18 Plaintiffs File Lawsuits over Counterfeit Surgical Mesh Used in Hernia RepairsAug 17, 2012 | Parker Waichman LLP
Medline Industries Inc., a Chicago-based medical supplier is facing lawsuits filed by 18 plaintiffs over counterfeit surgical mesh that was sold under the C. R. Bard/Davol brand name. The counterfeit surgical mesh, which was used in hernia repairs, was actually made by a company in Delhi, India.
According to a report from Crain's Chicago Business, Medline purchased the surgical mesh from New Jersey-based Ram Medical, which represented that it had been manufactured by C.R. Bard. In March 2010, the U.S. Food & Drug Administration (FDA) issued a warning about the products, stating that it did not know if the counterfeit mesh met the authentic products specifications, including its strength, sterility, or clinical performance. Ram voluntarily recalled the product, which was sold to five other distributors besides Medline, Crain's said.
In a letter issued in June 2010, the FDA warned that the surgical mesh was not sterile, and could increase the likelyhood of infections. The agency also said the mesh was made in a way that could unravel. In December, Ram Medical pleaded guilty to federal criminal charges in connection with the counterfeiting. The company was sentenced to three years probation, and ordered to pay a $100,000 fine and nearly $73,000 in restitution, Crain’s said.
According to Crain's, Medline has been named in eight lawsuits so far by people who claim the mesh was “defective and unreasonably dangerous,” and put patients at risk for infection, pain and suffering, economic damages and the need for more surgery to remove the counterfeit mesh. One of the lawsuits involves 11 plaintiffs. Two class action complaints were consolidated into a single action in U.S. District Court in New Jersey. The combined class-action case against Medline has been dismissed, but it's expected that the plaintiffs will appeal, Crain's said.
Medline Industries has filed its own lawsuit against Ram Medical, asserting it should be responsible for Medline's legal bills connected to the mesh lawsuits. It has also taken its insurance company, Landmark American Insurance Co., to court in an attempt to get it to cover the $500,000 it expects to spend on defending itself against personal injury claims.