Mifepristone and the rule of law, part III
The Fifth Circuit's decision is wrong too.
In a late-night order on April 12, 2023, the U.S. Court of Appeals for the Fifth Circuit partially granted, and partially denied, the FDA’s motion to stay the district court’s order overturning the FDA’s approval of mifepristone. The two-judge majority, composed of Judges Kurt Engelhardt and Andrew Oldham, stayed the district court’s decision with respect to the FDA’s approval of mifepristone in 2000. However, it declined to stay the district court’s decision with respect to more recent actions by the FDA. Most notably, in 2016, the FDA relaxed certain restrictions on mifepristone: 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 it. The district court overturned that decision by the FDA, and the Fifth Circuit denied the FDA’s motion to stay that aspect of the district court’s decision. (The third judge, Judge Catharina Haynes, would have temporarily stayed the district court’s entire order until a merits panel could consider the case more thoroughly.)
The practical effect of the Fifth Circuit’s order is that mifepristone stays on the market, but subject to pre-2016 regulatory requirements. Even on the 2000 order, however, we are not yet out of the woods. The Fifth Circuit said that DOJ was likely to succeed on its argument that challenges to the 2000 order were time-barred, but nonetheless pronounced itself “unsure” (p. 25) on that issue.
Thanks for reading Adam's Legal Newsletter! Subscribe for free to receive new posts and support my work.
The Fifth Circuit’s decision is less wrong than Judge Kacsmaryk’s decision. However, it is still very, very wrong. In this post, I will attempt to explain why.
For the plaintiff-doctors to obtain any relief—even as to the FDA’s 2016 decision—they must have standing. The district court held that that the plaintiffs have both associational standing—i.e., standing based on injuries suffered by their doctor-members—and organizational standing—i.e., standing based on injuries to the organizations themselves. The Fifth Circuit agreed with both holdings.
The Fifth Circuit began by addressing associational standing. At a high level of generality, the Fifth Circuit’s reasoning goes like this:
Lots of women use mifepristone (p. 12).
Statistically speaking, some fraction of those women will go to the emergency room (p. 13).
Statistically speaking, some fraction of the women who go to the emergency room will see the plaintiff-doctors (p. 13).
The plaintiff-doctors are harmed by seeing these women, because they have to devote “significant time and resources to caring” for them (p. 14), face “enormous stress and pressure” (p. 14), and face an “irreconcilable choice between performing their jobs and abiding by their consciences” (p. 16).
“Given how many women those doctors have seen in emergency departments in the past, these doctors quite reasonably know with statistical certainty … that women will continue needing plaintiffs’ ‘emergency care.’” (p. 17). The panel characterizes this as a “crisis” that is “concededly ongoing.” (p. 18).
“Even if one of the named doctors never sees another patient, it’s inevitable that one of the thousands of doctors in plaintiff associations will.” (p. 18).
Let’s start by explaining why this analysis is conceptually wrong, before turning to a more granular discussion of how the Fifth Circuit grossly distorts the record.
Conceptually, the Fifth Circuit’s analysis is irreconcilable with Summers v. Earth Island Institute, 555 U.S. 488 (2009), which, like the district court, the Fifth Circuit does not cite. I have adverted to this case in prior posts, but in view of the Fifth Circuit’s express reliance on the supposed “statistical certainty” of the plaintiff-doctors encountering patients suffering complications from mifepristone, a more detailed analysis is warranted.
In 2002, fire burned a large area of the Sequoia National Forest. In 2003, the Forest Service approved the Burnt Ridge Project, a salvage sale of timber on 238 acres of that Forest. Under the Forest Service’s rules at the time, for salvage sales of less than 250 acres, the Forest Service did not provide a period of public comment and did not make an appeal process available.
In Summers, the plaintiffs were environmental organizations with hundreds of thousands of members. It was undisputed that some of those members were harmed by the Forest Service’s failure to permit the public to comment on the Burnt Ridge Project. For example, one member submitted a declaration under oath stating that he had repeatedly visited the Burnt Ridge site, that he had imminent plans to do so again, and that his interests in viewing the flora and fauna of the area would be harmed if the Burnt Ridge Project went forward without incorporation of the ideas he would have suggested if the Forest Service had provided him an opportunity to comment.
However, by the time the case reached the Supreme Court, the challenge to the Burnt Ridge Project had been settled. The plaintiffs nonetheless sued the Forest Service, alleging that the Forest Service’s rules refusing to permit public comment on less-than-250-acre salvage sales were illegal.
Their theory of standing was quite intuitive. The Forest Service acknowledged that “it intends to conduct thousands of further salvage-timber sales and other projects exempted under the challenged regulations in the reasonably near future.” Meanwhile, one of the plaintiff organizations, the Sierra Club, had over 700,000 members. These were environmental organizations, composed of people who like to explore forests. It was statistically almost certain that some of the organizational members would be harmed by some of the thousands of future salvage-timber sales in exactly the same way that the organizational member was harmed by the Burnt Ridge Project.
The dissent, written by Justice Breyer and joined by Justices Stevens, Souter, and Ginsburg, would have held that this statistical certainty is enough. Justice Breyer asked: “How then can the Court deny that the plaintiffs have shown a ‘realistic’ threat that the Forest Service will continue to authorize (without the procedures claimed necessary) salvage-timber sales, and other Forest Service projects, that adversely affect the recreational, esthetic, and environmental interests of the plaintiffs' members?” Of course, the plaintiffs could not pinpoint which member would be harmed or where the future salvage-timber sale would be, but Justice Breyer observed: “a threat of future harm may be realistic even where the plaintiff cannot specify precise times, dates, and GPS coordinates.”
But the majority opinion—by Justice Scalia, and joined by Chief Justice Roberts and Justices Kennedy, Thomas, and Alito—concluded that the plaintiff organizations lacked associational standing.
In their view, statistical certainty was not enough. The Court began by holding that the declaration of a specific individual, Jim Bensman, did not establish that Bensman suffered a concrete injury that could be remedied by the relief he sought. Although Bensman alleged past injury, this allegation was insufficient for standing because, among other things, “it relates to past injury rather than imminent future injury that is sought to be enjoined.” And although Bensman also alleged future injury, he lacked standing because he failed to “allege that any particular timber sale or other project claimed to be unlawfully subject to the regulations will impede a specific and concrete plan of Bensman's to enjoy the national forests.”
Next, the Court rejected the dissent’s “statistical certainty” theory with reasoning that could be written for this case. Here’s what it said:
The dissent proposes a hitherto unheard-of test for organizational standing: whether, accepting the organization's self-description of the activities of its members, there is a statistical probability that some of those members are threatened with concrete injury. Since, for example, the Sierra Club asserts in its pleadings that it has more than "`700,000 members nationwide, including thousands of members in California'" who `use and enjoy the Sequoia National Forest,'" post, at 1154 (opinion of BREYER, J.), it is probable (according to the dissent) that some (unidentified) members have planned to visit some (unidentified) small parcels affected by the Forest Service's procedures and will suffer (unidentified) concrete harm as a result. This novel approach to the law of organizational standing would make a mockery of our prior cases, which have required plaintiff-organizations to make specific allegations establishing that at least one identified member had suffered or would suffer harm.
The Court then walked through several prior cases and explained: “This requirement of naming the affected members has never been dispensed with in light of statistical probabilities, but only where all the members of the organization are affected by the challenged activity.”
Well, there you go. I don’t think that even the Fifth Circuit could say with a straight face that all members of the plaintiff organizations face a concrete risk of harm based on hypothetical patients entering emergency rooms, especially given that only a small number of members submitted declarations regarding alleged harms in the past. The Fifth Circuit instead reasoned that some unspecified percentage of doctors are statistically likely to encounter patients in the emergency room who suffered complications of mifepristone, which is exactly the reasoning rejected in Summers. The rule of law requires that legal principles be applied neutrally. Article III does not apply differently depending on whether the plaintiffs support progressive causes or conservative causes.
Moreover, conceptually, the Fifth Circuit’s approach would dramatically expand the law of standing. Any federal rule that could in some way be said to reduce “safety” could be challenged by a sufficiently motivated plaintiff organization. Suppose the National Highway Traffic Safety Administration relaxes some airbag requirement. Under the Fifth Circuit’s theory, the American Association of Pro-Car Safety Doctors could sue, on the theory that an unspecified additional number of people will be injured in car accidents and go to the E.R., and some unspecified number of doctor-members will have to treat their injuries, stressing them out.
Even non-safety rules could be challenged on similar theories. Suppose an agency passes a rule that will increase the number of immigrants. Statistically speaking, an E.R. doctor will see an immigrant benefiting from the new rule at some point in the future which might divert resources from other patients, so apparently doctor organizations would have standing to challenge the rule. Now, suppose an agency passes a rule that will decrease the number of immigrants. Statistically speaking, some doctor in private practice somewhere will lose out on an employee at some future point that he hypothetically would have hired, so doctors can apparently challenge that too under the Fifth Circuit’s logic. I doubt the Fifth Circuit would actually reach these conclusions, they are too crazy, but this analysis merely underscores that the Fifth Circuit is applying unique rules to this case because it’s about abortion.
Let’s turn to a closer look at the Fifth Circuit’s reasoning. The Fifth Circuit begins by pointing out that an FDA-approved “Patient Agreement Form” for mifepristone discloses that the patient may encounter fever, heavy bleeding, and stomach pain. The form then recites:
“My healthcare provider has told me that these symptoms listed above could require emergency care. If I cannot reach the clinic/office/provider right away, my healthcare provider has told me who to call and what to do.”
“I know that, in some cases, the treatment will not work. This happens in about 2 to 7 out of 100 women who use this treatment. If my pregnancy continues after treatment with mifepristone and misoprostol, I will talk with my provider about a surgical procedure to end my pregnancy.”
“If I need a surgical procedure because the medicines did not end my pregnancy or to stop heavy bleeding, my healthcare providers has told me whether they will do the procedure or refer me to another healthcare provider who will.”
Based on this information, the panel says this (pp. 12-13):
FDA thus cannot deny that serious complications from mifepristone are certainly impending. Those complications are right there on the “Patient Agreement Form” that FDA itself approved and that Danco requires every mifepristone user to sign. According to the applicants, more than 5,000,000 women have taken this drug since the 2000 Approval. FDA Stay App. 1. That means that, again according to the applicants’ own information, between 100,000 (2%) and 350,000 (7%) of mifepristone users had unsuccessful chemical abortions and had to “talk with [their] provider[s] about a surgical procedure to end [their] pregnanc[ies].” 2023 Mail-Order Decision at 10. And where did those hundreds of thousands of women go for their “surgical procedures”? Again, we need not speculate because the 2016 Major REMS Changes, the 2021 Petition Denial, and the 2023 Mail-Order Decision all allow non-doctors to prescribe mifepristone. The women who use this drug cannot possibly go back to their non-doctor-prescribers for surgical abortions, so again, as the “Patient Agreement Form” itself says, they must instead seek “emergency care” from a qualified physician.
Do you see the problem with this reasoning? Let’s accept, as the panel represents, that “between 100,000 and 350,000 of mifepristone users had unsuccessful chemical abortions” and therefore have to “talk with their providers about a surgical procedure to end their pregnancies.” This cannot possibly affect the plaintiff-doctors because they do not perform surgical abortions. No one is forcing them to do so. The fact that these women were prescribed mifepristone by non-doctor-prescribers is completely irrelevant; perhaps these women will have to go to doctors to get surgical abortions, but not these doctors.
(Also, the panel does not appear aware of basic facts regarding the provision of abortion, such as that some of these women will simply get more medication, and also in many states, Advance Practice Clinicians (APCs) are permitted to conduct aspiration abortions.)
But anyway, the Fifth Circuit then says: “The women who use this drug cannot possibly go back to their non-doctor-prescribers for surgical abortions, so again, as the ‘Patient Agreement Form’ itself says, they must instead seek ‘emergency care’ from a qualified physician.” This is a flat-out lie. The Patient Agreement Form does not say that. It says that if the treatment doesn’t work, the patients should “talk with their providers about a surgical procedure to end their pregnancies”—not that they should go to the emergency room. Instead, the words “emergency care” appear elsewhere on the form, where the patient attests that certain symptoms such as fever or heavy bleeding “could require emergency care.” There is absolutely nothing on this form suggesting that hundreds of thousands of women require emergency care from mifepristone abortions and abundant evidence from the past 23 years showing that this is false.
But even assuming that it was the case that hundreds of thousands of women go to the ER, which it isn’t, this does not show that the emergency room doctors suffer Article III injury. I don’t think doctors are “harmed,” in general, by seeing patients. Seeing patients is their job.
The Fifth Circuit doesn’t seem to think so either, which is why it turns to a discussion of women who allegedly suffer extreme complications, such as “blood transfusions, overnight hospitalization, intensive care, and even surgical abortions” (p. 13). However, all available studies show that these events are extremely rare.
Hence, rather than look at actual data, the panel then turns to anecdotes from two doctors. One of them, Dr. Skop, is the Director of Medical Affairs at the Charlotte Lozier Institute (a pro-life organization). In her quoted statement (p. 13), she doesn’t say that she ever saw patients with these complications; her quotation refers to patients that her “group practice admitted.”
The other doctor, Dr. Francis, is the CEO-Elect of the plaintiff American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG). The quotation from Dr. Francis, as quoted by the Fifth Circuit, is as follows (pp. 13-14):
[O]ne of my patients had obtained mifepristone and misoprostol from a website, without an in-person visit … After taking the chemical abortion drugs, she began having very heavy bleeding followed by significant abdominal pain and a fever. When I saw her in the emergency room, she had evidence of retained pregnancy tissue along with endometritis, an infection of the uterine lining. She also had acute kidney injury, with elevate creatinine. She required a dilation and curettage (D&C) surgery to finish evacuating her uterus of the remaining pregnancy tissue and hospitalization for intravenous (IV) antibiotics, IV hydration, and a blood transfusion. I spent several hours with her the day of her surgery/hospital admission, keeping me from my primary patient responsibilities in the labor and delivery unit and requiring me to call in an additional physician to help cover those responsibilities.
I was intrigued by those ellipses after the word “visit” in the quotation and decided to take a look at the actual source material.
It turns out that the ellipses replace the following sentence: “She was told that the drugs would come from India.” Why is this relevant? First, because an order overturning the FDA’s approval could not possibly have prevented this patient from ordering drugs from a website in India (which I doubt were mifepristone and misoprostol). Second, if the court overturns the FDA’s approval of mifepristone, what do you think desperate pregnant women are going to do? They are going to order drugs over the Internet from foreign countries, causing exactly the type of event that the emergency room doctor is complaining about. Replacing this statement with an ellipses does not make those problems go away.
Anyway, these two anecdotes, offered by people who have leadership positions in organizations devoted to trying to ban abortion, are enough for the Fifth Circuit to declare: “As a result of FDA’s failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects. This harm is sufficiently concrete.”
Next, the Fifth Circuit finds (p. 14):
A second independent injury from the adverse effects of mifepristone is the “enormous stress and pressure” physicians face in treating these women. PI App. 215. One doctor said the strain “is some of the most emotionally taxing work I have done in my career.” PI App. 880. Thus, this is an independent injury because FDA’s actions “significantly affect” the doctors’ “quality of life.” Sierra Club v. Morton, 405 U.S. 727, 734–35 (1972).
The Fifth Circuit asserts that the “doctors offered specific facts to explain this stress.” These specific facts consists of things like the assertion that women may experience “torrential bleeding” (p.14), an anecdote by a doctor complaining about second-hand information about something Planned Parenthood did (pp. 14-15), and other assertions regarding the allegedly dangerous nature of mifepristone, particularly in women with ectopic pregnancies (pp. 15-16).
I must confess to being unsympathetic to emergency room doctors seeking to ban all women from taking mifepristone because they are stressed out about the hypothetical possibility of seeing a patient with side effects from mifepristone at some unspecified point in their lives. Being an ER doctor is a stressful job. If ER doctors are stressed out from seeing “torrential bleeding,” perhaps they should have chosen a different job, rather than filing lawsuits seeking to ban all women from taking mifepristone.
For similar reasons, I am unimpressed by the “injury” doctors face “from the irreconcilable choice between performing their jobs and abiding by their consciences” (p. 16). The court’s theory is that a patient might be prescribed mifepristone, experience complications, switch doctors, come to the ER, and come to one of the plaintiff doctors, who might have to “surgically complete an abortion or remove an unborn child” (p. 16). You will be unsurprised to learn that the court relies once again on the declarations of Dr. Skop and Dr. Francis, who assert that these events have happened at some point in the past (pp. 16-17).
Well, first, I’d think that most doctors—even staunchly pro-life doctors—wouldn’t think it’s a “conscience violation” if they had to save the life of a woman who showed up in the emergency room. Emergency room doctors have to help patients who have been in lots of different life situations, including life situations that the doctors might not approve of. If treating a patient makes you feel “complicit” in whatever the patient did to come to the emergency room, being an emergency room doctor is not the job for you. I find it remarkable that these physicians seek to police the activities of all women and all doctors based on these idiosyncratic convictions.
But setting that aside, it is notable that the declarations are careful not to say that the declarants themselves have had this experience. With respect to Dr. Skop, the Fifth Circuit says this (p. 16):
That same doctor described how she had to “perform a suction aspiration procedure” on one patient who took the pill but needed surgery to complete the abortion. PI App. 206.
Dr. Skop’s declaration actually doesn’t say this. Contrary to the Fifth Circuit’s inaccurate representation, Dr. Skop doesn’t say that she had to perform such an abortion; instead, she says that her “group practice admitted three women to the hospital,” and in one case “the doctors had to surgically finish the abortion with a suction aspiration procedure.” So, some other doctor from her practice admitted a woman, and some other doctor, possibly not even from her practice, performed an abortion (she asserts). As for Dr. Francis’s declaration, it refers to the experience of a “partner” of hers and complains that the “partner felt as though she was forced to participate in something that she did not want to be a part of—completing the abortion.” The unnamed “partner” is not a declarant and we do not know whether this is an accurate representation of her feelings or whether this incident ever occurred.
To be clear, even if these doctors had this experience, this would not establish standing. It is completely conjectural that any of this will happen to the doctors in the future. I’ve been beating this like a drum, but the legal standard for showing standing is that the harm must be “certainly impending.” It is absurd to say that Dr. Skop and Dr. Francis face “certainly impending” harm from this hypothetical possibility that they will experience emotional harm from having to complete a future abortion.
The Fifth Circuit tries to rebut this point by explaining that it is “inevitable that at least one of these doctors in one of these associations will face a harm in the future (p. 17).” It continues: “Several doctors testified that they have seen an increasing number of women coming to the emergency room with complications from chemical abortions due to FDA’s virtual elimination of controls on the dispensing and administration of the drugs (p. 17).”
The Fifth Circuit cites statements from four declarants: Dr. Skop, Dr. Francis, Dr. Wozniak (AAPLOG’s secretary) and one other one, Dr. Johnson. None of them suggest they’ve performed any actual research on this. They just say that they expect that there’s going to be more patients in the emergency room if restrictions on mifepristone are relaxed. For example, Dr. Wozniak declares: “The increasing number of chemical abortions through mail-order or telemedicine methods means that more women will suffer complications from unsupervised use of mifepristone and misoprostol” and “In my observation, incidents of women’s presenting to emergency departments with complaints of bleeding are becoming increasingly more common.” Who cares about the FDA and all of its boring controlled studies! Dr. Wozniak has made “observation[s]” that it is “more common” that women come to emergency rooms complaining of “bleeding,” case closed.
Next we get this from the court (p. 17):
And given how many women these doctors have seen in emergency departments in the past, these doctors quite reasonably know with statistical certainty—again, a statistic estimated on Mifeprex’s own “Patient Agreement Form”—that women will continue needing plaintiffs’ “emergency care.” See PI App. 205, 215, 868. The crisis is “concededly ongoing.” Friends of the Earth, 528 U.S. at 184.
There is minimal, if any, evidence in the record regarding “how many women these doctors have seen in emergency departments,” and certainly minimal evidence regarding how the FDA’s changes in 2016 caused these, or any other, doctors to see additional patients in the emergency room. And, as noted above, the “Patient Agreement Form” does not come close to estimating any kind of “statistic” on the number of patients seeking “emergency care.” Yet from all this, the judges feel at liberty to declare there is a “crisis.”
Then the court says (p. 18):
And even if one of the named doctors never sees another patient, it’s inevitable that one of the thousands of doctors in plaintiff associations will. For example, one of the plaintiff associations, the American Association of Pro-Life Obstetricians & Gynecologists, “is the largest organization of pro-life obstetricians and gynecologists” and has “more than 7,000 medical professionals nationwide.” PI App. 165.
“Thousands of doctors”? Not quite.
Just as the Holy Roman Empire was neither Holy, nor Roman, nor an Empire, the American Association of Pro-Life Obstetricians & Gynecologists is neither American, nor composed of Obstetricians & Gynecologists—at least not exclusively. First, AAPLOG is an international organization: according to Dr. Francis, AAPLOG has “7,000 members across the country and internationally.” This is relevant because foreign doctors would not benefit from a decision overturning the FDA’s approval of mifepristone, which applies only in the United States. Also, anyone can join AAPLOG. You can be a retired physician who will never see a patient again (dues of $125). You can be an active, or a retired, “other healthcare professional,” such as a Licensed Mental Health Clinician (annual dues of $125 or $75 respectively). You can even be a “Non-Medical Individual” (annual dues of $125). In summary, the fact that AAPLOG has 7,000 members does not establish that “thousands of doctors” will be overwhelmed by patients suffering from complications of mifepristone.
The court also points out that the “Christian Medical and Dental Association has ‘more than 600 physicians and approximately 35 OBGYNs’” and the “American College of Pediatricians has a membership of ‘more than 600 physicians and other healthcare professionals’” (p. 18). Presumably not very many members of an association of “Pediatricians” are OBGYNs. So I’m not seeing “thousands of doctors” here.
The court asserts that the “injuries are traceable to FDA regulations and redressable by this court” because the FDA’s decisions “all empower non-doctors to prescribe mifepristone and thus shift the costs of the drug onto the plaintiff physicians who must manage the aftermath” (p. 18). I don’t get it. Why are the plaintiff-doctors worse off if the prescriber was a non-doctor as opposed to a doctor? Maybe the court feels that if non-doctors can prescribe mifepristone, then statistically, more women will get mifepristone, which means that statistically, there is some incrementally higher likelihood that a patient will turn up in the ER. I really don’t think this conjectural reasoning can support standing.
The court insists that its holding is “narrow,” because “on the record before us applicants know that hundreds of thousands of women will—with applicants’ own statistical certainty—need emergency care on account of applicants’ actions” (p. 19). But it is a pure fabrication to say that “hundreds of thousands of women will … need emergency care on account of applicants’ actions.” I think this is another reference to the statement on the Patient Agreement Form, which as already noted, doesn’t say this.
The court maintains that “FDA’s principal contention to the contrary is that mifepristone is comparable to ‘ibuprofen.’” (p. 19). The court says that mifepristone is different from ibuprofen: it distinguishes mifepristone, which has a “Black Box” warning regarding the dangers of the drug, from ibuprofen, which doesn’t (pp. 19-21).
The court’s assertion that “FDA’s principal contention to the contrary is that mifepristone is comparable to ‘ibuprofen’” is unbelievably tendentious. Here’s what the FDA says in its brief regarding ibuprofen:
The court repeatedly characterizes mifepristone as unsafe. But over the last two decades, the available evidence conclusively demonstrates that mifepristone is safe under the approved conditions of use. More than five million women have used mifepristone to terminate their pregnancies in the United States. Add.658. Mifepristone is also approved in dozens of other countries. Add.759 (62 countries as of 2015). The literature reflects “exceedingly rare” rates of serious adverse events. Add.707. The mifepristone labeling indicates, for example, sepsis and hemorrhage are each 0.2% or less and transfusions and hospitalization related to medical abortion are each 0.7% or less. See Mifepristone Labeling 8, https://perma.cc/PU3Y-7TSK. All drugs can cause adverse events, including mifepristone. Even ibuprofen, which is commonly used for pain relief, can infrequently cause serious adverse events. Add.467. The FDCA does not require FDA to approve drugs only when they are without risk—no drug is—but to consider a drug’s risks in relation to its benefits. That is what FDA did here.
The FDA’s brief points to overwhelming evidence from the record, to which the Fifth Circuit was required to defer under basic principles of administrative law, regarding mifepristone’s safety. After summarizing all that evidence, the FDA then sensibly says that the mere fact that there are adverse events isn’t a sufficient reason to ban mifepristone, because after all, ibuprofen results in adverse events too. In response, the Fifth Circuit ignores all of the record evidence and reasoning from the FDA. The court doesn’t try to distinguish it, or analyze the FDA’s reasoning. It just treats all of the FDA’s reasoning as though it does not exist, and then summarizes the government’s argument as “mifepristone is the same thing as ibuprofen,” to which it offers the barbed rejoinder that mifepristone is different from ibuprofen.
The Fifth Circuit also finds that the organizations have organizational standing (pp. 22-23). Its reasoning is essentially a repeat of Judge Kacsmaryk’s reasoning: “Plaintiff associations have also suffered independent injuries because FDA’s actions have frustrated their organizational efforts to educate their members and the public on the effects of mifepristone” (p. 22). As I said in my prior post, this reasoning would allow any organization to challenge any rule in any case, merely by saying that it disagrees with the rule and has to spend money about educating people about why the rule is bad, giving it less money to spend on other things. There is no limiting principle here and no citation to Clapper v. Amnesty International USA, which explicitly rejects this very diversion-of-resources theory of standing.
There’s a lot that’s wrong with the Fifth Circuit’s analysis of timeliness (pp. 23-30) and exhaustion (pp. 31-33), but these errors are less relevant because the court does stay Judge Kacsmaryk’s ruling with respect to the 2000 approval of mifepristone. With regard to the 2016 decision, at least, there is no doubt that the plaintiffs’ arguments are timely and exhausted. So let’s skip over that and go to the merits—the plaintiffs’ argument that the FDA violated the Administrative Procedure Act.
The Fifth Circuit’s reasoning is brief and reflects a classic illustration of a court improperly second-guessing an agency. First, the FDA says:
First, FDA failed to “examine the relevant data” when it made the 2016 Major REMS changes. State Farm, 463 U.S. at 43. That’s because FDA eliminated REMS safeguards based on studies that included those very safeguards.
Nope! It is not clear the Fifth Circuit even read the FDA’s decision. Certainly there is no analysis of the FDA’s reasoning or the actual studies the FDA relied on, which do in fact evaluate the safety of mifepristone under the relaxed safety requirements. The Fifth Circuit eventually acknowledges this, grudgingly:
True, FDA studied the safety consequences of eliminating one or two of the 2000 Approval’s REMS in isolation. But it relied on zero studies that evaluated the safety-and-effectiveness consequences of the 2016 Major REMS Changes as a whole.
Come on. This is pure Calvinball. The FDA is entitled to review the agency record as a whole and make inferences about the likely safety effects of the new regime. There is no statute or legal principle requiring the FDA to review a study of conditions that are literally identical in all respects to the conditions on the labeling.
Next the Fifth Circuit says:
Second, the 2016 Major REMS Changes eliminated the requirement that non-fatal adverse events must be reported to FDA. After eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is “safe.” … It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.
I don’t get this either. In 2016, the FDA concluded that, in light of 16 years’ worth of safety information, it was no longer necessary to report non-adverse safety events. There was nothing arbitrary and capricious about this; the same rule applies with respect to many other drugs. The FDA also concluded that, in view of 16 years’ worth of safety information, certain safety rules could be relaxed. Abundant data supported this decision and the court doesn’t grapple with any of it or with any of the FDA’s reasoning. It just says, well, after 2016, there’s no reporting of non-adverse safety events, so therefore, the FDA’s decision in 2016 to relax safety requirements is arbitrary and capricious, not to mention all subsequent decisions. This isn’t a basis to overturn an agency decision. If the FDA’s decision to alter the reporting requirement in 2016 was reasonable, which it was (the Fifth Circuit certainly doesn’t explain why it wasn’t), than the Fifth Circuit can’t fault the FDA for the inevitable consequence of the FDA’s decision, which is that there will be less reporting going forward.
Next stop, Supreme Court. DOJ’s lawyers are incredibly skilled and I’m looking forward to reading the stay application.
Thanks for reading Adam's Legal Newsletter! Subscribe for free to receive new posts and support my work.