United States District Court, S.D. Indiana, Indianapolis Division
ORDER ON PLAINTIFF'S MOTION FOR A PRELIMINARY
INJUNCTION (DKT. 6)
EVANS BARKER, JUDGE
recent years, several states have adopted statutes
prohibiting an abortion procedure known to medicine as
“dilation and evacuation” (“D&E”)
and referred to by its political opponents as
“dismemberment abortion.” Among these statutes is
Indiana's House Enrolled Act 1211 (“HEA
1211”), enacted on April 24, 2019. We begin by noting
that every federal court to consider these prohibitions have
preliminarily or permanently enjoined them as violations of
the Due Process Clause of the Fourteenth Amendment. Today, we
join them, for the reasons given below.
analysis commences with (I) a review of HEA 1211, followed by
(II) an examination of the provision of D&E in Indiana
and (III) a general overview of second trimester abortion
methods, including (A) D&E, (B) induction of labor, and
(C) hysterotomy. Thereafter, we review (IV) methods for
inducing fetal demise before a D&E, including (A)
injections of digoxin, (B) injections of potassium chloride,
and (C) umbilical cord transections. We conclude by
recapitulating (V) the posture of the instant motion.
1211 creates a new statutory term “dismemberment
abortion” and defines it as follows:
(a) “Dismemberment abortion” means an abortion
with the purpose of killing a living fetus in which the
living fetus is extracted one (1) piece at a time from the
uterus through clamps, grasping forceps, tongs, scissors, or
another similar instrument that, through the convergence of
two (2) rigid levers, slices, crushes, or grasps a portion of
the fetus's body to cut or rip it off.
(b) “Dismemberment abortion” does not include an
abortion that uses suction to dismember a fetus by sucking
fetal parts into a collection container.
Act of April 24, 2019, Pub. L. 93-2019, § 1, 2019 Ind.
Acts-, 2019 Ind. Legis. Serv. P.L. 93-2019 (West) (to be
codified at Ind. Code § 16-18-2-96.4) [hereinafter HEA
1211]. This term is original to this statute and its
July 1, 2019, “knowingly or intentionally”
performing a “dismemberment abortion” will be a
Level 5 felony, see Ind. Code § 16-34-2-7(a),
punishable by up to six years' imprisonment and a $10,
000 fine, id. § 35-50-2-6(b), unless the
“reasonable medical judgment” of the physician
performing the abortion “dictates that performing the
dismemberment abortion is necessary to prevent any serious
health risk to the mother” or “to save the
mother's life.” HEA 1211, § 3 (internal
subdivisions omitted) (to be codified at Ind. Code §
D&E in Indiana
agree that HEA 1211 by its terms prohibits D&E, which is
“the usual abortion method” in the second
trimester of pregnancy in the United States, Gonzales v.
Carhart, 550 U.S. 124, 135 (2007), and “the
predominant method of second trimester abortion in many parts
of the world.” Dkt. 29 Ex. 1, at 3. D&E is
performed from early in the second trimester, beginning
approximately 15 weeks after the patient's last menstrual
period (LMP). Dkt. 9 Ex. 1, ¶ 22 [hereinafter Pl.
Decl.]. Through 10 weeks LMP, abortions may be performed
medically through administration of the chemical
abortifacients mifepristone and misoprostol. Id.
¶ 12. Aspiration and curettage procedures are also
commonly employed through the first trimester, but cease to
be effective by the beginning of the second trimester.
Id. ¶¶ 12, 16. Thus, a woman seeking a
second-trimester abortion receives a D&E or one of its
two alternatives, which are discussed in more detail below.
Dr. Caitlin Bernard, M.D., has brought this lawsuit on behalf
of her patients to challenge the restrictions imposed under
HEA 1211. She is a board-certified ob/gyn in Indianapolis
employed by the Indiana University Health physician network.
Id. ¶¶ 1, 5. She practices at two
Indianapolis hospitals, Methodist and Eskenazi. Dkt. 34,
8:3-4 [hereinafter Pl. Dep.]. Dr. Bernard also teaches at the
Indiana University School of Medicine. Pl. Decl. ¶ 5. As
part of her general ob/gyn practice at these hospitals, Dr.
provide[s] abortion services only for certain specified
indications. The overwhelming majority of second-trimester
[abortions] occurring in Indiana are because of fatal or
serious fetal anomalies. The identification of many major
genetic or anatomic anomalies in the fetus, including
anomalies that may cause the death of the fetus at, or
shortly after, birth, generally occur in the second
trimester. These might include such things as an intracranial
mass in the fetal brain, neural tube defects such as spina
bifida and anencephaly, or other disorders related to
autonomic function. The remainder are because of health risks
to the mother or because the pregnancy is the product of
Id. ¶ 15. At Methodist and Eskenazi, Dr.
Bernard performs only second-trimester abortions before fetal
viability and before 21 weeks 6 days LMP. Id. ¶
8. These abortions are all performed by D&E unless the
patient requests another procedure. Id. ¶¶
addition to Dr. Bernard, only one other physician in Indiana
performs D&E procedures: Dr. Hua Meng, Pl. Dep. 35:10-11,
an ob/gyn also employed by the Indiana University Health
physician network who practices at the same Indianapolis
hospitals as Dr. Bernard. Dkt. 36, 7:21-22, 10:11-13
[hereinafter Meng Dep.]. Dr. Bernard is also aware that Dr.
Katherine McHugh (formerly a plaintiff in this case,
see Dkt. 21) has performed D&E in the past
“and wishes to be able to do so in the future.”
Pl. Decl. ¶ 40. Neither Dr. Bernard nor Defendants are
aware of any other Indiana physicians who perform or have
Supreme Court in Gonzales described the D&E
procedure as follows:
Although individual techniques for performing D & E
differ, the general steps are the same.
A doctor must first dilate the cervix at least to the extent
needed to insert surgical instruments into the uterus and to
maneuver them to evacuate the fetus. The steps taken to cause
dilation differ by physician and gestational age of the
fetus. A doctor often begins the dilation process by
inserting osmotic dilators, such as laminaria (sticks of
seaweed), into the cervix. . . . [T]he length of time doctors
employ osmotic dilators varies. Some may keep dilators in the
cervix for two days, while others use dilators for a day or
After sufficient dilation the surgical operation can
commence. The woman is placed under general anesthesia or
conscious sedation. The doctor, often guided by ultrasound,
inserts grasping forceps through the woman's cervix and
into the uterus to grab the fetus. The doctor grips a fetal
part with the forceps and pulls it back through the cervix
and vagina, continuing to pull even after meeting resistance
from the cervix. The friction causes the fetus to tear apart.
For example, a leg might be ripped off the fetus as it is
pulled through the cervix and out of the woman. The process
of evacuating the fetus piece by piece continues until it has
been completely removed. . . . Once the fetus has been
evacuated, the placenta and any remaining fetal material are
suctioned or scraped out of the uterus. The doctor examines
the different parts to ensure the entire fetal body has been
Some doctors, especially later in the second trimester, may
kill the fetus a day or two before performing the surgical
evacuation. They inject digoxin or potassium chloride into
the fetus, the umbilical cord, or the amniotic fluid. Fetal
demise may cause contractions and make greater dilation
possible. Once dead, moreover, the fetus' body will
soften, and its removal will be easier. Other doctors refrain
from injecting chemical agents, believing it adds risk with
little or no medical benefit.
Gonzales, 550 U.S. at 135-36 (citations omitted).
Dr. Bernard and Defendants here describe the procedure in
materially identical terms. Pl. Decl. ¶¶ 17-20;
Dkt. 30, ¶¶ 10- 13 [hereinafter Francis Decl.].
Dr. Bernard performs D&E, she uses laminaria. Pl. Decl.
¶ 17. If the pregnancy is more than 17 weeks LMP, the
procedure takes two days: Dr. Bernard inserts the laminaria
on the first day; the patient leaves the hospital and returns
on the next day for the procedure. Id. ¶ 18. If
the pregnancy is less than 17 weeks LMP, dilation and
evacuation happen on the same day. Id. Once the
cervix is sufficiently dilated, evacuation “generally
takes no more than 10-15 minutes.” Id. ¶
20. Dr. Bernard uses ultrasound imaging to confirm the uterus
has been completely evacuated. Pl. Dep. 19:1-4.
Second-Trimester Abortion Methods
1 in 4 women [in the United States] obtain an abortion by the
age of 45.” Dkt. 12 Ex. 1, ¶ 9 [hereinafter Davis
Decl.]. Most are poor. Id. The risk of death from an
abortion (less than 1 in 100, 000) is fourteen times lower
than the risk of death from childbirth (8.8 in 100, 000) and
“significantly lower” than the risk of death from
common outpatient procedures such as colonoscopy (2.9 in 100,
000). Id. ¶ 10. These risks increase with time,
however, from 0.1 in 100, 000 at 8 weeks LMP and earlier to
8.9 in 100, 000 at 21 weeks LMP and later. Dkt. 40 Ex. 11, at
25 [hereinafter ACOG Practice Bulletin No. 135].
90 percent of abortions are performed in the first trimester
of pregnancy. See Id. at 22. Women obtain
second-trimester abortions because they did not know they
were pregnant in the first trimester; because they could not
access an abortion provider or obtain funding for an abortion
in the first trimester; and because, as Dr. Bernard explains
supra, major anatomic or genetic abnormalities are
most commonly detected in the second trimester. Id.
“Poverty, lower education level, and having multiple
disruptive life events have been associated with higher
rates of seeking second-trimester abortion.” Id.
See also Dkt. 30 Ex. 2, at 8 (“[T]he known risk
factors associated with presenting for second trimester
abortion include: adolescence, drug and alcohol addiction,
poverty, difficulty obtaining funding for the abortion, and
African-American race.”). Unprompted changes of heart
are apparently not among the common motivators for seeking a
second-trimester abortion. In any event, the factors that
lead women to seek second trimester abortions “are all
part of the complexity of women's lives, complexity that
the pregnant woman herself best understands.” Dkt. 30
Ex. 2, at 8.
abortion is the second most common surgery for
reproductive-aged women in the United States, after cesarean
delivery.” Soc'y Family Planning, Clinical
Guidelines: Induction of Fetal Demise Before Abortion,
81 Contraception 462, 462 (2010) [hereinafter Induction
of Fetal Demise Before Abortion]. The “vast
majority” of second-trimester abortions, as high as 95
percent, are performed by D&E. ACOG Practice Bulletin
No. 135 at 22. See also Dkt. 29 Ex. 1, at 4
(“99% of abortions between 13-15 weeks, 95% between
16-20 weeks, and 85% at 21 weeks or later.”); Dkt. 40
Ex. 9, at 77 (“the majority of procedures performed
between 14 and 20 weeks' gestation”). And the
“vast majority” of D&Es are performed before
18 weeks LMP. Davis Decl. ¶ 21. Also Id. ¶
29. D&E is generally recognized as the “fastest,
safest, and most common method” of second-trimester
abortion. Pl. Decl. ¶ 22. Also Davis Decl.
¶¶ 7, 15; Dkt. 40 Ex. 1, ¶ 9; Dkt. 40 Ex. 3,
¶ 26 [hereinafter Davis Reply Decl.]; Dkt. 40 Ex. 9, at
20, 78; ACOG Practice Bulletin No. 135 at 26.
complication rate ranges from 0.05 percent to 4 percent; the
major-complication rate is approximately 1 percent. Dkt. 40
Ex. 9, at 78-79. Potential complications of D&E include
hemorrhage requiring transfusion (0.1 to 0.6 percent of
cases); retained products of conception in the uterus (less
than 1 percent of cases); and uterine perforation (occurring
when an instrument punctures the uterus, often a “sub-
clinical” condition that may “resolve by [itself]
and without any long-term damage[, ]” Dkt. 40 Ex. 10,
¶ 5. Accord Dkt. 42 Ex. 118:15-19:22
[hereinafter Second Francis Dep.]) (0.2 to 0.5 percent of
cases); ACOG Practice Bulletin No. 135 at 25-26.
Infection and cervical laceration may occur in any
second-trimester abortion. ACOG Practice Bulletin No.
135 at 25-26.
only nonsurgical alternative to D&E in the second
trimester is abortion by inducing delivery of a previable
fetus, or “induction abortion.” “Labor
induction abortion affects expulsion of the fetus from the
uterus without instrumentation.” Dkt. 31 Ex. 1, at 2
[hereinafter Society of Family Planning Guidelines].
This procedure, like its first-trimester analogue, is also
sometimes called a “medical abortion, ” but we
will use “induction” only to distinguish the
procedures. Accord Id. “Under this method a
physician uses medications to induce labor and
delivery.” Pl. Decl. ¶ 23. Common agents include
mifepristone, misoprostol, oxytocin, and ethacridine lactate.
Society of Family Planning Guidelines at 3.
Induction is generally “safe” but takes longer,
costs more, and “is associated with a greater risk of
complications” than is D&E. ACOG Practice
Bulletin No. 135 at 23.
timing and duration, relative to induction “[t]he
timing of D&E is predictable, and although it may require
preoperative outpatient visits for cervical preparation, the
procedure usually is faster . . . .” ACOG Practice
Bulletin No. 135 at 26. Induction abortion “may
take 2-3 days to occur, during which time the woman has to be
hospitalized as an inpatient. Moreover, the woman has to go
through labor, which may involve hours of pain requiring
significant medication or anesthesia.” Pl. Decl. ¶
23. Accord Davis Decl. ¶ 17. However, induction
may take significantly less than two or three days,
particularly if mifepristone and misoprostol are used in
conjunction, which “reduce[s] the median
induction-to-abortion interval to as low as six
hours[.]” Dkt. 32 Ex. 1, at 9 [hereinafter
Complications After Second Trimester Abortion].
cost, D&E “may be more cost-effective than
[induction] abortion.” ACOG Practice Bulletin No.
135 at 26. “An induction abortion may cost more
than $20, 000 in Indiana, and a D&E may cost less than
half of that.” Pl. Decl. ¶ 24. Private insurance
coverage of abortion costs is variable and state and federal
public insurance coverage is unavailable. Id.
complications, “[a] comparison of D&E and induction
mortality rates from 1972 to 1987 showed that D&E had
lower death rates under 20 weeks of gestation, while
induction had lower rates after 20 weeks.” Society
of Family Planning Guidelines at 4. “Retained
[products of conception] or incomplete abortion has been
reported in less than 1% of cases of D&E, but occurs in
at least 8% of cases of medical abortion that involve use of
the mifepristone regimen[, ]” and “[i]n several
cohort studies, incomplete abortion was significantly more
common after medical abortion with misoprostol” as
well. ACOG Practice Bulletin No. 135 at 25. See
also Complications After Second Trimester Abortion at
7-8. The rate of retention may be as a high as 10 to 33
percent. Davis Decl. ¶ 18. In Dr. Bernard's
experience, “following an induction a significant
percentage of women have a retained placenta and must undergo
an additional surgical procedure to have it removed.”
Pl. Decl. ¶ 25. The “additional procedure”
is aspiration, sharp curettage, or D&E, in cases of
completely failed induction (“when the fetus is not
expelled within a specific timeframe, ” Society of
Family Planning Guidelines at 2). Davis Decl. ¶ 18.
Dr. Meng estimates that 40 percent of his patients require
additional intervention following induction of labor. Meng
complications include hemorrhage requiring transfusion at a
rate roughly comparable to D&E (0.7 of cases versus 0.1
to 0.6 percent of cases, respectively), but cf.
Complications After Second Trimester Abortion at 8
(“The higher proportion of women requiring blood
transfusion after medical induction compared to D&E is
concerning and deserves further study.”), and uterine
rupture at an unknown rate. ACOG Practice Bulletin No.
135 at 25. (“[T]here is much debate about whether
women who have had a prior caesarean delivery are at higher
risk for this complication. Complications After Second
Trimester Abortion at 9.) In Dr. Bernard's
experience, uterine rupture is “rare” but
“can be life threatening” when it occurs. Pl.
Decl. ¶ 25. Accord Davis Decl. ¶ 18.
Again, infection and cervical laceration may occur in any
second-trimester abortion. ACOG Practice Bulletin No.
135 at 25-26. Overall, D&E is “associated with
fewer complications (up to 4%) than [induction] abortion
involving misoprostol[-only] regimens (up to 29%)[.]”
Id. at 26. Induction using both misoprostol and
mifepristone may narrow this gap, id., though does
not eliminate it. Complications After Second Trimester
Abortion at 7. (As a general matter, “[t]he only
large trials comparing [induction] and [D&E] were carried
out . . . prior to the availability of mifepristone” in
the United States, necessitating further research comparing
D&E with modern induction methods. Dkt. 32, at 9.)
choice, most women prefer D&E to induction. ACOG
Practice Bulletin No. 135 at 26-27; Complications
After Second Trimester Abortion at 9; Davis Decl. ¶
18; Davis Reply Decl. ¶ 25; Pl. Decl. ¶ 26; Dkt. 29
Ex. 1, at 4. A need for fetal autopsy, ACOG Practice
Bulletin No. 135 at 26, or a desire to “bond
with the fetus after delivery, ” Dkt. 29 Ex. 1, at 5,
may render induction the preferred method, however.
Also Meng Dep. 12:12 (“If the patient wants
the fetus intact.”).
study designed to compare outcomes of midtrimester D&E
versus induction “failed to recruit its target sample
size because most potential study participants strongly
preferred D&E and declined to be randomized.”
ACOG Practice Bulletin No. 135 at 26. Another study
found that women who had undergone D&E “reported
less pain and were more likely to say they would opt for the
same procedure again compared with those who underwent
induction with mifepristone and misoprostol[.]” Id.
Accord Dkt. 29 Ex. 1, at 4; Complications After
Second Trimester Abortion at 4 (“significantly
more pain” reported for induction versus D&E).
Further, “many patients” view D&E as
“less emotionally challenging than induction.”
ACOG Practice Bulletin No. 135 at 26-27. Induction
abortions “are often performed in a labor and delivery
area, which can be psychologically challenging for some
women, especially those who are obtaining an abortion after
learning of a devastating fetal diagnosis.” Davis Decl.
¶ 17. “Several authors agree that D&E is
emotionally easier for a patient [than induction] because she
does not have to deliver a fetus that may show signs of
life.” Dkt. 31, at 1.
though the emotional trauma of the [D&E] experience is
reduced for the patient [relative to induction], it is
increased for those who perform the abortion.”
Id. Physicians, therefore, may prefer induction to
D&E for emotional or other personal reasons, as Dr.
Christina Francis, M.D., a board-certified ob/gyn in Fort
Wayne, explains with reference to herself and the physicians
with whom she is personally familiar. Francis Decl. ¶
15. (Some physicians may conflate their views with their
patients'. See ACOG Practice Bulletin No. 135 at
28 (“Although many obstetric providers believe that
women terminating a pregnancy for fetal anomalies and fetal
demise prefer induction of labor to D&E, this may not be
the case.”).) Indeed, “much of the emotional
burden of the [D&E] procedure is borne by the
physician.” Dkt. 32 Ex. 1, at 10. See also
Dkt. 30 Ex. 2 (discussing emotional and moral burdens of
second-trimester abortions on physician; acknowledging risk
that discussion would be “taken out of context and used
as evidence for further abortion practice
also may prefer induction to D&E because they view
D&E as “barbaric.” Francis Decl. ¶ 16.
Setting aside private religious or philosophical opinions on
zygotic, embryonic, or fetal personhood, see Dkt. 40
Ex. 2 60:17-20 [hereinafter First Francis Dep.]; Second
Francis Dep. 56:10-58:22; see generally John J.
Miklavcic & Paul Flaman, Personhood Status of the
Human Zygote, Embryo, Fetus, 84 Linacre Q. 130 (2017),
some physicians may decline to perform D&E because they
believe “a fetus is likely able to feel pain[.]”
Francis Decl. ¶ 17.
this opinion is contrary to the great weight of current
A  multidisciplinary review of the medical evidence
concluded that a fetus cannot experience pain until 29 weeks
of gestation at the earliest, when thalamocortical
connections are first present. . . . This review shows
evidence that both withdrawal reflexes and hormonal stress
hormones can be elicited by nonpainful stimuli and can occur
without conscious cortical processing. Therefore, the best
indicator as to when a fetus has potentially the capacity to
experience pain is the development of the thalamocortical
axons, which do not occur until at least 29 weeks of
gestational duration; however, their functionality within the
intrauterine environment has not been determined. With the
difficulty of establishing any clear way to measure fetal
pain and the lack of specific markers for fetal pain, any
potential pain of the means of inducing fetal demise cannot
be assessed either.
Induction of Fetal Demise Before Abortion at 464.
Accord Dkt. 40 Ex. 1, ¶¶ 38-49 (“[A]
widespread consensus exists in the medical and scientific
community that fetal pain is not possible before at least 24
weeks LMP.”) [hereinafter Ralston Decl.]; Dkt. 42 Ex.
1, at 38 (“[T]he fetus does not even have the
physiological capacity to perceive pain until at least 24
weeks of gestation.”).
D&E is regarded as the preferred method of
second-trimester abortion unless trained D&E providers
are unavailable. ACOG Practice Bulletin No. 135 at
26; Davis Reply Decl. ¶ 26; Dkt. 31 Ex. 2, at 3;
Complications After Second Trimester
Abortion at 3 (“Current evidence suggests
that, given trained providers and where otherwise feasible,
D&E is preferable to medical induction.”); Dkt. 40
Ex. 9, at 23 (“When abortion by aspiration is no longer
feasible, D&E and induction methods are used. D&E is
the superior method; in comparison, inductions are more
painful for women, take significantly more time, and are more
costly.”). Dr. Bernard “certainly would not
recommend that [her] patients undergo an induction rather
than a D&E unless the patient requested an induction[,
]” Pl. Decl. ¶ 39, though she
“[a]lways” offers both options to her patients.
Pl. Dep. 25:25. Accord Meng Dep. 12:1-8 (“If
the patient does not want [D&E] done, we do not do it. .
. . [But, in general, if] the patient wanted the termination
of the pregnancy in the second trimester, I would recommend
the safest route, safest procedure, and that would be the
only surgical alternative to D&E in the second trimester
is a hysterotomy abortion. “A hysterotomy is an
incision in the abdomen and uterus similar to what is
performed during a caesarean section and other uterine
surgeries.” Dkt. 40 Ex. 10, ¶ 4. This major
surgical procedure is “associated with a much higher
risk of complication than D&E or [induction] abortion and
should only be performed when the latter two procedures are
contraindicated.” ACOG Practice Bulletin No.
135 at 24. There is no evidence that any physician
recommends hysterotomy over D&E, as a general matter.
agree that, because HEA 1211 applies only to a “living
fetus, ” HEA 1211 does not prohibit D&E when fetal
demise has been induced before the evacuation and any
recent survey of abortion providers' fetal-demise
practices cited by Defendants notes that “[i]nducing
fetal demise is not without controversy, as it involves risks
to patients without associated medical benefit, making it
difficult to justify from an ethical standpoint.”
Colleen C. Denny et al., Induction of Fetal
Demise Before Pregnancy Termination: Practices of Family
Planning Providers, 92 Contraception 241 (2015)
[hereinafter Induction of Fetal Demise Before Pregnancy
Termination]. The survey found that, of the 105
responding abortion providers (62 percent of 169 eligible
respondents), 55 (52 percent) attempted to induce fetal
demise before performing the abortion. Id. Seventeen
respondents indicated their decision to induce demise was
made on a case-by-case basis. Of the 38 remaining
respondents, physicians who attempted to cause demise
beginning at a specific gestational threshold (36 percent of
all respondents), none attempted to induce fetal demise prior
to 17 weeks LMP; one attempted demise beginning at 17 weeks
LMP; five beginning at 18 weeks; three at 19 weeks; 16 at 20
weeks; none at 21 weeks; five at 22 weeks; and four at 23 and
24 weeks and later. Id. (The remaining four
respondents' practices do not appear to be accounted
larger and more recent survey found that “‘74%
(123/167) of clinicians who reported performing D&Es at
18 weeks LMP or greater did not routinely induce preoperative
fetal demise,' and among the minority (26%) who do use
demise procedures, the vast majority (70%) do so only for
procedures at 20 weeks LMP or greater.” Davis Reply
Decl. ¶ 15 (emphasis omitted) (citing Katharine O. White
et al., Second-Trimester Surgical Abortion
Practices in the United States, 98 Contraception 95
(2018)). These data support Dr. Bernard's
characterizations of inducing pre-D&E fetal demise as a
“minority” practice. Pl. Decl. ¶ 28.
Also Davis Decl. ¶ 21; Davis Reply Decl. ¶
physicians induce demise before performing a D&E, it is
not done to increase the safety of the procedure. “No
evidence currently supports the use of induced fetal demise
to increase the safety of second-trimester [induction] or
surgical abortion.” ACOG Practice Bulletin No.
135 at 24. “To demonstrate whether
second-trimester abortion is made safer by [inducing prior
fetal demise], additional [randomized controlled trials] are
necessary. . . . To justify the harm of the documented
increase[s] [in complication rates], a significant increase
in D&E safety would seem warranted.” Induction
of Fetal Demise Before Abortion at 470, cited at
inter alia Davis Decl. ¶ 20. Also Dkt. 40
Ex. 9, at 234 (“Research is limited, but the few
existing comparative studies suggest that [the most commonly
used methods of inducing fetal demise before a D&E] do
not confer a clinical benefit and may increase
fetal demise is induced, “[t]he reasons most frequently
cited for this practice are avoiding prosecution,
facilitation of D&E abortion, patient preference and
avoiding extramural [i.e., outside the healthcare facility]
abortion with signs of life.” Dkt. 33, at 1.
Also Dkt. 40 Ex. 9, at 234 (“Fetal demise is
induced before dilation and evacuation . . . by some abortion
providers in the belief that it facilitates an easier, faster
and safer evacuation. Other frequently cited reasons for this
practice are patient preference, avoiding prosecution, and
avoiding extramural delivery with signs of life.”). The
last of these reasons will be addressed relative to each
method of causing fetal demise, discussed below.
avoiding prosecution, “[p]assage of the Partial-Birth
Abortion (PBA) Ban Act in 200, ” sustained by the
Supreme Court in Gonzales v. Carhart, 550 U.S. 124
(2007), “resulted in a change in U.S. abortion practice
for legal reasons without medical indication.”
Id. The federal statute prohibits a variant of
D&E known as “intact” D&E. See
Gonzales, 550 U.S. at 136-37, 146-47. Though not
required to do so by the statute, abortion providers may
induce prior fetal demise as a prophylactic against
liability. Induction of Fetal Demise Before Abortion
at 462; Induction of Fetal Demise Before Pregnancy
Termination at 241; Dkt. 33, at 1; Dkt. 40 Ex. 9, at
facilitation of the D&E procedure, prior demise does not
in fact appear to make D&E faster or easier for the
physician. ACOG Practice Bulletin No. 135 at 24;
Society of Family Planning Guidelines at 11; Dkt. 35
Ex. 1, at 5-6. But see Dkt. 40 Ex. 9, at 238
(nonrandomized study finding reduction in mean procedure time
with prior demise).
patient preference, one study of inducing demise to
facilitate D&E found that 92 percent of study
participants preferred to induce demise before undergoing the
procedure. Dkt. 35 Ex. 1, at 2. But the authors of that study
recommended interpreting this data “cautiously because
only patients who were willing [to have the demise procedure
performed] entered the trial.” Id. at 6.
“This question was posed to patients within the context
of a clinical trial in which many of them believed the
injection might make their abortion safer[, ]” though
the trial found it did not. Induction of Fetal Demise
Before Abortion at 464. “Also, the social
acceptability of a positive response may have skewed the
results.” Id. “[B]y contrast, in a
different study when patients were offered the option not to
undergo digoxin injections, the vast
majority-81%-declined.” Davis Reply Decl. ¶ 13
(citing Aileen M. Gariepy et al., Transvaginal
Administration of Intraamnniotic Digoxin Prior to Dilation
and Evacuation, 87 Contraception 76 (2013), Dkt 33.).
parties discuss three specific methods for causing fetal
demise: injecting digoxin intrafetally (that is, into the
fetal body) or intra-amniotically (that is, into the amniotic
sac, the sac containing amniotic fluid in which the fetus
gestates); injecting potassium chloride (KCl) intracardially
(that is, into the fetal heart) or intracranially (that is,
into the fetal head); ...