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 costs.

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 decision:

  • 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 2009.

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 used.
  • 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 respects.

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 the product.

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).

For more information on this ruling and its implications, please read our client alert, “Defective products liability: new clarifications on the regime’s implementation.”