The U.S. Department of Justice Wednesday filed a civil complaint against two Southern California surgeons and their companies for allegedly offering unproven stem cell treatments at clinics in Rancho Mirage and Beverly Hills without government approval.
Federal prosecutors in Los Angeles are seeking a permanent injunction to stop Drs. Elliot B. Lander and Mark Berman, the California Stem Cell Treatment Center Inc. and Cell Surgical Network Corp. of Rancho Mirage from marketing stem cell products without the approval of the U.S. Food and Drug Administration.
Berman responded that the FDA has long known about his clinics’ same-day treatments, which he said have shown overwhelmingly positive results.
“We disagree with the mischaracterization that these treatments are dangerous,” Berman said. “All we’re doing is taking advantage of the cells in your own body. We’ve always been transparent with what we do.”
Berman and Lander control the operations of about 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center and Cell Surgical, which market treatments that have not been proven safe, the DOJ alleges in the complaint.
The government contends that the defendants manufacture “stromal vascular fraction” products from patients’ body fat, 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.
“Your stem cells are not a drug,” Berman said. “They’re your own property. We’re not manufacturing a drug.”
Prosecutors allege the defendants manufacture the products without Federal Drug Administration approval and without proof of safety and efficacy. The Justice Department filed the complaints at the request of the 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.”
But Berman contends that his treatments are innovative and highly successful. For example, he said, of 2,400 patients suffering from knee osteoarthritis, 82 percent have shown positive results after stem cell therapy.
According to the complaint, the defendants and their affiliates have used their products on thousands of patients without first obtaining necessary FDA approvals. In some cases, adverse events that harmed patients occurred after treatment with the products, the government alleges.
In addition, the complaint alleges that the defendants’ misbranded products fail to include adequate directions for use, such as dosages, warnings and side effects.
According to the complaint, recent FDA inspections showed that the products are not manufactured, processed, packed or held in conformance with current good manufacturing practice, and they are adulterated as a matter of law.
A similar complaint was also filed against Sunrise, Florida-based US Stem Cell Clinic LLC.