Sodium Valproate Legal Case

November 30, 2022

In 2014, the European Medicines Agency (EMA) reinforced its previous warnings about the drug. However, cases born between 2004 and 2018 are in the name of children born between 2004 and 2018, according to McPhillips, a partner at Michael Boylan Litigation. A total of 20 cases are in various stages of preparation, including a family whose child was only born in 2018. Any negligent medical treatment that has caused harm to your child may be subject to legal action. Children`s compensation claims are not limited to work performed by a paediatrician, nor to claimants who are still children. A landmark lawsuit between families of disabled children and a pharmaceutical giant is likely to be dropped after legal aid is withdrawn. The Independent Review of the Safety of Medicines and Medical Devices was established under the chairmanship of Baroness Cumberlege to review sodium valproate, primidos and pelvic meshes. “The medical and scientific community identified and reported the effects of sodium valproate – epilim – as early as 1980. Thirty years after that first report, it now appears that this case cannot be pursued to investigate the reasons for the children`s injuries. If the courtroom door is closed to these children, I believe that sanofi-aventis should take responsibility for the effects of its drugs and compensate the children harmed by it, in accordance with the social contract, which it considers the center of its business strategy. In Ireland, an HSE report estimated that between 153 and 341 children between 1975 and 2015 will have had a severe birth defect and up to 1,250 children will have experienced neurodevelopmental delay due to valproate exposure. This programme is necessary to meet the requirements of European and Irish regulators to require that women taking valproate be monitored annually and kept informed of the progress of the medicine. The charity Epilepsy Action said women and unborn children were still at risk.

Its deputy chief executive, Simon Wigglesworth, said: “Women of childbearing potential are still prescribed sodium valproate without receiving important advice before conception to help them decide if it is the right drug for them. The newspaper asked the Ministry of Health to comment on the court`s decision and provide an update on the investigation. In response, a spokesperson for the department said: “Department officials are working with affected patient groups on the terms of reference for the proposed sodium valproate investigation.” The families have not called for a ban on sodium valproate, which has been sold since 1972 and has been the subject of warnings about its use by researchers and medical safety consultants. They were willing to acknowledge its importance in controlling epilepsy, but said manufacturers were slow to issue warnings about possible side effects. The case, which has been in preparation for six years, was raised by families with 100 children. They claim the children were injured in the womb because their mothers had taken Epilim, the brand name for a drug whose active ingredient is sodium valproate. The drug is used to treat and reduce the risk of seizures in people with epilepsy, although the company says it is not a first-line treatment for women of childbearing age. Lanyon Bowdler`s lawyers have an excellent reputation for dealing effectively with drug infringement claims. Our legal specialists can provide all the knowledge and experience needed for a successful case.

“There`s a case coming to court at the end of November, this case is just a family,” she said. “There are two more for February, and there are more I`m expecting for next summer.” In response, the company issued a statement stating that it had addressed the Appeals Chamber of the French Public Prosecutor`s Office, stating that “Sanofi Aventis France has complied with its information obligations and disputes the basis of this procedure concerning Depakine. Sanofi also faces separate charges filed in February 2020 for aggravated fraud and unintentional injury in 42 cases filed by families. Sanofi said in a statement that its status as an “accused party” would allow the company “to fully exercise its rights of defense and demonstrate an opportunity that it has complied with its duty of disclosure and transparency.” He added: “Sanofi Aventis France has informed health authorities and requested updates to the information materials made available to physicians and patients based on evolving scientific knowledge.” The company “will continue to cooperate fully with the judicial authorities and remains confident in the proper conduct of the proceedings”. Sodium valproate, whose brand names also include Epilim, Epival and Episenta, is used to treat epilepsy, migraines and bipolar disorder. Sanofi has manufactured this drug in France since 1967 and in the United Kingdom in 1973. For many years, the drug has been associated with birth defects in the children of women who took the drug during pregnancy, resulting in physical disabilities, cardiovascular malformations, autism and developmental delays, among others. The Epilepsy Society reports that research has shown that sodium valproate can cause serious problems in a developing baby. Babies whose mothers take sodium valproate during pregnancy have a 1 in 10 (10%) chance of having a birth defect, and 4 in 10 children (up to 40%) have developmental and learning problems as they grow.

In the French legal system, charges do not automatically lead to a trial, as the prosecution may decide not to proceed due to a lack of evidence. Legal proceedings can take several years. The France case has been going on for years, with French courts concluding in 1983 that health officials knew about the risk of birth defects and that there was awareness of learning disabilities and autism as early as 2004. In the United Kingdom, sodium valporate underwent significant (albeit belated) review as part of the Independent Review of the Safety of Medicines and Medical Devices established in February 2018 under the chairmanship of Baroness Cumberlege. The report, titled “First Do No Harm,” released in July 2020, comes after a two-year review of the health system`s failure to warn women of the risks of taking sodium valproate, implanting pelvic meshes and using the Primados oral pregnancy test, which is no longer used. The report follows decades of patient campaigns to shed light on the dangers of these drugs and devices and the lack of warning of the risks they pose, and led to a series of nine recommendations to address gaps in the health system and prevent history from repeating itself. One of the recommendations of the Cumberlege review includes: creating “cost of care” systems for hormonal pregnancy tests, sodium valproate and pelvic mesh – to cover the cost of providing additional care and support to those who have suffered preventable harm and are eligible to make a claim.