[00:00:01] Speaker 04:
Good morning, and may it please the court.

[00:00:02] Speaker 04:
My name is Dwayne Robinson, and I represent military veterans who are seeking medical monitoring for harms caused by the defendant's manufacturing in sale of Mefuchen.

[00:00:11] Speaker 04:
I'm joined here today by one of those veterans, Sergeant Patrick Wager, who is with me there on the front row.

[00:00:17] Speaker 04:
I'm respectfully requesting three minutes for rebuttal.

[00:00:20] Speaker 04:
This court should reverse the trial court's dismissal of my client's claims.

[00:00:24] Speaker 04:
As to the three issues that we have raised in this appeal, our friends on the other side have conceded that the district court had error in at least two of those claims.

[00:00:32] Speaker 04:
First, the notion that the FDA's approval of a drug somehow insulates the drug from any sort of liability under the political question doctrine as the FDA.

[00:00:43] Speaker 04:
They've conceded that district court got that wrong.

[00:00:45] Speaker 04:
We think this is the only court in the nation that's ever found that way.

[00:00:48] Speaker 04:
We would respectfully request the court to reverse that decision.

[00:00:52] Speaker 04:
They also recognized that the district court erred in characterizing the Genentech entities as generic manufacturers.

[00:00:57] Speaker 04:
That's not what we list in our complaint.

[00:00:59] Speaker 04:
They recognize that's wrong.

[00:01:01] Speaker 04:
Therefore, the Supreme Court's messaging decision simply does not preclude liability as to that.

[00:01:05] Speaker 04:
The remaining issue in this case, at least for us, we understand that there is an issue about standing and some other collateral issues they've raised.

[00:01:11] Speaker 04:
But the last issue for us is jurisdiction.

[00:01:13] Speaker 04:
And here, we did meet our burden to show that the court had jurisdiction over the Roche entities.

[00:01:18] Speaker 04:
At the very least.

[00:01:20] Speaker 01:
Can you go to the Article III standing issue first before you get to the personal jurisdiction?

[00:01:24] Speaker 04:
Absolutely.

[00:01:25] Speaker 04:
So our friends on the other side raised two arguments as to standing.

[00:01:28] Speaker 04:
One argument is that they believe because other jurisdictions outside of California have recognized that you cannot bring a medical monitoring claim where a victim has already suffered the harm itself, you are precluded from seeking medical monitoring.

[00:01:41] Speaker 04:
There's a couple of problems with that.

[00:01:42] Speaker 04:
Number one, this is a diversity case.

[00:01:44] Speaker 04:
It's a diversity case.

[00:01:46] Speaker 04:
And the California Supreme Court

[00:01:48] Speaker 04:
sets the rules on the grounds of medical monitoring.

[00:01:50] Speaker 04:
And in the plot of versus funding.

[00:01:52] Speaker 02:
Yeah, but it doesn't set the rules on our Article 3 standing.

[00:01:55] Speaker 04:
I agree with that, certainly.

[00:01:56] Speaker 04:
But here, this is not really a standing issue in terms of what you have to allege to prove a claim.

[00:02:01] Speaker 04:
Standing is a very modest burden, which this court has recognized in the Brown case.

[00:02:06] Speaker 04:
They've recognized this injury in fact.

[00:02:08] Speaker 04:
They've recognized that there is traceability.

[00:02:10] Speaker 04:
What they're really arguing is, is it really redressable?

[00:02:13] Speaker 04:
And here, it is redressable.

[00:02:14] Speaker 04:
And there's a very simple reason why it's redressable.

[00:02:17] Speaker 04:
By our clients getting medical monitoring, they will then be able to get the diagnosis for methylcline toxicity.

[00:02:23] Speaker 04:
By that diagnosis alone, that means that they are no longer going to be taking drugs for PTSD, for other ailments that are actually probably making their symptoms much worse.

[00:02:32] Speaker 01:
I thought you alleged that they already have experienced that toxicity then, already.

[00:02:36] Speaker 04:
We've alleged that they've experienced symptoms associated with methylcline toxicity, but none of them have actually actually been diagnosed with methylcline toxicity.

[00:02:43] Speaker 04:
And that's what we're seeking.

[00:02:44] Speaker 00:
But you'll be proving that diagnosis as part of the liability case.

[00:02:48] Speaker 00:
Is that the right?

[00:02:50] Speaker 04:
Well, what we would prove as part of the liability case is a number of things, depending on the type of claims that we have.

[00:02:55] Speaker 04:
We would be proving, number one, that they were subject to toxic exposure, okay?

[00:03:00] Speaker 04:
Number two, that this is something that is not common, that the regular public would not experience these symptoms but for this action.

[00:03:06] Speaker 04:
And the other element that the Supreme Court of California requires in medical monitoring claims

[00:03:11] Speaker 04:
is that we also established that they will benefit from the medical monitoring.

[00:03:14] Speaker 04:
All of that is subject to expert reports and discovery.

[00:03:19] Speaker 02:
This is not a question that's at the... Can I ask you... Go ahead, please.

[00:03:24] Speaker 02:
Well, the question, I guess, comes into, are you seeking perspective?

[00:03:28] Speaker 02:
I mean, medical monitoring

[00:03:32] Speaker 02:
is not to rectify harm that's been done.

[00:03:35] Speaker 02:
It's to discover harm that hasn't yet been discovered.

[00:03:39] Speaker 02:
But that seems very inconsistent.

[00:03:41] Speaker 02:
I mean, maybe you would have a plaintiff that didn't have this, was exposed, but didn't have the medical diagnosis yet.

[00:03:50] Speaker 02:
But that doesn't seem to be your plaintiffs.

[00:03:52] Speaker 04:
Well, respectfully, Your Honor, I don't think that that's how the Supreme Court of California characterized medical monitoring in the Potter case.

[00:03:59] Speaker 04:
And I would really direct the court and its clerks to that case because what the court looked at is they said, listen, medical monitoring is just a remedy.

[00:04:06] Speaker 04:
It's just a different form of remedy.

[00:04:07] Speaker 04:
Indeed, it's an equitable remedy.

[00:04:09] Speaker 04:
But really, this is like any other tort case where, yes, we will have to go and establish that, yes, we were harmed.

[00:04:15] Speaker 04:
that we were injured and that yes, that this remedy will be related to curing our harm.

[00:04:19] Speaker 04:
We have to meet all those elements.

[00:04:21] Speaker 04:
But that case is not before us.

[00:04:22] Speaker 04:
We are simply here on very threshold issues, two of which our friends on the other side has conceded.

[00:04:27] Speaker 04:
And I will say this, there are now four decisions that have addressed these types of claims.

[00:04:32] Speaker 04:
The Poole case, the Montesano case, the Sheets case.

[00:04:35] Speaker 04:
than our case below.

[00:04:37] Speaker 04:
And here, the district court agreed that there was standing.

[00:04:39] Speaker 04:
If this court disagreed and thought there's a standing issue, we should at least be allowed the right to replede.

[00:04:44] Speaker 04:
This is not something that could be decided right here on the pleadings.

[00:04:47] Speaker 02:
What we hear a lot from our friends on the other side.

[00:04:49] Speaker 02:
Well, but standing isn't standing.

[00:04:52] Speaker 02:
I mean, what, you want to be able to recast your complaint and file?

[00:04:55] Speaker 02:
I mean, you asked for a certification of a class for medical monitoring.

[00:05:00] Speaker 02:
That was it.

[00:05:02] Speaker ?:
Correct.

[00:05:02] Speaker 02:
So the question is, does that provide standing here?

[00:05:06] Speaker 04:
Well, our claim definitely provides standing, Your Honor.

[00:05:09] Speaker 04:
The California Supreme Court has recognized that medical monitoring is a valid cause of action.

[00:05:14] Speaker 00:
Mr. Robinson, can I ask you to... This is a little bit unusual here because you're going first on an issue as to which the defendants disagreed with the district judge.

[00:05:26] Speaker 00:
The district judge said your pleading and standing was sufficient.

[00:05:30] Speaker 00:
And the defendants are arguing

[00:05:33] Speaker 00:
your key allegations, if I recall correctly, it was roughly paragraphs 88 to 92 or 93 of your complaint, are too speculative, not specific enough, too conclusory, the kinds of language we hear a lot in pleading debates.

[00:05:52] Speaker 00:
If we were to agree with them on that point, are there ways in which you could amend those allegations to make them more specific?

[00:06:02] Speaker 04:
Well, that's what we're saying, yes.

[00:06:03] Speaker 04:
I think there would be ways, if you're asking me for specific... How?

[00:06:06] Speaker 04:
If you're asking me today for specific allegations as to what our experts may opine, I cannot give that here from the lectern that's not in the record on appeal.

[00:06:14] Speaker 04:
And that's the point that I'm trying to make is that number one, the record here is sufficient to support standing.

[00:06:19] Speaker 00:
But if the court... I'm asking you to assume we might disagree with you on that.

[00:06:24] Speaker 04:
I heard you, Your Honor, and what I'm saying is I personally don't have that information in terms of what our experts would put in the record

[00:06:30] Speaker 04:
in order to bolster those allegations.

[00:06:33] Speaker 04:
Keep in mind, we're here on a Rule 8 situation.

[00:06:36] Speaker 04:
This Court has said that burden is modest.

[00:06:38] Speaker 04:
We're not required to submit an extra report to bust our claim at the pleading stage.

[00:06:45] Speaker 00:
But nobody really knows what Twombly and Ikeball really require, right?

[00:06:50] Speaker 00:
They're not applied consistently across the board, and that's why it's so important for courts to allow amendment when allegations are treated as insufficient.

[00:07:06] Speaker 00:
So I'm asking how you might be able to amend if there's a problem.

[00:07:09] Speaker 04:
Yes, and Your Honor, the record is silent on that, and I don't have anything in addition to add to the record.

[00:07:14] Speaker 01:
And precisely because... So let me ask, precisely though, if your clients get diagnosed with this toxicity, then you're saying that there's a different type of treatment for it.

[00:07:25] Speaker 04:
Absolutely.

[00:07:25] Speaker 01:
And so what is that different type of treatment?

[00:07:27] Speaker 04:
So there's a number of things we've outlined in our complaint.

[00:07:29] Speaker 04:
Let me give you two examples.

[00:07:31] Speaker 04:
So number one, there's different testing that can be done when you have methicone toxicity than if you have some other type of symptoms.

[00:07:37] Speaker 01:
Testing for what?

[00:07:38] Speaker 04:
I'm going to go to that, Your Honor, right now.

[00:07:40] Speaker 04:
Magnetic resonance imaging, for instance.

[00:07:42] Speaker 04:
That's one thing that can be done.

[00:07:43] Speaker 04:
This is a powerful non-invasive medical imaging technique, which basically take images of the human body.

[00:07:49] Speaker 04:
And the reason why they do this is because they want to ensure that the central nervous symptoms that you're experiencing

[00:07:56] Speaker 04:
It's not due to tumors or other physical ailments.

[00:07:59] Speaker 04:
It's actually due to your nervous system.

[00:08:00] Speaker 01:
But that's the monitoring part.

[00:08:02] Speaker 01:
That's the what?

[00:08:03] Speaker 01:
Isn't that determined to diagnose?

[00:08:05] Speaker 04:
Correct.

[00:08:06] Speaker 01:
But the whole point of monitoring is that then once you're diagnosed with something, something different is going to happen.

[00:08:10] Speaker 01:
So what's the difference that's going to happen?

[00:08:12] Speaker 04:
Sure.

[00:08:12] Speaker 04:
So what's going to happen then is that there's different sort of neuropsychology, neuroophthalmology, sort of, I guess, training.

[00:08:20] Speaker 04:
Not training, but treatment that you get.

[00:08:22] Speaker 04:
That's different than if you sort of had PTSD or multiple sclerosis.

[00:08:26] Speaker 04:
And again, all that is laid out.

[00:08:27] Speaker 01:
As I understand the complaint, it seems like the treatment is therapy in both cases.

[00:08:33] Speaker 04:
Well, again, I think that that's how our friends in the side try to characterize it.

[00:08:36] Speaker 01:
Right.

[00:08:36] Speaker 01:
And so that's why I'm trying to get you to tell me why that's wrong.

[00:08:38] Speaker 04:
Yeah.

[00:08:39] Speaker 04:
Well, why it's wrong is just a difference of factual allegations.

[00:08:43] Speaker 04:
In other words, we're saying that this treatment will actually help our people because that's what our experts are telling our side of it.

[00:08:49] Speaker 01:
But we don't know what that difference is yet.

[00:08:52] Speaker 04:
Yeah, and that's why we have discovery, Your Honor.

[00:08:54] Speaker 04:
And that's why Iqbal and Twombly is not to be used as this... But it has to be this speculative.

[00:09:00] Speaker 01:
It's completely speculative at this point whether or not the treatment would be different.

[00:09:03] Speaker 04:
Well, no, it's not speculative because we do allege that.

[00:09:05] Speaker 04:
We do allege that it's different.

[00:09:06] Speaker 04:
What they're saying is we disagree that it's different.

[00:09:09] Speaker 01:
You can't just say it's different and then not back it up.

[00:09:11] Speaker 01:
You have to have something to back it up.

[00:09:13] Speaker 04:
And we did, Your Honor, in our complaint.

[00:09:15] Speaker 04:
And I'm happy to go there and go through the allegations.

[00:09:17] Speaker 04:
we do identify that it's not just simple therapy.

[00:09:20] Speaker 04:
It's with neurologists, for instance, neuro-optimology therapists, that's different than your general practitioners who so far have been the only ones to look at and analyze our client's symptoms.

[00:09:30] Speaker 01:
So, again... Well, I thought it's just that they did disbelieve that this toxicity has happened, so that's why they haven't treated.

[00:09:37] Speaker 04:
Yes, yes.

[00:09:38] Speaker 04:
But again, but what you've heard, part of the argument that you would agree that they have said is that, well, the doctors already looked at them, and there's no issue, and they're not doing well.

[00:09:46] Speaker 04:
But what we're saying is, well, yes, because they haven't been diagnosed with the right materials yet.

[00:09:50] Speaker 04:
And once you get that diagnosis, then you can have treatment that's designated and that's detailed as to this issue.

[00:09:56] Speaker 04:
And again, the district court said we met our burden.

[00:09:58] Speaker 04:
If you disagree, the proper thing to do is to allow us the opportunity to at least make those allegations.

[00:10:03] Speaker 04:
If I can turn briefly to general jurisdiction with the time that I have left, because what we've heard from our friends on the other side is that we didn't meet our burden, and we did.

[00:10:12] Speaker 04:
If I can go through those allegations very, very quickly.

[00:10:14] Speaker 04:
For general jurisdiction or for specific jurisdiction?

[00:10:16] Speaker 04:
For general jurisdiction, yes.

[00:10:18] Speaker 04:
So I want to start with Roche Labs.

[00:10:20] Speaker 04:
We agree with our friends on the other side that the operative date is March 1st, 2023.

[00:10:25] Speaker 04:
We have in the record a May 2nd, 2022 annual report

[00:10:30] Speaker 04:
from Roche Labs that shows the majority of their officers and directors operating out of California.

[00:10:36] Speaker 04:
Again, what the Supreme Court has said is the nerve center is where it really matters here.

[00:10:39] Speaker 04:
Now what you sort of put in your file is it matters is where's the nerve center for operations.

[00:10:43] Speaker 04:
We then have a status report that we ourselves downloaded on May 9th, 2023.

[00:10:48] Speaker 04:
That's about three months or so, two or three months after Clint was filed.

[00:10:53] Speaker 04:
And there it showed the same orientation of officers and directors.

[00:10:56] Speaker 04:
It's not until June of 2023 that we then have a filing.

[00:11:01] Speaker 04:
that was submitted from our friends on the other side, that shows a change now.

[00:11:05] Speaker 04:
Where magically, after three different federal judges in Northern District of California had found that they were subject to general jurisdiction in California, they're magically now back in California.

[00:11:15] Speaker 04:
Focusing on Roche Inc.

[00:11:17] Speaker 04:
if we can, the district court respectfully ignored the well-planned allegations as a general jurisdiction as to Roche Inc.

[00:11:23] Speaker 04:
And if I can give you a few examples, the Roche website, up until the filing of our complaint, reported that Genentech South

[00:11:30] Speaker 04:
South San Francisco campus serves as a headquarters.

[00:11:33] Speaker 01:
Sorry, that May 2023 report, I thought it reflects information from May 2022.

[00:11:41] Speaker 04:
It was a status report that you basically download to see, okay, what's the current status of those entities?

[00:11:45] Speaker 04:
And that was the status as of that point.

[00:11:47] Speaker 04:
So yes, that reflects that the information had not changed between July 2022 and May 2023.

[00:11:54] Speaker 04:
If they had to, your honor, if I may,

[00:11:56] Speaker 04:
For instance, so if they had decided to switch all their people and move them to Natalie, New Jersey, they would have filed something interim, but they didn't do that.

[00:12:04] Speaker 04:
They only switched it over in June of 2020.

[00:12:06] Speaker 01:
So in May 2023, you're saying that this information is accurate as of May 2023?

[00:12:10] Speaker 04:
Correct.

[00:12:11] Speaker 04:
That's when we download the information.

[00:12:12] Speaker 04:
And at the very least, that's a factual question that allows us to go back and be heard on the merits.

[00:12:18] Speaker 04:
If I can go back to Rochette, Inc.

[00:12:20] Speaker 02:
So here we've identified multiple admissions by- I want to go back to this idea that that's a factual allegation.

[00:12:28] Speaker 02:
You're talking about personal jurisdiction.

[00:12:30] Speaker 02:
I guess the real question is should the district court allow limited discovery on the personal jurisdiction question?

[00:12:37] Speaker 02:
Because I don't think you get by personal jurisdiction just based on dueling allegations.

[00:12:45] Speaker 02:
You have to come up with evidence, don't you?

[00:12:47] Speaker 04:
Your Honor, and we said that in our brief, and we're thankful that you agree with us.

[00:12:50] Speaker 04:
Yes, at the very least, the district court should have had an evidentiary hearing.

[00:12:54] Speaker 04:
The district court should not have resolved facts and disputes about general jurisdiction on its own at the most indisputable stage.

[00:12:59] Speaker 04:
So you're correct.

[00:13:01] Speaker 04:
As to both entities, there were definite disputes of fact.

[00:13:03] Speaker 04:
If I can just say one other quick point before I address the other issues in the case.

[00:13:07] Speaker 04:
As to the Roche Inc.

[00:13:08] Speaker 04:
entity, we had multiple admissions from Roche through their websites, through press releases, through SEC filings,

[00:13:15] Speaker 04:
that all reported that after the 2009 merger with the Genentech entities, that all of the Roche entities were being housed in San Francisco.

[00:13:24] Speaker 04:
They submitted a declaration of Mr. Resnick.

[00:13:26] Speaker 04:
And on appeal, what they've said is, Mr. Resnick's declaration, this somehow negates everything in our allegations.

[00:13:31] Speaker 04:
But it doesn't.

[00:13:32] Speaker 04:
And here's what I judge Boumete.

[00:13:34] Speaker 04:
Nowhere in that declaration does he say, hey, you know, we had plans to relocate to San Francisco, but we decided not to do it.

[00:13:42] Speaker 04:
He doesn't say, oh, by the way, when the website refers to Roche,

[00:13:44] Speaker 04:
It's referring to some other Roche entities and not Roche that's a part of this case.

[00:13:48] Speaker 04:
The declaration, it says two relevant things that are important here.

[00:13:53] Speaker 04:
It says number one, that the minutes that were prepared, that they were remotely done and remotely done in New Jersey.

[00:14:00] Speaker 04:
Remote minutes does not establish where general jurisdiction is.

[00:14:03] Speaker 04:
They make a second point that says the primary activity now of Roche Inc.

[00:14:07] Speaker 04:
is now licensing of their patents.

[00:14:10] Speaker 04:
And they said that our officers sat

[00:14:14] Speaker 04:
and performed in Jersey in March 2023.

[00:14:18] Speaker 01:
Can I ask a question?

[00:14:19] Speaker 01:
If we were to disagree with you on the personal jurisdiction question about the Roche defendants, would that knock out the case, or would that leave the Genentech defendants left?

[00:14:30] Speaker 01:
It would leave the Genentech defendants left, Your Honor.

[00:14:33] Speaker 04:
But hopefully you don't disagree with us on the jurisdiction issue.

[00:14:36] Speaker 01:
I'm just asking questions.

[00:14:38] Speaker 04:
Because keep in mind, in Mr. Resnick's declaration, he says nothing at all.

[00:14:41] Speaker 04:
about the directors of the entities.

[00:14:44] Speaker 04:
He doesn't at all refute the allegations that are in our complaint.

[00:14:48] Speaker 01:
Let me just ask one other question.

[00:14:51] Speaker 01:
Can you just proceed on your claims on Genentech alone?

[00:14:56] Speaker 01:
Dependents alone, sorry.

[00:14:57] Speaker 04:
We could, Your Honor, but our concern is that there may not be complete relief for our clients and the class.

[00:15:01] Speaker 04:
And all these issues about, okay, which defendant should be liable, who can be subject to a judgment, these are all matters that can and will be ironed out later on in the case in discovery.

[00:15:11] Speaker 04:
All we're asking here is for our clients to have an opportunity to go forward with their case.

[00:15:15] Speaker 04:
If we can address the political question issue as to the military, okay, I see Judge Wippetay doesn't think we need to do that, so I'll move on unless there are other questions.

[00:15:25] Speaker 01:
Did you want her to save five minutes?

[00:15:27] Speaker 04:
I want to reserve three minutes.

[00:15:28] Speaker 04:
So maybe what I will say here, one of the things our friends on the other side is trying to get this court to do is to adopt a very broad federal preemptive ruling that would apply to name brand drug manufacturers.

[00:15:40] Speaker 04:
And the court should not do that.

[00:15:41] Speaker 04:
First of all, there's the Levine case from the Supreme Court that obviously precludes this court from finding there's preemption as to failure to warn claims as far as name brand manufacturers.

[00:15:51] Speaker 04:
And I strongly encourage the court to look at the concurring opinion of Justice Thomas in that decision.

[00:15:56] Speaker 04:
Justice Thomas was part of the majority of Levine, and then he also wrote the messing decision.

[00:16:01] Speaker 04:
And then there he identifies some key language that I think is very important for the court to consider if my friends on the other side want to argue about preemption.

[00:16:09] Speaker 04:
Justice Thomas wrote the following.

[00:16:11] Speaker 04:
Initial approval of a label amounts to a finding by the FDA that the label is safe for purposes of gaining federal approval

[00:16:19] Speaker 04:
to market the drug.

[00:16:21] Speaker 04:
It does not represent a finding that the drugs, as labeled, can never be deemed unsafe by later federal action or, as in this case, the application of state law.

[00:16:34] Speaker 04:
As the Levine Court makes very clear through the statutory language in the Food and Drug Cosmetic Act, Congress did not intend to abrogate state law that plays a critical role

[00:16:44] Speaker 04:
in overseeing and policing when drugs harm people.

[00:16:48] Speaker 01:
Here... So which case was that that you're recording Justice Thomas from?

[00:16:51] Speaker 01:
Bean.

[00:16:52] Speaker 01:
Levine.

[00:16:52] Speaker 02:
Yes.

[00:16:52] Speaker 02:
But the Supreme Court has... The Supreme Court in Levine.

[00:16:55] Speaker 02:
I guess I need to go back and look at that because I'm worried that your statement is a little bit too over-broad because the Supreme Court has clearly said there are cases where you're preempted.

[00:17:06] Speaker 02:
State claims are preempted once the FDA approves it.

[00:17:11] Speaker 04:
And Your Honor, I see I'm running out of time for you to answer your question and save my time.

[00:17:14] Speaker 04:
So you're right, your honor, and what the Supreme Court said in the Messing case and the Bartlett case is as it pertains to generic manufacturers, there is preemption.

[00:17:23] Speaker 04:
Because generic manufacturers, and again, this is a very important part here, generic manufacturers have to comply with the labels of the name brand drug manufacturers.

[00:17:34] Speaker 04:
And that's what the district court made a huge error here.

[00:17:36] Speaker 04:
The district court thought because the entity's name is Genentech, they must be generic manufacturers.

[00:17:40] Speaker 04:
and therefore messing Bartlett apart.

[00:17:46] Speaker 02:
Even the non-generic companies have to comply with the label.

[00:17:54] Speaker 02:
I don't understand that distinction.

[00:17:55] Speaker 04:
Well, that's the distinction the Supreme Court itself has drawn, Your Honor.

[00:17:58] Speaker 04:
If we look at Levine, the court has made it clear that as to a name brand manufacturer,

[00:18:02] Speaker 04:
They actually play a critical role in the labeling.

[00:18:05] Speaker 04:
They submit to the FDA proposals as to how to label it.

[00:18:08] Speaker 02:
There's also- But that seems different.

[00:18:10] Speaker 02:
So this is only about your design defect claim.

[00:18:12] Speaker 04:
No.

[00:18:12] Speaker 04:
Well, there's both.

[00:18:13] Speaker 04:
We have design defect and we have failure to warn claim.

[00:18:15] Speaker 02:
Yeah, I know.

[00:18:16] Speaker 02:
But I don't understand.

[00:18:18] Speaker 02:
Your argument might apply to design defect.

[00:18:20] Speaker 02:
I don't understand how it applies to failure to warn, because failure to warn is what the Supreme Court has said.

[00:18:25] Speaker 02:
We tell you what you have to say.

[00:18:28] Speaker 02:
No, Your Honor.

[00:18:30] Speaker 00:
Wyeth drew the distinction and was upheld in that in Mensing, but with the changes being affected regulation, correct?

[00:18:39] Speaker 04:
Correct, Your Honor, correct.

[00:18:40] Speaker 00:
And the NDA holder has that power and that obligation under certain circumstances that state law can recognize, right?

[00:18:50] Speaker 04:
Correct.

[00:18:50] Speaker 04:
And if I could just add one quick thing, in Justice Thomas's concurrence in Wyeth v. Levine,

[00:18:55] Speaker 04:
He goes through and he catalogs that the federal regulations that show that even after the drug is approved by the FDA.

[00:19:02] Speaker 04:
there are distinct reporting requirements where the drug manufacturer has to tell the FDA, are people having adverse effects?

[00:19:08] Speaker 04:
Are there things going on?

[00:19:09] Speaker 04:
So the simple approval by the FDA does not somehow insulate these drug manufacturers for liability, nor should that be the rule simply because it's the military that buys these products.

[00:19:18] Speaker 04:
If so, that leaves on military men and women in less protected general public when they use consumer goods.

[00:19:24] Speaker 04:
Thank you.

[00:19:25] Speaker 04:
We'll give you time for rebuttal.

[00:19:25] Speaker 04:
Thank you.

[00:19:26] Speaker 04:
Thank you so much.

[00:19:40] Speaker 03:
Good morning, Your Honor.

[00:19:41] Speaker 03:
May it please the Court, David Zients, on behalf of the defendants.

[00:19:44] Speaker 03:
I propose, subject to your questions, to start with the standing issue that we've been discussing already this morning.

[00:19:51] Speaker 03:
I would then like to talk, if the Court gets past subject matter jurisdiction, kind of two issues that together dispose of the whole case.

[00:19:58] Speaker 03:
One is personal jurisdiction, on which the District Court was entirely correct.

[00:20:02] Speaker 03:
In the second, Judge Bumate, you asked the question, what then happens to the Genentech defendants?

[00:20:06] Speaker 03:
The simple answer

[00:20:07] Speaker 03:
is the plaintiffs have now disclaimed everything but success or liability for the Genentech defendants.

[00:20:12] Speaker 03:
They have not come close to pleading the prerequisites for success or liability.

[00:20:15] Speaker 03:
So I'd hope to touch on that as well.

[00:20:18] Speaker 03:
To start, though, with standing.

[00:20:21] Speaker 02:
So standing, just help my framework here.

[00:20:23] Speaker 02:
We're looking at this as a federal issue.

[00:20:25] Speaker 02:
I mean, to what degree does the California, do California state court decisions influence or affect our Article III

[00:20:36] Speaker 03:
I don't think it's really relevant, you know, this is, you know, the question is, is there injury traceability, redressability as a matter of, you know, is it a case of controversy under the Constitution?

[00:20:48] Speaker 03:
You know, I think, you know, there is some, the Supreme Court said in O'Shea and Lyons, there can be some shading into between, you know, the scope of the remedy that exists and questions of redressability.

[00:21:02] Speaker 03:
Here, I think when you read the Potter decision, I don't actually see the delta between that and what everyone else talks about in terms of medical monitoring.

[00:21:09] Speaker 03:
The basic problem here is there's a mismatch.

[00:21:12] Speaker 03:
The whole concept of monitoring, it's in the word monitor.

[00:21:16] Speaker 03:
You monitor to catch something before it happens.

[00:21:18] Speaker 03:
So in the traditional case,

[00:21:20] Speaker 03:
If you have exposure to a toxin and that exposure increases your risk, then you might get some benefit to be able to have the polluter funding a regime where you go in and get regular checkups and they catch a cancer that is developing in your system before the symptoms arise.

[00:21:40] Speaker 03:
Here, they say, we are already injured.

[00:21:42] Speaker 03:
And they've sort of pled themselves into a Catch-22.

[00:21:45] Speaker 03:
And they did it for a reason, by the way.

[00:21:47] Speaker 03:
I don't think it's sort of an accident or something that could be fixed with some sort of, you know, amendment.

[00:21:54] Speaker 02:
That's my question is, shouldn't they be allowed to amend?

[00:21:58] Speaker 02:
But I have this lingering question of whether they could.

[00:22:00] Speaker 02:
If we agree with this theory that medical monitoring doesn't work here.

[00:22:09] Speaker 03:
So I think there's several standing problems and at least some of them are not fixable.

[00:22:15] Speaker 03:
One of them in theory, the idea of like a better treatment, better clinical treatment, that's the only one of them that's a real pleading issue that in theory is fixable.

[00:22:26] Speaker 03:
I didn't hear in response to your questions any answer as to how.

[00:22:30] Speaker 03:
But that's, I think, you don't even have to get to that issue because there's just a more conceptual problem here.

[00:22:36] Speaker 03:
They're basically trying to do this as a class action.

[00:22:40] Speaker 03:
To have a class action, you can't have individual issues predominate.

[00:22:44] Speaker 03:
And in a normal toxic torque case where you claim you've been injured by the side effects of a drug, you're going to have to prove on an individualized basis that that is actually the cause and it wasn't something else.

[00:22:56] Speaker 03:
And you can't do that as a class action.

[00:22:58] Speaker 03:
So they try to get around that with this medical monitoring, but it just winds up not fitting.

[00:23:04] Speaker 02:
What about, and I guess you don't remand it for them to add a new plaintiff, but theoretically they could add a plaintiff who hasn't yet had any symptoms.

[00:23:13] Speaker 02:
But I guess your argument would be, it's too late for that.

[00:23:17] Speaker 02:
If you do have such a plaintiff, let them bring a new claim.

[00:23:20] Speaker 02:
Because that doesn't fit within actually the class that they ask to be certified, right?

[00:23:25] Speaker 03:
No, Your Honor.

[00:23:26] Speaker 03:
The claim here is that people already have this condition.

[00:23:30] Speaker 03:
I think if there is another plaintiff out there that they want to find to bring a case, we might have a disaster limitations issue.

[00:23:35] Speaker 01:
I have to look at the complaint again.

[00:23:37] Speaker 01:
At least it was presented just this morning, though.

[00:23:39] Speaker 01:
It seems like they were saying, well, they have the symptoms, but they don't yet have the toxicity diagnosis.

[00:23:46] Speaker 03:
I think that's the catch-22, that they've led themselves into a box.

[00:23:50] Speaker 03:
So if they have the condition,

[00:23:52] Speaker 01:
Well, is there a difference between symptoms and the condition?

[00:23:55] Speaker 01:
Can't they have symptoms but not the condition?

[00:23:57] Speaker 01:
And so they're suggesting they could potentially get more symptoms in the future that then crosses a threshold into the diagnosis of, I can never say, the toxicity problem.

[00:24:11] Speaker 03:
Sure.

[00:24:12] Speaker 03:
Well, I think the plaintiffs, I don't think they've pled that they're worried

[00:24:18] Speaker 03:
that they have sort of the precursors to something, and then it's going to get worse or this condition will manifest.

[00:24:24] Speaker 03:
To be honest, I'm not entirely sure, because sometimes it changes, but if their position is

[00:24:30] Speaker 03:
We have these symptoms that might be caused by mefloquine, but they also might be caused by something else, like PTSD.

[00:24:38] Speaker 03:
And because we're uncertain about that, then we need to get monitored and get a diagnosis.

[00:24:44] Speaker 03:
If that's the claim, I think they have the problem that Judge Hamilton was alluding to earlier, which is part of the claim here is the causation.

[00:24:51] Speaker 03:
in its causation and redressability.

[00:24:55] Speaker 03:
And it's totally speculative.

[00:24:56] Speaker 03:
If they don't want to prove in court that this was a cause, because they want to have a class action, they don't actually want to have to go through the process of saying, you know, for this individual plaintiff, I can rule out PTSD.

[00:25:09] Speaker 01:
Why is that a causation problem?

[00:25:10] Speaker 01:
So, you know, say they were exposed to the toxin.

[00:25:13] Speaker 01:
They have some symptoms of this toxicity, but they're worried, you know, it has not been diagnosed

[00:25:21] Speaker 01:
Yet, but they're worried that it's a progressive problem, and they'll get worse, and then at some point, they'll cross a threshold into being diagnosed to that disease.

[00:25:29] Speaker 01:
So monitoring would help that, correct?

[00:25:33] Speaker 03:
Your Honor, I don't understand the allegations to be, you know, they haven't crossed a threshold yet, but they'll be able to catch it before they do.

[00:25:40] Speaker 03:
The allegation to me seems to be, you know, sometimes it's, we really think, you know, Plaintiff Caston

[00:25:47] Speaker 03:
in her complaint, this is at paragraph 186, says it is highly likely that her condition is related to her ingestion of mefloquine.

[00:25:56] Speaker 03:
You know, if she's right about that, then she's going to be able to prove by a preponderance of the evidence that actually this is what she has.

[00:26:02] Speaker 03:
And if this is what she has, it doesn't redress that to get a doctor to say, yes, this is what you have.

[00:26:09] Speaker 00:
it if it by the way if in a traditional well it could look sorry is the solution to the problem you're highlighting then just in essence a mass toward action of individual claims being brought by people who have been exposed to mefloquine

[00:26:26] Speaker 03:
Yeah, and a traditional, you know, this happens all the time.

[00:26:29] Speaker 03:
People who claim they've been injured by the side effects of a drug bring toxic tort actions.

[00:26:34] Speaker 03:
In general, these are done on an individualized basis.

[00:26:37] Speaker 03:
If there's a lot of them, they might be consolidated in a multi-district litigation.

[00:26:40] Speaker 00:
There are people... But in this case, there would be huge statute of limitations problems, correct?

[00:26:46] Speaker 03:
It would be a huge... I think that, you know, we raised the statute of limitations issue in our motion to defend... And that's why they're looking for medical monitoring, because they want to say it hasn't arisen yet.

[00:26:56] Speaker 03:
I think that is one reason.

[00:26:57] Speaker 03:
I think another reason is just to have a way to get a class action.

[00:27:02] Speaker 03:
I don't want to put words into the mouths of plaintiffs, but there is a sort of artificial construct here.

[00:27:08] Speaker 03:
And if I could just finish, I think to Judge Boumete, you were asking, is it really a causation issue?

[00:27:15] Speaker 03:
even if you can sort of avoid the causation problem by saying, you know, you're just getting the monitoring to sort of clear up the uncertainty about what they have or what they don't have, you then have, you know, a very big, you know, speculation problem.

[00:27:28] Speaker 03:
Because if they want to say, no, the reason we don't have this issue of no redressability is we don't actually know, and what we will benefit from is the diagnosis, it's

[00:27:40] Speaker 03:
If that's the allegation, it becomes totally speculative that it is that, rather than all the conditions that their doctors for the last 20 years have been telling me.

[00:27:49] Speaker 01:
But that seems like it could be fixed by repleting, potentially.

[00:27:53] Speaker 01:
He claims, so they say.

[00:27:55] Speaker 03:
I guess I haven't heard.

[00:27:56] Speaker 03:
I didn't hear what

[00:27:58] Speaker 03:
what that could be.

[00:27:59] Speaker 03:
I didn't see in the brief even a suggestion.

[00:28:02] Speaker 03:
You know, we raised, we crossed the field, they had an opportunity to raise this in response.

[00:28:06] Speaker 03:
I didn't see some suggestion that because of how this played out in the district court that they really ought to get a chance.

[00:28:12] Speaker 03:
I just don't see what the fix would be.

[00:28:13] Speaker 03:
To me, it's much more conceptual where they're trying to jam a square peg into a round hole.

[00:28:18] Speaker 00:
It's a little early to say it's impossible, however.

[00:28:23] Speaker 02:
Sure, Your Honor.

[00:28:24] Speaker 02:
I guess

[00:28:25] Speaker 02:
That's my question is what I mean our standard seems to be pretty high if we agreed with you on this theory The standard seems to be pretty high does this say well, they don't get a chance to amend I mean they didn't even need to ask to amend below because the district court said there was

[00:28:41] Speaker 02:
So I'm just not sure we can spin out all the hypotheticals.

[00:28:46] Speaker 02:
This is not intuitive how this would play out.

[00:28:50] Speaker 02:
I mean, you may be right, but I just wonder why we don't let the district court figure that out on remand.

[00:28:55] Speaker 02:
I know that's probably not what you want right now.

[00:28:58] Speaker 00:
In front of an actual amended complaint instead of a hypothetical one.

[00:29:02] Speaker 03:
You know, I understand that, Your Honor.

[00:29:05] Speaker 03:
I think, you know, there's aspects of this that are pleadings, there are aspects of it that the way they've engineered this entire case just lands them in this... No, I'm sensitive to that.

[00:29:16] Speaker 02:
I just don't... I mean, that was the question I had, is can they do it?

[00:29:20] Speaker 02:
And my gut tells me...

[00:29:21] Speaker 02:
If we agreed with this argument, it would be very difficult, but very difficult is different than impossible.

[00:29:27] Speaker 03:
Sure, Your Honor.

[00:29:28] Speaker 03:
Well, I mean, I guess I'd go further and say it's difficult.

[00:29:33] Speaker 03:
It's impossible.

[00:29:34] Speaker 03:
I think it's difficult to the point that without the plaintiffs coming here and saying what they would do,

[00:29:38] Speaker 03:
it would sort of be a waste of judicial resources.

[00:29:41] Speaker 03:
Obviously, normally this plays out in a district court where the district court says, I'm dismissing.

[00:29:46] Speaker 03:
Well, what do you got?

[00:29:47] Speaker 03:
Here, obviously, the district court had, in our view, an erroneous view of the standing issue.

[00:29:52] Speaker 03:
So I guess the court here would have options about what to do.

[00:29:54] Speaker 02:
Maybe this is a good transition to the personal jurisdiction issue because, I mean, just hypothetically, if we agreed with you on the standing and the personal jurisdiction issue,

[00:30:06] Speaker 02:
We could decide either one, right?

[00:30:08] Speaker 02:
We don't have to decide them both, and we don't have to decide them in order.

[00:30:11] Speaker 02:
We could decide either one, right?

[00:30:13] Speaker 03:
So as to the Roche defendants, that's absolutely correct.

[00:30:16] Speaker 02:
Genentech is different because of the successor.

[00:30:18] Speaker 03:
The Genentech defendants don't have a personal jurisdiction defense, because they are California corporations.

[00:30:27] Speaker 03:
Their defense is, we don't belong in this case, because we have nothing to do with any of this.

[00:30:30] Speaker 01:
So even if you wanted to go with personal jurisdiction, we would still need to confront the Article III issue with Genentech.

[00:30:38] Speaker 03:
I think that's right.

[00:30:39] Speaker 03:
And I was really looking for a way to tell the court.

[00:30:42] Speaker 03:
Because honestly, personal jurisdiction is quite straightforward in the successor liability issue.

[00:30:48] Speaker 03:
There's just nothing there.

[00:30:50] Speaker 03:
But Steel Co.

[00:30:51] Speaker 03:
is Steel Co.

[00:30:52] Speaker 03:
and I think probably the answer is that you have to get through subject matter jurisdiction in order to get to that one particular issue.

[00:31:04] Speaker 03:
But I will say, Your Honor, one advantage of standing is that it could dispose of the whole case if the court, and then I don't think you need to reach anything else.

[00:31:13] Speaker 03:
If the court is inclined to say this should have been dismissed for standing, but there should have been an opportunity to replede, you know, given that that would then not be kind of complete relief for at least for any of the defendants, you know, we'd suggest that it would be appropriate to then also, you know, reach and affirm the district court on the personal jurisdiction issue.

[00:31:35] Speaker 02:
Even though that would only take care of two of the defendants, not, I mean, you still have to, but the district court did say there was no successor liability, right?

[00:31:43] Speaker 03:
The district court, I think the

[00:31:48] Speaker 03:
Things got a little muddled in the way, it was sort of unclear what the plaintiffs were saying the problem was with Genentech.

[00:31:54] Speaker 03:
The district court dismissed Genentech.

[00:31:56] Speaker 03:
You know, I think when the district court was talking about generic, we agree that Genentech is not a generic manufacturer.

[00:32:03] Speaker 03:
I think what the district court was getting at is this, it's what Judge Hamilton was talking about before.

[00:32:07] Speaker 03:
It's the NDA holder is what matters.

[00:32:10] Speaker 03:
There's the NDA holder and then there's everyone else and the Genentech defendants are everyone else.

[00:32:14] Speaker 00:
Can we focus on that for just a moment?

[00:32:15] Speaker 00:
I want to make sure I understand

[00:32:18] Speaker 00:
relationship among the, we have four defendants, right?

[00:32:21] Speaker 00:
Two Genentech, two Roche and something.

[00:32:25] Speaker 00:
Correct, Your Honor.

[00:32:26] Speaker 00:
Are they under common ownership?

[00:32:28] Speaker 03:
They are not there is an ultimate parent that is the same yes, but they are not they don't fall in the same lines You know one is to one side.

[00:32:37] Speaker 00:
They are under the common ownership.

[00:32:39] Speaker 00:
Yes, your honor, okay, so help me out and I've been studying and trying to you know follow the difference between Levine and Mensing for a number of years now since those cases came out and

[00:32:54] Speaker 00:
But I've never before seen a situation in which the NDA holder and the, was a distinct entity from other defendants that are not generic, but are engaged in the business and they're all under common ownership.

[00:33:14] Speaker 00:
How do Levine and, Wyeth against Levine and Mensing play out in that situation?

[00:33:21] Speaker 03:
Sure.

[00:33:22] Speaker 03:
I think, Your Honor, the reason you haven't seen a case that looks quite like this is because they've pled two of these four companies have nothing at all to do with this drug.

[00:33:35] Speaker 03:
Roche, Roche Inc.

[00:33:38] Speaker 03:
stopped making larium around 2005, 2006.

[00:33:42] Speaker 03:
The transaction that they're talking about that they call a merger happened in 2009.

[00:33:47] Speaker 03:
There's no allegation that Genentech ever had anything to do with brand name larium, with generic mefloquin, anything.

[00:33:54] Speaker 03:
They've, they have clarified that all, all, the only reason that the Genentech defendants are here is they think that they have succeeded to the liabilities of Roche Inc.

[00:34:05] Speaker 03:
And so, you know, that's why I think the theory, as I understand it, that they're pursuing now is that, you know, Rochink is the NDA holder, so it can be liable, and Genentech has now been assigned those liabilities, which just, they have not come close to pleading

[00:34:21] Speaker 03:
the prerequisites for that because Roche Inc.

[00:34:26] Speaker 03:
still exists.

[00:34:27] Speaker 03:
They concede that it exists as a separate entity.

[00:34:33] Speaker 03:
The normal rule for successor liability in any state whose law could apply here is you don't have successor liability when the predecessor exists and you have recourse.

[00:34:43] Speaker 03:
Clearly there's recourse.

[00:34:44] Speaker 03:
They are suing the Roche Defenders.

[00:34:46] Speaker 00:
Did Genentech

[00:34:48] Speaker 00:
in the 2007 or so transaction receive assets related to Mephlaquin from any Roche entities?

[00:35:02] Speaker 03:
We are on it.

[00:35:02] Speaker 03:
Are you asking as a factual matter or under the complaint?

[00:35:04] Speaker 00:
As a fact, well, if they're different, please tell me.

[00:35:08] Speaker 03:
I don't think so.

[00:35:12] Speaker 03:
As I understand it, all they say in the complaint

[00:35:14] Speaker 03:
What we know is that the Roche Inc.

[00:35:20] Speaker 03:
got out of the larium business, stopped making it, voluntarily applied to withdraw its NDA before this 2009 transaction happened where Genentech became fully owned by the ultimate corporate parent.

[00:35:36] Speaker 03:
The plaintiffs, I think, are being a little clever in the complaint where they say,

[00:35:42] Speaker 03:
that part of the transfer of assets meant that Genentech acquired the capability of continuing on the Larium line of business, but I guess that just means they could if they wanted to.

[00:35:55] Speaker 03:
I'm not really sure what that means, but there's no allegation

[00:35:58] Speaker 03:
That the Genentech ever had anything to do with larium and and and I don't think that I think that is correct That just they've never had anything to do with it.

[00:36:06] Speaker 00:
Let me let me raise just my explicitly my concern It may or may not be applicable to this case But I'm concerned about some clever corporate lawyering That would in a case where a drug is causing trouble and is going to be inviting massive liability.

[00:36:25] Speaker 00:
We've all seen those cases and

[00:36:27] Speaker 00:
where a parent company decides we'll put the NDA in the shell subsidiary and we'll keep our operational, our operations in separate subsidiaries and assets in separate subsidiaries.

[00:36:43] Speaker 00:
and will say that Levine lets you only reach the one corporate entity that holds the NDA, which would be useless.

[00:36:54] Speaker 00:
Would you agree that that's not necessarily all insulated under Levine and Mensing?

[00:37:01] Speaker 03:
No, I don't think it would be.

[00:37:03] Speaker 03:
I think the same rules that preclude this case in terms of corporate relationships and how liabilities pass on, what you're describing I think would fall readily into one of these rules for if you set up a shell company to have the NDA but to not actually have the ability to pay a judgment, that's what's missing here.

[00:37:26] Speaker 03:
If you create a situation where you try to

[00:37:28] Speaker 03:
you know, put all the liability into a company that is not able to pay a judgment and then no one has recourse.

[00:37:34] Speaker 03:
You know, that's exactly when the rules the plaintiffs want to invoke would come into play.

[00:37:38] Speaker 03:
Here, there is absolutely no allegation that that's what happened.

[00:37:42] Speaker 03:
You know, as an actual matter, all of this, you know, the idea that Lariam had these liabilities, this is coming up much later, well after the relevant corporate transactions.

[00:37:52] Speaker 03:
have happened, but just on the face of the complaint, they don't allege that the Roche defendants are not capable of satisfying a judgment.

[00:37:59] Speaker 03:
And they voted with their feet on that.

[00:38:01] Speaker 03:
They've sued the Roche defendants.

[00:38:02] Speaker 03:
So obviously, they think they are separate entities who are capable of satisfying a judgment.

[00:38:09] Speaker 03:
Your Honor, I haven't spoken much about personal jurisdiction, so I thought, you know, just very quickly, you know, I think their argument has basically come down to this status report that they describe as the May 9th, 2023 status report.

[00:38:25] Speaker 03:
You know, page 79 of the excerpts of record is a declaration from plaintiff's counsel, one of plaintiff's counsel who says what this is, says, on May 9th, 2023, I purchased the status report for Roche Lapid

[00:38:38] Speaker 03:
laboratories.

[00:38:39] Speaker 03:
So, you know, it's very clear that what this means is that doesn't mean that on that day someone in New Jersey called up the Roche defendants and say, hey, is it still right?

[00:38:48] Speaker 03:
Can we still report that these are your officers and directors?

[00:38:51] Speaker 03:
It's just that's what was in the system as of that date.

[00:38:54] Speaker 03:
And when you look at it, page 82 and 83 of the record, it says following are the most recently reported officers and directors.

[00:39:01] Speaker 03:
And it says the date of that most recent report.

[00:39:03] Speaker 03:
It was May 2nd, 2022.

[00:39:05] Speaker 03:
The district court got this

[00:39:07] Speaker 03:
absolutely right.

[00:39:08] Speaker 03:
And I don't, this is not a factual dispute.

[00:39:10] Speaker 03:
This is the plaintiffs, you know, looking at a document and pretending it says something that it does not and using that, you know, ginned up idea of a factual dispute to controvert, you know, an affidavit.

[00:39:22] Speaker 03:
There is clear evidence in the record on an affidavit totally appropriate on a personal jurisdiction challenge saying as of March 1st, 2023, all of the officers and directors were located in New Jersey.

[00:39:35] Speaker 03:
And there's just nothing at all in that corporate filing that contradicts that in any way.

[00:39:41] Speaker 03:
Subject, I see my time is up.

[00:39:43] Speaker 03:
And absent any other questions, we'd ask you to vacate the decision on standing and reverse dismiss for that reason or alternatively to affirm the dismissal.

[00:39:54] Speaker 02:
Okay.

[00:39:55] Speaker 02:
Thank you.

[00:39:56] Speaker 02:
Thank you, Your Honor.

[00:39:57] Speaker 02:
We'll give three minutes for rebuttal.

[00:40:11] Speaker 04:
Your honors, I know I just have three minutes.

[00:40:12] Speaker 04:
I'll try to briefly address the questions you asked.

[00:40:15] Speaker 04:
So our friends on the other side can see that it's not impossible for us to replede this, and I think that's determinative.

[00:40:20] Speaker 04:
You asked about, well, what is it in the complaint that shows that this is redressable?

[00:40:25] Speaker 04:
Again, paragraph 90, we refer to therapy, specified therapy in this context.

[00:40:31] Speaker 04:
Now, what our friends are saying is, oh, therapy, that's not enough.

[00:40:33] Speaker 04:
That's a factual issue.

[00:40:35] Speaker 04:
The question is whether or not we plead that there is a basis.

[00:40:37] Speaker 04:
We also, in addition, in paragraph 91, refer to physical rehabilitation.

[00:40:41] Speaker 04:
to address neurological symptoms that can be more especially tailored where you have a methylcontoxicity diagnosis than when you don't.

[00:40:47] Speaker 04:
Again, what they're contesting is, hey, we don't think this stuff is going to work.

[00:40:49] Speaker 04:
Therefore, your client should not have their day in court.

[00:40:51] Speaker 04:
That's not the rule.

[00:40:52] Speaker 04:
I think, Judge Nelson, you were having a lot of questions about, well, what does this case really look like?

[00:40:56] Speaker 04:
Let me go back to Potter.

[00:40:57] Speaker 04:
Because really, Potter is what defines what is a medical monitoring case.

[00:41:02] Speaker 04:
And these are the elements.

[00:41:03] Speaker 04:
You have to show the significant exposure to a hazardous substance and the extent of the exposure.

[00:41:07] Speaker 04:
Here, they were taking weekly pills.

[00:41:11] Speaker 04:
that were interrupting the central nervous system of these military veterans, the toxicity of the chemicals.

[00:41:17] Speaker 04:
At the time that this drug was going for approval, they were telling the FDA that it's rare that anyone would have any suicide ideation, any sort of post-traumatic stress, or other types of symptoms associated with malignant toxicity.

[00:41:31] Speaker 04:
What we now know is that more than half of the people that take this drug will have these symptoms.

[00:41:36] Speaker 04:
The third element is an increased risk of disease.

[00:41:39] Speaker 04:
In other words, it's different than in the general public, and then also the clinical value of early detection.

[00:41:46] Speaker 04:
All these things are things that we will prove and we can establish.

[00:41:49] Speaker 04:
And I hear my friends now talking about class action, why we're working as a class action.

[00:41:53] Speaker 04:
Why are we talking about class actions?

[00:41:55] Speaker 04:
They're doing that because they know we have met our burden.

[00:41:57] Speaker 04:
We've met our burden under Ickley and Tomley.

[00:41:59] Speaker 04:
We've met our burden under Section 8.

[00:42:02] Speaker 01:
Sorry, just go back to your first point.

[00:42:04] Speaker 01:
You said Paragraph 90 is the one that talks about the actual treatment.

[00:42:08] Speaker 01:
So it just says the therapeutic treatment for the texosity differs substantially from therapeutic treatments provided to

[00:42:16] Speaker 01:
individuals with PTSD.

[00:42:17] Speaker 01:
So if we gave you an opportunity to amend, you could say how that's substantially different, right?

[00:42:23] Speaker 01:
I would assume.

[00:42:23] Speaker 04:
Yes, if the court felt that that was necessary, of course we would do that.

[00:42:27] Speaker 04:
Yes, Your Honor.

[00:42:27] Speaker 04:
Yes.

[00:42:28] Speaker 04:
I'm just telling you, sitting here today, I personally don't know.

[00:42:30] Speaker 04:
I'm not a doctor.

[00:42:31] Speaker 02:
That's fair.

[00:42:31] Speaker 04:
I can't testify as to that.

[00:42:33] Speaker 02:
I have 40 seconds left, so I will try to go through the rest of this.

[00:42:35] Speaker 02:
Can I just ask you real quickly, and we'll give you some more time if you need it.

[00:42:39] Speaker 02:
Potter, you said it was an equitable medical monitoring, was an equitable remedy in Potter.

[00:42:45] Speaker 04:
Well, California courts have described medical monitoring as an equitable remedy.

[00:42:50] Speaker 02:
That's correct.

[00:42:51] Speaker 02:
OK.

[00:42:51] Speaker 02:
But not damages.

[00:42:54] Speaker 02:
They haven't described them as damages.

[00:42:56] Speaker 04:
Well, I think the way that Potter sort of analogized the remedy to damages is to sort of say, hey, this is why we think it should be allowed.

[00:43:02] Speaker 04:
Because it's no different than if you were injured and you wanted to have money to pay for your medical bills.

[00:43:07] Speaker 04:
They looked at it in terms of, OK, is it?

[00:43:09] Speaker 02:
Well, I think it's totally different.

[00:43:10] Speaker 02:
That's the problem.

[00:43:11] Speaker 02:
Because medical monitoring is not

[00:43:16] Speaker 02:
to compensate you for damages you've already had.

[00:43:18] Speaker 02:
I mean, we're running around in circles here.

[00:43:21] Speaker 04:
But what I'm saying is, this is how the California Supreme Court analyzed whether they would allow medical monitoring under state law claims.

[00:43:29] Speaker 02:
And as the court today.

[00:43:30] Speaker 02:
Well, there's no question that medical monitoring is allowed.

[00:43:32] Speaker 02:
It's still allowed.

[00:43:33] Speaker 02:
Yeah, that's not the question.

[00:43:34] Speaker 02:
The question is what is it?

[00:43:36] Speaker 02:
Because if it's damages, then the class action that you've sought doesn't work.

[00:43:41] Speaker 02:
That's why I have questions about whether you can actually fix this on remand.

[00:43:46] Speaker 04:
And when we come before the court in our class certification, we'll be happy to argue that issue.

[00:43:51] Speaker 04:
But we're not here today on class.

[00:43:53] Speaker 02:
Go ahead.

[00:43:53] Speaker 02:
Yeah, we'll give you another minute.

[00:43:55] Speaker 04:
So to quickly go to the resident declaration,

[00:43:58] Speaker 04:
You didn't hear from my friend on the other side contest anything of what I told you.

[00:44:01] Speaker 04:
The things that are missing from the resident declaration that calls into question the many admissions from the Roche defendants over many, many years that they're in San Francisco.

[00:44:10] Speaker 04:
They didn't talk about Poole, they didn't talk about Sheese, they didn't talk about Mozzano.

[00:44:13] Speaker 04:
In addition to that, the Cleveland case is a very important case if this court even wants to go down the realm of successor liability.

[00:44:20] Speaker 04:
Because this is a 2012 case, a more recent case by the California Supreme Court.

[00:44:24] Speaker 04:
And in that case, the California Supreme Court made it clear there is no per se rule when it comes to successor liability and the idea that you have to have a predecessor that doesn't exist anymore.

[00:44:33] Speaker 04:
They said there is no per se rule.

[00:44:34] Speaker 04:
It's on a case by case basis.

[00:44:36] Speaker 04:
That's not a reason to destroy our case at the pleading stage.

[00:44:40] Speaker 04:
Also, the district court did not rule on successor liability at all.

[00:44:43] Speaker 04:
That's an alternative gun that they're raising.

[00:44:45] Speaker 04:
That's just not, I have to clear up the record on that.

[00:44:48] Speaker 02:
Well, I don't think they said anything inconsistent with that.

[00:44:51] Speaker 02:
I think they agreed it was pretty muddled.

[00:44:53] Speaker 00:
Could you address Mr. Zion's point, however, about this May 2023 status report referring back to 2022 information that they say was then stale?

[00:45:07] Speaker 04:
So what we downloaded was a status update.

[00:45:09] Speaker 04:
In other words, if there were any changes in your report, that update would tell you, OK, yes, there's been a new filing that has shown, OK, there's been a change in this date or that date.

[00:45:18] Speaker 04:
And I understand that my friends on this other side wants to argue that, well, you should interpret the evidence this way, that it's just because we forgot to update it when we decided to move everyone back to New Jersey.

[00:45:29] Speaker 04:
But that's an inference in their favor.

[00:45:31] Speaker 04:
What matters at this stage is, number one, is there allegations that are factual in the record?

[00:45:37] Speaker 04:
Did they contest them by the resident declaration?

[00:45:39] Speaker 04:
No.

[00:45:40] Speaker 04:
But even besides that, is there other evidence in the record that creates, at the very least, a factual question as a general jurisdiction?

[00:45:45] Speaker 04:
And the answer is yes.

[00:45:47] Speaker 04:
And for those reasons, this court should reverse.

[00:45:49] Speaker 04:
They recognize the trial court got it wrong in multiple respects.

[00:45:52] Speaker 04:
The ideal thing here is to send this back down for the trial court to do its work and get this done in the right way.

[00:45:57] Speaker 02:
Thank you.

[00:45:58] Speaker 02:
Thank you to both counsel for very well presented arguments that have helped us greatly.

[00:46:04] Speaker 02:
The case is now submitted and we will move on to