In a Law360 expert analysis, Mike Bongiorno, Tim Perla and Jessica Lewis examine how the absence of board-level FDA compliance oversight, lack of committee structure and sparse meeting documentation contributed to the court’s ruling. The case offers practical takeaways for boards and executives navigating mission-critical risks in regulated industries.
Excerpt: “While the decision in Giuliano v. Grenfell-Gardner emphasizes the high bar for Caremark liability, the ruling offers a clear reminder: To avoid litigation, boards and executives must actively monitor and document their oversight efforts when addressing their companies' mission-critical risks...The case illustrates how sustained inattention to regulatory compliance — particularly in highly regulated industries like pharmaceuticals — can trigger judicial scrutiny, even under Delaware's demanding standards. It also underscores the importance of board-level engagement, committee structure, and meeting documentation in demonstrating good faith oversight and avoiding personal liability.”