French prosecutors have charged Sanofi, the pharmaceutical manufacturers of Sodium Valproate, marketed in France as Depakine, with manslaughter after the deaths of four babies whose mothers took the drug.
In response, the company released a statement to indicate that it was appealing to the French prosecution appeals chamber, stating that ' Sanofi Aventis France has respected its obligations to provide information and contests the basis for these proceedings in respect of Depakine'.
Sanofi is also facing separate charges brought in February 2020 of aggravated fraud and unintentionally causing injury in 42 cases filed by families. Sanofi said in a statement that the status as an "indicted party" would enable the company to "fully exercise its rights of defence and will be an opportunity to demonstrate it has respected its duty to inform and show transparency." It added, "Sanofi Aventis France has informed healthcare authorities and requested updates to information documents provided to doctors and patients, according to advances in scientific knowledge." The company would "continue to cooperate fully with the judicial authorities and remains confident in the proper conduct of the process."
Sodium valproate, whose brand names also include Epilim, Epival and Episenta, is used to treat epilepsy, migraine and bipolar disorders. Sanofi has manufactured the medication since 1967 in France and 1973 in the UK. For many years the drug has been linked to birth defects in the children of women who took the drug during pregnancy leading to physical disability, cardiovascular defects, autism and developmental delay amongst many other disorders.
The Epilepsy Society report that research has shown that sodium valproate can cause serious problems in a developing baby. Babies whose mothers take sodium valproate during pregnancy, are at a 1 in 10 (10%) risk of having a birth defect, and 4 in 10 children (up to 40%) have problems with development and learning as they grow.
Under the French legal system, charges do not automatically result in a trial as prosecutors can decide not to proceed based on a lack of evidence. Legal proceedings can take several years. The case in France has been ongoing for years, with the French courts finding in 1983 that health officials knew about the risk of birth defects and that as early as 2004, there was an awareness of learning disabilities and autism was present.
In the UK, sodium valporate has been subject to significant (albeit belated) scrutiny under the Independent Medicines and Medical Devices Safety Review, which was set up in February 2018 and chaired by Baroness Cumberlege. The report entitled "First Do No Harm" which was published in July 2020, comes after a two-year review into the failure of the healthcare system in warning women about of the risks involved in taking sodium valproate, having pelvic mesh implanted and the use of the oral pregnancy test, primados which is no longer used. The report follows decades of patient campaigning to shine a light on the dangers of these drugs and devices and the lack of warning about the risks they present and has led to a raft of nine recommendations to redress the failings of the Healthcare System and prevent history repeating itself.
The one of the Recommendations of the Cumberlege Review includes : The creation of "costs of care" schemes for hormone pregnancy tests, sodium valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim. The review envisaged that the costs of running the Redress Agency could be met by contributions from manufacturers and the state.
In July 2020 a French court ordered the French state to pay tens of thousands of euros in damages to three families ranging from €20,000 to €290,000 after finding it responsible in a case over birth defects linked to an anti-epilepsy drug made by pharmaceutical giant Sanofi. The five children involved are now aged between 11 and 35 years old. Marine Martin, president of the APESAC association that represents 7,000 victims' families stated "I welcome the conviction of the state, which we were expecting, but I'm angry because 80 per cent of the children born before 2004 are excluded from compensation".
In 2017 a compensation scheme for those affected was set up by the French state, which has paid out around €6.5m (£5.5m) in compensation as at February 2020. France's social affairs inspection agency IGAS has estimated that between 2006 and 2014, 425 to 450 babies suffered congenital birth defects or were stillborn following exposure to Depakine. However, Sanofi has repeatedly said it has no intention to compensate or take part in a state-backed compensation mechanism for Depakine stating it had warned health authorities of the drug's risks beginning in the 1980s. It therefore remains to be seen whether they will accept or be forced to accept the recommendations of Baroness Cumberledge's report that manufacturers should contribute to compensatory schemes.
"It is galling that big pharmaceutical companies such as Sanofi, who have made very considerable profits from selling their medicines and devices to healthcare systems, avoid or refuse to meet the cost of redress when their products cause harm.
"The result is that they are not only profiteering from healthcare systems, such as the NHS, but they are also leaving the cost of recompense for the harm caused either to be picked up by the public purse or worse still, leaving families affected without the help they need to meet the costs of treatment, care, schooling and accommodation causing long term suffering and uncertainty.
"I hope that going forward, pharmaceutical companies can no longer be permitted to get away with significant profiteering without taking responsibility to redress matters when things go wrong."
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