{"id":31824,"date":"2022-01-06T21:10:18","date_gmt":"2022-01-06T20:10:18","guid":{"rendered":"https:\/\/antilla-martinique.com\/?p=31824"},"modified":"2022-01-06T21:10:18","modified_gmt":"2022-01-06T20:10:18","slug":"depakine-la-responsabilite-de-sanofi-reconnue-par-la-justice","status":"publish","type":"post","link":"https:\/\/antilla-martinique.com\/en\/depakine-la-responsabilite-de-sanofi-reconnue-par-la-justice\/","title":{"rendered":"Depakine: Sanofi's Liability Recognized by the Courts"},"content":{"rendered":"

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In a ruling handed down Wednesday, the Paris court found that the pharmaceutical company had failed to inform pregnant women of the risks of birth defects and neurodevelopmental disorders that this antiepileptic drug posed to their unborn children. Sanofi has appealed the decision.<\/span><\/p>\n

By Henri Seckel<\/a><\/span><\/p>\n

\"427b286_149303880-depakine-01-plan-de-travail-1.jpg\"<\/span><\/p>\n

Sanofi \u00abacted negligently by failing to fulfill its duty of care and its duty to inform\u00bb regarding the risks to the fetus posed by Depakine use in pregnant women. For several years, with this anti-epileptic drug\u2014whose effectiveness is well established\u2014the company \u00abmanufactured and marketed a defective product,\u00bb in the sense that it did not offer the \u00absafety that one can legitimately expect.\u00bb.<\/span><\/p>\n

Never before had Sanofi\u2019s liability in the Depakine case been so clearly established by the courts as in the ruling handed down on Wednesday, January 5, by the 7th Section of the 1st Civil Chamber of the Paris Judicial Court, which specializes in handling class-action lawsuits.<\/span><\/p>\n

Recent case\u20142014\u2014Under French law, class-action lawsuits allow victims of the same harm to join forces to take legal action. The lawsuit against Sanofi, the first of its kind in the healthcare sector, was filed in 2017 by the Association for Assistance to Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), which has been advocating on behalf of several thousand victims of Depakine since 2011.<\/span><\/p>\n

It is now well established that this medication, which has been on the market since 1967, increases the risk of congenital malformations (heart, kidneys, limbs, fingers, face, etc.) and neurodevelopmental disorders (language delay, autism spectrum disorder, etc.) in the children of women who took it during pregnancy. According to estimates\u2014contested by Sanofi\u2014from the French National Health Insurance system and the French National Agency for Medicines and Health Products Safety (ANSM), sodium valproate, the active ingredient in Depakine, is believed to be responsible for birth defects in 2,150 to 4,100 children and for neurodevelopmental disorders in 16,600 to 30,400 of them.<\/span><\/p>\n

In its ruling, the court found that birth defects and neurodevelopmental disorders caused by sodium valproate were \u00abconsistently mentioned in the medical literature beginning in 1984\u00bb for the former \u00aband beginning in 2001\u00bb for the latter. The pharmaceutical company should have, \u00abas soon as it became aware of these adverse effects, updated the patient information and the information for healthcare professionals accordingly.\u00bb However, it was not until January 2006 that the package insert for Depakine formally advised against its use by pregnant women.<\/span><\/p>\n

Half of the victims were excluded<\/span><\/p>\n

The court ruled that the class-action lawsuit filed by Apesac was \u00abadmissible\u00bb and specified who could join the lawsuit: for birth defects, all women who were pregnant \u00abbetween 1984 and January 2006\u00bb and who took the medication during their pregnancy, as well as all children exposed in utero during the same period; for neurodevelopmental disorders, the same population, but only for the period \u00abbetween 2001 and January 2006.\u00bb.<\/span><\/p>\n

Marine Martin, founder of Apesac, hailed this as a \u00abmajor victory,\u00bb while expressing regret that the time periods selected \u00abexclude half of the Depakine victims.\u00bb These dates are \u00abtoo restrictive,\u00bb according to Charles Joseph-Oudin, the association\u2019s attorney, who notes that the risk of birth defects was known as early as 1982, the risk of neurodevelopmental disorders as early as 1984, and that the lack of information persisted beyond 2006.<\/span><\/p>\n

The lawyer nevertheless welcomed the \u00abimmense symbolic significance\u00bb of a decision that \u00abcondemns Sanofi\u2019s philosophy and strategy of denying liability,\u00bb while acknowledging that, for the time being, it had \u00abrelatively limited practical consequences,\u00bb particularly because the pharmaceutical company has announced its intention to appeal, and the appeal has suspensive effect. We will therefore have to wait for a second ruling\u2014at the earliest in 2023\u2014to confirm or overturn Wednesday\u2019s decision before knowing whether the class-action lawsuit, the path to compensation, can proceed or not.<\/span><\/p>\n

Sanofi responded in a press release: \u00abThe position taken by the Paris Court of Justice is not consistent with earlier court rulings, which either do not hold the company liable or find that the primary liability rests with other actors in the healthcare system,\u00bb notably the ANSM, the government\u2019s health regulator, on which Sanofi places the blame.<\/span><\/p>\n

Also charged with \u00abinvoluntary manslaughter\u00bb<\/span><\/p>\n

The company states that it has \u00abalways been transparent in alerting health authorities and repeatedly requesting changes to the Depakine patient and healthcare professional information materials.\u00bb It asserts that \u00abthe patient information materials were updated in accordance with the evolving state of scientific knowledge and the decisions of the health authorities at the time.\u00bb.<\/span><\/p>\n

In addition to this class-action lawsuit, Sanofi is under investigation in the criminal aspect of the case\u2014as is the ANSM\u2014for \u00abaggravated fraud,\u00bb \u00abunintentional injury,\u00bb and \u00abinvoluntary manslaughter.\u00bb In addition, more than 3,000 claims have been filed with the National Office for Compensation of Medical Accidents, which, as of July 2021, had already approved more than 800, totaling 28.5 million euros\u2014public funds that Sanofi, in theory, will have to partially reimburse if its liability is ultimately established. Finally, dozens of individual civil lawsuits are pending\u2014several trials are scheduled for 2022. APESAC hopes that the ruling in the class-action lawsuit, even if it is suspended by the appeal, will lend weight to the plaintiffs\u2019 claims in all these parallel proceedings.<\/span><\/p>\n

It\u2019s not all bad news for Sanofi: it was reported on Wednesday that, in the criminal aspect of the case, the investigating judge had been compelled by the investigating chamber to commission a second expert analysis of the drug, in addition to the first one that had led to the company being placed under investigation. It was specifically this first expert analysis, dated January 2020\u2014which Sanofi strongly contested and had demanded be replaced\u2014that the Paris Judicial Court relied on to render its decision in the class-action lawsuit. If the second expert report reaches conclusions that differ from the first, it could be a game-changer. The legal battle over Depakine is far from over.<\/span><\/p>\n

Henri Seckel<\/span><\/p>","protected":false},"excerpt":{"rendered":"

Dans une d\u00e9cision rendue mercredi, le tribunal de Paris estime que le laboratoire n\u2019a pas inform\u00e9 les femmes enceintes des risques de malformations et de troubles neurod\u00e9veloppementaux que cet anti\u00e9pileptique faisait courir \u00e0 leurs futurs enfants. Sanofi a fait appel. Par Henri Seckel Sanofi a \u00ab\u00a0commis une faute en manquant \u00e0 son obligation de vigilance<\/p>","protected":false},"author":33,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":"","rank_math_focus_keyword":"","rank_math_title":"","rank_math_description":"","rank_math_canonical_url":"","rank_math_robots":null,"rank_math_facebook_title":"","rank_math_facebook_description":"","rank_math_twitter_title":"","rank_math_twitter_description":""},"categories":[818],"tags":[],"class_list":["post-31824","post","type-post","status-publish","format-standard","category-sante"],"acf":[],"_links":{"self":[{"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/posts\/31824","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/comments?post=31824"}],"version-history":[{"count":0,"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/posts\/31824\/revisions"}],"wp:attachment":[{"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/media?parent=31824"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/categories?post=31824"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/antilla-martinique.com\/en\/wp-json\/wp\/v2\/tags?post=31824"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}