Judge Rejects Bayer’s Injunction Against Johnson & Johnson

Bayer Sues Johnson & Johnson Over Prostate Cancer Drug Advertising Claims On February 23, 2026, Bayer filed a false advertising lawsuit against Johnson & Johnson (J&J) in the United States District Court for the Southern District of Latest York, alleging that J&J launched a misleading promotional campaign for its prostate cancer drug Erleada (apalutamide) that unfairly disparaged Bayer’s competing drug Nubeqa (darolutamide). [2] The lawsuit centers on a real-world evidence analysis J&J released on February 2, 2026, which compared overall survival rates after 24 months in patients with metastatic castration-sensitive prostate cancer treated with either Erleada or darolutamide without chemotherapy docetaxel. According to J&J’s press release, the analysis showed a 51% reduction in risk of death for patients initially treated with Erleada compared to those who received Nubeqa, with approximately 92% of the 1,460 Erleada patients still alive at 24 months versus just under 86% of the 287 Nubeqa patients. [1] Bayer contends that the analysis is scientifically flawed and misinforms healthcare providers and patients. The company argues that most Nubeqa patients in the comparison received the drug off-label, introducing selection bias that undermines the validity of the conclusions. Bayer also asserts that the U.S. Food and Drug Administration (FDA) did not vet J&J’s retrospective, real-world analysis as a substitute for traditional clinical trials, and that invoking FDA authority to lend credibility to the study misleads the public. [4] In response to Bayer’s request for an injunction to halt J&J’s advertising campaign, U.S. District Judge Dale Ho in Manhattan ruled on Friday night that Bayer did not demonstrate a likelihood of success on the merits of its claims. The judge found that J&J’s communications accurately reflected the study’s conclusions and that Bayer failed to identify methodological errors so substantial as to render the claims materially false or misleading. Judge Ho stated that the methodological choices made by the study’s authors were not errant or out of step within the relevant scientific community. [3] Despite the dismissal of the injunction request, Bayer maintains that the full body of evidence supports its false advertising claims and intends to pursue the case on its merits. A Bayer spokeswoman said the company looks forward to the court’s determination. Johnson & Johnson characterized the decision as “a win for scientific exchange and a strong win for patients.” [3] The legal dispute highlights ongoing tensions in the competitive prostate cancer treatment market, where both Erleada and Nubeqa are used as hormonal therapies for metastatic castration-sensitive prostate cancer. Bayer is seeking punitive and triple damages, recovery of ill-gotten profits, and a permanent injunction against further false advertising. The complaint also notes that artificial intelligence—evident in Google searches related to Erleada, Nubeqa, and mortality risk—is amplifying the contested claims and disseminating unsubstantiated messages about the risks associated with Nubeqa. [4] As of the filing date, neither company has commented further on the litigation beyond their initial statements. The case continues to proceed in federal court, with both parties preparing for arguments on the substantive merits of the false advertising allegations. [2]