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From Health Law Daily, October 8, 2015

FDA gets injunction after company claims device treats 200 diseases

By Kayla R. Bryant, J.D.

The creator and marketer of laser devices is permanently enjoined from selling his devices. The U.S. District Court for the District of South Dakota issued the injunction against 2035 Inc. and its owner, preventing the sale of the QLaser device. The company had marketed the device to be used for treating over 200 diseases in violation of the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq) (U.S. v. 2035 Inc., October 6, 2015, Viken, J.).

Device. According to the Department of Justice, the QLaser devices had been marketed and distributed nationwide and at least 20,000 devices were sold since 1998. Two of the devices have been cleared by the FDA for treating pain due to osteoarthritis in the hand. However, the device labeling contained false and misleading claims, such as providing viable treatments for cancer, diabetes, and HIV/AIDS. These claims are unsupported by clinical studies and, in certain situations, use of these devices for these types of treatments can be harmful.

Injunction. The court found that the company and its owner had violated the FDC Act by selling items that were adulterated and misbranded. The company and its affiliates are prohibited from introducing adulterated and misbranded items into interstate commerce. They are also prohibited from designing, manufacturing, and distributing any devices unless and until they are approved by the FDA. Before manufacturing any additional devices, the company is required to retain an independent inspector to certify to the FDA that all devices are FDA-approved and that all previously identified violations from prior FDA inspections have been addressed. The FDA is free to monitor the company’s operations in whatever way it deems necessary, and the company is required to reimburse the FDA for costs incurred by the agency while evaluating the company’s compliance.

The company is ordered to begin paying restitution payments to customers who purchased the devices after June 30, 2001. If the company violates any provisions of the injunction, it must pay the federal government $10,000 per day of violation. Additionally, the company is liable for any costs the U.S. incurs if the government brings and prevails in a contempt action to enforce the injunction.

The case is CIV. 14-5075-JLV.

Attorneys: Camela C. Theeler, U.S. Attorney's Office, and Ross S. Goldstein, U.S. Department of Justice, Consumer Protection Branch, for United States of America. Jay C. Shultz (Shultz Law Firm, Prof. LLC) for Robert L. Lytle dba 2035 PMA dba QLasers PMA.

Companies: 2035 Inc.

MainStory: TopStory CaseDecisions FDCActNews AdulterationNews MDeviceNews MisbrandingNews SouthDakotaNews

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