Bayer accuses Johnson & Johnson of false advertising over Erleada’s death risk claims, seeking damages and an injunction to stop the campaign.
NEW YORK: Bayer has filed a lawsuit against Johnson & Johnson, alleging the pharmaceutical giant falsely advertised that its prostate cancer drug Erleada cuts the risk of death by half compared to Bayer’s rival treatment, Nubeqa.
The complaint, filed in Manhattan federal court, states J&J’s new marketing campaign is causing irreparable harm and threatening to erode trust in Nubeqa. Bayer contends J&J falsely claimed patients had a “51% reduction in risk of death” using Erleada in a real-world analysis.
The German drugmaker argues the patient groups were not comparable, rendering claims of superiority unreliable. It states most Nubeqa patients received their drugs off-label, creating “irremediable selection bias,” and that J&J’s study included five times more patients.
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Bayer also said the FDA does not sanction J&J’s retrospective 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.
The company is seeking punitive and triple damages, the recoupment of profit, and an injunction against further alleged false advertising. Johnson & Johnson defended its testing and marketing in response to the litigation.
“Litigation does not change data,” a company spokesperson said. “Our analysis was designed to meet rigorous guidance on real-world evidence, and this legal action demonstrates Bayer’s obvious misunderstanding of methodological frameworks.”
Bayer further claimed artificial intelligence is amplifying J&J’s false claims. It cited a Google search regarding the drugs and risk of death as feeding people “unsubstantiated messages about the risk of dying with Nubeqa.”
According to the National Cancer Institute, about 313,780 men were diagnosed with prostate cancer in the United States in 2025, with 35,770 deaths. Nubeqa sales totaled about 1.63 billion euros in the first nine months of 2025.
Erleada sales totaled USD 2.62 billion over approximately the same period. Full-year sales of Erleada totaled USD 3.57 billion.
