Product Liability LAWS in EUROPE and the rest of the World

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International Product Liability Laws

By Bowman and Brooke LLP

Overview

Much has been written about the various European Union Directives enacted over the years, first establishing strict liability, and then providing more specific safety directives. Interestingly, this proliferation of product safety and product liability laws and standards has not really resulted in significant amounts of new litigation in Europe.

In fact, for U.S. manufacturers selling in Europe, the greatest risk appears to be that they either may not be allowed to sell into one or more countries, or customers will not buy their products if they fail to comply with these directives and additional technical standards. Similarly, with the passage of the Consumer Protection Law in Taiwan, the Toys and Children's Product Safety Ordinance in Hong Kong, and product liability and quality legislation in Japan and China respectively, Asian countries have taken major steps toward ensuring that only safe products are sold within their borders.

Like Europe, the rise of product liability standards in Asia means that manufacturers and retailers must pay even more attention to quality, product safety and product liability than in the past. In addition, all manufacturers who sell in the U.S. must consider the effect of compliance with foreign safety laws and standards on U.S. litigation. To the extent foreign sold products are or may be considered safer, the manufacturer runs the risk of providing the plaintiff with proof of an alternative design that can be used in a U.S. court.

This chapter highlights significant product safety legislation, directives and standards in Europe, Australia, Taiwan, Japan, China and Hong Kong. This chapter merely provides a starting point for those affected by these laws. They must still spend considerable time to ensure compliance. The current interpretation and enforcement policies of these laws in each individual country will evolve quickly. Any manufacturer must obtain current information as they try to comply.

Europe

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The European General Product Safety, Product Liability & Product Warranty Directives

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There are few lesser known European Directives that could have an impact on your business. Although we are not lawyers and not qualified to dispense legal advice, you should be aware of these three directives that can affect component and finished medical device manufacturers.

Other than the Medical Device Directive we all know, there are three directives designed to protect consumers and users in Europe. You should have a basic understanding of each one. They are the General Product Safety Directive, Product Liability Directive and the Product Warranty Directive.

European General Product Safety Directive (2001/95/EC)

The original directive (92/59/EEC) was revised and replaced with (2001/95/EC) in December 2001. The new version went into effect in most countries in January 2004 (later for 10 new EU countries and Oct. 1, 2005 in the UK). The directive covers nearly all products sold in the EU.

In general, it places responsibility on suppliers of consumer goods to make sure their products are safe for normal and foreseeable use. Obviously the goal is to make sure producers are placing safe products on the market, but it doesn't end there. The directive requires producers to supply consumers with relevant information that enables them to assess the risks inherent in that product. It takes into account various characteristics including packaging/labeling, instructions for use and disposal, packaging, maintenance and more.

You might think that finished device manufacturers are the only ones who need to contend with the issue of product safety. Not true. Importers, private labelers, representatives and, to a lesser degree, distributors, wholesalers and retailers are all culpable as well.

The directive requires "producers" to take appropriate action in the event of a product crisis, including notifying the appropriate competent authorities, temporarily withdrawing the product from the marketplace, warning consumers of a potential problem or, in severe cases, recalling product already in the marketplace.

To aid the compliance effort, the EU has implemented a single rapid alert system called RAPEX for reporting dangerous consumer products. It allows the rapid exchange of information among member countries. If, for example, a problem arises with your product in several member countries, that information is consolidated and may be disseminated to all EU competent authorities. At that point, a public warning might be issued or in extreme cases, a product recall might be ordered.

Product Liability Directive (85/374/EEC)

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