Cartiva Lawsuit Over Failed Toe Implant Scheduled for Jury Trial in October 2025

Manufacturers should have issued a Cartiva recall after discovering high failure rates with the toe implant, according to allegations being prepared for trial.

A federal judge has scheduled a trial date for next year, in a Cartiva lawsuit filed by a West Virginia man, who indicates that his synthetic cartilage toe implant failed less than four years after it was placed in his foot, due to a defective design that has also caused other individuals nationwide to experience similar problems.

The Cartiva toe implant is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted by the manufacturer as a revolutionary alternative to fusion surgery for individuals with hallux limitus or hallux rigidus, which are forms of degenerative arthritis in the first joint of the big toe.

However, concerns have emerged in recent years about alarming Cartiva failure rates, which have caused some users to experience severe toe pain, loosening of the implant and other problems, often resulting in the need for additional surgery that leaves them with a substantial loss of mobility.

The manufacturers, Cartiva Inc., Wright Medical Group N.V. and Stryker B.V., now face a number of Cartiva toe implant lawsuits, each raising similar allegations that the device was defectively designed and contained known risks that were not disclosed to patients and doctors. However, the allegations have not yet been presented to a jury at trial.

In a complaint (PDF) filed earlier this year, Bryan Hughes of West Virginia indicates he received a Cartiva synthetic cartilage implant (SCI) in 2019. However, he had to have the implant removed in 2023, after experiencing severe pain and complications.

According to allegations outlined in the complaint, the manufacturers knew or should have known about problems with Cartiva long before it was placed in his big toe, noting that at least 144 adverse events had been submitted by users involving the toe implants loosening or failing.

“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,” Hughes states in the lawsuit. “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.”

On September 17, Senior U.S. District Judge John T. Copenhaver, Jr., of the Southern District of West Virginia, issued an order (PDF) scheduling the trial in Hughes’ case to begin on October 28, 2025.

The schedule gives the parties until May 5, 2025, to serve discovery requests, with the close of all discovery set for June 17, 2025. The parties will then file any dispositive motions by July 7, 2025. However, if the manufacturer is unable to get the case dismissed, the claim will be prepared for trial about three months later.

In advance of the Cartiva trial date, Judge Copenhaver has ordered the parties to hold a settlement meeting on September 8, 2025, with a final Cartiva settlement conference the day before the trial, in hopes of exploring any last-minute agreement to resolve the case.

Cartiva Lawsuits Filed Nationwide

Hughes is one of a growing number of individuals who now accuse the manufacturers of deceiving the medical community and patients about the safety and effectiveness of Cartiva toe implants.

Originally, the manufacturers suggested the Cartiva synthetic cartilage implant had very low failure rates. However, a study published in November 2020 found that as many as 64% of patients who received a Cartiva SCI implant for hallus rigidus experienced failure within four weeks of surgery, and the failure rate increased to 79% after 19 months.

Some plaintiffs indicate that Cartiva toe implant failures left them in even worse condition than before they received the implants, due to the amount of bone removed during the implantation surgery. This can leave patients with significantly shorter big toes, which can lead to additional foot injuries from the offloading effect.

In addition, after removal, many patients have to have their big toe fused, rendering it immobile.