Stem cell decisions
Stem cell decisions include this growing list:
- United States v. US Stem Cell Clinic, Ltd. Liab. Co., 998 F.3d 1302, 1304 (11th Cir. 2021) ("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 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.")
- United States v. Cal. Stem Cell Treatment Ctr., No. EDCV 18-1005 JGB (KKx), 2022 U.S. Dist. LEXIS 156714 (C.D. Cal. Aug. 30, 2022) (ruling against the FDA in its attempt to stop stem cell treatments at a clinic in California).
- United States v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784, 793, 798 (1969) (“the word ‘drug’ [in the FDCA] “is a term of art for the purposes of the Act” and is broader than “the strict medical definition of that word”; “Congress fully intended that the Act’s coverage be as broad as its literal language indicates.”)
- United States v. Kaplan, 836 F.3d 1199, 1208-11 (9th Cir. 2016) (“The FDCA is to be interpreted broadly in order to protect public health.”; the Ninth Circuit ruled that a drug is “held for sale” not only when possessed by retailers and wholesalers and retailers, but also when possessed by healthcare professionals for their use in their practice)
- Kisor v. Wilkie, 139 S. Ct. 2400 (2019) (relied on by government)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 351 n.5, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001) (Congress rejected, in its authorization of the FDA, "any intent to directly regulate the practice of medicine.") - relied on by opponents of the FDA.
- United States v. Regenerative Scis., LLC, 741 F.3d 1314, 1319 (D.C. Cir. 2014) (1319 (explaining that “[n]otwithstanding” defendants’ “attempt to characterize this case as an effort by the FDA to ‘restrict[] the use of an autologous stem cell procedure’ the focus of the FDA’s regulation is the Mixture” (cleaned up).
An emerging concept of major questions doctrine should rein in FDA over-regulation in this field.
Additional decisions cited by the federal govt to expand FDA power
United States v. Evers, 643 F.2d 1043 (5th Cir. 1981) (expanding FDA authority despite its incursion on the practice of medicine)
United States v. 9/1 Kg. Containers, 854 F.2d 173 (7th Cir. 1988) (expanding FDA authority despite its incursion on the practice of medicine)
Auer v. Robbins, 519 U.S. 452 (1997)
Baker v. United States, 932 F.2d 813 (9th Cir. 1991)
Bax v. Doctors Med. Ctr. of Modesto, Inc., 52 F.4th 858 (9th Cir. 2022)
Bowles v. Seminole Rock & Sand Co., 325 U.S. 410 (1945)
Christopher v. SmithKline Beecham Corp., 567 U.S. 142 (2012)
Love v. Marriott Hotel Servs., Inc., 40 F.4th 1043 (9th Cir. 2022)
Massachusetts v. EPA, 549 U.S. 497, 531 (2007) (relied on govt to expand regulatory power)
Mountain Cmtys. for Fire Safety v. Elliott, 25 F.4th 667 (9th Cir. 2022)
Safari Club Int’l v. Haaland, 31 F.4th 1157 (9th Cir. 2022)
Skidmore v. Swift & Co., 323 U.S. 134 (1944)
Tanzin v. Tanvir, 141 S. Ct. 486 (2020)
Thomas Jefferson Univ. v. Shalala, 512 U.S. 504 (1994)
United States v. Dotterweich, 320 U.S. 277 (1943)
United States v. First City Nat’l Bank of Hous., 386 U.S. 361 (1967)
