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Fifth Circuit Preemption Win Draws National Attention

June 3, 2024

Firm News

Fifth Circuit Preemption Win Draws National Attention

June 3, 2024

On May 24, the U.S. Court of Appeals for the Fifth Circuit issued a published opinion vacating a summary judgment denial issued by the U.S. District Court for the Eastern District of Louisiana, which oversees the In re: Taxotere (Docetaxel) Products Liability Litigation. The decision clarifies the drug labeling regulations applicable to manufacturers of drugs approved under the Food, Drug and Cosmetic Act’s § 505(b)(2) approval pathway and addresses when failure-to-warn claims alleged against such manufacturers may be preempted by federal law due to the absence of “newly acquired information” as defined in 21 C.F.R. § 314.3(b).

The Fifth Circuit is the first federal appellate court to address these issues and the decision has received national coverage from publications such as Law360 – including Legal Lions of the Week recognition – and the Drug & Device Law blog. Mike Ruttinger, Julie Callsen, and Chad Eggspuehler represented Defendant-Appellant Accord Healthcare, Inc. in the appeal.

The decision, Hickey v. Hospira, Incorporated, appears below.

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