reasons number one the district court simply overlooked the we mocker study which pfizer presented into the record dr jill testified about it and it showed that there were significant severe congenital heart defects that would be sufficient to warrant expert testimony about general causation there's no discussion about we marker in the dog opinion there yes causation yes and under this court's precedents the first thing that the scientists would look at is is there an association you can determine if there is an association on the basis of one study record cite it in those pages the only citation is to the district court's opinion in a way grow ray grow in tron only referenced the defense scientific acts poor vis proposition so if this is a factual finding it has to be reversed for clear error because a district judge can't rely on the facts in another case in order to make a holding about carro his record for that proposition judge rough ass where the error is the judge cited a district court opinion in another case that relied on the defendant scientific expert and the proposition as a matter of law incorrect if you look at the first circuits decision in millward goes right directly to the point that you made to open this which is the threshold question is is there an association if there is an association which you can show  to the court the power to result all the reconcile what is a very complicated epidemiological record that's not what science has to what scientists do under this court's precedents and i'm thinking about canon deal but it was not she was irritating to her since the idea of her reconciling the studies and let me point out and this is really crucial you know i don't i don't agree with you on the hand i think she was  scientific expert and that is consistent with all of the scientific approaches to course taken these kinds of problems which is to look and see whether there is an association and if there is an association did evaluate  that proposition and i promise you there is nothing in this record that the judge sided on this chair to logical point so as a matter of fact if you did turn it to be a factual finding it has to be reversed for clear air it has to  another side it has the other side is that it cannot exclude the possibility of an all hypothesis and that's where this whole question about statistics starts to get really confusing frewer found it there was a positive it's a statistical matter what that means is that this study could not exclude the possibility of a null hypothesis but new or was it not inconsistent with the idea that there was a positive association and then asked why this idea about statistical significance throws right into the supreme court's decision in matrix which says when you're doing these kinds of questions of causation in the medical field you are not to rely solely on statistical significance because there are a lot of other factors that come into play and when you look at the nine bradford hill factors one of them is the biological back innocent by which the drug the potential birth defect and here the judge was happy except to the three biological mechanism experts that were proffered by the plaintiffs so we're all better for me and i think you're i'm not sure if you answered this if you did apologize but you twenty thirty forty years after the fact until there can be a complete reconciliation of every possible epidemiological study there's no court that i'm aware if it is imposed that strict a state or under dog or hurt to preclude that directly to his counsel i think that i promise you and then you can search the record you will find no evidence other than we grow that is frankly just demonstrably not true in fact at page twenty six of our brief we have at the end a number of finding so it is true that the court cited we grow she she said basically in looking at her factual determination what the court is it was everyone agrees that tara telegin epidemiology appropriate disciplines here so the court needed to review journal and of course the answer that is no so i think the questions judge will say is i'm not drawing a private ride you don't have to decide that one study does it or one study doesn't do it but sheer when you have a kind of overwhelming crushing amount of information over the course of twenty because the only funding there was severe cardiac waits it doesn't replicate the other thing that's interesting about the cases it was addressed at the hearing so apparently it seems that council she was known as you know a thousand page decision from a judge talking about everything we are to ignore you know ten days of hearings and mounds of paper in evidence in the record which there is in the record the other thing is there was no supplemental report in that case so it's important counsel is now saying it is there was never a supplement was discussed and dressed up here so clearly dr ruth understood the decision and here's i think also the kicker for that is that the authors of the women are stating to center when it can get in the weeds and that they did not adjust for depression alcohol or smoking so not only do you have dr drew saying it's not replication the authors themselves said they didn't do it just for the confounding and what they said was the authors quote cannot exclude confounding by indication or  factors and that their findings were quote compatible with confounding by depression as indication or other associated factors or exposures so you know the idea that this is a slam dunk silver very methodical decisions three of them where she said specifically here's the flaws here's the method out methodological flaws the plaintiffs have not even appeal from those decisions the pleas then are you you know give us a century another chance authorities who work in this field say that he first have to determine whether there is an association right it has to be a true association and then if there is a true association then you applied the graphical criteria and worked with it and everyone had agreed in this case essentially you need replication you need consistency so she looked at what professor julian had offered and she said well as to these three danish studies there's overlap and we have it now you have explain why you're doing bad then she said with respect to prove if there was any open question we now have a study in two thousand and fifteen that is looked at essentially all the population of those three studies and there is no statistically significant association or findings and you have do those that these constitute association and he or she can even get a plane is there a chance and determine that there was no association i suspect and she did discuss the connection with dr brar if she determine that that she went further and discussed the practical criteria but to the extent that you don't have an association you don't need to go further and discuss bradford hill with respect to causation but the question quick clearly roger that's what this whole ten days of hearings route was you know can and sold or cause birth jury by focusing on dr jules conclusions as opposed to his methods down to your honor and i think the judge was very very clear about that i mean just like she didn't follow the conclusions of you know  unless you have a statistically significant finding all else fails but in fact i would submit that the folks who are on the island are are a professor a doctor broad a professor cool because no one supports what they're saying and what i would also proffer is that if you you know if you really do take a step back practically think about it if in fact professor jewel had found something that no one else has found that so or course is birth defects one would expect  and what would judge rufe i think starkly understood was that if in fact you get past the reliability and this is a matter of true experts who have reasonably reliable opinions that differ that's exactly what we're supposed to about to go to the jury but there is a threshold issue a threshold inquiry about whether a pessimist output and whether it passes the reliability standard and that's what the judge ruled did exactly here and and it's consistent how do that is a factual determination that i think is subject to a higher standard ultimately the field of legal standard here is with summary judgment appropriate and i think the answer to that is not yes having no experts so you know i think again reading literature taking experts looking at peer reviewed studies looking at all of taking testimony from both sides and how it would be that epidemiologists in terre tower just would go about determining causation and  concept that but there are factual predicates and understanding of how you go about determining causation that's exactly what the court did and i submit respectfully that's exactly what the kind of analysis that we want courts to do is roll up our sleeves reconsideration they said judge you got it wrong in fact almost identical arguments here and frankly almost a democratic mix when i was reading the preacher case you know i thought in some regards we could change the name the place argued there and here but you created bright line rule and she said absolute says one thing and professor to all the study and says something else all of this without explaining the entire context because you have to understand there's a huge amount of information this is not a case where you have a new medicine come on the market you know maybe this one study that's really a case for another day for your eyes to deal with here we have a medicine that's been on the market for literally decades it's widely hugely studied and the information and data that has come out in fact the most recent data all of it all of it suggests no association much less causation there's a million women high pick study from harvard that was published there's a study which deals with a nice information there's the c d c commission they do judge roof didn't cite any evidence of that in the various opinions that she wrote on this subject none the only authority that she relied upon was weight grow but it the chair tala says to do that in some of the studies resulted in those studies that did reject the null hypothesis that there was a lack of replication but yet that gets exactly to the point of what is the jury to be doing which here first studies show an association even if you accept the statistically significant confidence interval form to that the judge is not to then say well there are six or seven other studies that i don't think quite get to the same level  statistical significance mr shatter made very important and good arguments that he can make to the jury clear on cross examination about the lack of peer review or confounding factors but those are cross examination issues that go to the weight because is this core care held just last week in the carlow case quote the question of whether a studies results were properly calculated or interpreted were merely goes to the root of the evidence not to