Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 451

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 451
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 during that time. As of December 31, 2024, there were approximately 700 ongoing product liability actions. To date, no cases have proceeded to trial. It is not possible, at this stage, to assess with certainty the outcome of these lawsuits. Depakine Product Litigation in France Civil proceedings As of December 31, 2024 , 79 families had brought a civil claim involving 133 people exposed in utero to sodium valproate against a French affiliate of Sanofi seeking indemnification under French law for personal injuries allegedly suffered by children in connection with the use of sodium valproate (Depakine) by their mothers during pregnancy to treat their epilepsy. These actions are being held in several jurisdictions in France. Forty lawsuits are in progress on the merits, the most advanced of which was tried at the level of the French Supreme Court, which in November 2019 issued a ruling sending the case before the Paris Appeal Court to rule on Sanofi’s argument on the compliance of the product with mandatory regulations, as well as on the question of defectiveness of the product and the assessment of damages. In January 2023, the Paris Appeal Court ordered a stay in the proceedings until the submission of the second expert opinion report as part of the criminal investigation (see below). Seven first instance rulings on the merits were handed down in 2022 by the Judicial Tribunal of Nanterre. In three cases, the Court declared the judicial expert report null and void and the Court dismissed one claim in another case. Concerning three other cases relating to births that occurred between 2005 and 2009, the Court held, on the basis of a non- fault liability, that Sanofi was liable in light of the wording of the patient information leaflet. Provisional compensation amounts were set in the range of € 0.1million to € 0.5million . To date, four first instance cases have ruled in favour of plaintiffs and two first instance rulings excluded Sanofi’s liability. All the judgments have been appealed and are still pending. In the class action lawsuit filed in May 2017 by the APESAC (Association des Parents d’Enfants souffrant du Syndrome de l’Anti- Convulsivant) against the French affiliate, the Judicial Tribunal of Paris ruled on January 5, 2022 that a class is admissible, retaining Sanofi’s liability between 1984 and January 2006 for malformations and between 2001 and January 2006 for