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
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
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