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France: victory for the first group action in the health field (Depakene case)

France: victory for the first group action in the health field (Depakene case)

This blog was written as part of the collaboration between Aston University and BIICL.

On 5 January 2022, the first group action in the health field in France, brough in 2017 in the so-called Depakine case, resulted in a first victory before the Paris Court of Justice (Tribunal judiciaire de Paris, 5 janvier 2022, case No 17/07001).

Representing fourteen families, the French association APESAC brought a group action against the laboratory SANOFI on the basis of articles L. 1143-2 of the French Public Health Code, under which a registered association of users of the health system can bring an action to obtain compensation for individual losses suffered by users of the health system placed in a similar or identical situation and having as their common cause a failure by a producer or supplier of a pharmaceutical drug.

The association considered that the laboratory SANOFI that marketed the pharmaceutical drug Depakene in 1967 and 1987 did not allow pregnant women who were treated with Depakene to make a free and informed choice, to initiate or continue their pregnancy, even though it appeared as early as 1970 in the medical literature that the use of Depakene could lead to physical malformations and neurodevelopmental disorders in utero in the fetuses. The association argued in particular that the laboratory had committed a fault of vigilance on the basis of Article 1240 of the Civil Code and had marketed a defective product within the meaning of Articles 1245 et seq. of the Civil Code.

On 5 January 2022, the Paris Judicial Court ruled in favour of the association and held that the laboratory had not sufficiently warned and informed pregnant women of the risks of malformations and neurodevelopmental disorders caused by Depakene. The Court ruled that the laboratory's failure to comply with its obligation of reinforced vigilance and its obligation to inform about the risks of Depakene constituted a fault within the meaning of Articles 1382 and 1240 of the Civil Code.

The Court found that by not having recourse during their pregnancy to an antiepileptic treatment other than Depakene, the women and their malformed children have suffered a 95% loss of chance of being born free of any pathology. The Court thus accepted a simple presumption of causality between exposure to Depakene during pregnancy and the pathologies presented by the children and accepted compensation for the victims. The Court provided for a period of five years for interested parties to join the association to receive compensation.

The laboratory has announced it will appeal the decision.

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