Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 448

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 448
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. The actions are held in several jurisdictions around the country. In 2021, there were two bellwether trials as part of a federal multi-district litigation in the Eastern District of Louisiana both resulting in jury verdicts in Sanofi's favor. Throughout 2024, Sanofi entered into a number of settlement agreements or agreements in principle with many plaintiffs’ firms encompassing nearly all the remaining cases. These agreements, still a work in progress, require the consent of the individual plaintiffs and will take some time to conclude, in order to ensure that certain threshold participation requirements are met. At the end of the settlement process, Sanofi expects approximately 100 plaintiffs to opt out of the settlement and litigation will continue. It is not possible, at this stage, to assess with certainty the outcome of these lawsuits.

| SANOFIFORM 20-F2024 | F-83 |

| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |

Zantac Litigation in the US In September 2019, the US Food and Drug Administration (FDA) announced it was investigating the claims of an online pharmacy’s Citizen Petition that the medication Zantac (the brand name for ranitidine) used for stomach heartburn contains or can generate the chemical N-Nitrosodimethylamine (NDMA), an alleged human carcinogen. As a precautionary measure, Sanofi initiated a voluntary recall of branded over-the-counter Zantac in October 2019. Concurrent with the FDA investigation, multiple personal injury lawsuits and class actions alleging that Zantac causes various cancers and seeking damages for either alleged personal injuries or alleged economic injuries were filed. Federal court cases were coordinated into a Multi-Districts Litigation (MDL) in the Southern District of Florida in February 2020. On December 6, 2022, the MDL Court granted Sanofi and other defendants’ Daubert and summary judgment motions. As a result, the Court entered final judgment in all cases involving plaintiffs’ five designated cancers and dismissed the class action cases. Based on the preliminary estimates, more than 12,000 plaintiffs have filed notices to appeal the Daubert ruling in the Eleventh Circuit. The MDL Court subsequently dismissed all pending cases alleging a non-designated cancer for failure to serve expert reports. Other cases are pending in various state courts. The majority of the state court plaintiffs have cases pending in Delaware, where a hearing on defendants’ Daubert motions to exclude plaintiffs’ experts took place in January 2024. In