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Update on NEC with Stephen Reck and Jose Rojas

By Susan Barfield
September 5, 2023

Interested in discussing a referral or co-counsel relationship for NEC cases with Levin Rojas Camassar and Reck? Contact Paul Levin, Founding Partner paul@lrcr.law or (860) 834-3333

Susan Barfield:

Hello everyone. Welcome back to another episode of the Leverage report. Today we’re going to be talking all things NEC, and I’m delighted to be joined by Jose Rojas and Stephen Reck, their firm Levin Rojas, Kasar and Reck is actively involved in this litigation. So gentlemen, if you don’t mind taking a couple of minutes, briefly introduce yourself and your role in this case.

Stephen Reck:

You want me to start?

Jose Rojas:

Go ahead, Steve.

Stephen Reck:

My name’s Stephen Reck and I was the original founder of the NEC litigation. Our law firm is based in Connecticut, and a mom called me several years ago and stated that her premature infant basically was fed Similac cows milk based formula and a few days later passed away from necrotizing NRO colitis. So from that first case, and I can go into that more with you, my partner Scott Kasar, and I joined up with Jose Rojas, who’s an excellent litigator, and Paul Levin and the four of us started this litigation and now, as you know, there’s thousands of cases all around the country.

Susan Barfield:

Yeah, no, certainly appreciate that. Jose, tell us about your background and your role.

Jose Rojas:

Sure. I am first generation to this country. I was born in Madrid, Spain, came to the United States when I was 17 to go to college, and I basically stayed, I went to law school in Connecticut and graduated, joined the United States Army Jag Corps. And then from there I joined the US Attorney’s Office in the Eastern District of North Carolina where I was a special assistant United States attorney. And I prosecuted all kinds of different types of crazy cases. I’ve worked for a large law firm here in Connecticut, and then I was on my own for many years. And really that took me to the point where I met Steve and Steve introduced me to this litigation, which really has been really the privilege of my career. It’s just a fascinating litigation. We’ll get more into it, but I know that what we’re doing is so important and so righteous that it truly has been the privilege of my entire career. And I’ve had some pretty interesting experiences, but nothing like that. So now I’ve been appointed as one of the co-lead counsels in the litigation and the M D L under Judge Paul Meyer. And so we’re full steam ahead.

Susan Barfield:

Yeah. And when you say you’ve been appointed co-lead counsel, what exactly does that mean?

Jose Rojas:

Yeah, so MDLs, it’s a military background. It actually kind of reminds me of a military structure in certain ways. It’s very pyramid style. We have within the leadership of an M D L there, there’s typically either a lead or multiple leads in our mdl, MDL 3 0 2 6, the infant formula litigation, there’s five co-leads. So the co-leads are really in charge of every aspect of the litigation. And then there’s a structure below, which is we have an executive committee and then we have a steering committee. And together those three sort of subsets form the leadership of the MDL where all the work really gets done in the litigation.

Susan Barfield:

Well, we certainly appreciate that. Steve, you just mentioned there was one phone call that kind of started this all. Tell us a little bit more about that moment and the why behind your involvement in this specific litigation.

Stephen Reck:

Yeah, so I do quite a bit of medical malpractice litigation, and that’s been in my background for many years. And I Received a call from this mom who basically said my child was doing well, I had an extremely premature infant. No one thought would survive and the child survived for 40 days. And when a child gets to 40 days of survival, who’s premature, chances are that child’s going to live and go on to have a full and productive life. And she said that they switched this baby from donor milk to infant formula Similac, which is a cow based formula. And she said within a few days her child got necrotizing enterocolitis. They tried to perform emergency bedside surgery where basically the bowel is necrotizing or dead, and unfortunately they were unable to save her child. So the story sounded almost ridiculous. I mean, how could food kill a baby?

It just seemed so wrong. She didn’t have a vehicle. So drove down to New Haven, Connecticut, I met her at a McDonald’s. We had a cup of coffee, and she went over the case. And this mom was very smart and she actually figured this out. I mean, she saw them feeding the Similac, saw them feeding the formula. I said, it sounds like almost like I said, it seems a little crazy that a food can kill a baby. But I went back to the office and started researching it and couldn’t believe that there were numerous peer reviewed articles out there stating that cow’s milk based formula significantly increases the risk of necrotizing enterocolitis. And mothers are never told this. Mothers never know why their baby gets neck. The doctors and the nurses simply say, it’s due to prematurity. No one tells ’em it’s the formula. And there’s scientific studies that have been going on for decades that have really been ignored by the formula companies.

And they just keep putting this stuff out there in all the hospitals because they really want the moms to be using this formula so that when they go home, they’re going to be buying Similac and Enfamil. So I did the research, I called the mom and I said, this is wrong and we’re going to do something about it. And from that one case we started our firm, as I mentioned with Jose here and Paul and Scott, and we did a very simple little Facebook campaign. And the Facebook campaign was so simple, it simply said, did your child get NEC or neck? Did your child get necrotizing enterocolitis? It didn’t even ask anything about formula. It just said, did your child get neck? And almost every single one of those moms that responded their child was fed infant formula, either Similac or Enfamil. So this problem has been going on for decades and it needs to be stopped. And that’s really the goal of our litigation.

Susan Barfield:

Yeah, absolutely. Well, just for the audience’s benefit, think about, we’ve got a lot of mass court attorneys here, but also personal injury attorneys that really want to understand a little bit more about not only mass tort, but about this case specifically. So if you don’t mind, would you share an overview of the NEC litigation and its significance in terms of the allegations against the infant formula manufacturers?

Jose Rojas:

Yeah, so segueing from what Steve just said into this question, one thing I really have thought so much about and want to point out to your audience is what Steve did here. And Steve has really become one of my friends in the world, and he’s my partner and he’s really a mentor to me. But what he did with this case, when you think about what he just told you, we’re talking about decades of science supporting this litigation. And I think of the thousands of mothers and babies that were affected by this before, he kind of brought this in the forefront. And I often think about how as lawyers, we get really busy and when we have a client that brings us a story that on its face seems so extraordinary that we maybe don’t give it the attention that it fairly deserves. And so what Steve did and what every trial lawyer who’s listening should do when you hear from a client is actually do the research, take the time to figure it out, because I can assure you that Steve was not the first lawyer that a mother came to telling this story.

It had to have happened. There were just too many, there’s too much precedent before it. So it didn’t get the attention for a long time, but it’s getting the attention now, and it really is a remarkable case. I mean, by way of background, the central notion of the case is that something about cow’s milk formula induces NEC. And we know that because the statistics, the epidemiology is so powerful that it shows a dramatic increase in NEC levels to babies that are fed formula, cows milk formula as opposed to an exclusive human milk regimen. So it’s extraordinarily strong epidemiology, and again, based on decades of studies. But one of the other things that I think is really dramatic and powerful about this case is first of all, the people that are being affected are most vulnerable members of our community.

These are the people that need to be most protected, that deserve the greatest forms of nutrition, highest level of medical care, because they literally are the most vulnerable population. They’re this big, they need every advantage they can get. And typically, the reason that human milk is not fed is really financial. It’s the cost of donor milk as compared to the cheap cow’s milk. And it’s a bigger story. I mean, this is kind of the story of our generation in terms of food manufacturers literally just poisoning us with lower quality products that create hazards and dangers. In this particular case, the hazard and danger is of the most vulnerable class of people that there is. But what is in mass torque cases, the problems that typically emerge in cases, as I’ve become more involved in mass warrant, I see three areas of difficulty that typically emerge.

One is epidemiology. We have very strong epidemiology. The other is causation, which is related to epidemiology. But we have in this case had so many cases where the babies develop the NEC very shortly after being fed the formula. So we can see an immediate transition, which I think is a very powerful message to a jury. Imagine if someone was litigating a tobacco case and a person had never smoked cigarettes and then smoked cigarettes for one day and the next day has cancer, lung cancer. I mean, that would be a dramatically powerful case, but that’s what we have here. We have babies that are being fed human milk, human milk, human milk, and then they suddenly get fed formula and 24 hours later they have NEC and they’re dead. So it’s a powerful sequence and a timeline. And then the last thing that this case has that I think is very dramatic is the absence of a preemption issue.

So from a pure legal summary judgment standpoint, we are not going to have a preemption problem because this is not a product that is pre-approved by the FDA and therefore federal preemptions and applicable. I won’t get too much into the weeds on that, but happy to talk to any folks about it offline. But those three things to me, I think define this litigation. And then the fourth would be that there’s actually an alternative, a perfectly safe alternative to their very dangerous product, which is human milk, donor milk, or prolacta. So anyway, I went on a little longer than I intended, but I tend to do that. I get really excited about this litigation. It has so many powerful aspects to it. The most powerful though, of course, is who we’re representing, which is a community of folks that most needs our help.

Susan Barfield:

For sure. Yeah. You talk about the vulnerable population. And so Steve, I’m wondering, can you shed a little light and help us understand why is it that it’s the premature and low birth weight infants that are particularly vulnerable and that have the risk that’s associated and the potential injuries associated with NEC? And maybe just explain for those that maybe are listening, they’re like, I kind of know what NEC stands for. I don’t necessarily know what exactly that is and the injuries associated with this case.

Stephen Reck:

Right? Yeah. So necrotizing enterocolitis is really seen only in premature infants. And the preemies, basically, their intestines are underdeveloped and there’s not as much motility that they would have in the intestines. And what they really need when they start, actually, when they’re usually born, they’re actually usually fed through the vein. At first they call it TPN, and they’re usually fed by vein for a few days, and then they switch to hopefully mother’s milk. Or if mom’s milk hasn’t come in yet. A lot of these moms, when they have a premature infant, their milk hasn’t come in. The next best thing would be donor milk. But what we know from all the articles out there is that when they’re fed this cow’s milk-based diet, it creates bacteria that grows in the bowel walls of the infants. And we’ve actually looked at a lot of radiology studies where you can actually see the bubbles that are occurring, where the bacteria is basically eating away at the intestinal walls and gases being released.

And if they see that early on the scans, a lot of times they’ll immediately stop the feeds and the child may survive. But if they are continued to be fed this product, then the bacteria continues to grow and it usually perforates, the bowel stool will then spill out and the baby will become septic. They’ll then have to go in and actually remove pieces of the dead intestines. And we have numerous cases where they actually remove the child’s entire intestines and put it in a silo they call it, and the surgeons will remove part of the dead bowel and then allow the bowel to heal outside of the body. And then if they see more necrosis, then they’ll snip away those areas and then reattach everything and hopefully put things back in. So, unfortunately, a lot of the children pass away. And then we’ve had other cases where there’s so much inflammation and stress on these little babies that have these little tiny veins in their brain that they get brain bleeds and hemorrhages.

And we have several cases where the children develop necrotizing enterocolitis. They did get surgery and they survived, however they suffered brain bleeds. And then some of ’em have cerebral palsy where they can’t walk or talk. And these children had completely normal ultrasounds. We have several of those cases where these children would’ve had a completely normal full life. They get the NEC, they get the brain bleeds, they get cerebral palsy, and they can’t walk or talk for the rest of their lives. They’re just tragic cases. And we have quite a few moms that we talk to on a regular basis that take care of their children 24 7, and they’re just incredibly loving moms and very special clients of ours.

Susan Barfield:

Yeah, I’m sure it’s hard hearing story after story and how this has impacted the babies and their families, and yeah, it’s tragic to listen to Jose. Tell us a little bit about the status of the litigation, and do you have any idea of the potential number of claimants involved, and has there been any recent significant developments like court decisions or anything like that in the litigation?

Jose Rojas:

So as you may know, there’s sort of a dual track. There’s state court litigation that’s proceeding mostly in Illinois, and then there’s the federal through the MDL. So we have cases in both locations. We sort of make a judgment call where they’re best suited, but the state court litigation’s proceeding at a faster level. They have a trial date which is scheduled for, what’s that date, February, I believe,

Stephen Reck:

February, 2024.

Jose Rojas:

2024. So really around the corner. And so that’s exciting. In the MDL, we’re just deep in discovery. I mean, we’ve received millions and millions of pages of documents, and we have a very large and effective team that’s man hours of looking through each of those documents. But we also have artificial intelligence that’s combing and crawling through those documents to try to identify the most critical documents. We’re very pleased with what we’ve seen. We don’t see anything that doesn’t support our litigation. We’ve only become a lot of it’s protected, unfortunately, by protective order. So I can’t discuss the details of what’s in there, but I’m very comfortable sharing that our belief in the strength of this litigation has only improved after having reviewed many of their internal documents at both Abbott and Mead. And ultimately, I think we can, we will be able to prove that they’ve known about this risk for a long time, and that they’ve made a decision to simply try to find a solution within their cow’s milk rather than just warning the public and doctors and eliminating the product altogether, which is what they should have done.

So in the M D L, we’re sort of in a quiet moment right now. We haven’t reached, I mean, individual cases have had, individual bellwethers have had different motions to sort of modify the pleadings. And we’ve dealt with those many by agreement. Some have required the judge’s rulings, but it’s nothing of any significance that affects the litigation in any way. It’s just little pieces that relate to the individual laws of the jurisdictions that those cases come from. So that’s been cleaned up. Discovery’s going full steam ahead. We are very actively doing depositions right now. So myself and the rest of the co-leads primarily are taking those depositions of Abbott and Mead representatives, but some other folks have joined us to help out as well as needed. And I think the team is just working really effectively to bring this case forward. One of the things that’s amazed me about mass to is how much talent is around. And when you get a case like this that piques folks’ interest, the quality of lawyering that sort of comes together and the level of resources that comes together, you need that to fight law firms like Jones Day. But we certainly respond in kind to their level of manpower and their level of talent.

Susan Barfield:

That’s great to hear. And if I’m thinking like attorneys listening, like, Jimmy, should I get in this litigation, is there enough going to be enough plaintiffs out there? Any idea of, has anyone said that? The potential population of cases?

Jose Rojas:

Yeah, so it’s really hard to know. Here’s what we know. We early on estimated that there were probably about 3000 babies annually that were impacted by a dc. So because of some of the statute of limitations, advantages that we have in this litigation that I won’t get too deep into the weeds about, but one of ’em happens to be that if the babies are alive, many states have a statute of limitations that doesn’t begin to kick until age of majority or even later. So that allows us to go back quite a long time. Sure. Yeah. So many firms are looking at 2006 forward, although that’s somewhat of an arbitrary point. So I think the reason it’s hard to answer the question is twofold. One is we don’t know how far folks want to go back. Depending on how far you go back, you could sort of calculate based on that.

The other issue that’s been challenging here is I think so many of the mothers have gone through, and dads have gone through so much trauma in this process that many of them are not really looking to do the litigation. And so although we can estimate the potential population of claimants, we don’t really know. And in a lot of litigations because of statutes of limitations, parties are forced to file the lawsuit because really you have a limited window. So the thing here is because the window’s so big firms are not necessarily filing their cases. So you have a bunch of firms sitting on a lot of cases that are not filed in any court, and that’s because they’ve assessed that there’s no real risk under the statute of limitations. So it’s a little bit of a hidden secret in this litigation. I mean, we kind of know I, we know how many cases we have and I think we have one of the largest inventories in the country, if not the largest. And then we know there’s a couple other firms that have pretty significant inventories as well. And so it’s thousands, I’d say, but we won’t really know for sure until a court forces some type of, at some point I think a judge is going to want to know what are the potential claims, and it’s probably going to make some kind of order to that effect, but that’s not the case yet.

Susan Barfield:

Yeah, okay.

Jose Rojas:

A mystery.

Susan Barfield:

Yeah. Steve, any plaintiff challenges that you see? And if so, are there any strategies being employed to address those challenges?

Stephen Reck:

Well, I actually don’t really see too many challenges incredibly Abbott that makes Similac and Mead Johnson that make the Infamil, they still don’t warn about n. And Jose was just talking about statute of limitations. It is our claim that until they finally put out that warning, the statute of limitations doesn’t run because moms are never told, so they don’t discover that the product has caused harm. I think that’s an argument that can be made. And a lot of lawyers can look at older cases that they may take in and say, there’s still a case here because the moms never knew. And as Jose said, I think the discovery in the case is going extremely well. And so there’s a lack of warning, as Jose said, there’s an alternative product. The case is really solid. And then there’s also the punitive aspect that Abbott and Mead have known for decades and really have done absolutely nothing about it.

The defense in the cases, in the depositions, we’re having depositions taken by Abbott and Mead of our clients, and Jose and I have been defending some of these depositions. And unfortunately, they attacked the mom and they try to get the moms to talk about their lies and maybe some of the things that are uncomfortable for them and try to make them somehow to blame for this. But the bottom line is the product was fed right after the product is fed, the child gets necrotizing enterocolitis. So we can’t see how you can blame the mom, but blaming the mom is really where they’re going. The other issue from the defense standpoint is they’re saying, well, it’s all up to the doctors. So what do we have to do? We have nothing to do with it. It’s all the doctors that decide this. It’s their clinical judgment that’s best.

Incredibly, though Abbott and indeed don’t give any instructions to the doctors or the hospitals. And unfortunately, a lot of the doctors and hospitals, they don’t know the science either, and they’re never instructed. And there really is very little training even for neonatologists about feeding. And it’s incredible that there’s not really a standard out there. Although the American Academy of Pediatrics said that premature infants should be fed only a human milk-based diet. So that core principle is really at the center of our cases, and that’s the guidelines that really should be followed at all of the NICUs. And since we started this litigation, we’ve actually seen quite a few NICUs have changed their policy, and they’re only using donor milk or donor milk, and occasionally they’ll use prolacta, and they’ve really shied away from using the Similac and the Enfamil, which they now realize is harmful to the infants. The other interesting thing is that they often add a fortifier milk to mom’s milk or donor milk, and they call it Abbott and need, they call it human milk fortifier. You’d think that would mean it’s made from human milk, but it’s cow’s milk. And a lot of practitioners, they actually think it’s human milk. So they create more and more confusion by calling it human milk fortifier.

Jose Rojas:

And there’s a study out there that showed the percentage of moms who believed human milk fortifier is from human milk. And then that same study shows how many physicians think the same thing, which the first part didn’t surprise me, but I was shocked when I saw the numbers relative to the second column. But

Susan Barfield:

Yeah, it’s interesting. It sounds like lack of education and lack of, you talked about Jose earlier, it’s just that it’s so much more expensive to feed babies. Yeah.

Jose Rojas:

Abbott and Mead know what they’re doing. And a point Steve brought up that part of the issue here is that I’m not sure doctors are really making the decision. I think as much of healthcare has gone, administrators in hospitals make decisions, and they tend to be either CPAs or MBAs as opposed to MDs. And so for financial reasons, I think, and the various relationships that they have with Abbott and Mead, and this is an area I probably can’t go too much further into, but suffice it to say, there’s very strong relationships that have really balanced, off, balanced the hospital’s desire to carry these products and really give the doctors no choice in the matter because the doctor can only use what’s available in the hospital. Sure.

Susan Barfield:

Right. Yeah, no, that makes sense. What potential outcomes, if any, are being discussed or anticipated at this stage of the litigation?

Jose Rojas:

Steve hopes none. He wants to go try these cases. I’ll

Stephen Reck:

Try every one of them. I honestly think that right at this moment, we’re going to be trying several cases before there’s going to ever be any resolution. So hopefully we’re going to get some big verdicts. I think we will.

Susan Barfield:

Well, you certainly can tell the two of you’re really passionate about this litigation and for advocating for these families. What strategies is your firm using to advocate on behalf of the affected families and trying to seek justice?

Jose Rojas:

So I mean, we came from a single event background and there was a fair amount of adaptation we needed to make to this. What is a very different industry? I mean, our motto has always been when we deal with clients is we literally treat every case. It was a single event case. And that just is a huge, it takes a lot on manpower. Our paralegals, we’ve had to ramp up the amount of paralegals we have. How many do we have now working exclusively on neck, I think like eight paralegals that are working exclusively on N E C cases. We touched on this earlier. It’s tough on them because to hear these stories every single day, eight hours a day is a, it’s not something I’m doing, but they are. So part of the strategy for our firm is to make sure that our paralegals have our passion and our work ethic, that we hire really good talent that caress deeply about people in general.

But these cases in particular, and I think that’s really been the heart of everything, are the folks that are working on the front lines there. We are looking for other different strategies to help with that client contact, because I think that’s really at the firm level. You have the m DL level, what we’re doing to advance the litigation that’s being handled by leadership, but then at every firm, you need these massive resources to be able to deal with these cases. This is not your typical mass tort. It’s much more difficult. Many of these babies are hospitalized for 20, 30, 40, 60 days, and you have thousands and thousands and thousands of pages of medical records. And so I think you got to be able to handle that. You need the infrastructure to be able to do that. And so that would be my only warning of caution to any folks listening that wants to get these cases. Just make sure you have the infrastructure or partner up with firms that are deeply involved in the litigation. Yeah, for

Stephen Reck:

Sure. I was going to mention one thing about our paralegals. They’re just so amazing. I mean, they’re just so kind and considerate, and they’ve developed relationships with so many of the moms and the dads over these last few years that they’re almost like friends to them and they chat regularly. And I think our paralegals have made our job a lot easier. And the paralegals also came up with an idea where either me or Jose will get on, you’re doing right now, like a Zoom type link, and every month we’ll talk to all of our clients by Zoom link and tell them the litigation, because some of the bellwether cases, there’s constant work going on on those cases. There’s depositions being taken, but a lot of the other plaintiffs, they’re just sort of waiting in line and a lot of time is going by and there’s not much happening with their case. So we want to tell them about the other cases and all the work that we’re doing and all the depositions that we’re taking so that they don’t feel that they’re left out. So it was kind of a good tip that I learned from my paralegals is let’s use modern technology. We’re in Connecticut. We can’t go to California to meet with a clients, but we can all around the country, we can all meet with a Zoom session and discuss the cases. So that’s something that we do regularly.

Susan Barfield:

Yeah, that’s huge. I mean, every tort is unique and every tot, I mean, the science and what’s happened is so tragic, but just listening to these, I mean, there’s not much, I mean, a mother and having to deal with losing their premature infant is just, it’s so tragic. And even if they didn’t have to lose them, kind of like the story you told earlier. I mean, it’s a lot. And your paralegals, like you said, it takes a unique individual to be able to have those conversations all day every day. And so I think that’s great that you guys are getting on monthly to give the updates because I’m sure the moms are super anxious and eager to understand how things are progressing. Speaking of progressing in a timeline, can you share a little bit about what we can expect in terms of the timeline for this litigation? And are there any significant milestones or events on the horizon?

Stephen Reck:

Go ahead. Yeah, I was just going to say, I think some of the state court trials are definitely going to occur next year. I think the M D L trials are all being litigated intensely. So those trials are going to be coming up. And it’s my personal feeling that there’s going to be several trials next year, and that is really going to define the litigation. I think I expect we’re going to win and win big.

Susan Barfield:

Okay. Haven’t I asked anything that I missed? Anything that you think we didn’t cover that’s important about the litigation or any other updates or insights to share? Or did you think we covered it all?

Stephen Reck:

I think we covered it. Yeah, I think, yeah, I think you did a great job, I think.

Susan Barfield:

Okay. No, I think we covered it too. So that concludes another episode of the leverage report. And I don’t know about those listening, but I certainly feel much more informed, Steve. Jose, I’m grateful for your expertise and taking the time to share these valuable updates and insights about the litigation with the industry. So thanks for doing that, taking the time. Certainly appreciate it and I hope you guys have a great rest of the day. And one other thing is that any attorneys listening and they either want to get involved or they potentially have cases and want to talk with you guys, we’ll make sure that we have the information available for those to reach out and connect with your firm.

Stephen Reck:

Thank you so much.

Susan Barfield:

Yeah, absolutely. Really

Stephen Reck: Appreciate it.

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