United States v. Regenerative Sciences, LLC
878 F. Supp. 2d 248
D.D.C.2012Background
- Drs. Centeno and Schultz co-own a clinic in Colorado and developed the Regenexx™ Procedure using patient-derived mesenchymal stem cells; Regenerative Sciences LLC owns the Regenexx™ Procedure and licenses clinic use; Michelle Cheever is Laboratory Director; FDA enforcement action accuses adulteration and misbranding under the FFDCA; Defendants argue the Regenexx™ Procedure is intrastate medical practice not subject to federal regulation; the court concludes the procedure has interstate commerce nexus and is a drug/biological product regulated by FDA; the court grants summary judgment to FDA and issues a permanent injunction.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Regenexx™ is a drug under the FFDCA | Regenexx™ is a drug/biological product due to its intended use and composition | Regenexx™ is intrastate medical practice not a drug | Yes, Regenexx™ is a drug/biological product subject to FDA regulation |
| Interstate commerce nexus under the FFDCA | Cell product is shipped in interstate commerce or contains interstate components | Process is intrastate | Interstate commerce nexus exists; regulation applies |
| CGMP compliance and adulteration | _regenerative cell product fails CGMP; adulteration under 21 U.S.C. § 351(a)(2)(B) | Dispute over applicability of CGMP to autologous stem cell therapy | Yes, CGMP violations render product adulterated |
| Misbranding of the cultured cell product | Labeling lacked Rx symbol and adequate directions; product misbranded | Prescription-drug exemptions apply; product is part of medical practice | Misbranding; Rx symbol and labeling deficiencies establish violation |
| Practice of medicine vs. FDA regulation | FDA regulation is limited by boundaries of medical practice | Regulation of medical practice excludes FDA oversight | FDA regulation extends to Regenexx™ because it is a drug with interstate nexus |
Key Cases Cited
- United States v. Walsh, 331 U.S. 432 (1947) (requires interstate nexus for regulation of adulterated/misbranded drugs)
- United States v. Sullivan, 332 U.S. 689 (1948) (expands interpretation of interstate drug regulation scope)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (limits federal preemption/policy balance for medical devices and regulation)
- Thomas Jefferson Univ. v. Shalala, 512 U.S. 504 (1994) (regulatory deference to agency scientific determinations)
- United States v. Evers, 643 F.2d 1043 (5th Cir. 1981) (held-for-sale and interstate commerce concepts apply to practitioner-held drugs)
- CareToLive v. von Eschenbach, 525 F. Supp. 2d 952 (S.D. Ohio 2007) (biologic/drug regulation overlap with FDA authority)
- United States v. Writers & Research, Inc., 113 F.3d 8 (2d Cir. 1997) (statutory interpretation of drug labeling/intended use under FDCA)
- Estee Lauder, Inc. v. FDA, 727 F. Supp. 1 (D.D.C. 1989) (determines how intended use guides drug classification)