In a ruling handed down on 25 February 2016, the Court of Cassation clarified the conditions for implementation of the defective products liability regime.

In this case, a patient was prescribed Mediator treatment between 1998 and 2008. Blaming the heart problems she suffered (valvular disease) on her use of the medication, she summoned the manufacturer, Servier Laboratories. She requested the appointment of an expert and the payment of a provision as compensation for damages and the costs of the proceedings.

The Versailles Court of Appeal, in view of the expert report, granted the provision sought, ruling that this obligation could not seriously be contested given the product’s lack of safety in terms of a negative benefit/risk report and the lack of information on related risks.

Servier Laboratories filed an appeal contesting several aspects of the order.

Firstly, Servier argued that the accountability of the medication for the pathology was subject to serious objection due to the existence of other causes, including the victim’s predispositions and her use of other medicines, favouring the onset of these cardiac disorders and rendering the conditions of Article 809 of the Civil Procedure Code inapplicable.

Secondly, the appeal argued that granting a provision was conditioned by the manufacturer’s knowledge of the risk when placing the product on the market or upon use of the product, which was lacking in this case.

It claimed, thirdly, that the Court of Appeal was required to consider scientific publications which did not detect the lack of safety before 2009.

The Court of Cassation rejected these three arguments.

It firstly recalled that the involvement of the medication in the damage which occurred was confirmed by the expert report by up to 80 per cent. Therefore, the causal link between the pathology and the medication was not seriously contestable.

The Court of Cassation also ruled that the existence of the product’s lack of safety did not imply that the manufacturer was aware of the risk when releasing or using it.

Finally, with regard to the issue of scientific knowledge at the time of the product’s release, the Court of Cassation maintained that the laboratory did not put forward the existence of grounds for exemption for development risks in relation to Article 1386-11 of the Civil Code before the Court of Appeal. The Court of Appeal was therefore not required to take into account the scientific publications.

This ruling is interesting in several respects.

It may be noted that when several likely causes for onset of the disease coexist with use of the defective product, the manufacturer’s liability is not seriously questionable in the context of summary proceedings in the proportion of accountability for the damage attributed to the contested use.

This ruling recalls that defective products liability is objective and therefore without fault, and that the manufacturer’s knowledge of the risk at the time of the product release is not a condition for this liability.

Finally, the grounds of exemption for development risks, which had not been invoked before lower courts, would very rarely be applicable, to such point that the preliminary draft relating to civil liability reform provides for its deletion (Art. 1240 of the draft).