Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.
We regularly cite to Buckman in our preemption arguments for support that Congress intended the FDCA to be enforced exclusively by the federal government. But this point is critical in defending against product liability plaintiffs who attempt private enforcement of the FDCA through negligence per se. Only statutes that the legislature (Congress, in the case of the FDCA) intended to be privately enforced can give rise to negligence per se. That’s why we make sure to include cases like K-V Pharmaceutical Co. v. FDA on our blog. While not a products liability case, it’s another decision that illustrates that Congress intended that the FDA be the exclusive enforcer of the FDCA and strengthens the argument that plaintiffs cannot create a private right of action via a back-door negligence per se claim. For a more thorough discussion of the defenses to negligence per se claims, including legislative intent, we direct you to our post here.