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.
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