The Development Risks Defence: How Future-Proof Is It?

Author:Ms Marion Palmer and Caroline Moore
Profession:Hogan Lovells


Article 7(e) of the Product Liability Directive sets out the "development risks defence"

The producer shall not be liable as a result of this Directive if he proves:

"that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered."

Although Member states may opt to derogate from Article 7(e), it provides an important defence to producers facing product liability claims in the EU, particularly those involving medicines, medical devices and other complex or innovative products.

Capturing the "state of scientific and technical knowledge" at the time a product was put into circulation can be very difficult. What this means was considered by the Court of Justice of the European Union (CJEU) in the case of Commission v UK,1 where the Court held that

"the clause providing for the defence in question does not contemplate the state of knowledge of which the producer in question actually or subjectively was or could have been apprised, but the objective state of scientific and technical knowledge of which the producer is presumed to have been informed." (Paragraph 27)

This was qualified by the criterion of the accessibility of this knowledge

"However, it is implicit in the wording of the Article 7(e) that the relevant scientific and technical knowledge must have been accessible at the time when the product in question was put into circulation." (Paragraph 28)

Understanding Accessibility

In his Opinion the Advocate-General had illustrated this point by differentiating between a study by an American university, published in an international English-language journal and similar research carried out by an academic in Manchuria, published in Chinese in a local scientific journal that is not circulated outside the region.

Judgment in this case was delivered in 1997 when digital search was still in its infancy. To obtain copies of the materials at that time, it would have been necessary either to physically visit a library which held the relevant journals, or to send written requests for paper copies to institutions such as the British Library.

The subsequent revolution in scientific publishing and accessibility means that it now takes just a few seconds to locate a Chinese journal and, if there is no English version of the webpage available, load the contents into an online translation tool, such as Google Scholar, and access a...

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