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From Health Law Daily, January 16, 2015

Laser device manufacturer lies repeatedly to FDA about indications, operations

By Patricia K. Ruiz, J.D.

The United States government has shown a substantial likelihood that Robert L. Lytle, the manufacturer and seller of a medical device involving lasers purported to treat “any unknown condition,” would continue to violate the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 9 et. seq.), despite multiple warnings from the FDA, according to the District of South Dakota. The government filed a motion for preliminary injunction to enjoin Lytle from violating the FDC Act during the pendency of the lawsuit after determining that Lytle had lied to the FDA regarding the use of his products after the FDA advised that they required approval before marketing and selling (United States v. 2035 Inc., January 14, 2015, Viken, J).

FDC Act violations. Lytle manufactured and distributed QLaser devices since 1997 under more than 10 different company names. He marketed the devices as low level laser therapy devices for home use and authored the “Low Level Laser Application Guide” for distribution with the devices. In addition to distributing the QLaser devises nationwide, Lytle held seminars, solicited individuals to join “private membership associations,” and distributed labeling and other materials related to the devices. In 2002, the FDA informed Lytle that the QLaser was a medical device for which he was required to obtain marketing clearance prior to offering it for sale. His attorney advised the FDA that the devices were veterinary devices and promised to remove certain statements from the labeling.

During an inspection in 2010, an FDA investigator collected samples of documents including “QLaser Use Instructions & Product Warranty” and “QLaser Low Level Laser Therapy: Tomorrow’s Health Care Today,” which both indicated that the device treated “tendonitis, arthritis, burns . . . [and] any pain or inflammation” and stated that the device is “proven effective and beneficial for healing, and to benefit inflammation or disorders of all internal [sic], and the treatment of any unknown condition.” Based on this finding, the FDA sent Lytle a warning letter advising that the QLaser device was within the meaning of sec. 321(h) of the FDC Act because they were “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease or are intended to affect the structure of any function of the body.” The letter further advised that the products were considered adulterated because they lacked premarket approval under sec. 515(a) of the FDC Act and misbranded because Lytle did not notify the FDA of his intent to introduce the devices into commercial distribution as required by sec. 510(k). The FDA also cited deficiencies in the premarket clearance of several of Lytle’s other devices. Lytle professed to the termination of his company’s operations, but in 2011, the FDA confirmed that his websites were still operating and contained further claims disallowed by the FDC Act.

FDA conclusions. An expert for the FDA stated that there were no published clinical studies demonstrating the effectiveness of any of the devices sold by Lytle for any of the 200 indications listed. Moreover, the devices could be dangerous to health when used in the way suggested by these indications. For instance, applying any of the devices directly over the open eye, as instructed by one of Lytle’s manuals, could lead to temporary or permanent damage.

Preliminary injunction. Based on the evidence in the record, the court determined that Lytle showed no intent to discontinue his company’s activities or voluntarily comply with the FDC Act. Accordingly, the court found that there was a substantial likelihood that the government would succeed on the merits of its claims and granted its motion for preliminary injunction.

The case number is CIV. 14-5075-JLV.

Attorneys: Camela C. Theeler, U.S. Attorney's Office, for United States of America. Robert L. Lytle, pro se.

Companies: 2035 Inc.; 2035 PMA; QLASERS PMA; United States of America.

MainStory: TopStory MDeviceNews FDCActNews AdulterationNews AdvertisingNews MisbrandingNews SafetyNews SouthDakotaNews

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