Cartiva SCI Lawsuit Alleges Big Toe Implant Migrated Out of Position

High failure rates associated with the big toe implant resulted in a Cartiva SCI recall in 2024, after hundreds of individuals experienced worsening pain, decreased mobility and many required toe fusion surgery.

A product liability lawsuit filed by an Illinois man indicates that his Cartiva SCI toe implant not only failed and migrated out of position, but that the device also ground down the nearby joints, requiring him to undergo permanent fusion of his big toe.

The complaint (PDF) was brought by Daniel Catanese in the U.S. District Court for the Northern District of Illinois on March 6, indicating that the big toe implant, which was meant to allow him to retain flexibility, actually left him with substantially worse problems.

Cartiva Inc., the lawsuit’s sole defendant, is the manufacturer of the synthetic cartilage implant (SCI), which is a polyvinyl alcohol-based hydrogel device that was introduced in 2016. It was designed and marketed as an alternative to big toe fusion for patients suffering from hallux limitus or hallux rigidus, both forms of degenerative arthritis affecting the big toe joint.

However, after it was introduced, the implant was linked to a higher-than-expected number of serious problems, failures and complications, often only fixable through the big toe fusion operation the Cartiva SCI was supposed to avoid. As a result, the manufacturer issued a Cartiva SCI recall in October 2024, permanently removing the implant from the market.

As more patients have learned that they were not alone in experiencing problems with the big toe implant, a growing number of individuals like Catanese have been filing Cartiva SCI lawsuits nationwide, each involving similar allegations that the implants were defectively designed and caused more risks than benefits.

According to the lawsuit, Catanese underwent a Cartiva SCI implantation procedure in late 2017, based on marketing that the device was a safe and effective alternative to having his big toe fused in place. However, he notes that the implant neither alleviated his pain nor restored his range of motion.

In October 2019, Catanese indicates he received steroid injections for the pain, yet that only brought relief for three to six months. In February 2023, he received additional treatment for the pain, which also failed to provide permanent relief.

Finally, in November 2024, a month after the Cartiva SCI toe recall was announced, doctors surgically removed the implant. At that time, they discovered that the Cartiva had migrated out of position, and eroded the bone.

“Upon removal of the Defective Device, the SCI had shifted laterally and hollowed out Plaintiff’s entire lateral aspect of the metatarsal head. Plaintiff’s dorsal cortex on his great toe became so thin that it was unstable to place any implant.”

– Daniel Catanese v. Cartiva Inc.

After the failed Cartiva SCI implant was removed, Catanese underwent a bone graft and other procedures to repair the bone cyst.

Catanese indicates that Cartiva knew, or should have known, that there was a problem with the implants long before his device was implanted, noting that a clinical study which helped lead to the device’s approval has been under scrutiny for years. In addition, the lawsuit alleges that the company suppressed adverse event data, knowingly low-balled Cartiva SCI toe implant failure rates, and suppressed medical data warning of potential problems.

He presents claims of strict products liability and failure to warn, negligence, misbranded and adulterated device, breach of warranty and failure to warn. He seeks both compensatory and punitive damages.

Cartiva SCI Toe Implant Lawsuits

Catanese’s complaint will be consolidated with other federal Cartiva SCI toe implant lawsuits in the Eastern District of Arkansas before U.S. District Judge Kristine G. Baker, where all cases brought nationwide have been consolidated as part of a multidistrict litigation (MDL).

Judge Baker, assigned to oversee the litigation last month, will shepherd the lawsuits through coordinated discovery and pretrial proceedings. It is also expected that the judge will eventually order the parties to prepare a series of cases for early “bellwether” trial dates, which will give them an opportunity to see how juries respond to arguments, evidence and testimony likely to be repeated throughout the litigation.

While not binding on any other lawsuits, bellwether trials are closely watched, as they often help form the basis of settlement negotiations. However, if the trials and pretrial proceedings end with no Cartiva SCI toe implant lawsuit settlement, Judge Baker would likely begin remanding the cases back to their originating districts for individual trial dates.

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