Month: February 2025

Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson[1] 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 a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices approved for one-time use.

Daniel Grooms, Andrew Goldstein, Zach Hafer, Sonia Nath, Matt Nguyen, Son Nguyen, Jim Santel