The United States filed civil complaints in Florida and California to enjoin two companies that purport to offer stem cell treatments, the Justice Department announced today.
The first complaint, filed May 9, 2018, in the Southern District of Florida, is against US Stem Cell Clinic LLC, of Sunrise, Florida, US Stem Cell, Inc., and company officers Kristin Comella and Theodore Gradel. A separate complaint was filed the same day in the Central District of California against California Stem Cell Treatment Center Inc., of Rancho Mirage and Beverly Hills, California, Cell Surgical Network Corporation, and company owners Elliot Lander, M.D. and Mark Berman, M.D.
Both complaints allege that the respective defendants manufacture “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments for a host of serious conditions and diseases, including cancer, pulmonary disease, arthritis, stroke, ALS, and multiple sclerosis, in the case of the California defendants; and Parkinson’s disease, spinal cord injuries, stroke, pulmonary disease, and traumatic brain injury, in the case of the Florida defendants. According to the complaints, both sets of defendants manufacture their products for these conditions without FDA approval and without proof of safety and efficacy. The Justice Department filed the complaints at the request of the U.S. Food and Drug Administration (FDA).
“Marketing unproven and potentially unsafe treatments puts consumers at risk,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with the FDA to make sure manufacturers of experimental therapies conduct their research within the safe and legal bounds for drug innovation.”
According to the complaints, the defendants and their affiliates have used their products on thousands of patients without first obtaining necessary FDA approvals. The complaints allege that that in some cases, adverse events that harmed patients occurred after treatment with the SVF products. In addition, the complaints allege that the defendants’ misbranded products fail to include adequate directions for use, such as dosages, warnings, and side effects. According to the complaints, recent FDA inspections showed that the defendants’ products are not manufactured, processed, packed, or held in conformance with current good manufacturing practice (CGMP), and they are adulterated as a matter of law.
“The Food, Drug, and Cosmetic Act is designed to protect the public health,” said U.S. Attorney Benjamin G. Greenberg for the Southern District of Florida. “This civil lawsuit reflects the ongoing efforts of the U.S. Attorney’s Offices to safeguard the public from potential harm caused by adulterated and misbranded drugs. Those individuals and corporations that fail to conform with FDA standards are subject to civil enforcement actions.”
The Florida matter is being handled by Trial Attorney Roger J. Gural of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant U.S. Attorney James A. Weinkle of the U.S. Attorney’s Office for the Southern District of Florida and Associate Chief Counsel for Enforcement Michael Helbing of the U.S. Department of Health and Human Services’ Office of General Counsel.
The California matter is being handled by Trial Attorney Natalie N. Sanders of the Civil Division’s Consumer Protection Branch, with the assistance of the U.S. Attorney’s Office for the Central District of California and Associate Chief Counsel for Enforcement Michael Shane of the U.S. Department of Health and Human Services’ Office of General Counsel.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Florida, visit its website at https://www.justice.gov/usao-sdfl. For more information about the U.S. Attorney’s Office for the Central District of California, visit its website at https://www.justice.gov/usao-cdca.
