Overview
- Bayer filed the complaint in the Southern District of New York after J&J promoted Erleada with a claimed 51% reduction in risk of death versus Nubeqa based on a retrospective real-world analysis.
- Bayer contends the methodology was unreliable, citing non-comparable cohorts with roughly five times more Erleada patients, widespread off-label Nubeqa use during most of the analysis period, and curtailed follow-up because most patients started therapy after June 2023.
- The suit seeks an injunction to stop the campaign, punitive and triple damages, and recoupment of profits.
- Johnson & Johnson defends the findings, saying the analysis was designed in line with regulatory standards for real-world evidence and calling the lawsuit a misunderstanding of those frameworks.
- The complaint also alleges that search and AI tools, including Google results, are amplifying disputed messages about mortality risk with Nubeqa.