Bayer has sued Johnson & Johnson, accusing the drugmaker of falsely advertising that its prostate cancer drug Erleada cuts the risk of death in half compared to Bayer’s Nubeqa.
In a complaint filed in Manhattan federal court, Bayer has said that Johnson & Johnson’s new campaign for Erleada has caused irreparable harm and threatened to erode trust in Nubeqa, as per media reports.
The German drugmaker has alleged that Johnson & Johnson falsely claimed patients experienced a “51% reduction in risk of death” if treated with Erleada instead of Nubeqa, based on testing that replicated a clinical trial and adhered to what it described as “rigorous” U.S. Food and Drug Administration standards.
Bayer has argued that the patients in the comparison were not comparable because most Nubeqa patients received their drugs off-label, creating what it called “irremediable selection bias” that made claims of superiority unreliable. It has also said Johnson & Johnson’s study included five times more patients. According to the complaint, the FDA does not sanction Johnson & Johnson’s retrospective, real-world analysis as a substitute for traditional clinical trials.
The lawsuit has sought punitive and triple damages, recoupment of alleged ill-gotten profits, and an injunction to prevent further false advertising.
Johnson & Johnson, based in New Brunswick, New Jersey, has defended its testing and marketing. A company spokesperson said in an email, “Litigation does not change data. Our analysis was designed to meet rigorous guidance on real-world evidence, and this legal action demonstrates Bayer’s obvious misunderstanding of methodological frameworks and real-world evidence principles.”
Bayer has also said that artificial intelligence, reflected in a Google search regarding Erleada, Nubeqa and risk of death, has amplified Johnson & Johnson’s alleged false claims and fed people “unsubstantiated messages about the risk of dying with Nubeqa.”
About 313,780 men were diagnosed with prostate cancer in the United States in 2025, and 35,770 died from the disease that year, according to the National Cancer Institute.
Nubeqa sales have totaled about 1.63 billion euros ($1.92 billion) in the first nine months of 2025, while Erleada sales have totaled $2.62 billion over approximately the same period. Full-year sales of Erleada have totaled $3.57 billion.
