On this episode of Drugwatch Podcast, hip implant lawyer G. Sean Jez of Fleming, Nolen and Jez joined me by telephone from his office in Houston. Jez earned his law degree from the University of Houston Law Center in 1996 and spent many years representing consumers.
Currently, Jez is handling cases involving defective metal-on-metal hip implants. He talked to me about health complications and lawsuits against the manufacturers of these implants.
According to Jez, metal-on-metal implants – those that have a metal cup and ball – have a higher failure rate than implants made of plastic or ceramic and metal. People with these implants may suffer complications when the metal ball rubs against the metal cup or shell, both made from chromium and cobalt.
These problems can range from severe pain to bone and tissue death.
“Chromium and cobalt that sheds from the implant becomes lodged in the surrounding tissue, and over time that can get worse and worse. There’s a whole host of problems that can happen,” Jez said. “You can have localized tissue damage where the tissue becomes gray and damaged, it can die – become necrotic – it can get into the bone and cause that to die at some point.”
Other complications Jez’s clients have suffered include:
While most implants fail at a rate of about 5 percent at the 5-year mark, some implants like the DePuy ASR have a failure rate as high as 45 percent, according to Jez.
There are currently several manufacturers of hip implants involved in massive multidistrict litigations. These companies and the problematic implants in question include:
There are thousands of lawsuits pending against these manufacturers in state and federal courts.
Johnson & Johnson, DePuy’s parent company, lost its first trial in California and a jury found the company guilty of negligence. The jury awarded $8.3 million to Loren Kransky after his DePuy ASR hip implant failed and caused him crippling injuries.
Now, the pharmaceutical giant is offering $2.5 billion to settle thousands of DePuy ASR hip implant lawsuits. The company faces 12,000 lawsuits for the DePuy ASR and thousands more for the Pinnacle hip implant.
Last modified: June 13, 2017
Michelle: On this episode, attorney Sean Jez of Fleming, Nolen and Jez answers some of your questions about defective hip implants. He talks about some of the complications his clients have suffered, as well as what people can expect when filing lawsuits. Sean joined me by telephone from Texas. Here is the recorded interview.
Michelle: First of all, how and when did you become involved in hip implant litigation?
Sean: Well, the first time I became involved in hip implant litigation was back in 1999, when Sulzer recalled one of their hip implant products due to a manufacturing defect that left, essentially, an oily residue on the acetabular shell, which caused the hips to fail.
Michelle: I see. You’ve definitely had substantial experience, then, with these types of implants, I would say. Right?
Sean: Yes, I have worked on many implants.
Michelle: I guess that’s knees and other implants, as well? Not just hips, right?
Sean: Right. Our firm has done hips; we’ve done some knees. We’ve done other product implants – for example, transvaginal mesh implants, litigation, those type of things.
Michelle: Can you share some of the complications you see, that maybe some of your clients are suffering, with some of these faulty implants?
Sean: The major problems that implants are having now concern metal-on-metal hip implants. There are about four to five manufacturers that have a metal-on-metal implant. What that is, you have a metal acetabular shell and then a femoral ball that come in direct contact with each other, and they’re both made of chromium cobalt, in most cases.
In the past, there used to be a polyethylene liner between those two surfaces. What we have now, with these metal-on-metal hip implants, is the metal ball rubbing against the acetabular shell creates micro debris of the chromium and cobalt that sheds from the implant and becomes lodged in the surrounding tissue. Over time, that can get worse and worse as the tissue builds up. There’s a whole host of problems that can happen.
You certainly can have your localized tissue damage, where the tissue becomes gray and damaged. It can die and become necrotic. It can get into the bone – the hip bone or the femoral bone (the femur), and cause that to die at some point, causing osteomyelitis, which is death of the bone. You can also have pseudotumors form in that area, where you have a fluid buildup that then presses against the nerve and the tissue and can cause pain and swelling in that hip joint.
And then, once the cobalt and chromium becomes absorbed into the tissue, it can get into the bloodstream, and it can circulate throughout the body. Typically, these type of individuals will have blood tests for chromium and cobalt levels, and those levels can vary. There’s really no known safe level of chromium and cobalt in the blood. ...
Michelle: I see. I’ve talked to some people – some doctors and maybe some people in the industry – that say, “Oh, that’s probably just people that are sensitive to metal.” This is certainly bigger than that, though, right? It’s not just this little allergy. It seems like a lot of people are having more issues than they suspect here.
Sean: That’s right. There certainly are those individuals who may have a metal sensitivity, but that’s not going to affect the circulating chromium cobalt levels in their body. Certainly you would have local tissue irritation for those type of people, that could cause the hip to fail. But no, in the metal-on-metal instances, the level of failure is much higher. You typically have about a 1 percent failure rate per year, as the hip is implanted in an individual and they continue to have it. What that means is, for everybody that has a hip implant, for the first year, out of all those people, about 1 percent will fail.
Michelle: That’s the standard, sort of expected failure rate, right?
Sean: That’s right – about 1 percent per year. People who have had a five-year implant, there’s an expected failure rate of about 5 percent of the folks. In the metal-on-metal hip cases, we’re seeing failure rates that can range anywhere from 20 to 45 percent at the seven-year mark. So you have substantially higher revision rates.
Michelle: It’s definitely a class sort of device issue – sort of across the board, with a lot of these metal-on-metal hips?
Sean: That’s exactly right. The metal-on-metal hips – every one of them, every manufacturer that has one, is having a higher failure rate.
Michelle: You mentioned the 20 to 45 percent. I remember the last one I read about was in the DePuy trial that was going on. It came out that they knew -- 40 percent failure rate, and they had known for some time that it was actually as high as that. So that was kind of shocking. I think what was published was 13 percent, or something like that, with joint registry in Australia, I believe. Right?
Sean: Early on, those were the numbers that were coming out. Then again, that wasn’t at the seven-, eight-year mark. That was closer to the four- and five-year revision.
Michelle: What are some of the reasons that people are suing hip companies? What are the actual things they did wrong, in this case, with these hip implants?
Sean: The legal causes of action – you have strict liability product design failure, you have a failure to warn case, and you’ve got a negligence theory that you would sue on. The bottom line is that none of these devices were tested in humans before they were put on the market. All of these products were approved under the 510(k) approval process through the FDA, which means all they had to prove was that the product was substantially equivalent to some similar design -- some earlier design -- of a hip implant.
Michelle: That’s huge, because I think most people assume, right, that as soon as something is on the market, it’s been tested, safety has been properly checked. But this 510(k) thing is huge.
Sean: That’s exactly right. There’s a big misnomer that people think the FDA itself tests these products or that the companies test them, but they don’t. There’s two ways to get a product on the market. There’s the 510(k), which requires the substantial equivalence test, or you have a Premarket Approval (PMA) process, where you have to prove to the FDA that your product is safe and effective – and that’s not what these implants went through.
Michelle: I think that’s only for what they call high-risk – class III – devices, right? All of these joints were considered class II at the time, right? They’re all going through the 510(k), not the actual testing.
Sean: That’s right. They were able to prove that it was substantially equivalent to an earlier device.
Michelle: I also want to point out that in a lot of those instances, some of the devices that these companies use to approve the newer devices – have already been recalled – or something crazy like that. Like in the case of the mesh.
Sean: That’s right. Some of the earlier products that they relied upon have since been recalled.
Michelle: Talking about recalling these hip devices -- every time there are problematic hips or any other devices, are they always recalled?
Sean: No, unfortunately, they are not. For example, with the metal-on-metal hip instance, the only metal-on-metal hip that has been recalled is the DePuy ASR. The other hips – for example, the Pinnacle, which is another metal-on-metal product that’s manufactured by Johnson & Johnson -- what Johnson & Johnson announced earlier this year is that they just weren’t going to offer it for sale anymore. Taking it off the shelves and not promoting it for sale is kind of a quasi recall, because you’re no longer out there promoting the product, but you’re not selling it anymore either.
Michelle: And of course they don’t say it’s because there are any problems with it. They’ll say it’s a financial decision or something like that, when they pull it off.
Sean: That’s exactly right. That’s … what I would call a soft recall, where it just kind of goes away and fades into the background.
Michelle: What should people do if they receive a recall letter? And what happens if they don’t get one?
Sean: Well, the first thing is, if they get a recall letter, they certainly should go to their doctor – especially if they’re experiencing any symptoms or any problems, such as swelling or soreness or unusual pain. That’s the first thing they should do.
They may not get a recall letter. Like I said, the DePuy ASR was the only metal-on-metal hip implant that was recalled. If you have a medical device and you are experiencing pain or some type of symptom in the area where that implant has been implanted, then you certainly should talk to your doctor first. Even if you are experiencing symptoms that are abnormal than your normal condition, and you know you have some type of implant, let your doctor know that you have that. Because sometimes -- if you go see your general physician, for example, he may not be aware that you have been implanted with something and may not know that that could be a cause-and-effect relationship there.
Michelle: So now if people are concerned, they shouldn’t wait, right? They shouldn’t wait to receive a letter notifying them or anything? They should probably, like you said, just go to the doctor and get it checked out.
Sean: Absolutely. That’s the first thing they should do – is to go to their doctor and let them know what’s going on. Because, sometimes, doctors may have clients with similar issues, and they may pick up on a problem before the patients do. That’s sometimes how the manufacturers find out – doctors will call them and report that they’re having problems with this particular group of patients that have a product.
Michelle: What should people do if hip manufacturers offer to pay for revision surgery? Say they’re having issues, and their doctor says, “Hey, we’re going to have to take this implant out. We’re going to have to replace it.” Is this usually a general practice that hip manufacturers do when they find out that someone’s having revision surgery with one of their products?
Sean: No, it’s not. Unfortunately, that’s not typically what happens. Fortunately in the DePuy ASR situation, Johnson & Johnson has a program where patients can go to seek reimbursement. Now it’s not 100 percent guarantee that they’re going to be reimbursed for everything, but at least they have that option. There’s another hip that’s been recalled – that’s not a metal-on-metal hip, but’s having some similar type problems – the Stryker Rejuvenate and ABG II hips. There’s also the same type of program that has been set up.
What people need to be aware of – if you’re receiving something from the manufacturer or the manufacturer offers to pay something – be careful what you sign. Make sure, if you’re given something, consult a lawyer about what you’re signing, so you’re not giving away any of your legal rights. Because that could have an impact if you decide to bring a legal action at a later date.
Michelle: Now, if there is no recall on a product – we mentioned that not everything is recalled even if there’s problems with the product – lawsuits still go on, right? You can still sue manufacturers, regardless of there being a recall or not.
Sean: That’s right. I think sometimes it’s harder to convince a jury that that product is defective, if the manufacturer hasn’t recalled it. But absolutely, you can still prove that there’s a manufacturing defect or product defect with a product even if it hasn’t been recalled. For example, in the case where the manufacturer may simply stop offering it for sale, there’s a reason they stopped offering it. It’s not always because there’s a problem with the product, but that can be one of the reasons.
Michelle: Gotcha. Now, how can people tell what kind of implant they have? Is it important, if they’re going to go to revision surgery, to preserve the implant?
Sean: Well, the surest way to find out what type of hip implant you have is to get your medical records. … When you have a device implanted in you, they will typically come with surgical stickers. When the implant is removed from its packaging, there will be some stickers in there. The doctors will take those stickers, and they’ll place them on their medical records. That will identify the exact part that was implanted. It will have the serial number, the lot number, when it was manufactured. And it will have a lot of information and will identify specifically which product you have.
If you do have an implant that has been removed – if you have to have a revision surgery – it’s very important that that explant (that implant that’s been removed) is preserved. Because that’s going to be evidence in the lawsuit, as to the defective nature of that implant. And the only way to definitely prove that there’s some problem with that explant is to have it tested. If the implant doesn’t exist anymore, then it’s impossible to do that.
Michelle: In some cases – and I’m not sure if this is common practice or not – I’ve heard some instances where people go in, they’re not really thinking about that aspect of it, and the implant is either tossed or sent back to the manufacturer by the doctor or the staff at the surgical center. Does that mean they basically forfeited the possibility of a case or anything like that?
Sean: No, I don’t believe they forfeited their opportunity to bring a lawsuit. What happens is it’s just going to make their lawsuit a little bit harder to prove.
Michelle: I gotcha. Without the evidence there, it’s a little tougher. OK.
Sean: That’s a very key piece of evidence in these cases.
Michelle: If you’re talking about a faulty product, you definitely have to have the product.
Sean: You want to be able to show where it’s defective, right.
Michelle: That’s right. Now, I’m not sure what the statute is on these cases. Is there a time limit that people have to file these? ‘Cause I know that a lot of these products have been on the market for a little while, and maybe some people might just be realizing now that they’re having issues or something like that with these implants.
Sean: The first thing you’d have to look at is where those individuals live. Each state has its own statute of limitations, which governs when a lawsuit needs to be filed. So that becomes a very specific exercise, based on where you live and what the law is in that state, which will control when you need to bring that lawsuit.
Michelle: I think a lot of people sometimes confuse class-action lawsuits and multidistrict litigations. They involve big numbers of plaintiffs – both of them do – but there’s a key difference, right, between class actions and multidistrict litigations?
Sean: That’s exactly right. A class action lawsuit has a different procedure. A class action essentially can be one person – for example, you would be representing everybody who has this implant. For example, the class would be defined by anybody who’s had a DePuy ASR hip implant during this period of time is considered a class member, and you would represent all of those people. Unfortunately, since these would be personal injury cases, you can’t do a class action on a personal injury case. So that’s the biggest setback, so to speak.
A multidistrict litigation sort of functions like a class action. … All the cases are consolidated in front of one judge typically, or multiple judges with larger groups of cases, and then that judge will make procedural decisions – specifically with regard to discovery – that apply to all of the cases. Once those issues of discovery have been resolved … the cases can be sent back to where they were originally filed for trial. Every individual in that situation has their own personal lawsuit filed.
Michelle: That’s the good thing about that, right? People retain their own individual case, as opposed to class action, where you sort of get lumped in with the one representative.
Sean: With the class action, you get lumped in. That person will make a decision, for example, if they want to accept a settlement. Then that settlement would be applied to everybody unless you opt out of a settlement, then have to bring your own lawsuit. Whereas, in a multidistrict litigation or a mass tort-type case, everybody already has their case on file. Everybody has the opportunity to have their case tried. Where the class action, there would be one trial – that ruling would apply to everybody – whereas in a multidistrict litigation, everybody can have their own case, and you could have varying outcomes. One person may win their case; another one may lose it, because of the specific facts of their case.
Michelle: So you’re not necessarily affected by that other case that came before you in the MDL, which is good. And you also retain your own counsel, right, your own attorney? There isn’t one attorney that’s basically handling the entire class action.
Sean: That’s correct. The lawyer that you hired will be the lawyer that will represent you. In a multidistrict litigation, there is a steering committee typically in place that will sit at the top of the food chain, so to speak, and make some of the bigger decisions on how discovery is conducted and make some of those decisions. When it comes down to your individual lawsuit, you and your lawyer make those decisions.
Michelle: Now, with the hip cases that are going on right now, we’ve seen some movement with some of the state cases with Johnson & Johnson. The MDLs themselves are kind of, sort of floating around right now. Is that because Johnson & Johnson is throwing out this settlement offer? I believe I read about somewhere that they are considering putting some money aside to just settle the cases. What do you think about that? Is that a realistic thing? Should plaintiffs be optimistic or just wait and see what happens?
Sean: I think it’s optimistic that Johnson & Johnson has set some money aside that they want to use with regard to trying to resolve this litigation. I think it’s still a wait-and-see process. There’s still many trials that have been set. Whether they’ll be settled before they come up, I don’t know.
Michelle: We were talking about settlements and trials and things like that. What kinds of compensation do people usually get in these instances? What kind of damages do they usually recover?
Sean: You can recover for your medical expenses – past and future – that you may have incurred as a result of the defective implant. You can have lost wage damages; for example, if you missed work or can no longer work in the future because of the damage that you had. Those are what we call your economic damages. Additional economic damages may be some out-of-pocket damages you have. You may be reimbursed for travel expenses, if you had to travel to get a hip implant.
Then you have non-economic damages, which come under the guise of pain and suffering, or mental anguish. Then there’s a third category, which are typically known as punitive damages. In some cases, you may recover those. But the majority of times, those aren’t recoverable. You’re not going to be able to get those. Especially in a settlement context, you’re not going to get paid for punitive damages. You would get non-economic and your economic damages covered.
Michelle: Punitive damages is usually something that the jury awards at trial, right?
Sean: That’s exactly right.
Michelle: After a suit is filed, does every case go to trial? We were mentioning settlement here – so that’s always an option. If there’s a settlement on the table, it’s either you can choose to do that or continue with the trial, correct?
Sean: That’s exactly right. Like we talked about earlier, everybody has their choice. If a settlement is offered, they have the right to accept that settlement or they can proceed further with trial.
Michelle: With the hip implants you’ve seen – and obviously DePuy’s ASR is probably at the top – which of these implants seems to be having the most issues?
Sean: From my experience, obviously the DePuy ASR has been the biggest failure, so to speak, from my clients’ standpoint. After that would be Wright Medical Technology’s CONSERVE Plus line of hip implants.
Michelle: I see. People that have those probably should be a little more concerned, than maybe the others.
Sean: Those have shown to have the higher failure rates, from my experience.
There are different MDL judges. There’s one in Ohio – that’s Judge Katz – who has the ASR. You have a judge in Dallas – Judge Kinkeade – who is over the Pinnacle. You have a judge up in South Bend, Indiana, who is doing Biomet. You have Judge Duffey in Atlanta, Georgia, who has the Wright CONSERVE.
Michelle: One last thing. I mentioned bellwether trials. Could you explain the difference between a regular trial and a bellwether trial?
Sean: From a practical standpoint, it’s the same thing. What the bellwether trial does is – the parties try to pick what they believe is the most representative plaintiff of a majority of the cases to try. It kind of fleshes out the liability issues: What are strengths and weaknesses in the liability case on both sides? What are damage ranges for different clients? That’s what that’s meant to do. Those bellwether trials are meant to give each side an understanding of what settlement values could be, because of verdict ranges. And it’s because there’s no way you could try 10,000 cases.
Michelle: That would be crazy. Though, generally – I think you mentioned this – when they decide which cases are going to be the bellwether cases, it’s usually cases that are representative of a lot of the plaintiffs, right?
Sean: That’s right. You don’t want to pick an outlier that’s the worst case out there or the best case. Typically what happens is the plaintiffs steering committee will pick several cases, the defense will pick several cases, and then those will be presented to the judge. And the judge, from there, will pick one or two of those cases to start with.
Michelle: And then it all goes from there. And obviously what happens in that trial sort of gives everybody an idea of what to expect going forward.
Sean: That’s the goal. That’s right.
Michelle: That’s what we’d hope anyway, right?
Sean: That’s what we hope.
Michelle: Yeah, these things are obviously very complicated. They never, ever go the same way twice, it seems.
Sean: That’s right. You’ve got the example – these weren’t bellwether trials; these were state court cases – you had a DePuy ASR case in California that resulted in an $8.3 million verdict.
Michelle: Yeah, a huge verdict.
Sean: And then in Chicago, you had a DePuy ASR case which the defense won. You have a big range between $8.3 (million) and zero. It definitely comes down to the specific issues with the case, because every plaintiff is different. That’s where the biggest part is. The evidence …
Michelle: Pre-existing conditions and things like that, right?
Sean: You’re right. The plaintiff can have a whole host of medical problems that may impact the way a jury thinks about a case.
Michelle: What was interesting to me – you brought up the Kransky case, which was the $8 million one – when I was following it, it seemed like they were just throwing everything at this poor guy. “He’s got this issue. He’s had cancer.” It was like, wow, they’re just going to blame everything else for this poor guy’s hip. The jury ultimately decided it was a design defect, I believe?
Michelle: It’s definitely interesting. Like you said, you cannot predict.
Sean: That’s right. If I could predict, my job would be much easier.
Michelle: Oh, yes, I bet it would be.
Thank you so much, Sean, for joining me today and offering some of your very extensive knowledge to my listeners. I think that sometimes people that are in these situations – it’s a little confusing. You’ve got medical problems to deal with. You’ve got bills piling up. And it’s a lot for people to handle, and I don’t think they always get to know how the process ends up. They think about filing a lawsuit, and it’s scary for some people. So, I’m really fortunate to have you here, and to have them understand some of these things that go on with filing a lawsuit. So thank you very much.
Sean: You’re welcome. No problem. Take care.
Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.
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