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Whole Woman's Health Alliance v. Hill
Citation: 388 F. Supp. 3d 1010Docket: No. 1:18-cv-01904-SEB-MJD
Court: District Court, S.D. Indiana; May 31, 2019; Federal District Court
An overview of the abortion procedure at the South Bend Clinic outlines the provision of medical abortions, specifically using mifepristone and misoprostol, while surgical abortions will not be offered. Nearly half of all pregnancies in the U.S. are unintended, with 22% ending in termination. Mifepristone, developed in the early 1980s and approved by the FDA in 2000, is subject to strict distribution regulations, requiring it to be dispensed only by physicians under specific agreements. The current FDA-approved regimen allows for administration of the two drugs up to 70 days of gestation. The patient first takes mifepristone to halt fetal growth, followed by misoprostol 24 to 48 hours later to induce contractions that expel the uterine contents, mimicking a miscarriage. Potential complications typically arise after the patient leaves the facility, as the drugs take time to take effect. The document also includes a review of Indiana's abortion regulation history, licensure requirements, and recent administrative proceedings regarding WWHA's license applications. Fewer than 5% of patients remain pregnant after a medical abortion, with less than 1% at 63 days LMP. Patients with a persistent gestational sac post-mifepristone may be treated with misoprostol, surgery, or may not need further intervention. The American College of Obstetricians and Gynecologists (ACOG) advises that medical abortion providers should either be trained in surgical abortion or have referral options available. Common experiences during a medical abortion include bleeding and cramping, which are necessary, along with potential adverse effects like nausea, vomiting, diarrhea, headache, dizziness, and thermoregulatory issues. The risk of fatal and nonfatal complications from abortion is low, lower than that of penicillin injections and childbirth, with a complication rate of 0.65% based on a study of over 230,000 medical-abortion patients. Complications requiring hospital admission and emergency treatment were 0.06% and 0.10%, respectively. The risk to patients increases with gestational age. Although a study suggested a theoretical connection between mifepristone and Clostridium sordellii infections, no specific link has been established. A review found an increased risk of mental health issues following abortion, but subsequent literature indicates that unwanted pregnancies pose similar mental health risks regardless of the outcome. Mifepristone may lead to excessive hemorrhage, and while both medical and surgical abortions are generally safe, medical abortions have a higher incidence of adverse events. Personal experiences with medical abortion vary, with some patients appreciating the comfort of home administration and feeling in control, while others report intense pain and trauma from the experience. In terms of access, Indiana has six licensed abortion clinics: three in Indianapolis, one in Lafayette, one in Bloomington, and one in Merrillville. South Bend, Indiana, the state's fourth most populous city, is situated near the Indiana-Michigan border and is home to two major universities along with smaller colleges. The city is geographically positioned approximately 65 miles from Merrillville and 199 miles from Bloomington. There is a significant unmet demand for abortion services in South Bend and the surrounding north-central and northeastern Indiana, where many women wish to terminate pregnancies but face barriers to access. The Women's Health Alliance (WWHA) aims to establish an abortion clinic in South Bend due to the lack of local providers. Research and outreach indicate that South Bend is underserved, with substantial community support from local physicians for the clinic's establishment. Current transportation and access issues hinder women, including college students, from obtaining abortion care, often forcing them to travel to Chicago. If the South Bend Clinic does not open, many women will likely be unable to access necessary abortion care. The disparity in access is exacerbated by socioeconomic factors, as women lacking financial resources or supportive networks face greater challenges in securing abortion services compared to their more advantaged counterparts. Travel poses a significant burden for patients seeking abortions in northern Indiana, as there are no direct public transportation routes connecting South Bend to nearby cities like Merrillville, Indianapolis, Lafayette, or Bloomington. Reliable private transportation is often necessary for the required 130 to 398-mile round trip, which is less accessible for economically disadvantaged patients. Weather and road conditions further complicate travel, making it unpredictable, particularly when patients have unreliable transportation. Patients undergoing medical abortions experience physical distress shortly after taking the medication, potentially leading to cramping and bleeding during the journey home. The requirement for patients to leave their communities can foster feelings of criminalization or ostracization. Financially, the travel burden increases the overall cost of the abortion procedure, which is already substantial for those on fixed incomes or lacking insurance coverage for abortion services. Many patients have faced severe financial strain, with reports of individuals unable to pay their rent or utilities due to abortion-related expenses, and some resorting to pawning belongings or high-interest payday loans to cover costs. Delays in obtaining an abortion can lead to increased costs as pregnancy gestation progresses. The situation is exacerbated by the mandatory eighteen-hour waiting period before receiving medication, requiring patients to make two trips to the clinic, often necessitating overnight accommodations. Additionally, the responsibilities of dependents, employment, or education add further complications, as patients must arrange for childcare, request time off work, or inform partners about their absence. Abortion seekers in South Bend face a challenging environment, characterized by hostility toward abortion access, as noted by local practitioners. This social context compounds the logistical and emotional burdens on women, particularly those with dependents, who struggle to find adequate support for childcare during their travels for abortion care. Hostility from employers, professors, or partners towards abortion can exacerbate the challenges women face in accessing abortion services, often leading them to seek care out of state, such as traveling to Chicago instead of nearby Merrillville. Indiana's legislative response to the Supreme Court's 1973 decisions in Roe v. Wade and Doe v. Bolton was swift and restrictive, establishing a framework of abortion regulations that began in 1973. Initially, abortions were classified as felonies unless performed under specific conditions, including requiring written consent from the patient at least 24 hours prior to the procedure and mandatory reporting of ten specific details to the health department. In 1993, these regulations were updated following the reaffirmation of Roe in Planned Parenthood v. Casey, moving abortion regulations from criminal law to public health statutes. This change allowed first-trimester abortions to be performed in unlicensed settings while maintaining requirements for later-term abortions to occur in licensed facilities. The regulations continued to mandate written consent and reporting. In 1995, the informed consent requirements were significantly expanded to include detailed disclosures about the fetus's probable gestational age and an offer for visual representations of the fetus. This requirement has evolved over time, becoming more complex, with the current law stipulating that consent is considered "voluntary and informed" only if necessary information is provided at least 18 hours prior to the abortion in a private setting, by the physician or a qualified delegate. Information regarding abortion procedures may be communicated to patients at locations other than the clinic, provided statutory conditions are met. However, WWHA plans to operate only one facility, limiting this option. Between 1993 and 2005, abortions outside hospitals or surgical centers occurred in unlicensed facilities. Mifepristone received FDA approval in 2000, and during a 2006 legislative debate, Representative Marlin Stutzman called for updated regulations for abortion clinics, which had operated without oversight for over 30 years. In 2005, a statutory definition for "abortion clinic" was introduced, subjecting these facilities to the same licensure standards as hospitals, although facilities providing medical abortions were initially excluded from this definition. From 2005 to 2013, medical abortions not performed in hospitals were conducted in unlicensed settings. In 2013, legislation expanded the definition to include medical-abortion providers under "abortion clinics," requiring licensure unless abortion-inducing drugs were not the primary medication dispensed. This definition faced legal challenges, resulting in a preliminary injunction in 2013 and a permanent injunction in 2014 due to equal protection violations. In 2015, the General Assembly repealed the previous definition and introduced a new one, which remains in effect, classifying medical-abortion providers as "abortion clinics" unless they serve fewer than five patients per year for abortions. The South Bend Clinic is now classified as an "abortion clinic" under the current definition. The plaintiffs' lawsuit targets the statutory provisions known as the "Licensing Law," related to various licensing requirements affecting the case. Indiana's abortion regulation framework includes the Licensing Law found in various sections of title 16, Health, article 21, Hospitals of the Indiana Code. It defines "abortion clinic" as a health care provider performing surgical abortions or providing abortion-inducing drugs, excluding licensed hospitals, ambulatory outpatient surgical centers, and providers administering medical abortions to fewer than five patients annually. "Abortion" is defined as the termination of pregnancy with the intent other than live birth, excluding miscarriages. According to Indiana Code § 16-21-2-10, a license from the Department is mandatory for establishing or operating an abortion clinic, hospital, ambulatory outpatient surgical center, or birthing center. Operating an unlicensed abortion clinic is a Class A misdemeanor, punishable by up to one year in prison and a $5,000 fine. The Department is responsible for licensing and regulating these facilities, with licenses valid for one year and renewable annually. Application for an abortion clinic license requires proof of "reputable and responsible character," compliance with minimum standards, and submission of the applicant's name and operational location. Starting July 1, 2018, applicants must also disclose any relevant past issues concerning patient health and safety, felony convictions of staff, or closures due to administrative or legal actions. They are required to provide supporting documents, including inspection reports and violation remediation contracts. The term "affiliate" is defined as any person who exercises control over, is controlled by, or shares common control with another person, a definition established in 2018 along with the additional application requirements. Provisions related to the licensing of abortion clinics in Indiana were likely enacted in response to WWHA's initial license application for the South Bend Clinic. Indiana Code 16-21-2-11(a)(1)(2) mandates that license applicants demonstrate their ability to meet minimum standards and comply with the Department's rules. Indiana Code 16-21-2-2.5 requires the Department to establish rules for abortion clinics, which include minimum license qualifications, medical record policies, license issuance and revocation procedures, inspection standards, and requirements for sanitation, infection control, and law enforcement training on coercion in abortion scenarios. The Department's regulations are detailed in title 410, article 26 of the Indiana Administrative Code. Under Indiana Code 16-21-1-9, the Department can waive rules for good cause, provided patient safety is not compromised. The Plaintiffs' challenges to this section within the Licensing Law are unclear. Rule 2 of the licensing process states that applications must meet the "reputable and responsible character" requirement and demonstrate compliance with applicable standards. If standards are not met, the Department may seek additional information, conduct investigations, or deny applications. Specific grounds for denying an application include lack of character of the licensee(s), non-compliance with minimum standards, violations of relevant codes or rules, and detrimental conduct towards patients. If an applicant meets the qualifications, a provisional license valid for 90 days may be issued, followed by a full license after a successful initial inspection. Additionally, the Department can revoke licenses for various reasons, including violations of regulations, illegal acts within the clinic, and detrimental practices affecting patient welfare. The Department is mandated to conduct annual inspections of all abortion clinics in Indiana and can perform additional inspections based on complaints. These inspections, termed "surveys," include both regular licensing surveys for compliance with regulations and complaint surveys in response to credible allegations of noncompliance. The authority to conduct these surveys is not dependent on the clinics' licensure status. The substantive regulations governing abortion procedures are primarily found in Title 16, Article 34 of the Indiana Code, which includes informed consent and physician reporting requirements. Outside of specified circumstances, abortion is considered a criminal act, with performing an abortion contrary to regulations classified as a Level 5 felony, carrying a potential one to six-year imprisonment and a $10,000 fine. Noncompliance with parental consent and informed consent requirements results in lesser penalties, such as a Class A misdemeanor and Class A infraction, respectively. Additionally, the Licensing Law does not override existing licensure requirements for medical professionals in Indiana, nor does it eliminate the possibility of legal actions based on professional negligence or battery arising from informed consent violations. WWHA, founded in 2014 by Amy Hagstrom Miller, operates two abortion clinics in Virginia and Texas and is structured as a 501(c)(3) nonprofit. Its governance is through a board of directors elected for three-year terms, with Hagstrom Miller serving as chair since its inception. The president and CEO, also Hagstrom Miller, oversees operational management and has the authority to manage personnel and contractual obligations. A board member characterized her role as encompassing overall responsibility for the organization’s operations, including financial management, compliance, medical care, and supply ordering. Board members assert that they take their oversight responsibilities regarding Hagstrom Miller seriously but have never opposed any of her decisions. Hagstrom Miller has a notable background in abortion advocacy, having opened an abortion clinic called "Whole Woman's Health" in Austin, Texas, in 2003. In 2007, she established Whole Woman's Health, LLC (WWH), a for-profit healthcare management company that provides management services to various abortion providers, including WWHA. Other for-profit LLCs operate under the "Whole Woman's Health" brand in different cities, such as Baltimore. These entities contract with WWH for services like bookkeeping and regulatory compliance. All these LLCs are managed by The Booyah Group, which is wholly owned by Hagstrom Miller. Hagstrom Miller uses "Whole Woman's Health" as a marketing term, but its legal status as a consortium of LLCs is ambiguous. In legal proceedings, "Whole Woman's Health" has been referenced in cases like Whole Woman's Health v. Hellerstedt, where it was identified as operating clinics in Texas. Hagstrom Miller founded WWHA in response to increasing restrictions on abortion services, aiming to create a sustainable model supported by donations and grants to withstand regulatory challenges. Maryland and Minnesota have fewer laws that hinder abortion practices, allowing facilities to operate similarly to standard medical offices. Whole Woman's Health Alliance (WWHA) aims to address the stigma surrounding abortion through open dialogue and positive representation in communities where abortion is heavily criticized. In 2014, local stakeholders invited WWHA to establish a clinic in South Bend, identified as a challenging environment for abortion access and providers. After a year of preparations, WWHA applied for a license to operate the South Bend Clinic on August 11, 2017. The Department requested a revised application on September 21, 2017, due to minor deficiencies, including the omission of a proposed clinic administrator. The revised application was submitted on October 6, 2017, with Trent Fox from the Department becoming involved in the review process, prompted by concerns about WWHA's unfamiliarity as a new entity in Indiana. The proposed clinic administrator, Liam Morley, raised concerns because of his past connections with Dr. Ulrich Klopfer, a former abortion provider who faced serious disciplinary actions. Concurrently, state Senator Joseph C. Zakas sent a letter to the governor expressing significant public concern over WWHA's application, citing over 200 messages from constituents worried about WWHA's history of health violations and emphasizing Indiana's pro-life stance. Similar letters followed from Senators Erin Houchin and Ryan Mishler, criticizing WWHA's safety record and framing its application as a threat to women's health, while invoking pro-life values. Plaintiffs assert that all factual claims made in prior correspondence were entirely false, a position not contested by the Defendants. Fox conducted online research on "Whole Woman's Health" and located the website for the "Whole Woman's Health consortium," which listed eight abortion clinics under that brand, including a ninth in South Bend. The website, owned by WWH, indicated its management services for various "Whole Woman's Health" LLCs, though Fox was unaware of this distinction during his research. He also discovered public statements by Hagstrom Miller, WWHA's president, referring to the clinics similarly. Prompted by correspondence from senators and his findings, Fox requested the Department to obtain additional information from WWHA on October 27, 2017. The requests included detailed inquiries into ownership structure and a list of all abortion and healthcare facilities operated by WWHA and its affiliates. Although there was no statutory definition of "affiliate" at the time, Fox had a general understanding that it implied common control by a single entity. This understanding was not communicated to WWHA. During oral arguments, Defendants claimed the Department's lack of guidance was a deliberate investigative strategy to determine if WWHA would reveal its affiliates. On December 8, 2017, WWHA responded, identifying itself as a Texas nonprofit with no owners and providing details about its clinics in Austin and Virginia, along with licensing information and a management agreement with WWH. The Management Company, a Texas limited liability entity, is contracted to provide management services to WWHA, which operates multiple clinics in the U.S. Some WWHA Board Members are affiliated with the Management Company, but most are independent. In response to a second information request from the Department, Bucy referred to prior answers, while Fox evaluated WWHA's response and identified two additional clinics. Fox noted discrepancies between the number of clinics listed and those disclosed, leading to confusion and a lack of clarity regarding potential violations. He concluded that there was inadequate information to justify granting WWHA a license. Fox determined that some clinics, under common control of Ms. Miller, were not disclosed. The Department, feeling no obligation to conduct further investigations, ultimately denied WWHA's license application on January 3, 2018, citing failure to disclose information about additional clinics and concluding that WWHA did not meet the criteria of being of reputable and responsible character due to inaccurate documentation. WWHA filed an administrative appeal on January 22, 2018, asserting that its responses to the Department's inquiries from October 27, 2017, were truthful and complete. Bucy, representing WWHA, emphasized that as a nonprofit, it had no owners or parent organization and no subsidiaries, as it did not hold ownership interests in other entities. While WWHA disclosed its management contract with WWH and its Texas and Virginia clinics, it did not disclose other Whole Woman's Health clinics managed by WWH, arguing they were independent and not under WWHA's control. Bucy speculated that the Department might view WWH as an affiliate of WWHA, referencing Indiana Code definitions of "affiliate" based on control. Bucy contended that WWHA’s board operated independently and was not controlled by others, including WWH. The administrative law judge (ALJ) held hearings on August 22 and 23, 2018, where substantial evidence was presented regarding the relationships among WWHA, WWH, and other Whole Woman's Health entities, focusing on the affiliate status of WWHA. The Department highlighted Hagstrom Miller's control over these entities, while WWHA referenced its board's independence and conflict-of-interest policy, which required Miller to recuse herself from certain decisions. Ultimately, in a September 14, 2018 recommended order, the ALJ determined that WWHA's license application was neither incomplete nor inaccurate, finding no evidence that WWHA's responses to the Department were misleading. WWHA established, by a preponderance of the evidence, that its responses to the Department's information request on October 27, 2017, were complete and accurate. The Department failed to provide evidence that it specifically questioned WWHA regarding concerns raised by Indiana Senators or from its own informal investigation. Consequently, the Department could not demonstrate that WWHA lacked a reputable and responsible character, which would warrant denial of the license for the South Bend clinic. The Administrative Law Judge (ALJ) recommended reversing the Department’s denial and granting WWHA the license based on its revised application and subsequent evidence. The Department's attorneys were confused by this recommendation, believing they had presented evidence showing Hagstrom Miller's control over both WWHA and other "Whole Woman's Health" entities, thus implying that WWHA's responses were inaccurate. Despite both parties debating the definitions of "affiliate" and "control," the ALJ did not address whether WWHA had "affiliates" under state law. Instead, the ruling focused on whether WWHA knowingly provided inaccurate information, concluding that the Department had not shown a lack of reputable and responsible character due to insufficient notice of the information sought. The Department objected to the ALJ’s order and escalated the matter to a three-member Appeals Panel, which held a hearing on November 28, 2018. The panel ultimately sided with the Department, concluding by a two-to-one vote that Hagstrom Miller does "control" WWHA, despite acknowledging that "control" is not defined in Indiana's abortion laws. The Appeals Panel derived its definition of control from the case Combs v. Daniels, which interpreted the authority granted to the Department in a different context. The term 'control' is defined as the authority to manage, oversee, or regulate operations, as established in the case Williams v. State. The Appeals Panel determined that Amy Hagstrom Miller exercises control over Whole Woman's Health Alliance (WWHA) under Indiana law, based on her powers as president and the testimony regarding her management duties. Consequently, several Whole Woman's Health LLCs are recognized as affiliates of WWHA due to this common control. WWHA’s failure to disclose these affiliates led to the denial of its license application under 410 Ind. Admin. Code 26-2-5(7). The Appeals Panel did not assess WWHA's character reputation. Instead of pursuing judicial review, WWHA reapplied for a license on January 19, 2019. Following this, the Department requested specific disclosures regarding WWHA's identified affiliates by March 15, 2019, including documents related to investigations, licensure applications, regulatory actions, and information about the affiliates' management. On the due date, WWHA complied with some requests but contested the Department's right to extensive information, asserting that the previous denial did not affect the current application. The Department's demands regarding Whole Woman's Health clinics are deemed irrelevant to licensure requirements and excessively broad, requiring extensive documentation that includes privileged communications and potentially hundreds of thousands of pages. The request for documents related to inspections and surveys over a five-year period across five states would necessitate weeks of document review, while retrieving all forms and correspondence related to licensure applications since January 1, 2014, would consume dozens of hours. Whole Woman's Health has already complied with Indiana's disclosure requirements, but the Department dismissed their concerns about the scope and relevance of these demands, leading to a stalemate following a March 15, 2019 letter from WWHA. In June 2018, while awaiting a review of the Department's denial of WWHA's initial license application, WWHA filed a lawsuit challenging Indiana's abortion regulations, seeking a "facial invalidation" of the Licensing Law on due process and equal protection grounds. The plaintiffs later filed a motion for a preliminary injunction on March 27, 2019, requesting narrower, "as-applied" relief to permit medication abortions at the South Bend Clinic while awaiting a final judgment. Although a request for a temporary restraining order was denied, a hearing for the preliminary injunction was scheduled for April 22, 2019. To obtain a preliminary injunction, plaintiffs must demonstrate a likelihood of success on the merits, potential for irreparable harm without the injunction, favorable balance of equities, and public interest alignment. This requires showing more than a negligible likelihood of success and irreparable harm, with the court aiming to minimize the risk of error. An injunction's issuance requires a balancing of private and public equities, where the likelihood of the plaintiffs' success on the merits influences the balance of irreparable harms. If the plaintiffs are likely to succeed, less weight is given to irreparable harm, and vice versa. The plaintiffs must prove their case by a preponderance of the evidence. Generally, constitutional injuries are presumed irreparable, particularly for individuals who lose their opportunity for abortion access. The plaintiffs argue that the "reputable and responsible character" requirement for WWHA's license applications is vague and violates the Due Process Clause of the Fourteenth Amendment. They also contend that the Licensing Law burdens access to previability abortions and violates the Equal Protection Clause. The analysis indicates a negligible chance of success on the first claim, but a better than negligible chance on the second and third claims. The decision on the injunction considers whether the plaintiffs will suffer irreparable injury without it. The Licensing Law's continued application to WWHA and the South Bend Clinic is at stake, reflecting the situation as of March 15, 2019. The analysis does not differentiate between the Department's actions, regulations, and state statutes, affirming that all are subject to constitutional scrutiny. If a state legislature enacts a statute that allows an administrative agency's actions, those actions are constitutional. Plaintiffs face a low likelihood of succeeding in their challenge to the "Reputable and Responsible Character" requirement based on vagueness under the Fourteenth Amendment. Due process prohibits laws that are so vague they do not provide fair notice of what conduct is punishable or invite arbitrary enforcement. This principle serves three constitutional policies: 1. Laws must allow individuals of ordinary intelligence to understand what is prohibited. 2. Vague laws improperly delegate policy decisions to law enforcement and the judiciary, risking arbitrary enforcement. 3. Vague statutes can inhibit First Amendment freedoms, leading individuals to avoid lawful conduct due to unclear boundaries. This vagueness analysis also applies to other constitutionally protected rights, such as abortion, where vague laws can deter lawful medical practices. Economic regulations face a less stringent vagueness test due to their narrower scope and the ability of businesses to seek clarification. Additionally, civil penalties are subject to greater tolerance for imprecision, and laws with a scienter requirement may reduce vagueness by ensuring individuals are aware that their conduct is prohibited. The clarity demanded by the Constitution in laws is significantly influenced by whether the law restricts constitutionally protected rights. The case Village of Hoffman Estates v. Flipside established this principle, highlighting that vagueness challenges typically pertain to conduct regulations rather than licensing qualifications. Although defendants acknowledge this distinction, it remains a point of uncertain relevance. The Supreme Court has considered vagueness in non-conduct-related rules, but successful challenges are rare, as demonstrated in Nat'l Endowment for the Arts v. Finley, which rejected a vagueness claim regarding NEA grant qualifications. The lack of severe constitutional consequences from imprecision is further supported by City of Mesquite v. Aladdin's Castle, which dismissed a vagueness challenge related to a non-existent license requirement. Due process mandates clarity in prohibitions, as seen in Law Students Civil Rights Research Council, which upheld New York's character-and-fitness bar-admission requirement against vagueness challenges. The Seventh Circuit interprets vagueness doctrine in a limited manner concerning licensing provisions, acknowledging some inherent limits, especially in refusal-to-license cases, but these limits were not breached in the current instance. The plaintiffs' challenge regarding the "reputable and responsible character" requirement is notably unclear, as the Department’s enforcement of this requirement was minimal. The Department’s Appeals Panel upheld the denial of a license application based solely on the "accurate statements and information" requirement, without addressing the character requirement, which the administrative law judge also did not significantly clarify. The Department's denial letter dated January 3, 2018, partially relied on the "reputable and responsible character" requirement, which was influenced by WWHA's perceived dishonesty towards the licensor. Indicators of this lack of character included a letter from Senator Houchin, which questioned WWHA's integrity, and insinuations made during the administrative hearing regarding WWHA's efforts to obscure its relationship with WWH due to reputational concerns. The Department asserted that a person or entity of reputable character must be truthful and forthcoming, viewing WWHA's responses to information requests as potentially incomplete or misleading. The Administrative Law Judge (ALJ) seemed to assume that the primary basis for the Department's assessment of WWHA's character was its alleged dishonesty. The Department's approach to the meaning of "affiliate" in its requests was intentionally vague, aimed at gauging whether WWHA would disclose known affiliations. The excerpt underscores that a reasonable person would interpret the requirement for reputable character as inherently including the obligation not to mislead the licensor during the licensing process, as dishonesty undermines the licensing framework's regulatory objectives. Licenses are deemed valuable only if the applicant is truthful, as dishonesty undermines the credibility of licensure. The plaintiffs argue that the Department has not established clear standards for evaluating “reputable and responsible character,” which they claim has led to arbitrary and discriminatory applications of this requirement, particularly against abortion and abortion providers. They highlight the significant constitutional implications of licensing in this context, contrasting it with less critical licenses, such as for amusement operators. The text references legal precedents affirming that subjective assessments of moral character are not inherently vague if necessary for regulatory purposes. Defendants cite numerous statutes from various jurisdictions that use "reputable and responsible character" as a licensing criterion, indicating that broad evaluations are common in health regulation. While the plaintiffs suggest that the requirement is prone to arbitrary enforcement, the text argues that such susceptibility does not equate to vagueness. It clarifies that the Department did not conclude that WWHA's interpretation of its ownership structure reflected a character flaw; rather, it did not find evidence to support any character issue. Thus, the plaintiffs' claims of abuse regarding the character requirement are based on a flawed premise. The Administrative Law Judge (ALJ) and the Appeals Panel found insufficient evidentiary support for the Department's license denial based on "reputable and responsible character." This aligns with the precedent set in Schware, where the Court ruled that advocating for the violent overthrow of the government could indicate "bad moral character," but using an applicant's past Communist Party membership as a proxy for such advocacy was impermissible without direct evidence. There was no indication of vagueness in the "good moral character" standard. The Plaintiffs failed to demonstrate that uncertainty regarding the "reputable and responsible character" requirement deterred prospective abortion providers from applying for licenses. The Department's request for information on WWHA's character suggests that the requirement will be applied again if WWHA pursues a license, but the impact of that application remains uncertain. The court cannot grant relief based on hypothetical scenarios or future applications lacking evidence of arbitrariness or discrimination. The Plaintiffs have a negligible chance of success on their vagueness challenge to the requirement but may have a better chance regarding their undue-burden and equal protection claims related to the Department's licensing law. The complaint primarily challenges the laws on their face, not as applied to WWHA, and does not include facts from the administrative proceedings that occurred after the complaint was filed, which affects the as-applied challenge. In a facial constitutional challenge, the specifics of individual applications are irrelevant. The legal dispute centers on whether the Department's actions have created a significant obstacle for women in northern Indiana seeking previability abortions by denying the Whole Woman's Health Alliance (WWHA) the ability to provide medical abortions at the South Bend Clinic. This situation arose after the Department denied WWHA's initial license application and subsequently withheld approval of a second application until WWHA complied with certain production demands, which relate to demonstrating its "reputable and responsible character." The claims presented by the Plaintiffs include an as-applied undue-burden claim and a facial equal protection claim. The precedent set by *Whole Woman's Health v. Hellerstedt* and *Planned Parenthood of Southeastern Pennsylvania v. Casey* is cited, emphasizing that the Due Process Clause protects a woman's right to terminate her pregnancy before viability without undue state interference. It is asserted that any law imposing an "undue burden" on this right is unconstitutional if it serves to create a substantial obstacle to obtaining an abortion. Furthermore, the Equal Protection Clause of the Fourteenth Amendment ensures that individuals in similar circumstances are treated equally. When reviewing social or economic legislation, courts typically apply a rational basis standard unless a "suspect" classification is involved, which warrants heightened scrutiny. The parties disagree on the appropriate standard of review for the equal protection claims, with Plaintiffs advocating for intermediate scrutiny and Defendants suggesting rational-basis review. The assertion is made that the standard for equal protection claims should align with the undue-burden standard under the Due Process Clause. The document references *Harris v. McRae*, which upheld the Hyde Amendment, indicating the ongoing complexities surrounding abortion rights and state legislation. The Court determined that the Hyde Amendment does not infringe upon the substantive right to abortion, leading to a rational-basis review of the plaintiffs' equal protection claim since the Amendment is not based on a suspect classification. The Court clarified that the Equal Protection Clause guarantees freedom from discrimination in governmental actions but does not create substantive rights. Consequently, where no constitutional rights are violated, heightened scrutiny is unnecessary. The assessment of whether the Licensing Law affects the abortion right is governed by the Due Process Clause. The Equal Protection Clause cannot extend the substantive abortion rights. Citing previous cases, the Court stated that any law that encroaches upon substantive rights is presumptively invalid. The burden of demonstrating constitutionality lies with the defendants, and courts must evaluate the burdens imposed by laws on abortion access against their benefits, including the state's legitimate interests. States can impose regulations for health and safety, but those that create significant obstacles to accessing pre-viability abortions constitute an undue burden. The state has a legitimate interest in preserving potential life and may implement measures to ensure a woman's choice regarding pregnancy is informed, reflecting philosophical and social considerations. However, such measures must not hinder a woman's free choice or create substantial obstacles. The integrity and ethics of the medical profession can also be safeguarded through state measures, but these must not impose undue burdens on women seeking previability abortions. The assessment of burdens focuses on their impact on women affected by the law, and if these burdens constitute a substantial obstacle for a significant portion of this group, they are deemed undue. The court evaluates whether the burdens imposed by the law significantly outweigh the state's justifications for those burdens, determining if the regulation genuinely advances the state's interests. Previous rulings, such as Hellerstedt and Planned Parenthood of Wisconsin, have highlighted that when burdens on abortion rights are substantial and the state's interests are minimal or nonexistent, such regulations can be struck down as unconstitutional. Examples include the invalidation of an admitting-privileges requirement due to its severe impact on clinic availability without health benefits, and a spousal-notification requirement deemed to lack legitimate state interest. The court ruled against certain abortion-related legal requirements, emphasizing the lack of evidence supporting their asserted benefits to the state. Specifically, the ultrasound requirement was struck down for imposing significant burdens without justification, while the admitting-privileges requirement was invalidated for substantially limiting statewide abortion access without legitimate benefits. The analysis then focused on the benefits of the Department's enforcement of the Licensing Law, identifying three interrelated sets of benefits: (1) the state's ability to assess the reputable and responsible character of WWHA, (2) the determination of WWHA's character as a licensure condition, and (3) the enforcement of licensure against WWHA. A critical distinction within the Licensing Law is made between providers of abortion-inducing drugs for abortion purposes, who must be licensed, and those providing the same drugs for other purposes, like treating miscarriages, who face no such restriction. The implications of this classification on abortion patients versus miscarriage patients were examined, questioning the benefits of such differential treatment. Additionally, the plaintiffs argued that the Licensing Law's five-patient rule unfairly treated early patients differently; however, the court clarified that both initial and subsequent patients are equally subject to the licensing requirement. The court deemed the plaintiffs' equal protection claims to be based on their patients' rights rather than their own, applying a rational-basis standard to the abortion providers' claims. Plaintiffs cannot leverage their patients' due process rights to elevate the standard of review for their own equal protection claims. The court applies the rational-basis standard to the abortion providers' equal protection claims, referencing the case of Planned Parenthood of Indiana and Kentucky. Plaintiffs assert that the Department's enforcement of the Licensing Law has subjected WWHA to greater scrutiny than other abortion clinics, framing this as a "class of one" claim. However, they do not formally allege class-of-one discrimination, which results in their failure to argue under an appropriate standard, leading to a lack of demonstrated likelihood of success on the merits. The benefits to the state from enforcing the Licensing Law's "reputable and responsible character" requirement are significant, contrary to plaintiffs' claims. The definition of "affiliate" has been clarified either through the Appeals Panel's determination or the statutory definition, indicating that WWHA's affiliates are indeed abortion clinics under Hagstrom Miller's control. The state-law determination does not impact the constitutional evaluation of the Department's actions, which must be assessed solely under constitutional standards. Evidence shows Hagstrom Miller's substantial involvement in WWHA's governance and operations, undermining plaintiffs' assertions of distinct organizational autonomy. The operational practices of other Whole Woman's Health clinics are relevant to evaluating WWHA's character and compliance with the Licensing Law, and the information requested by the Department is pertinent to its regulatory responsibilities. The "reputable and responsible character" requirement serves as a credentialing mechanism, ensuring that only health care providers with suitable character are licensed. Plaintiffs have not contested the state's interest in this requirement's application. However, the benefits of further applying this requirement in the current case appear minimal. Defendants highlight concerns based on testimony from Plaintiff Dr. Jeffrey Glazer, suggesting his practices warrant scrutiny; nevertheless, Plaintiffs argue Glazer is a competent provider. It is noted that Glazer has operated within Indiana's licensing rules without prior issues, raising doubts about the validity of Defendants' concerns. Additionally, Defendants claim evidence of safety failures at Whole Woman's Health clinics, referencing inspection reports from Texas that cite deficiencies. Plaintiffs counter that such deficiencies are common in healthcare inspections and do not indicate immediate threats to patient safety. Deficiencies are typically resolved through corrective action plans, and serious safety threats would prompt license suspensions or terminations. Overall, the evidence presented does not convincingly support Defendants' arguments regarding the need for further scrutiny of Glazer or the clinics. No "Whole Woman's Health" clinic has had its license or accreditation revoked, except for a mistaken revocation in 2006 that was rectified within eight days. The cited deficiencies at these clinics, such as improper storage of cleaning chemicals, do not significantly undermine the clinics' reputable status. The discussion shifts to the advantages of enforcing the Licensing Law, particularly regarding the Plaintiffs' due process claim. Licensure allows the Department to enforce essential health and safety regulations and conduct regular surveys and complaint investigations, which would be impossible without it. The Plaintiffs have not contested the validity of these regulations, which are assumed permissible. The timeline of Indiana’s abortion clinic licensure reveals that no licensure was required from 1993 to 2005 for surgical abortion providers, and from 2000 to 2013 for medical abortion providers, raising doubts about claims of meaningful regulatory oversight during these periods. The Defendants argue that licensure ensures compliance with informed-consent and reporting requirements established prior to the introduction of licensure; however, it appears that compliance has been historically achieved without the need for licensing. Furthermore, the authority of the Department to inspect clinics is not shown to be dependent on their licensure status, as Indiana law mandates annual inspections regardless of licensure. The Department's requirement to know the location of clinics is met through licensure, but this could also be achieved via registration. Without licensure, the Department may struggle to monitor clinic operations and compliance. The primary advantage of a license is the potential for revocation, which deters noncompliant abortion providers; however, this enforcement mechanism offers minimal additional benefit compared to existing methods like prosecution or physician license suspension. The Klopfer case exemplifies that noncompliance was addressed not through clinic license revocation but through suspension of a physician's license and criminal prosecution. Regarding the plaintiffs' due process claim, the defendants have demonstrated only marginal improvements in the state's interests in maternal health and fetal life due to the licensure requirement compared to pre-2013 laws. For the equal protection claim, the state's justification for treating women seeking abortion-inducing drugs differently—based on the distinction between abortion and miscarriage—fails, as the medical outcomes are nearly identical. The state's interest in fetal life does not substantiate the differential treatment, and its connection to licensure is tenuous. The defendants suggest an interest in managing their licensing and regulatory frameworks, which would benefit from the Licensing Law's application to WWHA without federal interference. However, such an interest is not admissible under legal precedents from Casey and Hellerstedt, which assert that the court must independently review constitutional rights issues. Disputes regarding WWHA's character should be resolved through state administrative proceedings and potentially state judicial review before federal intervention is considered. The court evaluates the burdens imposed on abortion rights by the Licensing Law as applied to the South Bend Clinic. The analysis focuses on women seeking abortions in South Bend and surrounding areas, particularly those with limited financial and social resources, including a significant population of college students. Evidence suggests that the unavailability of abortion services in South Bend presents substantial obstacles, exacerbated by factors such as long-distance travel, an eighteen-hour waiting period, high costs without state aid, and the need for social support in a hostile environment. These burdens can lead to increased healthcare risks and opportunity costs, such as lost wages and educational opportunities. Defendants argue that some women can access abortions in Illinois, but the court counters that this overlooks the unique challenges faced by many women who lack similar advantages. The court emphasizes that the harm to a constitutional right cannot be assessed solely based on access in another jurisdiction. Ultimately, the court must determine if the burdens of the law's requirements disproportionately affect the right to abortion compared to the benefits of the restrictions. It concludes that the state's marginal benefits from requiring a license for the South Bend Clinic are minimal, and suggests that a registration requirement could sufficiently serve the state's interests without imposing the same burdens. Thus, the licensing requirement is deemed "not necessary" to achieve the state's objectives. The "reputable and responsible character" requirement of the Licensing Law does not significantly further state interests and imposes substantial barriers to abortion access in South Bend, where there is unmet demand for such services. The plaintiffs have demonstrated a strong likelihood of success on the merits of their claim that the Licensing Law imposes an undue burden and violates equal protection rights. The risks of irreparable harm to women, who would face unwanted pregnancies and subsequent state-mandated motherhood, are considerable, while the state faces minimal harm if the Licensing Law is enjoined. The public interest favors granting injunctions that uphold constitutional rights. Ultimately, while the "reputable and responsible character" requirement is not deemed unconstitutionally vague, its application to the license application for the WWHA’s South Bend Clinic creates significant obstacles for women seeking previability abortions without offering benefits to women's health or informed decision-making. The Licensing Law's unequal treatment of patients seeking miscarriages compared to those seeking abortions creates significant barriers to abortion access without providing compensating state benefits. Consequently, the Department's enforcement of the Licensing Law is found to violate both the Due Process and Equal Protection Clauses of the Constitution. An injunction is deemed to pose minimal risk to the state, while the potential harm to women in northern Indiana is substantial if the injunction is not granted. Therefore, Plaintiffs' motion for a preliminary injunction is granted, and Defendants are prohibited from enforcing specific Indiana Code provisions against the Women’s Wellness Health Alliance (WWHA) regarding the South Bend Clinic. The document also references various legal citations and prior cases for context, while noting the importance of potential administrative clarifications.