While it received little notice among attorneys, a 2002 Minnesota trial provided the first evidence of the impact that the EU’s new approach safety directives could have in US courts of law. That trial involved a box-stacking machine that crushed the head of an employee, causing permanent injury. During the trial it was discovered that the same company made a safer machine for shipping into the EU and a less safe machine for the United States. The European machine had a laser light beam that would have stopped the machine’s operation if it detected the presence of a person.
The jury was shocked, and they awarded the plaintiff $35.5 million dollars in punitive damages. The reason for the safer EU machine was not explored in great depth or fully understood by the litigants. Starting in 1988 the EU has published 21 new approach safety directives. Compliance is mandatory for placing CE Marked products on the market covered by those directives. The method of compliance varies directive by directive.
For some directives third-party approval is required and for others self-certification is possible. Whichever approach is followed, however, specific safety requirements are mandated, including:
1. identification of the essential safety requirements that apply to the product
2. identification of European Standards that demonstrate compliance with safety requirements (including a risk assessment)
3. a quality management system (where required) and the construction of a product family Technical File containing all of the compliance information.
For those manufacturers self-certifying to directives, such as the Machinery Safety Directive, three possibilities exist:
1. Make a safe machine following the safety requirements of the directive for all markets
2. For US manufacturers who don’t want the expense of a safer machine for the US market because of competition, they risk product liability exposure with a possible Minnesota result
3. A large number of manufacturers conduct a weak self-certification which could land them in legal trouble in both the United States and European Union.
Because all of these CE Marking documents are discoverable in US courts, expect a significant increase in CE Mark based product liability lawsuits in US Courts in the future.
