Hickey v. Hospira, No. 23-30323 (5th Cir. 2024)
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The case involves four plaintiffs who took docetaxel, a chemotherapy drug, as part of their treatment for early-stage breast cancer and subsequently suffered permanent chemotherapy-induced alopecia (PCIA). The plaintiffs allege that the manufacturers of the drug, Hospira, Inc., Hospira Worldwide, LLC, and Accord Healthcare, Inc., violated state law by failing to warn them that docetaxel could cause PCIA.
The case was initially heard in the United States District Court for the Eastern District of Louisiana, where the defendants moved for summary judgment on the basis that the plaintiffs' state law failure-to-warn claims were preempted by federal law. The district court denied the motion, and the defendants appealed.
The United States Court of Appeals for the Fifth Circuit was tasked with determining whether federal law preempts the plaintiffs' state law failure-to-warn claims against the defendant drug manufacturers. The court found that the district court had erred in its interpretation of what constitutes "newly acquired information" under the changes-being-effected (CBE) regulation, which allows manufacturers to file a supplemental application with the FDA and simultaneously implement a labeling change before obtaining FDA approval. The court held that the district court failed to enforce the requirement that newly acquired information must "reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA."
The court vacated the district court's judgment on the plaintiffs' failure-to-warn claims and remanded the case for further consideration of one outstanding issue: whether the Bertrand Abstract, a scientific study, constituted "newly acquired information" that revealed a greater risk of PCIA than previously known. If the Bertrand Abstract does not meet this standard, the court held that the defendants would not be liable to the plaintiffs on their state law failure-to-warn claims.
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