Robert "Larry" Lytle, Unapproved Medical Device Distribution, South Dakota 2023

The Grimy Times has learned that a Rapid City man and his businesses have been ordered by a federal court to stop manufacturing and distributing unapproved medical devices.

A preliminary injunction was issued by U.S. District Court Chief Judge Jeffrey L. Viken against Robert “Larry” Lytle and his companies, QLasers PMA, 2035 PMA, and 2035 INC.

The court found that Lytle and his businesses have been violating the federal Food, Drug, and Cosmetic Act (FDCA) by marketing his laser devices for the treatment of more than 200 different diseases and medical disorders without clearance or approval from the U.S. Food and Drug Administration (FDA).

According to court documents, Lytle markets his devices by soliciting purchasers to join his “private membership associations” or “PMAs” before purchasing his lasers. The court noted, however, that “Hiding behind a curtain of private membership associations, 2035 PMA and QLaser PMA, does not shield Mr. Lytle from the authority of the FDCA or the jurisdiction of the court.”

The government alleges that not only are there no published clinical studies to support the use of Lytle’s lasers to treat other serious medical conditions, but that in fact, using the devices according to the device’s labeling could be dangerous to health.

The preliminary injunction takes effect immediately and will remain in force while the government’s case seeking a permanent injunction proceeds to final judgment.

“With the entry of this preliminary injunction, we have taken another step toward ensuring that only medical devices that have been shown to be safe and effective are placed in the hands of the American consumer,” said Acting Assistant Attorney General Joyce R. Branda. “Everyone who deals in products that affect people’s health must comply with the FDCA.”

The U.S. Attorney for the District of South Dakota, Brendan V. Johnson, added, “This action is crucial to prevent the company from continuing to operate on the periphery of the law, and potentially jeopardize the health and safety of its consumers.”

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