2023 Hernia Mesh Litigation Updates
Fleming, Nolen & Jez
Susan Barfield (00:06):
Hello everyone. Thank you for joining another Case Works Stream. So excited to have Kelsey Stokes with us. Kelsey, it’s been a while. I guess the last time we had a stream, it’s been a couple years, but was excited that I had an opportunity to see you in person at the Women’s and Legal Leadership reception there at Mass Torts Made Perfect a year or so ago.
So anyway, thank you so much for taking time to connect with us today. And for those of you, I don’t know if there’s many that don’t know who Kelsey is, but just in case, you just graduated from law school and you’re starting out. Kelsey is an attorney in Houston at the respected firm, it’s called Fleming, Nolen and Jez.
Kelsey is a recognized national leader in the hernia mesh litigation. So much so in 2018, she was appointed as the co-lead counsel for the plaintiff’s steering committee for Bard. Then in 2022, you were appointed as the co-lead counsel for the Covidien MDL in Boston. I know you’ve been busy at the state court level over the last five years serving as the co-lead for the three Ethicon New Jersey MCLs in front of Judge Bordeaux. So thank you, Kelsey, for being here with us today.
Kelsey Stokes (01:20):
Thanks For having me, Susan. Good to see you again.
Susan Barfield (01:24):
I know a lot has happened since we last connected in November 2021, when we did the stream on hernia mesh litigation. So I’m excited to talk about all the updates, but really interested to hear from you about what’s happened since then. Will you share with us the defendants that are left, the products and for those that may not be as familiar to some of the claims in this case?
Kelsey Stokes (01:49):
Sure, absolutely. So I think one of the most common questions I get is, given the maturity of the hernia mesh tort, is there still viability to hernia mesh cases? And my answer is simple, absolutely. The defendants that are left are the two biggest defendants.
The biggest defendant by far, as I said the last time we met is Bard. Bard has, I mean, at this point it’s probably well over 65% of the market share. They make over 20 devices that are all being implanted today. There has not been a removal from the market and that’s largely Bard’s decision. So people continue get to get implanted with these meshes made by Bard and also continue to be injured. So these constant revision surgeries that are coming, by far Bard is definitely still a viable case.
The other manufacturer that is left is Covidien, whose parent company is Medtronic. That was recently in the summer of 2022, MDL in the district of Massachusetts in front of Judge Sargus in Boston, and just like Bard, Covidien makes a substantial number of products, about over 20, and just Bard, those products are still being implanted as we speak. And just like Bard, those products are still injuring people.
So as long as those products continue to injure people and as long as they, by “they,” I mean the two defendants that I believe are really the most viable defendants still remaining, have not come to the table for any meaningful resolution. We are going to continue to prosecute these cases against these defendants and this is very much viable tort.
I would say that the defendants that remain, which would be Bard and Covidien, make up over 80% of the market share. Again, between the two of them, over 40 products are being implanted and injuring patients daily.
Susan Barfield (04:06):
Well, I’m so glad you said that because attorneys ask me all the time that are interested in getting into mass tort, they always say, “Do you think there’s any hernia mesh cases still to get?” But if they’re still out there manufacturing the same products, having the same injuries, you just said, we heard from you that, yes, absolutely there’s still cases to obtain and work up and we know… Go ahead.
Kelsey Stokes (04:27):
What I want to point out as well is that these products, because of the nature of these inflammatory polymers that these products are made of, they’re not acute injuries. In other words, they don’t manifest immediately. This inflammatory, I talked about it on our last interview and I hope that everybody watches that, is that the nature of these polymers is that it’s a chronic inflammatory stimulus that does not go away until it’s removed from the body.
Depending on the patient, that could be years. And so many people who have were implanted maybe in 2016, even before that, maybe 2012, they might have been fortunate enough to have the latency that’s maybe some patients didn’t. But as I said in the last interview, these products are a ticking time bomb. Unfortunately, the injuries will manifest, it’s just a matter of when.
So absolutely, even if a patient had a product implanted back in 2012, there could still be very serious injuries and a viable case.
Susan Barfield (05:35):
Well, I know that we were talking, and prior to recording Bard, the MDL grew by 23% in 2022. So what do you attribute this substantial growth to in claims?
Kelsey Stokes (05:50):
I think, again, this is a manufacturer, which is the largest market share of hernia mesh devices made of a highly problematic polymer in polypropylene. And it’s being implanted every day, unfortunately. The surgeons are unaware of the dangers that these products present.
As I said, it’s not an acute process. This is a process that happens over time. I think the growth in the MDL is a result of and illustrative of how problematic these products are. These the patients are going to continue to be injured, and as long as patients are injured by these products, I know that we are going to protect these people and file cases.
Susan Barfield (06:39):
Well, let’s talk a little bit about some of the bellwether trials. I know it’s been a rollercoaster so far in the first bellwether in July of 2021, so approaching a couple years ago, the jury ruled in favor of Bard. So how did that outcome shape the litigation strategy going forward?
Kelsey Stokes (06:57):
Well, so that’s a good question. The product that was at issue in that first bellwether case was the Ventralight ST. That is the ST stands for separate technology, which is the coding that is placed on top of this plastic polymer to be placed right up against the bowel, which, if it doesn’t work, causes significant injuries.
It’s all there in the filings and in the daily transcripts, you’ll see that any product that has an ST coating is very problematic. Tim O’Brien and I, along with our great trial team, our great plaintiff steering committee, put together a phenomenal trial package for the ST line of products. Of course, we can always learn from any trial, but really I think the lesson from that trial is more of a case specific issue. That verdict was a result of very case specific facts.
I know that this broadcast will go out to not only attorneys but also people that have hernia mesh devices in their body. I think that the lesson of that first trial, as a reminder, this plaintiff, he did have significant pain. He had a lot of pain. In fact, every morning on the way to the courthouse, he would grab his abdomen in pain.
The problem was is that he didn’t go to the doctor. I talked to so many plaintiffs who are just so disillusioned and frankly afraid of additional surgeries that they don’t necessarily want to go to the doctor, because these hernia mesh products have hurt them so bad, they don’t want a repeat incident.
So this gentleman did not go to the doctor, and so even though I know he was in pain, the jury didn’t see that. There was no evidence in the record where this man had gone to a doctor and addressed his problems with pain. While I understand the fear of additional treatment, I think the message is, look, if you are in pain, at least go look at your treatment options and talk to doctors.
Obviously, your decision needs to be a decision based upon the risks and the benefits after talking to a doctor. But really, the lack of any medical documents that show that this man was in pain is the reason why that trial was lost. So that was the takeaway, if I had the biggest takeaway from that case.
Susan Barfield (09:39):
Like you said, the outcome could have been the same, but at least you would have the documentations to substantiate the claim that you’re stating of the pain. So that makes sense.
Kelsey Stokes (09:49):
As I said in our last interview, we did have a little bit of feedback from that jury. But we also had the question that they asked, which was, “Well, in order to say yes to the general liability of the company, do all of the elements have to be yes?” And that final element of, and he was injured, also had to be yes. So because that was not a yes, in my humble opinion, that is the reason why that was a defense verdict.
Susan Barfield (10:20):
Got it. Well, tell us a little bit about the second bellwether trial, and what do you think was the reasoning behind the low jury verdict or payout?
Kelsey Stokes (10:32):
So the second bellwether trial, what I think to me, I’m very proud of that trial, by the way. This is a product, this is the Ventralex product, made by Bard, that’s been on the market for decades. We actually had a jury, a unanimous jury, say that a product that is still on the market was defective in its design.
That is a really big deal, that a product still on the market, a jury, again, this is federal court, so we have to be unanimous here, said that this product was defective and we won on design defect. I think the verdict, as far as the value goes, of course, do we want verdicts that are… Obviously as a plaintiff’s lawyer, you want the biggest verdict that you can get. We did not get very much feedback from this jury.
So this is all just me speculating. I simply think that we had maybe one juror that was a little bit more recalcitrant than the others. So when that happens, especially in federal court, where you need a unanimous verdict, that tends to pull any values down, when you have something like that happen.
Again, we don’t have complete feedback on the exact reasoning behind the verdict, but it was a plaintiff’s verdict, and it was, I think, an absolute declaration that this product should not be on the market. And many of these products that Bard makes and Covidien makes should not be on the market anymore, because they continue to hurt patients. So getting that design defect verdict in favor of the plaintiff was a big deal.
Susan Barfield (12:30):
Well, in the Milanesi trial, and we talked about this, it involved many of the same expert witnesses as the first trial. I guess the questions is this common and do you think this practice of using the same expert witnesses has a positive impact on the case outcome?
Kelsey Stokes (12:50):
Well, so there were a couple of overlapping witnesses on the plaintiff’s side. We had different surgeons, and especially on the case specific front, I would say it’s less common on case specific components just because you have surgeons who are more familiar with certain products and also with the defects associated with those products. So we did have a different surgeon, but from a material standpoint, the polypropylene is a problem.
So you’re going to have, we had Dr. Maze, for example, come and testify in both of those cases where this is a chronic inflammatory stimulus. This is a polymer that will degrade in the body and that will stiffen and that will cause chronic pain and excessive inflammation and all of the injuries that come with that.
Do you need someone, another expert, to say that same thing when you have someone who put it puts it so beautifully? I don’t think so. From a general standpoint, I think having consistency in expert testimony is fine. It’s just really a matter of from a case specific standpoint, which surgeons meet the criteria or have the experience that is needed for the various products.
Susan Barfield (14:13):
Kelsey Stokes (14:17):
Let me just point out, I think that we talked about this, I probably talked a little bit too much last time about the different buckets and the mechanisms of failures. So I again urge you to look at the last interview that we had for anybody who’s interested in the mechanisms of failure.
But in Bard, what we did and what we have created is a trial package for each bucket, so the first trial was an ST product. That’s the ST bucket of products. We have a beautiful package put together for that. The second trial was what’s known as the ePTFE or the permanent barrier, and that’s the Ventralex. Bard makes, I think it’s over eight products that have that problematic ePTFE barrier, and so we have a great trial package for that.
Our next trial that’s coming up is the third bucket, which is the bucket that does not have any of the barriers, but is the actual polymer and just the polymer itself. I’m sure you’re going to ask me about the third trial, so maybe this might be a good place to…
Susan Barfield (15:24):
Sure, go ahead.
Kelsey Stokes (15:26):
So the third trial is actually set for October of 2023, and that is a plaintiff pick. It’s a PerFix Plug. The PerFix Plug has been around since the ’90s, and the PerFix Plug is made of all polypropylene. There’s no components like the ST or the ePTFE, and the reason for that is because it’s an inguinal product.
Inguinal products are not placed up against the bowel. They don’t need that same barrier to protect the body from the problematic underlying polypropylene. Again, as I said in our last interview, neither one of the barriers, they present their own problems and so on those buckets of products. I don’t want my comment to suggest that either one of those barriers are effective, but they do have the barrier.
The PerFix does not. The PerFix is a plug that actually looks like a badminton birdie. It’s bizarre. I mean, you could literally take a badminton birdie you buy from Academy and it looks identical almost to the PerFix. Then what they do is they just plug the hole in the inguinal canal and then they put a little flat patch over that.
So this trial, it has been moved. It was originally set for May of this year, 2023, and it’s now set for October of 2023. This plaintiff has had a significant amount of problems due to this PerFix Plug.
Susan Barfield (16:59):
Well, thanks for sharing that about the next… I was going to talk a little bit about the case involving Paul Trevino, and I know that’s the first state court trial that’s then involved the defective mesh implant. It wasn’t an official bellwether trial, but does it lack any of the “official status” that you would see as compared to an official bellwether trial?
Kelsey Stokes (17:29):
So first of all, great job to the state court trial team with that case. Got a great verdict, and that was actually the same, I believe it might have actually been the exact same year of implant as the Milanesi case with the Ventralex products. So that’s that ePTFE line of products.
As a reminder of the Bard product line, there was the original Kugel litigation, which is what I would call in the ePTFE bucket of products. So prior to our two trials, the trial in Milanesi and then the Trevino trial in state court, there were two data points for ePTFE. There was one that was a plaintiff’s verdict, and that was the Kugel case, and there was a defense verdict and that was also a Kugel case.
What I think, to answer your question, absolutely the Trevino verdict, it absolutely helps because it’s another positive data point for plaintiffs, because there’s nothing more annoying than hearing Bard brag about, “Well, there’s only been two trials and one was a plaintiff and one was the defendant.” It’s like, “Well, no, now we have two in a row.”
I think one ours obviously was in April, and then I believe two months later, the Rhode Island State Court hit them with another verdict, two plaintiff verdicts in a row on a very problematic product. So absolutely, that’s a positive data point and just shows Bard that we can continue to try these cases and we can continue to win.
Susan Barfield (19:06):
Yeah, positive data point, but I guess why is this case being a standalone case such a big deal for the Bard MDL?
Kelsey Stokes (19:16):
Well, again, it’s because it’s products that are in the Bard MDL. It is a message frankly to Bard’s boardroom, which now is Becton Dickinson, which purchased CR Bard in 2017. That what the boardroom needs to realize is that we’re going to continue to fight and that we have had positive verdicts, and we’re going to continue to have positive verdicts. So it might make sense to come sit at the table.
Susan Barfield (19:51):
Tell us a little bit, and if you can speak to the loan pine motion that was filed last May.
Kelsey Stokes (19:58):
I’m happy you asked about the Lone Pine motion that was filed last May. Actually, it was filed just so nicely on the Friday before Memorial Day weekend. Frankly, it was a surprise. It was a very disappointing filing from the perspective of the PSC and the MDL. We were surprised and we were disappointed.
The filing essentially said that the cases that are being filed now are somehow weaker, not true, and that there should be this very, for those either who are just beginning practice in the mass tort arena or not lawyers, a loan pine motion asks for an extreme remedy, and it’s named after a New Jersey case, Loan Pine, obviously the same name.
What it asks for is for a burden to be placed on a filing plaintiff that is quite extraordinary, essentially giving expert proof, etc., prior to even being able to file the case. The judge pretty quickly actually denied that motion and cited several cases that essentially stood for the proposition that a Lone Pine order is an extraordinary order and is done when there is a settlement, typically global in nature, and it’s essentially a door closing mechanism.
In other words, it’s a mechanism to put a closure on litigation and to be a gatekeeper for future claims. But it’s such an extreme remedy that is only given when the defendants have earned that remedy. And the judge did not find that that had occurred here because the defendants have made no meaningful progress towards resolution. So it was denied, and we were very happy for that result.
Susan Barfield (22:16):
That sounds great. Settlement, everybody wants to know about settlement. I know there’s been some rumblings about the Bard MDL reaching settlement prior to the court date. What are your thoughts on this?
Kelsey Stokes (22:29):
So number one, I want to say that anybody who is reading tea leaves predicting why the case got continued, our third bellwether case got continued from May to October, should stop reading into anything. What happened there is that the plaintiff is continuing to have pain and has actually an upcoming procedure, and so the plaintiff’s medical care in that case has not reached a point where essentially we’re ready for trial. So that is the reason for that movement.
We did oppose the movement, but frankly, I think that the judge… I just wanted to get to the courthouse and try this case because I’m so excited to try it. But given the fact that he has a groin exploration coming up, and we’ll have depositions that will be necessitated because of this surgery, expert report supplementation, etc., it was just going to be too tight. So that’s why that trial got moved.
We also have an upcoming trial in January, the fourth bellwether trial, and there has not been an official setting, but the tentative plan is for that trial to take place in January, and that will be the fourth and final bellwether trial of this MDL. Here’s what I can tell you about settlement is that I think that the last interview, I might have been overly optimistic about the willingness and the approach of the defendant.
Here’s what I will say. We are preparing to try the third and the fourth bellwether cases, and I actually firmly believe that those cases will be tried and that I think case counsel needs to be ready for potential remands. And I think that’s all I can really say about that.
Susan Barfield (24:34):
Sure, that is great insight. As far as global settlements go, do you think that will happen, global settlements of the Bard MDL in 2023?
Kelsey Stokes (24:49):
I don’t know that global is on the table at this point, Susan. I don’t. And could it eventually be on the table? Maybe. Here’s what I will say is that I think when we talked back in 2021, we were at 13,000 cases, give or take. We’re now at 18,000 cases, and it’s going to continue to grow.
I just don’t know if it’s the sheer number that’s just so difficult for this particular defendant to address in a global fashion. I don’t know. And I’m not going to attempt to try to read any sort of motives or anything or try to get into the mind of the Bard boardroom. But what I can say is that we will continue to file cases.
We will continue to litigate these cases until there are fair values that are brought for our clients, because we feel very strongly about the strength of these cases. We feel very strongly about the trial package that we have put together for all of the buckets. Case counsel should not be concerned if there is a remand because we do have trial packages.
Susan Barfield (26:10):
Ethicon, I know you were associated with Ethicon lawsuit and as of May 20th, 2022, the J&J Ethicon Physiomesh lawsuits have been settled. I know there’s many differences. What would you say the biggest difference between Ethicon and Bard lawsuits are?
Kelsey Stokes (26:32):
I think that it simply boils down to the mentality of the defendant. I think that there’s the level of pragmatism, and I do think that the fact that there’s such a large number, and this is true for Covidien too, as I said in the beginning of this, that Bard and Covidien make up the largest market share and with a significant number of products.
I think that affects the mentality of the defendant and their willingness to sell, frankly, because it’s a huge chunk of their business. I don’t necessarily know that there’s… I think it’s as simple as just, it’s a different difference of personalities.
Susan Barfield (27:27):
What about just the strategy going forward in this case? Can you share any insight on that?
Kelsey Stokes (27:33):
Yeah, and when you say this case, let’s talk about just hernia mesh, generally the strategy going forward. I will tell you that Bard and Covidien are my focus, and it’s over 80% of the market share, Susan. Over 80% of the market share is still out there, still hurting people, and we’re going to continue to litigate.
And that’s really where my focus is is continuing to build the story and to strengthen the story and to continue to essentially refine our positions and our arguments. With Bard, we’re further along in the discovery process just by the nature and the history of that litigation. But Covidien, we’re going to put the same amount of effort that we put into Bard in building all of these stories.
The Covidien story, frankly, with the polyester polymer, it’s a terrible, terrible polymer. It’s highly inflammatory. We’re going to put together great trial packages for Covidien as well. That is an MDL that just got started. We’ve got bellwethers picked, and we’re looking forward to really building that case and trying those bellwether cases.
This is in the district of Massachusetts, where Covidien, that’s their hometown defendant. So the judge, arguably, I’m sure defendants will argue whether or not there’s personal jurisdiction, but we think that there is personal jurisdiction in Boston and there’s no lexicon waiver needed. This judge has indicated, Judge Sargus, that she said she’s ready for trials.
She says, “My docket’s not really crowded and this district is actually not crowded at all, so we’re ready to try these cases.” This is a long way of saying that the litigation strategy is to try these cases and continue to show these defendants that we put together a great trial package and that every single case that we take to them that there is a significant risk that jury’s going to give a verdict for the plaintiff.
Susan Barfield (29:51):
Awesome. You pretty much an answered all the questions that the attorneys are always asking me about hernia mesh, and I’ve had a lot of questions lately, and I was like, “We need to get Kelsey on again.” One, just because we need an update. It’s been a couple years. And then two, don’t ask me these questions, let’s ask Kelsey and hear it from her.
So Kelsey, as always, it’s such a pleasure. I really appreciate you taking time to spend the Friday afternoon connecting, talking all things hernia mesh and just to be able to give our listeners updates and the insights about this litigation. It’s just great to hear that, like you said, 80% of the market share is still out there. There’s still cases to obtain and get worked up, and so thank you so much for your time.
Kelsey Stokes (30:40):
No problem. Can I just [inaudible 00:30:43]
Susan Barfield (30:42):
Kelsey Stokes (30:43):
Can I just leave with one thing? For litigant’s case counsel out there, as well as the plaintiffs, I just want to stress that we are working our butts off on building these cases, and I think the sheer size of these defendants is one of the reasons why it’s taking the time that it’s taking.
I want to stress that people just ask for patience, because these cases are going to be successful. I firmly believe that. I really do, and I know that the clients are getting frustrated. I know that everybody is waiting for things to happen. We are working so hard to bring a great case against these defendants, and we will continue to go to trial until fair values are out there for these clients.
So please, I just ask for patience, and I hope everybody realizes how much work we have put into this.
Susan Barfield (31:44):
Absolutely. That’s a great message, and we appreciate all the things that you’re doing and your firm is doing in this litigation, for sure. Thank you again for taking the time, and we will talk soon.
Kelsey Stokes (31:57):
Thank you so much, Susan. It was such a pleasure.