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Whole Woman's Health Alliance v. Hill

United States District Court, S.D. Indiana, Indianapolis Division

May 31, 2019

WHOLE WOMAN'S HEALTH ALLIANCE, et al. Plaintiffs,
v.
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. 76)

          SARAH EVANS BARKER, JUDGE

         Plaintiff 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 futile.

         Now 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.

         Background

         We 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.

         I. Medical Abortions

         As one 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.[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.

         Mifepristone, 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.

         It was 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 by prescription.

         Today, 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.

         Fewer 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.

         “Bleeding 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.

         One 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. See id.

         Undisputed, 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.

         II. Access to Abortion in Northern Indiana

         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 Chicago.

         South 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 Bloomington.

         There 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 met[.]”).

         Why the 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.

         The 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.

         The 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, 43:2-9.

         The 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.

         These 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.

         By all 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.

         This 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.

         The 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.

         III. Indiana's Regulation of Abortion Since Roe

         Swift 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 reviewed below.

         From 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 § 35-1-58.5-5).

         The 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 art. 16-34).

         The 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).

         The 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.)

         From 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).

         From 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) (Magnus-Stinson, J.).

         In 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.

         IV. The Licensing Law

         Plaintiffs' 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 regulation.

         The 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 treatment.

         Indiana 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. Id.

         Indiana 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).

         Beginning July 1, 2018, abortion-clinic applicants, and only they, must also

(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 action.
(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;
if any.

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.

         As 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).

         The 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).

         Section 5 of the rule states that the Department may deny an application

(1) If the licensee or licensees are not of reputable and responsible character.
(2) If the abortion clinic is not in compliance with the minimum standards for an abortion clinic adopted under this article.
(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.

         Section 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 maintenance organization.
(4) Conduct or practice found by the council to be detrimental to the welfare of the patients of an abortion clinic.

410 Ind. Admin. Code 26-2-8(b) (internal subdivisions omitted).

         The 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 notwithstanding.

         Most of 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 provider's licensure.

         Finally, 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, ...


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