Opinion ID: 172805
Heading Depth: 1
Heading Rank: 5

Heading: The DAB Reasonably Affirmed the Money Penalties Assessed Against Dr. Christensen

Text: Dr. Christensen argues that only the manufacturer of the devices, not an individual, may be subject to money penalties under 21 U.S.C. § 333(f). This contention is not supported by the clear language of the governing statutes. Section 333(f) states that any person who violates a requirement of this chapter which relates to devices shall be liable to the United States for a civil penalty. Section 321(e) defines person to include an individual, partnership, corporation, and association. Moreover, in analogous circumstances, the Supreme Court has explicitly held that corporate officers may be liable for violations of the Food, Drug, and Cosmetic Act. See United States v. Park, 421 U.S. 658, 95 S.Ct. 1903, 44 L.Ed.2d 489 (1975); United States v. Dotterweich, 320 U.S. 277, 64 S.Ct. 134, 88 L.Ed. 48 (1943). While Dr. Christensen attempts to distinguish these cases because they involved criminal prosecutions rather than civil money penalties, the rationale for holding corporate officers criminally responsible for acts of the corporation, which could lead to incarceration, is even more persuasive where only civil liability is involved, which at most would result in a monetary penalty. United States v. Hodges X-Ray, Inc., 759 F.2d 557, 561 (6th Cir.1985). Accordingly, [t]he fact that a corporate officer could be subjected to criminal punishment upon a showing of a responsible relationship to the acts of a corporation that violate health and safety statutes renders civil liability appropriate as well. Id. Therefore, the DAB's similar conclusion was reasonable. We also reject Dr. Christensen's argument that § 333(f) should be interpreted to exclude individuals with extensive medical backgrounds who act as a manufacturer's expert under 21 C.F.R. § 803.20(c)(2). Such an interpretation is not founded in the letter or purpose of § 333(f). Therefore, the DAB reasonably affirmed the assessment of monetary penalties against Dr. Christensen.