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Opinion Issued in Stem Cell Clinic FDCA Suit

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An opinion was filed on Tuesday by the Central District of California in a suit initially brought by the federal government against defendant California Stem Cell Treatment Center, Inc. (CSCTC).

The action was filed by the United States on behalf of the Food and Drug Administration (FDA) and sought to permanently enjoin the defendant from performing stem cell treatment on patients, alleging that they violated the Federal Food, Drug, and Cosmetic Act (FDCA). Three of the defendant’s stromal vascular stem cell treatments are purported to violate the FDCA because they cause the adulteration of drugs, the misbranding of drugs, and cause patients to receive drugs that are misbranded, the opinion recounts.

The procedures offered by the defendant are the SVF Surgical Procedure, the Expanded MSC Surgical Procedure, and the SVF/ACAM2000 Treatment. Each of the procedures/treatments involve extracting cells from a patient and administering those cells back to the same patient after putting them through cellular processing. The plaintiff argues that when these cells are returned to the patient, they should be considered a drug and can then be regulated under the FDCA.

According to the opinion, ACAM2000, which is needed for the SVF/ACAM2000 Treatment, is controlled exclusively by the government and not publicly available. Vials of ACAM2000 were confiscated from the University of California San Diego in 2017, meaning that the defendant has not performed the treatment since then.

The government argued in the suit that the defendant had produced drugs under the FDCA by extracting cells from a patient’s body and reintroducing them after putting them through cellular processing. The defendant countered that they were merely conducting surgery and that the surgery was not something that could be regulated by the FDCA.

The Court concluded that the defendant’s SVF Surgical Procedure and Expanded MSC Procedure were not considered “drugs” under the FDCA, but their SVF/ACAM2000 treatment did involve the creation of drugs. Since the former two procedures are not drugs according to the Court, they are not subject to the rules from the FDCA.

Regarding the SVF Surgical Procedure and the Expanded MSC Surgical Procedure, the opinion detailed that the defendant’s doctors “may lawfully use FDA-cleared medical devices and FDA-approved pharmaceuticals in any manner that they determine is best to care for and treat their patients.” Since they determined that neither procedure constitutes the production of drugs, the plaintiff’s claims fail.

While the court determined that the SVF/ACAM2000 Treatment did constitute the manufacture of a drug, the plaintiff failed to establish standing in which it could pursue injunctive relief because the defendant has not performed the treatment since 2017.

The opinion was issued on Tuesday by Judge Jesus G. Bernal. Defendant California Stem Cell Treatment Center, Inc. was represented in the litigation by Jones Day, Willkie Farr & Gallagher, and Venable.

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