[00:00:08] Speaker 02:
Good morning, your honors.

[00:00:10] Speaker 02:
Good morning.

[00:00:10] Speaker 02:
I'm Lucy Inman of Millburg, appearing on behalf of plaintiff appellant Vincenza Buback.

[00:00:18] Speaker 02:
With me today, also representing the appellant, but not arguing, is my partner Trenton Kashima.

[00:00:24] Speaker 02:
And I'd like to reserve five minutes for rebuttal.

[00:00:26] Speaker 03:
OK, watch your clock, please.

[00:00:29] Speaker 02:
I'm sorry?

[00:00:31] Speaker 01:
Watch your clock.

[00:00:31] Speaker 02:
Oh, yes, I will.

[00:00:32] Speaker 02:
Thank you.

[00:00:33] Speaker 02:
So sorry.

[00:00:35] Speaker 02:
This case is about food labeling that misleads and confuses.

[00:00:39] Speaker 00:
Well, it's about preemption.

[00:00:42] Speaker 00:
It is about preemption.

[00:00:44] Speaker 00:
We're at the pleading stage.

[00:00:45] Speaker 00:
So you don't need to convince us that the other side did a bad thing or didn't do a bad thing.

[00:00:50] Speaker 02:
Don't need to get into that.

[00:00:52] Speaker 02:
But I do want to point out that because this is about implied disease claims, the facts and the legal issues before this court are virtually identical to those reviewed

[00:01:04] Speaker 02:
in Davidson v. Sprout.

[00:01:06] Speaker 02:
The only difference is that Davidson concerned baby food labeling.

[00:01:11] Speaker 02:
This case concerns food supplement labeling.

[00:01:14] Speaker 02:
And in both of these cases, consumers claimed that they were economically harmed by inherently deceptive labeling that's prohibited by California's... Here's the problem that I have.

[00:01:29] Speaker 01:
If Nexus said one thing and then Davison is like threading a needle.

[00:01:37] Speaker 01:
So if Davison is the law of the circuit, then I'm inclined to say, okay, something survived.

[00:01:49] Speaker 01:
If Nexus is the law of the circuit, that

[00:01:55] Speaker 01:
as Judge Droz when it came back to him said, okay, reversed and said you lose.

[00:02:02] Speaker 01:
I am having a hard time.

[00:02:03] Speaker 01:
Nexus is first.

[00:02:06] Speaker 01:
A three-judge panel cannot overrule, as you know, a prior three-judge panel.

[00:02:13] Speaker 01:
So unless Davidson has threaded that needle in a way that it followed Nexus and

[00:02:22] Speaker 01:
It's, it's, they can both be reconciled.

[00:02:26] Speaker 01:
I'm having trouble here determining what there's, there's certainly attention.

[00:02:32] Speaker 01:
There's certainly attention.

[00:02:34] Speaker 01:
And for me, for you to prevail at this stage would have to show me that David's that I can follow Davidson.

[00:02:42] Speaker 01:
If I can't reconcile the two, then I would think that our en banc court would have to tell us what is the law of the circuit.

[00:02:50] Speaker 01:
So that's where I'm struggling.

[00:02:52] Speaker 01:
And I'm not completely satisfied at this point that there's a way to reconcile.

[00:02:58] Speaker 01:
So that's where I am.

[00:03:00] Speaker 02:
Let me see if I can help with that.

[00:03:01] Speaker 01:
Yes.

[00:03:03] Speaker 02:
Davidson expressly distinguishes.

[00:03:08] Speaker 00:
Yeah, but what if we don't buy the distinction?

[00:03:10] Speaker 00:
I mean, I went back and looked at the pleadings in Nexus.

[00:03:16] Speaker 03:
It tried to distinguish it.

[00:03:17] Speaker 00:
Yeah, it tried to distinguish it.

[00:03:18] Speaker 00:
And this gets back to Judge Callahan's point.

[00:03:21] Speaker 00:
It may lead me to a different result, but I want to, let's assume for a moment.

[00:03:26] Speaker 00:
After all, I think Judge Schroeder does as good a job of trying to distinguish Nexus as you possibly can.

[00:03:32] Speaker 00:
Let's assume I don't buy it.

[00:03:35] Speaker 00:
Let's assume I think both cases involve the same issue and come to differing results.

[00:03:42] Speaker 00:
My question for you is, what do we do under that circumstance?

[00:03:45] Speaker 00:
One thing we can do is issue an initial en banc call, as your friend suggests.

[00:03:52] Speaker 00:
But we know that the en banc call

[00:03:56] Speaker 00:
failed last time.

[00:03:58] Speaker 00:
Are we obligated to say, well, whether or not I believe the distinction is correct?

[00:04:04] Speaker 00:
I'm required to follow Davidson, which makes a distinction, and it's up to somebody else to throw out that distinction.

[00:04:11] Speaker 00:
Or do we go, as Judge Callahan, I think, was suggesting, back to nexus?

[00:04:16] Speaker 00:
See, my inclination is to think that if they conflict, we're sort of under a life-o rule.

[00:04:23] Speaker 00:
We're bound by the last line.

[00:04:25] Speaker 02:
Well, there's another rule, however, that says when

[00:04:30] Speaker 02:
The second case, like Davidson, distinguishes the earlier case.

[00:04:36] Speaker 02:
And yes, you may not buy that.

[00:04:39] Speaker 02:
I'm hoping to persuade you that it is totally distinguishable.

[00:04:43] Speaker 02:
But even if you do not buy that, I believe this court is bound.

[00:04:49] Speaker 00:
Tell me what case says that.

[00:04:50] Speaker 02:
We just told me there was a rule.

[00:04:53] Speaker 00:
You must have some sense of the provenance of the rule.

[00:04:56] Speaker 01:
Yes.

[00:04:57] Speaker 01:
If we accept that, then the last one gets to be the final say every single time.

[00:05:03] Speaker 01:
No, it doesn't.

[00:05:04] Speaker 01:
Because we can't overrule a prior.

[00:05:07] Speaker 01:
And if I just say, I am not overruling the prior one and I'm distinguishing it, but I don't do a good job and it's clearly not, just because I'm last doesn't make me final.

[00:05:17] Speaker 01:
When you're the Supreme Court, that's true, but not with me.

[00:05:20] Speaker 02:
I also think that when the last case doesn't even address the earlier case, right, doesn't even address a distinction, just mows over it, that is an easier decision.

[00:05:33] Speaker 02:
But if I can try to point out the differences between Davidson and Nexus and this case and Nexus.

[00:05:41] Speaker 00:
Let me tell you what my difficulty is with that position so you can address it directly.

[00:05:45] Speaker 00:
The claim in Nexus was a Sherman Act violation, Sherman Law violation, premised on a violation of the federal FDCA.

[00:05:56] Speaker 00:
I can go back and look at the complaint in Nexus.

[00:05:59] Speaker 00:
It says that.

[00:06:01] Speaker 00:
The complaint in your case is a Sherman Law violation premised on a violation of the FDCA.

[00:06:09] Speaker 00:
I'm not sure I need to go farther than that.

[00:06:11] Speaker 00:
I mean, I'm sure they involve different facts and they involve different violations of the FDCA, but so what?

[00:06:19] Speaker 02:
Well, if I could point out that the provisions of the FDCA that Nexus addressed were provisions for drugs under a whole different section of the FDCA.

[00:06:39] Speaker 00:
But the preemption provision applies to both sections.

[00:06:44] Speaker 02:
But unlike the drug sections, the food labeling sections provides an express preemption provision that focuses specifically on food labeling claims.

[00:06:59] Speaker 02:
It's somewhat analogous to the express preemption provision for medical devices.

[00:07:06] Speaker 02:
So that is a distinction for that language, for Congress expressed its intent in that language to treat food labeling claims differently from drug labeling claims.

[00:07:23] Speaker 02:
To say that there is no difference would render Section 343-1 just surplus.

[00:07:32] Speaker 00:
No, it wouldn't, because what 341 says is that states may pass laws that are consistent with the FDCA.

[00:07:42] Speaker 00:
And nobody doubts that states may enforce laws consistent with the FDCA.

[00:07:47] Speaker 00:
The question is whether there's a private cause of action.

[00:07:50] Speaker 00:
So it doesn't render that, that's one of my problems with Davidson.

[00:07:55] Speaker 00:
It doesn't render that provision superfluous.

[00:07:58] Speaker 00:
It just means that states may pass those laws.

[00:08:01] Speaker 00:
It doesn't answer the question of implied preemption.

[00:08:04] Speaker 02:
Well, section six of the Nutrition Labeling Education Act expressly provides that 343-1, quote, shall not be construed to preempt

[00:08:18] Speaker 02:
any provision of state law unless such provision is expressly preempted under what became 343-1.

[00:08:29] Speaker 02:
So that's another express preemption provision that you don't see.

[00:08:37] Speaker 02:
And you certainly didn't see it in Nexus.

[00:08:40] Speaker 02:
Nexus didn't have the first step, which was the we're going to preempt laws that are not identical to it.

[00:08:47] Speaker 02:
And it sure didn't have a second step of saying it shall not be construed to preempt any provision of state law unless it's expressly preempted here.

[00:08:59] Speaker 02:
And Davidson pointed out other decisions in which.

[00:09:03] Speaker 00:
But isn't the 341 provision

[00:09:06] Speaker 00:
about preempting inconsistent state laws.

[00:09:11] Speaker 00:
That's different than whether or not there's an implied preemption in the act, which the Supreme Court has said there is, of private causes of action.

[00:09:19] Speaker 02:
But the Supreme Court has never said that there's an implied preemption of Sherman Law claims for food mislabeling.

[00:09:28] Speaker 02:
It has never said that.

[00:09:30] Speaker 02:
And this court, including- They might if we keep going.

[00:09:34] Speaker 02:
They might if we keep going.

[00:09:36] Speaker 02:
And I guess, you know, Judge Callahan, Judge Kruetz, to also address your concerns about this conflict, of course, the defendant in Davidson petitioned for en banc review and said, these cases are on a collision course.

[00:09:54] Speaker 02:
This has got to be resolved.

[00:09:56] Speaker 02:
This is a big problem.

[00:09:58] Speaker 02:
not one judge on this court requested rehearing of unbumped.

[00:10:04] Speaker 00:
I wouldn't put too much weight on that.

[00:10:06] Speaker 01:
Because if we have three of us here, that if we said that you've got to straighten this out, it would be a different situation.

[00:10:17] Speaker 01:
Other circuits, too, are, well, not binding on us.

[00:10:20] Speaker 01:
We always look.

[00:10:21] Speaker 01:
And I don't know that the other circuits help you that much.

[00:10:25] Speaker 01:
How do you distinguish this case from the First Circuit's recent decision in DeCroche?

[00:10:30] Speaker 01:
And the plaintiff in that case said lactate violated Section 343R6 because it claimed to treat lactose intolerance.

[00:10:39] Speaker 01:
Plaintiffs brought her claim under Massachusetts state law for deceptive trade practices.

[00:10:45] Speaker 01:
The First Circuit held

[00:10:46] Speaker 01:
that the claim was impliedly preempted.

[00:10:50] Speaker 01:
So I see that.

[00:10:52] Speaker 01:
I know you try to distinguish it, but I see that case is not hard for you.

[00:10:58] Speaker 02:
And we did argue to distinguish that in our reply brief, but there's a further reason that we didn't mention in the reply brief.

[00:11:06] Speaker 02:
And that is Massachusetts, unlike California, does not have

[00:11:12] Speaker 02:
state food labeling laws that incorporate the FDCA.

[00:11:18] Speaker 02:
States are allowed to and 343 says states can you can you can have laws as long as they're they're identical to the federal laws.

[00:11:28] Speaker 02:
But Massachusetts legislature didn't even pass that kind of law.

[00:11:33] Speaker 01:
I have no doubt that California favors your position.

[00:11:37] Speaker 01:
But that being said, the preemption issue is ultimately going to be a federal preemption issue on a federal level.

[00:11:43] Speaker 01:
I understand.

[00:11:44] Speaker 02:
But what was dispositive to the First Circuit in DeCroche was that Massachusetts did not have a state law to stand on.

[00:11:59] Speaker 02:
That claim was based on

[00:12:05] Speaker 02:
a violation of the FDCA only.

[00:12:08] Speaker 00:
But isn't that true in your case?

[00:12:11] Speaker 00:
If Congress tomorrow, or make it two years ago, because I don't want to worry about retroactivity, took out the provision of the FDCA that you're concerned about, you would have no claim, right?

[00:12:26] Speaker 02:
If Congress took it out?

[00:12:28] Speaker 00:
Yes.

[00:12:28] Speaker 02:
If Congress took it out?

[00:12:30] Speaker 00:
Remove the provision that you say was violated, you would have no claim.

[00:12:35] Speaker 00:
Your claim depends entirely on the existence of the FDCA.

[00:12:42] Speaker 02:
My claim depends on California.

[00:12:44] Speaker 00:
You would have no Sherman law claim if there was no FDCA claim, correct?

[00:12:49] Speaker 02:
You would.

[00:12:50] Speaker 02:
And here's the difference.

[00:12:51] Speaker 02:
Here's the difference.

[00:12:52] Speaker 02:
You would have a California state claim, even if the FDA never existed.

[00:12:57] Speaker 00:
A Sherman law claim for violation of your claim in this case, at least

[00:13:02] Speaker 00:
The claim in front of us is that there's a Sherman law violation, because the Sherman law incorporates by reference the FDCA, and there was an FDCA violation.

[00:13:12] Speaker 00:
That's a fair summary, right?

[00:13:15] Speaker 02:
That's a fair summary, yes.

[00:13:16] Speaker 00:
OK.

[00:13:16] Speaker 00:
So I'm asking you to, hypothetical, isn't it fact, to assume that Congress removed that provision of the FDCA that you rely on.

[00:13:26] Speaker 00:
Then you would have no Sherman law claim, would you?

[00:13:29] Speaker 02:
Yes, the Sherman law would then be amended just as it was amended in 1990.

[00:13:35] Speaker 00:
I get to make up the hypotheticals you don't get to say.

[00:13:38] Speaker 00:
Then California would amend the Sherman law to stick this back in.

[00:13:42] Speaker 02:
I would say California has historically, has historically protected consumers against food slavery.

[00:13:51] Speaker 00:
But let's not argue about what somebody might do in the future.

[00:13:54] Speaker 00:
It's true that in this case, your claim fails

[00:13:59] Speaker 00:
if this is not a violation of the FDCA, correct?

[00:14:03] Speaker 02:
Yes, and that's because at 343-1, Congress told states, you have to do it this way.

[00:14:11] Speaker 00:
Let me ask you one other question.

[00:14:13] Speaker 00:
There's a cert petition pending in Texas, Davidson, one of the two.

[00:14:20] Speaker 00:
Davidson, yes.

[00:14:20] Speaker 00:
One of the two.

[00:14:21] Speaker 00:
Shouldn't we wait for the Supreme Court to act on that before we do anything?

[00:14:25] Speaker 02:
I don't believe so, and here's why.

[00:14:27] Speaker 00:
So wait.

[00:14:29] Speaker 00:
Really?

[00:14:30] Speaker 00:
If the Supreme Court grants cert on the issue in that case, we should preempt them and rule beforehand about how they should come out?

[00:14:37] Speaker 02:
If the Supreme Court grants cert.

[00:14:40] Speaker 02:
Yes.

[00:14:40] Speaker 02:
Grants cert.

[00:14:41] Speaker 02:
Yes.

[00:14:42] Speaker 02:
I agree.

[00:14:43] Speaker 00:
So shouldn't we wait till we see whether they do or not?

[00:14:48] Speaker 02:
Here's why I don't think you should.

[00:14:49] Speaker 02:
Because I think the decision in this case that

[00:14:54] Speaker 02:
illuminates the very, very significant distinctions between the claims in Davidson and the claims in Nexus, that will clarify the law while we're waiting to see if this- So you want us to teach them.

[00:15:13] Speaker 02:
I do think that the United States Supreme Court learns from your decisions.

[00:15:18] Speaker 01:
But I think both of you want to win now and then

[00:15:21] Speaker 00:
win or lose later, but that- I appreciate your tenacity, but this is an easy one for me.

[00:15:27] Speaker 00:
We wait for the Supreme Court.

[00:15:30] Speaker 02:
Well, I appreciate that.

[00:15:32] Speaker 02:
The text, Congress's intent is what's key to preemption cases.

[00:15:38] Speaker 02:
And Congress has expressed its intent in 343-1 and also in the Nutrition Labeling Education Act.

[00:15:49] Speaker 02:
By providing, again, unless it is expressly preempted here in this section of the FDA about food mislabeling, it is not going to be preempted.

[00:16:02] Speaker 03:
All right, counsel, you haven't held on to your five-minute rebuttal, and now you're over.

[00:16:08] Speaker 02:
Thank you very much, and I will save my time.

[00:16:12] Speaker 02:
And thank you very much.

[00:16:13] Speaker 01:
You don't have any time to say.

[00:16:15] Speaker 02:
Oh, I'm sorry.

[00:16:15] Speaker 02:
One minute.

[00:16:16] Speaker 02:
OK, very well.

[00:16:17] Speaker 02:
All of it.

[00:16:18] Speaker 02:
OK, well, thank you very much.

[00:16:19] Speaker 02:
I appreciate it.

[00:16:22] Speaker 01:
She might give you time, though.

[00:16:23] Speaker 01:
It's OK.

[00:16:24] Speaker 01:
You can try.

[00:16:24] Speaker 01:
It's OK.

[00:16:36] Speaker 04:
Your honors may please the court.

[00:16:38] Speaker 04:
I'm Tacey Flinch for Golow.

[00:16:40] Speaker 01:
Good morning.

[00:16:41] Speaker 04:
Thank you.

[00:16:47] Speaker 04:
Let me start with the question of Davidson versus Sprout.

[00:16:53] Speaker 04:
Excuse me, Davidson versus Nexus.

[00:16:55] Speaker 00:
Let me pose, because maybe Judge Cowan and I have a slightly different initial cut on this.

[00:17:02] Speaker 00:
Here's my problem for you to solve.

[00:17:04] Speaker 01:
We don't know if we do.

[00:17:05] Speaker 00:
We haven't talked about it.

[00:17:06] Speaker 00:
At least our questions suggest maybe.

[00:17:10] Speaker 00:
Davidson, if Davidson is the law, you lose, do you not?

[00:17:15] Speaker 04:
respectfully disagree.

[00:17:16] Speaker 00:
Okay, you're gonna distinguish Davidson too.

[00:17:20] Speaker 00:
Tell me why Davidson doesn't kill your case.

[00:17:23] Speaker 04:
Well, Davidson at this moment is the law of the circuit and so is Nexus.

[00:17:27] Speaker 04:
In our case, it falls under Nexus.

[00:17:29] Speaker 00:
Then let me finish.

[00:17:31] Speaker 00:
Here's my problem.

[00:17:32] Speaker 00:
Davidson says, we're not overruling Nexus, we're just distinguishing it.

[00:17:37] Speaker 00:
I may not be convinced by that, but as a three-judge panel, we have to accept, in my view, that decision.

[00:17:44] Speaker 00:
So assuming that Davidson's ruling is correct, which is that the claim in that case is preempted, notwithstanding Nexus,

[00:17:57] Speaker 00:
is not preempted, not with the nexus, I'm sorry.

[00:18:00] Speaker 00:
Why is it the claim, why can the claim in your case be preempted?

[00:18:03] Speaker 04:
Well, let me start by saying that if the panel concludes that nexus cannot be reconciled with Davidson, that I think under this court's case law, I believe the case is Antonio versus Ward Grove, the court is obligated to request on bond consideration.

[00:18:18] Speaker 00:
However, as Your Honor observed- Well, we're never obligated to request en banc consideration.

[00:18:23] Speaker 00:
We may request en banc consideration, but one of the reasons I resist that suggestion in this case is we have at least some prior history, knowing that precisely the same argument was made to the en banc court, made to the entire court a little while ago, and they owned.

[00:18:41] Speaker 00:
And so I'm not sure I want to expend our energy calling for en banc consideration in a case in which

[00:18:47] Speaker 00:
We already know it was turned down once before.

[00:18:50] Speaker 04:
As Your Honor observed, Davidson does state that it distinguishes Nexus.

[00:18:55] Speaker 04:
And of course, it was obligated.

[00:18:57] Speaker 04:
The panel in that case was obligated to distinguish Nexus because no single panel can overrule another.

[00:19:03] Speaker 04:
And there's a clear difference between the claim that was deemed preempted in Nexus and the claim that was deemed not preempted in Davidson.

[00:19:12] Speaker 04:
And the difference relates to the FDA's involvement.

[00:19:17] Speaker 04:
In our case and in Nexus, the claim is that there is a product that is being sold without FDA approval.

[00:19:26] Speaker 04:
In our case, a dietary supplement, which FDA approval is not required before it is sold.

[00:19:32] Speaker 04:
In Nexus, it was a compounded drug where FDA approval is not required.

[00:19:37] Speaker 04:
And the plaintiff said, the reason this manufacturer believes FDA approval is not required is mistaken.

[00:19:44] Speaker 04:
I would like an opportunity to prove to the court

[00:19:46] Speaker 04:
that, in fact, FDA approval is required.

[00:19:49] Speaker 01:
In our case ... I don't find your distinguishing Davidson and Nexus on the basis that Nexus plaintiffs alleged FDCA violations that turned on the defendant not getting governmental approval, whereas the plaintiffs in Davidson merely alleged violations of the FDCA.

[00:20:08] Speaker 01:
I don't know, how is this distinction relevant for purposes of preemption?

[00:20:14] Speaker 01:
Didn't Buckman hold that a private party cannot bring suit to enforce violations of the FDCA full stop?

[00:20:21] Speaker 01:
And what does it matter that one violation turns on the defendant needing to get government approval?

[00:20:27] Speaker 01:
I'm just not finding that persuasive.

[00:20:29] Speaker 04:
Well, Your Honor, that is what Buckman held, and that is also the statement in Nexus.

[00:20:35] Speaker 01:
Is that your best argument?

[00:20:37] Speaker 01:
Is that your argument?

[00:20:39] Speaker 04:
I'm explaining how I think the Davidson Court carved out a separate small threaded a needle, as Your Honor said earlier, from Nexus.

[00:20:50] Speaker 04:
My reading of that case is,

[00:20:52] Speaker 04:
There was no FDA involvement required.

[00:20:55] Speaker 04:
That claim was about whether there was any nutrient statement at all.

[00:20:59] Speaker 00:
So you think the preemption doctrine turns on whether or not FDA involvement is required?

[00:21:05] Speaker 04:
That is a clear difference between the facts of the case.

[00:21:07] Speaker 00:
Well, I know it's a clear difference, but what case do you cite for the proposition at FDA?

[00:21:13] Speaker 00:
Other than these two cases, which you've, I think, quite ably tried to put in boxes, what case says FDA participation is required?

[00:21:23] Speaker 04:
Well, many cases refer to the importance of reserving the FDA's opportunity to exercise its discretion independently.

[00:21:32] Speaker 04:
And that is critical in order to ensure that... Well, but the FDA in your case has decided

[00:21:41] Speaker 00:
What?

[00:21:43] Speaker 00:
Has it decided not to proceed?

[00:21:46] Speaker 00:
Has it done anything?

[00:21:47] Speaker 00:
I mean, there's no indication in this case that the FDA has exercised any discretion independently.

[00:21:54] Speaker 04:
There's no allegation about enforcement action.

[00:21:57] Speaker 04:
The FDA is notified every time a dietary supplement is sold.

[00:21:59] Speaker 00:
Sure, but it may.

[00:22:02] Speaker 00:
All of its people got laid off last week for their opinions about diversity, equity, and inclusion, so they've decided not to proceed.

[00:22:10] Speaker 00:
I mean, we just can't read anything into, there's just anything into that.

[00:22:14] Speaker 00:
There's a prohibition in this case, which they, an FDCA prohibition, which they say was violated.

[00:22:21] Speaker 00:
That's exactly what, exactly what in, in the, in, in Davidson, the argument was you can't, there's an FDCA prohibition against you circulating this supplement without approval.

[00:22:33] Speaker 00:
And you violated that.

[00:22:35] Speaker 00:
Here, the argument is there's an FDCA prohibition on

[00:22:39] Speaker 00:
for some reason about putting this on the front of the baby food package as opposed to the back, and you violated that.

[00:22:45] Speaker 00:
But what's the difference?

[00:22:47] Speaker 00:
They're both premised on an underlying claim of an FDCA violation.

[00:22:52] Speaker 04:
The court in Davidson said, and I'm just taking the panel at its word here, the opinion says a claim that would require litigating whether the facilities, in that case a compounding facility,

[00:23:03] Speaker 04:
qualified for an exception to FDA approval, i.e., whether an FDCA violation had occurred, that a state law claim making that claim is preempted.

[00:23:12] Speaker 00:
So that is the law under Davidson.

[00:23:13] Speaker 00:
I take your point.

[00:23:14] Speaker 00:
And this goes back to my initial question.

[00:23:17] Speaker 00:
I may think Davidson is dead wrong, that its distinction doesn't work at all.

[00:23:24] Speaker 00:
But am I bound to accept its distinction because it is the decision of a three-judge panel?

[00:23:31] Speaker 04:
Your Honor, if the court concludes that Davidson is dead wrong, then because it- I might or might want to call it in bank.

[00:23:39] Speaker 00:
But put aside, that's an individual discretionary decision we get to make.

[00:23:44] Speaker 00:
And if we don't make it the way you like, you can petition for a hearing in bank.

[00:23:48] Speaker 00:
I'm asking what my duty is when confronted with a decision that distinguishes a prior case

[00:23:55] Speaker 00:
I don't buy the distinction, but I can't say Davidson was wrong, because it is a decision of a three-judge panel.

[00:24:04] Speaker 00:
So aren't I stuck with Davidson?

[00:24:07] Speaker 04:
Setting aside en banc, which you've asked me to set aside, the court can either accept the distinction in Davidson, under which we're clearly on the side of nexus, because the words I just read

[00:24:20] Speaker 04:
describe the claim advanced against Golow.

[00:24:23] Speaker 00:
OK, so your argument is that Davidson is in your favor.

[00:24:28] Speaker 01:
Do you think Davidson is wrongly decided?

[00:24:33] Speaker 04:
Of course it is not my position to say that.

[00:24:37] Speaker 04:
I do think that Davidson is in great tension.

[00:24:39] Speaker 01:
Well, people do that all the time in your position.

[00:24:42] Speaker 01:
They tell us we're wrong.

[00:24:43] Speaker 04:
I think it is challenging, as the panel has obviously recognized, to reconcile Davidson with

[00:24:50] Speaker 04:
with Nexus and with Buckman, which is the decision of the US Supreme Court, which of course no panel nor the en banc court is permitted to overlook.

[00:24:59] Speaker 04:
Those cases say that when a state law claim says, there's a state law claim that a product violates state law solely because it violates the FDCA with no other content to the state law claim than it is preempted under Section 377.

[00:25:16] Speaker 00:
So I'm going to understand your argument now.

[00:25:19] Speaker 00:
I think I'm getting it.

[00:25:21] Speaker 00:
But your argument is that the Davidson distinction of nexus leaves nexus alive for your purposes.

[00:25:33] Speaker 00:
And that therefore there is preemption.

[00:25:36] Speaker 04:
Preemption, for sure.

[00:25:38] Speaker 04:
If Davidson is correct, then its distinction of nexus clearly applies to... Well, but then we're getting back to this case.

[00:25:45] Speaker 00:
What's the allegation in this case?

[00:25:47] Speaker 04:
The allegation in this case is that our product bears implied disease claims on the label, and that is not permissible for a product marketed as a dietary supplement under section 101.93f.

[00:26:00] Speaker 04:
Anytime a dietary supplement bears implied or bears disease claims, period, on the label, it is subject to regulation as a drug, which means that most likely it requires approval by the FDA.

[00:26:11] Speaker 00:
So your argument is that in your case,

[00:26:14] Speaker 00:
further action by the FDA would be necessary.

[00:26:17] Speaker 03:
And that's a really important distinction.

[00:26:19] Speaker 03:
You are buying the distinction that Davidson utilized this distinguished nexus saying this was a task reserve.

[00:26:28] Speaker 03:
Because this was a task reserve for the FDA, we held that the claim was impliedly preempted.

[00:26:34] Speaker 03:
And you're arguing that there's one more step here that the FDA has to take.

[00:26:38] Speaker 03:
And therefore, it's reserved for the FDA.

[00:26:42] Speaker 03:
And so therefore, it's impliedly preempted.

[00:26:45] Speaker 03:
Under the works of Nexus.

[00:26:47] Speaker 03:
So you're saying, accepting their distinction of Nexus.

[00:26:53] Speaker 03:
Okay.

[00:26:54] Speaker 03:
Um, and so I'd like to, if I could still win.

[00:26:57] Speaker 04:
Yes, we still win.

[00:27:00] Speaker 01:
You still win no matter what.

[00:27:02] Speaker 04:
But that's the, well, if, if Davidson had not been decided, it would be very different.

[00:27:09] Speaker 04:
Given that Davidson has been decided and it's explanation of what is preempted under nexus, even after Davidson, then our claim is preempted even under Davidson.

[00:27:19] Speaker 04:
based on its own description of what nexus holds.

[00:27:22] Speaker 03:
And I want to just briefly talk about- So you want us to just suspend disbelief.

[00:27:26] Speaker 03:
Sorry?

[00:27:26] Speaker 03:
You want us to suspend disbelief and just say, here's what Davidson said, whether we agree with it or not.

[00:27:32] Speaker 03:
That's what they said, and your case is on all fours.

[00:27:35] Speaker 04:
Your Honor, it's the law of the Ninth Circuit that I'm doing my best to apply.

[00:27:39] Speaker 00:
Yeah, and I understand your position elsewhere that they're inconsistent.

[00:27:44] Speaker 00:
I mean, you're allowed, at least in appellate arguments, you're allowed to do alternative pleading.

[00:27:48] Speaker 04:
Well, Judge Wardlaw, if I could expand a little bit on your question about how there's something still reserved for the FDA.

[00:27:55] Speaker 04:
I think there's an important difference here, if we're trying to understand this distinction in Nexus, excuse me, in Davidson.

[00:28:01] Speaker 04:
There's an important difference between the implied disease claim in our case and the baby food claim in Davidson.

[00:28:09] Speaker 04:
So what an implied disease claim is?

[00:28:11] Speaker 04:
What that means is that the label on a dietary supplement says that that product can be used to benefit a disease.

[00:28:19] Speaker 04:
And what is a disease?

[00:28:21] Speaker 04:
That's explained in section 101.93 G, the FDA's regulation.

[00:28:27] Speaker 04:
And the FDA has explained at great length how it decides

[00:28:31] Speaker 04:
what counts as a disease.

[00:28:33] Speaker 04:
In its final rule, which we cite 60 Fedreg 1000, it goes through a series of examples.

[00:28:38] Speaker 04:
So a disease is something that is dysfunction of the body.

[00:28:42] Speaker 04:
There are lots of things that are conditions that people seek treatment for, people that are unpleasant, but they're not diseases because they count as normal bodily functions.

[00:28:53] Speaker 04:
So examples that the FDA cites are premenstrual syndrome, occasional constipation, acne,

[00:28:59] Speaker 04:
These are things that people seek treatment for all the time, but they don't count as diseases as the FDA understands it.

[00:29:05] Speaker 04:
In that same federal regulation, it goes on to say, if these conditions are severe or perpetual, then they may indicate a disease.

[00:29:16] Speaker 04:
So premenstrual dysphoric disorder, cystic acne, chronic constipation,

[00:29:21] Speaker 04:
Those things count as diseases.

[00:29:24] Speaker 00:
So if your label said, this cures chronic constipation, would we be in Davidson land or Nexus land?

[00:29:35] Speaker 04:
The point I'm making is that the FDA- No, I understand the point you're making.

[00:29:39] Speaker 00:
I'm asking a question.

[00:29:42] Speaker 00:
Let's assume your label says, this cures chronic constipation.

[00:29:47] Speaker 04:
Which maybe is a fair reading of the regulation.

[00:29:51] Speaker 04:
then under the way I read the data... Then it would just be like the label.

[00:29:56] Speaker 00:
It would be prohibited on its face by the act, and no further determinations would need to be made, right?

[00:30:03] Speaker 04:
Which is, the FDA has already evaluated that issue.

[00:30:05] Speaker 04:
It has already exercised its... Pick your favorite disease.

[00:30:09] Speaker 00:
Maybe I picked the wrong disease.

[00:30:11] Speaker 04:
I accept chronic constipation as the example.

[00:30:13] Speaker 04:
as that is to say here in the federal court.

[00:30:17] Speaker 04:
But anyway, the point is that the FDA has already sort of done its work.

[00:30:21] Speaker 04:
And that's true of the baby food label here, too.

[00:30:25] Speaker 04:
The FDA has said, we've thought about this.

[00:30:28] Speaker 04:
We have thought about potential nutrient claims on baby food labels.

[00:30:31] Speaker 04:
And we can say categorically, no nutrient claims on a baby food product, period.

[00:30:38] Speaker 04:
We don't need to think about whether it's

[00:30:40] Speaker 04:
a good claim, a useful claim, none of that, just no nutrient claims.

[00:30:44] Speaker 04:
So the FDA has done its work.

[00:30:44] Speaker 00:
So if your label said, this cures brain cancer, your view is that this would fall into the Davidson exception?

[00:30:55] Speaker 04:
Perhaps.

[00:30:56] Speaker 00:
Well, perhaps, yes or no.

[00:30:57] Speaker 00:
I mean, perhaps is, of course, where I started.

[00:30:59] Speaker 00:
I need you to push me to one side or the other.

[00:31:01] Speaker 04:
I mean, fundamentally, it's for the FDA to determine.

[00:31:04] Speaker 00:
So your answer is no.

[00:31:06] Speaker 00:
Your answer is it would fall into Davidson exception.

[00:31:09] Speaker 04:
If the FDA has said, we, the FDA, determined that brain cancer is a disease, we, the FDA, determined that a statement saying this product treats brain cancer is a disease claim, that would be pretty similar to Davidson.

[00:31:21] Speaker 04:
That would be the same as Davidson.

[00:31:23] Speaker 04:
Not our case at all.

[00:31:25] Speaker 04:
What the plaintiff is asking for, and they've said this explicitly on page 20 of their reply brief, they're asking for a court or a jury to decide in the first instance whether our product claims or disease claims.

[00:31:38] Speaker 04:
Is insulin resistance a disease?

[00:31:40] Speaker 04:
As the FDA understands it, do the words on our product claim imply that our product will treat it?

[00:31:46] Speaker 04:
That's what they're asking a court or a jury to decide in the first instance.

[00:31:50] Speaker 04:
And to return to D'Croce, which you brought up, Judge Callahan,

[00:31:54] Speaker 04:
Literally exactly the same thing was argued to the First Circuit there.

[00:31:57] Speaker 04:
That plaintiff said, we should be permitted to prove to a court that lactose intolerance counts as a disease, so that a product saying this treats lactose intolerance has disease claims and is therefore subject to regulation as a drug.

[00:32:12] Speaker 04:
And the First Circuit said, no, that lacks merit.

[00:32:16] Speaker 04:
You don't get to argue to a court.

[00:32:18] Speaker 04:
whether lactose intolerance counts as a disease, because that is for the FDA to determine.

[00:32:23] Speaker 00:
Wouldn't there have to be a fact determined by the finder of fact in Davidson?

[00:32:27] Speaker 04:
I'm sorry, could you ask the question again?

[00:32:29] Speaker 00:
In Davidson, wouldn't there be a fact that had to be determined by the finder of fact?

[00:32:34] Speaker 04:
The only question that the court allowed to proceed in Davidson is, is there any statement at all about nutrients on this baby food packaging?

[00:32:43] Speaker 00:
Well, typically.

[00:32:46] Speaker 00:
A jury would have to figure that out, right?

[00:32:49] Speaker 00:
Or a judge, or a finder of facts, or why is it any different than all the other cases?

[00:32:55] Speaker 04:
I think as Nexus would describe it, that is still a state law claim of an FDCA violation.

[00:33:00] Speaker 00:
I think it is.

[00:33:01] Speaker 04:
I think under the most straightforward reading of Nexus, that would be preempted.

[00:33:05] Speaker 04:
Obviously, the panel and Davidson disagreed.

[00:33:09] Speaker 01:
What's your response on the Supreme Court cases?

[00:33:12] Speaker 01:
Should we wait to see if they grant cert that Judge Hurwitz

[00:33:16] Speaker 01:
asked.

[00:33:19] Speaker 04:
I certainly have no problem with that.

[00:33:21] Speaker 04:
If they did answer it, I certainly agree with counsel on the other side that it would be appropriate for the court to wait.

[00:33:28] Speaker 04:
I think it is clear that our case, assuming Davidson is not granted, assuming Davidson, there is no en banc consideration of this question, just as the court didn't grant en banc for hearing of Davidson, assuming none of those things happen, then our claim is preempted.

[00:33:45] Speaker 04:
under Nexus and Davidson's description of what Nexus is.

[00:33:49] Speaker 00:
If Davidson went away, you win, right?

[00:33:53] Speaker 04:
Yes.

[00:33:54] Speaker 00:
OK.

[00:33:55] Speaker 00:
So that's the point of waiting for cert.

[00:33:57] Speaker 01:
But you're saying you still win, even if Davidson is.

[00:33:59] Speaker 01:
That's correct.

[00:34:00] Speaker 01:
Under Davidson's.

[00:34:02] Speaker 01:
You both say you win no matter what.

[00:34:04] Speaker 01:
So I get that.

[00:34:05] Speaker 04:
That would be an argument for not waiting, because we win under Davidson's description of nexus.

[00:34:10] Speaker 03:
We understand council, and you're well over your time.

[00:34:13] Speaker 03:
So I'm going to give your opposing council another minute or two to respond.

[00:34:20] Speaker 03:
same amount of time that you had going over, two minutes.

[00:34:26] Speaker 02:
Thank you very much, Judge Wardlaw.

[00:34:32] Speaker 02:
If we're waiting for the FDA approval of release, as my friend on the other side has suggested, looking at the complaint, there is no allegation that Golo gave notice

[00:34:49] Speaker 02:
to the FDA that it intended to have implied disease claims.

[00:34:55] Speaker 02:
Golo just, if you take the complaint alleged allegations as true, Golo has included these implied disease claims on the labeling without notifying the, we don't know one way or the other.

[00:35:15] Speaker 02:
It is like Davidson in that

[00:35:18] Speaker 02:
You can't say those things unless you go through the process.

[00:35:24] Speaker 02:
I have no idea if there would be a pending process because the complaint does not allege that.

[00:35:33] Speaker 02:
We are asking on page 20 of our reply brief for the reasonable consumer standard to be applied to decide if these are implied disease claims.

[00:35:46] Speaker 02:
Judges and juries have done that with no problem at all.

[00:35:53] Speaker 02:
We won't know.

[00:35:54] Speaker 02:
We won't know.

[00:35:56] Speaker 02:
I'm going to stop there.

[00:36:02] Speaker 02:
And I think that is my main response.

[00:36:05] Speaker 02:
Oh, DeCroche, I will say, DeCroche didn't allege an implied disease claim.

[00:36:10] Speaker 02:
It didn't.

[00:36:11] Speaker 02:
It alleged lactate is a drug.

[00:36:14] Speaker 02:
and it's being sold without approval.

[00:36:17] Speaker 02:
And they said, we don't even have an argument that the representations aren't true.

[00:36:22] Speaker 02:
Here, we're not alleging that release is a drug being sold without approval.

[00:36:30] Speaker 02:
There's one allegation in the complaint, and I think Judge Hurwitz, she mentioned claims in the alternative, sort of in the pejorative, that if it could do all the things it said,

[00:36:44] Speaker 02:
then it would be a drug.

[00:36:46] Speaker 02:
So with that, I will rest on our pleadings.

[00:36:49] Speaker 02:
And I thank your honors for considering this case.

[00:36:53] Speaker 03:
Thank you very much.

[00:36:53] Speaker 03:
Thank you, Bob.

[00:36:55] Speaker 03:
Bubeck Vigolo will be submitted.

[00:36:58] Speaker 03:
And this session of the court is adjourned for today.

[00:37:01] Speaker 03:
Thank you very much, counsel.

[00:37:12] Speaker 03:
This court for this session stands adjourned.