August 20, 2012 — Medline, a United States medical device company, is facing at least 18 lawsuits from plaintiffs who allege they were implanted with counterfeit surgical mesh from India that was contaminated with bacteria. Surgical mesh is often used to reinforce weakened tissue. It is unknown how many people are implanted with counterfeit surgical mesh.
In 2008 and 2009, Medline purchased the surgical mesh from Ram Medical, which purchased the mesh from dealers in the United Arab Emirates. The counterfeit mesh was manufactured in Delhi, India, in a non-sterile environment. The packaging fraudulently claimed be made by C.R. Bard, a well-known U.S. medical device manufacturer, and was labeled with authentic lot numbers.
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice (DOJ) got wind of the counterfeit products and issued a warning in June 2010. They announced that they were investigating false marketing claims, and anyone who had problems with their surgical mesh should ask their doctor whether their mesh could have been counterfeit. The FDA warned that the counterfeit mesh was contaminated with bacteria and prone to unraveling, which could cause life-threatening injury.
When Ram Medical sold the counterfeit surgical mesh to Medline, they claimed that the products were from C.R. Bard. The products were recalled in 2010. Recently, Ram Medical has pleaded guilty to federal criminal charges. The company has paid hundreds of thousands of dollars in fines and legal fees.
Now, Ram Medical and Medline are facing lawsuits from people who were injured by the defective devices and are seeking compensation for their injuries. However, liability for the injuries is not clear. The lawsuits are bringing attention to the problem medical device companies face when determining the source and safety of the products they purchase.
Plaintiffs in these lawsuits allege that Medline and Ram Medical were negligent and fraudulent for failing to ensure that the products were sterile, safe, or authentic. The companies are also accused of selling a product that was not approved by the FDA.
Medline is currently in a dispute with their insurance company over who should cover the cost of the litigation. Medline expects the costs of defending against the lawsuits to climb above $500,000 in the next few months. The company’s reported revenue for 2011 was $4.7 billion.
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