Country
France
Court
Cour de Cassation 1, 15 May 2007, pourvoi n°05-10.234, Bull. civ. I, n° 185
Topics
Development risk defence
Defect
Impact of non-implemented Directive
Facts
The claimant sustained serious side-effects (interstitial nephritis), after taking a drug, Pentasa, between 1994 and 1997. A claim was duly brought against the producer. A debate arose about the applicability of the development risk defence enshrined in Article 7(e) of the Directive. In this case, the drug had been put into circulation before the implemented provision entered into force in France (1998). Was the defendant able to rely upon the development risk defence even though the Directive had yet to be implemented ? Were the courts under a duty to interpret the pre-existing provisions in light of the Directive, including potential defences ?
Decision
The Paris Court of Appeal held that, whilst the drug was put into circulation before the entering into force of the implemented Directive in France, the pre-existing French provisions were to be "interpreted in the light of the Directive" and that the development risk defence could thus in principle be relied upon by the producer of the drug in any claim brought against it (CA Paris 23 September 2004, n° 02/16713). The Court of Appeal went on to apply the defence and exonerate the producer on this basis.
The Court of Cassation overturned this decision, holding that as the development risk defence was an optional feature of Directive 85/374 (see Article 15(b) of the Directive) the Community law principle of harmonious interpretation did not apply in this regard, and the defence could not be relied upon by the defendant. The defence was quite simply inapplicable prior to the coming into force of the transposed provisions.
Commentary
The development risk defence has been a controversial topic in France ever since its appearance during the legislative process leading to the adoption of the Product Liability Directive. Delay in the implementational process in France in part stemmed from worries about the impact of the development risk defence. It is therefore of great interest how the French courts will apply this notion. The prominent view of commentators is that, as an exception to liability, the French courts should in general terms interpret the defence in a restrictive fashion.
The current case law failed to clarify the way in which the French courts will interpret this defence. In the absence of specific case law at a highest level, there is therefore continuing uncertainty concerning the judicial interpretation of this defence. Borghetti has thus argued in his case-note on this decision: "the matter decided on 15 May 2007 did not allow the Cour de cassation to rule on the conditions of the development risk defence and it will therefore be necessary to wait a little longer in order to know more about the way in which the highest court intends to interpret the notion."
