Cartiva Implant Lawsuit

The Cartiva toe implant is a synthetic cartilage device used to treat arthritis in the big toe. New evidence suggests that these implants are defectively designed and prone to failures that can result in pain, further surgery, and other injuries. Cartiva toe implant lawsuits are now being filed by individuals who experienced a premature failure of their implant.

We hoped to see Cartiva settlement payouts by 2024 from a global settlement. That has not happened. This litigation is dragging on, unfortunately. But these lawsuits could reach a settlement at any time. You want to submit a case before that happens. So if you have a claim, call us or another lawyer sooner rather than later.

 Cartiva Toe Implant

The Cartiva Synthetic Cartilage Implant (SCI)is a medical device used to treat arthritis in the big toe, specifically addressing conditions such as hallux rigidus. Hallux rigidus is characterized by stiffness and pain in the big toe due to arthritis, and it can significantly affect mobility and quality of life. The Cartiva SCI aims to provide a solution that retains more joint mobility compared to traditional treatments like fusion surgery, which immobilizes the joint to alleviate pain but also restricts movement.

Big toe arthritis is a condition that impacts over 2 million people in the U.S. Arthritis in the big toe gradually degrades the cartilage in the toe joint. This eventually causes the bones to grind against each other, which is extremely painful.

Until recently, the only real treatment option to alleviate the pain of advanced arthritis in the big toe was fusion surgery (arthrodesis).

So the Cartiva toe implant is a medical device that was developed as an alternative treatment for osteoarthritis of the big toe joint to deal with the injury that causes significant pain and mobility issues for patients with painful degenerative or post-traumatic arthritis in the first metatarsophalangeal joint, with or without mild hallux valgus.

This changed several years ago with the development of the Cartiva implant. The Cartiva implant is tiny and can be inserted into the metatarsophalangeal joint in the toe.

Design and Material

The implant is made from a biocompatible, durable hydrogel that mimics the properties of natural cartilage. This material is polyvinyl alcohol (PVA), known for its good swelling properties and compatibility with human tissues. The implant is designed to function like cartilage, allowing for natural joint movement and aiming to reduce the pain caused by bone-on-bone friction in the joint.

The Cartiva implant is a molded cylindrical device placed into the metatarsal head of the first metatarsophalangeal joint using instruments explicitly designed for its implantation. It is marketed as a simple procedure where damaged cartilage is replaced with a bullet-sized implant inserted into a pilot hole created in the first metatarsal head.

Implantation Procedure

The Cartiva SCI is inserted into the metatarsal head at the base of the big toe through a minimally invasive surgical procedure. This typically involves creating a small pilot hole where the implant is then press-fit. The procedure is touted as relatively simple and designed to preserve more of the foot’s natural structure and function, promoting quicker recovery times than invasive procedures like fusion.

The Cartiva instrumentation is used to create a cavity of the appropriate size in the metatarsal head and to insert the Cartiva toe implant into the cavity. The instrumentation drills a cavity in the metatarsal head to deploy the implant, which is claimed to be a straightforward process that requires minimal removal of healthy tissue, results in minimal surgical trauma, and allows for rapid recovery.

Unlike natural cartilage, which has a very slow turnover and limited self-repair capability, the Cartiva implant uses a polyvinyl alcohol-based hydrogel (PVA) as a joint replacement alternative to traditional fusion treatments. This hydrogel is biocompatible and has good swelling properties, though the biomechanical design of the implants does not replicate the soft-on-soft interactions of natural cartilage.

Once implanted, the Cartiva is supposed to essentially replace the degraded cartilage in the toe and alleviate the bone-on-bone rubbing.

Told It Was Simple

The defendants claim that joint resurfacing with the Cartiva implant is a simple procedure that does not involve significant removal of healthy tissue. It also results – we were told, anyway – in minimal surgical trauma and a quick recovery time.

Big Toe Arthritis

Big toe arthritis, also known as hallux rigidus, is a type of arthritis that affects the joint at the base of the big toe. This joint, called the first metatarsophalangeal joint, allows the big toe to move up and down, which is important for walking, running, and jumping effectively and pain-free.

In people with big toe arthritis, the cartilage that covers the ends of the bones in the joint begins to wear away. This can lead to pain, stiffness, and decreased range of motion in the joint. Over time, bone spurs may also develop around the joint, further restricting movement and increasing pain. Big toe arthritis affects about 2.2 million Americans.

Big toe arthritis is most commonly caused by wear and tear on the joint—the kind of stress we all put on our big toes. Other factors contributing to the development of big toe arthritis include genetics, foot injuries, and inflammatory conditions such as gout and rheumatoid arthritis.

Problems With the Cartiva Implant

The Cartiva toe implant has a very high rate of failure because it tends to shrink once implanted. This shrinkage causes the implant to come loose and migrate from its implant site, which can cause nerve damage and debilitating pain. Patients eventually are forced to undergo additional surgery to have the Cartiva implant removed and the bones fused together.

In addition, problems with the Cartiva implant have resulted in infections, implant fracture, osteolysis, bone over-production, cysts, silastic granulomas, and other complications.

The high failure rate from shrinkage and migration of the Captiva appears to be related to the material from which the implants are made. The Cartiva implant is a polyvinyl membrane gel (PVA). The PVA material is designed to be biocompatible and mimic the properties of cartilage.

Unfortunately, in some patients, the PVA material degrades rapidly after implantation. The resulting shrinkage causes the implant to loosen and migrate.

The Manufacturer Failed to Disclose the Risks of the Cartiva Implant

Stryker, an international medical device and healthcare company based in Michigan, manufactures and sells the Cartiva toe implant. The FDA approved it through the pre-market approval process because it was “substantially equivalent” to the existing fusion surgery technique. This shortcut evades full FDA review before approval.

0441579001629991025Stryker has suppressed facts from the FDA and the public that the Cartiva implants have a very high failure rate due to shrinkage and implant migration. The initial FDA approval was obtained based on a single, very limited study that significantly understated the failure rate of the implants.

Subsequent studies have shown that the Cartiva has a much higher failure rate and presents numerous complication risks. This has prompted some health insurance companies to deem the Cartiva implant “experimental” and refuse coverage for it.

The warning label for the Cartiva implant indicates a 13.5% failure rate, but evidence suggests that the actual failure rate is much higher. Since it was first approved, the FDA has been notified of 144 adverse events involving the Cartiva. Almost all of these events involved implant migration due to shrinkage. A post-market study found that patients with the Cartiva implant reported failure rates as high as 64%.

Stryker is fully aware of the evidence indicating that the Cartiva implant has an extremely high failure rate but has failed to disclose this risk to the FDA. Despite the post-market study suggesting failure rates over 60%, Stryker has not taken action to recall the Cartiva implant. To this day, there has not been a Cartiva implant recall.

Stryker has also not amended its warning label or product information to accurately reflect the true risk level. The post-market studies and adverse event reports suggest that the Cartiva implant failure rate is seven times higher than the failure rate disclosed in the warning label.

Why Did the FDA Approve Cartivia?

Baumhauer et al. (2016) conducted a study, also known as the “Motion Study,” to evaluate the effectiveness of the Cartiva Synthetic Cartilage Implant for treating big toe arthritis. The study included 236 patients who received either the Cartiva implant or traditional surgical treatment for their condition.

The study found that patients who received the Cartiva toe implant experienced significantly greater pain and function improvement than those who underwent traditional surgical treatment. Specifically, patients who received the Cartiva implant reported a 91% reduction in pain and a 128% improvement in joint function at two years post-surgery.

The study also found that patients who received the Cartiva implant had a lower complication rate than those who underwent traditional surgical treatment. Specifically, the Cartiva group had a 7.3% rate of complications compared to a 16.3% rate of complications in the traditional surgical group.

A follow-up Motion Study showed similar results. Based on these studies’ results, the Cartiva toe implant was approved by the FDA for the treatment of big toe arthritis in 2016. But the clinical experience could not have been more different from the Motion Study. A follow-up study found failure rates as high as 64%. That was an admittedly small study, but it is consistent with the high failure rate doctors saw on the ground.

What was the deal with the Motion Studies? We have to figure that out. But we know that the lead author of the Motion Studies also saw failures due to the implant slipping into the bone. His clinic longer uses Cartiva because he an unacceptable failure rate of these toe implants.

In 2024, many in the medical community now recognize that implant shrinkage is a precursor to failure, with numerous reports and studies indicating an exponentially higher failure rate than admitted by the defendants. Despite being marketed as a revolutionary treatment for great toe arthritis, the Cartiva implant showed a high incidence of failure in clinical practice, leading to significant patient dissatisfaction and a high rate of revision surgeries.

Cartiva Implant Failure Lawsuits

Individuals who experienced a failure of their Cartiva toe implant are now bringing product liability lawsuits against the manufacturer. These Cartiva implant lawsuits allege that the implant was defectively designed due to issues with the PVA material. They also allege that the manufacturer knew or should have known about the high failure rate and other problems with the Captiva but failed to disclose these risks on the warning label.

A growing number of Cartiva implant lawsuits have already been filed across the country. Many more are expected to be filed as patients experience premature failures and complications. If a high volume of these cases gets filed over the next few months, they could potentially be consolidated into a new class action MDL.

Cartiva Timeline – The Path to Litigation

Here’s an overview of the development of the Cartiva Toe Implant:

  1. In the early 2000s, Cartiva, a medical device company based in Alpharetta, Georgia, began working on a synthetic cartilage implant that could be used to treat osteoarthritis of the big toe joint. The goal was to create a device that would provide the same cushioning and shock absorption as natural cartilage while also being durable and long-lasting.
  2. The Cartiva Toe Implant was developed using a proprietary polymer material similar in structure and function to natural cartilage. The implant is a small cylindrical device inserted into the big toe joint to replace damaged cartilage. It is designed to preserve joint motion and function, reduce pain and swelling, and improve patients’ overall quality of life.
  3. Clinical trials of the Cartiva Toe Implant began in the mid-2000s, and the device received FDA approval in 2016. The approval was based on the results of two randomized controlled trials, which showed that the Cartiva Toe Implant provided significant pain relief and improved joint function compared to traditional fusion surgery.
  4. Since its approval in 2023, the Cartiva Toe Implant has been used in thousands of procedures in the United States and other countries.
  5. A post-market study suggested the failure rate with a Cartiva toe implant may be as high as 64%.

Last year, lawyers began to file a Cartiva toe implant lawsuit.

Pending Cartiva Implant Cases

At least five Cartiva toe implant lawsuits have been filed in federal courts nationwide in the early stages of this litigation. The table below lists these Cartiva product liability lawsuits, each filed in a different federal district court.

Interestingly, four of the five cases were voluntarily dismissed, suggesting they may have been settled out of court. But the defendants seemingly changed their view on settlement and now seem to be looking to defend these cases at least a bit longer in 2024.

Case Title Court Date Filed
Gesmer v. Cartiva, Inc. et al. Northern District of California 3/14/2022
Thompson v. Cartiva, Inc. et al Eastern District of California 3/18/2022
Neil v. Cartiva, Inc., et al. Western District of North Carolina 5/31/2022
Peterson v. Cartiva Inc., et al. Eastern District of Wisconsin 6/14/2022
Atkinson v. Cartiva Inc., et al. Western District of Texas 10/14/2022

The Complaint filed in Peterson v. Cartiva et al. (2:22-cv-685) in the U.S. District Court for the Eastern District of Wisconsin is typical of those filed in all other cases. It contains a long section detailing the development history of the Cartiva toe implant and the FDA short-track approval process.

Next, the Complaint contains a short section with detailed factual allegations regarding the plaintiff’s experience with the Cartiva implant. According to the Complaint, Peterson had the Cartiva implant surgically inserted in January 2018. The Complaint does not allege a specific failure of Peterson’s implant but claims that it was defective and failed to alleviate Peterson’s pain, resulting in surgical removal and medical expenses.

Sample Cartiva Lawsuit

An example of a Cartiva implant lawsuit that may have settled is Atkinson v. Cartiva, Inc.- 1:22-cv-01037 (W.D. Texas). The plaintiff in that case had the Cartiva implant installed in her toe in November 2018. Subsequently, she experienced continuing pain and limited range of motion. Just two years later, she was told that the device was defective, and it was surgically removed. Atkinson filed her lawsuit against Cartiva in the Western District of Texas.

A notice of voluntary dismissal was filed in the case last month. The voluntary dismissal strongly suggests that a confidential settlement agreement was reached in the case.

Example of a Newly Filed Cartiva Toe Implant Lawsuit

A Texas woman filed a lawsuit against Cartiva, Inc., Wright Medical Group, N.V., and Stryker B.V. in April 2024 following complications from a Cartiva implant procedure.

The plaintiff underwent the procedure on March 30, 2018, at the Texas Institute of Surgery, aiming to alleviate pain and restore mobility in a toe affected by degenerative arthritis. The procedure did not provide the anticipated relief or restoration of motion. Instead, the plaintiff experienced severe and debilitating pain, loss of mobility, nerve damage, and constant irritation at the implant site.

The failure of the Cartiva implant became evident over time, marked by implant subsidence (shrinkage), which led to further complications, including toe deformity and bone loss. This necessitated additional medical interventions, including surgery in December 2023 to remove the defective implant and a subsequent “fusion” surgery to correct the damage. The fusion procedure involved using bone from another part of the body to fuse the bones in the toe, resulting in further pain and suffering.

The ongoing severe pain and loss of mobility significantly impacted the plaintiff’s quality of life, causing both physical and mental anguish. The plaintiff suffered diminished enjoyment of life, incurred extensive medical costs, and lost income due to an inability to work. Consequently, the plaintiff seeks compensation for injuries and damages through this lawsuit.

What Are the Specific Allegations in a Cartiva Toe Implant?

In the case involving the Cartiva Synthetic Cartilage Implant, the negligence claims are centered around several key allegations against the defendants, who are the manufacturers and distributors of the SCI. The main points of the negligence alleged in a Cartiva lawsuit are:

  1. Negligent Design, Manufacture, and Distribution: Each Cartiva lawsuit alleges that the Cartiva SCI was defectively designed and manufactured, which resulted in the implant not performing as intended. This is the core of what these claims are about. Cartiva lawsuits argue that the devices are prone to degradation and migration and did not adequately mimic natural cartilage functions, leading to higher failure rates than reported. So the negligence claim is based on the premise that the defendants should have foreseen these defects and either corrected them or adequately warned users.
  2. Failure to Warn: Cartiva defective toe implant suits argue that the defendants failed to adequately warn about the risks and potential failures associated with the SCI. This includes the risk of the device failing and the severe consequences of such failures, which could include additional surgeries, increased pain, and mobility issues.
  3. Misrepresentation of Product Safety and Efficacy: These lawsuits include allegations the defendants misrepresented the safety and effectiveness of the SCI in their marketing and communications with the FDA and the medical community. By allegedly providing false or misleading information, the defendants could have prevented users and healthcare providers from making fully informed decisions about using the SCI.
  4. Non-Compliance with Federal Regulations: The defendants are accused of not complying with various federal regulations governing medical device manufacturing and sale. These include alleged violations related to the manufacturing process, quality control, reporting of adverse events, and monitoring of the product’s performance post-market.
  5. Breach of Implied and Express Warranties: Most Cartiva implant lawsuits further allege that the defendants breached implied and express warranties by providing a product that was not fit for its intended use and did not perform as expressly stated by the defendants.
  6. Failure to Conduct Adequate Testing: There are claims that the defendants did not conduct adequate pre-market testing to ensure the SCI’s safety and effectiveness, particularly regarding its long-term durability and interaction with body tissues.
  7. Improper Response to Adverse Reports: Allegations include that the defendants did not adequately respond to adverse outcomes and reports of device failure, nor did they take appropriate action, such as issuing recalls or enhancing the product’s design and manufacturing processes in response to such reports.

Cartiva Implant Lawsuit Punitive Damages Claims

There is also a real risk of punitive damages in this litigation. Punitive damages in cases like the one involving the Cartiva SCI are intended as a form of punishment for the defendant and a deterrent against future wrongful actions by the defendant or others. The primary goal of punitive damages is not to compensate the plaintiff but to penalize the defendant for egregious, reckless, or particularly harmful behavior and to prevent similar conduct by them or others in the future.

Punitive damages are typically awarded when the defendant’s actions are found to be willfully negligent, fraudulent, or reckless to the rights and safety of others. The plaintiff must usually prove that the defendant acted with a conscious disregard for the safety of others.

In the context of a case like Cartiva SCI, if the court considers punitive damages, it would assess whether the defendants’ actions, such as allegedly misleading the FDA, failing to adequately test the product, or not warning about potential risks, were so negligent or deceitful that they merit not just compensation for the victim but also a financial punishment that could deter such behavior in the future.

Punitive Damages May Drive Cartiva Settlements

The risk of punitive damages may increase expected settlement amounts in legal disputes, primarily because these damages are designed to punish defendants for particularly egregious behavior and deter similar future conduct. When punitive damages are possible, defendants may face significantly higher financial penalties beyond compensatory damages for the actual harm caused.

This potential for substantial financial liability makes defendants more inclined to settle cases out of court to avoid the unpredictability of a jury decision on punitive damages, which can be considerably large and financially damaging. Settlements provide a more controlled resolution, allowing defendants to manage their financial exposure and avoid the negative publicity that a trial could bring, especially when punitive damages highlight wrongful behaviors to the public.

Contact Our Cartiva Implant Lawyers

Our firm is currently seeking Caritva implant cases from anyone who had the Cartiva toe implant surgically installed and subsequently experienced a failure or other complications with the implant. Contact us at 800-553-8082 for a free consultation or reach out for a case evaluation online.

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