Three young people affected by the aftermath derived from drug use Depakine by their mothers during pregnancy will be indemnified with amounts ranging from €600,000 to €1,300,000.
This is stated in the ruling of the Court of First Instance number 91 of Madrid last Thursday, March 17, and in which condemns the insurer of the pharmaceutical company Sanofi to compensate three boys for the damages suffered by valproic acid when they were gestated, as reported by those responsible for the Association of Victims of Valproic Acid Syndrome (Avisav), who have been represented by lawyer Ignacio Martínez.
The first lawsuit in Spain against the pharmaceutical company Sanofi was presented in April 2019, when four families affected by serious sequelae due to the consumption of the drug Depakine during pregnancy denounced the company, which they accused of “information deficit” of an antiepileptic marketed by the company and to which they attribute malformations and autism in children whose mothers took it during pregnancy.
In this case, the sentence sentences to compensate three of the four affected that they denounced, since the court considers that one of the cases has prescribed.
The drug, whose active ingredient is sodium valproate, is indicated for the treatment of epilepsy and bipolar disorder and has been marketed since 1980, but until 2015 the pharmaceutical company did not warn of contraindications in pregnancy, despite the fact that there were studies that confirmed the relationship with malformations in children, according to the lawyer who has represented these families and who in turn handles cases such as that of thalidomide and works as a lawyer of the Patient Ombudsman in Murcia.
All cases of minors with sequelae have been diagnosed in the Pediatric Environmental Health Unit of the Virgen de la Arrixaca Hospital Murcia by the team led by Dr. Juan Antonio Ortega.
This specialist indicated a few months ago to La Opinion that so far the Arrixaca has diagnosed 25 minors with damage caused by Depakine.
The Asociation Notify me states that the teratogenic effects of Depakine have been known since 1980, when it was described that intrauterine exposure to valproate caused impaired neural tube closure (spina bifida) in children. “Subsequently, different scientific publications confirmed that it produced connatal malformations compatible with a characteristic phenotype called fetal valproate syndrome characterized by facial dysmorphia, congenital anomalies, developmental delayespecially in language and communication, and various disorders compatible with an autism spectrum”, they point out.
Those affected indicate that “After many years of struggle, now, for the first time, this judgment considers the causal relationship between Depakine and damages to the boys, and also strongly asserts Sanofi’s fault.”
In 2018, when the scandal broke of the effects this drug had on fetusesfrom the Ministry of Health of the Region of Murcia it was confirmed that half a thousand pregnant women from Murcia were taking the prohibited drug for pregnant women.
According Notify medespite the information that was offered about the risks of the drug, the pharmacist Sanofi chose to continue marketing, without immediately communicating such studies to the health authority (no evidence has been provided in this regard); “Thus choosing the maintenance of their benefits over the health security of patients and their descendants.”
In the sentence it is detailed that “it is completely evident that by acting in this way the Sanofi company deprived the prescribing doctors and the consumers of the possibility of knowing that sodium valproate caused birth defects in more than 10% of children of women who took such medication, cognitive development problems in 30-40% of these childrena risk of suffering autism spectrum disorders three times higher than normal and five times in the case of childhood autismas we have already shown.
Therefore, prescribing physicians were deprived of the possibility of substituting valproate by another antiepileptic that entailed less risks, when there were any”.