Dr. D would like to start of this week’s guidance by expressing his disappointment that 30% of the readers would think that the doctor would mislead them with an April Fool’s Day story that was not: “the truth, the whole truth, and nothing but the truth.” Just kidding, the doctor hopes you thoroughly enjoyed all of the stories written by the MedTech Intelligence staff. That being said, the doctor has come across another example of an industry professional winning a prized Department of Justice (DOJ) indictment for behaving badly (supposedly). Please keep in mind, the vagaries (look-it-up) of the DOJ will result in the placing of Chief Jailable Officers (CJOs) and other violators of the act into precarious positions. Can you say prison? You see, the FDA frowns down upon the entering of counterfeit medical devices into commerce in the United States. Can you say misbranded? For those with inquiring minds, did you know that contact lenses (as is the DOJ case referenced in this week’s guidance) are considered medical devices in the eyes of the agency? Additionally, when contact lenses, being introduced into commerce, are identified as “counterfeit”, “misbranded”, or “adulterated”, and/or they result in “contamination” in the form of hazardous bacteria being identified during testing and sold to unsuspecting consumers, then bad things are going to happen. Very bad things are going to happen. Enjoy!
It appears the feds were operating a joint sting operation that was appropriately named “Operation Double Vision.” Frequent readers of Devine Guidance may remember a piece Dr. D wrote last year pertaining to an establishment in Hawaii that was entering decorative contact lenses into commerce without first obtaining clearance from the FDA. Entering medical devices into U.S. commerce without the benefit of clearance or approval from the FDA is always going to end badly—no crystal ball is needed to see the future. Operation Double Vision was the brain child of the FDA. In fact, the agency’s Office of Criminal Investigations assumed the lead in the investigation. The supporting cast of characters included the U.S. Postal Inspection Service and the U.S. Immigration and Customs Enforcement’s Homeland Security Investigations (an arm of the Department of Homeland Security). This formidable group of federal agencies soon became the worst nightmare of one Dmitriy V. Melnik. Mr. Melnik was charged with one count of conspiracy to traffic counterfeit goods and introduce misbranded devices into interstate commerce; four counts of trafficking counterfeit goods; and five counts of introducing misbranded devices into interstate commerce. Please keep in mind that Melnik is considered innocent until proven guilty, as these transgressions supposedly happened. However, if the DOJ took time to script a press release, Dr. D believes that bad things are already being planned for Melnik. Is Ben Dover still looking for a cellmate in Leavenworth (federal penitentiary located in Kansas)?
United States Department of Justice Press Release (February 10, 2016)4
“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 Fresh Look 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.”
Compliance for Dummies
The doctor could climb up onto his trusty pulpit and pontificate about what happens to evil doers when they run afoul of FDA, but the readers already know what happens to CJOs convicted of willfully violating the act: They end up behind bars with their wallets considerably lighter. Dr. D struggles to understand the mindset of individuals who are hell-bent on making money at the expense of hurting or potentially killing a patient or a healthcare provider with counterfeit medical devices. Now granted, counterfeit contact lens may not kill an unsuspecting consumer, but they may result in impaired or permanent loss of vision. However, the FDA does not care about what some may consider a benign device such as a contact lens. The FDA deals in device classes premised on risk, with Class I considered a low-risk device versus a Class III device (PMA) being high-risk device.
For readers living outside of the United States, the doctor would like to introduce you to Dr. D’s appropriately named Sandbox Rule: “If one wants to play in the FDA’s sandbox, thou shalt play by their rules!” Fail to do so and bad things will happen to violators of the sandbox rule (also known as the Act):
- Form 483 observations
- Warning letters
- Detention orders
- Product seizures,
- Consent decrees
- Prison time (yes, prison time)
For this week’s guidance, Dr. D will leave the readers with just one takeaway. If a device industry professional makes a bad decision (with malice) then bad things are going to happen. The FDA, DOJ and the federal courts, are all too willing to accommodate bad actors. In fact, there are special places in hades (and federal penitentiaries) for device industry CJO’s, entrepreneurs, and professionals willing to violate the Act. If one is inclined to believe money is more important than product and patient safety and efficacy, then just maybe the doctor will have the opportunity to write about you someday. Please do not become one of these characters that end up in one of Dr. D’s columns. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.
- Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (February 10, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. “Las Vegas Resident Indicted For Running Counterfeit and Misbranded Contact Lens Operation”. Accessed April 4, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm487327.htm