Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more
On June 21, 2022, the Supreme Court agreed to review a US Court of Appeals for the Third Circuit decision holding that the federal government’s ability to dismiss False Claims Act (FCA) lawsuits is controlled by Federal Rule...more
On December 9, 2021, one of the nation’s top healthcare prosecutors made clear that clinical trial fraud will be a major enforcement priority of President Joe Biden’s Department of Justice. Speaking at the Food and Drug Law...more
Overview Last week, the #2 official at the Department of Justice announced significant new measures intended to strengthen the DOJ’s response to criminal corporate misconduct. In an address to the ABA’s National Institute on...more