Failed Cartiva Implant Required Multiple Toe Surgeries, Lawsuit Alleges

Lawsuit claims Cartiva Inc. intentionally misled federal regulators, doctors and patients about the safety and effectiveness of its toe implant.

An Arizona woman has filed a lawsuit alleging her Cartiva toe implant failed four years after it was placed in her foot, leaving her with serious complications before the device was ultimately pulled from the market two years later.

The complaint (PDF) was brought by Andrea Valentine in the U.S. District Court for the District of Arizona late last month, naming Cartiva Inc. as the sole defendant.

Valentine claims her Cartiva implant was defectively designed and that its effectiveness was overhyped by a company placing profits ahead of patient safety.

Cartiva Toe Implant Risks

The Cartiva synthetic cartilage implant (SCI) was designed to treat degenerative arthritis conditions including hallux limitus and hallux rigidus. Made from a polyvinyl alcohol-based gel and implanted in the big toe, Cartiva Inc. promoted the device as an alternative to big toe fusion, a standard treatment for such conditions that greatly reduces mobility. The company also claimed its toe implant had presented an 87% success rate in pre-market testing.

However, according to real-world data reviewed by the U.S. Food and Drug Administration (FDA), the Cartiva implant’s success rate was only between 21% and 46%, meaning most patients’ devices failed. This resulted in a Cartiva implant recall in October 2024.

Since then, a growing number of recipients have begun filing Cartiva toe lawsuits in courts nationwide, indicating the defective design of the implants resulted in complications including chronic pain, loosening implants, fractures, bone erosion and total implant failures. This frequently requires a failed implant to be surgically removed and the big toe fused into place, which is usually what the patient sought to avoid.

Failed Cartiva Implant Allegations

According to her complaint, Valentine received a Cartiva implant in her left big toe in December 2018. At the time, Cartiva’s promotions claimed that her recovery time would be faster and less painful than if the toe were fused.

Instead, the lawsuit states Valentine experienced chronic pain, stiffness and limited range of motion. After four years of failing to provide the relief advertised, the Cartiva implant was surgically removed in May 2024, and Valentine’s big toe was fused in place.

The lawsuit indicates Valentine has undergone several additional surgeries related to the failed Cartiva implant, which caused toe deformity and bone loss.

Valentine alleges that Cartiva knowingly inflated the success rates of the device and refused to update its label when doctors and patients began reporting problems.

“Numerous surgeons and podiatrists informed Cartiva soon after device approval that the Cartiva device was failing at a high rate and not performing as intended. When these surgeons contacted Cartiva, they were told the device was safe and they simply needed to adjust their expectations for patient recovery and pain.”

– Andrea Valentine v. Cartiva Inc.

The complaint indicates that, to date, there are at least 144 Cartiva implant adverse event reports submitted to the FDA, which conducted its own analysis amid a flood of doctor and patient complaints. It was only then that the true failure rates came to light, and the device was pulled from the market, Valentine notes.

The filing presents claims of design, manufacture and failure to warn, negligence, misbranded and adulterated device, product liability and negligence for class II/class III medical devices, and breach of warranty. It seeks both punitive and compensatory damages.

Cartiva Implant Failure Lawsuits

Valentine’s claim will be consolidated with about 20 similar Cartiva implant failure lawsuits in the Eastern District of Arkansas before U.S. District Chief Judge Kristine G. Baker as part of a multidistrict litigation (MDL) for coordinated discovery and pretrial proceedings.

Judge Baker is expected to propose a bellwether trial plan, which would involve holding a series of early trials to test the strengths and weaknesses of the parties’ cases before a jury. Although they are not binding on other lawsuits, the outcomes of these trials could help form the basis of a Cartiva implant settlement agreement.

If no agreement or other resolution is reached after the bellwether trials and pretrial proceedings are completed, Judge Baker would likely begin remanding the cases back to their originating federal courts for individual trial dates.

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