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Hernia Mesh Updates

By Susan Barfield
May 19, 2023

Susan Barfield (00:00):

Hello everyone. Thank you so much for joining another Case Work stream. I’m excited to have Kelsey Stokes on today. We’re going to talk all things hernia mesh, but before we dive in and start talking a little bit more about hernia mesh with her, wanted to give a quick introduction about Kelsey. Kelsey is a attorney at the respected Fleming Nolan Jez firm out of Houston. And she was recognized as a national leader in the hernia mesh litigation. In fact, in 2018 Kelsey was appointed as the co-lead council for the Plaintiff Steering Committee. And prior to leading the hernia mesh docket, Kelsey played an integral role in successfully litigating the firm’s transvaginal mesh docket.

Susan Barfield (00:46):
So first Kelsey, thank you so much. I know you’re a busy lady, but really appreciate you taking time today to talk to us, provide some updates about hernia mesh. And some of these questions, I just want you to bear in mind that some of the attorneys that are listening to the podcast and to these streams are personal injury attorneys that are considering getting into mass torts. And so while there’s lots of mass tort attorneys that’ll listen, maybe give some background and information for those that don’t have as much insight into mass torts as you do.

Kelsey Stokes (01:20):
Gotcha.

Susan Barfield (01:20):
Yeah. Well, thanks so much again for being on today’s stream.

Kelsey Stokes (01:25):
Thank you so much for having me, Susan.

Susan Barfield (01:27):
Yeah, absolutely. Well, one of the first things I wanted to talk about and just get a little background is just what initially interested you in the mass tort litigation and products liability?

Kelsey Stokes (01:38):
Well, I actually started, I was a summer associate at a defense firm in their litigation department, and that’s when I realized that I really liked litigation. And the reason is because you can learn so much about so many different things, just depending on what case you’re on. You’re not pigeonholed into one topic or another. And so I had an opportunity to interview at Fleming Nollen and Jaz when I was in law school. And so I started, and that’s what attracted me to the firm was the litigation experience. And so I started as a law clerk here and they hired me on. And I’ve done several personal injury one-offs and those are fun, but I really felt I got a niche for the mass tort world and what I love about mass tort is you can both litigate the cases, do workup experts, do discovery and then also manage dockets depending on how you want to approach the mass tort case.

Kelsey Stokes (02:36):
And for example, in GranuFlo, I managed the GranuFlo docket, and I wasn’t on the leadership but I was able to have communications with the clients, review medical records, very complex stuff. And then if you want, you can also do the hands on stuff, the discovery depositions, and frankly even if you’re not on the Plaintiff Steering Committee, I would urge anybody who is interested in doing work for the Plaintiff Steering Committee to reach out to somebody because there’s always help that’s needed. And so if you’re not on leadership, you can certainly still do work for the leadership committee. And that’s what I really like about it is you can work up experts and do depositions and do a whole kitten caboodle of litigation.

Susan Barfield (03:22):
Yeah. No, that’s awesome. And I think one thing that you touched on and is important is the mass tort and personal injury community is really small. And I think that what I have seen, although we are working as an extension of the law firms, there are attorneys like yourself and those that are on leadership that really welcome questions and want to spend time with attorneys that want to work up the docket’s right, and want to make the right decisions and know which ones to invest in. And so I think it’s a small community and there’s a lot of people that are willing to help.

Kelsey Stokes (03:56):
Right. Yeah, it’s so important to work up the docket even if what you’re doing is managing your docket, I cannot stress enough how critical it is for you to know the case, to know the case management orders that are in place so that you’re case counsel that’s responsible and that’s really informing their clients. And in addition, if your case gets picked as a bellwether, it’s really critical that you know the litigation and that you have done the background homework on knowing what is a good case and what’s not so that if your case gets picked as a bellwether you’re prepared to go and take those case specific depositions.

Susan Barfield (04:34):
Yeah. Yeah, absolutely. Well, tell us a little bit about your professional journey through the mesh litigations.

Kelsey Stokes (04:40):
Well, transvaginal mesh is where I really got started on polypropylene mesh litigation. The lead attorney at the time left and so I was basically given the docket to run. And we had several bellwether cases. I think we had in the teens, between Bard, Ethicon, Boston Scientific, we had a ton of work to do on bellwether cases. And so I did several depositions, I did a lot of that. And then in, I remember in Ethicon, we had 40 bellwether cases selected.

Kelsey Stokes (05:24):
And so I went out and worked with the experts and got expert reports for all 40 of those cases, and then of course we resolved them. So that was how I really got familiar with the polypropylene mesh and story and all of the problems that polypropylene mesh can cause once it’s placed inside the body. And then hernia mesh started when really, I would say that of course there was the Kugel back in about a decade ago which was very specific defect, not really focused on the polypropylene aspect of it, then Physiomesh was voluntarily withdrawn from the market, careful not to say recalled.

Kelsey Stokes (06:04):
And that was when the hernia mesh started to pick up generally amongst all manufacturers. And as far as Bard goes, Bard is by far the largest market share in hernia mesh, it’s over 60% of the market share. And so what I saw there was there was a small state court litigation, by small I mean small state in Rhode Island. And I just felt like, I had a couple of cases filed federally and was working those cases up and it seemed like an MDL was an appropriate move.

Susan Barfield (06:40):
Yeah. And for those attorneys that may be listening that are considering trying to acquire some hernia mesh cases, what are the reported injuries or the injuries we can expect to see in the future?

Kelsey Stokes (06:54):
Well, so there’s generally injuries… The basic problem with polypropylene mesh is that polypropylene insights a chronic inflammatory response that doesn’t go away until the product is removed. And it might not happen immediately, but I kind of view it as a ticking time bomb. And so what you see is, it’s almost like a vicious cycle that this chronic inflammation will essentially degrade the mesh. Not essentially, it does degrade the mesh and this degradation makes the mesh stiffer, it makes it harder. And so that’s kind of the basic structure of what you see in the polypropylene story, which is the hardening of the mesh. You’ll, for example in transvaginal mesh, that hardening in that really sensitive spot, women felt like they had sandpaper, that they were walking with sandpaper. And a similar story with the plugs in hernia mesh is I’ve had clients say that they feel like they have a cigarette pack in their groin, and that’s because the mesh is hardened throughout this inflammatory process that’s just essentially contracting the mesh and squeezing the nerves and causing chronic pain.

Kelsey Stokes (08:10):
One thing I want to point out since your question is about injuries that this mesh causes is that you need to know the devices and you need to know the mechanism of failure for each device, because while there’s this overarching issue of polypropylene being problematic for the human body, you need to know the mechanism of failure. So for example, the ST line of products and ST stands for separate technology, which is the technology that Bard uses for their resorbable barrier. And the resorbable barrier is used for… They basically slap this ST, it’s like a film on this piece of plastic, which is all polypropylene is, and they place it in this very very delicate part of the body you’ve known as the intraperitoneal cavity or in the abdomen right up against the bowels and very delicate visceral tissue.

Kelsey Stokes (09:01):
And so in order to do that, you have to guard essentially the polypropylene from this delicate tissue. And so these companies use these barriers. So this ST coating, what the problem is and what this trial was that we do it in this summer is that the barrier goes away way too quickly, way before the body can heal itself and essentially create its own natural barrier. And so the problems that are associated with that are going to be adhesions, dense adhesions, very dense, not just the filming ones that you can just sweep away, dense adhesions that essentially stick the bowel to the mesh and then the mesh can erode through the valve. So if you see something like that in an ST product, that’s a signature injury.

Kelsey Stokes (09:44):
ePTFE is a permanent barrier. That’s your Ventralexs, your composites. Anytime you see a composites product ID, that’s going to be an ePTFE case. And that has a slightly different mechanism of failure, all centering around essentially exposing polypropylene to the bowel, but the reason behind it is different. So there’s a different contraction rate of this ePTFE and polypropylene, and it essentially allows the polypropylene to flip or waffle or potato chip or buckle is what the term is called. And so it flips the polypropylene side to the bowel, and that then causes problems like what I just discussed, the erosion and whatnot. Inguinal meshes, those are not coded meshes, because there’s nothing, they’re not protecting it’s bowel. But those are the problems that are actually more similar to the transvaginal mesh story, which is delicate structure entangled in nerves, chronic pain, that type of thing. So you need to know the case, you need to know the products to know how they relate to the injury that you’re seeing.

Susan Barfield (10:44):
Yeah. That’s awesome. If attorneys are listening, they’re like, man, Kelsey, that’s just a lot of information. How do I find out about all the different failure modes? Is there a specific area that we can direct attorneys to go to, to understand not only the different manufacturers that are part of this tort, but also like you mentioned, the defects.

Kelsey Stokes (11:05):
Yeah. So one thing I would suggest is always going to the… First of all for anything that I’m in leadership on, we have nifty little websites to go to. So for Bard it’s bardmdl.com. For Ethicon, I’m on the executive committee in the Ethicon New Jersey litigation pursuing proceed and Prolene hernia system, it’s ethiconmeshnj.com. And those have all of your case management orders.

Kelsey Stokes (11:30):
If it’s a different litigation, I always, always, always go to the case management orders. That’s the first place to go, always go to the master complaint. Look at our master complaint because the master complaint lays out what these modes of failures are and we split it up based upon the product type, et cetera. There’s always conferences to go to, but I would start with the master complaint and that’s also why leadership is here, feel free to reach out. If Daubert has been briefed which it has, at least in the bar MDL, then go to the PACER and look at the Daubert briefing because the reports are attached to those Daubert briefs. So you have the capability of looking at the experts reports that have been produced in this litigation.

Susan Barfield (12:18):
Okay, great. Those are great resources. Any thoughts or feedback on attorneys and firms that are wanting to either acquire more cases or thinking about getting into hernia mesh, what would you say your feedback and thoughts would be?

Kelsey Stokes (12:33):
Well, I think at this point, I would call this a mature tort because as I just said, there’s already been Dauberts. Some of them are at different stages. For example, Bard is pretty far along. We’ve had our first bellwether trial, our second bellwether trial is set for January 10th. And I’m just going to tell you, it’s not a state secret that we are really working hard, we have both a litigation team but also a parallel negotiation team that we are trying to resolve these cases globally. And the timeline that we’re looking at my hope is, and this might be a bit too optimistic, my hope is that we can get there in the next couple of months.

Kelsey Stokes (13:21):
So what that means is you’re kind of running out of time if your goal is to get is to get Bard cases, just because I think we’re getting real close to resolution. And so that said, there are other manufacturers out there. For example, the proceed litigation, we have our trial pick deadline coming up in a week. And so we haven’t produced expert reports in that case. We’re still litigating those, we still haven’t had a trial. And though that makes up about 10% of the market share. An interesting development and probably sure everybody wants to hear about this is Covidian and what’s happening with Covidian. There is a litigation right now, it’s organized and consolidated in Massachusetts State Court. However, the leadership there has expressed that they’re really only interested the multifilament. And let me just back up real quick, if you don’t know, Cavidian is a polyester, predominantly polyester. There’s a couple products out there that are polypropylene based, but the Cavidian, the bulk of their product line is polyester so it’s a slightly different story.

Kelsey Stokes (14:31):
And multifilament is, I like to imagine, you know those little twizzler strips that you get at the movies or you can like pull off, imagine when you don’t pull off the strip, that’s what multifilament looks like. So a bunch of little cylinders, and so you can have bacteria get stuck in those little nooks and crannies. And so that’s one of the problems with that. But there’s also monofilament, which is just if you were to pull off that little thing, and that’s just the one little cylinder, and that’s what monofilament multifillment means for those of you that don’t know. And so anyway, for that case, the focus of Massachusetts State Court is on the multifilament products. However, there are a significant number of products that Covidian makes, Symbotex ProGrip that are monofilament, but are terrible, terrible products.

Kelsey Stokes (15:20):
Symbotex is very similar to the ST line of products or the Pro C line of products with the resorbable barrier that is problematic, that doesn’t work. I’ve seen internal study that show that these are problematic when they compare them to other devices. And then the ProGrip if you look at it, I wish I had a picture of it, but it’s designed, it almost has little teeth. It’s a plug that has little teeth on it that essentially it’s like velcro. And so it’s implanted and it’s designed to create this inflammatory response and these teeth kind of just stick into it. So imagine if you have problems with it, what it’s going to do if you try to pull that out. So those are cases that I am actively pursuing, and I would say that about 50% of my inventory, and I hate to use the word inventory, but it’s just for lack of a better word. 50% of my client’s cases are these monofilament cases.

Kelsey Stokes (16:13):
And so if you want to know what’s happening with those, call me, we’re still exploring the best venue to file those in. And it might be looking like federal court is the way to go on those cases, but certainly do not throw those cases away. A lot of people have thrown those cases away because they’ve been advised by people who just aren’t interested in the monofilament cases. And Covidian makes up about 13, 15% of the market. So that’s not an insignificant number.

Kelsey Stokes (16:44):
Atrium is a very, very tiny market share. I would say it’s about 3%, three to 4% of the market share. Interesting terrible product, it’s the C-QUR. And they use for their barrier this Omega3 fatty acid, it’s like fish oil. It leads to all kinds of problems, but that’s also in the real, real tell end of that litigation that you’re probably not going to see many of those cases. So I think I answerd your question, not in the shortest way, but there’s still cases out there, but it’s not as new as if you would’ve gotten into it three years ago, you’re not going to see the same type of cases.

Susan Barfield (17:27):
Yeah. Well, two things you mentioned that I had follow up questions to. You’re talking about a lot of different products, are there any certain products that you believe are stronger than others?

Kelsey Stokes (17:37):
Stronger as far as better liability cases?

Susan Barfield (17:40):
Yes.

Kelsey Stokes (17:41):
Yeah. I think that there’s always naturally going to be, that’s always going to be the case I think no matter if you have multiple products within one litigation, I really love the ST story. And then we have that trial, it’s all there, but the ST story is great. They advertise for this barrier to last a certain amount of time and all of their data showed it didn’t. Same thing with the proceed story, I love the resorbable barrier stories because they just don’t last long enough for repair or for the body to heal over and create its own little barrier to protect the bowel. I would say the weaker cases, definitely the weaker cases are going to be the ones that are just the flat meshes, the ones that have been around for decades really. They’re polypropylene and they cannot be placed in preperitoneal space so they’re placed in the retrorectus space or extra peritoneal. In other words, there’s protection that the body naturally provides. And typically surgeons that are able to implant in this manner are very skilled surgeons.

Kelsey Stokes (18:55):
And so if I had a family member, for example that came to me and said, what should I get, I have a big vental hernia, you’re going to have to have some sort of grafting material to keep that repair strong. And so what I suggest to people is a soft, a lightweight mesh, like a Prolene soft, Bard soft, any of those softer, lightweight meshes in the retrorectus space, because that’s going to be a solid repair, with probably minimal complications compared to all of your other options out there. The ePTFE polypropylene stories, also a really good one, that’s that Kugel. Kugel was a real ring break issue, but the Kugel line of products, the ventralex and whatnot, those have been probably the most litigated and those are solid cases.

Kelsey Stokes (19:45):
One, you have the ePTFE which is a permanent material. So it’s a foreign body over load basically. And then too, this different contracture rates causes the buckle. I also love the plug story. 3Dmax is not as great, but the plugs where the Prolene hernia system, the perfects, where they just basically plug the hole and it’s just a bunch of mesh just on top of each other. So not only is it heavyweight mesh, but it’s multi-layered heavyweight mesh, and that just causes a extreme fibrotic reaction causing scar tissue that results in meshoma, is kind of what surgeons will call it cause it looks like a little tumor that they pull out and it’s just balled up and that can really squeeze the nerves right there and cause chronic pain. And it can also lead to orchiectomy or testicle removal because it essentially squeezes the blood flow from the testicular artery.

Susan Barfield (20:40):
Yeah. The other thing that you mentioned was a global settlement or global resolution. Do you anticipate a global resolution of both the Bard MDL and the Bard Rhode Island at the same time?

Kelsey Stokes (20:56):
I cannot speak to what’s happening in Rhode Island, so I don’t even want to try to guess on what’s what’s happening there. But I will tell you as co-lead council of the Bard MDL, that one of the things that is very, very important to us is to try the best that we possibly can to reach a global resolution. That’s what I believe that our judge wants, and that’s what we think will be best for the litigants and for everybody out there. And so we are trying our hearted and we are in negotiations and I’m very optimistic that we are going to achieve that. You never know, depending on if the values just aren’t there, then we’re not going to settle for low values. And so if we have to keep trying cases, then we’re going to do that before we going to resolve these cases for less than a fair value. So it is absolutely 100% our goal to resolve these globally and that’s what we’re trying to do.

Susan Barfield (21:57):
Okay. You also mentioned the recent bellwether trial. What was your thoughts? Were you surprised with the outcome?

Kelsey Stokes (22:05):
Well, it was a defense pick and it’s a defense pick for a reason. That this was a unique injury profile, the plaintiff had an issue that was sort of a, in my mind, it was a little bit of a red herring, but it was certainly something that was unique, which is a diastasis recti. He didn’t go to the doctor, and so there was not the proof of injury that is ideal. And so because of that, we were limited in what we could discuss. We actually could only talk about from his first surgery to the removal surgery and the removal was incidental to another procedure. So it wasn’t like the surgery was indicated because he was having problems with the mesh. It was for something else, it was for this Diastasis recti.

Kelsey Stokes (23:07):
And so the fact that we could not talk about anything after that, so we were basically time stood still after October of 2016. That was severely limiting, and I understand the reasoning behind the ruling, but that did lead to a limitation. And so am I surprised? Absolutely not. I am surprised in the sense that we put on a really, really good case. And the jury seemed to really want to… The jury seemed like that the liability story, and we did not talk to the jury afterwards, but the reason that I’m kind of speculating is because of the question that the jury actually asked during the deliberations, which was the following,` in order for us to say yes on this jury verdict form, do we have to say yes to all of the elements?

Kelsey Stokes (24:01):
And so to me, that indicates that they wanted to yes to liability, but because of the fact that every element or every single count said, and he was injured, I think that it was that final element that the jury was caught up on. And that’s just me reading the tea leaves for whatever that’s worth, but again it’s a defense pick. It was a defense pick for a reason. And so am I surprised? Not really. And nobody else should really be discouraged by it, because what we did do is show that we put on a really solid case against this product line, which is their state of the art product. And frankly, defendants were sweating. They called 10 live witnesses, which is, if you’re familiar with defendant’s playbook, that’s a significant number of witnesses. And if they don’t have to, they’re not going to call those witnesses. So they obviously felt like they needed to call those witnesses. And to me, that indicates that that they were really concerned. So, like I said, it’s a defense pick, so I am not discouraged, nobody else should be.

Susan Barfield (25:07):
Yeah. Well, that’s great. I mean, Kelsey, this has been fantastic. I mean, lots of wonderful information. Again this is going to be great feedback for attorneys that have lots of cases and those that are considering getting into hernia mesh. So, I know we’ve taken up a lot of time already, but this has been super valuable and I greatly appreciate all the time and the answers to all the questions and such. One thing, you mentioned attorneys to reach out to you, what’s the best way to contact you?

Kelsey Stokes (25:41):
Send me an email at kstokes, that’s K-S-T-O-K-E-S at fleming-law.com. That’s F-L-E-M-I-N-G-law.com. So Kstokes@fleming-law.com.

Susan Barfield (25:53):
Perfect. Well, again… Yeah.

Kelsey Stokes (25:56):
Thank you so much for having me. It’s been a real pleasure. I love talking about this stuff.

Susan Barfield (26:00):
I can tell you’re very passionate and I can certainly see why you’re a leadership. I don’t know if you know my background as being a nurse and I mean, you know a lot about the science, so that’s fantastic. It’s great to hear and to see your passion. So, thank you again for your time and we greatly appreciate it.

Kelsey Stokes (26:19):
Thank you.

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