Many people need knee, hip, or ankle replacement surgery, and these procedures can be life-changing. However, some medical device makers fail to ensure their products are safe. After the Exactech product recalls, many people with the company’s orthopedic implants are facing the pain and costs of these defective devices. This includes revision surgery, travel costs to get to a qualified hospital for care, and lost time at work. If you’re dealing with these challenges, you could have legal options.
At Laborde Earles Injury Lawyers, we know how to fight for you against a medical device maker like Exactech. While these cases can be complex, an Exactech recall lawsuit lawyer from our team has extensive experience defending plaintiffs like you. We know how to navigate the court system, deal with the other party’s lawyers, and go after the justice and compensation you deserve. Read on to learn everything you need to know about the Exactech recall lawsuit and how we can help.
What Is Exactech?
Exactech is a Gainesville, Florida-based medical device maker that creates orthopedic implants for hips, knees, ankles, and shoulders. The company develops its products in collaboration with the Hospital for Special Surgery (HSS), which focuses on orthopedic surgery and treating rheumatological diseases.
Since its founding in 1985, Exactech’s stated mission is to find solutions for people with joint diseases from a surgeon’s perspective. Surgical implants aim to increase quality of life and improve physical function for people suffering from arthritis, pain, and physical disability, among other conditions. However, as the American Association of Orthopedic Surgeons (AAOS) notes, these implants often come with substantial costs to the patient. They can also come with health complications, including implant failure.
Exactech is not the only implant maker on the market, but it is known for a few key products, including the Optetrak Knee System. The device was designed along with the HSS to increase stability, range of motion, and offer more resilience against certain types of stresses that can lead to implant failure (Forbes). According to Exactech, the knee cap should feel natural when you bend the knee, and the Optetrak knee system was intended to do that.
Exactech’s Major Products
Some of the company’s other key products include:
- Truliant Total Knee System
- Vantage Total Ankle System
However, in spite of their innovative features, all three of the above-named surgical implants (Optetrak, Truliant, and Vantage) were affected by Exactech’s 2021 recalls. As Exactech’s recall letters describe, certain components of these implants were subject to defects that could result in a device fracture.
The manufacturer also notes that hip implant inserts are affected by the recall, including the Exactech Connexion GXL and hip implants made with conventional polyethylene.
Recall on Exactech Knee and Ankle Replacement Implants
Exactech issued two recall notices in 2021 and 2022.
First, the company announced in August of 2021 that certain models of its ankle and knee replacement were recalled due to a packaging error. The polyethylene (PE) inserts in these devices can quickly deteriorate when exposed to oxygen, and some devices were stored and shipped with inadequate packaging. Because they were not in oxygen-tight wrapping, the inserts could be subjected to severe deterioration from oxidation.
With this damage, the devices could:
- Loosen inside the body
- Show signs of rapid wear
- Crack inside the patient’s body
The Expansion of the Recall
Later, in April of 2022, Exactech announced it was expanding the initial recall, saying the affected devices included any arthroplasty polyethylene inserts, regardless of their shelf life or label. The company estimated that over 80% of its inserts produced since 2004 could have been affected. You can find a full list of recalled products on Exactech’s website.
In the recall letter, the company admitted it had reports from government agencies worldwide showing increased rates of revision surgery associated with its total knee replacement systems (TKR). Some contained polyethylene inserts, possibly due to the damaged PE from inadequate packaging.
The company also warned doctors not to use any of the affected devices for future surgery. However, Exactech acknowledged that many of the affected inserts were potentially already implanted inside of patients, and that they may have already required revision surgery or required other care associated with premature wear or device failure.
Revision Surgery: Costs and Outcomes
Because many patients may already have had implant surgery with a recalled TKR device, they may end up needing revision surgery. However, that’s not the ideal outcome for TKR patients—especially when they need these surgeries prematurely.
An article published in the journal Experimental and Therapeutic Medicine notes that these procedures:
- Can be challenging. Revision surgery is technically difficult for surgeons and often comes with a higher failure rate than the initial procedure. It can also come with worse outcomes. Some studies show that revision surgery leads to complications between 5-50% of cases.
- May lead to more surgeries. Research shows that patients who need one revision surgery often go on to require more surgeries in the future.
Many factors can influence the outcome of revision surgery, including the patient’s age, physical condition, gender, and other health factors. However, if you need revision surgery, you may not see as successful of an outcome as you would have had the initial surgery and device performed as intended. Additionally, you may need to spend money on several more surgeries to address future complications.
You could hold Exactech accountable for these additional costs and losses. Our recall lawsuit lawyers can help you build a case and file a lawsuit for damages.
Do Knee Implants Usually Fail?
Patients who undergo total knee replacement surgery can typically expect some of the highest success rates out of any orthopedic procedure, according to the Hospital for Special Surgery (HSS). However, that doesn’t mean they work flawlessly for all patients or will last forever.
Some of the most common reasons for knee replacement failure includes:
- Loosening and wear
- Leg fractures
Patients may see increased wear and loosening of an Exactech Optetrak or a Truliant knee implant due to excessive wear from the polyethylene insert. Since PE wear and tear is already a common reason for device failure, the deterioration of the PE inserts in the affected Exactech knee systems could contribute even more to the catastrophic wear of these devices.
Are Medical Implants Like Exactech’s TKR Safe?
Unfortunately, many Exactech implants, such as its total knee replacement systems, could be affected by the company’s recalls. This means that many people with an Exactech device implanted before the recall date could have faulty devices in their knees, hips, or ankles. Exactech has advised that doctors monitor patients with devices part of the recall.
Also, if you notice any signs of a device failure, such as pain, alignment changes, instability, or swelling and stiffness in the joint, you should speak with your doctor immediately. Additionally, patients may have reason to be concerned about the safety of many medical implants beyond Exactech’s products. As The New Yorker reports, the FDA had about 16,000 reports of fatal incidents due to medical devices as of 2015.
Plus, this number could be substantially underreported. Further, the U.S. Governmental Accountability Office (GAO) says the FDA approves new medical devices based on the methods that are “least burdensome” for device makers, but still hasn’t established consistent standards for what that means. It has urged the FDA to do so to better protect consumers and ensure these devices are safe.
Is There a Class Action Lawsuit Against Exactech?
There is a multidistrict litigation action against Exactech. Multidistrict litigation (MDL) is similar to a class action lawsuit. However, they also differ in some important ways. In both an MDL and a class action lawsuit, plaintiffs across the country with many similar damages bring a lawsuit against a single defendant. But in an MDL, plaintiffs can typically seek more differentiated compensatory damages based on their level of harm and unique losses.
The case against Exactech is referred to as MDL No. 3044, which will go to trial in the Eastern District of New York. Even though Exactech is based in Florida, the company works collaboratively with a New York-based hospital, which is one reason the case will proceed there. Also, over a third of the 75 lawsuits against the company were filed in that district.
Typically, the next steps in an MDL involve selecting the bellwether trials. These are test trials that showcase the evidence and arguments from key plaintiffs. These trials often give the rest of the plaintiffs in the case a sense of whether they could win compensation or if the company will offer a settlement.
Exactech Lawsuit Update
Here’s an overview of the main events in the Exactech recall lawsuit.
Exactech Lawsuits Become an MDL — October 10, 2022
Following its September hearing, the judicial panel announced it would green light re: Exactech Polyethylene Orthopedic Products Liability Litigation, MDL No. 3044, consolidating the Exactech lawsuits in the Eastern District of New York. By that time, this order sent 75 lawsuits to an MDL under U.S. District Judge Nicholas Garaufis in Brooklyn.
About a third of the existing 75 lawsuits had been filed in that district, and the Hospital for Special Surgery is in Brooklyn. Exactech worked with the HSS to design its implants.
Judicial Panel on Multidistrict Litigation Considers MDL — September 29, 2022
The United States Judicial Panel on Multidistrict Litigation said it would have a hearing to consider consolidating the Exactech lawsuits into an MDL. The attorneys for both sides were invited to present their arguments for or against centralization.
The Recall Expands Again — August 11, 2022
Once again, Exactech had to inform consumers that the recall affected more devices than previously thought. In August 2022, the company announced that:
- Acetabular hip liner components in its Acumatch, Connexion, Novation, and other implant models were affected
- Over 40,000 additional hip devices were now part of the recall
Again, the issue was related to the polyethylene liners in these implants. Like with the other recalls, the company discovered that oxidation had potentially damaged the plastic in these devices.
Exactech Recall Expands — April 7, 2022
At this point, Exactech announced that far more devices were affected than originally stated in the first recall. The company said that:
- All remaining polyethylene inserts in the market were affected.
- About 80% of inserts made since 2004 were in inadequate packaging and could be damaged.
- Over 140,000 total implants on the market since 2004 were now part of the recall.
Plaintiffs File Motion for MDL — June 15, 2022
By June of 2022, a lawyer for the plaintiffs filed a motion to move 28 lawsuits into MDL consolidation in New York. At that time, lawsuits had been filed across 11 states, including Connecticut, New Jersey, Pennsylvania, Texas, and New York.
Exactech Announces Initial Recall — August 31, 2021
The first recall for Exactech knee and ankle implants came on August 31, 2021. In this recall, the company stated that only certain devices with a specific shelf life were affected: those labeled to have an eight-year shelf life and that would have a shelf life of at least five years at the time of the recall.
Exactech Also Faces Allegations of Silencing Concerned Doctors
In a lawsuit filed in August of 2020, whistleblower Dr. Manuel Fuentes and two other former employees of Exactech brought a lawsuit against the company (United States ex rel. Wallace v. Exactech, Inc.). When surgeons spoke up about their concerns related to defective knee implants, Exactech paid them off to retain the company’s sales and keep them quiet (Kaiser Family Foundation).
According to the filing, Exactech knew about significant failures in a tibia implant component as of 2008. The failure rate for these devices was ten times the expected rate for similar knee replacements. When surgeons spoke up about their concerns, the company reassured them that they would investigate. However, the subsequent audit contained several flaws and seemed to downplay the extent of the failures.
The whistleblowers say that by using false survival rate data to sell Exactech devices, these implants were misbranded. A lawyer from our team can inform you how any information regarding Exactech’s negligence could be relevant to your case.
What to Do if You Think You Have a Defective Exactech Device
Figuring out what you need to do next when you’re facing complications after a knee, ankle, or hip surgery can seem daunting. Follow the steps below to give yourself the strongest possible start on your case.
Determine if Your Implant Was Part of the Recall
Exactech says that it will cover the costs of revision surgery and other medical costs associated with a defective recalled device. They have a claims department in place to help victims get their costs covered. You can call the service number provided to get help with reimbursement. However, you may also be eligible to file a lawsuit and seek additional forms of compensation.
It’s important to start by identifying whether you have a recalled implant and if you’re eligible to take further action. If you’re unsure whether you have a defective device, a lawyer from our team can help you understand your eligibility to file a lawsuit.
Hang Onto Any Relevant Evidence
Evidence is key to building your lawsuit against Exactech. Hang onto any documentation that could be relevant.
This includes receipts for any out-of-pocket expenses, such as doctor visits, medications, medical assistive devices, or medical invoices. If you had to pay travel costs to visit a doctor or get a surgery, hang onto evidence of these costs. These could also be part of your settlement or award.
You may also want to keep a pain journal to track your everyday experience with the injury and your suffering. If you’re in regular pain and must limit your activities, keep a record to share with a lawyer from our team.
Get All Necessary Medical Care
If you’re having complications with your knee, ankle, or other implant, you should consult your doctor. Get testing or regular monitoring. If your doctor advises revision surgery or makes other recommendations for your care, follow their orders.
If you fail to do so, the other party could argue that you made your complications worse. They can also use this to dismiss or downplay your case. You could also risk your health if you don’t get the care you need.
Avoid Posting About Your Case
Many people turn to social media to connect with family and friends during a challenging time in their lives. That’s normal, but refrain from making posts about your injuries or your Exactech case.
The other side can scour your internet presence and social posts to gather evidence that could hurt your case. They may take your words out of context or use it to show you weren’t as hurt as you are.
Don’t Just Accept a Reimbursement from Exactech
Exactech has said it will cover out-of-pocket expenses for medical care and travel costs related to revision surgery for failed implants. However, we don’t advise that you only accept this reimbursement as payment for your losses.
After all, this payout won’t truly reflect all your costs and losses. Our attorneys can argue for what you deserve in a settlement from Exactech.
How an Exactech Recall Lawsuit Lawyer Builds Your Case for Compensation
Mass tort cases like the Exactech recall lawsuit involve complex medical details and big corporate defendants. This is one of the biggest reasons why you may want to hire a lawyer to handle your lawsuit.
Here’s how an Exactech attorney from Laborde Earles Injury Lawyers can help you build your case:
Learn How the Injury Affected You
One of the first things we’ll do is learn your story. Our attorneys know this could feel like a stressful and overwhelming experience. After all, you’re likely facing a pile of medical bills while wondering if you’ll ever return to your former mobility.
Let our compassionate team know what you’re dealing with. Whether you’re facing physical pain, career challenges due to limited mobility, or other emotional hardships, we want to know. With this knowledge, we can gather strong evidence to show Exactech’s legal team how you were harmed and the damages you deserve.
You could qualify to seek compensation for your:
- Medical bills (past, present, and future) for revision surgery or other past, present, or expected medical treatment
- Physical therapy and rehabilitation costs
- Lost income
- Reduced earning capacity
- Scarring and disfigurement
- Pain and suffering
- Reduced ability to enjoy life
Gather Evidence of Your Losses
In a product liability case, we must link the defective implant to your injuries and losses. This will require substantial evidence. Our attorneys can use sources such as:
- Your medical records, including your surgery date and the performing surgeon
- Evidence of the implant used in your surgery
- Your doctors’ statements
- Medical expert testimony from orthopedic surgeons and other experts
- Bills and invoices for medical costs
- Payment records to show lost earnings
- Scientific papers and other data to prove your injuries
Collecting this evidence and knowing how to present it can prove challenging—if not impossible—to handle on your own. That’s especially true when you’re dealing with pain, medical appointments, or recovery from surgery.
Our lawyers have a network of medical experts who can shed light on your situation, helping us show that Exactech is liable for your revision surgery or TKR failure.
Handle All Communications with Third Parties
A mass tort case is a complex legal process involving many parties. You’ll need to meet certain deadlines and file paperwork appropriately. You’ll need to respond to emails, attend necessary meetings, and more. Our attorneys can handle all of this for you, however.
- Submit evidence
- Handle court processes and procedures
- Negotiate a settlement
- Represent you in mediation or at trial, if necessary
- Inform you of any updates in the lawsuit
- Advise you of your options at every step
Seek the Compensation You Deserve
Our attorneys have training and experience in mass tort litigation. We’ve represented victims like you against negligent corporations and medical companies, including Zantac injury victims. That means we know how to go after the full, fair compensation you deserve.
We’ve secured six- and seven-figure settlements for previous injury victims. Our Exactech recall lawyers know how to use our experience to make your case and negotiate for your best possible outcome.
Other Benefits of Working with a Lawyer in an Exactech Recall Lawsuit Case
A lawyer can help you navigate all the challenges of a case against Exactech. When you hire a lawyer from Laborde Earles Injury Lawyers, you can have someone who:
Understands Your Case’s Value
If you try to represent yourself in a product liability case, one of your biggest challenges may be related to assessing your case’s value. If you don’t know the value of your damages, you may not have a good sense of what you could get in a settlement.
It’s true that your medical bills may seem relatively straightforward. These you can add up and come to a certain figure. However, even medical expenses can prove complicated, as you may require future treatment or surgeries. Our lawyers will estimate these future costs based on your prognosis from a doctor; victims who represent themselves may miss or underestimate these costs.
Other forms of compensation are easy to forget or underestimate, such as your pain and suffering damages or even the possibility of punitive damages. Our attorneys know how to gather evidence to demonstrate your pain and the compensation you deserve as a result. We can also keep you informed about whether you could receive punitive damages, which can be awarded when a defendant acts with particular recklessness or is willfully neglectful.
Can Handle All the Legal Details for You
The day-to-day process of filing a product liability lawsuit can be demanding. You shouldn’t have to deal with it all on your own.
We can submit the important paperwork, respond to or file motions, and communicate with the courts and the other party’s legal team.
Understands State and Product Liability Law
You must know a lot about the law to bring a successful lawsuit against a company like Exactech. You’ll need to know about:
- State law: For example, every state sets unique statutes of limitations that restrict your time to file a lawsuit. These laws also vary depending on the type of lawsuit you bring; in some cases, there are also exceptions to the deadline.
- Product liability law: The Exactech case is a product liability lawsuit. This area of law comes with specific standards and expectations for evidence. For instance, some states say you do not need to prove a manufacturer was negligent to bring a case—only that a device was defective and you suffered damages.
- Court process and procedure: The U.S. court system is complex, and an MDL case will proceed through one of the U.S. District Courts. This is a major trial court, but our attorneys know how to navigate its processes and procedures for you.
Our attorneys understand state law, product liability standards, and court processes. We can use our experience to ensure you meet all necessary expectations and deadlines—and you don’t make any unnecessary mistakes.
Will Stand Up Against a Major Corporation
Bringing a case against a medical device manufacturer can feel intimidating for most people. After all, a company like Exactech will come prepared for litigation with a team of lawyers, expert witnesses, and substantial evidence to make its case.
Our attorneys routinely interact with major corporations. We know how to interact with their lawyers. We know what to say to motivate a big company to work with our demands. We can be your voice so you don’t have to strain yourself during this time.
Frequently Asked Questions in Mass Tort Lawsuits
Our Exactech attorneys know you likely have several questions as you begin thinking about your legal options for an Exactech lawsuit. Below, we offer answers to some of the most common questions we get in these cases. We can also give you more specific answers based on your case’s unique circumstances if you hire our team.
How Is an MDL Different from a Class Action?
An MDL is different from a class action in some important ways. They both allow similarly injured victims to bring a lawsuit against a single defendant. This often comes in handy in product liability cases involving a big company like Exactech. With a class action or MDL, you can have strength in numbers.
However, settlements or awards often work differently in an MDL or a class action. In a class action, all the cases get grouped together in one lawsuit. In an MDL, plaintiffs keep their individual lawsuits against the company; however, they get consolidated into one court for the sake of efficiency.
So, victims can often seek more unique damages in an MDL based on the unique details of their individual lawsuits. Generally speaking, the more serious the injury and costlier the medical expenses, the more a plaintiff in an MDL can seek.
How Much Will I Get in a Settlement?
As mentioned, plaintiffs can often seek compensation based on the facts of their cases. The biggest factors that can affect your settlement or award value include:
- The seriousness of the injury or the health complications
- The cost of the necessary medical care
- The extent to which your life and career were affected by the injury
- Whether punitive damages are awarded
Once our attorneys review the facts of your case and the initial bellwether trials conclude, we can give you a better sense of how much you could seek.
How Long Does It Take to Bring a Lawsuit?
The legal process can take time, especially in big MDL cases like the one against Exactech.
Typically, there will be several bellwether trials before all other lawsuits in the case can be resolved. These trials may take several months each. Also, certain legal issues can arise during the process that can delay the case. So, an MDL may take a year or more to conclude.
An Exactech recall lawyer from our team can explain what you should expect and keep you updated on any major events in the lawsuit process.
Contact Laborde Earles Injury Lawyers to Get a Free Case Review
At Laborde Earles Injury Lawyers, we’re ready to be your voice in the fight against Exactech. Contact our team today to get a free case review and explore your options. We can tell you more about who qualifies for a lawsuit, how we can help you, and what comes next for your case.
During your call, you can ask us all your questions—at no cost or obligation. Call now to get started seeking the justice and compensation you may deserve.