Quack Device Marketers Get Prison Sentences

Stephen Barrett, M.D.

In April 2018, three defendants who marketed and sold light-emitting medical devices as a cure-all to consumers, primarily targeting the elderly, were sentenced by a federal judge in Rapid City, South Dakota:

Lytle began manufacturing and distributing low-level laser devices in 1997, shortly before the South Dakota Board of Dentistry had revoked his dental license for fraud and substandard patient care. In 2002, the FDA informed him that the QLaser was a medical device for which he was required to obtain marketing clearance prior to offering it for sale. His attorney told the FDA that the devices were veterinary devices and promised to remove certain statements from the labeling.

Low-level laser therapy (LLLT) refers to the use of a red-beam or near-infrared laser with a wave-length between 600 and 1000 nanometers and power from 5 to 500 milliwatts. Depending on wavelength, tissues absorb energy to produce heat. LLLT lasers transfer small or very small amounts of energy into the skin. In contrast, lasers used in ablative surgery typically use 300 watts and burn the tissues they encounter. LLLT devices may bring about temporary relief of some types of pain, but there is no reason to believe that they will influence the course of any ailment or are more effective than standard forms of heat delivery [2].

In 2009, the QLaser System received an FDA 510(k) clearance for "providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed' by a physician or other licensed medical professional." [3] This enabled Lytle to legally market such devices, but only for this limited purpose. But he apparently went much further. Information I found on the Internet indicates that his 2011 book, Low Level Application Guide, contained "protocols for more than 300 conditions" and was distributed free-of-charge to QLaser buyers [4} The book was subtitled, "Application guide for the direct use of low level lasers combined with laser acupoint therapy." Another book Lytle published, Universal Healer, Book 2 Type II Diabetes, claimed that "energy manifested by the right combination of laser light may be the biggest breakthrough in health care, ever" and that he looked forward to "having a QLaser in every home by the year 2035, and then the whole body will be healed with energy." [5}  

In 2011, the FDA issued a warning letter ordering Lytle to stop making illegal claims that his QLaser devices were effective against various diseases and conditions [6]. But he continued to do so. In 2013 and 2014, for example, Lytle's QLaser Web site home page stated:

In 2014, the FDA initiated a civil lawsuit which charged that Lytle, doing business as QLasers PMA and 2035 PMA, had marketed a dozen devices with illegal claims that they could treat "over 200 different diseases and disorders," including cancer, cardiac arrest, deafness, diabetes, HIV/AIDS, macular degeneration, and venereal disease. QLasers PMA and 2035 PMA were were organized as "private marketing associations" whose customers were required to sign a membership agreement declaring their right and willingness to learn how the QLaser System could help them. The complaint also noted that during a 2012 inspection, Lytle had refused to provide information requested by FDA investigators because they were not members, and he claimed that the the activities of his "private membership associations" were outside of FDA jurisdiction [7].

During the court proceedings, Lytle claimed that his devices were (a) "primarily for people's private education, (b) private experimentation and research, (c) for veterinary use on their pets, domestic animals and beasts; and (d) for whatever other private use a man or woman who elects to obtain one decides to apply it." and that neither the FDA nor the court could exert any lawful personal jurisdiction over the "private noncommercial distribution activity" of the defendant associations. However, the presiding judge—noting that placing devices and their operational manuals into the stream of commerce went beyond the First Amendment—issued a preliminary injunction which noted that "hiding behind a curtain of private membership associations" did not shield Lytle from the law or the court's jurisdiction [8].

After the U.S. Court of Appeals upheld this ruling, the injunction was made permanent [9]. However, court documents indicate that Lytle (a) continued to sell the devices, (b) made false statements to the court and FDA investigators, (c) sent collection letters to QLaser purchasers rather than pay them court-ordered restitution,(d) smuggled hundreds devices out of South Dakota to upstate New York prevent their seizure, and (e) received a steady stream of income from continued QLaser sales made by Kossovskaia, Weir, and others]. In 2017, all three were charged with criminal conspiracy [10,11].

In January 2018, Lytle pleaded guilty to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead, and one count of criminal contempt. As part of his plea agreement, Lytle admitted that beginning in 2005 he entered into an agreement with others to sell medical devices with false and misleading labeling in order to defraud consumers, and that he continued to do so in violation of a federal court order. He also acknowledged that he obtained at least $16,669,015 over the course of the scheme [12,13].

As part of the plea agreement, Lytle made an initial restitution payment of $637,000 and turned over several thousand dollars' worth of gold and silver coins to be applied to restitution. Kossovskaia [14,15] and Weir [16,17] also pleaded guilty for their roles in the fraud. The government agreed to dismiss criminal contempt charges against a fourth individual, Fredretta Eason.  

Lytle's 12-year sentence is one of the longest ever imposed on a device marketer who made outrageous health claims. That is admirable, but the fact that he was permitted to market his devices for nearly 20 years is not.

References

  1. Three conspirators sentenced in $16.6M fraudulent medical device scheme: Trio marketed laser devices to elderly consumers as cure-all. USDOJ press release #18-522, April 23, 2018.
  2. Barrett S. A skeptical look at low level laser therapy. Device Watch, April 26, 2018.
  3. QLaser system. 510(k) #080513, Jan 30, 2009.
  4. QLasercare Web site, accessed April 26, 2018.
  5. Lytle L Universal Healer, Book 2 Type II Diabetes. Self-published, 2011.
  6. Berg GJ. Warning letter to Robert L. Lytle, DDS, PhD, March 3, 2011.
  7. Complaint for injunction. USA v. 2035 Inc, and Robert L. Lytle, d/b/a 2035 PMA and QLasers PMA. U.S. District Court, District of South Dakota, Western Division, Case No. 5:14-cv-05075, filed Oct 21, 2014.
  8. Order granting preliminary injunction. USA vs. 2035 Inc, and Robert L. Lytle, d/b/a 2035 PMA and QLasers PMA. U.S. District Court, District of South Dakota, Western Division, Case No. 5:14-cv-05075, filed Jan 14, 2015.
  9. Order of permanent injunction. USA vs. 2035 Inc, and Robert L. Lytle, d/b/a 2035 PMA and QLasers PMA. U.S. District Court, District of South Dakota, Western Division, Case No. 5:14-cv-05075, filed Oct 6. 2015.
  10. Indictment. USA vs. Robert Larry Little, Irina Kossovskaia, and Fredretta L. Eason. U.S. District Court, District of South Dakota, Western Division, Case No. 5:17-cr-50020, filed Jan 26, 2017.
  11. Information. USA vs. Ronald D. Weir, Jr. U.S. District Court, District of South Dakota, Western Division, Case No. 5:17-cr-50022, filed Jan 30, 2017.
  12. Plea agreement. USA vs. Robert Larry Lytle. U.S. District Court, District of South Dakota, Western Division, Case No. 5:17-cr-50020, filed Jan 26, 2018.
  13. Factual basis statement. USA vs. Robert Larry Lytle. U.S. District Court, District of South Dakota, Western Division, Case No. 5:17-cr-50020, filed Jan 26, 2018.
  14. Plea agreement. USA vs.Irina Kossovskia. U.S. District Court, District of South Dakota, Western Division, Case No. 5:17-cr-50020-RAL, filed Jan 5, 2018.
  15. Factual basis statement. USA vs. Irina Kossovskia. U.S. District Court, District of South Dakota, Western Division, Case No. 5:17-cr-50020-RAL, filed Jan 5, 2018.
  16. Plea agreement. USA vs. Ronald D. Weir. U.S. District Court, District of South Dakota, Western Division, Case No. 5:17-cr-50022, filed Jan 30, 2018.
  17. Factual basis statement. USA vs. Ronald D. Weir. U.S. District Court, District of South Dakota, Western Division, Case No. 5:17-cr-50022, filed Jan 30, 2018.

This article was posted on April 26, 2018.

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