Counterfeit and Contaminated Medical Devices Lead to Guilty Plea by Distributor

December 14, 2011

A medical device distributor recently pleaded guilty to selling counterfeit and contaminated surgical hernia mesh. The New Jersey-based RAM Medical, Inc., a distributor of medical devices, pharmaceuticals, food, cosmetics and miscellaneous products, admitted to introducing adulterated and misbranded medical devices into interstate commerce in 2008 and 2009.

RAM’s owner admitted to reselling misbranded and adulterated hernia mesh that contained numerous microorganisms from 2008 to 2010. The FDA’s Office of Criminal Investigations unearthed purchases of some 420 boxes of surgical hernia mesh from a company in the United Arab Emirates, which had purchased the products from an India-based company. RAM had also purchased 100 additional products from India. RAM has agreed to provide restitution for the value of the adulterated and misbranded products to certain companies or individuals believed to have purchased the mesh and has accepted responsibility for locating and destroying all counterfeit mesh. RAM is due to be sentenced in March of 2012.

In March 2010, the FDA warned healthcare providers and consumers about the counterfeit surgical mesh being marketed and distributed under a legitimate company’s name.

Counterfeiting of medical device products is a significant and growing problem. Distributors such as RAM purchase overstocked and discounted products from wholesalers and suppliers worldwide and resell the products to American distributors and end-users. Purchases made through secondary market channels enable counterfeiters of products to pass off counterfeit products as legitimate. Moreover, medical device manufacturers’ business practices can facilitate the movement of counterfeit products through seemingly legitimate market channels. RAM’s guilty plea underscores the health risks posed by secondary markets and the need for medical device manufacturers to shore up and monitor their supply chains. McGuireWoods routinely counsels medical device and pharmaceutical device companies in best practices for preventing, detecting and deterring diversion of their products through secondary market channels.