We'll call the first case for the morning, which is Pennsylvania employees benefit trust fund versus the Santa Fe Inc. And as I await the, as I wait council, I'm going to come to the podium. I want to thank again as I did yesterday, Judge Jean Seiler, the sixth circuit, who is facing this group of presidents this week helping us. And honestly, Judge Seiler is an old and dear friend of mine, my old, not nearer as a old Jean, but I've known him for about as long as I've been a federal judge, which has become perilously close to 20 years. He is one of the true workers of the federal judiciary, someone who, even as a senior judge in the sixth circuit, has carried a full workload, quite often, and has been out to help others or gets through out the country. So, Judge Seiler, we thank you and Judge Cown joins us really good. Good work. All right. Mr. Spiegel, I do a full look for the appellants. Thank you, Your Honor, and good morning. Please support my name is Craig Spiegel. I'm representing the appellants today. I would request three minutes, I'll say for rebuttal, if I may. Thank you. This case concerns our allegation of a broad-based national campaign directed from AstraZeneca's headquarters for the purpose of selling the prescription drug, Nexium, and inflated products. The reason for this campaign was that the blockbuster drug, Prylosec, which sold billions of dollars in the 1990s, was scheduled to go off patent in approximately 2001
. As a result, it was highly likely that Prylosec would face generic competition sometimes soon thereafter. So, AstraZeneca worked to develop a new drug, and they came up with a drug they call Nexium. Nexium has one of the two ice immerts that are in the drug, Prylosec. AstraZeneca presented a new drug application to the FDA. Now, as I know the court knows, in order to get a drug approved, all AstraZeneca has to show is that that drug is better than a placebo. But AstraZeneca shows to try to convince the FDA that Nexium is clinically superior to Prylosec. As we allege in detail are complete however, the FDA found that Nexium is not clinically superior to Prylosec. None of the last... Well, the FDA never correct me if I'm wrong. I'm not aware that the FDA ever, in their approval process, says that one drug is better than another. They normally do not. In this case, they did reject the argument by AstraZeneca, that Nexium is superior to Prylosec. Because AstraZeneca, in this process, presented some evidence about Nexium and Prylosec in comparison. And therefore, while the FDA normally does not have to say anything about it, because in this case, AstraZeneca shows to try to convince the FDA that Nexium is superior to Prylosec
. The FDA responded and said it's not. The FDA has a marketing section as well as an approval section. Well, it's really more the FTC, but there is the DDMAC, that is correct or unheard, that looks at marketing materials. Did this ever go to that section for its approval? There were certain ads, certain marketing materials that did go to the DDMAC. We don't talk about that in the complaint, but as I'll give you more detail later, a very important part of our case is that the oral conversations that the detailers, that is the salespeople, have with doctors, don't go through any kind of approval process. I mean, the DDMAC can't approve what was actually said orally to physicians, and that's a major part of our case. So that part of what was said did not go and could not have gotten to the DDMAC. Let me begin for purposes. My area is of interest in any event with the statutory exemption issue under the Delaware statute. There is in place a working agreement between the FDA and the FTC. Yes, Ron. Why should we not regard that working agreement as an effective delegation from the FDA, such as to Prydner, the exemption under the Delaware statute? Because no one is required to submit anything to the DDMAC. It is not a case where everything has to be submitted to the DDMAC, which then passes on whether that material passes muster. Therefore, essentially, unless I'm just understanding, your eye would be saying that that delegation would print any claim for false advertising, because merely because there is the DDMAC present, and no court to a minor, I should ever held that. In addition, we don't know what in fact is submitted to the DDMAC upfront. And further, the DDMAC has nothing to say, as I mentioned earlier, about what is said in oral conversations between the detailers and the physicians
. And as your honor knows from our complaint, we alleged that AstraZeneca held a meeting of 6,000 salespeople in Hawaii, but purpose of telling them what they should say warily to physicians. And these detailers should go out and do just that. Now, we don't have them in this case, but in other cases, we have call notes from AstraZeneca. I can't talk about the details, and I'm going because we obtained them at a marked confidential. But the point is, those detailing notes, those call notes are out there to help us know what in fact was said warily to the physicians. And a holding that the delegation or the agreement between the FDA and the FTC preamps all false advertising claims would let detailers say whatever they want in an oral conversation, and yet a claim of deception would be preempted. Even though the agreement between the FTC and the FDA says has no effect. How do you state, the state was this case from Brockman, the Supreme Court, the fraud on the FDA. We are not, we are not alleging the fraud on the FDA at all. In fact, we are saying that the FDA agrees with what we are saying. In other words, the FDA said, next is not superior to Prolus Act. So we are not claiming any kind of fraud on the FDA, what we are claiming is AstraZeneca presented studies to the FDA. The FDA came to the conclusion that those studies do not support a claim that next year is clinically superior to Prolus Act. And then nonetheless, AstraZeneca, detailers went out and said exactly that to physicians. Wouldn't it be unreasonable for the Court to conclude that if the Delaware legislature, with its Consumer Froids Act, exempted that approved by the FDA that if there was an approval or an applied approval by the FDA through the FTC or vice versa by the FTC through the FDA, that this would be a, this would be a tap list. I don't believe so, Your Honor, because the DDMAC does not, it's, there is not the kind of process there that would allow for a preemption of all claims
. And by that I mean, it's not a rigorous process. The reason I believe that the Court's hold that what the FDA says may go on a label preempt state law claims is precisely because the FDA goes into such rigorous steps. Mr. Speaker, I don't understand why your response to Judge County's question and for that matter in my previous question isn't simply the Delaware legislature said the FTC. They could have said the FDA, they could have selected an over of acronyms or alphabet soup variations, but they did. They chose me. Why doesn't the inquiry simply stop there? With the fact that, and I want to make sure I understand it, I understand what the statute says about the FTC. And it is a, it's your question, Your Honor, that therefore because the FTC is the plain language of the statute. Why are we talking about anything other than the reach of FTC regulation when it's all the statutes? Well, in terms of the statute, you're on the state par, I'm sorry, we are, we are talking about, excuse me. I was also thinking there is the preemption argument that make the broader argument, I apologize. On the safe harbor, yes, it is the FTC, that is correct. Well, your friend across the aisle would say, yeah, the Delaware statute says the FTC, but the FTC and the FAA have a working agreement. Ergo, it makes only sense that if they said the FTC, they included anything that the FTC had a working agreement with. What's wrong with that thinking? Well, even if that were correct, the problem in this case is that the statute also says that the, that must have been, what is alleged must have been specifically permitted. It doesn't say just because there's an FTC involvement. What the statute says it must be specifically, I'm sorry, I didn't follow that
. Yes, that for a safe harbor, for there to be a safe harbor, the act must be specifically permitted. But it's not just that there is regulation in the general field and therefore there's preemption. And this case, what we're saying is that no one specifically permitted in any way, in fact quite the opposite, they prohibited a claim that NECCM is clinically superior to private sector. Let me answer me. If we agree with you, do you can see that at most you have a question of fact for a jury. This is not a question that we would resolve one way or that a district court would resolve. I think that's right. There's a lot more material out there that would be relevant to this. So your basic position is if you prevail on this appeal, that there's a jury question if you are able to. I go with jury on this case. Well, whether or not this is in fact false advertising. Well, that's correct, John. We're not cleaning at this point. Oh, it doesn't matter. Are you from basing your false advertising on what was printed or on the news media? Are you basing it upon what the salesman was saying? It's both your honor. It was like in the, we started to the court, the in-rate war fair in case this court decided
. And in there, the court talked about a broad-based national campaign. And that's what we're alleging. Part of that campaign was to convince consumers to either ask for maximum or if it were offered to take maximum as a drug. The main point at which we believe that those claims in those ads were deceptive is insane that maximum is today's purple pill from the makers of private sector. They don't say it was superior, did they? No. It's not. No, no. They said it's the purple pill of the future. But under the, in Delaware apps, the question is whether a reasonable consumer would take away the impression that it's superior. And we believe that at this stage, at the cleaning stage, that the court cannot say that no reasonable person could take away from the claim that next thing is today's purple pill from the makers of private sector or the new purple pill from the makers of private sector. But they couldn't, a reasonable person could take away from that. That private sector is inferior to Mexico. Mr. Speaker, yes, right. Is there any claim that can be made based upon the Delaware statute against a drug company and based upon its advertising, other than a claim based on safety and efficacy of the drug? I don't know, Your Honor. In this case, our claim is based on the efficacy, the comparative efficacy
. So yes, we do. It can be there because just like in, I see my time's up, I think. Just like in Warfare. It wasn't, there was the, it was a purely economic claim. And this court made that clear and said that with a purely economic claim, that reliance is not necessary. And that in fact reliance is irrelevant to a finding reliability. And we're saying the same time here. We're not claiming. I want to make sure in case it isn't clear. We're not claiming the next thing harmed anyone. We're not making that kind of claim. What we're saying is it was sold at a much higher price than it would have been but for these misrepresentations. And that's very much the same as occurred in the Henry Warfare case. We'll have you back on her, Mr. President. Thank you
. Mr. Head-In. That's a question. One day should I head-in or hit it? You got the exact right, you're on it with the job. Well that may be the only time today. But thank you. Thank you, Your Honor. May I please the court? My name is Mark Hadden. I represent the appellees this morning. The FDA expressly permits manufacturers of prescription drugs to advertise those drugs in a manner that is supported by the FDA approved labeling of those drugs. And the FDA does so because in the labeling, which is part of the new drug approval process, the FDA has found that all of the information in that labeling is supported by substantial evidence and is not falsely misleading. But to cut to the chase, your adversary says that a fair implication, he says a reasonable person could conclude that your advertisement says in effect that it is superior to nexium is superior to violence. And that was never approved. There was never any approval of that by the FDA. Your Honor, everything that the plaintiffs here say gives rise to that impression was specifically approved by the FDA as part of the label. They have a tax
. How in the FDA process said that it was superior to this drug? That went over my head if it is in the briefing or the record. Let me take it in two pieces, Your Honor. First of all, virtually 98% of what they point to here, not all of it, are benign statements such as today's purple pill, the new purple pill. The fact that the nexium is manufactured by the same manufacturers, the priori-second, all of these facts that they say give rise to this impression are inherently the facts on which AstraZeneca proceeded. They are not included with the FDA to get approval for nexium and to get approval to market nexium, including down to the color of the capsule. So in that sense, they are attacking not just simply a false statement or false head, but they are attacking the entire marketing of this product. Let me ask you, do you concede or would you acknowledge that the FDA never said that this nexium is better than priori-second? What? I mean, is that a yes or no, or do you have to explain your answer? No, I can say the FDA never said those words in the last one, or no sentence that says it is better. But let's look at what the FDA- If that is true then, if they never said it is better, then wouldn't it follow that if sufficient other words were said, from which a reasonable person could conclude, could infer from those words in their totality, that it is better, that such a statement was never approved by the FDA? No, Your Honor, because the impression that is being alleged to be drawn here is the same impression that flows directly from the words and the facts that the FDA did approve. And so to go to the second part of the answer, I would say the court should look at pages 283 to 285 of the joint appendix, which are the pages and which the FDA sets forth. The studies and the results of the studies on the healing of the rest of the suffigitis and the treatment of the symptoms of the rest of the suffigitis. But they never said nexium is better than priori-second, did they? No, it is true, and that section may not say that, however, what they do is they set forth the results of the studies that supported the approval of a 40-milligram dose of nexium for the healing and the treatment of the symptoms of the rest of the suffigitis. And that is something that they did not do for priori-second. But if you would have said in so many words that nexium is better than priori-second, if you would have said that, would you acknowledge that that would be a violation? You'd have to look at the context in which we said that, Your Honor. It would be contextualized, because if it was understood, then we were saying that in line, for example, the better healing effectiveness of the 40-milligram dose of nexium over 20-milligram dose. The fact that it cures, it gives forwardly of the symptoms on average five days as opposed to seven to nine days of priori-second. And then it's quite clear that that's supported by the lately
. Did you ever say that? Well, we are alleged to have said something like that in paragraph 88 of the complaint, and that's another paragraph that is very telling you. The only example that the plaintiffs have of an oral conversation between AstraZeneca, sales representative and a doctor is described in paragraph 88. That's an excerpt of the Wall Street Journal article. And if the court looks at what happens in that paragraph, the court will see that the sales representative is directing the doctor to the data on the healing studies comparing nexium to priori-second. And those are the very studies that the FDA looked at, concluded we're not false to this leading. But the FDA never concluded that the nexium was better. They never said that in so many words, didn't it? That's true. They didn't say that in so many words. So, let if you say it, inferentially, you can't conclude that it would be FDA approved, would you? Not if we say it, if the inference blows from the very same things that the FDA said we could say. I think that is the critical part of this answer. We, for example, point to the data that supported a 40-milligram approval for the healing of a row of the suffigitis. That is very significant because the FDA did not approve a 40-milligram indication for other indications. It didn't approve it, for example, for the maintenance of healing of a EE. And if you look again in the labeling, you will see that the FDA explains we didn't approve 40 milligrams for the healing of EE. Because a 40-milligram wasn't more effective than 20. So, when they approve a higher dose, it's because they have found substantial evidence to support the increased effectiveness that goes with that dose. Well, they've got effectiveness in there for sellability. But as a matter of policy, the FDA does not rate one drug against another drug. They approve drugs, but they do not have a rating system of one drug visibly another drug. Not to my knowledge. Well, but that's exactly if the inference can be drawn reasonably that what you're saying is in effect that the FDA has concluded that next year is better than pilot set. You are attributing to the FDA something which they never express words uttered. But we rely on the regulatory scheme, your honor, which allows us to make comparative claims when they are supported by substantial evidence. But if a reasonable jury can conclude that you made these claims that next year is superior to pilot set, why wouldn't I spell a cause of action under the Consumer Act? Since, according to what you've said yourself, the FDA never said that next year is superior to pilot set. The FDA doesn't have to use those words to allow us to make the statements that we made. Remember that we don't have these abstract statements of superiority. What we're being challenged on are statements that are directly supported by the labeling. And here, I think it would be helpful if I were to point the court to the regulatory framework specifically that permits us to do what we did. Would that be an argument more appropriately addressed to a jury instead of an appellate court? Absolutely not, your honor. We think it's critical that this court addressed this regulatory framework because the FDA has set forward by law a framework that which manufacturers operate and are permitted expressly to operate and sell the products they sell. Prescription drugs are unlike almost any other product in that they are never sold. They are never marketed at all unless they survive the FDA review process
. Well, they've got effectiveness in there for sellability. But as a matter of policy, the FDA does not rate one drug against another drug. They approve drugs, but they do not have a rating system of one drug visibly another drug. Not to my knowledge. Well, but that's exactly if the inference can be drawn reasonably that what you're saying is in effect that the FDA has concluded that next year is better than pilot set. You are attributing to the FDA something which they never express words uttered. But we rely on the regulatory scheme, your honor, which allows us to make comparative claims when they are supported by substantial evidence. But if a reasonable jury can conclude that you made these claims that next year is superior to pilot set, why wouldn't I spell a cause of action under the Consumer Act? Since, according to what you've said yourself, the FDA never said that next year is superior to pilot set. The FDA doesn't have to use those words to allow us to make the statements that we made. Remember that we don't have these abstract statements of superiority. What we're being challenged on are statements that are directly supported by the labeling. And here, I think it would be helpful if I were to point the court to the regulatory framework specifically that permits us to do what we did. Would that be an argument more appropriately addressed to a jury instead of an appellate court? Absolutely not, your honor. We think it's critical that this court addressed this regulatory framework because the FDA has set forward by law a framework that which manufacturers operate and are permitted expressly to operate and sell the products they sell. Prescription drugs are unlike almost any other product in that they are never sold. They are never marketed at all unless they survive the FDA review process. And it's a two-part regulatory framework that's critical for the court to appreciate here. The first part is the labeling and the rags there that I would particularly ask the court to focus on. The 21 CFR 314.125 subparts B5 and 6 because those are the rags that say that the FDA's labeling is going, is not going to be approved unless it's supported by substantial evidence and is not false in misleading. Can I just dovetail onto one of my colleagues, Judge Smith's question. The act says FTC, pure and simple, doesn't say FDA. That's right. You're calling across the aisle. Are you that the plain meaning of the statute should be followed and the FDA is not involved in this dispute. It was never approved by the FTC. Why is that the end of the argument? For essentially the reasons that you attributed me during the questioning of Mr. Spiegel, it seems clear to us that the Delaware legislature said here is we're deferring to the FTC here. If it's good enough for the FTC, if it simply is subject to FTC rules and it complies with them, then Delaware is not in the business of second guessing whether there's a consumer or a product problem. Now the FTC has written agreements that the experts here are the FDA and they're the ones we're going to delegate to. It is so obvious is probably not to be worth my wasting your argument time but the Delaware legislature didn't say that. It didn't say what you're saying right now
. And it's a two-part regulatory framework that's critical for the court to appreciate here. The first part is the labeling and the rags there that I would particularly ask the court to focus on. The 21 CFR 314.125 subparts B5 and 6 because those are the rags that say that the FDA's labeling is going, is not going to be approved unless it's supported by substantial evidence and is not false in misleading. Can I just dovetail onto one of my colleagues, Judge Smith's question. The act says FTC, pure and simple, doesn't say FDA. That's right. You're calling across the aisle. Are you that the plain meaning of the statute should be followed and the FDA is not involved in this dispute. It was never approved by the FTC. Why is that the end of the argument? For essentially the reasons that you attributed me during the questioning of Mr. Spiegel, it seems clear to us that the Delaware legislature said here is we're deferring to the FTC here. If it's good enough for the FTC, if it simply is subject to FTC rules and it complies with them, then Delaware is not in the business of second guessing whether there's a consumer or a product problem. Now the FTC has written agreements that the experts here are the FDA and they're the ones we're going to delegate to. It is so obvious is probably not to be worth my wasting your argument time but the Delaware legislature didn't say that. It didn't say what you're saying right now. True your honor and I don't know we have to believe in the seat of but I'm talking to us. It seems fairly straightforward that if the Delaware legislature is going to defer in every other respect to the FTC, we can't see why they would not defer to this judgment of the FTC. If you're in full compliance with the FDA, then you don't, there's not a further enforcement issue under the FTC. And it makes sense because prescription drug advertising is not something that consumers act on directly. It's close to alerted intermediary. And this really takes us back to the second part of the regulatory structure that I wanted to point out which is at 21 CFR 202.1. The working agreement? No this is not the working agreement. 222.1 is very important because those are the regs that govern the advertising of prescription drugs and it's an extraordinarily detailed set of regulations. And the court will seem looking through them and they are all built around the labeling. And the one reg in the Walter regs that many of which are important but that I can call the court's attention to specifically here this morning is at 202.1.1.6. This room too, little too, because there the FDA has expressly permitted comparative advertising between drugs so long as it is supported by either substantial evidence or by substantial clinical experience
. True your honor and I don't know we have to believe in the seat of but I'm talking to us. It seems fairly straightforward that if the Delaware legislature is going to defer in every other respect to the FTC, we can't see why they would not defer to this judgment of the FTC. If you're in full compliance with the FDA, then you don't, there's not a further enforcement issue under the FTC. And it makes sense because prescription drug advertising is not something that consumers act on directly. It's close to alerted intermediary. And this really takes us back to the second part of the regulatory structure that I wanted to point out which is at 21 CFR 202.1. The working agreement? No this is not the working agreement. 222.1 is very important because those are the regs that govern the advertising of prescription drugs and it's an extraordinarily detailed set of regulations. And the court will seem looking through them and they are all built around the labeling. And the one reg in the Walter regs that many of which are important but that I can call the court's attention to specifically here this morning is at 202.1.1.6. This room too, little too, because there the FDA has expressly permitted comparative advertising between drugs so long as it is supported by either substantial evidence or by substantial clinical experience. Well we know from the labeling rules that substantial evidence needs to support all of the studies that are on the labeling before they will get on the labeling. So we know that we have substantial evidence for the fear not misleading comparisons between 40 milligrams or next year and 20 milligrams of primacy. And the FDA is saying in 202.2.1.6.2 that that is permissible then to do the comparative advertising. So we know it's for purposes of the preemption issue. I'd like to ask you the same question that I asked people and that is under the Delaware statute. Is there any claim that could be made against a drug company based on the company's advertising drug? Other than a claim that's based on the safety and efficacy of the drug. Well no such claim has been made here of course. But I suppose there could be other kinds of claims that would be made. There could be a claim that it was advertised at a certain, it's hard to see in a prescription drug context, but you can imagine that over the counter drug was advertised at a certain price. It wasn't sold at that price or something like that. You could see going outside safety and efficacy. But you know really our argument is a fairly narrow one, but it's critically important as a legal argument and as an appellate court argument
. Well we know from the labeling rules that substantial evidence needs to support all of the studies that are on the labeling before they will get on the labeling. So we know that we have substantial evidence for the fear not misleading comparisons between 40 milligrams or next year and 20 milligrams of primacy. And the FDA is saying in 202.2.1.6.2 that that is permissible then to do the comparative advertising. So we know it's for purposes of the preemption issue. I'd like to ask you the same question that I asked people and that is under the Delaware statute. Is there any claim that could be made against a drug company based on the company's advertising drug? Other than a claim that's based on the safety and efficacy of the drug. Well no such claim has been made here of course. But I suppose there could be other kinds of claims that would be made. There could be a claim that it was advertised at a certain, it's hard to see in a prescription drug context, but you can imagine that over the counter drug was advertised at a certain price. It wasn't sold at that price or something like that. You could see going outside safety and efficacy. But you know really our argument is a fairly narrow one, but it's critically important as a legal argument and as an appellate court argument. And at the preemption level it is this that federal law through the regulations that we've cited has set to many factors. Yes, if you survive the new drug approval process, if we improve your labeling and supported by substantial evidence and not false rules leading, then you can rely on that. And if that's the foundation of your advertising, it is permitted. That's what we allow you to do. And I would like to correct a couple of the statements this morning along those lines. If you look at our brief at page 20, you'll find the site to the regulation where all of the ads that are done by a manufacturing company at the time of first use are submitted to the FDA's division of drug management marketing and advertising communications, the DMACC. So it is a comprehensive regulatory scheme. And the upshot is really the analogy there is to guy or the guy versus Honda case because they are the federal agency said car manufacturers can choose to put airbags and their cars all at once or they can choose to use other kinds of password strengths. And state law came in and said no, we think airbags have to be in every car. And this reports that can fix that's an interference with the federal scheme. And the same thing is true here. Where we are at the conflict preempt. Yes, it's conflict preempt. The state is law is being evoked here to say that we can't do something that the federal framework has been set up to allow us to do. And that is to market as supported by our labeling. And so if you look at the advertising that is challenged here, the advertising that markets us as a new pill that gives rise to these inferences of being better than the old pill and so on
. And at the preemption level it is this that federal law through the regulations that we've cited has set to many factors. Yes, if you survive the new drug approval process, if we improve your labeling and supported by substantial evidence and not false rules leading, then you can rely on that. And if that's the foundation of your advertising, it is permitted. That's what we allow you to do. And I would like to correct a couple of the statements this morning along those lines. If you look at our brief at page 20, you'll find the site to the regulation where all of the ads that are done by a manufacturing company at the time of first use are submitted to the FDA's division of drug management marketing and advertising communications, the DMACC. So it is a comprehensive regulatory scheme. And the upshot is really the analogy there is to guy or the guy versus Honda case because they are the federal agency said car manufacturers can choose to put airbags and their cars all at once or they can choose to use other kinds of password strengths. And state law came in and said no, we think airbags have to be in every car. And this reports that can fix that's an interference with the federal scheme. And the same thing is true here. Where we are at the conflict preempt. Yes, it's conflict preempt. The state is law is being evoked here to say that we can't do something that the federal framework has been set up to allow us to do. And that is to market as supported by our labeling. And so if you look at the advertising that is challenged here, the advertising that markets us as a new pill that gives rise to these inferences of being better than the old pill and so on. All of that is what we were in our permitted to do by the FDA as a result of this process. And all that we are asking to have happened here is essentially what Judge Wilson did in the recent Adamson case. It's what the sound circuit did essentially in the poker case. You look at what's being challenged. And if it's supported by the labeling, then state law can't come in and hold it to be unlawful. I would like to know my time is run, but if I have time to just talk briefly about the detailing. I would just say there that beyond the allegations of in paragraph 88, the plaintiffs have only made pure generalized statements about what they could prove the PAN-BOS statements are. Yes, they're not sufficient for rule 9B. Well, the question 9B, this is not a fraud case. Consumer fraud acts do not are not common law fraud type cases. Why would 9B be implicated at all? Are we in this directly implicated? You're on it because it's the heart if you think back even how Mr. Spiegel introduced the argument this morning. He said this was a broad based campaign directed from the head for us. It's designed to mislead doctors about the treatment about the product. Yeah, but under that delirical they don't have to prove it 10 under consumer fraud. I told I have to prove his act was misleading
. All of that is what we were in our permitted to do by the FDA as a result of this process. And all that we are asking to have happened here is essentially what Judge Wilson did in the recent Adamson case. It's what the sound circuit did essentially in the poker case. You look at what's being challenged. And if it's supported by the labeling, then state law can't come in and hold it to be unlawful. I would like to know my time is run, but if I have time to just talk briefly about the detailing. I would just say there that beyond the allegations of in paragraph 88, the plaintiffs have only made pure generalized statements about what they could prove the PAN-BOS statements are. Yes, they're not sufficient for rule 9B. Well, the question 9B, this is not a fraud case. Consumer fraud acts do not are not common law fraud type cases. Why would 9B be implicated at all? Are we in this directly implicated? You're on it because it's the heart if you think back even how Mr. Spiegel introduced the argument this morning. He said this was a broad based campaign directed from the head for us. It's designed to mislead doctors about the treatment about the product. Yeah, but under that delirical they don't have to prove it 10 under consumer fraud. I told I have to prove his act was misleading. But they have a pleated case as if it were an intent case and under FDIC versus back cave and other decisions where we pleaded as a fraud case. They pleaded under the act and you could say the consumer fraud is an act. But they didn't plead common law fraud. Even under rule 8, you're on our knuckles with this. We think that under the ballot landing versus quammy case, what they have pleaded is equally consistent with lawful conduct as it is with their allegations of unlawful conduct. When all they say is representative said things were superior, that could mean that the district court never reached it. Didn't mean to because it's fairly found that all of this was directly supported by the labor. If we disagree with you on your position, should we reach it or should we remain it for resolution by the district court? I think you could reach it, your honor. I think it's pretty straightforward. The court can make its own credential judgment there, but we think we've laid out the core legal issue which should yet result at this stage. The core legal issue under rule 8 is simply where we have generic statements or allegations. The representative said something was superior. We know from ballot landing that that's not sufficient because that could mean that the representatives were calling it the new purple pill. We're pointing out that it has greater effectiveness for healing EE at 40 milligrams to usage. The things, in other words, every specific example in this complaint of the alleged superiority is fundamentally supported under law. If they just have vague allegations, those don't get them any farther than it got twangly in the ballot landing case where his allegations of conspiracy were equally consistent with independent action
. But they have a pleated case as if it were an intent case and under FDIC versus back cave and other decisions where we pleaded as a fraud case. They pleaded under the act and you could say the consumer fraud is an act. But they didn't plead common law fraud. Even under rule 8, you're on our knuckles with this. We think that under the ballot landing versus quammy case, what they have pleaded is equally consistent with lawful conduct as it is with their allegations of unlawful conduct. When all they say is representative said things were superior, that could mean that the district court never reached it. Didn't mean to because it's fairly found that all of this was directly supported by the labor. If we disagree with you on your position, should we reach it or should we remain it for resolution by the district court? I think you could reach it, your honor. I think it's pretty straightforward. The court can make its own credential judgment there, but we think we've laid out the core legal issue which should yet result at this stage. The core legal issue under rule 8 is simply where we have generic statements or allegations. The representative said something was superior. We know from ballot landing that that's not sufficient because that could mean that the representatives were calling it the new purple pill. We're pointing out that it has greater effectiveness for healing EE at 40 milligrams to usage. The things, in other words, every specific example in this complaint of the alleged superiority is fundamentally supported under law. If they just have vague allegations, those don't get them any farther than it got twangly in the ballot landing case where his allegations of conspiracy were equally consistent with independent action. Thank you very much Mr. Hennie. Mr. Speedman, the vote. Thank you, Your Honor. If I may very quickly, I know normally one has to give notice of a new case, but the Supreme Court decided a new case yesterday under rule 8 that the court may want to look at. I don't think that could be a part of the law. There are two points I would like to make. First of all, on the DDMAC, the FTC's involvement in this. One thing is not before the court is what the DDMAC found when AstraZeneca presented some of their ads. The mere fact that the DDMAC is involved doesn't tell you whether an ad was submitted to the DDC. It doesn't tell anyone what the DDMAC said. It doesn't tell the court whether AstraZeneca complied with the FTC requirements to submit advertisements. I don't think it's possible at the pleading stage to say that even if what the FTC does, what the DDMAC does, matters in terms of safe harbor. It's not possible on this record to say what was done, what was submitted, what was said, what isn't submitted, such as the detailing statements by the detailers, the thousands of detailers that went out to the marketplace and touted them next year. The only other point I'd like to make in this rebuttal is its counts appointed the court to the label
. Thank you very much Mr. Hennie. Mr. Speedman, the vote. Thank you, Your Honor. If I may very quickly, I know normally one has to give notice of a new case, but the Supreme Court decided a new case yesterday under rule 8 that the court may want to look at. I don't think that could be a part of the law. There are two points I would like to make. First of all, on the DDMAC, the FTC's involvement in this. One thing is not before the court is what the DDMAC found when AstraZeneca presented some of their ads. The mere fact that the DDMAC is involved doesn't tell you whether an ad was submitted to the DDC. It doesn't tell anyone what the DDMAC said. It doesn't tell the court whether AstraZeneca complied with the FTC requirements to submit advertisements. I don't think it's possible at the pleading stage to say that even if what the FTC does, what the DDMAC does, matters in terms of safe harbor. It's not possible on this record to say what was done, what was submitted, what was said, what isn't submitted, such as the detailing statements by the detailers, the thousands of detailers that went out to the marketplace and touted them next year. The only other point I'd like to make in this rebuttal is its counts appointed the court to the label. I think it's very important to note that there were four types of tests referenced on the label. On two of the tests, maintenance of healing of roles in this offigitis and H. Pylori, there was nothing set about Pylosec. On another one, a third type of study, GERD, Gastro and S. It's off a G-O reflex disease, easy for me to say. It naturally says that there were three European studies which showed there were no differences between 40 milligrams of Nexium and 20 milligrams of Pylosec or 20 milligrams of Nexium and 20 milligrams of Pylosec. Only with respect to one of the four types of studies in the label is there anything that could even remotely be interpreted as showing that Nexium and by particular shortens dance, depending on dosage, and relating to a particular matter, the healing of roles in its offigitis, that there are two studies that show a clinical difference and two studies that show there isn't. The reason I'm saying this is that we are alleging is that in their detailing and in their advertising, Nexium is AstraZeneca state that Nexium is clinically superior to Pylosec, period, and counseling knowledge that context matters. If all anything a detailer said was to walk in and say, here's the label, here's everything on it, there are two tests that show this, two tests that show that, and walked out, we don't have a client, but that's not what we're alleging. We are alleging that in fact they went in and said, Nexium is clinically superior to Pylosec, period, and if there are no questions I see my time is up, then I will step down. Thank you very much Mr. Spiegel. Thank you. And thank you to both of the Council for very helpful arguments in this exquisitely interesting case. We're going to take a very brief recess of that five minutes. We'll be right back
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