Plusieurs voies s’offrent aux porteuses d’implants mammaires fabriqués par la société PIP pour l’indemnisation de leurs préjudices. La présente étude aborde certaines des implications, au regard du droit international privé, des actions en responsabilité délictuelle qui peuvent être intentées par les victimes contre le fabricant ou ses dirigeants sociaux, contre son assureur, et enfin contre l’organisme notifié, c’est-à-dire l’entité chargée de conduire la procédure d’évaluation de conformité d’un produit de santé aux exigences européennes. Dans chaque hypothèse, les aspects relatifs à la compétence internationale et à la loi applicable seront évoqués. Il ressort de cette analyse que de nombreuses stratégies contentieuses peuvent être envisagées, et si cette diversité peut sembler servir l’objectif assurément louable d’une meilleure indemnisation des victimes, ou au moins de certaines d’entre elles, elle doit aussi conduire à nuancer la vision du marché intérieur comme un ensemble cohérent. Certaines de ces difficultés pourraient être atténuées, sinon résolues, par la généralisation de mécanismes d’actions de groupe, mais l’articulation de ces derniers et des règles de droit international privé soulèverait d’autres complications.
It is now common knowledge that the PIP company, domiciled in France, fraudulently mixed industrial-grade and medical-grade silicone gels to make its breast implants. The victims, women who have received the defective implants and have subsequently developed medical conditions, or who wish to have the implants removed or replaced as a precaution, can claim damages from a variety of actors. Because the victims, the clinics where the operations were performed, and the companies that were part of the supply chain, as well as their insurers, are domiciled in states spread all over the world, this case raises innumerable private international law issues. This paper focuses on some of these issues, specifically those related to the tort actions which the victims can bring against the manufacturer, its executives, its insurer, and the notified body, which is the entity that was tasked with ensuring that PIP complied with its obligations under the European Union legal framework for medical products. In each case, both international jurisdiction and applicable law will be addressed. To that end, some technical questions have to be answered first, for instance determining the place where the damage is sustained following the insertion of a potentially defective implant, or to what extent criminal courts can be expected to apply private international rules. But on a more fundamental level, the PIP case highlights some of the shortcomings of the product liability regime in the single market. To take just one striking example, a French judge ruling on a claim against the manufacturer would apply the rules of the 1973 Hague Convention on the law applicable to products liability, while a German judge would apply the specific provision for product liability of the Rome II Regulation, a discrepancy which might ultimately result in the two claims being subject to different laws. Even though this particular field of the law has been harmonized by the 1985 Product Liability Directive, significant differences remain between the legislations of Member States, and these could have a decisive influence on the outcome of the cases. This is just one factor that parties should take into account when deciding before which court to start proceedings, and it is likely that the significant forum shopping opportunities afforded to the victims by the Brussels I Regulation will be put to good use by the best-informed among them. This state of affairs might legitimately be regarded as a lesser evil, since what is ultimately at stake is the compensation of victims of actual or possible bodily harm brought about by the fraudulent behaviour of a manufacturer. But the unequal treatment of victims, particularly depending on their domicile, cannot be regarded as satisfactory, any more than the considerable risk that contradictory or incoherent decisions will be rendered by the courts of different Member States, as some lower courts in Germany and France have already done. The development of class actions, as introduced recently in French law, albeit in a very limited way, could help suppress or mitigate these difficulties, but accommodating these mechanisms within the framework of European private international law will create additional challenges.
