Injunction Issued to Stop Laser Device Sales

Robert Lytle of Rapid City, S.D., marketed the QLaser devices with labeling claims they could be used for treating conditions such as cancer, HIV/AIDS, and diabetes. "Although two of the devices are cleared for providing temporary relief of pain associated with osteoarthritis of the hand, none of the devices have been cleared by the FDA or otherwise approved to treat any other medical conditions," according to DOJ.

A federal judge in South Dakota has issued a permanent injunction against Robert Lytle of Rapid City, S.D.,and his medical device businesses. Lytle marketed laser devices to treat various medical conditions and diseases through several entities, including QLasers PMA and 2035 PMA, and is the owner of 2035 Inc., the Justice Department announced Oct. 7. DOJ last year filed a civil action to enforce provisions of the federal Food, Drug and Cosmetic Act, alleging -- as the judge found -- that Lytle and his businesses violated the act by marketing and distributing the QLaser devices nationwide to treat more than 200 diseases and medical disorders without clearance or approval from the U.S. Food and Drug Administration.

"We brought this lawsuit because Mr. Lytle had been putting consumers at risk while attempting to evade the FDCA – a law Congress enacted to protect public health and safety," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, who heads the Justice Department's Civil Division. "It is especially noteworthy and gratifying that the department was able to obtain some recompense for the innocent consumers whom Lytle victimized."

He marketed the QLaser devices with labeling claims that they could be used for treating conditions such as cancer, HIV/AIDS, and diabetes. "Although two of the devices are cleared for providing temporary relief of pain associated with osteoarthritis of the hand, none of the devices have been cleared by the FDA or otherwise approved to treat any other medical conditions. Moreover, using the QLaser devices can be harmful in certain situations, and its use to treat other serious conditions is unsupported by any published clinical studies," according to DOJ.

The injunction was issued by U.S. District Court Chief Judge Jeffrey L. Viken after a trial in March 2015. The injunction requires that Lytle and his businesses cease directly or indirectly manufacturing, packing, labeling, and/or distributing any medical device unless and until they comply with certain terms of the injunction, and Viken ordered Lytle to refund the full amount consumers paid for their QLaser devices. Depending on the specific package they purchased, each consumer typically paid between $4,295 and $12,600; DOJ reports Lytle has admitted that he has sold at least 20,000 devices since 1998. He is required to pay the United States $10,000 per day for any violation of the permanent injunction and is subject to other sanctions, including fines and imprisonment, for failing to comply."This ruling will help restore consumer confidence and send a strong message that a company cannot exercise blatant disregard of the law, especially when consumers' health is at risk," said U.S. Attorney Randolph J. Seiler of the District of South Dakota. "Justice has been served with this permanent injunction, and it will prohibit Mr. Lytle from continuing to thumb his nose at federal regulations that protect public health and safety."

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