The FDA had okayed two QLaser devices for providing temporary relief of pain associated with osteoarthritis of the hand but not any other medical conditions.

“Robert Lytle and his businesses ignored previous FDA warnings and continued to produce and distribute these devices in violation of federal law,” acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health Jan Welch said in a DOJ statement. “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 First Amendment provides protection to Mr. Lytle for embracing and advocating alternative medical treatment," the court ruled, according to Courthouse News. "[But] by placing the devices and their operational manuals into the stream of commerce, Mr. Lytle goes beyond protection ensured by the First Amendment. Hiding behind a curtain of private membership associations... does not shield Mr. Lytle from the authority of the FDCA [Federal Drug and Cosmetics Act] or the jurisdiction of the court."

The FDA has been after the dentist's QLaser business since 2010. In March 2011, it issued a warning letter, which did not stop Lytle. FDA got warrants that it executed in 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.

“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,” U.S. Attorney Randolph J. Seiler of the District of South Dakota stated. “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 also ordered Lytle to pay restitution to QLaser customers for the profits he received due to the misbranding.

“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,” Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division said. “It is especially noteworthy and gratifying that the Department was able to obtain some recompense for the innocent consumers whom Lytle victimized.”

Lytle has been in trouble before, and lost his dental license, according to the South Dakota Board of Dentistry.

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