STORY FROM: Drugs & Medical Devices

Negligent Failure-To-Warn Claims to Proceed in Ky. Prozac Birth Defect Action

LEXINGTON, Ky. — A Kentucky federal judge has allowed claims of negligent failure-to-warn to proceed against Eli Lilly & Co. in a Prozac birth defect case, finding a lack of evidence that federal law barred the drug maker from warning consumers of the risks of taking the drug while pregnant.

However, in an Aug. 23 order, Judge Karen K. Caldwell of the U.S. District Court for the Eastern District of Kentucky held that the plaintiff’s design defect claims are preempted because Lilly could not legally change Prozac’s chemical makeup without FDA approval.

The judge also dismissed without prejudice the fraudulent ...

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