Briefing in the Supreme Court on the stay applications filed by the FDA and by Danco Laboratories is now complete. You may review the couple of dozen briefs filed by the parties and their amici on each application on the separate docket pages (FDA here, Danco here) for the two applications.
Beyond the Comstock Act issue on which I filed an amicus brief in support of the various respondent organizations and individuals, I don’t claim to have studied with care the legal questions that the stay applications present. But I figured that it might be useful to the interested reader for me to highlight some of the rejoinders made by the challengers to the FDA actions in their opposition brief and to make a couple of additional points in response to the FDA’s reply brief:
1. On standing generally:
[N]either Summers v. Earth Island Institute, nor Clapper v. Amnesty Int’l USA, pose a hurdle here. The government mischaracterizes the Fifth Circuit’s decision as relying on a statistical-probability-of-injury-to-a-member theory. But that court found—and Plaintiffs plainly allege—“specific allegations establishing that at least one identified member had suffered or would suffer harm.” Summers, 555 U.S. at 498. Plaintiffs’ complaint “identif[ied] members who have suffered the requisite harm—surely not a difficult task here, when so many thousands are alleged to have been harmed.” Id. at 499. Here, both lower courts concluded that named organizational as well as individual plaintiffs alleged sufficiently concrete and certainly impending harms from the 2016 Major Changes and subsequent removal of safety standards. Indeed, in Summers the government conceded that associational standing would exist where a member alleged injury to “interests in viewing the flora and fauna” and that he “had repeatedly visited [a certain park]” and “had imminent plans to do so again.” Id. at 494.
Defendants overread Clapper to suggest that the Fifth Circuit erred in finding harm to be “certainly impending.” As the lower courts held, Clapper is distinguishable because no plaintiff there had ever suffered an injury. Further, recent cases reaffirm what Clapper stated in footnote five: that a material risk of future harm satisfies Article III “so long as the risk of harm is sufficiently imminent and substantial.” TransUnion, 141 S. Ct. at 2210; SBA List, 573 U.S. at 158 (“An allegation of future injury may suffice if the threatened injury is ‘certainly impending,’ or there is a ‘substantial risk’ that the harm will occur.”) (cleaned up); Massachusetts v. EPA, 549 U.S. 497, 525 n.23 (2007).
2. On harm to conscience rights:
This constitutional conscience harm is not speculative. Several doctors testified that they have had to surgically perform an abortion either through suction aspiration or dilation and curtilage. See Alliance.CA5.App.111 (needed to “perform[ ] a dilation and curettage procedure” for a woman who took mifepristone at ten weeks’ gestation, a late abortion now authorized by the 2016 Major Changes); Alliance.CA5.App.016 (required “to perform a suction aspiration” to remove “a significant amount of pregnancy tissue” after woman received an additional dose of misoprostol from Planned Parenthood, a part of the approved regimen after the 2016 Major Changes); Alliance.CA5.App.005–06 (colleague left with “no choice but to perform an emergency D&C” despite detecting a fetal heartbeat at about ten weeks’ gestation— again, now FDA-authorized by the 2016 Major Changes). One doctor testified: “In my practice, I have cared for at least a dozen women who have required surgery to remove retained pregnancy tissue after a chemical abortion. Sometimes this includes the embryo or fetus, and sometimes it is placental tissue that has not been completely expelled.” Alliance.CA5.App.015. And plaintiff doctors have seen firsthand increasing numbers of complications related to chemical abortions, including cases where 17 doctors were forced to perform elective abortions to save a mother’s life, even though they were “able to detect a fetal heartbeat.” Alliance.CA5.App.005.
3. On the FDA’s cynical invocation of conscience protections: The FDA points in its reply brief to federal conscience protections that respondents can supposedly avail themselves of. But it neglects to point out that the Biden administration has argued that those protections don’t apply when women arrive at hospitals with injuries caused by chemical abortion. For example, the Biden administration issued a mandate attempting to rewrite the Emergency Medical Treatment and Active Labor Act (EMTALA) to force hospitals to perform abortions including “a patient with an incomplete medical abortion,” that is, mifepristone taken at home. The EMTALA abortion mandate said nothing about conscience laws constituting an exception to that mandate. On the contrary, when pro-life doctors and Texas sued, the government argued that EMTALA trumps federal conscience laws. In response to the plaintiffs’ claims that the EMTALA guidance violated various federal conscience protections, the government in its brief approvingly quoted a district-court ruling that stated that “there is no evidence that Congress intended, sub silentio, for any of the Conscience Provisions to override EMTALA, a separate statute.” Accordingly, the federal district court in that case found it likely the federal government might prosecute doctors who object to performing elective abortions because FDA illegally removed in-person requirements for mifepristone.
4. On the merits: In arguing that the FDA has failed to demonstrate a strong probability that it will prevail on the merits, respondents emphasize that the FDA’s “scientific judgment” does not exempt its decisions from ordinary APA review. E.g.:
Both [the Winikoff and the Smith] studies admitted that researchers lost a significant amount of their respective sample populations to followup (13–14% for Winikoff, and 4.1% for Smith)—meaning that the health outcomes of these women cannot be determined. Rather than explain why these flaws do not matter, FDA throws up the words “scientific judgment” as if that should end the matter. But FDA is not the unchallengeable king of the “science” domain. The entire point of the APA (and the scientific process itself) is to test, challenge, explain, and improve. FDA’s failure to provide a “reasoned explanation” for its decision to rely on flawed data is fatal. FCC v. Fox Television Studios, Inc., 556 U.S. 502, 516 (2009); In re NTE Conn., LLC, 26 F.4th 980, 989 (D.C. Cir. 2022) (“An agency’s failure to respond meaningfully to objections raised by a party renders its decision arbitrary and capricious. We have stressed that unless the agency answers objections that on their face seem legitimate, its decision can hardly be classified as reasoned.”).
And:
Without sufficient explanation, FDA’s 2016 Major Changes removed critical safeguards on mifepristone’s use. Compounding this failure, FDA justified its decision based on studies that “included those very safeguards.” FDA.App.34a. That’s like an agency that removes seatbelt and airbag requirements based on safety studies that all included seatbelts. Cf. State Farm, 463 U.S. at 34–36, 47–49. As this Court has held, that cannot constitute “reasonable” decision-making. Ibid. “The fact that mifepristone might be safe when used with” critical safeguards “says nothing about whether FDA can eliminate [those safeguards] (a question not studied by the FDA).” FDA.App.35a (emphasis added). By failing to “reasonably consider[ ] the relevant issues and reasonably explain[ ]” its actions, FDA violated the APA. FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021).
And:
Applicants argue that all these decisions were within the agency’s discretion and this Court should therefore defer to its “scientific judgment.” But there’s nothing scientific about identifying safeguards as interrelated but then failing to examine the effect these safeguards would have if removed completely. FDA may have examined “data gained in the last 20 years” when considering removing one of those safeguards. And it may have looked at “14 major studies and review articles” when examining another safeguard. But it looked at “zero” studies that considered what would happen when all safeguards were removed at the same time. This, even after FDA identified these safeguards as “interrelated.” That is a failure to “reasonably consider[ ] the relevant issues,” not scientific judgment. Prometheus Radio Project, 141 S. Ct. at 1158.
Similarly, no amount of agency discretion allows FDA to “entirely fail[ ] to consider an important aspect of the problem.” State Farm, 463 U.S. at 43. Applicants spill much ink arguing that the Fifth Circuit’s holding would require an exact “study match,” but it would do no such thing. Nowhere in its opinion did the Fifth Circuit say that FDA needed to approve mifepristone under the exact conditions studied in trials. In fact, the court went out of its way to say the opposite. FDA.App.19a. What the court did hold was that when FDA identifies various safeguards as “interrelated,” it is arbitrary and capricious for the agency to remove all of those safeguards based on “zero studies that evaluated the safety-and-effectiveness of” removing those safeguards “as a whole.” FDA.App.35a. In other words: a problem identified needs to be, at the very least, a problem “reasonably explained.” Prometheus Radio Project, 141 S. Ct. at 1158. That’s not novel—it’s basic administrative law. [Some citations omitted.]
5. On whether to credit the declaration of the FDA principal deputy commissioner: The FDA invokes the declaration of its principal deputy commissioner Janet Woodcock on the supposed disruption that the lower courts’ orders would entail. But Woodcock is hardly a disinterested expert. In addition to being a named defendant in this case, she served as director of the FDA branch that approved mifepristone in 2000 and that removed safeguards in 2016. She was also acting FDA commissioner when the FDA in 2021 removed the in-person dispensing requirement.