Chief U.S. District Judge Jeffrey Viken on Wednesday granted a preliminary injunction against 2035 Inc. dba 2035 PMA and Qlasers, forbidding owner Robert Lytle from selling his “medical lasers” while the case is pending.
The government’s October 2014 lawsuit quoted a paragraph from Lytle’s “Application Guide” for his lasers: “A doctor in California has developed a very successful cancer protocol using the QLaser System and homeopathic detoxification of toxic metals, viruses, bacteria, and parasites all of which suppress the immune system. This program can be used by you in your own home for all stages of cancer. The doctor who developed this very successful protocol states IT IS NOT POSSIBLE TO HAVE CANCER WHEN YOU FOLLOW THIS PROTOCOL.”
This is not the first time Lytle’s lasers, which he has been selling since 1997 under 10 different business names, have come under federal scrutiny, the judge wrote in his order.
In 2002, the government informed Lytle that his lasers were medical devices and required governmental clearance before being sold to the public. Lytle claimed that his lasers were for veterinary use and continued to sell.
A 2013 FDA inspection turned up a document titled “Low Level Laser Application guide,” which claimed the lasers could treat up to 200 medical conditions, including cancer, AIDS and venereal diseases. But the government’s expert witness, Dr. Ilko Ilev, claims the lasers can be dangerous if used as directed.
Lytle insists the FDA has no jurisdiction over his products because they are offered to a “private membership” rather than the public.
Judge Viken disagreed.
“The First Amendment provides protection to Mr. Lytle for embracing and advocating alternative medical treatment,” he ruled, 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.”
Citing a long history of contention between Lytle and the FDA, Viken added: “Defendants have shown no intent to discontinue their activities and voluntarily comply with the FDCA,” and “there is a substantial likelihood the government will succeed on the merits of its claims.”
Viken denied multiple motions from Lytle, including a motion to dismiss for lack of jurisdiction and a motion to strike all the government’s pleadings.
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