Lawsuit Claims Cartiva Recall Should Have Been Issued For Big Toe Synthetic Cartilage Implant (SCI)

Manufacturer failed to issue a Cartiva SCI recall even after receiving nearly 150 reports of implant failures and device loosening, according to the lawsuit.

A product liability lawsuit filed by a West Virginia man argues that there should have been a Cartiva recall issued after the manufacturer began receiving reports of failures involving the synthetic cartilage implant (SCI), which has been used in recent years to treat individuals big toe arthritis.

The Cartiva SCI is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted by the manufacturer as a revolutionary toe implant. However, within a few years after it was introduced, concerns emerged about alarming Cartiva synthetic cartilage implant failure rates, which 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.

As a result, the manufacturers now face a growing number of similar Cartiva SCI lawsuits, each raising allegations that the device was defectively designed and contained known risks that were not disclosed to patients and doctors.

In a complaint (PDF) filed late last month in the U.S. District Court for the Southern District of West Virginia, Bryan Hughes indicates that the manufacturers ignored signs of problems with the big toe synthetic cartilage implant and failed to issue a Cartiva recall, which may have allowed many individuals to avoid devastating foot injuries.

Hughes indicates that he received a Cartiva synthetic cartilage implant in September 2019, for the treatment of hallux rigidis and capsulitis. However, the lawsuit indicates that not only did the Cartiva SCI not alleviate his pain or restore motion, but ot also led to permanent restrictions in the use of Hughe’s big toe. This led to him being forced to adapt using other joints, which led to wear and tear on his foot and leg.

As a result of the Cartiva complications, Hughes had to undergo removal of the big toe implant in February 2023. However, he continues to experience severe and painful injuries, which the lawsuit indicates are permanent.

The lawsuit names Cartiva Inc., Wright Medical Group, N.V. and Stryker B.V. as defendants, indicating that the manufacturers were aware of the serious risk of problems from Cartiva long before he had the synthetic cartilage implant placed in his big toe. Hughes notes that at least 144 adverse event reports had been submitted by that time, involving Cartiva implants loosening or failing. According to the complaint, this loosening is likely due to shrinkage of the implant, which is what caused Hughes Cartiva toe implant to fail.

“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 lawsuit 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.”

The lawsuit presents claims of strict products liability, negligent design, manufacture and distribution, misbranded and adulterated device, common law product liability and negligence, and breach of warranty. Hughes seeks both compensatory and punitive damages.

Cartiva Implant Lawsuits Being Pursued Nationwide

Although the manufacturer originally suggested Cartiva synthetic cartilage implant failure rates were low, Hughes’ and other plaintiffs now pursuing product liability lawsuits point to a study published in November 2020, which found that as many as 64% of individuals who received a Cartiva SCI for hallux rigidus experienced failure within four weeks of surgery, and the failure rate increased to 79% after 19 months.

Some reports also suggest that Cartiva SCI failures have left individuals in a much worse position, due to the amount of bone removed during the toe implant surgery. In this scenario, patients have been left with significantly shorted big toes, which can lead to additional foot injuries from the offloading effect.

Such poor patient outcomes will likely result in many more implant recipients seeking settlements or compensation from the manufacturer through the filing of a Cartiva lawsuit, alleging that the manufacturer did not uphold their duty to adequately investigate and ensure that the devices were safe. The company also faces claims that it failed to promptly issue a Cartiva recall, or adequately warn patients about the increased risk of implant failure.