by
Thomas Dworetzky, Contributing Reporter | October 08, 2015
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.