Willkie Trial Win Ends FDA Move to Regulate Stem Cell Treatment

September 8, 2022

Willkie and Jones Day obtained a complete defense verdict in the government’s lawsuit to bring stem cell procedure under FDA regulation.

On August 30, a federal judge in California issued a landmark decision on behalf of California Stem Cell Treatment Center (CSCTC) in a lawsuit brought by the U.S. Food and Drug Administration (FDA) over whether it can assert regulatory authority over the clinic’s stem cell treatment.

After a seven-day trial, Judge Jesus G. Bernal of the Central District of California ruled that that the defendants’ innovative surgical procedure that uses patients' own stem cells to treat a range of medical conditions does not fall under the FDA's regulatory jurisdiction, barring the FDA from prohibiting physicians from performing the stem cell treatment on their patients.

The ruling is significant for people seeking to utilize their own stem cells as part of medical treatment, firmly holding that the FDA lacks authority to regulate these personal stem cell treatments on the grounds that they do not qualify as “drugs” under the applicable FDA regulations.

The FDA brought the lawsuit against CSCTC, its founders Drs. Mark Berman and Elliot Lander, and their company Cell Surgical Network Corporation in 2018, in an attempt to establish regulatory authority over stem cell therapies. The agency argued that a physician's use of his 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.

In addition to holding these procedures are not “drugs”, the court found that defendants satisfied their burden of establishing that the primary stem cell procedure at issue qualifies for an exception to FDA regulation called the same surgical procedure exception (SSP Exception). The government argued that the defendants’ stromal vascular fraction (SVF) process does not qualify for the SSP Exception because tissue is removed, but only SVF stem cells are implanted back into the body. Under the government's interpretation, defendants would have to remove stem cells only, and then implant those same stem cells back into the patient to qualify for the exception. The defendants argued that the SVF process is a surgical procedure in which SVF stem cells are removed from the patient (albeit as part of the tissue removed) and that those same SVF stem cells are implanted back in the patient. The defendants argued that the SSP Exception does not contemplate whether the stem cells are modified to qualify, but regardless, the SVF stem cells are unaltered before and after the procedure. The court adopted the defendants’ interpretation.

The Willkie team was led by partner Matthew Gurvitz.