[00:00:05] Speaker 01: Good morning, Your Honors. [00:00:07] Speaker 04: Good morning. [00:00:08] Speaker 01: May it please the Court, I'm Charles Weller on behalf of Appellant Jacob Scheibe. [00:00:13] Speaker 01: I'd like to reserve three minutes for rebuttal, please. [00:00:15] Speaker 04: All right. [00:00:19] Speaker 01: Preemption is an affirmative defense. [00:00:23] Speaker 01: The burden is on the defendant to show there's no plausible set of facts under which this case is not preempted. [00:00:31] Speaker 01: The District Court flipped that burden. [00:00:35] Speaker 01: The district court's requiring the plaintiff to prove his case is not preempted at the pleading stage. [00:00:41] Speaker 03: I have some sympathy with the district court, right? [00:00:43] Speaker 03: Because there's this split of authority. [00:00:45] Speaker 03: District courts have gone both ways on this, right? [00:00:48] Speaker 03: Isn't that fair to say? [00:00:49] Speaker 01: That is correct. [00:00:50] Speaker 01: There is a split of authority. [00:00:51] Speaker 03: OK. [00:00:52] Speaker 03: Why do you think we should adopt the side of the split that you're advocating? [00:01:02] Speaker 01: Under the standard of Rule 12B, [00:01:05] Speaker 01: A complaint avoids dismissal if it meets a standard of mere facial plausibility. [00:01:11] Speaker 01: And when it comes to preemption, the burden is solely on the defendant. [00:01:17] Speaker 01: It's not on the plaintiff. [00:01:18] Speaker 03: I think it is sort of this odd Iqbal Twombly thing. [00:01:23] Speaker 03: It's not enough to just make an assertion. [00:01:24] Speaker 03: We know that in a complaint. [00:01:27] Speaker 03: It has to be plausible. [00:01:29] Speaker 03: And so in this case, and you don't have to prove your case in a complaint. [00:01:34] Speaker 03: So we're trying to navigate all of that. [00:01:35] Speaker 03: And it seems to me, if you stitch those together, the question becomes, but this is really what I'm asking you. [00:01:41] Speaker 03: Should I be looking at this as? [00:01:44] Speaker 03: Well, I'm asking myself whether the allegation that the plaintiff has done, you know, one of the correct kinds of tests, even though there would need to be 12, that that's enough to show that this is a plausible allegation. [00:01:57] Speaker 03: Should I be looking at this as an Iqbal Twombly? [00:02:01] Speaker 01: Well, the plausible allegation could be testing or it could be some other fact. [00:02:05] Speaker 01: It just only needs to be plausible. [00:02:07] Speaker 03: Right. [00:02:08] Speaker 03: But in this case, now apply that to this. [00:02:10] Speaker 01: Well, in this case, in this case, we have dietary supplement testing. [00:02:14] Speaker 01: And the dietary supplement testing shows that the carbohydrates are 11 times the amount that could be declared as zero. [00:02:22] Speaker 03: Right. [00:02:23] Speaker 03: And I'm going to paraphrase this, but aren't I correct to understand that you have testing and you have the right type of testing, but that you don't have testing that complies with the required protocol, if you will. [00:02:35] Speaker 03: There would need to be a lot more sample tested. [00:02:39] Speaker 01: That is correct, Your Honor. [00:02:41] Speaker 01: The way the FDA statute works is it requires a composite of 12 subsamples. [00:02:47] Speaker 01: And these 12 samples are one from each of 12 different randomly chosen shipping cases. [00:02:52] Speaker 01: From a practical standpoint, as a practical matter, no plaintiff will ever be able to meet this burden at the pleading stage. [00:03:00] Speaker 02: Well, couldn't the—I guess the question is, is the testing method part of the substantive federal rule that does the preemption work? [00:03:10] Speaker 02: So, for example, would Mr. Scheib have had to at least allege that if he were to have tested it in compliance—I don't think the testing method appears at all in the complaint, the 12—if he were to have tested it, [00:03:28] Speaker 02: then it would have been consistent with the one test. [00:03:33] Speaker 02: Does he have to allege that much compliance with the FDA testing protocol? [00:03:38] Speaker 01: Is the court inquiring as to whether he has to allege that he used FDA-compliant testing? [00:03:43] Speaker 02: Well, one would be had to use FDA-compliant testing. [00:03:46] Speaker 02: I think there is some of that. [00:03:48] Speaker 02: But not compliant in that [00:03:52] Speaker 02: there's no allegation that if you were to use the FDA compliant testing including twelve samples uh... that it would have been misleading does he have to i'd submit to this court that as long as the plaintiff meets the plausibility standard but plausible as to what does it does it have to be i guess again it's substantively does it do does the district court have to find it plausible [00:04:20] Speaker 02: that the underlying fact that it doesn't contain enough, that it discloses the wrong amount of carbohydrates? [00:04:30] Speaker 02: Or does it have to be plausible that the FDA compliant testing with all 12 samples would disclose that it doesn't contain the right level? [00:04:41] Speaker 01: It has to be plausible that the dietary supplement product could be misbranded. [00:04:45] Speaker 01: Wait, wait, wait. [00:04:46] Speaker 03: So that's important. [00:04:47] Speaker 03: That's the legal conclusion. [00:04:48] Speaker 03: And I think Judge Johnson's trying to really, he's going right to the nub of it. [00:04:52] Speaker 03: What the complaint has to show, not which you have to prove at trial, but what the complaint has to allege. [00:04:57] Speaker 01: The complaint has to allege mere plausibility. [00:04:59] Speaker 01: Mere plausibility that through testing, through the trial sample method, a plaintiff will be able to prove his case. [00:05:06] Speaker 02: But you didn't allege that. [00:05:08] Speaker 01: We have alleged that the testing results and other facts nudge this claim from the conceivable to the probable and that we would be able to show that it's facially plausible that these products are misbranded under the 12 sample testing that's required by the FDA. [00:05:26] Speaker 01: You could only do that testing, though, at discovery. [00:05:29] Speaker 01: In Hollins and Vital, the two cases that the district court relied on, both those cases, the plaintiffs had the opportunity to complete discovery. [00:05:38] Speaker 01: They chose, for whatever reason, not to use the 12-sample method. [00:05:41] Speaker 01: So it was dismissed on summary judgment. [00:05:43] Speaker 01: So the appellate in this case should have the same chance that those plaintiffs in Hollins and Vital got to prove his liability after completing discovery. [00:05:52] Speaker 03: But you'd be in a better position, and this may require amendment, you'd be in a better position, it seems, to have alleged that upon FDA-compliant testing, this product wouldn't suffice, and that you know that because you've done what I'll call a sample of the testing, you know, a subset of the required testing. [00:06:13] Speaker 03: I don't think it'd be enough for you to just make the assertion, because that gets back to the, well, twompy part. [00:06:18] Speaker 03: You can't just assert it. [00:06:19] Speaker 03: But it seems to me that what you're relying on, if I can read between the lines here, is that by having done one twelfth of what you would need to do, you've made the required assertion, and it is plausible. [00:06:31] Speaker 03: But I think Judge Johnstone's right. [00:06:32] Speaker 03: You haven't made the assertion that if you did all twelve, you'd be over the line. [00:06:38] Speaker 03: Is that a fair summary? [00:06:41] Speaker 01: Your Honor, I don't think it's required to make the ultimate conclusion as to liability in the complaint. [00:06:47] Speaker 03: Well, this part is intended to be a trick question because this, as I indicated in the preface to my question, I think this is something that could be cured. [00:06:57] Speaker 03: Yes. [00:06:57] Speaker 03: I mean, it wouldn't be futile. [00:06:59] Speaker 03: But we are talking about preemption here today. [00:07:01] Speaker 03: And I think you would have to have both, and I'm trying to stress test and get your honest answer, and this is intended to be directed to opposing counsel as well. [00:07:08] Speaker 03: Wouldn't we need both allegations in a complaint? [00:07:12] Speaker 01: If we do, it's certainly something that's easy to satisfy on an amendment. [00:07:20] Speaker 02: Nine B come into this. [00:07:22] Speaker 02: I guess one of the concerns is, as you say, this is an affirmative defense, so you have to plead it. [00:07:31] Speaker 02: Well, I'll just ask you, does Nine B impose a requirement that for your affirmative claim, and not whether you've pleaded into preemption, [00:07:45] Speaker 02: that you plead the testing method with particularity, is that the thing that substantiates the falsity? [00:07:54] Speaker 02: I think there's suggestions. [00:07:55] Speaker 02: I think that your friend on the other side suggests that it is, that you must plead out of preemption with particularity. [00:08:04] Speaker 02: Is that right? [00:08:05] Speaker 01: What the case law says is under for rule nine being you do not need to have irrefutable evidence of a statement's falsity at the pleading stage, but getting to the answer to your question. [00:08:18] Speaker 01: the allegations will suffice so long as he give the defendant notice of the fraud and provide the court some assurance that the theory has a basis in fact. [00:08:29] Speaker 01: And we've done that with the testing that show carbohydrates at more than 11 times the limit that can be declared as zero. [00:08:37] Speaker 01: Furthermore, the particularity requirement of Rule 9B, it must be read in conjunction with the plausibility pleading standards. [00:08:48] Speaker 01: And in this case, appellants pled the who, when, and where, and has satisfied what Rule B requires, what Rule 9B requires. [00:08:57] Speaker 02: Just not the how, which is the FDA testing. [00:08:59] Speaker 01: Well, the how is also the testing that has been completed. [00:09:05] Speaker 01: And that is enough to take, as the Murr case, and nudge the appellant's claims across the line from conceivable to plausible, [00:09:17] Speaker 01: to meet the pleading standard. [00:09:20] Speaker 01: Now for preemption, preemption can be raised at summary judgment, preemption can be raised at trial, but it's an affirmative defense, it's disfavored by the law, and it's not claimed as burdened to plead around an affirmative defense. [00:09:34] Speaker 01: It's defendant's burden, it's defendant's burden to show there's no set of plausible facts for which this claim is not preempted. [00:09:42] Speaker 03: There's quite a lot of district court number of district courts who have written about this. [00:09:49] Speaker 03: And I'm wondering which case you think is the one that we should be emulating. [00:09:56] Speaker 03: Which one supports you most clearly? [00:09:57] Speaker 01: I would suggest this court look at Lozano v. Beaumont nutrition. [00:10:03] Speaker 03: OK. [00:10:05] Speaker 01: I think that's one of the most recent cases. [00:10:07] Speaker 03: How about Murphy? [00:10:09] Speaker 03: One of Judge Breyer's opinions? [00:10:14] Speaker 03: Could you both unnotice? [00:10:15] Speaker 03: I'm going to have questions about that case. [00:10:17] Speaker 03: So if that's not on your radar, that's fine, because there are so many. [00:10:20] Speaker 01: But that's one that I have some questions about. [00:10:24] Speaker 01: And Your Honor, you are correct that there is a split. [00:10:26] Speaker 01: And that's exactly why. [00:10:27] Speaker 03: I know. [00:10:27] Speaker 03: And there's a lot of them. [00:10:28] Speaker 01: So I didn't mean to. [00:10:29] Speaker 01: We are here today. [00:10:30] Speaker 01: There is quite a few cases. [00:10:31] Speaker 01: Yes, that is correct. [00:10:32] Speaker 03: Well, maybe that's a related question. [00:10:33] Speaker 03: Do we need to publish on this so that the district courts have an answer? [00:10:39] Speaker 01: I would request that the court do so. [00:10:42] Speaker 03: Okay. [00:10:43] Speaker 03: And what question exactly do you think we ought to be responding to? [00:10:48] Speaker 01: I think the issue is whether a consumer deception claim is preempted if a plaintiff fails to plead dietary supplement testing consistent with the FDA's 12-sample method as set forth at 21 CFR Section 101.9 G2. [00:11:09] Speaker 03: That wasn't a trick question, either. [00:11:11] Speaker 01: Very helpful. [00:11:12] Speaker 01: Thank you. [00:11:15] Speaker 01: I have about a minute left before I need to reserve time. [00:11:17] Speaker 04: A couple of minutes, so do you want... Oh, before you want... Before I need to reserve some time for rebuttal. [00:11:21] Speaker 01: Okay. [00:11:22] Speaker 01: So I will... [00:11:26] Speaker 01: I'm going to briefly talk about this factual nexus that the appellee raised. [00:11:30] Speaker 01: It's vague. [00:11:31] Speaker 01: It's unworkable. [00:11:32] Speaker 01: It's completely unsupported by case law. [00:11:34] Speaker 01: It's totally at odds with pleading on an affirmative defense to shifting the burden improperly back to the plaintiff. [00:11:41] Speaker 01: And pleading out of court needs to be equivocal, definitive, and clear from the face of the complaint. [00:11:47] Speaker 01: An appellant's not put himself out of court in this case. [00:11:50] Speaker 01: And then the final argument [00:11:52] Speaker 01: is the appellee is asking this court to affirm on other grounds. [00:11:57] Speaker 01: More specifically, that the calorie claim, the zero calorie claim is preempted under the five methods by the FDA. [00:12:04] Speaker 01: This argument is flawed for several reasons. [00:12:07] Speaker 01: First, there's independent grounds for pro seps liability. [00:12:10] Speaker 01: Simply because the calorie claim fails does not mean the carbohydrate claim is going to fail. [00:12:14] Speaker 01: All the methods rely on an accurate accounting of macronutrients. [00:12:18] Speaker 01: This is because all carbohydrates contain calories. [00:12:20] Speaker 01: This is an ER 15 paragraph 28 of the amended complaint. [00:12:25] Speaker 01: It's also a complicated issue. [00:12:27] Speaker 01: District courts have gone both ways. [00:12:29] Speaker 01: I refer this court to the Woodbolt distribution case. [00:12:32] Speaker 03: To what case? [00:12:33] Speaker 01: Woodbolt distribution. [00:12:35] Speaker 01: It's out of Maryland. [00:12:36] Speaker 01: And finally, there is no record at the district court on this issue. [00:12:42] Speaker 01: No court's passed on this issue. [00:12:44] Speaker 01: So appellant court should not decide issues that district courts did not consider. [00:12:50] Speaker 01: That's from the Singleton v. Wolf case. [00:12:53] Speaker 01: So to conclude, and save myself two minutes for my rebuttal, district court's order ignores well established pleading standards. [00:13:01] Speaker 01: It improperly shifts the burden [00:13:04] Speaker 01: to the plaintiff to plead around an affirmative defense. [00:13:07] Speaker 01: It's based on plainly inapt case law, and it would have the practical effect of precluding an entire class of meritorious claims. [00:13:14] Speaker 01: For these reasons, we respectfully request that this court reverse and remand. [00:13:20] Speaker 01: And if there's no further questions, I'll reserve my remaining time for rebuttal. [00:13:23] Speaker 04: Thank you, counsel. [00:13:24] Speaker 01: Thank you. [00:13:44] Speaker 00: Good morning, and may it please the court. [00:13:45] Speaker 00: My name is Jay Singh, and I'm here on behalf of defendant in this case. [00:13:51] Speaker 00: As the district court correctly held, the plaintiff's state law claims are preempted by federal law. [00:13:57] Speaker 00: The FDA's regulations permit a supplement manufacturer to use a 12-sample method of testing products for quantitative nutrient content for purposes of listing the amounts of nutrients in FDA-mandated supplement facts, panel label, or nutritional panel. [00:14:16] Speaker 00: 101.9G2 mandates that a manufacturer use a 12 sample method of testing products for quantitative nutrient content for product labeling. [00:14:27] Speaker 00: And quoting from 101.9G, it states, quote, compliance with this section shall be determined as follows. [00:14:35] Speaker 00: 101.36 F1 slightly modifies this section for dietary supplements by allowing testing based either on a 12-sub sample method or 10% of the number of packages in the same inspection lot, whichever is small or randomly selected to be representative of the lot. [00:14:54] Speaker 00: And again, that section under F1 talks about compliance and says compliance shall be determined as set forth herein. [00:15:03] Speaker 02: And where in the complaint should we look to see Mr. Shai pleading himself into that preemption defense? [00:15:13] Speaker 00: Your Honor, it's in paragraphs 21 and 25. [00:15:17] Speaker 00: He refers to testing of a sample. [00:15:21] Speaker 00: And that can only mean one sample from one product. [00:15:26] Speaker 00: It's a far, far cry away from the 12 sample method [00:15:30] Speaker 02: But he doesn't, I guess, so in terms of preemption, which we construe narrowly, that doesn't necessarily conflict with the FDA guidance. [00:15:44] Speaker 02: It can be true that the first test sample is misleading, and also true that the next 11 are similarly misleading. [00:15:53] Speaker 02: In fact, it might be a plausible inference that we might ask the district court to judge in other circumstances. [00:15:59] Speaker 00: Your honor, we think it's fundamentally incompatible because as in this court that the district court cited to Hollins and also more importantly to vital on the reasoning of the 12 sample methodology has set forth in vital that FDA allows a manufacturer to rely not just [00:16:20] Speaker 00: on one or requires a manufacturer not to rely on or be required to label based on one sample. [00:16:28] Speaker 03: That's why I referred to it as a subset. [00:16:31] Speaker 03: He's only alleged that he's done a subset. [00:16:34] Speaker 03: But what about that is inconsistent? [00:16:36] Speaker 03: I think that's what Judge Johnstone's getting at. [00:16:38] Speaker 03: How did he plead himself out of? [00:16:40] Speaker 03: He didn't suggest he's going to do a different kind of testing, and he didn't suggest that one out of 12 is sufficient. [00:16:47] Speaker 03: So that's what we're grappling with. [00:16:49] Speaker 00: Well, Your Honor, I think, and then maybe this goes to, has he alleged enough? [00:16:54] Speaker 03: That's right. [00:16:55] Speaker 00: To plausibly infer that if the 12 sample methodology would be used, that it would establish that the label is false. [00:17:03] Speaker 03: I think that's exactly it. [00:17:04] Speaker 03: And that's why I started by saying, I think this is sort of an Iqbal Twombly thing, right? [00:17:08] Speaker 03: I think he would have to allege, this is, I'm positing this for you to respond to. [00:17:12] Speaker 03: If a complaint plausibly alleges that the product doesn't—labeling doesn't comply with whatever testing it is that the FDA requires for that product, right, and then alleges he's done part of that, maybe not all of it, but he's done part of it, why isn't that enough for Iqbal Twombly? [00:17:33] Speaker 00: Because, Your Honor, the regulation requires and allows the manufacturer to use a composite sample. [00:17:40] Speaker 03: I understand. [00:17:41] Speaker 00: And one sample cannot be a composite sample. [00:17:44] Speaker 00: Maybe two could. [00:17:45] Speaker 00: Maybe three could. [00:17:46] Speaker 03: We're talking about how he pled himself out. [00:17:49] Speaker 03: Correct. [00:17:50] Speaker 03: So you brought Naccarino to the court's attention. [00:17:52] Speaker 03: I've just mentioned Murphy. [00:17:53] Speaker 03: And those are cases where a complaint, right, alleged, let me put it this way, Judge Breyer put it this way, the complaint didn't allege that defendant did something wrong by doing something specifically allowed by the FDA. [00:18:07] Speaker 03: That's exactly what happened in Naccarino, the case that you brought to our attention, right? [00:18:11] Speaker 03: They're saying, hey, we've got this complaint because it didn't fully disclose the amount of protein, and here's why. [00:18:17] Speaker 03: But what the manufacturer did in that case is something that's specifically allowed by the FDA. [00:18:23] Speaker 03: So the fact that the plaintiff found it lacking is neither here nor there, right? [00:18:27] Speaker 03: He pled himself right into preemption. [00:18:30] Speaker 03: But here, what they're pleading isn't inconsistent with the FDA testing. [00:18:37] Speaker 03: It's just not complete. [00:18:40] Speaker 00: And we would say that if you look at, as the district court cited, the reasoning set forth in vital, talking about the FDA's regulations. [00:18:51] Speaker 03: I'm listening. [00:18:51] Speaker 03: Tell me what I'm missing by thinking of this as being a subset. [00:18:56] Speaker 03: It's not going to be enough. [00:18:57] Speaker 03: He's going to have to do more later. [00:18:59] Speaker 03: He doesn't get to come to trial and say 1 12th is good enough. [00:19:02] Speaker 03: I'm not suggesting any of that. [00:19:03] Speaker 03: I'm just looking at this preemption issue. [00:19:05] Speaker 00: Correct, Your Honor. [00:19:06] Speaker 00: And I'm going to quote from [00:19:09] Speaker 00: specifically, as the district court did, from Vital, the court specifically found that FDA regulations reject the requirement that every individual product be labeled in compliance with the food labeling rule. [00:19:27] Speaker 00: But that's exactly what the plaintiff here relied on for alleging an element of his claim in falsity. [00:19:36] Speaker 00: In other words, he relied only on one sample. [00:19:40] Speaker 00: And in doing that, he pled himself out of court to establish falsity. [00:19:46] Speaker 03: If you can just let me get in a word. [00:19:47] Speaker 03: I realize I'm interrupting you, but we have limited time to ask questions. [00:19:50] Speaker 00: Understood, Your Honor. [00:19:51] Speaker 03: We have limited time to ask our questions. [00:19:53] Speaker 03: So I think what you're saying is he's basing his allegation of falsity on this one test. [00:19:59] Speaker 03: So he's saying because, this is your interpretation of his complaint, is that he's alleging because one-twelfth of the required testing doesn't measure up, the product labeling is false. [00:20:11] Speaker 03: And what you're saying is that is black letter insufficient is what you're saying. [00:20:14] Speaker 00: That is black letter insufficient. [00:20:16] Speaker 00: And in that way, it's fundamentally incompatible because FDA would say, as it's spoken to on the regulation, one sample doesn't tell you anything. [00:20:26] Speaker 02: So Mr. Singh, what if he then alleges that the testing under the 12 samples would establish the same thing? [00:20:35] Speaker 02: Is that all we're here to argue about? [00:20:38] Speaker 00: That allegation appears nowhere in the complaint. [00:20:41] Speaker 00: Exactly. [00:20:41] Speaker 03: Exactly. [00:20:42] Speaker 03: If it did, that is a curable problem. [00:20:44] Speaker 03: And I do think, and I haven't been very shy about saying, I think it would need to be there. [00:20:49] Speaker 03: If it were there, would he be OK? [00:20:52] Speaker 00: Your Honor, I think that [00:20:55] Speaker 00: The question of what allegations would be sufficient to avoid preemption. [00:21:01] Speaker 00: That question really doesn't need to be decided here because he planned himself out of court by relying on one sample. [00:21:10] Speaker 03: You don't think he gets to amend? [00:21:12] Speaker 00: Well, the district court gave him leave to amend. [00:21:17] Speaker 00: Gave plaintiff leave to amend. [00:21:18] Speaker 00: Plaintiff chose not to amend and stand by his one sample test. [00:21:22] Speaker 03: Councilman, I'm going to ask you to let me interrupt you so that I can get to this point, because I think it's important. [00:21:27] Speaker 03: We might be thinking about the procedure differently. [00:21:29] Speaker 03: Just think of a hypothetical, if you would, of a complaint like this that comes in at the original complaint. [00:21:35] Speaker 03: that alleges something part of an FDA required testing but not all of it and then from that premise just makes the allegation that the labeling is false [00:21:45] Speaker 03: And then the question is, if the district court finds that lacking, does the district court have to decide, well, an amendment wouldn't be futile because they could make the allegation that all the testing would get this over the hurdle? [00:22:00] Speaker 03: Or is the district court required to take up the preemption issue first because you get there first? [00:22:07] Speaker 00: I think the district court would be required to take up the preemption issue. [00:22:11] Speaker 03: Have we said that? [00:22:13] Speaker 00: I'm sorry. [00:22:13] Speaker 03: Have we said that anywhere? [00:22:14] Speaker 03: I actually don't know the answer to this question. [00:22:16] Speaker 03: It is a sincere question. [00:22:19] Speaker 00: I mean, I think you have to take a look at the complaint as a whole. [00:22:21] Speaker 00: And your honor, you know, this complaint taken as a whole plaintiff has played himself as Dunford founds, you know, as the court notes in footnote eight. [00:22:32] Speaker 00: As this court noted in footnote eight, this is a situation where the plaintiff has pled himself out of court. [00:22:42] Speaker 00: And here's the point on that. [00:22:44] Speaker 00: In Dunford, this court said, listen, we're going to raise, but we're not going to answer the question of whether, in this sort of a situation, a plaintiff has to allege testing. [00:22:56] Speaker 00: Query whether that's the case. [00:22:59] Speaker 00: And the court said that we know that a plaintiff isn't otherwise required at the pleading stage to put forth evidence and to establish their entitlement to relief. [00:23:13] Speaker 00: But that's different than if the plaintiff, like here, affirmatively alleges testing that they've done, chosen to allege testing, bases it on [00:23:28] Speaker 00: one sample that, again, as we discussed earlier, Your Honor, is fundamentally incompatible with FDA regulations. [00:23:36] Speaker 00: And in that way, we would say this case is like Dunford, Hollins, [00:23:41] Speaker 00: and knock her in. [00:23:42] Speaker 02: So Mr. Singh, I guess, so is your position then that if Mr. Shaib did no testing whatsoever and simply recited the FDA testing and said that I believe that should we get past the motion to dismiss with discovery, I can establish that it would satisfy it. [00:24:02] Speaker 02: In other words, if he had less proof to bring a complaint, but simply recites a statute, that that should pass and this shouldn't? [00:24:10] Speaker 00: well your honor but how does that make sense I think it makes sense in this in this way I don't know about that hypothetical complaint in the future but this complaint based on the testing that was alleged [00:24:24] Speaker 00: is such that the plaintiff pled himself out of court because it's completely inconsistent with the composite approach that FDA has taken here. [00:24:34] Speaker 00: Why is it completely inconsistent? [00:24:35] Speaker 00: The other cases. [00:24:36] Speaker 03: Why is it completely inconsistent? [00:24:38] Speaker 03: It's incomplete. [00:24:39] Speaker 03: But is it inconsistent? [00:24:40] Speaker 03: He's not saying, hey, I did this other type of testing. [00:24:43] Speaker 03: That's a big problem. [00:24:44] Speaker 00: By contrast, other cases that were cited where the courts permitted [00:24:51] Speaker 00: based on allegations of some testing, but not the 12 sample. [00:24:56] Speaker 00: There was more samples that were used. [00:24:58] Speaker 00: Your Honor brought up Murphy. [00:24:59] Speaker 00: In Murphy, they alleged testing of a few gummies, each from a total of eight bottles. [00:25:07] Speaker 00: And four non-expired bottles and four expired, a nearly expired bottle. [00:25:10] Speaker 00: This is in the briefing. [00:25:11] Speaker 00: But my point is, Your Honor brought up Murphy. [00:25:13] Speaker 00: Murphy's a great example of where the arguments made that a plaintiff doesn't have the ability [00:25:21] Speaker 00: to do the FDA testing in order. [00:25:24] Speaker 00: Yes, your honor. [00:25:27] Speaker 00: But nothing would stop, for example, a plaintiff from buying 12 random bottles of a product, putting together a composite sample, and alleging that. [00:25:36] Speaker 02: But I guess given the way that we typically viewed preemption and the way we typically view the pleading standards for establishing an affirmative defense on the face of the complaint, I don't see where we start asking, well, two would be enough or four would be enough. [00:25:55] Speaker 02: It seems like either they can plead [00:25:59] Speaker 02: without any testing and get past the line of preemption. [00:26:05] Speaker 02: Or, I guess, why isn't doing a little bit of the testing, but not all of the testing, even better? [00:26:14] Speaker 02: Anyone completed, Scheib went ahead and tested. [00:26:17] Speaker 00: So, Your Honor, as to the former approach, that's a question that's raised in Durnford. [00:26:24] Speaker 00: whether testing is even required to be able to state a claim in this type of a situation. [00:26:32] Speaker 00: And we would submit that this is not the case to answer that question. [00:26:36] Speaker 00: So then getting to your honors. [00:26:38] Speaker 02: Well, that's the case that follows if we say that all he has to do is allege testing as opposed to do testing. [00:26:45] Speaker 00: I think the point is that here, based on what the plaintiff affirmatively alleged, [00:26:53] Speaker 00: which is a sample, one sample from one product, that that isn't, I mean, one way to look at it, it would be say, yes, it's one of 11 other samples that FDA would require. [00:27:11] Speaker 02: But you've suggested that some form of composite testing or sample testing could satisfy it, but that doesn't comply with, that would also be incomplete. [00:27:20] Speaker 00: But Your Honor, it would at least be consistent. [00:27:23] Speaker 00: This is my point. [00:27:23] Speaker 00: This is what I've been trying to stress is that it would at least be consistent with the composite sample approach that FDA requires. [00:27:33] Speaker 00: Requiring a particular product to have that level of nutrient when tested is fundamentally inconsistent. [00:27:45] Speaker 00: But if at least a composite sampling were [00:27:50] Speaker 00: were provided by the plaintiff if they choose to do testing. [00:27:54] Speaker 02: So there's some math here that underlies the FDA's sampling method. [00:27:59] Speaker 02: And why isn't the math given that there is this safe harbors and all of that? [00:28:07] Speaker 02: But when you're dealing with a quantity that's 11 times over what's disclosed on the label, and you need 11 more samples [00:28:15] Speaker 02: It's not quite this. [00:28:17] Speaker 02: I haven't done the math. [00:28:18] Speaker 02: But it seems like you're basically asking, is it plausible that if you took 11 more samples, you'd be able to run the table on a zero score in order to get it back down under the safe harbor? [00:28:33] Speaker 02: why isn't plausible enough for a plaintiff to get through the door by saying, there's a whole lot of carbs in this first sample, and if I tested 11 more, it would be very unlikely that they'd get it back down to zero. [00:28:47] Speaker 00: Sure, Your Honor. [00:28:48] Speaker 00: So, one, none of that was alleged in this complaint. [00:28:52] Speaker 00: And again, there's not even a mention of the 12 sample methodology in the complaint. [00:28:58] Speaker 02: But stick with me on the math. [00:28:59] Speaker 00: Why is that not plausible? [00:29:02] Speaker 00: But on the math, the numbers don't matter, because the point is that alleging falsity based on one sample from one product [00:29:19] Speaker 00: as the district court found, is inconsistent with the reasoning and the regulatory scheme that's at play here that allows a manufacturer to label based on a composite sample. [00:29:35] Speaker 00: And so one is, again, two, three, four might not be. [00:29:46] Speaker 00: But one certainly takes this out of the realm of plausibility. [00:29:52] Speaker 03: Judge Robinson, may I ask one more question? [00:29:54] Speaker 03: Of course. [00:29:55] Speaker 03: I have one more question. [00:29:56] Speaker 03: You mentioned that Naccarino, you think, helps your side. [00:30:00] Speaker 03: Yes. [00:30:00] Speaker 03: I'd just like to hear why you think that is so. [00:30:02] Speaker 00: Sure, Your Honor. [00:30:04] Speaker 00: So in Naccarino, as in this case, the plaintiff sought to use [00:30:16] Speaker 00: Well, in Naccarino, as in this case, the plaintiff based its state claim allegations based on a methodology for testing that was inconsistent with FDA mandated or approved method. [00:30:43] Speaker 00: And that's exactly the case here. [00:30:45] Speaker 00: that he's essentially alleging falsity for the state claims, the plaintiff here, based on a testing methodology that is, again, not just inconsistent, but in our view fundamentally incompatible with FDA mandated testing methodology. [00:31:05] Speaker 00: Both cases involve the testing methodology. [00:31:08] Speaker 03: Thank you. [00:31:09] Speaker 00: Thank you. [00:31:09] Speaker 03: And thank you for your patience with the questions. [00:31:11] Speaker 00: Thank you. [00:31:23] Speaker 01: Your honors, we are here on an appeal from a motion to dismiss. [00:31:30] Speaker 01: So we should not be talking about probability, but we should be talking about plausibility. [00:31:37] Speaker 01: And if we have a test result, which shows that carbohydrates are 11 times the limit that can be declared as zero, it is plausible. [00:31:51] Speaker 01: that we can show these products are misbranded if we test 11 more samples under the FDA's 12 sample method. [00:31:58] Speaker 01: This is where the district court got this wrong. [00:32:02] Speaker 01: It's in the last sentence before the conclusion. [00:32:06] Speaker 01: Plaintiff's complaint pleads it tested defendant's products using methods not identical to the FDA's methods. [00:32:13] Speaker 01: Plaintiff's claims are therefore preempted. [00:32:16] Speaker 01: What this district court is saying is that unless you do all this FDA testing upfront, [00:32:21] Speaker 01: which as we've discussed, as a practical matter is not possible, then these claims are barred. [00:32:28] Speaker 04: So you're saying it's not possible at this point, but it would be possible before a summary judgment stage? [00:32:35] Speaker 04: Is that your? [00:32:36] Speaker 01: Yes, absolutely, Your Honor. [00:32:37] Speaker 01: That's correct. [00:32:38] Speaker 01: And that's what happens in Hollins and happened in the vital case, is those plaintiffs had the opportunity to complete discovery. [00:32:46] Speaker 01: And then it was dismissed on summary judgment. [00:32:48] Speaker 01: And appellants should have the same opportunity. [00:32:51] Speaker 04: But discovery can be very expensive in these types of cases where you're talking about punitive class actions. [00:32:57] Speaker 04: And so I think it's really important to determine whether or not the claim is preempted. [00:33:05] Speaker 04: before you go to all of discovery, if it's possible to do that. [00:33:09] Speaker 04: I wanted to ask you this. [00:33:12] Speaker 04: So are you saying that you would not request leave to amend because you elected to stand on your pleadings as they were? [00:33:22] Speaker 01: We elected to appeal based on this legal issue. [00:33:25] Speaker 01: We believe this legal issue is incorrect. [00:33:27] Speaker 01: But in pursuing this case, we would bolster the allegations. [00:33:32] Speaker 04: Well, but if you chose to stand on your pleadings and the court gave you the opportunity to amend, should you now be allowed to amend after you did not take advantage of the opportunity that was afforded to you by the district court? [00:33:44] Speaker 01: Once again, Your Honor, the district court precluded that opportunity based on the wording of their order. [00:33:50] Speaker 01: The judge was extremely clear. [00:33:53] Speaker 03: What wording? [00:33:53] Speaker 01: That's the wording I just read into the record. [00:33:56] Speaker 01: Plaintiff's complaint pleads attested defendant's products using methods not identical to the FDA's methods. [00:34:02] Speaker 01: Therefore, it's preempted. [00:34:03] Speaker 04: But you're now saying that you could plead to say if we would be able to replicate those, but you didn't take the opportunity to amend your pleadings to try to persuade the court that you could replicate that at a later point. [00:34:21] Speaker 01: No, Your Honor, we could not allege that we have done the FDA compliant testing at the pleading stage. [00:34:28] Speaker 01: But what we could allege, as Your Honor had pointed out, is that we could allege that we will be doing the FDA 12 sample method testing to show liability and based on information and belief will show these products are misbranded. [00:34:42] Speaker 01: We could allege that, but that doesn't get around the district court's order, which is why we appealed it. [00:34:46] Speaker 03: Well, the district court dismissed without prejudice. [00:34:49] Speaker 03: And what you're saying, I think, if I'm understanding you correctly, is that even though the order was without prejudice, you think the nub of it, which was on page six of the court's order, the nub of the reason that he found your pleading inadequate was going to remain no matter what, because you couldn't do the 12 randomly. [00:35:11] Speaker 03: In other words, you couldn't meet the FDA testing standards to the letter. [00:35:15] Speaker 01: That's correct. [00:35:16] Speaker 01: It was a deficiency we were unable to cure based on the district court's order. [00:35:20] Speaker 03: I see. [00:35:21] Speaker 02: Why would saying that you would test according to the FDA method make it any more plausible than the fact that you did test one sample? [00:35:33] Speaker 01: Your Honor, I don't think it would, but Your Honor had asked the example earlier if we could do so, and we could certainly allege that, but I do not think it gets us any further along the line on plausibility. [00:35:43] Speaker 01: I do not think it's required at the pleading stage. [00:35:46] Speaker 03: Well, you haven't pled. [00:35:47] Speaker 03: I think what I said earlier, although we could roll back the tape, but I think the point was I don't think your complaint alleges that because of this one sample, you're alleging that upon compliant testing, the product would still fail. [00:36:02] Speaker 03: and hence opposing counsel's argument. [00:36:05] Speaker 03: What he's saying is your complaint, he thinks fairly red, is that the allegations, the labeling is false based upon one sample, and everybody agrees. [00:36:13] Speaker 03: And that's not enough. [00:36:15] Speaker 03: Ultimately, that's not enough. [00:36:17] Speaker 01: That's not enough for liability, but it's certainly enough for plausibility under Rule 12b-6 standard. [00:36:23] Speaker 04: Maybe or maybe not. [00:36:24] Speaker 04: All right. [00:36:25] Speaker 04: Thank you, counsel. [00:36:25] Speaker 04: Thank you to both counsels for your helpful arguments. [00:36:28] Speaker 04: The case just argued is submitted for decision by the court.