A February 25, 2016, decision by the French Supreme Court
clarifies some conditions for the imposition of liability with
respect to defective products in ways that may be surprising to
those more accustomed to U.S. product liability law.
In the case at hand, a patient was prescribed Mediator, an
appetite suppressant, between 1998 and 2008. She allegedly had
heart problems which she blamed on the medication, and sued the
manufacturer, Servier Laboratories, for damages and legal
The Versailles Court of Appeal, after reviewing an expert's
report, granted her requests. This court was of the view that the
issues could not be seriously contested given Mediator's
purported lack of safety (based on a negative risk-benefit report)
as well as the lack of information on related risks.
Servier filed an appeal contesting several parts of the
First, the company contested the
claim that Mediator was responsible for the patient's ailment,
citing the patient's predisposition and use of other
medications as potential causes favoring the onset of the heart
problems she developed. It claimed this rendered the conditions of
Article 809 of the Civil Procedure Code inapplicable.
Second, Servier argued that, for the
patient's request to be granted, it needed to be shown that
Servier was aware of Mediator's risks when it placed the
product on the market or upon use of the product, and that this had
not been shown.
Finally, Servier argued that the
Court of Appeal should have been required to consider scientific
publications which did not show safety issues for Mediator prior to
The French Supreme Court, however, rejected these arguments.
With respect to Servier's first
argument, the Court pointed back to the aforementioned expert
report that supported the conclusion that there was a causal link
between Mediator and the disease in question and showed that
Mediator's proportional responsibility for the patient's
heart disease could be as high as 80 percent.
The Court also ruled that a
product's lack of safety was not contingent on its manufacturer
being aware of this risk when releasing it, or when the product was
Finally, with regard to the issue of
scientific knowledge at the time of the product's release, the
Supreme Court maintained that Servier 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.
The French Supreme Court ruling is interesting in several
First, it looks like even when use of a defective product is
just one of several likely causes for a disease, the manufacturer
of the defective product can still be liable in the context of
summary proceedings for the proportion of the damage attributed to
Second, the ruling seems to state that the standard for
liability based on risks is objective; it is not conditioned on the
manufacturer's awareness of a product's purported
defectiveness when it releases the product.
Finally, it looks like the grounds of exemption for development
risks, which had not been invoked before lower courts, would very
rarely be applicable, to such a point that the preliminary draft
relating to civil liability reform provides for its deletion (Art.
1240 of the draft).
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