valid claim for express warranty has been stated one would be the geisha in that the manufacturer of the prescription drug represented that its drug was safe and effective for its intended use the second would be that the complaint identified either the specific document with a specific category of documents in which the warranty that the drug was safe and effective was contained and the third element would be that the complaint alleges that at the time the manufacturer represented that its drug was safe and effective the manufacturer either completely failed to mention the existence of the specific risk knew was associated with the use of its drug or the manufacturer failed to disclose the true nature insofar as a very of a specific risk and i would submit to the court i know that there have been numerous cases cited  before your honor's in the briefing but i would submit that if you put all of those cases together you come to the conclusion that those three elements state a valid claim for x breach of express warranty under new jersey law but in this case now you cited a number of cases that contained those points that you thought line that you haven't cited a pharmaceutical case nervous in his initial decision in that case hilde that the plaintiff failed to state a valid claim of four express warranty and in and the question i guess is is house pacific as new jersey right require the warranty and a lot of cases just saying it's safe and effective it's nice fishing well i don't think i think that's correct your honor but that's not all we see here we make it very clear in or complaint in this case that what the point what the defendant failed to do was to properly disclose the main primarily the cardiac risk the risk of heart attack and other cardiac related diseases is a matter of fact there is a an allegation in paragraph nine of that the drug actually increases one's chance of heart attack by over forty percent that's a very substantial of risk involved in this case and if you were saying it was not this was you argue the safe prong as opposed to the drug even aspirin or even aspirin with which is not a tie that's good for headaches or for minor or or problems of a minor nature has side effects there's nothing in the in your complaint that says that this is going to is there or has nothing what which will ever harm you it's absolutely safe for every purpose whatsoever well your honor i do not believe that that approach of that you are suggesting created with respect to the prescription drug is if a plaintiff asserts or or the manufacturer represents that there's absolutely nothing harmful well i don't think they say that but they say you have to identify the source of the carrier for which the warranty comes and the specific language now in your whole complaint of a couple hundred paragraphs he only thing you have is paragraph two fifty nine which does not have a promise  specific would you say was specifically breached well the way the cases if you look at all of the cases in this area are you will see that none of the cases require that  when the manufacturer represents that their drug is safe and effective that they also make the statement about the specific risk that that's what would give the ship alone cases just the opposite this court when when when the cigarette he said look you could smoke the cigarettes and there's no harm to your nose or your throat it's absolutely safe that's a promise but there's no promises this case that this drug is completely safe for everything and anything they merely say describe the way it should be used but every drug i think i have to recognize you can't name a drug that doesn't have some side effect that's correct your honor and they're merely describe to hear how you should take this put but what i think the court really needs to focus in on here is the critical importance when in manufacturer has in its position and this is what religion here this is critically important and this is what separates all of the cases under new jersey law or otherwise when a manufacturer when the allegation is that a manufacturer has in its possession knowledge and information indicat that a specific drug has a specific risk that is that is potentially dangerous to the user but says absolutely nothing about that or understates your third complaint concerning something which they allege that that they that was a false statement well your honor our position and i you know i appreciate your honor disagrees with this our position is that the promise is one that when the promise that is made is that the drug is safe and effective if you made that if if that's all that was that the geisha in that we had we never well i would submit that there is an overlap between a failure to disclose claim and express warrants you think they're the same they're that they're the same thing and i don't think that they're the same thing but they could be your say they could be the same thing i think it's perhaps opinion in the in the parker case in his first opinion he basically said exactly what you did the only contention in the complaint was that there were some representations made by the manufacturer that  implant system was affectively safe and effective then on in his second opinion he says this plaintiffs second amended complaint is a new factually specific allegation regarding the point five percent defect rate printed on the products a label plaintiff alleges that her product malfunctioned that evidence showed the rate of defect to be much higher than point five percent and that the failure of the tried it system to adhere to the published defect rate gives rise to a claim for breach of express warrant sick now so once the specific allegation was in it that is what made the difference now one analogy that could be made  monitored and then there were more explicit warnings subsidy that's correct your honor but the but the what was not disclosed was the full extent of that risk and that's fact that it actually increases one's chance of heart attack by over forty percent but haven't the new jersey court essentially said safe is where the benefits outweigh the risks i'm sorry on hasn't the new jersey krevin new jersey point that was raised a moment ago is that nowhere within mr whose is there an amended complaint did he point to any specific statement containing the words safe and effective nor did he point to a promise or an affirmation of fact he quoted just eight words in point in the district court did he did he cite till the label nor did he point to any specific statement in the district court and that's in spite of filing this action when six years ago amending his complaint three times and briefing two separate motions to dismiss there two hundred fifty nine paragraphs they talk very broadly about other types of dockings but not with respect to their expressed warranty claim nor do they even in the express warranty claim on any specific statement and mr diffuses counsel brought up the parker case for example and i think actually that that highlights what is lacking here rather than reinforcing the position they're judging are still with the claim that was precisely analogous to what we're dealing with here a general allegation about the safety and efficacy of an f d a approved medical device there were no specific statements alleged in that in that plaintiff's complaint and judge lamar's found that they they failed to meet the standards of long term only now to illustrate the difference which research approves of counsel brought up again is that in the second followup decision one of the plaintiffs there did exactly what mattoo to mr de has not done she amended her complaint to include a specific statement that was an affirmation of fact contained in the label about eight point five percent defect under new jersey law but that it does not follow that just because you don't need formal words to create an express warranty that you don't have to identify the language that you're basing your claim on when you when you're filing a claim for breach that the two do not logically connect because this recorder said you need to have those magic words but me on this record here said you need to have those magic words the as as i read the opinion your honor the district court said that you need to point to the exact language which is based on i think that is analytically distinct from saying that there's a certain type of word that needs to be stated to give rise to even if we disagreed with the district court's analysis of what the law needs to be and express w claim we can still decide whether or not in this case there was a specific express warranty you're not at i believe the answer to your question is yes but i asked for a point of clarity as to what precisely you're suggesting th disagreement was suggesting that we can look at the merits here whether or not this true whether or not we disagree whether or not we agree with all of this your group decided this i think it's a question of law as to whether an amorphous statement regarding the generalized statements about safety and efficacy there were several particular statements at issue in that case about the use for that medication in off label populations so i think to contrast one day pointed to actual language which they were challenging as the basis of the then i i do not believe that they could reasonably find that that language constitutes a warranty in this context i think it's a matter of law the statements are neither an affirmation of any particular fact as as encountered in one this document is not intended for general consumption is an f d a medication therefore there is a doctor who is interpret in this label they are specialized meanings in the content in the context that we're dealing with here one of which was mentioned before it means that the benefit was recognized by the way in new jersey case and i can that's the bell reversed why a case that the benefits appear to outweigh the risks there are a litany of other warnings in the event you label and in the labels of many other prescription medicines that state the potential ways the drug could harm you so no i think the answer is is that a jury could not reasonably find those languages in this narrow context of an f d a approved indication constitutive express warranty you go find that the average person which would say well this is safer to use beyond the statue even even usury so on the question of jury it this court has recognized in other courts that when you have a statement that could plausibly give rise to an express warranty beyond the questions of breach that may be for the jury but even the new jersey court several of which mr to decided to they made the determination as a matter of law as to whether a statement could constitute a warrant in the first instance and this is not just a matter of new were in part decided to put the defendant on notice of what the problem was where were you really on notice of the complaint your honor i don't think if you construe this purely as a question of notice which which i mean and in your aspect of that is not a small subset of documents nor does it nor does it correspondent put this in the realm of other cases where they're spending precise language alleged any specific source identified how much weight do we give to the extent that i think it's an important consideration i don't think it supports a broad determination here anything beyond that safe and effective when used in reference to an f d a approved indication cannot give rise to a warrant and that gets to the specialized meaning of those words in this context i don't think that it gives as mr cruiser's characterized some sort of broader community to statements in the label we don't contest that if there is a specific statement like point five percent defect rate in the human cases the judge when ours decision that that could potentially give rise to warranty or be a viable claim and many of the other cases i mean look at in terms of settling which was discussed before there you have an outright clear promise absolutely safe will not harm nose throat ears just as well in the new jersey appellate court decision with serious risk their statements about a long more or at issue again specific words identified and those were absolute promises that the device was absolutely safe and that it would stop immediately upon contact with any object so that's not how far sea bass go for example the rationale there as apply this is very narrow recognition that in this context safe and effective brought a number of other counts in this action previously in the district court several of which were premised on allegations of a failure to warn the district court dismissed those claims under new jersey law as it seemed by the product liability act that issue is not challenged on appeal and i it's not an appropriate basis to censure the repackage a failure to warn claim into a contract basically were duties arise soley by operation of words between the two parties and i i will just direct the court's attention to to one of the case that i think is is particularly on point here interpret in the basco decision which is the in many in remarried yet decision out of the district of ohio there they were they were applying the u c c express warranty claim and there were directly analogous allegations to what weapon fronting here the plaintiffs had claimed that the that the manufacture of an anti obesity drug there had represented it struck to be safe and effective in advertising the court held that that statement was not sufficiently clear to give rise to an expressed warranty as a matter of law and as further support cited basque oh for the proposition that but absent another modifying statement this is the product is absolutely harmless or free of all thing is relatively narrow there simply speaking about the use of safe and effective in this context and not talking about other types of statements europe or five point five percent defect rate absolutely safe so on and so forth it's really just to those two amorphous terms you're not that a narrow subset of a statement which is at the heart of the allegation here which again they have even pointed to a statement the first instance that tracks the election so just to make that clear we're not talking about an actual statement this is still their general allegation that new jersey law specifically but the exact same statute identical word for word and have rejected the the application of best go in the manner in which the court has been discussing it with us today one of those cases is writing a corporation versus levy great which rejected the idea that basket provides a blanket immunity for drug manufacturers from liability for express warranties based on the affirmative statements regarding the safety of the drug palmer versus age robin's company rejected best go that's the supreme court of colorado rejected best go as a basis for overturning a jury's verdic express warranty claim based upon the defendant's representation that its birth control shield device was a safe and effective means of contraception that was the only representation that was the only promise what i think the court it and then grinnell versus charles pfizer a company that's a california case upholding a charge of court's decision to charge a jury on an express warranty claim arising from the defendants of affirmative representations regarding the safety of an oral polio vaccine and then the other case of course which which i think is a case i should have come up with immediately when judge fischer asked me which is the case analyzing new jersey that is best for us and that is like his new jersey law reject summary judgment and holes that the defendants asserted in various articles conferences in journals to the medical community that paxil was safe and effective for children to use and that was sufficient to establish a express warranty claim but here's why because here's where the specific comes in it's not in the promise it's in the ability of the plaintiff and the question did the pla identify something that the manufacturer did not state in or left out were understated when it made its warranty and in that case it was the suit the fact that  process of the manufacturer asserting and making that promise that it was safe and effective and i think that that specific of allegation o misrepresentation is what's the difference and that's what we have in the case in our allegation that they failed to disclose the risk of heart attack and i think that we're talking about something that we're in a would conclude when this type of specific misrepresentation is provided and puts the defendant on notice of exactly what they're facing this is your claim here that you did not reveal the risk of cordy i caressed the risk of cardiac disease that was associated with your product what's so important about that is because if the fenders are permitted manufacturers of drugs are permitted to just make of reckless or negligent representations about the safety and effectiveness of their drugs without stating the knowledge that's in their possession about specific problems then i think we've  got a dangerous situation on our hands