STORY FROM: Drugs & Medical Devices

Warning, Design Defect Claims in Eliquis Action Preempted, N.Y. Federal Judge Rules

NEW YORK — Failure-to-warn claims asserted in an Eliquis injury action are preempted by the Food, Drug and Cosmetic Act because they are not based on any information “known or scientifically knowable” at the time of manufacture and distribution that might constitute “newly acquired information” under the Changes Being Effected regulation, a New York federal judge has ruled.

On Dec. 23, Judge Denise Cote of the U.S. District Court for the Southern District of New York further ruled that the plaintiffs’ design defect claims are preempted to the extent plaintiffs suggest that defendants should never have sold the FDA-approved formulation ...

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