The Fifth Circuit's mifepristone opinion is wrong, part 2
Part 2 of 2: The merits
I’d like to begin this post by thanking the many readers who advised me that my prior post contained a gross error: it incorrectly attributed an extremely famous quotation of Leo Tolstoy to Fyodor Dostoevsky. I have greatly suffered from the embarrassment therefrom. As Dostoevsky actually did say, “The man who has a conscience suffers whilst acknowledging his sin. That is his punishment.” (The post has now been edited.)
To honor Tolstoy’s memory, I have commissioned from Dall-E a marble statue of Tolstoy:
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I feel he would have appreciated that.
With that out of the way, let us turn to the second part of the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA, addressing the merits of the plaintiffs’ challenges.
The Fifth Circuit correctly held that the plaintiffs’ challenge to the FDA’s 2000 approval of mifepristone was barred by the statute of limitations. However, as to the challenges that weren’t time-barred, the FDA could do no right. The Fifth Circuit held that the FDA did not adequately consider safety when it loosened certain restrictions on mifepristone in 2016, also did not adequately consider safety when it decided to stop collecting certain data in 2016, and yet again did not adequately consider safety when it loosened another restriction in 2021.
These holdings are wrong. The FDA’s analysis of safety was more than adequate. The Fifth Circuit had no basis for forcing thousands of women to have surgical abortions, or engage in doctor’s visits that the FDA has determined to be unnecessary, based on the implausible assessment that the FDA did not think hard enough about safety.
The FDA’s 2016 changes to mifepristone’s conditions of use
In 2016, the FDA made three relevant changes to mifepristone’s regulatory regime: it increased the gestational age limit from 49 to 70 days, reduced the number of required in-person clinic visits to one, and allowed healthcare providers other than doctors to prescribe the drug.
One would not know from reading the Fifth Circuit’s decision, but the FDA exhaustively analyzed a massive body of evidence establishing that these changes were safe.
First, the FDA analyzed studies involving over 30,000 women regarding the effect of mifepristone (alongside the second drug in the regimen, misoprostol) at up to 70 days gestation. Among other things, the FDA noted: “Four studies and one systematic review evaluated the exact proposed dosing regimen through 70 days gestation. These include three prospective observational studies (Winikoff et al 2012, Boersma et al, Sanhueza Smith et al) and one randomized controlled study (RCT) (Olavarrieta et al) that had a primary objective of evaluating medical abortion provision by non-physicians. The systematic review by Chen and Creinin covered 20 studies including over 30,000 women; all but one of the studies used the proposed regimen in gestations through 70 days.” The FDA concluded that mifepristone and misoprostol work as well at 70 days as they do at 49 days.
Second, the the FDA reduced the number of required in-person clinic visits to one based on 11 studies, with over 30,000 participants, confirming that the home use of misoprostol (i.e., the second drug in the regimen) was safe. Based on these studies, the FDA concluded: “The studies reported on large numbers of women in the U.S. who took misoprostol at home. The authors showed that home administration of misoprostol, as part of the proposed regimen, is associated with exceedingly low rates of serious adverse events, and with rates of common adverse events comparable to those in the studies of clinic administration of misoprostol that supported the initial approval in 2000. Given that information is available on approximately 45,000 women from the published literature, half of which incorporated home use of misoprostol, there is no clinical reason to restrict the location in which misoprostol may be taken.”
Third, the FDA authorized non-doctors to prescribe mifepristone based on “data on the efficacy of medical abortion provided by non-physician healthcare providers, including four studies with 3,200 women in randomized controlled clinical trials and 596 women in prospective cohorts.” According to the FDA’s reviewer, the “studies were conducted in varying settings (international, urban, rural, low-resource) and found no differences in efficacy, serious adverse events, ongoing pregnancy or incomplete abortion between the groups.” In fact, in a “randomized controlled equivalence trial of 1,068 women in Sweden who were randomized to receive medical abortion care from two nurse midwives experienced in medical terminations and trained in early pregnancy ultrasound versus a group of 34 physicians with varying training and experience,” the study showed “fewer complications for the nurse midwife group, though this was not statistically significant.” The FDA observed: “Midlevel providers are already practicing abortion care under the supervision of physicians, and the approved labeling and the REMS Prescriber’s Agreement already stipulate that prescribers must be able to refer patients for additional care, including surgical management if needed. Therefore, facilities that employ midlevel prescribers already have an infrastructure in place for consultation and referral.”
The FDA recognized that it was making several changes at the same time, and therefore should consider studies considering how these changes work together: “As these major changes are interrelated, in some cases data from a given study were relied on to provide evidence to support multiple changes.” For example, the FDA chose three studies (Winikoff, Boersma, and Sanhueza) both for purposes of assessing the 70-day gestational age limit and for purposes of assessing home use of misoprostol. Indeed, the FDA’s brief in the Fifth Circuit points out:
One peer-reviewed study (Sanhueza Smith) evaluated the relevant dosing regimen through 70 days gestation with an in-person follow-up seven days later. ROA.2179, 2182, 2210. The only distinction is that the 2016 changes offer prescribers flexibility on how to conduct follow-up. ROA.2208-2209. Another peer-reviewed study (Winikoff 2012) evaluated the proposed dosing regimen through 70 days gestation, with an ultrasound to confirm gestational age and an in-person follow-up 7-14 days later. ROA.728, 2171, 2179, 2182.
In addition, in its assessment of the 70-day gestational age limit, the FDA went out of its way to rely on a study (Olavarrieta) that “had a primary objective of evaluating medical abortion provision by non-physicians.”
Not good enough, says the Fifth Circuit.
The Fifth Circuit says that all of these changes have to be rolled back for the following reason (pp. 44-45):
FDA admits that none of the studies it relied on examined the effect of implementing all of those changes together. It studied the amendments individually. FDA Medical Review of 2016 Amendments at 32–38 (Mar. 29, 2016) (gestational age); id. at 38–41 (in-person appointments); id. at 43–44 (prescription by non-physician). And some clinical trials considered “multiple changes.” FDA Summary Review of 2016 Amendments at 5–9. But FDA neither considered the effects as a whole, nor explained why it declined to do so. The cumulative effect of the 2016 Amendments is unquestionably an important aspect of the problem; indeed, that was the whole point of FDA’s action. Because FDA failed to seek data on the cumulative effect, and failed to explain why it did not, its decision to approve the amendments was likely arbitrary and capricious.
The Fifth Circuit correctly acknowledges that there’s no requirement that the FDA review a study that precisely mirrors the new regulatory regime, but then goes on to say (p. 45):
The problem is not that FDA failed to conduct a clinical trial that included each of the proposed changes as a control. It is that FDA failed to address the cumulative effect at all. At a minimum, the agency needed to acknowledge the question, determine if the evidence before it adequately satisfied the concern, and explain its reasoning.
The Fifth Circuit’s decision is wrong.
The FDA’s decision was neither arbitrary nor capricious. It is obvious that the FDA considered the cumulative effect of its actions, and its failure to utter the magic words “we are considering the cumulative effect of our actions” does not justify wiping out all of those actions.
To satisfy its obligations under the Administrative Procedure Act (APA), an agency must articulate a “rational connection between the facts found and the choice made.” Bowman Transp., Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 285 (1974). While a court will not “supply a reasoned basis for the agency's action that the agency itself has not given,” it “will uphold a decision of less than ideal clarity if the agency's path may reasonably be discerned.” Id.
A recent Supreme Court decision illustrates this principle in action. Before non-citizens are removed from the United States, they generally get a hearing before an immigration judge, subject to review in the Board of Immigration Appeals and then deferential review by a federal court. For many years, the Ninth Circuit had the habit of deeming non-citizens’ statements in these hearings to be true unless the immigration judge or Board of Immigration Appeals made an explicit finding that the alien was not credible. In Garland v. Ming Dai, 141 S. Ct. 1669 (2021), the Supreme Court unanimously told the Ninth Circuit to knock it off. As relevant to us, here’s what it said:
Of course, reviewing courts remain bound by traditional administrative law principles, including the rule that judges generally must assess the lawfulness of an agency's action in light of the explanations the agency offered for it rather than any ex post rationales a court can devise. See, e.g., SEC v. Chenery Corp., 318 U.S. 80, 63 (1943). But none of that means the BIA must follow a particular formula or incant “magic words” like “incredible” or “rebutted” to overcome the INA's presumption of credibility on appeal. Cf. INS v. Aguirre-Aguirre, 526 U.S. 415, 431-432 (1999). To the contrary, a reviewing court must "uphold" even "a decision of less than ideal clarity if the agency’s path may reasonably be discerned." Bowman Transp., Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 286 (1974); see also 5 U.S.C. § 701 et seq. So long as the BIA's reasons for rejecting an alien’s credibility are reasonably discernible, the agency must be understood as having rebutted the presumption of credibility. It need not use any particular words to do so.
Similarly, here, the FDA wasn’t required to use any “particular words” to demonstrate that it adequately considered the cumulative effect of the changes. Instead, as long as the FDA’s path “may reasonably be discerned,” its decision must be upheld.
That standard is easily satisfied here. The FDA plainly considered the cumulative effect of the changes to the conditions of use and concluded that the new conditions of use were safe.
How do we know the FDA considered the cumulative effect of the changes? The FDA said: “As these major changes are interrelated, in some cases data from a given study were relied on to provide evidence to support multiple changes.” Why would the FDA say this unless it was considering the cumulative effects of these changes?
Also, do you really think the FDA somehow forgot it was making multiple changes at once? FDA officials think about drug interactions like plumbers think about pipes. All day, every day, FDA officials read studies about how drugs interact with other drugs. The Fifth Circuit does not need to educate the FDA on the proposition that “if you make multiple changes, think about how those changes will interact.”
OK, so why did the FDA conclude that the changes to mifepristone’s conditions of use, taken together, were safe?
Because it looked at lots of studies saying the changes were individually safe, as well as multiple studies saying that various combinations of the changes were safe, so it made the predictive judgment that the changes, together, were safe.
This is certainly a rational conclusion; in fact, in my opinion, it’s the only rational conclusion on this record. “Getting mifepristone from a non-doctor” and “taking misoprostol at home” aren’t like taking two different medicines that might have some weird chemical reaction when combined. If women in the “got mifepristone from a non-doctor” cohort had identical outcomes to women in the “got mifepristone from a doctor” cohort, and women in the “got mifepristone from a doctor” cohort didn’t have negative outcomes when they took misoprostol at home, it ineluctably follows that women in the “got mifepristone from a non-doctor” cohort also won’t have negative outcomes if they take misoprostol at home. And ditto for the other combinations of changes.
Sure, if getting mifepristone from a non-doctor (supervised by a doctor) led to worse outcomes than getting it directly from a doctor, then those worse outcomes might theoretically be exacerbated if women who got the mifepristone from the non-doctor then took the misoprostol at home. But the FDA concluded upon an exhaustive analysis of the literature that getting mifepristone from the non-doctor didn’t lead to worse outcomes than getting it from a doctor, so it makes no sense to say that taking misoprostol at home is safe for one cohort but not the other.
So why didn’t the FDA come out and say “we’ve considered the changes together, and made a predictive judgment that, taken together, they’re safe”?
As far as I can tell (I haven’t grinded through the entire agency record), no one suggested during the agency proceeding that there might be some strange interaction between the changes that would make them uniquely dangerous if they occurred together, even if they were individually safe and various combinations of them were safe.
Notably, the Fifth Circuit doesn’t offer any kind of theory of why, in light of the FDA’s findings regarding the individual changes and its express consideration of studies of combinations of changes, there might be some additional increment of risk if all three changes were made at the same time. It just asserts that the FDA failed to explicitly address an illogical argument that apparently wasn’t made during the agency proceeding, so the FDA loses.
I don’t think the FDA made any kind of error, but if it did, the APA requires that “due account shall be taken of the rule of prejudicial error.” I don’t understand how the plaintiffs, or anyone else, were prejudiced by the FDA’s failure to add a sentence saying “we haven’t forgotten that we’re making several changes! But we’ve looked at lots of studies regarding each change, as well as several studies with various combinations of the changes, and everything looks good, and no one has given any reason why the safety profile would change if we make all three changes at the same time, so we find that the new conditions of use are safe.”
At most, the proper remedy would be “remand without vacatur.” In the Fifth Circuit, remand without vacatur is appropriate when “there is at least a serious possibility that the agency will be able to substantiate its decision given an opportunity to do so.” Texas v. United States, 50 F.4th 498, 529 (5th Cir. 2022). Obviously there’s a serious possibility that the FDA will be able to substantiate its decision given an opportunity to do so. One extra paragraph saying that the agency didn’t forget to consider the cumulative effect of all three changes and did, in fact, make the predictive judgment that they’re safe would be good enough.
But the Fifth Circuit refuses to enter the remand-without-vacatur remedy. Instead, it insists on vacating the FDA’s decision. Why? Because: “‘it is far from certain’ that FDA could cure its mistakes with further consideration” (p. 60).
I don’t get it. Why is this “far from certain”? It is, or at least should be, 100% certain that the FDA could cure its purported mistake simply by saying that it considered the full record and made the predictive judgment that the changes, in combination, were safe. The Fifth Circuit explicitly acknowledges that “FDA is not required to conduct a study that perfectly mirrors the conditions under which the drug will be used” (p. 45). The sole asserted defect is the FDA’s failure to make an explicit on-the-record predictive judgment that the changes, in combination, are safe. So why wouldn’t making this judgment on the record cure the failure? Or is the Fifth Circuit just saber-rattling and saying that if the FDA cures the alleged failure, the Fifth Circuit will just find some other reason to hold that the FDA didn’t adequately consider safety?
The Fifth Circuit also says: “The record does not tend to show that FDA would have arrived at the same decision if it had considered those things” (p. 60).
Really? The FDA exhaustively studied the changes and found them safe. It acknowledged the changes are interrelated and studied combinations of the changes. Does the Fifth Circuit seriously think that if the FDA is reminded “don’t forget, you are doing three things,” the FDA would say “oh we totally forgot, guess these changes are unsafe after all”?
In my view the Fifth Circuit’s decision on the 2016 changes to mifepristone’s conditions of use is clearly wrong. But the Fifth Circuit doesn’t stop there.
The FDA’s 2016 changes to data reporting
In 2016, when it was changing mifepristone’s conditions of use, the FDA made an additional change to data reporting requirements.
When mifepristone was approved in 2000, the FDA required prescribers to report all serious adverse events—both fatal and non-fatal. In 2016, the FDA decided that, going forward, prescribers would only have to report fatal events. The approving official reasoned: “After 15 years of reporting serious adverse events, the safety profile of Mifeprex is essentially unchanged. Therefore, I agree that reporting of labeled serious adverse events other than deaths can be collected in the periodic safety update reports and annual reports to the Agency.”
In 2021, the FDA rejected a challenge to this change. It offered the following additional explanation:
We acknowledge that there is always a possibility with any drug that some adverse events are not being reported, because reporting to the Agency’s MedWatch program by health care professionals and patients is voluntary. We do not agree, however, that the 2016 changes to the prescriber reporting requirements limit our ability to adequately monitor the safety of mifepristone for medical termination of pregnancy. Prior to the 2016 approval of the S-20 efficacy supplement, we assessed approximately 15 years of adverse event reports both from the Applicant and through the MedWatch program and determined that certain ongoing additional reporting requirements under the Mifeprex REMS, such as hospitalization and blood transfusions, were not warranted. This assessment was based on the well-characterized safety profile of Mifeprex, with known risks occurring rarely, along with the essentially unchanged safety profile of Mifeprex during this 15-year period of surveillance. Accordingly the Prescriber Agreement Form was amended as part of our 2016 approval of the S-290 efficacy supplement to require, with respect to adverse event reporting, only that prescribers report any cases of death to the Applicant.
To me this explanation looks completely reasonable. There’s no statutory or regulatory requirement to require prescriber reporting of non-fatal adverse events. It’s within the agency’s discretion. The agency exercised its discretion and concluded that prescriber reporting wasn’t necessary anymore. The FDA is allowed to do this without being second-guessed.
The FDA also pointed out that the drug manufacturer, Danco, does have to report non-fatal serious adverse events:
We also note that the reporting changes to the Prescriber Agreement Form as part of our 2016 approval do not change the adverse event reporting requirements for the Applicants. Like all other holders of approved NDAs and ANDAs, the Applicants are required to report all adverse events, including serious adverse events, to FDA in accordance with the requirements set forth in FDA’s regulations. FDA also routinely reviews the safety information provided by the Applicants in the Annual Reports. As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.
Again, seems completely rational. The FDA is getting reports from Danco, it doesn’t also need reports from prescribers.
Yet, the Fifth Circuit finds this change to be arbitrary and capricious.
It reasons as follows (pp. 45-46):
The second important aspect that FDA failed to consider is whether it needed to continue to collect data of non-fatal adverse events in light of the “major” changes to the mifepristone REMS. When considering the data collection question, FDA reasoned that non-fatal adverse events did not have to be recorded because the risks associated with mifepristone were well known. FDA Summary Review of 2016 Amendments at 26 (“[A]fter 15 years of reporting serious adverse events, the safety profile for Mifeprex is essentially unchanged.”). But FDA failed to account for the fact that it was about to significantly loosen mifepristone’s conditions for use. At no point during the decision did the agency acknowledge that the 2016 Amendments might alter the risk profile. And when FDA addressed this subject in its response to the 2019 citizen petition, it just referred back to its statement that the risks were minimal under the 2011 REMS. See 2021 Denial Letter at 20. We conclude that FDA ignored “an important aspect of the problem,” Michigan, 576 U.S. at 752 (quoting State Farm, 463 U.S. at 43), and that its explanation of the basis for the change contains significant “shortcomings.” Sw. Elec. Power Co., 920 F.3d at 1018–19. This also likely violates the APA.
This reasoning is incorrect.
The Fifth Circuit holds that “At no point during the decision did the agency acknowledge that the 2016 Amendments might alter the risk profile.” But the FDA concluded that the 2016 Amendments didn’t materially alter the risk profile! That’s why it approved them!
If (a) mifepristone is safe enough that prescriber reporting isn’t necessary, and (b) the FDA has just exhaustively studied a zillion studies showing that its changes to the conditions of use won’t alter safety, then it follows that (c) prescriber reporting isn’t necessary under the new conditions of use, either.
To me this is so obvious that I don’t understand why the FDA has to spell this out, but this alleged defect could be cured with a couple of extra sentences: “We realize that we’re changing the conditions of use, but we’ve just finished analyzing lots of studies saying that mifepristone will be just as safe after as before those changes. Therefore, the changes don’t alter our judgment that prescriber reporting isn’t necessary anymore.”
Again, assuming the FDA erred by failing to explicitly say this, which I doubt, this is a classic case for remand without vacatur to add these extra sentences. But the Fifth Circuit refuses the remand-without-vacatur remedy, again without any meaningful explanation.
The FDA’s 2021 and 2023 changes
So what’s the big deal? Seems pretty harmless to force prescribers to do some more safety reporting, no?
Sure, but that’s not what the Fifth Circuit does. Instead, it holds that the 2016 decision to end the prescriber-reporting requirement tainted the agency’s subsequent mifepristone-related decisions.
Specifically, in 2021, the FDA decided that it would temporarily stop enforcing the requirement of in-person dispensing of mifepristone. In 2023, it decided to make this change permanent.
The FDA concluded that this change would be safe based on two sources of information: (1) adverse events that had been reported, and (2) studies.
First, the FDA examined adverse events that had been reported and concluded that “there does not appear to be a difference in adverse events when in-person dispensing was and was not enforced and that mifepristone may be safely used without in-person dispensing.”
Was data regarding adverse events as voluminous as it would have been if there was mandatory prescriber reporting of adverse events? No. But Danco was required to report adverse events if it learned of them, so the FDA did have some data. Based on the FDA’s study of the data in its possession, it didn’t find any reason to believe that women are better off if they get mifepristone in person.
Second, the FDA exhaustively analyzed the published literature on this issue—a total of 12 studies. The FDA concluded, in a nutshell, that the studies weren’t that great and weren’t independently sufficient to conclude that in-person dispensing is safe, but that the studies were at least consistent with the conclusion that it’s safe.
The FDA’s reasoning should have satisfied APA review. The data might not be perfect, but the FDA examined all of the data available to it and made a reasonable judgment based on those data. Agencies are allowed to do this. The FDA “did not have perfect empirical or statistical data. Far from it. But that is not unusual in day-to-day agency decisionmaking within the Executive Branch. The APA imposes no general obligation on agencies to conduct or commission their own empirical or statistical studies.” FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1160 (2021). “In the absence of additional data from commenters,” the FDA “made a reasonable predictive judgment based on the evidence it had.” Id.
But the Fifth Circuit decides that this was arbitrary and capricious, too.
Why? The Fifth Circuit basically punishes the FDA for its decision in 2016 to end the prescriber reporting requirement (pp. 49-50):
First, FDA gave dispositive weight to adverse-event data in FAERS—despite the uncontested limitations of doing so. Recall that, because of the 2016 Amendments, FDA no longer had access to perhaps the best source of data: the prescribers. The agency is responsible for its own inability to obtain probative data; it cannot then cite its lack of information as an argument in favor of removing further safeguards.
It then says that the adverse-event reporting database doesn’t contain as much data as it would have contained if the FDA had continued to require prescriber reporting (pp. 50-51). It also criticizes the FDA for relying on studies that weren’t adequate, on their own, to establish the safety of eliminating in-person dispensing (pp. 51-52). The Fifth Circuit concludes as follows (p. 53):
In the face of concededly limited data, and lacking more probative information from prescribers, FDA fell back on studies that were merely “not inconsistent” with its intended conclusion. It did not refer to any literature that affirmatively supported the notion that mifepristone would remain safe and effective even without the in-person dispensing requirement.
Once again, I strongly disagree with this reasoning.
When a federal agency decides that something is safe, a federal court shouldn’t overturn that decision because the agency could, theoretically, have collected more safety data. It’s always possible to collect more safety data. At some point, the cost of collecting extra safety data exceeds the benefit.
Here, in 2016, the FDA concluded that the cost and hassle of requiring prescriber reporting of non-fatal events exceeded the benefits. This is hardly a novel conclusion: for the vast majority of medicines, there is no prescriber-reporting requirement. The FDA is allowed to reach that conclusion, and in fact I welcome an FDA that’s willing to acknowledge that more safety reporting isn’t always better.
Having reached that conclusion in 2016, the FDA subsequently received less information about mifepristone than it otherwise would have received. That was the expected and natural outcome of the data-reporting change. That doesn’t mean the FDA should be paralyzed and terrified to make further changes to mifepristone’s conditions of use. The FDA determined in 2016 that even without prescriber reporting, it would receive sufficient data to make informed decisions. Having reasonably made that determination, the FDA should be allowed to rely on the data it collects rather than being criticized for failing to collect more data.
Note the difficult situation that the FDA now faces. The FDA can’t make any changes regarding mifepristone’s conditions of use, apparently, because it hasn’t collected safety data for the past seven years that it didn’t think it needed. But the FDA can’t start collecting that safety data, at least with respect to the 2016 changes, because the 2016 changes have been rolled back too! The FDA has to start again from scratch, secure in the knowledge that if it does anything other than completely ban mifepristone, it will get sued again in Amarillo, Texas.
I’d like to close by observing that this litigation illustrates our legal system at its most dysfunctional. Consider a woman who is eight weeks pregnant in say, New York, who wants to end her pregnancy with mifepristone. The FDA thinks that isn’t too risky. Her state government thinks that isn’t too risky. Her doctor thinks that isn’t too risky. She thinks that isn’t too risky. Yet if the Fifth Circuit’s decision stands, all of those judgments are worth nothing. The Fifth Circuit gets to overrule everyone else based on its view that more analysis of safety is needed. So, for that woman, it’s just too bad. She has to either get a surgical abortion she doesn’t want or continue a pregnancy she wants to, and is legally permitted to, terminate.
Or, consider a woman who is five weeks pregnant in New York who wants to receive mifepristone without having to see a doctor in person. The FDA thinks it’s unnecessary for her to see a doctor. Her state legislators think it’s unnecessary for her to see a doctor. Her doctor says it’s unnecessary for her to see her doctor. She thinks it’s unnecessary for her to see her doctor. It doesn’t matter. All must yield to the Fifth Circuit’s judgment that she has to see her doctor.
And so she has to get a surgical abortion, or do a doctor’s visit that both she and her doctor feel is useless, to protect against the theoretical risk that she’ll have an incredibly rare complication and then randomly switch to a pro-life doctor who doesn’t want to take care of her. Our legal system should not operate this way, and I am hopeful that the Supreme Court will not stand for it.
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