SIOUX FALLS, S.D.—A 63-year-old Canadian woman is the second person to enter a guilty plea regarding a scheme to defraud consumers by selling light-emitting devices as a treatment for more than 200 different diseases and disorders, the Department of Justice announced Thursday, Jan. 11.
Irina Kossovskaia, of Ontario, Canada, pleaded guilty in federal court in Sioux Falls on Wednesday to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead.
She faced charges along with Robert "Larry" Lytle and Fredretta Eason for their involvement with the devices, known as the "QLaser System." A fourth individual, Ronald Weir Jr., pleaded guilty to his role in the conspiracy last February.
According to documents filed in federal court in South Dakota, Kossovskaia and her three co-conspirators marketed and distributed QLaser devices by falsely claiming they could safely and effectively treat numerous medical conditions at home, including cancer, diabetes, autism, HIV and heart disease.
No published clinical or scientific studies supported the use of QLaser devices to treat such serious conditions, and the U.S. Food and Drug Administration (FDA) never approved them for such use.
As part of her plea agreement, Kossovskaia admitted that she and Lytle made false claims about the QLasers' curative powers to mislead consumers into purchasing the devices, which sold for more than $4,000 per unit. Kossovskaia further admitted to assisting Lytle by smuggling hundreds of QLaser devices out of Rapid City, South Dakota, to her facility in upstate New York after a federal court ordered Lytle to stop selling the devices.
Kossovskaia continued to sell the devices until 2017 and funneled tens of thousands of dollars in proceeds to Lytle, even though he was under court order to refund consumers for every QLaser purchase made since 2001.
"Fraudulent medical device scams exploit vulnerable citizens," Acting U.S. Assistant Attorney General Chad Readler of the Justice Department's Civil Division said in a news release. "The Department of Justice will continue its efforts to protect people from those who knowingly peddle ineffective and potentially dangerous products as treatments for serious illnesses."
U.S. District Judge Karen Schreier accepted Kossovkaia's plea on Wednesday. In addition to fines, Kossovskaia faces a maximum sentence of five years' imprisonment. A sentencing date has not yet been set.
The U.S. Postal Inspection Service investigated this case. Trial attorney Ross Goldstein of the U.S. Justice Department's Consumer Protection Branch and Assistant U.S. Attorney for South Dakota Kevin Koliner are prosecuting the case.