United States Files Enforcement Action Against South Dakota Laser Medical Device Distributor
WASHINGTON – The United States filed a civil complaint for injunctive relief in the U.S. District Court for the District of South Dakota against 2035 Inc. and its president, Dr. Robert L. Lytle, the Department of Justice announced. Lytle, who does business as 2035 Private Membership Association and QLasers Private Membership Association, is the owner and operator of 2035 Inc.
According to the complaint, the defendants are responsible for designing, manufacturing, marketing and distributing the QLaser System, a collection of approximately 12 devices that are marketed as low level laser devices for home use. The defendants market their devices throughout the country – through seminars, websites, newspaper ads and other means – for treatment of “over 200 different diseases and disorders,” including cancer, cardiac arrest, HIV/AIDS, diseases and disorders of the eye and ear, venereal disease 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 U.S. Food and Drug Administration (FDA) or otherwise approved to treat any other medical conditions. Failure to obtain FDA clearance or premarket approval before marketing and distributing a device renders the device adulterated and misbranded and violates the Food, Drug, and Cosmetic Act (FDCA).
“The public should be able to trust that medical devices marketed to them to treat certain conditions are shown to be safe and effective,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division. “The Department of Justice will take action to ensure that public health is not put at risk.”
According to the complaint, the defendants distribute labeling with the QLaser devices that touts their use for treatment of the serious conditions listed above, as well as their use on eyes and skin. However, the complaint alleges, applying the laser devices to the eyes and skin can be harmful, and use of the devices to treat serious conditions such as cancer, HIV/AIDS and diabetes, among others, is unsupported by any published clinical studies. The complaint further alleges that the medical claims regarding use of the laser devices to treat these conditions are false and misleading and that the devices are unsafe if used in the manner recommended or suggested in defendants’ labeling.
During multiple inspections of the defendants’ operations over the course of approximately 11 years, the FDA informed the defendants – both verbally and in writing – that they were violating the FDCA. Despite these warnings, the complaint alleges that defendants continue their violations. Most recently, in August and September 2014, FDA investigated the defendants’ business operations, including QLasers PMA, and www.qlaserspma.com, a website owned and operated by Lytle through QLasers PMA. According to the complaint, these investigations revealed that the defendants continue to make claims that cause their QLaser devices to be in violation of the law.
The government requests that the court enjoin the defendants from continuing to market their QLaser devices, or any other device, unless or until such devices receive FDA clearance or approval. The complaint further requests the court order the defendants to cease manufacturing, processing, packaging, labeling, holding or distributing any product that is a device unless and until the defendants have come into compliance with the FDCA.
“After several warnings from the FDA, this distributor was well aware he was in violation of the law by continuing to market laser devices for unapproved uses,” said U.S. Attorney Brendan V. Johnson for the District of South Dakota. “Regardless, he continued to put consumers at risk, leading them to believe the product they were buying from his companies could treat certain serious medical conditions. Consumer confidence is critical, and the Department of Justice will work to protect that confidence and keep the public safe.”
The FDA referred this matter to the Department of Justice. Trial Attorneys Cindy Cho and Ross Goldstein of the Consumer Protection Branch in the Civil Division, together with the U.S. Attorney’s Office for the District of South Dakota, brought this case on behalf of the United States.