Life Science Compliance Update

October 13, 2015

District Court Grants Permanent Injunction Against Device Maker


On Wednesday October 7, a federal judge in South Dakota granted the Food and Drug Administration (FDA) a permanent injunction against 2035 Inc. and Robert “Larry” Lytle, doing business as QLasers PMA and 2035 PMA. Interestingly, despite the “PMA” in the business name, the company had not in fact received PMA, or pre-market approval, from FDA before distributing their low-level laser devices. As a result, the government alleged that the devices are adulterated and misbranded within the meaning of the Federal Food, Drug & Cosmetic (FD&C) Act.

According to the complaint for injunction filed on Oct. 21, 2014, by the Department of Justice on behalf of the FDA, Lytle had been manufacturing and distributing QLaser devices for more than a decade and markets the devices through private membership associations (PMAs). “Lytle and his businesses promote the devices with false and misleading claims that they treat cancer, cardiac arrest, HIV/AIDS, diseases and disorders of the eye and ear, venereal disease, diabetes and many other health conditions,” notes FDA. The DOJ elaborates that Lytle marketing QLasers for treatments of over 200 different diseases and medical disorders without clearance or approval from FDA.

Click here for one writer’s take on a QLaser advertisement from 2013, which targeted elderly women.

Although the FDA cleared two of the QLaser devices for providing temporary relief of pain associated with osteoarthritis of the hand (as diagnosed by a physician or other licensed medical professional), the FDA has not cleared or approved any of the devices to treat any other medical conditions. Further, as demonstrated by the evidence presented at trial, use of the QLaser devices according to the labeling could be dangerous to the health of the consumer.

"The FDA inspected or attempted to inspect Lytle’s businesses five times since 2010," FDA writes. In March 2011, the agency issued a Warning Letter to Lytle and 2035 Inc informing Lytle that distributing his QLaser devices across the country violated the FD&C Act. Despite this warning, Lytle failed to correct the violations. The FDA went on to obtain an administrative warrant after Lytle refused inspection in December 2012. The agency executed the warrant in September 2013.

“Robert Lytle and his businesses ignored previous FDA warnings and continued to produce and distribute these devices in violation of federal law,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “The FDA will remain vigilant in protecting the health of the American public by ensuring that medical devices are shown to be safe and effective before being used by patients.”

The permanent injunction order follows a preliminary injunction entered by the U.S. District Court for the District of South Dakota on Jan. 14, 2015. The court subsequently held a trial on the case on March 3-4, 2015. "As a result of the injunction, Lytle and his businesses must cease directly or indirectly manufacturing, packing, labeling and/or distributing any device unless and until they obtain premarket approval or clearance from the FDA and comply with other terms of the injunction," FDA states

The court order also authorizes the FDA to inspect Lytle’s businesses to ensure compliance with the terms of this injunction, with costs for the inspection borne by Lytle and 2035 Inc. The court also ordered him to refund the full amount consumers paid for their QLaser devices, whether the devices were purchased directly from Lytle’s businesses or through one of his several distributors.  "Depending on the specific package purchased, each consumer typically paid between $4,295 and $12,600, according to the evidence before the court," states DOJ. Lytle admitted he sold at least 20,000 devices since 1998. Lytle is ALSO required to pay the United States $10,000 per day for any violation of the permanent injunction, and is subject to other sanctions, including fines and imprisonment, for failing to comply.

“This ruling will help restore consumer confidence and send a strong message that a company cannot exercise blatant disregard of the law, especially when consumers’ health is at risk,” said U.S. Attorney Randolph J. Seiler of the District of South Dakota. “Justice has been served with this permanent injunction, and it will prohibit Mr. Lytle from continuing to thumb his nose at federal regulations that protect public health and safety.”

“We brought this lawsuit because Mr. Lytle had been putting consumers at risk, while attempting to evade the FD&C Act—a law Congress enacted to protect public health and safety,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “It is especially noteworthy and gratifying that the Department was able to obtain some recompense for the innocent consumers whom Lytle victimized.”


Open Payments Analytics Webinar

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This Thursday, October 15, 2015, at 2:00 pm EST, Streebo will be presenting a webinar on “Strategies to Improve Compliance Programs Using Open Payments Analytics.”

The webinar will be presented by Seth Whitelaw, a licensed attorney with over twenty years of experience in food and drug law, as well as corporate governance and compliance within medical devices, pharmaceutical sales, and pharmaceutical R&D, and Ned Mumtaz, the leader of Streebo’s transparency directive program in the United States and the European Union.

The webinar will focus on the OPA Vitals platform, and inform attendees how it can help meet their business needs. Attendees will learn how to take action on current year’s data, spot an outlier before submitting your final report, compare your budget versus the actual spending, and improve your overall programs.

Attendees will also receive an offer for an exclusive start-up package for early adopters.

If you are interested in attending this informative webinar, you can register here.  


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