June 2007

International Harmonization of Safety Standards and Product Liability Litigation

Holland & Knight Newsletter
Colin P. Smith

The increased globalization of industry has led to corresponding pressure for uniform design, performance and safety standards for products produced and used throughout the world. Such uniform standards could potentially improve efficiency, reduce costs, eliminate trade barriers and promote safety. In order for these benefits to be realized, however, the balkanized and differing rules and regulations that currently apply within individual countries must be standardized. That process, known as harmonization, is presently ongoing and accelerating in a number of international industries. At this point, however, it appears that little attention has been paid to the effects harmonization may have on product liability law and practice in the United States.

Automotive Safety Standards

The development of global standards in the automotive industry serves as a useful illustration of the creation of uniform international standards and of the effects harmonization could have on domestic government agencies and litigation. Automotive safety standards have traditionally been developed by government agencies in individual countries. In the United States, for example, the National Highway Traffic Safety Administration (NHTSA) develops and promulgates motor vehicle safety standards pursuant to statutory authority extended by the National Traffic and Motor Vehicle Safety Act of 1966. While this system made America a motor vehicle safety leader for many years, that leadership role has declined along with Detroit’s dominance in the automotive industry, as new leaders have emerged on three continents to create a truly international industry. At the same time, other standards-making efforts began, including those spearheaded by the World Forum for Harmonization of Vehicle Regulations (WP.29) under the United Nations Economic Commission for Europe.

Although the WP.29 harmonization of automotive safety standards activity began as a movement towards greater integration among European nations, it has since spread beyond the boundaries of Europe to 28 participating nations, including the United States. Automobile safety harmonization is aimed at involving all nations in the process of developing and adopting what are termed Global Technical Regulations (GTRs). The first GTR, dealing with door locks and door-retention components, was adopted in 2004. Several other such regulations have since been adopted and dozens of candidate GTRs are under consideration. As the harmonization process is plainly gaining momentum, it appears likely that standards will be adopted that address a wide range of vehicle safety and performance issues.

Harmonization – A Plethora of Influences

The WP.29 process, and all harmonization processes, should be of concern to those in the product liability field because of the plethora of influences they potentially exert upon the standards-making process. Participants in the process include not only multiple nations – each with varying economic and political goals – but also widely differing companies and, significantly, nongovernmental organizations such as safety and consumer groups. These groups have a multitude of disparate motivations and agendas, all of which may affect the process. Moreover, the entire process will be played out in public, with virtually all the information immediately available worldwide over the Internet.

The full effect of harmonization on automotive product liability litigation remains to be seen, but it appears obvious that the development of global standards is likely to have multiple impacts on the conduct of litigation at both the trial and pretrial stages. First, harmonized standards will create a body of global standards of safety or performance that parties may use as evidence of defect, the applicable standard of care, or the state of the art in a product liability claim – regardless of whether the standard was adopted or rejected globally or domestically.

Furthermore, the process of proposing, analyzing, debating, modifying and adopting global regulations produce innumerable drafts, supporting documents and other information. These materials could serve as the bases for an expert opinion, since the Federal Rules of Evidence and most state court rules permit experts to use otherwise inadmissible evidence in forming their opinions. This inadmissible information may also find its way directly to the jury if the applicable rules of evidence grant the court the discretion to permit the disclosure of the bases of an expert’s opinion to the jury.

Harmonization is also likely to have a significant impact on the admissibility of expert testimony in general. In federal courts, as well as many state courts, the admissibility of an expert’s testimony depends on his or her qualifications, relevance, reliability and helpfulness to the jury. It is presently unclear whether the individuals involved in or the material produced by the harmonization process will presumptively meet this standard. But to the extent that harmonized safety regulations appear to represent the consensus of a worldwide scientific community, the opinions of these individuals may bear a heightened aura of authority.

In the pretrial context, the documents produced in the global regulation process may provide a plaintiff with a discovery shortcut. Prior to harmonization, extensive discovery was necessary to determine what were the existing expert opinions on a particular topic, whether the defendant was aware of the expert opinions regarding that topic, and when the defendant was aware of them. Harmonization can point a plaintiff to a host of opinions and data to allow for limited, targeted discovery.

More broadly, for those companies in heavily-regulated industries, the promised efficiency of uniform standards may be lost in the application of those standards to the unique characteristics of a particular country or in creating standards that can be applied to most or all participating countries.

Although the effects of harmonization are beginning to be seen in the area of automotive safety, the movement may eventually reach beyond the automotive industry to any company that does business in a highly-regulated field, lobbies government agencies, or manufactures a product of even minimal sophistication. The issues raised in this article represent a few of the challenges likely to arise due to harmonization. One must have a clear understanding of the impact of harmonization in order to both take advantage of its benefits and to avoid its pitfalls.1

1 For a fuller explanation of harmonization and its impact on the U.S. legal system, see World Consensus on Vehicle Safety Standards: Speed Bumps on the Road to Common Ground, 34 Prod. Safety Liab. Rep. (BNA) No. 47, at 1183 (Dec. 11, 2006), co-authored by Colin Smith, a partner in the Chicago office of Holland & Knight and leader of the firm’s Product Liability Practice Group. 

Related Insights