Three defendants who marketed and sold light-emitting medical devices as a cure-all to consumers more than $16 million, primarily targeting the elderly, were sentenced to federal prison.
Robert “Larry” Lytle, 83, of Rapid City, who was the leader and organizer of the scheme, was sentenced to twelve years in federal prison, followed by two years of supervised release.
Ronald D. Weir Jr., 39, of Sioux Falls, was sentenced to 24 months in federal prison, followed by three years of supervised release.
Irina Kossovskaia, 63, a Canadian resident, was sentenced to 15 months in federal prison, followed by two years of supervised release.
Lytle pleaded guilty on January 26, 2018, to 1 count of conspiracy to introduce misbranded devices into interstate commerce with the intent to deceive and mislead, and 1 count of criminal contempt. As part of his plea, Lytle admitted that beginning in 2005 he entered into an agreement with others to sell medical devices with false and misleading labeling to deceive customers and that he continued to do in violation of a court order.
Lytle also acknowledged that he obtained at least $16,669,015 over the course of the scheme. He made an initial restitution payment of $637,000 and had turned over several thousand dollars worths of gold and silver coins to be applied to restitution.
Irina Kossovskaia and Ronald D. Weir Jr. previously pleaded guilty for their roles in the fraud scheme. The U.S. government agreed to dismiss criminal contempt charges against a fourth conspirator, Fredretta Eason.
Lytle and his associates including Kossovskaia and Weir (who operated QLaser distribution) marketed and distributed QLaser devices to consumers across the U.S. by falsely claiming that the medical devices could safely and efficiently treat a panoply of medical conditions at home, including cancer, emphysema, diabetes, autism, HIV, and heart disease.
Lytle created false and misleading product labeling that was designed to create the false impression that these claims had been scientifically proven. In truth, no published clinical or scientific studies supported the use of QLaser devices to treat those and other serious conditions, and the U.S. Food and Drug Administration never approved the medical devices for such purposes. To lend credibility and authority to his claims, the potential QLaser purchasers were told: “Dr. Lytle” was a retired dentist and medical laser expert while omitting the fact that his licenses to practice dentistry had been permanently revoked for engaging in fraud and material deception.
Lytle and his accomplices forged ahead with the fraud even after a federal court ordered them to stop selling and refund all QLaser purchasers in a series of injunctions issued in 2015. In violation of the injunctions, he made false statements to the federal court and FDA investigators.
He sent collection letters to QLaser purchasers rather than pay them court-ordered restitution, smuggled hundreds of medical devices out of South Dakota to New York to prevent their seizure, and received a steady stream of income from continued QLaser sales made by Weir and Kossovskaia.