[ The preliminary ruling from Judge Matthew J. Kacsmaryk adopts
the terminology of anti-abortion groups, such as “chemical
abortion,” “abortionist” and “unborn human.”]
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JUDGE’S RULING AGAINST ABORTION PILL IS FILLED WITH ACTIVISTS’
LANGUAGE  
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Charlie Savage and Pam Belluck
April 11, 2023
The New York Times
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_ The preliminary ruling from Judge Matthew J. Kacsmaryk adopts the
terminology of anti-abortion groups, such as “chemical abortion,”
“abortionist” and “unborn human.” _

Judge Matthew Kacsmaryk’s nomination hearing to the federal bench
in 2017; he took his seat in 2019. Previously, he had written
critically about Roe v. Wade and worked for the First Liberty
Institute, a conservative Christian legal activist group., U.S. Senate
Committee on the Judiciary

 

A federal judge in Texas last week invalidated the Food and Drug
Administration’s approval of an abortion pill, mifepristone
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The decision, should it withstand court challenges, could make it
more difficult for patients to obtain abortions
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in states where abortion is legal.

The preliminary ruling
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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 7

Here, 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 11

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.

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 13

Defendants 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
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have shown medication abortion is very safe and that complications are
rare, with patients needing hospitalization in less than 1 percent of
cases.

PAGE 15

Considering 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 22

F.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 34-35

The 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
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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 46

Other 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
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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 61-62

Plaintiffs 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.

_Charlie Savage is a Washington-based national security and legal
policy correspondent. A recipient of the Pulitzer Prize, he previously
worked at The Boston Globe and The Miami Herald. His most recent book
is “Power Wars: The Relentless Rise of Presidential Authority and
Secrecy.”
[[link removed]] @charlie_savage
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_Pam Belluck is a health and science writer whose honors include
sharing a Pulitzer Prize and winning the Victor Cohn Prize for
Excellence in Medical Science Reporting. She is the author of
“Island Practice,” a book about an unusual doctor. @PamBelluck
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* abortion bans
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* abortion pills
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* Federal Courts;
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