CHARLESTON – A local meteorologist has sued the manufacturers of a cartilage implant he says led to more issues with his big toe, saying the companies should have issued a recall because of multiple previous failures.
Bryan Hughes, a meteorologist for WOWK-TV in the Charleston-Huntington market, filed his complaint in federal court against Cartiva Inc., Wright Medical Group N.V. and Stryker B.V.
According to the complaint, Hughes received a Cartiva synthetic cartilage implant in September 2019 for the treatment of hallux rigidis and capsulitis. Hallux rigidus is stiff big toe or arthritis, and capsulitis is the inflammation that causes discomfort in the ball of the foot.
Hughes
| File photo
Hughes says the implant didn’t alleviate his pain or restore motion to his big toe, and he also says it led to permanent restrictions in the use of his big toe. This caused him to have to adapt to using other joints, which led to wear and tear on his foot and leg.
As a result of the complications, Hughes had to undergo removal of the big toe implant in February 2023. But, the complaint says he continues to experience severe and painful permanent injuries.
Hughes also says the defendants ignored signs of problems with the big toe synthetic cartilage implant and failed to issue a Cartiva recall, which the complaint states may have allowed many individuals to avoid devastating foot injuries.
The Cartiva SCI is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel, which has been promoted by the manufacturer as a revolutionary toe implant. However, within a few years after it was introduced, concerns emerged about failure rates with the implant that have caused patients to experience widespread complications, including reports of severe toe pain, loosening, fracture and other problems, often resulting in the need for a surgery to fuse the big toe, resulting in a loss of mobility.
Hughes is one of many similar lawsuits filed across the country against the manufacturers. The complaint says there were at least 144 adverse event reports filed before he had his implant, mostly involving the implants loosening or failing. This loosening is likely due to shrinkage of the implant, which is what caused Hughes’ implant to fail, according to the complaint.
“Defendants had the ability of a voluntary recall at their disposal to protect the public from the known shrinkage, migration and bone loss issues associated with SCIs,” the complaint states. “The defendants continued to market and sell a defective device that they knew should have been voluntarily recalled, in violation of federal regulations including making an adulterated device that proximately and directly caused plaintiff’s injuries and damages.”
A 2020 study found that as many as 64 percent of those who received a Cartiva implant for stiff big toe experienced failure within four weeks of surgery, and that failure rate rose to 79 percent after 19 months.
Hughes accuses the defendants of strict products liability, negligent design, manufacture and distribution, misbranded and adulterated device, common law product liability and negligence and breach of warranty. He seeks compensatory damages for past and future medical expenses, lost wages and lost earning capacity, emotional distress, pain, suffering and loss of enjoyment of life as well as punitive damages, attorney fees, court costs and other relief.
He is being represented by L. Lee Javins II, David A. Bosak and Taylor M. Norman of Bailey Javins & Carter in Charleston and by Ben Salango of Salango Law in Charleston.
U.S. District Court for the Southern District of West Virginia case number 2:24-cv-319