Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 454

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 454
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, liabilities were retained against the State, the healthcare professionals and Sanofi, notably for discrepancy between the SmPC (Summary of the Product Characteristics) and the patient leaflet. In other cases involving births in 2005-2008, the State was held liable both for malformations and neurodevelopmental disorders but partially exonerated, taking into account the roles of healthcare practitioners and Sanofi. Given that the French affiliate was not a party to these administrative proceedings, its arguments (including several requests from the French affiliate to the Health Authorities to reinforce warnings to healthcare professionals and patients in relation to Depakine) were not considered. All rulings were appealed by the claimants. Sanofi has filed requests for voluntary intervention in these proceedings to present its arguments before the Administrative Court of Appeal, which has been granted for some of them. In one proceeding, the claimants decided to withdraw their claims. In January 2025, the Paris Administrative Court of Appeal handed down five rulings. In cases concerning births in 2006 onwards, the Court retained the State’s liability and no fault from Sanofi due to the reiterated variation requests of the medicine’s information documents. In a case concerning births in 1999 and 2002, the Court retained the State’s liability with a 50% liability retained for Sanofi. It i s not possible, at this stage, to make a reliable assessment of the outcome of these cases. Depakine Product Litigation in other EU countries, in the UK and Switzerland In Switzerland, eleven families have filed a civil claim for damages concerning seventeen people exposed in utero. Some of them also involve the claimants’ physicians. In November 2022, one action was declared time-barred by the judge. The claimant appealed this court decision on the merit. In November 2024, the court confirmed the first instance judgment. The claimant appealed against this court decision to the Federal Tribunal (last Instance). In Spain, there are seven ongoing actions relating to fifteen children. In March 2022, in one trial, the Court ordered Sanofi to indemnify four patients. Sanofi appealed this decision. In January 2023, in another trial filed by one patient, the Appeal Court confirmed the first instance's decision and dismissed the claim. As of December 2024, two actions are pending in front of the Supreme Court and five are at the first instance stage. In Belgium, there are two civil proceedings (currently on hold) and a criminal complaint against X and against Sanofi. In