Stem Cell Treatment- Findings of Fact and Conclusions of Law

Recently there was a statutory injunction proceeding involving the U.S. Food and Drug Administration (“FDA”). The United States, on behalf of the FDA, seeks to permanently prohibit Defendants California Stem Cell Treatment Center, Inc., Cell Surgical Network Corporation, and Drs. Elliot B. Lander, M.D., and Mark Berman, M.D., from performing various stem cell treatments on patients. In this injunction, the United States alleges that three of the Defendants' treatments violate United States Code. The Defendants' stromal vascular stem cell treatments allegedly violate:

• 21 U.S.C. § 331(k) by causing the adulteration of drugs;
• 21 U.S.C. § 331(k) by causing the misbranding of drugs; and
• 21 U.S.C. § 331(c) by receiving drugs that are misbranded.

Due to the circumstances of the ongoing COVID-19 pandemic, the United States appeared to the Court through videoconference. On May 4, 5, 6, 7, 11, 12 and 13 of 2021, this case was tried. On August 20, 2021, oral closing arguments were presented. At these closing arguments, the Court ordered supplemental briefing, which was submitted by both sides on August 27, 2021, and September 1, 2021. (“Pl’s Supp Br.,” Dkt. No. 179; “Defs Supp Br.,” Dkt. No. 178; “Pl’s Supp Opp.,” Dkt. No. 181; “Defs Supp Opp.,” Dkt. No. 180.)

The Court, having considered all the evidence presented by the parties, the written submissions from both sides, and the argument of counsel, issues the following Findings of Fact and Conclusions of Law.