Trio Marketed Laser Devices to Elderly Consumers as Cure-All

Three defendants who marketed and sold light-emitting medical devices as a cure-all to consumers, primarily targeting the elderly, were sentenced on April 20, 2018 by a federal judge in Rapid City, South Dakota.

Robert “Larry” Lytle, 83, of Rapid City, who was the leader and organizer of the scheme, was sentenced to 12 years in prison, followed by 2 years of supervised release. Ronald D. Weir Jr., 39, of Sioux Falls was sentenced to 24 months in prison, followed by 3 years of supervised release. Irina Kossovskaia, 63, a Canadian resident, was sentenced to 15 months in prison, followed by 2 years of supervised release. U.S. District Judge Roberto A. Lange will issue a final restitution order within 90 days.

Lytle pleaded guilty on January 26, 2018, in the District of South Dakota to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead, and one count of criminal contempt. As part of his plea agreement, Lytle admitted that beginning in 2005 he entered into an agreement with others to sell medical devices with false and misleading labeling in order to defraud consumers, and that he continued to do so in violation of a federal court order. He also acknowledged that he obtained at least $16,669,015 over the course of the scheme. Lytle made an initial restitution payment of $637,000 and has turned over several thousand dollars’ worth 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. The government agreed to dismiss criminal contempt charges against a fourth individual, Fredretta Eason.

Lytle and his co-conspirators including Kossovskaia and Weir (who operated QLaser distributorships) marketed and distributed QLaser devices to (mostly elderly) consumers across the United States by falsely claiming that the devices could safely and effectively 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 (FDA) never approved the devices for such uses. 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 license to practice dentistry had been permanently revoked for engaging in fraud and material deception.

Lytle and his co-conspirators 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, Lytle made false statements to the court and FDA investigators, sent collection letters to QLaser purchasers rather than pay them court-ordered restitution, smuggled hundreds devices out of South Dakota to upstate New York to prevent their seizure, and received a steady stream of income from continued QLaser sales made by Kossovskaia, Weir, and others.   back...
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