Robert “Larry” Lytle sold at least 20,000 devices since 1998, with the FDA saying prices went as high as $12,000 each.
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A federal judge in South Dakota has issued a permanent injunction against a former dentist and medical device manufacturer in Rapid City who for more than a decade has been selling lasers he claimed could be used to treat everything from HIV/AIDS to diabetes and cancer.
Although not approved by the FDA, the laser devices were sold to consumers as an at-home treatment for over 200 health conditions, according to the regulator. One user guide said the device could be used to treat cardiac arrest, warning owners: "NEVER LEAVE HOME WITHOUT YOUR LASER BECAUSE YOU MIGHT SAVE YOUR OR SOMEBODY ELSE'S LIFE."
In 2009 the FDA had cleared two of Robert "Larry" Lytle's QLaser devices for providing temporary relief of pain associated with osteoarthritis of the hand, but it had not cleared any of the lasers to treat other medical conditions.
The injunction requires Lytle to stop manufacturing, packing, labeling, and distributing any devices and provide a full refund to consumers. Some lasers cost less than $1,000, said Lytle. According to a release by the U.S. Department of Justice, most consumers paid between $4,295 and $12,600, depending on the laser package they bought.
The former dentist said he has sold at least 20,000 lasers since 1998. That year, the South Dakota Board of Dentistry permanently revoked Lytle's license to practice dentistry.
In an interview with BuzzFeed News, Lytle, age 80, said that while he has already stopped selling the lasers, he plans to appeal the injunction, which requires refunding all the purchasers.
QLaser / Via softlaser.net
Calling the FDA approval process "burdensome" — getting the OK to market a device for osteoarthritis involving hand pain, for example, is separate from osteoarthritis of the knee — Lytle told BuzzFeed News that the lasers were not offered to the general public. Instead, they were sold through "private membership associations" (PMAs) where consumers would pay a roughly $10 to $20 fee to join the private clubs, making them eligible to purchase a device.
Lytle said there was "good research" behind the products and "I tried to work my way around it with the PMA," comparing the associations to churches and calling a PMA a "private right."
"Church members can claim ways to treat diseases within their church," he said. "I don't know why I am the target."
The FDA said PMAs did not excuse him from complying with the law, and this past January, the court issued a preliminary injunction.
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