At least 18 lawsuits have been filed over counterfeit surgical mesh devices. The U.S. Food & Drug Administration (FDA) previously issued a warning on the counterfeit surgical polypropylene mesh products marketed as C. R. Bard/Davol.
According to Crain’s, the counterfeit surgical mesh was typically used in surgeries such as hernia repairs. Medline Industries bought the mesh in 2008-2009 from Ram Medical Inc., which said the mesh was manufactured by Murray Hill, New Jersey-based C.R. Bard Inc., according to court records. The mesh was not manufactured by the well-known surgical device manufacturer but, rather, by a Delhi, India, firm, said Medline.
Last year, Ram Medical, which is based in Wayne, New Jersey, pleaded guilty to federal criminal charges related to drug counterfeiting; the firm was sentenced to three years of probation and ordered to pay a $100,000 fine and about $73,000 in restitution, according to the U.S. attorney’s office in Newark, wrote Crain’s.
“Unfortunately a lot of these products change hands several times,” Kevin Stout, executive director of the Medical Device Supply Chain Council, told Crain’s. “Just trying to track them is a challenge…. So, in this particular case, part of the challenge is, who’s responsible for this?” Stout noted.
The Council, a network of industry executives, supports an FDA proposal that the majority of U.S. distributed medical devices bear a unique identifier to better track medical products, explained Crain’s.
Problems with the counterfeit mesh were revealed in 2010, when the FDA announced its investigation of claims that a product used to reinforce soft tissue was being marketed bogusly in the U.S. under the Bard brand, wrote Crain’s. At that time, Ram voluntarily recalled the product, which was also sold to five other distributors.
In a June 2010 letter, the FDA said the counterfeit samples were not sterile, infection risks could increase when the fake devices were implanted in patients, and the mesh could unravel.
Eight lawsuits have been filed against Medline; one includes 11 individual plaintiffs and cases include two separate class actions that were consolidated into a single action in U.S. District Court in New Jersey, explained Crain’s. Patients allege, among other issues, that Medline and Ram Medical were both negligent and fraudulent, that they failed to determine if the mesh product was sterile and free from defects, and that the device was not FDA-approved for implantation, said Crain’s.
The number of patients potentially involved and the Medline’s possible liability remain unknown.
Meanwhile, noted Crain’s, the combined class-action against Medline was dismissed; however, an appeal is expected, said Medline in a lawsuit it filed against Landmark American Insurance Co., its general liability insurer.
Medline is also suing Ram in federal court in Chicago, said Crain’s.