court i'm happy to answer questions a court has about any subject but let's lead off with the threshold issue of subject matter jurisdiction we've offered three independent reasons why this case should not have been removed from state court several court that the complaint does not necessarily raise federal issues that any federal issues that were raised are not substantial to the federal system as a whole and then the last factor is the sort of credential veto that there would be a disruption to the state federal balance if all of these cases about medical device liability were on their way into federal or before talking about the specifics of any of these are just want to highlight some of the big picture concerns that drive the doctrine in this area it is well settled that removal jurisdiction should be construed very narrowly and any doubt should be resolved in favor of a reman and that is because fundamentally federal courts trust state courts to adjudicate their cases including cases that raise issues of federal law a particularly instructive decision is the supreme court's decision in the franchise tax board of california case where the court says expressly that even if a federal defense of appears on the face of the complaint even if that defense is going to be the only issue anybody ever talks about in the that's not enough to get you federal jurisdiction and that really i think informs how you ought to look at the claims in this case these state law claims all filed in north carolina also lead violations of federal law but they do so overwhelmingly to anticipate a federal preemption defense because everybody knows that defense is coming in any case involving a medical device we have pointed out a single contrary example there is a single paragraph that alleges negligence per se on the basis of violation of federal regulations right which could be an independent basis for lives but that is only one of many theories of negligence and we have cited multiple controlling precedents saying that if you have other theories of negligence that don't depend on federal law which of course we do here because we've alleged violations of ferals duty's the complaint doesn't necessarily raise a federal claim bayer really has i think two answers to this argument the first one is well look you're inevitably going to have to interpret federal but this just loops back on the franchise tax board point the only reason you're going to have to interpret federal law is because they have a preemption defense but church without the court the trial court ever having to interpret that or a law and think of this hypothetical just to smooth it out if they waive their preemption defense are there going to be discussions of federal law in this case but for that one paragraph that i talked about the answer is no test works is there are three pieces first necessarily race actually disputed and substantial to the federal system as a whole if all of those are met then you could have federal jurisdiction but there is also a credential veto power over federal jurisdiction which arises when exercising federal jurisdiction was substantially disrupt the balance that congress anticipated between state and federal courts and that in this case is a very important point as we've noted the rule that bayer is asking you to adopt would bring in a tremendous number of cases even if we were only talking about this birth control device there are already more than ten thousand cases winding their way through the state court systems that could be brought into federal court and of course up this rule for all class three medical devices to undergo premarket approval which would mean all class three medical devices prospect of lee and honestly there is no clean way to cabinet to class three medical devices it would not be long before defendants were talking about two medical devices before they were talking about other products that are also regulated by federal law and a minimum the lack of any bright lines that would allow you to cap and this would lead to years of collateral litigation about federal jurisdiction a nd then ultimately would either lead to a bunch of garden variety products liability claims winding their way into federal court that are here now or and then you know ultimately making their way here and i just want to make it clear that there is no reason to do this because to the extent bear has a point that there are some federal questions in these cases the supreme court has made it very clear we trust a course to juda kate those and ultimately the supreme court can settle any the best case to look at is the christianson versus cold industries case so this is a supreme court case that is about whether in issue of patent law was necessarily race which would have conferred jurisdiction on the federal circuit and start the regional circuit and it was an int est case and the plaintiffs had brought two kinds of claims a monopolist claim under section two of the sherman act and a global boycott a group boycott climate research under both claims the theory that the point of principle he proceeded on was these patents are invalid and so your attempts to restrain or trade are unlawful right and everyone agreed ok that theory raises an issue of law but the point of it also alleged in the complaint that they received permission from the defendants to go ahead and use this intellectual property and so therefore the patents didn't matter and what the supreme court said was these are two different theories of monopolization are two different theories of they are not separate claims right even though they rested on different facts right one set of facts being the facts about the validity of the patent the other set of facts being the facts about whether consent been given totally unrelated sets of facts but they were grouped under yeah i mean there is an argument for doing it that way because there's this whole idea stems from the well to complete rule which makes the point if the master of the complaint so there is a rational reason to do it that way it does seem a little bit you know we're that if it was just segregated out that way but yeah there is th and this court says you know that's a different theory of negligence and not a separate one and that case was reaffirmed in the dixon versus coburg dairy case an on bunk decision of this or and spent relied on subsequently so i think there is a lot of controlling precedent that says when as here the complaint groups negligence per se under the aegis of a negligence count at a minimum then you're ok i actually think the argument could be broader we could be in or whatever but it doesn't matter you don't have to reach here  no necessarily raised that's the easy one i think the weather is substantial to the federal system as a whole you know the other side has an argument and i won't deny that it has a little bit of force that says these are heavily regulated federal products maybe it would matter you know to the federal system i think that argument is wrong i think it's clearly wrong under the controlling precedents following gun the supreme court's holding about what it means to be substantial to the federal system as a whole but you can make policy arguments about the need for uniformity i don't think those arguments weigh in favor of federal jurisdiction i think you know but there are real there is a need for uniformity in this area right but i think that those you know so that that probably is the argument that i would say is the one that's the most contentious the the last argument about the prudential veto i think that's an incredibly strong argument for us this a congress has recognized for decades now that there's going to be medical device litigation state right that's why the express preemption provision this and there is no federal cause of action is because they know these cases are going to go forward since two thousand and eight when the supreme court decided riegel and even before then these cases were being brought subject to federal substantive preemption it was understood st courts were going to applied and that's how this was going to work to shift all of that litigation to federal courts would be remarkably disruptive and they tried to minimize it but i don't think they have any clean way of doing so we you know as we point out in the court supreme court turn away federal jurisdiction merril down right which was pharmaceuticals we're talking about claims that are very very similar to the types of claims we're talking about here the only real difference that bayer has been able to identify is the existence of this express preemption ru but that doesn't have anything to do with the number of cases or how disruptive it would be it would be a lot of cases and as i said it could easily metastasize to the point where we're talking about class two devices rather federally regulated crops too and i don't think we want to open the door of what claims are brought on the face of the complaint now the motivation may well be because they know that a direct failure to warn claim saying you are labeling is inadequate is preempted by federal law and so they choose to bring this other type of claim but that's not the question the question is just do the claims as lad necessarily raise a question of federal law and the answer to that is ye federal law in order to satisfy an element of the state law claim so take again this claim that they are failed to report adverse events to the f d a and they're saying they are full are they were injured and therefore there's liability under north carolina law but there is no way that they can establish that liability under north carolina law without demonstrating a violation of federal law and that is because duty to report adverse events is entirely created and to find by federal regulations and you can't have an independent north carolina standard that governs what and all of the cases under the great us recognize that if need a violation of federal law to establish an element of a state law claim that means that a federal question is necessarily raised in that and a number of the cases that the plaintiffs themselves are lying on cases such as empire health choice gun find a federal question necessary for precisely this reason because it is in bed it into an element of  e a federal court's greater uniformity within the federal system are going to be of benefit to achieving federal jackson and that is such an area here because you've got unique in traffic going on with this class of pre market approved medical devices which is a very narrow class devices and particularly with a particular types of claims that are in this compl you have uniquely federal interest because the claims really go to the heart of our relationship between the federal agency and the entities it's regulating and in that area coeur directly to again that relationship between the agency a federal agency and the entity it's regulating and unlike in maryland down where you have no preemption provision claim that does mean that you have a federal issue so that it does then they say that the other factors that you can't have as you said every case where that's true does not belong in federal court and we're not arguing that it does we're arguing that there are very unique factors at issue here to the pre market approve medical devices and it's the same factors that led congress in this narrow class to put such available medical alternatives and congress charged after with maintaining a delicate balance of regulatory objectives in this field as supreme court explained in regal and bachmann they're both trying to ensure that the devices are safe and effective but at the same time to preserve public access and encourage innovation despite the potentially high risk devices and in that narrow contact time merrill dow did recognize that preemption is relevant to the final two factors of the tast and preemption is relevant because it has implications for how did congress expect this to work what kind of balance did congress expect there to be in this area and in merrill dowling the prescription drug contacts there is no express preemption whatsoever and they all dow took that as implying that congress did indeed expect there to be significant state court actions over state causes of action and tort liability for prescription drugs but in a medical device field particularly w state or actions proceeding on these devices at all and numerous courts have recognized there is only and narrow gap in this where state tour actions can potentially proceed and it's because it's not we yet congress was not contemplating that garden variety torts we're going to see and for similar reasons you're not going to have a disruption of interest there are different interests at stake here than there are for drugs there are different interests at stake here than there are for cost to medical devices use you don't have the same preemption you don't have nearly as as intens state law claims even if federal issues might arise around the periphery that alone doesn't but it is also not limited just to a federal cause of action or just the complete  pre market approved medical devices that you don't have for other devices you don't have for drugs you don't have in the mine where you might have  approval process where you don't have the premarket approval process you don't have the express preemption in nearly the same way that's the difference between regal and lowell are and where you don't have free market approval you don't have than a thousand hours after a review time and much more intensive ongoing involvement and that goes back to the unique interests their own you raise five class three pre market approved devices having to do with the under those final two prongs what you're really balancing standards and it looks to them as an indication of congress's interest in the area and how congress anticipated the federalism balance working out and it's very relevant to that because it shows what did what is the federal interest in regulating in this area and also what's going to be the impact of the cases are allowed it i don't know who are and it's going to significantly lasting impact because these claims are all preempted as the district court correctly held so you're not going to have huge numbers of cases proceeding in federal court because the cases can't proceed at all and so under those final two just a couple of quick thoughts first i do think just harris your intuition is right that the other side's argument is really not so much an argument against a court adjudication as it is an argument against cases and they say this at the end where they say you know all of these things are just going to be thrown out on  s regardless of the court and that is really kind of what they're saying they don't have a good reason why these cases need to be adjudicated in federal court as opposed to state court what they have is an argument about why the federal agency has some interests here but that can be addressed in either form now it can be true that when a federal agencies operations are substantially like in the grable case where the irises notices are all going to be opened a situational you start to think really closely about this but they actually have not been able to point to a single instance of where the federal government is going to have to do anything differently the closest they come during this malaise entire presentation is she says if you in if a core interprets the adverse support event reporting regulation to require more reporting that could have an effect on the way the f d a does its work that's the closest thing maybe there would be more reports filed right let's go ahead and spot them everything they said oh yes they still w the idea is they have to show they have a heavy burden to carry to show that there were actually would be some disruption here all they've given you is a little bit of speculation without any specific right about how this would work moreover the concerned they're raising arises whether it's federal court or the state court that interprets the adverse event porting regulation moreover the adverse event reporting regulation is not one of those device specific requirements that they highlight so much when they talk about the express preemption provision that's devices so you can already see how their rule will start to creep into every medical device because you have to report adverse events all meant and so you know all of this i think just underscores our point that there is no strong argument here for