The Federal Trade Commission (“FTC”) recently settled a case against a physician and his two clinics over allegedly deceptive and unsubstantiated claims relating to their “amniotic stem cell therapy.” The physician, Dr. Bryn Jarald Henderson, frequently appeared in his companies’ advertisements and claimed that this therapy, which purported to use stem cells derived from amniotic fluid, could treat diseases such as Parkinson’s disease, autism, macular degeneration, cerebral palsy, and multiple sclerosis. The proposed settlement order imposed a $3.31 million judgment, which will be partially suspended after the defendants pay $525,000 to the FTC for refunds to harmed consumers, and a broad injunctive order. The order prohibits unsubstantiated claims relating not only to amniotic stem cell therapies, but also to several other therapies not included in the complaint, such as therapies using stem cells derived from adipose tissue, bone marrow, umbilical cord blood, and peripheral blood. In addition, unsubstantiated claims relating to food, dietary supplements, drugs, and medical devices are covered.
According to the FTC’s complaint, “[t]here are no human clinical studies in the scientific literature showing that amniotic stem cell therapy cures, treats, or mitigates diseases or health conditions in humans, and the medical community considers amniotic stem cell therapy to be an experimental and unproven treatment.” Despite this, Dr. Henderson’s clinics charged patients between $9,500 and $15,000 for initial stem cell injections and $5,000 to $8,000 for follow-up “booster” procedures. The clinics’ marketing materials included claims such as: “Lives are being saved, the blind see, the crippled walk . . . with a single therapy that lasts for years and impacts their lives NOW”; “[w]e can reverse autism symptoms”; “[t]hese macular degeneration stem cell treatments have been shown to improve sight in patients with macular degeneration”; and “[y]es, we can treat Parkinson’s.” The FTC alleged that Dr. Henderson could not substantiate these claims.
This isn’t the FTC’s first settlement in the medical space this year. Just last month, the FTC settled its complaint against iV Bars, alleging that the company lacked substantiation for its claims regarding the efficacy of its intravenously injected therapy products (“iV Cocktails”) in treating cancer, multiple sclerosis, and congestive heart failure. Earlier this year, the FTC settled its complaint against CellMark, alleging that the company deceptively advertised its products as effective treatments for cancer patients’ malnutrition and treatment-related cognitive dysfunction. The FTC appears to remain focused on health claims of all types and also to be following the marketing of new or innovative treatment modalities. Folks involved in advertising health care services would be wise to remember that an ounce of prevention is worth a pound of cure. In other words, talk to a lawyer before making aggressive health claims.