By Jonathan Stempel
NEW YORK, Feb 23 (Reuters) – Bayer sued Johnson & Johnson on Monday, accusing the drugmaker of falsely advertising that its rival multibillion-dollar drug cuts the risk of death from prostate cancer in half.
In a complaint filed in Manhattan federal court, Bayer said Johnson & Johnson’s new campaign for its drug Erleada is causing irreparable harm and threatening to erode trust in the own drug Nubeqa.
Bayer said Johnson & Johnson falsely claimed that patients had a “51% reduction in risk of death” if treated with Erleada instead of Nubeqa, in testing that replicated a clinical trial and adhered to “rigorous” U.S. Food and Drug Administration standards.
The German drugmaker said the patients were not comparable because most Nubeqa patients received their drugs off-label, creating “irremediable selection bias” that made claims of superiority unreliable, and Johnson & Johnson’s study included five times more patients.
Bayer also said the FDA does not sanction Johnson & Johnson’s retrospective, real-world analysis as a substitute for traditional clinical trials.
“By invoking FDA authority to lend unwarranted credibility to scientifically flawed analyses, J&J has misled patients and healthcare providers,” the complaint said.
Bayer is seeking punitive and triple damages, the recoupment of ill-gotten profit, and an injunction against further false advertising.
J&J DEFENDS MARKETING, BAYER SAYS AI SPREADS FALSE MESSAGE
Johnson & Johnson, based in New Brunswick, New Jersey, defended its testing and marketing.
“Litigation does not change data,” a company spokesperson said in an email. “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 also said artificial intelligence – reflected in a Google search regarding Erleada, Nubeqa and risk of death – is amplifying Johnson & Johnson’s false claims, and feeding 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 totaled about 1.63 billion euros ($1.92 billion) in the first nine months of 2025, while Erleada sales totaled $2.62 billion over approximately the same period. Full-year sales of Erleada totaled $3.57 billion.
(Reporting by Jonathan Stempel in New York; Additional reporting by Friederike Heine in Berlin; Editing by Tomasz Janowski, Chizu Nomiyama and Matthew Lewis)
Comments