Matthew Joseph Kacsmaryk

“ Thus, FDA took its chemical abortion regimen — which had already culminated in thousands of adverse events suffered by women and girls — and removed what little restrictions protected these women and girls, systematically ensuring that almost all new adverse events would go unreported or underreported.
Defendants aver that “Plaintiffs point to no statutory provision requiring the conditions of use in a drug’s approved labeling to duplicate the protocol requirements used in the studies supporting its approval.” ”

“ Under a theory of “associational standing,” an association “has standing to bring a suit on behalf of its members when its members would otherwise have standing to sue in their own right, the interests at stake are germane to the organization’s purpose, and neither the claim asserted nor the relief requested requires the participation of individual members in the lawsuit.” ”

“ Subsequently, in addition to the typical privacy concerns present in third-party standing in abortion cases, adverse abortion experiences that are often deeply traumatizing pose a hindrance to a woman’s ability to bring suit. In short, Plaintiffs — rather than their patients — are most likely the “least awkward challenger [s] ” to Defendants’ actions. ”

“ Because mifepristone alone will not always complete the abortion, FDA mandates a two-step drug regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother’s womb. ”

“ Women who have aborted a child — especially through chemical abortion drugs that necessitate the woman seeing her aborted child once it passes — often experience shame, regret, anxiety, depression, drug abuse, and suicidal thoughts because of the abortion. ”

“ The Court also disagrees that Plaintiffs’ theories of injury “are too speculative to even show standing.” ECF No. 28 at 42. Plaintiffs have credibly alleged past and future harm resulting from the removal of restrictions for chemical abortion drugs. “Although a court’s analysis of likelihood of success in the context of an injunctive relief request is governed by the deferential APA’s arbitrary and capricious standard, a court does not always owe deference to federal agencies’ positions concerning irreparable harm, balance of hardships, or public interest.” ”

“ It is better for all the world, if instead of waiting to execute degenerate offspring for crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind. ”

“ Given the Supreme Court’s jurisprudence on the close relationship between abortionists and women, the facts of this case indicate that Plaintiffs’ relationships with their patients are at least as close — if not closer — for purposes of third-party standing.
Finally, women who have already obtained an abortion may be more hindered than women who challenge restrictions on abortion. ”

“ Studies show that women are thirty percent more likely to die from a ruptured ectopic pregnancy while seeking abortions if the condition remains undiagnosed. [53] A woman may interpret the warning signs of an ectopic pregnancy — cramping and severe bleeding — as side effects of mifepristone. In reality, the symptoms indicate her life is in danger. [54] Another study revealed that of 5,619 chemical abortion visits, 452 patients had a pregnancy of “unknown location” and 31 were treated for ectopic pregnancy — including 4 that were ruptured. ”

“ Considering FDA’s 2021 decision to permit “mail-in” chemical abortion, many women and girls will consume mifepristone without physician supervision. And in maternity-care “deserts,” women may not have ready access to emergency care. In sum, there are fewer safety restrictions for women and girls today than ever before. Plaintiffs have good reasons to believe their alleged injuries will continue in the future, and possibly with greater frequency than in the past. ”

“ Parenthetically, said “individual justice” and “irreparable injury” analysis also arguably applies to the unborn humans extinguished by mifepristone — especially in the post-Dobbs era. See Dobbs, 142 S. Ct. at 2261 (“Nothing in the Constitution or in our Nation’s legal traditions authorizes the Court to adopt [the] theory of life” that States are required “to regard a fetus as lacking even the most basic human right — to live — at least until an arbitrary point in a pregnancy has passed.”) ”

“ See James Studnicki et al., A Post Hoc Exploratory Analysis: Induced Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization, 9 Health Serv. Rsch. Mgmt. Epidemiology 1, 1 (2022) ; see also ECF No. 1-8 at 7 (describing Plaintiffs’ difficulty in submitting adverse event reports to mifepristone manufacturer Danco) . Other data sources such as the Center for Disease Control and Prevention Abortion Surveillance Reports are “profoundly flawed” because state reporting “is voluntary, with many states reporting intermittently and some not at all.” ”

“ Unlike the crucial studies FDA relied upon to extend the maximum gestational age, change the dosing regimen, and authorize a repeat dose of misoprostol, the labeling approved by FDA in 2016 did not require: (1) an ultrasound; (2) an in-person follow-up exam; or (3) the ability of abortionists to personally perform a surgical abortion if necessary. Id. Simply put, FDA built on its already-suspect 2000 Approval by removing even more restrictions related to chemical abortion drugs that were present during the final phase of the investigation. ”

“ Wulff, 428 U.S. 106, 117 (1976) (women seeking abortions may be chilled “by a desire to protect the very privacy of [their] decision from the publicity of a court suit”) ; Pa. Psychiatric, 280 F.3d at 290 (“ [A] party need not face insurmountable hurdles to warrant third-party standing.”) . The injuries suffered by patients of the Plaintiff medical associations’ members are sufficient to confer associational standing.
Here, the physician-patient dynamic favors third-party standing. ”

“ A Case Study to Understand the Communicative Tensions in Women’s Medication Abortion Narratives, 36 Health Commc’n 1485, 1485–94 (2021) . Plaintiff physicians’ lack of pertinent information on chemical abortion harms their physician-patient relationships because they cannot receive informed consent from the women and girls they treat in their clinics. Plaintiffs allege these actions have “radically altered the standard of care.” ECF No. 1-6 at 7.
Additionally, Plaintiff medical associations have associational standing via their members’ third-party standing to sue on behalf of their patients. ”

“ Compelling evidence suggests the statistics provided by FDA on the adverse effects of chemical abortion understate the negative impact the chemical abortion regimen has on women and girls. When women seek emergency care after receiving the chemical abortion pills, the abortionist that prescribed the drugs is usually not the provider to manage the mother’s complications. ”

“ Singular equitable relief is “commonplace” in APA cases and is often “necessary to provide the plaintiffs” with “complete redress.” E. Bay Sanctuary Covenant v. Biden, 993 F.3d 640, 681 (9th Cir. 2021) (internal marks omitted) . Although the Court finds Plaintiffs have a substantial likelihood of prevailing on the merits, the Court instead exercises its authority under the APA to order less drastic relief. Section 705 of the APA provides:
When an agency finds that justice so requires, it may postpone the effective date of action taken by it, pending judicial review. ”

“ In Heckler, the Supreme Court held that FDA’s decision not to recommend civil or criminal enforcement action to prevent violations of the FFDCA was “committed to agency discretion by law.” 470 U.S. at 837–38; see also Texas v. Biden, 20 F.4th at 982 (“In other words, a litigant may not waltz into court, point his finger, and demand an agency investigate (or sue, or otherwise enforce against) ‘that person over there.’”) . “ [T] he Supreme Court and the Fifth Circuit have consistently read Heckler as sheltering one-off nonenforcement decisions rather than decisions to suspend entire statutes.” ”

“ Women who underwent chemical abortions also experienced far higher rates of hemorrhaging, incomplete abortion, and unplanned surgical evacuation. [39] Chemical abortion patients “reported significantly higher levels of pain, nausea, vomiting and diarrhea during the actual abortion than did surgical patients ... Post-abortion pain occurred in 77.1% of mifepristone patients compared with only 10.5% of surgical patients.” ECF No 1-13 at 24. And before the approval, an FDA medical officer recognized the “medical regimen had more adverse events, particularly bleeding, than did surgical abortion. ”

“ In response, the Population Council rejected the proposal and repudiated the restrictions the sponsor itself proposed in 1996 — what FDA deemed a “very significant change” in the sponsor’s position. Id. at 50. Because “ [t] he whole idea of mifepristone was to increase access,” abortion advocates argued that restrictions on mifepristone “would effectively eliminate” the drug’s “main advantage” and would “kill [] the drug.” [60]
In September 2000, FDA abandoned its safety proposals and acquiesced to the objections of the Population Council and Danco. ”

“ Here, the U.S. trials FDA relied upon when approving mifepristone required that: (1) each woman receive an ultrasound to confirm gestational age and exclude an ectopic pregnancy; [47] (2) physicians have experience in performing surgical abortions and admitting privileges at medical facilities that provide emergency care; (3) all patients be within one hour of emergency facilities or the facilities of the principal investigator; and (4) women be monitored for four hours to check for adverse events after taking misoprostol. ”

“ The entire abortion process takes place within the mother’s home, without physician oversight, potentially leading to undetected ectopic pregnancies, failure of rH factor incompatibility detection, and misdiagnosis of gestational age — all leading to severe or even fatal consequences. ”

“ Plaintiffs are doctors and national medical associations that provide healthcare for pregnant and post-abortive women and girls. Plaintiffs sued Defendants to challenge multiple administrative actions culminating in the 2000 Approval of the chemical abortion regimen for mifepristone. ”

“ Considering the intense psychological trauma and post-traumatic stress women often experience from chemical abortion, this failure should not be overlooked or understated. Nor was the drug tested for under-18 girls undergoing reproductive development. [49] But that is not all. Clinical trial protocols in the United States for the 2000 Approval required a transvaginal ultrasound for each patient to accurately date pregnancies and identify ectopic pregnancies. ”

“ Though eugenics were once fashionable in the Commanding Heights and High Court, they hold less purchase after the conflict, carnage, and casualties of the last century revealed the bloody consequences of Social Darwinism practiced by would-be Übermenschen. ”

“ And a court will review for the first time “a particular challenge to an agency’s decision which was not raised during the agency proceedings” where the agency action is “likely to result in individual injustice” or is “contrary to an important public policy extending beyond the rights of the individual litigants.” Id.; see also Mathews v. Eldridge, 424 U.S. 319, 330 (1976) (“ [C] ases may arise where a claimant’s interest in having a particular issue resolved promptly is so great that deference to the agency’s judgment is inappropriate.”) ”

“ In any case, the Comstock Act plainly forecloses mail-order abortion in the present, and Defendants have stated no present or future intention of complying with the law. Defendants cannot immunize the illegality of their actions by pointing to a small window in the past where those actions might have been legal. ”

“ Brief of Amici Curiae Scholars of Jurisprudence John M. Finnis and Robert P. George in Support of Petitioners, Dobbs, 142 S. Ct. 2228 (2022) (arguing unborn humans are constitutional “persons” entitled to equal protection) .
c. Administrative Procedures are Inadequate Third, FDA’s combined response time of over sixteen years to Plaintiffs’ two petitions shows their procedures have been inadequate. See Coit, 489 U.S. at 587; Bowen v. City of New York, 476 U.S. 467, 476 (1986) (“ [T] he harm imposed by exhaustion would be irreparable.”) ”

“ And at least two women died from chemical abortion drugs last year. See ECF No. 120 at 30 n.5. One of those women was an estimated twenty-one weeks pregnant. See id. Presumably, the fact that the woman obtained chemical abortion drugs more than two months past FDA’s gestational age cutoff suggests that no adequate procedures confirmed the gestational age in her case.
FDA has also reported at least ninety-seven cases where women with ectopic pregnancies took mifepristone. [52] But these data are likely incomplete because FDA now only requires reporting on deaths. ”

“ Additionally, the elements “shall include [one] or more goals to mitigate a specific serious risk listed in the labeling of the drug.” 21 U.S.C. § 355-1 (f) (3) . And as the Court will later explain, federal law prohibits the mailing of chemical abortion drugs. Thus, unlike in Heckler, there is “law to apply” to FDA’s decision. See Texas v. Biden, 20 F.4th at 982 (“ [T] he executive cannot look at a statute, recognize that the statute is telling it to enforce the law in a particular way or against a particular entity, and tell Congress to pound sand.”) ”