The U.S. District Court for the Eastern District of Virginia is the latest court to weigh in on the continuing debate surrounding the scope of the Federal Anti-Kickback Statute (AKS) as it applies to patient assistance programs (PAPs). In a lengthy opinion issued in January 2024, the court endorsed the broad interpretation advanced by the government, expressing little sympathy for the legal or policy arguments advanced by the plaintiffs, a coalition of pharmaceutical manufacturers. The coalition has indicated it will appeal the case to the Fourth Circuit.

Class certification is the most important moment of any putative class action. Before class certification, the defendant’s exposure beyond the individual claim is still theoretical rather than concrete. But certification of a class allows a single plaintiff (or a small group of plaintiffs) to formally pursue the claims of numerous absent individuals, which raises the stakes for defendants. This article will explain basic strategies defendants should consider in class certification briefing.