mcnair and larry mcnair today this court has a unique opportunity to revisit reinterpret and clarify foster v american home products while applying the same logic in foreseeability a different set of summary judgment in favor of the appellate today the school should find that one west virginia products liability case law allow for claims a failure to warn against a branded manufacturer who in some way is responsible for the package insert and two because generics are prohibited from making any lead unilateral change to the package insert as opposed to the ability to do so by the brand of manufacturer that consumers right remedy  while j p i continue to maintain its exclusive right over levick when j p i n two thousand to remove the adverse reaction of art's acute respiratory distress and drawn from the package insert it's all over the west virginia maintain control of the package insert which is the issue before the court and the issue that's raised in macnair they continue to distribute that package insert be it to a generic or anywhere else the generic does not have a right now laterally change that package manufacturer as the johnson and johnson as the manufacturer of the product and that's what's required in the west virginia law of the manufacture and in the manufacture of the person producing the product that product or did not like what they that it was manufactured by somebody else and they put a label on which was obviously pursuing it was the same label that johnson but under this the west virginia that there are two cases that control the products liability let a geisha in this case and west virginia and i would also add your honor that west virginia unlike a number of jurisdictions are a lot upon by the paoli there is no statute there's no statutory provision for and and that's the way you played it because you assume johnson manufactured the drug in this case but it turns out that this happens it generic for the logical course for you to take that is not to sue johnson but simply generic but as you point out because of their curiosity about plead a case and you can't sue generics and the supreme court said that is a real aberration in the law in its own fortune it but are yes ah yes sod it no no i do know i disagree i disagree i disagree respectfully with your honor that the two k the two cases in two prongs of products liability that both parties are a lot upon before the supplementation of jury instructions as to few days ago is done v can our county board of education where plaintiff is a title to bring an action and products liability if she can show that the product which is alleged to have cause injury was defective when it left the again that is the whole key i'm not talking about the the deep effect of label does give you a right to sue but you have to sue the manufacturer of the product own with which the labels attached to which the labels that and  in this case that which you did you sued johnson and johnson on the assumption that they manufacture sold distribute product after the affidavits came in you learned that johnson and johnson didn't manufacture this product macor granted s now your argument is i guess johnson and johnson is now liable for generic manufacture product labeling product and that's pretty that's not under west virginia law well under appellee here is worse ultimately responsible in every way that can be imagined for the product of the package insert because the generic doesn't know it because generics doesn't even want generics they didn't have any dealing with the generics they didn't create the generics the generic manufacturers are so to speak interlopers they come in under federal law able to do these drugs but that's not johnson and johnson's duty or responsibility johnson and johnson registers it total control of the package and we're not talking about the formula or the pill itself the package insert and because they decided in two thousand and two to drop a r d s from the package insert and the generic it doesn't have a right to change it unilaterally according to messing the man singing and mutual the bartlett the responsibility goes to john the appellee the and again going back to west virginia products liability law again this is a statement that was put forth by the appellee to begin with was in some way responsible for the product but for the brain to manufacture there would be no generic so ultimately it comes back to the brain to manufacture when you're talking about failure to warn when it comes to the packag honor part of that what you get it now yes your honor when he said this and well whether or not a brain a manufacturer can be held liable for failure to warn and or west virginia law that would be the question to to be sought before the supreme court of appeals of west virginia and i may yeah has long gone back to the jury instructions that were produced again a week ago those from my personal experience the trial attorney joining structures are not even a formal law until before the jury goes up based upon the evidence before the court the court went out of its way the supreme court went about of its way to to specifically state that these are non binding however the cases until the johnson rogerson is bond in the i notice that and reference that the dunn case there was an argument i think it says specifically to don strict liability expense that those products and products liability chain to distribute distribution so that innocen sellers can be subject to law billing as entirely derivative simply by virtue of being present in the chain of distribution the again the package insert is part of the chain of distribution it begins with  argue put forth to the court that in fact the a poly is at the top of the chain to distribute they are in the beginning again but for the brain to manufacture there would be no generic so your honor i reserve five minutes for a bottle i think that's already  honor and that is the way federal law works which is why preemption exists so the dispute here is not a question of west virginia law and both the supreme court cases are very explicit allowed you to do that and you your position is no that's correct your honor and you know i could say to you now that there are eighty decisions in more than thirty states that follow that rule which follows this court's ruling in foster and there's one foster the the decision says we don't agree about generics being not being able to change the labeling the next paragraph says we also  reject that's a quote from this court we also reject the notion that a plaintive consumer a manufacturer whose product they didn't buy and use now foster was looking at maryland law the corporate logo falling foster looked at the need decision quotes done which dunn cites morningstar to west virginia cases you're pretty confident bring order west virginia will go with rule well i think your honor if we look at the pattern instructions which the court issued less than a year approximately a year ago and you look at section four twenty six which is essential elements of a failure to one claim the first element is did the defendant it's like defend  like did the defendant manufacture the product that the plaintiff used very clear unequivocal one the first element of a five i believe you're on  right now i don't think there's an unsettled issue under west virginia law therefore the reason to certify it doesn't exist  candidly my colleague's arguments about unfairness is an issue that is something that's a function of federal law congress could change the statu to allow people to suit you narratives f d a could amend its regulations to allow people to sue generics that is where the issue is that is not an issue for this court or a west virginia court know i think what would have to happen your honor is the f d a would have to amend its regulations to say generic manufacturers can amend their labeling therefore someone could sue a generic for not adequately warning if you go back to the supreme court decision it's a function of the regulations as they apply to generics so you'd have to amend the regulations which has been bantered about for several years now is well the way the system is constructed your honor that that is an important point but there is a need for consistency because you could have fifteen different generic manufacturers and all of them get different information about the use of their product as every pharmaceutical company gets so if one generic manufacturer gets certain information and decides to change its labeling you have and menzel the supreme court said this is the way the law is which drives the result in men saying no generic liability the supreme court was very clear if congress wanted to amend that statute congress could amend the statute and obviously you might have i mean a supreme court didn't say we would rule differently but the supreme court was very clear that it could result in a different outcome so i think that's that's where the very tough case our case and it centrally holds that generic manufacturers cannot be sued under state law because of preemption and they then accept explicitly if congress think it's a court will solve this problem at the supreme court said it couldn't solve it wouldn't solve it i'm trying to figure out how how you try to accom honor i mean how do we address that you know it's sort of i guess there are causes of action i mean there are injuries caused by the military where people don't have those action and certain other areas maybe but this is a very strange bird your honor having spent a lot of my career looking at federal preemption that is the way our judicial system our courts work if there are questions of what supreme court said basically is that congress took the cause of action away from the states and killed it yes your honor i think that's  faster your honor is been followed by a foster did what it had to do basically on the generic side it thought that there changes could be made that's been changed minds but on the other side when they talked about a product liability they said the cause of action flows a product liability action blows against is that after mensing which is what i call it i think there are at least three or four circuit courts that have looked at this issue with the benefit of the supreme court saying you can't sue a generic and every circuit court is uniform saying the foster rule about suing a brand under state law still applies because when you look to the state law it's just common law product liability law and my only questions here ali here were it looks like west virginia isn't   and that's why i believe this is not an unsettled issue anybody going to congress about but there have been attempts several times after mensing both with congress's medicines over five years ago both with congress and with the f d a to get to get relief i mean quite candidly and it's obviously the plaintiff's bar that that is done that and it becomes as anything in washington an issue of politics and whether something is going to get through congress you know it's one of those type issues but there have been concerted efforts made to try and and or developed a generic division or generic business that this is a good reason to do so in addition to the economic well that that that is one thought process for some companies that's not what johnson and johnson does we we really deal with the innovator brand products we think that's the way as a business model the company should work having said that from time to time we have worked with an authorized generic so that it but that's not the company's business model in that you know there's all sorts of considerations when you talk about the price of something and what you're factoring in terms of litigation costs but but my point was going to be your honor when we meaning johnson and johnson have had a medicine and it goes generic we understand how the process works we never preist thought or conceived that we would someday be the insurer for someone else's product that is in essence what someone is now asking when we looked at the regulations and monday grown to the f d a website which has the labeling for every prescription medicine go look up leaving when it's still up there go to section five point seven what's below the  quinn labeling like the brand or label the package insert the section five groups seven in the runnings which is like the important stuff you will see in their acute respiratory distress  back medicines approved in one thousand nine hundred six acute respiratory distress is in the running section there's a section at the end of the package insert called adverse reactions but adverse events reported in clinical studies at the time the f d a regulations said if you saw one percent of something you needed to put it in the adverse reactions section a i d s was in the adverse reaction section and the ruining section from the beginning two thousand and two a new indication was approved there was more clinical data the incidence of a i d s in those clinical studies went below zero point one percent so pursuant to the regulations it came out of the adverse reaction section but stayed in the ruling section and it has stayed in the running section to today i checked on monday i know it didn't come out yesterday or th morning so it has always been in the ruining section now we didn't miss out to the court of law because it actually is not germane to the legal issue the court faced but to answer your honest question germane it is to maintain the equities it's been in the warning section and it's a matter of public record it's you know you can take judicial notice of it if i need to send you the decision that allows you to go to f d a website and say we can take now it did require the supreme make that interpretation under the preemption but we have situations like under rissa and under some of the labor where federal law sucks up state law and then regulate honor i just was going to the point of rights and remedies and the fact that and hill v joseph of west virginia tace it on page three zero three it must be remembered that the field of product liability has a fall through judicial decisions in fact you can go all the way back to the winterbottom case of eight hundred forty four eight hundred forty two where you had to have you had to prove privity if you were a third party injured by the product that's then the state law in developed under the common law that's the way the common  and west virginia they basically applied the restatement which is a restatement of the common law but what manson did is said regardless of what state law is it's preempted with respect to labeling warning and drugs race in the in the wake of that problem is ok a manufacturer can be liable for a product that it didn't manufacture that somebody else manufactured because of the federal labeling  structure and now with your expertise your range your honor i would submit that it isn't strange because what we're talking about is a package insert that is under the control of the appellee here so it's a fiction that they're not the manufacturer of the package insert and to the extent that a right to remedy can be pursued the court to nevada based upon mensing what rights and remedies are available to plaintiffs if the supreme court of the i'm from west virginia of course and i did medical malpractise litigation the court through to reform has restricted certain action put caps on everything but the court the legislature the sixth even the legislature did that at the legislature said you know what no medical malpractise the supreme court even if it's a conservative court will say no that's a cause of action that needs to be resurrected and pursued through the population we don't circus certify cases that under existing law supple and say to the state you want to now create a new course of action that's what you're asking us to do if we asked this or our certification statute is trying to get a clarification we have a duty to decide cases that come before us under federal jurisdiction have state law that precludes this but maybe they want to change you know the federal regulation pretty novel you're on i don't i submit that to the court and again it's an argument that that the appellee put forth  that in any way shape or form is responsible for the product that's west virginia law that's always been was gee law that hasn't been overturned before ah before i leave your honor what i would suggest the court is that a court that the court's decision in  four as raised by justice when was a different circumstance in that the court found no for see ability because the generic at that time had the opportunity to change that label that was central to the court's decision this court's decision back in hundred forty i submit to the court of the court can follow that same logic and come to the conclusion and fine for the appellant here because it is forseeable for johnson and johnson to be responsible for the package insert and light of men sitting and fine for