FINDINGS OF FACT AND CONCLUSION OF LAW
SARAH EVANS BARKER, United States District Judge.
On June 21, 2018, Plaintiffs Whole Woman's Health Alliance, All-Options, Inc., and Jeffrey Glazer, MD. (collectively, "Plaintiffs") initiated this lawsuit against Defendants Todd Rokita (previously Curtis Hill, Jr.), Attorney General of Indiana; Kristina Box, M.D., Commissioner of the Indiana State Department of Health; John Strobel, M.D., President of the Medical Licensing Board of Indiana; and Kenneth P. Cotter, St. Joseph County Prosecutor ("the State") under 42 U.S.C. § 1983, waging a global assault on the constitutionality of Indiana's statutory and regulatory restrictions on abortions. Plaintiffs' complaint challenges twenty-five separate sections of Indiana's wide-ranging regime to regulate abortion, asserting that these provisions violate the Substantive Due Process Clause of the Fourteenth Amendment (Count I), the Equal Protection Clause of the Fourteenth Amendment (Count II), and the Freedom of Speech Clause of the First Amendment (Count III). Plaintiffs also challenge various statutes as unconstitutionally vague in violation of the Fourteenth Amendment's Procedural Due Process Clause (Count IV).
Given the expansive scope of Plaintiffs' legal claims as well as challenges imposed by the COVID-19 pandemic, the parties and the Court agreed to bifurcate the trial of these issues into two parts. "Phase I" issues were heard during a "virtual" bench trial on March 15, 2021; "Phase II" were presented in similar fashion on June 23, 2021.
For the reasons explicated in the following decision, based on the Court's thorough review and consideration of all evidence presented at trial, the following provisions are ruled unconstitutional, and their enforcement permanently enjoined: The Telemedicine Ban, the In-Person Examination Requirement, the Physician-Only Law as it relates to the first-trimester provision of medication abortion, the Second-Trimester Hospitalization Requirement, and the Mandatory Disclosures and Facility Requirements identified herein. The Court also rules that the following provisions pass constitutional muster: the Ultrasound Requirement, the Physician-Only Law as it relates to the provision of aspiration abortion, and the limitation on preabortion counseling sessions by only physicians and advanced practice clinicians, as well as the criminal penalties provisions imposed for violations of the abortion restrictions.
Accordingly, the following findings of facts and conclusions of law are hereby entered.
I. Scope of Claims
The Constitution, among its many protections and liberties, includes in poignant judicial parlance the freedom from state-required motherhood. Roe v. Wade, 410 U.S. 113,
Plaintiffs, a group of abortion providers and nonprofit intermediaries, have challenged a broad array of Indiana's statutory and regulatory restrictions on abortions, which they contend infringe upon a woman's freedom to control her own destiny and body. Indiana law, according to Plaintiffs, places futile and burdensome regulatory requirement's on healthcare providers who administer abortion care, mandates the dissemination of misleading and incorrect information to patients relating to the mental and physical health risks of abortion as a condition of securing a woman's informed consent, and unreasonably restricts minors from accessing abortions. The twenty-five sections and subsections of the Indiana abortion code and their accompanying regulations are challenged as facially violative of the Fourteenth Amendment's Substantive Due Process, Procedural Due Process and Equal Protection Clauses, and the First Amendment. The Court has previously determined in ruling on the State's summary judgment motion that certain challenges could and did not survive.
Clearly, this lawsuit reflects an attempt by Plaintiffs to reduce Indiana's prolix and often burdensome legal scheme governing abortion services, the number and complexity of which limitations have increased during the decades following Roe v. Wade. These controls, according to Plaintiffs, have resulted in women facing substantial obstacles to securing abortion services in Indiana. Plaintiffs expressly seek to "return [Indiana] to a system of reasonable and medically appropriate abortion regulations by striking down Indiana's unduly burdensome abortion laws." [Comp. ¶ 9].
We examine these alleged burdens in the context of the Substantive Due Process Clause, which requires consideration of "the burdens a law imposes on abortion access together with the benefits those laws confer." Whole Woman's Health Alliance v. Hellerstedt, ___ U.S. ___, 136 S.Ct. 2292, 2309, 195 L.Ed.2d 665 (2016).
II. Procedural Background
Plaintiffs' Successful Motion for Preliminary Injunctive Relief re: the South Bend Clinic
On May 31, 2019, the Court issued a Preliminary Injunction, which was thereafter modified on October 1, 2019. While Plaintiffs' Complaint advances facial challenges to Indiana's abortion statutes, the motion for preliminary injunction sought limited, specific relief from various procedural prerequisites to licensure relative to the opening and operation of an abortion clinic by Whole Woman's Health Alliance ("WWHA"),
Following expedited briefings and oral arguments, we granted Plaintiffs' motion for preliminary injunctive relief. Specifically, we ruled that Plaintiffs had established a likelihood of success on the merits on their claim that Indiana's requirements of licensure for clinics providing medication abortions (that is, those abortions induced by ingesting certain medications) had been applied to WWHA in a manner that was violative of the Fourteenth Amendment's Substantive Due Process and Equal Protection Clauses. This ruling was affirmed with certain procedural modifications by the Seventh Circuit. The modified preliminary injunction requires the Health Department to treat WWHA's clinic (hereinafter, the "South Bend Clinic") as provisionally licensed until a final judgment could issue on the merits of this case. The South Bend Clinic thus commenced operation and continues to provide medication abortions for women up to ten weeks following gestation.
The State's Motion for Summary Judgment
On November 8, 2019, the State moved for summary judgment on all the claims asserted against it. No cross-motion was filed by Plaintiffs.
Given that Plaintiffs' request for preliminary injunctive relief was unrelated to other allegations in their Complaint, the parties' extensive summary judgment briefing did not address the issues in the preliminary injunction. Indeed, as noted in our Preliminary Injunction, Plaintiffs' motion was "not strictly preliminary to anything" because the Complaint had alleged that the challenged laws were facially unconstitutional, not as applied to WWHA, which reflected the fact that the Complaint has been filed six months before WWHA received the final decision on its first licensure application. [Dkt. 116, at 50]. "Thus," as we explained, "none of the facts related to the administrative proceeding relied upon by Plaintiffs in support of their as-applied undue-burden challenge are pleaded in the [C]omplaint. None would be heard at the time of final judgment on Plaintiffs' facial challenges." [Id., at 50-51]. Accordingly, the State's motion for summary judgment responded to Plaintiffs' challenges to the facial validity of the licensure requirements and various other statutes.
We granted in part and denied in part the State's Motion for Summary Judgment, holding that the following statutory and regulatory requirements are not violative of the Substantive Due Process Clause of the Fourteenth Amendment (as advanced in Count I of the Complaint):
Issues of material fact precluded summary judgment on Plaintiffs' Substantive Due Process challenges to the following statutory and regulatory requirements:
Summary judgment was also granted in favor of the State with respect to Plaintiffs' claim that the Indiana abortion code constitutes impermissible gender discrimination, in violation of the Fourteenth Amendment's Equal Protection Clause, as set out in Count II of the Complaint. Plaintiffs had alleged, regarding each of the statutes which they challenged as violative of the Due Process Clause, that they are violative of the Equal Protection Clause as well. We withheld a ruling on these equal protection challenges because they "ha[d] not received the kind of thorough discussion and fulsome briefing required"
With respect to Count III of the Complaint, we granted summary judgment to the State in part, upholding certain mandatory disclosures as not violative of the First Amendment. We held that the State had prevailed in showing that the disclosures regarding the disposal of fetal tissue and the physical health risks stated in Indiana's Perinatal Hospice Brochure were neither untruthful nor misleading and thus satisfied the First Amendment standards. We denied summary judgment to the State, however, with respect to Plaintiffs' claims that the mandatory disclosures regarding fetal pain, the beginning of life, and the mental health risks of abortion contained in the Perinatal Hospice Brochure were violative of the First Amendment, given the significant conflicting testimony and evidence regarding the truthfulness of these assertions.
Finally, we ruled that the State was entitled to summary judgment on Plaintiffs' allegations that three sections specified of the Indiana abortion code were void for vagueness.
The Structure of the Trial
A bench trial on the unresolved claims commenced on March 15, 2021. In light of the COVID-19 pandemic restrictions, the parties acceded to the Court's decision to conduct the trial in two installments or "phases."
"Phase I" of the trial encompassed Plaintiffs' challenges to the In-Person Counseling Requirement, the Ultrasound Requirement, the In-Personal Physical Examination Requirement, and the Telemedicine Ban. Plaintiffs' challenges to the In-Person Counseling and Examination Requirements and the Telemedicine Ban included both Fourteenth Amendment Substantive Due Process and Equal Protection claims. Given our summary judgment ruling that the Ultrasound Requirement did not violate the Substantive Due Process Clause, only Plaintiffs' Equal Protection challenge to this provision proceeded to trial.
"Phase II" of the trial addressed Plaintiffs' Substantive Due Process and Equal Protection challenges to the following provisions: (1) the Physician-Only Law; (2) the Second-Trimester Hospitalization Requirement; (3) the Licensure Requirement; (4) certain facility regulations governing medication and aspiration abortion clinics; and (5) the criminal penalties provisions. Plaintiffs also challenged various mandatory disclosures as violative of the First Amendment and the Fourteenth Amendment's Substantive Due Process Clause. Plaintiffs abandoned their remaining claims, even though they had survived summary judgment.
In their final pretrial filings submitted in advance of the Phase II trial, Plaintiffs asserted that they were entitled to facial relief from Indiana's Licensure Requirement on Equal Protection grounds. Plaintiffs' pretrial submissions also indicated, for the first time during the three-year pendency of this litigation, that they wished to seek permanent injunctive relief against the Licensure Requirement as applied to the South Bend Clinic.
III. Findings of Fact
Because any constitutional determination regarding the statutes governing abortion must be predicated on an accurate portrayal of the underlying scientific and medical facts, we shall structure our analysis as follows: we begin with (A) an examination of certain scientific background information dealing generally with the safety of abortion procedures in the United States, drawing on evidence and arguments proffered by both parties at trial. Then, we turn to a review of (B) the data reflecting the availability of abortion care in Indiana as well as the challenges faced by women seeking to access this care. The final part of our analysis, (C), lays out the specific Indiana statutes challenged in both Phase I and II of trial.
Safety of Abortion Procedures
Abortion is a commonly performed medical procedure in the United States; in fact, approximately it is estimated that one in four women in the United States had or will have an abortion at some time during their lifetimes. [Phase I. Tr. Vol. II, 17: 17-20].
Based on a broad consensus of views and data in reputable medical literature, abortion procedures performed in the United States are regarded as generally safe for the woman undergoing them. In 2018, the National Academies of Sciences, Engineering, and Medicine ("NASEM"), a nongovernmental body established and chartered by the United States Congress, conducted a broad-based survey and analysis of legal abortion procedures being performed clinically throughout the United States. This report (hereinafter, the "NASEM report") is widely recognized as an authoritative source on the safety and quality of abortion care throughout the United States, and its findings hold that abortion is generally a safe and effective process involving minimal medical risks. [Phase I Tr. Vol. II, 21:8-25, 22:1-6, 23:3-9].
Major complications following an abortion are uncommon: a peer-reviewed study published in 2015 by The Journal of Obstetrics and Gynecology
Obviously, not all medical risks associated with abortion can be entirely avoided; it is, after all, a medical procedure. Generally, the level of risk varies, however, based generally on the type of abortion being performed. In the United States, abortion is performed by one of the following three methods: medication abortion, aspiration abortion, or dilation & evacuation. [Phase I. Tr. Vol. II, 17:23-25, 18:1-4]. Fundamental disagreements over the inherent risks associated with each method persist between the parties to this lawsuit. There is no dispute, however, that the risks associated with abortion, including the risk of an incomplete abortion and maternal death, increase with the gestational age of the fetus. [Dkt. 347, Joint Stip. of Fact
1. Medication Abortion
Medication abortion is generally available to a woman through the first seventy days (ten weeks) of gestation as measured from her last menstrual period (lmp). [Dkt. 347, Joint Stip. of Fact ¶ 63]. It involves the termination of a pregnancy through the combined administration of two medications: mifepristone and misoprostol. [Id. ¶ 65]. This combination of drugs is also viewed by doctors as the most effective medical treatment for miscarriage management. [Phase I Tr. Vol. II, 67:12-23].
Mifepristone (also known by its brand name, "Mifeprex") is among a small number of drugs that the Food and Drug Administration (the "FDA") subjects to a Risk Evaluation and Mitigation Strategy ("REMS"), which, among other things, prohibits mifepristone from being dispensed in pharmacies, requiring that it "be dispensed to patients only in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber." [Dkt. 347, Joint Stip. of Fact ¶ 69].
Prior to receiving a medication abortion, the woman is screened for eligibility and contraindications, is provided counseling, and is then administered the abortion-related medications. [Phase I Tr. Vol. II, 41:7-25, 42:7-8]. When the dose of mifepristone is ingested, it acts to block the hormone progesterone, which halts further growth and development of the fetus. [Phase I Tr. Vol. II, 18:5-11]. Within twenty-four to forty-eight hours after ingestion, the second drug, misoprostol, is ingested by mouth at any location of the patient's choosing, typically at home. This second drug causes the uterus to expel its contents, thereby completing the abortion. [Dkt. 347, Joint Stip. of Fact ¶ 68; Phase I Tr. Vol. II, 18:12-16, 65:10-16]. Medication abortions require no anesthesia or sedation. [Phase I Tr. Vol. II, 39:2-4].
Because the abortion-inducing medications exert their effects over time, most complications associated with a medication abortion typically occur after the patient has left the abortion facility. [Phase I Tr. Vol. II, 65:1-9].
The most common complication following a medication abortion is an incomplete abortion. This occurs when the medications do not completely empty the uterus or halt the pregnancy; in such instances, the antidote involves providing the patient with either an additional dose of misoprostol or having her undergo an aspiration procedure to complete the abortion. [Id. 56:1-7]. An incomplete abortion following a medication abortion has been calculated to affect only to 3% of women. Stated otherwise, medication abortion is proven to be 97% effective. [Id. 56:7-13.]. Other risks of a medication abortion may include hemorrhage or infection. [Phase I Tr. Vol. III, 7-20]. Ordinarily, all these potential risks and their likelihood of occurring are communicated to women during the initial informed consent process. [Phase I Tr. Vol. II, 56:13-16].
These complications are rare, According to Dr. Grossman. "Major complications" or "clinically significant adverse events," such as excessive bleeding necessitating a blood transfusion or other complications necessitating surgery, emergency department treatment, or intravenous antibiotics, for example, affect between 0.16 and 0.31% of women, that is, less than half a percent, according to his testimony. [Id. at 62:22-25, 63:1; 64:13-25]. Even fewer complications— 0.06%—necessitate hospital admission.
Even these (uncommon) risks of complications from a medication abortion are mitigated when a competent provider, prior to proceeding with this care, evaluates a patient, screens for and diagnoses any potential contraindications, and confirms her mental and physical capacity to undergo the medication abortion, according to all the uncontroverted evidence. Though Dr. Grossman and Dr. Harrison dispute the inherent risks posed by medication abortion, they generally agree as to the contraindications for mifepristone, which must be properly screened for prior to the provision of a medication abortion. The most common contraindications include an ectopic pregnancy (that is, a pregnancy out-side of the uterus), the presence of an intrauterine device (an "IUD") that would need to be removed, or a history of taking certain medications such as blood thinners. [Phase I Tr. Vol. II, 53: 18-24; Phase I Tr. Vol. III, 125:21-25; 126: 1-11, 129:14-20]. In addition, the experts all agree that screening for gestational age is critical to safely providing all forms of abortion care
2. Surgical (Aspiration and D&E) Abortion
Aspiration abortion involves the use of suction to empty the contents of the uterus. The procedure begins by gently opening or dilating the patient's cervix, either with medications or instruments. [Phase I Tr. Vol. II, 19:1-2]. A hollow curette is then inserted into the patient's uterus. At the non-inserted end of the curette, a vacuum is applied to create suction to remove the contents of the uterus. [Id. at 19:2-4]. The procedure typically takes less than five minutes complete. [Id. at 19:5-8]. Aspiration abortion is most commonly used prior to fourteen to sixteen weeks lmp. [Id. at 19:9-14]. An aspiration abortion is identical to what is commonly referred to as a "dilation and curettage" ("D&C") in the context of miscarriage management. [Phase I Tr. Vol. II, 70:21-25; Phase II Tr. Vol. II, 141:14-18].
Dr. Grossman describe the incidence of complications following aspiration abortions as quite "rare." Complications that do occur are typically associated with the dilation of the cervix, which creates a risk of forming a false passageway in the cervix that can lead to the perforation of the uterus. [Phase II. Tr. Vol. I, 170:24-25, 171:1-2]. Aspiration abortion may also pose a risk of bleeding or infection. Similar to medication abortion, Dr. Grossman testified that studies show that only .16% of women experience a major complication requiring hospital admission, surgery, or blood transfusion following an aspiration abortion. [Phase I Tr. Vol. II, 70:1-4]. The overall complication rate (including both minor and major complications) for aspiration abortion is lower than the rate for medication abortion, given that aspiration abortions pose a lower risk of the occurrence of an incomplete miscarriage. [Id., at 65:17-25].
Dilation & evacuation ("D&E") is an abortion method commonly used during the second trimester of pregnancy. It utilizes both suction and medical instruments to empty the contents of the uterus. The first step in administering this procedure is the dilation of the cervix using osmotic dilators and/or medications. The overall duration of this process depends on the gestational age of the fetus; it may take several hours on the same day that the evacuation procedure takes place, or it may be performed twenty-four to forty-eight hours in advance. Once the cervix is dilated, a combination of suction and forceps is used to empty the uterus, requiring five to ten minutes to complete. [Phase I. Tr. Vol. II, 19:18-25, 20:1-7].
D&Es are highly effective abortion procedures and rarely result in complications; they are calculated to be 99% effective, with complications occurring in only .05% to 4.0% of cases. [Phase II Tr. Vol. I, 191:12-15, 195:19-23]. These complications may include infection, bleeding, or, on rare occasions, the laceration or perforation of the uterine wall, which may lead to excessive bleeding, though such complications are rare, according to Dr. Grossman. [Id., at 140:3-17, 141:1-8; infra Section III.C.3].
Though aspiration abortion and D&E abortion have historically been regarded as forms of "surgical abortion," neither requires making any incision into a patient's body. [Phase I Tr. Vol. II, 20:8-9; Phase II Tr. Vol. III, 46:1-9; Dkt. 347 Join Stip. Fact. ¶ 70].
Prevalence of and Access to Abortion in Indiana
1. Availability of Abortion Services in Indiana
In 2018, the year this lawsuit was filed, six abortion clinics were in operation in Indiana, three of which were located in Indianapolis [Dkt. 347, Joint Stip. Fact. ¶¶ 31, 38, 39, 41]. A seventh clinic, the South Bend Clinic, opened in 2019, see Dkt. 186 Modified Preliminary Injunction.
Of these clinics, two—Planned Parenthood of Lafayette and the South Bend Clinic—provide only medication abortions and no clinic provides abortion services after the first trimester. These clinics offer abortion services primarily on only one or two days of the week or once every other week. Specifically, Planned Parenthood of Merrillville offers services one day a week and one Saturday a month; Planned Parenthood of Lafayette offers services two days a month; Planned Parenthood of Bloomington offers services one day a week; Planned Parenthood of Georgetown Road (Indianapolis) offers services two days a week and one Saturday each month; Women's Med of Indianapolis offers services two days a week; and the South Bend Clinic provides services three days a month. [Phase I Tr. Vol. I, 28:11-14; 28:24-25, 29:1-23, 165:18-20, 83:5-8].
In addition to the clinics, five Indiana hospitals provide abortion services, all of which are located in Indianapolis or an adjacent suburb. [Dkt. 347, Joint Stip. Fact. ¶¶ 49-53]. However, these hospitals provide only second-trimester services and only then if a maternal or fetal indication has presented. [Phase II Tr. Vol. I, 32:15-19]. No Indiana ambulatory surgical center currently provides abortions. [Id. ¶ 54].
No Indiana abortion clinics are located east of Indianapolis or south of Bloomington, which deprives residents living in Indiana's second-largest and third-largest cities, Fort Wayne and Evansville, respectively, [Id. ¶¶ 58-62], from convenient geographic access to these services. Women who live in these cities must travel 250 miles round trip to obtain abortion care in Indiana.
As discussed in greater detail below, Indiana law mandates that patients seeking an abortion appear twice at two separate appointments. They must first report to the abortion clinic or (an affiliated facility) to review Indiana's mandated counseling materials with a physician or advanced practice clinician in a counseling session, which includes an ultrasound procedure to screen for contraindications and gestational age, and a required viewing of the image and discussion with the patient. No sooner than eighteen hours thereafter, the patient returns to the abortion clinic where a physician must conduct a physical examination before dispensing the abortion-inducing drugs to the patient.
2. Demographics of Women Seeking Services and Challenges to Accessing Care
The majority of women impacted most severely by Indiana's highly restrictive statutory regulation of abortion are low-income individuals, living in households at or below 200% of the federal poverty line.
It is undeniable that low-income women face greater barriers in accessing health care than others. Unsurprisingly, public health research, including that which was reviewed and conducted by Plaintiffs' expert, Dr. Diana Romero,
Dr. Romero's research findings are consistent with the firsthand experiences reported by women seeking abortion services in Indiana. Ms. Paulina Guerrero serves as the National Programs Manager of All-Options, a nonprofit organization whose purpose is to provide unbiased support to women navigating unplanned pregnancies.
The State's stated justifications for these abortion restrictions are to essentially protect women's health as well as the potential life of the unborn fetus. Indiana's reduction and restrictions of access to public benefits, however, make securing this care hugely challenging for low-income women and poverty-stricken families. Indiana's participation in various "social safety net programs" designed to assist individuals living in poverty to meet their basic living needs, such as "Temporary Assistance for Needy Families" ("TANF"), Supplemental Nutritional Assistance Program ("SNAP"), and Medicaid, come with strict standards and limitations as to the eligibility of those who might seek to receive these benefits. [Id. 174:7-15].
For example, SNAP, or what is commonly referred to as "food stamps," allows federal funds to flow through the states' coffers so that each may provide food-related assistance to their own poor and
As another example, Indiana also restricts eligibility for TANF, which provides cash assistance to poverty-stricken families and individuals, only to Hoosiers living well-below the federal poverty line. For example, a family of three in Indiana is eligible for TANF if it earns less than $600 per month, or approximately $7000 per year. Accordingly, only those families who earn income at a level approximately 66% below the federal poverty line or less are eligible for these benefits. The State thus provides TANF benefits to only five out every one hundred poor families in Indiana. In addition, Indiana does not provide support to mothers with newborns through TANF; rather, Indiana is one of only twelve states that enforce a "family cap policy." Pursuant to this penurious policy, an individual with one or more children does not receive any additional TANF benefits based on those additional children. Expressed otherwise, a mother with a single child is not entitled to any additional cash assistance for her second child, even though the size of her family has increased from two to three members. [Id. 175:9-25; 176:1-7]. Indiana imposes this family cap restriction notwithstanding the uncontroverted fact that single mothers suffer from poverty at a strikingly disproportionate rate: whereas Indiana's poverty rate hovers around 14.5%, the rate of poverty for single mothers in Indiana is 39%. Four out of ten single mothers are thus to be viewed as struggling to meet their basic needs. [Id. at 164:9-13; 165:15-19; 166:8-10].
Medicaid is another, highly familiar government-funded health program that provides insurance coverage to low-income residents who qualify for its benefits. Though the federal government mandates the imposition of no work requirements as a condition of receiving health insurance, Indiana nonetheless has elected to impose such requirements as conditions precedent to coverage. Specifically, Indiana requires individuals to work a minimum of 80 hours per month in order to receive Medicaid benefits, and, to compound the hardship of this requirement, caring for children or dependents does not qualify as work.
These burdens intensify for women experiencing intimate partner violence, who often face the necessity of hiding their pregnancies from their perpetrators. [Phase I. Tr. Vol. II, 108:15-23]. To these women, accessing care may feel like "a matter of life and death," Ms. Guerrero testified. [Phase I. Tr. Vol. III, 3:12-19].
As one young woman recounted, these factors create a long and stressful "line of dominos," each of which must be carefully assembled—and then reassembled when Planned Parenthood has to reschedule her appointment because of its physician's unavailability —in order for her to access care. [Phase I. Tr. Vol. II, 190:14-21, 191:4-13].
The Hoosier Abortion Fund provides a means to alleviate some of the financial burdens of accessing care, but it has a "very limited budget, and a very high need." [Phase I Tr. Vol. 18:23-25]. On average, the Hoosier Abortion Fund pledges payments of $225 for women who are fewer than ten weeks lmp and $350 for those who have passed this threshold. Some women may still be unable to access abortion care even with this financial assistance because the associated costs of abortion services, such as paying for child care or gas, make it prohibitive. In such instances, the Hoosier Abortion Fund tries to increase its pledge by $40-50 to cover the additional costs. [Id., at 31:25, 32: 1-6].
The burdens associated with client travel also often lead to delays in their accessing abortion care, which, in turn, increases
Though the State broadly counters with the argument that Indiana's abortion regulations do not prevent women from accessing abortion in Indiana nor qualified practitioners from providing these services, Plaintiffs have presented at this trial substantial, highly persuasive evidence to the contrary, demonstrating that under Indiana's onerous requirements, Indiana women who must contend faced with the above-referenced burdens, either struggle or ultimately fail to overcome them, causing them to travel to neighboring states. It is these burdens and obstacles to accessing care that provide the framework for our constitutional review of the challenged regulation and statutes imposed by Indiana law.
Plaintiffs' (Remaining) Challenges to Indiana's Regulation of Abortion
As stated previously, following our summary judgment determinations, Plaintiffs' surviving claims proceeded to trial in phases. Phase I addressed: (1) laws prohibiting the use of telemedicine in abortion care. Phase II addressed: Indiana's statutory and regulatory provisions (2) prohibiting non-physicians from providing first-trimester abortion care; (3) limiting the provision of second-trimester abortion care to hospitals or ambulatory surgical centers; (4) imposing purportedly unnecessary facility requirements on abortion clinics; and (5) mandating that allegedly false and/or misleading information be disclosed to women as a component of the informed consent process. Plaintiffs also challenge (6) the criminal penalties imposed under Indiana statutes for violating these regulations.
1. Laws Prohibiting the Use of Telemedicine, Including the In-Person Examination Requirement, the In-Person Counseling Requirement, and the Ultrasound Requirement
Plaintiffs challenge Indiana's prohibitions on telemedicine as a means of providing abortion-related services and care. Four sections of Indiana's abortion code are targeted, each of which restricts a woman's ability to receive abortion services, particularly medication abortion services,
Indiana's "Telemedicine Ban" prohibits healthcare providers from using telemedicine to prescribe "an abortion inducing drug."
a. The Telemedicine Ban and the In-Person Examination Requirement
As noted, the Telemedicine Ban prohibits physicians from utilizing telemedicine to prescribe an an-abortion inducing drug. The In-Person Examination Requirement requires the treating physician to examine a pregnant woman in person prior to dispensing an abortion-inducing drug and operates as a de facto ban on using telemedicine to provide medication abortion services.
Significantly, the FDA prohibits mifepristone from being dispensed anywhere except a medical clinic or hospital; thus, it cannot be dispensed at pharmacy or mailed to a patient.
Given these restrictions, telemedicine is typically incorporated into the provision of abortion care not through a "direct-to-patient" model, where a patient may, from any location, connect to a health care provider, but via "site-to-site" communications, wherein the patient reports to the clinic and is remotely connected via technology to a health care provider who is not physically present at the clinic. The provider remotely reviews the patient's medical history and ultrasound results (which have typically been obtained from qualified personnel at the clinic) to screen for contraindications. The provider also conducts direct, face-to-face communications with the patients through secured videoconferencing to determine the appropriateness of the medication abortion. Through this procedure and platform, the provider reviews with the patient the risks and benefits of medication abortion, including information about normal side effects, warning signs, and follow-up care. After obtaining the patient's informed consent, the provider directs clinic staff members to dispense the abortion medications to the patient. [Phase I Tr. Vol. I, 48:8-25, pp. 49-51, 53:16-25; Phase I. Tr. Vol. II, 76:5-25, 77:1-6, 84:3-18].
This telemedicine methodology has been incorporated into the provision of medication abortion by Planned Parenthoods (and other clinics) in other states. Additionally, Planned Parenthoods located within Indiana use this site-to-site model in the provision of other kinds of care, including birth control and sexually transmitted infection ("STI") services. [Phase I Tr. Vol. I, 48:21-25; 49:1-25, 50:1-5, 51:6-25; 52:20-23].
Dr. Grossman attests that utilizing telemedicine for medication abortions is as safe and effective as in-person treatment. In terms of safety, Dr. Grossman's research indicates that the complication rate for medication abortion remains exceedingly low, regardless of whether the procedure is provided in-person or through site-to-site telemedicine. [Id., pp. 60-63; 91-93]. One peer-reviewed study published in 2017 (for which he served as the lead author), for example, reviewed data relating to adverse events reported in a seven-year period among patients obtaining medication abortions at Planned Parenthoods in Iowa. Data reflecting in-person visits by women with a physician were compared to data relating to medication abortion for women who received their care via telemedicine. The study reviewed nearly 20,000 abortions patients, almost half of whom had received abortion care through telemedicine, and ultimately concluded that the overall rate of significant adverse events for medication abortions was very low (approximately.26%). Importantly, there was no significant difference in the rate of adverse events between patients who received telemedicine care compared to those who received in-person services.
ACOG supports the provision of telemedicine care as a safe and effective method of providing medication abortion care, holding, in fact, that the utilization of telemedicine may actually improve access to early abortion, thus reducing the need for second-trimester abortion services. [Id., at 94:1-3; 22-25, 95:1-3]. Though the most recent ACOG practice bulletin,
Dr. Grossman also opined that the COVID-19 Pandemic has broadened and inspired innovations in the use of telemedicine. Dr. Grossman, who works primarily with low-income patients, testified that a bias that previously existed among providers predicting that patients with limited means would be generally unwilling or unable to effectively utilize telemedicine. As the pandemic unfolded, however, one of his colleagues conducted a study on this issue and found that low-income patients were highly interested in telemedicine resources and could, in fact, successfully utilize them. [Id., at 150:17-25, 151:1-23]. Ms. Guerrero, consistent with Dr. Grossman's opinions, also believes her clients could and would effectively utilize telemedicine for their abortion care. [Phase I. Tr. Vol. III, 32:24-25; 33:1-23]. Ms. Roth, however, voiced concerns over whether the women she encounters at A Mother's Hope in Fort Wayne would benefit from telemedicine
In non-abortion contexts, telemedicine is increasingly and widely available. Indeed, expanded use as a means of reducing healthcare costs, increasing access to specialty care, and improving healthcare access for people in underserved communities has been widely encouraged. [Phase I Tr. Vol. II, 72:18-25; Phase I Tr. Vol. IV, 35:6-22]. In fact, Indiana has over the past five years authorized major expansions of telemedicine services. In 2015, Indiana enacted a statute requiring health insurance policies to include coverage for telemedicine services on the same terms as coverage is provided for healthcare services delivered in person. See Pub. L. No. 185-2015, §§ 25-27, 2015 Ind. Acts 2102-04 (codified at Ind. Code §§ 27-8-34-1 to 27-8-34-7, 27-13-1-34, 27-13-7-22). In 2016, Indiana enacted another statute broadly authorizing healthcare providers to use telemedicine to treat patients in Indiana. See Pub. L. No. 78-2016, § 2, 2016 Ind. Acts 711-15 (codified at Ind. Code §§ 25-1-9.5-1 to 25-1-9.5-12). One year later, in 2017, Indiana expanded telemedicine authority to include the prescription of controlled substances. See Pub. L. No. 150-2017, § 7, 2017 Ind. Acts 1430-31 (codified in relevant part at Ind. Code § 25-1-9.5-8).
Providers regularly utilize telemedicine to prescribe medications, and, in so doing, screen for contraindications utilizing this same medium. [Phase I Tr. Vol. II, 73:5-25, 74:1-7]. As noted, Planned Parenthoods in Indiana currently utilize telemedicine for non-abortion services, employing both direct-to-patient and site-to-site models of care and utilizing secure platforms to ensure the patient's confidentiality. From an operational standpoint, Planned Parenthoods have been largely successful in implementing both models of telemedicine and plan to utilize telemedicine for abortion services in Indiana, if and when they are legally permitted to do so. [Phase I Tr. Vol. I, 52: 2-25, 53:1-8]. Ms. Laura Miller, the Area Services Director for Planned Parenthood Great Northwest,
To further illustrate, Planned Parenthood in Bloomington currently has one physician available to provide services on Thursdays. If telemedicine services were permitted, this physician could and would provide services not only to women in Bloomington, but to women from across the state. Because the remaining Planned Parenthoods have physicians available on other days of the week, telemedicine's expanded capacity would enable Planned Parenthood to offer abortion appointments five days of every week at every clinic.
For women who do not reside in the same geographic location as a clinic, the possibility and desirability of obtaining care any day of the week would greatly increase, due to the expanded access to appointments and to care. Currently, women seeking abortion services typically must wait a few days to a week and half between their first and second appointments at Planned Parenthood, and it is not uncommon for women struggling to secure child care and/or traveling long distances to be delayed even longer due to the clinics' limited appointment availability. [Phase I Tr. Vol. I, 36:5-18, 53:24-25, 54:1-2]. Such a delay may be critical in terms of whether the kind of care a patient requires and seeks is available to her. As Ms. Miller testified, Indiana's Planned Parenthoods encounter women who are less than ten weeks lmp when they first contact the clinic or when they have their counseling/ultrasound appointment, but who will become post-ten weeks lmp before their second appointment can be scheduled. Planned Parenthoods encounter women who are less than thirteen weeks, six days lmp at their initial contact or first appointment who will progress past this gestational threshold prior to being able to schedule a first-trimester aspiration procedure. [Id. at 45:8-25, 46:1-11].
Ms. Miller also testified that Planned Parenthoods in Indiana could easily implement telemedicine in their abortion care based on the already existing care models employed by Planned Parenthoods in both the non-abortion and abortion settings. [Id. at 52:15-19]. Women's Med and the South Bend Clinic reported that the incorporation of telemedicine would similarly improve accessibility for their patients by creating increased flexibility and reducing delays in scheduling appointments.
Ms. Hagstrom Miller testified that WWHA, much like Planned Parenthood, has successfully incorporated telemedicine procedures into its abortion services in other states, resulting (as predicting) in reduced costs of care and increased availability of appointments. [Id., at 101:25, 102-104]. She expects the incorporation of telemedicine at the South Bend Clinic would result in a comparable, favorable impact on care, allowing the clinic to offer appointments four to five days a week and to increase its patient capacity by 50 percent. [Id. at 110:6-12, 121: 7-20]. Accordingly, she said, women who normally must wait one to two weeks between their first and second appointments at the South Bend Clinic would be able to access care much sooner. [Id. at 110:4-13]. The impact of such delays in care is not insignificant: the South Bend Clinic regularly must refer to other providers women who may not be at ten weeks lmp at the scheduling of their first appointment but who will pass this gestational line before they can access the second appointment. [Id. at 90:2-6]. Telemedicine would also reduce the costs of care at the South Bend Clinic by reducing the funding that is currently allocated to reimburse physicians' travel expenses. [Id. at 11:5-10].
Ms. Hagstrom Miller further testified that WWHA has rigorously sought feedback from patients following the implementation of telemedicine procedures and determined that there are very high levels of satisfaction with the quality of care provided via telemedicine; many express appreciation
As Dr. William Haskell, the Medical Director of Women's Med, testified, Women's Med currently has very few appointments open to women because of limitations on physician availability [Id. at 201:5-13]. Allowing physicians to provide services from remote locations would expand the availability of services as well as access. Indeed, he said, Women's Med would be able to offer appointments five days of the week, rather than the current schedule of only one or two. [Id. at 206:15-20]. According to Dr. Haskell, women who prefer in-person appointments with a provider would continue to have that option. [Id., at 201:22-24]. Dr. Jeffrey Glazer, who also provides services at Women's Med as well as the South Bend Clinic, echoed these views with respect to the availability of telemedicine services, emphasizing that the desire to utilize telemedicine is not primarily motivated by convenience to physicians, relieving them of the burdens of travel, but by the increases patients' access to care. [Id. at 177:18-24, 178:1-2].
There is no real dispute that the incorporation of telemedicine techniques would impact the availability of services in the manner described above. Dr. Nancy Goodwine-Wozniak
The In-Person Examination Requirement clearly interfaces with the restriction on telemedicine in the provision of abortion care by requiring a treating physician to conduct a physical examination of a patient prior to performing the abortion procedure.
However, Dr. Grossman testified, there is no sound medical purpose served by
The State's experts testified that in their opinions a physical examination does, in fact, enhance the safety of abortion care. Dr. Harrison and Dr. Goodwine-Wozniak opined that an examination aids with gestational dating (though, as discussed herein, they testify elsewhere that an ultrasound is certainly the most accurate way to date a pregnancy), assists in diagnosing an ectopic pregnancy (which is also best identified through an ultrasound, according to these same experts), and reveals the presence of an IUD (the existence of which can also be readily determined via an ultrasound, or, as Dr. Grossman testified, by simply asking the patient whether she has an IUD). [Phase I Tr. Vol. III, 129:11-20, 130:8-9, 18-22, 14-18, 175:1-15, 176:1-19].
b. In-Person Counseling Requirement
Indiana's In-Person Counseling Requirement directs that "consent to an abortion is voluntary and informed only if" abortion providers satisfy certain requirements, which include the furnishing of certain
As previously discussed, telemedicine would enable providers to remotely review patients' medical histories and ultrasound results and to utilize videoconferencing to determine the appropriateness of medication abortion for an individual patient. Telemedicine may be delivered either through the "direct-to-patient" model or "site-to-site" model. [Phase I. Tr. Vol. II, 52:11-19].
Dr. Grossman's experiences and research again informed his view that providers utilizing telemedicine are able to obtain informed consent as effectively as if the participants were present in person. He testified that the process for obtaining informed consent via telemedicine is "identical" to the process of obtaining informed consent in person, [Phase I Tr. Vol. II, 77:14-22], that no aspect of the process differs when telemedicine is utilized, and no part of the process technically requires the physician or health care provider to be physically present in the same room with the patient. Videoconferencing technology enables the same kind of personal interaction with a patient that would occur in person and also provides various options for reviewing and signing documents. [Id. at 77:23-25, 78:16; Phase I Tr. Vol. II, 50:8-15, 104:4-15].
Dr. Grossman's opinions are based on his own research as well as his extensive review and knowledge of respected medical literature. Specifically, as applicable here, he coauthored a qualitative, peer-reviewed study reviewing women's experiences using telemedicine for their preabortion counseling appointments in Utah in an effort to acquire in-depth information from the patients' perspectives. As he explained, Planned Parenthoods in Utah provide patients with the option of completing their preabortion counseling appointments either via telemedicine or in-person. The women who selected the former option were provided instructions on how to access a video platform whereby they connected with a nurse, who reviewed the state-mandated information and answered any questions from the patient. [Phase I Tr. Vol. II, 78:19-25, 79, 80:2-9].
Dr. Grossman's research concluded with a finding that patients generally were very satisfied with this form of interaction. Though some reportedly possessed initial concerns about their ability to use the technology successfully, or were apprehensive about connecting via this medium, most women's concerns were alleviated once they were connected to the nurse. Women reported that they generally liked using telemedicine for their counseling appointments
Dr. Grossman also co-authored a peer-reviewed, qualitative study to determine providers' perspectives utilizing telemedicine as a means of delivering preabortion counseling information. Dr. Grossman gleaned from this research the finding that providers felt that their interactions with patients were substantively no different when telemedicine was utilized rather than through in-person consultation. He reported that healthcare providers assess in the same manner whether a patient is providing voluntary, informed consent as they would if they were meeting with that patient in person. In both settings, the provider seeks to confirm that the patient understands what an abortion will entail as well as the risks, benefits, and alternatives to the procedure, before ultimately determining that the patient has voluntarily and knowingly elected to proceed with the abortion. [Id. at 8:1-17]. This process can be done "by telemedicine as easily as in person," Dr. Grossman's research revealed. [Id. at 82:18-25; 83:1-9]. Moreover, importantly, the incorporation of telemedicine communications allowed patients to access care sooner than otherwise would have been able to them. [Id. at 82:22-25].
To screen for intimate partner violence through telemedicine, a provider, through verbal prompts, seeks to have the patient disclose this information, sometimes requesting patients to complete written forms or questionnaires to elicit further this information. Dr. Grossman testified that research shows that screening for intimate partner violence through these efforts is as effective as asking the same questions in person. [Id., at 83:10-20]. When utilizing telemedicine for counseling appointments, the provider, of course, seeks to ensure that the patient is currently in a secure place where she can provide honest answers. In fact, in non-abortion contexts, healthcare providers screen for intimate partner violence utilizing telehealth for "all kinds of visits." [Id. at 84:22-25].
Because abortion patients will at some point always be required to appear in person at the clinic to receive the abortion-inducing drugs, opportunities still exist for clinic staff to meet with patients in a confidential, private settings to determine if there are concerns of intimate partner violence, despite utilization of telemedicine techniques as part of the treatment process. [Id., at 84:3-11].
Cassie Herr, a nurse practitioner at Women's Med who regularly conducts preabortion counseling sessions and who has herself received a medication abortion, testified to having no reservations concerning whether these sessions could be conducted effectively and safely via telemedicine. She specifically testified that each aspect of the counseling process—when the procedure is explained, questions answered, the patient screened for coercion or abuse and the state-mandated information and forms are disseminated—could easily be completed through telemedicine in the form of videoconferencing. Consistent with Dr. Grossman's testimony, she stated that the process would look virtually the same as if it were conducted in person. [Phase I Tr. Vol. I, 141:16-25, 142:1-4, 143:6-25, 144, 1-3].
The expansion of telemedicine, particularly during the COVID-19 pandemic, has
The State's experts, including Dr. Christopher Stroud,
By enacting the requirement that patients receive in-person counseling, the travel time and expenses for women seeking abortions are obviously increased. These expenditures are increased due to Indiana's requirement that women undergo a waiting period of at least eighteen hours between their receipt of prescribed information related to informed consent and proceeding with the abortion.
The two-trip requirement obviously also imposes the obligation on the women who do not live in geographic proximity to a clinic either to expend resources on travel occurring on two separate days or on overnight lodging. (We were told that women who lack the financial means to fund either of these alternatives often must make the Hobson's choice of choosing between sleeping overnight in their cars outside of the clinics or foregoing an abortion.) [Phase I Tr. Vol. I, 152:3-5; Phase I Tr. Vol. II, pp. 28-30, 45:11-21].
Telemedicine services, had they been available to Indiana women seeking abortion care, would have ameliorated the burdens of the two-trip requirement. Ms. Herr, who obtained a medication abortion at Women's Med in 2019, and Ms. Grace Hutson, who received a medication abortion at a Planned Parenthood in 2014, testified that the in-person counseling requirements were, indeed, significantly burdensome for, rather than beneficial to them. [Phase I. Tr. Vol. I, 131:1-7, 133:17-25, 134:1-7; Phase I Tr. Vol. II, 190:1-21, 192:22-25, 193:1-3].
c. Indiana's Ultrasound Requirement
Prior to an abortion, Indiana law requires that "the provider shall perform, and the pregnant woman shall view, the fetal ultrasound imaging and hear the auscultation of the fetal heart tone if the fetal heart tone is audible," unless the patient certifies in writing, before the abortion, that she declines to do so. Ind. Code. § 16-34-2-1.1(a)(5) (the "Ultrasound Requirement"). The ultrasound must occur at least eighteen hours in advance of the abortion, though that requirement is not directly challenged here.
Plaintiffs argued at summary judgment that ultrasounds do not enhance decision-making, citing findings from two studies supporting that conclusion—one focused on patients at a Los Angeles clinic and the other focused on abortions patients in Wisconsin. However, even these studies proffered by Plaintiffs reveal that some women's abortion decision-making was impacted by their having first viewed their ultrasounds. [Dkt. 297, at 93].
Plaintiffs also criticized the burdens of the Ultrasound Requirement on the grounds that it requires some patients to receive duplicative ultrasounds since it limits abortion providers to relying on an ultrasound performed only by an affiliated physician or technician. Plaintiffs offered no evidence to show that women are subjected to duplicative ultrasounds because of this requirement, nor did they provide "any constructive analysis as to the way(s) in which potentially duplicative ultrasounds create a substantial obstacle." [Id. at 93-4].
We address the additional facts cited by Plaintiffs at trial to the extent they illuminate our understanding of whether the Ultrasound Requirement comports with the requirements of the Equal Protection Clause.
Plaintiffs appear to concede that the accurate dating of a pregnancy is an essential and important component of safe abortion care. Their evidence does establish that in no other prenatal (or medical) context is an ultrasound mandated by state law, despite its importance in the safe
Performing an ultrasound, however, remains by all accounts the "gold standard" for providing safe care, according to Dr. Harrison, even by ACOG standards. [Phase I Tr. Vol. III, 155:24, 156:1-12], whose "Level B" recommendation is that no ultrasound need to be conducted for some women. [Phase I Tr. Vol. II, 133:1-20]. ACOG's Level A recommendation counsels in favor of an ultrasound or a physical examination for all abortions patients, and the FDA directs that an ultrasound be conducted if there is any uncertainty as to gestational age or concerns of an ectopic pregnancy. [Phase I Tr. Vol. IV, 2-7, 242:21-25]. Dr. Grossman testified at his own facility, in fact, the practice includes ultrasounds being administered prior to proceeding with abortion care. [Phase I Tr. Vol. II, at 41:18-21]. The experts also agree that ultrasound technology is a highly accurate tool by which providers can and ordinarily do date pregnancies. [Id. 42:25, 43:1-3, 111:4-7; Phase I Tr. Vol. III, 195:14-22].
Apart from the value of performing an ultrasound, Dr. Grossman testified that there is no specific medical benefit that follows from a requirement that the ultrasound be performed by the abortion provider or an affiliate thereof rather than by an unaffiliated technician, which undercuts the limitation contained in the Ultrasound Requirement that abortion providers may not rely on ultrasounds conducted by other unaffiliated facilities nor may they refer a patient to a radiology lab near their home. [Phase I Tr. Vol. III, 77:7-13]. This restriction appears to be sui generis: in no other prenatal setting does such a limitation exist for women seeking medical services. The State defends this restriction on the grounds that, though a patient may not be referred to an unaffiliated technician, the ultrasound may be performed at an affiliated facility and is not necessarily limited to the abortion clinic location. A woman could visit, for example, the Planned Parenthood of Fort Wayne (or Columbus or Evansville or Mishawaka) for her ultrasound and then have the abortion performed elsewhere at a licensed abortion clinic also operated by Planned Parenthood. [Phase I Tr. Vol. I, 32:19-25, 33:1-7].
Dr. Grossman estimates that approximately 10% of his patients have already obtained an ultrasound when they first come to him for care; in those instances, he only conducts an additional ultrasound if it were for some reason clinically necessary. [Id., at 113:2-6]. Similarly, Ms. Hagstrom Miller reported that approximately one out of every ten patients, when they first come to the South Bend Clinic, have already received an ultrasound but, due to Indiana's Ultrasound Requirement, they must receive an additional ultrasound at or by the clinic. [Phase I Tr. Vol. I, 93:22-24].
Because this requirement must be satisfied at least eighteen hours in advance of receiving an abortion, it results in the two-trip regimen for patients.
2. Indiana's Physician-Only Law
The "Physician-Only Law" limits the performance of a first-trimester abortion in Indiana only to a physician. Ind. Code § 16-34-2-1(a)(1); see also 410 Ind. Admin. Code § 26-13-2(b). First enacted in 1973, this law is being challenged now, almost
The 2016 amendment to the label for Mifeprex by the FDA removing language restrictions to the administration of this drug solely by physicians provides context to Plaintiffs' claim in this regard. The label as amended provides that "any certified healthcare provider" or any "certified prescriber" is authorized to dispense Mifeprex so long as the provider can diagnose ectopic pregnancies and provide surgical intervention in the case of incomplete abortion or severe bleeding or has "made a plan to provide such care through others." [Phase II Tr. Vol. I, 157:8-16; Phase II Tr. Vol. II, 122:14-15, 123:1-19; see Dkt. 347, Joint Stip. Fact, ¶ 67]. This amendment to the Mifeprex label, as interpreted by providers, states an implicit endorsement by the FDA of the opinion that medication abortions can be safely and competently performed by Advanced Practice Clinicians ("APCs"), such as physician assistants or nurse practitioners. [Phase II Trial, Vol. I, 157:17-21]. Indeed, ACOG, the American Public Health Association, and the World Health Organization have all also endorsed abortion care provided by APCs. [Phase II Tr. Vol. I, 152:16-25, 153:1-25, 154:1-21]. As of June 23, 2021, the evidence adduced at trial established that approximately one-third of the states currently permit APCs to provide medication abortions. In one-quarter of the states, APCs are also authorized to provide first-trimester aspiration abortions. [Id. at 154:22-25; 155:1-5].
In California, for example, where Dr. Grossman practices, APCs are authorized to provide both medication and first-trimester aspiration abortions. He has personally trained APCs to provide these services, which training he describes as being identical to the training a physician received for providing first-trimester abortion care. [Id. at 155]. Dr. Grossman's experiences in training and working with APCs as well as his in-depth review of published medical literature on this topic inform his opinion that APCs can and do provide medication and first-trimester aspiration abortions as safely and effectively as physicians; thus, he opined, Indiana's Physician-Only Law is inconsistent with the accepted medical knowledge and practice in the United States. [Id. at 156:1-13].
Included in his medical literature review was the NASEM report, which, as we have previously noted, is the authoritative source on abortion care standards/procedures in the United States. The report concludes as follows: "Both physicians ... and APCs can provide medication and aspiration abortions safely and effectively." [Id. at 156:19-25]. Similarly, a 2013 peer-review study conducted by the American Journal of Public Health determined that there was no clinically significant difference in the risk of complications (minor or major) arising from first-trimester aspiration abortions, when the abortion is performed by an APC as opposed to a physician. [Id. at 158:1-25, 160:1-25; 161:1-7]. Though an increase in minor complications was observed among the APC-treated group, Dr. Grossman reiterated that any difference in complications did not rise to a level of clinical significance, and, importantly, there was no difference between the groups with respect to major complications. [Id., 161:1-19]. Any gap between these groups' respective proficiency levels, according to Dr. Grossman, disappears as APCs gain experience in performing these procedure. [Id., 161:8-19].
A 2015 meta-analysis comparative study examining APCs and physicians regarding their respective provision of both medication abortion and first-trimester aspiration abortion determined that there was nothing more than a minimal difference between the two groups with respect to
APCs are authorized to provide a range of non-abortion related medical services, which Dr. Grossman contends present comparable risks to first-trimester abortion care. In Indiana, APCs can (and do) prescribe misoprostol for miscarriage management or to treat incomplete abortions. [Id. at 36:13-15; 165:22-25; 166:1-4]. Kelly McKinney, a nurse practitioner with the Community Health Network and Women's Med, testified that she currently provides care of this nature. [Id. at 66: 3-10]. IU Health also utilizes APCs to provide miscarriage management care through the use of mifepristone and misoprostol. Id. 36:10-15].
According to Dr. Grossman, the risks associated with misoprostol (the potential for infection, the risk of excessive bleeding, or the incomplete evacuation of the uterus, for example) are no greater in the context of the provision of abortion care than they are in the context of miscarriage management. [Phase I Tr. Vol. II, 60:6-12; Phase II Tr. Vol. I, 167:12-18]. The challenges faced in managing any potential complications following a medication abortion would present in a similar way as those with a miscarriage management patient. [Phase II Tr. Vol. I 167:19-25]. Other medications that APCs are authorized to prescribe that pose equal or greater risks than abortion-inducing drugs include birth control and opioids. [Id. at 165:23-25; 166:1-7]. When prescribing such drugs, APCs must screen in the same fashion for contraindications as would be required for abortion patients to determine whether the patient is an appropriate candidate for that kind/level of care. [Id. at 63:7-9, 13-23, 166:11-13].
APCs currently perform a wide range of non-abortion-related gynecological procedures: the insertion or removal of an IUD, colposcopies to evaluate for cervical cancer or dysplasia, endometrial biopsies, and loop electrocautery excising ("LEEP") procedures applied the cervix, which involve excising small bits of cervical tissue. Certified nurse midwifes are authorized to perform vaginal deliveries in connection with childbirth and related care in this context, including suturing torn vaginal tissue and administrating intravenously narcotics medication, though a physician is often available and on call in those situations.
Dr. Grossman testified that these authorized gynecological procedures are at least comparable to and sometimes riskier than first-trimester aspiration abortions. [Phase II Tr. Vol. I, 168:15-25]. The insertion of an IUD, for example, is much like a first-trimester aspiration abortion, sometimes necessitating manual dilation of the cervix, thereby creating a risk of forming a false passage way in the cervix which can lead to the perforation of the uterus. [Id. at 170:11-25, 171:1-15]. Dr. Grossman reiterated that an APC would manage these risks associated with aspiration abortion much like he or she would manage the risk of any of the aforementioned procedures, which may include referral to a hospital (where the patient might actually be treated by another APC) or to a physician, if
Ms. McKinney testified that she was confident that she could, if properly trained by a physician, perform a first-trimester aspiration abortion. [Id. at 68:15-25, 69:1-3]. Dr. Bernard testified that she would refer her patients in need of first-trimester abortion services to an APC, if she were legally permitted to do so. [Id. at 37:1-20].
Dr. Calhoun testified, however, that in his opinion and experience, physicians are better trained to "recognize" and to "deal with and/or be able to fix any complication that might occur as a result" of an aspiration abortion. [Phase I Tr. Vol. II, 95:4-10]. This training of physicians their encompasses years of residency in specific areas of medical practice, including obstetrics and gynecology as well as surgery. [Id. at 96:1-12; Phase II Tr. Vol. III, 8:7-25, pp. 9-13]. Though Dr. Calhoun and Dr. Stroud concur with Dr. Grossman that APCs are qualified to perform procedures such as colposcopies and LEEPs, these procedures, they say, are not properly viewed as being in the same "realm" as aspiration abortion, which requires the dilation of the cervix and is thus significantly more complex. [Phase I Tr. Vol. II, 40:16-24]. Dr. Calhoun agrees that the most common complication associated with an aspiration abortion or a D&C arises from the dilation of the cervix, which poses a risk of creating a false passageway that could lead to the perforation or laceration of the uterus; however, Dr. Calhoun disagrees with Dr. Grossman that the insertion of an IUD also involves the manual dilation of the cervix. His practice does not include the manual dilation of the cervix for patients in his care. [Phase I Tr. Vol. II, 94:5-14; 128:25, 129:1-20, 131:22-25, 132:1-4; 133:6-14].
Dr. Goodwine-Wozniak asserts that aspiration abortions are more invasive and complex than the procedures listed by Dr. Grossman, maintaining that physicians are better trained to handle complications that may arise during this procedure. In agreement with the State's other expert witnesses, she holds that aspiration abortion, unlike the procedures delineated by Dr. Grossman, entails the dilation of the cervix and thus is beyond the scope of an APC's competency and practice. [Id., at pp. 149-50, 151:4-13].
Dr. Stroud testified that although he employs numerous APCs in his practice, he echoes Dr. Goodwine-Wozniak's concerns. In response to Dr. Grossman's view that APCS can provide D&Cs in the context of miscarriage management, Dr. Stroud indicated that he was not aware of any non-physicians performing D&Cs and did not believe that APCs could perform D&Cs consistent with the appropriate standard of care. He also specifically indicated that he would not permit APCs under his supervision to perform D&Cs—a procedure that he personally performs routinely in his practice. In his expert opinion, allowing APCs to perform this procedure would be medically inappropriate. [Phase II Tr. Vol. III, 13-15].
The evidence includes no specific testimony from or identification of APCs who currently provide D&Cs for miscarriage management patients or APCs who perform dilations of the cervix when inserting IUDs. Dr. Grossman clarified that such dilations are only "sometimes" necessary in those contexts.
With respect to medication abortions, Dr. Calhoun,
Dr. Goodwine-Wozniak also opined that APCs may not be qualified to manage hemorrhaging caused by the abortion—though, as we previously noted, APCs are authorized to handle this potential complication when it arises in the course of miscarriage management. Dr. Stroud shared the view that APCs are not qualified to perform D&Cs, which could be required in an incomplete medication abortion. Again, however, APCs are trusted with managing this complication with a miscarriage management patient. It is also undisputed that such complications as these most likely arise after the patient has left the abortion facility, following the ingestion of misoprostol.
In non-abortion settings, APCs are subject to all generally applicable laws/regulations defining the scope of practice and professional standards. See Ind. Code §§ 25-22.5-1-1.1(i)(1), 25-23-1-1, 25-23-1-19.4; 844 Ind. Admin. Code §§ 2.2-1.1-13, 2.2-1.1-16, 2.2-2-6; 848 Ind. Admin. Code §§ 3-1-1, 3-1-2, 4-1-4, 4-2-1. Physician assistants must be supervised by licensed physicians pursuant to written supervisory agreements. See Ind. Code § 25-22.5-1-1.1(i)(1); 844 Ind. Admin. Code 2.2-1.1-16. Nurse practitioners practicing in outpatient settings are required to collaborate with licensed physicians, also pursuant to written agreements. See Ind. Code § 25-23-1-19.4.
The size of Indiana's pool of abortion providers eligible to perform first-trimester abortions is obviously significantly reduced by the impact of the Physician-Only Law. Physician availability and recruitment, as previously explained, is a significant barrier to patient access of abortion services in Indiana, supra Section III.B.1. Because of a shortage of available physicians, the limited capacity of Indiana's licensed abortion clinics results in long wait times and an inability to expand the provision of services to additional days.
The recruitment of APCs does not pose such obstacles, however. Indeed, we were told, there exists a supply of APCs willing and able to provide abortion care, who would do so but for the Physician-Only Law. Many APCs are already employed by licensed abortion clinics, but their duties are curtailed by this statutory restriction. Planned Parenthood, for example, employs a base of twenty APCs across its three
Similarly, Women's Med currently employs three APCs who prescribe contraceptives, conduct preabortion counseling, review ultrasounds, and perform follow-up examinations on abortion patients. Likewise, these APCs would perform abortion-related care at Women's Med, if the law permitted them to do so. [Id. at 48, 49:1-2]. The South Bend Clinic employs one APC who currently works only two Fridays a month, but, if she were permitted to provide medication abortions, she would expand her time commitment to the clinic. [Id. at 76:14-21, 78:25, 79:1-4].
If APCs were eligible to provide abortion services, they could staff the clinics on days when physicians are unavailable, thereby increasing the availability of abortion services to patients, and, in turn, reducing the existing delays in accessing care. Without this restriction, each licensed abortion clinic in Indiana could and would significantly expand its services: Indiana's Planned Parenthoods would offer appointments every day of the week they are open, rather than one or two days (or less for some, such as the Lafayette clinic) and Women's Med would expand its offering from two days a week to five days a week. [Id. at 12:22-25, 13:1-3, 49:3-9]. The South Bend Clinic would expand the number of days on which abortion appointments are available. [Id. at 75:3-9, 78:21-25, 79:1-7].
Allowing APCs to provide abortion services would also reduce procedural costs for patients. As. Dr. Haskell testified, APCs are employed at a lower salaries; an abortion performed by an APC would result in a cost reduction of 10%, from $700 to $630. [Id., at 49:10-23]. The South Bend Clinic would also be able to reduce the cost of medication abortions provided by APCs, which savings would be passed on to the patients. [Id., at 75:10-19, 79:1-14].
3. Indiana's Second Trimester Hospitalization Requirement
Indiana's "Second Trimester Hospitalization Requirement" provides that "after the first trimester of pregnancy," an abortion may only be "performed in a hospital or ambulatory outpatient surgical center." Ind. Code § 16-34-2-1(2). As detailed herein, hospitals and ambulatory surgical centers are subject to heightened construction and staffing requirements necessary (among other reasons) to maintain a sterile operating environment. Such requirements are unnecessary to safely perform second-trimester abortions, according to Plaintiffs, and the hospitalization requirement reduces access and increases costs for abortions performed in Indiana.
Early second-trimester abortions, up to sixteen weeks lmp, may be performed utilizing aspiration abortion; however, the vast majority (90%) of second-trimester abortions are performed through D&Es. [Phase II Tr. Vol. I, 190:1-16].
When an aspiration abortion is performed in the second trimester, that procedure is "exactly the same" as when it is performed in the first trimester. [Id. 190:14-25, 191:1-2]. Currently, as we have previously noted, five of Indiana's abortion clinics are licensed to provide first-trimester aspiration abortions.
D&Es, as currently performed, utilize both suction and medical instruments to empty the contents of the uterus. The first step is the dilation of the cervix using
Plaintiffs' evidence indicates that second-trimester D&E abortions in places outside of Indiana can be and are safely performed in out-patient, office-based settings. Dr. Grossman, whose opinions, again, are anchored in his personal experiences as well as his review of relevant medical literature and his own published research, testified that there are no minimum facility requirements necessary to safely perform D&Es beyond those connected with the type of anesthesia used, which, for D&Es, is likely to be moderate sedation or intravenous deep sedation. [Id. 176: 16-25, 1-7; 178:10-16, 192:1-9]. Heightened construction and personnel requirements applicable to hospitals do not enhance the safety of a D&E, according to Dr. Grossman, given that the primary purpose of such requirements is to ensure the sterility of operating rooms within the context of performing sterile surgeries during which surgeons make incisions into the body. As previously noted, D&Es do not require incisions into sterile tissue. Additionally, operating rooms in hospitals and ASCs require that they be of adequate size to allow for the presence and movement of an anesthetist and general anesthesia equipment as well as other surgical equipment. None of these needs for space apply when safely performing a D&E. [Id. at 181:2-15, 192].
Dr. Grossman stated that an ambulatory surgical center is no better equipped than an out-patient medical clinic to treat the potential complications of a D&E, and, in any event, complications are "very, very rare." On such rare occasions when a complication does arise, both an ASC and an outpatient clinic would almost certainly transfer the patient to a hospital for consultation or collaboration with a surgeon. Accordingly, the care provided in an ASC would be no different or better or safer than that which would and could be provided by an outpatient abortion clinic. [Id. at 193:1-14].
Dr. Grossman's opinions find substantial support in medical literature, including the NASEM report. [Id. at 175:19-25, 176, 177:1-7]. Similarly, "Consensus Guidelines," developed by ACOG and the American College of Physicians as well as other
In addition, a 2018 peer-reviewed study published in The Journal of the American Medical Association reviewed incidences of complications and adverse events occurring in ASCs compared to out-patient office-based settings over a three-year period. The findings of this study determined that there is no evidence that second-trimester D&Es are any safer when they are performed in an ASC compared to an office-based setting. [Id. at 193:16-25, 194:1-15, 195:9-14].
Dr. Grossman reports that he routinely and safely provides D&E care in an outpatient clinic setting. [Id., at 195:25, 196:1-5]. He further noted that D&Es in the context of miscarriage management are provided in office-based settings, as are procedures of comparable complexity and risk, such as operative hysteroscopies, which involve dilating the cervix and then inserting instruments into the cervix to remove fibroids, polyps, or a septum of the uterus. [Phase II Tr. Vol. III, 44:10-25].
The State's experts did not counter these findings from Dr. Grossman's research.
Planned Parenthood currently provides second-trimester abortion care in their clinics located in other states, including Hawaii, Alaska, Idaho, and Washington. [Id. at 16:2-7]. The Planned Parenthoods licensed in Indiana to provide aspiration abortion services (Merrillville, Indianapolis, and Bloomington)
As Ms. Miller testified, it would be cost-prohibitive to retrofit Planned Parenthood's existing facilities to comply with the scheme of ASC regulations. Such retrofitting would require adding space to satisfy the larger square footage requirements and installing expanded HVAC systems. [Id., p. 17]. Dr. Haskell of Women's Med notes similar challenges impeding their ability to upgrade to an ASC. He estimated
There is no dispute that the Second-Trimester Hospitalization Requirement increases the costs and reduces the availability of second-trimester abortion care. Few hospitals and no ASCs currently provide any abortion services. Those hospitals that do provide second-trimester abortions in Indiana are all located within twenty miles of Indianapolis and provide D&Es only where there is maternal or fetal concern indicated. Supra, Section III.B.1. As a result, most women seeking this service in Indiana must travel out-of-state, typically to Illinois, Ohio, or Kentucky, to obtain care. [Id. at 34:2-10, Id. at 115:22-25, 116:1-15].
The evidence reflects that it is not uncommon for women in Indiana to need second-trimester care but be unable to access it. Dr. Bernard testified that she encounters at least one patient a month whom she must refer out of state for second-trimester services. [Id. at 34:20-22]. Women's Med encounters two or three second-trimester patients a week who must be referred out-of-state, typically to Ohio, and Ms. Miller of Planned Parenthood refers three to four patients a month to neighboring states. [Id. at 52:7-16]. About one-quarter of Ms. Guerrero's clients are in need of second-trimester care but unable to access it in Indiana. And Dr. Cowett testified that approximately one out of nine second-trimester patients for whom she provides care at Family Planning Associates has traveled to her Chicago facility from Indiana. [Id. 127:15-19]. These Indiana women travel there from all of over the state. [Id., at 128:8-24]. She understands (and testified) that the primary factor motivating Hoosier women to come to her facility is that they are unable to access abortion care in Indiana. [Id. at 129:6-25, 130:1-15, 135].
Because D&Es procedures often extend over a period of time, these out-of-state trips necessitate overnight stays. The expenses associated with such arrangements are significant and burdensome for many women seeking services, who, as previously discussed, often struggle to pull together fund to cover the transportation and lodging in addition to the money to fund abortion services, even within Indiana. [Id. at 130:14-25, 131:1-25, 117]. To access care, women will "scrap[e] together every penny they have" to pay for these expenses. [Id. at 117:20-23]. Many women sleep in their cars or bus stations. [Id. at 132:19-25, 133:1-2]. Women's stress levels related to their ability to maintain their employment relationships and secure adequate child care for other children are exacerbated further when they must travel to a neighboring state for care. [Id. at 117:16-19]. The emotional burdens of managing all of this, coupled with the challenges of maintaining confidentiality, are compounded especially for women in violent partnerships. [Id. at p. 118].
Even if a woman were successful in accessing a second-trimester elective abortion care in a hospital in Indiana, the costs of securing such care would be exponentially greater than they would be in a clinic. It is estimated that the cost of a second-trimester abortion in a clinic is between $800 and $2400, whereas the cost of a second-trimester abortion in a hospital ranges from $10,000 to $20,000. (The costs of first-trimester abortion care range from $500 to $1000 before any other expenses
4. Indiana's Physical Facility Requirements
Indiana law imposes various structural requirements on clinic facilities which provide medication and aspiration abortion services.
a. Restrictions on Facilities Providing Medication Abortions
In order to obtain licensure to operate a medication abortion clinic, clinics are required to maintain on the premises a housekeeping room with a service sink and storage. 410 Ind. Admin. Code 26.5-17-2(e)(1). Plaintiffs contend that this provision is wholly unnecessary and that abortion clinics can operate and maintain sanitary and safe facilities without requiring this separate room.
Dr. Grossman has testified that there are no specific facility standards required to ensure safe abortion care, with the exception of facility requirements tailored to the provision of certain forms of anesthesia. This opinion is supported by the NASEM report and the Consensus Guidelines. Dr. Grossman could identify no other outpatient medical facilities that are subject to any specific facilities requirements. [Id. at 175:16-24, 180:1-20].
With specific respect to the requirement that medication abortion clinics maintain housekeeping rooms with storage sinks, Dr. Grossman deemed this requirement as being medically unnecessary and lacking any safety benefit connection. As he explained, medication abortion does not involve the use of instruments that require any cleaning or sterilization that would necessitate this kind of separate room. Such care is provided "essentially without touching the patient." There is no reason to do more than simply disinfect surfaces similar to how providers would in any office setting in administering safe medication abortion care. [Id. at 185:4-12].
The effect of this facility restriction is to prevent otherwise qualified healthcare centers from providing medication abortion services, including, for example, the Planned Parenthood located in Evansville, which, as Ms. Miller testified, satisfies all requirements necessary for licensure except for this particular facility requirement Her clinic could fully administer safe, hygienic care as it is, particularly since it outsources most of its janitorial duties to a third party that provides all cleaning supplies and removes from the facility all materials, such as towels, that may need to be laundered. Further, Planned Parenthood's janitorial services do not use "an old-fashioned mop with a mop bucket" since "that's just not how medical spaces are cleaned anymore." Rather, most areas are cleaned using single-use materials that are discarded afterwards. Within the Evansville clinic, to the extent various materials require washing or rinsing, a clearly labeled "dirty sink" is maintained separate and apart from the sink designated for use by patients. [Id. at 20-21; 22:1-19].
The State proffered virtually no evidence as to the benefits of requiring medication abortion clinics to maintain a housekeeping room with a service sink and storage. Dr. Stroud testified that a separate janitorial closet was useful at his birthing center to store cleaning supplies and hazardous waste materials. He also testified that in his view facilities should keep sinks that are utilized for cleaning instruments or other medical supplies segregated from the sinks utilized by patients for handwashing. [Phase II Tr. Vol. III, 25:25, 26:1-23]. He offered no opinion,
Planned Parenthood of Evansville made clear that it cannot simply retrofit its facility to comply with this requirement, since it would require modifications to one of its existing exam rooms to install running water, thereby reducing the availability of space for other services. Such renovations would be very expensive. Alternatively, one of its bathrooms would need to be converted into janitorial space. These are neither reasonable nor necessary modifications, according to Ms. Miller. [Phase II Tr. Vol. I, 22:20-25, 23:2-12]. No other abortion clinic operates in Evansville; the closest available clinic for women in Evansville is in Bloomington, approximately 125 miles away. [Id. at 13-17].
b. Indiana's Facility Requirements for Aspiration Abortion Clinics
Plaintiffs also challenge the following restrictions imposed upon clinics performing aspiration procedures:
Dr. Grossman's review of relevant medical literature, including the Consensus Guidelines and the NASEM report, undermines the necessity of these kinds of specific space standards for facilities providing first-trimester-aspiration abortion services.
Regarding the requirement that procedure room dimensions measure no less than 120 square feet, Dr. Grossman testified that there is no evidence indicating that this regulation enhances the safety of first-trimester aspiration abortions. The size of the room need only be large enough to accommodate the required number of people to appropriately care for the patient, the patient herself, and the equipment entailed in performing the procedure. A standard examination room thus suffices as the space needed to perform a first-trimester aspiration abortion. Again, this opinion by Dr. Grossman mirrors the Consensus Guidelines. [Id., at 186:2-25, 187:1-3].
Dr. Grossman further testified that a scrub facility, which includes automatic soap and water dispensers typically found within or outside operating rooms where sterile procedures are being performed, is not required to safely provide first-trimester aspiration abortion care, given that this procedure does not present any need for a sterile environment such as when an incision is made into a person's body. For first-trimester aspiration abortions, simple hand washing with soap and water is sufficient to ensure safe abortion care. [Id., at 187:3-18, 188:4-15].
Dr. Grossman also testified that the requirement of 44-inch corridors does not enhance the safety of first-trimester aspiration abortion care. As he explained, this provision appears to be an extrapolation from regulations governing hospitals or
Dr. Calhoun testified, however, that he believe each of these restrictions furthers the safety of the care being provided. Square footage requirements, for example, he said, ensure that there is adequate room for emergency personnel. The 44-inch corridor requirement allows for a gurney to be easily navigated through the hallways. A scrub facility, he testified, allows sterilization of one's hands prior to surgery. [Phase II Tr. Vol. II, 102:24-25, 103, 104:1-13]. But Dr. Calhoun did not dispute that first-trimester aspiration abortions do not mandate sterile conditions and that it is highly unlikely that two gurneys would ever be needed in the same hallway of a clinic at the same time (indeed, it is rare that even one would be needed). He also did not contest that a standard procedure room in a medical clinic provides sufficient space for the necessary personnel engaged in providing first-trimester aspiration abortion care.
Dr. Stroud, in addressing the benefits of scrub facilities,
Clearly, regulatory restrictions (particularly unnecessary regulatory restrictions) place burdens on the operation of facilities offering first-trimester aspiration abortion services, thereby reducing their availability. Regarding the South Bend Clinic, Ms. Hagstrom Miller testified that her efforts to locate a facility in the South Bend area that complied with these facility requirements were unsuccessful and that significant construction would be required to retrofit a facility to comply with these requirements, making it cost-prohibitive or at least infeasible or both. To come into compliance with the 120-square-foot procedure room requirement, for example, the South Bend Clinic would have to expand its current examination room(s), which would, as a result, violate the 44-inch corridor requirement. The South Bend Clinic also cannot add scrub facilities outside its procedure room; in order to do so, significant and costly construction would be required
Ms. Hagstrom Miller also testified that no other state in which she operates first-trimester abortion clinics subjects its clinics to such requirements. [Id. at 88:21-25, 89:1-2]. When asked whether she would proceed with the aforementioned construction if it were feasible and affordable in order to provide the highest quality of care, Ms. Hagstrom Miller responded no, explaining that the various provisions were simply unnecessary and added no value to the quality of care that can be and is otherwise provided without such renovations. As she explained, the scrub facilities are not beneficial because clinics are already required to have handwashing facilities inside of each examination room. The other requirements similarly are of little or no value. [Id. at 89:9-25; 90].
5. Indiana's Mandatory Disclosures
Plaintiffs have also challenged certain "Mandatory Disclosures" prescribed by the State in conjunction with the informed consent process. Indiana law specifically mandates that at least eighteen hours prior to an abortion and "in the private, not group, presence of the pregnant woman," a physician or APC must provide orally and in writing certain information to the patient, including the Mandatory Disclosures discussed below, and patients are required to certify in writing that they have received this information. Id. § 16-34-2-1.1(a)(3).
Eighteen hours prior to the abortion, patients must also be provided a color copy of Indiana's "Informed Consent Brochure," id. § 16-34-2-1.1(a)(4), which contains much of the information required during the oral informed consent process.
A patient who has received a diagnosis of a lethal fetal anomaly (that is, a condition likely to be fatal before birth or shortly thereafter) must be provided additional disclosures. Again, at least eighteen hours prior to an abortion, "the physician who will perform the abortion" must "orally and in person, inform the pregnant woman of the availability of perinatal hospice services" and provide her with copies of the State's "Perinatal Hospice Brochure" and a "list of perinatal hospice providers and programs." Id. § 16-34-2-1.1(b). If the woman chooses to proceed with the abortion, she must certify in writing that she received these materials. Id. § 16-34-2-1.1(b).
Much of the information required to be disclosed to women prior to an abortion is uncontroverted here. Other disclosure requirements, according to Plaintiffs' witnesses, are inaccurate, misleading, or ideologically biased. Plaintiffs specifically challenge the Mandatory Disclosures which include: 1) when life begins, 2) fetal pain, and 3) information relating to mental health contained with the Perinatal Hospital Brochure.
Indiana's mandated disclosure related to the beginning of life provides that, "human physical life begins when a human ovum is fertilized by a human sperm." Ind. Code § 16-34-2-1.1(a)(1)(E). Dr. Grossman testified that this disclosure does not convey objective or truthful scientific information in large part because there is no recognized medical definition for "human physical life," nor is there any scientific, medical
In contrast, Dr. Curlin testified that it is "beyond debate" that all living organisms begin as fertilized eggs, including all human beings. Human physical life is thus deemed to begin when the human ovum is fertilized by a human sperm thereby creating a fertilized egg. Dr. Curlin criticized Dr. Grossman's view for conflating "physical life" with a philosophical theory, explaining that the inclusion of the word "physical" clarifies that the State's definition refers to a medical fact. This definition moots any criticisms that the required disclosure defines life in spiritual or philosophical terms. According to Dr. Curlin, this required assertion is critical to the informed consent process because the woman considering the abortion needs to understand that the procedure will "kill a living human being." [Phase II Tr. Vol. II, 6:21-25, 7-9, 10:1-20; 12:21-25].
Plaintiffs also object to the statutory requirement that abortion providers must inform their patients that "objective scientific information shows that a fetus can feel pain at or before twenty (20) weeks of postfertilization age," Ind. Code § 16-34-2-1.1(a)(1)(G). This statement, according to Dr. Grossman, is contrary to the positions endorsed by the leading medical associations, including ACOG, which group represents 90% of OB-GYNs in the United States, as well as the Royal College of Obstetrician Gynecologists ("RCOG"), the major professional organization of OB-GYNs in the United Kingdom. Dr. Grossman cites the position of ACOG, which relies, in part, on research recounted in a peer-reviewed article published by The Journal of the American Medical Association, that concludes that it is unlikely that a fetus is capable of perceiving or experiencing pain prior to 24 weeks postfertilization. RCOG has reached this same conclusion. This finding is extrapolated from anatomic connections existing in the brain between the thalamus and the cortex, which are not developed until 24 weeks gestation when they yield the experience of pain. No major medical organization has concluded that a fetus is capable of experiencing pain prior to this point, according to Dr. Grossman. To claim that a fetus feels pain at 20 weeks of postfertilization age reflects a "fringe view in the medical community." [Phase II Tr. Vol. I, 198:2:25, 199, 200, 201:1-20].
Dr. Maureen Condic
Plaintiffs' final challenge is to the scientific validity of the required disclosure in the Perinatal Hospice Brochure, as follows: "Studies show that mothers who choose to carry their baby [sic] to term recover to baseline mental health more quickly than those who aborted due to fetal anomaly." [Stip. Exh. 17]. Dr. Grossman contested this disclosure as not being medically accurate. There simply is no medical evidence supporting the claim that a pregnant woman with a diagnosed fetal anomaly who continues her pregnancy to term is any more likely to return to "baseline" (that is, the mental health that the person had prior to her pregnancy) any more quickly than a woman who elects to have an abortion. To the extent any research has suggested such a fact, that research has been soundly debunked for its failure to include proper comparator groups and to properly control for prior mental health. [Phase II Tr. Vol. I, 202:17-25, 203, 204:1-20].
The State's expert on the "psychology of abortion," Dr. Coleman, testified that, while perhaps not entirely accurate, the "gist" of this disclosure is true, while acknowledging that there is not "sufficient empirical evidence where baseline data is collected." [Phase II Tr. Vol. II, 27:18-20, 28:24-25]. Continuing, she conceded that "women reading that [disclosure] may not really understand it." [Id., at 29:2-4]. She thought it would be more helpful to inform women that "they were more likely to experience positive outcomes more quickly than those who abort," which statement she believes better captures the intent of the disclosure as currently formulated. [Id., 27:8-25, 28, 29:1-16].
Plaintiffs also challenge the requirement that the various informed consent materials must be delivered only be an APC or physician, as opposed to any other appropriately trained clinic personnel. Dr. Grossman testified that it is clearly within the standard of care for physicians/APCs to delegate the provision of preabortion counseling to properly trained counselors or medical assistants. Indeed, in his own practice, patients undergo in-depth and thorough counseling sessions with a trained counselor who is not a licensed practitioner. When the patient chooses to proceed with an abortion, either by a physician or an APC, the provider will review the information with the patient and determine whether she has any questions to which they will respond. This
Dr. Clark, who operates a private practice providing non-abortion medical services in South Bend, similarly allows properly trained staff in his medical practice, who are not APCs or physicians, to provide patients various kind of information as part of the informed consent process; however, Dr. Clark leads his own discussion about the specific procedure with the patient. [Id., at 111:8-24]. Ms. Hagstrom-Miller testified that, outside of Indiana, WWHA clinics allow preabortion counseling to be conducted by non-physicians or non-APCs, such as nurses, counselors, or medical assistants. [Id. at 79:20-25].
Dr. Calhoun countered that in his experiences only physicians and APCs possess
The impact of these requirements foreclosing the assistance of nonphysician/APC personnel is to reduce a clinic's ability to offer preabortion counseling services since, as Ms. Hagstrom-Miller testified, the WWHA South Bend Clinic already lacks physicians and APCs sufficient to satisfy the demand for these appointments. If permitted, her facility would engage and utilize other properly trained staff to provide preabortion counseling, thereby allowing the clinic to expand the days on which it offers counseling appointments from three days a month to five days a week every week and to better utilize physician and APC resources. [Phase II Tr. Vol. I, 80:1-21].
6. Criminal Penalties
The majority of the abortion restrictions imposed by Indiana statutes are enforced through criminal penalties in addition to professional sanctions and civil liability. See Ind. Code §§ 16-21-2-2.5(b), 16-34-2-1, 16-34-2-5(d), 16-34-2-7. For example, abortion providers face criminal liability for non-compliance with administrative requirements, such as a failure to "retain a copy of the signed patient agreement form, and the signed physician's agreement form required by the manufacturer [of Mifeprex], in the patient's file." Ind. Code § 16-34-2-1(a)(1); see also id. 16-34-2-7(a). In no other healthcare context are healthcare providers subject to criminal penalties for such omissions and errors; elsewhere, sanctions are limited to disciplinary actions against the physicians' licensing privileges. See Ind. Code § 25-1-9-4. Dr. Hagstrom Miller testified that criminal penalties deter qualified, pro-choice physicians from providing abortion care at the South Bend Clinic. [Phase II Tr. Vol. I, 82:8-18].
IV. Conclusions of Law
Plaintiffs' legal theories are pinned primarily to the Substantive Due Process Clause of the Fourteenth Amendment. Plaintiffs' Due Process claims—as well as their Equal Protection claims—turn on whether the challenged provisions of Indiana law have, as their purpose or effect, the imposition of substantial obstacles to women in Indiana seeking to obtain previability abortions. We begin our analysis therefore with a review of (A) the "undue burden" standard according to the Supreme Court and Seventh Circuit precedents, followed by (B) a discussion of the undue burden standard in the context of the Equal Protection clause, and, finally, (C) the application of those legal principles to the specific claims presented in this litigation.
The Undue Burden Standard
The undue burden standard entails a weighing of the benefits of the challenged laws against the burdens they impose.
Well-established legal precedent recognizes that among the liberties protected by the Substantive Due Process Clause is a woman's freedom from state-required motherhood. See, e.g., Whole Woman's Health v. Hellerstedt, 579 U.S. 582, 136 S.Ct. 2292, 2309-10, 195 L.Ed.2d 665 (2016); Lawrence v. Texas, 539 U.S. 558, 565, 573-74, 123 S.Ct. 2472, 156 L.Ed.2d 508 (2003); Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 851-53,
The State has a legitimate interest in ensuring that abortion services are provided safely. Roe, 410 U.S. at 150, 93 S.Ct. 705. However, "a statute which, while furthering [a] valid state interest, has the effect of placing a substantial obstacle in the path of a woman's choice cannot be considered a permissible means of serving its legitimate ends." Hellerstedt, 136 S. Ct. at 2309 (quoting Casey, 505 U.S. at 877, 112 S.Ct. 2791 (plurality opinion)). Moreover, "unnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on the right." Hellerstedt, 136 S. Ct. at 2309 (quoting Casey, 505 U.S. at 878, 112 S.Ct. 2791).
In determining whether a statute comports with due process requirements, we must "consider the burdens a law imposes on abortion access together with the benefits those laws confer." Hellerstedt, 136 S. Ct. at 2309. "In other words, we are instructed to conduct a balancing test[.]" Whole Woman's Health All. v. Hill, 937 F.3d 864, 876 (7th Cir. 2019), cert. denied, ___ U.S. ___, 141 S.Ct. 189, 207 L.Ed.2d 1115 (2020).
The benefits of a law are measured against the state's legitimate interests in this field. First, "[a]s with any medical procedure, the State may enact regulations to further the health and safety of a woman seeking an abortion." Casey, 505 U.S. at 878, 112 S.Ct. 2791 (joint op.). Second, the state has a legitimate interest in preserving a life that may one day become a human being. Id. To promote that interest, the state may enact measures to ensure the woman's choice is philosophically and socially informed and to communicate its preference (if it has one) that the woman carry her pregnancy to term. Id. at 872, 112 S.Ct. 2791 (joint op.). But such measures "must be calculated to inform the woman's free choice, not hinder it[,]" and even if so calculated may not present a substantial obstacle to its exercise. Id. at 877, 112 S.Ct. 2791 (joint op.). Third, the state may choose to further the same interest by enacting measures "`protecting the integrity and ethics of the medical profession' ... in order to promote respect for life," Gonzales v. Carhart, 550 U.S. 124, 158, 127 S.Ct. 1610, 167 L.Ed.2d 480 (quoting Washington v. Glucksberg, 521 U.S. 702, 731, 117 S.Ct. 2258, 138 L.Ed.2d 772 (1997)), but such measures equally may not impose undue burdens. Id.
The burdens of a law are measured by their impacts on women for whom they pose a relevant restriction on the choice to seek a previability abortion. Hellerstedt, 136 S. Ct. at 2313; Casey, 505 U.S. at 895, 112 S.Ct. 2791 (maj. op.). "The proper focus of constitutional inquiry is the group for whom the law is a restriction, not the group for whom the law is irrelevant." Casey, 505 U.S. at 894-95, 112 S.Ct. 2791 ("[T]he analysis does not end with the one percent of women upon whom the statute operates; it begins there[.]"). If the impacts of the law amount to a substantial obstacle to the abortion decision for a "large fraction" of this group, the burdens imposed are undue. Hellerstedt, 136 S. Ct. at 2313; Casey, 505 U.S. at 895, 112 S.Ct. 2791.
The court's analysis then shifts to a determination of whether the burdens imposed by the law are "disproportionate, in their effect on the right to an abortion" compared "to the benefits that the restrictions are believed to confer." Planned Parenthood of Wisconsin, Inc. v. Schimel, 806 F.3d 908, 919 (7th Cir. 2015). To determine whether a burden is undue, the court "must weigh the burdens against the state's justification, asking whether and to what extent the challenged regulation actually advances the state's interests. If a burden significantly exceeds what is necessary to advance the state's interests, it is
Hellerstedt ratified Schimel's conclusion that Casey balancing is not conducted under a simple preponderance standard. Rather, in striking down provisions of law as imposing undue burdens on the previability abortion right, the Supreme Court and the Seventh Circuit have found the state's asserted legitimate interests to be nil or their marginal advancement de minimis, and the burdens on the abortion right to be substantial. Hellerstedt, 136 S. Ct. at 2311-13; id. at 2318; Casey, 505 U.S. at 887-898, 112 S.Ct. 2791 (joint op.); Schimel, 806 F.3d at 916. At the same time, the Seventh Circuit has cautioned that, when an abortion-restriction statute is sought to be justified on medical grounds, "the feebler the medical grounds... the likelier is the burden on the right to abortion to be disproportionate to the benefits and therefore excessive." Schimel, 806 F.3d at 920. To that end, unless and until a woman's right to choose an abortion is revoked by the Supreme Court, "a statute likely to restrict access to abortion with no offsetting medical benefits cannot be held to be within the enacting state's constitutional authority." Id. at 916. In addition, "If the evidence does not support the state's proffered reason, ... the state law cannot stand." Hill, 937 F.3d at 877. "This conclusion flows from the more general proposition that the Constitution does not tolerate pretext that covers up unconstitutional motives." Id.
The Undue Burden Standard Applies to Plaintiffs' Equal Protection and Due Process Claims
The Fourteenth Amendment provides that no state may "deny to any person within its jurisdiction the equal protection of the laws." U.S. Const. amend. XIV, § 1, cl. 4. This is "essentially a direction that all persons similarly situated should be treated alike." City of Cleburne v. Cleburne Living Ctr., 473 U.S. 432, 439, 105 S.Ct. 3249, 87 L.Ed.2d 313 (1985). "When social or economic legislation is at issue, the Equal Protection Clause allows the States wide latitude" to draw appropriate lines: their "legislation is presumed to be valid and will be sustained if the classification drawn by the statute is rationally related to a legitimate state interest." Id. But a heightened standard of judicial review applies to state laws predicated on certain "suspect" classifications such as race, as well as to those which "impinge on personal rights protected by the Constitution[,]" id., such as the right to obtain a previability abortion. Mass. Bd. of Ret. v. Murgia, 427 U.S. 307, 312 n.3, 96 S.Ct. 2562, 49 L.Ed.2d 520 (1976).
Plaintiffs allege here that the challenged Indiana statutes violate the Equal Protection Clause by drawing impermissible distinctions between women seeking abortion care and women seeking other, comparable medical care (such as miscarriage management). The parties initially disputed the applicable standard of judicial scrutiny for Plaintiffs' Equal Protection claims at both the preliminary injunction and summary judgment phases of litigation. In ruling on Plaintiffs' request for preliminary injunctive relief, we concluded as follows:
[Dkt. 116, at 52-53]. In our Preliminary Injunction Order, after combining an analysis of Plaintiffs' due process and equal protection challenges, we held that Plaintiffs had prevailed in showing a likelihood of prevailing on the merits of their claim, to wit, that Indiana's licensing requirements had been applied to the South Bend Clinic in a manner that violated both the Substantive Due Process and Equal Protection Clauses of the Fourteenth Amendment. In reaching this conclusion, we analyzed the benefits and burdens which flowed from the State's application of its licensure provisions. We determined there were de minimis benefits from these requirements, explaining that, for Equal Protection purposes, the State must "justify its disparate treatment of ... women seeking an abortion-inducing drug for the purposes of inducing an abortion, and ... women seeking an abortion-inducing drug for the purposes of treating a miscarriage." In other words, to pass constitutional muster under the Equal Protection Clause, the State must be able to establish some benefit flowing from the differential treatment of abortion patients vis-à-vis patients treated for miscarriage which justifies its restrictions. We could find no such justification. Thus, following a careful balancing of the benefits (or lack thereof) flowing from the State's application of the licensing regime against the burdens imposed on abortion patients, we held that the State's restriction as applied in the context of the South Bend Clinic violated the Due Process and Equal Protection Clauses. [Id. at 66, 71].
At summary judgment, contrary to our previous ruling regarding the legal standards governing review of Plaintiffs' Equal Protection claims, the parties continued to dispute the appropriate legal standard of review. Consequently, in our summary judgment order, we reiterated our interpretation of the Equal Protection Clause in this context but refrained from ruling on the State's motion for summary judgment as related to Plaintiffs' Equal Protection challenges.
Now, in determining whether the challenged statutory provisions comport with the Equal Protection Clause, we shall apply the undue burden standard, as explained above.
The Undue Burden Analysis Applied to the Challenged Indiana Statutes
In determining whether under Indiana law the Constitutional rights of women seeking an abortion have been infringed,
1. Restrictions On Facilities and Physicians
a. Indiana's Physician-Only Law
We begin by addressing the constitutional challenges brought by Plaintiffs to Indiana's Physician-Only Law, Ind. Code § 16-34-2-1(a)(1). This law restricts the performance of a first-trimester aspiration abortion and the prescription of an abortion-inducing pill to only a physician.
At summary judgment, the State sought judgment in its favor on this claim based on the Supreme Court's holding in Mazurek v. Armstrong, which upheld a Montana law prohibiting abortions, except for those provided by licensed physicians. 520 U.S. 968, 117 S.Ct. 1865, 138 L.Ed.2d 162 (1997). Licensed physicians along with a physician assistant sought to enjoin the Montana statute, asserting that it had an "invalid purpose." The Supreme Court ruled that:
Mazurek, 520 U.S. at 973, 117 S.Ct. 1865. Citing its "repeated statements in past cases," the Court held that there was "no doubt that, to ensure the safety of the abortion procedure, the State may mandate that only physicians perform abortions." Id. at 975, 117 S.Ct. 1865.
Plaintiffs attempt to distinguish Mazurek from the case at bar by framing the question in Mazurek as whether the law had been enacted for an improper purpose, not whether it created a substantial obstacle to abortion access. In fact, they note, it was uncontested in Mazurek that there was "insufficient evidence of a substantial obstacle." Id. at 972, 117 S.Ct. 1865. Here, by contrast, Plaintiffs assert that they have proffered substantial evidence establishing the burdens on the delivery of abortion care and the obstacles to its availability to patients that are imposed by this requirement. Plaintiffs also assert that the medical landscape regarding abortions has significantly evolved since the decision in Mazurek was handed down nearly twenty-five years ago. Plaintiffs support their interpretation of Mazurek by citing to a recent ruling from the District of Idaho. Planned Parenthood of the Great Nw. & the Hawaiian Islands v. Wasden, 406 F.Supp.3d 922, 928 (D. Idaho), motion to certify appeal denied sub nom. Planned Parenthood of Great Nw. & Hawaiian Islands v. Wasden, 410 F.Supp.3d 1108 (D. Idaho 2019).
We agreed at summary judgment, and we agree today, with Plaintiffs' argument that Mazurek does not automatically foreclose further judicial review of this physician-only issue. Though the Seventh Circuit has not yet addressed Mazurek's precise scope and application,
The evidence before us establishes that the reach of Indiana's physician-only statute is substantially broader than Montana's statute in Mazurek. In Mazurek, the record reflected that only one non-physician was impacted by the new Montana statute. Here, Plaintiffs have identified dozens of APCs already working in licensed abortion facilities who would provide abortion care but for the prohibitions imposed by Indiana's Physician-Only Law. See A Woman's Choice-E. Side Women's Clinic v. Newman, 305 F.3d 684, 688, 2002 WL 31050945 (7th Cir. 2002) ("Findings based on new evidence could produce a new understanding, and thus a different legal outcome[.]"). As we establish below, allowing APCs to provide abortion services would significantly increase the availability of abortion services in Indiana.
Moreover, Mazurek directs that physician-only laws are valid only to the extent that they "ensure the safety of the abortion procedure." 520 U.S. at 975, 117 S.Ct. 1865. Here, the nature of abortion care has evolved substantially in the years since Mazurek was decided, and even more during the nearly fifty years since Indiana enacted its Physician-Only Law. For example, medication abortions available today did not even exist at the time that Mazurek was decided or this Indiana prohibition was enacted. [Phase I Tr. Vol. II, 40:15-20]. Thus, it was not possible for the Mazurek court, or those that came before it, to consider whether restricting medication abortion care to physicians-only ensures the safety of the procedure. Our review of Plaintiffs' claim clearly is not foreclosed by Mazurek.
The benefits cited by the State conferred by the Physician-Only law reflect the state's interest in promoting the health and safety of women seeking abortions. This restriction on care limiting it to a physician ensures that a person with extensive professional, educational, and specialized training performs abortions, thereby reducing the risk of procedure-related complications and enhancing the level of care if complications do occur. In reviewing the specific benefits conferred by the Physician-Only Law, we find it helpful to distinguish between the provision of medication abortion care and aspiration abortion care.
With respect to medication abortion, Dr. Grossman, on behalf of Plaintiffs, testified that APCs provide other kinds of care that are comparable in risk, or even riskier, than medication abortions, the most obvious
The State's experts hold to their view that physicians by their education and training and experience are better qualified and capable than APCs to respond to complications (such as hemorrhaging or blood-clotting) relating to medication abortion. However, Indiana law permits APCs to administer misoprostol for miscarriage management care or to treat incomplete abortions, thereby entrusting them to respond to and care for the very same complications cited by the State's witnesses. IU Health, for example, utilizes APCs in the medical management of miscarriages, which process is identical to a medication abortion. As Ms. McKinney, a nurse practitioner employed with Women's Med, testified, she already provides care of this nature, which would look no different for abortion patients.
In addition, most complications occur not while a patient remains under the direct observation of an abortion provider, since the patient typically ingests the misoprostol at home. The State's experts did not dispute that APCs can and do prescribe medications involving comparable or greater risks than abortion inducing-drugs, including birth control and opioids. Their view seems to be not so much that properly trained and supervised APCs are not qualified to manage the potential complications of a medication abortion but that physicians are better qualified. This argument sidesteps the real issue, however, which is whether a law excluding well-qualified care providers who are not physicians from providing medication abortions, when shortages of available physicians to perform them greatly reduce access to abortions and burdens unduly the patient's right to an abortion, if she chooses to secure such care, is constitutional. Such a law cannot stand.
The State's experts also testified that APCs are not qualified to interpret an ultrasound to screen for potential problems such as an ectopic pregnancy, which is a contraindication for medication abortion. Dr. Grossman, by contrast, opined that APCs are fully qualified to screen for the contraindications of medication abortion. We consider Dr. Grossman's opinion authoritative on this point, based as it is on his personal experiences as an OB-GYN, who engages with and works side-by-side APCs in his practice, as well as his extensive medical research and knowledge of the relevant medical literature. His opinion is also consistent with the positions taken by the major medical and public health organizations, including ACOG, the World Health Organization, and the American Public Health Association. The State's experts, by comparison, drew on no medical literature in preparing for their testimony as the basis for their opinions offered during this portion of the case, crafting their opinions instead from their personal medical experiences and beliefs, which do not include any provision of medication abortion care by them.
Additionally, as noted by Dr. Grossman, the FDA's 2016 decision to amend the Mifeprex labeling directions to no longer restrict the dispensing of this medication to physicians appears to implicitly endorse the role of an APC in the provision of Mifeprex. Though the State's experts contend that APCs are not qualified to review ultrasounds to screen for contraindications, Indiana law does not mandate that only a physician may conduct and interpret the required preabortion ultrasound. Thus, APCs licensed to practice in Indiana are, in fact, permitted to review and interpret ultrasounds for abortion patients, screening for the potential aforementioned contraindications.
For these reasons, and for purposes of Plaintiffs' Due Process claim, we conclude that there is no advancement of the State's interest in the safety of maternal and fetal health derived from restricting the provision of medication abortion care to physicians only.
For purposes of Plaintiffs' Equal Protection claim, the State's case fares no better. Here, the State must be able justify its differential treatment between women seeking abortion-related drugs for the purposes of inducing an elective abortion, and women seeking abortion-related drugs for the purposes of treating a miscarriage. Given that the medical and physiological effects of these procedures are identical, the State's interest in patient health and safety evaporates.
The State identified additional benefits, which it contends flow from restricting the provision of first-trimester aspiration (as opposed to medication) abortion services to physicians only. Here, the State's experts controvert Dr. Grossman's contentions that APCs are authorized to and do perform procedures that are comparable in complexity and risk to first-trimester aspiration abortions, including, for example, endometrial biopsies, colposcopies, and LEEPs. Dr. Grossman's opinion that these procedures are similar in complexity to aspiration abortion does not take into account the differences in the manner in which these procedures, respectively, are performed. Stated otherwise, the procedures which APCs currently perform are not technically comparable to an aspiration abortion procedure. These kinds of permissible procedures are distinguishable by virtue of the fact that the abortion procedure requires cervical dilation whereas the biopsies, colposcopies, and LEEPs involve merely the insertion of an object into the uterus.
The procedure most comparable to aspiration abortion, according to Dr. Grossman, is the insertion of an IUD, due to its involving utilization of a manual dilation procedure of the cervix. This process, he says, is identical to what occurs in a first-trimester aspiration abortion. Consequently, the risks posed by these procedures— including the possibility of forming a false passageway and perforating the uterus— are identical.
Dr. Calhoun concurred with Dr. Grossman respecting the identified risks of the manual dilation which occurs in a first-trimester aspiration abortion. He further agreed that APCs are qualified to insert IUDs. However, he does not view the placement of IUDs to require manual dilation, so he disagrees with Dr. Grossman that comparable risks are posed. Dr. Grossman also testified that APCs are capable of performing D&Cs in the miscarriage management context, but Dr. Stroud, who commonly performs D&Cs for his miscarriage management patients, regards it as medically inappropriate to delegate performance of that procedure to an APC.
Here, we agree with the State. The evidence establishes that regulations restricting the provision of aspiration abortion care to physicians-only serves the State's interest in ensuring the safe provision of abortion services. Aspiration abortion is a more complex procedure than medication abortion, which benefits from a heightened skill set to address and hopefully prevent unique risks. Dr. Grossman's reliance on cited medical literature in support of his opinions is countered, even he
We turn next to a discussion of the burdens imposed by the Physician-Only Law. Plaintiffs' evidence establishes that limited physician availability is a real and significant barrier to abortion access in Indiana. The shortage of available physicians restricts clinics from being able to schedule appointments on more than one or two days a week, causing limited capacities and long wait times often upward of two weeks. Delaying an abortion, even by a week or two, for whatever reason, leads to increased risks for maternal health and forces women to continue to endure the physical and emotional stress associated with pregnancy. The evidence clearly establishes that delays of this nature and for these reasons regularly affect the availability of abortion care services for which a woman may be eligible. Women who are delayed beyond ten weeks lmp are no longer eligible for a medication abortion. In addition, restrictions on appointment availability are particularly burdensome for low-income women (that is, the primary demographic of women seeking abortion services in Indiana), who struggle to arrange transportation, child care, and time off work, which are essential to accessing care. We have no doubt about the significance of these challenges and obstacles— these burden—for many women.
Helpfully, Plaintiffs have identified multiple APCs who, in addition to abortion-seeking patients, are also being directly impacted by this physician-only restriction, employees who would and could provide abortion services, if permitted by law to do so. With specific respect to medication abortion care, APCs already provide comparable services, including miscarriage management, and are ready, willing, and well-qualified to begin providing medication abortion services, if the enforcement of this law were to be enjoined. Significantly, the use of APCs in this setting at Indiana's licensed clinics would dramatically expand the availability of abortion services. But for the effects of the Physician-Only Law, abortion clinics in Indiana would expand to provide services five days a week, which expansions would reduce wait times and allow women to access care at an earlier point in their pregnancies and with greater convenience, reduced anxieties, and ameliorated risks that result when women are delayed in receiving abortion services and their likelihood of needing aspiration abortion care increases. The Physician-Only law thus places concrete and significant burdens on Indiana women attempting to access medication abortion services. See Hellerstedt, 136 S. Ct. at 2313.
We do not find evidence of similar burdens resulting from physician-only restrictions on the provision of aspiration abortion services. Arguably, enjoining this provision would increase access to care by permitting more healthcare professionals to provide such services. However, there is little proof that this law is actually burdening abortion providers, at least
Finally, we hold, based on the evidence before us, that enjoining this law with respect to medication abortions would reduce the cost of abortion care for women seeking services—at Women's Med, for example, by $70, which is no small amount for many women seeking care in Indiana. For some, $40 may make the difference as to whether or not they can afford an abortion.
In determining whether the burdens of the Physician-Only Law are disproportionate in their impact on the right to an abortion compared "to the benefits the restrictions are believed to confer," (Schimel, 806 F. 3d at 916), we hold on the facts before us that the benefits to the State in restricting the provision of medication abortion care to physicians are slight to none. This fifty-year-old restriction is out of sync with contemporary medical practice standards and views as well as required safety requirements. The findings and opinions recounted in the medical literature support the provision of medication abortion care by APCs, a level of care for which APCs in Indiana are qualified to provide. The level and kind of care which they currently provide is comparable in complexity and risk to medication abortion. The State's rebuttal evidence, minimal as it was, does not advance the State's stated purpose and contention that this restriction furthers its interest in patient health and safety.
Whatever de minimis benefits there may be for this limitation, they are far outweighed in importance by the substantial burdens it places on women's access to abortion in Indiana. As previously noted: "[T]he feebler the medical grounds... the likelier is the burden on the right to abortion to be disproportionate to the benefits and therefore excessive." Schimel, 806 F.3d at 920. Such is the case here: the State has proffered at best a weak justification for restricting the provision of medication abortion care to physicians-only, a justification that does not equal or offset the resultant substantial burdens identified above. We are tempted to characterize the State's position as pretextual—that is, an effort to restrict access for the sake of restricting access.
This analysis does not yield the same results with respect to the physician-only limitation for provision of aspiration abortion care. The evidence reflects clear benefits from that restriction, given the higher level of complexity for the performance of this procedure. Plaintiffs have identified no APCs in Indiana currently performing procedures comparable in complexity and medical risks or consequences to aspiration abortion. This void in the record bolsters the State's position that APCs are not qualified to perform the task of manual cervical dilation or to manage the risks imposed by this procedure. In addition, Plaintiffs have failed to identify any burdens which "substantially outweigh" the legitimate benefits of the physician-only requirement for performing aspiration abortions. Further, we find no deleterious impact on access to care by the enforcement of this statutory limitation. Having carefully considered the benefits flowing from this law in light of this fact, we hold in favor of the State and uphold the physicians-only restriction for the provision of aspiration abortions.
Neither does this restriction run afoul of the Equal Protection Clause. Though state law does not specifically forbid APCs from performing D&Cs or dilating the cervix when inserting an IUD, there is no evidence before us that APCs are actually providing such services in Indiana. Plaintiffs have thus failed to identify any unique burdens that this law imposes on abortion patients as compared to non-abortion patients that would cause it to fail under the Equal Protection Clause.
For all these reasons, we hold that the Physician-Only Law, to the extent it restricts the provision of first-trimester medication abortion care to physicians only, is unduly burdensome, and its enforcement must be enjoined. To the extent this law limits the provision of first-trimester aspiration abortion care to physicians only, it serves the State's legitimate interests in providing for the health and safety of patients and does not impose any burdens that are undue. This portion of the law thus shall stand.
b. Indiana's Second-Trimester Hospitalization/ASC Requirement Is Unduly Burdensome
We examine next Indiana's requirement that all second-trimester abortions must be performed in a hospital or ASC. Ind. Code § 16-34-2-1(2).
At summary judgment, we began our analysis with a review of the two cases that the State cited as conclusive in resolving the law's constitutionality: Gary-Northwest Indiana Women's Services, Inc. v. Bowen, 496 F.Supp. 894 (N.D. Ind. 1980), aff'd, 451 U.S. 934, 101 S.Ct. 2012, 68 L.Ed.2d 321 (1981) and Simopoulos v. Virginia,
As for the holding in Bowen, Plaintiffs quickly and correctly rejoined at summary judgment that this case holding that Indiana's second-trimester hospitalization requirement was per se constitutional under Roe's trimester framework was abrogated by Simopoulus and its companion cases, City of Akron, 462 U.S. 416, 103 S.Ct. 2481, and Planned Parenthood Association of Kansas City, Missouri, Inc. v. Ashcroft, 462 U.S. 476, 103 S.Ct. 2517, 76 L.Ed.2d 733 (1983).
In Simopoulos, the Court upheld the challenged second-trimester law requiring second-trimester abortions be performed in outpatient surgical hospitals (similar to ACSs) in part because the plaintiff there did "not attack [it] as being insufficiently related to the State's interest in protecting health." 462 U.S. at 517, 103 S.Ct. 2532; see Whole Woman's Health, 136 S. Ct. at 2320 ("[T]he Court in Simopoulos found that the petitioner in that case ... had waived any argument that the regulation did not significantly help protect women's health."). In City of Akron, the Court recognized that recent medical advancements had made second-trimester abortions much safer over time, such that they could now be safely performed in outpatient settings. The Court thus struck down the state's requirement that second-trimester abortions be performed in hospitals. See City of Akron, 462 U.S. at 435-36, 103 S.Ct. 2481. The Court in Ashcroft reached the same conclusion. 462 U.S. at 481-82, 103 S.Ct. 2517.
The State maintains here that Simopoulos is binding on our analysis. Unlike the statutes determined to be unconstitutional in Akron and Ashcroft, Indiana does not limit its second-trimester abortions to hospital facilities. Instead, Indiana permits such abortions to be performed in ACSs, as well as in hospitals, much like the statute under review in Simopoulos, which was found to be constitutional. Accordingly, the State argues we should go no further in our analysis.
We find Plaintiffs' interpretation of Simopoulos to be much more apt, however. In Simopoulos, no issue was raised as to whether the challenged statute served the state's interest in protecting health. Simopoulos, 462 U.S. at 517, 103 S.Ct. 2532. In our case, by contrast, significant evidence has been proffered which undermines the State's asserted justifications for this restriction. Moreover, the decision in Simopoulus was handed down by the Supreme Court almost forty years ago. As the Akron Court recognized, medical advancements in administering second-trimester abortions have developed substantially since the Court's prior decision was issued, counseling that we cannot ignore the likely fact that second-trimester abortions may no longer be performed in the same ways they were in the mid-80s. See City of Akron, 462 U.S. at 435-36, 103 S.Ct. 2481.
Indeed, there is no dispute that D&E procedures have, in fact, evolved significantly since Simopoulus was decided. It was not until the 1990s that osmotic dilators were introduced into the provision of D&E services, which process simplified D&Es and increased their safety. With this in mind, we proceed with our review of the constitutionality of this statute.
The evidence conclusively establishes that APCs and hospitals are both legally subject to demanding and onerous construction and staffing requirements imposed by law inter alia to ensure the sterility of operating rooms and adequate space to allow for the presence and movement of an anesthetist and general anesthesia equipment. The State did not attempt to rebut the opinions of Dr. Grossman that
The State also has not refuted Plaintiffs' evidence, again presented through Dr. Grossman's testimony, that complications associated with D&E abortions are extremely rare, and that this procedure can be and is elsewhere (outside of Indiana) safely performed in out-patient, office-based settings, including in Ohio (where Dr. Glazer practices), in California (where Dr. Grossman practices), in Illinois (where Dr. Cowett practices), and numerous other states where Planned Parenthoods and WWHA operate. This opinion, like all others offered by Dr. Grossman, is based on his review of medical literature as well as his own extensive medical practice providing safe and effective D&E abortions in out-patient, office-based settings. The State does not contest that the conclusions advanced in this literature hold that there is no evidence showing that second-trimester abortions are any safer when they are performed in an ASC as compared to an outpatient, office-based setting. The State's experts did not refute that medical procedures comparable in complexity and risk are performed in these off-site locations. This enactment restricting D&E abortion procedures to hospitals and certain facilities on the grounds that those locations are best prepared to deal with medical emergencies when the care provided rarely if ever produces any medical emergency further undermines the State's claim that this statute advances its interest in maternal health and safety. Schimel, 806 F.3d at 921.
Dr. Calhoun attempted to rebut Plaintiffs' evidence and claims, testifying that he believes ASCs or hospitals are better equipped to treat complications should they arise. However, Dr. Calhoun did not address or otherwise refute Dr. Grossman's testimony that ASCs are not actually any better equipped to address the specific (albeit rare) complications associated with D&Es than clinics, which may include post-operative bleeding necessitating a blood transfusion. Such a complication, regardless of whether it occurs at an ACS or a clinic, would result in the patient being transferred immediately to a hospital for care. There is no dispute that a patient could be transported and referred for such hospital-based care just as safely from an out-patient clinic as she could from an ASC.
We also note the limitations of Dr. Calhoun's expertise in this area. His opinions are not based on medical research or literature, nor did he attempt to refute the findings of relevant medical literature as discussed by Dr. Grossman. His opinions were based solely on his experiences, but his experiences were quite limited: He has performed only 10 to 15 D&Es (in the context of miscarriage management) in the course of his long medical career, and he has not performed even a single such procedure in recent decades. We thus find Dr. Grossman's opinions, grounded as they are in both experience and medical research, persuasive once again.
According to Dr. Grossman's testimony, no benefit flows from performing a D&E at an ASC as compared to an outpatient clinic comparable to those in Indiana licensed to provide aspiration abortion
Similarly, there can be no serious dispute regarding the substantial obstacles imposed by this restriction. Plaintiffs have presented testimony from numerous witnesses reporting difficulties that women encounter in obtaining second-trimester abortions in Indiana. For example, no ASC in Indiana provides abortion services, and only four Indiana hospitals, all located in and around Indianapolis, perform second-trimester abortions, and only if a fetal or maternal indication has been identified. Even assuming women could access abortion care at one of these hospitals, any woman living outside of Indianapolis would face significant geographical and financial disadvantages in seeking second-trimester care. In addition, because D&Es often must be performed over a period of twenty-four to forty-eight hours, these women, the majority of whom are low-income mothers, must secure overnight lodging and child care for two days. For those who live in Indianapolis or could secure transportation, the costs of a second-trimester abortion provided by a hospital are significant —upwards of $20,000, according to the estimates. It cannot reasonably be argued that such costs would be a nominal burden for a large fraction of women seeking services. If a woman's health needs generally are covered by insurance, policy coverage for abortion care is still usually unavailable.
These costs, combined with the sparse availability of facilities, force most Indiana women to travel out of state to receive second-trimester abortions, further exacerbating their costs of and inconveniences in accessing care. Theses burdens of travel are particular crippling for the demographic that includes women in need of abortion services. The combined effect of these burdens, considered together, reflects the substantial obstacles that exist for a large portion of the women in need of second-trimester services in Indiana. Hellerstedt, 136 S. Ct. at 2313, 2316; Hill, 937 F.3d at 869, 878; Schimel, 806 F.3d at 918-20.
We have been informed by Plaintiffs' proffers that, without this law, Indiana's abortion clinics in Merrillville, Indianapolis, and Bloomington (that is, those licensed to provide aspiration abortion services) would provide second-trimester abortion care.
When, as here, the benefits of a restrictive law are nominal or nonexistent or "feeble," and the burdens of the law are substantial, these burdens cannot be deemed "due." Schimel, 806 F. 3d at 918-20. As Plaintiffs' evidence establishes, the Second-Trimester Hospital Requirement substantially curtails the constitutional right to an abortion by effectively foreclosing access to second-trimester abortions
For all these reasons, we hold that the Second-Trimester Hospitalization Requirement violates the Fourteenth Amendment's Substantive Due Process and Equal Protection Clauses.
c. Indiana's Facility Requirements are Unconstitutional
Plaintiffs also challenge the various, onerous facility specifications for clinics seeking to provide abortion services.
As previously explained, to obtain licensure to operate a medication abortion clinic, clinics are required to maintain a specific housekeeping room with a service sink and storage. 410 Ind. Admin. Code 26.5-17-2(e)(1). Plaintiffs' challenge this provision as unduly burdensome, arguing that it has no offsetting medical benefit vis-à-vis the burdens imposed by it.
When searching the record for specific benefits associated with this law, we can see without much difficulty that there are none. Dr. Grossman's expert testimony, again reflective of relevant medical literature and his broad-based experience providing medication abortion care, established that imposing such facility requirements on medication abortion clinics offers absolutely no safety benefits for the provision of care. This opinion went largely unrebutted. As discussed previously in our Findings of Facts, both Dr. Stroud's and Dr. Calhoun's testimony on this issue was largely irrelevant, omitted a direct response to the issues presented, and lacked any basis in their personal experiences in this area of medical practice or their review of any relevant medical research. Ms. Miller's testimony that Planned Parenthood facilities are able to maintain clean and sanitary medication abortion clinics regardless of whether they maintain housekeeping rooms with storage sinks also went entirely unrebutted.
When viewed through the analytical lens of the Equal Protection Clause, the State's case is weaker yet, given that there was no evidence addressed to show that this particular requirement is imposed on non-abortion medical offices or other clinics providing comparable care.
The impact of this structural, facility requirement is clearly burdensome in that it restricts a clinic's ability to provide services on seemingly arbitrary grounds. The Planned Parenthood of Evansville offers a clear example of the impact of this law; it was undisputed at trial that the treatment protocols employed by the Evansville clinic, that could also be employed by other clinics, are suitable to provide safe medication abortion services. However, it is not eligible for licensure because it is unable to satisfy the facility structural requirement imposed by this law. As a consequence, the
Weighing the benefits of this law against its burdens poses no difficulty, given the State's minimal evidentiary proffers. Plaintiffs' evidence, by contrast, established that no benefits of any sort flow from this facility requirement the clinics, their patients, or the State. Thus, we agree that this "requirement cannot be taken seriously as a measure to improve women's health." Schimel, 806 F.3d at 921. In light of these non-existent benefits, the burdens on access that this law imposes are clearly excessive. Id. at 922; Hellerstedt, 136 S. Ct. at 2318.
For these reasons, we hold that 410 Ind. Admin. Code 26.5-17-2(e)(1) unduly burdens women's abortion rights and thus does not withstand scrutiny under the Due Process and Equal Protection Clauses of the Fourteenth Amendment.
The de minimis benefits produced by these specific facility requirements imposed on clinics seeking to offer first-trimester aspiration abortion services similarly lack any convincing force. To reiterate, this provision includes the following requirements:
With respect to the first requirement, Dr. Grossman, again, relying on his experiences and his review of the NASEM report and the Consensus Guidelines, testified that this requirement is totally unnecessary, offering no enhancement to the safety of aspiration abortion care. Indeed, Ms. Hagstrom Miller testified that Whole Woman's Health clinics operating outside of Indiana provide safe and effective first-trimester aspiration abortion services without such specific requirements. Though Dr. Calhoun testified that it was important to ensure that a procedure room was adequately sized to accommodate medical personnel and equipment, he did not rebut Dr. Grossman's testimony that a standard procedure room
Dr. Grossman's opinion debunking any purpose served by the 44-inch corridor requirement is similarly persuasive. Such a
Finally, Dr. Grossman testified that the presence of scrub facilities outside of procedure rooms is also unnecessary, given that sterility (not to be confused with cleanliness) is not required to safely provide first-trimester abortion services. As Ms. Hagstrom Miller noted, clinics are already required to equip procedure rooms with handwashing sinks. Dr. Stroud testified, however, that he thought scrub facilities were important in this setting, explaining that he would, in fact, utilize a scrub facility to sterilize his hands prior to proceeding with a D&C in the context of a miscarriage. However, Indiana law does not mandate this precaution, and procedures which pose a similar risk of infection are, in fact, regularly performed in facilities in Indiana that do not have scrub sinks. We thus find no basis in the evidence to support the necessity of this requirement to ensure safe aspiration abortion care. Once again, we credit the reliable and informed opinions of Dr. Grossman, who testified that no benefits flow from this requirement that are not already satisfied by other requirements, including those which require clinics to maintain handwashing stations within procedure rooms.
To that end, and for the reasons identified above with respect to these facility requirements governing medication abortion clinics, the minimal nature of alleged benefits which flow from these provisions further demonstrate their insufficiencies when viewed under the Equal Protection Clause, given that the State does not impose any such restrictions on the provision of any other category of medical care, singling out abortion services for reasons that may be easily inferred but need not be specifically discussed.
The effect of these restrictions and requirements obviously limits the ability of otherwise qualified clinics to provide first-trimester aspiration abortion services. Such clinics are forced either to locate facilities that are already equipped with such specifications, which as Ms. Hagstrom Miller testified is exceedingly difficult, or undergo expensive and significant retrofitting of existing structures, which construction is often cost-prohibitive for clinics providing services to primarily low-income women. We reiterate that clinics providing first-trimester aspiration abortions currently operate only in Indianapolis, Bloomington, and Merrillville, thus requiring women outside of these cities to travel for aspiration abortion services. We have already established that such travel imposes significant burdens on women seeking to access care.
Given that no medical or patient related safety benefits flow from these required structural, facility-based specifications for abortion care clinics and that Indiana does not interpose similar restrictions on facilities providing other similar medical services, these facility restrictions do not achieve any purpose beyond unnecessarily restricting who can provide abortion care and, in turn, limiting access to abortion services. These burdens cannot stand when offset by no medical benefit which furthers the State's interests. See Hill, 937 F.3d at 876-77; Schimel, 806 F. 3d. at 916, 919-22. In addition, the absence of similar
For these reasons, we hold that the identified facility requirements specified herein are violative of the Substantive Due Process and Equal Protection Clauses of the Constitution and must be enjoined.
2. Telemedicine Restrictions
As discussed above in detail, Plaintiffs have challenged Indiana's Telemedicine Ban as well as other statutes that create de facto restrictions on the use of telemedicine in the provision of abortion care, including the In-Person Examination Requirement, the In-Person Counseling Requirement, and the Ultrasound Requirement. We review each of these provisions in turn.
a. The "Ultrasound Requirement" Does Not Violate the Equal Protection Clause
Prior to obtaining an abortion in Indiana, "the provider shall perform, and the pregnant woman shall view, the fetal ultrasound imaging and hear the auscultation of the fetal heart tone if the fetal heart tone is audible," unless the patient certifies in writing, before the abortion, that she declines to do so. Ind. Code. § 16-34-2-1.1(a)(5) (the "Ultrasound Requirement").
We have already determined that the benefits of this statute (including determining gestational age and enhancing patient-decision making) outweighed its burdens (as previously stated, Plaintiffs' summary judgment discussion of the burdens of this requirement was severely lacking both in evidence and critical analysis). Accordingly, the only issue remaining at trial with respect to this requirement is whether it violates the Equal Protection Clause.
In this context, the State must justify its differential treatment of women seeking abortion services by requiring the ultrasound and its review by the provider only and women seeking other prenatal services for whom ultrasounds are also critical to the safe provision of care but not legally required. Regarding this latter category, the State entrusts the healthcare provider with determining when an ultrasound is necessary and whether it may be conduct by unaffiliated but competent technician. Thus, we ask what benefits accrue to the State by classifying abortion patients differently from other prenatal patients. Because the State has not disputed that the medical benefits of an ultrasound are any different for abortion patients than other pregnant women, this classification can be sustained only to the extent it serves the State's interests in preserving a life that may one day becomes human. Hill, 388 F. Supp. 3d at 1047. As previously stated, the State may promote that interest through the enactment of measures that ensure the woman's choice is philosophically and socially informed.
Accordingly, imposing the Ultrasound Requirement on abortion patients benefits the State by serving its interesting in promoting fetal life and ensuring that abortion patients make informed decisions.
The primary burdens identified by Plaintiffs at summary judgment and trial include the potential for duplicative ultrasounds, which may be a triggering factor for some women who have suffered sexual assaults; however, it appears that only ten percent of abortion patients in Indiana will receive a second ultrasound because of this provision. We cannot say that ten percent is a "large fraction" of women affected by this statute—in Dr. Grossman's words, it is a "small proportion." [Phase I Tr. Vol. II, 113:2-6]. In addition, is unclear how many of these patients were sexual assault survivors or found the second ultrasound to be triggering because of their experiences with sexual assault. Plaintiffs have thus obviously mustered little concrete evidence that the potential for duplicative ultrasounds poses any major obstacle for a large fraction of women hoping to obtain care.
Plaintiffs also cite the burden of travel imposed by the requirement; though we do not intend to minimize the burdensome nature of travel imposed by Indiana's abortion restrictions, this particular travel burden is mitigated by the fact that women may obtain their preabortion ultrasounds at affiliated health centers. This mitigation is of sufficient significance that the facilities challenging the State's requirement that the ultrasound be performed eighteen hours in advance stipulated to the dismissal of their prior lawsuit once they were able to procure additional ultrasound machines for their affiliated clinics.
Weighing the unique benefits which flow from the Ultrasound Requirement in this context against these burdens, we find no basis on which to conclude that the benefits are "substantially outweighed" by any burdens that they impose. Though the Ultrasound Requirement may impose some burdens on women seeking abortion services
b. The In-Person Counseling Requirement is Unduly Burdensome
Plaintiffs' next constitutional challenge is to the In-Person Counseling Requirement, which provides that "consent to an abortion is voluntary and informed only if" abortion providers satisfy certain requirements, which include the furnishing of certain information—including the name of the physician performing the abortion, the nature of the proposed procedure, the probable gestational age, and more—to abortion patients, both orally in person and in writing, at least eighteen hours in advance of the patient's abortion. Ind. Code § 16-34-2-1.1(a)(1). Also eighteen hours in advance and in person, patients must receive a color copy of the State's "Informed Consent Brochure," and, if a fetal anomaly has been identified, a copy of the State's "Perinatal Hospice Brochure." Id. § 16-34-2-1.1(a)(4), (b).The specific issue raised here by Plaintiffs is the requirement that all preabortion counseling be conducted solely in person, which forecloses the use of telemedicine.
As we have previously discussed, telemedicine enables providers to remotely review patients' medical histories and ultrasound results and to utilize videoconferencing to determine the appropriateness of medication abortion for an individual patient. Telemedicine for preabortion counseling appointments may be delivered through either the "direct-to-patient" model or "site-to-site" model, both of which incorporate face-to-face communications with the patient through secured videoconferencing.
Dr. Grossman's extensive experience and research established that providers utilizing telemedicine are able to obtain informed consent as effectively as if the participants were present in person. The process for doing so through telemedicine would look "identical" to the in-person process. In both settings, the provider will confirm that the patient understands what an abortion entails as well as the risks, benefits, and alternatives of the procedure, before ultimately confirming that the patient wishes to proceed with the abortion. And, in both settings, if the provider has hesitations as to the patient's voluntary, informed consent, he or she will not proceed with the procedure and instead direct the patient to additional resources so that she may contemplate her decision.
Through advancements in videoconferencing technology, the personal interactions between providers and patients are enabled to a degree that the same quality and kind of communications occurs with patients as would have occurred in person. Indeed, Dr. Grossman's research reflects high levels of both patient and provider satisfaction regarding the use of telemedicine in this aspect of abortion care. Patients
Dr. Grossman's research is consistent with the experiences of providers and patients throughout Indiana. The witnesses in this case who lead preabortion counseling sessions and who obtain informed consent from abortion patients agree that they could complete these aspects of abortion care as effectively via videoconferencing, and these witnesses have "no reservations" about doing so. In addition, the witness testifying in this case who have received abortion care in Indiana explained that the In-Person Counseling Requirement imposed unnecessary stress and burden for them. They said they would have appreciated the opportunity to conduct their counseling sessions through telemedicine.
Dr. Grossman's research further established that intimate partner violence can be effectively screened for via telemedicine through a series of oral and written communications. Indeed, intimate partner violence is frequently screened for via telemedicine in other aspects of healthcare. Ms. Herr, for example, explained that she is well-trained to screen for and provide resources to potential victims of intimate partner violence over videoconferencing. She has become particularly well-equipped to perform these tasks given the expansion of telemedicine that has occurred throughout the COVID-19 pandemic and quarantines. This process may be tailored to the telemedicine setting to ensure the safety (and privacy) of a patient who might be at home with a potentially violent perpetrator.
Importantly, because an abortion patient will always be required to report in person to the clinic to receive her abortion, clinic staff are not deprived of an opportunity for in-person contact with patients to provide resources to those who may be suffering from intimate partner violence. To the extent there are concerns of coercion, this appointment provides an opportunity for the patient to be segregated from the perpetrator in order to confer with her provider in a confidential, private setting. We note that the State's experts lacked any familiarity with the site-to-site telemedicine model, and thus did not indicate an understanding of the fact that a woman will still report to a clinic when expressing their concerns of coercion and intimate partner violence.
The State maintains through its expert testimony that in-person counseling inspires better engagement between provider and patient. In-person interactions lead to better eye contact, a greater ability to read body language, and the development of a person-to-person relationship, they attest. Though these opinions may be true in a general sense, they ignore the significant research and testimonials reflecting the perspective of abortion patients and providers which show that these individuals— those actually involved in the process— typically find the interactions to be just as meaningful when delivered through videoconferencing and, in fact, would prefer that this option be available. We will not quarrel with the fact that in-person interactions yield some benefits in building a trusting relationship between patient and provider; however, we accord significantly greater weight to the testimony of Plaintiffs' witness as the only individuals in this case who have had extensive experience providing and receiving abortion care and researching
Accordingly, given the broad-based societal advancements to telemedicine technology and the successful incorporation of videoconferencing into preabortion counseling care elsewhere, we find the benefits imposed by this requirement to be at best slight. Given that no other aspect of healthcare is restricted in its ability to utilize telemedicine, this provision suffers under the Equal Protection Clause analysis as well because there appears to be little to no justification for excluding abortion patients from the benefits of telemedicine.
The burdens imposed by this de facto two-trip requirement are significant, however.
This conclusion holds even in light of the fact that women must report to an abortion clinic or its affiliated facility eighteen hours in advance for their preabortion ultrasounds. Plaintiffs' evidence shows that women often struggle to schedule their counseling appointments, given the various considerations that must be accounted for. As a consequence, women frequently delay care or seek care at a location farther away. Again, we stress that these delays and this travel are significant burdens for a large fraction of women seeking services in Indiana.
By enjoining the In-Person Counseling Requirement, providers could incorporate the site-to-site telemedicine model into the provision of preabortion counseling appointments; indeed, Plaintiffs' evidence establishes that either the direct-to-patient model or the site-to-site model could be successfully incorporated into this aspect of abortion care. Doing so would provide greater accessibility to appointments and flexibility in scheduling. A woman could, for example, report to the clinic closest to her where a qualified technician conducts the ultrasound and completes the necessary intake information. These materials could then be transmitted electronically to a remote physician or APC, who could conduct the counseling session. Doing so would significantly mitigate at least some of those burdens established by Plaintiffs. Given that we have determined the effectiveness of such remote counseling sessions, the State has not justified its withholding of this expanded access to care.
c. The Telemedicine Ban and Physical Examination Requirement are Unduly Burdensome
In reviewing the State's restrictions on the use of telemedicine in providing medication abortions, we find it useful to revisit and highlight the State's efforts to encourage and make available telemedicine in non-abortion contexts, with specific regard to the widespread expansion of telemedicine in Indiana in various other aspects of healthcare over the past five years.
In 2015, Indiana enacted a statute requiring that health insurance policies include coverage for telemedicine services on the same terms as coverage is provided for healthcare services delivered in person. In 2016, the State enacted another statute broadly authorizing healthcare providers to use telemedicine to treat patients in Indiana. One year later, in 2017, Indiana expanded the telemedicine authority to include the prescription of controlled substances.
In other states, telemedicine is already used by Planned Parenthoods and Whole Woman's Health clinics to provide medication abortion care. As explained, to comply with the FDA's REMS requirements, this care occurs through the site-to-site model of telemedicine, wherein the patient reports to the clinic and is then remotely connected via technology to a health care provider who is not physically located at the clinic. The provider can remotely review the patient's medical history and ultrasound results to screen for contraindications. The provider will also conduct direct, face-to-face communications with the patients through secured videoconferencing to review with the patient the risks and benefits of medication abortion, and ultimately to determine the appropriateness of the medication abortion.
The unrefuted evidence adduced at trial establishes that utilizing telemedicine for medication abortions is as safe and effective as in-person treatment. Dr. Grossman's extensive testimony on this topic, wherein he discussed his in-depth research into this area as well as his review of available medical literature, went unrebutted by the State's experts.
Indiana nonetheless requires that, prior to receiving an abortion, a woman must receive a physical examination by a licensed physician and that the dispensing or prescribing of abortion-inducing drugs not occur via telemedicine.
The cited benefit of these laws is sparse, and therefore so is our discussion.
The In-Person Examination Requirement operates to enforce the restriction on telemedicine in abortion care by requiring a treating physician to conduct a physical examination of an abortion patient prior to proceeding with care. As Dr. Grossman opined, performing a physical examination prior to a medication abortion is simply not a part of the standard of care. As the only expert witness in this case to have provided medication abortion care and to have conducted and reviewed medical research on the safety of abortion care through telemedicine, we afford his opinion significant weight, concluding that the In-Person Examination Requirement does not offer any benefits necessary to ensure the safe provision of medication abortion services. This is particularly true in light of our ruling upholding the requirement that an ultrasound be performed prior to an abortion. An ultrasound, as we have discussed and as the State's experts agree, provides the most accurate means to gestationally date a pregnancy and to diagnose an ectopic pregnancy. Physical examinations do not appear to provide any greater reliability or accuracy for these identification purposes than an ultrasound. The necessity of a physical examination, particularly in addition to an ultrasound, is not supported by any medical research proffered by the State. If an ultrasound is adequate in this regard, then the required physical examination provides no additional established benefits. In those rare instances
The State's experts also discussed the advantages of physical examinations in establishing rapport with one's patient. We find this testimony of little value as a basis for mandating physical examinations for all patients, especially when none of the State's experts even perform medication abortions, nor have they conducted any research on this topic. By contrast, significant evidence was introduced by Plaintiffs, including extensive medical literature and the opinions of medical professionals in this field, which buttresses Plaintiffs' contention that medication abortion care can be and is being safely delivered via telemedicine without a physical examination. Moreover, if building rapport is beneficial enough to justify a requirement that an otherwise unnecessary physical examination be performed, we question why Indiana would permit the use of telemedicine in any context. The prevalence of telemedicine services throughout Indiana once again influences our analysis here.
The only remaining explanation by the State is the claim that the Telemedicine Ban is necessary to prevent the diversion of the medications used in an abortion procedure, mifepristone and misoprostol. This concern regarding drug diversion, however, is entirely speculative. There is no medical research that validates this concern, and Dr. Grossman testified that he has never observed during his decades of providing medication abortion care a problem or practice of drug diversion. The State's only evidence was the testimony of physicians who upon cross-examination could not articulate any specific basis for their opinions, who have never performed medication abortions, and who hold the overarching opinion that an elective abortion is rarely, if ever, in a woman's best interest. For these reasons, the attempt by the State to sound the alarm of "drug diversion" is nothing more than that, untethered as it is from any evidentiary anchors. We give it no weight in our analysis.
Accordingly, we hold that the Telemedicine Ban and In-Person Examination Requirements, for Due Process purposes, accomplish little more than to impose unjustifiable restrictions on the use of telemedicine in abortion care. Against the backdrop of Indiana's otherwise widespread and encouraged use of telemedicine, these restrictions raise serious concerns as to their constitutionality under the Equal Protection Clause.
The In-Person Examination Requirement and Telemedicine Ban also impose identical burdens. Incorporating telemedicine into healthcare services generally has resulted in well-documented, widely accepted benefits in the form of reduced costs of care and expanded access thereto. Plaintiffs' evidence conclusively and indisputably established these benefits accrue even with site-to-site telemedicine procedures. Even when abortion patients must still report in person to the clinic to receive their medications, the utilization of telemedicine increases patient accessibility by allowing clinics to realize greater efficiencies from their existing cadres of care providers. As referenced in our Findings of Fact, the introduction of site-to-site telemedicine at Indiana's abortion clinics would increase appointment days from one or two days a week or month to five days a week, without the need to recruit an additional physician or APC. Site-to-site telemedicine would allow Indiana's abortion clinics to dramatically expand the availability of appointments and reduce delays in care.
Conducting the required balancing of factors in contexts where the benefits of a particular law are unidentifiable and the burdens are significant is not a difficult challenge. The burdens imposed by such laws which include a reduction in access to care with no offsetting medical benefits cannot be deemed anything other than undue. The State lacks constitutional authority to "strew impediments" to services without sufficient offsetting benefits that advance women's health. Schimel, 806 F. 3d at 921. The State's attempt to explain its basis for excluding the far-reaching benefits of telemedicine from this category of patients is feeble at best, especially given the widespread use of telemedicine throughout Indiana as well as the overall safety of medication abortions. Schimel, 806 F. 3d at 915, 919-22; see also Hellerstedt, 136 S. Ct. at 2318.
Having carefully weighed the respective benefits and burdens imposed by these provisions, we hold that the ban on telemedicine services and the requirement of an in-person physical examination prior to accessing a medication abortion do not comport with the Fourteenth Amendment's Substantive Due Process and Equal Protection Clauses.
3. Indiana's Informed Consent Provisions
Plaintiffs have also challenged certain "Mandatory Disclosures" that require the treating physician or the physician's designees to provide to a woman prior to receiving her abortion. Id. § 16-34-2-1.1(a)(1)-(2), (b). All women must be provided with the State's informed consent brochure.
Much of the information required to be disclosed to women as part of the informed consent process prior to receiving abortion care is uncontroverted in this lawsuit. Plaintiffs do specifically challenge the Mandatory Disclosures which include statements regarding: 1) when life begins, 2) fetal pain, and 3) information related to
In reviewing the constitutionality of Indiana's mandatory disclosures relating to informed consent, we begin with the standard set out in Casey, wherein the Court held that "as with any medical procedure, the State may require a woman to give her written informed consent to an abortion." 505 U.S. at 881, 112 S.Ct. 2791 (joint op). Further, states may "require doctors to inform a woman seeking an abortion of the availability of materials relating to the consequences to the fetus, even when those consequences have no direct relation to her health." Id. at 882, 112 S.Ct. 2791. Casey thus implicitly holds that Indiana's Mandatory Disclosures further the state's interests in the health of the patient seeking the abortion as well as its interest in potential fetal life.
To promote the interest in potential fetal life, the state may enact measures aimed at ensuring that the woman's choice is philosophically and socially informed and communicate its preference (if it has one) that the woman carry her pregnancy to term. Id. at 872, 112 S.Ct. 2791. But such measures "must be calculated to inform the woman's free choice, not hinder it[,]" and even if so calculated may not present a substantial obstacle to its exercise. Id. at 877, 112 S.Ct. 2791. At a minimum, to comport with the Due Process Clause, the information provided must be "truthful and not misleading." Id. at 882, 112 S.Ct. 2791.
At trial, the parties proffered competing expert testimony on each of the three challenged provisions.
a. The Mental Health Disclosure Contained Within the Perinatal Hospital Brochure is Unconstitutional
Indiana's mandatory disclosure, as contained in the State's Perinatal Hospice Brochure, declares: "Studies show that mothers who choose to carry their baby [sic] to term recover to baseline mental health more quickly than those who aborted due to fetal anomaly." Ind. Code. § 16-34-2-1.1(b)(2). As previously explained, Dr. Grossman's testimony that this disclosure is not scientifically accurate was firm and unequivocal. There is simply no medical evidence, he said, establishing that a pregnant woman who has received the unfortunate diagnosis of a fetal anomaly is more likely to return to her baseline mental health more quickly if she carries her
The State called Dr. Coleman to defend the accuracy of its statements in the Perinatal Hospice Brochure. Surprisingly, the State, after eliciting from Dr. Coleman her opinion that this disclosure is, indeed, problematic, proceeded (with the help of a poster board, a magic marker, and an associate attorney) to propose amendments to the disclosure, such that in changed form it would read as follows:
The State then elicited Dr. Coleman's opinions regarding the amended language. Indeed, the majority of Dr. Coleman's testimony related to this rewritten version of the disclosure. Her testimony, therefore, was irrelevant given, that the Court is tasked with deciding the constitutionality of the disclosure as it is mandated by the State, not a redlined version thereof produced for trial purposes apparently to avoid the obvious, admitted embarrassments with the required texts.
Dr. Coleman's testimony with respect to the actual language of the mandatory disclosure does not persuade us that this statement is, in fact, truthful and non-misleading or otherwise useful in assisting women to make informed decisions as to whether to undergo abortions where there has been a fetal anomaly diagnosis. Though Dr. Coleman answered in the negative the question posed by counsel for the State as to whether she believes the disclosure was "affirmatively false or misleading," her subsequent testimony plainly did not support that response. Consistent with the opinions of Dr. Grossman, Dr. Coleman testified that there is not sufficient empirical evidence to support the statement that women may return to "baseline" (whatever that means) more quickly if they carry pregnancies to term. Thus, there appears to be no dispute among the experts that this mandatory disclosure is not grounded in any medical or scientific evidence. In addition, Dr. Coleman conceded that "women reading that [disclosure] may not really understand it."
We note as well that Dr. Coleman emphasized throughout her testimony that it is imperative to furnish information which allows women to "make the choice that they believe is best for them."
This provision does not comport with Casey, which, we say again, requires mandatory disclosures to be truthful and non-misleading and "calculated to inform the women's free choice." We do not believe that a disclosure which is not understandable to its target audience is calculated to inform or enhance autonomous decision-making. Nor do we believe that the mandated disclosure of information that is indisputably not supported by medical science and confusing for its recipients enables women to make such the choice "they believe is best for them."
For these reasons, we hold that the statement related to mental health contained within Indiana's Perinatal Hospice Brochure does not satisfy the standards laid out in Casey. By all accounts, this disclosure offers nothing more than confusing information that is not anchored in any fact-based scientific or medical evidence. It hinders, rather than advances, informed decision-making and consequently is violative of the Fourteenth Amendment's
b. The Mandatory Disclosure Related to Fetal Pain is Unconstitutional
Plaintiffs also object to the statutory requirement that abortion providers inform their patients that "[o]bjective scientific information shows that a fetus can feel pain at or before twenty (20) weeks of postfertilization age," Ind. Code § 16-34-2-1.1(a)(1)(G). As previously explained, the factual assertion that a fetus feels pain prior to twenty weeks of postfertilization age has been rejected by all the major medical organizations, including ACOG (the views of which are based, in part, by the findings of The Journal of the American Medical Association) and RCOG. These organizations have concluded from their research and related findings that a fetus cannot feel pain prior to twenty-four weeks gestation because anatomic connections between the thalamus and brain cortex, which are necessary for the experience of pain, are not developed until this time. No major medical organizations endorses a contrary view. For these reasons, Dr. Grossman has categorized this disclosure as representing at best a "fringe view" within the medical community.
Dr. Condic, the State's proffered expert, however, testified that the conclusions and findings produced by ACOG, JAMA, and RCOG are scientifically incorrect. According to her opinion, these organizations have failed to considered animal-based research which shows that connections between the thalamus and the cortex are not necessary for the fetus to have a conscious experience of pain. Her review of this research reveals instead that neural circuitry present within the thalamus as a precondition for the conscious experience of pain is fully developed by 12-18 weeks of postfertilization age.
In analyzing this disclosure, we turn again to the standard set forth by Casey: the information must be truthful and non-misleading so to inform, rather than hinder, a woman's decision-making. Here, two experts disagree as to whether this disclosure comports with the Casey standard. After careful consideration of this conflicting testimony, we hold that this mandated disclosure does not satisfy the framework prescribed by Casey.
As written, the disclosure communicates to women that objective scientific findings establish that a fetus is capable of feeling pain at twenty weeks gestation—or earlier. We cannot contest that there apparently exists some body of scientific research and literature, including that reviewed and discussed by Dr. Condic, supporting this view. However, it does, in fact, appear to represent a "fringe view" within the medical community. It directly conflicts with the findings of ACOG (which, as we have noted, represents 90% of licensed to practice OB-GYNs in the United States), The Journal of the American Medical Association, and RCOG (the United Kingdom's ACOG). This information contained within this mandatory disclosure has specifically been rejected by these leading medical organizations. The State law nonetheless mandates the disclosure of this view in a manner that most certainly risks communicating to women that scholars have factually, scientifically, reliably determined that a fetus is experiencing pain as early as twenty weeks gestation.
The mandated disclosure could have, perhaps, been framed in terms of "some scholars disagree as to when a fetus feels pain," or perhaps "some scientific research suggests that a fetus can feel pain" at twenty weeks gestation. The language of this disclosure in its current form, however, conveys that this fact represents settled, medical science, which it does not (since the prevailing opinion among medical
c. The Mandatory Disclosure Relating to Fetal Life Is Unconstitutional
Finally, we turn to Plaintiffs' challenge to the State-mandated disclosure that "human physical life begins when a human ovum is fertilized by a human sperm." Ind. Code. § 16-34-2-1.1(a)(1)(E). Plaintiffs again contend that this statement is at best misleading, conflating a religious or ideological view of when "life" begins with one sounding in science. As Dr. Grossman testified, there is no medical consensus as to when human life begins; thus, to advance such a position it not "truthful."
Dr. Curlin has rebutted Dr. Grossman's assessment, testifying that the disclosure, carefully crafted to reference only "physical" life, is not scientifically controversial. As he explained, there is no dispute among medical professionals that all living organisms begin as fertilized eggs. In other words, a living human organism is created when a human ovum is fertilized by a human sperm, and thus Indiana's mandated disclosure advances nothing more than this uncontroversial biological statement.
Plaintiffs contend that the State cannot attempt to save this statute through semantics, by characterizing the prescribed statement as conveying only biological trivia rather than an assertion about the moral or ethical personhood of a fetus.
We share Plaintiffs' concerns in this regard, finding superficial the State's efforts to neutralize the import of this statement by declaring it medically accurate, scientifically uncontroversial, and not ideologically charged. As to whether there is any medical consensus on this issue, we find Dr. Grossman's opinions credible and ultimately more persuasive. As Dr. Grossman testified—and Dr. Curlin did not dispute— "human physical life" is not a medical term that is defined in any extant medical literature. Dr. Curlin's opinion that the statement is neutral is based on his personal understanding (and belief) of when a "human organism" is created; however, the mandatory disclosure at issue here does not speak of the creation of an "organism," it references the beginning of human life— a question ripe for debate among "those trained in the respective disciplines of medicine, philosophy, and theology," about which neither the State nor the judiciary may "speculate as to the answer." Roe, 410 U.S. at 159, 93 S.Ct. 705. We are further troubled by the reliability of Dr. Curlin's opinions on this topic, given that they are informed by his overall belief that abortion is the killing of an innocent human being and as such must be provided to women so that they may understand that proceeding with an abortion kills innocent life. Unless and until Roe v. Wade is overturned, these sentiments from Dr. Curlin do not serve to bolster the accuracy or usefulness or appropriateness of the State's mandated messaging.
In addition, the State has presented no evidence that this mandatory disclosure has actually ever served to inform or enhance the decision-making of a single woman; to the contrary, the evidence before us shows that this mandatory disclosure confuses and angers women.
d. Indiana's Requirement That Only Physicians and APCs Conduct Preabortion Counseling Is Not Unduly Burdensome
Plaintiffs' final challenge in the category of informed consent pertains to Indiana's requirement that the various informed consent materials be delivered
In Dr. Grossman's expert opinion, this provision does not comport with the applicable standard of care, which permits any preabortion counseling to be delegated to properly trained medical assistants. Indeed, in Dr. Grossman's clinic, patients participate in in-depth and thorough preabortion counseling sessions with trained counselors. A similar practice is utilized by WWHA clinics in other states than Indiana with the assistance and direct involvement of nurses, counselors, and medical assistants.
Dr. Calhoun testified that he believes this counseling is best conducted only by a physician or APC, which ensures that the patient is provided an opportunity to know the details of the procedure as well is the potential side effects and risks by an individual qualified and capable of leading an informed discussion and thoroughly answering any questions that the patient may have.
We agree that such benefits as identified by Dr. Calhoun attach to this mandate. As all the experts testifying at trial agreed, obtaining informed consent is an essential aspect of good medical care, and critical to the process of securing the patient's informed consent is ensuring that the patient understands what the procedure entails and is given the opportunity to ask and have answered any questions or concerns. We do not believe it is controversial to acknowledge that an APC or physician is best-suited to perform this function.
Regarding the burdens imposed by this requirement, Plaintiffs' evidence reveals that in restricting preabortion counseling tasks to physicians or APCs limits their availability to perform abortions by utilizing their already limited time on tasks of lesser importance as well as clinics' capacity to offer counseling appointments. This clearly impacts women's ability to schedule the first of their two abortion-related appointments. As previously discussed in detail, navigating the two-appointment requirement is onerous for many women seeking services.
We have no doubt that this provision creates difficulties for women attempting to schedule preabortion counseling appointments. However, we expect these burdens to be mitigated by our holding that telemedicine may be incorporated into this process, which, as we have discussed, extends the reach and accessibility of providers.
For these reasons, we hold that this requirement is not unduly burdensome and thus comports with the Due Process Clause. In addition, Plaintiffs have not identified how abortion patients are being treated differently than similarly situated non-abortion patients, and thus they have failed to show that this provision is violative of the Equal Protection Clause.
4. Indiana's Criminal Penalties Provisions
The final issue raised in this litigation is Plaintiffs' challenge to the criminal penalties imposed for violations of Indiana's substantive abortion regulations. See Ind. Code §§ 16-34-2-7(a)-(b), 16-21-2-2.5(b), 16-34-2-5(d).
The majority of the abortion statutes under Indiana law are enforced through criminal penalties in addition to professional sanctions and civil liability. In no other healthcare context are healthcare providers subject to such a vast array of criminal penalties; sanctions are ordinarily limited to disciplinary actions against them by their professional licensing boards and hospital/practice affiliations. Plaintiffs contend that these criminal penalties pose a "chilling effect" on providers, deterring them from otherwise performing abortion services.
The parties diverge in their views as to whether the Court should conduct a separate undue-burden analysis of Indiana's criminal penalties provisions. The State maintains that "these challenges do not constitute a unique constitutional issue; the criminal prohibitions are valid if the substantive restrictions they enforce are valid." The State relies on the Supreme Court's decisions in Gonzales v. Carhart and Casey as support for its view. In Gonzales, the Supreme Court held that the federal partial-birth abortion ban, 18 U.S.C. § 1531, which criminalizes performance of partial-birth abortions, was not void for vagueness nor was it facially unconstitutional based on its overbreadth. 550 U.S. at 124, 127 S.Ct. 1610. In Casey, the Court upheld Pennsylvania's informed-consent requirements, which were enforced by exposure to criminal penalties. 505 U.S. at 844, 112 S.Ct. 2791 (maj. op.). Plaintiffs respond that neither of these cases independently addresses the constitutionality of the challenged laws' criminal enforcement mechanisms apart from the laws' substantive requirements because the parties in those cases did not raise this specific constitutional challenge.
Like Plaintiffs, we question the legitimacy of such expansive criminal sanctions in furthering the State's interests in maternal and fetal health; in any event, no evidence is before us indicating that Indiana's civil medical malpractice laws or civil penalties do not suffice to ensure that abortions services are provided safely and effectively in Indiana. Plaintiffs' theory that these criminal sanctions have been enacted with the purpose and effect of placing a substantial obstacle in the paths of women seeking abortion care in Indiana is not without persuasive force. On the other hand, Plaintiffs have not shown that there is a real and legitimate threat of prosecution attached to these provisions that deters qualified professionals from providing care. They have directed us to no instances where healthcare professionals providing abortion care in Indiana
This theory ultimately fails, however, due to Plaintiffs' failure to identify any legal authorities supporting a constitutional challenge to the criminal penalties provisions independent from the substantive prohibitions that they are intended to enforce. Though Gonzales and Casey did not address the question that Plaintiffs have presented to us in this litigation, these cases nonetheless offer insight as to how the Supreme Court might view this issue. In those cases, the Supreme Court upheld abortion laws, which were enforced through the threat of criminal penalties, as constitutionally sound. The Court did so without any indication that the potential imposition of criminal penalties was constitutionally problematic. We find the Court's silence to be instructive, particularly given the dearth of case law supporting Plaintiffs' position. Accordingly, we hold that the criminal penalties are valid to the extent that substantive provisions that they enforce are valid.
V. Remaining Factors for Permanent Injunctive Relief
Plaintiffs have requested permanent injunctive relief from enforcement of those statutes determined to be unconstitutional. Permanent injunctive relief is appropriate when a plaintiff has shown: "(1) success on the merits; (2) irreparable harm; (3) that the benefits of granting the injunction outweigh the injury to the defendant; and, (4) that the public interest will not be harmed by the relief requested." Lacy v. Cook Cty., Illinois, 897 F.3d 847, 867 (7th Cir. 2018) (internal punctuation omitted).
As explicated above, Plaintiffs have proven their constitutional injuries with respect to those statutes which we have determined to be unconstitutional at a minimum beyond a preponderance of the evidence. The State has not disputed that irreparable harm to women occurs when their fundamental right to previability abortion services is unduly burdened. It is, in fact, well-established that the enforcement of unconstitutional laws ipso facto imposes irreparable harm. Preston v. Thompson, 589 F.2d 300, 303 n.3 (7th Cir. 1978). We further hold that no identifiable harm will be suffered by the State from the issuance of a permanent injunction in this case, given that there is "no harm to a [government agency] when it is prevented from enforcing an unconstitutional statute." Joelner v. Vill. of Wash. Park, 378 F.3d 613, 620 (7th Cir. 2004); see also Does v. City of Indianapolis, Case No. 1:06-CV-865-RLY-WTL, 2006 WL 2927598, at *11 (S.D. Ind. Oct. 5, 2006) ("Defendants will not be harmed by having to conform to constitutional standards, and without an injunction, Plaintiffs will continue to be denied their constitutional rights.").
Any public interest to be equitably balanced in the State's favor is usually coextensive with the governmental interest appearing in the merits analysis. See
Finding no just reason for delay, FED. R. CIV. P. 54(b), partial final judgment shall now issue.
For all the reasons explicated above, judgment shall enter in favor of Plaintiffs with respect to the following provisions on the grounds that each violates the Substantive Due Process and Equal Protection Clauses of the Fourteenth Amendment, and henceforth their enforcement shall be permanently enjoined:
We further hold that the Mandatory Disclosures regarding fetal pain, the beginning of life, and the mental health risks of abortion contained in the Perinatal Hospice Brochure violate Casey's truthful and non-misleading standard and thus are unconstitutional under the First Amendment and the Fourteenth Amendment's Substantive Due Process Clause and shall be henceforth permanently enjoined.
A permanent injunction shall enter by separate order.
Judgment shall enter
Judgment shall also enter
IT IS SO ORDERED.
At the time of the summary judgment briefing in our case, Judge Pratt's preliminary injunction remained in force, and we followed the parties' request in reviewing the Ultrasound Requirement as not being subject to any eighteen-hour delay requirement restrictions. Accordingly, we held at summary judgment that the Ultrasound Requirement did not violate the Substantive Due Process Clause, leaving unaddressed the issue of whether it violated the Equal Protection Clause. In the interim, the State sought Supreme Court review of the Seventh Circuit's affirmance of Judge Pratt's preliminary injunction and, ultimately, the Supreme Court granted the petition for writ of certiorari, vacated the decision of the Seventh Circuit, and remanded the case to the Seventh Circuit for further consideration in light of June Medical Services LLC v. Russo, 591 U.S. ___, 140 S.Ct. 2103, 207 L.Ed.2d 566 (2020). On remand before the Seventh Circuit, the parties agreed that the case should be remanded to the district court, stating that: "[T]he factual circumstances that have occurred in the more than three years since the district court entered its preliminary injunction are significantly different and, in recognition of this, the parties ... agree that the preliminary injunction should continue until January 1, 2021, at which point the injunction should be vacated and the case dismissed." Case No. 17-1883 [Dkt. 76-1, at 3]. The referenced change in "factual circumstances" pertained to the acquisition by Planned Parenthood's affiliates of a sufficient number of ultrasound machines to overcome the burdens to women of receiving their preabortion ultrasounds at their facilities at the same time they received their preabortion counseling eighteen hours in advance of the abortion. Consistent with this stipulation, the Seventh Circuit remanded the case, and its Mandate was received on October 22, 2020. On November 2, 2020, Judge Pratt issued an order accepting the parties' stipulations; the case was subsequently closed on January 4, 2021. See Case No. 1:16-cv-01807-TWP-DML, [Dkt. Nos. 84-90]. Accordingly, Indiana law currently requires that an ultrasound be performed eighteen hours prior to an abortion. Thus, a woman, irrespective of the In-Person Counseling Requirement at issue here, is required to make two trips to a clinic, no sooner than eighteen hours apart. Against this backdrop, we here review the narrow issue of whether the Ultrasound Requirement violates the Equal Protection Clause. Lacking authority to address the constitutionality of the eighteen-hour requirement, we treat it as settled law.