A South Dakota ex-dentist is no longer smiling over his home-use laser business that sold the devices through private membership associations.

Chief Judge Jeffrey Viken, in the U.S. District Court for the District of South Dakota, has now 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.

Lytle told Black Hills Fox News, "Obviously the impact on me isn't as important as is the impact that it's having on those people that have found success with using the laser. Over the 15, 17 years that the laser's been in production, we've never had one single complaint about the laser hurting somebody."

The former dentist reported that he is thinking of appealing the decision. The order also put a $10,000-a-day price tag for any violations of the injunction.

Lytle, as a dentist in Rapid City, South Dakota, began selling lasers for the purposes of treating “cancer, cardiac arrest, HIV/AIDS, diseases and disorders of the eye and ear, venereal disease, and diabetes," according to The Rapid City Journal.

The court noted that QLaser's label claims it can treat “tendonitis, arthritis, burns, and any pain or inflammation... speed bone repair... help repair damaged DNA... repolarize damaged cell walls. It also states that it is a "multiorgan cell-re-energizer... [and is] proven effective and beneficial for healing, and to benefit inflammation or disorders of all internal [organs], and the treatment of any unknown condition," according to Vice's Motherboard.

Lytle explained to the Journal in 2014, when the DOJ legal fireworks began, that 2035 PMA and QLasers PMA are both private membership associations.
 
"That is the crux of (the) argument between myself and the FDA," Lytle said. "The FDA refuses to recognize that it has no authority to regulate private membership associations. We don't do business with the general public."

The injunction blocks both the manufacture and distribution of "QLaser devices, which have not received FDA approval," according to the Journal.

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.