L’affaire du Distilbène® : la primauté de l’indemnisation des victimes sur les règles d’administration de la preuve

www.des-france.orgLa première Chambre civile de la Cour de cassation a rendu deux arrêts le 24 septembre 2009 dans l’affaire du diéthylstillbestrol (DES), oestrogène de synthèse plus communément appelée Distilbène, prescrit aux femmes enceintes présentant un risque de fausse couche ou de naissance prématurée entre 1948 et 1977. Cette molécule a été retirée du marché français des médicaments en 1977, en raison de son caractère dangereux pour la santé, traduit notamment par la survenance de malformations ou pathologies importantes chez un grand nombre de filles, dont la mère en avait absorbé sur prescription médicale.

Ces filles, victimes de maladies graves, ont décidé d’agir en responsabilité à l’encontre des deux laboratoires fabricants, UCB Pharma et Novartis Santé familiale, aux fins d’obtenir une indemnisation de leur préjudice.

Elles ont été contraintes dès la première instance de démontrer, sur le fondement de l’article 1382 du Code civil, d’une part qu’elles avaient été « exposées » à la molécule DES sous la forme commercialisée par l’un au moins des laboratoires mis en cause, et d’autre part que cette molécule était bien à l’origine de leur dommage.

Dans le premier arrêt, la plaignante a été déboutée de son pourvoi par la Cour de cassation au motif qu’il n’était pas prouvé que le DES était la seule cause possible de sa maladie et qu’il lui appartenait en conséquence de rapporter la preuve qu’elle avait été « exposée » au médicament. La Cour de cassation a en revanche, dans le second arrêt, accueilli le pourvoi d’une autre plaignante, au motif que dans la mesure où il a été établi que le Distilbène était la cause directe du dommage qui lui a été causé, cette dernière était dispensée de rapporter la preuve de son exposition au Distilbène.

C’est par l’intermédiaire d’un raisonnement juridique fondé sur l’évidence de l’existence d’un lien entre le fait que le Distilbène est la cause unique de la pathologie chez la victime et le monopole de deux laboratoires dans la commercialisation de cette molécule, que les juges ont considéré que la victime a été « exposée » au Distilbène et l’ont dispensée de le démontrer, permettant ainsi un renversement de la charge de la preuve au profit de la victime.

En conséquence de ce deuxième arrêt de la première Chambre civile de la Cour de cassation, il appartient désormais aux deux laboratoires mis en cause, de démontrer à leur tour que le produit tel qu’ils l’ont chacun commercialisé, n’est pas à l’origine du dommage et n’a donc pas été administré à la mère de la plaignante, afin d’échapper à une responsabilité in solidum.

Outre l’originalité de cet arrêt qui réside dans la dispense pour la victime de rapporter la preuve qu’un laboratoire est l’auteur du dommage qu’elle subit, cette décision pose une nouvelle fois le problème de la traçabilité du médicament et de la gestion du risque théorique.

L’exigence de sécurité est devenue une préoccupation majeure des autorités françaises de santé. Elle se traduit notamment par l’existence d’un dossier médical personnel du patient incluant les traitements et le numéro de lot des produits délivrés et par le projet de mise en place dès le 1er janvier 2011 d’un nouveau dispositif de traçabilité du médicament jusqu’à sa délivrance au patient au moyen d’un standard de codification avec un marquage « DATAMATRIX GS1-128 ». On mesure ainsi davantage la difficulté pour un laboratoire fabricant et exploitant de démontrer, sous l’ancien régime, que sa spécialité n’est pas à l’origine d’un dommage causé à un patient.

Mais face à l’impossibilité pour les victimes du Distilbène de produire des preuves de la prescription de cette molécule à leur mère, en raison de l’ancienneté des faits, la Cour de cassation a renversé la charge de la preuve.

Ce régime juridique de responsabilité se révèle particulièrement sévère pour les laboratoires, alors même que les études sur le produit n’étaient pas aussi approfondies qu’elles le sont de nos jours. Aujourd’hui, l’AMM (autorisation de mise sur le marché) d’un médicament n’est délivrée qu’après des essais précliniques évolués permettant l’évaluation de la toxicité des produits sur la descendance.

Il est toutefois acquis que tout médicament présente un risque potentiel et des effets indésirables, souvent mentionnés dans le dossier d’AMM et communément admis sur la base du principe d’équilibre entre le bénéfice escompté d’un produit et le danger encouru par le patient.

Même s’il pèse sur chaque laboratoire une obligation légale de vigilance, on ne peut qu’espérer que cette décision n’ouvre pas systématiquement la voie à une responsabilité solidaire des laboratoires pharmaceutiques lorsque la relation directe entre une mise sur le marché d’un médicament et un dommage au patient devient difficile à démontrer.

Sophie TATOT
Avocat – Cabinet Lefèvre Pelletier & Associés

Pauline AIGUILLON
Direction des affaires réglementaires – Laboratoire LEO Pharma

This Post Has 2 660 Comments

  1. best pron dit :

    ZrqgTZ This is a topic that as near to my heart Take care! Where are your contact details though?

  2. Very informative blog.Really thank you! Much obliged.

  3. persian tar dit :

    Quite nice post. I recently located your web site along with wanted to point out that We’ve absolutely experienced surfing around your blog site posts. Regardless I am opt-in in your feed and i am expecting you write one more time in the near future!

  4. « Hi there. I found your website by the use of Google at the same time as looking for a related matter, your web site got here up. It seems great. I have bookmarked it in my google bookmarks to visit then. »

  5. obat sipilis dit :

    The other day, while I was at work, my cousin stole my apple ipad and tested to see if it can survive a 40 foot drop, just so she can be a youtube sensation. My iPad is now broken and she has 83 views. I know this is entirely off topic but I had to share it with someone!|

  6. related dit :

    This is a neat as well as beneficial section of facts. I’m joyful that you simply discussed this useful details about. You should continue to be us informed such as this. Appreciate your expressing.. قاب اپل

  7. Rather good post. I just now located a person’s blog site along with wanted to say that I’ve truly seriously enjoyed searching ones web site content. All things considered I am signing up ones feed so i i do hope you write yet again quickly!

  8. Many thanks for almost every other useful web site. In which else may perhaps I recieve that type of info developed in this kind of great method? I’ve a starting that we’re at the moment managing for, and I’ve been in the design out for these data.. قاب آیفون 6

  9. خرید Vps dit :

    Great blog site here! And your web site a lot in place very quick! What exactly host have you been the application of? Am i able to was taking your affiliate url for your sponsor? If only this site rich up as promptly since your own house haha

  10. Sex dit :

    Today, I went to the beach with my children. I found a sea shell and gave it to my 4 year old daughter and said « You can hear the ocean if you put this to your ear. » She put the shell to her ear and screamed. There was a hermit crab inside and it pinched her ear. She never wants to go back! LoL I know this is totally off topic but I had to tell someone!|

  11. The best Kona Coffee took 16 centuries to arrive Online. Kona Coffee originated from the Arabica tree discovered 5th century although roast coffees best medicinal properties were not discovered until late 14th century A.D.

  12. Viagra dit :

    I am not positive the place you are getting your info, however good topic. I needs to spend some time learning more or understanding more. Thanks for magnificent information I used to be on the lookout for this information for my mission.|

  13. Viagra dit :

    I absolutely love your site. I found it a few weeks ago while searching Google and can’t get enough of it. If you have the time, I think you would like my marketing website.

  14. Hi would you mind letting me know which hosting company you’re working with? I’ve loaded your blog in 3 completely different web browsers and I must say this blog loads a lot quicker then most. Can you suggest a good internet hosting provider at a reasonable price? Thank you, I appreciate it!|

  15. The Best Kona Coffee took 16 centuries to arrive Online. The best Kona coffee online is still brewed as a drink prepared from the Kona roasted cherry.

  16. we prefer to honor many other internet sites around the net, even though they arent linked to us, by linking to them. Under are some webpages worth checking out

  17. Do you mind if I quote a couple of your posts as long as I provide credit and sources back to your site? My blog is in the exact same niche as yours and my visitors would certainly benefit from a lot of the information you provide here. Please let me know if this okay with you. Appreciate it!|

  18. Viagra dit :

    I’m still learning from you, as I’m trying to reach my goals. I absolutely love reading everything that is posted on your blog.Keep the tips coming. I loved it!

  19. Hi, i think that i saw you visited my blog so i came to “return the favor”.I’m attempting to find things to improve my web site!I suppose its ok to use a few of your ideas!!|

  20. gambling dit :

    Thanks for every other informative blog. Where else could I get that type of information written in such a perfect method? I have a undertaking that I’m simply now running on, and I have been on the glance out for such info.|

  21. MiguSaro dit :

    Buy Propecia Fda Approved Dove Trovare Viagra Tab Bentyl [url=http://cialtobuy.com ]cialis[/url] Comprar Viagra Internet Foro Cheap Kamagra Uk Reviews

  22. Haroamurdy dit :

    Why Cialis Cost So Much [url=http://costofcial.com ]cialis online[/url] Buy Doxycycline No Prescription Online

  23. .linengallery dit :

    Your way of telling all in this piece of writing is genuinely pleasant, all be capable of effortlessly know it, Thanks a lot.|

  24. avis negatif dit :

    Wow, this paragraph is good, my younger sister is analyzing such things, therefore I am going to convey her.|

  25. Please let me know if you’re looking for a author for your blog. You have some really good articles and I believe I would be a good asset. If you ever want to take some of the load off, I’d love to write some content for your blog in exchange for a link back to mine. Please blast me an e-mail if interested. Cheers!|

  26. adam and eve dit :

    always a large fan of linking to bloggers that I appreciate but do not get lots of link really like from

  27. farsi books dit :

    farsi books of course appreciate your site but you should check out the punctuational in several of your respective discussions. A variety of them are generally rife with transliteration complications i find it very frustrating to share with the fact however , I will undoubtedly appear all over again yet again.

  28. For most recent information you have to pay a visit web and on internet I found this website as a most excellent site for latest updates.|

  29. Amazing things completely, خرید قاب فانتزی آیفون 6 simply won a new readers. What will you advise in terms of ones submit that you simply developed a couple of days before? Just about any confident?

  30. Sources dit :

    Hello there, Neat article. Likely to situation and your site within internet explorer, could check this? IE ‘s still industry leading and a substantial section other people can leave out the terrific producing therefore issue persian books.

  31. Hi there great internet site! Person. Outstanding. Remarkable. We’ll search for your web site plus use the bottles also? I will be satisfied to locate numerous beneficial info through the article, we really wish for build a lot more practices for this respect, thank you for revealing.. خرید هاست

  32. dildos dit :

    just beneath, are various entirely not connected web pages to ours, on the other hand, they are certainly worth going over

  33. Her dit :

    Excellent challenges once and for all, you just obtained a whole new visitor. Exactly what could you shahnameh suggest concerning your post which you designed at times ago? Almost any positive?

  34. Outstanding concerns in this article. I’m just thrilled to view your post. Thanks with this particular having a look forward to touch people. Might you be sure to drop us a mail? Outstanding concerns in this article. I’m just thrilled to view your post. Thanks with this particular having a look forward to touch people. Might you be sure to drop us a mail?

  35. Excellent . buy persian booksissues permanently, simply earned a whole new target audience. What can you advocate about your organize that you simply produced week prior to now? Every constructive?

  36. Info dit :

    Valuable information and facts. Fortunate enough my family I uncovered your internet site inadvertently, using this program خرید وی پی اس. surprised why this particular crash did not developed earlier! My partner and i book marked that.

  37. Many thanks almost every other educational web-site.. خرید سرور مجازی The site altogether different could I am getting that type of info coded in this type of excellent fashion? I own a objective that we are at the moment running in, and i also have already been for the peek outside for similarly info.

  38. Jenkem dit :

    Fantastic beat ! I wish to apprentice while you amend your web site, how could i subscribe for a blog web site? The account helped me a acceptable deal. I had been tiny bit acquainted of this your broadcast offered bright clear idea|

  39. It is possible to definitely go to your excitement from the do the job you’re.. سرور مجازی The entire world hopes for far more fervent freelance writers as if you who aren’t reluctant to cover that they think. Constantly pursue your current cardiovascular.

  40. I prefer the precious details anyone present on your reports. I’ll take a note of your blog page plus check out yet again below regularly. My business is moderately sure I are going to be informed plenty of fresh things correct the following! All the best ! for!

  41. always a large fan of linking to bloggers that I love but dont get a great deal of link appreciate from

  42. below youll obtain the link to some internet sites that we believe you’ll want to visit

  43. I am curious to find out what blog system you’re working with? I’m having some minor security issues with my latest blog and I would like to find something more safe. Do you have any suggestions?|

  44. Hmm it appears like your website ate my first comment (it was extremely long) so I guess I’ll just sum it up what I submitted and say, I’m thoroughly enjoying your blog. I as well am an aspiring blog blogger but I’m still new to the whole thing. Do you have any helpful hints for first-time blog writers? I’d genuinely appreciate it.|

  45. 脱毛 dit :

    we came across a cool website that you may love. Take a appear for those who want

  46. This is very interesting, You are a very skilled blogger. I’ve joined your feed and look forward to seeking more of your magnificent post. Also, I have shared your web site in my social networks!|

  47. always a massive fan of linking to bloggers that I enjoy but dont get lots of link adore from

  48. هاست dit :

    Hey there, Tidy article.. هاست Likely to problem with the web site within world wide web internet explorer, may check this? For instance is still this market chief and also a significant amount associated with other individuals may take out the magnificent composing because of this dilemma.

  49. check below, are some entirely unrelated web-sites to ours, on the other hand, they may be most trustworthy sources that we use

  50. Google dit :

    One of our guests recently encouraged the following website.

  51. Buy Sex Toy dit :

    very couple of internet sites that happen to become comprehensive beneath, from our point of view are undoubtedly nicely worth checking out

  52. You can definitely see your enthusiasm in the work you write. The sector hopes for more passionate writers like you who are not afraid to mention how they believe. At all times follow your heart.|

  53. termeh dit :

    Good day my buddy! I would like to point out that this particular blog post is actually amazing, wonderful composed you need to include almost all substantial infos. I want to observe far more posts like this .

  54. always a large fan of linking to bloggers that I adore but do not get a great deal of link appreciate from

  55. I do agree with all the concepts you’ve offered for your post. They are very convincing and can definitely work. Nonetheless, the posts are very quick for starters. May you please lengthen them a little from next time? Thanks for the post.|

  56. pet service dit :

    It’s awesome designed for me to have a website, which is valuable designed for my experience. thanks admin|

  57. Fantastic beat! I would like to newbie because you modify your website, exactly how may possibly my partner and i join for any blog page web site? This profile forced me to be your suitable خريد اپل ايدي فوري package. I actually had been small amount acquainted in this your broadcast offered fantastic see-through concept

  58. Hey I know this is off topic but I was wondering if you knew of any widgets I could add to my blog that automatically tweet my newest twitter updates. I’ve been looking for a plug-in like this for quite some time and was hoping maybe you would have some experience with something like this. Please let me know if you run into anything. I truly enjoy reading your blog and I look forward to your new updates.|

  59. just another dit :

    VjPPpv There is perceptibly a lot to identify about this. I suppose you made some good points in features also.

  60. Right here is the perfect web site for anyone who would like to understand this topic. You understand a whole lot its almost hard to argue with you (not that I personally would want to…HaHa). You certainly put a new spin on a topic that has been written about for decades. Wonderful stuff, just wonderful!|

Leave A Reply