united states supreme court including the worth versus selling case that everyone cites the phillips case that this case with this court has issued and numerous other cases say that when you're talking about article three constitutional standing the merits don't matter you're looking at an allegation of fact a generalized allegation of an injury sufficient to suggest that the party has standing what was the injury  very good question a lot of the injury is entirely financial we paid for drugs that were in our allegations supported by abundant detail in this complaint which judge kessler recognized inferior and they were inferior in this case because they were not as touted they were no doubt what they were not as they had been touted to be judge kessler said you had to allege that they were either on a ineffective or unsafe and didn't find that you had allegations that rose to that level in order for you to show that they were worth worse less than they should have been two immediate responses that your honor first in our pleadings we allege specifically that is a factual matter which at the pleading stage the trial court was required to was accept this true we said these drugs are inferior because they are ineffective compared to the standard of care but they cost much more that was true for both  would expect would be your question is how does that injury take us away from the paradigm that you set forth in the mail with opinion and mayo that of course everyone cites in this case and it's quite simple the injury in mayo which the court found insufficien grandstanding was that the party in interest said we paid for an h m o we paid for a plan that is now informed by corporate policies that disincentive buys doctors to deliver quality health care in the court pointed out well that may be true but you are claiming a present financial injury for a harm that has not yet resulted we don't have that paradigm we actually have comparatives and we have specific the actual evidence in the complaint from the defendant's own records that say this stuff either doesn't work any better than the standard of care and in some cases it's dangerous our complaint is so full of relevant detail that gets this case into the land of possibility merely possibility do we have the defendant's own documents saying things like the following we are getting reports of neutropenia from the use of this drug and what that is is a white blood cell disorder that is potentially essence i'm going to answer it yet rhonda we purchased prescriptions for two of our members for a drug called rabbit tron revetment isn't in trying a franchise drug and it's important not to lose sight of what this court  held in phillips that what is important is context and judge chessplayers opinion gives no credence to the context of this case which is a corporate defendant that pled guilty to lying to the united states government about the extent of its impermissible marketing paid fines of four hundred thirty five million dollars in criminal penalties in civil pines and subjected itself to a corporate integrity agreement for wrong doing that the government was able to recover money for you know congress didn't provide a private right of action for violation of the f t c i know you're honestly you're arguing unjust enrichment and torsos interference with contract just because there is not a private right of action for off label marketing doesn't mean we the only people who have standing to bring our claims because we are the only people who paid this money can't make out a cause of action to seek to recover it not to judge judge kessler said off label marketing isn't the same as much as showing that the products were ineffective or arms and accepting that argue end internally believed according to their own documents and according to the office of inspector general that temodar claims that it crossed the blood brain barrier which was a huge competitive advantage if it were true was believe men did complain allege that local three thirty one paid for temodar no it is not your honor but there it does not now right to the horns of what i believe the trial court called the dilemma and that is how close a connection a red light is on so you have standing and injury suffice it to pleading stage we alleged more than enough in this case in this context to get us to discovery and its philip said we need only show anough to suggest that discovery would produce causation it's very simple your honor there was a shearing paid nurse placed in the liver disease specialists we have been able to identify or because we've gotten no discovery her name is diana her last initial is s she has signed the treatment records she called my client in she taught her how to inject the medications she made sure she paid for them she made sure she stayed on the medications it's as direct as could happen my fear is what happened in this case with the m d he decided when he talked to mrs montgomery when she was getting married and wanted to have children that she should not take these medications because it was contra indicated the medications actually cause her to have birth defects two years later she was called back in on september nineteenth two thousand and one that same day diane ass was in the office that same day diana's sent her out for tech protests unnecessary tests my client had to pay two hundred dollars to six hundred dollars we don't have the  causation correct so we're in the middle prom here trying to show the lines to the un to level marketing and sales and i submit in the record your honor you've got a line by judge sesar he says that dr willis changed his plan for mrs montgomery this is the opinion pa thirteen and that he took an asymptomatic patient and gave her these drugs are allegation that he was subjected to the marketing sales scheme this allegation would be if supported from the critical link between the evert harm and the complaint of conduct then he goes on to say that equally reasonable inferences such as dr willis may have come to such an understanding from his own correct or incorrect reading of available medical literature the compendium of discussions with other medical professionals none of that's in the record that was in shearing's brief appendix six ninety one where they opined that it could have been the result of all these other things just greenberg i want to co opt your question what happens when you remand this case we'll ask those questions what was the doctor thinking at the time and why don't we ask this diane asked this mysterious person whom sharon has yet to say is not their employee they reach so deeply into the record here to pull medical records out to try to say that mrs montgomery should have known a lot more i respectfully submit to you when you go to your doctor and you're sitting there waiting for the doctor to come in you don't know what's happening in the next room when the drug representative is talking to the doctor that happened here we've alleged quite clearly that there was a sharing paid c nurse and i want to spend a little bit of time on the record because it's wholly ignored by judge shuster in terms of traceability if you go to our under seal volume and you begin with just what the relator said now these are three former employees of the company who had personal knowledge of what they were saying in their allegations which are part of the key to the criminal prosecution the resolution by the company at appendix thirteen thirty one they say patient care consultants were in house defendant nurses that the sales representatives directed to physician offices there were approximately thirty to thirty five of them carrying over it says p c c he's attended sales meetings gave input and worked with the sales force to maximize cells at targeted accounts their job was not to act like nurses in the best interest of patients it was to sell drugs for off label purposes the record is crystal clear from one nine hundred ninety nine to two thousand and one mrs montgomery was a symptomatic she had no evidence of compensated liver disease for which the drugs were proved she was given an option cocktail of not one but two drugs judge sesar i think misapprehend that reba tall is the one that had the facts that could have caused birth defects in both situations the judge was or the doctor was very concerned about reba tall and said that she was contraindicated both times but the key here is she was given a cocktail for something she shouldn't have gotten and that's what's offensive  against the company for placing a sales representative under the auspices of the doctor and if i may complete you go to the next step one of the companies say in the documents that we put in the record they have a training protocol in appendix thirteen eighty four and it says  what am i going to talk to my doctors of patent promoting these therapies on page thirty five what is a patient care consultant the doctor asks the rebel says back they're part of the sales team and they will pull the patient's records pull the patient's records to identify patients for the therapies that i submit is a hip of violation the patients never called about that the drug reps are given the access to the records to identify patients now what did we put in the record that we know about our particular client and the traceability at appendix beginning with the medical records on thirteen sixty one in one thousand nine hundred nine we have the record saying that she was asymptomatic if you begin with the progress notes of september of two thousand and one at page thirteen sixty nine when the dr willis changes his mind and recommends the combination therapy he says this combination has not been completely approved as yet i likely to be approved soon in other words it's off label he says it right there in black and white he never tells our client it's off label he never tells our client that that same doctor you know you traceability has to go back to sherry absolutely your honor now where does that line come from we've alleged that came from sharon's marketing sales promotion that record i just read from september nineteenth two thousand and one if you turn to pages in the record you'll see i'm sorry it's at thirteen seventy four you will see the signature of diana s the patient care consultant she wrote to my client on the exact same day she ordered a blood test she says your physician has ordered a blood test please go get it you'll have to pay for it yourself she writes on there that she called the patient and spoke to her directly now what's really troubling about this case is if you look at that record in the next record from a few months later where she sends the actual prescriptions to my client she is using the liver in disease specialist letterhead she is it's fast the tensest to have a sharing representative i acting as a nurse for the doctor but this is not been false pretenses it's about consumer fraud your honor and if i may our claims are put before you that this nurse paid by sharing using the letterhead of the of the practice writing to my client this nurse actually brought her in prescribed the medications taught her how to inject made sure she stayed on the therapy  for two weeks it's not a personal injury case in fairness it's an economic case but it's an economic case against a company that's promoting unnecessary medications that's the problem and i finished by just citing the cases your honor that the talk about how you would of standing specifically injury and traceability let me start by saying that the matter before this court is vastly more simple than what chess chesler decided at the just a court level and the reason for that is that only one  four third party payer plaintiffs brought this appeal the only one that is before this court is local three three one fund and i believe the court correctly has pointed out their allegations are very limited they allege that they paid for two prescriptions of a drug called the riba toll and that's really about it there's no allegations in the complaint that the reboots all that was for scribe for their members proved unsafe there are no allegations in the complaint that the prescriptions for proved ineffective for their members there's no allegation in the complaint that the doctors the specific doctors who prescribed those drugs were somehow misled by shearing plough through some false or misleading statements there's no allegations that those doctors whoever they might be were somehow induced to prescribe this drug through a bribe or some sort of improper remuneration the only allegation is a conclusion re one that the prescription was quote off label without any sort of backup or any sort of facts to substantiate that conclusion which one would think would at least include the indication for which the drug was actually prescribed but as we know from a recent supreme court jurisprudence conclusory allegations like this are not enough if we step take a step back from the allegations of local three three one and read through the complaint the court will read in vain for any even general allegations of any materiality with regard to re paid for that drug it's neither here nor there there were allegations in the complaint about another drug called in tron a that again these are not issues that are pertinent to this particular third party payer point if you that's not enough if that's enough that it suggests that any insurance company any health maintenance organization or any consumer that paid for the purchase price of rebuttal has a right to sue them in that that appeal on a certification of a class said there was no standing because there was no allegations that the drugs purchased by the plaintiffs proved unsafe or ineffective so i think this is a standing issue as recognized  fifth circuit but i agree with your honor that the eleventh circuit in the ironworkers case in an opinion that relied heavily on the opinion by judge chesler below dismissed on a twelve b sixteen hundred essentially applying the same sort of analysis so i think that is that is correct i want to emphasize a couple more things with regard to the third party payer complaint first of all the court can read the complaint at length and the allegations about rebuttal even those allegations that are what the third party player plaintiff here paid for it did not involve what mr montgomery paid for either which was a combination of ripa tall and another drug called paikin tron which was given to her as a combination therapy so that's what w left with we're left with the bare allegation that this third party payer plaintiff paid for two scripts of revit toll period and as judge chester correctly help that is simply not enough to establish the necessary elements of article three standing to even open the have been sold off like well it's not injury unless you don't get what you're paying for as i think judge greenberg and recognized in the mayo opinion involving case of insurance  simply being sold a drug off label doesn't really tell you that much as we've cited in our brief off label prescriptions are permitted by doctors supreme court united states is recognize that in certain instances that's the standard of  care with regard to certain kinds of diseases so the mere allegation that was was private off label use conclusory as it is in this complaint with this plaintiff would not be enough to show injury that's why the court why the presidents have told us you need to ask is it unsafe is it ineffective why do you like it that's what supplies the injury why aren't the allegations of ms montgomery adequate you referred to the iron workers case where the court said the purchased drugs must have been either on safe or ineffective for the prescribe use i e the prescription needs to have been medically unnecessary or inappropriate according to sound medical practice and when i listen to counsel from his newcomer that's what he seems to be saying he alleged in the amended complaint he does allege that and i recognize the judge  found that the complaint sufficed the state injury in fact and i think that analysis there is a traceability one and i want to spend most of my time on that but the answer on his question i don't think there is injury here really for two reasons one the drug was effect and we put in the additional excerpts from the medical records that show that after treatment appetite a c was undetectible in this plaintiff's bloodstream which means it's been eradicated so it was ability or causation on the twelve the six analysis requires something more than speculation and suspicion which is what it sums up that is the allegation by this plaintiff is that there was stated as a quote belief that's in paragraph ten of the mongery complaint a belief that sharing had a nurse on its employ on its payroll that was in the physician's office that was administering the treatment but  what is it that that nurse that license practical nurse was alleged to have done the only thing that license practical nurse was alleged to have done is that which license practical nurses normally do help train a patient to give injections herself of the drug that's being prescribed even during mr have ones argument a few minutes ago that's what it sums up to what is missing is any allegation that this nurse somehow supplied false statements misleading statements misled this doctor and prescribing the drug war somehow supplied some inappropriate payment that subverted the physicians judgment that there are no allegations of fact that all in the complaint addressing that and that is why that theory fails additionally the belief is mere speculation nothing more that this was a shearing paid nurse it's based upon nothing more than the fact that on the letterhead of the medical practice this person's name is not listed but if you look at the letterhead what it lists or end these doctors and physicians and you know and and and the nurses the professional nurses that are diploma and a couple years of training to become a license practical nurse you're not entitled to treat patients you nine title to prescribe medicine so that's that's all it's based upon the at the rest of the stay accusation arises from the theory that there was a change in miss montgomery's treatment plan and that must have been due to some funny business by sharing plan again that's based upon speculation and suspicion and nothing more the medical records and these are actually quoted in the complaint and these are attached to the complaint tell a much more reasonable inference a much more reasonable explanation much more likely explanation than that and the explanation which is alluded to by mr havilland is that rebuttal one of the components is contra indicated  for women who may become pregnant wife because it may cause birth defects when she initially consulted with her doctor in one thousand nine hundred nine she said i'm about to get married with thinking about having kids so the doctor says you know let's not go forward with the treatment now she comes back two years later and in the september one thousand two thousand and one document that's attached i think is exhibit b to the complaint she tells the doctor well i've not been able to conceive a child so now i'm reconsidering my treatment options that is the likely explanation as to why that person the therapy proceeded in two thousand and one where is it not in one thousand nine hundred nine and it comes right out of the complaint and right out of the exhibits the complaint you know under the current system  the nails in the coffin of the old conley versus gibson test which by the way is explicitly relied upon by miss montgomery in a brief on page twenty three of her brief as i recall there's no question that that is not the standard anymore and those sorts of facts are not played here we need to strip away the conclusory allegations look at the allegations of fact and then ask whether that creates a plausible claim for relief and also consider whether there's more likely explanations and as the supreme court taught us and it ball judges also need to use their common sense and good judgment entered into this and that's exactly what judge chesley did here finally i'll just close by saying that obviously while these are presently just individual suits they're punitive for would be class actions the plaintiffs have sought to bring a very large controversy in the federal court in new jersey teaches that we should take a look at these cases with the with no no no no longer no hunger your honor that's that's certainly true and i would close by noting that these plaintiffs have had multiple opportunities to get it right in their complaint the complaints before this court or actually the fourth  through there were two complaints before judge kessler in his two thousand and nine opinion dismissed them without prejudice and he dismissed the third complain at that point and he gave a very long well written opinion that explained exactly what they needed to plead and ball are ill suited to the application in the constitutional standard context we simply note the twamley nichol deal with fundamentally different issues than the jurisdictional question that judge greenberg you just addressed this court has repeatedly said in the issue of the ca causation in the ballantine decision cited by just chester and then in the recent in re insurance brokerage case they were not required to prove injuries at this point judge just there your honor when when he says that we haven't had that connection he said we needed to demonstrate our injuries i submit to you we don't the so the injuries are not the issue with respect to ms mcgregory but the traceability is and where is their evidence that fraud perpetrated on dr the treatment regimen she was that's were i think we lost we lost touch with judge just and we did not have a hearing on these issues we weren't able to have this dialogue or having it here we have a sharing nurse right there sharing interjected a number record saying that look at all these different records look at the fact that the sharing paid nurses having direct interactions is actually calling the patient in that the doctor is there in the actual medication record you see the doctor stamped signature but it's diana s's actual signature she's regulating and if you go back and look at what the relator said that's exactly what sharing intended to have these nurses paid by the company going to facilitate treatment but in fact to promote medications paid nurse as we sit here today that's the status of the record judge greenberg the last point if i may is if you just remember back we get to ask those questions of dr willis diana as we get to find out who these thirty five nurses were where were they station and who are they bringing in to promote these drugs it's not the doctors it's cierra thank you thank you thank you