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New Considerations on Warnings Issues

January 9, 2012 in  News

New York Law Journal

In our February 2011 column, the problems of open-ended warnings litigation were discussed.1 In product use the range of possible dangers to be warned against is virtually limitless. The universe of potential warnings one can conjure up, particularly if all varieties of product misuse are included, is markedly open-ended. One doesn’t have to be terribly creative to simply identify a risk that may accompany a product’s design, its packaging, its range of normal and abnormal uses and then allege that the risk selected should have been the subject of a warning. In the case of product misuse, one simply might allege that the misuse was “foreseeable.” And, if a warning had been given, little problem, just say that the warning could have been made better, safer, or more effective. Our February article probed this subject in some depth.

A Dec. 23 decision by the Appellate Division, Fourth Department,Johnson v. Unifirst Corp.,2  shows just how “stubborn” and dismissal-resistant a warnings claim can be. Plaintiff was a welder whose uniform caught fire. Defendant supplied the uniform pursuant to an agreement with plaintiff’s employer. Plaintiff claimed negligence, strict products liability and breach of implied warranties because the uniforms were not flame-resistant. Defendant moved for summary judgment which was denied.

However, the Fourth Department held that the negligence and warranty causes of action should have been dismissed because “defendant established as a matter of law that it owed no duty to plaintiff to provide or recommend flame resistant uniforms” and because defendant established that the uniform was “fit and reasonably safe for the ordinary purposes for which it was to be used.” Plaintiff’s submissions in opposition were deemed insufficient to raise a triable issue of fact.

The strict products liability defective design claim likewise had to be dismissed. Defendant submitted evidence that it offered the employer flame resistant uniforms and that the employer, “which was in the best position to evaluate the needs of its employees, made a deliberate decision not to make defendant’s flame resistant uniforms available to its employees.” Instead, the employer obtained flame resistant garments from another vendor. This evidence was sufficient to establish as a matter of law that defendant fulfilled its duty not to market or supply a defective product.

What about the strict products liability claim predicated on the theory of failure to warn? Here the trial court’s denial of summary judgment was upheld. First, the Fourth Department stated, “[I]n all but the most unusual circumstances, the adequacy of a warning is a question of fact” to be determined at trial. Defendant had an independent duty, said the court, to warn employees that the uniforms were not flame resistant irrespective of the duty undertaken by the employer under the supply agreement. Further, defendant “failed to establish as a matter of law that the uniform label provided an adequate warning with respect to the flammability of the fabric.” Moreover, plaintiff’s “admitted failure” to read the label on his uniform “did not necessarily sever the causal connection” between the alleged inadequacy of the warning and the occurrence of the accident.

The murky labyrinth of open-ended warnings litigation discussed in our February column and hinted at in this new Johnson decision usually roils and boils and churns well after the products have been made. Often, an accident occurs many years after the labels, warnings, instructions and owners’ manuals were formulated. Generally, the applicable time frame for gauging defectiveness is at the time the product left the seller’s hands or at the time of design or production.3  Thus, the relevant time frame regarding the state of the art in warnings practice and what the manufacturer knew or should have known is the time when the product was marketed. Post-sale warnings in regulated industries that require them or when a manufacturer acquires later knowledge about a defect in the field are properly governed by principles of reasonable care, i.e., negligence, not strict products liability.

Manufacturers, whether years ago or today, need some certainty in how to formulate labels, warnings and instructions. Unfortunately, the hodgepodge, hindsight approach of spotty case law holding that this or that warning in this or that scenario was sufficient or deficient does not supply the certainty that warnings creators truly need. Accordingly, manufacturers have resorted to norms or standards such as ANSI Z535 dealing with product safety labels. Complying with such guidance, however, likely will not preclude future warnings litigation. And, with the advent of a truly global economy, the guidance supplied by standard-setting bodies has become more complicated.

Recent Articles

Two recent articles reflect that manufacturers now have and, in the future, will have their work cut out for them in formulating labels, warnings and instructions. Warnings legal expert Kenneth Ross has issued a helpful article in a Defense Research Institute (DRI) publication; the article is titled, “Warnings and Instructions: Updated U.S. Standards and Global Requirements.”4 Mr. Ross is a prolific and incisive author on warnings law and other prevention subjects.5  In the cited article, Mr. Ross reviews the basic duty to warn and instruct, the goals of a warning as reflected in case law and commentary, the ANSI standards dealing with on-product safety labels, the 2011 revisions to prior ANSI standards, the use of signal words such as “CAUTION,” “NOTICE” and the like, the differences between “warnings” and “instructions” and the formulation of warnings materials.

Mr. Ross observes that there is emerging a set of foreign labeling standards and directives by the International Organization for Standardization (ISO) whose labeling standard, ISO 3864-2, is “very different from ANSI Z535.” The ISO approach uses symbols as the essential ingredient. Thus, via shape, colors and symbols ISO believes each symbol can adequately communicate a safety message. Such a system is preferable in Europe because many languages are spoken and read in different countries that have open borders, allowing much mobility. Manufacturers may not know where their products will be used during their useful lives. Symbols help to communicate some warnings of the hazard.

Mr. Ross also observes that the European Union’s “Machinery Directive,” effective December 2009, seems to prefer warnings in the form of “readily understandable symbols or pictograms.” ANSI Z535.4, however, still sees a role for word messages. Mr. Ross’ article suggests to this writer that both warnings litigation and the objective of staving off warnings liability have now become significantly more complex. It is likely that battles of experts will punctuate future warnings litigation. Frye, Daubert and “foundational reliability” challenges to such testimony will ensue.

A second valuable article issued in November 2011 also reflects a ramping up of the complexity of warnings issues, both at the manufacturer level and at the end of the litigation food chain, when warnings issues are battled in courtrooms. This fine work product deals with warnings for products containing “nanomaterials,” emerging from a robust nanotechnology revolution. The authors are William S. Rogers, Jr., Joseph A. Clark, Joyce S. Tsuji, David L. Dahlstrom and Steven R. Arndt. The authors are attorneys and scientists. Their article is titled, “Labeling and Warning for Products Containing Engineered Nanomaterials: Learning From the Past or We Are Doomed to Repeat It.”6

The increasing commercialization of nanomaterials and the rapid introduction of nano-enabled products into the marketplace, now a global economy, raise questions about how one warns or instructs about potential health risks concerning nanomaterials. Some 1,300 products containing nanotechnology were on the market as of March 10, 2011, nearly a 521 percent increase since March 2006. Among products with identified nano-scale constituents are those with nanoscale silver, carbon nanotubes, nanofibers and fullerenes, titanium, silica and silicon, zinc, and gold. Other nanomaterials such as polymers, clays, quantum dots, and organic micelles are incorporated in a few products. Over 50 percent of the products are in health and fitness such as personal care, clothing, cosmetics and sporting goods. Fewer are in categories such as home and garden, automotive, and food and beverage.

The article surveys the state of knowledge on health risks of engineered nanomaterials, potential for exposure, available toxicity information and potential for health risk. The latter is likely low for current consumer products since the major types of nanomaterials being used are of lower toxicity or are encapsulated or incorporated within components resulting in low human exposures under most circumstances. However, information is still considered incomplete and, as new nanomaterials are produced, health risks in products will have to be assessed.

The article goes on to survey warnings law in three states (Massachusetts, California and New York) as well as the Restatement (3d) on Products Liability. The authors discuss whether a draft technical standard (DTS) for warnings on nanomaterials and products containing them would provide much-needed guidance. The ISO has released a new Technical Report that may serve as an informative, “due diligence reference” for all manufacturers of nanomaterials or products containing them. A short survey on ANSI and ISO standards related to warning and labeling is provided.

The authors conclude that the development of proper warnings and/or labeling “is a multidisciplinary process” that should include “careful input from risk managers, engineers, industrial hygienists, toxicologists and qualified legal counsel.” A list of “references cited” is helpful for those interested in further research.


The open-ended nature of warnings litigation already presents enormous challenges to the justice system. The new developments reported in the two articles mentioned above suggest that, if anything, warnings litigation will continue to play a significant role, perhaps at a more complicated level.

Michael Hoenig is a member of Herzfeld & Rubin.


  1.  Hoenig, “The Ills of Open-Ended Warnings Litigation,” New York Law Journal, Feb. 14, 2011, p. 3.
  2.  2011 NY Slip Op 09431 (4th Dept. Dec. 23, 2011).
  3.  Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102, 107, 108, 111 (1983); Liriano v. Hobart Corp., 92 N.Y. 2d 232, 238 (1998); Cover v. Cohen, 61 N.Y. 2d 261 (1984).
  4.  K. Ross, DRI Products Liab. Committee, Strictly Speaking, vol. 8, Issue 4 (Dec. 30, 2011).
  5.  Mr. Ross’ other articles on warnings and various prevention topics can be accessed at He can be reached at
  6.  BNA, Product Safety & Liability Rptr., vol. 39, no. 46, pp. 1283—1293 (Nov. 21, 2011).