Lawsuit Information Center
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. Unfortunately, this litigation is dragging on. 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.
Not many of these lawsuits have been filed. The last Cartiva lawsuit we saw was on June 28, 2024, in West Virginia. But there are a lot more cases out there, and that is likely to change if there is not a settlement soon. If you have a potential claim, call us today at 800-553-8082 or get a free consultation online.
December 2024 Cartiva Lawsuit Update
Stryker has issued a recall for all Cartiva synthetic cartilage implants sold since July 2016, following reports of alarmingly high failure rates and severe complications that often require revision or removal surgeries. The Cartiva implant was marketed as a game-changing alternative to big toe fusion surgery for hallux limitus or hallux rigidus (forms of degenerative arthritis in the big toe joint). The reality? This product is a disaster.
Despite its initial FDA approval in 2016, which relied on a reported 13% failure rate, subsequent studies suggest a catastrophic failure rate of up to 79% within two years. A study published just this month found that patients with Cartiva implants were 30 times more likely to require reoperation than those who underwent alternative procedures. These numbers are staggering. Why was this device allowed on the market for so long?
Stryker announced the recall encompassing all sizes of the Cartiva implant (6mm, 8mm, 10mm, and 12mm). Healthcare providers are now tasked with identifying and returning unused devices. Physicians are also instructed to closely monitor patients for troubling complications, including persistent pain, nerve damage, implant displacement, or fragmentation. Patients already experiencing symptoms like swelling, stiffness, or difficulty walking are urged to report their experiences to both Stryker and the FDA.
The Cartiva recall comes amidst growing litigation against Stryker, with lawsuits alleging that the Cartiva implant was defectively designed, prone to failure, and inadequately tested before its release. Plaintiffs argue that Stryker prioritized profits over patient safety, pointing to studies that directly undermine the manufacturer’s claims of a low complication risk. Why hasn’t Stryker settled these cases yet? The logic is hard to grasp. Stryker will kick itself for not offering reasonable settlement amounts before the recall.
The evidence against Cartiva is mounting, as we talked about last month. Post-recall studies and firsthand patient accounts reveal the devastating impact of the device on many lives. Victims deserve accountability and justice, not drawn-out court battles. Instead of dragging its feet, Stryker should take responsibility and work toward fair settlement compensation payouts for those harmed.
November 2024 Cartiva Lawsuit Update
A new study comparing the Cartiva Synthetic Cartilage Implant (SCI) to traditional joint fusion (arthrodesis) for treating hallux rigidus reveals that Cartiva may not provide superior outcomes and carries a significantly higher risk of reoperation. This will be an important study in any Cartiva lawsuit.
Conducted at King’s College Hospital, the study analyzed outcomes in 33 patients (17 with Cartiva and 16 with arthrodesis), tracking key metrics like pain, functional improvement, and quality of life over an average follow-up period of 2.3 years. The primary measure, the Manchester-Oxford Foot Questionnaire (MOXFQ), alongside other indicators such as EQ-5D and pain scores, showed no significant difference in benefits between the two procedures. However, the Cartiva group exhibited a 29.4% reoperation rate, starkly contrasting with the 0% reoperation rate in the arthrodesis group.
The findings add to the growing body of research questioning Cartiva’s durability and effectiveness, suggesting that, despite its goal of preserving joint motion, Cartiva SCI may lead to more complications, including loosening and pain, often necessitating additional surgery. In light of these outcomes, the authors recommend arthrodesis as a more reliable option for hallux rigidus, especially as studies continue to reveal the high reoperation rates associated with Cartiva. This study further supports claims in ongoing lawsuits alleging that Cartiva’s manufacturers failed to disclose the implant’s high failure rate, leading many patients to endure prolonged pain and complex revision surgeries.
The findings from this study impact individuals pursuing Cartiva lawsuits, particularly those who received the implant expecting a reliable alternative to traditional joint fusion. Many patients with hallux rigidus, a form of arthritis in the big toe joint, opted for Cartiva based on promises of preserved joint mobility and effective pain relief. However, with new evidence showing a significantly higher reoperation rate compared to arthrodesis, these patients may now face unexpected and costly complications, often requiring additional surgeries to address implant failure, loosening, or persistent pain.
So this growing body of evidence will strengthen claims that Cartiva’s manufacturers failed to adequately warn recipients about the risks associated with the device, potentially paving the way for higher compensation as plaintiffs seek damages for prolonged pain, further medical costs, and the need for future interventions.
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. It deals 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 tiny Cartiva implant 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
Moreover, the Cartiva implant has been linked to a range of complications, including infections, implant fractures, osteolysis, excessive bone production, cyst formation, and the development of silastic granulomas. These issues can significantly impact a patient’s quality of life and necessitate further medical intervention.
The high failure rate of the Cartiva implant appears to be primarily related to the material from which it is made. The Cartiva implant is constructed from a polyvinyl alcohol (PVA) hydrogel, designed to be biocompatible and mimic the properties of natural cartilage. However, in some patients, the PVA material degrades rapidly after implantation, leading to shrinkage. This shrinkage causes the implant to loosen and migrate from its intended location, resulting in the aforementioned complications and the need for additional corrective surgeries.
The rapid degradation and subsequent issues with the PVA material underscore the challenges and risks associated with the Cartiva implant, highlighting the need for careful consideration and monitoring of patients who receive this device.
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.
Stryker 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 stopped using Cartiva—long before the Cartiva recall—because he an unacceptable failure rate of these toe implants.
Defendants have been accused of misrepresenting data to the FDA, particularly regarding adverse events like implant loosening and subsidence. Criticism from the medical community and insurance providers, including Cigna, highlighted insufficient evidence supporting the device’s safety and efficacy. A Hayes report also noted inconsistencies in outcomes and the need for larger, long-term studies.
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:
Early 2000s: Cartiva, a medical device company based in Alpharetta, Georgia, begins developing a synthetic cartilage implant aimed at treating osteoarthritis of the big toe joint. The goal is to create a durable, long-lasting device that mimics the cushioning and shock absorption of natural cartilage, providing an alternative to joint fusion surgery.
Mid-2000s: Clinical trials for the Cartiva Toe Implant commence, evaluating its ability to preserve joint motion, reduce pain, and improve patients’ quality of life. Initial results show promise, positioning the device as a potential breakthrough in treating hallux limitus and hallux rigidus, forms of degenerative arthritis.
2016: The Cartiva Toe Implant receives FDA approval based on data from two randomized controlled trials. These studies indicate that the implant provides significant pain relief and improved joint function compared to traditional fusion surgery. The device is marketed as a revolutionary solution for maintaining mobility while reducing pain in the big toe joint.
2016–2023: The Cartiva Toe Implant is widely adopted, with thousands of procedures performed in the United States and internationally. Patients seek the implant as a motion-preserving alternative to fusion surgery.
2023: Post-market surveillance and studies raise concerns about the device’s long-term performance. Reports from surgeons and patients suggest a failure rate as high as 64%, significantly higher than the initial clinical trial data of a 13% failure rate. Common complications include pain, implant loosening, displacement, and the need for revision surgeries.
2024: Amid growing evidence of failure and patient complaints, Stryker, which now owns Cartiva, issues a recall for all Cartiva Synthetic Cartilage Implants (SCI) sold since July 2016. The Cartiva recall cites “higher-than-expected” rates of complications, including persistent pain, nerve damage, and implant fragmentation, as well as a higher-than-anticipated need for revision or removal surgeries.
As a result, lawyers began to file a Cartiva toe implant lawsuits.
Example of a Newly Filed Cartiva Toe Implant Lawsuit
In a new lawsuit filed in December 2024, in the United States District Court for the District of Maryland, a Maryland resident alleges severe injuries caused by a defective synthetic cartilage implant manufactured by Cartiva, Inc., Wright Medical Group, N.V., and Stryker, B.V. The lawsuit claims the Cartiva Synthetic Cartilage Implant (SCI), implanted in the resident’s left big toe in 2021, failed due to defects in its design and manufacturing, leading to severe pain, swelling, and loss of mobility. As a result, the individual underwent revision surgery, including removal of the implant and fusion of the toe bones.
The complaint alleges that the Cartiva SCI, made from polyvinyl alcohol hydrogel, was prone to shrinkage and migration, which caused premature failure in approximately two-thirds of cases, as supported by independent studies. Despite knowing about these issues, the defendants allegedly continued to market the device as a safer alternative to traditional fusion surgery, citing misleading success rates. The lawsuit further accuses the defendants of failing to report adverse events to the FDA and violating federal regulations for medical device safety and labeling.
The device was recalled in October 2024 after reports of widespread failures, but the recall came too late to prevent the injuries in this case. The lawsuit seeks compensation for medical expenses, pain and suffering, loss of enjoyment of life, and other damages resulting from the defective product.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.