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Good morning, Your Honors.

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Good morning.

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I believe it's still morning for a little bit yet.

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May it please the Court, my name is John Brugger. I'm from the law firm Paraphinsic-Wolf.

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I'm here with my partner, Justin Paraphinsic. We represent the appellant, the plaintiff below, Mr. Edward Wilson.

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This is a complicated case with a lot of factual issues and a lot of legal issues.

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So if the Court would allow, I'd like to give just a brief recitation of some of the salient facts here.

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You certainly can. I don't think it's all that complicated. It's just an evidentiary question.

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But you present it the way you want to.

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Sure. Thank you, Your Honor. This is a Zantac case. Zantac was a heartburn medication.

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It was sold in the United States.

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The active ingredient is a chemical called ranitidine.

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Ranitidine or Zantac testing came out that indicated

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that Zantac was contaminated with a compound called NDMA.

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NDMA has been known as a carcinogen for 50 years.

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It has no purpose in the human body. It's an industrial byproduct.

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Its only scientific use is to induce tumors in lab animals to study cancer.

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At the time, the maker of Zantac voluntarily withdrew Zantac from the market,

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and then the FDA followed up with a nationwide recall of ranitidine products.

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Several other countries did the same.

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This is a case where the plaintiff below, Mr. Wilson, took Zantac for 19 years

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and alleges that he developed prostate cancer as a result of his use.

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One issue I do want to point out to the court,

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and if the court is familiar with the Zantac litigation at all,

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it has been going on for a few years now.

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I want to state the obvious by saying we are here today in a Florida appellate court.

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This case comes from Hillsborough County, a Florida state court.

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But upon reading the appellee's brief, you'll see that there are references

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to the Zantac federal MDL throughout.

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We understand our role versus that of the federal court.

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I do want to point out to the court, and I'm not sure how clear it was in the briefs,

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that that decision has been appealed to the Eleventh Circuit.

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That issue has been fully briefed, and that was actually fully argued back in October,

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so almost eight months now.

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We do expect a ruling from the Eleventh Circuit any day now,

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and we expect a ruling from the trial court.

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First is a procedural due process issue for violating the doctrine laid out

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in Perlow v. Burke. Perlow, which is a Florida Supreme Court case,

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that said, well, it's not per se illegal for a lower court to adopt the draft order of a party.

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The reasoning in the order should still reflect...

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an error in the order itself.

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Correct, Your Honor. And that is our second grounds that we present to the court today for reversing the trial order.

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On your first ground, are the actual submitted orders,

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not the one that was adopted, but the ones that were submitted by your opposing side,

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are they in the record?

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They are in the trial court's appendix and cited throughout our brief.

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And so we have first the procedural issue about how these orders came to be,

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and then there's the underlying issue

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that by adopting these orders the way they did,

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the lower court misapplied the law of Daubert in Florida

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and had an erroneous view of the facts that gave them the basis to issue those orders.

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Now, to start with the procedural due process issue,

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there are many cases out there cited by us, cited by the appellees,

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that talk about how courts are allowed to adopt the draft orders of a party.

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However, in cases like Perlow itself, and just last year

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this court ruled in Washington v. Purcell recoveries,

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that those orders have to reflect an independent and thoughtful analysis of the law,

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issues, and evidence.

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Those cases all dealt with perhaps one order that was entered, or one judgment that was entered.

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Our case today involves seven different orders.

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This case came to the court in Hillsborough County with hundreds of pages of briefing

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on four different Daubert orders and three different motions for summary and judgment.

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There are thousands of pages of exhibits to those orders.

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In August of 2024, the court heard argument all day in Hillsborough County.

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I don't know if it lasted a full eight hours, but it was a full day of argument.

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During the entire argument on any of the motions,

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the lower court did not make any findings on the record.

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Most of the questions asked by the lower court were logistical questions about taking breaks

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and what argument was next and that type of thing,

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although some questions were asked later on about a couple of the issues.

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The lower court asked the parties to simultaneously submit draft proposed orders.

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The parties did, and within 72 hours,

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the lower court adopted substantively verbatim

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the ruling, the orders provided by the appellees here.

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I say substantively verbatim because the arguments,

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the evidence that the arguments rely on, and even a lot of the wording of the reasoning

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was taken directly from the draft orders. There are no arguments. There's no evidence

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that was provided by the court that's different from what the defendants provided them.

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All seven of them, seven four-Daubert motions and three summary judgments

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were all signed by the court within 72 hours. The only changes the court made

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are some structural changes, splitting one paragraph

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into two, moving an argument maybe from the body to a footnote,

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but raised no independent issues not provided to them by the defendants.

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There was no opportunity provided by the court,

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especially with less than 72 hours, for the parties to object

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to the order. Now in Washington, the case that was decided by this court

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last year, they upheld the Perlow rule in a case

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where both parties submitted draft orders

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to the court. And counsel, I was just double-checking my own notes on this case.

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You said that the proposed orders are in the appendix, but were they provided in the record or the

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supplemental record? I would have to go back . . .

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Because my notes indicate they were not. I don't believe they were officially part . . .

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I don't think they were filed as part of the record. I think the drafts were probably

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emailed to the court, and that's why we provided them in our appendix so they would become part of it.

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I just wanted to make sure that I didn't have the wrong note on this. Okay. Thank you, Your Honor.

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And so, what the case has really boiled down to

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on that issue is, if the court adopts a party's

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draft order, the court really should make findings on the record.

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Whenever feasible, the court should do that. The court should write its own orders, again, wherever feasible.

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And the court

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should undertake an independent analysis of the issues.

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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.

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Sure. I agree, Your Honor. Thank you very much. And you didn't ask to reserve time for rebuttal.

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You've gone about 9 minutes. You have 11 minutes left. So, how much time do you want to reserve?

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I think about 5 minutes would be okay, Your Honor. Thank you for reminding me.

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So, Your Honor, as you pointed out, the attorney for the

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appellees is going to tell you sort of an ends justify the means argument

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because they'll tell you, even if all of that is true,

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it doesn't matter because the court reached the right outcome, the right outcome provided by the defendants

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below to the court. And therefore, there's no grounds for reversal here.

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But on an abuse of discretion standard, an abuse of discretion is where there's an erroneous view of the law

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and an erroneous view of the facts, both of which are the case here.

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Dawbert, when adopted by Florida to replace Frye, charged the court with a preliminary

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examination of the expert evidence in order to make sure the evidence was reliable before it went to the jury.

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Did not give the court the power to weigh the evidence, to make decisions

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about believability, to rule on the conclusions reached by the experts.

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And we believe that's what happened here. Some of these same issues were raised by the 11th Circuit during

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lower argument by Judge Jordan and Judge Lagoa.

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In this case,

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Your Honors, there are several grounds where the lower court made errors

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in applying Dawbert and in construing the facts, one of which

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is on general causation, there were two experts produced

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to speak about general causation, whether NDMA in reninidine

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can generally cause prostate cancer. That would be Dr. Matthew Simmons and Dr. Steven Berg.

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And the lower court and the defendants below

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accused them of cherry picking the studies. They didn't rely on or didn't address

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the handful of reninidine epidemiological studies

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that are relatively late coming and instead relied on the 50

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plus years of research into NDMA itself as a carcinogen.

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Your Honor, we posit that that is

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a ruling based on the conclusions reached by the expert, but

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that's also not even the case here because even if these other studies that the defendants raised

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were not part of their report, they were discussed extensively during their depositions.

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All of these experts gave day long depositions.

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You're talking about the trial court's

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mention of cherry picking, but isn't

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whether or not an expert cherry picked the evidence

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that are derived from studies relevant to whether the theory

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or technique is widespread acceptance?

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Isn't how widespread it is a question to which

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all the studies should be relevant?

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Sure, and Your Honor, the widespread acceptance would be of the methodology itself,

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not the conclusions reached by those studies.

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You're talking about something different now. You're talking about the fact that he's weighing evidence by

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he or she, the trial judges, weighing evidence by homing in on the point that the expert

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picks studies. Correct.

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Doesn't cherry picking studies go to the question of whether

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it's gained widespread acceptance?

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Your Honor, on that issue, I think it may be a moot point because I don't believe cherry picking even occurred here.

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I think that's one of the factual disputes that the court didn't appreciate because

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when they questioned about these studies, the experts said they reviewed them, and then they talked about them at length.

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How they reviewed them, the methodological flaws they found in those studies,

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the same flaws found by the authors of those studies, and why in their weighing of the evidence

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they weighed the NDMA studies higher than they weighed the Rinitidine studies,

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but they considered all of the evidence, which is the exact type of analysis

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that Florida courts approve of, as they approved of in

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Berry v. CSX Transportation. It's not a blind reliance on the epidemiology.

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It's an analysis based on how the study was conducted and giving the expert

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the ability to weigh the different studies that may be in conflict

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with each other and determine causation and reliability

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based on what their professional scientific opinion is of which studies are more reliable and which ones are not.

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That is what happened here. Again, this would all be

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furthering the purpose of Dawberg, which is to present reliable evidence to the jury

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so the jury can weigh the evidence, so the jury can see the Biggers cross-examination

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during the trial and presentation of contrary evidence

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so they can make a decision as to which experts to believe, not to keep these experts

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from the jury. There are other

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factual issues, Your Honor. One has to do with, and these are

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interrelated, the laboratory testing. A lab

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by the name of Eurofins EAG, Eurofins is a worldwide, highly respected

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laboratory organization. The local office that we used was called Eurofins EAG.

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They provided testing of rinitidine Zantac tablets.

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Now, the appellees will tell you, well, they didn't review

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Mr. Wilson's tablets, they didn't test his tablets, and the tablets that they tested were expired.

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All of that's irrelevant, and then they'll tell you, well, because of that, Dr. Bird

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relied on that testing, so his opinion is out. Now, there's a wrong on two

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counts. One, the laboratory was never produced to give a case-specific

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opinion about how much NDMA was in Mr. Wilson's tablets. Like many people,

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by the time the drug was pulled and by the time Mr. Wilson brought his case

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a couple of years later, he no longer had the pills in his

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hands.

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possession.

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This is a common occurrence that we've seen in Zantac litigation.

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But EHE tested pills from other clients of ours,

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some of which were expired.

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And they showed levels of NDMA.

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But the lab witnesses were brought

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in to talk about two things, the complicated procedure approved

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by the FDA for testing rinitidine for NDMA.

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And to counter the argument we've

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heard from defendants numerous times

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that rinitidine does not form NDMA

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under real world conditions.

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And so they tested real people's NDMA and found that it does.

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Now,

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Counsel, I'll just let you know you're at your five minute mark.

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You can go ahead or you can reserve.

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So however you wish to proceed.

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Just make one brief point, Your Honor,

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and please deduct it from my time.

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But if we take that and move on to Dr. Byrd,

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Dr. Byrd didn't just rely on the EHE testing

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to form his opinion about what dosage of NDMA

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Mr. Wilson would have ingested.

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Dr. Byrd reviewed that testing.

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But he reviewed the testing for the FDA

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from the testing out of Japan called the Abe study,

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testing from GlaxoSmithKline itself.

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GlaxoSmithKline was the original inventor of rinitidine.

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He took testing from all these sources.

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And based on calculations of other published studies,

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such as the Lowe study and the Hidijan study,

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he was able to form a conservative opinion

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about how much NDMA Mr. Wilson likely would have ingested

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to a reasonable degree of scientific certainty.

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Now, his estimate that he used in his report

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and a deposition is far lower

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than the levels that urofins found,

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but still enough for him to opine

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that Mr. Wilson was at increased risk

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and that the NDMA contaminated rinitidine

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was a substantial factor in causing his cancer.

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So those are just a couple of the factual issues

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that we believe the court got wrong

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as a result of over-reliance on the defendant's draft orders

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and the language that they used.

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And thank you, Your Honor.

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I'll just reserve the rest of my time.

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Very good.

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You'll have four minutes.

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Thank you.

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Thank you, counsel.

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May it please the court, Matt Leppert for the Appellees.

234
00:17:32,199 --> 00:17:35,319
The judgment in this case rests on three independent grounds.

235
00:17:35,319 --> 00:17:37,599
A Daubert determination that there wasn't

236
00:17:37,599 --> 00:17:40,019
competent evidence on general causation,

237
00:17:40,019 --> 00:17:42,278
which is in line with every other court in the country

238
00:17:42,278 --> 00:17:45,398
applying Daubert in Zantac cases.

239
00:17:45,398 --> 00:17:47,360
Counselor, are you splitting time?

240
00:17:47,360 --> 00:17:49,639
I don't think so, unless there's a question

241
00:17:49,639 --> 00:17:51,479
specific to Sanovey.

242
00:17:51,479 --> 00:17:53,278
And if you are.

243
00:17:53,278 --> 00:17:56,838
Sorry, I don't know where my mic's at.

244
00:17:57,038 --> 00:17:59,000
My name is Sally Pay from Arnold and Porter,

245
00:17:59,000 --> 00:18:00,118
representing Sanovey.

246
00:18:00,118 --> 00:18:01,319
And you're representing, I'm sorry.

247
00:18:01,319 --> 00:18:03,240
Sanovey, the Sanovey defendants.

248
00:18:03,240 --> 00:18:05,360
So you're doing the entire argument?

249
00:18:05,360 --> 00:18:06,199
Correct.

250
00:18:06,199 --> 00:18:07,199
Just making sure.

251
00:18:07,199 --> 00:18:08,038
Thank you, counsel.

252
00:18:08,038 --> 00:18:09,000
Go ahead.

253
00:18:09,000 --> 00:18:10,360
So there's three independent grounds.

254
00:18:10,360 --> 00:18:13,360
First is general causation, the Daubert ruling on that.

255
00:18:13,360 --> 00:18:16,160
The second one is the Daubert ruling on dose.

256
00:18:16,160 --> 00:18:19,838
The plaintiff's experts did not calculate a threshold dose.

257
00:18:19,838 --> 00:18:22,079
And then there's a third independent ground,

258
00:18:22,079 --> 00:18:24,179
and it's a lack of competent expert evidence

259
00:18:24,179 --> 00:18:26,240
on specific causation.

260
00:18:26,240 --> 00:18:31,118
And in this case, Mr. Wilson had a strong family history

261
00:18:31,118 --> 00:18:33,720
that according to the plaintiff's own sources,

262
00:18:33,720 --> 00:18:36,519
their own literature, increased his risk

263
00:18:36,519 --> 00:18:40,639
of getting prostate cancer by over 900%.

264
00:18:40,639 --> 00:18:43,038
His dad and two of his older brothers

265
00:18:43,038 --> 00:18:46,419
both got prostate cancer around the same age

266
00:18:46,419 --> 00:18:48,720
without ever taking reninidine.

267
00:18:48,720 --> 00:18:50,639
And that's why his treating urologist said

268
00:18:50,639 --> 00:18:54,558
that he was 99.9% certain that this cancer

269
00:18:54,558 --> 00:18:57,000
is genetic in origin.

270
00:18:57,000 --> 00:19:01,639
And the plaintiff's specific causation expert, Dr. Connery,

271
00:19:01,639 --> 00:19:07,038
did not reliably exclude this obvious alternative cause.

272
00:19:07,038 --> 00:19:10,160
That's required for differential diagnosis.

273
00:19:10,160 --> 00:19:13,118
And that differential diagnosis, he

274
00:19:13,118 --> 00:19:17,519
relied solely on one genetic test that tested 35 out

275
00:19:17,519 --> 00:19:21,078
of 20,000 possible genes.

276
00:19:21,440 --> 00:19:22,880
It looked like you had a question.

277
00:19:22,880 --> 00:19:24,398
That's why I stopped.

278
00:19:24,398 --> 00:19:27,480
It only tested 35 out of 20,000 genes,

279
00:19:27,480 --> 00:19:32,599
including several genes that are associated with prostate cancer.

280
00:19:32,599 --> 00:19:34,679
And the test itself said it can't

281
00:19:34,679 --> 00:19:38,880
be used to exclude genetics as the sole cause of what

282
00:19:38,880 --> 00:19:40,838
happened to Mr. Wilson.

283
00:19:40,838 --> 00:19:45,519
So that basis alone, that is a straightforward reason.

284
00:19:45,519 --> 00:19:48,720
Because as the Dahlberg case law from the 11th Circuit

285
00:19:48,720 --> 00:19:51,798
says, when an expert uses differential ideology,

286
00:19:51,798 --> 00:19:55,358
differential diagnosis to opine on specific causation,

287
00:19:55,358 --> 00:19:58,480
the expert must give an explanation for ruling out

288
00:19:58,480 --> 00:19:59,920
other alternative causes.

289
00:19:59,920 --> 00:20:02,679
And in this case, and that has to be scientifically supported,

290
00:20:02,679 --> 00:20:05,200
in this case, Dr. Connery conceded

291
00:20:05,200 --> 00:20:07,519
that the source he's relying on does not

292
00:20:07,519 --> 00:20:11,480
allow him to fully rule out the genetics

293
00:20:11,480 --> 00:20:13,358
as the sole cause in this case.

294
00:20:13,358 --> 00:20:17,160
So that's the issue of specific causation, which

295
00:20:17,160 --> 00:20:20,319
provides an independent ground to support the judgment that

296
00:20:20,319 --> 00:20:22,700
was entered here in this case, because the plaintiff needs

297
00:20:22,700 --> 00:20:24,480
evidence on specific causation.

298
00:20:24,480 --> 00:20:27,679
The exclusion of Dr. Connery on his differential ideology.

299
00:20:27,679 --> 00:20:31,160
Dr. Burt said he did a differential ideology

300
00:20:31,160 --> 00:20:34,039
for specific causation, but agreed that he actually never

301
00:20:34,039 --> 00:20:38,319
ruled out the genetic cause, the 99.9 certainty

302
00:20:38,319 --> 00:20:42,639
that the treating urologist had about the origin of the cancer.

303
00:20:42,639 --> 00:20:44,798
Then we have a finding as to dose.

304
00:20:45,519 --> 00:20:47,119
The 11th Circuit has said multiple times

305
00:20:47,119 --> 00:20:49,880
that in a toxic tort case, particularly

306
00:20:49,880 --> 00:20:53,720
with a substance that is as ubiquitous as NDMA is,

307
00:20:53,720 --> 00:20:55,838
there needs to be a threshold dose.

308
00:20:55,838 --> 00:20:57,160
Dose makes the poison.

309
00:20:57,160 --> 00:20:59,639
NDMA is all around us.

310
00:20:59,639 --> 00:21:01,160
It's in smoked meat.

311
00:21:01,160 --> 00:21:03,200
It is in the air that we breathe.

312
00:21:03,200 --> 00:21:05,358
It is in the food that we eat.

313
00:21:05,358 --> 00:21:07,119
It is all around us.

314
00:21:07,119 --> 00:21:10,959
So in order for an expert to opine in a toxic tort case,

315
00:21:10,959 --> 00:21:14,599
there needs to be an opinion on threshold dose.

316
00:21:15,440 --> 00:21:18,838
As the Circuit Court Judge Ferfanti found here,

317
00:21:18,838 --> 00:21:21,599
there was no determination of a threshold dose,

318
00:21:21,599 --> 00:21:25,558
of a minimum as to when it could become carcinogenic.

319
00:21:26,679 --> 00:21:29,160
In other words, there's no barometer to put it against

320
00:21:29,160 --> 00:21:34,078
what the testimony of what Mr. Wilson may have ingested.

321
00:21:34,078 --> 00:21:36,519
Through rinitidine, that's speculative.

322
00:21:36,519 --> 00:21:38,200
There's a separate ruling on that

323
00:21:39,119 --> 00:21:42,420
as to why that calculation is speculative from Dr. Burt,

324
00:21:42,420 --> 00:21:44,358
but there wasn't even a threshold dose.

325
00:21:45,358 --> 00:21:46,720
Then you have the general causation issue,

326
00:21:46,720 --> 00:21:49,480
which, yes, every court in the country

327
00:21:49,480 --> 00:21:52,000
to apply the Daubert standard in these cases

328
00:21:52,000 --> 00:21:55,558
has found that this cherry-picking methodology

329
00:21:55,558 --> 00:21:58,160
is not reliable under Daubert.

330
00:21:58,160 --> 00:21:59,000
Why not?

331
00:21:59,000 --> 00:22:02,838
Because there are six studies, six epidemiology studies

332
00:22:02,838 --> 00:22:05,200
that have looked at the relationship

333
00:22:05,200 --> 00:22:08,380
between rinitidine and prostate cancer,

334
00:22:08,380 --> 00:22:12,480
and none have found statistically significant relationship.

335
00:22:12,480 --> 00:22:14,759
Now, in the report, Dr. Simmons,

336
00:22:14,759 --> 00:22:16,398
the general causation expert,

337
00:22:16,398 --> 00:22:19,558
as the Circuit Court Judge Ferfanti found,

338
00:22:19,558 --> 00:22:22,819
never even bothered to address them in his report.

339
00:22:22,819 --> 00:22:25,358
His job was to opine on general causation

340
00:22:25,358 --> 00:22:29,319
between prostate cancer and rinitidine,

341
00:22:29,319 --> 00:22:30,759
and he concedes in his deposition

342
00:22:30,759 --> 00:22:33,358
that in order to do that, I need data on rinitidine.

343
00:22:33,358 --> 00:22:37,119
He also concedes he needs data on prostate cancer,

344
00:22:37,119 --> 00:22:38,959
but there are six studies on this topic,

345
00:22:38,959 --> 00:22:41,720
and his report doesn't mention any of them.

346
00:22:41,720 --> 00:22:46,338
Instead, the only study out there that even links NDMA,

347
00:22:46,338 --> 00:22:50,220
not rinitidine, NDMA with prostate cancer

348
00:22:50,220 --> 00:22:52,739
is a rubber worker study from England,

349
00:22:52,739 --> 00:22:55,200
people who worked with rubber fumes.

350
00:22:55,200 --> 00:22:58,440
The authors of these studies say,

351
00:22:58,440 --> 00:23:00,838
we can't pinpoint it to any one of these fumes

352
00:23:00,838 --> 00:23:03,639
that they're inhaling because the rubber workers

353
00:23:03,639 --> 00:23:07,838
are exposed to tremendous other toxins and carcinogens,

354
00:23:07,838 --> 00:23:09,920
so it's not even a study that says

355
00:23:09,920 --> 00:23:14,920
we have proven a link between NDMA and prostate cancer,

356
00:23:15,200 --> 00:23:19,398
but at a minimum, what you don't have is rinitidine,

357
00:23:19,398 --> 00:23:21,599
the progress issue in this case.

358
00:23:21,599 --> 00:23:24,160
You don't have a study that says

359
00:23:24,160 --> 00:23:27,959
rinitidine can cause prostate cancer.

360
00:23:27,959 --> 00:23:32,200
What about the fact that the Zantac pills,

361
00:23:32,200 --> 00:23:34,119
at least at one point in time,

362
00:23:34,119 --> 00:23:37,719
had more than the amounts that the FDA had approved?

363
00:23:37,719 --> 00:23:39,119
How does that weigh into it?

364
00:23:40,320 --> 00:23:43,358
I mean, I think they've been tested multiple times.

365
00:23:43,358 --> 00:23:45,798
I think the latest tests from FDA

366
00:23:45,798 --> 00:23:48,679
say they're around the same level as smoked meat,

367
00:23:48,679 --> 00:23:49,918
so that's the latest testing.

368
00:23:49,918 --> 00:23:51,679
They've been tested again over time,

369
00:23:51,679 --> 00:23:55,679
so the numbers on the testing have come down,

370
00:23:55,679 --> 00:23:59,960
but the point is we still need a link

371
00:23:59,960 --> 00:24:03,479
between rinitidine and prostate cancer,

372
00:24:03,479 --> 00:24:06,900
and that link scientifically doesn't exist in the science.

373
00:24:06,900 --> 00:24:10,900
No association, no medical science, no textbook,

374
00:24:10,900 --> 00:24:15,579
no association has ever said there is a link

375
00:24:15,579 --> 00:24:18,940
between rinitidine, the product, right,

376
00:24:18,940 --> 00:24:21,259
and prostate cancer.

377
00:24:21,259 --> 00:24:24,739
In fact, the link between NDMA and prostate cancer

378
00:24:24,739 --> 00:24:26,418
isn't even established, right,

379
00:24:26,418 --> 00:24:29,099
because all you have is the RoboWorker study,

380
00:24:29,099 --> 00:24:32,858
and the RoboWorker study has multiple confounding factor,

381
00:24:32,858 --> 00:24:36,779
and those RoboWorkers did not use rinitidine.

382
00:24:37,538 --> 00:24:38,820
So I think the consensus on the case law

383
00:24:38,820 --> 00:24:42,179
is that to give a reliable general causation opinion

384
00:24:42,179 --> 00:24:46,259
about a product, the link between a product and disease,

385
00:24:46,259 --> 00:24:49,538
you need evidence about the product and the disease,

386
00:24:49,538 --> 00:24:53,558
and here there are six studies that refute it, right?

387
00:24:53,558 --> 00:24:56,058
It has been tested, and so when you look

388
00:24:56,058 --> 00:24:59,219
at the five Dalbert factors, I think Judge Atkinson

389
00:24:59,219 --> 00:25:01,538
identified one, general acceptance.

390
00:25:01,538 --> 00:25:03,340
That's just one of them, right,

391
00:25:03,340 --> 00:25:06,719
but there is also whether this theory has been tested.

392
00:25:07,558 --> 00:25:08,599
That's a Dalbert consideration.

393
00:25:08,599 --> 00:25:12,918
Here, the theory has been tested six times,

394
00:25:12,918 --> 00:25:15,639
and it came up against Dr. Simmons' conclusion

395
00:25:15,639 --> 00:25:18,639
every single time, and he didn't even put it in his report.

396
00:25:19,719 --> 00:25:22,298
In his deposition, he was confronted with these six studies,

397
00:25:22,298 --> 00:25:25,119
and he said, well, I don't know the screening rates

398
00:25:25,119 --> 00:25:28,558
in the countries where these studies were done.

399
00:25:28,558 --> 00:25:30,418
Well, the truth is that some of these studies

400
00:25:30,418 --> 00:25:32,779
were done right here in the United States.

401
00:25:32,779 --> 00:25:35,320
What is also true is that he didn't know any differences

402
00:25:35,840 --> 00:25:39,798
in screening rates in the United Kingdom or Taiwan

403
00:25:39,798 --> 00:25:41,079
where a couple of other studies were done.

404
00:25:41,079 --> 00:25:42,599
He didn't know the screening rates,

405
00:25:42,599 --> 00:25:44,679
and of course, he also had to concede

406
00:25:44,679 --> 00:25:46,079
that the issue with screening rates

407
00:25:46,079 --> 00:25:50,400
applies to both the control group and the exposed group,

408
00:25:50,400 --> 00:25:53,200
so in terms of the ratio, which is what epidemiology

409
00:25:53,200 --> 00:25:55,759
looks at, right, the relative risk,

410
00:25:55,759 --> 00:25:56,960
there shouldn't be any difference,

411
00:25:56,960 --> 00:25:58,960
and he had to concede that as well,

412
00:25:58,960 --> 00:26:01,840
so it was easily within the discretion of trial court

413
00:26:01,840 --> 00:26:04,400
to say that's not a reliable methodology,

414
00:26:04,479 --> 00:26:06,880
and if you look at the order from Dr. Simmons,

415
00:26:06,880 --> 00:26:09,798
it carefully goes through each five,

416
00:26:09,798 --> 00:26:13,200
each of the five Daubert considerations that are outlined.

417
00:26:13,200 --> 00:26:15,558
It's not a checklist or anything like that.

418
00:26:15,558 --> 00:26:16,759
It's five considerations,

419
00:26:16,759 --> 00:26:18,119
one of them being general acceptance,

420
00:26:18,119 --> 00:26:19,918
one of them being testability,

421
00:26:19,918 --> 00:26:21,798
one of them being peer review, right?

422
00:26:21,798 --> 00:26:24,798
He's never peer reviewed, he's never had published anything.

423
00:26:24,798 --> 00:26:29,798
Neither his conclusion nor his methodology here

424
00:26:29,798 --> 00:26:31,558
has ever been subject to peer review,

425
00:26:31,558 --> 00:26:32,380
and on the other side,

426
00:26:32,380 --> 00:26:34,858
there are six peer reviewed studies

427
00:26:34,858 --> 00:26:36,219
that cut the other way,

428
00:26:36,219 --> 00:26:40,900
so all of these factors weigh in favor of exclusion,

429
00:26:40,900 --> 00:26:43,538
and one thing we know about Daubert

430
00:26:43,538 --> 00:26:47,019
is the significant deference that is afforded

431
00:26:47,019 --> 00:26:48,739
to a lower court determination.

432
00:26:48,739 --> 00:26:51,460
It is the trial judge who is uniquely

433
00:26:51,460 --> 00:26:54,179
in the role of gatekeeper,

434
00:26:54,179 --> 00:26:58,298
and let me circle back around to the due process issue

435
00:26:58,298 --> 00:27:00,380
where my colleague started.

436
00:27:00,380 --> 00:27:02,599
There was briefings issue,

437
00:27:02,599 --> 00:27:04,019
there was an all-day hearing on it,

438
00:27:04,019 --> 00:27:05,820
which was on August 2nd,

439
00:27:05,820 --> 00:27:09,159
and everyone showed up with PowerPoint presentations.

440
00:27:09,159 --> 00:27:11,979
Each of these PowerPoint presentations were shown,

441
00:27:11,979 --> 00:27:14,659
and then they were handed to Judge Farfanti.

442
00:27:14,659 --> 00:27:17,858
The fact that he didn't make rulings from the bench,

443
00:27:17,858 --> 00:27:21,579
to me, suggests deliberate judicial process

444
00:27:21,579 --> 00:27:23,779
as opposed to ruling right from the bench

445
00:27:23,779 --> 00:27:26,900
after being confronted with so much material,

446
00:27:26,900 --> 00:27:29,219
so the fact that they weren't findings right in the moment

447
00:27:29,219 --> 00:27:31,779
does not suggest lack of independent judgment.

448
00:27:31,779 --> 00:27:34,979
I think that's a prudent way of handling this,

449
00:27:34,979 --> 00:27:37,058
and then there was the question at the end of that hearing

450
00:27:37,058 --> 00:27:39,219
after he received the PowerPoint slides,

451
00:27:40,380 --> 00:27:45,380
he actually asked the plaintiffs simultaneous submission,

452
00:27:45,659 --> 00:27:48,219
that's at A-286 of the appendix.

453
00:27:48,219 --> 00:27:50,159
Let me make sure I said that right.

454
00:27:51,259 --> 00:27:54,700
Yes, excuse me, A-268 of their appendix.

455
00:27:55,739 --> 00:27:58,219
He asks the plaintiffs whether they wanna do

456
00:27:58,219 --> 00:28:00,500
simultaneous submission.

457
00:28:00,500 --> 00:28:03,700
He's asked us when are we gonna submit our proposed orders,

458
00:28:03,700 --> 00:28:05,380
and it says it's gonna be August 15,

459
00:28:05,380 --> 00:28:07,139
which is 10 days later.

460
00:28:07,139 --> 00:28:09,380
Then he asks the plaintiff, how about you?

461
00:28:09,380 --> 00:28:11,179
They say we're fine on the same day,

462
00:28:11,179 --> 00:28:14,460
so he then asks, simultaneous submission, question mark,

463
00:28:14,460 --> 00:28:16,179
that's in the transcript,

464
00:28:16,179 --> 00:28:18,460
and the plaintiffs are saying yes,

465
00:28:18,460 --> 00:28:20,340
simultaneous submission,

466
00:28:20,340 --> 00:28:22,538
so they can't now come here and complain

467
00:28:22,538 --> 00:28:25,779
over the fact that there was simultaneous submission

468
00:28:25,779 --> 00:28:27,000
in this case.

469
00:28:27,038 --> 00:28:30,159
They were both submitted, the draft orders were submitted,

470
00:28:30,159 --> 00:28:33,358
and he didn't enter them immediately.

471
00:28:33,358 --> 00:28:36,358
He entered them 15 days after the hearing,

472
00:28:36,358 --> 00:28:38,798
and three days after they were submitted,

473
00:28:38,798 --> 00:28:40,880
and what I really wanna push back

474
00:28:40,880 --> 00:28:44,279
is the notion that there were no substantive changes,

475
00:28:44,279 --> 00:28:47,599
that this was just rubber stamping the defense proposal.

476
00:28:47,599 --> 00:28:48,759
That's just not true.

477
00:28:48,759 --> 00:28:52,840
If we run a compare, and they're at least in the appendix,

478
00:28:52,840 --> 00:28:54,719
if not, they need to be supplemented as a record

479
00:28:54,719 --> 00:28:55,918
if they're currently not on the record,

480
00:28:56,759 --> 00:29:01,000
but if we run a compare between the proposed orders

481
00:29:01,000 --> 00:29:05,159
and the actual orders, they are heavily, heavily edited,

482
00:29:05,159 --> 00:29:07,759
and they're not just edits along the lines

483
00:29:07,759 --> 00:29:11,440
of stylistic changes, they're substantive changes.

484
00:29:11,440 --> 00:29:13,440
Let me give you one example.

485
00:29:13,440 --> 00:29:15,840
We made an argument when we were subsection three,

486
00:29:15,840 --> 00:29:18,000
902 subsection three,

487
00:29:18,000 --> 00:29:20,320
which is the fit analysis of Dahlberg, right?

488
00:29:20,320 --> 00:29:23,038
We said, these are NDMA evidence,

489
00:29:23,079 --> 00:29:25,320
it doesn't fit with the remitted in evidence.

490
00:29:26,880 --> 00:29:29,200
Every time, and every time we make that order,

491
00:29:29,200 --> 00:29:32,679
that argument in our order, put it in our proposed order,

492
00:29:32,679 --> 00:29:35,200
Judge Farfanti cut it out,

493
00:29:35,200 --> 00:29:36,719
because he didn't agree with it.

494
00:29:36,719 --> 00:29:40,320
He removed those from the proposed orders.

495
00:29:40,320 --> 00:29:42,880
He didn't just move things around, he did that too,

496
00:29:43,960 --> 00:29:47,840
but he also removed an argument

497
00:29:47,840 --> 00:29:50,119
with which he apparently did not agree.

498
00:29:50,119 --> 00:29:53,038
Likewise, there's the statement

499
00:29:53,038 --> 00:29:55,279
from the plaintiff's draft orders

500
00:29:55,279 --> 00:29:59,038
about exclusion is the exception under Dahlberg,

501
00:29:59,038 --> 00:30:01,840
and a trial judge must take care

502
00:30:01,840 --> 00:30:05,000
not to cross the line into weighing evidence.

503
00:30:05,000 --> 00:30:10,960
And that language came from the plaintiff's proposed orders.

504
00:30:10,960 --> 00:30:14,720
So he didn't just push their orders aside.

505
00:30:14,720 --> 00:30:16,519
He looked at both sides.

506
00:30:16,519 --> 00:30:18,039
And the parts that he thought needed

507
00:30:18,039 --> 00:30:20,680
to be in there from the plaintiff's,

508
00:30:20,680 --> 00:30:23,039
he took from the plaintiff's order

509
00:30:23,039 --> 00:30:25,680
and put it into the final orders.

510
00:30:25,680 --> 00:30:29,200
And he took out the part about the fit.

511
00:30:29,200 --> 00:30:31,000
And then he also removed the part about,

512
00:30:31,000 --> 00:30:33,160
we had an argument about ipsa dixit.

513
00:30:33,680 --> 00:30:36,440
That's a language that comes from Dauber.

514
00:30:36,440 --> 00:30:39,319
He took out our argument regarding ipsa dixit.

515
00:30:39,319 --> 00:30:42,039
So it's not a verbatim adoption.

516
00:30:42,039 --> 00:30:44,559
We're not even in the Perlow framework,

517
00:30:44,559 --> 00:30:48,400
because that deals with when there is a verbatim adoption.

518
00:30:48,400 --> 00:30:49,720
We don't have other errors.

519
00:30:49,720 --> 00:30:51,839
We don't have Washington, the Washington case

520
00:30:51,839 --> 00:30:53,720
my colleague mentioned to you.

521
00:30:53,720 --> 00:30:57,400
In Washington, the title of the order that was actually

522
00:30:57,400 --> 00:30:59,720
entered on the docket was still called

523
00:30:59,720 --> 00:31:01,598
defendant's proposed order.

524
00:31:01,598 --> 00:31:04,359
And it had several errors in it,

525
00:31:04,359 --> 00:31:07,519
findings that weren't supported by the record.

526
00:31:07,519 --> 00:31:08,680
That's the problem.

527
00:31:08,680 --> 00:31:11,239
That's what Perlow seeks to prevent,

528
00:31:11,239 --> 00:31:14,400
when there's basically obvious lack of judicial consideration,

529
00:31:14,400 --> 00:31:18,400
because factual errors are being imported

530
00:31:18,400 --> 00:31:19,638
from a proposed order.

531
00:31:19,638 --> 00:31:22,440
And Perlow itself only dealt with the case

532
00:31:22,440 --> 00:31:25,039
where the trial court discouraged the husband

533
00:31:25,039 --> 00:31:27,759
from submitting a proposed order and only

534
00:31:27,759 --> 00:31:30,160
accepted one from the wife.

535
00:31:30,160 --> 00:31:31,440
That's not what happened.

536
00:31:31,440 --> 00:31:33,278
By agreement of the plaintiff, there

537
00:31:33,278 --> 00:31:36,480
was simultaneous submission, submission from both sides.

538
00:31:36,480 --> 00:31:38,278
He didn't enter them immediately.

539
00:31:38,278 --> 00:31:39,959
He entered them three days later.

540
00:31:39,959 --> 00:31:41,919
He made substantive changes.

541
00:31:41,919 --> 00:31:46,239
And I think what my colleague's argument falls down to is,

542
00:31:46,239 --> 00:31:50,959
yes, the orders granting the motion substantively

543
00:31:50,959 --> 00:31:54,319
agree with the arguments made in the motion.

544
00:31:54,319 --> 00:31:56,359
That is to be expected.

545
00:31:56,359 --> 00:32:00,319
It would have been improper for Judge Farfanti

546
00:32:00,319 --> 00:32:02,638
to go outside of what the parties argued.

547
00:32:02,638 --> 00:32:04,558
And that seems to be what he's asking for

548
00:32:04,558 --> 00:32:06,359
as independent judgment, right?

549
00:32:06,359 --> 00:32:08,440
That basically, Judge Farfanti now

550
00:32:08,440 --> 00:32:13,079
goes outside of what we argued and adds additional points

551
00:32:13,079 --> 00:32:13,799
into the order.

552
00:32:13,799 --> 00:32:16,038
That would have been a due process violation.

553
00:32:16,038 --> 00:32:19,160
If Judge Farfanti now relies on case law

554
00:32:19,160 --> 00:32:21,599
that hadn't been cited by the parties,

555
00:32:21,599 --> 00:32:23,639
that would have been problematic.

556
00:32:23,639 --> 00:32:27,720
So I think, far from a due process violation,

557
00:32:27,720 --> 00:32:30,278
there was plenty of opportunity to be heard.

558
00:32:30,278 --> 00:32:32,519
There was an opportunity to object if they wanted to.

559
00:32:32,519 --> 00:32:33,960
He didn't immediately enter them.

560
00:32:33,960 --> 00:32:36,759
He didn't enter them the same day as in parole or the next

561
00:32:36,759 --> 00:32:37,960
day.

562
00:32:37,960 --> 00:32:42,278
Those issues that are present in these cases,

563
00:32:42,278 --> 00:32:45,759
where there is obvious mistakes in these orders,

564
00:32:45,759 --> 00:32:49,079
it's just not present in this case.

565
00:32:49,079 --> 00:32:51,440
Unless the court has any questions for me at this point,

566
00:32:51,440 --> 00:32:54,000
I would reheat my time.

567
00:32:54,000 --> 00:32:54,500
Very good.

568
00:32:54,500 --> 00:32:55,278
Thank you, counsel.

569
00:33:05,240 --> 00:33:07,118
Your Honors, I know I only have four minutes.

570
00:33:07,118 --> 00:33:09,919
I just want to address a couple of those comments briefly.

571
00:33:12,440 --> 00:33:14,398
To say that there was no reliable methodology

572
00:33:14,398 --> 00:33:17,838
for not only doing a general causation analysis,

573
00:33:17,838 --> 00:33:20,720
but doing a specific causation analysis is simply not true.

574
00:33:21,440 --> 00:33:24,799
What happened here is the experts on general causation,

575
00:33:24,799 --> 00:33:26,679
and actually Dr. Connery as well,

576
00:33:26,679 --> 00:33:28,679
all three of the medical experts,

577
00:33:28,679 --> 00:33:30,880
performed a Bradford Hill analysis,

578
00:33:30,880 --> 00:33:33,880
which is a set of nine criteria widely used

579
00:33:33,880 --> 00:33:37,479
by epidemiologists that have a number of different things

580
00:33:37,479 --> 00:33:39,759
that they should consider.

581
00:33:39,759 --> 00:33:43,079
Not one outweighs any other one, and the courts

582
00:33:43,079 --> 00:33:45,720
have held that different experts can apply them

583
00:33:45,720 --> 00:33:48,118
in different ways.

584
00:33:48,118 --> 00:33:50,440
But all three of those experts conducted

585
00:33:50,440 --> 00:33:53,118
their own Bradford Hill analysis and still

586
00:33:53,118 --> 00:33:58,038
came to the conclusion that the NDMA contaminated reninine was

587
00:33:58,038 --> 00:34:02,038
a substantial contributing factor to his disease.

588
00:34:02,038 --> 00:34:05,079
Again, to the additional point that Dr. Connery didn't

589
00:34:05,079 --> 00:34:07,519
have a reliable methodology, Dr. Connery

590
00:34:07,519 --> 00:34:09,599
conducted a differential diagnosis,

591
00:34:09,599 --> 00:34:12,679
which is the hallmark reliable method for determining

592
00:34:12,679 --> 00:34:15,360
causation in cases like this.

593
00:34:15,360 --> 00:34:17,199
He went through all of the factors.

594
00:34:17,199 --> 00:34:24,159
He went through age, race, weight, family history.

595
00:34:24,159 --> 00:34:26,480
And again, Mr. Wilson had some family

596
00:34:26,480 --> 00:34:28,480
that was diagnosed with prostate cancer,

597
00:34:28,480 --> 00:34:34,358
but he's a rare case that has genetic testing that says

598
00:34:34,358 --> 00:34:38,159
his cancer was not genetically linked.

599
00:34:38,159 --> 00:34:40,239
And that is the evidence in the case

600
00:34:40,239 --> 00:34:41,920
that the experts relied on.

601
00:34:41,920 --> 00:34:44,159
So to conduct a Bradford Hill analysis,

602
00:34:44,159 --> 00:34:46,278
to conduct a differential diagnosis,

603
00:34:46,278 --> 00:34:49,440
to thoroughly discuss all of these other issues

604
00:34:49,440 --> 00:34:51,320
and be able to rule them out.

605
00:34:51,320 --> 00:34:55,119
And of course, the law is not that they

606
00:34:55,119 --> 00:34:58,798
have to completely rule out all other sole causes.

607
00:35:01,880 --> 00:35:04,119
This is from the Gwynn case in the 11th Circuit, Gwynn

608
00:35:04,119 --> 00:35:06,119
versus AstraZeneca.

609
00:35:06,119 --> 00:35:08,398
They don't need to rule out all the alternative causes.

610
00:35:08,398 --> 00:35:11,239
All they have to do is consider the factors that

611
00:35:11,239 --> 00:35:13,398
could have been the sole cause.

612
00:35:13,398 --> 00:35:16,358
These experts considered these other factors.

613
00:35:16,358 --> 00:35:19,159
They weighed them, they discussed them,

614
00:35:19,159 --> 00:35:22,000
they analyzed them, and then they came to their conclusion.

615
00:35:22,000 --> 00:35:24,838
That is the hallmark of the reliable methodology.

616
00:35:24,838 --> 00:35:27,159
And just because they weighed some factors

617
00:35:27,159 --> 00:35:29,320
heavier than what the plaintiff's attorneys,

618
00:35:29,320 --> 00:35:32,599
or I'm sorry, the appellee's attorneys

619
00:35:32,599 --> 00:35:35,639
would have liked them to weigh, is a different story.

620
00:35:35,639 --> 00:35:39,798
Again, on this issue of threshold dose,

621
00:35:39,798 --> 00:35:41,838
it's never been the law in the state of Florida

622
00:35:41,880 --> 00:35:44,958
that the expert has to calculate an exact threshold dose.

623
00:35:44,958 --> 00:35:47,720
And the reason for that was addressed by the Henderson case

624
00:35:47,720 --> 00:35:49,958
in the Middle District of Florida just five months ago.

625
00:35:49,958 --> 00:35:53,278
It's because in cases of carcinogenicity,

626
00:35:53,278 --> 00:35:56,119
it's very hard to determine exact threshold doses

627
00:35:56,119 --> 00:35:59,440
because simply you can't do the experiment

628
00:35:59,440 --> 00:36:01,760
where you have a control group and a test group

629
00:36:01,760 --> 00:36:04,159
and you give the test group a known carcinogen

630
00:36:04,159 --> 00:36:06,760
and wait for them to develop cancer.

631
00:36:06,760 --> 00:36:09,079
So the evidence on minimum threshold dose

632
00:36:09,079 --> 00:36:11,440
has to come from other sources.

633
00:36:12,039 --> 00:36:15,679
And that's perfectly acceptable in Florida.

634
00:36:15,679 --> 00:36:18,760
In fact, the McLean case, McLean v. Metabolife,

635
00:36:18,760 --> 00:36:20,278
Florida Supreme Court case,

636
00:36:20,278 --> 00:36:22,519
has specifically said in footnote six,

637
00:36:23,599 --> 00:36:26,519
they should address the dose-response relationship,

638
00:36:26,519 --> 00:36:28,480
but they don't need to calculate exact numbers.

639
00:36:28,480 --> 00:36:32,119
They don't need to, such levels do not need to be proven

640
00:36:32,119 --> 00:36:33,599
by precise dose numbers.

641
00:36:33,599 --> 00:36:36,880
Qualitative proof can be sufficient.

642
00:36:36,880 --> 00:36:38,720
That's what Dr. Byrd did in this case,

643
00:36:38,720 --> 00:36:40,778
and that's what Dr. Connery said in this case.

644
00:36:40,820 --> 00:36:44,220
Dr. Connery looked at things like water consumption,

645
00:36:44,220 --> 00:36:48,739
dietary, and said the science that he reviewed

646
00:36:48,739 --> 00:36:52,099
shows that the levels of NDMA and Zantac

647
00:36:52,099 --> 00:36:54,139
were nine to 18 times higher

648
00:36:54,139 --> 00:36:55,980
than all the other sources combined.

649
00:36:58,659 --> 00:37:01,059
Dr. Byrd, relying on the Hitajat study

650
00:37:01,059 --> 00:37:06,059
and other materials, discussed the different quartiles

651
00:37:06,500 --> 00:37:11,500
of when a level of exposure increases the risk for cancer.

652
00:37:11,980 --> 00:37:15,838
Now, to say that Hitajat was just some rubber worker study

653
00:37:15,838 --> 00:37:17,559
and there was no way to tell anything

654
00:37:17,559 --> 00:37:19,260
is simply not the case.

655
00:37:19,260 --> 00:37:24,260
But again, I caution attorneys, I caution the court

656
00:37:24,298 --> 00:37:28,298
to not go the way that was described in Dover

657
00:37:28,298 --> 00:37:31,220
of donning the white scientist's coat

658
00:37:31,220 --> 00:37:33,139
and playing amateur scientist.

659
00:37:33,139 --> 00:37:34,778
Counsel, you've got about 30 seconds left.

660
00:37:34,778 --> 00:37:36,380
Thank you, Your Honor.

661
00:37:36,380 --> 00:37:39,139
In this case, the underlying methodologies

662
00:37:40,778 --> 00:37:45,778
of Bradford Hill, of differential diagnosis,

663
00:37:46,539 --> 00:37:48,539
of considering all these other factors,

664
00:37:48,539 --> 00:37:51,139
considering all the epidemiology and the other science,

665
00:37:51,139 --> 00:37:54,458
weighing all of it, being cross-examined on all of it,

666
00:37:54,458 --> 00:37:56,820
is a hallmark of reliability in the Dover.

667
00:37:56,820 --> 00:37:58,619
That occurred in this case.

668
00:37:58,619 --> 00:38:00,619
Now, the orders that came out

669
00:38:01,298 --> 00:38:04,338
disagreed with how the analysis was performed.

670
00:38:04,338 --> 00:38:08,059
And that is a role for the jury, not the court.

671
00:38:08,059 --> 00:38:11,179
So, Your Honor, we ask that the court reverse these orders

672
00:38:11,179 --> 00:38:13,458
and remand the case back to Hillsborough County

673
00:38:13,458 --> 00:38:16,338
for further proceedings consistent with the court's opinion.

674
00:38:16,338 --> 00:38:17,179
Very good.

675
00:38:17,179 --> 00:38:18,019
Thank you both.

676
00:38:18,019 --> 00:38:18,858
Interesting.

677
00:38:18,858 --> 00:38:20,579
Okay, we had some interesting cases today

678
00:38:20,579 --> 00:38:21,458
and this was one of them.

679
00:38:21,458 --> 00:38:22,880
So, thank you all.

680
00:38:22,880 --> 00:38:25,099
And that concludes the oral argument docket

681
00:38:25,099 --> 00:38:26,420
and we are adjourned.

682
00:38:26,420 --> 00:38:27,519
Thank you, Your Honor.

683
00:38:30,619 --> 00:38:31,458
Thank you.