In a judgment rendered on September 9, the Paris judicial court ordered the Sanofi laboratory to pay Marine Martinpresident of the Apesac association (Association to Help Parents of Children Suffering from Anti-Convulsant Syndrome), and two of her children, 284,867.24 euros in compensation. During her pregnancy, Marine Martin exposed her two children in utero to taking depakine, an anticonvulsant, which caused numerous neurodevelopmental delays and physical after-effects in her children. Master Charles Joseph-Oudinlawyer for several victims of depakine, including Marine Martin, explains to us why Sanofi was condemned, as well as the details of the current procedures.
What are the main damages caused by Dépakine?
Master Charles Joseph-Oudin: Overall, we know today that 10% of children exposed in utero to Dépakine will suffer from physical malformations and 30 to 40% from neurodevelopmental disorders which include autism, learning disorders, social interactions, etc. .
How many victims of Dépakine are estimated?
Master Charles Joseph-Oudin: Broad estimates estimate there are 30,000.
Concerning Marine Martin, what was the laboratory sentenced to do?
Master Charles Joseph-Oudin: Concerning Marine Martin, her children were largely compensated in the Oniam procedure. Marine Martin had refused this procedure for herself. She receives there, among other things, sums for professional damage (80,750 euros), and the children receive anxiety damage of around 50,000 euros, the rest having already been compensated as part of the Oniam procedure.
The fact that the limitation period was not retained for Marine Martin should allow other civil parties to take legal action. In your opinion, how many of these alleged victims will be able to have their damage recognized?
Master Charles Joseph-Oudin: Potentially almost all of the 2000 files I have at the office. We are in a situation where families have favored the route of the National Office for Compensation for Medical Accidents (Oniam) but there are imperfections in Oniam and for this reason we could consider launching legal action, taking into account the extremely long delays of justice. It took us twelve years to bring Marine Martin’s case to trial.
Medscape French edition: Can we take stock of the various ongoing procedures concerning Dépakine?
Master Charles Joseph-Oudin: There are, on the one hand, individual procedures, some of which have been opened at the Nanterre judicial court – and which led to favorable decisions in the summer of 2020 – and appeals in progress. The responsibility of the State via the National Medicines Safety Agency (ANSM) was recognized in judgments of the Montreuil administrative court. On the other hand, collective procedures – which are not group actions – for anxiety, were declared admissible by the Nanterre court. The group procedure opened in Paris gave rise to a judgment in January 2022, during the appeal, which also ruled in our favour. For the moment, in this latest procedure, there has been no conviction but recognition in principle of the laboratory’s responsibility by the court. Finally, there are also criminal proceedings opened against the laboratory indicted for acts of injury, involuntary homicide and aggravated deception. The State via the ANSM is also indicted for injuries and manslaughter. These criminal proceedings are still ongoing and could lead to referral proceedings by the summer of 2025.
Who initiated this criminal procedure?
Master Charles Joseph-Oudin: A group of individuals, around 70 civil parties came forward, including Marine Martin. There are also files open at Oniam: there are almost 1000 families who have submitted files there and this is where the compensation dispute mainly takes place. The laboratory, for these procedures at Oniam, refuses to compensate the victims, so it is public funds that pay instead of the laboratory. We are currently receiving compensation of around 80 million euros.
How will Oniam be reimbursed by the laboratory?
Master Charles Joseph-Oudin: Procedures are underway. The procedures that I cited previously are essential to demonstrate the liability of the laboratory and Oniam will invoke them in particular on the prescription of the limitation period.
In the case of the court decision favorable to Marine Martin, the court did not retain the ten-year limitation period invoked by Sanofi, why?
Master Charles Joseph-Oudin: The position of the case law, whether in Nanterre, in Paris or in the anxiety procedure, is precise: as soon as there is a fault, this fault defeats the limitation period of the defective products regime. The regime for defective products defined in a 1985 directive provides that there are deadlines for extinguishing the producer’s liability, in particular ten years after the circulation of the product, in this case at the start of Marine Martin’s pregnancy. However, this limitation period is not applied if there is fault. In this case we can go beyond the limitation periods of this legal regime. Concerning the Sanofi laboratory, the fault is a lack of vigilance. Since the emergence of risks in the early 1980s, the laboratory has not conducted studies likely to rule out or confirm this risk. The laboratory also failed to inform patients and practitioners of the doubts that emerged. This case law for Dépakine is the same as for the Médiator affair. In the Mediator affair, from the first pharmacovigilance cases in 1999, the laboratory had a duty to investigate and inform. It’s the same situation for Dépakine. If this has not been done, then the limitation period jumps, and we return to common law, namely that there is limitation ten years after the consolidation of the damage.
What is called consolidation of damage?
Master Charles Joseph-Oudin: This is the moment when the damage is stabilized. Let me give you an example: you were hit by a car. They operate on you, they put pins in you and six months later, they take them out and you are cured. It is at this point that the damage is considered to have stabilized.
Regarding Marine Martin, when does consolidation begin?
Master Charles Joseph-Oudin: For one of the two children, consolidation is not achieved, because he is not an adult, is still studying, and his state of health continues to deteriorate. For the young girl, consolidation came at the end of her studies.
Does opening a file at Oniam extinguish all civil or criminal proceedings?
Master Charles Joseph-Oudin: You cannot be compensated twice for the same fault. On the other hand, and this was the case for the Marine Martin case, if there are damages which are not assessed by Oniam, such as the anxiety of the Martin children, they could be recognized before a judicial court.
What are the next legal meetings regarding dépakine® for your practice?
Master Charles Joseph-Oudin: We have procedural hearings coming up regarding the class action, we also have a partial end to the criminal proceedings hoping for referral proceedings by the summer of 2025. And we will continue the legal proceedings.
You also defended victims of Mediator. What are the similarities and differences between these two public health dramas?
Master Charles Joseph-Oudin: Regarding the fault of the laboratory and the lack of vigilance, the files are identical, it is the same behavior which is sanctioned. We have laboratories which are waiting to see the emergence of risks, initially small, poorly quantified and poorly qualified. They are sanctioned because they did not behave correctly: as soon as a risk emerges, it must be monitored. But the Dépakine affair did not reveal any villainous behavior, as in the Mediator case. We have not noted any influence peddling or breach of integrity as in the Mediator, where members of the drug agency also worked for the laboratory, etc.
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