The Paris court ruled on Wednesday January 5 that the French pharmaceutical group Sanofi had “Committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform” concerning the risks of its drug Depakine for the fetus if taken during pregnancy.
He also estimated “Admissible” the group action presented by the association of victims of Depakine against the laboratory, the first step towards their possible compensation. Sanofi having announced its intention to appeal, it will however be necessary to wait for the confirmation or the reversal of this decision so that the class action can actually open.
This type of action, authorized in France since 2014 in the field of consumption and then extended in 2016 to health products, allows patients who are victims of accidents related to their treatment to join together in a single procedure to seek redress before the courts. .
Information delay
Sodium valproate (the active principle of Depakine) has been marketed since 1967 under the brands Dépakine (for epilepsy), Dépakote and Dépamide (for bipolar patients) and under generic brands. It is used in the treatment of epilepsy and bipolar disorders, but has serious side effects: it increases the risk of physical malformations (absence of closure of the spine, cardiovascular anomalies, etc.) and neurodevelopmental disorders (language delay , autism spectrum disorders…) in children exposed in their mother’s womb.
The Association for the Assistance of Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), which initiated the group action in 2017, maintains that Sanofi, like health authorities, took too long to inform of these risks.
In its judgment, the court fixes between 1984 and 2006 the period of time during which the risk of congenital malformations was not sufficiently taken into account. For neurodevelopmental disorders, which took longer to be recognized, he reduced this period to 2001-2006. In view of the scientific information available at the time, the court also considers that Sanofi “Produced and marketed a defective product between May 22, 1998 and January 2006 for congenital malformations, and between 2001 and January 2006 for neurodevelopmental disorders”.
“It is a huge relief that the Paris court recognizes the fault of the Sanofi laboratory”, reacted Charles Joseph-Oudin, lawyer of Apesac, greeting “The symbolic scope [du jugement] for the victims ”. He regrets, however, that the “Selected dates” by the court be “Too restrictive and do not [soient] not consistent with scientific data ”, adding that he was going ” to study “ with Apesac the opportunity to appeal. The chosen dates “Exclude half of the victims of Depakine”, added the founder of Apesac, Michèle Martin.
The association believes, in fact, that the risk of developmental disorders was known before 2001 and that the lack of information persisted beyond 2006, when the drug became ” not recommended “ during pregnancy. Prescribing conditions continued to be restricted thereafter, until a total contraindication in women of childbearing age in June 2018, except in exceptional situations where other treatments are not effective.
For its part, Sanofi considered that the judgment was “Not in line with the first court decisions which, either do not retain the responsibility of the laboratory, or note that the preponderant responsibility rests on other actors of the health system”, such as the National Agency for Medicines and Health Products Safety (ANSM). The laboratory assured to have “Always been transparent, alerting the health authorities and repeatedly requesting changes to the Dépakine information documents”.
Risk of brain disorders multiplied by five
For the ANSM, children exposed during pregnancy to drugs based on valproate or its derivatives also have “A high risk of birth defects”. Because of these risks, this molecule has been contraindicated for several years for “Girls, adolescent girls, women of childbearing age and pregnant women”. “These drugs should not be prescribed in these patients, except in cases of ineffectiveness or intolerance to drug alternatives”, according to the Medicines Agency.
According to estimates from Medicare and ANSM, sodium valproate is responsible for malformations in 2,150 to 4,100 children and neurodevelopmental disorders in 16,600 to 30,400 children. Researchers published in October 2020 concluded at a risk multiplied by five.
A victim compensation system has been entrusted to the National Office for Compensation for Medical Accidents (Oniam). In July 2020, the administrative justice recognized for the first time the responsibility of the State – condemned to compensate several families of severely disabled children – as well as that of Sanofi and doctors. In the criminal investigation, Sanofi and the ANSM were indicted in 2020, for “manslaughter” in particular.
The examining magistrate will have to carry out a new expertise
Regarding the penal aspect, the magistrate in charge of the instruction on the marketing of Dépakine will have to carry out a second expertise, we learned Wednesday from corroborating sources.
According to a judicial source, the investigating chamber of the Paris Court of Appeal reversed on December 15 the decision made by the investigating magistrate refusing to initiate a new expertise, requested by the laboratory. The judge must now set the number of experts who will produce a new report.
This ” against expertise “ goes “In the interest of the good administration of justice” and will be able “Guarantee respect for the right to a fair trial and that of the rights of the defense”, responded Sanofi in a message sent to Agence France-Presse. She “Will allow new legal experts to answer essential public health questions raised in the context of criminal proceedings”.
In this criminal section, the Sanofi laboratory and the National Agency for the Safety of Medicines and Health Products are indicted.