Latest Baby Formula NEC Updates

By Susan Barfield
February 7, 2022

Susan Barfield: (00:06)
Hello everyone! Thank you for joining another Caseworks stream. The topic of today’s stream is infant formula, and unfortunately, the scary topic of necrotizing enterocolitis. We are joined today and I’m super thrilled to have two outstanding attorneys, really to spend time with us and give us their thoughts about the litigation. We have both Amelia Frankel and Seth Meyer from Keller Lenkner joining us today. Again, really appreciate both of you for hopping on and spending time with Dan, and also Dan Comunale is our VP of sales, so the two of us are going to talk to you guys and hopefully this information will be valuable and we can disseminate it out to other firms that are looking to invest and acquire these net cases. What I thought we would do is just kind of start off by a brief introduction and if you guys will tell us a little bit about yourself and about your background and the practice of Keller Lenkner. Amelia, why don’t you start us off?

Amelia Frenkel: (01:07)
Sure, absolutely. First of all, thank you for having us today. It’s great to be here talking with you and to be able to talk about these cases. I joined Keller Lenkner just about a year ago. Three days ago was my one year anniversary. These cases were the very first thing that I got on my very first day to kind of look at, and obviously the litigation has really taken off since that point. So it’s really fantastic to be working on them and to be talking about them here with you guys today.

Susan Barfield: (01:43)
Yeah. Thank you!.

Seth Meyer: (01:45)
Awesome! I’ll piggyback off that. Thank you again, Susan and Dan. Excited to be here with both of you, having worked with you so much, it’s a fun platform to continue the conversation. I joined KL, it’s been about four years now, will be in a month or so. I was one of the first to come over when we formed the firm. I think I was the first to come over when we formed the firm. Background on the defense side and have worked on a lot of our litigation that’s been interesting from the mass [inaudible 00:02:20] side to the mass work and class action side, but excited to be involved in this case. It’s certainly a case with some tragic consequences and one that KL is proud to be out front of.

Susan Barfield: (02:36)
Fantastic! Why don’t you tell us a little bit about how did the product liability come to be on the forefront of the litigation?

Amelia Frenkel: (02:47)
When we started to look at these cases, something that really struck us is this is a pattern that you see repeated over and over and over again. You have a baby, a preterm baby, who is doing well, who gets that formula and fortifier and all of a sudden is set on a different, really tragic trajectory. That was happening across hospitals, across doctors, and so to us, it seemed like this is this really is a products case and a products problem.

Susan Barfield: (03:24)
As getting into this litigation, just doing some research for our team and one of the oldest studies we found related to this case was from the UK back in the 90s and the study determined that the NEC was 10 times more common in premature babies who were given formula. So as far as existing plaintiffs scope, how far back do you see like the timelines? We’ll just stop there and see if you can give us a little bit of background on the timeline.

Seth Meyer: (03:54)
I think that 1990 study is a critical inflection point in the trajectory of the litigation. I think the reason is without a doubt the company should have known, at least from that study on, that they had no business recommending or even allowing their cow’s milk-based formulas and fortifiers to be provided to preemies, so I think the critical juncture, like in any products cases, is when they should have known. I think that’s a key line in the sand. Now, we’re not suggesting that that is the only piece. I think our investigation has indicated that there was some knowledge out there in the marketplace about the danger of cow’s milk-based formulas and fortifiers before 1990, but based on the size and scope and prominence of this particular study, it’s pretty inexcusable, frankly, that the manufacturers allowed that to continue beyond that point.

Dan Comunale: (04:51)
That’s a great point. Seth and Amelia, one thing obviously when you hear the word preemie or premature, it’s a very tenuous time that families have to deal with this in general something like that. Is there any idea of the size and the scope of how many families might be affected by this during that time period?

Amelia Frenkel: (05:11)
It’s unfortunately a tragically large number. In sort of the grand scheme of things, it’s not huge, but the estimates are that this affects up to 9000 families a year, up to 9000 infants, so that is substantial. Not all of those infants have the same level of injury. Of those, somewhere around half end up having to have sort of serious interventionists surgery as opposed to treatment with antibiotics and other things, and about half of those, don’t make it.

Susan Barfield: (05:54)
That’s terrible. That’s a large number. I don’t know if the criteria of acquiring cases is going to be different from firm to firm, but as of right now and where things stand, what is Keller Lenkner’s case criteria on the types of cases that they’re accepting?

Amelia Frenkel: (06:17)
The first key criteria is the infant does need to be premature, and the way that line is drawn is at 37 weeks gestation. So before that point, an infant is considered premature. The second criteria is that the infant received a cow’s milk based formula or fortifier before their diagnosis. One of the really incredible things is there are now out there on the market and have been for quite some time products that are made with human milk that are designed to meet the nutritional needs of these babies safely, without that increased risk of NEC. Those are not unfortunately commonly given, so we are finding that most infants who did receive formula at that very young age were getting your cow’s milk-based products, your Similia, and then we’re requiring generally a NEC diagnosis or other verification that it does seem like this was an infant who got NEC even if they don’t precisely remember what that diagnosis was.

Seth Meyer: (07:28)
Let me just expand a little bit on the first one in the Preemie piece, I think it’s important because it speaks to the defendant control and culpability in this particular circumstance. We’re not suggesting that these products are dangerous to all infants. In fact, based on what we’ve seen thus far, the lion share of infants that are not born prematurely tolerate these well, and I think making it all the more concerning that these companies continue to suggest that they were safe to be provided to Preemie infants, so it’s really only a small subset of infants that are born that would have a real problem and as the studies indicate a demonstrably worse time when provided those products.

Susan Barfield: (08:20)
For those Preemies that were diagnosed with NEC, how far back are you taking cases?

Seth Meyer: (08:27)
Right now, we’re drawing the line at that 1990 study, but that said, I think like in any case, we’re going to continue doing our investigation and seeing what discovery reveals about what the defendants knew or should have known over the past several decades and so. There are some folks who’ve had this diagnosis before the 1990 deadline. What we are trying to accomplish is, as I said, drawling a line in the sand of where the defendant’s knowledge of the inappropriateness of providing these products to preemies was.

Susan Barfield: (09:05)
Let me ask you this. I know what we’re doing for firms that we’re working up cases, but as far as obtaining the medical records to help substantiate and ones that they had took formula and then had the diagnosis, what are you guys doing from a medical record ordering perspective? What does the scope look like or have we not begun ordering records yet?

Amelia Frenkel: (09:29)
That is a process that we are working through. One thing to know is for these little babies, especially the ones that had the longer hospital stays, the medical records can run into the thousands or even the tens of thousands of pages, so there can be real cost issues associated with that as well as issues with making sure that you have that complete record set. One slice of the records that we believe is really important for these cases are called the flow sheets. That’s really where the nurses who are in the NICU write down on a very regular basis sometimes to the hour and this is what the infant was fed, this is how they reacted, this is how they were doing. Those are really, really crucial records. A lot of these hospitals we’re finding do have them going some years back, but it can take some doing to get there, absolutely.

Susan Barfield: (10:29)
What would you say is unique about this case in regards to the reported injuries or the injuries that you’re thinking we can expect to see in the future?

Seth Meyer: (10:40)
I think one of the most obvious things, especially many of the other leading mass towards right now, is just how definitive it’s been among clients that we’ve communicated with us far, that their infant suffered from this. It’s one of those diagnoses that you know when it happens, and I think in terms of certainty of the folks that are affected by it, it’s been pretty remarkable. Number two is just the gravity of the consequences, and we’ve talked about that already, but these are very, very severe and grave injuries. I think Amelia noted death is not uncommon, so very severe surgeries, neurological issues and death. One, the fact that you know that you had it or that it was the problem too, is just the significance of what happened as a result.

Susan Barfield: (11:36)
Go ahead, Dan.

Dan Comunale: (11:38)
What’s the quality of life for some of the infants that have sort of, your clients that have made it through and obviously fortunately survived, has there been any sort of information that [inaudible 00:11:53].

Amelia Frenkel: (11:53)
There are lasting consequences for those infants who had severe disease who had their intestines removed, short bowel syndrome, even in the absence of those removals, all kinds of gastrointestinal issues that persist through childhood and potentially beyond. One of the things that we have learned about, I would not have known starting out this case, is there can also be a lot of neurocognitive impairments that result from this disease. It is a super crucial time for brain development and when you have all of that infection and inflammation and sepsis often comes along with this disease, there can be a big impact on the child’s brain as well.

Susan Barfield: (12:43)
Going back to some of the research that we have done at Caseworks and also listening to the great webinar that you guys did for Harris Morton that was just fantastic information and heard just such great feedback from attorneys. Everyone’s really appreciative for the information that was presented on that webinar, but one of the first infant formula lawsuits was Ferry versus Mead there in Connecticut, and this case ended up being voluntarily dismissed, so just curious about what does this mean and how does this impact the work that you’re trying to do?

Amelia Frenkel: (13:19)
That was not one of our cases, so I can’t speak to precisely the decisions that the attorneys in that case would’ve made. In terms of how it has impacted our litigation and decision making, I think the answer would be that it has not. Our cases are on file, we’re on file in Illinois state court. We’re moving forward toward a first trial date of March 2023, and we are really optimistic about keeping that date and doing everything that we can do to get there.

Dan Comunale: (13:54)
One thing you were mentioning, what is the significance of any of the amount of lawsuits that are being filed in Illinois, which happens to also be the same state at which the defendant is based. Can you just sort of speak to the significance if any as to how that helps.

Amelia Frenkel: (14:10)
This is a case where we believe both defendants are at home. There is some litigation about that with regard to Mead Johnson, no question about it with regard to Abbot Labs, but it has allowed us to sort of put the litigation where we think it can move forward in a way that we’re able to move forward quickly, we don’t have to wait for that federal MDL. We have filed a state motion for pretrial consolidation that is going to help us to move cases forward regardless of where they’re filed in the state and move those forward on the same sort of timeline that we have already established, which is a good timeline.

Dan Comunale: (14:56)
Part and parcel with that I believe you are also seeking a statewide consolidation in the 30 separate lawsuits that were filed, could you just speak to a little bit of the ideology there?

Amelia Frenkel: (15:12)
For the cases that we have filed down in Madison county, we have sort of an informal pretrial consolidation, but the idea was there is this mechanism under Illinois state law, which does approximate sort of the federal MDL process and would allow us to formalize that not only for the cases in Madison County, but also though for cases that have been filed elsewhere in the state, so that all of those cases could come in and everyone could work together on that pretrial discovery and corporate discovery and get things done in an efficient and coordinated way.

Seth Meyer: (15:50)
I just wanted to talk a little bit about the rationale there. I think Amelia noted a portion of it and that’s to pursue the most expeditious and fair resolution for the victims of these products who develop these symptoms. We are pleased with the timeline that we’ve been given, we think it’s an aggressive timeline, but it’s a timeline that is appropriate under the circumstances, and I think the big challenge in many of these large mass torts is what is the most expeditious way to hoard all of these together and resolve them in a cogent and fair way, and I think the state procedure and the approach that we’ve taken as a procedural matter is appropriate and will lead to the quickest and best result for our clients.

Susan Barfield: (16:46)
You have given us some great feedback about the history of the tort and the case criteria and we talked a little bit about this earlier that this is not just your run of the mill mass tort case. It’s so sensitive and the types of plaintiffs that we’re trying to market to. If we talk a little bit about advertisement, what would you think is best practice for advertising for plaintiffs when it comes to such a sensitive topic?

Seth Meyer: (17:14)
I think you’re spot on per usual, and I think that’s why we’ve had such a positive time working together, Susan, over the years. This is a remarkably sensitive issue, and that’s not to discount many of the other mass torts who are out there and all of the consequences, but it’s hard to imagine anything more worse than the death or severe injury to a child at that point. So these are families that are grieving. These are families that have suffered the unimaginable. I think the sensitivity is crucial both in terms of just general compassion, but also understanding what they’ve been through from a medical standpoint, understanding what they experience at the hospital as they recount these episodes. I think having that cognizance, having a well trained staff that’s able to deal with that in a professional way, but also a compassionate way is something that’s so important as I noted, these are folks that generally know what happened. This is an extraordinarily engaged group of people; again based on the gravity of what happened, but that needs to be met with the utmost in professionalism and knowledge and care and compassion on the attorney side.

Susan Barfield: (18:30)
Yeah absolutely! As the evolution of this tort and what you guys are following and just wondering what your thoughts are on this stage; what is the Keller Lenkner’s team really focused on?

Seth Meyer: (18:43)
I think there are a number of different components at a relatively early juncture in the matter, but it’s amazing how much we’ve developed thus far in terms of the factual investigative record and what we understand about what transpired by working with our clients, listening to our clients, and also conducting some investigation into the product and what the literature in the experts have to say about it, but I think it’s a few things, one it’s to understand the size and scope of the problem is a key component of that with an [inaudible 00:19:20] early resolution, but also to streamline and hopefully resolve all of these early and procedural matters as quickly as expeditiously as possible to get down the road toward actually resolving the merits of the case. I think that’s something that is extraordinarily important to us as a firm to understand who this impacts, that’s something that we talk about on a daily basis is to understand the full population that’s impacted by these products and to be able to manage that as well a process as possible.

Susan Barfield: (19:55)
You mentioned problems and also combined with these plaintiffs typically are very engaged, so if we look at this isn’t too dissimilar from other torts and it’s really tough if you’re doing this on a mass level to keep people informed and engaged throughout the process, but what do you think as far as problems that you might encounter when it comes to managing these client expectations in such a widespread mass tort case?

Amelia Frenkel: (20:22)
One of the things is what we have seen from clients over and over again is oftentimes, they haven’t had the opportunity to really share with anyone, what happened to their child and what happened to their family. So in some sense, you are helping them to process those events, which for some of these parents happened a while ago, but for some happened really, really recently, so there’s a lot of emotion that comes with that either way. The other thing is once a client has shared that with you, one thing that we are hearing is clients want to know not just what’s happening in their case, but what’s happening in the litigation.

Amelia Frenkel: (21:06)
These people care about the outcome of their individual case for their family, but a lot of these parents are really, really highly motivated to make sure that this litigation and the facts of these cases get broader public attention, so that families who are facing decisions about what to give their pretty much to our infant today are able to make informed choices that can maybe save them some of the pain that their own family went through, and so I think that level of communication and recognizing that that’s something that clients are looking for is a really, really important aspect of this litigation management.

Susan Barfield: (21:48)
Yeah for sure, and I think you’ve answered my next question just by some of the responses and how are you going to handle these types of cases, they’re so sensitive, how do you deal with these families, but how would you say Keller Lenkner’s is setting themselves aside apart from other their firms?

Seth Meyer: (22:09)
I think from the beginning beside being one of the first in the space, just based on how serious it was and how important it was to bring this to light and to pursue indication for these folks, building that process internally and with our partners, both firms and vendors that we work with has been crucial component of what we’ve done over the past year-plus that we’ve been working on this case. I think being able to deal with each individual client in a mass tort is always important, but I’d underscore that a thousand times here based on the seriousness of the injury, but also based on the engagement of the individuals along the way, and it’s always frustrating to people how long it takes because these things are consolidated.

Seth Meyer: (22:59)
It’s not a matter of simply bringing their case and filing it immediately, and we’ll see you in court the next day and having them understand that process and how this works. It is an integral component of how we handle it, but I think we have built a process that we’re particularly proud of in terms of a very knowledgeable and caring staff that is approaching each client the best way possible, but also creating within the firm a matter of pursuing a litigation aggressively and a really engaged team internally that with every part of the operation, talking to one another about what we’re hearing from the clients and what’s going on in Madison county and ensuring that we’re doing everything we can to maximize value of these cases and also to handle it as professionally as possible.

Dan Comunale: (23:59)
Seth and Amelia, what would be the best way? We both were actually recently at national trial lawyers summit Miami, there’s a lot of firms there that have a couple of these cases, they’re not really big into mass torts, they’re primarily a personal injury, what would be the best way for a lot of these firms that you don’t want to refer the cases because they’re not quite equipped to handle it Like your firm is, what would be the best way for them to get in touch with you.

Seth Meyer: (24:26)
For lack of a better answer, email me, call me. We’re extraordinarily receptive. We like to chat with people who are out there, we recognize that so many of these injuries are brought to that sort of first-line at a single event or personal injury shop, so that’s not an uncommon situation, but you’re right, Dan. This is a bit of an unusual case for a PI shop and to be able to understand all of these competing dynamics and all these challenges is critical.

Seth Meyer: (24:56)
My phone is always available, my inbox is always open, and I’m more than happy, as I know you all, to chat with folks about how to address this besides being what we do for a living these are critical issues that matter a great deal to us and ensuring that this litigation is dealt with in the best way possible is what we’re both committed to and we spend most of our waking hours on, so I’m happy to chat with anyone who’s dealing with those issues, whether it is ultimately working with us or working with another of the many law firms that are out there handling this. I think in a way we’re all in this together in terms of pursuing justice and appropriate results for the injured here to the extent we can collaborate on that, I’d love to do it.

Susan Barfield: (25:47)
Last question, this has been fantastic as always, great information, but I’m always interested to hear from the attorneys that we talk with is what has been your most fulfilling case to date, and it’s been really interesting to hear about those cases, so Amelia, what’s been your most fulfilling case and the one that you’ll always remember.

Amelia Frenkel: (26:08)
I think it’s going to be this one, I can’t lie about that. I really do.

Susan Barfield: (26:12)
It’s going to touch a lot of people’s lives, for sure.

Seth Meyer: (26:19)
I’d be remiss if I just repeated what Amelia said, even though I’m obviously extraordinarily passionate about this particular case, but KL has been very active in [inaudible 00:26:28] litigation, and I think it is the biggest litigation in American history and probably will be for some time, so just solving a problem of that size and scope, I think I read today that another million people are expected to die in the coming years from the consequences of opioid addiction, so being able to play our small part in addressing that case and doing it through litigation and consolidated litigation and all the lessons learned along the way really close second to NEC.

Susan Barfield: (27:00)
Thank you both for taking time to spend Friday afternoon with Dan and I and talking about this litigation, and we very much appreciate your time and excited to share this with other attorneys that we’re working with, and for those that are listening, like Dan mentioned, if they have cases that they’re wondering about what are they going to do within the future, either reach out to Amelia or Seth directly, or we’re happy to introduce you guys, but again, thanks so much for taking time to connect with us on this topic.

Seth Meyer: (27:34)
Thanks for having us on Susan, and we obviously love working with y’all, but it’s been a pleasure to spend time here today and look forward to working together more in the future.

Susan Barfield: (27:44)

Featured Streams