At least 18 lawsuits have been filed over sold by supplier Medline Industries Inc., as a product bought from Ram Medical Inc., and manufactured by C.R. Bard, when in fact the mesh had been manufactured by a company in Delhi, India.
Medline is suing Ram over the counterfeit mesh, but is in turn facing lawsuits by patients who received the mesh during surgical procedures.
Medical Device Supply Chain Council Executive Director Kevin Stout said, “Unfortunately a lot of these products change hands several times. Just trying to track them is a challenge…So in this particular case, part of the challenge is, who’s responsible for this?”
In 2010, the FDA said it was investigating claims that a mesh was being falsely marketed as a Bard product. Ram recalled the mesh voluntarily, and in that announcement, the FDA reported that samples of the counterfeit mesh were not sterile, increasing the risk of infection in patients, and that the mesh was improperly made and could unravel, Crain’s reports.
Eight lawsuits have been filed, including two class action lawsuits, and have been consolidated to the U.S. District Court in New Jersey. The suits allege negligence and fraud, calling the mesh “defective and unreasonably dangerous.” The suits also claim an increased risk of severe infection, suffering and pain, and seek damages for, among other things, the need for surgical removal of the mesh.