Optetrak Lawsuits: What’s the Status of Exactech Recall?

Attorney Explains Exactech Optetrak Recall Lawsuits

Video Transcript:

George McLaughlin: 

This has been going on since 2004. So there are many thousands of devices that may have been subjected to this excessive oxygen attack. 

Rob Rosenthal: 

So how do you know if your knee or ankle replacement could be involved in a lawsuit? And then what do you do? We're gonna find out right now, on this episode of Ask the Lawyer, my guest is attorney George McLaughlin, who's based in Denver, but handles these kind of cases all over the country, and I want to remind you, if you wanna ask George questions about your situation, just go to askthelawyers.com, click the button up at the top that says Ask a Lawyer. It'll walk you right though the process, it doesn't cost anything to ask your questions. Or of course, you can always call the phone number you'll see on the screen during our conversation. George, good to see you as always. Thank you for helping us out.

George McLaughlin: 

Thanks for having me, Rob.

Rob Rosenthal: 

We're talking about knee and ankle replacement. The ones made by Exactech. Tell me what's going on. What's the issue here?

George McLaughlin: 

Well, Exactech is a orthopaedics device manufacturer based in Gainesville, Florida. And they have a series of orthopaedic products including artificial hips and artificial knees and ankle joints. And they've realized that they have a problem with the polyethylene, the plastic components of both the knee and ankle devices, but also with their hip devices. I can talk about the knees, if you wanna hear about the knees.

Rob Rosenthal: 

Let's talk about knees and ankles, focus on that for just now. Tell me what's going on and I know there's been a recall. What does that mean?

George McLaughlin: 

In August of 2021, the end of August, Exactech in conjunction with the Food and Drug Administration, the FDA, issued a recall of one of their products called the Optetrak knee. And it's because of a problem they're having with the polyethylene, the plastic insert that goes between your femur and your tibia, it's like the shock absorber of the artificial knee. The polyethylene inserts are wearing at a higher rate, wearing more than they expected and they discovered that the reason was when these things are packaged, they're packaged in a vacuum-sealed container, plastic-sealed bag. And they have to protect them from oxygen, because oxygen permeates into the polyethylene and can cause what's technically called oxidation, which is a degradation, a degrading of the material, which leads to excessive wear and early wear. Exactech discovered this problem and figured out that this has been going on since 2004. So there are many thousands of devices that may have been subjected to this excessive oxygen attack.

Rob Rosenthal: 

What would the patient... Might they experience, George, if the polyethylene breaks down too early if there's an issue, what would it be like for the patient?

George McLaughlin: 

Well, most people don't even know what the manufacturer, who the manufacturer is, of their artificial knees. You need to check with your orthopaedic surgeon to find out, "Do I have one of these products? Do I have the Exactech knee?" The surgeon will know, because the surgeon either did or didn't use the Exactech knee product. If you have the Exactech knee product, surgeons are recommending that you contact them to come in and have an appointment and see if you may need to have additional follow-up. See if you might even need to have surgery to remove and replace the defective components.

Rob Rosenthal: 

Is there litigation surrounding this George? Is it happening? Is it going to happen? What do we know about that?

George McLaughlin: 

The answer to all of those is yes. There is already litigation, I have filed knee case against Exactech. I was keyed in to this problem many months ago by the orthopaedic surgeon for one of my clients who said, "This is going to be a big problem. There are going to be more of these failing." And the recall didn't occur until August of this past year, but then it wasn't until just a month ago, on February the 7th, 2022, surgeons received a letter from the company, telling them that this is a problem and that you should have your patients come in and see you and in great detail told the surgeons what the problem was. But in addition to sending surgeons a letter telling them what was going on and what the problem was, the company actually drafted a letter that a surgeon could edit to send to their patient, to notify the patient by mail. And the company is asking surgeons who know that they have patients with this device to send the patients a letter telling them what the problem is and asking them to come in and see the doctors so that they can be evaluated.

Rob Rosenthal: 

If a patient goes in and sees a doctor, say they have that particular product. And let's say even though you have surgery and replace the insert. Does that affect their ability to participate in this litigation at all?

George McLaughlin: 

Well, everyone has their own case, it's not like there's a class action out there. If someone has a failed Exactech knee, they should bring a lawsuit. The company may be willing to, without litigation, pay some of your medical bills. But I'm skeptical that the company would say, "Well, gee, what else is it gonna take to make it right here?" I would recommend that anybody who has a failed Exactech knee, if they're having a revision surgery, first of all, the thing they need to do is contact a lawyer before the surgery, so letters can be written requesting the defective product be preserved after it's taken out of their body. Then, they obviously need to do what their doctor recommends to get as well as they can, but don't drag your feet, get in to see your attorney and start the legal process. Because everyone has to file their own case. It's not like you're going to get a letter saying, "Since you had the Exactech knee, there's a settlement and you're gonna get X dollars." That's not how it works. You have to bring your own case and make your own claim for your specific damages.

Rob Rosenthal: 

George, do we have any idea of how many units might be involved in this?

George McLaughlin: 

We do. In the recall that went out in August, it states that there are 122,742 of these Optetrak devices that had been distributed. Now, what that means is they were sent out from the company to device representatives to give the doctors and hospitals for implantation. How many of those were implanted, it's hard to say, but I would say, based on my experience doing device cases for more than 10 years, that most of those were probably implanted. When a device, a medical device is recalled, what that does, it just brings it off the shelf. It brings it out of the hands of the distributor and the device representatives, it takes it out of the hands of the hospitals and sends it back to the company so no more of them get implanted. But if it's already implanted in you, it's too late to do a recall. They don't go in and take it out because it's been recalled, you only have the surgery if the device is failing and if it's become problematic for you.

Rob Rosenthal: 

So what's your advice, George? You said, if someone's had a knee replacement, they don't know who the manufacturer was, contact their surgeon, and find out. What if they find out it was one of these Exactech knees and maybe it was in that time frame, but let's say they haven't had any issues yet, what's your advice? What should they do?

George McLaughlin: 

If they haven't had an issue yet, they should still follow up with their doctor on a regular basis because these things fail over time. When they're put in, they perform fine, but over time, the wear occurs and you can have problems with loosening and excessive wear and other complications that may lead to a revision surgery. Until you actually have the revision surgery, you probably don't have a claim that most attorneys would file. Most of these device manufacturers do not recognise a claim having value unless and until the device actually has been removed and replaced because of a failure. Not all of these will fail, depending on your level of activity, just depending on your luck, you may never need to have your device removed and replaced.

Rob Rosenthal: 

Right. Lots of really interesting and helpful information, George, thank you for making some time to answer our questions.

George McLaughlin: 

Thank you, Rob.

Rob Rosenthal: 

And that's gonna do it for this episode of Ask the Lawyer. My guest has been attorney, George McLaughlin. Remember, if you wanna ask George any questions about your situation, just go to askthelawyers.com, there's a button at the top that says, Ask a Lawyer, and you can fill out a form there. It doesn't cost anything to ask your questions or you can call the phone number that was on the screen during our conversation. Thanks for watching everybody. I'm Rob Rosenthal for Ask The Lawyers.

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