{"id":1120,"date":"2017-11-27T14:30:10","date_gmt":"2017-11-27T14:30:10","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=1120"},"modified":"2017-11-27T14:30:10","modified_gmt":"2017-11-27T14:30:10","slug":"sanofi-class-action-suit-over-epilepsy-drug-linked-birth-defects","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/sanofi-class-action-suit-over-epilepsy-drug-linked-birth-defects","title":{"rendered":"The class-action suit against Sanofi over epilepsy drug linked to birth defects"},"content":{"rendered":"<p>Thousands joined together to bring a class action case against French drug company Sanofi for allegedly not warning expectant mothers of the adverse side-effects of taking the epilepsy drug <em>Depakine\/Depakote<\/em>. French newspaper Le Canard Enchaine reported that over 10,000 pregnant women were given this drug between 2007 and 2014, and it&#8217;s suspected that around 450 children may have been born with congenital defects due to exposure of the drug whilst in the womb.<\/p>\n<p>Epilepsy drugs have been in focus in the news recently, and when it comes to birth defect claims, it&#8217;s always a very serious matter indeed.<br \/>\n<!--more--><\/p>\n<h2>Warnings about potential problems<\/h2>\n<p>The Depakote drug is an anticonvulsant that contains sodium valproate. In Safoni&#8217;s own Product Characteristic file on Depakote, there is apparently an entire section dedicated to pregnancy. Section 4.6 titled Pregnancy and Lactation apparently reportedly said: &#8216;this medicine should not be used during pregnancy and in women of child-bearing potential unless clearly necessary&#8217;.<\/p>\n<p>It seems clear that when there is a warning saying something &#8216;<strong>should not be used<\/strong>&#8216;, extreme caution must be taken if you are to go ahead anyway. The next line warns women of &#8216;<strong>child-bearing potential<\/strong>&#8216; who use the drug to use contraception to stop them from getting pregnant whilst on the drug.<\/p>\n<p>Section 4.6.1 reportedly speaks about the risks associated with valproate which is contained in the drug. Valproate had been tested in animals and humans, both with evidence of deformation of foetuses. For humans, there were malformations of:<\/p>\n<div class=\"well\">\n<ul class=\"blog-list\">\n<li>Neural tubes defects<\/li>\n<li>Cranial facial defects<\/li>\n<li>Limbs<\/li>\n<li>Cardiovascular<\/li>\n<li>Hypospadias<\/li>\n<li>Multiple anomalies involving various body systems<\/li>\n<\/ul>\n<\/div>\n<p>It&#8217;s safe to say that, with the data Sanofi had, they must have known there was a much higher rate of malformations in foetuses. The number of malformations was reportedly higher in cases of multiple drug therapy.<\/p>\n<h3>Allegations of insufficient warnings<\/h3>\n<p>The group action, headed by the <em>French Association of People<\/em>, based their claim mainly on Sanofi&#8217;s alleged negligence for allegedly insufficiently warning expectant mothers of the <em>exact risks<\/em> of taking Depakote. Within the drug profile, it contained warnings that the drug should only be used if absolutely necessary, and even so, expectant mothers or women of child-bearing potential should be given counselling advice.<\/p>\n<blockquote><p><strong><em>&#8220;Women of child-bearing potential should be informed of the risks and benefits of the use of Depakote during pregnancy. Specialist advice is required and physicians are strongly encouraged to discuss reproductive issues with their patients before Depakote is prescribed for the first time.&#8221;<\/em><\/strong><\/p><\/blockquote>\n<p>For the prescribers of the medicine, it may be just a simple error; but for the families and the affected children, the impact is lifelong.<\/p>\n<p>This was thought to be the first group class action to be brought in the health sector in France. Using this method, all 2,900 families can bring all their evidence into one joint case. Although the Sanofi is based in France, they are present here in the U.K. <\/p>\n<p><strong>If anyone here in the U.K. may have been affected by this, please get in touch with our team.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Thousands joined together to bring a class action case against French drug company Sanofi for allegedly not warning expectant mothers of the adverse side-effects of taking the epilepsy drug Depakine\/Depakote. French newspaper Le Canard Enchaine reported that over 10,000 pregnant women were given this drug between 2007 and 2014, and it&#8217;s suspected that around 450 &hellip; <a href=\"https:\/\/www.groupactionlawyers.co.uk\/blog\/sanofi-class-action-suit-over-epilepsy-drug-linked-birth-defects\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">The class-action suit against Sanofi over epilepsy drug linked to birth defects<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":403,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[5],"tags":[14],"class_list":["post-1120","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-class-actions"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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Depakote epilepsy drug that reportedly caused birth defects in 10,000 unborn babies","author":"Admin","date":"23rd December 2016","format":false,"excerpt":"Valproate Semisodium, better known as Depakote, has reportedly put more than 10,000 pregnant women at risk in France, and there are raising concerns that the same amount of women in the U.K. may also be affected by the epilepsy drug. Our Group Action Lawyers are investigating the issues, and anyone\u2026","rel":"","context":"In &quot;Latest&quot;","block_context":{"text":"Latest","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/latest"},"img":{"alt_text":"unborn babies at risk","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/unborn-babies-at-risk.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/unborn-babies-at-risk.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/unborn-babies-at-risk.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/unborn-babies-at-risk.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1404,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/birth-defects-reportedly-caused-utero-exposure-epilepsy-drug","url_meta":{"origin":1120,"position":1},"title":"Birth defects reportedly caused by in-utero exposure to Epilepsy Drug","author":"Admin","date":"28th February 2018","format":false,"excerpt":"A drug that helps control epileptic seizures has been reportedly linked to birth defects and should not be used by pregnant women or women of child-bearing potential. Depakote was created by French pharmaceutical drug company Sanofi back in 1967. The British equivalent, Epilim, has been available since 1973. The drug\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"pregnancy epilepsy drug concerns","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":1601,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/calls-for-uk-inquiry-into-sodium-valproate-epilepsy-drug","url_meta":{"origin":1120,"position":2},"title":"Calls for UK inquiry into sodium valproate epilepsy drug","author":"Author","date":"25th May 2018","format":false,"excerpt":"There are calls for a UK inquiry into the sodium valproate epilepsy drug that has been linked to birth defects and developmental issues in children. It\u2019s also understood that UK health professionals were warned about the dangers of people using sodium valproate epilepsy drugs, but little seems to have been\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"pregnancy epilepsy drug concerns","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/pregnancy-epilepsy-drug-concerns.png?fit=1200%2C414&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":2304,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/sodium-valproate-claims-for-compensation","url_meta":{"origin":1120,"position":3},"title":"Sodium Valproate claims for compensation","author":"Author","date":"26th April 2022","format":false,"excerpt":"Sodium Valproate claims for compensation can be pursued for damages for any injury and suffering that has arisen from the use of the drug. The risks of using the drug during pregnancy can be significant and can lead to birth defects and serious developmental problems in infants. Unfortunately, consent and\u2026","rel":"","context":"In &quot;Group Actions&quot;","block_context":{"text":"Group Actions","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/group-actions"},"img":{"alt_text":"experts warn of buying diet pills online","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/buying-diet-pills-online-warning.png?fit=1200%2C414&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/buying-diet-pills-online-warning.png?fit=1200%2C414&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/buying-diet-pills-online-warning.png?fit=1200%2C414&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/buying-diet-pills-online-warning.png?fit=1200%2C414&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/buying-diet-pills-online-warning.png?fit=1200%2C414&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":517,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/arthritis-tablets-may-adversely-affect-braille-users","url_meta":{"origin":1120,"position":4},"title":"Arthritis tablets may adversely affect users who rely solely on Braille","author":"Admin","date":"6th February 2017","format":false,"excerpt":"The Medicines and Healthcare products Regulatory Agency (MHRA) recently issued a caution relating to a drug that treats adult patients with active rheumatoid arthritis or active psoriatic arthritis. Global pharmaceutical company\u00a0Sanofi informed the medical agency of the error on the Braille on the packaging of some batches of the Arava\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/xarelto-concerns.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/xarelto-concerns.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/xarelto-concerns.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/xarelto-concerns.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":942,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/drug-manufacturers-distributors-suspected-colluding-inflate-profits","url_meta":{"origin":1120,"position":5},"title":"Major drug manufacturers and distributors suspected of colluding to inflate profits at consumers&#8217; expense","author":"Admin","date":"11th September 2017","format":false,"excerpt":"Several drug manufacturers, suppliers and pharmacy benefit managers have reportedly been caught colluding to fix prices for insulin. In what's believed to be efforts to allegedly inflate profits, companies reportedly worked together to set consistently high prices for the drugs. This way, no matter where consumers purchased their insulin from,\u2026","rel":"","context":"In &quot;Latest&quot;","block_context":{"text":"Latest","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/latest"},"img":{"alt_text":"drugs","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/drugs-recall-750x250.png?fit=750%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/drugs-recall-750x250.png?fit=750%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/drugs-recall-750x250.png?fit=750%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/drugs-recall-750x250.png?fit=750%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1120","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/comments?post=1120"}],"version-history":[{"count":5,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1120\/revisions"}],"predecessor-version":[{"id":1127,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1120\/revisions\/1127"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media\/403"}],"wp:attachment":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=1120"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=1120"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=1120"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}