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Falls Church Medical Center, LLC v. Oliver

United States District Court, E.D. Virginia, Richmond Division

September 30, 2019

FALLS CHURCH MEDICAL CENTER, LLC d/b/a FALLS CHURCH HEALTHCARE CENTER, et al, Plaintiffs,
v.
M. NORMAN OLIVER, VIRGINIA HEALTH COMMISSIONER, et al., Defendants.

          MEMORANDUM OPINION (POST-TRIAL JUDGMENT)

          Henry E. Hudson, Senior United States District Judge

         I. INTRODUCTION

         For more than five decades, the Supreme Court has recognized that within the right to privacy exists a woman's right to make decisions regarding the circumstances surrounding when and with whom she will bear a child-or whether she chooses to bear a child at all. See, e.g., Planned Parenthood of S.E. Pa. v. Casey, 505 U.S. 833 (1992); Roe v. Wade, 410 U.S. 113 (1973); Eisenstadt v. Baird, 405 U.S. 438 (1972); Griswold v. Connecticut, 381 U.S. 479 (1965). In the landmark decision of Roe v. Wade, the Supreme Court established that women have a "fundamental right grounded in the Fourteenth Amendment to end a pregnancy by aborting the life of the fetus." Greenville Women's Clinic v. Bryant, 222 F.3d 157, 165 (4th Cir. 2000) (citing Roe, 410 U.S. at 153-56). That right "involv[es] the most intimate and personal choices a person may make in a lifetime," choices that are central to the individual autonomy and liberty protected by the Fourteenth Amendment. Casey, 505 U.S. at 851.

         However, the Supreme Court has also recognized that "[a]bortion is a unique act," and one that is "fraught with consequences ... for the woman who must live with the implications of her decision; for the persons who perform and assist in the procedure; [and] for the spouse, family, and society which must confront the knowledge that these procedures exist...." Id. at 852. As a result, the right to choose to have an abortion is not unfettered. In addition to a woman's personal liberty interest, the state has profound interests in protecting potential life and protecting the health and safety of women. Id. at 878. The state, therefore, may take measures to further these interests so long as it does not create a substantial obstacle that unduly burdens a woman's right to choose. Id.

         At issue in this case is whether Virginia statutes and regulations unduly burden the right of Virginia women, under the Fourteenth Amendment, to choose to have an abortion. This Court is fully cognizant of the unique nature of the abortion right and its controversial history. Accordingly, the Court acknowledges that "[m]en and women of good conscience can disagree, and ... some always shall disagree, about the profound moral and spiritual implications of terminating a pregnancy, even in its earliest stage." Id. at 850. However, even though some "individuals find abortion offensive to [the] most basic principles of morality," it is the duty of this Court to neutrally evaluate and determine whether the challenged Virginia statutes and regulations violate the Fourteenth Amendment. Id. Thus, as it would with any other matter, this Court will faithfully interpret and apply the law and not, "mandate [its] own moral code." Id. Within the boundaries of the law, this Court recognizes that the ultimate tribunal is the conscience of women contemplating an abortion.

         II. BACKGROUND

         A. THE PARTIES

         Plaintiffs in this case include Falls Church Medical Center, LLC; Whole Woman's Health Alliance; Virginia League for Planned Parenthood; and Dr. Jane Doe.[1] Each is a Virginia health care provider that provides elective abortion care in addition to other gynecological and family planning services. Collectively, Plaintiffs challenge the constitutionality of several Virginia statutes and regulations that govern the provision of abortion care throughout the Commonwealth. They contend that these interrelated statutes and regulations effectively place a constitutionally prohibited undue burden on Virginia women who have decided to terminate their pregnancies through abortion. The named Defendants include almost all of Virginia's regulatory agencies that have jurisdiction over abortion services, as well as commonwealths' attorneys in jurisdictions where facilities provide these services.[2]

         B. THE CHALLENGED LAWS

         In the Amended Complaint filed by Plaintiffs in this case, they charge that

Virginia has adopted an array of unnecessary and discriminatory laws, some over four decades old, that target the provision of abortion care without any meaningful improvement to safety or health, or any other benefits-let alone benefits that outweigh burdens. Instead, these laws serve only to negatively impact Virginians' access to reproductive healthcare.

(Am. Compl. ¶ 65, ECF No. 41.) Plaintiffs maintain that the wide array of restrictive regulations and statutory provisions governing abortion care in Virginia are a constitutionally offensive obstacle to a woman's right to seek an abortion.

         This Court conducted an eight-day bench trial, at the beginning of which only six counts remained of Plaintiffs' Amended Complaint.[3] Each of these six counts challenges an individual component of Virginia's legal framework that collectively governs the administration of pre-viability first and second trimester abortions throughout the Commonwealth. Plaintiffs' counts are as follows:

         Count I focuses on Va. Code Ann. § 32.1-127(B)(1) (the "Licensing Statute"), which classifies any facility "in which five or more first trimester abortions per month are performed" as a category of "hospital." Va. Code Ann. § 32.1-127(B)(1). Pursuant to this classification, the Licensing Statute requires the Virginia Board of Health ("Board of Health") to establish and promulgate minimum standards for the licensing of facilities. These regulations encapsulate requirements for "hospitals" across the following categories:

(i) the construction and maintenance of hospitals ... to ensure the environmental protection and the life safety of its patients, employees, and the public; (ii) the operation, staffing and equipping of hospitals . . .; (iii) qualifications and training of staff of hospitals ... except those professionals licensed or certified by the Department of Health Professions; (iv) conditions under which a hospital . . . may provide medical and nursing services to patients in their places of residence; and (v) policies related to infection prevention, disaster preparedness, and facility security of hospitals ....

Id.

         Count II challenges Virginia's "Regulations for Licensure of Abortion Facilities," 12 Va. Admin. Code § 5-412, et seq. (hereinafter "VAC") (the "Licensing Regulations"), which are the direct result of the Licensing Statute. Plaintiffs also challenge the associated laws that criminalize the violation of state regulations.[4] The Licensing Regulations contain 37 individual regulations; Plaintiffs challenge this chapter in its entirety and contend that these 37 regulations collectively impose an undue burden on Virginia women's access to abortion care.

         Count III focuses on what is commonly referred to as Virginia's "Hospital Requirement," Va. Code Ann. § 18.2-73, and the associated regulations that require all second trimester abortions be performed in general hospitals or outpatient surgical hospitals. By providing an exception to Virginia's statute that criminalizes abortions, Va. Code Ann. § 18.2-71, the Hospital Requirement makes it lawful for a licensed physician to provide a second trimester abortion so long as the procedure is conducted in a hospital licensed by the Virginia Department of Health ("VDH"). See Va. Code Ann. § 18.2-73. Notably, however, by function of the regulations, second trimester abortion procedures cannot be conducted in abortion facilities despite the fact that those facilities are classified as a category of "hospital." See Va. Code Ann § 32.1-127(B)(1); see also 12 VAC § 5-412-230(A) ("Abortions performed in abortion facilities shall be performed only on patients who are within the first trimester of pregnancy meaning 13 weeks and 6 days after last menstrual period or based on an appropriate clinical estimate by a licensed health care provider."); 12 VAC § 5-412-40 (stating that general hospitals and outpatient surgical hospitals are not subject to the Licensing Regulations). Plaintiffs contend that limiting the lawful provision of second trimester abortions to general hospitals and outpatient surgical hospitals places an undue burden on Virginia women's access to this type of abortion care.

         Count IV challenges Va. Code Ann. § 18.2-72 (the "Physician-Only law") that permits only physicians licensed by Virginia's Board of Medicine to perform abortion procedures in the Commonwealth lawfully. Plaintiffs contend that this law is unduly burdensome because it limits access to abortion care by precluding other licensed medical professions, namely Nurse Practitioners, Certified Nurse Midwives, and Physicians Assistants, from providing abortions during the first trimester and in the early weeks of the second trimester.

         Count V challenges Va. Code Ann. § 18.2-76. Plaintiffs refer to this statute as Virginia's "Two-Trip Mandatory Delay law" because it requires that a woman receive an ultrasound at least 24 hours before an abortion if she lives less than 100 miles from the location where the procedure is performed. Implicitly, this waiting period requires a woman to make two separate trips before she can obtain an abortion-the first to satisfy the ultrasound requirement, and the second for the abortion.[5] While there are exceptions to the mandatory waiting period and the mandatory ultrasound, Plaintiffs contend that, in the vast majority of cases, the statute creates an undue burden by compelling women to undertake unnecessary travel that raises the cost of obtaining the abortion and delaying the actual procedure. Plaintiffs argue that these additional burdens create a substantial obstacle that the women most impacted by the law cannot overcome.

         Finally, in Count VIII of Plaintiffs' Amended Complaint, Plaintiffs challenge 12 VAC § 5-412-90, the regulatory provision that authorizes agents of the VDH to enter abortion facilities for the purpose of conducting inspections. The regulation states that "[s]uch entries and inspections shall be made with the permission of the owner or person in charge, unless an inspection warrant is obtained after denial of entry from an appropriate circuit court." 12 VAC § 5-412-90. The regulation further provides that refusal to allow such entry "shall be sufficient cause for immediate revocation or suspension of the license." Id. Plaintiffs argue that the threat of immediate suspension of an abortion facility's license is coercive in its effect and violates Plaintiffs' constitutional rights under the Fourth Amendment.

         III. STANDARD OF REVIEW

         Roe and its progeny have clearly established that a woman's constitutional right to abort a pre-viability fetus is beyond debate at the district court level. See Whole Woman 's Health v. Hellerstedt, 136 S.Ct. 2292, 2309 (2016); Casey, 505 U.S. at 879. Accordingly, the standard that this Court must apply in resolving the current matter is the undue burden standard, which the Supreme Court established in Casey and then restated in Hellerstedt. In Hellerstedt, the majority opinion stated as follows:

[T]here "exists" an "undue burden" on a woman's right to decide to have an abortion, and consequently a provision of law is constitutionally invalid, if the "purpose or effect" of the provision "is to place a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability." The plurality [of the Court] added that "[u]nnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on that right."

136 S.Ct. at 2300 (quoting Casey, 505 U.S. at 878). The Supreme Court instructed that district courts must weigh the law's benefits against the burdens it imposes to determine whether the law constitutes an undue burden. See Id. at 2309-10. In reviewing the benefits and burdens of a challenged law, the scope of a district court's review begins with "the [subset] of women upon whom the statute operates," because "[t]he 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.

         This Court also recognizes that, as the Supreme Court stressed in both Hellerstedt and Casey, the benefits and burdens analysis is both fact and context specific. See Hellerstedt, 136 S.Ct. at 2306; Casey 505 U.S. at 885. Simply put, "[a]n abortion statute valid as to one set of facts and external circumstances can be invalid as to another." Planned Parenthood of In. & Ky, Inc. v. Comm'r of In. Dep't of Health, 896 F.3d 809, 817 (7th Cir. 2018) (citing Hellerstedt, 136 S.Ct. at 2306), petition for cert, docketed, No. 18-10109 ( S.Ct. Feb. 4, 2019).

         IV. DISCUSSION

         To fully evaluate the benefits and burdens associated with the challenged laws, and to determine whether they present a substantial obstacle to Virginia women seeking an abortion, the Court must first review how abortions are provided at various stages of pregnancy and the relative safety of these procedures. The Court received extensive evidence on this subject from the parties' expert witnesses over the course of the eight-day trial.

         A. FIRST TRIMESTER ABORTION PROCEDURES

         Plaintiffs' medical experts, Dr. Mark Nichols ("Dr. Nichols") and Dr. Shanthi Ramesh ("Dr. Ramesh"), both of whom provide abortion care as part of their regular medical practice, testified regarding the relative safety of various forms of abortions. Dr. Nichols, a professor at Oregon Health & Science University, is board-certified in obstetrics and gynecology ("OB/GYN") and also serves on the Planned Parenthood Federation of America's National Board of Directors. Dr. Ramesh is board-certified in OB/GYN and serves as the Medical Director of the Virginia League of Planned Parenthood ("VLPP")• In this capacity, Dr. Ramesh oversees VLPP's three abortion facilities located in Richmond, Hampton, and Virginia Beach.

         Witnesses for the Plaintiffs and Defendants both testified that abortion is a common procedure, and one woman in four will choose to have an abortion during her life. (Trial Tr. 11:22-24; 1272:9-10 (hereinafter "Tr.").) According to Dr. Nichols's testimony, of these abortions, 90 percent occur during the first trimester of pregnancy, which begins at conception and ends at approximately 13-14 weeks from the woman's last menstrual period ("LMP").[6] (Id. at 12:6-18; 89:5-9.) Defense expert Dr. Elizabeth Lunsford (Dr. Lunsford") concurred. (Id. at 1304:10-13.) Dr. Lunsford, who is board-certified in OB/GYN medicine, practices at the Riverside Hospital in Gloucester, Virginia, sees approximately 60 to 80 patients a week, and performs approximately 100 surgical procedures a year. (Id. at 1206:3-10.)

         Two different methods of abortion are available during the first trimester. The first method is provided by administering a combination of FDA-approved medications, Mifepristone and Misoprostol. (Id. at 13:5-14:6.) Both medications are prescribed simultaneously, and then ingested approximately 24- to 48-hours apart. (Id.) The abortion is completed after the woman takes the second medication. (Id. at 14:2-10.) The pregnancy ends outside of a clinical setting in a manner similar to a miscarriage, usually while the woman is at home. (Id.) This regimen of medication can be prescribed up to ten weeks into the pregnancy. (Id. at 13:24-14:1.)

         Dr. Ramesh testified that "[m]edication abortion is exceedingly safe. Complications are very rare," and these complications occur in less than one percent of patients. (Id. at 234:19-20.) Similarly, Dr. Nichols testified that "[c]omplications ... occur[] in no more than a fraction of a percent of patients." (Id. at 33:15-34:1.)

         The second method for providing a first trimester abortion is aspiration. During an aspiration procedure, a plastic tube is inserted into the uterine cavity and suction is applied to remove the pregnancy, (Id. at 15:5-12.) Similar to medication abortions, complications during aspiration procedures are very rare. (Id. at 16:2.) The most serious complication-uterine perforation[7]-occurs in less than one percent of women, approximately one out of every thousand. (Id. at 16:8-10; 34:9-14; 149:6-10.) Dr. Nichols testified that 99 percent of uterine perforations heal without any additional medical intervention; however, the remaining 1 percent of complications require hospitalization and possible surgical intervention. (Id. at 1629:2-12.)

         Based upon her practice experience at VLPP, Dr. Ramesh testified generally that the practice of abortion care is exceedingly safe and that the rate of complications Virginia women experience is consistent with the national figures. (Id. at 223:17-224:1.)

         Dr. Lunsford testified that she periodically encounters patients who suffer side effects from medication abortion such as vomiting, diarrhea, and bleeding. (Id. at 1225:14-17.) She added that while complications such as infections are rare, they do occasionally occur. (Id. at 1231:18-24; 1232:12-15.) With respect to aspiration abortions, "at more advanced gestational ages there's more risk." (Id. at 1255:15-19.) She further testified that "as the pregnancy advances, the complications can go up." (Id. at 1277:16-17.)

         Dr. Mary Catherine Slusher ("Dr. Slusher"), a former member of the Board of Health, generally concurred. Dr. Slusher, who is also board-certified in OB/GYN, was of the opinion that because of potential complications, it is beneficial to have physicians perform abortion procedures. (Id. at 1552:9-17.)

         B. SECOND TRIMESTER ABORTION PROCEDURES

         As a pregnancy advances with each additional week of gestational age, the risk of a potential complication during an abortion procedure increases statistically. (Id. at 35:1-25.) However, even with this increased risk, pre-viability abortions conducted during the second trimester, while not without risk, are fairly safe. (Id.)

         Aspiration abortions, which are used in the later weeks of the first trimester, are also utilized during the second trimester up to 16 weeks. (Id. at 15:19-20.) After 16 weeks LMP, abortions are provided through a procedure known as Dilation and Evacuation, commonly referred to as "D&E." (Id. at 16:23-17:15.) During a D&E procedure, a combination of suction and sterile instruments are used to remove the pregnancy from the uterine cavity. (Id. at 17:6-7.) Mild or moderate sedation may be used to manage a patient's pain and anxiety. (Id. at 17:1-18:2.) Dr. Nichols testified that the risk of uterine perforation during a D&E procedure is also less than 1 percent, approximately 3 per 1, 000. (Id. at 149:6-9.) Based upon her practice experience at VLPP, Dr. Ramesh confirmed that the rate of complications for second trimester abortions in Virginia women is on par with national figures. (Id. at 280:23-281:2.)

         While the medical experts offered differing assessments on the potential for complications associated with second trimester procedures, they agreed that the risk increases with the gestational age of the fetus.

         C. BENEFITS AND BURDENS ANALYSIS

         1. THE VIRGINIA LICENSING STATUTE, LICENSING REGULATIONS, AND THE VIRGINIA HOSPITAL REQUIREMENT

         The constellation of regulations and requirements comprising the claims in Counts I, II, and III are challenged individually and collectively. Count I embraces Va. Code Ann. § 32.1-127(B)(1), which vests regulatory authority in the Board of Health over any facility performing five or more first trimester abortions per month.[8] It classifies such facilities as a hospital, triggering the allegedly burdensome regulatory requirements at issue in the counts that follow. In Plaintiffs' view, the impact of the Hospital Requirement challenged in Count III is compounded by the regulations at issue in Count II. 12 VAC § 5-412, et seq. While the statutory scheme permits licensed physicians to perform first trimester procedures in a licensed setting, the statutes declare the performance of a second trimester abortion anywhere except a licensed hospital to be a class IV felony. See Va. Code Ann. §§ 18.2-71, 73. Plaintiffs maintain that these "Criminalization Laws, violate [their] patients' rights to liberty as guaranteed by [the Due Process Clause of] the Fourteenth Amendment to the U.S. Constitution because they impose an undue burden on the fundamental right to choose an abortion prior to viability." (Am. Compl. ¶ 255.)

         The epicenter of Plaintiffs' challenge appears to be the so-called "FGI Guidelines," which are an integral part of the hospital classification under the statutory scheme.[9] These guidelines were promulgated by the Facilities Guidelines Institute which is an "independent, not-for-profit organization dedicated to developing guidance for the planning, design, and construction of hospitals, outpatient facilities, and residential health, care, and support facilities." Facilities Guidelines Institute, https://www.fgiguidelines.org/about-FGI/. Compliance with the FGI Guidelines on Design and Construction for Health Care Facilities is mandated by 12 VAC § 5-412-370, Part VII. Based on the hesitant recommendation of the Board of Health, the FGI Guidelines were enacted by the Virginia General Assembly as part of the Commonwealth's licensing and regulations for abortion facilities.[10]

         Dr. Karen Remley ("Dr. Remley"), a physician specializing in pediatric emergency care who served as the Virginia Commissioner of Health from 2008 to 2012, was part of that adoption process. Based on the advice of a panel of OB/GYN experts, [11] the Board of Health initially rejected the adoption of the FGI Guidelines. In 2013, based on the advice of the Virginia Attorney General's Office, the Board of Health chose to incorporate the FGI Guidelines into the statutory scheme regulating abortion clinics. In Dr. Remley's opinion, however, the resulting regulations were not only unduly burdensome on abortion providers (Tr. 607:7-13) but also increased the cost of abortion procedures. (Id. at 615:7-616:5.) She testified that she was unaware of any reason to single out abortion clinics for additional regulatory measures. (Id. at 613:2-614:9.)

         Dr. Norman Oliver ("Dr. Oliver"), the current Virginia Health Commissioner and lead Defendant in this case, testified as a witness for Plaintiffs. Dr. Oliver recounted the history of the adoption of the FGI Guidelines. Before expressing his viewpoint on the guidelines, Dr. Oliver, testifying as a practicing physician, indicated that in his opinion, there was no medical necessity for treating abortion clinics as hospitals and that the licensing regulations were unnecessary. (Id. at 869:23-870:2; 874:23-875:16; 867:17- 23.) In his view, facilities in which five or more abortions are provided per month are subject to more stringent regulations than other facilities offering comparable medical services. (Id. at 831:21-884:15.) He added, however, that he was unaware of any abortion clinic closing as a result of enforcement of the regulations. (Id. at 880:7-10.) Furthermore, all current abortion facilities have received waivers which require periodic review. (Id. at 908:8-9.)

         According to Dr. Oliver, in 2017, in the wake of the Supreme Court decision in Hellerstedt, 136 S.Ct. 2292, the Board of Health amended 12 VAC § 5-412 by removing the FGI Guidelines requirements. The Court in Hellerstedt found the Texas statutory surgical-center requirement at issue placed an undue burden on women seeking abortion care. 136 S.Ct. at 2318.

         Dr. Oliver testified that in the interim, the Henrico County Circuit Court ruled that the Board of Health violated the Virginia Administrative Procedures Act in amending the regulations. (Id. at 869:17-22.) According to Dr. Oliver, when the Henrico Circuit Court struck down the amended regulations, it had the effect of restoring the FGI Guidelines. (Id.) Because Dr. Oliver had concerns about the constitutionality of the physical requirements necessitated by the FGI Guidelines, he solicited an opinion from the Attorney General's Office[12] as to their enforceability. After review, the Attorney General's Office advised Dr. Oliver that the guidelines were unconstitutional and should not be enforced. (Id. at 909:4-18.) Consequently, the FGI Guidelines are not presently being enforced. As Plaintiffs point out, however, this policy of non-enforcement does not preclude future administrations from resuming enforcement.[13] Dr. Oliver added that the Governor proposed amendments during the last session of the Virginia General Assembly to amend the stringent regulations. (Id. at 866:11-867:2.)

         Dr. Oliver indicated that both first and second trimester abortions could safely be performed on an outpatient basis in a clinical setting since they are not surgical procedures. (Id. at 867:17-23.) Dr. Oliver further opined that because aspiration and medication abortions are not surgery-in that they do not involve an incision into the body-it is not medically necessary for abortion facilities to meet the requirements of Section 3.7 of the FGI Guidelines governing facilities that provide surgery. (Id. at 877:2-15.)

         On the other hand, while Dr. Oliver testified that parts of 12 VAC § 5-412 are unnecessary, others are critical. For example, as to equipment enabling the facility to respond to medical emergencies such as cardiac arrest, Dr. Oliver elaborated, "I believe doctors' offices, hospitals, clinics should have the ability to deal with someone who has an emergent event, even though emergent events are rare." (Id. at 873:11-14.)

         The Defendants called Dr. Slusher, a member of the Board of Health from 2012 to 2015, to provide further context on the adoption of the FGI Guidelines and related regulations. In 2012, Dr. Slusher voted to exempt existing abortion facilities from compliance with the FGI regulations. The Board of Health, however, was advised by the Attorney General's Office that exempting those facilities from FGI regulations "was not permissible." (Id. at 1558:16-19.) Consequently, she voted for further review of the abortion facilities regulations that included the FGI regulations.

         In 2013, Dr. Slusher reversed her position and supported a version that included the regulations. In her view, the 2013 version of the regulations improved the safety and quality of abortion services in Virginia. (Id. at 1534:16-22.) She described the Board of Health's adoption of the regulations as a reaction to unsafe practices. (Id. at 1535:5-12.) As examples, she cited inaccurate or incomplete recordkeeping, cleanliness, and access, such as staircases too narrow to permit removal of patients on stretchers. (Id. at 1536:10- 24.) In her opinion, the regulations were needed, and there was no intent on the part of the Board of Health to shut down clinics or affect access. (Id. at 1538:22-1539:5.)

         To explain the legislative history of the eventual adoption of the regulatory statutes at issue in this case, the defense called Joseph Hilbert ("Mr. Hilbert"), Deputy Commissioner of Governmental and Regulatory Affairs of the VDH. Mr. Hilbert is the agency's regulatory coordinator and reports directly to the Virginia Health Commissioner. In that capacity, he also interacts with the Board of Health and drafts the agenda for their meetings. Mr. Hilbert was asked about legislation adopted by the General Assembly in 2011, specifically Senate Bill 924, which promulgated regulatory requirements for facilities that performed five or more first trimester abortions per month, classifying them as a category of hospital.

         The Virginia Health Commissioner and the chief deputy participated in drafting the abortion facility regulations. In crafting their content, the VDH "reviewed documentation from several organizations, including the National Abortion Federation, Planned Parenthood, the World Health Organization, the Centers for Disease Control and Prevention, the Joint Commission on Accreditation of Healthcare Organizations" along with regulations from other states. (Id. at 1484:13-22.) The Virginia Health Commissioner also empaneled OB/GYN physicians and the chairs of the OB/GYN departments for the State's teaching hospitals to provide advice on the proposed regulations. In addition, VDH consulted and analyzed abortion clinic regulations for 22 other states who had them in place at the time. The panel reviewed "data and information concerning things such as testing and laboratory services, infection control, quality improvement, staffing and credentialing, administrative disaster preparedness and security, facility design, family planning counseling and data reporting." (Id. at 1488:5-18.) VDH also inquired whether the other states had specific regulations governing abortion facilities, whether they regulate them as outpatient hospitals, and how the number of abortion facilities in the state had changed since the time the regulations were adopted.

         According to Mr. Hilbert, once the proposed regulations were completed, they were presented to the Board of Health, which approved them. One member of the Board of Health made a motion to exempt or grandfather all of the then-existing licensed facilities from the facility design and construction requirements of the regulations. This amendment was adopted. However, when the proposed amendments were presented to the Attorney General's Office for review, they declined certification because the proposed amendments did not comply with the provisions of Va. Code Ann. § 32.1-127.001. This section, according to the Attorney General's Office, required the facility design and construction guidelines of the Code of Virginia to comport with the guidelines published by the Facilities Guidelines Institute. Consequently, the Board of Health adopted revised proposed amendments without the previously agreed upon grandfathering provision. (Id. at 1498:24-1500:15.)

         On cross-examination, Plaintiffs' counsel amplified the history underlying promulgation of these abortion regulations, which took effect in 2013. Mr. Hilbert testified that prior to enacting emergency regulations in 2011, which evolved into the regulations adopted in 2013, the VDH did not license abortion clinics. (Id. at 1504:16- 18; 1505:24-1506:1.) He also indicated that prior to the adoption of those regulations, he was unaware of any evidence indicating that women's health and safety was at risk in abortion facilities in Virginia. (Id. at 1506:2-9.) Mr. Hilbert also stated on cross-examination that at the time the proposed regulations containing an exemption for preexisting abortion clinics were under review, the Governor, Attorney General, and Deputy Secretary of Health and Human Resources harbored pro-life beliefs and supported regulations containing the FGI guidelines. (Id. at 1506:10-1509:6.)

         Also developed on cross-examination was the fact that, in 2008, the General Assembly had proposed legislation to regulate abortion facilities that provided 25 or more procedures per year. Mr. Hilbert acknowledged that Virginia had sufficient and appropriate safeguards in place at the time to assure the health and safety of women faced with the decision to terminate a pregnancy. In addition, he agreed that another reason underlying the Board of Health's decision to exempt existing clinics was its belief that the legislation would place additional financial burdens on women's health care providers. Furthermore, between the Board of Health's opposition to regulation in 2008, and the Board of Health's support of additional regulation in 2011, the VDH had not been presented with any evidence that women in Virginia were receiving unsafe abortion care. In fact, between 1977 and 1989, there were only two deaths occurring in Virginia as a result of abortion procedures. (Id. at 1520:8-12.)

         Dr. Ramesh testified that in her opinion, first and second trimester abortion procedures can be performed in a sterile procedure room without the equipment necessary to qualify as a surgical hospital or comply with the FGI Guidelines. (Id. at 278:9-25.)

         Dr. Nichols saw no demonstrated need or medical benefit to requiring that abortion procedures, particularly in the early stages of pregnancy, be performed in a facility qualifying as a hospital under Virginia law. (Id. at 56:9-20; 60:11-17.) In his view, this requirement, along with the attendant FGI specifications, not only affects convenience, but may result in more costs than necessary. (Id. at 62:2-12; 64:4-18.)

         A number of operators or administrators of abortion clinics testified that the cost of compliance with the FGI Guidelines would be significant. Paulette McElwain ("Ms. McElwain"), CEO for VLPP, estimated that the required renovations would be costly and place her organization in substantial debt. For example, she testified that the cost of renovating a recently purchased facility in Richmond to comply with the FGI requirements was in the vicinity of $3.6 million. (Id. at 366:19-24.) Furthermore, VLPP has had to hire a consultant to ensure compliance with the regulations, increasing the costs of procedures by about $100.00. Ms. McElwain believed that if licensing regulations were less onerous, her organization would consider opening additional clinics in the vicinity of Washington, DC and in western portions of Virginia.

         Amy Hagstrom-Miller ("Ms. Hagstrom-Miller"), CEO of Whole Woman's Health Alliance, who operates the only reproductive health care facility in the Blue Ridge mountains, described compliance with the FGI Guidelines as cost-prohibitive. (Id. at 427:8-19; 431:12-I4.) In her opinion, the regulations do not contribute to the safety of health outcomes. (Id. at 425:23-25.)

         Rosemary Codding ("Ms. Codding"), policy director for Falls Church Healthcare Center, testified that following the adoption of the licensing statute, her facility felt the need to engage an architect and legal counsel to ensure compliance. (Id. at 509:15- 510:23.) Based on the architect's report, Ms. Codding testified that the cost of compliance would be close to a million dollars and would result in additional costs for women seeking abortion care. (Id. at 516:2-15.) "For instance, our entrance doorway was three-fourths of an inch too narrow in relationship to a hospital doorway. It would have meant that we would have had to take out the door frame and rebuild.... [T]hat alone would have been in the excess of a $50, 000 remodel." (Id. at 516:18-24.) In her opinion, there was no public health reported need for the licensing and regulatory statutes in Virginia. (Id. at 508:14-18.) When Ms. Codding opened her facility in Falls Church in 2002, there were no facility specifications governing physicians' offices providing abortion care. (Id. at 489:12-15.)

         The overwhelming preponderance of the evidence has demonstrated that as a direct consequence of the FGI regulations, particularly when coupled with the costs associated with acquiring the necessary Certificate of Public Need (see 12 VAC § 5-220-20), abortion providers face a significant monetary burden. These costs in turn are passed on to women seeking abortion services and particularly affect those of lesser income.

         The burdensome effect of the FGI Guidelines is an integral part of Plaintiffs' claims in Counts I through III. Any women's health clinic performing five or more first trimester abortions per month must comply with these onerous regulatory requirements. This Court agrees with the Virginia Health Commissioner and the Virginia Attorney General that the FGI Guidelines pose a significant burden on the fundamental right of women to choose an abortion during the ...


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