Spotlight On:
State Enforcement of Regulations
States are toughening their stance on medical spas and physicians not adhering to regulations concerning the use of lasers and light-emitting devices in such facilities. Recent developments in two state boards in the Midwest demonstrate that non-compliance with state regulations risks sanctions, litigation and monetary penalties.
Earlier this month, the Iowa Board of Medicine sanctioned Anthony Colby, M.D., medical director of three American Laser Center sites in Iowa, for lacking appropriate training and experience to supervise individuals performing medical aesthetic services and for failure to provide adequate supervision to those who performed such procedures. In addition to a reprimand and a $5000 fine, Dr. Colby has been prohibited from serving as medical director and/or supervising individuals who perform medical aesthetic services at any medical spa in the future. A cease and desist order was also issued for the West Des Moines office of American Laser Center for performing medical services without proper physician oversight. A Board of Medicine investigation concluded that non-physicians performed examinations, diagnosed medical conditions, offered treatment recommendations and performed medical procedures, including the use of lasers for treatment of hyperpigmentation and cellulite removal.
Last December, Ilinois Attorney General Lisa Madigan filed suit against Nu U Med Spas, claiming the company used deceptive marketing and that its unapproved practices caused some patients to experience extreme pain and lasting injuries. The company promoted Lipodissolve, an injected therapy used to dissolve fat cells, but failed to inform consumers that its treatments had not been approved by the U.S. Food and Drug Administration as safe and effective. In addition Nu U was injecting clients without a doctor's order, a direct violation of Illinois state law.
Madigan's lawsuit charged Nu U with violating the Illinois Food, Drug and Cosmetic Act, the Illinois Medical Practice Act and the Illinois Consumer Fraud and Deceptive Business Practices Act. It asked the court to permanently enjoin the defendants from owning or operating medical or beauty clinics in Illinois and to order the company to pay civil penalties of $50,000, an additional $50,000 penalty for each violation committed with the intent to defraud, an additional $10,000 penalty for each violation committed against a senior citizen 65 years of age or older, and the costs associated with the investigation and prosecution of the lawsuit.
Both of these cases demonstrate that states are taking action against those who violate the law. Providers should strive to ensure their practices are in compliance with their state statuatory requirements. Contact LILIS if you have questions or would like assistance in obtaining copies of the pertinent state regulations and professional boards' recommendations. |
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