Table Of Contents
- Latest Cartiva Implants Lawsuit Update 2023
- Cartiva Synthetic Cartilage Implant Background
- Cartiva Toe Implant FDA Approval
- Cartiva Big Toe Joint Implant Injuries
- Manufacturers Withheld Information on Cartiva Implant Failures
- Recent Cartiva Lawsuits
- Can I File a Cartiva Big Toe Joint Implant Lawsuit?
- What is Big Toe Arthritis?
- Big Toe Arthritis Symptoms
- Reasons Leading to Cartiva Implant Failure
- What Compensation Could I Be Awarded in a Cartiva Lawsuit?
- Allegations in Cartiva Implant Failure Lawsuits
- Get a Free Cartiva Implant Lawsuit Evaluation With Our Lawyers
Latest Cartiva Implants Lawsuit Update 2023
Several voluntary dismissals have been entered in early Cartiva implant failure lawsuits filed, giving plaintiffs the option to refile their claims at a future date, and raising speculation of potential settlements or an agreement to toll the statute of limitations may have been confidentially reached.
In the latest of a half dozen Cartiva toe implant lawsuits to be filed in recent months, a Texas woman filed a complaint against Wright Medical Group, N.V. and Cartiva, Inc., claiming that the companies negligently marketed a defective medical device to consumers and failed to disclose the potential health risks.
Cartiva Synthetic Cartilage Implant Background
The Cartiva Synthetic Cartilage Implant (SCI) is intended to treat painful big-toe arthritis, the most common arthritic condition in the foot.
Before Cartiva’s approval, the standard of care involved fusing the bones in the arthritic joint with screws and plates. While fusion proves effective for eliminating pain, it permanently prevents movement of the joint.
The Cartiva toe implant, an alternative treatment to fusion, is a biocompatible, biomedical polymer device that features physical properties similar to those of articular cartilage.
Damaged cartilage is replaced with a small Cartiva toe implant that provides a cartilage-like compressible, low-friction, and durable bearing surface. The implant is designed to provide pain relief and improve both function and motion.
Cartiva Toe Implant FDA Approval
Cartiva Inc. received pre-market approval from the U.S. Food and Drug Administration (FDA) in July 2016 for its Synthetic Cartilage Implant (SCI) for arthritis of the big toe joint. The approval allowed Cartiva to begin marketing the first synthetic cartilage device approved by the FDA.
The agency’s decision to approve the Cartiva implant was supported by the MOTION clinical study, a 236-patient, multi-center, prospective, randomized study comparing Cartiva SCI to other fusion surgery – the largest study ever conducted for this condition.
Cartiva Big Toe Joint Implant Injuries
Wright Medical Group purchased the rights to the Cartiva synthetic cartilage implant in 2018 for $435 million, expecting success comparable to the implant’s positive clinical trials.
However, reports quickly surfaced that physicians could not replicate the results of prior studies. Therefore, many doctors stopped recommending the use of the Cartiva implant due to complaints of:
- Motion issues
- Significant pain
- Nerve damage
- Bone loss
- Bone spurs
- Subsidence (implant caving into the bone)
- Degraded cartilage
- Implant fracture
- Implant slipping
- Implant shrinks
- Device failure
- High failure rate
- The need for revision surgery
Manufacturers Withheld Information on Cartiva Implant Failures
In several recently filed Cartiva lawsuits, plaintiffs have alleged that manufacturers withheld information about the increasing number of Cartiva implant fails in an attempt to avoid a recall and increase profits.
These suits also claim that the manufacturers were aware of higher failure rates than the 13% failure rate disclosed to patients.
Plaintiffs further allege that the manufacturers had direct knowledge of the potential Cartiva defects, citing more than 144 adverse event reports involving loss of toe mobility, pain, and high failure rates.
Along with the FDA reports numerous medical studies have been published highlighting the increasing rate of implant failures and complications.
However, rather than the manufacturers fulfilling their legal obligations to report the increasing rate of Cartiva implant failures and complications to the FDA, the medical device companies chose to take no action to protect patients.
Recent Cartiva Lawsuits
Plaintiffs who have recently filed lawsuits for damages related to Cartiva defects include:
- Gina Neil, who entered a complaint in the Western District of North Carolina on May 31, 2022
- Gabriel Gesmer, filing in the Northern District of California on March 14, 2022
Gesmer’s lawsuit alleges that the Cartiva implant did not meet federal standards before it was brought to market. Gesmer also claims that Cartiva Inc. knew or should have known about the device’s risks, having received thousands of adverse event reports associated with the product.
Can I File a Cartiva Big Toe Joint Implant Lawsuit?
You may be eligible to file a Cartiva Lawsuit if you:
- Had surgery to implant Cartiva toe implant
- Ended up with the failure of the implant
- Were required to undergo additional surgeries
- Have not been diagnosed with cancer, rheumatoid arthritis, Crohn’s Disease, or Multiple Sclerosis
What is Big Toe Arthritis?
Also known as stiff big toe or hallux rigidus, arthritis of the big toe joint occurs when the cartilage covering the ends of the bones in the big toe joint (metatarsophalangeal joint) is worn down. This causes the bones in the joint to begin rubbing together, resulting in stiffness and pain.
Most cases of big toe arthritis are due to having a different foot anatomy that places increased pressure on the big toe, but the condition may also be caused by an injury to the big toe that damages the cartilage.
Big Toe Arthritis Symptoms
- Stiffness and pain in the big toe joint.
- Difficulty moving the big toe up and down.
- Inflammation and swelling around the joint.
- Pain that worsens with an increase in activity.
Reasons Leading to Cartiva Implant Failure
There are 4 reasons why Cartiva Implants are prone to failure:
- Smooth implant surface – The Cartiva Implant is made of an inert substance that shows very little reactivity in the body. However, the device is very smooth on all surfaces, which creates a functional flaw in the design.
- Violation of the Subchondral Plate – The subchondral plate is the hard bone found underlying the cartilage on both the head and the base of the 1st metatarsal. The subchondral bone is essential in the management of load applied to the first metatarsal head. Although the 1st metatarsal phalangeal joint (big toe joint) has always been referred to as a non-weight bearing joint, significant load is applied to the head of the first metatarsal with gait. Loss of the support of the subchondral plate with no alternative means of support places the Cartiva Implant into the soft metaphyseal bone and is prone to impaction failure.
- Lack of Osteointegration – Osteointegration, or ingrowth of bone into the implant, is as an essential aspect of implant stability. This mechanism is lacking with the Cartiva implant.
- Placement in Bone Too Soft for Support – How many loads can the Cartiva Implant carry without mechanical failure? There is long-term data related to implant viability and integrity, but what the data has missed is a simple relationship: over the 20 or so-year lifetime of the implant, what is the force applied to the implant and how supportive is the metaphyseal bone? This may be the key design failure in that the supporting bone is too weak to provide meaningful, long-term support to resist the load applied to the implant.
What Compensation Could I Be Awarded in a Cartiva Lawsuit?
By filing a lawsuit against the manufacturer of Cartiva implants, patients could seek compensation for any costs and losses associated with the toe implant, including:
- Medical costs – This may include corrective procedures, therapies, medications, and other medical needs following an adverse outcome with a Cartiva toe implant.
- Income losses – People with substantial pain or lost mobility in the big toe may be unable to earn their usual income and may be seeking Cartiva implant cases.
- Intangible losses – Suffering serious pain or lost function in the toe could impact patients’ quality of life. Damages could be recoverable for pain and suffering, depression, and other non-financial losses.
See all related defective medical device lawsuits our lawyers have covered.
Allegations in Cartiva Implant Failure Lawsuits
People who suffered a failure of their Cartiva toe implant are now filing Cartiva Lawsuits against Wright Medical Group and health insurance companies for the failure to warn patients about the numerous complication risks. These Cartiva implant lawsuits allege that Cartiva toe implants were defectively designed due to problems with the PVA material.
They further claim that Wright Medical knew or should have known about the high failure rate and other problems with the Cartiva joint replacement before initial FDA approval, but failed to disclose these risks in the warning label.
A growing number of lawsuits have already been filed in courts across the United States, and many more similar complaints are expected to be filed as patients experience premature Cartiva implant failures. If a high volume of these Cartiva implant problems and complications cases get filed in the coming weeks and months, they may be consolidated into multidistrict litigation (MDL).
Get a Free Cartiva Implant Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers focusing on plaintiffs’ representation in Cartiva Toe Implant Lawsuits. We are handling individual litigation nationwide and currently accepting new adverse event reports involving Cartiva implants in all 50 states.
Free Case Evaluation: Again, if you had severe pain or other complications following Cartiva implant surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a product liability lawsuit and a Cartiva Failure Lawyer can help.