which is eg nine am if i have the pronunciation right versus boston scientific corp morning morning morning may please the court my name is daniel rogers i am here representing the appellant boston scientific corp your honors as you know this is an appeal from a prescription medical device products liability case we appeal from substantial verdicts and judgments following a four plaintiffs consolidated trial we raise two different types of issues for the court today we rescind case specific judgment as a matter of law which could potentially affect new future cases in this multi district litigation proceeding that's pending up north there are two distinct ways that boston scientific was denied a fair trial first was the fact of consolidation of for fact intensive medical device cases it was improper when it was sue a sponsor a done initially based upon the pleadings alone and the record bears out that there was substantial and the tons of prejudice that resulted as a result of that consolidation the second way in which boston scientific was denied a fair trial had to do with precluding this medical device manufacturer from discussing the regulatory environment in which it operates and the governmental clearance it obtained to market the subject devices now this denied boston scientific very important evidence that rebutted the plaintiff's main themes in the case concerning things like pre market testing not being conducted which the f d a doesn't require or that there was a material safety data sheet caution that was important boston scientific wasn't allowed to inform the jury that we actually submitted that to the f d a and the f d a still cleared the  device with the court's indulgence i'd like to start with those broader issues first so first talking about the consolidation the differences amongst the plaintiffs in this case substantially outweighed the common issues and consolidation was improper in consolidation is generally improper in nearly all product liability cases and medical device cases because of the fact intensive nature of of them let's begin with the proposition that you've got to establish that the district court determination about consolidation constituted a clear abuse of discretion so we don't start with a blank slate you've got a hill you have to climb in order to do that show us why it amounted to a clear abuse of discretion for the trial court to consolidate the four cases well the first way the initial consolidation order that was based upon the pleadings basically found that there are substantial common issues that will produce over the differences and i believe that the evidence shows about was a the facts bear out that that was a clear error of judgment because the factual differences in this case were substantially greater then the commonalities at the end of the day the only common issues in this case was that it involved the same product from women who were implanted with the product in the same state so therefore florida law applied you have the same defendant and the same product those are really the only commonalities that exist here because all of the other issues well the claim was that the pinnacle device was under reasonably dangerous in a particular way that was common to the claims of each of the four plaintiffs right the design defect claim under florida law was common but i think the analysis what they said was wrong with the product was common wasn't it yet in a general didn't it to the extent that they are claiming polypropylene the use of the device yeah that was one of the essential claims they made it wasn't an only claim they made but that was common to both was it not yes your honor what was the second claim they made about about the danger in the product that they claimed that there were three different ways that the warnings were inadequate pursuant to you know that but they talked about the the method the the way the match mesh was designed that was common to all of the plaintiffs wasn't your honor as the evidence came out at trial i don't believe that that was really the focus of the design defect claim that it was the nature of the mesh it was more the focus on the polypropylene and how that interacted and they did talk about how when you take the polypropylene and you extrude it out into long strands it creates more surface area and they try to prove that claim we don't think they did prove that claim because there was no essential element of what is the threshold that's crossed in which it causes harm but those are the two types of ways that they try to prove that the product was harmful and there was something common in terms of the claim about the warnings right the sufficien warnings was another part of the plaintiff's case yes your honor wasn't the claim about whether the warnings were sufficient or insufficient common to each of the four yes your honor they relied on the same expert as to inadequacies correct out the damages arguably are different causation is arguably different but why wasn't there a nod here to allow the judge within pretty broad parameters to try the four cases together without clearly abusing his discretion maybe it would have been wiser to try them individually maybe if i was sitting in the district what i would have but you've got to show me that where there are substantial common issues or a liability and meaningful issues that a disparity and i think you've got both your that the district cour abused his discretion by putting it into one trial your what your are described to have been appropriate maybe to consolidate on the issue of design defect or in the limited issue of the warning adequacy but the reason why there was a clear of discretion here and a clear error of judgment is because those disparate issues that you're on a reference regarding causation and damages here were the most important and material issues and they get lost in the shuffle when you have a three didn't the trial judge tell the jury they've got to take each case on its own for years and you've got to look at the issue among other things of causation and damages individually and specifically to each of the foreplay news yes your honor but that instruction it's our position didn't really do and we have to assume that the jury was unable or unwilling to follow the instruct honor i think that it was more unable to follow the instruction given the way that the evidence came in in this case and i think that we've we've set that forth with regard to the order in which the evidence was presented in the spillover in which the plaintiffs argued their  case looking at the plaintiff's opening statement in their closing argument i think it's very telling when they talk about how the only common issue here is the product you've got all of these differences and their closing argument i think they spent what maybe fifteen percent sixteen percent of their time actually talking about the plaintiffs and eighty four percent of the time talking about the products it creates a composite plaintiff where you have prejudicial spillover we had the trial judge even acknowledging that the jury was missing things we had plaintiffs counsel in the middle of an exchange of cross examination with an opposing expert where they couldn't even keep straight oh did she have it planted in the interior compartment of the post here compartment nobody could keep those critical critical facts straight and those facts are very material because you make a pretty strong case with respect to that but our deference and particularly what i would think is the difference to a district court overcomes most of that the part of your argument that is most  concerning to me is the exclusion of the five a one k process and i hate for you to to not get a chance to address that yes absolutely your honor we think that the district court there made it clear error of law first in determining that this evidence was not relevant that was an issue for the jury to decide in the court was relevant in two different ways the judge get to decide whether stuff is relevant or not the judge and the judge can decide whether relevant but here there was our determination is whether the judge properly decided that it was irrelevant right yes your honor and in this particular case the judge basically said that well yeah it's it  means something that it was cleared but it doesn't relate to safety and efficacy outs that was the argument the right did right what's wrong with that argument well it seems to be correct your honor if that is correct then you lose on that argument when you say if it's just not relevant to safety or not directly relevant to safety or if indirectly related to safety would create a whole mini trial if if the judge is right on that then under under our scope of review certainly your honor i would have to if the judge is right on those things then there was no abuse of discretion but we submit he was did if it's reasonably debatable even if we might read for all three differently you've got to show again that it was an abuse of discretion here yes and gets to try the case and he's got to go beyond the goalpost before we can kick what he did isn't that right your honor i understand that i as you put it i feel it's an uphill battle on these abuse of discretion standards and i agree that it is a tougher standard ok so tell me why it amounted to an abuse of discretion when the district court explained quote that had so little relevance in the fact that pinnacle was cleared pursuant t the five one ok process because the supreme court did explain that quote compliance with five ten k focuses on equivalence not safety and that products entering the market through the five ten k process have never been formally reviewed for safety or africa see end quote and the court explained that the jurors are likely to believe or at least he was concerned that the jurors were likely to believe that battle a mini trial if you will on whether b s e in fact complied with the regulations why couldn't he say it was wise or on balance to keep this out because whatever pro would have a value would had in advancing the theory of safety was modest and limited maybe not nonexistent but the dangers of confusion great and you could compound the length of the trial considerably if you moved into a new ballpark and had to address this many issue why couldn't he say that and for within the a discretion number one your honor because the minimal relevance that he found we believe that was a misapplication of the lore precedent belying upon the grandfather provision of the five ten k when this was not a device that was introduced pursuant to equivalent to a device that was cleared pursuant to the grandfathering provision this device the pinnacle device was actually substantially equivalent to invite a device that had received a safety review a comprehensive safety review that it was equivalent to so that was a clear error of judgment number one but as to the balancing of the things and whether or not it would have confused the jury well the discussion that we believe just had about jury instructions i think is more apt here than it is in the consolidation context because here the judge could instruct the jury specifically as to what the significance of five ten k means and that's an instruction that a jury can understand which is very different from the concept of when you're throwing evidence at a jury of four different plaintiffs and then the judge says oh you need to keep that straight that's a sub conscious thing you can't unconfuse a jury with an instruction like that however when you're dealing with the significance of the five ten k and whether or not it is dispositive of the case that's a type of instruction that a jury can receive and should be able to follow it this seems to be the same issue as in the four circuit case is that correct   that there was a misapplication of lord there and obviously we disagree with that the distinguishing factor here i'm just talking about the five ten k evidence that's all i'm talking about the distinguishing factor here in the four zero three  four circuit case how was it consolidated to that was that was a one plaintiff plan ok i get it in this case you had central themes that were being pressed by the plaintiffs about a lack of pre market testing about how the warnings for the p device you're just saying it was more relevant here than it was in that case what do you know it was in its exclusion was deeply deeply prejudicial here when it wasn't in that case given the if you're talking about the balance of events and my question thank you scientific fail to show any grounds for reversal of these judgments like boston scientific i plan to focus on the consolidation and five ten k arguments unless this court has questions on the others point three and point four i'll plan to rely on my briefs and ask the court to affirm on those points turning first to consolidation i believe that judge marcus hit it on the head this trial judge who has been charged with presiding over one hundred four thousand of these trends bajan all mesh cases and seven different and deals had very broad discretion to consolidate these four similar cases for trial these four plaintiffs brought very similar claims all under the same florida law for design defect and for failure to warn and the trial court had broad discretion discretion to decide that those general issues of design defect failure to warn whether this device could cause this type of injuries substantially outweighed any of the individual differences between these plaintiffs one of the family ask  question what do we have to make of the fact that when you look at the verdicts themselves they're almost identical in two of the instances they are identical sixty seven six million seven hundred twenty two thousand two hundred twenty two for two the third one was sixty six million seven hundred sixty six thousand six six six and the fourth was sixty five three three three three three  suggests that these verdicts in this amount suggests that they really were confused this is it would be remarkable what they did was they obviously lump them all together and came out with the same result even though the nature of causation and the nature of harm and damages was profoundly different from plaintiff to plaintiff and this suggests i'll be and in a circumstantial w one reason why the district court made a mistake in lumping all four together well your honor i would the trial court presiding over the motion for new trial consider that exact argument and he rejected it as as guesswork relation and trying to work backwards from the jury's verdict because this the amount of the verdicts were well within the reasonable amount we offered juror to we often work backwards from  award and ask whether the award was reasonable and whether was tethered to the the corpus of evidence so it wouldn't be unusual that we work backwards well your honor it's always working backwards i  d yes i agree but in this case i think it really goes rather than showing the confusion of the juries it goes to show just how similar their injuries were they were the the jury was instructed before at the beginning a trial and at the end a trial to consider each of these plaintiffs cases individually to consider their standards strength of their evidence on each plaintiff merits to skin suit or the damages on their own merits and there's no evidence there's no jury question or anything else to indicate that the jury did not follow those instructions and in this case there were very similar damages suffered by these women each one of these four women was implanted permanently with this mesh we presented evidence that it was as part of the design defect was that it was irreversible and couldn't be removed from their body so each of these women suffered arose in contraction of the mesh pain in the pelvic area pain during intercourse they had to undergo painful procedures and in office provision procedures to try and remove that mesh and then again surgery under anesthesia each one of these women went under at least one surgery under general anesthesia some went under as many as three surgeries and so and the the jury were did differentiate the two plaintiffs that were awarded the same amount missing niamh and misspend court actually had very it miscible for several purposes you know for example to show notice of the defect and to show a tendency for injury and so that's what the trial court concluded that it was not prejudicial because when evaluating the defect that this type of in south florida almost concurrently there was a four plaintiffs trial tried in the in the the same the home court the southern district of west virginia was actually tried by a substitute judge while judge goodwin was here so those that case is also proceeding up in the this court's decision and hendricks it's recognized that the trial judges have very broad discretion to consolidate when there's common issues in law and in this case the evidence on design defect and failure to warn was pervasive in this trial i think the extent of time the plaintiff spent in closing argument while it was more directed to general causation i think that just goes to show of what a much more significant issue the general causation was than the failure to warn we presented the same each of these four women presented the same evidence the same expert witnesses on design defect they each presented dr jimmy mays who was a polymer chemists who testified to the nature of the polypropylene the nature of the design the fact that it grew a road an integrated when exposed to oxygen and then became stiff hard brittle cuts through these women's bodies in an area that's designed to be flexible and soft and sensitive and yet those mesh degrade hardens and cuts through their tissue like fishing line in addition we presented the expert dr margolis a uro gynecologist common to each one of these plaintiffs who testified that the crosshatch design of this mesh made it impossible to remove and irreversible which was a very serious concern that should have been included in these defendants warnings and so he was an expert as to the design defect and the warning that was kind to each of us that were plaintiffs it was able to remove from one of the plaintiffs actually your honor they her doctor tried but her testimony was she was not able to completely remove all of the mesh although that was certainly the attempt of the surgery her testimony was at page docket entry three fifteen pages twenty nine to thirty she testified she could not remove all the mesh and excessive bleeding prevented her from doing that so miss and  just like the other plaintiffs suffers that same risk of repeat surgery over and over again because this has been irreversibly implanted in the body and can't be removed we also presented the testimony of boston scientific witnesses there were six witnesses from boston scientific or their independent consultants who testified about the process of designing the product what boston scientific knew before it released the product which not surprisingly was that they understood the risks of erosion they understood the risks of multiple procedures yet they proceeded to go ahead and market this project without doing clinical tests on women we presented an f d a or excuse me regulatory expert talked about marketing who dr peggy pence just testified as to really the state of what boston scientific knowledge was and whether or not a clinical test was necessary before marketing it and she did agree that clinical tests should have been undergone counsel and i just want to express why i think the second issue is is more troubling i mean normally we when we have when we have a jury verdict in a difficult case where the judge has been making discretionary determinations one after the other we give him a lot of leeway where it's more problematic to give them leeway is if they kept something from the jury that a jury m really have come to a different conclusion at least from my perspective that's where i focus and the part of this case that appears to be like that is the five ten k shoe because if the jury knew that this defendant was complying with regulatory requirements which were at least indirectly safety related that would go kind of to the heart of much of the case and that evidence appears to have been broadly excluded for questionable reasons can you address that show your honor i'd be happy to  the fourth circuit as judge hall pointed out recently addressed this exact issue in the context of two trans bajan all mesh cases the first is i send vs c r bard and the second is husky vs eat the con both of those involved they were different conclusion but how do you draw and i understand that it's persuasive as opposed to controlling authority but i think they had a very let's say argument and i'm not saying the argument just that it lost in another circuit but what's the ire of one in another circuit but what's what's the argument i mean why shouldn't the jury get this it is related to safety in an indirect way isn't it because the it's not like the roar cases of lower case or case law or your case in lore you were dealing with equivalence to something that had been grandfathered in where as this is an equivalence to something that's been deemed to be sufficiently safe is that not right no your honor first of all boston scientific if you look in the trial court their response to the motion to exclude dr christine brower on the dabur grounds they are only argument in response to medtronic versus lore was that it is a preemption case not an evidentiary case they did not make the distinction that you're making your honor and which missed a lot and science has been allowed to valuate precedence to see whether they're controlling or not in reviewing the legal determination the just district court makes our we're in late but they do need to preserve their arguments for review they hadn't made it in the wild court i don't like an argument that to well anyway go ahead yes the the reason the law versus medtronic is on point is because in that case the u s supreme court was deciding whether or not the five ten k process preempted state law and it what it held is the five on five ten cake process really is goes to the substantial equivalence of the project product and not to its safety or effectiveness and that's why the controlling analysis is whether or not this is an reason a dangerous under state law not whether or not the product complied with the five ten k product process and whether or not part of state law whether the whether the the defendant has complied with safety regulations of the government whether it's a state or federal government it is only a part of state law a product liability law whether they've complied with government regulations when those government regulations go to safety and effectiveness of the product right in this and that's the argument that it does because this is a provision which  categorize these products as being i guess in the same category as something that has passed a safety threshold while you're on i did not even before the husky case i mean i'm from places  you do with the actual argument well the actual argument is that because what the f d a is focusing on is substantial equivalents to an earlier product that it's not an independent safety determination i said there's a very real risk of confusing and misleading the jury that they get this imprint and this stamp of approval from the f d a making it sound like it's a terminal determination of safety and effectiveness when actually it's really not it's in a determination that it's equivalent to an earlier an earlier that has been determined safe and effective we're not your honor but not it's not the same as saying it's this product name and it's logic it's pretty close isn't it that's what i want that's what i'm saying you know this is the one thing that bothers me about this well the case is that you say well there's a there's a determination that this is in safety terms equivalent to something that has passed a safety test but that's not safety that well it sounds wrong  see what i'm concerned about i hear what you're saying but so for the other circuit courts who have a lawyer but we don't but i'm one of the substance of the answer not that you've won on this elsewhere well the substance of the answer is as was stated by the sixth circuit in rodriguez the f d a is action means only that no other device on the market carried that indication for use it doesn't mean the pump was dangerous for that particular use that involved the flip situation where the plaintiff was trying to admit evidence but we did cite the team he versus radionics case out of the tenth circuit that a very similar government rule statute at a utah now it's not a florida statute true but it's very similar but then they satcher seems to contemplate that relevant to the harm well it was it was a very similar statute in to me and it says that the five ten k clearance lacks independent substantive content and i says no standard am i correct there is no florida  contemplating no your honor i don't think it's unclear i think that under the as the district court recognized that this is not designed to prevent the type of harm involved here because really it's just to show that it's it's similar to an earlier product rather than an imposing a specific safety requirement on this product required for sale and the wire the five ten k process is not designed to prevent harm while your honor it is as i've mentioned instead of preventing harm it is designed to show that it's equivalent enough to an earlier product the regal decision out of the u s supreme and earlier approved products and earlier approved product but as regal explain the five to let it go on market it's got a big go through that process to show what a quite a lot to us some are product and that helps reduce the potential harm of this new product on the market why is that wrong well but the us supreme court in rico vs medtronic said that that compliance is really more to provide an exemption to the manufacturer from safety regulations rather than imposing a specific requirement on the manufacturer evented thank you but i'm not i'm not sure i get the answer totally what if it is a similarity could mean lots of things you could the name similar where the chemical content could be similar or it could have passed similar safety tests which would they look at when they're trying to tell whether it's similar or not well your honor that question actually just invite the type of many trial that judge goodwin was concerned about here as you would invite in and i'm asking a question about the nature of five a one which is the whole five ten i'm sorry which is right all nature of your argument is that five ten doesn't go to safety i'm asking if it does go to safety and you say well i can't answer that because it's a mini trial it doesn't make sense to me well if the the five ten k process says that if it's an article or if it's a type two device then it can be marketed because it's substantially similar to an earlier product they can put special controls on it but it has i can't say there's nothing more in the in the law or in the record which tells us what they mean by similar similar could mean similar with respect to all kinds of things so similar in the number of years that it's been out or similar you know your honor is miller in the states where it's been produced or similar what does the similar relate to do you see what i'm asking you know i understand your honor and they do have a definition of substantially similar substantial equivalents and it's and looks like subsection eye of the statute and it talks about it's substantially equivalent if it has the same technological characteristics or it has different technological characteristics and the information is substantially equivalent to the predicate device that contains information including a clinical or scientific data  necessary by the f d a but again that is at those makes it seem like you're determining that this is the equivalent of something that's been tested or not tested at least determine that a test is unnecessary it's a deterrent and it's huge determined that it's the equivalent for those kinds of purposes to something that has passed muster per the agency it just seems very artificial to say that doesn't relate to the criteria that were applied to the thing that it's equivalent to well your honor i think it under that reasoning i think that there would have been a different outcome in the metro nick versus lower case if it if it were something that difference that they drop or for partly for interrupting but the difference that the they draw in the briefs is that that in lower they were dealing with a grandfather situation where there had been any kind of testing or determination the testing was unnecessary  whatever it was just a pure grandfather thing whereas in this case we're talking about a provision that deals with substantially similar to something that has gone through something like that right in the lower case in footnotes three and four of what is required to demonstrate substantial equivalence and if you look at boston scientific spree they have a footnote where they recognize that no other case has made this distinction that they're drawing and it's contrary to those decisions that i mentioned from the ten helpful analysis for the reasoning thank you i'm sorry you i think you yes i was just going explored that i'm sorry you can bring your remarks through that thank you thank you your honor i appreciate that with with that said i would like arabians all mental litigation that was going on in tennessee i believe and then there was appealed up and in that case they applied this florida statute actually to enter summary judgment in a drug case because there was compliance with the f regulations so there is precedent for the application of this in the f d a context in the drug context now we also need to look at the this court should give great deference to the f d a has determination which has been repeatedly stated even as recent as this year which we've cited to the court that this is something that is relevant and we provided this argument in the record below in our five ten k proffer which i encourage the courts read we preserve all of these issues but the real work significance are catch to the fact that the pm a process is really a federal safety review and the five zero five one ok process is not and that the five one ok process isn't really calm in any meaningful way to the p m a process because in contrast to twelve hundred hours for for example necessary to complete a p m a review the five ten k review is completed in only twenty hours we made reference to that and that's why i'm asking you in one of our cases the on another matter on a case we say the f d a completes the average five ten k review within twenty hours the agency reviews only whether the device is indeed the equivalent of a preexisting device regardless of how unsafe ineffective the device happens to play isn't there a powerful difference between the two processes your honor there is certainly a day in the process sees i don't think it is as significant in this case because there was p m a there were i think i don't doubt it was last year you say may not have been that it was undoubtedly not the equivalent well there was not the twelve hundred hours on this five ten k but if you look at the history of the predi devices there was i believe three years in which these medical pseudo scientific and medical panels analyzed this issue and they looked at the predicate device of surgical mesh then there was a public comment period and the f d a spent time reviewing the types of things so there is certainly not just the typical five ten k grandfathered well let's look at twenty hours to see if this is equivalent to a grandfather device that was at issue and lower there is a substantial and robust record that could have been presented to this jury that would have that it was something to do with safety and effectiveness and the boston scientific was reasonable for that for complying it went to the heart of the issues in this case were guarding things like pre market testing and whether or not the warnings were based on those testings and whether or not the a considered in that limited form a could you have could you have presented that information without specifically presenting the five ten information just saying something indistinguishable had a lot of tests made with respect to that or would you have been a precluded from doing that as well but you judge there was a very stern warning from the trial judge about not getting into anything having anything remotely to do with the f d a so if we would have said well this is equivalent to this device you know they found out i don't understand how we could do that we did present evidence obviously that there is a strong history of mesh and has been used in the body for decades and all that and we did present that type of evidence but we were not able to present the evidence that this was cleared as something that was substantially equivalent to something that a had such a robust and approved safety review by the federal government at substantially equivalent to other devices when they're putting up power points and opening statements saying it's a different product it's not equivalent to anything else out there when the f d a had determined that it was this was just deeply deeply prejudicial in the in this case your honor and so we believe that there should be a reversal i see my time is up so we believe we understand that there are abuse of discretion issues that we are bring before the court we think that the nature of this multi district litigation and the issues that are raised in this multi district litigation the potential for the due process concerns this court should actually give closer scrutiny to the discretionary decisions in this case because of their far reaching ramifications and want one last question you said you made a five ten k proffer as part of that proffer did you five i believe i believe it's docket entry to ninety five ok thank your honour's thank you both will proceed with the next case