Recently, Bayer Healthcare (hereinafter referred to as “Bayer”) filed a lawsuit in the U.S. District Court for the Southern District of New York against Johnson & Johnson (hereinafter referred to as “Johnson & Johnson”) and its subsidiary Janssen Biotech. In the lawsuit, Bayer alleges that Johnson & Johnson engaged in false advertising using research data that does not meet FDA standards. Bayer is seeking an immediate court order to halt the relevant advertising and is pursuing damages.

On February 23, 2026, Bayer filed a complaint with the U.S. District Court for the Southern District of New York, seeking a preliminary injunction against Johnson & Johnson to prevent the continued dissemination of what it claims is misleading advertising. Specifically, Bayer challenges Johnson & Johnson's assertion that “prostate cancer patients treated with Johnson & Johnson's Erleada experience a 51% lower risk of death compared to those treated with Bayer's Nubeqa.” Bayer contends that Johnson & Johnson's purported “real-world head-to-head analysis” suffers from severe methodological flaws, rendering the baseline conditions of the two patient groups incomparable.

According to court filings, Erleada received approval in 2019, while Nubeqa was approved for combination therapy in 2020. Bayer stated that Nubeqa achieved sales of $1.81 billion (approximately RMB 12.4 billion) in the first three quarters of 2025 amid intense market competition. Johnson & Johnson launched an advertising campaign in February 2026 claiming Erleada reduced the risk of death by 51% compared to Nubeqa over 24 months. Bayer points out that at least 60% of patients in this analysis began treatment too late to meet the 24-month follow-up period.

Bayer contends that the study period occurred almost entirely before Nubeqa's approved indications. During this period, physicians used Bayer's drug off-label to treat prostate cancer when standard therapies failed. The complaint alleges this implies many Bayer patients had more advanced disease, rendering them incomparable to Johnson & Johnson's patient cohort. Such claims not only eroded physician and patient confidence in Nubeqa but may have caused irreversible long-term damage to prescription patterns.

Johnson & Johnson responded that its analysis followed regulatory guidelines for real-world evidence, maintaining the data's scientific integrity. The company asserted that Bayer's lawsuit demonstrates a misunderstanding of the methodological framework. J&J stated, “The lawsuit does not change the data,” and upheld the validity of its research findings.

Scan the QR code to access the complaint.