Federal Government Sues South Dakota Medical Device Distributor

Uncle Sam is trying to stop a South Dakota businessman from distributing laser devices that allegedly treat “over 200 different diseases and disorders.”

The United States sued Robert L. Lytle and his companies 2035 PMA, 2035 Inc. and QLasers PMA, on Oct. 21 in federal court.

Lytle’s lasers, manufactured in Rapid City, S.D., are accompanied by a “Low Level Laser Application Guide” which Lytle wrote, the government contends in the lawsuit. In the Application Guide, and on his website, Lytle claims the “QLaser devices are intended for use in the treatment of ‘over 200 different diseases and disorders,’ including cancer, cardiac arrest, HIV/AIDS, diseases and disorders of the eye and ear, venereal disease and diabetes,” according to the complaint.

However, “there are no published clinical studies demonstrating that the QLaser devices treat these diseases,” the government claims in the complaint.

“The public should be able to trust that medical devices marketed to them to treat certain conditions are shown to be safe and effective,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division. “The Department of Justice will take action to ensure that public health is not put at risk.”

The U.S. Food and Drug Administration (FDA) has approved two of the laser models to treat low-level osteoarthritis of the hand, but has not approved them for anything else, the Department of Justice noted in a statement announcing the lawsuit.

In fact, according to the complaint, the lasers are “dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in their labeling.”

For example, QLaser labeling indicates the lasers can be used to treat eye disorders such as macular degeneration, though “direct application of any of these devices to the eye could result in injury, including temporary or permanent blindness,” the government said.

The FDA conducted multiple investigations of the company in the past 11 years and has informed Lytle that he is violating of federal law.

In 2013, Lytle filed a petition for declaratory judgment, Lytle v. United States Department of Health and Human Services et al., claiming the FDA had no right to interfere with his products because he operates a “private membership organization,” which “would generally not be subject to public laws and regulations.”
     
The petition was dismissed from federal court, and the 8th Circuit affirmed the dismissal.
     
“This distributor was well aware he was in violation of the law by continuing to market laser devices for unapproved uses,” U.S. Attorney Brendan V. Johnson said in a statement. “Regardless, he continued to put consumers at risk, leading them to believe the product they were buying from his companies could treat certain serious medical conditions.”
     
The lawsuit quotes a paragraph from Lytle’s Application Guide: “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.”