French pharmaceutical laboratory Sanofi has been judged responsible for a lack of care and risk information on the epilepsy drug Dépakine, after it was found to cause developmental delay and deformities in unborn children if taken in pregnancy.
A court in Paris made the ruling this week (Wednesday, January 5) saying that Sanofi had “committed an error and failed in its obligation of care and its obligation of information.”
The parent support group for children with epilepsy, l’Association d’aide aux parents d’enfants souffrant du syndrome de l’anticonvulsivant (Apesac), began action against Sanofi in 2017, and believes that the lab and the health authorities took too long to inform patients of the risks.
The court judged the victims’ association case as “valid”. Taking the lab to court is the first step on the road towards possible compensation.
In France, victims of accidents or similar incidents are permitted to group together in a single case to demand compensation before a court. This has been legal for consumer issues since 2014, and for health issues since 2016.
Severe developmental risks
The active ingredient in Dépakine (sodium valproate) has been sold since 1967 under the brand Dépakine for epilepsy, and as Dépakote and Dépamide for bipolar disorder (and also under generic names). Sodium valproate is also sometimes used to treat severe migraines.
Yet, it carries risks of severe side effects for unborn babies when taken during pregnancy. It can cause physical deformity (cardiovascular and spinal column issues) and neurodevelopmental issues (autism spectrum, slow language learning) in the developing foetus.
The court said that during the period 1984 and 2006, Sanofi did not take the risk of congenital deformities into high enough account. It said the same of neurodevelopmental issues during the years 2001-2006.
The court also specified that, given the scientific information available at the time, Sanofi had “produced and marketed a defective product between May 22, 1998, and January 2006 for congenital deformities, and between 2001 and January 2006 for neurodevelopmental disorders”.
Lawyer for Apesac, Charles Joseph-Oudin, told Le Monde: “It’s a huge relief that the judicial court of Paris has recognised Sanofi’s error. This is symbolic for the victims.”
Yet, he said that the court had focused on “too restrictive dates…that do not reflect the scientific data”. Similarly, Asepac founder Marine Martin said that the dates highlighted by the court “do not apply to half of the victims of Dépakine”.
Asepac claims that the risk of developmental issues was known before 2001, and that the lack of proper information persisted after 2006, when the drug was finally termed “unadvised” during pregnancy.
It took until June 2018 for drug safety agency l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) to contraindicate valproate-based drugs completely for people of childbearing age, except in very exceptional cases where other treatments have proven ineffective.
Sanofi disputes decision; plans to appeal
Sanofi has said that it plans to appeal the court’s latest decision. Yet, it must wait for further confirmation and information on the ruling before it can decide.
In a statement, Sanofi responded: “[This ruling was not] in alignment with previous court decisions that either did not hold the laboratory responsible, or found that the main responsibility lies with other parts of the health system [such as ANSM]”.
Sanofi said it had “always been transparent, alerting the health authorities [to issues], and on several occasions requesting changes to information documents for Dépakine".
ANSM estimates that sodium valproate is linked to deformities in 2,150-4,100 children, and neurodevelopmental issues in 16,600-30,400 children. A research study published in October 2020 found that the drug increased the risk of issues by five.
The “previous court decisions” Sanofi referred to include a court ruling from July 2020, which recognised the state’s role in the incidents, and required the state to pay compensation to several families whose children were severely handicapped as a result of the drug.
Yet, Sanofi and prescribing doctors were also implicated, and both Sanofi and ANSM were investigated in 2020 for alleged manslaughter charges in particular.
Now, the investigating magistrate is set to have a new independent expert report carried out after a decision against this was reversed on December 15, 2021. The judge must now decide the number of experts that will undertake this new report.
Sanofi has welcomed the report. In a statement to the Agence France-Presse, it said that it will be “in the interest of the proper administration of justice” and would “guarantee the right to a fair trial and rights of the defence”.
It would “allow new legal experts to answer essential questions of public health that had been raised in the new criminal proceedings”, it said.
Both Sanofi and ANSM are still under criminal investigation under the banner of this new report.