Company: PRGO
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001585364-25-000122
Chunk: 43

Company: PERRIGO Co plc
Filing Date: 2025-08-06
Form: 10-Q
Item: Item 1
Chunk 43
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 as well as explore various means of expeditiously resolving these claims. Trials for these cases are currently scheduled throughout 2025 and 2026. There are currently over 70 trials set for these cases in the remainder of 2025. We expect that a substantial majority of these trial dates will be postponed. Two cases are currently set for trial in Alameda County, California in September 2025. It is expected that trials for these two cases begin in September or October 2025.RanitidineAfter regulatory bodies announced worldwide that ranitidine may potentially contain N-nitrosodimethylamine ("NDMA"), the Company promptly began testing its externally sourced ranitidine Active Pharmaceutical Ingredients ("API") and ranitidine-based products. On October 8, 2019, the Company halted shipments of the product based upon preliminary results and on October 23, 2019, the Company made the decision to conduct a voluntary retail market withdrawal. In February 2020, the resulting actions involving Zantac® and other ranitidine products were transferred for coordinated pretrial proceedings to a MDL (In re Zantac®/Ranitidine Products Liability Litigation, MDL No. 2924) in the U.S. District Court for the Southern District of Florida. The Company successfully moved to dismiss the first set of Master Complaints in the MDL based on federal preemption, which the Court granted without prejudice.After the filing of Amended Complaints, on June 30, 2021, the Court again dismissed all claims against the retail and distributor defendants with prejudice and on July 8, 2021, the Court again dismissed all claims against the Company, this time with prejudice. Appeals of these dismissal orders to the U.S. Court of Appeals for the 11th Circuit have been filed. In December 2022, the Court granted in full the brand defendants' Daubert motions, finding that Plaintiffs' causation experts' opinions were unreliable and thus inadmissible. The Court later ruled that it was appropriate to apply the same expert causation standards to the retail and distributor defendants as well as the generic defendants, and the Court thereby ruled that its Daubert decision, barring Plaintiffs' expert opinions applied equally to these defendants as well. Thus, the Court's rulings on both federal preemption and scientific causation grounds dismissed all claims against the Company on two independent grounds and are also binding on all claims remaining in the MDL Census Registry. Appeals of these orders have