Justice [ ]: Is there a number of consequences or a higher likelihood which would confer standing?
Answer: Its hard to imagine it could. We could pick out different links in the chain and wildly depart from the facts, that 1-2% of those events being more likely. But we object to the entire theory, that independent decisions not party to the lawsuit are involved and make it all speculative and uncertain, too much to confer standing.
Answer: No. States do not have standing in this scenario.
Justice []: A doctor on duty, woman has complications from the drug, this one is the only one who can attend. Doctor has to abort a viable fetus to save her. Does that doctor have standing?
Answer: That would constitute past harm and is cognizable. That situation hasn't come to pass,
Justice []: Is there anyone who can sue? Shouldn't someone be able to challenge that in court?
Answer: With respect to these changes, it is hard to find someone with standing to sue. But this Court has said lack of cognizable standing does not mean that the Court dispenses with Article III requirements.
Justice []: So the American people have no remedy?
Answer: Not Article III jurisdiction, but adjustments can be made, the tort system holds the companies/sponsors responsible. There are remedies outside the court system.
Justice Barrett: Can you distinguish the diversion of resources theory of standing in Havens (organizational injuries case, unclear on spelling).
Answers: Havens said that it was not blessing a theory of standing that allows an organization to obtain standing on abstract harms and still seeks concrete harm. Some read it as a broad case, but we have rejected this routinely. It would confer standing on all associations.
Justice []: What about with respect to individuals? How about standing under the Establishment Clause, or other first amendment precedent?
Answer: That is first amendment case law...
Justice[]: Well standing is standing. So how do we square that?
Answer: Generally it's a situation with a direct government action creating that injury. The FDA approval was so far upstream of the downstream harm, does not confer standing.
Justice []: Why didn't the FDA consider the changes in conjunction with each other. Can't small harms create bigger harms when combined that none in isolation may?
Answer: There is simply not that kind of correlative or inconnected effects. And there are newer studies which considered them as the standard of care evolved over time.
Justice []: Shouldn't the FDA have at least said we considered the arguments and provided some explanation to maintaining the restrictions due to Comstock?
Answer: We don't believe the FDA could permissibly even respond to that. However they did have a memo on Comstock, advice from OLS, conveying the interpretation of Comstock. (But not included originally in response, but in the updated record).
Justice []: (Reads off "no additional serious adverse effects") is this sufficient reasoning here?
Answer: Yes. They looked at the studies, they found there was not sufficient link. Looked at safety and efficacy, and clearly meets the zone of reasonableness under arbitrary and capricious analysis.
Justice Sotomayor: All drugs have side effects, whatever the statistical increase was, the FDA determined it wasn't sufficient to create a risk that counterbalanced the need for it?
Answer: Yes. On balance there was no reason to keep the rules in place as they were.
Justice []: Is this still true: "To the government's knowledge this marks the first time any court has restricted access to an FDA drug by second guessing the FDA conditions required for safe use."
Answer: Yes in this kind of way, although as part of a worrying trend of overturning other various FDA judgments.
Justice Barrett: Would there still be federal conscience protections even if the affidavit objected to transfusions and other care provided after the abortion?
Answer: Yes, it is tied to the nature of the doctor's beliefs and not the specific procedures.
Justice Jackson: I'm worried there is a mismatch between the claimed injury and the remedy being sought. That might or should matter for standing, but I don't know if our doctrine captures this. The injury appears to be a conscience injury alone, the obvious remedy is an exemption. You say that federal law provides that. I guess then is they are asking for more than that. ...
Justice Jackson: I am wondering how they could possibly be entitled to their remedy when it doesn't seem to match the claim.
Answer: We agree. If they have a conscience objection, then they have a federal protection and process already. Their remedy specific to them, but applied to everyone, would be way, way too broad a remedy. This is all because the injury is so attenuated that it almost required a broad remedy.
Justice Jackson: Setting aside standing, have you thought about how a ruling on statute of limitations would affect this kind of case?
Answer: If this court approved a broader theory of statute of limitations, it would create a huge amount of challenges (this being the ability to challenge old rules which only recently applied to you because you entered the market, as opposed to from start of the rule being implemented).
Thomas: How would you argue against that your stance violates the Comstock Act?
Answer: The FDA routinely approves drugs that are restricted or regulated by other statutes. This would invite mischief if agencies could take actions on legislative responsibilities assigned to other agencies.
Justice []: When does something become risky enough to infer standing? What % of adverse consequences, emergency room visits, etc?
Answer: It is whether there is an "attenuated chain of contingencies" that must happen, especially with third-party decisions not party to the lawsuit making specific decisions together.
Justice []: How is your company aggrieved by the challenge? The Fifth Circuit doesn't prohibit the production or sale of the product? So the injury is that you think you will sell more?
Answer: Yes, Yes, Yes. We are prevented from selling our product in line with FDA guidelines on safety and health.
Justice []: The statement that no court has second guessed the FDA's judgment about access to a drug was said before. Is the FDA infallible?
Answer: No, but that is not a question in this case here. We believe the fact that the FDA has screwed up is why the after-market surveys and studies. If there was an unknown safety component, they can take steps to bring that to the FDA's attention.
Justice []: Should the FDA had stopped reporting on the adverse effects when they did?
Answer: They did that after 15 years of not seeing any issues.
Justice []: Why wouldn't you want that data?
Answer: Sure, it is part of the reporting obligations for manufacturers. I think you are getting at who would have standing if anyone, though. And we are subject to torts all the time.
Justice []: What are the normal standard for adverse effects reporting?
Answer: Danco's reporting has not changed. Prescribers report to Danco, and we have obligations to report to FDA. There are only seven others that have the reporting mifepristone gets (I believe that was what she said).
Justice Jackson: As a company with pharmaceuticals, do you have an issue with judges parsing scientific studies?
Answer: Yes. Companies are reliant on the FDA's approval process for when drugs are safe enough to provide. There have been two studies that were used in this Mifepristone case that have been retracted. Judges are not statistic experts, do not know the methodology. It is why the FDA are experts.
Intro: Abortion bad. So much mifepristone everywhere. So much harm. Violating consciences without judicial recourse. Article III no like. On the merits FDA failed to comply with the APA. Used data it found unreliable. Ignored cumulative effects of the removal of safeguards. The APA requires more.
Justice Thomas: Diverted time and resources as an injury for standing. Isn't that just a cost of pursing this litigation?
Answer: No. Respondents chose their specific practices to bring life into the world. Treating abortion drug harm, it is opposed to their reason for providing care. Just so stressful for them!
Justice Thomas: Specific to diversion of resources as organizational standing though.
Answer: This court has said that the nature of the harm was non economic did not prevent the court from finding an injury. Whether there was an impairment of the org's mission and expenditure of resources. Both satisfied here.
Justice Sotomayor: Is there not a distinction that the organization in our cases were providing services directly, whereas here the organization itself is not losing anything, it is merely to investigate problems as it was designed to do. That isn't redressable, no?
Answer: We interpret it as not only being about the economic cost, but that the Court was broader and applied to to the noneconomic costs to the members of the org.
Justice Jackson: Do the doctors not already have an exemption, such that the prevent the potential injury, we should prevent anyone from having the drug. Why is that not plainly overboard as a remedy?
Answer: We don't believe the doctors can object. These are often emergency situations. For example...
Justice Jackson: I don't want a hypothetical. Use her declaration. Point me somewhere. Where is the actualized objection.
Answer: [Doesn't actually answer] The government cannot get its story straight on EMTALA!
Justice Jackson: Let's say that we find some actual objection. And they can lodge objections they have and receive accommodation. Why does that not remedy the harms your client faces?
Justice []: Interjecting, I think what Justice Jackson is saying is that normally we would allow equitable relief to address them specifically. Recently, we have had a rash of universal injunctions and vacateurs. This seems like a nationwide legislative act when it should be a narrow remedy.
Answer: This was necessary and appropriate relief. Without that relief, the parties will not get it.
Answer: Equity before the courts require the parties get relief. These are unregulated parties, but the only availability for relief is to d something to the FDA regulation at issue. Otherwise the parties are out of luck because of the unregulated parties involved.
Justice Sotomayor: Your three injuries seemed pretty probabilistic and uncertain. What is your theory if not based on probabilistic theory?
Answer: The FDA's own acknowledgments provide us standing. They provide that doctor's are critical to
Justice Sotomayor: So your theory is that some person will come face-to-face with one of your doctors at some point? Why isn't that probabilistic? Who is your person who has the clearest injury
Justice Alito: Have we not had probabilistic standing? What about the immigration question on the census case? Where there was a probability that we might undercount and we would lose money for funding, etc.
Answer: We agree! There have been cases on how far bees might fly. Here, the FDA admits that 2.9-4.6% will go to the emergency room. That up to 7% will need surgical intervention. The FDA had to have ignored this.
Justice Sotomayor: What do we do with your two individuals, when states have abolished abortion. What does that do to your probability. It is already infinitesimally small.
Answer: The best answer is that past is prologue. We have doctors who treated things. There are cases where the FDA rules will likely mean emergency rooms will be the follow-up visits. It will cause more harm.
Justice Barrett: A D&C doesn't mean there was a living fetus, right? You can have a D&C after a miscarriage? These affidavits really seem like conscience objections, but not actual injuries. The two you provide don't seem to have been involved... at all.
Answer: There is still a substantial risk of these things occurring. Some percent will have pregnancies ongoing that will not be after a miscarriage.
Justice Jackson: You suggest there is a broader conscience objection. What is that?
Answer: The conscience harm is either taking the life of an unborn child (Jackson: this is the narrow one) and the other being complicit in providing healthcare which is connected to taking life.
Answer: There are procedures like D&C which are related to broader objections than being directly involved. (Her answer is muddled, so I'm not sure that even makes sense).
Justice Thomas: On Comstock, I'd like you to comment on the other side's answers.
Answer: We don't think there is any case of this Court that allows the FDA to ignore federal law. Comstock says drugs should not be mailed through common carriers or mail. It seems clearly applicable.
Justice Sotomayor: What about tradability of the injury to the FDA actions being challenged. Showing that these incidents you're talking about are caused by the incremental increase in risk of the 2016/21 actions. Do you agree with that? And if so, how do you satisfy that?
Answer: Yes. Traceability is de facto and satisfied by FDA's finding lack to in-person visits and increased risk.
Justice Barrett: Prelagar said that an in-person visit wouldn't necessary provide for gestational age or pregnancy problems. Why does the elimination increase those risks?
Answer: FDA data shows those risks increased.
Justice Barrett: Was that just because of provision of additional care while you happen to be there?
Justice Barrett: On organization standard. Explain what additional costs or how the resources were diverted to satisfy Havens.
Answer: Respondent organizations conducted studies and analyzed studies.
Justice Barrett: Is... that it?
Answer: Yes but they are pretty comprehensive to assess the harm of abortion drugs. It's separate from the litigation because it was done in response to the lack of reporting.
Prelagar: On organizational standing, there is no indication that there has ever been a specific doctor whose conscience objection was violated and proving a harm. It demonstrates that the past harm didn't happen and is so speculative and would be backstopped by federal objection allowances.
Prelagar: An organization cannot have standing on studies it runs and analyzes or else presents all organizations with potential standing in most cases.
On remedy, the only possibility was a nationwide injunction because the harms are so attenuated and enforcement has to occur so locally. Some doctor, some day, providing some woman, who needs some treatment, that violaties a potential objection in an emergency.
Add comment