Claims Can Still Be Preempted If the Drug Is Later Withdrawn

Litigation attorney Eric Alexander published a blog for Drug & Device Law discussing Cosey v. Global Blood Therapeutics Inc., a decision from the U.S. District Court for the Northern District of Illinois holding that prescription drug claims may remain preempted even after a manufacturer voluntarily withdraws a product from the market. The case involved a sickle cell disease treatment that was withdrawn after post-marketing data raised concerns about an increased risk of vaso-occlusive crises (VOCs). The court dismissed the plaintiff's design defect claim because any alternative design would have required U.S. Food and Drug Administration (FDA) approval and rejected the failure to warn claims because they failed to identify newly acquired information that would have supported a unilateral label change under the FDA's Changes Being Effected (CBE) regulation. Eric concludes the decision reinforces that preemption turns on the manufacturer's ability to act at the time of the alleged injury, not on a subsequent product withdrawal.

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