davis who wrote our briefs and who had hoped to be here but suddenly and regrettably could not and whose parting words to be yesterday were the very her reassuring just don't screw it up so with that in mind here i am and here we are the survey needs are back and our district court has still not allowed us fact discovery beyond the limited scope of defendants conflict preemption defense which was the subject of the first summary judgment ruling and our prior appeal to this court and this court's may have twenty seventeen opinion at a fifty five a third to ninety one the district courts latest memorandum decision and order november twenty ninth twenty seventeen is erroneous and should be reversed and the case remanded to move forward with a complete discovery with complete discovery and a jury trial because the surviving these three remaining claims for failure to warn fraud and negligent misrepresentation are based on unsupported by utah law and by the facts in the record submitted in the survey ynys on the contested elements even without the benefit yet of full discovery so one reason possibly for the district court's erroneous granting of summary judgment the second time is that the court neither acknowledged nor applied we believe its responsibility to view the evidence and the reasonable inferences to be drawn therefrom in the light most us the nonmoving party so my plan is to address each of the surviving these claims and explain briefly why they should not have been granted summary judgment against them and i know the panel is familiar with the facts but let me in fact is that in the record i know that she must have been become pregnant in late october and it just says that she used it was administered clomid in october there is what led to davi elation we know that well i guess we don't know  lation we do know she took clomid in october of ninety two and she thereafter became pregnant and that is in the record in her affidavit and there is not you know we have not contended that she continued to take after the point in time that she became actually pregnant and so that's there in leads to some confusion that i think brings us here today it seems to me in reading this that that's not even an issue the fact that she never took the acknowledges that she never took this medication washee was pregnant correct and it has and it serves no purpose when she's pregnant the purpose of clone that is to facilitate to help someone become pregnant that is its only purpose it is clone it is not taken by a pregnant woman to help her become more pregnant for example you know it doesn't have a use in a pregnant woman and so that's correct she took it prior to becoming pregnant and that is the usual way in which the drugs take she testified that she had no knowledge and was not warned that taking clomid to assist in becoming pregnant which is the indicated an approved use of clomid could present a risk to the baby if conceived and had she known that in september of one thousand nine hundred two that using clomid could present a risk to the baby she hoped to conceive she would not have used it and would have continued to try to conceive a child naturally which there was no genetic family history of birth defects alexander who was born after clomid had birth defects she continued she conceived a child naturally without the use of clomid later and that child had no birth defects so we contend that mr bean is use of clomid in fact caused the birth defects from which alexander suffers and all three claims here center on the adequacy and the accuracy of the warnings provided by defendants the claimants manufacture about the drugs now there's two aspects of causation proximate cause and let me ask you about a legal last component of that inquiry and that is does proximate cause and under state law require force see ability of the mechanism of of the mechanism that causes the injury in other words in your partner's briefing he's extensively argued that with regard to that that she didn't know that the manner of the injury that would be caused by taking clomid prior to pregnancy but under state law for proximate causation the question is whether or not is reasonably foreseeable that that  mechanism would cause the injury correct i don't necessarily agree with that characterization of what the focus is of the foreseeability injury and probably is not exactly what the case that you cited  these specifically say that the appropriate inquiry focuses on the specifics of the alleged torture asc conduct such as whether specific mechanism of the harm could be forcing right and let me try to put that into context then what is not necessary is that the exact or precise mechanism or sequence between the higher the the defendant's wrong and the injury suffered be known or predicted precisely in advance what is necessary is that there be an unbroken chain of foreseeable events that lead from the act to the injury suffered and the best way to look at it is is comparing for example the jacobs peterson excuse me the the i believe the jacobs peterson case in the band assign case that are both cited and discussed in the briefs because one one there's a there's the one is the national guard machine gun training in extreme fire conditions the us agreed it was negligent starts a fire fire gets out of control mandatory evacuations and a woman who was loading her horse into a trailer is injured by the horse while she is hurrying to evacuate because of the fire now my point the mechanism did someone know exactly how she was going to be injured by her horse loading into a horse trailer should they have foreseen that when they were deciding negligently to do gun testing on an extreme fire danger day maybe not but the mechanism or the sequence was foreseeable each way it's foreseeable that you do firearms training on an extreme fire danger day that causes a fire the fire gets out of control that leads to evacuations and the court said each of those steps is foreseeable from the original act as opposed to the band assigned case which is a passenger in the car is shot by another driver of a different vehicle shot and killed the defendant was the driver of the car in which the victim passenger was riding and the defendant was driving recklessly it is foreseeable that driving recklessly might cause death of a passenger that's not the issue but the issue is it's not foreseeable that death might result from an act by a criminal act by that right if you make that argument extremely well but but let me ask you this this warning for taking clomid during pregnancy that event is should have reasonably foreseen that if someone takes clomid prior to pregnancy that they might very well experience the same injury the same potential for birth defects that would have otherwise trying transpired by taking clomid after pregnancy well i have t answers i mean i think it's i think it's in the proposed i think you can infer it from the proposed language of the warning that the f d a want to the ventus to it was a class ten warning right i mean the definition the warning would have well actually that was before otherwise the language of that proposed warning in one thousand and seven is very critical it was pregnancy category acts that was what they wanted to declare which is risk to the fetus of a drug taken during pregnancy so let's let's categorize it that but then this was the warning that they  wanted event to say since there is a reasonable likelihood of the patient becoming pregnant while receiving clomid the patient should be apprised of the potential hazard to the fetus i don't understand how that helps you because it is it's putting a spotlight on be very careful you don't take lohmann while you're pregnant it doesn't say anything about any danger of taking it before you're pregnant which i'm not even sure it is a danger again there is no use and no one is there's no one's arguing otherwise here there is no use of clomid once you are pregnant the there's only one class of clomid users i think the failure of the district court here is to get hung up on thinking there's two classes of clomid users and this warning only applies to the class of clomid users who take it while they're pregnant that's not a class of clomid users the only class of clo d it is to assist a woman in obvious lading to become pregnant it is only used by women who are not pregnant to become pregnant the danger is the danger is there's no light bulb that goes on the moment a woman becomes pregnant you're not positive of when that moment to curse and if you continue to take clomid ingest it in have that substance in your body it can cause harm to the fetus and we contend it can cause harm to the fetus and we have evidence and we will have evidence it can cause harm to the phoenix if taken before pregnancy but remaining in the body in sufficient quantities to effect the fetus and had this warning been given that the f d a said you should get out of it is a warning by its terms it is a warning directed to women who are not pregnant that just since there's a reason the likelihood of the patient talking about one patient becoming pregnant while receiving clomid the patient same patient who is not yet pregnant should be apprised of the potential risk to the fetus and potential hazard to the fetus the point being there's one class of patients in mrs survie was in it and she says if i had been told that a drug i might put in my body attempting to become pregnant might cause harm to my fetus to my baby i simply wouldn't i would have chose not to take the drug other women might choose differently other women might choose to accept that risk because they really believe they need clomid to become pregnant that's a choice that women should be free to make but they should be free to make it based on adequate warnings they should get the full information and the ventus resistant that the f d a said give the woman give women the information about potential hazard to the fetus and eventa said no we don't want to say of women taking clomid therapy and then when i go back to the summary judgment record it was fifty eight out of to two thousand three hundred sixty nine women who had taken clomid therapy and so what i took the calculator is i'm not very good at math that's two is there for birth defects in other words if you take all of the women in the united states that become pregnant what percentage of those women have offspring with birth defects we have no information is it more than two and a half percent is it less than two and a half percent so that's not i don't think at least i wonder how could that be causative evidence and the other evidence was simply that an i q sixty three someone had expressed concerns i just ok i'm obviously out of time and i will i will respond simply by saying i think we we believe we did submit evidence that proves the falsity of the statement we also believe the f d a has proposed warning is also evidence that goes to the plaintiff's challenge the accuracy sufficiency and adequacy of a warning when it is undisputed that the plaintiff never encountered the risk that the warning addressed here it's undisputed that mrs server any did not take clomid while she was pregnant with alexander serveti the warning that plaintiff's advocate the one nine hundred eighty seven f d a pregnancy category x warning is a warning about the risks of taking pregnant the warning that the plaintiffs challenge is inadequate than one nine hundred ninety two clomid pregnancy contra indication and we'll get to contraindications later because i think the fact that it's a pregnancy contraindication is extremely important it's not merely a warning it's an absolute prohibition of the use of the medication during pregnancy because of the rest of birth facts did you argue this case the first time it was up here no your honor i did not remember this counsel m know this case better than you do they think they very well may and i do want to lean on their knowledge as well because well that's what brings me to the point because i was and your opposing counsel is saying this case can you give me any utah case that's similar to this that we're she never took him in the issue is that she never took it that that is sufficient for her to be able to claim  action there's any you talk a first there's a warning as the warning there's no utah case directly on point and there are number of cases throughout the country that deal with these issues and we've cited a bunch of them in our brief  the utah supreme court and utah courts have not addressed this type of situation i think there's a simple reason for it well i mean if i'm agreeing with only the simple reason for it i wasn't able to find a case unlock that now as to fraud is are you talking you can cite to me that the district court in this case may have overlooked on behalf of this lady in a there's not a utah case that i could cite to you on fraud that the court may have do think there's a reason for that which is that when you have a situation where a warning addresses a particular risk and there's been discussion about time and manner of warnings and time and manner of warnings are actually fairly common because warnings addressed risks they don't address outcomes and if you look at the house case when the house case talks about the duty to warn it talks about the presence of a risk that renders the product and recently dangerous it doesn't talk about an outcome it doesn't talk about an injury it talks about a rip and sometimes with a drug a risk applies across the board and you have a broad warning in their cases that address you know if a drug has a risk of cancer and there's a warning about a risk of cancer and whether that's adequate or not but then there are other situations where a risk of rises in a particular circumstance where their risk only exists in a particular manner and that's where the contra indication of clomid comes in is is we're dealing with a situation where we have a manner of risk and when we have a focused warning on a manner of risk the adequacy of that warning and whether that warning causes injury can only be addressed in the question of whether that manner happened and we have a couple of analogies that we used in the district court that i think are apt here we didn't include them in our brief here but if you buy a car seat today every single child car seat has a very stern warning on it's do not install this warning this car seat in the front seat of the car severe injury can happen if you install it in the front seat well imagine a case where a person bought a car seat installed in the back seat of the car had a car accident where the child was injured and the plaintiff came in a said you know what if i had been more given a stronger warning about the dangers of installing it in the front seat of the car i would have looked and bought a safer car seat that's very much what we have here the warning is disconnected from the of the case and the house case which is the seminal case sort of on warnings in utah it involved a bulletproof vest a police officer was involved on a a siege of an armed compound he was wearing a bulletproof vest and he was not warned that his bulletproof vest would not stop a rifle bullet and he unfortunately was shot and killed by someone using a rifle with a bullet hit his vest and penetrated through it the defendants in that case argued we should not be liable because it's open an obvious that you can get shot and killed while we're out wearing a bulletproof vest you could get shot in the head you could get shot in the leg there are all sorts of places the vest doesn't cover it's an opiate open and obvious risk of being shot and dying the court in the house case rejected that and said no here the bullet hit the vest and yes it's true had he been shot in the head had he been shot in the leg that would be a different case but he was shot through his vest so if you sort of flip palace around the house was a situation where defendant was trying to argue facts that didn't happen chat to argue that their warning was adequate here we have the opposite where we have the plaintiff is trying to take a situation where and apply it where the facts don't match the warning we have a very specific warning against use during pregnancy mrs serve any didn't use the medication during pregnancy she's trying to convert this warning to challenge the warning because it was did not warn her of the risks of not taking it remembering let me ask you there may because what we're brushing up given we wouldn't even be here and the only reason i can think that it would resist is because of sales well i think that the reason they resisted it and there's correspondence it's in the record back and forth awaits wish i could tell you exactly where it is in the record but they went back and they said pregnancy category x is supposed to be for medications that not only are not used during pregnancy but are not supposed to be used by women who are trying to get pregnant we have a a pregnancy drug that is in fact only indicated for use when a woman is trying to get pregnancy so we don't think that president pregnancy category x designation is the right that's admission the other thing they told me i will wait a minute let me stop you there because that's an ambiguity that i could use some help from you as far as explaining you just kind of use the language or may become pregnant as and that could mean if you're concerned about your fetus don't use this even before you become pregnant or it could mean that the warning as for people who may become pregnant ten no once you are pregnant don't take it because the fetus could be damage and that's that's how i read it you're reading in a different way i'm reading it a different way because the way i'm reading the warning and and first the when when that be the end of clomid if the warning were don't use this while you're pregnant and don't use this before you're pregnant and  i think that if that would be the end of it makes no sense on a pregnancy medication and if it were the end of clomid that would be a tragedy and that's why that's why you don't read it that way at all well but but clomid is one of the longest standing and most successful fertility medications on the market today it's on the market today it has a warning very similar to the warning that was on the label back in one thousand nine hundred two it's been on the market sense i believe one thousand nine hundred sixty seven caused the birth defects here it's it's not for the purpose of this brief this or this this motion for summary judgment was filed early on an incomplete record we absolutely do dispute that and i mean  so and i'm not sure that i'm fully getting getting to your point but i think it makes sense to go back to the languages that the f d a proposed and the language that the f d a proposed in one nine hundred eighty seven is come contained in the for patients contraindications clomid is contra indicated in pregnant women clomid may cause fetal harm when administered to pregnant women since there is a reasonable likelihood of the patient becoming pregnant while receiving  the patient should be apprised of the potential hazard to the fetus and then information for patients under this heading appropriate statement should be included which correspond with the statements under contraindications so what the f d a proposed is very clearly a warning that clomid may cause fetal harm when it ministered to pregnant women and then it says since there's a likelihood that the patient may become pregnant while receiving clomid the patient should be a prize of the potential hazard to the fetus what's the hazard to the f that may cause fetal harm when it's administered to pregnant women now now let's compare that to what she had which is the one thousand nine hundred two version and there we see although no cost of evidence a deleterious effect of clomid therapy on the human fetus has been seen but not too scary such evidence in regard to the rat and the rabbit have been presented therefore and so least i can see how a person would read that and say oh here we are living in a slip to just society and they have to cover everything and so they're telling us that no big deal but rabbits and rats than you drink a thousand diet cokes a day that sort of thing and the first thing is contra indications contra indications are the very first type of warning that appears in the label it is the strongest type of warning that appears in the label and it is viewed by doctors and others as an absolute prohibition a minister during pregnancy to avoid inadvertent clomid administration during early pregnancy the basal body temperature should be recorded through all treatment cycles and the patient should be carefully observed to determine whether  the body temperature following clomid is by fact by fast ik as not followed by mensis the patient should be examined carefully for the presence of an ovarian cyst and should have a pregnancy test the next course of therapy should be delayed until the  is been determined so it may not be in the late term so when you approach it as a layman i agree with you fetal arm in the late term does does come out and hits you but this is something that's being written for doctors and it very clearly tells the doctor this can't be administered during pregnancy you have to observe the patient carefully you have to run these tests you have to give a pregnancy test to make sure it's not administered during pregnancy and again i keep coming back to the regulation we cited in our brief it's twenty one c f r section two a one point five seven subsection c five which discusses contraindications and its a concert indication describes any situation in which the drug should not be used to because the risk of  clearly outweighs any possible therapeutic benefit those situations include the use of drugs and patients who because of their particular age sex concomitant therapy disease state or other condition have a substantial risk of being harmed by the drug and for whom no potential benefit makes the rest acceptable so just by including this in including pregnancy in contra indications they're communicating to doctors that the risks outweigh the benefits you can't use it in th circumstance and i do think that going back to cases i think that if this court were to say a a patient could challenge the adequacy of a contra indication with respect to the contra indicated use i'm not aware of any court in the country that has ever said a contra indication could be an adequate warning of what it is saying is contraindicated so on your argument let's say we don't agree with everything you just said which element of a duty to warn claim would your argument in trigger i think it would trigger sever i mean it was certainly trigger proximate cause i think it would trigger duty utah law on duty is that we have a duty to warrant of the rest when the risk make dangerous to her and then finally i think adequacy we have a contraindication to challenge the addict is of contraindication and say it's inadequate to warren when you talk a lot written merely requires that a risk be stated clearly it doesn't require a perfect warning it doesn't require the strongest possible warning and in fact the warning here worked mrs server any did not take long and while she was pregnant to hold a pregnancy the clomid label an adequate because the contraindication wasn't the material difference between the warning proposed by the f d a and the warning that was actually given in one thousand nine hundred two we believe that material difference that this court has already observed  explains and reasonably allows someone to infer that that ms survey needs affidavit testimony is reasonable and it may or may not be believed by a jury that's up to a jury but she is intitled to have directed at physicians but the expectation is physicians convey the warnings to their patients that apply to the drugs so i guess that's how i'd answer that but we believe that there is adequate evidence to allow the her claims to move forward she is entitle to all evidence and reasonable inferences drawn in her favor we don't think that's been done and we would like to see the case go back thank you thank you counsel for both sides for your excellent advocacy this matter will be submitted and court is in recess until eight thirty tomorrow morning