the State “responsible for part of the damage suffered”, according to justice

Since January 6, the Medicines Agency (ANSM) has tightened the prescription conditions for valporate-based drugs, such as Dépakine, used in cases of epilepsy. From now on, only neurologists, psychiatrists and pediatricians will be able to prescribe, for the first time, these treatments to adolescents and men likely to have children. On the other hand, renewal can be done by any doctor. Another method: each year, a certificate of shared information, which now also replaces the care agreement form for girls, must be signed by the patient and their doctor. In order to obtain anti-epileptic drugs in a pharmacy, this must be presented in addition to the prescription.

Pregnancy: malformations and neurodevelopmental disorders linked to taking Dékapine

By more closely regulating the prescription of medications for epilepsy, the health authority wants to better protect patients and their babies, because taking these treatments during pregnancy is linked to malformations and neurodevelopmental disorders for unborn children. “The malformations most often encountered are anomalies of the neural tube (opening of the spinal column), a malformation of the face such as a cleft of the upper lip and palate, a malformation of the skull, anomalies of the heart, a malformation of the penis involving the urinary opening (hypospadias) and abnormalities in the fingers”, can we read in a press release from the ANSM. This is why these anti-epileptics are contraindicated in pregnant women and those of childbearing age.

“For children born between 1999 and 2009, the State must partially repair the consequences of insufficient information”

This January 14, the Paris administrative court of appeal ruled on the Dépakine health scandal, carried by the whistleblower Marine Martin, which is marketed by the Sanofi laboratory. She judges that in “by not modifying the marketing authorization for Dépakine so that patients are sufficiently informed of the risks for the fetus, the agency responsible for the safety of the drug failed in its obligations and committed an error giving rise to liability of the State (…) For children born between 1999 and 2009, the State must partially repair the consequences of the insufficient information given to doctors and patients. on the risks of malformations for the fetus or developmental disorders in the children of women treated during pregnancy.

According to the details of the instance, “insufficient information is not the direct cause of the problems experienced by children”, but the latter has “resulting, for mothers, in a loss of chance of making the decision to change treatment, when such a possibility existed, or to abandon a pregnancy. (…) The State is, however, only responsible for one part of the damage suffered”, indicated the court, which considers that “mistakes” committed by the laboratory or by the prescribing doctors “are likely to exempt the State from all or part of the obligation to repair the damage suffered by the children and their relatives.” However, the latter “does not accept the fault of the laboratory which had unsuccessfully proposed modifications to the information contained in the documents, for pregnancies carried out in 2006, 2008 and 2009.” She doesn’t hold back either, “except in special cases, due to doctors’ fault.”