STORY FROM: Drugs & Medical Devices

11th Cir. Upholds Verdict Issued in Favor of Cook in Biliary Stent Action

ATLANTA — A federal appeals court has upheld a judgment issued in favor of Cook Inc. in a case involving the “off-label” use of its biliary stent, ruling that the trial court properly barred the plaintiff from introducing clinical trial evidence on rebuttal and a post-procedure warning label, holding that such evidence was irrelevant.

On Nov. 23, the 11th Circuit U.S. Court of Appeals further held that the evidence presented at trial overwhelmingly supported the jury’s verdict.

The plaintiff filed the action in the U.S. District Court for the Southern District of Florida on behalf of his deceased mother, Margaret ...

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