STORY FROM: Drugs & Medical Devices

Jury Should Decide ‘Clear Evidence’ Issue in Januvia Action, Ill. App. Court Rules

CHICAGO — A jury should resolve the question of whether Merck presented “clear evidence” that the FDA would not have permitted it to include a warning concerning pancreatic cancer in Januvia’s labeling, an Illinois appellate court has ruled.

In a Dec. 26 opinion, the Illinois Appellate Court, 1st District, explained that Merck is not seeking review of an actual rejection by the FDA of an attempt to add the warning, but rather it has asked the court “to extrapolate from other evidence whether it is clear what the FDA’s action or decision would have been if Merck had attempted to ...

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