MDL Sought for Cartiva Implant Lawsuits Filed in Federal Court System

Lawyers have proposed transferring all lawsuits over Cartiva toe implant failures to a U.S. District Judge in West Virginia, for coordinated discovery and pretrial proceedings.

Individuals who experienced problems with a defective big toe implant have asked a panel of federal judges to consolidate the growing number of Cartiva lawsuits before a single judge, to help manage discovery and pretrial proceedings in what could be hundreds of individual claims brought over the coming months and years.

The litigation involves the Cartiva SCI (Synthetic Cartilage Implant), which was approved by the U.S. Food and Drug Administration (FDA) in 2016, as a first-of-its-kind alternative to traditional joint fusion surgery for patients suffering from hallux limitus and hallux rigidus, two forms of degenerative arthritis that cause stiffness and pain in the big toe joint.

The implant is made of a polyvinyl alcohol-based (PVA) hydrogel and was marketed as a durable synthetic cartilage that could preserve joint motion and reduce recovery time.

However, in October 2024, manufacturer Cartiva Inc. acknowledged that the device had a “higher-than-expected failure rate” and issued a Cartiva toe implant recall, reversing earlier claims that only 13% of implants failed. Subsequent reports and surgeon data have suggested Cartiva failure rates may reach up to two-thirds of all procedures.

The company now faces at least seven Cartiva toe implant lawsuits filed in five different federal district courts, each involving nearly identical allegations that individuals experienced painful complications when the device failed, leading to the need for removal surgery and often requiring that the big toe be fused into place, permanently reducing mobility.

Last week, five of those plaintiffs filed a motion for transfer (PDF) with the U.S. Judicial Panel on Multidistrict Litigation (JPML), calling for all of the federal claims to be consolidated before one judge in the Southern District of West Virginia for coordinated discovery and pretrial proceedings.

The plaintiffs argue that all of the cases involve common questions of fact, that the number of cases is likely to continue to grow in the wake of last year’s Cartiva recall, and that consolidation would serve the convenience of the parties and witnesses.

“All of the plaintiffs with pending lawsuits against Cartiva allege the same operative facts, specifically that they were surgically implanted with the Cartiva synthetic cartilage device, that it failed prematurely due to loosening, shrinkage and/or subsidence, and that the failure of the recalled device forced them to undergo a painful and risky second surgery.”

– Memorandum in Support of Motion to Transfer

According to plaintiffs, two of the Cartiva toe implant lawsuits are filed in West Virginia. Those two claims, and one filed in Maryland, are the only cases that have advanced beyond the filing of a complaint, and are already presenting challenges that the plaintiffs’ attorneys say could lead to conflicting rulings and schedules and other problems, which a multidistrict litigation (MDL) is designed to alleviate.

The plaintiffs note that such consolidation is common for recalled medical devices linked to high failure rates, particularly joint replacement devices.

If the JPML agrees to consolidate the Cartiva toe implant lawsuits, all current and future claims filed in federal courts will be transferred to one judge, who will oversee coordinated discovery, pretrial motions, settlement talks, and potentially a series of early bellwether test cases.  

However, each case would remain an individual lawsuit, and if the parties fail to reach a Cartiva toe implant settlement agreement or other resolution after all the pretrial proceedings are concluded, each individual lawsuit may be later remanded back to the U.S. District Court where it was originally filed to be prepared for individual trial dates.