Ah, America—land of both PT Barnum and Steve Jobs—huckster and innovator or both. We'll defend to the death someone's right to say "don't vaccinate your kids," but once they wade "into the stream of commerce," all bets are off. Or so a federal judge told the man behind the Qlaser, claimed to be a low-level, laser-based solution to just about every single imaginable problem, save for legal ones.
A federal judge for the US District Court in South Dakota just put an injunction on selling Qlasers—a home laser treatment for "whatever"—while a lawsuit filed against the company by the United States is pending. It's illegal to advertise something as a medical device without approval from the FDA, and if a business keeps doing so, even after being warned several times, the agency gets pissed. Claiming to be selling "information" to "private membership," doesn't work either, apparently.
"The First Amendment provides protection to Mr. Lytle for embracing and advocating alternative medical treatment," Chief District Judge Jeff Viken 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."
Lytle, as a dentist in Rapid City, South Dakota, first started selling lasers to people 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 judge's decision notes that the Qlaser's label claims that it is supposed to treat "tendonitis, arthritis, burns, and any pain or inflammation …speed bone repair …help repair damaged DNA …repolarize damaged cell walls…and [is] a multiorgan cell-reenergizer…[and is] proven effective and beneficial for healing, and to benefit inflammation or disorders of all internal, and the treatment of any unknown condition."
You can see the appeal, of course. I know I need "multiorgan cell-reenergizing" all the time, not to mention all my unknown conditions, and I don't have time to go to a laser doctor's office.
That "private membership" Hail Mary is just latest weird defense of Qlasers, raised by their founder and creator, Robert "Larry" Lytle. Qlasers have been sold since 1997, but under 10 different company names.
Also, Lytle isn't a dentist anymore because, on February 24, 1998, his license to practice dentistry was permanently revoked by the South Dakota Board of Dentistry, for "fraud or material deception in the course of professional services, employing unlicensed personnel to engage in the practice of dentistry or to function as a dental hygienist, and substandard patient care," according to the South Dakota Board of Dentistry's website.
Lytle had been improperly billing insurance and Medicaid, according to the Rapid City Journal, and was having employees do dental work they weren't licensed to do (personal nightmare of mine), and also used "improper procedures or defective materials in treating patients" (another nightmare).
His methods for fighting back against the man are confusing, if not just inept, as well.
After being told to stop selling Qlasers and get FDA approval in 2002, Lytle's attorney told the FDA that Qlasers were actually veterinary equipment, a ploy that was ruined when, the judge's decision states, "in a voicemail left on the FDA investigator's cell phone, Mr. Lytle, apparently believing that the call had terminated, declared to an unknown person that if the FDA investigator questions Mr. Lytle about his businesses or his laser devices, he will tell the FDA investigator that he makes 'low level lasers for a veterinary type of thing.'"
Ouch. He also opted to represent himself in a 2014 preliminary injunction hearing, but then asked the court "to point out any error or omission he may make in his pleadings and then give him an opportunity to correct his mistakes," which the court declined to do.
Perhaps strangest of all, the Qlaser is already at least partially cleared for medical use. A 2011 warning letter from the FDA sent to the maker states, "A review of our records indicates that we cleared a premarket notification (510(k)) for the Q1000 Laser and 660 Enhancer Probe (QLaser System), K080513, with an intended use 'for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional.'"
But apparently the heartbreaking story about a bear cub being paralyzed by falling out a tree and being healed with lasers ( seriously) is a bridge too far, and telling people that lasers could help with their eye problems (which is up there!) is flat out dangerous, so the FDA is putting a stop to it.