Dépakine scandal: Sanofi found responsible for a lack of vigilance and information
Several criminal proceedings are underway concerning Dekapine.
In 2020, the Sanofi laboratory was indicted for unintentional injury, manslaughter and aggravated deception.
Max PPP
Text by: RFI Follow
6 mins
Sanofi, the largest French pharmaceutical company, was held responsible for a lack of vigilance and information on the risks of Dépakine, as part of a group action, the first in the field of health.
This epilepsy medicine may, when taken by a pregnant woman, cause problems in the unborn child.
In France, it is thought to be responsible for malformations in 2,000 to 4,000 children and neuro-developmental disorders (drop in IQ, autism spectrum disorders, etc.) in 16,000 to 30,000 children.
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Depakine was marketed in 1967 in France.
The molecule, sodium valproate, is first intended for people with epilepsy, then also for those with bipolar disorder.
This important antiepileptic drug is marketed in many countries around the world.
The problem is that, taken during pregnancy, it can cause several types of birth defects as well as neurodevelopmental disorders in children.
This is what happened to Nathalie Orti's only son.
Now 15 years old, he has learning and behavioral disabilities - the link with Dépakine is made several years after his birth.
► Listen to: La Dépakine (Priorité Santé, 2016)
When Nathalie Orti plans to become pregnant in 2004, when she becomes pregnant the following year, she tells doctors that she is taking Depakine for her epilepsy.
They only tell him about the increased risk of spina bifida for the child, a neural tube defect.
They do not mention any other risk; and in the leaflet of the drug at this period there is no clarification in case of pregnancy. "
In the leaflet it was only written to see your doctor, that's what I did, I went to my doctors and they all said to me, '
take vitamin B9 for spina bifida and all .
will be fine
". And as during pregnancy, on ultrasound scans, my child had no problem with neural tube defects, I was extremely reassured
, ”she says.
Shortly after the birth of her son, in May 2006, Nathalie Orti is worried. “
We realized that my son was very hypotonic, that he did not move or babble. At the age of one, a pediatric neurologist diagnoses an overall developmental delay, and there it is all that collapses
, ”she continues. “
Today, I am very angry that I was not informed. When you look back, the lab knew, you realize that there were studies in the 1980s that described neurodevelopmental disorders, so why weren't we informed? Why was there nothing in the leaflet?
», Protested Nathalie Orti.
So what exactly did we know about the risks involved in the 1980s, 1990s, and then in the early 2000s?
Was the information intended specifically for physicians as well as that intended for patients - via the leaflet - complete, faithful to scientific knowledge?
Why were they transmitted late, not before 2006?
Who bears the responsibility?
These questions are at the heart of the Dépakine affair.
In a 2016 report, the General Inspectorate of Social Affairs points to a lack of responsiveness, inertia on the part of the health authorities and the Sanofi laboratory.
In 2020, the administrative court established that the state had some responsibility.
Sanofi's responsibility
On January 3, 2022, the Paris judicial court ruled on Sanofi's liability in the context of the group action initiated in 2017 by Apesac, the Association for the assistance of parents of children suffering from the syndrome. anti-convulsant. The laboratory "
committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform
", such are the terms of the judgment. The responsibility of the pharmaceutical giant is engaged over the period 1984-2006 for congenital malformations, and 2001-2006 for neuro-developmental disorders.
The pharmaceutical giant, which has announced its intention to appeal, affirms in a press release that it sent to us, to have "
always been transparent, alerting the health authorities and repeatedly requesting changes to the information documents of Depakine, intended for patients and healthcare professionals.
The information documents were modified in accordance with the evolution of the state of knowledge and the decisions of the health authorities of the time.
"
►Read again: Dépakine scandal, the French Medicines Agency indicted
Charles Joseph-Oudin, lawyer for Apesac and many families of victims, vigorously contests this argument: "
When the laboratory says that it has informed the health authority and that we will look in detail, and that the Legal experts will look in detail, there is indeed a trace of information, but fragmentary information, even misleading, and especially information that is not brought to the knowledge of women and doctors.
"
For the lawyer, "
the symbolic significance of the court's decision is immense, because it thwarts the strategy of denial of responsibility of the Sanofi laboratory
". He regrets, however, that "
the periods retained by the court during which the laboratory is responsible [are] too restrictive
". Thus according to Apesac, the neuro-developmental risks were known from the 1980s, and the lack of information persisted beyond 2006, year when the drug became not recommended during pregnancy, without it being made. mention in the leaflet of the risks to the fetus.
The decision will have to be confirmed so that the class action can effectively open and thus the subject of reparations can be considered.
But "
it will have consequences on individual files
," said Mr. Charles Joseph-Oudin.
Numerous civil proceedings are underway, launched by families of victims.
Compensation, a crucial subject
Marine Martin, mother of two children suffering from Depakine-related disorders, is the founder of Apesac. It was she who launched the alert in 2011 on the lack of patient information and who fought for this to change - since 2016 the prescription of Dépakine is clearly contraindicated for women of childbearing age. She also worked for the State to set up a compensation fund (the State compensating the victim in place of Sanofi if the latter refuses, then turning against the laboratory, in court); so far, few families have been compensated in this way.
For Marine Martin, the fight for compensation is essential, and the laboratory is on the front line.
"
He must assume his responsibilities and compensate families for the damage suffered, because our children are dependent for life,
" she insists.
Me, that's what worries me the most;
when I am no longer there, and in addition women with epilepsy do not have a monstrous life expectancy, who will take care of it?
And that is the purpose of compensation.
"
Of course, it is important to have the damage recognized, etc.
but the most important thing is that our children have decent conditions for life and a helper who provides them with meals and everything they need
Several criminal proceedings are also in progress.
In 2020, the Sanofi laboratory was indicted for unintentional injury, manslaughter and aggravated deception.
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