www.nytimes.com Open in urlscan Pro
151.101.65.164  Public Scan

Form analysis
0 forms found in the DOM

Text Content

Skip to content

Sections
SEARCH
U.S.


Friday, April 14, 2023
Today’s Paper

U.S.|Judge’s Ruling Against Abortion Pill Is Filled With Activists’ Language

https://www.nytimes.com/2023/04/11/us/abortion-pill-ruling.html
 * Give this article
 * 
 * 


ABORTION PILL RULINGS

 * What to Know
 * Appeals Court Order
 * Texas Judge Ruling, Annotated
 * What Happens Next
 * Online Market for Abortion Pills

Advertisement

Continue reading the main story



Supported by

Continue reading the main story





JUDGE’S RULING AGAINST ABORTION PILL IS FILLED WITH ACTIVISTS’ LANGUAGE

The preliminary ruling from Judge Matthew J. Kacsmaryk adopts the terminology of
anti-abortion groups, such as “chemical abortion,” “abortionist” and “unborn
human.”

 * Send any friend a story
   
   As a subscriber, you have 10 gift articles to give each month. Anyone can
   read what you share.
   
   
   Give this article
 * 
 * 


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.Credit...U.S. Senate Committee on the Judiciary


By Charlie Savage and Pam Belluck

April 11, 2023

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 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.


THE PUSH TO RESTRICT ABORTION PILLS


A FEDERAL JUDGE IN TEXAS INVALIDATED THE F.D.A.’S APPROVAL OF AN ABORTION PILL,
MIFEPRISTONE. THE DECISION COULD MAKE IT MORE DIFFICULT FOR PATIENTS TO OBTAIN
ABORTIONS.

 * Dueling Rulings: On the same day as the Texas decision, a federal judge in
   Washington State issued an opposing ruling in a different case saying that
   the F.D.A. not limit access to mifepristone in 18 jurisdictions.
 * Under Review: After an appellate ruling in response to the Texas decision
   imposed barriers to abortion pill access, the Supreme Court is poised to
   consider whether medication abortion can be curtailed in states where
   abortion is legal.
 * Temporary Stay: On April 14, Justice Samuel Alito issued a temporary
   stay ensuring that a mifepristone would remain widely available while the
   Supreme Court decides whether to grant a formal stay.
 * Stockpiling Abortion Pills: As the ruling could affect availability even
   where abortion is legal, states led by Democrats have been scrambling to
   adjust to a possible future without mifepristone.

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 that 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 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 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 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 61-62

> 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.




EMBED ONLY







Advertisement

Continue reading the main story




SITE INDEX




SITE INFORMATION NAVIGATION

 * © 2023 The New York Times Company

 * NYTCo
 * Contact Us
 * Accessibility
 * Work with us
 * Advertise
 * T Brand Studio
 * Your Ad Choices
 * Privacy Policy
 * Terms of Service
 * Terms of Sale
 * Site Map
 * Canada
 * International
 * Help
 * Subscriptions