Counterfeit surgical mesh distributor pleads guilty14-Dec-2011
distributor Ram Medical has admitted selling counterfeit and
contaminated surgical mesh in the USA that it had purchased from
suppliers in the Middle East and India.
Ram Medical's chief executive Richard Mazon pleaded guilty to the charges of introducing adulterated and misbranded medical devices into interstate commerce in a court in Newark, New Jersey, last week.
Each charge 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, said the US Department of Justice in a statement.
The distributor purchased 420 boxes of surgical hernia mesh from United Arab Emirates-based Alpa Vision FZE, which in turn had procured the product from Indian company M/S Medserve.
Ram Medical also purchased roughly 100 additional boxes of the mesh - which was a copy of a genuine product sold by C R Bard subsidiary Davol Inc - from M/S Medserve directly.
Last year, the US Food and Drug Administration (FDA) warned that counterfeit versions of flat polypropylene meshes sold under the Bard or Davol brand names were in circulation and being used in place of genuine product for procedures such as the repair of hernias and chest wall defects (see Counterfeit surgical mesh confirmed as health risk).
The distributor has agreed to make full restitution for the value of the adulterated and misbranded surgical hernia mesh to those who purchased or used the mesh, and has taken responsibility for locating and destroying the counterfeit product.
Ram Medical and another distributor - Medline Industries - are facing lawsuits from patients who claim to have been injured as a result of exposure to the counterfeit mesh.
Sentencing is scheduled for March 8, 2012.
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