CHARLESTON – A Boone County woman has sued the manufacturers of a cartilage implant she says led to more issues with his big toe, saying the companies should have issued a recall because of multiple previous failures.
Tammy May filed her complaint November 26 in federal court against Cartiva Inc., Wright Medical Group N.V. and Stryker B.V.
According to the complaint, May received a Cartiva synthetic cartilage implant in April 2022 at Charleston Area Medical Center for the treatment of hallux rigidus, which is known as stiff big toe or arthritis.
Salango
| File photo
“This is the second lawsuit we have filed on behalf of victims of the Cartiva implaint failure,” attorney Ben Salango told The West Virginia Record. “We look forward to presenting these cases to juries in West Virginia.”
The first such lawsuit by Salango and other Charleston attorneys was filed earlier this year on behalf of WOWK-TV meteorologist Bryan Hughes.
In her complaint, May says the implant didn’t alleviate her pain or restore range of motion to her big toe, and she also says it led to permanent restrictions in the use of her big toe. This caused him to have to adapt to using other joints, which led to wear and tear on his foot and leg.
Big toe arthritis affects about 2.2 million people in the United States. As arthritis deteriorates the joint’s cartilage, a person develops painful bone-on-bone friction. This condition is treated surgically via two methods: (1) arthrodesis (also known as “fusion”); or, (2) implant of an SCI, which purportedly acts like a cushion to prevent bone-on-bone pain.
As a result of the complications, May had to undergo removal of the big toe implant in October, just days before the defendants issued a recall for the SCI.
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.
May’s complaint is one of many similar lawsuits filed across the country against the manufacturers. Most of them involve the implants loosening or failing. This loosening is likely due to shrinkage of the implant.
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.
May 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. May 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.
She is being represented by L. Lee Javins II, David A. Bosak and Taylor M. Norman of Bailey Javins & Carter in Charleston and by Salango of Salango Law in Charleston.
U.S. District Court for the Southern District of West Virginia case number 2:24-cv-687