A federal court in South Carolina has rejected 2 medical device distributors' requests to dismiss a lawsuit holding them accountable for post-op complications stemming from the use of counterfeit surgical mesh they supplied to a surgical facility.
A patient named 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.
After undergoing a surgical procedure which implanted the mesh, Mr. Jones developed a "severe abdominal staph infection," according to court records, and required several additional surgeries to repair the damage.
His attorneys argue that the companies named in the lawsuit knowingly "sold, manufactured, and / or marketed counterfeit and otherwise defective surgical mesh," about which the FDA had issued warnings. These actions constitute violations of consumer law, they note.
While the distributors countered that state warranty laws did not apply to them and that the trade law allegations failed to state a valid claim, among other arguments, the court's Aug. 8 ruling allowed the plaintiffs to proceed with their claim, even the federal racketeering charges.
"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 one hundred fifty 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 patient's attorneys declined comment. Attorneys for Ram Medical and Medline did not respond a request for comment.
David Bernard
