A federal court has barred a Rapid City, South Dakota, company and its president from further manufacturing and distributing its laser devices, which they marketed to treat a variety of medical conditions and diseases, the Justice Department announced today.
U.S. District Court Chief Judge Jeffrey L. Viken for the District of South Dakota entered the preliminary injunction on Wednesday against Robert “Larry” Lytle and his businesses, QLasers PMA, 2035 PMA, and 2035 INC., in an action filed by the Justice Department to enforce provisions of the federal Food, Drug, and Cosmetic Act (FDCA). The court’s order prohibiting the manufacture and distribution of the QLaser devices also applies to Lytle’s business affiliates and franchisees.
Last October, the Justice Department and the U.S. Attorney’s Office for the District of South Dakota filed a civil complaint for injunctive relief against Lytle and his businesses, alleging that they have been violating the FDCA by nationally marketing Lytle’s laser devices for the treatment of more than 200 different diseases and medical disorders without clearance or approval from the U.S. Food and Drug Administration (FDA). The preliminary injunction entered on Wednesday takes effect immediately and will remain in force while the government’s case seeking a permanent injunction proceeds to final judgment.
Judge Viken found, based on what he called an “extensive and well developed record,” that Lytle and his various businesses “have shown no intent to discontinue their activities and voluntarily comply with the FDCA. “The injunction bars the defendants from continuing to market and distribute any medical devices until they receive written permission from the FDA to do so.
Lytle, whom the court noted was a dentist in Rapid City until his license to practice dentistry was permanently revoked by the South Dakota Board of Dentistry in 1998, markets the devices by soliciting purchasers to join his “private membership associations” or “PMAs” before purchasing his lasers. As the court explained, however, “Hiding behind a curtain of private membership associations, 2035 PMA and QLaser PMA, does not shield Mr. Lytle from the authority of the FDCA or the jurisdiction of the court.”
“With the entry of this preliminary injunction, we have taken another step toward ensuring that only medical devices that have been shown to be safe and effective are placed in the hands of the American consumer,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division. “Everyone who deals in products that affect people’s health must comply with the FDCA.”
According to court documents filed in the case, the defendants have been distributing the QLaser devices with labeling that contains false and misleading claims, touting their use in treating such serious conditions as cancer, HIV/AIDS, venereal disease and diabetes. Although two of his laser devices were FDA-cleared for providing temporary relief of pain associated with osteoarthritis of the hand, none of the devices has been cleared or approved to treat any other medical conditions. The government alleges that not only are there no published clinical studies to support the use of Lytle’s lasers to treat other serious medical conditions, but that in fact, using the devices according to the device’s labeling could be dangerous to health. The court’s order finds that the United States is substantially likely to succeed on the merits on this claim and the others within the government’s complaint.
“The preliminary injunction granted should provide consumers a renewed sense of confidence,” said U.S. Attorney Brendan V. Johnson for the District of South Dakota. “This action is crucial to prevent the company from continuing to operate on the periphery of the law, and potentially jeopardize the health and safety of its consumers.”
The FDA referred this enforcement action to the Department of Justice. The government’s case is being litigated by Trial Attorney Ross S. Goldstein of the Civil Division’s Consumer Protection Branch, with assistance from the U.S. Attorney’s Office for the District of South Dakota and the FDA’s Office of Chief Counsel.