Opinion ID: 2967271
Heading Depth: 3
Heading Rank: 6

Heading: Supp. 2d at 718.

Text: Second, the district court found that physicians' offices and clinics that provide less than five first trimester abortions per month perform identical procedures to those which provide five or more first trimester abortions per month, and the risk to the patient undergoing the abortion procedure is identical. See id. Third, the district court found that first trimester suction curettage abortions are comparable in terms of risks, duration, and invasiveness to a variety of obstetrical and gynecological surgical procedures which are frequently performed in physicians' offices in South Carolina. These would include suction curettage procedures performed on women who have experienced an incomplete spontaneous abortion, dilation and curettage procedures, endometrial biopsies, hysteroscopies, and insertion of intrauterine devices for birth control. See id. Fourth, the district court found that first trimester suction curettage abortions are also comparable in terms of risks, duration, and invasiveness to a variety of non-obstetrical/gynecological surgical proce51 dures that are frequently performed in physicians' offices in South Carolina. These would include the removal of subcutaneous lipomas and cysts, minor breast biopsies, and the removal of implanted ports and catheters which have been inserted into large veins in the neck and collarbone region for use in administering chemotherapy and dialysis. See id. Fifth, the district court found that South Carolina is not currently experiencing a public health problem related to the provision of first trimester abortions by licensed physicians, nor was the state experiencing such a problem when Regulation 61-12 was promulgated. The district court found no evidence that the plaintiffs or any other abortion providers in South Carolina are providing inadequate care to women seeking abortions or that the rate of complications from abortions performed in South Carolina is greater than the national average. On the contrary, the district court found that South Carolina has experienced a similar, if not lower, average complication rate. See id. at 718-19. Sixth, the district court found that, although the principal draftsmen of Regulation 61-12 have some expertise in hospital and health care administration, they have no training or education in the provision of hands-on medical care and little knowledge of the medical needs of women seeking first trimester abortions in South Carolina. See id. at 719. The district court found that they engaged in virtually no research, investigation, or other efforts to determine what types of requirements would be necessary or advisable for the abortion procedure, or what types of requirements would further or hinder the state's interest in maternal health. Nor did DHEC officials possess or seek information concerning the present safety of first trimester abortions or the relative risks associated with the procedure. See id. Seventh, the district court found that, despite their admitted lack of medical knowledge in general and of abortion procedures in particular, the drafters of Regulation 61-12 sought only minimal input and assistance from knowledgeable medical experts during the drafting process, choosing to rely solely upon the limited review and advice of Dr. Goodrich and Lawyer as to discrete portions of the regulation. See id. Furthermore, DHEC either rejected or ignored an offer by ACOG to assist in the drafting process. Although DHEC was under 52 no legal obligation to consult with ACOG or to accept their assistance during the drafting process, the district court found that ACOG is unanimously considered to be a well-respected medical organization dedicated to improving the standard of health care in the field of obstetrics and gynecology. See id. According to the district court, DHEC's rejection of ACOG's assistance further demonstrated DHEC's lack of interest in ensuring that Regulation 61-12 actually met the proffered goal of promoting maternal health and is consistent with the testimony of the DHEC witnesses that such a goal was not their primary motivation during the drafting process. See id. Eighth, the district court found that, although it is uncontroverted that first trimester abortions are significantly less risky to the health of women than second trimester abortions, an existing South Carolina regulation governing second trimester abortions was utilized as a starting point for Regulation 61-12. With the exception of Section 309 of Regulation 61-12 which specifically pertains to second trimester abortions,8 the DHEC drafters drew no distinction between first and second trimester abortions in the text of the regulation. In addition, the DHEC drafters admitted that virtually no such distinctions were considered during the drafting process. See id. Ninth, the district court found that, instead of attempting to tailor Regulation 61-12 to the particularized medical needs of women seeking first trimester abortion services in South Carolina, DHEC's goal during the drafting process was to standardize its health care and facility regulations and to codify existing departmental practices. See id. at 719-20. According to the district court, to the extent this was done, it was done without any meaningful inquiry or assessment as to whether the requirements would further the state's interest in maternal health and without assessing whether first trimester abortions were comparable to the procedures performed in the other facilities regulated by DHEC. See id. at 720. The district court further found that clinics that provide first trimester abortions provide services that are significantly less risky, invasive, and lengthy than the _________________________________________________________________ 8 Section 309 mandates additional qualifications which the performing physician must possess, additional equipment which must be on hand, and additional medical tests which must be administered for second trimester abortions. See S.C. Code Ann. Regs. 61-12, §§ 309(A)-(D). 53 services offered in ambulatory surgical centers, yet many of the requirements of Regulation 61-12 are as stringent, or in some respects more stringent, than those imposed upon ambulatory surgical centers.9 See id. Tenth, the district court found that Planned Parenthood, NAF, and ACOG standards and guidelines relied upon in part by DHEC are recommendations by the respective organizations and are not fairly characterized as mandated standards of care which can or should be imposed upon licensed physicians as regulatory requirements. Rather, they are guidelines which should be followed with due regard for the medical judgment of the treating physicians and the special needs of the patients they serve. Even if some of the existing guidelines could, in isolation, be appropriate matters for regulation, the district court found that Regulation 61-12 imposes requirements which greatly exceed the guidelines. See id. Eleventh, the district court found that, in imposing the detailed requirements of Regulation 61-12, the DHEC drafters also failed to take any meaningful steps to evaluate the costs of compliance or its impact upon the availability of abortion services in South Carolina. See id. Based upon the evidence presented, the district court found that Regulation 61-12 will significantly increase the cost of abortion services in South Carolina. See id. The district court found that this _________________________________________________________________ 9 In fact, Regulation 61-12 recognizes that the risks and potential complications of surgical procedures typically performed in ambulatory surgical centers are significantly higher than those associated with first trimester abortions. Under Regulation 61-12, licensed abortion clinics are restricted to performing abortions through eighteen weeks of pregnancy measured from the pregnant woman's lmp. See S.C. Code Ann. Regs. 61-12, § 302(A). Abortion clinics performing abortions beyond fourteen weeks of pregnancy measured from the pregnant woman's lmp must meet the additional patient requirements in Section 309 of Regulation 6112, which requires additional physician qualifications, medical equipment, and mandatory laboratory tests. See id. § 302(B). Abortions beyond eighteen weeks of pregnancy measured from the pregnant woman's lmp must be performed in a hospital, although a licensed ambulatory surgical center that is also licensed as an abortion clinic may perform abortions on patients through twenty-six weeks of pregnancy measured from the pregnant woman's lmp. See id. § 302(A). 54 increase in the cost of abortion services will delay a significant number of women from obtaining the procedure and, in some cases, result in their inability to obtain the procedure. See id. The district court further found that, as a pregnancy advances, the medical risks associated with abortion increase, and a full term pregnancy and childbirth is much more risky to the physical health of a woman than a first trimester abortion. See id. Twelfth, the district court found that Regulation 61-12 contained a myriad of detailed and costly provisions that were medically unnecessary and, thus, were neither designed to further the health of women seeking first trimester abortions nor likely to accomplish this goal. For example, with respect to Part I of Regulation 61-12, the district court observed that its definition of an abortion included medical abortions currently used to terminate ectopic pregnancies. See id. at 721. However, all of the evidence in the record, including the testimony of Dr. Goodrich, suggested that Regulation 61-12's stringent requirements were medically unnecessary for a physician or abortion clinic that performed only medical abortions. With respect to Part II, the district court found that this portion of Regulation 61-12 is permeated with unnecessary requirements governing physician qualifications, staffing, and staff training. See id. The district court observed that Regulation 61-12 requires physicians and clinics to hire a registered nurse to supervise all nursing care in the abortion clinic regardless of the fact that a licensed physician is present in the clinic to supervise all medical care, including nursing care. See id. The district court found that it is within accepted medical practice, both within the abortion context and in physicians' offices performing comparable surgical procedures, for a physician to hire licensed practical nurses (who command a lower salary than registered nurses) so long as they act under the supervision of the attending physician. See id. The district court found that the defendants offered no persuasive reason why a physician could not supervise the nursing care of patients during the recovery process simply because the physician may be in another room for a brief period of time. See id. In making this finding, the district court recognized that even DHEC's own medical consultant, Dr. Goodrich, opined that a registered nurse need not be on the premises to supervise care--only that the nurse have overall supervisory duties. See id. 55 Also with respect to Part II, the district court found that Part II's requirement that all abortion clinic health care personnel receive tuberculin skin testing is medically unnecessary in view of the fact that DHEC has not required such testing of all health care personnel and did not offer any justification for arbitrarily requiring this testing of all abortion care workers, but not all other health care workers. See id. at 722. The district court also found that Regulation 61-12's requirement that all allied health care personnel in abortion clinics receive CPR training, as opposed to having one qualified person at the clinic at all times, was medically unnecessary in view of the fact that this requirement is imposed solely upon abortion providers who perform, according to all of the witnesses, one of the safest surgical procedures that is performed in this country, and DHEC did not offer any justification for arbitrarily imposing this requirement. See id. With respect to Part III, the district court found that the level of policies and procedures required by this part, as well as the extensive in-service training requirements and other policies required in Part II, are costly endeavors unsubstantiated by a medical need. See id. The district court observed that such requirements may be appropriate for large medical care facilities with large staffs that do not interact on a daily basis. See id. However, according to the district court, Regulation 61-12 arbitrarily imposes it upon every clinic and every physician's office which performs five or more first trimester abortions per month--regardless of the number of staff or hours of operation. See id. The district court also found that it was medically unnecessary to have every woman undergo (and pay for) testing for certain sexually transmitted diseases (but not others), without regard to whether such tests are medically indicated and indeed even when the physician determines that they are not, simply because the woman has chosen to obtain a first trimester abortion from a physician who performs them on a regular basis.10 See id. The district court further found that _________________________________________________________________ 10 Of note, the district court found that the defendants presented insufficient evidence to support a finding that sexually transmitted diseases are more prevalent in woman seeking abortions or that abortion clinics present a public health problem in this regard. See Greenville Women's Clinic, 66 F. Supp. 2d at 733 n.16. 56 Section 307's requirement that abortion providers have consulting arrangements with various specialists before they can obtain a license to operate is medically unnecessary and unduly burdensome because no evidence was presented relating to why licensed physicians are not capable of exercising appropriate discretion in recognizing and acting upon the medical needs of their patients in this regard. See id. at 72223. Also with respect to Part III, the district court found that Regulation 61-12 inexplicably imposes requirements concerning access to emergency drugs which are not imposed upon any other physicians. See id. at 723. The district court also found that the equipment and supplies required by Regulation 61-12 will also increase the costs of providing abortions in South Carolina, and require equipment unnecessary for the safe performance of the first trimester abortion procedure. See id. With respect to Part IV, the district court found that this part of Regulation 61-12 was particularly troubling. For example, the district court found that the requirement that a woman seeking an abortion provide the name of her spouse in addition to an emergency contact is a medically unnecessary requirement which imposes a substantial obstacle in the path of a woman who, for personal reasons, may not wish to disclose this information. See id. The district court also found that, although the abortion clinic was required to keep patient records confidential, nothing prohibited DHEC from publicizing these records once it obtained them pursuant to an inspection. See id. at 702. With respect to Part VIII, the district court observed that this part of Regulation 61-12 imposed extensive and detailed design and construction requirements for abortion facilities, which far exceed building code requirements applicable to other physicians' offices, including those that perform identical and comparable procedures. See id. at 723. The district court found that these extensive requirements, while perhaps appropriate for a hospital or large ambulatory surgical center, are not justified by expected medical benefits to the women undergoing the relatively safe, first trimester suction curettage abortion in a small physician's office or clinic. See id. Also with respect to Part VIII, the district court found that additional requirements, which were advanced as unique to the medical 57 field, had no justification in medical necessity. For example, the district court found no evidence supporting a need for an abortion clinic to install additional bathroom equipment and emergency call buttons or that it have a recovery area separate from the procedure area. See id. at 724. The district court further found that no credible evidence was presented demonstrating that physicians should be required to widen their doors and corridors to a width sufficient to accommodate both an ambulance stretcher and a person walking alongside to perform cardiopulmonary resuscitation, particularly given the unanimous testimony that a first trimester abortion is a relatively safe procedure with infrequent complications. See id. The district court found no evidence that this need had ever arisen from the performance of a first trimester abortion in South Carolina or elsewhere. See id. Finally, the district court observed that physicians performing surgical procedures of comparable invasiveness and risk are not required to renovate their offices to meet a similar requirement. See id. With respect to Part IX, the district court found that this part of Regulation 61-12 required numerous certifications and laboratory test results concerning various parts of the abortion clinic (such as the carpets and draperies) without any evidence that the these requirements would further the goal of protecting women's health in South Carolina. See id. With respect to Part X, the district court observed that, in conjunction with Section 103(C), Part X grants to DHEC unfettered power to manage[ ] abortion providers in accordance with the best practices as interpreted by the Department, S.C. Code Ann. Regs. 61-12, Part X, and to cite providers with a Class III violation and penalty if DHEC observes a condition deemed to be against the best practices as interpreted by the Department, id.§ 103(C). The district court found that Part X imposed upon abortion providers the additional burden of determining and complying with standards or practices not specified in the regulation, but which DHEC may in the future find to be best for an abortion clinic. See Greenville Women's Clinic, 66 F. Supp. 2d at 724. Finally, the district court found that a first trimester suction curettage abortion in South Carolina currently costs between $325 and $480, depending on the gestational age, the type of sedation or anes58 thesia needed, and the medical testing indicated. See id. at 717. The district court further found that Regulation 61-12 would raise the cost of each abortion performed by the plaintiffs in the following ranges:11 (1) For CWMC, the cost will increase between $36.48 and $75.03; (2) For Dr. Lynn's Greenville practice, the cost will increase between $93.09 and $170.39; (3) For Dr. Lynn's Beaufort practice, the cost will increase between $115.67 and $367.50; (4) For GWC, the cost will increase between $22.68 and $32.39.12 See id. The district court found that the substantial alterations that Dr. Lynn would have to undertake to bring his Beaufort practice in compliance with Regulation 61-12 will likely force him to close his prac_________________________________________________________________ 11 The lowest figure represents the defendants' revision of the plaintiffs' estimates of complying with Regulation 61-12. The highest figure represents the plaintiffs' estimate. The district court observed that neither figure, however, takes into account the standard 15% profit factor which the plaintiffs' accountant testified would be appropriate. See Greenville Women's Clinic, 66 F. Supp. 2d at 717 n.10. 12 At trial, the parties entered into several notable stipulations concerning the cost of complying with certain specific provisions of Regulation 61-12: (1) When directly billing physicians, laboratories in South Carolina generally charge between $20 and $40 per sample to perform a combined test for chlamydia and gonorrhea. (2) When directly billing physicians, laboratories in South Carolina generally charge between $17 and $30 per sample to test for the Du variant. (3) When directly billing physicians, laboratories in South Carolina charge between $7 and $20 per sample to perform a test for syphilis and between $10 and $22 to perform a test from a pap smear. 59 tice, thereby eliminating the availability of abortions in this area of South Carolina.13 See id. The district court also found that the increased cost of providing abortions and/or the closure of the only abortion clinic in one area of a state resulting from Regulation 61-12 will prevent a significant number of women from obtaining an abortion or, at a minimum, delay them from obtaining the abortion, both of which carry increased risks to the health of women.14 See id. at 718. The district court found that, as a pregnancy advances, the medical risks associated with an abortion procedure increase, and a full term pregnancy is more risky to the physical health of a woman than a first trimester abortion. See id. at 720. _________________________________________________________________ 13 At trial, the plaintiffs presented evidence that, to comply with Regulation 61-12, CWMC would require renovations costing approximately $27,235, that Dr. Lynn's Greenville practice would require renovations costing approximately $2,700, that Dr. Lynn's Beaufort office would need renovations costing approximately $12,256, and that GWC would need renovations costing approximately $3,700. 14 The district court's finding in this regard was premised on the testimony of the plaintiffs' expert, Dr. Stanley Henshaw, who is currently deputy director of research at the Alan Guttmacher Institute in New York, where he conducts studies relating to family planning and abortion services. Dr. Henshaw testified that an increase in the price of abortion procedures prevents a number of women from obtaining abortions and causes other women to delay their abortions until further along into their pregnancies. Dr. Henshaw also testified that relatively small increases in the cost of an abortion will have this effect, and that an increase of just $25 can be expected to prevent one or two out of every 100 low-income women seeking an abortion from being able to obtain one. Dr. Henshaw also testified that a decrease in the number of abortion providers in South Carolina will result in a decrease in the number of women who are able to obtain an abortion in the state, and a corresponding increase in the number of women who must travel to obtain the procedure, e.g., from Beaufort to Savannah, Georgia and/or Charleston, South Carolina. Such a need to travel will, in turn, reduce the ability to obtain an abortion or result in a delay in obtaining the abortion. And the need to travel carries its own costs, which will increase the overall cost of obtaining the abortion and compound the financial problem. 60 F Based on the findings of the district court summarized above, the district court concluded that Regulation 61-12 violated the Due Process and Equal Protection Clauses of the Fourteenth Amendment. See id. at 724-43. With respect to the Due Process Clause, the district court held that Regulation 61-12 failed to pass constitutional muster under either the facial invalidity standard set forth in United States v. Salerno, 481 U.S. 739 (1987), or the undue burden test set forth in Planned Parenthood v. Casey, 505 U.S. 833 (1992) (plurality joint opinion of O'Connor, Kennedy, and Souter, J.J.). See Greenville Women's Clinic, 66 F. Supp. 2d at 727-37. With respect to the undue burden standard set forth in Casey, the district court held that Regulation 61-12 did not serve and was not designed to serve the state's interest in maternal health. See id. at 730-35. To the contrary, the district court concluded that Regulation 61-12 would likely harm the health of women in South Carolina. See id. Accordingly, the district court concluded that Regulation 61-12 was unconstitutional under Casey. See id. at 735. The district court also concluded that even if Regulation 61-12 furthered the state's interest in maternal health, the burdens imposed by Regulation 61-12 upon abortion patients and providers constituted an undue burden on a woman's right to have an abortion prior to viability. See id. at 735-43. With respect to the standard set forth in Salerno, the district court concluded that Regulation 61-12 was unconstitutional in all of its applications and, therefore, could not stand under Salerno. See id. at 736-43. With respect to the Equal Protection Clause, the district court held that Regulation 61-12 violated the Equal Protection Clause under both the strict scrutiny test and the more lenient rational basis test. See id. at 737-43. With respect to the rational basis test, the district court held that Regulation 61-12 failed that test because it singles out physicians and abortion clinics performing five or more first trimester abortions per month from other physicians and clinics performing four or less first trimester abortions per month and/or other virtually identical procedures and places additional and onerous burdens upon physicians and abortion clinics which are neither justified by actual differences nor rationally related to the state's legitimate interest in protecting the health and safety of women seeking first trimester abortions. See id. at 740-43. 61 Finally, the district court concluded, in light of both South Carolina law and the text of Regulation 61-12, that Regulation 61-12 was not subject to the doctrine of severability.15 See id. at 743-44.