be an option that we will that judge will and i will respect but you know in the normal course if we had had enough time we probably would have gone for a third judge but  given the press of time we will do things as we do is a matter of standard procedure in this kind of situation and we will hear the case thank you we understand and thank you very much and we also thank attention to this thank you please proceed good afternoon your honour's landowner from simpson bartlett together with my partner bill russell we represent appellant pfizer inc and our clients are present in the courtroom this afternoon this appeal turns on the meaning of the term advil in a twenty eight year old consent judgment negotiated and agreed to by the party's predecessors the consent judgment at issue imposes a restriction on advertising for advil we contend that this judgment applies to the adult bill that was being litigated and does not apply to the pediatric adult products that were simply not in matter ibuprofen is it the same across all the products and does it have the same effects the medicine is the same the products are different there are different doses there are different formulations and they're being used on different populations that themselves have different physiological characteristics so let me be clear the product that was at issue in the prior underlying litigation was two hundred milligrams that was being utilized in adult populations and one very important issue  is what was judge connor ruling on when he made conclusions that ibuprofen does not have the same effects on the stomach macneill would have you believe that all of his conclusions turn solely and exclusively on mechanism of action and suppress his prostate gland and synthesis in the stomach which can lead to problems for the gastrointestinal tract i would submit that if you look very carefully at the advil one opinion which is where the clinical and decisions regarding the characteristics of these two medicines are found you will see that the discussion about mechanism of action is found at page five seventy two of the opinion which is the part describing in the background the two or three medicines aspirin acetaminophen and prof when you get and this is very important to the actual findings about stomach upset and gastrointestinal effect what you see at pages five seventy six and five eighty four is judge connor talking about the evidence regarding users what is that the evidence are the clinical studies the clinical studies were taking place solely on adults you understand from the record the pediatric products simply were all being developed they hadn't been approved for prescription use no studies had been wrong the big camp study the boston fever study those took place afterward critical issue is this mcneil would have you believe that ibuprofen is ibuprofen as ibuprofen advil was used to refer to ibuprofen and therefore the negative consequences  clear in its mandate it can leave no room for uncertainty in the recipients of the decree so my first line argument is that the word advil in this consent final judgment is not referring to pediatric products and i would submit as a first line that this court can determine based on what i've just said that the consent final judgment does not apply to pediatric products i think you can also under i t t continental bakery which is the supreme court's precedent look at the circumstances surrounding the formation of this judgment without actually violating the four corners rule under the supreme court precedent those surrounding circumstances are not even extrinsic evidence so you that means you can also look at the consent final judgment from advil one which clearly helps us because it refers to ibuprofen products or ibuprofen in general in a list meaning they're not all synonymous these are different you give examples  of the kinds of extremes that would show that your interpretation of the consent judgment is is the right one yes your honor so extrinsic evidence would be for example the parties course of conduct in the one nine hundred ninety s in one thousand nine hundred six when they introduced the children's medicine that actually advertised the claim that's at issue here so it said the fact is children's advil is safe as safe on a child's stomach as children's tylenol that's course of conduct h p predecessor actually advertised this claim and a second piece of  submit is that tylenol makers back in one thousand nine hundred six when this medicine came on the market tried to do a negative claim they said my doctor said that children's that here it is it's one thousand nine hundred six my doctor said children's tylenol won't irritate a child stomach the way ibuprofen can so they made the negative claim that they say right now they're allowed to make and what happened we challenged it we went to the networks we said that's not fair and a b c actually agreed with us and took their ad off the air and said judge connor was silent as to this children's products and furthermore said that the there was no basis to extrapolate adult medicine to children's no and that is just what i was about to say this is not in the record because it's extrinsic and that's a response to chief judge katz and question the point is if you thought there was ambiguity to reasonable competing interpretations both have logic and are compelling then what you would find and this is our last line of argument is that this consent final judgment is in the end an ambiguous document and at that point you would  and further proceedings where we do go into course of performance and i would put in deposition testimony in affidavits from the h p executives and outside counsel and arnold and porter because we've spoken with them they sure will say they never ever ever meant to give up claims about pediatric products they simply didn't exist and there's no way a self respecting sorry they didn't exist so there was no reason one way or the other to stop they didn't almost and one step further they didn't exist so they certainly did not tie their hands wouldn't have agreed in the settlement agreement or in this consent judgment to tie their hands and anticipated that children are not little adults the f d a held them to different standards so there was reason to believe don't use it for long term use tends to be an episodic periodic dose for high fever that we moms give our babies so that the h p executives would not have agreed without any data without any testing without any clinical findings to to tie their hands for all future more about this and respectfully judge connor wasn't making decisions and he had that very interesting letter to the parties where he said i don't want to see drug advertising i'm not going to render advisory opinions i'm ruling only on what's before me and that in this record is undisputedly only adult clinical studies with respect to this two hundred milligrams dose in adult populations i see i've gone over my time reserve thank you thank you very much an afternoon maybe he's the court steves allison for apple e mcneil i think it's useful to remind ourselves how this particular dispute between the parties began the ad that pfizer ran that spawn this controversy which is in the record unlike most of the things that my adversary referred you to at the pendants page twenty nine said the following it said quote i view profound the active ingredient in finn's advil has a comparable incidence of digestive system adverse events overall to see them if in the active ingredient in infants tylenol that was the ad that they ran which provoked a protest which eventually led to this declaratory judgment action and that claim that the ingredient ibuprofen is overall equivalent to acetaminophen the ingredient in the stomach digestive system events is precisely the claim the judge connor found to be false in advil one it is precisely the claim that he in joined in advil two there was worded quote like tylenol advil doesn't upset my stomach and it's precisely the claim that the parties decided would be permanently banned when they agreed to the consent final judgment in one nine hundred eighty nine making permanent judge conner's preliminary injunction isn't the i mean that the challenge is th to define and fall in at least two different ways one of which includes a future i do pro from products and one which which doesn't  you could read it as and o t c internal analysts whose principal active ingredient is ibuprofen which would include pediatric advil that's one way to read it but you can also sold at the time that the decision was was was written which would exclude paediatric at all and the latter reading as suggested by ad tuesday use arguably the present tense and so you've got this you know yet to interpretations that on this argument that are reasonable so for this reason the argument would be that the that advil too doesn't resolve the consent judgments ambiguity so chief judge katz but i think if we were looking  vacuum and the advil to consent judgment and perhaps even the advil to decision and nothing else you might i would say that it's still on in big asli clear it says advil we're talking about advil every one of these products is advil but as the district court found although the more logical reading is the one that it covers all advil ibuprofen products because they're one in the same it's plausible to say that it might have referred only to the so called adult product which by the way is labeled and approved for people ages twelve and up but the so called adult product that was on the market in one thousand nine hundred ninety the the the critical issue though in this case your honor is that we are not looking just at the contract just that the consent judgment in a vacuum as for example was the case in the j apparel decision that your honor was on the panel on where there were two plausible interpretations are looking at it in the context of the documents the materials that are explicitly incorporated by reference into the judgment or the contract which we didn't have in j apparel and that that is the advil to decision itself which in turn explicitly cross references and adopts the findings in advil one advil one was a final judgment the only thing left to be decided in advil one was damages it was a final trial on the merits judge connor clearly was basing his decision in advil to upon the science ific findings he'd made an advil one that's the only scientific record that exists and bill to was simply about the question whether the ad campaign on television at the time like tylenol advil doesn't upset my stomach conveyed the message that the judge judge connor it already determined to be false that is that the two products are equal with respect to overall digestive system effects and if we look at advil one an understanding advil one is the absolute key to this case and i agree with ms nooner it's useful to look at the advil one decision and it's useful to look at the apple one consent final judgement so let's do both in the ad for one decision church connor talks about ibuprofen the drug the drug itself what kind of drug is it it's a the inflammatory drug how does it work it works by suppressing prostate gland it's what does that do it relieves pain and inflammation but it also compromises the digestive system because the p g's also protect the stomach lining as a result like aspirin and every other and said it has a propensity to cause gastrointestinal intestinal side effects including g i erosion occult bleeding massive g i hemorrhage etc all of which he said indisputably occurred with ibuprofen but not with acetaminophen so the rules of the road that emerged from the advil one litigation were that tylenol is gentler the stomach is safer on the digestive system and can make that advertising claim and judge connor put that in his decision and then the parties in the consent final judgement which is starts at page a one sixty nine of the appendix said that in the judgment itself so the judgment uses the word ibuprofen over and over and over again for example paragraph one d mcneil is enjoying from saying that tylenol provides relief quote without the stomach irritation you can get with aspirin or the ibuprofen pain relievers or other claims that equate the irritation possible  aspirin ibuprofen but this junction does not part of defense from advertising the quote highlight all doesn't irritate your stomach the way aspirin or even ibuprofen cat unquote and that line of  discussion proceeds paragraph after paragraph to a talks about ibuprofen to be to see to d paragraph three every single paragraph of the consent final judgment is about acetaminophen or tylenol compares with ibuprofen the drug you know it's the same drug whether it's given to an eighteen year old or a fourteen year old or a twelve year old or a ten year old these are  not this is not a movie that's appropriate for some adults but not for some children it's a drug that has properties the f d a warning labels are across identical all of the products drugs connor drew no distinction based upon particular populations there were no studies conducted or presented in evidence in the one nine hundred eighty s litigation about twelve to eighteen year olds that's just a fact but because that's not the way drugs a study but advil then and today was labeled for children ages twelve and up as well as adults and the dosage by the way is the same as well a junior strength advil dose for a child age six to ten to one hundred milligram tablets for an adult it's one two hundred milligram tablets same drug same dose same label mornings same properties same propensities and the controlling decision here as we described in our brief is the wilder versus bernstein decision advil was being used in children it was label for children twelve and up in the one nine hundred eighty nine when this agreement or consent judgment was entered it was under development a pending f d a application for approval which was approved just months later there was every reason to know that pediatric use was on the way and every reason for pfizer's predecessor to say in the consent judgment that pediatric products were excluded if that had been their intent and that's exactly the situation that the court faced and wilder with the city's foster care program for so called kinship care which was in development regulations pending but not yet approved here and you're the advil to decision it incorporates expressly the findings in that bill one because again that is the only factual record that exists on the science of ibuprofen and acetaminophen and how they compare in the stomach and so and that this court has approved in the norton case which include all documents that might have been at been presented in and don't know it does not it does not include for example every piece of evidence that was offered at trial it includes what it says the opinions the opinion caution are france is the opinion and that's it and that's what is explicitly cross referenced you can have two layers of of incorporation by reference this co face that with an insurance policy which which explicitly referred to an endorsement which in turn referred to a statement in in the new alton case which is cited in our papers but if eyes are truly believe that it's a different drug when given to a person all the things that are outside the record of the council stood up and said before and she may say again which he's entitled to they're absolutely entitled to their opinion they have a remedy just like the city had in the wild case they can bring a motion under rule sixty b to vacate or modify the injunction to the extent that it's no lark consistent with with legal developments factual developments or scientific developments and we will have a proceeding and the burden will be on phaser as it should be to show that this injunction should be issued be leave of the injunction as relates to specific populations but since there was no limitation and no exclusion in the original consent final judgement for any population whether it be the elderly women people of certain ethnic minorities or children and since its predecessor pfizer's person has every incentive to write such an exclusion into the consent final judgment had that been their intent just like in wilder the result here should be they have to make a sixty b motion they don't get to rewrite the judgment in the form of construing it in an unnaturally and narrow narrow construction whether it's an adult's or ten year olds or infants that's just not true that's something that they're trying to persuade you about but it's not true and it's not in the record s  ruling against them do this in a more orderly sequential drawn out way have pfizer come in with the sixty b application no harm no foul and i would say to you that's actually dodging the legal question that's being put to this court because which is please declare that the consent final judgment does not apply to pediatric advil products because they didn't exist the parties didn't negotiate for them and they're not written into the consent final judgment if we are right then we're entitled to a declaration that this consent final judgment does not apply to pediatric products the burden should not be on us to go to make an application to modify a judgement that doesn't apply to us in the first place if we're worried about fold backs mcneal has fought back it can come in any day of the week and contest that infants advil at and the burden would be on mcneil and that point and what we were proclaiming is comparable incidence which is a parity claim and under the lanham act they would have to come in and prove their superior that's what they're scared about they can't do that they can't show that children infants tylenol is superior to infants advil and that's why they're fighting so hard from our perspective chief judge katzman when you said referring to wilder do you have language that explicitly carries the weight of your client's view and that consent final judgment well the answer is surely no because the word is just advil it's not all adult products and if you thought about wilder which specifically refer to all foster children that are the responsibility of the new york city commissioner of social services the analog here would be all products containing ibuprofen under the label advil that are produced in the future by american home products or its successor that's simply not there it's not built in the parties to negotiate for and after all this isn't just a contract we're not just here with a settlement agreement it's a consent decree that's punishable by contempt and that was what was threatened to us in two thousand and thirteen and it's why the whole legal as not enter national continental bakery comes into play because consent decrees have special force and that's why the second circuit has said they do have to be construed narrowly if there's any ambiguity in our minds as the recipients and not fabricated or fictitious or self serving ambiguity but if there is real genuine ambiguity because we never bargained for pediatric products to be covered and we thought as i obviously showed you that we had the right to advertise for pediatric products separately and then the whole problem with ambiguous consent decrees is in play and that's why as a legal matter you could rule that if there is ambiguity the judgment has to be in pfizer's favor because you can't have consent to create these that are variable or uncertain in their meaning respectfully and i understand it's been a very long morning and afternoon for you we would say that our first position would be this consent decree is unambiguously in our favor but if there is uncertainty to it that still means judgment should be entered in pfizer's favor and if you think where and poise and were well matched and were both presenting reasonable positions then what you've determined is that this consent final judgement is ambiguous and