Lawsuit Indicates Cartiva Synthetic Cartilage Implant (SCI) Led to Restrictions in Use of Big Toe

Cartiva SCI manufacturers knew about the high rates of complications linked to the big toe implant, but failed to warn the medical community or patients, according to the complaint.

A West Virginia man has filed a product liability lawsuit, indicating that Cartiva synthetic cartilage implant (SCI) not only failed to alleviate his big toe arthritis problems, but also left him with severely limited movement of the toe, which has resulted in pain and stress on other joints.

The complaint (PDF) was filed by Bryan Hughes in the U.S. District Court for the Southern District of West Virginia on November 20, pursuing damages from the toe implant manufacturers, including Cartiva, Inc., Wright Medical Group and Stryker.

The Cartiva Synthetic Cartilage Implant is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted as a revolutionary toe implant since it was introduced. However, concerns have emerged about alarming toe 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.

As a result of an alleged failure to accurately disclose these risks, the manufacturers now face a growing number Cartiva SCI lawsuits brought by patients who indicate that they have been left with worse foot problems, which could have been avoided with other treatment options.

Hughes indicates that his doctors implanted a 10mm Cartiva SCI in September 2019, after he was diagnosed with hallux rigidis and capsulitis, which result in pain and stiffness in the big toe and foot.

Cartiva implants involve a synthetic cartilage that is placed in the joint, to replace degraded cartilage and provide pain relief. It is considered an alternative to more severe toe fusion surgery, which is known as arthrodesis, and involves a longer recovery time and is a more complicated surgical procedure.

However, contrary to the marketing claims made by the manufacturers, Hughes indicates that the Cartiva SCI was not effective at alleviating his pain or restoring range of motion. In fact, it has worsened his problems, forcing adaptations to account for this restruction in neirboring joints, which has increased wear and tear on his foot and leg.

Ultimately, Hughes had to undergo a revision surgery to have the Cartiva SCI removed in February of this year.

Lawsuit Claims Cartiva SCI Problems Downplayed

The lawsuit claims that neither Hughes nor his doctor were made adequately aware of the risk of Cartiva SCI complication risks, which by some estimates affect nearly half of all SCI recipients.

“During the time Defendants have marketed, labeled and sold their [Cartiva] SCI they knew, or should have known, that the likelihood of patients experiencing implant shrinkage was significantly higher than they reported, and in fact is higher than any comparable product on the market and that pain and discomfort would be a likely consequence of implant shrinkage and migration,” the complaint states.

Hughes accuses the manufacturer of suppressing negative data and test results, which would have alerted federal regulators and doctors about the potential risk of Cartiva implant problems. While the early clinical trials looked promising, doctors have reported being unable to duplicate the results seen in the manufacturer-led studies, reporting much higher complication rates and lower patient satisfaction than they were told to expect.

Although the manufacturers suggested the Cartiva failure rates were low, the lawsuit points 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.

The manufacturers should have issued a Cartiva SCI recall when the true problems were revealed, but the company instead put profits ahead of patient welfare, the lawsuit indicates.

“Prior to the implantation of Plaintiff’s SCI, Defendants were aware of higher than reported loss of toe mobility, pain and high failure rates of the SCI due to shrinkage, including but not limited to 144 adverse event reports in the Maude database with the majority of events attributed to implant loosening,” Hughes’ lawsuit notes. “The loosening is likely due to shrinkage of the implant that is well supported by peer-reviewed literature.”

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

Cartiva SCI Lawsuits

Hughes’ complaint joins a number of other similar lawsuits over Cartiva SCIs filed in recent months, each raising similar allegations of fact and law, claiming that the product fails due to design defects.

The lawsuits often 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 that the devices were safe and failed to warn patients about the increased risk of implant failure.