California Stem Cell obtains complete defense ruling in FDA enforcement action

Client(s) California Stem Cell Treatment Center, Inc.

Jones Day obtained a full defense ruling in an FDA enforcement action, defeating the FDA's efforts to obtain an injunction to prohibit our client's surgical procedure.

Founded in 2010 by Drs. Lander and Berman, California Stem Cell has delivered personal stem cell therapies to more than 14,000 patients. In 2018, the FDA brought an enforcement action, arguing that their cutting edge treatment was the unlawful manufacture of a drug and attempted to assert regulatory authority over stem cell therapies. The agency argued that a physician's use of her patient's own stem cells as part of the medical treatment provided to the patient was equivalent to manufacturing a biological drug product and therefore subject to regulation by the FDA.

After a two-week bench trial, the court rejected this argument, ruling that the surgical procedure does not create a new drug and that the cells themselves are not drugs. The court wrote: "The adipose tissue Defendants remove from patients clearly consists of human cells. And whatever is injected back into patients as part of Defendants' SVF Surgical Procedure and Expanded MSC Surgical Procedure certainly contains such cells." The decision concluded that the FDA overreached its authority and the treatments were not drug-manufacturing, but rather medical procedures. This ruling recognizes a person's ability to utilize their own stem cells as part of medical treatment, when the procedure is performed by a licensed physician. It further affirmed that the FDA cannot use guidance documents to circumvent legislative or administrative process to modify existing, unambiguous regulations.

United States of America v. California Stem Cell Treatment Center, Inc. et al, No. 5-18-cv-01005 (C.D. Cal.)