Judge Rules That Actos Warning Claims Can Move Forward

A judge in the U.S. District Court for the Western District of Louisiana denied Takeda Pharmaceuticals’ request to dismiss claims that it failed to warn patients taking the Type 2 diabetes drug.  Despite Actos’ link to bladder cancer, the drug company failed to warn patients using Actos of the danger.

As of January 15, court records indicated that there are 2,692 Actos cases pending in the Multidistrict Litigation (MDL).

Takeda argued that “failure to warn” claims are preempted by federal law because the U.S. Food and Drug Administration (FDA) worked closely with the manufacturer in the labeling of Actos, and the police powers of FDA preempt any claim of state laws.

However, in its ruling, the court disagreed, stating, “The defendants appear to misunderstand their federal labeling-law duties as they might relate to preemption.” It also cited a Supreme Court case, Wyeth v. Levine, which said a central premise of federal drug regulation is that the manufacturer bears responsibility for the content of its label at all times.

Takeda could and should have put stronger warning language in the Actos label to warn patients of the danger of bladder cancer. The mere fact that the FDA approved the submitted label language does not excuse Takeda from responsibility.

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Zoll, Kranz & Borgess, LLC – Actos attorneys

Source: http://www.lawd.uscourts.gov/sites/default/files/UPLOADS/11-md-2299.010714.MSJ%20%28preemption%29%20Mem%20Ruling.pdf