Cartiva Toe Implants Failed Due to Design Problems, Lawsuit Claims

Manufacturer misled medical community and patients by inflating Cartiva toe implant success rates, plaintiff says after suffering two device failures.

A Chicago woman is pursuing a lawsuit against the makers of the Cartiva toe implant, after experiencing failures in both feet, resulting in surgical removal of the device, which left her with permanent injuries.

In a complaint (PDF) filed in the U.S. District Court for the Northern District of Illinois on November 13, Michelle Paulsen argues that the manufacturer, Cartiva Inc., knew or should have known that design problems with the Cartiva SCI toe implant were causing patients to experience an excessively high rate of failure, yet withheld information about the potential risk from the medical community.

The Cartiva Synthetic Cartilage Implant (SCI) was approved by the U.S. Food and Drug Administration (FDA) in 2016, as an alternative to bone fusion for patients suffering from hallux limitus or hallux rigidus. The conditions 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 permanently.

However, widespread reports of problems ultimately resulted in a national Cartiva toe implant recall being issued 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, but often resulted in the need for the big toe to be fused, which the patient had originally sought to avoid.

Paulsen’s complaint joins a growing number of Cartiva toe implant 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.

According to her lawsuit, Paulsen received the Cartiva toe implants in 2022, about five years after developing discomfort in her right foot’s metatarsophalangeal joints, which link the toes to the base of the foot. A year later, she underwent a similar implantation on her left foot.

Instead of the relief she hoped for, Paulsen experienced worsening pain and a decreased range of motion in both feet. After her doctor made several attempts to relieve the pain, including the use of steroids, the implant was removed in September 2024. The left foot’s Cartiva toe implant was removed in May of this year.

Paulsen’s complaint notes that when originally released, the Cartiva toe implant was touted as having a very high success rate, but now some estimates claim that as many as two-thirds of the implants may fail, which helped lead to its removal from the market. It also points out that doctors were never able to independently recreate the success rates the manufacturer claimed it had seen during its own testing, arguing that the company misrepresented the Cartiva toe implant to the FDA and the medical community.

“Prior to the implantation of Plaintiff’s Cartiva implants, Defendant was aware of higher than reported loss of toe mobility, pain, and high failure rates associated with the Cartiva implant, including but not limited to over 144 adverse reports filed with the FDA.”

– Michelle Paulsen v. Cartiva Inc.

The lawsuit states that the Patient Brochure contained no warning that the patient is at risk of loss of range of motion, bone lysis, shrinkage of the implant, bone erosion or losing the ability to walk, all of which are complications now linked to the Cartiva toe implant.

Paulsen presents claims of strict product liability and negligence.

Cartiva Toe Implant Lawsuits

In late October, several plaintiffs filed a motion 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.

Centralization is a common step in litigation involving recalled medical and consumer devices, especially when linked to injuries or widespread complications. The plaintiffs argue that a Cartiva toe implant MDL, or multidistrict litigation, would prevent contradictory rulings from different judges, as well as streamline document production, depositions and expert challenges. 

Cartiva sent a response to the JPML last month 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.

The manufacturer also claims that the cases are unfit for consolidation because the injuries and failures all stemmed from a variety of different causes. That is contrary to what most plaintiffs say, whose lawsuits allege that Cartiva toe implant problems are a result of a common, underlying design defect.

As the JPML weighs 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.