Autism & Acetaminophen Lawsuit Updates

Susan Barfield (00:06):
Hello everyone. Thank you for joining another Case Works stream. I’m excited to be joined by two attorneys today, one attorney I know very well, and that is my brother Bill Barfield, and we are also joined by Patrick Luff. And Patrick has his firm, and it’s called the Luff Law Firm, and we are going to be talking about all things’ acetaminophen. And we are excited, Patrick, that you’re here today to share the updates and the insights on this litigation.

Patrick Luff (00:35):
I’m happy to be here and excited to talk about acetaminophen.

Susan Barfield (00:40):
Yeah. Well, before we get started, first, I want to hear a little bit about you and your background. And I don’t know, Patrick, if you know this, but this litigation is near and dear to my heart. Prior to starting Case Works, I was an OBGYN nurse for many, many years. I also taught childbirth classes, and so did that, like I said, for many years. And so this is an important litigation, something near and dear to my heart. And so, we’re excited that you’re here to talk with us, but tell us a little bit about yourself and your background and your firm.

Patrick Luff (01:15):
I’d say I’m probably a little bit of an outlier, maybe a little bit unique when it comes to the mass tort world. Before, I was in the practice of law, I was a professor of law and I spent a number of years teaching civil procedure, administrative law, and statutory interpretation, those really meaty classes that there’s always a long wait list to sign up for. And my research and writing was all in the area of mass torts and really how mass torts in the United States have developed as a regulatory device. And so, when I decided to make the transition into practice, I never had any interest in going to a big defense side firm in New York or DC, I was plaintiff’s spar all the way just based on the work that I had done in my academic life.

Susan Barfield (02:11):
Yeah. Did you ever consider going into other areas before landing on personal injury and mass tort?

Patrick Luff (02:18):
Not really. When I was in law school, I thought maybe about doing some appellate practice, but ultimately I took the direction of teaching law and that’s what I thought I was going to do, but it turned out that I didn’t really love the research and the writing and the teaching as much as I thought I would, and I really wanted some of that, frankly, more adversarial type of practice that I think we get.

Susan Barfield (02:52):
Yeah, for sure. And I know that you’ve been appointed to multiple mass tort cases as co-liaison council, the co-lead council, and as a member of the PSC. Which of those positions do you find to have been the most fulfilling?

Patrick Luff (03:08):
Well, I feel like I’m being asked a little bit on which is my favorite child. I’ve got my favorite boy child, and my favorite girl child. Let me answer your question by not answering your question and say, what really makes the leadership positions meaningful other than the opportunity to help our clients, which of course is always premier importance, is the people that you get to work with. And I think I post on LinkedIn or something a couple of months ago when I got appointed to Tylenol, which was no disrespect to any of the other leaderships that I’ve been on, and no disrespect to any of the other litigations I’ve been involved in, but the leadership team that we have in Tylenol is really an incredible group. And I do have to say, again, not that I haven’t liked working on my other steering committees, but it’s a really exciting group to be working with and bouncing ideas off on a day-to-day basis.

Bill Barfield (04:17):
Patrick, I mean, I know that because we worked on cases together in the past, but just looking back, and I know that you’ve personally been involved in some major cases themselves, cases and not MDLs, but the actual cases themselves. Are there certain case or is there a certain case that stands out in your mind as you look back as to, “Hey, this was a sentinel case from me, or this was an important case for me”?

Patrick Luff (04:46):
So in a previous lifetime, I was a de-facto lead council in the Walmart shooting case in El Paso, Texas. And I think that was probably one of the most important and impactful cases both of my career and in terms of just the issues that we’re dealing with. And again, that’s never to take anything away from any of the other cases we work on, but that was one that was unlike anything that I’ve ever done and I hope unlike anything I’ll ever do again.

Susan Barfield (05:26):
Well, I know Bill is going to dive in and ask some questions as it relates to acetaminophen, but right before we do that, what about practicing law continues to inspire you to excel?

Patrick Luff (05:40):
Again, it’s always about the focus on the clients, and that’s always got to be at the front of our minds. Frankly, in the mass tort world, it’s easy to get away from that, we have a lot of clients. I mean, I’m speaking to you from Dorado, Puerto Rico right now, and we’re fortunate that we have a type of practice that allows us to do that and do a lot of things remotely. So that’s one thing that I want to stress. The other thing that I particularly love about doing this sort of work is that collaboration that you just don’t have on individual cases, even complicated individual cases. There are so many different moving parts, and it’s not just the law, it’s the legal strategy, it’s the legal tactics, it’s the interpersonal relationships and managing personalities sometime on both sides. And I really enjoy that interaction as well. And so I think that’s what really energizes me day in and day out, is those opportunities to interact with my peers and push forward a righteous cause. I mean, what more can you really ask for?

Bill Barfield (07:05):
Sure, 100%. And so, Patrick, that takes me right back to acetaminophen and just what you said earlier in dealing and just speaking more toward the people in the firms that are involved in this litigation, certainly it brings comfort to you and a sense of excitement to know you’re working on such a great team, right?

Patrick Luff (07:29):
That’s exactly right. I mean, nothing is guaranteed in this business, unfortunately. But again, speaking to the idea of being energized by your interactions, when you get to work with people like Mikal Watts and Mark Lanier and Ashley Keller and all their incredibly talented teams along with everyone else, there’s a lot to be said for that. And it’s exciting too because it’s very easy to find yourself in the vacuum, in the practice of law, and particularly in the practice of law in mass torts. So to be able to really have that very high level interaction with incredibly intelligent and talented people, but also who think very differently from me, it’s truly one of those situations where the sum is greater than the parts.

Bill Barfield (08:29):
Most definitely. Well, going back to this acetaminophen litigation, Patrick, we’re grateful that you’re here today to help us walk through this acetaminophen litigation. And so, with that in mind, let’s talk a little bit about the basics of where this lawsuit came from and then what we should be thinking in terms of the legal community that’s involved in this lawsuit.

Patrick Luff (08:55):
I think the genesis of this lawsuit is one or two years back at least, there has been some literature actually even further back than that for, I would say, a good eight or 10 years there’s been growing bodies of literature about the relationship between Tylenol during pregnancy, and I say Tylenol, acetaminophen containing products including Tylenol and autism, autism spectrum disorders, and ADHD. And it should be noted here, we’re talking about pregnant women consuming acetaminophen products during pregnancy and the children having either ADHD or ASD when they’re born.

(09:46):
So, I think this is, in many ways, a very interesting litigation in the sense of the science. It’s also very interesting in the way it’s being conducted, and I think it has some precedence in terms of how we think the case is going to progress, that may show shades of the opioid litigation, but in some ways, particularly because of the way the judges is conducting it is very much a unique litigation. So all sorts of very exciting things from a scientific point of view, from a procedural point of view, again, I’m one of those sick people who taught and enjoyed civil procedures, so those things are interesting to me. So it’s a really cool litigation.

Bill Barfield (10:37):
Perfect. At the basic level, Patrick, what is the issue? What’s the problem with the medication? And then how do we link the problem with the medication, how is that linked to the development of autism?

Patrick Luff (10:53):
There are a few questions in there, and so I want to take them one bite at a time.

Bill Barfield (10:58):
Sure.

Patrick Luff (10:59):
The link generally starts with the epidemiological one. That is to say you have these scientific studies and they have very large data sets, and you identify these trends, and then these trends then in turn lead to more focused research and the like. Now, I think if you haven’t dug into the science, you might say, “Well, autism and ADHD seem to be ubiquitous, everybody seems to have one or the other or both.” And so this can’t all be Tylenol or acetaminophen. Well, that’s when you start looking at what we call the confounding factors, the other things that may cause it, and that may correlate with acetaminophen usage during pregnancy.

(11:52):
I won’t go into to all the details, but the bottom line for me is when you look at your intake criteria, or at least when I look at my intake criteria, there are a few qualifying factors and probably two dozen disqualifying factors because the science that we have takes account of these factors, it’s known that parental age, for example, can seems to correlate with ASD, ADHD. And so, we’re trying to get out ahead of that because we know defendants will always throw whatever they can to the jury and hope that the jury bites on some hair brain theory on what caused it. Whatever it is, it’s not ours, that’s what they always do.

Bill Barfield (12:45):
Yes. And so, you talk about the injuries of autism and ADHD, and those are the injuries that we’re speaking of this morning. Are there any other neurodevelopmental injuries or conditions that we might see come into play in this litigation in the future?

Patrick Luff (13:06):
I think unlikely in this litigation. Again, getting the weeds on procedure, the way that the MDL was created is specific to autism spectrum disorders and ADHD. However, knowing that these are neurodevelopmental issues and knowing that the part of the brain that we believe is affected by acetaminophen products in utero, conceivably, you do have some of these other injuries that could lead to future litigation.

Bill Barfield (13:39):
Okay.

Susan Barfield (13:43):
I’m just curious, Patrick, given that acetaminophen is a common household item, is there any concerns that this is a dangerous drug to the general public?

Patrick Luff (13:54):
I don’t think so. And remember, when we’re talking about drugs, we’re often talking about that risk benefit analysis. We have to have effective warnings, we’re not necessarily going to say, even a drug that has a large number of side effects generally is not going to be banned, it’s going to be warned about, and there’s going to be a risk benefit calculation either by the patient if it’s over-the-counter or by the patient and their healthcare provider if it’s a prescription drug, at least that’s how it’s supposed to work, and that’s the purpose of these warnings. So to answer your more specific question, we’re talking about autism and ADHD as a result of acetaminophen usage during pregnancy. Outside of that, I mean, we know that acetaminophen and liver toxicity is linked, and so you have warnings about that on your acetaminophen levels. But in terms of general societal risk outside of the confines of what we’ve been discussing, not to my knowledge and I mean, I take Tylenol, but I’m not a pregnant woman.

Susan Barfield (15:07):
How did the issue with acetaminophen even get brought into the courtroom, Patrick?

Patrick Luff (15:12):
What we often find in the literature is you will have some studies and then you will have some more studies, what I was talking about a little while ago, and over time, that momentum builds because when you’ve got one or two studies, you say, “Well, that’s interesting. There may be something there.” When you have a lot of studies and they’re studies with large numbers of participants, that’s something that can really just take time to generate momentum. And I think it’s simply a matter of we’ve now got the critical mass of science that shows very strongly the relationship between acetaminophen during pregnancy and these conditions we’re discussing.

Susan Barfield (15:57):
Right. And I know that the MDL was just created as early October 2022. At this early stage, what are attorneys focused on? What are they working on first?

Patrick Luff (16:09):
If this were a usual MDL, we’d be doing things like talking about, what’s the discovery protocol? What is our short form complaint going to look like? What’s the print of fact sheet? Are we going to do a fact sheet, are we going to do a census form, are we going to do a assessment questionnaire? This is not your mother’s MDL. We are doing all those things, but we also have our general expert reports do this spring. I wouldn’t say it’s unprecedented because somebody watching would probably say, “No, no, no. They did that in so-and-so litigation.” But certainly it’s uncommon. So in addition to all these other things that we talk about early in litigations of what are the discovery stages, what are the search terms for the electronic discovery that we’re doing, we are also in the weeds on all this general causation expert work that we’re going to do. And I think that’s going to dominate the work that we do through the end of this year between the reports, the depositions, and then the Daubert briefing that will happen this fall.

Bill Barfield (17:27):
And so, Patrick, my first question would be, in terms of the link that you spoke about earlier between the use of acetaminophen in autism, ADHD, you developed that in a failure to warn type claim. Is that correct? Am I saying that correctly? Is that one of the main claims that are being brought?

Patrick Luff (17:53):
Correct. Failure to warn is one of the main claims, although in a drug or medical device case or even a consumer products case, you’ll often see these other causes of action for each of express or implied warranty. Sometimes design defect, things like that. Design defect, you generally won’t see in a pharmaceutical case because the design is the chemical, and so if you got a different chemical, you got a different drug. But failure to warn is one of the big ones. And so, the question of course, aside from the general causation one of, does product A cause condition B, did the defendants know about it? When did they know about it, etc. And that issue can become more or less important depending on the state’s law that is going to be applied in a particular case.

(18:47):
But as we know we always are thinking about how is this going to appear to a jury, that’s always got to be forefront in our mind. And so even if the law allows us to prevail without that information, I think we always want to be aware of what did the defendants know, when did they know it, how long did they know about it, and what did they do.

Bill Barfield (19:10):
Exactly. And then also from our perspective, and then just the perspective of the community at large, always think, “Well, what is the plaintiff numerosity? How many people do we believe were impacted by these potential injuries and the use of this drug?”

Patrick Luff (19:29):
I mean, that is the question that we have for any developing litigation. And I think the answer in this one is it’s potentially a staggering number. I don’t know that it’s going to be as many claimants as Camp Lejeune, but it may be as many or more as there were in 3M. So we’re talking possibly hundreds of thousands of people. And the reason why, I think, Susan, you’ll probably back me up on this. I mean, I’ve got a four and a five-year-old, and when my wife was pregnant, the doctor had a big long list of things that you can’t take while you’re pregnant, but you can take Tylenol-

Susan Barfield (20:12):
For everything.

Patrick Luff (20:13):
… and that’s the only pain reliever that doctors tell women they can take. Now, some women, I think, still choose not to take anything. My wife did that for our children, but women take it because everyone believes and is told that it’s safe. And so potentially, Bill, you’ve got a staggering number of cases out there.

Bill Barfield (20:43):
Patrick, in terms of the existing plaintiff pool, in looking at the timeline, how far back does this go? I mean, how far back do the injury claims go with this specific tort?

Patrick Luff (20:56):
I think that depends on who you ask. I think some firms have criteria that take it back to some very early studies, potentially as early as maybe 1990 or something. I think another group of firms are just going for people who are still minors. And that’s generally what I’m doing is if you haven’t reached the age of majority, then those are the cases, but it’s really going to be firm dependent. And for me, if you take an adult case, you want probably a pretty profoundly disabled case where you’ve got a guardianship and the like.

Bill Barfield (21:46):
Makes sense. So we’ve talked about the injuries and the claims involved, but when we think of who the defendants are, who would you say, Patrick, who is liable for this? Who are those defendants?

Patrick Luff (22:02):
The most obvious one is Johnson & Johnson who’s the manufacturer of Tylenol, the branded Tylenol. One of the things that’s unique about this litigation is the ability to go after sellers of generics. So if you remember some of the Supreme Court decisions from the 2010s, PLIVA v. Mensing and a couple others, we can’t sue generic manufacturers of prescription drugs for failure to warn. However, because of the way that generic over-the-counter drugs are regulated, we think that there’s a viable claim against those retailers like CVS, Walgreens and the like. And you’ll see, if you look at the litigation, Walmart is one of the major targets, CVS and Walgreens and the dollar store. These are going to be major targets. And that’s why I said, at the beginning of our discussion, there are some shades of the opioid litigation in here because you’ve got companies like Johnson & Johnson, but you’ve also got retailer defendants.

Bill Barfield (23:10):
Definitely.

Susan Barfield (23:12):
And you talk about the sellers, why exactly are they being targeted in the lawsuit?

Patrick Luff (23:17):
Well, because a lot of people don’t buy branded Tylenol, they buy the Equate brand, they buy the CVS brand. And so, they are essentially the same as Johnson & Johnson with respect to their store product, they are the ones who are in control of the labeling and the selling.

Susan Barfield (23:39):
Yeah. Patrick, I know Walmart filed a motion to dismiss based on the federal preemption back in November, which was denied. What impact, if any, will this have on the case moving forward?

Patrick Luff (23:53):
It’s an interesting question. This was one of the other things that was somewhat, I think, unprecedented about this litigation. The judge decided the preemption motion not only very early, but without allowing the other defendants to weigh in on the issue. And normally, if the judge is going to make a decision that quickly, he or she will of course allow the other defendants to submit briefing on the question. Well, that didn’t happen here. What effect does that have on the litigation? Well, one possibility is that the preemption issue is simply a settled issue at this point. Hopefully that’s what it is. I mean, we’ve always thought that the preemption issue in this case was very straightforward and very much in favor of the plaintiffs, but of course, if you ask a defense attorney, they will tell you the complete opposite.

Bill Barfield (24:55):
Yeah. Patrick, that’s a good point. We talked earlier about the claims that we’re going to see put forth by the plaintiffs in this litigation, whether it’s failure to warn, breach of express warranty, breach of implied warranty, and violation of multiple consumer protection laws. But once you have those claims, then the next question is, what is the level of evidence? What do we have to show? What do we have to prove? And so, that would be my question, Patrick, how does someone like yourself look into that and understand and appreciate what level of evidence needs to be brought in this lawsuit or needs to be proven in the lawsuit?

Patrick Luff (25:40):
Well, you’ve got probably a couple different types of things that you want to think through. The first one is the very scientific evidentiary question that is, what does the epidemiology say? What is the mechanism of action? Is there dose response that is, do you find that women who take more of it are more likely to have children affected by these conditions? But then you’ve got another question in a drug case, and again, we don’t think that as a truly legal matter, we have to say label says X, it should say Y. But invariably, I think judges are going to ask for that, you’re going to end up in a hearing someday where the judge says, “Counsel, what are you telling me the label should say?”

(26:33):
And even if the judge doesn’t require that, I think a jury is going to expect that. And so that’s another big question in our mind, what would an effective label look like? And then of course, from there, you’ve got the question of, does that label actually warn women who are of childbearing age who might be taking this? And that’s an entirely different sort of evidence. And then of course, you’ve got the case specific evidence of dosage and blah, blah, blah.

Bill Barfield (27:09):
Right.

Susan Barfield (27:10):
Patrick, what do you think makes this case special, and how was it able to grow so quickly?

Patrick Luff (27:16):
Well, in terms of special, this is probably just me having younger children, but over the last few years, I’ve seemed to have gotten a lot of litigations that involve young children. You’ve got the NEC litigation, you’ve got the infant formula recall litigation, you’ve now got the Tylenol ASD and ADHD litigation. What’s special about this litigation is it involves children, and there is no worthier cause in my mind than that. And so, that coupled with the fact that we’ve got potentially this very, very large number of individuals who have been affected. I mean, I think when you think about these large societal issues that we have, obesity, heart disease, and the like, ASD, ADHD is up there, and we may have identified one of the large contributing factors to this big societal problem that maybe we have a chance to fix and to stop.

Bill Barfield (28:24):
100%. Patrick, let me transition and just ask a few questions about the MDL. Tell us a little bit about the judge, why is she unique, what is her approach, and why is that unique? And then what is the status of the MDL? What’s going on right now?

Patrick Luff (28:40):
The judge is Denise Cote, Southern District of New York. If memory serves, she was a Clinton appointee. She’s been on the bench for some time. And in the Southern District you get a lot of big antitrust cases, big white-collar criminal cases and the like. She is not a judge who’s had a dozen MDLs, but in doing some research work on Daubert in the Second Circuit, and specifically for Judge Cote, she is a brilliant judge. I mean, you can tell that her intelligence is off the charts. She’s got a bit of a reputation, at least, she did when we were preparing for our initial appearances before of being a little bit of a difficult judge. And I think that’s because if you appear before her and you’re not ready, you’re going to be in trouble. But I always appreciate practicing before a judge like that. They hold you accountable and the cream rises to the top in front of a judge like that.

Bill Barfield (29:51):
Sure.

Patrick Luff (29:52):
In terms of the status of the litigation, as I said, we have done a whole bunch very quickly. One of the really interesting things about this case was when we showed up for the initial status conference, very first hearing for the court, she was impeccably prepared, but also we were working with Johnson & Johnson’s counsel from Barnes and Thornburg in the lead up to this, and we’d actually done an awful lot of work. I presented her, I think, six joint proposed orders. And I think that really helped us to give her comfort that she was working with professionals.

Bill Barfield (30:36):
Sure.

Patrick Luff (30:37):
She was going to have to resolve fights that really mattered, but not deal with a bunch of junk. So because of that, I think, we’ve really moved the ball forward very quickly on some of these things that can take months or a year or more in any other MDL.

Susan Barfield (30:56):
What can we expect to see going forward with this case? And are there any hidden landmines that you are preparing for?

Patrick Luff (31:04):
The question on everyone’s mind right now is what happens with Daubert. And again, it’s I think unique or at least rare that you’ll have a case, particularly case of this size, where you’re going to have the general Daubert at the very beginning of the case. We think by Christmastime, we’re going to have an order and that either means we’re done and we’re licking our wounds or we’re off to the races. So that’s the question on everyone’s mind right now.

Bill Barfield (31:38):
Perfect, Patrick. And at this stage, and I know like you said, Daubert in the fall Christmastime, but someone in our position as an attorney involved in the litigation, what should we be focused on?

Patrick Luff (31:54):
High quality cases.

Bill Barfield (31:56):
Okay.

Patrick Luff (31:59):
I think assuming we get pass Daubert, the defendants are in a very difficult position at that point. The science is good. We’re going to be pass Daubert. And in any other MDL, once you get pass Daubert, you’re in pretty good shape.

(32:20):
So the question at this point is, how big does that potential settlement pool become? What sort of cases are and are not going to be paid? And for me, as I say, the goal is to identify and screen out the cases that the defendants can point to and say, “Well, look, mom was 45, dad was 55. Those very high risk of ASD separate and apart from Tylenol.” And so I think simple diligence on your case screening and then just continuing the customer service and the customer engagement to ensure that you keep your clients engaged and informed over the course of these long litigations.

Bill Barfield (33:14):
Yes, Patrick, and that brings me to that next question. Once you get past the intake process, we’re dealing with such an emotional type case that impacts vulnerable individuals in our community and our society. What would you say, what kind of advice do you give to an attorney handling this type of an emotional case?

Patrick Luff (33:37):
What I always tell my clients very, very early in the case is it’s going to take a long time. This is a case that’s going to be measured in years and not months. And expectation setting in any sort of professional service, but I think particularly in the law, and particularly when we’re talking about mass tort cases, that can take five or seven years to resolve from beginning to end. I don’t know how successful or unsuccessful that expectation setting is, but I think it’s the best shot you have.

Bill Barfield (34:13):
Sure.

Patrick Luff (34:14):
And developing that relationship with your clients, empathizing with your clients, engaging with your clients, and informing your clients continuously for seven years or 10 years if it takes it, is the number one thing that a firm has to do.

Bill Barfield (34:32):
Yeah.

Susan Barfield (34:35):
Awesome. Patrick, this has been fantastic. Great insight. Really appreciate you taking time to connect with Bill and I today and of all of our viewers, listeners, and just sharing the updates about this litigation. Thank you so much for doing that and spending time with us.

Patrick Luff (34:53):
My pleasure. Thank you.

Bill Barfield (34:54):
Thanks, Patrick. I appreciate it.