February 10, 2016: Las Vegas Resident Indicted For Running Counterfeit and Misbranded Contact Lens Operation
WASHINGTON – A federal grand jury in the District of Nevada has charged a Las Vegas resident with running a large operation selling counterfeit and misbranded contact lenses online to customers throughout the United States.
Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, U.S. Attorney Daniel G. Bogden of the District of Nevada and Director George M. Karavetsos of the U.S. Food and Drug Administration’s Office of Criminal Investigations (FDA OCI) made the announcement today after the indictment was unsealed and the defendant made his initial appearance before U.S. Magistrate Judge Peggy A. Leen of the District of Nevada.
Dmitriy V. Melnik, 29, was charged with one count of conspiracy to traffic in counterfeit goods and to introduce into interstate commerce misbranded devices; four counts of trafficking in counterfeit goods; and five counts of introducing misbranded devices into interstate commerce.
According to the indictment, Melnik allegedly imported thousands of colored contact lenses from the People’s Republic of China and South Korea that he knew were counterfeit, unauthorized by the FDA for import to and sale in the United States, or both. Many of these contact lenses bore counterfeit trademarks for Ciba Vision FreshLook COLORBLENDS, which are manufactured by Novartis International AG, and others had labels of brands of contact lenses produced and sold in Asia.
As noted in the indictment, contact lenses—even decorative ones—are medical devices that must receive FDA authorization to enter the United States and be further distributed. Melnik allegedly sold “authentic” contact lenses to customers without a prescription and without adequate directions for use or adequate warnings. After purchasing the contact lenses, many customers complained directly to Melnik about the quality of the contact lenses and questioned Melnik about whether the contact lenses were genuine and FDA approved. Some of the contact lenses that Melnik sold were tested and allegedly found to be contaminated with possibly hazardous bacteria.
The charges and allegations contained in the indictment are merely accusations. The defendant is presumed innocent until and unless proven guilty.
Anyone with information about individuals committing intellectual property offenses can report those crimes to the National Intellectual Property Rights Coordination Center by going to http://www.iprcenter.gov/referral or calling (866) IPR-2060.
The prosecution is the result of an ongoing multiagency effort to combat counterfeit, illegally imported and unapproved contact lenses called Operation Double Vision. The FDA OCI led the investigation, with significant support from the U.S. Postal Inspection Service and the U.S. Immigration and Customs Enforcement’s Homeland Security Investigations. Senior Counsel Matthew A. Lamberti of the Criminal Division’s Computer Crime and Intellectual Property Section and Assistant U.S. Attorney Crane M. Pomerantz of the District of Nevada are prosecuting the case.
The indictment is related to the many efforts being undertaken by the department’s Task Force on Intellectual Property, which supports prosecution priorities, promotes innovation through heightened civil enforcement, enhances coordination among federal, state and local law enforcement partners and focuses on international enforcement efforts, including reinforcing relationships with key foreign partners and U.S. industry leaders.