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Country:

France

Court:

Cour de cassation, 1re civ., 26 September 2012, pourvoi n° 11-17.738, Bull. civ. I, n° 187

Topics:

Notion of defect

Articles:

Art. 1386-4, Code civil

Facts:

The claimant was vaccinated for hepatitis B on three separate occasions in December 1998, January 1999 and July 1999, and subsequently suffered from health problems starting in August 1999, which led to the diagnosis of multiple sclerosis in November 2000. He brought an action in damages against the vaccine manufacturer, Sanofi Pasteur MSD, based upon the implemented Directive. The procedure was continued by his estate after his death.

At first instance, the Tribunal de Grande Instance de Nanterre held the vaccine manufacturer liable on the basis that the vaccine was defective, and that there were "serious, precise and concordant" presumptions in favour of the existence of a causal link between the vaccination and the illness. The Court of appeal upheld the lower court on causation, but denied liability on the basis that the defectiveness of the product was not made out, notably due to the fact that the benefit / risk profile of the vaccine had never been challenged.

Legal questions:

Was the decision of the Court of Appeal justified in denying liability for absence of defectiveness?

Decision:

The Court of cassation overturned the Court of Appeal's judgment, holding that the Court of Appeal should have examined whether the "serious, precise and concordant" presumptions in favour of the existence of a causal link between the vaccination and the illness did not also constitute similar presumptions in favour of the existence of a defect of the vaccine. It was also held that he Court of Appeal should not have based its decision solely on "general considerations concerning the benefit / risk profile of the vaccine."

This decision has been subject to criticism by commentators. First, the reliance on presumptions has been the subject of much debate. There has been a series of cases concerning hepatitis B vaccinations, in which presumptions have been applied to the issue of causation. (See the leading case of the Cour de cassation, 1re civ., 22 May 2008). This case seems to extend that analysis to the notion of defect. Prof. Borghetti argues that, over and above the problems in using presumptions of causation in cases where scientific causation is not made out, it is problematic for the courts to resort to the same presumptions for both causation and defect (J.-S. Borghetti, "Qu'est-ce qu'un vaccine défectueux?", Dalloz 2012, p.2853).

The second point relates to the very notion of defect. The Court of cassation overturned the Court of appeal's judgment, but failed to develop the analysis of the notion of defect further than indicating that presumptions may be applicable. One issue does, however, appear clearly from the Court of cassation's judgment. The French Supreme Court disapproved the Court of appeal's taking into account the benefit / risk profile of the vaccine in determining the lack of defect, and overturned the Court of Appeal's judgment to the extent that it was based upon "general considerations concerning the benefit / risk profile of the vaccine."

Prof. Borghetti argues that the impact of this decision is that much will depend upon how presumptions are applied. He points out that in the finding of causation, practice differs greatly depending upon the Court of appeal which hears the case, and that while some courts are perceived as "pro-victim", (eg. Versailles), others are seen as more "orthodox" (J.-S. Borghetti, "Qu'est-ce qu'un vaccine défectueux?", Dalloz 2012, p.2853, para 15). He also asks the fundamental question of the co-ordination of regulatory and legal standards : "Is it possible at once to consider that a product is defective and to maintain it in circulation, and even recommend its use?"

It might however be argued that this judgment means that the risk/benefit analysis has no relevance at all. It might be said that the risk/benefit calculus may play its part in evaluating whether a disclosed risk is socially acceptable, but only as a basket of broader factors.

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