Good morning, Your Honors.
Good morning.
I believe it's still morning for a little bit yet.
May it please the Court, my name is John Brugger. I'm from the law firm Paraphinsic-Wolf.
I'm here with my partner, Justin Paraphinsic. We represent the appellant, the plaintiff below, Mr. Edward Wilson.
This is a complicated case with a lot of factual issues and a lot of legal issues.
So if the Court would allow, I'd like to give just a brief recitation of some of the salient facts here.
You certainly can. I don't think it's all that complicated. It's just an evidentiary question.
But you present it the way you want to.
Sure. Thank you, Your Honor. This is a Zantac case. Zantac was a heartburn medication.
It was sold in the United States.
The active ingredient is a chemical called ranitidine.
Ranitidine or Zantac testing came out that indicated
that Zantac was contaminated with a compound called NDMA.
NDMA has been known as a carcinogen for 50 years.
It has no purpose in the human body. It's an industrial byproduct.
Its only scientific use is to induce tumors in lab animals to study cancer.
At the time, the maker of Zantac voluntarily withdrew Zantac from the market,
and then the FDA followed up with a nationwide recall of ranitidine products.
Several other countries did the same.
This is a case where the plaintiff below, Mr. Wilson, took Zantac for 19 years
and alleges that he developed prostate cancer as a result of his use.
One issue I do want to point out to the court,
and if the court is familiar with the Zantac litigation at all,
it has been going on for a few years now.
I want to state the obvious by saying we are here today in a Florida appellate court.
This case comes from Hillsborough County, a Florida state court.
But upon reading the appellee's brief, you'll see that there are references
to the Zantac federal MDL throughout.
We understand our role versus that of the federal court.
I do want to point out to the court, and I'm not sure how clear it was in the briefs,
that that decision has been appealed to the Eleventh Circuit.
That issue has been fully briefed, and that was actually fully argued back in October,
so almost eight months now.
We do expect a ruling from the Eleventh Circuit any day now,
and we expect a ruling from the trial court.
First is a procedural due process issue for violating the doctrine laid out
in Perlow v. Burke. Perlow, which is a Florida Supreme Court case,
that said, well, it's not per se illegal for a lower court to adopt the draft order of a party.
The reasoning in the order should still reflect...
an error in the order itself.
Correct, Your Honor. And that is our second grounds that we present to the court today for reversing the trial order.
On your first ground, are the actual submitted orders,
not the one that was adopted, but the ones that were submitted by your opposing side,
are they in the record?
They are in the trial court's appendix and cited throughout our brief.
And so we have first the procedural issue about how these orders came to be,
and then there's the underlying issue
that by adopting these orders the way they did,
the lower court misapplied the law of Daubert in Florida
and had an erroneous view of the facts that gave them the basis to issue those orders.
Now, to start with the procedural due process issue,
there are many cases out there cited by us, cited by the appellees,
that talk about how courts are allowed to adopt the draft orders of a party.
However, in cases like Perlow itself, and just last year
this court ruled in Washington v. Purcell recoveries,
that those orders have to reflect an independent and thoughtful analysis of the law,
issues, and evidence.
Those cases all dealt with perhaps one order that was entered, or one judgment that was entered.
Our case today involves seven different orders.
This case came to the court in Hillsborough County with hundreds of pages of briefing
on four different Daubert orders and three different motions for summary and judgment.
There are thousands of pages of exhibits to those orders.
In August of 2024, the court heard argument all day in Hillsborough County.
I don't know if it lasted a full eight hours, but it was a full day of argument.
During the entire argument on any of the motions,
the lower court did not make any findings on the record.
Most of the questions asked by the lower court were logistical questions about taking breaks
and what argument was next and that type of thing,
although some questions were asked later on about a couple of the issues.
The lower court asked the parties to simultaneously submit draft proposed orders.
The parties did, and within 72 hours,
the lower court adopted substantively verbatim
the ruling, the orders provided by the appellees here.
I say substantively verbatim because the arguments,
the evidence that the arguments rely on, and even a lot of the wording of the reasoning
was taken directly from the draft orders. There are no arguments. There's no evidence
that was provided by the court that's different from what the defendants provided them.
All seven of them, seven four-Daubert motions and three summary judgments
were all signed by the court within 72 hours. The only changes the court made
are some structural changes, splitting one paragraph
into two, moving an argument maybe from the body to a footnote,
but raised no independent issues not provided to them by the defendants.
There was no opportunity provided by the court,
especially with less than 72 hours, for the parties to object
to the order. Now in Washington, the case that was decided by this court
last year, they upheld the Perlow rule in a case
where both parties submitted draft orders
to the court. And counsel, I was just double-checking my own notes on this case.
You said that the proposed orders are in the appendix, but were they provided in the record or the
supplemental record? I would have to go back . . .
Because my notes indicate they were not. I don't believe they were officially part . . .
I don't think they were filed as part of the record. I think the drafts were probably
emailed to the court, and that's why we provided them in our appendix so they would become part of it.
I just wanted to make sure that I didn't have the wrong note on this. Okay. Thank you, Your Honor.
And so, what the case has really boiled down to
on that issue is, if the court adopts a party's
draft order, the court really should make findings on the record.
Whenever feasible, the court should do that. The court should write its own orders, again, wherever feasible.
And the court
should undertake an independent analysis of the issues.
Counsel, why don't we move on to the other issue? I think that's the more meaty issue that we need to deal with right now.
Sure. I agree, Your Honor. Thank you very much. And you didn't ask to reserve time for rebuttal.
You've gone about 9 minutes. You have 11 minutes left. So, how much time do you want to reserve?
I think about 5 minutes would be okay, Your Honor. Thank you for reminding me.
So, Your Honor, as you pointed out, the attorney for the
appellees is going to tell you sort of an ends justify the means argument
because they'll tell you, even if all of that is true,
it doesn't matter because the court reached the right outcome, the right outcome provided by the defendants
below to the court. And therefore, there's no grounds for reversal here.
But on an abuse of discretion standard, an abuse of discretion is where there's an erroneous view of the law
and an erroneous view of the facts, both of which are the case here.
Dawbert, when adopted by Florida to replace Frye, charged the court with a preliminary
examination of the expert evidence in order to make sure the evidence was reliable before it went to the jury.
Did not give the court the power to weigh the evidence, to make decisions
about believability, to rule on the conclusions reached by the experts.
And we believe that's what happened here. Some of these same issues were raised by the 11th Circuit during
lower argument by Judge Jordan and Judge Lagoa.
In this case,
Your Honors, there are several grounds where the lower court made errors
in applying Dawbert and in construing the facts, one of which
is on general causation, there were two experts produced
to speak about general causation, whether NDMA in reninidine
can generally cause prostate cancer. That would be Dr. Matthew Simmons and Dr. Steven Berg.
And the lower court and the defendants below
accused them of cherry picking the studies. They didn't rely on or didn't address
the handful of reninidine epidemiological studies
that are relatively late coming and instead relied on the 50
plus years of research into NDMA itself as a carcinogen.
Your Honor, we posit that that is
a ruling based on the conclusions reached by the expert, but
that's also not even the case here because even if these other studies that the defendants raised
were not part of their report, they were discussed extensively during their depositions.
All of these experts gave day long depositions.
You're talking about the trial court's
mention of cherry picking, but isn't
whether or not an expert cherry picked the evidence
that are derived from studies relevant to whether the theory
or technique is widespread acceptance?
Isn't how widespread it is a question to which
all the studies should be relevant?
Sure, and Your Honor, the widespread acceptance would be of the methodology itself,
not the conclusions reached by those studies.
You're talking about something different now. You're talking about the fact that he's weighing evidence by
he or she, the trial judges, weighing evidence by homing in on the point that the expert
picks studies. Correct.
Doesn't cherry picking studies go to the question of whether
it's gained widespread acceptance?
Your Honor, on that issue, I think it may be a moot point because I don't believe cherry picking even occurred here.
I think that's one of the factual disputes that the court didn't appreciate because
when they questioned about these studies, the experts said they reviewed them, and then they talked about them at length.
How they reviewed them, the methodological flaws they found in those studies,
the same flaws found by the authors of those studies, and why in their weighing of the evidence
they weighed the NDMA studies higher than they weighed the Rinitidine studies,
but they considered all of the evidence, which is the exact type of analysis
that Florida courts approve of, as they approved of in
Berry v. CSX Transportation. It's not a blind reliance on the epidemiology.
It's an analysis based on how the study was conducted and giving the expert
the ability to weigh the different studies that may be in conflict
with each other and determine causation and reliability
based on what their professional scientific opinion is of which studies are more reliable and which ones are not.
That is what happened here. Again, this would all be
furthering the purpose of Dawberg, which is to present reliable evidence to the jury
so the jury can weigh the evidence, so the jury can see the Biggers cross-examination
during the trial and presentation of contrary evidence
so they can make a decision as to which experts to believe, not to keep these experts
from the jury. There are other
factual issues, Your Honor. One has to do with, and these are
interrelated, the laboratory testing. A lab
by the name of Eurofins EAG, Eurofins is a worldwide, highly respected
laboratory organization. The local office that we used was called Eurofins EAG.
They provided testing of rinitidine Zantac tablets.
Now, the appellees will tell you, well, they didn't review
Mr. Wilson's tablets, they didn't test his tablets, and the tablets that they tested were expired.
All of that's irrelevant, and then they'll tell you, well, because of that, Dr. Bird
relied on that testing, so his opinion is out. Now, there's a wrong on two
counts. One, the laboratory was never produced to give a case-specific
opinion about how much NDMA was in Mr. Wilson's tablets. Like many people,
by the time the drug was pulled and by the time Mr. Wilson brought his case
a couple of years later, he no longer had the pills in his
hands.
possession.
This is a common occurrence that we've seen in Zantac litigation.
But EHE tested pills from other clients of ours,
some of which were expired.
And they showed levels of NDMA.
But the lab witnesses were brought
in to talk about two things, the complicated procedure approved
by the FDA for testing rinitidine for NDMA.
And to counter the argument we've
heard from defendants numerous times
that rinitidine does not form NDMA
under real world conditions.
And so they tested real people's NDMA and found that it does.
Now,
Counsel, I'll just let you know you're at your five minute mark.
You can go ahead or you can reserve.
So however you wish to proceed.
Just make one brief point, Your Honor,
and please deduct it from my time.
But if we take that and move on to Dr. Byrd,
Dr. Byrd didn't just rely on the EHE testing
to form his opinion about what dosage of NDMA
Mr. Wilson would have ingested.
Dr. Byrd reviewed that testing.
But he reviewed the testing for the FDA
from the testing out of Japan called the Abe study,
testing from GlaxoSmithKline itself.
GlaxoSmithKline was the original inventor of rinitidine.
He took testing from all these sources.
And based on calculations of other published studies,
such as the Lowe study and the Hidijan study,
he was able to form a conservative opinion
about how much NDMA Mr. Wilson likely would have ingested
to a reasonable degree of scientific certainty.
Now, his estimate that he used in his report
and a deposition is far lower
than the levels that urofins found,
but still enough for him to opine
that Mr. Wilson was at increased risk
and that the NDMA contaminated rinitidine
was a substantial factor in causing his cancer.
So those are just a couple of the factual issues
that we believe the court got wrong
as a result of over-reliance on the defendant's draft orders
and the language that they used.
And thank you, Your Honor.
I'll just reserve the rest of my time.
Very good.
You'll have four minutes.
Thank you.
Thank you, counsel.
May it please the court, Matt Leppert for the Appellees.
The judgment in this case rests on three independent grounds.
A Daubert determination that there wasn't
competent evidence on general causation,
which is in line with every other court in the country
applying Daubert in Zantac cases.
Counselor, are you splitting time?
I don't think so, unless there's a question
specific to Sanovey.
And if you are.
Sorry, I don't know where my mic's at.
My name is Sally Pay from Arnold and Porter,
representing Sanovey.
And you're representing, I'm sorry.
Sanovey, the Sanovey defendants.
So you're doing the entire argument?
Correct.
Just making sure.
Thank you, counsel.
Go ahead.
So there's three independent grounds.
First is general causation, the Daubert ruling on that.
The second one is the Daubert ruling on dose.
The plaintiff's experts did not calculate a threshold dose.
And then there's a third independent ground,
and it's a lack of competent expert evidence
on specific causation.
And in this case, Mr. Wilson had a strong family history
that according to the plaintiff's own sources,
their own literature, increased his risk
of getting prostate cancer by over 900%.
His dad and two of his older brothers
both got prostate cancer around the same age
without ever taking reninidine.
And that's why his treating urologist said
that he was 99.9% certain that this cancer
is genetic in origin.
And the plaintiff's specific causation expert, Dr. Connery,
did not reliably exclude this obvious alternative cause.
That's required for differential diagnosis.
And that differential diagnosis, he
relied solely on one genetic test that tested 35 out
of 20,000 possible genes.
It looked like you had a question.
That's why I stopped.
It only tested 35 out of 20,000 genes,
including several genes that are associated with prostate cancer.
And the test itself said it can't
be used to exclude genetics as the sole cause of what
happened to Mr. Wilson.
So that basis alone, that is a straightforward reason.
Because as the Dahlberg case law from the 11th Circuit
says, when an expert uses differential ideology,
differential diagnosis to opine on specific causation,
the expert must give an explanation for ruling out
other alternative causes.
And in this case, and that has to be scientifically supported,
in this case, Dr. Connery conceded
that the source he's relying on does not
allow him to fully rule out the genetics
as the sole cause in this case.
So that's the issue of specific causation, which
provides an independent ground to support the judgment that
was entered here in this case, because the plaintiff needs
evidence on specific causation.
The exclusion of Dr. Connery on his differential ideology.
Dr. Burt said he did a differential ideology
for specific causation, but agreed that he actually never
ruled out the genetic cause, the 99.9 certainty
that the treating urologist had about the origin of the cancer.
Then we have a finding as to dose.
The 11th Circuit has said multiple times
that in a toxic tort case, particularly
with a substance that is as ubiquitous as NDMA is,
there needs to be a threshold dose.
Dose makes the poison.
NDMA is all around us.
It's in smoked meat.
It is in the air that we breathe.
It is in the food that we eat.
It is all around us.
So in order for an expert to opine in a toxic tort case,
there needs to be an opinion on threshold dose.
As the Circuit Court Judge Ferfanti found here,
there was no determination of a threshold dose,
of a minimum as to when it could become carcinogenic.
In other words, there's no barometer to put it against
what the testimony of what Mr. Wilson may have ingested.
Through rinitidine, that's speculative.
There's a separate ruling on that
as to why that calculation is speculative from Dr. Burt,
but there wasn't even a threshold dose.
Then you have the general causation issue,
which, yes, every court in the country
to apply the Daubert standard in these cases
has found that this cherry-picking methodology
is not reliable under Daubert.
Why not?
Because there are six studies, six epidemiology studies
that have looked at the relationship
between rinitidine and prostate cancer,
and none have found statistically significant relationship.
Now, in the report, Dr. Simmons,
the general causation expert,
as the Circuit Court Judge Ferfanti found,
never even bothered to address them in his report.
His job was to opine on general causation
between prostate cancer and rinitidine,
and he concedes in his deposition
that in order to do that, I need data on rinitidine.
He also concedes he needs data on prostate cancer,
but there are six studies on this topic,
and his report doesn't mention any of them.
Instead, the only study out there that even links NDMA,
not rinitidine, NDMA with prostate cancer
is a rubber worker study from England,
people who worked with rubber fumes.
The authors of these studies say,
we can't pinpoint it to any one of these fumes
that they're inhaling because the rubber workers
are exposed to tremendous other toxins and carcinogens,
so it's not even a study that says
we have proven a link between NDMA and prostate cancer,
but at a minimum, what you don't have is rinitidine,
the progress issue in this case.
You don't have a study that says
rinitidine can cause prostate cancer.
What about the fact that the Zantac pills,
at least at one point in time,
had more than the amounts that the FDA had approved?
How does that weigh into it?
I mean, I think they've been tested multiple times.
I think the latest tests from FDA
say they're around the same level as smoked meat,
so that's the latest testing.
They've been tested again over time,
so the numbers on the testing have come down,
but the point is we still need a link
between rinitidine and prostate cancer,
and that link scientifically doesn't exist in the science.
No association, no medical science, no textbook,
no association has ever said there is a link
between rinitidine, the product, right,
and prostate cancer.
In fact, the link between NDMA and prostate cancer
isn't even established, right,
because all you have is the RoboWorker study,
and the RoboWorker study has multiple confounding factor,
and those RoboWorkers did not use rinitidine.
So I think the consensus on the case law
is that to give a reliable general causation opinion
about a product, the link between a product and disease,
you need evidence about the product and the disease,
and here there are six studies that refute it, right?
It has been tested, and so when you look
at the five Dalbert factors, I think Judge Atkinson
identified one, general acceptance.
That's just one of them, right,
but there is also whether this theory has been tested.
That's a Dalbert consideration.
Here, the theory has been tested six times,
and it came up against Dr. Simmons' conclusion
every single time, and he didn't even put it in his report.
In his deposition, he was confronted with these six studies,
and he said, well, I don't know the screening rates
in the countries where these studies were done.
Well, the truth is that some of these studies
were done right here in the United States.
What is also true is that he didn't know any differences
in screening rates in the United Kingdom or Taiwan
where a couple of other studies were done.
He didn't know the screening rates,
and of course, he also had to concede
that the issue with screening rates
applies to both the control group and the exposed group,
so in terms of the ratio, which is what epidemiology
looks at, right, the relative risk,
there shouldn't be any difference,
and he had to concede that as well,
so it was easily within the discretion of trial court
to say that's not a reliable methodology,
and if you look at the order from Dr. Simmons,
it carefully goes through each five,
each of the five Daubert considerations that are outlined.
It's not a checklist or anything like that.
It's five considerations,
one of them being general acceptance,
one of them being testability,
one of them being peer review, right?
He's never peer reviewed, he's never had published anything.
Neither his conclusion nor his methodology here
has ever been subject to peer review,
and on the other side,
there are six peer reviewed studies
that cut the other way,
so all of these factors weigh in favor of exclusion,
and one thing we know about Daubert
is the significant deference that is afforded
to a lower court determination.
It is the trial judge who is uniquely
in the role of gatekeeper,
and let me circle back around to the due process issue
where my colleague started.
There was briefings issue,
there was an all-day hearing on it,
which was on August 2nd,
and everyone showed up with PowerPoint presentations.
Each of these PowerPoint presentations were shown,
and then they were handed to Judge Farfanti.
The fact that he didn't make rulings from the bench,
to me, suggests deliberate judicial process
as opposed to ruling right from the bench
after being confronted with so much material,
so the fact that they weren't findings right in the moment
does not suggest lack of independent judgment.
I think that's a prudent way of handling this,
and then there was the question at the end of that hearing
after he received the PowerPoint slides,
he actually asked the plaintiffs simultaneous submission,
that's at A-286 of the appendix.
Let me make sure I said that right.
Yes, excuse me, A-268 of their appendix.
He asks the plaintiffs whether they wanna do
simultaneous submission.
He's asked us when are we gonna submit our proposed orders,
and it says it's gonna be August 15,
which is 10 days later.
Then he asks the plaintiff, how about you?
They say we're fine on the same day,
so he then asks, simultaneous submission, question mark,
that's in the transcript,
and the plaintiffs are saying yes,
simultaneous submission,
so they can't now come here and complain
over the fact that there was simultaneous submission
in this case.
They were both submitted, the draft orders were submitted,
and he didn't enter them immediately.
He entered them 15 days after the hearing,
and three days after they were submitted,
and what I really wanna push back
is the notion that there were no substantive changes,
that this was just rubber stamping the defense proposal.
That's just not true.
If we run a compare, and they're at least in the appendix,
if not, they need to be supplemented as a record
if they're currently not on the record,
but if we run a compare between the proposed orders
and the actual orders, they are heavily, heavily edited,
and they're not just edits along the lines
of stylistic changes, they're substantive changes.
Let me give you one example.
We made an argument when we were subsection three,
902 subsection three,
which is the fit analysis of Dahlberg, right?
We said, these are NDMA evidence,
it doesn't fit with the remitted in evidence.
Every time, and every time we make that order,
that argument in our order, put it in our proposed order,
Judge Farfanti cut it out,
because he didn't agree with it.
He removed those from the proposed orders.
He didn't just move things around, he did that too,
but he also removed an argument
with which he apparently did not agree.
Likewise, there's the statement
from the plaintiff's draft orders
about exclusion is the exception under Dahlberg,
and a trial judge must take care
not to cross the line into weighing evidence.
And that language came from the plaintiff's proposed orders.
So he didn't just push their orders aside.
He looked at both sides.
And the parts that he thought needed
to be in there from the plaintiff's,
he took from the plaintiff's order
and put it into the final orders.
And he took out the part about the fit.
And then he also removed the part about,
we had an argument about ipsa dixit.
That's a language that comes from Dauber.
He took out our argument regarding ipsa dixit.
So it's not a verbatim adoption.
We're not even in the Perlow framework,
because that deals with when there is a verbatim adoption.
We don't have other errors.
We don't have Washington, the Washington case
my colleague mentioned to you.
In Washington, the title of the order that was actually
entered on the docket was still called
defendant's proposed order.
And it had several errors in it,
findings that weren't supported by the record.
That's the problem.
That's what Perlow seeks to prevent,
when there's basically obvious lack of judicial consideration,
because factual errors are being imported
from a proposed order.
And Perlow itself only dealt with the case
where the trial court discouraged the husband
from submitting a proposed order and only
accepted one from the wife.
That's not what happened.
By agreement of the plaintiff, there
was simultaneous submission, submission from both sides.
He didn't enter them immediately.
He entered them three days later.
He made substantive changes.
And I think what my colleague's argument falls down to is,
yes, the orders granting the motion substantively
agree with the arguments made in the motion.
That is to be expected.
It would have been improper for Judge Farfanti
to go outside of what the parties argued.
And that seems to be what he's asking for
as independent judgment, right?
That basically, Judge Farfanti now
goes outside of what we argued and adds additional points
into the order.
That would have been a due process violation.
If Judge Farfanti now relies on case law
that hadn't been cited by the parties,
that would have been problematic.
So I think, far from a due process violation,
there was plenty of opportunity to be heard.
There was an opportunity to object if they wanted to.
He didn't immediately enter them.
He didn't enter them the same day as in parole or the next
day.
Those issues that are present in these cases,
where there is obvious mistakes in these orders,
it's just not present in this case.
Unless the court has any questions for me at this point,
I would reheat my time.
Very good.
Thank you, counsel.
Your Honors, I know I only have four minutes.
I just want to address a couple of those comments briefly.
To say that there was no reliable methodology
for not only doing a general causation analysis,
but doing a specific causation analysis is simply not true.
What happened here is the experts on general causation,
and actually Dr. Connery as well,
all three of the medical experts,
performed a Bradford Hill analysis,
which is a set of nine criteria widely used
by epidemiologists that have a number of different things
that they should consider.
Not one outweighs any other one, and the courts
have held that different experts can apply them
in different ways.
But all three of those experts conducted
their own Bradford Hill analysis and still
came to the conclusion that the NDMA contaminated reninine was
a substantial contributing factor to his disease.
Again, to the additional point that Dr. Connery didn't
have a reliable methodology, Dr. Connery
conducted a differential diagnosis,
which is the hallmark reliable method for determining
causation in cases like this.
He went through all of the factors.
He went through age, race, weight, family history.
And again, Mr. Wilson had some family
that was diagnosed with prostate cancer,
but he's a rare case that has genetic testing that says
his cancer was not genetically linked.
And that is the evidence in the case
that the experts relied on.
So to conduct a Bradford Hill analysis,
to conduct a differential diagnosis,
to thoroughly discuss all of these other issues
and be able to rule them out.
And of course, the law is not that they
have to completely rule out all other sole causes.
This is from the Gwynn case in the 11th Circuit, Gwynn
versus AstraZeneca.
They don't need to rule out all the alternative causes.
All they have to do is consider the factors that
could have been the sole cause.
These experts considered these other factors.
They weighed them, they discussed them,
they analyzed them, and then they came to their conclusion.
That is the hallmark of the reliable methodology.
And just because they weighed some factors
heavier than what the plaintiff's attorneys,
or I'm sorry, the appellee's attorneys
would have liked them to weigh, is a different story.
Again, on this issue of threshold dose,
it's never been the law in the state of Florida
that the expert has to calculate an exact threshold dose.
And the reason for that was addressed by the Henderson case
in the Middle District of Florida just five months ago.
It's because in cases of carcinogenicity,
it's very hard to determine exact threshold doses
because simply you can't do the experiment
where you have a control group and a test group
and you give the test group a known carcinogen
and wait for them to develop cancer.
So the evidence on minimum threshold dose
has to come from other sources.
And that's perfectly acceptable in Florida.
In fact, the McLean case, McLean v. Metabolife,
Florida Supreme Court case,
has specifically said in footnote six,
they should address the dose-response relationship,
but they don't need to calculate exact numbers.
They don't need to, such levels do not need to be proven
by precise dose numbers.
Qualitative proof can be sufficient.
That's what Dr. Byrd did in this case,
and that's what Dr. Connery said in this case.
Dr. Connery looked at things like water consumption,
dietary, and said the science that he reviewed
shows that the levels of NDMA and Zantac
were nine to 18 times higher
than all the other sources combined.
Dr. Byrd, relying on the Hitajat study
and other materials, discussed the different quartiles
of when a level of exposure increases the risk for cancer.
Now, to say that Hitajat was just some rubber worker study
and there was no way to tell anything
is simply not the case.
But again, I caution attorneys, I caution the court
to not go the way that was described in Dover
of donning the white scientist's coat
and playing amateur scientist.
Counsel, you've got about 30 seconds left.
Thank you, Your Honor.
In this case, the underlying methodologies
of Bradford Hill, of differential diagnosis,
of considering all these other factors,
considering all the epidemiology and the other science,
weighing all of it, being cross-examined on all of it,
is a hallmark of reliability in the Dover.
That occurred in this case.
Now, the orders that came out
disagreed with how the analysis was performed.
And that is a role for the jury, not the court.
So, Your Honor, we ask that the court reverse these orders
and remand the case back to Hillsborough County
for further proceedings consistent with the court's opinion.
Very good.
Thank you both.
Interesting.
Okay, we had some interesting cases today
and this was one of them.
So, thank you all.
And that concludes the oral argument docket
and we are adjourned.
Thank you, Your Honor.
Thank you.