Inspections, Compliance, Enforcement, and Criminal Investigations
December 7, 2011: Medical Device Distributor Pleads Guilty For Importing, Reselling Counterfeit and Contaminated Surgical Hernia Mesh
NEWARK, N.J. – RAM Medical, Inc. (“RAM Medical”) – a distributor of medical devices, pharmaceuticals, food, cosmetics, and miscellaneous commodities – admitted today to importing and selling counterfeit and contaminated surgical hernia mesh, U.S. Attorney Paul J. Fishman announced.
RAM Medical, headquartered in Wayne, N.J., entered a guilty plea through its founder, owner and president, Richard A. Mazon, 61, of Wayne, to an Information charging the company with one count of introducing adulterated medical devices into interstate commerce and one count of introducing misbranded medical devices into interstate commerce.
According to documents filed in this case and statements made in court:
In October 2008, RAM Medical – which purchases overstocked and discounted products from wholesalers and suppliers all over the world and resells these products to distributors and end-users in the United States – purchased approximately 420 boxes of surgical hernia mesh from Alpa Vision F.Z.E. in the United Arab Emirates, which in turn had purchased the mesh from M/S Medserve in Delhi, India. RAM Medical also purchased approximately 100 additional boxes directly from Medserve in September 2009.
RAM Medical admitted that the mesh, which was ostensibly manufactured by Davol Inc., a subsidiary of C.R. Bard, was periodically sold and distributed to seven RAM Medical customers. The company also admitted that numerous boxes sold between December 2008 and June 2009 included adulterated mesh which contained numerous microorganisms.
RAM Medical also acknowledged that boxes the company distributed between October 2008 and January 2010 contained misbranded, counterfeit mesh.
Each count of the Information carries a maximum potential penalty of five years of probation and a maximum fine of $200,000 or twice the gain or loss caused by the offense.
RAM Medical has agreed to make full restitution for the value of the adulterated and misbranded surgical hernia mesh to identified companies or any other entity or individual determined to have purchased or used the mesh. The company has also agreed that as a special condition of probation, it will undertake responsibility for the locating and destruction of all the counterfeit Davol Inc. mesh it imported. Sentencing is currently scheduled for March 8, 2012.
U.S. Attorney Fishman credited special agents of the U.S. Food and Drug Administration (FDA), Office of Criminal Investigations, under the direction of Special Agent in Charge Mark Dragonetti, for the investigation leading to the guilty plea.
The government is represented by Assistant U.S. Attorney Scott B. McBride of the U.S. Attorney’s Office Healthcare and Government Fraud Unit.
In March 2010, the FDA issued a warning concerning the counterfeit surgical mesh products, which can be accessed at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm204199.htm. FDA’s warning is of particular significance to health care professionals and their patients with surgical mesh implants as well as hospitals and surgical centers, operating room medical professionals and staff, and purchasing and risk managers.
Defense counsel: Kenneth M. Laptook Esq., West Orange, N.J.