Counterfeit Mesh Distributors Liable for Post-op Complications
A federal court in South Carolina has rejected two medical device distributors’ requests to dismiss a lawsuit holding them accountable for post-op complications due to the use of counterfeit surgical mesh they supplied to a surgical facility.
The mesh, supplied by Ram Medical and Medline Industries, was labeled and sold as C. R. Bard/Davol brand name surgical mesh, but is believed to be counterfeit mesh made in China. This kind of surgical mesh is used to reinforce weak soft tissue, such as for hernia repair and chest wall defects.
A patient, Heyward Thomas Jones, and his wife filed the suit against Ram Medical and Medline Industries alleging negligence, product liability, breach of warranty, fraud, violation of South Carolina’s trade practices, and violation of federal racketeering laws.
According to court records, Mr. Jones developed a “severe abdominal staph infection” after undergoing a surgical procedure that implanted the mesh. The staph infection required additional surgeries to repair the damage.
Jones’ attorneys claim the companies involved in the lawsuit knowingly “sold, manufactured, and/or marketed counterfeit and otherwise defective surgical mesh,” although the Food and Drug Administration (FDA) had issued warnings. This constitutes violations of consumer law, his attorneys noted.
“Plaintiffs point to the FDA Notice of Recall and argue that Defendants have distributed and sold fifteen lots of counterfeit surgical mesh,” the ruling reads. “Plaintiffs allege there are potentially 150 individual victims that have been implanted with counterfeit surgical mesh … Plaintiffs argue further that the purpose of the sale was to defraud individual patients into paying full price for an inferior counterfeit good, which is common to all potential victims.”
The distributors argued to no avail that state warranty laws did not apply to them and trade law allegations failed to state a valid claim. The court’s Aug. 8 ruling allowed plaintiffs to proceed with the claim.
The counterfeit mesh has been recalled by the FDA. You can read about the recall on the FDA website.