DOJ ANNOUNCES COURT INJUNCTION AGAINST MEDICAL LASER MANUFACTURER

FROM:  U.S. JUSTICE DEPARTMENT 
Friday, January 16, 2015
Federal Court Issues Preliminary Injunction Against South Dakota Medical laser Manufacturer

A federal court has barred a Rapid City, South Dakota, company and its president from further manufacturing and distributing its laser devices, which they marketed to treat a variety of medical conditions and diseases, the Justice Department announced today.

U.S. District Court Chief Judge Jeffrey L. Viken for the District of South Dakota entered the preliminary injunction on Wednesday against Robert “Larry” Lytle and his businesses, QLasers PMA, 2035 PMA, and 2035 INC., in an action filed by the Justice Department to enforce provisions of the federal Food, Drug, and Cosmetic Act (FDCA).  The court’s order prohibiting the manufacture and distribution of the QLaser devices also applies to Lytle’s business affiliates and franchisees.

Last October, the Justice Department and the U.S. Attorney’s Office for the District of South Dakota filed a civil complaint for injunctive relief against Lytle and his businesses, alleging that they have been violating the FDCA by nationally marketing Lytle’s 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).  The preliminary injunction entered on Wednesday takes effect immediately and will remain in force while the government’s case seeking a permanent injunction proceeds to final judgment.

Judge Viken found, based on what he called an “extensive and well developed record,” that Lytle and his various businesses “have shown no intent to discontinue their activities and voluntarily comply with the FDCA.  “The injunction bars the defendants from continuing to market and distribute any medical devices until they receive written permission from the FDA to do so.

Lytle, whom the court noted was a dentist in Rapid City until his license to practice dentistry was permanently revoked by the South Dakota Board of Dentistry in 1998, markets the devices by soliciting purchasers to join his “private membership associations” or “PMAs” before purchasing his lasers.  As the court explained, however, “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.”

“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 for the Justice Department’s Civil Division.  “Everyone who deals in products that affect people’s health must comply with the FDCA.”

According to court documents filed in the case, the defendants have been distributing the QLaser devices with labeling that contains false and misleading claims, touting their use in treating such serious conditions as cancer, HIV/AIDS, venereal disease and diabetes.  Although two of his laser devices were FDA-cleared for providing temporary relief of pain associated with osteoarthritis of the hand, none of the devices has been cleared or approved to treat any other medical conditions.  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 court’s order finds that the United States is substantially likely to succeed on the merits on this claim and the others within the government’s complaint.

“The preliminary injunction granted should provide consumers a renewed sense of confidence,” said U.S. Attorney Brendan V. Johnson for the District of South Dakota.  “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.”

The FDA referred this enforcement action to the Department of Justice.  The government’s case is being litigated by Trial Attorney Ross S. Goldstein of the Civil Division’s Consumer Protection Branch, with assistance from the U.S. Attorney’s Office for the District of South Dakota and the FDA’s Office of Chief Counsel.

MARKETERS SETTLE WITH FTC REGARDING AUTOMOBILE ENGINE "MULTIVITAMIN" CLAIMS

FROM:  FEDERAL TRADE COMMISSION
Marketers Who Claimed Fuel Additive Could Drastically Increase Fuel Economy and Reduce Emissions Settle with FTC

Under a settlement with the Federal Trade Commission, the marketers of a fuel additive called EnviroTabs will pay $800,000 for consumer redress and is prohibited from making false, misleading, or unsubstantiated claims that EnviroTabs, when added to any type of fuel, will increase fuel efficiency, reduce emissions, and save consumers money.

According to the FTC’s complaint, Green Foot Global LLC (GFG) represented EnviroTabs as the “World’s 1st Multi-Vitamin for Your Engine!” and sold it nationwide through its website and through multi-level marketing via distributors.  In English and Spanish, GFG advertised EnviroTabs as a fuel additive that drastically improves fuel mileage and significantly reduces vehicle emissions, and claimed it was scientifically proven to be effective.

The individual defendants are William C. Hyman, also known as Bill Hyman; Mary Ann P. Hyman, a/k/a Mary Ann Proulx Hyman, Mary A. Hyman, Mary P. Hyman, Mary Ann Proulx, MaryAnn Denise L. Proulx, Mary Ann Prouleaux, Mary P. Proulx Hyman, Mary Ann A. Hyman, and Mary Hyman; Ralph M. Flynn Jr., a/k/a Ralph Flynn; Martinez Van Turner, a/k/a Martinez V. Turner, Marty Turnberg, and Marty Turner; and Patrick Hintze, a/k/a Pat Hintze.  The corporate defendant is Green Foot Global LLC, also doing business as Green Foot Global, Greenfoot Global, GFG, GFG Commercial, GFG Industrial, GreenFootGlobal.com, GFG Fuel Tech LLC, and GWO Network.

In addition to the $800,000 judgment, the settlement prohibits the defendants from misrepresenting tests or studies about any product or service, and bars them from making claims about any product without having competent and reliable scientific evidence.  For example, the defendants may not claim that any product saves fuel;  increases motor vehicle fuel economy or decreases fuel consumption rates; reduces emissions; helps a vehicle pass an emissions inspection; saves money on fuel, maintenance or repairs; is environmentally friendly, “green” or “eco-friendly;” has any environmental benefit; removes engine carbon deposits; or extends oil or engine life.

The settlement also bars the defendants from selling or otherwise benefitting from consumers’ personal information and from failing to properly dispose of customer information after providing the information to the FTC so that the agency can return money to defendants’ customers.

The Commission vote authorizing the staff to file the complaint and approving the proposed consent judgments was 4-0.  The judgment against Flynn, Turner and Hintze was entered by the U.S. District Court for the District of Nevada on November 18, 2013.  The order against GFG, William C. Hyman and Mary Ann P. Hyman was entered by the court on November 19, 2013.

NOTE:  The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest.  Consent judgments have the force of law when approved and signed by the District Court judge.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them.