don't stop there; standards are typically the minimum in terms of performance, and your competition may not have done a thorough assessment in developing their warning statements.
  • Analyze how the product is used -- including foreseeable use and misuse -- to determine if hazards are present to users or others.
  • Analyze if a design or other change is technologically and economically feasible to avoid the hazard, and assess the implications for standards compliance.
  • Evaluate who might be injured. The user? Workers? Children? Pay special attention to particularly vulnerable groups. For products designed for use in the work place, it may be feasible only to provide warnings to the employer.
  • Analyze the likelihood of injury and the probable seriousness of injuries that may occur.
  • Analyze how to avoid the hazard.

This type of analysis will help you decide whether a warning is needed. If it is, you should adopt the appropriate signal word ("Danger," "Warning," or "Caution"). Consider using icons, colors, and graphics as part of the warning statement. The warning statements should alert those who may foreseeably come in contact with the product of the nature of the hazard, ways to avoid the hazard, and/or the type of injury or risk expected if the hazard is encountered. Warnings must be complete, conspicuous, and unambiguous, and should be supplemented by instructions where appropriate.

Designing adequate warnings is particularly difficult because they are subjective. Manufacturers should always consult federal, state, and local government codes to see if regulations apply. In addition, industry standards often are a source of appropriate warning label guidelines. One guideline for developing a comprehensive warning label program is American National Standard Z535.4-1991, published by the American National Standards Institute (ANSI).

In addition to following these guidelines and standards, companies should continually review their warnings and instructions, as compliance with any of the voluntary standards will not necessarily protect a manufacturer from liability. During litigation, manufacturers are often subject to second-guessing on the existence and adequacy of their warnings. Thus, developing and reviewing warnings are key parts of any company's liability-prevention program.

For more information, contact Sheila A. Millar, a partner in Keller and Heckman's product safety practice group, at 202-434-4143 or millar@khlaw.com.