Vaccination anti-hépatite B et responsabilité du laboratoire

smallpox_vaccine1C’est une décision fort importante que la Cour de cassation vient de rendre récemment sur la question de la défectuosité du vaccin contre l’hépatite B et qui prouve, s’il en était encore besoin, que la Haute juridiction se montre sensible à l’intérêt des victimes.

En effet, par arrêt du 9 juillet 2009 ((Cass. Civ. 1ère, n°08-11.073.)), la Cour régulatrice a jugé que la défectuosité du vaccin contre l’hépatite B pouvait être déduite de l’absence de mention, dans la notice l’accompagnant, du risque de développer une sclérose en plaques. Elle a également estimé qu’une causalité probable entre la vaccination et le préjudice dont il est demandé réparation était suffisante pour satisfaire à l’exigence juridique du lien de causalité.

Dans un mouvement amorcé par les arrêts du 22 mai 2008 ((Cass. Civ. 1ère, 22 mai 2008, D. 2008. AJ. 1544 ; RTD civ. 2008. 492, obs. Jourdain ; JCP 2008. II. 10131, note Grynbaum.)), elle confirme finalement l’assouplissement de sa jurisprudence, tant en ce qui concerne l’appréciation du caractère défectueux du produit, que la preuve du lien de causalité entre celle-ci et le dommage dont la victime demande réparation.

Il n’en a pas toujours été ainsi.

Sur la défectuosité du vaccin en question, par exemple, la Cour de cassation a su faire montre de rigueur en décidant que cette défectuosité ne pouvait se déduire du seul fait que le vaccin a été le facteur déclenchant d’une pathologie développée par la victime et que cette pathologie était mentionnée au titre des effets indésirables du produit ((Cass. Civ. 1ère, 24 janvier 2006, D. 2006. Jur. 1273, note Neyret ; RDSS 2006. 495, obs. Peigné.)). En d’autres termes, un vaccin peut avoir des effets indésirables sans pour autant être considéré comme défectueux.

En l’espèce, l’attendu portant sur cette question mérite une attention particulière :

« Mais attendu qu’aux termes de l’article 1386 4 du code civil, un produit est défectueux lorsqu’il n’offre pas la sécurité à laquelle on peut légitimement s’attendre ; que dans l’appréciation de cette exigence, il doit être tenu compte, notamment, de la présentation du produit, de l’usage qui peut en être raisonnablement attendu, et du moment de sa mise en circulation ; que la cour d’appel a constaté que le dictionnaire médical Vidal, comme la notice actuelle de présentation du vaccin, fait figurer au nombre des effets indésirables possibles du produit la poussée de sclérose en plaque, quand la notice de présentation du produit litigieux ne contenait pas cette information ; qu’elle en a exactement déduit que le vaccin présentait le caractère d’un produit défectueux au sens de ce texte ; »

Concernant la preuve du lien de causalité, la Cour rappelle ce qu’elle avait déjà énoncé dans les arrêts précédents du 22 mai 2008 et du 25 juin 2009 ((Cass. Civ. 1ère, 25 juin 2009, n°08-12.781.)), à savoir que la causalité peut résulter de présomptions, dès lors qu’elles sont graves, précises et concordantes. Tel était le cas en l’occurrence, où l’on pouvait conclure à une causalité probable entre l’injection du vaccin et la pathologie développée par la victime.

« Mais attendu qu’ayant relevé, d’abord, que si les études scientifiques versées aux débats par la société Sanofi Pasteur MSD n’ont pas permis de mettre en évidence une augmentation statistiquement significative du risque relatif à la sclérose en plaque ou de démyélinisation après vaccination contre l’hépatite B, elles n’excluent pas, pour autant, un lien possible entre cette vaccination et la survenance d’une démyélinisation de type sclérose en plaque ; qu’ayant ensuite relevé que les premières manifestations de sclérose en plaque avaient eu lieu moins de deux mois après la dernière injection du produit ; que ni Mme K… ni aucun membre de sa famille n’avaient souffert d’antécédents neurologiques, et que dès lors aucune autre cause ne pouvait expliquer cette maladie, dont le lien avec la vaccination relevait de l’évidence selon le médecin traitant de Mme K…, la cour d’appel, qui a souverainement estimé que ces faits constituaient des présomptions graves, précises et concordantes, a pu en déduire un lien causal entre la vaccination de Mme K…, et le préjudice subi par elle ; »

A la lecture de cet attendu, il semble acquis qu’une certitude toute relative suffit désormais à admettre l’existence d’un lien de causalité, ce qui peut laisser les juristes dubitatifs, au plan des principes.

Omar YAHIA

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