United States District Court, S.D. Indiana, Indianapolis Division
WHOLE WOMAN'S HEALTH ALLIANCE, et al. Plaintiffs,
CURTIS T. HILL, JR. Attorney General of the State of Indiana, in his official capacity, et al. Defendants.
ORDER ON MOTION FOR PRELIMINARY INJUNCTION (DKT.
EVANS BARKER, JUDGE
Whole Woman's Health Alliance (WWHA) applied to the
Indiana State Department of Health (“the
Department”) and its commissioner Kristina Box,
Defendant here in her official capacity, for a license to
operate an abortion clinic in South Bend, Indiana (“the
South Bend Clinic”). The Department initially denied
WHHA's application. WWHA applied again but abandoned its
effort when it came to perceive its second application was
before the Court is Plaintiffs' motion for a preliminary
injunction enjoining the Department's implementation of
the licensing requirement as to the South Bend Clinic. Dkt.
76. For the reasons given below, the motion is granted.
begin with (I) an overview of the abortion procedure to be
offered at the South Bend Clinic and (II) a review of the
availability of abortions generally to women in and around
South Bend. We next (III) review Indiana's history of
abortion regulation and specifically (IV) its licensure
requirements. We conclude (V) by summarizing the
administrative proceedings on WWHA's license applications
and (VI) by setting forth a discussion as to the posture of
the instant motion.
researcher has noted, “in the United States, nearly
half of [all] pregnancies are unintended, and 22% of all
pregnancies (excluding miscarriages) end in
termination.” Defs.' Ex. 6, at 1. Medical (or
medication) abortions, as opposed to surgical abortions, are
performed by the administration of a chemical abortifacient
or combination of them. According to the American College of
Obstetricians and Gynecologists (ACOG), most medical
abortions in the United States today are performed by
administering the drug mifepristone in conjunction with the
drug misoprostol. Defs.' Ex. 8, at 1-2. Both are
dispensed in pill form. WWHA proposes to provide medical
abortions using this regimen at the South Bend Clinic; it
does not intend to provide surgical abortions at that
location. Pls.' Ex. 10, at 32.
also known by the brand name Mifeprex or the developer's
code RU 486, was first developed in the early 1980s and made
publicly available in 1988 after the French Minister of
Health, declaring it “the moral property of women, not
just the property of the drug company, ” ordered its
developer to begin marketing it in France. Steven Greenhouse,
France Ordering Company to Sell Its Abortion Drug,
N.Y. Times, Oct. 29, 1988, at A1.
first approved for marketing in the United States by the U.S.
Food and Drug Administration (FDA) in 2000 for use with
misoprostol, also known by the brand name Cytotec. Defs.'
Ex. 16, at 1; Pls.' Ex. 1, at 4. In addition to their use
as abortifacients, mifepristone and misoprostol are also used
together in the treatment of incomplete or difficult
miscarriages. Courtney A. Schreiber et al.,
Mifepristone Pretreatment for the Medical Management of
Early Pregnancy Loss, 378 New Eng. J. Med. 2161 (2018).
Mifepristone is among the small number of drugs FDA subjects
to a Risk Evaluation and Mitigation Strategy (REMS), which
among other things prohibits mifepristone from being
dispensed in pharmacies; it is available to patients only
directly from physicians who have executed supplier
agreements with the drug's U.S. licensee. Defs.' Ex.
16, at 1. But for the REMS, mifepristone would be available
the FDA-approved abortifacient regimen provides for
administration of the two drugs through 70 days of fetal
gestation, as measured by the number of days from the
patient's last menstrual period (LMP). Defs.' Ex. 16,
at 1. (The current FDA-approved regimen was adopted in 2016.
The originally approved regimen was found by clinicians and
researchers to be suboptimal; an “evidence-based
regimen” was developed in response. In 2016, FDA
approved a new label for mifepristone incorporating the
“evidence-based regimen.” See Defs.'
Ex. 16, at 1; Pls.' Ex. 1, at 4-5.) The patient first
takes a dose of mifepristone orally. The mifepristone blocks
the further growth and development of the fetus. Between 24
to 48 hours later, she takes a dose of misoprostol buccally
“at a location appropriate for the patient.”
Defs.' Ex. 16, at 1. Often this location is the
patient's home. See Pls.' Ex. 1, at 6. The
misoprostol causes the uterus to contract and expel its
contents in a process “resembl[ing] a
miscarriage[.]” Id. “If there were a
major complication associated with a medication abortion, it
would occur after the patient left the abortion facility
since the medications take time to exert their
effects.” Id. at 8.
than 5 percent of patients remain pregnant following a
medical abortion; fewer than 1 percent remain pregnant
following a medical abortion within 63 days LMP. Defs.'
Ex. 8, at 5; Pls.' Ex. 1, at 6. Patients with “a
persistent gestational sac” one week after receiving
mifepristone may be treated by an additional dose of
misoprostol, by surgical intervention, or may not require any
additional intervention. Defs.' Ex. 8, at 5. ACOG
recommends that medical abortion providers either be trained
to perform surgical abortions as needed or else be able to
refer a patient to a clinician who is. Id.
and cramping will be experienced by most women undergoing
medical abortion and are necessary for the process to
occur.” Id. at 3. Other common adverse effects
include “nausea, vomiting, diarrhea, headache,
dizziness, and thermoregulatory effects.” Id.
Abortion generally has a low risk of fatal and nonfatal
complications. The risk of death is lower than that from a
penicillin injection, as well as that from childbirth.
Pls.' Ex. 1, at 3. One study of more than 230, 000
medical-abortion patients found an overall complication rate
of 0.65 percent. Pls.' Reply Ex. 2, at 2. The rate of
complications requiring hospital admission was found to be
0.06 percent; of complications requiring emergency-room
treatment, 0.10 percent. Id. The risk to the patient
varies directly with the gestational age of the fetus: the
longer she waits, the more dangerous abortion becomes.
Pls.' Ex. 1, at 3.
study concluded that “[t]heoretically, it appears that
the mechanisms of mifepristone action favor the development
of [Clostridium sordellii] infection that leads to
septic shock, ” Defs.' Ex. 9, at 1, though
“it has since become evident that no specific
connection exists between clostridial organisms and medical
abortion.” Defs.' Ex. 8, at 8. Another study, a
review of fourteen years' literature on the topic, found
a “moderate to highly increased risk of mental health
problems after abortion” generally. Defs.' Ex. 7,
at 1. Further literature reviews, however, including of the
previously cited study, have found that unwanted pregnancies
carry the same risks to mental health no matter whether the
pregnancy is carried to term. See Pls.' Reply
Ex. 2, at 3. Mifepristone may be the cause of
“excessive hemorrhage” not seen in surgical
abortions. Defs.' Ex. 10, at 1. Similarly, one study
found that, while surgical and medical abortions “are
generally safe, . . . medical termination is associated with
a higher incidence of adverse events” relative to
surgical termination. Defs.' Ex. 6, at 1. Dr. Allison
Cowett, one of Plaintiffs' experts, finds that study
“to have several limitations which call into question
its findings[, ]” Pls.' Reply Ex. 2, at 2, though
she does not elaborate her concerns for a lay readership.
however, is the gravity of the abortion decision, as well as
the fact that the personal experiences of women who have
received medical abortions vary widely. For some, the
prospect of taking the misoprostol at home promises
“comfort and familiarity.” Pls.' Ex. 2, at 4.
Further, “[p]atients have reported that they feel more
in control of what is happening to their bodies with
medication abortion” as opposed to surgical abortions.
Pls.' Ex. 1, at 5. Others, however, experienced intense
physical pain, found themselves traumatized by the experience
of passing their pregnancies by themselves, and deeply regret
their decisions. Defs.' Ex. 11, at 3; Defs.' Ex. 12,
at 3, 6; Defs.' Ex. 13, at 3-4; Defs.' Ex. 14, at 2;
Defs.' Ex. 15, at 3.
Access to Abortion in Northern Indiana
currently has six licensed abortion clinics. Three are
located in Indianapolis, at the center of the state. One is
located in Lafayette, northwest of Indianapolis and
approximately one third of the way between Indianapolis and
Chicago. One is located in Bloomington, southwest of
Indianapolis and approximately halfway between Indianapolis
and Indiana's southern border. One is located in
Merrillville, in the northwest corner of the state close to
Bend, Indiana's fourth most populous city, is located
north of Indianapolis near the Indiana-Michigan state line
and approximately halfway between Indiana's western and
eastern borders. It is home to two universities, Indiana
University South Bend and the University of Notre Dame, as
well as several smaller colleges, including St. Mary's
College. South Bend is approximately 65 miles from
Merrillville, 107 miles from Lafayette, 150 miles from
Indianapolis, and 199 miles from Bloomington. Fort Wayne,
Indiana's second most populous city after Indianapolis,
lies in the northeastern corner of the state near the
Indiana-Ohio state line and is approximately 86 miles from
South Bend, 114 miles from Lafayette, 124 miles from
Merrillville, 126 miles from Indianapolis, and 176 miles from
is an unmet demand for abortion services in and around South
Bend, and more broadly in north-central and northeastern
Indiana. That is, there are women living in these areas who
desire to terminate their pregnancies but, in Indiana,
cannot. See Pls.' Ex. 1, ¶ 35 (Cowett
Decl.) (“WWHA is trying to open a clinic in South Bend
because abortion access is very limited in northern Indiana.
. . . [As an abortion provider in Chicago, ] [a]t least 20%
of [Cowett's] patients are from out of state, including
Indiana.”); Pls.' Ex. 3, ¶¶ 32 (Hagstrom
Miller Decl.) (“Based on . . . outreach [from a group
of local physicians, academics, and activists] and
[WWHA's] own independent research, [WWHA] determined that
South Bend is an underserved community. There is substantial
demand for abortion care in the region, but no local
providers.”), 65 (“Nearly all the physicians to
whom [WWHA] reached out [to serve as the South Bend
Clinic's backup doctor] were supportive of WWHA's
plans to open an abortion clinic in South Bend[.]”);
Pls.' Ex. 5, ¶¶ 12 (Guerrero Decl.) (Plaintiff
All-Options, Inc., has “facilitated rides” to
abortion providers for women seeking abortions in South Bend
but is “unable to meet the transportation needs of all
people in northern Indiana seeking abortion.”), 17
(“The barriers [Plaintiff All Options's] clients
face make it difficult, and sometimes impossible, for them
to obtain abortion care in Indiana.”); Pls.' Ex. 6,
¶ 9 (Lidinksy Decl.) (“Some [of Lidinsky's
undergraduate students] find the burdens of obtaining
abortion care within Indiana to be insurmountable. Many of
these students travel to Chicago[.]”); Pls.' Ex. 7,
¶ 14 (Stecker Decl.) (“Many physicians [WWHA]
reached out to [to serve as the South Bend Clinic's
backup doctor] were very supportive of WWHA opening an
abortion clinic in South Bend. They told [WWHA] that the
clinic would fill a much-needed gap [sic] in
care.”); Pls.' Ex. 8, ¶ 24 (Whipple Decl.)
(Unless the South Bend Clinic opens, “[a]t worst,
[abortion care] will be for[e]gone altogether.”);
Defs.' Ex. 1, 71:14-19 (Hagstrom Miller Dep.)
(“[WWHA] ha[s] formed relationships in South Bend with
many people who've lived in the community for a long
time, and [Hagstrom Miller] know[s] that having a safe
abortion facility in that community would meet a need in
Northern Indiana that's currently not being
demand for abortion care in north-central and northeastern
Indiana cannot be met by the six extant Indiana abortion
clinics may be traced to a confluence of factors, though the
shortest correct answer, as often, is power. It can be
difficult for federal judges and federal litigators, from our
comfortable vantage points, to understand how completely the
everyday life of another may be outside of her control-but we
must try to understand it. For women in northern Indiana who
enjoy ample financial means, supportive personal
relationships, and power over their own conditions of labor
and movement, the scarcity of abortion access there likely
presents an insubstantial burden. But many women in these
areas (as in most) do not enjoy those advantages, and lacking
even one of them can cause substantial difficulties.
See Pls.' Ex. 2, ¶ 14; Pls.' Ex. 3,
¶ 32; Pls.' Ex. 6, ¶ 11.
primary burden is travel. No direct lines of public
transportation connect South Bend to Merrillville,
Indianapolis, Lafayette, or Bloomington. Thus, reliable
private transportation is almost required to make the minimum
130-mile, maximum 398-mile, round trip. Naturally the poorer
the patient the less likely that such reliable private
transportation is available. The well known vagaries of
weather- and road conditions in northern Indiana can make the
extent of the travel burden difficult to anticipate
precisely, especially when coupled with unreliable
transportation. This unpredictability in turn increases the
difficulty of making all other necessary arrangements, as
detailed below. Moreover, because “patients usually
begin passing the pregnancy between one and four hours after
taking the misoprostol, the second medication in the medical
abortion regimen[, ]” medical-abortion patients driving
long distances to obtain the abortion may be “le[ft] .
. . to cramp and bleed en route to home.” Pls.' Ex.
1, ¶ 18. Finally, requiring women seeking abortions to
leave their communities causes in some feelings of
criminalization or ostracization. Pls.' Ex. 6, ¶ 11.
travel burden increases the overall cost of the procedure,
which is substantial for those on fixed or limited incomes,
for whom “[u]nexpected expenses are difficult to
manage[, ]” Pls.' Ex. 2, ¶ 13; those without
private health insurance covering abortion; and those on
Indiana's low-income health insurance program,
“which cover[s] abortions only in very limited
circumstances.” Pls.' Ex. 5, ¶ 9. As many as
twenty northern Indiana clients of Plaintiff All Options
“have been unable to pay rent or utility bills due to
having to pay for abortion care[.]” Defs.' Ex. 18,
37:6-15. Five have pawned belongings. Id. 37:16-22.
Some have taken out short-term “payday” loans at
confiscatory interest rates. As abortion costs (as well as
risks) increase with gestation, even minor delays in
obtaining an abortion can increase costs significantly.
See Pls.' Ex. 5, ¶ 16; Defs.' Ex. 18,
impacts of the travel burden are compounded by a mandatory
eighteen-hour waiting period, the statutory basis for which
is discussed in Part III, infra. The upshot is, a
woman seeking a medical abortion must visit the abortion
clinic twice, once at least eighteen hours before receiving
the medications, and again to receive them. Thus, the trip
must be undertaken twice over two or more days, or overnight
accommodations near the clinic must be secured.
burdens are compounded again if the woman seeking an abortion
is, as nearly all persons are, responsible to and for others.
If she has dependent children, or dependents of any
description, they must be accommodated on the trip or at home
during her absence. If she is employed, her employer must be
asked for time off work. If she is a student, she must miss
class or an exam. If she is married or in a close
relationship, she will be expected to explain her absence to
her spouse or partner.
accounts, South Bend appears to be an inhospitable
environment for abortion seekers and abortion providers. An
unmarried woman may encounter difficulty obtaining even
contraception there. E.g., Pls.' Ex. 2,
¶¶ 2 (recounting physician advice that IUDs
appropriate only for married women and that having multiple
sexual partners causes infertility), 16 (student at
university opposed to contraception has difficulty accessing
birth control with university-sponsored insurance, increasing
likelihood of unintended pregnancy). That is in part why WWHA
seeks to operate there, as will be discussed further. Part V,
infra. Dr. Ellyn Stecker practiced ob/gyn medicine
in South Bend for thirty-five years and finds
“pervasive” hostility to abortion there.
Pls.' Ex. 7, ¶ 7. She furnishes anecdotal examples
of that hostility and its consequences, both for abortion
seekers and abortion providers. See Id. ¶¶
7-9, 15-18, 19 (“leads providers in our community to
fear counseling pregnant patients about their
options”). Also Pls.' Ex. 2, ¶ 17;
Pls.' Ex. 3, ¶ 65.
social context exacerbates the burdens on women seeking
abortions who rely on and are responsible to others. Child
care (or other dependent care) is more difficult to find or
is foregone entirely because “there's a lot of
folks that don't know who to ask[, ]” particularly
for two days' care. Defs.' Ex. 18, 41:11-15. An
employer's, professor's, or partner's hostility
to abortion may increase the necessity for, and risks of,
“sneak[ing] around” them. See Pls.'
Ex. 6, ¶ 10.
obstacles to obtaining abortions in northern Indiana are such
that women find it easier to travel out of state to Chicago,
bypassing nearby Merrillville, to obtain abortions there.
Pls.' Ex. 1, ¶ 35; Pls.' Ex. 6, ¶ 9.
Indiana's Regulation of Abortion Since
and hostile was the reaction of the Indiana General Assembly
to the Supreme Court's 1973 decisions in Roe v.
Wade, 410 U.S. 113, and Doe v. Bolton, 410 U.S.
179. Disavowing any “intent . . . to acknowledge that
there is a constitutional right to abortion on demand,
” but finding itself “controlled to a certain
extent” by Roe and Doe, the General
Assembly that same year inaugurated Indiana's
contemporary regime of abortion regulations. Act effective
May 1, 1973, Pub. L. No. 322, § 1, 1973 Ind. Acts 1740,
1740-41. The history of that regime in relevant part is
1973, abortion was a felony under Indiana law unless, if
performed in the first trimester, performed by a licensed
physician in a licensed hospital, ambulatory outpatient
surgical center, or other licensed health facility; or, if
performed thereafter, performed by a physician in a hospital
or ambulatory outpatient surgical center. Id.,
§ 2, 1973 Ind. Acts at 1742-43 (formerly codified at
Ind. Code § 35-1-58.5-2(a)-(c)). The patient was
required to file with the physician her written consent to
the abortion no fewer than twenty-four hours before receiving
it, id. at 1744 (formerly codified at Ind. Code
§ 35-1-58.5-2(d)), and the physician was required to
report to the Department ten items of information for each
abortion he performed, including where it was performed.
Id. (formerly codified at Ind. Code §
1973 regulations were repealed and replaced in 1993, the year
after the Supreme Court “reaffirm[ed]”
Roe's “central holding” in
Planned Parenthood of Southeastern Pennsylvania v.
Casey, 505 U.S. 833, 879 (1992). The substantive
regulation of the abortion procedure was moved from title 35
of the Indiana Code, criminal law, to title 16, public
health, a new article treating abortion exclusively being
added to title 16 to accommodate the shift. Act of April 30,
1993, Pub. L. No. 2-1993, §§ 17, 209, 1993 Ind.
Acts 244, 568, 1109 (codified in relevant part at Ind. Code
1993 regulations permitted a first-trimester abortion to be
performed in an unlicensed setting. See id., §
17, 1993 Ind. Acts at 568-69 (codified at Ind. Code
§§ 16-34-1-4, 16-34-2-1). Later-term abortions were
still required to be performed in licensed hospitals or
ambulatory outpatient surgical centers. Id. at 569
(codified at Ind. Code § 16-34-2-1). The 1993
regulations continued to require the filing of the
patient's written consent and the reporting to the
Department of the same ten items of information for each
abortion performed. Id. at 569, 572-73 (codified at
Ind. Code §§ 16-34-2-1, 16-34-2-5).
General Assembly substantially expanded the written-consent
requirement in 1995. Establishing the patient's
“voluntary and informed consent” now required
detailed disclosures to her by the physician, including
information on the “probable gestational age of the
fetus” and “an offer to provide a picture or
drawing of a fetus[.]” Act of April 26, 1995, Pub. L.
No. 187-1995, § 4, 1995 Ind. Acts 3327, 3328 (internal
subdivisions omitted) (codified at Ind. Code §
16-34-2-1.1). The informed-consent requirement has continued
lobster-like to grow in scope and complexity until the
present. See Ind. Code § 16-34-2-1.1 (most
recently substantively amended by Act of March 24, 2016, Pub.
L. No. 213-2016, § 14, 2016 Ind. Acts 3099, 3105).
Today, as relevant here, the patient's consent is deemed
“voluntary and informed only if” the required
information is provided to her “[a]t least eighteen . .
. hours before the abortion” in a “private, not
group, ” setting by the physician who will perform the
abortion, the physician who referred the patient for an
abortion, or their qualified delegate. Id. §
16-34-2-1.1(a)(1). (It is possible that the required
information may be communicated to the patient at a location
other than the clinic at which the abortion will be
performed, so long as all the statutory conditions are
satisfied, see Defs.' Ex. 18, at 43-44, but it
does not appear that this is an option for WWHA, which
proposes to operate only one office or facility.)
1993 to 2005, abortions not performed in hospitals or
ambulatory outpatient surgical centers were performed in
unlicensed facilities. (As already noted, mifepristone was
approved by FDA in 2000.) As the Indiana General Assembly
debated a raft of new abortion-clinic regulations in 2006,
state Representative Marlin Stutzman remarked,
“It's been over 30 years that abortion clinics have
operated without any type of [facilities] regulation[.] . . .
We need to get them up to date as quickly as possible.”
Greg Hafkin, Abortion Clinics May Have to Close,
Indianapolis Star, Feb. 3, 2006, at ¶ 1 (original
alteration parentheses changed to brackets). In 2005,
“abortion clinic” received for the first time a
statutory definition and “abortion clinics” were
subjected to the same licensure requirements as hospitals and
ambulatory outpatient surgical centers. Act of April 26,
2005, Pub. L. No. 96-2005, §§ 2, 6, 2005 Ind. Acts
1897, 1899, 1900 (codified at Ind. Code §§
16-18-2-1.5, 16-21-2-2(4)). “Abortion clinic” was
defined as “a freestanding entity that performs
surgical abortion procedures”; facilities providing
medical abortions were not within the definition.
Id., § 2, 2005 Ind. Acts at 1899 (codified at
Ind. Code §§ 16-18-2-1.5).
2005 to 2013, a medical abortion that was not provided by a
hospital (presumably none were provided in ambulatory
outpatient surgical centers) was perforce provided in an
unlicensed setting. In 2013, as part of a broader effort to
regulate the provision of medical abortions specifically,
medical-abortion providers were brought within the definition
of “abortion clinics, ” and thereby subject to
licensure requirements, unless “abortion inducing drugs
[were] not the primarily dispensed or prescribed drug”
at the provider's facility. Act of May 1, 2013, Pub. L.
No. 136-2013, § 2, 2013 Ind. Acts 1002, 1002 (formerly
codified at Ind. Code § 16-18-2-1.5(a)(2), (b)(3)(B)).
Soon after the new definition took effect on July 1, 2013,
this Court preliminarily enjoined its operation as violative
of equal protection. Planned Parenthood of Ind. &
Ky., Inc. v. Comm'r, Ind. State Dep't of Health,
984 F.Supp.2d 912, 925, 931 (S.D. Ind. 2013) (Magnus-Stinson,
J.). A permanent injunction to the same effect was entered
late the following year. See Planned Parenthood of Ind.
& Ky., Inc. v. Comm'r, Ind. State Dep't of
Health, 64 F.Supp.3d 1235, 1258, 1260 (S.D. Ind. 2013)
2015, the General Assembly repealed the enjoined definition
of “abortion clinic” and replaced it with a new
one, which continues in force today. Act of April 30, 2015,
Pub. L. No. 92-2015, § 1, 2015 Ind. Acts. 633, 633
(codified at Ind. Code § 16-18-2-1.5(b)(3)). Now a
medical-abortion provider is an “abortion clinic,
” and thereby subject to licensure requirements, unless
the provider “provides, prescribes, administers, or
dispenses an abortion inducing drug to fewer than five (5)
patients per year for the purposes of inducing an
abortion.” Ind. Code § 16-18-2-1.5(b)(3).
Unquestionably, the South Bend Clinic qualifies as an
“abortion clinic” under this definition.
The Licensing Law
lawsuit attacks a set of statutory provisions they refer to
here as the “Licensing Law.” Br. Supp. 1 (citing
Ind. Code §§ 16-18-2-1.5, 16-21-1-9, 16-21-2-2.5,
16-21-2-10, 16-21-2-11). Other licensing provisions bear on
this case as well, see Compl. ¶ 82(b), though
Plaintiffs have not organized them under the “Licensing
Law” rubric for purposes of the instant motion for a
preliminary injunction. Below, we review these provisions and
their role in Indiana's broader regime of abortion
Licensing Law is codified in scattered sections of title 16
(“Health”), article 21 (“Hospitals”)
of the Indiana Code. As noted above, Indiana Code §
16-18-2-1.5 defines “abortion clinic, ” and
thereby the universe of health care providers subject to
regulation as such, as “a health care provider . . .
that performs surgical abortion procedures or . . .
provides an abortion inducing drug for the purpose of
inducing an abortion[, ]” excepting licensed hospitals,
licensed ambulatory outpatient surgical centers, and
providers who administer medical abortions to fewer than five
patients per year. “Abortion” is defined as
“the termination of human pregnancy with an intention
other than to produce a live birth or to remove a dead
fetus[, ]” id. § 16-18-2-1, thus
excluding spontaneous pregnancy loss or miscarriage and its
Code § 16-21-2-10 provides that a person “must
obtain a license” from the Department “before
establishing, conducting, operating, or maintaining . . . an
abortion clinic, ” as well as a hospital, ambulatory
outpatient surgical center, or birthing center. Operating or
advertising the operation of an unlicensed abortion clinic is
a Class A misdemeanor. Ind. Code § 16-21-2-2.5(b).
See Id. § 35-50-3-2 (Class A misdemeanants
liable to maximum one year's imprisonment and $5, 000
fine). Indiana Code § 16-21-2-2 (cited at Compl. ¶
82(b)) provides that the Department “shall license and
regulate” abortion clinics, as well as hospitals,
ambulatory outpatient surgical centers, and birthing centers.
A license is valid for one year. Ind. Code § 16-21-2-14
(cited at Compl. ¶ 82(b)). It may be renewed annually.
Code § 16-21-2-11 establishes the requirements for
applying for and receiving a license. An abortion-clinic
applicant must show that it is “of reputable and
responsible character” and that it is “able to
comply with the minimum standards for . . . an abortion
clinic . . . and with rules adopted [by the Department] under
this chapter [scil., Ind. Code ch. 16-21-2].”
Ind. Code § 16-21-2-11(a)(1)-(2). The application must
also contain the applicant's name, proposed location of
operation, and other similar information, as well as any
“[o]ther information [the Department] requires.”
Id. § 16-21-2-11(b).
July 1, 2018, abortion-clinic applicants, and only they, must
(1) Disclose whether the applicant, or an owner or affiliate
of the applicant, operated an abortion clinic that was closed
as a direct result of patient health and safety concerns.
(2) Disclose whether a principal or clinic staff member was
convicted of a felony.
(3) Disclose whether a principal or clinic staff member was
ever employed by a facility owned or operated by the
applicant that closed as a result of administrative or legal
(4) Provide copies of:
(A) administrative and legal documentation relating to the
information required under subdivisions (1) and (2);
(B) inspection reports; and
(C) violation remediation contracts;
Id. § 16-21-2-11(d). “Affiliate”
has its own statutory definition for these purposes, which
is, “[A]ny person who directly or indirectly controls,
is controlled by, or is under common control of another
person.” Id. § 16-18-2-9.4. Both the new
application requirement and the “affiliate”
definition were enacted in 2018. Act of March 25, 2018, Pub.
L. No. 205-2018, §§ 3, 6, 2018 Ind. Acts 2930,
2931, 2934. The content of these provisions and the timing of
their enactment strongly suggest that they were adopted in
response to the first license application WWHA submitted for
the South Bend Clinic, discussed further below.
Indiana Code § 16-21-2-11(a)(1)(2) requires a license
applicant to show it is able to meet the “minimum
standards” applicable to its proposed facility and to
comply with the Department's rules, Indiana Code §
16-21-2-2.5 requires the Department to adopt rules for
abortion clinics (as well as birthing centers, but not
hospitals or ambulatory outpatient surgical centers, though
cf. Ind. Code § 16-21-1-7 (cited at Compl.
¶ 82(b)) which establish “minimum license
qualifications”; prescribe policies for maintaining
medical records; establish procedures for the issuance,
renewal, denial, and revocation of licenses; prescribe
procedures and standards for inspections by the Department;
prescribe procedures for implementing and enforcing remedial
plans designed to redress violations of the applicable
standards; and establish eleven further requirements,
including “[s]anitation standards, ”
“[i]nfection control, ” and “[a]nnual
training by law enforcement officers on identifying and
assisting women who are coerced into an abortion[.]”
Ind. Code § 16-21-2-2.5(a).
Department's rules for abortion clinics are contained in
title 410, article 26 of the Indiana Administrative Code.
(Under Indiana Code § 16-21-1-9, the Department may
waive a rule for good cause, so long as waiver will not
endanger the clinic's patients. It is not clear why
Plaintiffs attack this section as part of the Licensing Law.)
Rule 2 governs licensure. Section 4 of that rule, 410 Ind.
Admin. Code 26-2-4(a), provides that the Department will
review license applications for compliance with the
“reputable and responsible character”
requirement, Ind. Code § 16-21-2-11(a)(1), and the
requirement to show ability to comply with applicable
standards. Id. § 16-21-2-11(a)(2). If the
applicant fails to comply with the application or licensure
standards, the Department may request additional information,
conduct further investigation, or deny the application. 410
Ind. Admin. Code 26-2-4(b).
5 of the rule states that the Department may deny an
(1) If the licensee or licensees are not of reputable and
(2) If the abortion clinic is not in compliance with the
minimum standards for an abortion clinic adopted under this
(3) For violation of any of the provisions of [Ind. Code art.
16-21] or [410 Ind. Admin. Code art. 26].
(4) For permitting, aiding, or abetting the commission of any
illegal act in the clinic.
(5) For knowingly collecting or attempting to collect from
a subscriber . . . or an enrollee . . . of a health
maintenance organization . . . any amounts that are owed by
the health maintenance organization.
(6) If conduct or practices of the clinic are found to be
detrimental to the patients of the abortion clinic.
(7) If the application for a license to operate an abortion
clinic or supporting documentation provided inaccurate
statements or information.
410 Ind. Admin. Code 26-2-5 (internal subdivisions omitted).
If the Department determines that the applicant qualifies for
a license, it will issue to the applicant a provisional
license, valid for ninety days, and then a full license upon
satisfactory initial inspection of the clinic “to
ensure that the clinic is operating in compliance with”
article 26 of title 410. Id. § 26-2-4.
8 of the rule states that the Department may revoke a license
in consequence of the licensee's
(1) Violation of any provision of this article.
(2) Permitting, aiding, or abetting the commission of any
illegal act in an abortion clinic.
(3) Knowingly collecting or attempting to collect from a
subscriber . . . or an enrollee . . . of a health maintenance
organization . . . any amounts that are owed by the health
(4) Conduct or practice found by the council to be
detrimental to the welfare of the patients of an abortion
410 Ind. Admin. Code 26-2-8(b) (internal subdivisions
Department is required to inspect every abortion clinic in
Indiana once annually and “may conduct a complaint
inspection as needed.” Ind. Code § 16-21-2-2.6.
The Department refers to such inspections as
“surveys.” Governed by rule 3 of article 26 of
the Department's regulations, the Department will perform
regular “licensing surveys” “to ensure that
the abortion clinic is operating in compliance” with
article 26, and “complaint surveys” upon
“credible complaints received by [the Department] that
allege noncompliance” with article 26. 410 Ind. Admin.
Code 26-3-2, 26-3-3. Nothing in the cited statutes or rules
makes the Department's authority or ability to conduct
such surveys contingent on the abortion clinic's
licensure, the “licensing survey” appellation
the substantive regulations of the abortion procedure are
found in title 16, article 34 (“Abortion”) of the
Indiana Code. This includes the informed-consent requirement,
Ind. Code §§ 16-34-2-1.1, 16-34-2-1.5, and the
physician-reporting requirement. Id. §
16-34-2-5. Outside the statutorily specified set of
circumstances, abortion is “in all instances . . . a
criminal act[.]” Id. § 16-34-2-1.
Specifically, performing an abortion not in accordance with
the provisions of chapter 2 of article 34 is a Level 5
felony, id. § 16-34-2-7(a), and see
id. § 35-50-2-6(b) (Level 5 felons liable to
one to six years' imprisonment and $10, 000 fine), except
that it is a Class A misdemeanor to fail to comply with the
parental consent requirement (codified at Ind. Code §
16-34-2-4), id. § 16-34-2-7(b), and a Class A
infraction to fail to comply with the informed-consent
requirement. Id. § 16-34-2-7(c). See
Id. § 34-28-5-4 (Class A infractor liable to $10,
000 judgment). Again, no requirement imposed by these
regulations on abortion providers is made contingent on the
nothing in the Licensing Law displaces the licensure
requirements imposed by Indiana on physicians and other
medical professionals, see Ind. Code arts. 25-22.5
(physicians), 22-23 (nurses), or Indiana's common-law
regulation of the same through negligence and other tort
actions. See, e.g., Spar v. Cha, 907 N.E.2d 974,