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 medice and the consolidedase. >> may it please the court, fda approved mifepristone placed on the agency's scientific judgment that the drug is safe and effective. it has maintained that judgment across five presidential administrations and milonof americans have used mifepristone to safely end there

pregnancies. at the outset, responden lk standing. they cannot re on a statistical theory of injury like the low crts did. instead, they have to identify a specific doctor who faces imminent hm t their theories rest on a lgchain of remote contingencies. only an exceptionally small number of women suffer the kinds of serious competionthat could trigger any need for emergency treatment. it is speculivthat any would seek care from the two doctors and even if thatapned, federal cautions protections would guard against the injuries. and there iso sis to conclude that any of that would be traceable to the incremental changes that the fda made in 16nd 2021 as to the availability of mifepristone in general.

they are too attenuated as a matter of law and the court should say so and put an end to this case. if the court reaches the merits that the fda wasawl the agency relied on dozens of studies including tens of thousands of women. they do not identify any evidence thathagency overlooked and they just disagree with the analysis of the data, but that does not provide an office -- a license authorize second-guessing. finally on the remedy, the releasenred below would severely disrupt the federal system for develinand improving drugs harming the agency and pharmaceutical industry and inflict great harm on women across the nation. lling back these changes would unnecessarily restrict access tho justification. some women could be forced to undergo surgic artions and others might not be able to access the drug at all and all of this ulhappen at the request of plaintiff's who have no certain injury of their own. thcot should reject that profoundly inequitable result. i welcome questions. justice thomas: if we agree with you on the standing could you give us an example of who would have stainto challenge these fda actions?

as a general matter we have seen lawsuits brought by for example prescribing physicians or patients who want greater access. sometimes we have seen theories of competitor standing where compindrug manufacturer ght 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 who opposeboion who would have standing and went to challenge the actions the answer is no. the reason is cae those people are not regulated in any relevant way under the fda here. they do not esibe 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 ecific doctors so they stand at a deficit -- at a distance from the aiothey are challenging and the court said in many cases that in

situatn ke that when you are not the direct object of regulation it can be more difficult to establish standing. juicthomas: isn't that a criticism of some of our association and standing cases and organizationaltaing cases? >> i do not think it is. with respect to associational standings this crtas said that the association needs to identify a specific member ffering a concrete harm and an injury that is nonspecate. i do not take issue with that fact, they are agreeing it would be necessary to identify a specific doctor. the obm with the asciational standing theory is that it rests on this chain of reteossibility with so many steps in the process that would have to occur laying one speculative remote odds of chance oinry across another to get to the ultimate harm on behalff ese doctors.

>> you associate the remote nature and it affects the likelihood thae patients will go to the emergency room and so on. 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 e ergency room, at some point does this analysis lead to the otr sult? ms. prelogar: it is hard to imagine that it could for a couple of different reasons. i kehe point you will pick out different links and suggest th tre are ways to depart and say that maybe has a specific matteonor two could be more likely to occur. but we have an objection to the underlngheory has a legal matter because it rests on so ma different things that would

happen one on top of anothernd turn on independent decisions made by third parties who are strangers and not rtf the suit. that brings the case like klappeorummers where the court has recognized that wh the theory of injury turns on many intervening events separated by independent decisions it cou mean that there is an insurmountable hurdle to establishing standing. >> could you provide a more specific answer to the first question that justice thomas ked you, is there anybody who could challenge in court the ness of what the fda did? ms. prelogar: in this case i think e swer was no. justice kavanaugh: is there anybody that could do that? let us start with the states that intervened.

will you say that in that litigation fine, you can chalngit and let us get the ri of this issue and what the lawfulness of the fda d? ms. prelogar: the states lacked standing, th a asserting indirect injuries and could result in the states aay suing the united states government. justice kavanaugh: how about a doctor who opposes abortion, he is on duty wn woman who comes in with complications from taken mifepristoneanthe doctor is the only one on duty who can attend to the wom's problem and as a result in order to save her life she has to abort the viableet. with that doctor then have standing to seek injunctive relief? or would you say this is too speculative. this is like being struck by lightning and it is not sufficiently likely th ts will happen to this doctor again? ms. prelog: at would represent past harm and we are not sping that conscious violation would be cognizable. we think that situation has vecome to pass and respondents have not identifie

an incident in more than 20 yes that mifepristone has been available that resembles that situation. so our view would be iis unduly speculative. you have to think about the events that woulha to transpire. justice alo:ow about a woman who suffers adverse consequences fromavg taken mifepristone, would she sue for damages or wod 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 tracbity that is harder for us. justice alito: is there anybody who can so and get a judicial ruling on what the fda did was lawful. and maybe what they did was perfectly lawful, but shouldn't somebody be able to challenge that in cot d who? who would have standing to bring the it ms. prelogar: with respect to these regulatory changest hard to argue that anyone has standing but the court has said

that the fact that no one would ha snding does not have a basis to depart from article ree principles, so i think it is clear that even if the 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 imrtt. your argument that it does not matter if the fda flagnt violated the law it did not do what it should havdo and endanger the health of women it is too bad that nobody can sue in court? there is no remedy, the american ople have no remedy. ms. prelogar: i think it would be wrong tsuest that if the fda had made a mistake and a drug was producing safety consequences that there is nothintoe done. i do not think these respondents could invoke articlehr to have the court step in. thfdtakes seriously its responsibility to ensure the fety of drugs and conducts ongoing surveillance andan make adjustments as safety

situations emerge. drug sponsors remain responsible at all times and we have a court system that n sure that there -- that if there aren't safety problems the sponsors will take action. if the premise is that unsaf drugs could remain on the market, that is incorrect. >> your argument hd as i said, i have great respect for article threwe all do we have to comply with it. your argument is that even if the ted unlawfully, nobody calenge that in court, and that is basically the argument you made last week, we should not get to the question r violated the right to freedom of speech and we shay that the plaintiffs cannot bring suit? ms. prelogar: we are lking at

the specific respondents and we do not think they come in 10 miles of the circumstances this court has identified of nonspeculative harm that can eate the injuries for forward-looking relief. >> i am assuming that if there were -- if this had been unsafe a grossly visible way, you know, 40 percent more crsed hospitalizations that some doctor would've challengeth lack of an in person? ms. prelogar: no doctor is qued to dispense other things. justice sotomayor: but they want to, but we have said if they are regulations that stop them from doing it, i guess that dr. could come in and say this is unsafe by not having people visit me fohand, we are not warning them and etc. ms. prelogar: certainly those kinds of distinct safety concerns emerge there are steps at t ancy level. there is nothing like that here. justice sotomayor: i a conjuring a hypothetical. ms. prelogarthfda 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 required to dispense mifepristone through a itical arrangement. >> can i ask you a question about the roadblocks that you identified in a chain cae you said a doctor could invoke conscious protection to refuse to complete an abortion when the emyor fetus was still alive. so i want to be clear, the federal gont's position is at 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 circuit misunderstood the arguments and respondents have repead at misunderstanding. we never thought that this would override conscious objections. he said the opposite. if you look at the texas litigati we disclaimed that detanding and made clear that we understand that nscious detection should continue to apply and ie a

doctor who does t nt to provide care. >> with that be tr ia health-care desert haswell? ms. prelogar: we do not think would override conscious prottis and imposes obligations on hospitals and hospitals have plans in place to address these contingeie they have staffing plans and it is a matter of best practices and they often asked for doctors to articulate the objections in advance so they can take accou of that. ey have cross staffing agreements and in the government's experience, almost four decese are not aware of any situation where there has

been that kind of direct nflict. >> one last question about the sociation standing. its own standing and its own right th ibased on injury to one of its members. so, the injuries that the association is aui found in the associational standing and they are the kind of allocations that we see in advacgroups, increased expenses, that results from the complatns of having to address and explain the new changes. i amotalking about expenses of filing the petition. let us just talk about resources. can you distinguish that? msprelogar: i think havens was trying to distinguish betwn two types of organizational juries and they said in that

case the organization had come forward wi dect and concrete injury to itself and they had a contract to provide low income housing or search to secure it r ients and the practices directly interfered with that and ma imore difficult for the organization to carry out its obligatis t haven said it was not in a standing that would allow the ornition to describe a setback. that is the court trying t distinguish between demonstrable harm and that kind of abstract setback on the other hand. i recognize and your question ucs on it that some lower courts have seemed to read it as far oar standings. the government has been resisting stdi because that would essentially mean that any advocacy orgizion could say it opposes what the federal government is doinan therefore has to devote resources to the opposition.

if that were enough every organization would have standing and it would be an expansion of ordinary article three princi we would welcome an eventual clarification on organizational standing, but i think the assertion of injury falls into e bucket of the abstract setback and does not come close to tonstrable harm that was the issue in haven. >> that elpful clarification. on a similar clarification. thank you. with respect to individuals, i have heard and listen to your argument and read e iefs and i think i understand it. how does it t your mind with offended observers standing under thesblishment cause or some injuries about -- i access a park and i like to lk it in a certain way, and those kind of injuries at the court has sometimes recognednd sometimes cast doubt on. ms. prelogar: there are different stndof precedent and i woulputhe establishmentprecedent and first amendment in its own bucket. the court has recognized different theories. stice gorsuch: standing is standing at it is article three. we have to find some way to stitch it togethernd am

looking for idce from you. >> i think the way to approach this is if you are going to recognize an offense or stress injury to recognized -- no, i represent the government so think that kind of theorof injury would go far too much in the direction of allowing article three courtsigh paste on genaled grievances. to distinguish the acacias -- the cases, generally it is in a situation where there is a direct governmental acti producing that type of injury. here the argument is that the fda actions in approving

fepristone in 2016 and 2021, which was an incremental change, so far upstream of the downstream assertion of harm that the rents are asserting that as a matter of law and a attenuatk that cannot suffice for article three. >> thank y justice alito? justice alito: you said that the sixtuit 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 incus or not excessively dangerous if engaged in by themselves might become very dangerous when they are all done together? and why shoul't the fda have address that? ms. prelogar: the only way that would be te if the three changes are interconnected and mutually reinforcingguding against the same kind of risk. if there was reason to think that the reason y fepristone is up to safe up to 10 weeks is becausits being prescribed by doctors instead of nurse practitioners then those changes would be interconnected becae one change would be the safety net for another. there is nothing like at the studies at the fda examined demonstrated wh exhaustive examination that the changes were safe not because there were

other safear to guard against risk because if you go up to 10 weeks there is no observable increase in adverse ents no matter who is prescribing. in the absence of that effect of the changes do n tnk you can fault the agency for not giving more explicit attention to this issue and it did. it cedultiple studies i combined in multiple changes because a standard of care had evolved over the 1years it had been approved and many of e changes were being deployed together safely. justice alito: shoul'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 restctns if it is necessary to ensure safe use. in 2020 one what they determined ithat you do not need in person dispensing so the ftca did noreire that restriction and it could not be imposed. the fda was not approving,

mailing in violation of comstock even if you interethat and we do not think it means what the respondents suggested means. but i don't t it was the fda's responsibility to consider that. justice alito: it did not say anythi aut it and this is a prominent provision. its not some obscure subsection of a complicate obscure law. they knew about it, everybody in the field knew about it, shouldn't ey address it. you have answers to the arguntmade on the others, should the fda said we have considered that and provide some sort of an explanation? msprelogar: let me give two responses, it would not have been permissible for the fda to consider maintaining that restrictn cause of comstock. if you look at the relative statorconception, this is reproduced on page 6a, the only thing thfdcan take into account for restrictions are fe and efficacy concerns in deciding to maintain a progr. the other thing i would say is at the agency did have a memorandum on comstock at ja535, whicishe advice conveying

the interpretation. justice alito: they got the advice but it did not refer to that? msprogar: in the 2021 desion, no, but it was modified in 2023 and this is part of the administrative record for that. justice alito:helaintiffs to say that the studies that they relied osa that mail order mifepristone suggests more frequent trips to the emergency om. now, this is what i see as the fda's response "although the teture suggests that there might be more frequent emergency room care visits related to the use of mifrione when dispensed by mail, there are no impairment increases and other serious adverse events related to mifepristone use." does that really counts explanation to the suggestion that the data showth there are going bmore emergency room visits? this is the increase of emgey room visits are of no coequence and it does not merit some comments?

ms. prelogar: thats reasoned explanation of what they were observing. although it knledged that some of the studies reported additional visits, did not equate to additional serious adverse events. one of the studi, lf the women who went to the emergency room did not get treatnt many might go because they are experiencing heavy bedg which mimics a miscarriage and they need to know whether or not they are havg complication. in that circumstance the woman is not having a serious adverse event from mifepristone, wch does not call into account the safety determinations. thfda parsed those studies and it made specific determinations outhe results with respect to safety and efficacy. it fully explained its desion-making and falls well into the zone of reasonableness. justice sotomayor: on the last question the reali ieven if there is some increase in emergency room visits, the question of when that rises to a sufficient safety risk is up to the fda, correct?

ms. prelogar: that is right and the fdacowledges this. it did not overlook it. i want to emphasize that the stiewere far from the only evidence that the fda consulted. at theimit acted it had real-world experience during the covid-19 pandemic, a perioof time when the in person dispensing requirement was not enforced and the fda started by looking at a compati analysis the two periods when you had in psodispensing and when youidot and saw that there was no serious increase of verse event -- events or the difference. 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 difficult quti, isn't it? ms. prelogar: that is a question entrusted to the fda. justice toyor: whatever the increase was, lee fda determined undethstandard that it was not sufficient to create a risk that counterbalanced the need for access, correct? ms. prelogar: because the fda is instructed to take into cot burdens on the health care system as well and looked at a variety of sources tcolude that the burden suggested that it was not necessary to keep this restricti iplace to ensure safe use. justice kagan: if i could take you back to the discussion with justice baetabout the

conscious objection and i'm sure that you have read the declario carefully and i am sure that ms. holly will have in to say about this. as you read those declaratio, what is the conscious objection? what are the doctors objecting to exactly? ms. prelogar: i think the declarations are specific. there are only seven docrsho regularly practice and submitted evidence and thear relatively short. this isja 1520because there are only two who provide any inrmion about their specific objections. ose are dr. scope and francis. the others do not ove specific detail about exactly what care woulviate their conscience. dr. francis is ja155 and the other j57. they object to ending the life t womb. justice kagan: they do not object to providing whatever care is necessary aerson

who ghhave complications from taking mifepristone, in other words supposed somebody has bled significalyn need a transfusion or any of a number of other things that might happen, as you understane is not objection to that? ms. prelogar: i think the fairest reading is that they are not objecting to that. i acknowledge that respondents suggested thathe is a broader conscious injury and there might be other doctors who have aroader concern about providing care, and even if th injury had been in this claration we think as a matter of law it could not demonstrate that they have a nonspeculative injury. in part because of all the things that uld have to happen in a woman going to the specific doctors and the fact that the adderall conscious protections e designed to deal with this issue and they would coverhe range of objections that exist. justice kan:here are

obviouy ones of all kinds and was just asking about these particular declaration ms. prelogar: i think they have not asserted a broader injury, bueven if they could come forward with other doctors or adjust theecration still that would not suffice. juice kagan a quick question about the merits.

you open your brief with the dateea, but with the statement and it starts with the government's owdge 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 and ask you whether it is still

true. to the government's knowledge. "this ca mks the first time" and i'm going to say is at the first time or only time "any court has restricted access to thf's drug by second-guessing the safe use." is it ilthe only time? ms. prelogar: still to our owdge, and we have seen a trend of courts overwriting fda's judgment to grant greater access to drugs. 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 conscious is to perform or assist in an abortion, correct? . prelogar: we think that federal conscious protectis provide broad coverage and there are some triggering requirements on receiving federal funding. we cited the relevant provisions on page five. the church amendmentha the most comprehensive instructions and they gua ainst the kind of injury and there are state laprections that often apply. justice barrett: would that be true if the declarations were interpreted that they regard any paicipation such as transfusion as after otherwise complete as ss being removed?

ms. prelogar: the most relevant chchmendment provision is 42a-7d that said that doctors shall nobeequired to perform or assist in any part of the health care prrathat would violate the doctors' religious or moral beliefs which a td to the nature of beliefs than ures. justice barrett: this goes to the merits. as i understd , the serious consequences that have to be repoedr that the fda considers risks are death and transfusion but it seems to me at the data bears it out that the elimination of the ipeon dispensing requirement or visit at the outset would ado 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 list of serious events and i am not sure that he all of them down to

be able to recite them although they are in the co. i think thprise is wrong the idea that they changed in person dispensing would increase the risk. that w n reflected in the data that the fda consulted and would point you to a particular section in partul where the fda explains that even in person you are not geing an ultrasound, that has never been required. the relevant qstn might be is your provider is going to ask you a number of's straining questions and there is no reason y at difference would lead to different safety outps. 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 spt to the er visits there were increedour visits although as i explained that was not actually correlated with an increase in serious adrs events. i do not want to represent all

of the different studies because they varied a little bit but the ultimate concliowas that mifepristone could be prescribed without inern visits. there have been no contrary evidence introduced. justicbaett: there was no requirement of an ultrasound or detecting a fetal heart beats or anything like thatbefore the doctor could go based on when the last menstrual peod was. ms. prelogar: that dates back to the initial pral. it has not been required used to have an ultrasound. it is of course necessary for providers to diagnose and date geational age which remains true. they still have to have that capability and deployed whatever mechanmshey believe would accurately allow them to identify contraindications. but iwrong to suggest that if the court was versus changes that every woman will gea te for sound. that has never beethstate of play. justice barrt:ow even under that w ipossible to detect

an ectopic pregnancy unless the woman was esting with plane? ms. prelogar: there is a set of qutis such as did you become pregnant with an iud or after tubal ligation. are you experiencing unusual bleeding or ask ty have had a prior pregnancy. if the woman has that kind of risk factors imaging might be necessary but that remains true as well that the prescriber has to be confident that it has excludedho kinds of conditions before prescribing. the standard of care around the rld, 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 sought. and that that might or should matter for standing purposes. i do not know that the doctrines caure this. injuries that the respondents

allege as you articulate them our conscience injury that they are being foedo participate in a medical procedure that they object to. d the obvious commonsense remedy would be to provide tm with an exemption that ty not have to participate in this procedure. and you said several times that federal law aladgives him that. so i guess then what they e asking for in this lawsuit is more than that. they are saying because we object to having to be forced to participatinhis procedure we are seeking an order preventing anyone from having access to these drugs at all. d i guess i am trying to understand how they could possibly bentled to that given the injury they have led? ms. prelogar: i agree and i thinits relevant to

stdi. there is a mismatch between e claimed injury and the remedy they were seeking. you could think of this as a typef ne of interest analysis. if the doctors have a conscious inry there are statutes designed to dealitit specifically to guard against the injury occurring and instead they are reachg t and invoki rhts under a different statute that does not regulate them atllr make them do or not do anything and the relief that they are seeking would dramatically alter the improved conditions for e d affect women all around the nation simply because of this 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 thinut trying to tailor relief is they are asserting such a diffuse theory so that the only option was to grant a nationwide remedy and it runs counter to ordinary principles ofarty specific relief. it shows that there is something wrong with the theory of injury in the first place because it is so attenuated and claim that they would need so much relief alover the country. justice jackson: in addition to the challeeshat we have here, the respondents below challenge the initiasion to approve mifepristone in the year 200 of course, that occurred a long time ago and they said that challenge was not timely because of the statute of lions. in the context of another case that this court is continug, the statute of limitations issue. setting aside standing, have you thought about how a ruling on the statute of limitationsn either direction might impact what happens in these kinds of

casewi these kinds of challenges? ms. prelogar: it just reflects the stakes of the corner post case and provides the stivid example of the wayt uld be possible if this court were to approve threest for the broader series of the statute of limitatis the way it could open the door to plaintiffs saying became a doctor later or started working in emergency room later and wldry to unsettle long-standing actions that occurred decades previously. i understand to suggest that there might bequable defenses that the government could raise and we wld certainly want to raise that type of defense with the approval of mifepristone and has proven to be safe and effective. >> thank you counsel. >> mr. chief justice and may it the court, in 2016 and 2021, the fda made certain 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 could be called someday to an unknown emgency room after a series of decisions by third-partys. no facts link that possible future encounter to a specific change that e a made in 2016 or 2021. respondents view of the food, drug and cosmetic act is so inflexible it willotnly upend this butirally every drug approval or modification that the fda has made for decade rersal is required for two reasons. article three standing is not an academic exercise and what is conceivable. they lacked standing under every prong of the analysis. t merits, fda exhaustively consider the evidence and explaid s conclusions, which is what is required to do. i welcome questions. stice thomas: the solicitor general points out it would not be susceptible to a coto act

problem. but in yr se, you would be. soowo you respond to an arme that mailing your product and advertising it wou violate the comstock act? ms. ellsworth: we agree with the government that the fda's charge under the food, drug and coetic act is minted to looking at safety d at is true for new drug approvals and dications. the fda routinely approves drugs that are restricted oer laws such as environmental laws, customs laws and so on. i think this court should think hard about the mischief it would

intef it allowed agencies to start taking action based on statutory responsibiti that congress has assigned to other agencies. on the merits, this issue is not ruled on below, and in any event i would point out that in 2021, the decision allows the use of brick-and-mortar pharmacies in addition to mail oer justice thomas: my problem is that you are private. the governme, understand the government's argument. you are private and the statute does not have the sortf fe harbor that you are suggesting. and it is fairly broad. and it specifically covers drugs such as yours. ms. ellswoh:our honor, we disagree that that is the correct interpretati othe statute. we think in order to address the correct interpretation they would need to be a situation in which this situation is to do. this has noteeenforced for 100 years and i do not believe that this case presents an pounity for the court to ine on the reach of the statute. >> counsel, i would keo ask

you the same questions i was posing to the solicitor general. klapper and susan b. anthony lk about requiring a substantial risk that harm will occur. you argue that that is not present. how are we supto 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 degree. you are trying to evaluate whether something is actual and imminent or whether it is conjectural or hypothetical. risk and pending which has been

used to dating back to 1923 that we are a claim falls in the spectr. >> and we toss around a lot oudetails, but as a practical matter, how do you figure out? at percentage would be enough and what percentage of emeen room visits would be enough? ms. ellsworth: i tnkt the way klapper got at this question is to really think about whether there is an attenuated chain and contingenciethat have to happen. inittions where there is this chain of circumstances involving third-party decisions that have to play out and hear the chain is long. if that pulaintiff's theory on the side of coral or hypothetical and not impending injury. >> hyour company aggrieved by the challenge that is brought in thi? i gather that this is your version of mifepristone is the only product you aketing?

ms. ellsworth: that is correct. justice alito: the fifth circuit decision does not prohibit you from continuing to produce a sell that product, correct? ms. ellsworth: that is correct. justice alito: i gather your injury is that you think you will sell more if the restrictions that previously were in place were lifted. so you will make more mone ms. ellsworth: the injury is that we are prevtefrom selling our product in line with fda's scientific judenabout the safe use of the drug.

justice alito and you will be harmed because he will sell more? ms. ellsworth: a company's ability to market its product is how it considers theevatory scheme that governs it product. justice alito: during e questioning of the solicitor general statement was made that no course has ever previously second-guessed the fda's judgment about access to a drug, correct? it has never second-guse that. ms. ellsworth: that is correct. justice alito: do you think the fda is infallible? mselworth: we do not and we do not think that is t-ed up in 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 the vee event reporting and the post-market surveillance and the abitthat these plaintiffs have, even if they do not have standing,erinly if they are seeing patients presenting with adverse even and doing studies that show that there is some unknown safety component that the fda should acknowledge, they can take siifant steps to bring that to the agency's attention and ouatntion. justice alito: do you thinth 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. ere 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? you do notanto sell a product that causes harm to the people who take the product relying on your tests and the f's tests, wouldn't you want that data? ms. ellsworth: that data is certainly somethinthat we are okg for all the time. it is part of the reportin obligations for a manufacturer to be aware of anyatbecoming available through any means. we have a one 80number and a one 800 number on the labeling. i think that gs at concern that i have heard the early questioning on who would have standing if the aintiffs do not. drug manufacturers are varies frequently subject to tort litigation, product liability suits and failure to warn suits, deceptivadrtising suits when someone is claiming harm from a

product. what is so i think revolutna really about the arguments here both on standing and merit on e y that they attempt by individuals who do not use this oduct and do not prescribe this product and have e conscious right not to treat anyone who has taken the product, they nto prevent anyone else from using it in line with f's considered scientific judgment. justice alito: just one more pot 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 brought by the nec company that do make that gunt. and i think that is for late 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. >> could youo ck to the questions about adverse event reporting and said you would bject your product to higher standards and now we are being brought down to the regular, uld you talk about that a

little bit, what are the normal standards for adverse event reporting and y e they there? what instead where youubct to in the past? >> what changed was not danco's adverse event reportg responsibility. it has been the same throughout this period. what change was from 2000 until 2016 prescribers were reported to reporevts to danco and then we had a separate ligation. in 2016 the rems were aligd be more consistent with the reporting requemt that applies to all 20,000 plus fda approved drugs there are only today seven that continue to have even the limited higher adverse event reporting for debts then applied to mifepristone. it is only one of seven that ha that. >> any further? justicett? justice jackson? e 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 medicascientific studies? ms. ellsworth: yes. i think we have gnicant concerns and there are two amicus briefs from the pharmaceutical industry that expands on why exactly that so concerning for pharmaceutical companies who depend on fda's gold standard review pce to approve their drugs and be able to sell their odts in line with that considered judgment. justice jackson: can you say what ty y? . lsworth: 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 things rieon one study that was an analysis of anonymous bl pts. you have another set of studies that he li on that were not in the administrative record and would not bause they posttehe decisions. they have been retracted for a

lack of scientific rigor a misleading presentations of data. those sorts of errors can in fact judicial analyses precisely because judges are not experts in statistics or the methodology used for scientific studies and clinical trials. that is why the fda has many hundreds of pages of analysis in the record of whathe scientific data showed and courts are not in a position to parse throh d second-guess that. >> thank you counsel. >> thank you. >> ms. hawley. >> mr. chitice and may it

please the court. fda approved was not adequate. that violates the apa. the lower court's decision reored long-standing and crucial protections undewhh millions of women used abortion drugs. we have heard lothis morning about standing. article three is satisfied because the fda relies on hospitals to care for women harmed by abortion drugs and concedes that between 9 d 4.6% of women will end up in the emergency room and three the fda acknowledges that women are more likely to need surgical intervention and other medical care without an in person visit. nearly 650,000 women te mifepristone every single year. it is no surprise that respondents experienced an increase in emergency room visits and treated women suffering from abortion drug harms te othousands of times.

-- dozens of times. women's have suffered tens of thousands of times. the respondent doctors will be forced to manage harm is not a bug in the system but part of its desi. ruling against respondents on standing will allow federal agencies to constrict -- conscript nonregulated policies fr sfering other harm without judicial recourse. article three neither demands r permits this. the outsourcing of abortion drug responding to spsive doctors forces them to choose between a woman with a life threatening conditioanviolates their conscience. this choice is intolerable. the fda failed to comply with basic requirements and in 2021 eminated the initial in rson visit based on data that it says elsewhere is unriae and in 2016 it failed to explain the cumulative effects of the wholesale removal of safeguards. these actions arfashort of what was requires and this court

shld affirm. i welcome their questions. >> council, you assert an injury the part of the alliance of diverted time and soces. isn't that just the cost of litigating a psuing this litigation? ms. hawley: i do not think so r a couple of reasons. first what respondent doctors have donishosen their practice as well as structured the medical practi tbring life into the world. and they areald from the labor and delivery floor down to the operatinro to treat a woman suffering from abortion drug harm that is opposed to why they entedhe medical profession and it comes along with emotional harm. drsct talks about them being heartbreaking situations and some of the most stressful work he has had to deal with.

>> this court case specifically said that the nature of the harm was "non-economic" and did not prevent theou from finding an injury. the court look atwo things. etr there was an impairment as the organization's mission and whether there was an expenditure of resources. both of those are satisfied here. if you look at how our organizations have been haed they have been forced to der resources from advocating for their pro-life mission generally explaining the dangers of the rm from abortion drugs.

one of the primary reasons that that is required is because in 2016, the fda took away the requirement that abortio providers report adverse events. >> that would be anye o is grsive or vigilant about bringing lawsuits. just simply by using resources to advocate their poti in court. you say now,t causes an injury which seems easy to manufacture. >> i don't think that is true, juicthomas. i acknowledge they had havens where you had prudto litigation types of activities. to resource justifications don't count. inhicase, if you look at respondent declarations, they perform studies, analyzed uds in several of those are in the record. they are not short. they come through medicaid data to look at the true nature of

adverse events and all those sortof things are neither prudto ligion nor would they have heard abr fda's unlawful conduct. >> the line you quoted about economic crimes had to do with the fact that they did n contend to rent an apartment s there was no economic loss or gain to them renting the aptmt. at i think you are pointing to is that th pvided services on their own. itasn't just the member services they were relying on. they were providing services to people to help them rent apartments. so that is a very important distinction from here. separate from the individual attendance claims of standing based on wasted resources, their resources. the organizationsreot losing

anything. their job is to dextly what you are talking about and they are doing it. they are investigating certain problems but that is not an injury that is her are above by this -- by vacating this rule. >> a couple of things, your honor. where the court system did not economic nature of the interested housing, again, u have to lk the underlying embrace. th respect to our injury. if the regulations are put back place, the protections whereby individual abortion providers would provide o

organizations with more accurate information. >> council, can i as you about the remedy? areblto object for two reasons. one is the emergency nature. manyom 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 don't nto hypothesize. tell me in her declaration which he talks aboutoteing able to object or post a conscientious obction. when she talks about -- can you point me to any place in the declaration where they attempted to object but were unable to? >> no. fotwo reasons. responde dtors don't necessarily know until they scrub into that operating room whether this m omay not b in operation it could be a miscarriage. it could be an elective abortion. the government simply cannot get it story straight. jt heard that the church amendment applies. they called the district court. >> let me ask you -- if we were to find that there were content just objections and tse

doctors do have a way to deal with thesein of procedures, should we in this case on that basis? >> no. because these arouemergency situations. they can't waive process -- precious moments. >> assuming we have a world in which th can actually watch the objectio you say they have. to remedy theirss?t enough do we have to also entertain your argument that no one else in the world can havth drug or no one else in america should have this drug in order to protect your clients? >> it is not possible given the emergency nurof the situation. i am sorry.errupt there. i think justice jackson is a glass spot all tha

-- is saying let's get rid of all that. we should provide a remedy suicnt and go no further. we have a handle individuals. normally we would allow equitable relief to address them . recently i think what justice jackson is colluded to -- we had what one might call aas of universal injunctions. this seems like a prime exame of what could tning 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 court remedy waspppriate under section 705. it grants reviewing court' the ability. when the parties befe the court are nonregulatedares, the only avenuinhich they could possibly g release is what the parties before the court get. that is for a state issue or in other cases, of a cultur >> why can't the court spe that this reliefto 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 be

impractical. if we are thinking about the situation with regardso . francis -- this is what she does day in and day out and so it seems to say thathe would run -- these two particular aiiff would be missing. that t rulations would still be in place. they would permit things like mail-order abortio. if we look at the merits of what they did in 2021, they relied on two things. they relied first on the data. can understand your impulse there. there are exactly zero universal injunctions. pretty consequential ones. and over the last four years or , e number is something like 60 and may be thanha

they are relatively new things. to ask us to pursue this new remedial force which this court has never adopted. lower court's kind of run with this. i just want to give you one more shot at that. >>ur divorcencapsulates equitable remedies and they have fed from the beginning of the 1h century thathearties before the court get release. in this instance, we have nonregulatedarties, the party cod farmers, ranchers, they are -- the only ailility for police is if the court does something to the fda order or regulation issue. otherwise these parties are simply out of l

et me ask you about your basically -- your basic theory standing. when you did your 123 your opening statemen isounded very problstick to me. i d't remember exactly what the 123 let's say it is something along the lines of representing the doctors and the were a lot of women out there. they are going t have -- they are going to have adverse events. to come to the emergency room and sthere is some probability of the like that one of ou doctors who has a content is objection is going to come face-to-face with one of these women who has an adverse event. is that your theory? >> no. what we think reallyho the report -- the respondent have danny heres that the fda had not knledged. in regulating them, they have continuay said emergencs

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 going to owp in emergency rooms. people are going to come face-to-face with one of our doctors who objects to some aspect of the treatme. that is the theory. >> recentlthink all of that is true. we don't think it isroem with probabilistictaing. here we have seven named plaintiffs in addition. >> does yourhey really depend on you having at least e rson? i te them to say these probability theories based on very nice. ey have nothing to do with our article three requemts. you need a person to be able to

come i and meet the court's regular anng requirements. you agrewi that. sohos your person? you had to pick one and say go rea that and that declaration is going to tell you why we are entitled to be up here. >> dr. francis and doctors gone. >> what about those two doctors gives you e nd of imminent injury let alone the traceability. request to speak to dr. francis at the beginning, there has been some confusion abo t precise nature of the conscious part. if you look at 155 paragraph 15, she is talking about objecting to not only taking theifof a child but also compti that process.

that echoes this decoration at 142 and 143. >> i read that declaration pretty clearly. what actuaemgency treatment has she participated in that e objects to and that she has stated an objection to? >> the prior page talks about what she was required to perform due to a life-threatening emergency. quick she herself performed that. >> that is correct. quick did he have an opportunity tobject? >>o. these are life-threatening situations to scrub out and find something else or treat the woman. quickly when the people with cocious objections to this is they make those objections known. it may be harder, it may be

easier in a particul context but both hospitals have mechanmsn place to ensure the doctors who are allowed to do thiin advance a a allowed to do it at the moment. th say so and when i looked at dr. francis and dr. scott, there's just nothing you have there th suggest there are other requirements. this happened to them in the past. i don't think you have it for either one of those door >> i think we do. given the emergency nature. it is impractical to have an objection launched prior to understandhais going on in that operating room. this is to the district crt fifth circuit brief where the government set the church nor any of the other intended them

to apply - and titing this with the federalovernment saying they don't have conscious protection. >> is it true i decisions hav not relied on probabilistic determination? the court said they were andingecse there was a question about citizenship included on the questionnaire. they would not fill out the census at all. it was probable that thereas some risk that your state would risk losing a representativer would risk losing money under some federal program. you put together this chain of probabilities. >> absuty. 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 substantlisk. e fda admits this is a 533. this is at 5:42. seven won ll need serve -- will need surgical intervention. wh they talk about there being noncase in adverse events from the increased gestational age, the only way they canay that is by ignoring surgical intervention. that is because -- >> wuld we do with the fact thatse two rely on the scope the indiana and texas ha

abolished abortions and abolished them by pills o otherwise. when you get into whether other people are illegally breakg the law -- what does that do -- it is already infinitesimally smalbeuse there are thousands of hospitals in the country. thoundand thousands of places where pregnant women may beufring from miscarriages or otherwise to know or even imagine how one dr. is going to ever actuallsea patient that he or she is going to be forced to intervene on their balf but then add to it that this is lel in the states. >> i think the best answer is a

prologue. we have two examples. when you go out of the state, higher likelihood.ike the -- this tur erooms into those follow-up visits. a woman went to mexico and tu to texas as well as dr. johnson where one we t illinois and returneto indiana. one in five abortions takple out of state in third state like new mexico. the border states in which our doctors reside. >> can i take you backe affidavits? >> you were talking about dr. francis. and as i read her allegatio, she said her ptn was forced toerform a d&c when there was a living fetus.

she said she performed a d&c on a woman who was suffering serious applications but the fact that she performed that do not necessalyean there is no living embryo or fetus cae you can have one aft a miscarriage. if that is right, i think the fficulty here is that these affidavits do read more like conscientious objection as opposed to actually participating in the abortioto end the life. -- and the lgtof the embryo or fetus. do you want to address that? >> sure. i think dr. francis can be read for the broader conscious harm. it is beyond sibley requiring ending and unborn fe

with respect to enore narrow conscious arms whether a doctor may need to end a life, we think there is still sstantial risk. th mns 3.1% of pregnancies will be ongoing, ruing a d&c. 55% of those occur in the emergency room. there is a substantial number of women suffering abortn ug harm. >> not all those will iolve the privacy that will otherwise be viable in an embryo or fetus. you can have complatns or excessive bleeding even afte the abortion is completed in at respect whetherhe is pregnancy tissue remaining. queson.1 is ongoing and the fda says they will need

surgeries to stop bleeding or ongoing pregnancies or failures. >> you have a broad number of doctors in your organization that are dentistsndoctors that are retired. how many members of your organization are a beach i went to hospitals who might be -- >> there are hundreds of them. i think in particular, the named plaintiff our ob/n hospitalists who spent time on delivery floors. >> can you clarify the broader conscious harm from the narrow one? i understood it as justice barrett does but you suggest there is a broad one. what is that? >> in a district court, understand the conscious hm be either taking the le 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 at is enng the life. so what is the broader one? being cplit in the process that takes a number life such as ortion. it is not that hard to -- >> complicit like i wo ithe emergency rm ere this is going on? i amammering -- i am handing em a water bottle? what do you mean complicit in the process? >> this -- atarms our doctors is being involved in completing andhe terms of our declaration an ective abortion. it is not that hard to see why there might be a conscious har if you think about what is involved. >> is being involved in

completed an elective abti. i took that to be a conscientious objection. i think wh justice jackson is askingerhat i asked before of justice barrett is if there is anyroer conscious objection that appears and i am no sure i care all that much abouthdistrict court but it appears in the declarations. >> in this instcecompleting elective abortion means removing an embryo, fetus -- . ancis talks about being required to perform a d&c. >> whether or not there is any live tissue. >> yes, your honor. i wod t you to paragraph 115. they also describe the complicity of harm from being elected -- invvein elective abortion.

these docts st agree about a woman's uteru of fus. in cases like little sisters of the poor. sometie completion doesn'tthat involve surgical intervention. do you have a sense offt ? weayet all the way down the chain to the person having the emergency procedure. my understanding with mef these chemical aboron scenarios is the completion occurs by describing additional meditis. could it be done by another physician? that the dose has been since 2016. i think all the way back to 2001.

it has been appve since 2016. the bestemrs 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 at -- i'm still working onowany circumstances or how often it would be your clients actually have to complete the procedure in theayou are describing. >> the doctors talk about doing this at asa dozen times. removing embryos, fetuses. if you think about 3.1% at 10 weeks -- this has only gone up. the in person vis w both necessary and minimally

buenme -- minimally burdenme these sorts of situations occur less frequthan. >> thank you. >> i am sure you heard the answers of the solicitor genal and counselor for dancoit respect to this act. i would like you to comment on their answers. >> for sure. we don't think there is any case in this court that empowers the fd to ignorotr federal law with respect to the comstock act aselevant here. says drugs should not be mailed either throh e mail or through common carriers. so we think the plaintext is very clear. >> when did you first raise the comstockct >> i thinkt s first raised in district court.

we think exhaustion ds not apply for two reasons. first it would be legally futile . this is a whole another kettle of fish. if you look at section 704, exhaustion is only required in two stces. this isonsistent. the lower court have taken inns. there iso often required or agency will that stays the precin >> pi ask about the traceability of it all? i want you to tell me if you agree with this understanding. even beyond ovg whatever injury you are part -- whatever jury you are trying toro, you have to shift that injury is

traceable to the 2016 and 2021 fda actions that you e challenging and of course that means showin that these incidents you are talking about in the emergency room are caused by wtever incremental increase and risk there is as a result. i guess my first question is do you agree with that statement? what do you need to show? anifou do, how do you satisfy that? why do you satisfy that? ice we believe that we need to show the 2016 and 2020 one action increase the risk of harm. >> i gss we are saying you have to link whatever and for your members he two that incread sk. do you agree with that? >> we do and we agree with that for a couplef asons.

we are not in rtognition. you look at the 2021 acti within traceability status is as j 845 -- without that in person visit, er and other medical care question might be some dpu 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 injurieshayour members have undergone or llndergo? >> t original risk. i think the declarations e really quickly on this. if you look at dr. francis's declaration.

she thoughshsaw an increase in emergency visits from dr. johnson, dr. scott said the same thing. it is tily consistent with fda numbers. 20, the fda said the emperor visit was necessary to preserve women's health because the impression visit is the best opportunity to examine things like -- things to obs pregnancy and age of consent. because t geral said that initial impression visit that had no requirement of an ultrasndr any effort to detect fetal heartbeat except it would not necessarily gi inaccurate read on gestaon age. so i would not necessarily be eliminated? >> i think the fda's unte

ows that race didn't go u if you look at the study, it shows a nearly threefold increase when you have -- when you removed it. it was about 2.1 without. >> when they remove this, it took away the opportunity to d that. i think a cog -- medical organizationth created that are best practice. what is allowed under this is a couple of screening questions. i do think that is nearly as go aan in-person exam. quest let's say that -- let's

st carve out and put asi this - explain to me what additional costs you might have incurred or what your resources had diverted in a way thawod set aside havens. >> putting aside thenc this and present -- o citizen petition, it w car the respondent organization coucted studies and analyzed studies including going through thmecaid data. it included going toheffairs data. cour iould do one of them at roa five. sorry roa 70. those are pretty comprehensive sties. quest at the end of the litigation or were they to the end of? >> to accurately assess the harm fr artion drugs. getting absolutely separate from the negation. that is the only w i which anyone c raise a concern to

e a. 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? >> under this u's administrative procedure, a peer review ino toothless. instd,n this case, we are not asking tt e court second-guess the agency at all burather look at what the fbi id it did so based on their data. iuess i don't understand how thaisot second-guessing

the agency. u are saying the court can look at studies. maybe different studies. maybe the same studies. and critique tironclusions about them. what difference do we owe them at all with respect to their assessment that these studies establish whatt is they say they do about safety and effica? >> and think that is inaccurate to portray. the as being is we are looking at what fta said. it says you ha t have adequate tests. >> did the lower court's go beyond that? representations were major today. they have since been found removed. they are obviously lookingt not just what the fda was looking at. are you asking us to just look at the fda and nothing else?

>> that claim is not even before this crt but with respect to the two clms before the court, the 2015nd021, we think theda is arbitrary. what the fda said is we are going tooo at individual studies and even the we say they are interrelated, we are going to takprections away. that is arbitrary. >> thank you. hank you counsel. on the assocal standing, where do you cross the line to 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 guarantee there wl be a future injury but what is soelling is that respondents don't have a specific example of any doctor ever having to olate this care in violation of their conscience.

this is for the declarations that never specifically say here is how the care is provided. the fact that they don't hava doctor willing to submit that i think demonstrates the past time as it happened and the reason that happed because it is speculative. the are so many links in the chain that would have to occur. it would be about having the federal in play. they said that they voluntarily conducted studies. if that is enough, every organization in this country has standing to challee y federal policth dislike. havenseay could not possibly say that. he does at the oeralance. remedy, justice courses,

justice jackson, you plan out e riking anomaly here of the nationwideate of this remedy. mae 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 only way tpride a remedy therefore was to grant this kd nationwide release that is so far mod from the regulatory authorities that it is ultimately reqrent all women everywhere tohae for this drug. i think it isorth stepping back and thinking about the profound mismatch between that inrynd the remedy of the response obtained. they said the fear that there might be some emergency room doctors who may be presented wi iredibly rare applications and the doctor may have to overement -- we don't think that harm has

materialized but with the court date is entered sweeping nationwide belie that restricts access for every single woman in this count a that causes profound harm. ha t 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