Cartiva Lawyers Select Settlement Mediator in Toe Implant Lawsuit

A former U.S. Magistrate Judge will meet with lawyers involved in the Cartiva toe implant lawsuit in March 2026, to begin mediation settlement talks.

The makers of the Cartiva big toe implant have agreed to enter into mediation proceedings with a Pennsylvania man, who claims the recalled device was defectively designed, causing it to fail and leaving him with lasting mobility problems.

Approved by the U.S. Food and Drug Administration (FDA) in 2016, the Cartiva SCI (Synthetic Cartilage Implant) is a molded cylindrical device made from polyvinyl alcohol-based (PVA) hydrogel. It was promoted as an innovative alternative for patients with hallux limitus or hallux rigidus, forms of degenerative arthritis affecting the big toe joint.

However, in October 2024, the FDA announced a nationwide Cartiva toe implant recall, after the company acknowledged “higher-than-expected” failure rates. When the implant fails and must be removed, often leaving patients needing toe fusion surgery, which permanently reduces mobility in the foot.

Although Cartiva gained approval based on clinical trial data suggesting a 13% failure rate, lawsuits allege the company was aware the real-world failure rate was far higher. In February, Pennsylvania resident Robert J. Didonato filed a Cartiva lawsuit accusing the manufacturer of concealing evidence that the implant failed in nearly two-thirds of patients, while continuing to market it as safe and effective.

According to a court document (PDF) issued on September 4, Didonato and Cartiva Inc. have agreed to attempt to settle the Cartiva lawsuit through a formal mediation process, as part of the court’s Alternative Dispute Resolution (ADR) program, before the case proceeds to trial before a jury.

The parties selected Judge Lisa Lenihan, a former magistrate judge who served in the Western District of Pennsylvania for 20 years, before retiring in October 2003 and focusing on litigation mediation.

Didonato and Cartiva agreed to split Judge Lenihan’s fees 50/50. Their attorneys will meet with the judge on March 12, 2026, for the first mediation session.

Possible Cartiva Lawsuit Settlements

The move toward mediation in Didonato’s case comes amid speculation that a number of other Cartiva lawsuits have recently been quietly resolved or settled outside of the court system, with other complaints brought since the October 2024 recall being voluntarily dismissed by the parties shortly after they were filed.

While no global Cartiva settlement agreement has been announced to resolve all claims brought by individuals who experienced problems with the toe implant, there has been growing speculation that the manufacturer was entering into confidential Cartiva lawsuit settlement agreements or tolling arrangements with certain law firms, since a number of claims were being dropped shortly after they were filed.

However, the claim filed by Didonato and others have been proceeding through formal discovery and pretrial proceedings, with trial dates set in 2026 in a few of the pending cases.

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