Cartiva Lawsuits Allege Toe Implant Fails in About 64% of Patients

Lawsuit comes a year after a Cartiva recall was announced due to high failure rates and reports of revision surgeries and big toe fusions.

A Pennsylvania man is among a growing number of plaintiffs who say their big toe was fused after a Cartiva implant failed, a complication they claim occurs in roughly two-thirds of all recipients.

Scott Knoflicek filed a complaint (PDF) in the U.S. District Court for the Eastern District of Pennsylvania on November 5, naming Cartiva Inc. as the sole defendant. His lawsuit is one of about half a dozen filed just since the end of October, nearly doubling the number filed over the last year or so in a matter of days.

The Cartiva Synthetic Cartilage Implant (SCI) was approved in 2016 by the U.S. Food and Drug Administration (FDA) as an alternative for patients suffering from hallux limitus or hallux rigidus, which are forms of degenerative arthritis affecting the big toe joint. It is made from polyvinyl alcohol-based (PVA) hydrogel.

In October 2024, the FDA announced a national Cartiva toe implant recall following the company’s admission that the implant was linked to “higher-than-expected” failure rates. Those failures not only require revision surgery to remove the implant, they also often result in the big toe being fused into immobility.

Even before the recall, a growing number of patients like Knoflicek began filing Cartiva toe implant lawsuits, indicating the device was defectively designed and left them with severe pain, reduced mobility and other complications. Each complaint contains similar allegations, that Cartiva failed to properly design and test the implant before making it available to the medical community.

Knoflicek’s lawsuit indicates he was implanted with a Cartiva right big toe implant in August 2018. However, less than a year later the implant failed.

In July 2019, Knoflicek underwent revision surgery to have the implant removed. Afterward, his big toe was fused into place, causing him to lose significant mobility. In addition, the toe became infected, which spread through his foot over the next three years.

From then until September of this year, Knoflicek had several additional surgeries to fight the infection, resulting in multiple toe amputations. His lawsuit accuses Cartiva of lying about the device’s failure rate for years, hiding adverse event reports and exaggerating the implant’s efficacy and success rate.

“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.”

– Scott Knoflicek v. Cartiva Inc.

The lawsuit argues that the manufacturer failed to design or test the implants properly, in violation of federal laws. Knoflicek indicates the manufacturer misrepresented the effectiveness of the implant as a result, claiming that the company’s claims about the implants were false and misleading.

Cartiva Toe Implant Lawsuits

The complaint comes amid growing speculation that Cartiva, Inc. is entering into confidential Cartiva lawsuit settlement agreements or tolling arrangements with certain law firms, although no global settlement has been announced.

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

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

Late last month, several plaintiffs filed a motion for transfer 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 will likely continue to grow in the wake of last year’s Cartiva recall, and that consolidation would serve the convenience of the parties and witnesses.

If the JPML agrees to consolidate the Cartiva lawsuits into a multidistrict litigation (MDL), 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.  

If consolidated, each case will 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.

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