Federal judge grants permanent injunction against South Dakota medical laser manufacturer

A federal judge in the U.S. District Court for the District of South Dakota yesterday granted the U.S. Food and Drug Administration a permanent injunction against 2035 Inc. and Robert "Larry" Lytle, doing business as QLasers PMA and 2035 PMA.

The injunction, granted by Chief Judge Jeffrey Viken, prohibits the manufacture and distribution of "QLaser" low-level laser devices, which have not received FDA approval. As a result, the devices are adulterated and misbranded within the meaning of the Federal Food, Drug & Cosmetic (FD&C) Act.

According to the complaint for injunction filed on Oct. 21, 2014, by the Department of Justice on behalf of the FDA, Lytle has been manufacturing and distributing QLaser devices for more than a decade and markets the devices through private membership associations (PMAs). Lytle and his businesses promote the devices with false and misleading claims that they treat cancer, cardiac arrest, HIV/AIDS, diseases and disorders of the eye and ear, venereal disease, diabetes and many other health conditions.

Although the FDA cleared two of the QLaser devices for providing temporary relief of pain associated with osteoarthritis of the hand (as diagnosed by a physician or other licensed medical professional), the FDA has not cleared or approved any of the devices to treat any other medical conditions. Further, as demonstrated by the evidence presented at trial, use of the QLaser devices according to the labeling could be dangerous to the health of the consumer.

"Robert Lytle and his businesses ignored previous FDA warnings and continued to produce and distribute these devices in violation of federal law," said Jan Welch, acting director of the Office of Compliance in the FDA's Center for Devices and Radiological Health. "The FDA will remain vigilant in protecting the health of the American public by ensuring that medical devices are shown to be safe and effective before being used by patients."

The FDA inspected or attempted to inspect Lytle's businesses five times since 2010. In March 2011, the agency issued a Warning Letter to Lytle and 2035 Inc. The Warning Letter informed Lytle that distributing his QLaser devices across the country violated the FD&C Act. Despite this warning, Lytle failed to correct the violations. The FDA went on to obtain an administrative warrant after Lytle refused inspection in December 2012. The agency executed the warrant in September 2013.

The permanent injunction order follows a preliminary injunction entered by the U.S. District Court for the District of South Dakota on Jan. 14, 2015. The court subsequently held a trial on the case on March 3-4, 2015. As a result of the injunction the court entered today, Lytle and his businesses must cease directly or indirectly manufacturing, packing, labeling and/or distributing any device unless and until they obtain premarket approval or clearance from the FDA and comply with other terms of the injunction.

"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."

The court order also authorizes the FDA to inspect Lytle's businesses to ensure compliance with the terms of this injunction, with costs for the inspection borne by Lytle and 2035 Inc. The court's order also requires Lytle to pay restitution to QLaser customers for the profits he received from sales of his adulterated and misbranded devices.

"We brought this lawsuit because Mr. Lytle had been putting consumers at risk, while attempting to evade the FD&C Act-;a law Congress enacted to protect public health and safety," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of 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."