Animal Law Podcast #100: The Case of the Drugged Cattle

Mariann Sullivan: Now, this is a difficult case for me, because it's kind of sciencey, and it gets into environmental law, which I will trust your expertise on that. But it's so important, because I think it is really, it's important in and of itself, and it's important for what's going on in the ag industry about trying to cope with climate change in ways that are probably not very benign. Or trying to at least cover up climate change in a way that's not very benign. So it's really important that we be able to use the tools that we've got to counter the industry when they start to do these things. And I don't want to get too deep into the scientific weeds, but we do need to get some information to understand what is happening in this case.

So let's start with the facts a little bit. We've all heard about cows and methane, but I am not familiar with the impact of cows and ammonia. Can you just explain that a little bit?

Larissa Liebmann: Certainly, yeah, so ammonia is created from the manure of cows, so pretty much they pee it out. So, it's excess nitrogen, so whenever they have too much nitrogen in their diet, it comes out in their pee and of course at feedlots this is all mixed together. And then it can either enter the ground and have ammonia, or a lot of times it volatizes in the air, and it's actually a very powerful air pollutant.

It has really bad impacts on people's health, both workers at feedlots, and then also communities. Ammonia is a really dangerous air pollutant.

Mariann Sullivan: So tell us what Experior is.

Larissa Liebmann: So, Experior is, not trying to get too much in the weed in the science. It is a Beta agonist antagonist, technically, that's its classification. So, it is a drug that has been approved by the FDA for reducing, and I'm going to say the very simplified version, and then we can maybe get into the nitty gritty to the extent it matters.

FDA has approved it for use in cows raised for beef to reduce their ammonia emission. Now, I will give the caveat that, or maybe the detail, that it's only been approved for reducing 16 percent, is what the company, Elanco, that makes it, 16 percent reduction when used at 91 days per pound of hot carcass weight.

That is important because that means it's not approved... they will not say, okay, if you're a feedlot owner, you can say, hey, my feedlot is producing this much ammonia, because they haven't been able to prove that. What they have approved it for is this reduction in hot carcass weight.

Though we contest not even that has been shown in the effectiveness studies.

Mariann Sullivan: I hate to do this because I'm afraid it's going to get really complicated, but what the hell is hot carcass weight?

Larissa Liebmann: It sounds like such a gross term. I hate saying it.

Mariann Sullivan: It really does.

Larissa Liebmann: So, once you've slaughtered the cow, and I think taken out the innards and things like that, the weight of that carcass before it gets chilled. So it's essentially saying per pound of weight of meat you would be selling, this much reduction.

Mariann Sullivan: Okay. I assume it's beneficial for them to put it in that way, but I won't go into why. I'm just going to go with that assumption. So, that is really interesting though, because it's really not that much, is it? Like 16 percent is... I didn't realize from looking at the papers that even the claim, It's not that much.

So how did the animal agriculture industry arrive at this belief that Experior reduces ammonia emissions? I mean, there are beta agonists. I've heard that term before. There are beta agonists used in animal agriculture. Are they all good at this or did they just come up with this idea that this would reduce ammonia?

Larissa Liebmann: Right, so beta agonists, kind of as a broad class, are already used extensively by animal agriculture. So, I feel like many people that work on this are familiar with rectopamine, which is a beta 1 and beta 2 agonist. I promise that information will become relevant later, because we have different receptors... everyone has, all animals have different receptors in different parts of their body. And so these kinds of drugs will do different things depending on which receptors they either agonize or antagonize. So upregulate or downregulate. So rectopamine is currently used in turkeys. In pigs, in cows, and it is mainly used for weight gain.

It increases the amount of weight they pack on, which makes it more efficient, of course. At the same time, though, it has horrible health effects on these animals that have been documented. It causes higher instances of heat stress. It causes behavioral issues. Essentially, it increases the stress for the animals.

So they pack on more weight. But then they're really stressed. They have issues with their hooves, there's higher instances of what the industry calls downers. So animals that fall down and just can't get back up. These are already used widely in the industry. It's actually banned in 160 countries, but the U. S. and a number of other countries still uses them in their meat production. So this is already, you know, just to kind of give the background of the use of this class of drugs.

Mariann Sullivan: Right. Yeah. So now you're just talking about beta agonists in general because you can't really talk about Experior because your whole argument is that we don't know enough about Experior because the research hasn't been done. Is that right?

Larissa Liebmann: Well, we do know a little bit about Experior. We do know it is similar but different to the drugs that already exist, and I think that's the reason that Experior really set off alarms, when it was approved by FDA, among people that are keeping an eye on animal drugs, because we knew it was in the similar class as things like Ractopamine, and we knew that Ractopamine been shown to have awful, awful animal health impacts. But importantly, especially once you dig in on Experior, it acts a little differently.

And Elanco would say, oh, well, because it acts differently, it means it won't have the same animal health impacts. However, our argument is that, and the administrative record shows this, is that they didn't actually study Experior properly because they didn't look at these different impacts. Yeah, and let me know if you want me to go into a little bit more of the background on how this drug came to be because it's actually a very interesting, uh...

Mariann Sullivan: Well, if it's a good story and it won't take us too long, I'm kind of interested to hear. Though, I also want to hear you... we've talked a little bit about the harm to farm animals of these drugs generally, and probably of Experior, but as you said, the research is incomplete and they're making different claims.

But tell us a little bit about the background of how it came into being. And then also, we've talked about the harms to the farm animals, which of course is a huge concern to our listeners, but I'd also like to talk about the environmental harms, the food safety harms, the health harms. So, I do want to get into that as well before we even get to the case.

But if this is an interesting story, yeah, tell us. How did it come to be?

Larissa Liebmann: So, and I think for people that work in pharmaceuticals, this is probably not a surprise, but for those of us that don't... This was my first case definitely dealing with this. Pretty much the company that, you know, discovered this drug, and I think this is actually how many drugs come to be, is they found a drug, and then they had to try to find a use for it, essentially.

So first they tested it, okay, we used it as a human drug for this, and this, and this, and it didn't do any of the stuff they wanted it to do. Eventually, they landed on using it in beef cows to reduce ammonia, but it was just interesting because it clearly was a solution in search of a problem.

It was the approach, and it was clear, yeah, they kept trying, well, will it do this? Will it do this? And then finally, they found something that FDA was willing to be like, okay, yeah, yeah, we think you can use it.

Mariann Sullivan: Yeah, and it really doesn't do it, as you pointed out before, that well, even according to their claims. But let's go into some of the other, not just what it does, but some of the bad things it does, because you've told us about the animals. What about the environmental issues, the food safety issues?

Larissa Liebmann: So, I guess maybe I can hold off on going into the legal background. I want to jump into the legal, but we can hold off on that.

Mariann Sullivan: We haven't gotten to the case yet, so...

Larissa Liebmann: Yeah! I know, I'm eager, I'm eager.

Mariann Sullivan: I always, I always like to do, you know, I don't know, law school had a big effect to me. I do the facts, then the law, then put them together. It still works for me. And so I like to get a lot of facts up front, because none of the rest of us know anything about this.

Larissa Liebmann: Yeah. That's a really good point. So, yeah, so the facts are... a lot of it is a big question mark, and that's important in terms of when we get into the legal, the burden, who has to prove what, right? And so I'm going to put a pin in that.

Mariann Sullivan: Yeah, and also, we, you can talk more generally about this class of drugs, if you don't know the specifics about Experior, just so we know what some of the concerns are.

Larissa Liebmann: So, I guess first of all, just thinking about human health one of the biggest concerns is the way these drugs are used, right? They're used in animals that are eaten by people, by some people. And there's no way for consumers to know what drugs are going into the meat they buy at the supermarket, right?

When you buy conventional beef, there is no label on it saying, Okay, this beef was given this antibiotic and then this beta agonist and these hormones and all these things, you know, you might be able to get like, drug free beef, but otherwise it's a big question mark. So the first thing is just, every time FDA approves a new drug to be given to farmed animals that will have either made products or are the products that people consume, that is going out into the food chain and the food system, and people have no idea what they're exposing themselves to. They have no way of knowing.

So in the case with Experior, our biggest concern is the impact Experior could have on people that are experiencing heart failure due to the specific properties of Experior. With other drugs, there might be other things that sensitive populations might be impacted by.

So that's kind of the first thing, it's for meat consumers. There's also health concerns in terms of communities that live in the vicinity or downstream from feedlots, because, right, this is all going into the manure, getting spread on the land, it's getting, you know, held in lagoons, depending on the type of system they have, and then it's entering soil, it's entering groundwater, some of it might be even entering the air. And people, once again, there are no warning signs on a creek, like, heads up, here are all the various drugs that might be in this water because of the feedlot upstream. So, it's once again this thing that you don't get to opt in, right? It's not like you make a decision with other types of drugs. Like, oh, I'm going to take some Tylenol. Here, you don't even know what the risks are because you don't even know you're being exposed necessarily.

That's kind of the big thing. And Experior is also, in terms of environmental impacts, concerning because it does have a very long half life, so it probably will exist for a while, and it really has, I think that the term is a high soil coefficient, which I'll describe as kind of sticks in the sediment well, which means it could be impacting certain organisms living in the soil, also people that might, you know, be interacting with the soil more.

So that's kind of the human health concerns. Of course, there's feedlot workers, which are exposed to everything. Especially for Experior, ones with heart problems, we think there might be a higher risk.

Mariann Sullivan: Yeah, you know, as you were telling that story, it made me think of how the meat industry's propaganda about plant based meats, I am going somewhere with this, is always saying, you know, they have a million ingredients, look at all the ingredients, and here, meat, it's only one ingredient. It's beef. But if they actually had to list the actual things that that cow ate, people would never ever buy it. Ever.

Larissa Liebmann: Exactly, that's a good point.

Mariann Sullivan: There's a lot of ingredients in there.

Larissa Liebmann: A lot of ingredients, a lot of different drugs, a lot of things that, as we found out with Experior, that haven't maybe even looked at that closely.

Mariann Sullivan: So if the approval of this drug stands, how widely will it be used? Is this going to be industry wide that everybody will be giving their cows this drug?

Larissa Liebmann: So, that's a very interesting question. So, right now, Experior has only been approved for this really small reduction in ammonia, and industrial agriculture, right now, their air emissions are not actually regulated, right? So there are no standards on how much ammonia they need to be taking out of the air, and that's a whole different issue that we could talk about.

Mariann Sullivan: Yeah, no, that's a big topic. That's a big topic.

Larissa Liebmann: It's sort of, I guess, in one way we think maybe this was created in anticipation that eventually there will be standards.

And this could be a way to, you know, feedlots help them comply. I think another reason people would use it, though, is also just to have some sort of sustainable certification or something. Like, hey, our beef makes 16 percent less ammonia. Yeah. So, I'm saying all that because we have no idea if it's being currently used anywhere, how much it would be used. And if we talk about standing, this became a big issue, right?

Because, like, we have no idea. FDA has no idea. They don't keep track of it. We don't even know if Elanco, the company that makes the drug, is keeping track of, like, who's using it where. However, we do know that Elanco has called it a blockbuster drug and, in reports to their investors, expects to make a lot of money off of it.

So they clearly think there will be a market for it. And it could be that they already are mixing it in. They sell, you know, these medicated feeds, right? That's how Experior is administered. So they could start adding it to their feed and it could just be one more component of this feed that has antibiotics and this and that because FDA's approved Experior to be used with antibiotics that are given to cows.

Mariann Sullivan: So, in spite of all of these problems, or maybe because of them, it got approved and you then petitioned for a stay. This was not, I mean, when I first saw a stay, I thought it had something to do with the lawsuit, but it didn't. It's a different type of stay, isn't it? You don't have to go into a lot of detail because we'll get into the issues as we discuss the suit, but I was just unfamiliar with that process.

Larissa Liebmann: Yes, and there's kind of an interesting, well, interesting for those of us that care about administrative procedure. Interesting backstory there. So there has been attempts to sue F D A for its approval of Ractopamine and that has had an issue where there is a bit of an administrative exhaustion issue.

So 'cause rectopamine was already approved, you have to go through the citizen petition process. So now, if anyone ever does citizen petitions to agencies, it's just a long, long wait process and it's really difficult to get it to actually go anywhere. So, with Experior, what ALDF did is, we used a provision in the Food, Drugs, and Cosmetics Act to... essentially what it provides for within 30 days of a drug being approved, you can petition for FDA to stay the approval of the drug. So we were like, hey, we looked at the publicly available information, here are all our concerns, you should stay this approval. So it's sort of an administrative process, and that then was necessary for us later then to sue FDA for their approval, and also for denying our stay.

So it was sort of an administrative loophole we had to jump through in order to have that, um, evolve.

Mariann Sullivan: So that was denied and then I think we can now get to the lawsuit at long last. So you decided to sue, as you said, that was something of a formality because you figured it was going to be denied, but to set up your lawsuit. And, tell us your causes of action.

Larissa Liebmann: Yes, so we are challenging FDA's approval of Experior under both the Food, Drugs, and Cosmetics Act. So that's the law that empowers the FDA. As the name suggests, FDA regulates drugs, they regulate food items, and cosmetics. So we're challenging under that.

And to dig in a little bit more, before FDA approves a drug, whether it be for animals or humans, They need to have substantial evidence that it is effective and reasonable certainty that it is safe, both, and in the case of drugs for animals, both for people and for the target animal. So, that's Food, Drug, and Cosmetics Act, FDCA, safety and effectiveness.

The second statute. Is the National Environmental Policy Act, which just says in the simplest terms, federal agencies need to look at the environmental impacts of their actions before they take them. So, those are the two main causes of action.

Mariann Sullivan: And, Experior intervened. Is that right? I guess that wasn't a surprise.

Larissa Liebmann: Yes, I don't think we contested that yet. So, Elanco, the company that makes Experior, they are intervener defenders in this action.

Mariann Sullivan: The company is Elanco. The drug is Experior. I got that confused. Yeah.

Larissa Liebmann: Yeah, exactly. We use it kind of to talk about all of it. But yeah, so Elanco intervened. So it's FDA and Elanco and ALDF on the other side.

Mariann Sullivan: And there's two causes of action. And, you mentioned ALDF on the other side, but there are other organizations involved as well. So if we can all just take a moment out from the case itself, I'm always interested, not having done this litigation, about how organizations work together, who does what.

I guess it varies from case to case. So can you just talk a little bit about who the other plaintiffs are and what role they have?

Larissa Liebmann: Yes, definitely! The 2 other plaintiffs are Food and Water Watch and Food Animal Concerns Trust, FACT. So, they are both clients of ALDF. So, ALDF in this case has done the primary litigating. Sometimes it's different. Other cases, sometimes we're co counsel. Here, we've worked with the two groups, which do amazing work, for anyone's not familiar with them.

Food and Water Watch works on food systems, climate, water, and they have done some amazing litigation on animal ag. And then Food Animals Concerns Trust really focuses on the impacts of confined animal agriculture. So they really focus, they're like experts in all these drugs that the FDA passes, when it comes to using in CAFOs, and really seek to just remake our food system to make it kinder and safer and healthier.

So they are our clients and they also, of course, helped us get standing through their members. Happy to talk about standing whenever you want.

Mariann Sullivan: That's exactly what I wanted to ask about next because of course, of course, there couldn't be an animal law case that doesn't start off with a standing challenge. So can you talk about it a little bit? What was their challenge?

Larissa Liebmann: Yes, so as you're saying, with the all of these kinds of cases, whether it be animal, environmental, right? It's live and die on standing so much of the time. Would you like me to kind of give a little background into what standing is? Article 3 standing? You think that would be helpful?

Mariann Sullivan: Sure. You know, if people feel like it's too much, they can skip over it, but I think it's always... you know, I go over these things so many times. I teach them every year and it's still helpful when you're talking about it to kind of set it up in your brain.

Larissa Liebmann: Yes, definitely. Every once in a while I freeze. I'm like, wait, do I even, do I remember what standing is? I argued all these. So, standing is jurisdictional, which means that it can come up at any point in the case, and even if neither party raises it, the court can still toss the case out on that premise.

And it's based in the Constitution, and Article 3. And courts have interpreted it to mean that in order for someone to bring a cause of action, they need to show an injury, causation, and redressability. So, in our case, we had a few different ways of getting at this because we're working with multiple claims under multiple statutes.

Technically, you need, standing for every single claim, which can be very tricky at times. So first for talking about the safety and effectiveness of Experior, we found members that are consumers of conventionally raised beef, because they're the ones that could currently be, or have been, will be exposed to this drug in the food they eat, the food they give their family. We also found members that live, recreate, vacation near feedlots or downstream from feedlots.

Because they're the ones that could be impacted by Experior in the water. They talked about being afraid, not wanting their kids to go swimming in the rivers that they went to as a child, things like that. And that also goes to National Environmental Policy Act, NEPA.

Also, the fact that FDA did not look at the environmental impacts fully of this drug. People are impacted because they have no idea. Oh, and we also had a standing declarant that actually sells drug free beef, and he talked about the impact that this can have on his, business. Creating uncertainty for consumers, consumers already are getting really scared about eating beef for many reasons.

Really, to bring these cases, you need to find a whole scope of different people impacted, right? People that maybe...

Mariann Sullivan: Yeah. And it's always been an issue in animal law, or used to be an issue in animal law, that it's just hard to find those particular members if it's purely an animal rights organization. So that's a huge benefit for you to be able to be representing organizations that are, you know, in line with you on this particular issue, but also are going to have a lot of members who are meat eaters, to put it bluntly, cause that can be very useful in bringing the case.

Larissa Liebmann: Exactly. Yes, it is. You know, in order to bring these it's just the fact, we need people that are eating the meat if we're going to be challenging what the FDA is doing. So we are very lucky and, for example, Food and Water Watch, they had a member that actually used to work in a feedlot, and they have experienced that, so it's just really important to be able to show all the different ways that our members, and our, meaning us and our clients, have been and continue to be impacted by FDA approving this drug improperly.

Mariann Sullivan: And I didn't feel the court gave a lot of credence to their standing challenge. It seemed very convinced by your arguments, but I just wanted to mention that they also brought up causation and redressability, which are the other elements, as you mentioned, of standing. And I thought it was interesting because the court ... They were kind of arguing, correct me if I'm wrong, that you haven't shown causation or redressability because you don't have enough information about the harms being caused by these drugs. And that's your whole point, that you don't have enough information. That's the problem here. So I thought that was an interesting analysis by the court. A brief but interesting analysis by the court.

Larissa Liebmann: Yes, I think we definitely appreciated that Judge Seaborg recognized that they were really trying to confuse the merits argument with standing, which is, it's a common thing in these cases. And also this is at the motion to dismiss phase, and for anyone that's done an administrative law case, you haven't even gotten the administrative record at that point, right?

So most of this, a lot of the information we would have needed to make that argument, we didn't even have yet. So we definitely appreciate that the judge recognized that, and also he recognized that their argument about geographic proximity and things like that was also similar. It just didn't make sense, right?

The defendants and intervener defendants were saying that, oh, well, you can't say where this drug is being used. So, you haven't satisfied that proximity to actually show, injury and causation. And he pointed out that, not to skip ahead, but this also came up in our hearing of like, does anyone know where this is being used?

This would essentially keep anyone from ever having standing, because it's not information that's widely known.

Mariann Sullivan: They keep it a secret, and then they say you have to know what's going on. So, that brings up a point, it is being currently used. Is that at an experimental basis, or is it really in widespread use at this point?

Larissa Liebmann: What we do know is it's being very heavily marketed. So if you just type in, you know, Google Elanco Experior, you will see webpages dedicated to it. Elanco even has a webpage about generally trying to create more. Like they, it's clear they're trying to build an entire business around this idea of making beef more sustainable, right?

And I guess podcast listeners can't see that I'm doing air quotes, so greenwashing. It's essentially in a greenwashing industry. This is one of the main reasons that ALDF is taking this on, is because companies realize that people are wising up to the enormous environmental impacts of Industrial animal agriculture and eating animal products in general. So they're trying to find ways to show they're being more sustainable. And a lot of those ways, like Experior, seem to not really work. And even if they do maybe do that tiny, little thing that they say they do, it just allows them to continue this system of extreme confinement, and that's what really ALDF is concerned about, because it just perpetuates this unsustainable, horribly cruel system.

So, if you look it up, they're definitely marketing it as a way for producers to show their sustainability bona fides, I guess.

Mariann Sullivan: No, you're seeing so much of that. The whole seaweed thing and the methane capture. It's all nonsense but, you know, allows them to hold on for a while longer.

Larissa Liebmann: Exactly.

Mariann Sullivan: This is obviously an important tool for them in doing that. All right, let's get to these claims. All right. The first, as you pointed out, is the Food, Drug and Cosmetic Act claim.

And first of all, your actual, Citizen suit cause of action is through the Administrative Procedure Act, correct? You, that means you have to have arbitrary and capricious standard?

Larissa Liebmann: Thank you for bringing that up. Yes, there isn't a separate sort of cause of action in the FDCA and NEPA, so we're going through the Administrative Procedure Act and essentially arguing that in making these determinations, FDA acted arbitraciously and capriciously. So, I guess I could jump in a little bit on the various decisions, if you'd like.

Mariann Sullivan: Yeah, well, can you tell us what the Food and Drug Cosmetic Act requires here?

Larissa Liebmann: I don't know if any of the listeners have ever looked at the FDCA, but it is, it's a lot.

But I'm going to try and pare it down.

Mariann Sullivan: I've seen it on the shelf.

Larissa Liebmann: yeah, yes.

Mariann Sullivan: Even that's a lot.

Larissa Liebmann: I, it drives me crazy when I have to look it on Westlaw because all the sections are so long that they're barely indented and you never know, like, you're in, like, section 1A, B, C, Roman numeral, and you're like, it's,

anyway.

Mariann Sullivan: Yeah. I, I have to say for, for younger lawyers, younger than me, which is like everybody, statutes in books are so much easier to look at. It was so much easier. Cases, it's fine. It's, brilliant. That's wonderful. But for statutes, it's really helpful to just have the book.

Larissa Liebmann: That is so true.

Mariann Sullivan: If it's a complicated statute.

Larissa Liebmann: Yeah, looking at the FDCA regs and the statute on Westlaw is just, it's rough. So I, definitely agree with you on that one. So the first thing is, right, it makes sense. Before FDA can approve a drug, it needs to be effective. So that means that the drug sponsor, in this case, Elanco, needs to show substantial evidence of the drugs effectiveness. And we went through a whole thing where, when we were initially drafting our briefs, where we're like, wait, is it effectivity? Is it effectiveness? And it turns out those words are not synonymous. It is effectiveness. And I forgot exactly. There's like subtle differences. And I was very personally upset when I found out we had to use effectiveness because it's such a clunky word.

But it is a sort of a term of art that is... I'm sure other lawyers can appreciate where you have to realize they have to use this like complicated word and you're like, oh, that's the one I have to use?

Mariann Sullivan: Yeah, and it's very good to actually stick to the actual words. Yeah,

Larissa Liebmann: Even if it's not as elegant as you want it to be.

Yes, we have effectiveness and our first claim is that there was not substantial evidence that this drug works as Elanco purports it does in the conditions that it's supposed to be used. And these are all, you know, requirements, obviously, so if you're gonna market a drug to be used in feedlots, for example, you should make sure it actually works in feedlots.

And so that's one of the biggest concerns we have with the effectiveness is that they didn't actually ever study whether this drug is effective when used in feedlots.

Mariann Sullivan: So was it like in a laboratory type setting?

Larissa Liebmann: Yes, like enclosed. And you can imagine it. It's in some ways a little, it is tricky, right? Because you're trying to measure an air pollutant. So in order to do it, they kind of did need to create this, or they decided the only way they could do it is create essentially chambers to measure the amount of ammonia in the air.

So they had enclosed chambers, either with cows in individual chambers, or just a few, and in no way reflected the many different factors that would be present at a feedlot that could impact the actual ammonia emissions and FDA admits this, you know, when they did their environmental assessment. And this is kind of the both interesting and confusing aspect of this case, is that while the NEPA claims are separate, because this drug is indicated for environmental use, all these things kind of bleed together.

Right? So whether the environmental assessment is related to whether this drug actually works the way it's supposed to, which is also a unique aspect of this drug. It's not approved for any really clinical purpose, right? There's no reason anyone should be giving this to their cows other than to reduce ammonia, which is an environmental, not, you know...

Mariann Sullivan: So all this normally in another type of case wouldn't affect the NEPA analysis here because it's specifically for an environmental reason, which is kind of probably a fairly new thing.

Larissa Liebmann: Yep.

Mariann Sullivan: That it will enter into the NEPA claim, which we'll discuss in a minute. But, before we do get to that, I just wanted to ask because I saw, not that I know the papers that well, but one of their positions was that, well, it would be so much better in a feed lot.

Because we kind of did the experiment in a confined system where the drug would have more challenges because it's confined. The whole situation would be better at a feedlot. How did you counter that?

Larissa Liebmann: I'm not off the top of my head thinking of our exact argument to that point. However, broadly, that's not the standard under the FDCA. You can't, there are no assumptions allowed in this. You need to make sure the drug works in the conditions that it is approved to work. So, we can't just assume that, oh, it might work better.

And even FDA admits that they don't really know how these various factors would impact the emissions of ammonia from cows that take it, right? So they admit that, you know, the type of soil could impact it, the weather could impact it, the feed, the type of food the cows, I mean, there's so many different factors that come into it, and they readily admit that they didn't look at all those factors.

And, you know, it's been a while since I've studied anything sciencey, but I mean, even people that know the basic principles of scientific theory is you can't come to a conclusion with all these factors up in the air, right? You can't say, oh, well it works, but, oh, ignore all these other things that may or may not make it work.

Mariann Sullivan: And there are ways to measure that. I mean, they, they could do. They could do more research. I guess that's the whole grommet of your lawsuit is that there's a lot more that they could do to figure out whether this is true.

Larissa Liebmann: Yes, and I mean, luckily, it's not our burden to show FDA and Elanco how to do their jobs.

Mariann Sullivan: Right, And it's their burden to figure out how.

Larissa Liebmann: It's their burden to figure it out, and if they can't figure it out, then they shouldn't approve the drug, right? And there are many other issues with the effectiveness studies, and I just need to give a quick shout out to my colleague, Christina Clattis, who spent countless hours digging into the record, looking at the studies they did on effectiveness. Actually, I was on maternity leave. So she was just in there. I think our record was over 130, 000 pages of studies and memoranda and she picked apart all the studies and figured out that there were various confounding factors that made the results less sound than they appeared.

FDA just kind of overlooked all these things. They kind of just always gave Elanco the benefit of the doubt. And I think that's kind of a common thread in our lawsuit, whenever there was something that would speak to not approving the drug, FDA kind of brushed it aside. And when there was, like, any tiny bit of showing of effectiveness and safety, FDA would just be like, OK, great, thank you, Elanco.

It's clear they were just doing what they could to move it along.

Mariann Sullivan: Now, now you had mentioned that it's not just effectiveness, but also safety. So for this cause of action. And so, You're also arguing if they didn't look sufficiently into the issues that you were talking about before about human safety. Is that right?

Larissa Liebmann: Yes, so when we talk about safety, we're actually really focused on, I guess I'll say, like, four groups. We're putting them in sort of buckets, right? So, consumers of beef, people that live near downstream feedlots, feedlot workers, and the cows themselves.

Mariann Sullivan: So you are allowed, under this act, to consider the safety of the cows themselves.

Larissa Liebmann: Yes, so for animal drugs, you need to consider the safety of the target animal. So they did extensive studies of that and they overlooked evidence that there might be increased lameness, which for people that know about ractopamine, that's Big alarm bells, because that's one of the main issues with Ractopamine.

It causes issues with lameness. So they brushed aside indications that it could cause lameness. They overlooked troubling results that showed that there might be some impact on the ability for the cows to absorb nutrients when they're taking Experior. And the results were a little confusing, but once again, not our burden to figure out what exactly is happening.

It was on them, but it looked like there's issues with their kidneys that FDA just kind of brushed aside. And really something frustrating, and unfortunately something we didn't have a good legal basis to argue, a lot of times FDA would brush aside these troubling health results on cows by saying, Oh, well, this is no worse than you'd see on average at a feedlot, which is just so frustrating because you see these horrible health outcomes and it's like, oh, well, because feedlots already are so horrible for the health of the animals, it doesn't mean anything.

Personally, it was so frustrating to see that argument, um, and it is, it's interesting because, you know, we didn't really get to make this argument in this case, but it just shows how there's a different standard, right? Because if they're looking for a drug, at a drug that you would be giving to your, you know, fancy, I don't know, poodle, they would be way more careful about what kind of health impacts they would tolerate than what's been given to a cow being slaughtered, so, but that's nowhere in the statute necessarily.

Nowhere does it say that, like, anyway, so I'm going on a tangent, maybe a rant, just that like many things in our society, it's this double standard for the animals that we raise for meat and other products versus, you know,

Mariann Sullivan: Well, rants are always welcome here on the Animal Law Podcast.

They also, I think I saw in your papers, they just didn't even consider the risks to the workers. Is that right? Which seemed to me that would be very substantial. And I remember reading somewhere in the papers that there's advice of protective equipment that they should be wearing in order to handle this.

And like, they're feedlot workers. They don't wear any protective equipment at all, at least that's what I was reading in the papers.

Larissa Liebmann: Yeah, so we found quote from one of the reviewers at FDA that was just saying, oh, the, I believe he called them the feedlot cowboys, they never wear any of the protective equipment. So, while the label that will come on the Experior says, Hey, if you're handling this, you should be wearing this protective equipment, you know, masks and gloves, whatever.

Uh, FDA readily admitted that, like, let's be real, the feedlot workers are not going to be using this.

Mariann Sullivan: Yeah, again, they're not going to be required to use it, which if they were required, you know, you can't leave it up to the workers, like if they're required to use it, then they'd use it. It's the company's fault.

Larissa Liebmann: Exactly, exactly. It's like, there should probably be a requirement. Hey, company, if you're going to be buying Experior, you need to be providing... no, it just says, hey, you really should do this. And they, they knew it wasn't going to happen.

Mariann Sullivan: Yeah, this kind of attitude, well, they're not going to do that, they're cowboys, like they're not going to do it if they're not made to do it.

Larissa Liebmann: Exactly.

Mariann Sullivan: So what is the relief under this cause of action, that you're seeking?

Larissa Liebmann: That FDA revoke its approval. So take back approval and, really what would then happen is order more studies, or maybe Elanco will give up and realize it's not worth it. But we just want to see it taken off the market. And as part of that, Elanco stop making these claims that through this amazing drug, producers can just magically reduce their ammonia.

Mariann Sullivan: So let's talk a little bit about the NEPA claim. I love this statute. I kind of know when it was passed, a lot of people criticized it because they said it wouldn't do anything. Because it doesn't actually require anything other than information. But actually, it has been a very powerful statute in a lot of cases.

So, this is also through the citizen supervision of the Administrative Procedure Act. Is that right? There's no independent citizen suit.

Okay. And what does the statute require? And I think maybe there are probably people who haven't heard of NEPA, but they've probably heard of an environmental impact statement.

Everybody's heard of them. So can you tell us how this all works? It's relatively simple, you know, the easy version.

Larissa Liebmann: Yep, okay, the easy version. What NEPA says is when a federal agency takes an action, and there's a whole definition of that, major federal action, when they take an action, they need to study the environmental impacts of it. So in simplest terms, when an agency is taking this action, they kind of have three options.

Maybe four. I'll say four. Okay, so some things can be categorically excluded. So agencies have their own regulations related to NEPA, and they can say, we've found that whenever we do this thing, it doesn't have any significant environmental impacts, so we don't need to do any analysis. I could go on a whole rant about categorical exclusions and how agencies abuse them, but that's not relevant here.

So, the first step is an environmental assessment. So, it's pretty much just you look at the environmental impacts, and you get an idea, is there going to be a significant environmental impact?

And if there looks like there's going to be an impact, and there's many different factors that come into that, you then need to do an environmental impact statement, which is in a more involved study. If you think there isn't going to be an impact, you do a FONSI, finding of no significant impact. So here they did environmental assessment, that's available online if anyone wants to look at it, and then issued a FONSI. And like I was saying, it's intellectually interesting to think about the fact that they said this will have no significant environmental impact, when the entire purpose of the drug is to have environmental impacts.

Mariann Sullivan: That is sort of hilarious.

Larissa Liebmann: It seems a little absurd. And there are many different things that FDA overlooked when they make these decisions.

One thing that I think you probably see in all farmed animal drug approvals is just really glossing over the combined impact on both the animals and the environment of all these different drugs that are being used at feedlots. You can imagine like a feedlot using antibiotics, they might have been using some other drug that maybe now it's been revoked, and it's not really looked at in these environmental assessments of like, okay, what's going to one more drug being added to that cocktail in the soil, in the water, all those things?

How is that going to impact groundwater? Things like that. That's something that they don't really look at, once they approve one, they just, they're like, okay, that's approved and what's one more? It seems like.

Mariann Sullivan: Wow.

Larissa Liebmann: So that's one thing that we raised.

Beyond that, I guess just to get back to what we're arguing, we think instead of just doing an EA and a FONSI, I'm getting into those acronyms. So instead of taking a quick look and saying, oh, no impact, they should have done a more thorough study. So that was our argument for numerous reasons, like I was saying, and I think once again that the scope of the potential use of this drug, right? Like I was saying, we don't know where it's being used.

But it's been approved to be used nationwide. So feasibly, this drug could be used at feedlots around the country, which means it could be in rivers, and groundwater, and soil

around the country.

Mariann Sullivan: So presumably it could get into not just humans from eating beef, but into loads of other animals as well, if it's in rivers and streams.

Larissa Liebmann: And so they did look at some, they did do an EA, so that means they did do some studies. But we think they did not look at all the right things, and they also didn't look hard enough. And something else is, once again, going back to that theme of kind of contradictions in FDA's approval, so they approve this drug saying, okay, it reduces ammonia, but then the same time, say in their environmental assessment, well there won't be a significant environmental impact, even though reducing ammonia in the air is an environmental impact.

But we also don't know how much ammonia it's gonna reduce or where that ammonia that it reduced goes. I think that's another thing is like no one understands how, Experior, if it were to work, how it would work. Which kind of raises both environmental and health concerns.

Mariann Sullivan: I think, I mean, correct me if I'm wrong, but my understanding is, is that doing an environment impact statement, if they had been required to take that further step, and I assume that's the relief that you're seeking here, is a really big deal. I mean, that's a lot of work, right? Companies do not want to have to do that.

All

Larissa Liebmann: Yeah, they will definitely try to avoid that. And I think the really cool thing and the thing that they would really not like is the NEPA process under FDA is a little unique because of the fact that, when a company's applying for a new drug approval, there's concerns about, confidential business information, you know. They don't want another company to know they're trying to get approval for this drug. You don't get to see the environmental assessment for a drug until after it's been approved, for new drugs. As opposed to if, I don't know, a bridge being built. They do an environmental assessment that's available publicly before the bridge even is built, people get to comment. So if there are an environmental impact statement, Now people would be able to comment and, you know, ask questions and things like that.

And I think that's where, like you're saying, NEPA is procedural, but it's really the public engagement aspect of it is so powerful, both in terms of informing the public and letting the public voice their thoughts and raise their concerns. So I think that's another reason that companies would prefer not to do that.

Mariann Sullivan: So, so. That's your case. I have to admit, I didn't really review the opposition papers. I don't know whether there's anything in there that surprised you or you want to highlight. And I'm also curious, I assume you had oral argument or a hearing on this, and did you get any hints about what the court is particularly concerned about?

Larissa Liebmann: Let's see, I guess I'll first talk about oral argument. We did have that back in March and we were just really happy to see Judge Seaborg asked many questions about many aspects of the case, which already I think, you know, something I feel like I haven't really touched on in this interview is just how novel this case is.

If you look up case law on state petitions, non profits, citizens challenging drug approvals, especially the approval of drugs used in animals, the case law is far and few between, and no one has ever prevailed. Usually, most of the cases are, like, one company fighting another company.

Oh, you shouldn't be able to sell this because it's ours, right? It's all about the money. So, we knew from the beginning this was an uphill battle for many reasons, right? First was the overcoming the exhaustion issue that had held up the ractopamine lawsuits. Then, you know, the standing.

It's just often hard to know where a judge is going to rule on standing, even if we think our standing argument is ironclad, it still can be very tricky for these types of cases. So we were just so happy when we even got past the motion to dismiss states. That in itself was a victory.

So, I think just having Judge Seaborg ask about almost every aspect of our case and really had us explain our arguments. When it came to standing, as I mentioned earlier, it made me so happy when he asked, I think it was the FDA's counsel. Well, does FDA know where this drug is going to be used or where it's being used?

And they're like, nope, that's not something we tracked. And because FDA kept hammering that, oh, well, they don't even know if it's being used. How can they have standing? And he's like, well, do you know?

Mariann Sullivan: That's great. I love it.

Larissa Liebmann: Uh, so, I'm trying to think. I'm sure there were other memorable moments, but yeah, it was just great to see that it clearly, the judge was thinking carefully about it and not just, you know, defer to the agency, right? Which would be the easy out.

So we appreciate that.

Mariann Sullivan: Yeah. No, that, I mean, that sounds like as much as you can hope for.

The behavior that you have set forth here from FDA is, is really pretty bad and just a lot. Substantive failures, procedural failures. I don't know how familiar you are with F D A or whether that's a agency you've litigated against a lot.

You said there are very few cases that are specifically about this type of issue.

Do you think this is exceptional behavior, or is this just normal poor behavior? I, it's really interesting getting a close look into how an agency is dealing with something. And sometimes it can be shocking.

Do you think there's something particular going on here?

Larissa Liebmann: You know, I think there are a few things that I think are just unfortunate truths about our regulatory system in general, whether we're talking about EPA, FDA, is lack of a precautionary principle. That is not applied here, right? You know, we have other, Europe has more of a precautionary principle.

You have to prove everything like, the level of proving is just higher there. So I think that's just a broad thing. And I think there definitely felt like there was, you know, FDA's, based on the memoranda, their job was to figure out how to get this drug approved. And they were willing to hold Elanco's hand and be like, oh, well, that didn't work, we'll try this.

Or, oh, those numbers didn't turn out, well, maybe if we pool them with these numbers, you'll get the results you want. I don't want to get into big Pharmaceutical, FDA, industrial ag, conspiracy theories here, but of course we all know how. Agency Capture, the, Elanco is a massive company that probably, you know, is constantly getting new drug approvals from FDA.

So they're used to working hand in hand. I'd definitely say probably some agency capture, and of course animal ag is an enormous powerful industry, as well.

Mariann Sullivan: Yeah, absolutely.

Larissa Liebmann: But, I do wonder, if you were to sue over, I don't know, flea medication for cats, what would that kind of scrutiny look like versus the scrutiny they give to animals being raised for meat?

I remember, I don't know if it was intervener defendant or defendant's arguments for one of our health concerns, their response was, Oh, well, even if that was like a health issue, I forgot what it was, they're like, the cows would be slaughtered before that could even, really manifest.

And that's just...

Mariann Sullivan: That's exactly what I was going to ask you next or comment on next is that I mean, it's just a fact that it's hard for people, I mean, not just these regulators, but for people in general to get their heads around the fact that these animals matter at all and that what they're going through matters at all.

Larissa Liebmann: Yep, exactly, they're just like, oh, they're going to get slaughtered. What difference does it make if their kidneys are having issues

Mariann Sullivan: If they're suffering. Yeah,

Larissa Liebmann: Anything like that. And I feel like the best outcome from this case, if we could just get a little bit of case law that says, you know, that it matters that these animals are suffering a lot more than, especially in the balance of things, right? The tiny, maybe, possibly not anything reduction of ammonia versus additional suffering, I think that's something that it would just be amazing to get something on, because it's just so awful.

Mariann Sullivan: And this is the kind of case where, you know, knock on wood. It does seem possible because there are so many other harms, you know, the harm to the animals is going along with so many other harms that could be the kind of case that would create that step of recognizing the harm to the animals.

Well, I'm looking forward, I think, to getting the decision. One is always looking forward and dreading decisions. So, so, uh, there's fear and hope, but thank you so much for sharing all of this with us today. It's really been interesting. And I, I have to admit, I was worried that it would not be because it's science y, but you've made it all make sense.

Is there anything I should have asked you that I didn't?

Larissa Liebmann: I'm glad it was interesting. Yeah, it's always been when I'm sure you know when you've been working on a case, things that you never thought would get interesting suddenly become interesting, like the process of fighting over redactions in this case. Like, I never thought I'd find the rule of 9 2 process interesting, but it turned into such a fun fight.

Mariann Sullivan: Well, there were like, I looked at the papers and they're redacted all over the place. I mean, just the papers that I looked at, it was really kind of difficult to get into them.

Larissa Liebmann: Yes, I found it actually entertaining how things turned out because I think, you know, in the end, right, the whole discussion about what in the end is going to be redacted, you know, FDA didn't feel like their counsel sometimes acted like they'd ever say it, but it didn't really matter because it was confidential business information of Elanco.

And I think Elanco's counsel is used to usually dealing with other private.

companies

Mariann Sullivan: Yeah.

Larissa Liebmann: that don't really care about transparency. So it felt like they were really surprised when we were, like, pushing back on every single thing. Yeah, and I mean, in the end, I think the paper is going to be mostly not redacted.

And then that's one thing, credit, credit to my colleague, Christina Cladis. She was the one who was like, no, we are going to push them. And she found all the case law.. And I think that's also really important. You know, the transparency work is, it's so important, not letting companies just hide all this information, for no good reason.

A lot of times, even they don't even have a claim of CBI. So I think that's. Yeah, so important. I think that was a one fun part. And the fight over the expert declarations was another for admin law buffs was a fun time as well.

So a lot of interesting motions practice that...

Mariann Sullivan: Yeah, I always think people think that becoming a lawyer, you want to find an area that's interesting, you know, substantively, like entertainment law or whatever, you know, of course, we want to do things, something we really care about. But it's those weird little nitty gritty arguments that don't have anything to do with the subject matter of the case, but that, I don't know, involve these little problems and something you can really fight on that turn out to be the most fun.

Larissa Liebmann: Exactly. Yeah, like we submitted an expert declaration with our motion for summary judgment, which for people that practice in admin law, usually administrative law, you only are allowed to rely on the administrative record. So, you either can try to supplement it or ask a judge to consider something outside the record.

So, we asked the judge, hey, It's really complicated. We had this wonderful animal toxicologist that worked with us, and he wrote this declaration explaining the science and everything. And so we just submitted a motion, asked the judge to consider it, and of course, Elanco and FDA were livid that we would try to do this.

And then FDA came back and submitted Two declarations with their response to our motion for summary judgment. And I did not expect myself to be so mad. Because it's like, the entire record is FDA's record. 130, 000 pages of studies and memoranda. And they still are like, oh, well, you have a declaration, we get declarations. You had an entire administrative record to prove you did your job, so I'm also very hopeful that the judge will rule with us on that and strike their declarations, because it just felt so just absurd to me.

Mariann Sullivan: Really, really.

Well, that's great. Well, I hope you winj on that and I hope you win on everything. We'll all be really keeping an eye on this case because it has implication. I mean, it is important in and of itself and it has implications far beyond what happens in this particular case, because this use of these dangerous drugs to try to greenwash and cover up

climate gases are, it's just.

It's something that is not going to stop.

Larissa Liebmann: Yep, we're just going to keep seeing more and more, so gotta...

Mariann Sullivan: I kind of like my idea. I wonder if anybody's willing to do that. You know how they keep advertising how many ingredients there are in plant based meats. I mean, somebody should do ads listing how many drugs are used in animal based meats.

I think that might get people's attention.

Larissa Liebmann: I feel like I've actually seen someone send that around in one of the listservs, like someone...

Mariann Sullivan: All right. Well, they need to get it in the New York times.

Larissa Liebmann: Yeah, like in New York Times, exactly.

Mariann Sullivan: Yeah.

Shocking stuff. Thanks so much. It's really been great, Larissa.

Larissa Liebmann: Thank you so much.