Medical Device Manufacturer Permanently Enjoined
Late yesterday, a federal judge in South Dakota issued a permanent injunction against Robert “Larry” Lytle of Rapid City, South Dakota and his medical device businesses, the Justice Department announced. Lytle marketed laser devices to treat a variety of medical conditions and diseases through several entities, including QLasers PMA and 2035 PMA, and is the owner and operator of 2035 Inc.
In October 2014, the Justice Department brought a civil action to enforce provisions of the federal Food, Drug and Cosmetic Act (FDCA). As the court found, Lytle and his businesses violated the FDCA by marketing and distributing the QLaser devices nationwide 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).
“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, 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.”
According to the complaint and evidence adduced at a trial, Lytle has been distributing the QLaser devices with false and misleading labeling claims, touting their use for treating such serious conditions 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.
The permanent injunction issued yesterday by U.S. District Court Chief Judge Jeffrey L. Viken follows a trial held in March 2015, in which the government established that the QLaser’s labeling was false and misleading and that, in fact, using the lasers according to their directions could be dangerous to health. Yesterday’s court order 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.
The court also ordered Lytle to refund the full amount consumers paid for their QLaser devices, whether the devices were purchased directly from Lytle’s businesses or through one of his several distributors. Depending on the specific package purchased, each consumer typically paid between $4,295 and $12,600, according to the evidence before the court. Lytle has admitted that he has sold at least 20,000 devices since 1998.
Lytle 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.”
“Robert Lytle and his businesses ignored previous FDA warnings and continued to produce and distribute these devices in violation of federal law,” said Acting Director Jan Welch 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 government’s case is being handled by Trial Attorney Ross S. Goldstein of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Camela C. Theeler of the District of South Dakota. Sonia Nath, with the FDA’s Office of Chief Counsel, is assisting with this case.