France: the pharmaceutical laboratory Sanofi sentenced in the Dépakine case
In France, the pharmaceutical laboratory Sanofi was ordered to compensate up to 450,000 euros to a family victim of Dépakine.
It is a court decision of the court of Nanterre.
Depakine is a drug prescribed for epileptic and bipolar patients.
But it is responsible for physical malformations and neurological disorders for the babies of pregnant women treated with this treatment.
© Captura de tela/ France Bleu
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In France, the pharmaceutical laboratory Sanofi is ordered to compensate a family victim of Depakine, a drug prescribed for epileptic and bipolar patients.
But it is responsible for physical malformations and neurological disorders for the babies of pregnant women treated with this treatment.
It is a decision of the court of Nanterre.
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This is a first in an individual legal case: the French group Sanofi was ordered by the Nanterre court to compensate up to 450,000 euros to a family whose daughter, exposed to Dépakine in utero, was born in 2005 with malformations. .
The Nanterre court considered that the risk of autistic disorders in connection with Dépakine was known to the laboratory, at least in 2005, and that consequently it should be mentioned in the notice, according to the judgment consulted on Saturday by Agence France hurry.
The mother, followed for epileptic seizures, took this drug since 1982, including during her pregnancy.
A “global acquisition delay” and psychomotor developmental delays were observed in her daughter throughout her childhood.
In 2014, his parents took Sanofi to court.
Used since 1967 in the treatment of epilepsy and bipolar disorders, sodium valproate (active ingredient of Depakine) increases the risk of physical malformations (lack of closure of the spine, cardiovascular anomalies, etc.) neuro-developmental (language delay, autism spectrum disorders, etc.) in children exposed in their mother's womb.
According to the judgement, Sanofi acknowledged having been aware since 2003 of the risks, in particular neuro-developmental, and therefore had a duty to inform patients more clearly.
It was only in 2006 that the leaflet advised against Depakine during pregnancy and recommended prompt consultation with a doctor in the event of the discovery of such a condition, the decision specifies.
The number of disabled children due to sodium valproate is estimated between 15,000 and 30,000, according to several studies.
A legal turn?
In Nanterre, this file is the first of a long series to be judged on the merits.
In all, the court is seized of 23 civil cases, including one involving 272 claimants, according to a judicial source.
Four other cases involving children born in 1989, 2005 and 2006 will be tried on Thursday.
The family's lawyer, Maître Charles Joseph-Oudin, joined by Stéphane Duguet, of the France service, welcomes this judgment and is optimistic for the other complaints against Sanofi that the court must examine.
In a week, four new cases will be pleaded before this same Nanterre court.
This decision, it gives the feeling that the laboratory must change its strategy today, in particular with regard to the victims, must assume its responsibility
Maître Joseph-Oudin lawyer for the victim family: “The court dismissed all the arguments that are usually put forward by the laboratory to refuse to assume its responsibility”
Stephane Duguet
The pharmaceutical group Sanofi has appealed this first decision.
(and with agencies)
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