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RAPID CITY, S.D. (AP) — A federal judge has barred a Rapid City man and his company from manufacturing and distributing laser devices that were marketed as being able to treat more than 200 different diseases and medical disorders.
U.S. District Chief Court Judge Jeffrey Viken filed a preliminary injunction this week against Dr. Robert "Larry" Lytle, QLasers PMA and several associated companies.
In October, the U.S. Department of Justice and the U.S. Attorney's Office in South Dakota filed a civil complaint against Lytle and his businesses, alleging that they'd violated the federal Food, Drug and Cosmetic Act by nationally marketing their lasers and their effects without approval from the U.S. Food and Drug Administration.
In the complaint, the agencies allege Lytle and his companies have been distributing approximately 12 devices that are marketed as low-level laser devices for home use. The Department of Justice said the devices have "labeling that contains false and misleading claims, touting their use in treating such serious conditions as cancer, HIV/AIDS, venereal disease and diabetes."
Lytle, who is representing himself, could not be reached at a number listed at his home in Rapid City. A message left at the QLaser offices in Rapid City was not immediately returned on Saturday.
Lytle, 80, has previously told the Rapid City Journal that his companies are private membership associations and do not do business with the public. He said the FDA refuses to recognize that it doesn't have the authority to regulate such associations.
"That is the crux of (the) argument between myself and the FDA," Lytle told the newspaper. "We don't do business with the general public."
But Viken said, "Hiding behind a curtain of private membership associations ... does not shield Mr. Lytle from the authority of the FDCA or the jurisdiction of the court."
"The injunction bars the defendants from continuing to market and distribute any medical devices until they receive written permission from the FDA to do so," Viken added.
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