Cartiva Failure Lawsuit: Did You Experience Problems with Your Toe Implant?

Lawsuits are being filed alleging the companies behind Cartiva knowingly suppressed information regarding the product’s high failure rate and are now responsible for the harm incurred by patients who require a second surgery to have the device removed.

The lawsuits take particular issue with the decisions of Cartiva Inc., Wright Medical Group and Stryker to continue to market and sell a device whose failure rate is alleged to be six to seven times higher than what the companies have reported.

Even the doctor who helped launch the toe implant now refuses to use it, warning patients that they should “NOT GET A CARTIVA IMPLANT until further notice” as his clinic quickly noticed that “there was something wrong.” One major insurance company, Cigna, has also gone so far as to classify the use of Cartiva to treat big toe arthritis as experimental, as there has been little evidence to back up the manufacturers’ successful treatment claims.  

Now, patients are seeking money from the manufacturers for medical expenses, rehabilitative care, lost wages, physical pain and more through Cartiva failure lawsuits.

Why Does Cartiva Allegedly Fail?

According to the University Foot and Ankle Institute, Cartiva fails “due to the implant slipping into the bone.” It’s been alleged that this happens because the device can shrink after implantation, causing it to become loose and move out of place.  

Cartiva Implant Problems

The lawsuits allege that the main problem with Cartiva is that the implant fails prematurely and that real world results with the device do not match up with the success the manufacturer reported in the study that helped the implant gain approval.

Other Cartiva problems can include infection, implant fracture, bone overproduction and cyst formation. Patients experiencing Cartiva implant failure may need to have revision surgery to remove the implant and fuse the bones across the joint. They may also require additional treatments, including surgery to remove bone spurs and injections to relieve pain.

Cartiva gained premarket approval based on a study that compared it to traditional fusion surgery. This surgery, also known as arthrodesis, requires a surgeon to cut and shape the bones on each side of the joint and fuse the bones together. Fusion surgery relieves the pain caused by big toe arthritis but eliminates the ability to move the toe.

Cartiva’s pivotal clinical study included 152 implant patients and 50 fusion patients and concluded that Cartiva is an “excellent alternative” to fusion surgery in patients who want to retain motion in the joint located at the base of the big toe. It was also noted that the rate of secondary surgeries was “similar between groups” and that less than 10 percent of the implant group needed revision surgery at two years.

It has been alleged, however, that the results of the study have not been replicated in clinical practice and that the Cartiva failure rate is actually much higher than what the company lists on the label (13.5 percent). One small study found the Cartiva implant failure rate to be 64 percent.

Indeed, the study that was the basis for Cartiva’s approval has been “widely criticized” due to its insufficient sample size, lawsuits claim. Further, it has been alleged that clinical practice guidelines published by the First Metatarsophalangeal Joint Disorders Panel of the American College of Foot and Ankle Surgeons in 2003 “suggest a different implant design is recommended,” rendering the Cartiva implant “unreasonably dangerous by design.”

Has There Been a Cartiva Implant Recall?

No. There has been no recall for Cartiva. Lawsuits claim that the manufacturers could have voluntarily recalled Cartiva but chose instead to “largely ignore[] the clinical evidence” and take over sale of the big toe implant when distributors and doctors decreased the sale and use of the device.  

Is Cartiva a Class Action Lawsuit?

No. Attorneys working with ClassAction.org are handling Cartiva failure lawsuits individually – and not on a class action basis. Class action lawsuits typically involve a large group of people suffering a small loss, while Cartiva patients who needed revision surgeries have likely incurred costly medical bills and lost wages. For more information on this topic, you can check out our article on why lawsuits involving allegedly defective medical devices are not handled as class actions.  

What’s Involved in Filing a Cartiva Implant Lawsuit?

If you decide to move forward with a Cartiva implant lawsuit, your attorney will first collect some information from you, as well as copies of your medical records. They may ask you questions about how the failed Cartiva implant has affected your personal and social life, what symptoms you experienced following surgery and how long you needed to take off work to deal with complications of Cartiva.

Once this basic information is gathered, your Cartiva attorney will draft what’s known as a complaint. This is a legal document that outlines your history with the Cartiva implant, what damages you are seeking from the device manufacturers and the allegations you are making. For instance, your Cartiva implant failure lawsuit may allege that:

Once your complaint is submitted to the court, your lawsuit has officially begun.

Ultimately, the lawsuit will either settle, get dismissed or head to trial, though jury trials are increasingly rare in civil cases.

It’s also possible that Cartiva implant failure lawsuits are consolidated to a single court before a single judge to help efficiently manage the cases, ensure consistent rulings, and save time and money for all parties involved. This is known as multidistrict litigation and is common when a large number of lawsuits are filed against a drug or medical device maker and allege similar injuries.

What Could I Get from a Cartiva Failure Lawsuit?

How Much Does a Cartiva Lawyer Cost?

Most attorneys handling Cartiva lawsuits, including those working with ClassAction.org, work on a contingency-fee basis. This means you will only pay if they win your case, and their payment will come as a percentage of your settlement or jury award.

How Much Could a Cartiva Settlement Be Worth?

At this point, there are no predictions as to how much a successful Cartiva lawsuit could be worth. Ultimately, the value of any medical device case will rely on several factors, including how much the injury impacted the patient’s life, the cost of medical bills, how much time was needed away from work and more.   

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