STORY FROM: Drugs & Medical Devices

Design Defect, Failure-To-Warn Claims in Jardiance Case Not Preempted, Ind. Federal Judge Rules

INDIANAPOLIS — An Indiana federal judge has allowed failure-to-warn and design defect claims to proceed against Boehringer Ingelheim in a Jardiance action, finding they are not preempted because Boehringer did not show that the FDA would have rejected any proposed changes to the label.

However, in the Sept. 7 opinion, Judge Sarah E. Baker of the U.S. District Court for the Southern District of Indiana dismissed the claims against defendant Eli Lilly & Co., finding they are preempted because Lilly is not the Jardiance New Drug Application holder and thus could not unilaterally make changes to the drug’s label.

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