In United States v. Marschall, --- F.4th ---, No. 22-30048 (9th Cir. 2023), the Court affirmed Richard Marschall’s conviction under the Federal Food, Drug, and Cosmetic Act (“FDCA”) for shipping misbranded drugs in interstate commerce in violation of 21 U.S.C. §§ 331(a) and 333(a)(2).
On appeal, Marschall argued that the district court erred in concluding that the charged offense did not require proof that he knew that the drugs he shipped were misbranded.
The Court rejected this argument, concluding there was no mens rea requirement:
[W]e conclude that this is the unusual case in which a public welfare offense lacks a scienter element even though it is a felony with moderately severe potential penalties. In short, (1) Congress augmented, into a felony, a predicate misdemeanor offense that concededly lacks a scienter requirement; (2) it did so by adding, not a scienter requirement, but a prior conviction requirement; (3) this action contrasts with Congress’s explicit addition of a scienter requirement in the other clause of § 333(a)(2); and (4) the prior conviction requirement, as a functional matter, largely serves the same purposes as an express scienter requirement. Under this confluence of circumstances, we conclude that the first clause of § 333(a)(2) does not require the Government to prove that the defendant knew that the drugs were misbranded. Accordingly, the indictment here did not need to allege that Marschall knew that the labeling of the “Dynamic Duo” rendered those products misbranded in the respects described in the indictment. The district court therefore properly denied Marschall’s motion to dismiss the indictment.
