Medical product distributor RAM Medical Inc. admitted this week to importing and reselling counterfeit and contaminated surgical hernia mesh products.
The Wayne, N.J.-based company pled guilty to two counts of introducing adulterated and misbranded med-tech into interstate commerce, including some that contained numerous microorganisms, according to the U.S. Attorney Paul Fishman.
The news follows this summer’s high-priority recall for counterfeit versions of C.R. Bard’s (NYSE:BCR) Davol Inc. brand. surgical mesh.
The FDA warned in June that the fake versions of the product, commonly known as Marlex mesh, should not be used. Investigations by the FDA and Bard found most of the counterfeit product is labeled with genuine Bard lot numbers.
Leading back as October 2008, RAM purchased surgical mesh falsely branded as made by Bard subsidiary Davol Inc. from sellers in the Unite Arab Emirates and Delhi, India.
The fakes were sold to seven RAM customers, owner and president Richard Mazon, 61, revealed during the Dept. of Justice investigation. Many boxes sold between December 2008 and June 2009 were contaminated with microorganisms.
The company agreed to make full restitution for the value of the fake mesh products to its customers or any other companies who purchased them, according to a DOJ press release, and as a special condition of its probation RAM will track down and destroy all of the counterfeit mesh it imported.
Each of the two counts against the company carries a maximum penalty of 5 years of probation as well as maximum fines of $200,000 or twice the gain or loss caused by the offense. Sentencing is scheduled for March 8, 2012.
Illinois-based medical products supplier Medline Industries filed a case against RAM after facing lawsuits over the fake mesh. Medline’s suit argues that RAM should be held responsible for legal bills it racks up defending itself, Law360.com reported. Both Medline and RAM are facing at least five lawsuits, including two class actions, and more suits may be in the works.
The FDA first issued warnings about counterfeit surgical mesh circulating in the U.S. market in March 2010.