On April 20, 2018, a South Dakota federal judge sentenced three conspirators who admitted to marketing and selling light-emitting medical devices (“QLaser”) as a cure-all to mostly elderly consumers. The 83-year-old ringleader who was the primary organizer of the fraudulent medical device scheme was sentenced to 12 years in prison, followed by 2 years of supervised release; a 39-year-old co-conspirator received a sentenced of 24 months in prison, followed by 3 years of supervised release; and, the 63-year-old Canadian defendant was sentenced to 15 months in prison, followed by 2 years of supervised release.
The ringleader admitted as part of his plea agreement 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, acknowledging that he obtained at least $16,669,015 over the course of the scheme. The ringleader pleaded guilty 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, on January 26, 2018.
The defendants admitted that they marketed and distributed QLaser devices to consumers across the United States by falsely claiming that the devices could safely and effectively treat various medical conditions at home, including cancer, emphysema, diabetes, autism, HIV, and heart disease. The ringleader allegedly created false and misleading product labeling that was designed to create the false impression that these claims had been scientifically proven but in reality, no published clinical or scientific studies supported the use of QLaser devices to treat those and other serious conditions, and the FDA never approved the devices for such uses. Potential QLaser purchasers were told that the ringleader 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.
The federal prosecutors alleged that the 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. The federal prosecutors alleged that the ringleader made false statements to the court and FDA investigators, sent collection letters to QLaser purchasers rather than pay them court-ordered restitution, smuggled hundreds of devices out of South Dakota to upstate New York to prevent their seizure, and received a steady stream of income from continued QLaser sales, in violation of the injunctions.
The U.S. Attorney for the District of South Dakota stated in announcing the sentences, “These defendants were motivated by greed, and they targeted vulnerable people by giving them false hope while fleecing them. The sentences today should serve as a deterrent to anyone contemplating similar schemes.”
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