Bayer Moves Court Against J&J Over Misleading Advertising on Cancer Drug Erleada

In a complaint filed in Manhattan federal court, Bayer said Johnson & Johnson is causing irreparable ‌harm through ⁠a campaign begun ⁠this month for the drug Erleada that threatens to erode trust in the German company's drug ​Nubeqa.

Bayer said Johnson & Johnson falsely claimed that patients treated with Erleada had a "51% reduction in ​risk of death" compared with Nubeqa patients, in testing that replicated a clinical trial and adhered to "rigorous" U.S. Food and Drug Administration standards.

According to the complaint, the two ​groups of patients were not comparable because most Nubeqa ⁠patients in ‌the comparison received their drug off-label, creating "selection bias" that makes claims of ​superiority unreliable, ​and Johnson & Johnson's study included five times more patients.

Bayer also ⁠said the FDA does not sanction the retrospective, real-world analysis that ​Johnson & Johnson allegedly used 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.

Johnson & Johnson, based in New Brunswick, New Jersey, did not immediately respond to requests for comment.

BAYER SAYS AI SPREADS JOHNSON & JOHNSON'S FALSE MESSAGE

Bayer is seeking punitive and triple damages, the recoupment of ‌ill-gotten profit, and an injunction against further false advertising.

The complaint 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.