Lawsuit Claims Cartiva SCI Failure Caused by Defective Design of Big Toe Implant

Cartiva is being accused of inflating the implant’s success rate and hiding reports of device failure due to shrinkage.

A North Carolina woman claims she has lost significant mobility after her Cartiva Synthetic Cartilage Implant (SCI) shifted out of position, requiring removal and fusion of her big toe.

Judy Kiel filed the complaint (PDF) against Cartiva Inc. in the U.S. District Court for the Eastern District of North Carolina on September 9, alleging that the Cartiva SCI big toe implant was defectively designed.

The Cartiva SCI, approved by the U.S. Food and Drug Administration (FDA) in 2016, is a molded cylindrical device made from polyvinyl alcohol-based (PVA) hydrogel. The manufacturer promoted the implant as an innovative alternative for patients with hallux limitus or hallux rigidus, forms of degenerative arthritis affecting the big toe joint.

However, the FDA announced a nationwide Cartiva SCI recall in October 2024, after the company admitted it was seeing “higher-than-expected” failure rates. When the implant fails, not only does it require revision surgery, but often also requires the big toe to be fused into immobility.

Kiel is one of a growing number of patients who have filed Cartiva SCI lawsuits following her implant’s failure, which can lead to severe pain, implant loosening and other complications. Each complaint makes similar claims, that Cartiva failed to properly design and test the implant before putting it into the stream of commerce.

According to her lawsuit, Kiel received her Cartiva SCI implant in December 2022 in her right big toe. However, she began to develop persistent pain and stiffness in her right foot, along with a limited range of motion, which is the exact opposite of what the implant was supposed to achieve.

In May of this year, Kiel’s doctor determined that the implant had subsided, or shrunk, two millimeters out of position. The complaint indicates that many medical experts warn this shrinkage is a sign of pending implant failure.  

On May 25, Kiel’s doctor performed revision surgery to remove the failed Cartiva SCI implant, and then permanently fused her big toe into place.

The lawsuit accuses Cartiva of inflating the implant’s success rate even as it received numerous complaints about the device’s failure.

“These claimed success rates, however, do not exist in clinical practice. Actual patient results have reported failure rates of 64% as opposed to the 13.5% failure rate Defendant reported to the FDA.”

— Judy Kiel v. Cartiva, Inc.

Kiel’s lawsuit presents claims of strict products liability design, manufacture and failure to warn, Negligence – design, manufacture, misbranded and improper transfer of 510(k) without FDA approval, misbranded and adulterated device, breach of express warranty, and violations of state and common law product liability. She seeks both compensatory and punitive damages.

Cartiva SCI Lawsuit Settlement Negotiations

While no global Cartiva settlement agreement has been announced to resolve all claims brought by individuals who experienced problems with the toe implant, there has been growing speculation that the manufacturer is entering into confidential Cartiva lawsuit settlement agreements or tolling arrangements with certain law firms.

The speculation comes after several recently filed lawsuits, all following the October 2024 recall, were quietly and voluntarily dismissed.

In the meantime, the claims have been proceeding through formal discovery and pretrial proceedings, with trial dates set in 2026 in a few of the pending cases.

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