Lawsuit Alleges Cartiva Implant Loosened, Degraded in Great Toe

Woman claims Cartiva Inc. knew for years that the toe implants had high failure rates, yet hid that information from federal regulators.

A Cartiva lawsuit filed by a Maryland woman claims she suffered permanent big toe injuries after the manufacturers suppressed reports of problems with the implants and hid information on failure rates.

The complaint (PDF) was brought by Melissa Hyatt in the U.S. District Court for the District of Maryland on January 23, naming Cartiva Inc. as the defendant.

The Cartiva SCI is a polyvinyl alcohol–based (PVA) hydrogel implant approved by the U.S. Food and Drug Administration (FDA) in 2016, as an alternative to big toe fusion for patients suffering hallux limitus or hallux rigidus, both forms of degenerative arthritis affecting the big toe joint.

The implants have been marketed as a breakthrough treatment allowing patients to retain flexibility in the big toe, which plays a key role in balance and mobility. The alternative is big toe fusion, which locks the toe in a permanently fixed position.

While originally considered revolutionary for those seeking to maintain mobility, the manufacturer later announced a Cartiva recall in October 2024, admitting 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.

As a result, plaintiffs like Hyatt have filed a growing number of Cartiva lawsuits, each indicating the toe implant was defectively designed, and that Cartiva Inc. failed to properly test it before marketing the implant to the medical community.

In her lawsuit, Hyatt indicates she was diagnosed with hallux rigidus, which causes stiffness and limited motion in the big toe. To resolve the issue, her doctor implanted a Cartiva SCI in the left big toe in August 2017.

According to the lawsuit, the surgery and recovery were “extremely painful” and the pain never got better. After several attempts to find other solutions, Hyatt had the Cartiva surgically removed in January 2022.

Hyatt states that Cartiva Inc. knew their device had a high rate of failure, yet hid that truth from the public and the medical community. While 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.

In addition, the company failed to follow post-marketing surveillance requirements, thus hiding those failure rates from federal regulators at the FDA, she claims. The lawsuit states that Cartiva knew it needed to issue a recall years before the implants were removed from the market.

“Defendant’s label reflects a Cartiva implant failure of 13.5%. However, in view of continual and ongoing reports and studies, the actual rate of failure of the defective Cartiva device is likely 6-7 times higher than Defendant’s reported failure rate, which it is believed the Defendant knew of before December 2019.”

– Melissa Hyatt v. Cartiva Inc.

Hyatt presents claims of strict product liability, negligent design, manufacture and/or distribution, misbranded and adulterated device, common law product liability and negligence, and breach of warranty. She seeks both compensatory and punitive damages.

Cartiva Lawsuit Consolidation Under Consideration

The lawsuit was filed days before the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments on whether all federal Cartiva lawsuits should be consolidated before one judge for coordinated discovery and pretrial proceedings in the Southern District of West Virginia.

Cartiva lawsuit consolidation was proposed by several plaintiffs in October. However, the following month, 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.

While no decision by the JPML has yet been announced, Cartiva implant lawyers are continuing to investigate new claims for those who have suffered injuries. If the JPML refuses the request to consolidate the litigation, each Cartiva lawsuit will continue on as an individual complaint.

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