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.