Risk assessment and product liability in the European Union

The legal concept of product liability is the same in the European Union as it is in the United States, although the scale of award in the United States is considerably higher.

New Approach (CE Marking) Directives do not always provide guidance on how to implement, nor do they provide interpretations of the law. Legal critiques of design(s) are conducted in hindsight at trials, where the issue may be whether or not the manufacturer was negligent, and whether or not the designer produced a reasonably safe design. When these are the issues, a national European court will inquire as to how the manufacturer of the product applied (or didn't apply) good safety engineering practices.

A review of the law will show that some designs are deemed "not reasonably safe" and that some manufacturers have judgments rendered against them for failing to exercise reasonable engineering practices. The legal obligation to use good engineering practices in safety matters is not embedded in Directives, but exists independently of them.

This does not make design decisions straightforward for the manufacturer, but it does place the manufacturer in a unique position. A manufacturer, or more precisely the designer, is the only one who can evaluate and change the design of a product before it is put on the market. It follows, then, that in the event of a breach of safety, the manufacturer and/or the designer will be the responsible parties required to defend the design decisions related to the product.

Most New Approach Directives, including the Directives for medical devices require a risk evaluation of the products they govern (in accordance with a European developed standard, EN 1441). A good designer examines all possible risks related to a design and does everything possible to remove them. A designer must be able to (legally) defend the safety aspects of his design decisions for a period of time. A systematic risk assessment on the one hand, and good documentation of the design decisions concerning safety on the other, are the heart of CE Marking. The strongest defense against liability is the combination of the use of standards where reasonable, and a documented design review that shows how the manufacturer effectively minimized risk.

Some manufacturers are reluctant to prepare written design reviews. They reason that such reviews could be used against them in a products liability lawsuit. Not recognizing or effectively dealing with a hazard, however, is not a winning argument. A more powerful defense is available when the manufacturer can show awareness of hazards, and can also show how risks to the user were minimized through the thoughtful application of design, guarding, and instructions.

In the event of a lawsuit, the court might use the concept of "reasonableness" in deciding whether or not the manufacturer or the injured user is at fault. In other words, the court might have to decide which of the two behaved more reasonably. The design hierarchy, "design out, then guard against, and warn as a last resort," is applied in New Approach Directives, and by the common law in the United States.