The preliminary ruling from Judge Matthew J. Kacsmaryk adopts the terminology of anti-abortion groups, such as “chemical abortion,” “abortionist” and “unborn human.”A federal judge in Texas last week invalidated the Food and Drug Administration’s approval of an abortion pill, mifepristone. The decision, should it withstand court challenges, could make it more difficult for patients to obtain abortions even in states where abortion is legal.The preliminary ruling by Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, an appointee of President Donald J. Trump who is known for his conservative views and openly opposes abortion access, could be the most consequential abortion decision since the Supreme Court overturned Roe v. Wade last June.Here’s a look at the ruling.PAGE 2… ultimately starves the unborn human until death. Because mifepristone alone will not always complete the abortion, F.D.A. 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.Throughout the opinion, Judge Kacsmaryk uses the language of the anti-abortion movement instead of conventional medical terms. The ruling calls medication abortion “chemical abortion,” refers to abortion providers as “abortionists” and describes a fetus or embryo as an “unborn human” or “unborn child.” By contrast, a conflicting ruling by a judge in Washington State that barred the F.D.A. from limiting the availability of mifepristone used terminology like “the termination of an early pregnancy,” “fetal loss” and “patients and providers.” Before Mr. Trump gave Judge Kacsmaryk a lifetime appointment to the bench in 2019, the jurist had written critically about Roe v. Wade and worked for the First Liberty Institute, a conservative Christian legal activist group.PAGE 7Here, the associations’ members have standing because they allege adverse events from chemical abortion drugs can overwhelm the medical system and place “enormous pressure and stress” on doctors during emergencies and complications.By law, only people who can show they have suffered an actual or imminent injury from something — not one that is merely speculative — have “standing” to sue. In this case, the plaintiffs challenging the F.D.A.’s approval of mifepristone more than two decades ago are doctors who oppose abortion and do not prescribe the drug. They contended that they have standing because other doctors might prescribe the drug to women who might then experience complications and seek out the plaintiffs for care, rather than their own doctors. The plaintiff-doctors claimed that they have suffered harm because treating such patients diverts their time and resources from treating other patients and because in some cases, they said, they have had to contradict their anti-abortion values by assisting in completing a patient’s abortion process. Judge Kacsmaryk found that this rationale was sufficient; the legitimacy of that conclusion is one reason the Justice Department asked an appeals court to block Judge Kacsmaryk’s order.PAGE 11Women 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.Medication abortion is used in early pregnancies, typically before gestation at 12 weeks, and the tissue that passes out of a patient’s body is often in the form of blood clots. Patients cite varying reasons for having abortions, but several studies and surveys have suggested that patients often feel relief and experience fewer mental health symptoms like depression, anxiety and suicidal thoughts after terminating pregnancies they felt unprepared or unable to handle.PAGE 13Defendants contend that plaintiffs’ theories of standing “depend upon layer after layer of speculation.” But plaintiffs allege F.D.A.’s chemical abortion regimen “caused” intense side effects and significant complications for their patients requiring medical intervention and attention.Judge Kacsmaryk’s opinion cites a handful of studies, several conducted by anti-abortion organizations, that the plaintiffs in the case submitted as evidence. The judge devotes little attention to the scores of studies that have shown medication abortion is very safe and that complications are rare, with patients needing hospitalization in fewer than 1 percent of cases.PAGE 15Considering F.D.A.’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.In 2021, the F.D.A. permanently lifted a requirement that patients obtain mifepristone in person from a provider, citing years of studies indicating this change would be safe. The drug still needs to be prescribed by a certified health provider, but not necessarily by a physician. For years before the rule was lifted, mifepristone was the only drug that the F.D.A. required to be obtained in person from a medical provider but that did not need to be taken in the presence of a provider — it could be taken at home or anywhere the patient chose. As a result, the F.D.A. and medical experts would dispute the judge’s contention that the 2021 rule change would create greater safety risks, especially since serious complications with mifepristone are rare.PAGE 22F.D.A.’s 2016 and 2021 changes thus significantly departed from the agency’s original approval of the abortion regimen. F.D.A. repeatedly altered its original decision by removing safeguards and changing the regulatory scheme for chemical abortion drugs.Another point of contention in Judge Kacsmaryk’s order centers on the statute of limitations to file a lawsuit challenging the F.D.A.’s approval of a drug, which is six years. The F.D.A. approved mifepristone in 2000 and eased certain restrictions on the pill in 2016 before lifting the in-person requirement in 2021. The Justice Department argued that it is too late to file a lawsuit challenging the 2000 and 2016 decisions, and that only the most recent measure falls within the six-year limit. Judge Kacsmaryk interpreted each change as restarting the clock to challenge approval for the drug.PAGE 34-35The Comstock Act declares “nonmailable” every “article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use it or apply it for producing abortion.” 18 U.S.C. § 1461 (emphasis added). It is indisputable that chemical abortion drugs are both “drug[s]” and are “for producing abortion.” Therefore, federal criminal law declares they are “nonmailable.”Judge Kacsmaryk relies in part upon the Comstock Act, an 1873 anti-vice law that barred the mailing of contraceptives and “lewd” materials, along with drugs that could be used in an abortion. His strict interpretation of that statute conflicts with a December 2022 opinion by the Justice Department’s Office of Legal Counsel, which concluded that abortion-causing drugs could be sent by mail if the sender does not intend for the recipient to use them unlawfully.PAGE 40… to satisfy Subpart H, F.D.A. deemed pregnancy a “serious or life-threatening illness[]” and concluded that mifepristone “provide[d] [a] meaningful therapeutic benefit to patients over existing treatments.” See 21 C.F.R. §§ 314.500; 314.560. F.D.A. was wrong on both counts.One of the plaintiffs’ claims is that the F.D.A. improperly approved mifepristone because it did so using a regulation called Subpart H that was intended for drugs to treat serious illnesses. “Pregnancy is not an illness,” the plaintiffs claim, and the judge agreed, saying, “Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life.” The F.D.A. argues that the word “illness” included “conditions” like pregnancy, which can in some cases be life-threatening. The agency also says that any semantic ambiguity was clarified in 2007, when Congress passed a law that essentially moved drugs that had been approved under Subpart H into a new regulatory framework, which explicitly used the term “disease or condition.”PAGE 46Other studies show 83 percent of women report that chemical abortion “changed” them — and 77 percent of those women reported a negative change.In requesting that an appeals court block Judge Kacsmaryk’s ruling, the Justice Department noted that the court’s role is supposed to be limited to ensuring that an agency has acted within a zone of reasonableness. But the judge had overridden “F.D.A.’s. eminently reasonable scientific judgments based on the court’s own interpretation of articles and studies.” It referred to his reliance on this 2020 article as particularly egregious. The study was based on 98 comments anonymously submitted to a website called “Abortion Changes You,” and its authors acknowledged that “the population of women who write an anonymous post about their abortion experience may be different from those who do not.”PAGE 61-62Plaintiffs are likely to suffer irreparable harm if the motion is not granted. At least two women died from chemical abortion drugs just last year. See ECF No. 120 at 30 n.5;65 Deerfield Med. Ctr. v. City of Deerfield Beach, 661 F.2d 328, 338 (5th Cir. 1981) (finding irreparable harm to third-party pregnant women). “The physical and emotional trauma that chemical abortion inflicts on women and girls cannot be reversed or erased.” ECF No. 7 at 28; see also E.E.O.C. v. Chrysler Corp., 733 F.2d 1183, 1186 (6th Cir. 1984) (affirming irreparable harm for plaintiffs’ “emotional distress”). “The crucial time that doctors need to treat these injured women and girls cannot be replaced.” Id. Generally, at the preliminary stage of litigation, judges are supposed to preserve the status quo unless the plaintiffs can show they would suffer irreparable harm. Judge Kacsmaryk ruled that the plaintiffs’ claims that women who suffer complications from mifepristone might seek their care meet that standard and issued a sweeping order that would block access to a drug that has been available nationwide for more than two decades. In requesting a stay, the Justice Department said that the plaintiffs had not met that standard and contended that it was the judge’s order that would cause irreparable harm — citing, among other things, the drug’s use in managing miscarriages.Embed Only