Thousands joined together to bring a class action case against French drug company Sanofi for allegedly not warning expectant mothers of the adverse side-effects of taking the epilepsy drug Depakine/Depakote. French newspaper Le Canard Enchaine reported that over 10,000 pregnant women were given this drug between 2007 and 2014, and it’s suspected that around 450 children may have been born with congenital defects due to exposure of the drug whilst in the womb.
Epilepsy drugs have been in focus in the news recently, and when it comes to birth defect claims, it’s always a very serious matter indeed.
Warnings about potential problems
The Depakote drug is an anticonvulsant that contains sodium valproate. In Safoni’s own Product Characteristic file on Depakote, there is apparently an entire section dedicated to pregnancy. Section 4.6 titled Pregnancy and Lactation apparently reportedly said: ‘this medicine should not be used during pregnancy and in women of child-bearing potential unless clearly necessary’.
It seems clear that when there is a warning saying something ‘should not be used‘, extreme caution must be taken if you are to go ahead anyway. The next line warns women of ‘child-bearing potential‘ who use the drug to use contraception to stop them from getting pregnant whilst on the drug.
Section 4.6.1 reportedly speaks about the risks associated with valproate which is contained in the drug. Valproate had been tested in animals and humans, both with evidence of deformation of foetuses. For humans, there were malformations of:
- Neural tubes defects
- Cranial facial defects
- Limbs
- Cardiovascular
- Hypospadias
- Multiple anomalies involving various body systems
It’s safe to say that, with the data Sanofi had, they must have known there was a much higher rate of malformations in foetuses. The number of malformations was reportedly higher in cases of multiple drug therapy.
Allegations of insufficient warnings
The group action, headed by the French Association of People, based their claim mainly on Sanofi’s alleged negligence for allegedly insufficiently warning expectant mothers of the exact risks of taking Depakote. Within the drug profile, it contained warnings that the drug should only be used if absolutely necessary, and even so, expectant mothers or women of child-bearing potential should be given counselling advice.
“Women of child-bearing potential should be informed of the risks and benefits of the use of Depakote during pregnancy. Specialist advice is required and physicians are strongly encouraged to discuss reproductive issues with their patients before Depakote is prescribed for the first time.”
For the prescribers of the medicine, it may be just a simple error; but for the families and the affected children, the impact is lifelong.
This was thought to be the first group class action to be brought in the health sector in France. Using this method, all 2,900 families can bring all their evidence into one joint case. Although the Sanofi is based in France, they are present here in the U.K.
If anyone here in the U.K. may have been affected by this, please get in touch with our team.
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