has until june to make a ruling in this case. >> we will hear argument this morning in the food and drug administration versus alliance for hippocratic medicine and the nsidated case. >> may it please the court, fda approved mifepriston placed on the agency's scientific judgment that the dru is safe and effective. it has maiaid that judgment across five presidential administrationsndillions of americans have used mifepristone to safely end there pregnancies. at the outset, rpoents lack standing. they cnorely on a statistical theory of injury likeheower courts did.

instead, they have to identify specific doctor who faces imne harm but their theories rest on a longchain of remote contingencies. only an exceptnay small number of women suffer the kinds of seriousomtitions that could trigger any need for emergency treatment. it ispulative that any would seek care from the two doctors and evenf at happened, federal cautions protections would guard against e injuries. and eris no basis to conclude that any of that woul be traceable to the incremental changes that the fda made in 2016 and 2021 as to the availability of mifepristone in gera

they are too attenuated as a matter of law and the court should say so and put an endo this case. if the court reaches the merits that thedaas lawful the agency relied on dozens of studies including te o thousands of women. they do not identify any evidcehat the agency overlooked and they just disagree with the analisf the data, but that does not provide an office -- a license to authorize second-guessing. finally on the remedy, the rease entered below would severely disrupt the federal system f deloping and improving drugs harming the agency and pharmaceuca industry and inflict great harm on women across the nation. rolling back these changes would unnecessarily restrict access with no justification. some women could be forced to undergsuical abortions and others might not be able to access the drug at all and all ts would happen at the request of plaintiff's o ve no certain injury of their own. the court should reject that profoundly inequitable result. i welcome queson justice thomas: if we agree with you on the standing could you give us an example of who would vetanding to challenge these fda actions? as a general matter we have en lawsuits brought by for example prescribing physicians or patients who want greater access. sometimes we have seen theorie of competitor standing where mpeting drug manufacturer

might sue and claim that the fda approval creates a competitive harm or injury in that sense. justice thomas, if the question is whether there would be individuals whopse abortion who would have standing and went to challenge the actions the answer is no. the reons because those people are not regulated in any relevant way under the fda here. theyo t prescribe or take mifepristone. the fda is not requiring them to refrain from doing anything, they are not required to treat women who take mifepristone, and the fda is not requiring that they seek out scare from these specific doctors so they stand at a deficit -- at a distance fr t action they are challenging and the court said in many cases atn a siation like that when you are not the direct object of regulation it can be more difficult to establish standing.

justice thomas: isn't that a criticism of some of our association and standing cases and organitial standing cases? >> i do not think it is. with respect to associational standingth court has said that the association needs to identify a specific member suffering a concrete harm and an injury that isoneculative. i do not take issue with that fact, they are agreeing it would be necessary to identify a specific doctor. e problem with the associational standing theory is that it rests on this chain of remote possibility with so many steps in the process that would have to occur laying one speculative remote odds of an of injury across another to get to the ultimate harm on belf of these doctors. you associate the remote nature and it affects the likelihat these patients

will go to the emergency room and so on. is there a number of which your argument would change, the significant number of consequences, higher likelihood of an emergency room visit, doctors who spend more time in the emergency room, at some point does this analysis lead to thother result? ms. prelogar: it is hard to imagine that it could for a couple of different reasons. i take the point you will pick out different links and suggest that there are ways to depart and say that maybe has a specif mter one or two could be more likely to occur. but we have an objection to the unrlying theory has a legal matter because it rests on so many different things that would happen one on top ofnoer and turn on independent decisions made by third parties who are strangers d t part of the suit. that brings the case like

klper or summers where the court has recognizedhawhen the theory of injury turns on many intervening events separated by independent decionit could mean that there is an insurmountable hurdle to establishing standing. >> could you provide a more specific answer to the first question that justice thomas asked you, is there anybody who lawfulness of what the fda did? ms. prelogar: in this case i thk the answer was no. justice kavanaugh: is ther anybody that could do that? let us start with the states that intervened. will you say that in that litigation fine, you can allenge it and let us get the merits of this issue and what the lawfulness of e a did? ms. prelogar: the states lacked stanngthey are asserting indirect injuries and could result in the at always suing the united states government.

justice kavanaugh: how about a doctor who opposes abortion, he is odu when a woman who comes in with complications from taken mifeisne, and the doctor is the only one on duty who can attend to e man's problem and as a result in order to save her life she has to abort thvile fetus. with that doctor then have standing to seek injunctive li? or would you say this is too speculative. this is like being struck by lightning and it is not sufficiently lelthat this will happen to this doctor again? msprogar: that would represent past harm and we are t disputing that conscious violation would be cognibl we think that situation has never come to pass and respondents have not intied an incident in more than 20 years that mifepristone has been available that resembles that situation. so our view wod it is unduly speculative. you have to think about the events tt uld have to transpire. juicalito: how about a woman

who suffers adverse consequences om having taken mifepristone, would she sue for damas would you say that is barred by sovereign immunity ms. prelogar: i expect that we would have those arguments and i recognize that with respect to aceability that is harder for us. justice alito: is there anybody who can so and get a judicial ruling on what the fda d w lawful. and maybe what they did was perfectly lawful, but shouldn' somebody be able to challenge th icourt and who? who would have standing to bri e suit? ms. prelogar: with respe t these regulatoryhaes it is hard to argue that anyone has standing but the court has said that the fact that no one would have standing does not have a basis to depart from article three principles, so i think it is clear that even if there is

no alternative person who could sue, that does not mean that the court should dispense with the requirements of article three. justice alito article three is important. your argument that it esot matter if the a agrantly violated the law it did not do what it shave done and endanger the health of women it is too bad that nobody can sue in court? there is no remedy, the american people have no remedy. ms. prelogar: i think it would bero to suggest that if the fda had made a mistake and a drug was producing safety consequences that there is noing to be done. i do not think these respondents could invokertle three to have the court step in. the fda takes seriously its responsibility to ensure the safety of drugs and conducts ongoing surveillcend can make adjustments as safety situations emerge. drug sponsors remain responsible at all times and we have a court syst tt can ensure that there -- that if there aren't safety problems the sponso

will take action. if the premise is th uafe drugs could remain on the market, that is incorrect. >> your ar here and as i said, i have great respect for artiree d we all do we have to comply with it. your argument is that even if e fda acted unlawfully, nobody can challenge that in court, and that is basically the nt you made last week, we should not get to the qn whher the white house and others violated the right to freedom of speech ashould say that these plaintiffs cannot bring suit? ms. prelog: are looking at the specific respondents and we do not think they co100 miles of the circumstances this

court has identified of nonspeculative harm that can create the injuries for forward-looking relief. >> i am assuming that if there were -- if this had been unsafe in a grossly visible way, you know, 40 perce me increased hospitalizations that some doctor would've cllged the lack of an in person? ms. prelogar: no doctor is required to dispense other things. justice sotomayor: but ty nt to, but we have said if they are regulations that stop themro doing it, i guess that dr. could come in and say this is unsa by not having people visit me beforehand, we are not warning them and etc. ms. prelogar: certainly those kinds of distinct safety concerns emerge there are steps the agency level. there is nothing like that here. justice sotomar: am conjuring a hypothetical. ms. elar: the fda regulations do not require doctors to not grant an in person visit. they think that is the best way to provide a standard of care. they are not directly reir to dispense mifepristone through a critical arrangement. >> can i ask you a question about the roadblocks that you identified in chn because you said a doctor could invoke conscious protection to refuse to complete an abortion whenhe

embryo or fetus was still alive. so i want to be clear, the fegovement's position is that the doctor what have conscious objections but it is your position that such doctors would have recourse for the protections of federal law? ms. prelogar: let me be clear because i think that the circu misunderstood the arguments and respondents haeated that misunderstanding. we never thought that this would override conscious objections. he said the opposite. if you look at the texas tigation we disclaimed that understanding and made clear that we understand that conscious detection should continue to apy d shield a doctor w ds not want to provide care. >> with th btrue in a health-care desert haswell? ms. prelogar: we do nothk it would override conscious otections and imposes obligations on hospitalsnd hospitals have plans in place to

address these ntgencies. they have staffing plans and it is a matter of best practice and they often asked for doctors to articulate the objections in advance so they can ta aount of that. they have cross staffing agreements and in the government's experience, almost urecades we are not aware of any situation where there has been that kind of direct conflict. >> one last question about the association standing. its own standing and its own

ghthat is based on injury to one of its members. so, the injuries that the associatn arguing found in the associational standing and they are the kind of allocations that we sedvocacy groups, increased expenses, that results from t cplications of having to address and explain the new chge am not talking about expenses of filing the petition. let us just talk about resources. can you distinguish that? ms. prelogar: i think havens was trying to distinguh tween two types of organizational injuries and they said in that case the organization had come foarwith direct and concrete injury to itself and they had contract to provide low income housing or search to secure it for clients and the practices directly interfered with that anmade it more difficult for the organization to carry out its litions but haven said it was not in a standing that would allothorganization to describe a setback. that is the court yi to distinguish between demonstrable

harm and that kind of abra setback on the other hand. i recognize and your question touches on it that some lower courts have seemed to read it as r broader standings. the government has been resiinstanding because that would essentially mean that any advocyrganization could say it opposes what the federal governments ing and therefore has to devote resources to the oppositio if that were enoury organization would have standing and it would be an expansion of ordinary article three ciples. we would welcome an eventual clarification on organizl standing, but i think the assertion of injury falls into the bucket of the abstract setback and does not come close the demonstrable harm that was the issue in haven. t is a helpful

clarification. on a similar clarification. thank you. with respect to individuals, i have heard and listen to your argument a rd the briefs and i think i understand it. how est fit in your mind with offended observers standing dethe establishment cause or some injuries about -- i accs a park and i le look at it in a certain way, and those kind of injuries at the court has sometimeregnized and sometimes cast doubt on. ms. prelogar: there are diffenstrands of precedent ani uld put the establishmentprecedent and first amendment in its own bucket. the court has recognized different theories. justice gorsuch: standing is standing at it is article three. we have to find some way to stitch it geer and i am lookg r guidance from you. >> i think the way to approach this is if you are going to recognize an offense or stress

injury to recognized -- noi represent the governnto i think that kind tory of injury would go far too much in the direction of allowing article threcots to weigh in pastoneneralized grievances. to distinguish the acacias -- the cases, generally it ia situation where there is a direct governmenl tion producing that type of injury. here the argument is that the fda actions in approving mifepristone in 2016 and 2021, it is so far upstream of thenge, downstream assertion of harm th respondents are asserting that as a matter of law and a ated link that cannot suffice for article three. >> you. justice alito? justice alito: you said that the xth circuit did not give any reason to think that the changes would be more dangerous in combination than individually, but isn't that obvious that three things that might be

innocuous or not excessively dangerous if engaged iby themselves might become very dangerous when they are all done together? and whshldn't the fda have address that? ms. prelogar: the only way that wod true is if the three changes are interconnected and mutually reiorng, guarding against the same kind of risk. if there was reason to think that theean why mifepristone is up to safe up to 10 weeks is beuse it is being prescribed by doctors instead of nurse practitioners then those changes would be interconnecd cause one change would be the safety net for another. there is nothi le that. the studies at the fda examined demonsat with an exhaustive examination that the changes were safe not because there were otr feguards to guard against risk because if you go up to 10 weeks there is no observable increase indvse events no matter who is prescribing. in the absence of that effect of the chans not think you can

fault the agency for not givg more explicit attention to this issue and it did. cited multiple studies i combined in multiple cng because a standard of care had evolveov the 15 years it had been approved and nyf the changes were being deployed together safely. justice alit suldn't the fda considered the application of the comstock provisions? ms. prelogar: i think it does not fall under that lane. the fda can maintain strictions if it is necessary to ensure safe use. in 2020 one what they determined it is that you do not need in person dispensing so the ftca dinot require that restriction and it could not be imposed. the fda was not approving, mailing in violation of comstock even if u terpret that and we do not think it means what the respondents suggested means. but d't not it was the fda's responsibility to consider that. justice alito: it did not say anhing about it and this is a prominent provision. it is not some obscure

subsection of a colited obscure law. they knew about it, everybody in the field knew about it, shl't they address it. you have answers to the guments made on the others, should the fda said we he considered that and provide some sort of an explanation? ms. prelogar: let me give two responses, it would not have been permissible for the fda to consider maintaining that stction because of comstock. if you look at the relative atutory conception, this is reproduced on page 6a, the only inthe fda can take into account for restrictions are safety and efficacy concerns in deciding to maintain pgram. the other thing i would say is that the agency did have a memorandum on comstock at ja535, ich is the advice conveying the interpretation. justice alito: they got the advice but it did not refeto that? ms. prelogar: in the 2021 decision, no, but it was modified in 2023 and this is part of the administrative record for tt.

justicalo: the plaintiffs to say that the studies that they li on said that mail order mifepristone suggests more frequent trips to the emergency room. now, this is what i see as the fda's spse. "althoh e literature suggests that there might be more frequent emergency room care visits related to the use ofifepristone when dispensed by mail, there are no impairment increases and other serious adverse events related to mifepristone use." does that real cnt as an explanation to the suggestion that the da ows that there argog to be more emergency room visits? this is the increase of emergency room visits are of no consequence and it does not merit some cmes? ms. prelog: at is a reasoned explanation of what they were observing. althght acknowledged that some of the studies reported

additional visits, did not equate to additional serious adverse events. one of t sdies, half the women who went to the emergency room did not g tatment. many might go because they are experiencingea bleeding which mimics a miscarriage and they need to know whether or not theyreaving a complication. in that circumstance the woman is not having a serious adverse event from mifeprion which does not call into account the safety determinations. the fda parsed those studies and it made specific determinations about the results with respect to safety and efficacy. it fully explained its decision-making and falls well into the zone of reasonableness. justice sotomayor: on the last question t rlity is even if there is some increase in emergency room visits, the question of when that rises to sufficient safety risk is up to the fda, correct? ms. prelogar: that is right and thfda acknowledges this. it did not overlook it. i want to emphasize that the studies were far from the only evidence that the fda consulted. athe time it acted it had real-world experience during the covid-19 pandemic, piod of time when the in person

dispensing requirement was not enforced and the fda started by looking at cparative analysis the two periods when you d person dispensing and enou did not and saw that there was no serious increase of adverse event -- events or the difference. justice sotomayor: the pro is that there are complications in virtually all of them. at what level the cost benefit analysis tells you to stop prescribing something is a very diffulquestion, isn't it? ms. prelogar: that is a question entrusted to the fda. ste sotomayor: whatever the increase was, lee fda determin der the standard that it was not sufficient to create a risk that counterbalanced t nd for access, correct? ms. prelogar: because the fda is instructed to ta io account burdens on the health care system as well and looked at a variety of src to conclude that the burden suggested that it was not necessary to keep this rtrtion in place to ensure safe use. justice kagan: if i could ta you back to the discussion with juicbarrett about the conscious objection and i'su that you have read the dearations carefully and i am sure that ms. holly will he things to say about this. as you read those dearions, what is the conscious objection? what are the doctors objecting to exactly? ms. prelogar: i think the declarations are specific. there are only senoctors who

regularly practice and submitted evidencendhey are relatively short. thissj150-200 because there are only two who provide any information about their specific objections. those are dr. scope and francis. the otherso t provide specific detail about exactly what care uld violate their conscience. dr. francis is ja155 and the other at ja157. they object to ending the life in the womb. justice kagan: they do not object to providing whatever care is ney to a person o might have complications from taking mifepristonein other words supposed somebody has bled snicantly in need a transfusion or any of a number of other things that might happen, as you uand ere is not objection to that? ms. prelogar: i think the

fairest reading is that they are not objecting to that. i acknowledge that respondents suggesd at there is a broader conscious injury and there might be other doctors who have a broader concern about providing care, and ev ithat injury had been in this declaration we think as a matter of law it could not demonstrate that they have a nonspeculative injury in part because of all the thin that would have to happen in a woman going to the spif doctors and the fact that the adderall conscious protections are designed to deal with this issue and they wou cer the range of objections that exist. juickagan: there are obviously ones of all kinds and i was just asking about these particular decraons.

ms. prelogar: i think they have not asserted a broader injury, but even if they could come forward with other doctors or adsthe declaration still that would not suffice. justice kagan a quick question about the merits. you open your brief with the te meant, but with the statement and it starts thhe

governmen's knowledge and since then i am sure that you have had lots of time to think about this case and get all of the background information on it. i will read you the sentence a ask you whether it is still true.

to the government's knowledge. hicase marks the first time" and i'm going to say is athe first time or only time "any court has restricted access the fda's drug by second-guessing the safe use." ist still the only time? ms. prelogar: still to our knowledge, and we have seen a trend of courts overwriting fda's judgment to grant greater access ts. and whatever direction you, at it from we believe that the courts have no authority to make those kind of judgments.

justice kavanaugh: just confirm on the standing issue, under federal law no doctors can be forced against their conio is to perform or assist in an abortion, correct? ms. prelogar: we think that federal conscious ottions provide broad coverage and there are some triggering requirements on receiving federal funding. we cited the relevant provisions on page five. the church andnts have the most comprehensive instructions and eyuard against the kind of injury and there are state law protections that often apply. justice barrett: would that true if the declarations were interpreted that they regard any participation such as transfusion as after otherwise comptes tissue being removed? ms. prelogar: the most relevant church amendment provision is 42a-7d that said that doctors alnot be required to perform or assist in any part of the healtharprogram that would violate the doctors' religious or moral beliefshi are tied

to the nature of beliefs than procedures. justice barrett: this goes to the merits. as indstand it, the serious consequences that have to be ported or that the fda considers risks are deh d transfusion but it seems to me that the data bears it out that the elimination t in person dispensing requirement or visit at the outsewod lead to mistakes in gestational aging, which could increase the need for a dnc or the amount of bleeding but that does not count as an adverse event? ms. prelogar: there is a lisof serious events and i am not sure at i have all of them down to be able to recite them although they aren e record. i inthe premise is wrong the idea that they changed in pers

dispensing would increase the risk. th was not reflected in the data that the fda consulted and i would point you to a particular sectionn rticular where the fda explains that even in person yoarnot getting an ultrasound, that has never been required. the reva question might be is your provider is going to ask you a number of's straining questions and there is no reason why that difference would lead to different saftputs. justice barrett: i thought there was a small percentage increase about tracking which i might be wrong about that? ms. prelogar: i think that with respect to the er visits there we ireased four visits although as i explained that was not actually correlated with an increase in seouadverse events. i do not want to represent a of the different studies because they varied a little bit but the ultima cclusion was that mifepristone could be prescribed wiouin-person visits. there have been no contrary evidence introduced. juice barrett: there was no requirement of an ultrasound or detecting a fetal heart beats or anything le at even before

the doctor could go based on when the last mensuaperiod was. ms. prelogar: that dates back to the itl approval. it has not been required used to have an ultrasou. it is of course necessary for providers to diagnose and date gestational age which remains true. they still have to he at capability and deployed whatever meanisms they believe would accurately allow them to identify contraindications. t it is wrong to suggest that if the court was versus changes that every womanilget a note for sound. that has nereen the state of play. juste rrett: how even under th was it possible to detect an ectopic pregnancy unless the wos presenting with plane? ms. prelogar: there is a set of questions such as did you become

pregnant with an iud or afte tubal ligation. are you experiencing unusual bleedingr k if they have had a prior pregnancy. if the woman has that ki o risk factors imaging might be necessary but that remai te as well that the prescriber has to be confident that it has cled those kinds of conditions before prescribin the standard of care around the world, most medication abortion occurs without an ultrasound. justice jackson: good morning. i am worried that there is a significant mismatch in this case between the claimed injury and the remedy that is being soug and that that might or should matter for standing purp i do not know that the doctrines capture this. i guess i see it that the injuries that the respondents allege as you articulate them our conscience injury that they are forced to participate in a medical procedure that and so the obvious commonsense remedy would be to pvi them with an exemptio they do

not have to participate in this procedure. and you said several times that federalaalready gives him th. so i guess then wh ty are asking for in this lawsuit is more than that. they are saying because we object to having to be forced to paicate in this procedure we are seeking an order preventin anyone from having access to these drugs at all. and i guess i am trying to understand how they could poib be entitled to that alleged?e injury they have ms. prelogar: i agree and i ink it is relevant to standing. there is a mismatch twn the claimed injury and the remedy

they were seeking. you could think of this as a pe of zone of interest analysis. if the doctors have a conscious injury there are statutes designedo al with it specifically to guard against the injury occurring and instead they a rching out and inking rights under a different statute that does not regulateheat all or make them do or not do anything and the relief that they are seeking would dramatically alter the improved conditir use and affect women all around the nation simply because of ts injury already directly addressed. justice jackson: if it was not addressed the remedy would be to exempt them, right? ms. prelogar: one of the hard

ings about trying to tailor relief is they are assein such a diffuse theory so that the only option was to grant a nationwide remedy and it runs counter to ordinary principles of party specific relief. it shows that there is something wrong with the theory of injury in the first place becauset so attenuated and claim that they would need so much relief all over the country. justice jackson: in addition to thlenges that we have here, the respondents below challenge thinial decision to approve mifepristone in the ar000. of course, that occurred a long time ago and they said t challenge was not timely because of the statu olimitations. in the context of another case that this court isonnuing, the statute of limitations issue. setting aside standing, have you thought about how a ruling on the statute of limatns in either direction might impact what happens in these kinds of ses with these kinds of challenges? ms. prelogar: it just flts the stakes of the corner post

case and provis e most vivid example ofheay it would be possible if this court were to apovthe request for the broader series of the statute of mitions in the way it could open the door to plaintiffs saying i became a doctor later or started working in emergency room lat a would try to unsettle long-standing actions that occurred dede previously. i understand to suggest that there ghbe equitable defenses that the government could raise d would certainly want to raise that type of defense with the approval of mifepristone and has proven to be safe and effective. >> thank you counsel. please the court, in 2016 andit 2021, the fda made c changes to the labeling and use restrictions. the decision below stops them from selling it in line with that scientific judgment based on a highly attenuated claim that an unknown doctor clde called someday to an unknown emergency room after a series of decisions by thi-pty is. no facts link that possible future encounter to a specific chan tt the fda made in 2016

21. respondents view of the food drug and cosmetic act is so inflexiblet ll not only upend isut virtually every drug approval or modification that the fda has made for dedes. reversal is required for two reasons. article three standing is not an academic exercise and what is concvae. they lacked standing under every prong of the analysis. on the merits, fda exhaustively consider the evidence and exained its conclusions, which is what is required to d i welcome questions. justice thomas: the solicitor general points out it would not be susceptibleo comstock act problem. t your case, you would be. so how do you respond to an argument that mailing your product and advertisinitould violate the comstock act? ms. ellsworth: we agree with t

government that the fda's charge under the food, dr a cosmetic act is minted to looking atafy and that is true for new drug approvals and modifications. the fda routinely approves drugs that are resicd by other laws such as environmental laws, customs laws and son i think this court should think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory reonbilities that congress has assigned to other

agencies. on the merits, this issue is not ruled on below, and in any eve i would point out that in 2021, the decision allows the use of brick-and-mortar pharmacies in addition tma order. justice thomas: my problem is that you are private. the vement, i understand the government's argument. you are private and the statute does not have e rt of safe harbor that you are suggesting. and it is fairly bad and it specifically covers drugs such as yours. mselworth: your honor, we disagree that that is the correct interetion of the statute. we think in order to address the correct interpretation they would need to be a situation in which this situation is to do. thisasot been enforced for 100 years and i do not believe that this case presents an opportunity for the court to opine on the reach of the statute. >> counsel, wod like to ask you the same questions i was posing to the solicitor general. klapper and susan b. anthony talk about requiring a

substantial risk that harm will r. you argue that that is not present. how arupposed to find a spot at which the risk becomes substantial? ms. ellsworth: i think this court has always thought about the standing inquiries as a question of deee you are trying to evaluate whether something is actual and imminent or whether it is conjectural or hypothetical. and these terms, substantial risk and pending which has been used to dating back to 1923 that we are a claim falls in the sptrum. >> and we toss around a lo about details, but as a

practical matter, hodoou figure out? what percentage would be enough and what percentagofmergency room visits would be enough? ms. ellswoh: think it the way klapper got at this question is to really think about whether there is an attenuated chain and ntgencies that have to happen. in situations where there is this chain of circumstances involving third-party decisions that have to play out and hear the is quite long. ifputs a plaintiff's theory on the side of conjectural or hypothetical and not impending injury. how is your company aggrieved by the challenge that is brought his case? i gather that this is your version of mifepristone is the only produ are marketing? ms. ellsworth: that is correct. justice alito: the fifth circuit decision does not prohibit you from continuing to pdu and sell that product, correct?

ms. ellsworth: that is correct. justice alito: i gather your injury is that you think you will sell more ith restrictions that previously were in place were lifted. so you will make me ney. ms. ellsworth: the injury is that we e evented from selling our product in line with fda's scienticudgment about the safe use of the drug. justice alito and you will be harmed because he willell more? ms. ellsworth: a company's ability to market its product is how it consirshe revelatory scheme that governs it product. justice alito:urg the questioning of the solicitor general statement was madeha no course has ever previously second-guessed the fda's judgment about access to a drug, correct? it has never songuessed that. ms. ellsworth: that is correct justice alito: do you think the

fda is infallible? ms. ellsworth: we do not and we do not think that is t-eupn any way. justice alito has the fda ever created a drug and then pulled it after experience showed it had adverse consequences? ms. ellsworth: it has done that and i think that underscores why e adverse event reporting and the post-market surveillance and thability that these plaintiffs have, even if they do not have sndg, certainly if they are seeing patients presenting with advee ents and doing studies that show that there is some unknown saty component that the fda should acknowledge, they can take significant steps to bring that to the agency's attention and our attention. justice alito: do u ink that the fda should've continued reporting nonfatal consequences? ms. ellsworth: they decided not to in 2016 based on more than 15 years of a well established safety profile when that reporting was required. there is no drug on the market today under any rem that requires any reporting that the plaintiffs said should be reimposed. justice alito: one. be a bad thing? yodoot want to sell a product that causes harm to th people who take the product relying on your tests anth fda's tests, wouldn't you want that data?

ms. ellsworth: that data is certainly mething that we are looking for all the time. it is part of the poing obligations for a manufacturer to be awarofny data becoming available through any means. we have one 800 number and a one 800 number on the labeling. i thinth gets that concern that i have heard the early questioning on who would have standi ithese plaintiffs do not. drug manufacturers are varies frequently subject to to litigation, product liability suits and failure to warn suits, ceive advertising suits when someone is claiming harm froa product. what is so i thinkevutionary really about the arguments here both on standing and merit on

the way that they attempt by individuals who do not use this product and do not prescribe this product a he the conscious right not to treat anyone who has taken the produc ty want to prevent anyone else from using it in lineitfda's considered scientific judgment. justice alito: just one more point along sort of the same lines. does your company think what the fda has done preempts state laws that prohibit the dispensation of mifepristone within those borders? ms. ellsworth: we have not taken a stance on the issue. justice alito: what is your issue on it, and you have not thought about it? ms. ellsworth: there are lawsuits broughty e generic company that do make that

argument. and i think that is r ter courts to sort out. our position in this case has been that this is about fda scientific judgments reached in 2016 and 2021. justice alito: you do not want to answer? ms. ellsworth: we do not have a position prepared to say today. >> cldou go back to the questions about adverse event reporting and said you would subject your product to higher standards and now we are being brought down to the rela could you talk about that a little bit, what are the normal standards for adverse event reportg d why are they there?

what instead wreou subject to in the past? >> what changed was not danco's adverse evenrerting responsibility. it has been the same throughout this period. what change was from 2000 until 2016 prescribers were reported rort events to danco and then we had a separate obligation. in 2016 the rems we igned to be more consistent with the reportg quirement that applies to all 20,000 plus fda approv dgs. there are only today seven that continue to have even th limited higher adverse event reporting for debts then applied to mifepristone. it is only one of seven that have that. >> any further? ice rrett? justice jackson: you are asked if the agency is infallible and i guess i am wondering if you think that the courts have specialized scientific knowledge with respect to pharmaceuticals and as a company that has pharmaceuticals, you have

concerns about judges parsing mecal and scientific studies? ms. ellsworth: yes. i think he significant concerns and there are two amicus briefs from the pharmaceutical industry that expands on why exact tt is so concerning for pharmaceutical companies who depend on fda's gold standard vi process to approve their drugs and be able to selthr products in line with that considered judgment. justice jackson: can you say wh they say? ms. ellsworth: i am happy to. i think the reality is and this decision allow is a good example of a. you have a district court that among other in relied on one study that was an analysis of anonoublog posts. you have another set of studies ate relied on that were not in the administrative record and wod t be because they stdate the decisions. they have been retracted for a lack of scientificig and misleading presentations of data. those sorts of errors can in fact judicial analyses precisely because judges are not experts

in statistics or the methodogy used for scientific studies and clinical trials. that is why the fda has many hundreds of pages of analysis in the recordf at the scientific data showed and courts are not in a position to pae rough and second-guess that. >> thank you counsel. >> thank you. >> ms. hawley. >>hief justice and may it please the court. fda approved was not adequate. that violates the apa. the lower court's decision restored long-standing and

crucial protectis der which millions of women used abortion drugs. we havhed a lot this morning about standing. article three is satisfied because the fda reli o hospitals to care for women harmed by abortion drugs and concedes that twn 2.9 and 4.6% of women will end up in the emergency room and three theda acknowledges that women are more likely to need surgica intervention and other medical care without an in person visit. nearly 650,000om take mifepristone every single year. it is no surprise that respondents experienced an increase in emergency room visits and treated women suffering from abortion drug rmtens of thousands of times. -- dozens of times. women's have suffered tens of thousands ofim. the respondent doctors will be forced to manage harm is not a bug in the system but part of s sign.

ruling against respondents on standing will allow fedel agencies to constrict -- conscript nonregulated policies from suffering other harm without judicial recou article three neither demands nor permits this. the outsourcing of abortion drug responngo responsive doctors forces them to choose between a woman with a life threatening ndion and violates their conscience. this choice is intolerable. the fda failed to complyit basic requirements and in 2021 it eliminated the initial in person visit based on data that it says elsewherisnreliable and in 2016 it failed to explain the cumulative effects of the wholesale removal of safeguards. these aconare far short of what was requires and this court should affirm. i welcome their queson >> council, you assert an injury on the part of the alliance of diverted te d resources.

isn't that just the cost of lititi and pursuing this litigation? ms. hawley: i do not think so for a couple of reasons. first what respondent doctors veone is chosen their practice as well as structured the medicaprtice to bring life into the world. and eyre called from the labor and delivery floor down to the ering room to treat a woman suffering from abortion drug harm that is opposed to why ntered the medical profession and it comes alg with emotional harm. dr. scott talks about them being heartbreaking situations and some of the most stressful work he has had to deal with.

>> this court case specicay said that the nature of the harm was "non-economic" and did not preventhe court from finding an injury. the cot oked at two things. whether there was an impairment as the organization's ssn and whether there was an expenditure of resources. both of thosar satisfied here. if you looat how our organizations haveeeharmed, they have been for divert resources from advocating for their pro-life mission generally to explaining the dangers of the harm from abortion drugs. one of the primary reasons that that is required because in 2016, the fda took away the requirement thation providers report adverse event >> that would benyone who is

aggressive or vigilant about bringing lawsuits. just simply by using resources to advocate eiposition in court. u y now, it causes an injury which seems easy to manufacture >> i don't think that is true, justice thomas. i acknowledge they had havens where yohaprelude to litigation tes of activities. to resource justifications don't count. in this case, if you look at respondent declarations, they perform studies, analyzed studies in several of those are in the record. they are not short. they come through medicaid dat to look at the true nature of adverse events and all those rts of things are neither prelude to litigation nor would they have about for fda's unlawful conduct. >> the line you quoted abou

economic crimes had to do with the fact that th d not contend to rent an apartment so there was no economic lossr gain to them renting the apartment. what i think you are pointing to ishathey provided services on their own. it wasn't just the member services they were relying on. they were providing services to people to help them rent apartments. that is a very important distinction from here. separate from the individual attendance claims of standing based on wasted resources, their resources. the organatns are not losing anything. their jobs do exactly what you are talking about and they are doing it. they are investigating certain problems but that is not an

injury that h address above by this -- by vacating ts rule. >> a couple of things, your no where the court system did not economic nature of the interested housing,, you have to look to the underlying embrace. with respect to our injury. if the regulations are put back in place, the protections whereby individual abortion providers would provide our organizations with more accurate information. >> council, ask you about the remedy?

re able to object for two reasons. one is the emergency nature. many women do go to the emergency room and if we think about what that might look like, take dr. francis. she is on the labor and delivery floor. >> i dont want to hypothesize. tell me in her declaration whi he talks aut not being able to object or post a conscientious

objection. when she talks about -- can you point me to any place in declaration where they attempted to object bu were unable to? >> no. for two reasons. spdent doctors don't necessarily know until ty scrub into that operating room whetheth may or may not be in oraon. it could be a miscarriage. it could be an elective abortion. the government simply cannotet it story straight. we just heard that the church amendment applies. they called the diri court. >> let me ask you -- if w to find that there were content ju objecon a these doctors do have a way to deal with these kinds of procedures, should we in this case on that si >> no.

because esare our emergency situations. they can't waive process -- precious moments. >> ass we have a world in they can actually watch jections you say they have. my question is isn't that eno to remedy their issue? do we have to also entertain your argument that no one else in the worldanave this drug or no one else in america should have this drug in order to protect your clients? >> it is not possible given the emergency nature of the situation. >> let me interrupt i am sorry. i think justice jackson is a glass spothat. -- is saying let's get rid of all that. we should provide a remedy sufficient and go no further.

we have a handle individuals. normally we would all equitable relief to drshe . rent i think what justice jackson is colluded to -- we had what one might call a rash of universal injunctions. this seems like a pre ample of whacod be turning a small sword into a nationwide legislative assembly on an fda rule or other federal government action. >> yes. i think it is impractical. i think the district c remedy was appropriate under section 705. it grants reviewing cou's the

ability. when the partiesefore the court are nonruled parties, the only anue in which they could possibly get release is what the parties before the court get. that is for a state issue or in other cases, of cuure. >> why can't the courtpecify that this relief runs to the parties before the court? as opposed to looking to the agency in general and think the agency can't do this anywhere? >> i think that might b impractical. if we are thinking about the situation withds to dr. francis- this is what she does day in and day out and so it

seems to y at these would run -- these two particular plaintiff would be missing. that the regulations would still be in place. they would permit things like mail-orderboions. if we look at the merits of what they did in 2021, they relied on two in. they relied first on the data. >> i can understand your impulse there. there are exactly zero universal injunctions. pretty consequential ones. and over the last four yearsr so, the number is something like 60 and may be than that. they are relatively new things. to ask us toure this new remedial force which this court

has never adopted. lower court's kind of run with this. i just want to give you e re shot at that. >> sure. divorce encapsulates equitable remedies and they have fed from the beginning t 19th centy at the parties before the court get release. in this instance, we ha nonregulated parties, the party could be farmers, rancher ty are -- thon availability for police is if the court does something to the fda order or regulation issue. otherwise these parties are simply out of luck. >> let me ask you about your basically -- your theory standing. when you did your 123 your opening atent, it sounded ryrobably stick to me. i don't remember exactly what

the 123 let's say it is something alg e lines of representing the doctors and there were a lot of women out there. they areoi to have -- the are going to have adverse events. to come to the emergency room and so there is some probability of the like that o oour doctors who has a content is objection is going to come faceo-ce with one of these women who has an adverse event. is that your theory? >> no. what we think really shows the report -- the respondent have day re is that the fda had t acknowledged. in regulating them, they have ually said erncies from doctors and ob/gyn hospitals are critical. >> you are just saying that even the fda admits they are going to

see some adverse events. people are gngo show up in emergency rooms. people are going to come face-to-face with one of our doctor objts to some aspect of therement. that is the theory. >>ecently think all of that is true. we don't think it is problem with probaliic standing. here we have seven named plaintiffs in addition. >> ds ur theory really depend on you having at least one person? i take them to say these probability theories based on very nice. they have nothing to do with our article the quirements. you need a person to be able to co in and meet the court's gur standing requirements. u ree with that. so who is your person? if you had to pick one and say goead that and that

declaration is goingo ll you why we are entitled to here. >> dr. francis and doctors gone. >> what about those two doctors gis u the kind of imminent injury let alone traceability. request to speak to dr. fnc at the beginning, there has been some confusionbout the precise nature of the conscious part. if you loo at 155 paragraph 15, she is talking about objecting to not only tanghe life of a child but ao mpleting that process. echoes this decoration at 142 and 143. >> i read that declaration pretty car.

wh aual emergency treatment has she participated in tt she objects to and that she has stated an objection to >> the prior page ta about what she was required to perform due to a life-threatening emernc quick she herself performed that. >> that is correct. quick did he have an opportunity to object? >> no. these are life-threatening situations tscrub out and find something else or treat the woman. quickly when the people with conscious objections to this is they make those objections known. it may be harder, it may be easier in a rtular context but both hospitals have meanisms in place to ensure the doctors who are allowed to dohis in advance and are allowed to do it at the moment.

they say so and when i looke dr. francis and dr. sco, there's just nothing you have thatugsts there are other requirements. this happened to them in the past. i don't think you have it for either one of osdoctors. >> i think we do. given the emergency nature. it is imprtil to have an objeio launched prior to unrsnd what is going on in that operating room. this is to the district court fifth circuit brief where the government set the c nor any of the oth intended them topp -- d litigating this with the federal government saying they don't have conscious protection. >> is it true i decisnsave

not relied on probabilistic determination? the court said they were standing because there was a question about citizenship included on the questionnai. they would not fill out the census at all. it was probable that there was some risk that your state would risk losing a representate or would risk losin money under some federal program. you put geer this chain of probabilities. bsolutely. we agree with that. you can look at the case. it is certainly true that the

data is appropriate to consider in determining whether there is bsntial risk. the fda admits this is a 533. th i at 5:42. vewomen will need serve- will need surgical intervention. when they talk about there being no increase in adverse events from the increased gestational age, the only way eyan say that is by ignoring surgical intervention. that i because -- what would we do with the fact that these two rely on the scope the indiana and texahave abolished abortions and abolished them byil or otherwise. when you get into whether other people are illegal baking the law -- what does that do --

it is alread infinitesimally all because there are thousands of hospitals in the country. ousands and thousands of places where pregnant women may be suffering from miscarriages or otherwise to know or even imagin how one dr. is going to everctlly see aatnt that he or she is going to be forced to intervene on their behalf but illegal in the states.is is >> i think the best answer is a prologue. we have two examples.

when you go out of the state, that is a highly like the- higher likelihood. isurns er rooms into those follow-up . a woman went to mexico and return to texas as well as dr. johnson wheronwent to illinois andetned to indiana. one in five abortnsake place out of state in third stes like new mexico. the border states in which our doctors reside >> can i take ck to the affidavits? >> you were talking about dr. francis. and as i read her aions, she said her partner was forced to perform a d&c when there wa a living fetus. she said she performed a&cn a woman who was sfeng serious applications but the fact that she performed that does notsarily mean there is no living embryo or fetus because you can havenefter a miscarriage.

if that is right, i think the difficulty here is that these affidavits do read more like conscientious objection as opposed to actually participating in theion to end the life. -- a t length of thembo or fetus. do you want to address t >> sure. i think dr. francis can be read for the broader conscious harm. it is beyond sle requiring ending andnbn life. with rescto even more narrow conscious arms whether a doctor may need to end a life, we think there sll a substantial risk. that means 3.1% of pregnancies

will be ongoing, requiring a d&c. 55% of those occur in the emergency room. there is a substantial number of women sufferi artion drug harm. >> not all those w involve the privacy that will otherwise be viable in an embryo ofes. you can haplications or excessive bleeding even after the abortion is completed in that respectheer there is pregnancy tissue remaining. estion 3.1 is ongoing and the fda says they will need surgeries to stop bleeding or ongoing pregnancies or failures. >> you have a broad number o doctors in your organization that are dentists and doctors that are retired.

how many members of your organization are a beach i wen to hospitals who might be -- >> there are hundreds of them. i think in particular, the named plaintiffurb/gyn hospitalists who spent time on delivery floors. >> can you clarify the broader conscious harm from the narrow one? i understood i as jti barrett does but you suggest there is a broad one. what is that? in a district court, understand the conscious harm to be either taking the life of an unborn child which would sometimes require a partner in an emergency situation. request that is what i understood the narrow want to be participating in a procedure that is ending the life.

so what is the broader one being complicit in the process that takes a number life such as abortion. it is not that hard to -- >> complicit le work in the emergency room where this is going on? i am hammering -- i am handing them a water bottle? what do you mean complicit in the process? >> this -- what harms our doctors is being involved in completing and the terms of our declaration an elective abortion. it is not that hard to see why there might be a conscusarm if you think about what is involved. >> is being invold in completed an eleivabortion. i took that to be a conscientious objection. i inwhat justice jackson is asng her what i asked before of justice barrett is if there a broader conscious objection that appears and i am

not sure i care all that much out the district court but it appears in the declarations. >> in ts stance, completing elective abortion means removing an embryo, fetus -- dr. francis talks about being required to perform a d&c. >> whether or not there is any live tissue. >> yes, your honor. would put you to paragraph 5. complicity of harm from being electe--nvolved in elective abortion. the ctors must agree about a woman's urus of a fetus. in cases like little sisters of the poor.

>> it is my understanding times the completion doesn't involve surgical intervention. do you have a of how often ? we may get all the way down the chain to the person having the emergency procedure. my understandih some of these chemil ortion scenarios is the completion occurs by describing additional dications. could it be done by another physician? that the dose has been since 2016. i think all the way backo 2001. it has beenpproved since 2016. the best members we have are so consistent with that. that means it will be ongoing. i encourage you to look at j for

a five and this explains these risks go up. >> and just trying to get i'm still working on how many circumstances or how often it would be your clients actuly have to complete the procedure inhe way you are describing. >> the doctors talk about doing ist least a dozen times. removing embryos, fetuse if you think about 3.1% at 10 weeks -- this has on ge up. the in personisit was both necessary and minimally burdensome -- minimally buensome. these sorts of situations occur lequently than. >> thank you

>> i am sure you hea the answers of the solicitoreneral and counselor for danco with respect to this act. i would like you to comment on their answer >> for s we don't think there is any case in this court that empowers the fda to iore other federal law with respect to the comstock act as relevant here. it says drugs should not be mailed eitr rough the mail or through common carriers. so we think the plaintext is very clear. >> when did you first raise the ck act? >> tnk it was first raised in distric court. we think exhaustion does not apply for two reasons. first it would be gay futile this is a whole another kettle of fish. if youat section 7

exhaustion is only required in o instances. this is consistent. the lower court have taken opinions. eris no is often requiredr agency will that stays the eceding. >> pi ask about the traceability of it all? i want you to tell me if you agree with this understandg. eveneyd proving whatever injury you are part -- whatever injury you are trying to prove, you have to shift that injury is traceable to the 2016 and 2021 fda actions tt u are challenging and of course that meanshing that these incidents you are talking about

in the emergency room are caused by whatever incremental increase and risk there is as a result. i guess my first question ido you agree with that statement? what do you need to show? and if you do, how do you satisfy that? why do you satisfy that? twice we believe that we need to show the 2016 and 2020 one action increase the risk of harm. >> i guess we are saying you have to link whatever and for your members have two that ineased risk. do you agree with that? >> we do and we agree with that for cole of reasons. we areotn tort cognition. you look at the 21 tion within traceability status i as j 845 -- without that in person

visit, er and other medical care question might be some dispute between the two of you about how big the increase -- increased risk is. how do you connect that risk to particular actions that your members have to particular jues that your members have undergoner will undergo? >> the original risk. >> i think the declatis are really quickly on this. if you look at dr. francis's declatn. shthght she saw an increase in emergencyiss fm dr. johnson, dr. s said the same thing. its entirely consistent with

fda number in 2020, the fda said the emperor visit was necessary to preserve women's al because the impression visit is the best opportunity to examine things like -- thingbserve pregnancy and age of consent. because the general said that initial impression visit that had no requirement of an ulasound or any effort to detect fetal heartbe except it would not necessgive inaccurate read gtational age. so i would not necessarily be eliminated? >> i think the fda'undated shows that race didn' up. if you look at the study, it shows a nearly threefold increa when you have -- when you removed it.

it was about 2.1 without. >> when they remove this, it took away the opportuny do that. i think a cog -- medical orgazaons that created that are best practice. what is allowed under this a couple of screening questions. i do think that is nearly as good as an in-person exam. quest let's say that -- let's just carve out and putside this -- explain to me what addion costs you might have incurred or what your resources had diverted

in aayhat would set aside havens. >> putting ahe once this and prest one citizen petition, it was clear the respondent organization conducted studies and analyzed studies including going through the medicaid data. it included into the affairs data. urse i would do one of them at roa five. sorry roa 70. those are pretty comprehensive studies. quest at the end of the litigation or were they to the end of? >> to accurately assess the harm from abortion drugs. getting absolutely separate fr the negation. that is the only way in which the fda.se a concern to these proceedings go on behind closed doors. the first time is a citizens

prediction. >> what difference if any do court of the opinions of the expert agency concerning the safety and efficacy of drugs? >> und ts court's administrative procedure, a peer vi is not toothless. stead, in this case, we are not asking that the court second-guess the agency at all but rather look at what the fbi said. it did so based on their ta >> i guess i don't understand hohat is not second-guessing the agency. you are saying the court can look at studies. maybe different studies maybe the same studies. and criq their conclusions about them.

what difference do we owe them at all with respect to their assessment that these studies establh at it is they say they do about safety and efcacy? >> and think that is inaccurate to portray. e reason being is were looking at what fta said. it sayyohave to have adequate tests. >> did the lower court's go beyot? representations were major today. they have since been found remo they are obviously looking at not just what the fdaas looking at. are you asking us to just look the f and nothing else? >> that claim is not even before th court. but with respect to the two claims before the court, the 2015 and 2021, we think the fda is arbitrary.

what the fda said is we are into look at individual studies and even the we say they are interrelated, we are going toake protections away. that is arbitrary. >> thank you counsel. >> thank on tociational standing, where do you cross theto get the impending injury? what's wanting to look at is whether that harm has materialized in the past and how often. there is no guaranteehe will be a future injury but what is so telling is that respondents don't have a specific example o any doctor ever having to violate this care in violation of their conscience. this is for the declarations that never specifically say he is how the care is provided.

the fact that they don'tave a doctor willing to submit that think demonstrates the past time as it happened and the reason th hpened is because it is speculative. there are so many links in the chain that would have to occur. it would be about having the fedel in play. they said that they voluntarily conducted studie if that is enough, every organization in this country has standing tchlenge any federal picy they dislike. hans realty could not possibly say that. he does t outer balance. on remedy, justice courses, justice jackson, you plan out the striking anomaly here of the naonde nature of this remedy. maybe a more tailored remedy to the party. the problem here is they sued

the fda. the fda has nothing to do with it -- with the enforcement of protection. that is all happening far downstream. and the on w to provide a remedy therefore was to grant th kind of natnwe release that iso r removed from the regulatory authorities that it is ultimatelyequirement all women everywhere to change for thisru i think it is worth stepping back and thinkin about the profound mismatch betwn that injury and the remedy of the response obtained. they said the fear that there might be some emergency room doctors who ye presented with incredibly rare applications and the doctor may veo provide treatment -- we don't think that harm has materialized but with the ur date is entered sweeping nationwi bief that rtrts access for every single woman this cntry and that causes profound harm.

harm the agency. it harms the part of it -- it harms the pharmaceutical industry saying that this would be -- destabilize the system for approving and regulating drugs. the court should reverse instructions to dis