United States v. US Stem Cell Clinic, LLC

United States v. US Stem Cell Clinic, LLC

Opinion

 [*1304]  GINSBURG, [**2]  Circuit Judge:

US Stem Cell Clinic, LLC, its parent company, and its chief scientific officer (collectively, the Clinic) offer a procedure in which they remove fat tissue from a patient, isolate the portion containing stem cells, and inject that portion back into the patient. This procedure purportedly treats all manner of chronic conditions, from pain to Parkinson's disease.

The United States Food and Drug Administration is skeptical of the Clinic's claims. It sued the Clinic, alleging the stem cell procedure violates the Federal Food, Drug, and Cosmetics Act (codified at 21 U.S.C. §§ 301 et seq.). The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective. The Clinic appeals, arguing it is exempt from regulation because the procedure falls into either the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. See 21 C.F.R. § 1271.15(b); id. § 1271.10. We disagree: The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second exception because the Clinic intends the stem [**3]  cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. We therefore affirm the judgment of the district court.

I. Background

] Since 2001 the FDA has regulated human cells, tissues, and cellular and tissue-based products or "HCT/Ps," which the FDA defines as "articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient," 21 C.F.R. § 1271.3(d), under both the FDCA and the Public Health Service Act (codified at 42 U.S.C. §§ 201 et seq.). See Human Cells, Tissues, and Cellular and Tissue-Based Products, Establishment Registration and Listing, 66 Fed. Reg. 5447, 5447-69 (Jan. 19, 2001) (codified at 21 C.F.R. § 1271) [hereinafter Final Rule]. ] The FDA has three goals in regulating HCT/Ps:

1) preventing unwitting use of contaminated tissues with the potential for transmitting infectious diseases such as AIDS and hepatitis; 2) preventing improper [*1305]  handling or processing that might contaminate or damage tissues; [and] 3) ensuring that clinical safety and effectiveness is demonstrated for tissues that are highly processed, are used for other than their normal function, are combined with non-tissue components, or are used for metabolic purposes.

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