After almost two years, the US Food and Drug Administration (FDA) has won its appeal in a stem cell lawsuit in California brought by the FDA against the California Stem Cell Treatment Center (CSCTC), which was brought to the Court of Appeals for the Ninth Circuit.
In August 2022, federal judge Judge Jesus Bernal of the central district of California, entered a judgment in favour of the defendants, CSCTC, in a decision concluding that the medical procedure using patients' stem cells to treat different diseases and medical conditions at the CSCTC does not fall within the FDA's authority (see BioNews 1160).
The significance of the appeal court's decision is that it reaffirms the FDA's authority over bogus stem cell treatments.
In recent years, unscrupulous stem cell clinics have emerged in various countries, promoting cures to treat multiple conditions such as Parkinson's disease and spinal cord injury or disorder. Some proffer therapies that the federal health regulatory bodies, such as the FDA, have not approved. The only currently approved treatments are the blood-forming stem cells used to treat some types of cancers and blood disorders (see BioNews 1251, 1220 and 1216).
Some unproven stem cell therapies have been shown to be ineffective. Moreover, some patients have suffered adverse effects such as infection, blindness and even death after receiving the so-called medical procedures. Unregulated stem cell therapies at CSCTC's clinics can cost $8900 for a single treatment, or $41,500 for a 12 treatment option. Furthermore, they are not covered by insurance; thus, the patients pay out of pocket.
The CSCTC stem cell lawsuit dates back to 2018 when the FDA took legal action against the clinic after inspecting their two clinics in Beverly Hills and Rancho Mirage. Patients were able to have a procedure at the clinic where their fat tissue was removed to create a mixture of cells called a stromal vascular fraction (SVF), these cells were then injected back into the patient to treat a specific body location, such as the knees, in the treatment of osteoarthritis.
In August 2022, Judge Bernal decided that the clinics' SVF surgical procedure was not a 'drug', as per the definition of the Federal Food, Drug, and Cosmetic Act (FDCA). Thus, they were not subject to the Act's adulteration and misbranding sections. Moreover, the court also held that the clinics' SVF procedure qualified for the same surgical procedure exception.
The concern was that the ruling was inconsistent with a previous judgment on an identical case in Florida, which was approved by the 11th Circuit. The court in Florida granted a summary judgment against the defendants, US Stem Cell Clinic, who appealed the decision. Even so, the court still ruled in favour of the FDA, with the defendant losing the appeal.
The contradictory rulings in these cases were unsettling as they raised questions about the FDA's power to control these unscrupulous clinics. The worry was that if the ninth Circuit were to uphold the district court's ruling, the circuit split could undermine the FDA's authority to scrutinise these clinics.
Fortunately, the FDA timely appealed in 2022. The three-judge appeal panel unanimously reversed the district court's judgment, with the court rejecting the defendant's arguments. The bench held that the defendant's SVF constitutes a drug under the FDCA based on the plain language of the legislation. The judges examined the word 'drug' under the Act. Furthermore, the appeal court referred to precedents such as the United States v Regenerative Sciences, where the court held that based on the plain text of the FDCA, they were obliged to conclude that the stem cell mixture was a drug under the legislation.
Next, the panel rejected the defendant's argument that even if SVF is a drug, the same-day SVF treatment for patients is exempt from the FDA's oversight under the same surgical procedure exception. The exemption applies to an establishment that removes human cells or tissues from a patient and implants them into the same patient in the same surgical procedure. The court stated that this regulation is ambiguous.
Where there is ambiguity, the court will attempt to resolve it by carefully considering the Act's text, structure, history and purpose. Two panel members determined the uncertainty in the FDA's favour because the SVF process removes fat tissue but implants SVF. The third judge stated that the court defers to the FDA's interpretation of the surgical procedure exception (Auer deference).
As a federal regulatory authority, the FDA ensures that drugs are safe and effective. It regulates human cells, tissues and cellular and tissue-based products. In recent years, the FDA has become concerned about stem cell businesses that promote stem cell therapies as cures for various diseases and conditions without scientific evidence to back the safety and efficacy of medical procedures. The FDA created governance to regulate regenerative medicine products and cellular therapies in 2017. It also intends to increase its enforcement measures of cellular therapies.
Indeed, this great news is a vital legal triumph for the FDA. The appellate court's ruling strengthens the FDA's authority over the stem cell industry. Dodgy stem cell clinics will likely decline in the USA. However, whether the defendant might appeal this decision to the nation's Supreme Court, the highest court, remains to be seen... and if they win, we'll be back to square one.
However, Professor Hank Greely, professor of law at Stanford University, California, doesn't think that will happen. He told me: 'Recent US Supreme Court decisions have made this a time of great uncertainty for American administrative agencies, including the FDA. The Ninth Circuit decision creates a solid front in favour of FDA jurisdiction among the two appellate courts that have considered the question. Although nothing is impossible, I think it is unlikely that the Supreme Court will hear an appeal of this case and, therefore, the FDA will have clearer legal power to protect the safety of patients in stem cell clinics. (How forcefully it will use that power remains to be seen!).'
Leave a Reply
You must be logged in to post a comment.