please this honorable court i wanted to say thank you in the beginning for allowing me to consolidate and have these oral arguments together on the same day for both cracks program palace that has i think it will be more efficient for the court and certainly for me i i wrote a very large check on april fifteenth and i'm sure i'm not alone in this room and eyes are mr witt get our tax get a tax advisor go ahead your honor i think the way it works is the government has a forty percent contingent fee contract with me so i don't think there's much i can do to get denkinger blew a call in kansas city this is a this is a case since they where the judge just made a couple of errors that i think are are fairly important and i want to be of assistance to the court i know the courts read the briefs and understands the factual situation i have some prepared comments but obviously i'm more than happy to address whatever questions the court has to  the first issue that we briefed was the procedural rule with regard to whether or not this is an affirmative defense or a jurisdictional bar and how this court applies to the supreme court precedent in that regard is important in land graft and several of the other cases the issue was whether or jurisdictional change applied at the time that that statute took effect or whether it applied to contact prior to it and certainly much of the conduct issue here occurred prior to the changes in the statute in two thousand and ten but the statute was implemented and it effectively change what was a jurisdictional bar because the statute read no court shall have jurisdiction and changed it over to a non jurisdictional bar that said the court child this mess unless opposed by the government and then it listed the requirements of the public disclosure of our the reason i think that's important is because with a procedural rule like that unlike other false claims act cases the one where for example they tried to use that that was clearly a retroactivity issue you're talking about hughes aircraft right yes or well doesn't he has aircraft or isn't it pretty much directly on point because it says if it affects a substantial change in congress to make it retroactive retroactive well the reason i think it's not precisely on point is because the eighty six amendments essentially created jurisdiction for issues that had not been fallen outside the jurisdiction of the act prior to those one thousand nine hundred sixty amendments in this situation the jurisdiction the only thing that's changed is the jurisdictional bar and it barred jurisdiction previously and now they remove that jurisdictional bar so i think it actually falls closer to land graph and and hit home and versus rumsfeld i think is a case that that you should look at because i believe that what they did there was essentially recognize that you're not you're not altering a right case was certainly defensible under public disclosure after the two thousand and ten change it just changed it from an absolute jurisdictional bar over make a jurisdictional inquiry you have to look at the facts with regard to jurisdiction so you don't normally get to the facts of the case i would agree with that but you do get to the facts of jurisdiction so therefore i dismissal pardon me away but therefore under the new law a dismissal can be before you look at any facts except those that are relevant to the dismissal i think that's true however in if there's a difference between a jurisdictional dismissal at least as i've always understood it and a dismissal on the basis of failure to plead and prove the requisite facts to support the case and seems to me that that if this is an affirmative  certainly what the fifth circuit seems to think it is and i would encourage the court to look at those cases if it's an affirmative defense they have a burden to plead and prove that affirmative defense and certainly if this case is dispensable in public disclosure grounds they can renew that claim on summary judgment and they may stand a chance of winning on that basis after the facts are fully developed and what i or my you may have drawn a distinction there i just look at this practically i don't know the now an affirmative defense but one other practical difference is that your honor that's a good question you know it's hard to outside the facts of this case hypothecate about what might be in a in another matter but in this particular case the issue of public disclosure and original source are fact dependent and they are tied together in that manner in that if the court finds that there is a public disclosure then it must apply the original source exception if the original source exception fits and it seems to me that as a practical matter wouldn't it be better to have all of the facts sworn depositions record you know everything in the record before you made that determination as opposed to doing it at the outset on the basis of affidavits and the i think it just i think it would be and i think that's the reason why congress changed the statute frankly that and the fact that since one thousand nine hundred six the whole procedural issue of based upon and public disclosure has given every circuit court of appeals and the supreme court nothing but fits it's one of those situations where the language certainly appears clear when it's written in the statute but it's been very very difficult for every one of the courts of appeals and certainly th district courts to apply that standard so by changing it over from as you're stiction a bar where you don't even you know get the door of your foot in the courthouse door over to a situation where you have to plead and prove it as an affirmative defen e it improves the fact finding in an improves the access for it certainly for a later scoundrel and for later as to the courts to be heard that's what i think that particular issue is but if i may i you have alleged enough of the who what when where how and so forth to meet the rule might be fireman's well your honor we've certainly alleged all of the facts necessary under rule ninety the district court made that determination i assume now you're asking about the cross appeal and that cross appeal only come i mean i assume if you're saying that that's an additional ground upon which to affirm the case we pleaded in we included information about individual claims where those individuals had either medicare or tri care or us military and they were they had had these pumps implanted as i said you didn't your you time my dear list of seventy seven yes you're right but i didn't see that that tied to any particular doctor or even that they had a particular particular procedure or that somehow they they were there was a connection to your allegations here well your honor that goes back to the other case that i discussed in my brief levesque about what level of generality you want to use to look at at  require encyclopedic pleading about whatever procedure that you know we're we have to follow our precedent i mean how would you distinguish this case from josh or well aruba this is a c the common scheme and plan was that i they didn't disclose to pardon me as i recall joshie was two or maybe was route one of the i don't enjoy your honor you wrote a very good opinion in that basically joshua came in and said everything's bad they put you know every every case was fraudulent because they didn't have these well i think it was in a speech a case they didn't have you know be couldn't lay out which individual patients he didn't have a list of patients who or where this had been done he just said that everything that had been done was wrong here we have patients that we've identified who had these procedures done and who suffered damages as a result of it or were complications and one of the things this court should be sensitive to is the fact that we're spending more and more and more of our health care and if we are constantly going to allow people to put products out that are defective and do it in violation of federal regulations you know we're going to have more of these kinds of issues and it's just going to it's certainly going to be a problem but if i could if i could back up a moment and go to the issue of the original source one of the problems that i have in this case is that that in this is sort of the don denkinger moment you know that the court says that  tially the doctor palace waited for the for the studies he actually performed those studies he was one of the first people along with dr back who determined that there was a problem with these pumps and he took that information to the defendants in this case at least with regard to see enter and certainly with regard to the the causal connection between the pumps and the joint damage dr paulose is an original source and i don't know you know there were a lot of pages of documents that were in those motions defense counsel did an excellent job of bringing this motion at the beginning of the case and laying out their factual predicate there were a lot of documents maybe the court thinks it saw that but that's simply not in the record dr paulose was an original source with regard to the patients his his knowledge was acquired in the operating room he didn't read about this by reading a brief or a newspaper article he saw these patients he treated them he's an original source so even if there is a public disclosure he should be able to bring this case because it's an original source he's an original source and the other error and because it's pleaded both of these facts are pleaded in the complaint and i don't believe they're ever really controverted by the defendant's nothing shows he did not disclose this to the federal government in fact we pleaded that he did we served a disclosure on the federal government before we filed this case and of course we filed an evidentiary disclosure after we filed the case and don's allowance met i'm a paragraph behind you now i think the district court's not too accurate about saying that he never learned of until he read the published audi's but and with that concern they sat down and worked through it together and they started looking at cases dr paulos did not believe that there was a problem and he didn't believe that the pumps were causing an issue because he had had pumps placed or he had he had basically not put any of these pumps in place because he didn't really think they were that helpful but he knew that one of the med been placed on one of his patients and when he looked back he saw that that patient had this p so that was a wake up call for him and he went back to doctor back and he said yes let's investigate this and he worked with dr beck so he you know it doesn't say he has to be the original source it says he has to be an original source and your honor i'm going to have to reserve some time for rebuttal i know but i think that's really the heart of this case the heart of this case is the original source question i think the court just dropped the ball on that one and certainly we pleaded that he was an original source and we pleaded that he had this direct and in dependent knowledge and if you don't get that knowledge by treating these patients and remember in addition to working with dr back he helped repair a number of patients who had this p a g c l in their shoulder he actually did the surgeries that corrected those to the extent they could be corrected so i know that  questions that the court raised with mr de witt but if i may just step back and provide a little bit of context i think the timeline is important for this court to understand this key ten complaint was filed in january of two thousand and eleven that is years after the first media reports about the problems with these pain pumps in particularly in the insertion in the joint space years after public complaints have been filed and even even judicial decisions so this is not a case of a person who is bring and his counsel had every incentive to put in this record everything they knew about the misconduct they allege strike or any other companies why because they didn't know filing this whether prepare prepare parker version which is clearly jurisdictional would apply with the postal parker the record is fully developed and if you went down the path that mr de witt proposed which is having discovery you would really undermine one of the key policy objectives with the public disclosure bar the congress wants people to come forward and give the government knows what filing is a government but b the government wants to avoid parasitic lawsuits that do nothing but recycle allegations are in the public disclosures and cut into the government share and if you allow if you allowed discovery  some representative examples of the of the of the false claims you need to provide the details of who the what the when the where in this complaint fairly clearly fails to do that it does not provide the details of the of the supposed fraudulent promotion it does not not even patients who are alleged to have suffered injury if you look at the the manner in which they're pled in there and they also not not clearly stated in the in the allegations that the pain pump was placed in the joint space which is the key issue in this case i think the put the complaint is deficient bar suffices in the first one is whether the central allegations of fraud were sufficient to put the government on notice that there might be a that the government might have been defrauded in i think are the record that's down below of all the public disclosures whether they're court complaints knowledge of the fraud alleged and that's the key question does he have direct and independent independent knowledge of what of the conduct that that would give rise to a false claims act and in the briefing below the focus has been doc the policy of direct an independent knowledge of the fraudulent promotion that he alleges in his complaint and i think the newel case that this court decided fairly recently is very instructive on what the new york a stance for the proposition that admission does not know the true state of facts hit the allegation in the complaint is that that stryker applied to the get clearance for use in the joint space and that the f d a said no we're not going to clear a device for that use and then dr possibly is on a mission learned that in the course of the litigation that those are the true state of facts in the new case which is a false claims act matter against the city of st paul through state of facts were that the comp that the city was mission of false a fraudulent claims the federal government so direct knowledge that a device may harm a patient does not qualify as direct knowledge of fraud against the government i would also submit though that even by its in the record and mr de witt stated up here to the agree there could be more than one original source right there certainly could be a case where there's more than one original source if more than one you may have first to file issues in that case but if there could more than one a regional source if there are multiple individuals who know the true state of facts and i would submit to the court the true state of facts here have to be the facts that give rise to the falsity of the subsequent representations that's what the court said and in the new a case about the city of st paul that's what  approved for the intro to kill or use is still an unsettled question the sixth circuit in the rodriguez case ruled that the indications for use covered the joint space so the stand on the false claim that you do knowingly cause you accuracy enter to cause an individual some in a false claim even if it's true the allegations that struck are supposedly told doctors to use the device and the pain pump in the shoulder joint space that that is still unclear whether that's an off label use or not so we would trial may please the court i'm here on behalf of the defendant i flow i don't want to you want to repeat things that mr levy just said and i agree with i think virtually everything he said on the retroactive retroactive  effect of the statute the only thing i would add there is that dr palos himself in his briefs said that the two thousand and ten amendment changed the scope of the public disclosure bar and and changed the scope of the original source exception so that standing alone shows that this was a substantive amendment not just a purely jurisdictional procedural one and cannot be applied retroactively as as mr de witt said and mr levy emphasize original source is really the heart of the case there is no serious dispute i think that all of the essential elements of the fraud the true state of facts and the alleged misrepresentations had been made public in lawsuits and media reports f releases s e c filings and that sort of thing now to be an original source you have to be a direct have direct and independent knowledge or direct knowledge is what you saw with your own eyes it is not as this court held in barth and other cases things you learn from somebody else secondhand or even the results of collateral research and investigations and what i'd like to do is is jump right to your question  about the district court's comment that dr palos didn't learn about the connection until he saw it saw it and published sources i think that's that sentenced standing alone is is too broad brush as mr levy said but i think that was that appendix page to all five if you continue reading and go on to two of six i think the district court explains more what what he really meant when he talks about dr paul it was really reacting to inquiries and and studies by other doctors that's really the point and if you look at even what dr palos has said himself both in the district court and in this court it's pretty clear the doctor back was the original source and the doctor was an original source i'm a doctor he said the original source is that's that's a fair point your honor and you're quite right there can be more than one original source but when in this case we don't have that because dr paul los but dr paul of learned he got from dr back it's not like he had a separate track for this knowledge  according to the complaint and this is paragraph eighty eight the amended complaint dr beck came to dr pollack in two thousand and four and it was after that in two thousand and five according to his declaration the doctor policy became convinced about the connection the opening brief says that it was a doctor back and this is a page twenty eight who had been the first to report this discovery to dr paul los the declaration says that he meaning dr beck raced with me the possibility of this relationship and then after that dr paul also went back to dr back and said you know i think you're right and then he and the when he talks about the articles that dr beck wrote he talks about publishing the findings of his research meaning dr beck's research dr palos role was encouraging dr back to write the article promoting it helping get it published that's all fine but that's the work of you know that's like the work of a literary agent or an editor it's not the work of an author and that's what your talk about me direct you to a big picture issue what do you think the real pleading standard is in this case i'm not sure i understand your question you're you know if you try to put together either the pre affordable care after affordable care version the statute it seems to me at some odd combination way and enough facts to overcome the public disclosure when you think about that i think that that is i think in the priest certainly the prepackaged statute i think that's right i think there may be an argument post to pocket whether the last of those is  a requirement of the of the pleading or whether it's something that is raised on a motion to dismiss after the pleading is file but i think i think that's generally right your honor and of course all of that's with the overlay of and there are separate requirements but there's also the overlay of rule nine b of course which applies to false claims act because it's a basically a fraud claim and what you what you have here i think is i was trying to get around nine b twelve b and all of the alphabet soup of stuff going on the what the misrepresentation was and and a connection to somehow that that produces the false claims and some indication that this was not already publicly disclosed and as i said certainly in the prepackaged world i think that's a a pleading requirement and in this case what we where we where dr policy runs afoul of the pleading standard is obviously in the public disclosure area  there's no dispute that all of the allegations of the complaint had been publicly disclosed so then again as as i said a moment ago you get down to original source as to i follow in particular dr palos has a real problem with the original source and paragraph twelve of his amended complaint he explains that he learned he got much of his knowledge from his work as a consultant for stryker and bragg and he makes clear a couple paragraphs later that  he never had that kind of a relationship with high flow he doesn't have any contention that he had any source of inside information or any non public's information about i flow he does not claim that he  personally was that i feel personally sold to him personally made any representations to him about f d a approval or the safety of the device or anything like that and in fact if you i look at there's a complaint that we've reproduced in the defendant's appendix it's the role of complaint and on the page number handy but it starts it actually starts at the end of volume one and carries over to volume two of the defendants appendix paragraph after paragraph from that complaint are verbatim virtually in dr paul of complaint so we see the source of his knowledge concerning i flow it came from from it's not direct an independent knowledge at all he does and he doesn't even claim that he ever used an page forty eight points out that he actually learned that working as an expert witness in connection with product liability litigation again clearly not direct an independent knowledge so the in another thing i would note for the court if you look at his original complaint he's got a section about i flow and then at appendix his appendix pages sixty one to sixty four he lists a whole bunch of documents that are the source of his knowledge for that for those allegations it's all discovery materials from these product liability and other lawsuits against you go to the amended complaint after we filed the motion to dismiss on public disclosure grounds and the all the allegations are the same but the supporting documents have been deleted from the amended complaint because obviously he recognized the problem that that identifying those sources created for him as a as an original source matter so the bottom line i think with respect to i flow is that dr paulo's does not have direct an independent knowledge of either the true state of facts or the alleged misrepresentations by i flow as i said he does not claim that that he was the recipient of any eyeful of sales pi alludes generally in paragraph one twenty four i think it is his complaint he says he saw presentations to nurses and clinic employees but that's all he says he doesn't say there was anything was said about f d a approval anything was said about safety anything was said about using it in the joint it's just this bald allegation with nothing more that is not direct an independent knowledge of anything relevant to his claims if i still have time but i don't want to burden the court if the court has no questions i will sit down although i do believe that the pleading could certainly have been more artful with regard to i flow and the allegations with regard to what he knew about high flow he had seen these pumps in action and he'd seen what happens to patients there's a quotation that's in the briefing about all knowledge is inferential when he worked when when dr paulose worked with dr beck trying to put this together as a study and i  don't know what level of expertise the court might have with regard to medical studies i was a registered just for a therapist and i've worked on them you work together as a group and and information is shared essentially what the defendants want and i think this is would be terrible policy they want an original source in public disclosure bar that essentially means that if you are not a coconspirator you don't you don't qualify if you weren't in on the decision defraud the government and help apply that decision then you're not an original source i think from a public policy point of view that's a really bad idea in this situation dr paulose had patients that he had that he made the repairs on that he actually did the joint surgery on i don't think that's in the record and you know it should have been we we put this together to put the briefing in front of the district court we believed we had pleaded all of the elements necessary to establish the original source we put the affidavit in for the purpose of buttressing that it could have been a lot longer our pleadings could have been a lot longer and yes they could have been more detail but the key element as far as i'm concerned with regard to the fraud is they weren't doctors were not told these were not approved for use in the joint space they were market is being approved in the joint space and that is the common element to all of these cases all seventy seven of those people who were listed that that is a common element with regard to each one of those i do believe it could have been more artfully plated you know in hindsight there are a lot of things you would do differently in a case like this but did die would your do you believe your complaint against either of the defendants here as a lamb some representative examples of you know situations to support your claim i believe certainly with respect to stryker i think it's less so with regard to i flow and i think some of the gentleman's criticisms are accurate told them is you know if you guys decide to do these pain pumps you need to test them you need to do animal studies first so that you can get f d a approval for them and then he would off to do other things and they would about the process of making these pumps whe all started to show up he went back to the stryker reps that he worked with because he has actually done a design did number of products that stryker continues to sell and he would have been he said you know these things are hurt people you need to fix this that certainly has not ever been publicly disclosed but certainly with respect to that he's an original source solent certainly with respect to the patients that he repaired that is an original source i don't believe we've pleaded that any of those patients were medicare or tri care patients but i do believe that he certainly pleaded that with regard to stryker and i think that again when the rule with regard to  plain statement supposed to be notice pleading with the exception of the allegations of fraud allegations of a original source or not allegations of fraud we do not have to plead that at the at the ten foot level we can plead those from five thousand feet and i think we've done that and if that's how this court you know if they think the court is true to the standard of review with regard to rule rules eight twelve and and nine d and particularly with regard to this really unusual statute that has been so badly i mean it every court has had trouble with this original source and and public disclosure and that's my congress amended it and that's why you should apply the admitted status because i think it shows