In early June 2019, the Southern District of Florida granted the U.S. government’s motion for summary judgment against US Stem Cell Clinic LLC of Weston, Florida, US Stem Cell Inc. of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D., holding that the defendants had adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
The U.S. government had filed a civil action against US Stem Cell Clinic LLC, US Stem Cell Inc., and Comella in May 2018, seeking a permanent injunction to stop the defendants’ illegal behavior after several attempts to provide the clinic and the individual defendants the opportunity to work with the agency to come into compliance with FDA regulations and protect patients from harm.
The FDA initially raised concerns about US Stem Cell in a warning letter issued in 2017 for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, following an FDA inspection of the facility that found that the company was administering its product intravenously or via other methods of administration to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. The FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use.
The clinic was also cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections. Following these steps, a U.S. court previously entered a consent decree of permanent injunction agreed to by the FDA and defendant Theodore Gradel, a former manager of US Stem Cell LLC that requires Mr. Gradel to notify the FDA if he intends to re-enter the biologics industry and to comply with any corrective actions ordered by the FDA.
The Acting FDA Commissioner Ned Sharpless, M.D. stated in announcing the injunction, “Cell-based regenerative medicine holds significant medical opportunity, but those in this field who do not operate in compliance with the law can potentially cause serious harm to patients. We support sound, scientific research and regulation of cell-based regenerative medicine. The FDA has advanced a comprehensive policy framework to promote the development and approval of regenerative medicine products. But at the same time, the FDA will continue to take action—such as issuing warning letters or initiating court cases—against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by manufacturing and promoting products in ways that make them drugs under the law, but which have not been proven to be safe or effective for any use. It is our responsibility to promote and protect public health, and we take this responsibility seriously.”
The Director of the FDA’s Center for Biologics Evaluation and Research stated, “In the case against US Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients. We are committed to continuing to pursue actions against those who put patients in harm’s way by marketing unapproved stem cell products that skirt FDA’s regulations and federal law.”
If you or a loved one suffered injuries (or worse) as a result of a stem cell product in the United States, you should promptly seek the legal advice of a product liability/medical malpractice lawyer in your state who may investigate your stem cell claim for you and represent you in a claim against a stem cell company, if appropriate.
Visit our website or call us toll-free in the United States at 800-295-3959 to find stem cell lawyers in your state who may assist you.
Turn to us when you don’t know where to turn.