Lawsuits Over Cartiva Toe Implant Complications Voluntarily Withdrawn, Without Prejudice

A number of plaintiffs have voluntarily withdrawn recently filed lawsuits over Cartiva toe implant complications, raising speculation that the manufacturer may be quietly negotiating settlements or entering tolling agreements to work on resolving the claims.

The Cartiva toe implant is a molded cylindrical device made of polyvinyl alcohol-based hydrogel (PVA), which is placed in the first joint of the big toe, known as the first metatarsophalangeal joint. The device is promoted to treat hallux limitus or hallus rigidus, which occurs when arthritis has caused the cartilage to degrade.

Although it was promoted as a revolutionary treatment alternative, individuals have reported high failure rates with the big toe implant, including increased pain, loosening, fracture and other problems. Often these Cartiva complications result in the need for a big toe fusion surgery, which leaves the patient with permanent disability.

Over the past year, about a half-dozen individuals have filed a Cartiva implant lawsuit against the manufacturer, alleging the product is defective and unreasonably dangerous, and it was expected that a growing number of complaints may be filed throughout 2023.

Cartiva Lawsuit Voluntary Dismissals

One of the most recent complaints (PDF) was filed by Cathy Atkinson in October 2022. However, that complaint was withdrawn last week, following the same pattern seen in a number of other lawsuits filed over the past year.

Atkinson is from Texas and indicated in her lawsuit that she experienced complications following a Cartiva implant surgery in November 2018. Just two years later, she was told the device had failed, resulting in revision surgery in December 2020 and an arthrodesis fusion surgery in 2021.

Only three months after the lawsuit was filed, a voluntary dismissal (PDF) was entered on January 12, providing the option for Atkinson to bring the claim again in the future. However, under the Texas statute of limitations, the manufacturer may argue that any subsequent attempt to refile the lawsuit is barred, unless the parties reached an out-of-court settlement or agreed to toll the deadline.

At least three other Cartiva lawsuits filed earlier last year were all withdrawn in September 2022, under similar conditions.

A complaint (PDF) filed by Sally Peterson was originally brought in June 2022, in the U.S. District Court for the Eastern District of Wisconsin, weeks before the two year statute of limitations would expire based on the date when she had surgery to remove the Cartiva implant in August 2020. However, the case was voluntarily dismissed without prejudice (PDF) on September 13, 2022.

Another complaint (PDF) was filed by Gina Neil in the U.S. District Court for the Western District of North Carolina in May 2022, indicating that she required a Reference Total Toe Replacement with bone void filler of her right big in June 2019, to remove a Cartiva implant. Neil filed a notice (PDF) dismissing the claim without prejudice on September 9, 2022.

On the exact same day, a complaint (PDF) filed originally by Tammie Thompson in March 2022 was also the subject of Notice of Voluntary Dismissal (PDF). Her lawsuit was brought over complications with a Cartiva toe implant received in October 2017, indicating that radiology images eventually found the implant had slipped into the bone and that she was going to require surgery to remove the device, bone debridement and a big toe fusion surgery.

Cartiva Settlement Speculation

While there have been no reported Cartiva settlements in any of these cases, the timing of the complaints and voluntary dismissals suggests that the manufacturer may have reached an agreement to resolve the claims, or convinced the plaintiffs to dismiss their lawsuits by entering a tolling agreement, which would extend the statute of limitations for a period of time to refile the lawsuit in the future.

Each of the lawsuits raised similar allegations of fact and law, which are likely to be repeated in future complaints filed as individuals discover that their Cartiva toe implant failed due to design defects.

Although the manufacturer suggested the Cartiva failure rates were low, the lawsuits point to a study published in November 2020, which found that as many as 64% of individuals who received a Cartiva implant 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 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.