Lawsuits Over Cartiva Real-World Failure Rates Continue To Roll Into MDL

Individuals who once believed their Cartiva implant complications were isolated are now filing lawsuits, citing higher-than-expected failure rates and alleged design defects.

The number of Cartiva lawsuits brought in federal courts over problems with the recalled big toe implant has tripled in recent weeks, as more patients learn their complications may reflect broader, allegedly undisclosed failure rates.

The Cartiva synthetic cartilage implant (SCI) is a big toe implant designed for those suffering from hallux limitus or hallux rigidus, which are forms of degenerative arthritis. It is constructed of polyvinyl alcohol-based gel, and meant to be used as an alternative to having the big toe permanently fused into place. The fusion technique includes significant loss of mobility, which the Cartiva SCI is supposed to preserve.

However, the U.S. Food and Drug Administration announced a Cartiva toe implant recall in October 2024 after the manufacturer revealed that real-world failure rates for the implants were significantly higher than previously indicated.

Since then, as more individuals have learned about the recall and recognized their complications were not isolated, the number of Cartiva SCI lawsuits filed nationwide has grown. The complaints raise similar allegations, claiming the implants were defectively designed and that those risks were concealed from both consumers and the medical community.

Cartiva Toe Implant MDL

In February, the U.S. Judicial Panel on Multidistrict Litigation consolidated all Cartiva real-world failure rate lawsuits into a multidistrict litigation (MDL) before U.S. District Judge Kristine G. Baker in the Eastern District of Arkansas. The combined complaints will now be ushered through coordinated discovery, pretrial proceedings, and, if necessary, a series of early test cases known as bellwether trials.

These trials are designed to test the strengths and weaknesses of evidence, testimony and arguments that would likely be used in most, if not all, Cartiva toe lawsuits. Though not binding on any other cases, bellwether trials are usually closely watched for jury trends and commonalities, which could help the parties reach a Cartiva settlement agreement some time in the future.

In one of the more recent claims brought by Daniel Catanese on March 6, he indicates that his Cartiva implant migrated out of position and ground down nearby joints. These factors caused his situation to worsen rather than improve. He was eventually required to undergo permanent fusion of his big toe, the event the Cartiva implant was supposed to help him avoid.

In a transfer order (PDF) issued on April 16, Catanese’s lawsuit was moved from the U.S. District of Northern Illinois, where it was originally filed, to the Eastern District of Arkansas. According to the order, there were originally only five Cartiva lawsuits filed in federal courts nationwide, while now there are at least 14.

That number is expected to continue to rise as more implant recipients discover that Cartiva real-world failure rates were much higher than advertised, and that their injuries may be due more to design and manufacturing problems than bad luck.

Following the bellwether trials and pretrial proceedings, if there are no Cartiva settlements or other resolutions reached, the judge is likely to begin remanding claims back to their original district courts for individual trial dates.

To stay up to date on this litigation, sign up to receive Cartiva toe implant lawsuit updates sent directly to your inbox.