August 20, 2012 — The medical device company Medline is facing lawsuits from 18 people who claim that they were implanted with counterfeit surgical mesh made in Delhi, India, which was contaminated with bacteria. Medline purchased the surgical mesh in 2008 and 2009 from Ram Medical Inc., which told Medline that the mesh was manufactured by well-known device manufacturer C.R. Bard, when in fact the mesh was actually made by a company in India. In 2011, Ram Medical pleaded guilty to federal criminal charges and was fined $73,000.
Now, the people who received the counterfeit surgical mesh have filed counterfeit mesh lawsuits seeking financial compensation for their injuries. However, it is not clear who is responsible for the injuries. The lawsuits highlight the difficulties medical device companies face when establishing the source and safety of their products.
The scandal began in June 2010, when the U.S. Food and Drug Administration (FDA) and U.S. Department of Justice (DOJ) said they were investigating false marketing claims related to the surgical mesh products. The mesh is often used to reinforce soft tissue in hernia repair surgery, although C.R. Bard also manufactures a type of vaginal mesh used to reinforce weakened pelvic muscles.
Ram Medical apparently purchased counterfeit surgical mesh as early as October 2008, from dealers in the United Arab Emirates, who had purchased the products in Delhi, India. The products were falsely branded with C.R. Bard / Davol lot numbers. After Ram Medical sold the counterfeit surgical mesh to five distributors, the products were recalled.
In the recall, the FDA warned that the counterfeit surgical mesh was not sterile, which could lead to a life-threatening infection. The mesh also had a defective design that could unravel.
Counterfeit mesh lawsuits have been filed against both Medline and Ram Medical. The plaintiffs allege that the companies were negligent and fraudulent because they failed to ensure the sterility and quality of their products. They also allege that the surgical mesh was not approved by the FDA before it was sold.
Medline expects the cost of defending the lawsuits will climb upwards of $500,000, and they are currently in a dispute with their insurance company over responsibility for the costs of the litigation. Medline reported revenue of $4.7 billion in 2011.
Do I have a Counterfeit Surgical Mesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting counterfeit surgical mesh induced injury cases in all 50 states. If you or somebody you know has been injured by defective counterfeit surgical mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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