Big Toe Fusion Lawsuit Filed Over Failed Cartiva SCI Implant

Cartiva implant failure led to permanent fusion of the big toe, resulting in lifelong complications and loss of mobility.

A Maine resident has filed a Cartiva big toe fusion lawsuit, indicating that he had to undergo big toe fusion after the implant failed, causing a permanent loss of mobility.

The Cartiva Synthetic Cartilage Implant (SCI) was approved by the U.S. Food and Drug Administration (FDA) in 2016, as an alternative to big toe fusion for patients suffering from hallux limitus or hallux rigidus, two conditions that are both forms of degenerative arthritis, which affect the big toe joint.

The implant is made from a polyvinyl alcohol–based (PVA) hydrogel and was marketed as a breakthrough treatment that would allow patients to retain flexibility in the big toe, which plays a key role in balance and mobility. By contrast, bone fusion locks the toe in a fixed position, which also permanently reduces the toe’s mobility.

However, those expectations increasingly gave way to reports of serious complications, which resulted in a national Cartiva toe implant recall being announced in October 2024, after the manufacturer finally admitted the implant was linked to “higher-than-expected” failure rates. Those failures not only required revision surgery to remove the implant, they often resulted in the need for the big toe to be fused, which the patient had originally sought to avoid.

In a complaint (PDF) brought in the U.S. District Court for the District of Maine on January 20, Douglas L. Snow indicates he had to have his big toe fused due to the defective design of the Cartiva implant. 

His claim joins a growing number of Cartiva big toe fusion lawsuits, each indicating the device is defectively designed, and that Cartiva Inc. failed to properly test the implant before marketing it to the medical community.

Snow indicates he was first implanted with the Cartiva SCI in June 2023 for treatment of arthritic pain and stiffness in his left big toe. However, the lawsuit notes that he began to experience problems with the device shortly after implantation.

By March 2024, it was apparent that the Cartiva had failed, requiring him to undergo revision surgery to have it removed, as well as having his big toe permanently fused into place.

Big toe fusion operations are usually reserved for severe arthritis conditions, toe deformities or as a result of failed procedures to address other problems, as with a Cartiva implant failure. Not only does it make the toe extremely stiff, it permanently affects the way the patient walks, limits them to shoes with a maximum of a 1-inch heel, and some have to use inserts in their shoes or have alterations done to continue walking comfortably.

However, Cartiva Inc. allegedly failed to warn the medical community or patients of the implant’s true failure rate, according to Snow’s big toe fusion lawsuit. Originally claiming that the Cartiva toe only failed 13% of the time, the complaint says that later reports and data suggest Cartiva failure rates may reach up to two-thirds of all procedures.

“Contrary to Defendant’s representations, the Cartiva SCI was not safe as the device was defective and unreasonably dangerous, failed causing him significant and permanent injuries, and was ineffective at alleviating Plaintiff’s pain or restoring his range of motion.”

– Douglas Snow v. Cartiva Inc.

Snow presents claims of design defect, manufacturing defect, failure to warn, negligence – design manufacturer, misbranded and improper transfer of 510k/PMA without FDA approval, misbranded and adulterated medical device, state and common law claims of product liability and negligence for FDA class II and III devices, and breach of warranty. He seeks compensatory and punitive damages.

Cartiva Big Toe Fusion Lawsuits

Several plaintiffs pursuing big toe fusion lawsuits  filed a motion in October with the U.S. Judicial Panel on Multidistrict Litigation (JPML), calling for all federal Cartiva toe implant lawsuits to be consolidated before one judge in the Southern District of West Virginia for coordinated discovery and pretrial proceedings. However, in November, Cartiva sent a response to the JPML opposing consolidation, arguing that it could disrupt ongoing Cartiva settlement negotiations, which have already resolved several lawsuits brought by individuals who experienced problems with the implant.

This week the JPML will hear oral arguments and weigh whether to consolidate the lawsuits into a multidistrict litigation. Cartiva implant lawyers are continuing to investigate new claims for those who have suffered injuries.

Financial compensation may be available through a Cartiva implant failure lawsuit settlement for individuals who received the big toe implant and experienced any of the following complications:

• Implant Failure/Fracture
• Subsidence (implant sinks into the bone)
• Toe Fusion Surgery
• Replacement Surgery
• Revision Surgery

All claims are being pursued by Cartiva implant lawyers on a contingency fee basis, which means that there are no fees or expenses paid unless a Cartiva settlement or lawsuit payout is received.

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