Judge Jennifer Sung, who was nominated by President Biden to the Ninth Circuit court of appeals, wrote a key segment of an opinion that reversed a lower court and upheld the authority of the FDA to regulate stem cell clinics. A lower court ruled that such clinics fall within an exception to the FDA’s authority, but all three judges on the panel disagreed. Judge Sung wrote a part of the opinion that ruled that the content and structure of the exception made this conclusion clear, which was joined by Judge Kim Wardlaw; Judge Michelle Friedland concurred because she thought the FDA should receive deference on what she claimed was an ambiguous provision. The September 2024 decision was in United States v California Stem Cell Treatment Center Inc.
What is this case about?
Stem cell clinics have “popped up” in California and elsewhere in recent years, claiming they can provide cures for arthritis, Alzheimer’s, and other conditions. Some, however, offer treatments that have not been approved by the FDA, and a lower court decision found that they fell under an exemption to the FDA’s regulatory framework. The FDA appealed this decision to the Ninth Circuit.
Why is the decision by Judge Sung and the Ninth Circuit important?
All three judges on the appeals court panel found that the lower court was wrong and that the FDA has the authority to regulate the stem cell clinics and their treatment. Based on a careful review of the record, the statute, and applicable precedent, they concluded that the stem cell mixture used by the clinics constitutes a “drug” subject to FDA regulation. They also rejected the claim that it is exempt from FDA regulation under the “same surgical procedure” exception, which applies when human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) are removed and then re-implanted in the same individual during the same surgical procedure. Judge Sung explained that because the removed HCT/P is fat tissue that is not specifically targeted for re-implantation, the exception does not apply. The court thus reversed the decision below and sent the case back to the lower court to proceed with the FDA’s efforts to regulate the stem cell treatment.
The opinion by Judge Sung and the other judges is obviously important to uphold the FDA’s regulatory authority of stem cell treatment. Unproven and unregulated stem cell therapies, experts have stated, have led to “infections, disabilities, and even death.” This decision will help FDA keep patients healthy and safe around the country. In addition, the ruling serves as a reminder of the importance of promptly confirming fair-minded judges to our federal courts.