opinions for the first expert is dr banks henshaw he's a gynecologist specializing in the treatment of osteoporosis for women who are post menopausal the court well yes are we or misunderstood is that she she narrowly focused on the fact that there is not a case that basically in the title says reclass causes a typical human fractures it's not surprising that there is not a case that does that because are several different studies that mention different clinical data from the reclass trials the horizon trial if you look at the second a s b a more task force report which is document one seventeen dash one that is from two thousand and fourteen it it goes into the clinical data from the reclass trials and in that paper they they indicate that there is evidence for an association between bisphosphonates and a typical femur r is relying on yes or yes sir he's intimately familiar with all three of the a s b m our task force reports the doctor were then was aware of the there are minor and major features that when you're  characteristics i don't believe i believe what dr ware than testified to was that he had never read the full paper but he was intimately familiar with what the major characteristics were which would require him to do that analysis to diagnose her and he did do that analysis and i can go through those  yes sir yes yes or dr worse than the treating physician she did she ignored some of his testimony his testimony was that when someone comes in with a femur  fracture that they he looks for different causes such as does has that person had cancer could it be a re break and also other other medications that that person could take which steroids is one of them mr jones had been on steroids and he  he did a differential diagnosis and said that the steroids could not be the calls and he gave several reasons one of which was where it was on her diathesis is not where steroid induced fracture would typically be on an o fractures and i think what's important in this case is that it's not just some injury that you know for example if a drug could cause you to have a stroke or if a drug could cause you to have cancer or something like that these atypical femur fractures have osteoporosis that's right and that is all that is required for dr hinshaw to give a general causation opinion with regards to his bradford hill analysis before he does his bradford hill analysis which the court accepted as as reliable methodology he must point to evidence of an association what judge hopkins ignored was vast evidence dr hinshaw dr henchoz the general general causation expert he did the bradford hill analysis which is accepted in this in many circuits and judged hopkins accepted it before you do that analysis you us point to evidence of an association not causation and there is ample evidence of s that are dealing with these a typical femur fracture she failand that oddly the district court found that banks henshaw who is our general causation expert  analyzed all none of the bradford hill factors and fov of the bradford hill factors have to do with the analysis regarding an association so by requiring him to just point to is that it was not appropriate for him to extrapolate from other studies and they cite the rider case rider as an eleventh circuit case where this court rightfully found that extrapolation from a class to a specific stroke well that is the exact opposite injury is not what we have here we're talking about the exact injury that only happens in these bisphosphonate cases so there was also no theory of the mechanism of action in ryder  causation and in those cases it was drugs that call suicidal tendencies for depression and they were allowed to extrapolate because the medical and scientific communities treated them as a class the f d a issued a class wide warning which the about thank you your honor may please the court steven klein for happily i want to begin with the standard we all know it's a deferential standard here use of discretion manifest error judge hopkins did not ignore the studies in the literature studies and extrapolating from those two reclast so it's not true that she ignored the question here is not whether the district court was right or wrong this panel respectfully is not to substitute its judgment for the truckers judge it's a deferential standard of review is whether the trial court acted within its considerable discretion examining the evidence looking at the extensive record and coming to know what what the record shows and what's really at the bottom of this given daily weekly or monthly they obviously are ingested through the digestive system reclast in contrast is the only intravenously administered bisphosphonate in this class and it's given once a year in some cases once every other year it's not given daily it's not given weekly it's not given month and what that means is that the serum level of the bisphosphonate is not constantly being replenished throughout the year and this can have very significant impacts on the literature no your honor because that's exactly what the discourse the district court acknowledged that the first step of bradford hill is not a causal association not causation but simply an established association and in fact that's the whole purpose of the bradford hill if there is science to support his assertion that there is an association which is a prerequisite for the brad friedel analysis to establish general causation and then if the specific causation expert is able to sufficiently rule out using a literature that actually does separate out the different bisphosphonates has never found an association statistically significant association with so we have a study called edwards and doctor in charge knowledge this which looked at the  this study looked at the impact of individual bisphosphonates on the material properties of bone specifically the fatigue life of bone which is thought to be one of the mechanisms for these a typical femur fracture so it really cut to the heart of what respectfully the clinical trial found no increase association and found three fractures that could potentially be considered a typical based on location in treatment group and in found two in the placebo group so there was  statistically significant increased risk based on the clinical trial data and so what brock not only did find that there was no impact on the fatigue life of bone from reclass whereas there was from europe is also needs to explain the mechanism of why this might be the case and if i could read briefly from from brock differences in the administration of the bisphosphonates may contribute to the altered fatigue properties with daily dosing of is present in the serum continuously affecting biomarkers of bone turnover were as a single dose of the lender in a which is reclast may allow the serum biomarker levels to return to pretreatment homeostasis so this court has recognized in writer and in mclean that even minor differences are deviations in the chemical structure of a drug can have major differences in the clinical impact of that drug and in fact it is the burden of the proponent of the evidence in the burden of dr hinshaw to prove that those differences in chemical structure make no difference in dr inches of pain not only did he fail to do that he actually conceded the opposite intravenously impacts bone is not likely to be parallel to the process of how the oral bisphosphonates those are his words he acknowledged that the different route of administration of the different dosing regimen make a huge difference again his word it made it would be invalid to extrapolate from the oral bisphosphonates because the route of administration and the different dosing regimen make a big difference a huge difference yet that's the basis for his general causation  so we think the record is absolutely clear that it's not legitimate to extrapolate that it's dr burton's doctor henchoz burden to establish that there is a scientific basis and reliable scientific basis for it and he failed to do that the district court issued a detailed one hundred nineteen page memorandum opinion examining the record the district court is closer to the record she weighed the testimony of dr hinshaw and plaintiffs other experts she did not weigh credibility that's not the proper role at this stage she simply their testimony at face value using their own words and determined that dr hinshaw was not able to establish the reliability of his extrapolat there are independent grounds to exclude dr worth which the court found apart from the lack of general causation through dr in terms of pain first the court found the doctor worth and was not qualified to o jones as frak dr were than was the emergency room physician who happened to be on call when ms jones walked into the emergency room he's an orthopedic surgeon he's seen a lot of femur fractures testified that he he did not testify that he had atypical femur fractures before ms jones well he may be qualified to repair her fracture he may be qualified to diagnose it as an atypical fracture and there are specific diagnostic criteria that's very different than being qualified to opine as to the c the court quoted this in her memorandum opinion what is your basis for excluding steroids and his only answer was i thought it was an atypical theme so he looked at the criteria he thought i meant the in potential cause so it's a potential cause it's not established that it can cause it but it hasn't been ruled out same thing with  well i would take issue with the word even possibly science doesn't know what the record says is that there's a strong association but causation has not been established and it's same thing with the oral bisphosphonates correct so it's appropriate for steroids embassy  he's gotta have some reliable basis for in his opinion ruling out steroids and he does not have that he simply assumed that because he thought it met the definition the fracture met the definition of an atypical femur fracture therefore he assumed ok it's caused by bischoff he could have come to the same conclusion with regard to steroids the doctors required to rule out the other major reasonable according to the doctor based on scientific support he did and he purported to do it simply based on well he claims he considered steroids and rejected him so the court appropriately looked into his basis his methodology for excluding steroids and that's where he fell sho you i'd like to start with dr ware then he did consider steroids he did a proper differential diagnosis he ruled out steroids but said that there was a thinking of the quarter which that is not present he properly nailed it back together she presented with pain in her left leg that was just like the pain in her right leg dr worden had read about this faucets and had known that in twenty percent of people who experience in a typical femur fracture they are going to experience an atypical femur fracture in the corresponding leg he prophylactic lee nailed her left femur back together so i guess my point is that the second second differential diagnosis solidified his first differential diagnosis which said that it was caused by a to typical femur fractures he ruled out steroids because these a typical femur that's not where steroids induced fractures occur in the body naturally and he explained that the district court totally ignored his deposition testimony where he carefully goes through and says why he did not think that he did not diagnose it as a steroid fracture and i will say i think it's telling that agree with mr klein that he is qualified to diagnose this isn't a typical femur fracture dr where than is is definitely qualified and did have familiarity with the diagnosis criteria and if you look at the diagnosis criteria and they are it is very specific and he if you look at his deposition testimony he went down the line and gave none of the major there's major features or not and minor features but not of the features from the a s b amar he did that properly and found them to all be met so this is not this is not like the harvey case where where the district court  not only on the first diagnosis but on the second diagnosis to qualify these as a typical femur fractures and to tell ms jones to quit taking bisphosphonates i'd like to address to something that mr klein said we  the standard of review is abuse of discretion we have candidly acknowledged the standard of review from the very beginning in all of our briefs respectfully this is a situation where the court needs to be reversed when there is so so much evidence that has been absolutely ignored and that his has resulted in a summary judgment and as you know this circuit since two thousand and ten has reversed six other district courts where they improperly abuse discretion and kick all of plaintiffs experts so that there is no causation opinion so we would we would we would strongly suggest that this is a situation where that is appropriate  typical femur fracture clearly increases with b p therapy duration and the whole point of this paper was to and they and they point out that they don't just look at the oral oral bisphosphonates they also look reclast which is the which is the injectable and they suggest that after five years of oral b p use that the doctor should should consider taking a break because the risk might outweigh the benefit at that point and with the intravenous one which is the one that we hear about today they consider taking a break after three years so i would suggest i'm no doctor but i would suggest that that means that they are spam or is recognizing that reclast is stronger than the and therefore you need to take a break after three years instead of five because the risk of a typical femur fractures is outweighed in some patients not at all but in some so respectfully i would say that they as b m r has has h