| [1] | UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT |
| [2] | No. 99-1319, No. 99-1710 No. 99-1725 |
| [3] | 2000.C04.0043891 <http://www.versuslaw.com> |
| [4] | August 15, 2000 |
| [5] | GREENVILLE WOMEN'S CLINIC; CHARLESTON WOMEN'S MEDICAL CLINIC, INCORPORATED;
WILLIAM LYNN, MD, ON BEHALF OF THEMSELVES AND THEIR PATIENTS SEEKING ABORTIONS,
PLAINTIFFS-APPELLEES, V. DOUGLAS E. BRYANT, IN HIS OFFICIAL CAPACITY AS COMMISSIONER OF SOUTH CAROLINA DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL; CHARLES M. CONDON, IN HIS OFFICIAL CAPACITY AS ATTORNEY GENERAL OF THE STATE OF SOUTH CAROLINA, DEFENDANTS-APPELLANTS, GOVERNOR OF SOUTH CAROLINA, DEFENDANT. GREENVILLE WOMEN'S CLINIC; CHARLESTON WOMEN'S MEDICAL CLINIC, INCORPORATED; WILLIAM LYNN, MD, ON BEHALF OF THEMSELVES AND THEIR PATIENTS SEEKING ABORTIONS, PLAINTIFFS-APPELLEES, V. GOVERNOR OF SOUTH CAROLINA, DEFENDANT-APPELLANT, AND DOUGLAS E. BRYANT, IN HIS OFFICIAL CAPACITY AS COMMISSIONER OF SOUTH CAROLINA DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL; CHARLES M. CONDON, IN HIS OFFICIAL CAPACITY AS ATTORNEY GENERAL OF THE STATE OF SOUTH CAROLINA, DEFENDANTS. GREENVILLE WOMEN'S CLINIC; CHARLESTON WOMEN'S MEDICAL CLINIC, INCORPORATED; WILLIAM LYNN, MD, ON BEHALF OF THEMSELVES AND THEIR PATIENTS SEEKING ABORTIONS, PLAINTIFFS-APPELLEES, V. DOUGLAS E. BRYANT, IN HIS OFFICIAL CAPACITY AS COMMISSIONER OF SOUTH CAROLINA DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL; CHARLES M. CONDON, IN HIS OFFICIAL CAPACITY AS ATTORNEY GENERAL OF THE STATE OF SOUTH CAROLINA, DEFENDANTS-APPELLANTS, GOVERNOR OF SOUTH CAROLINA, DEFENDANT. |
| [6] | Appeals from the United States District Court for the District of South
Carolina, at Greenville. William B. Traxler, Jr., District Judge. (CA-96-1898-6-21) |
| [7] | Counsel Argued: Floyd Matlock Elliott, Haynsworth, Marion, Mckay &
Guerard, L.L.P., Greenville, South Carolina, for Appellants. Bonnie Scott
Jones, The Center For Reproductive Law & Policy, New York, New York,
for Appellees. ON Brief: George Dewey Oxner, Jr., Boyd Benjamin Nicholson,
Jr., Haynsworth, Marion, Mckay & Guerard, L.L.P., Greenville, South
Carolina; Nancy Staats Layman, Legal Division, Department OF Health And
Environmental Control, Columbia, South Carolina; Charles Molony Condon,
James Emory Smith, Jr., Office OF The Attorney General, Columbia, South
Carolina; Charles E. Carpenter, Jr., Donald V. Richardson, III, S. Elizabeth
Brosnan, Richardson, Plowden, Carpenter & Robinson, P.A., Columbia,
South Carolina, for Appellants. Randall Hiller, Greenville, South Carolina,
for Appellees. |
| [8] | Before Niemeyer, Circuit Judge, Hamilton, Senior Circuit Judge, and Frederic
N. Smalkin, United States District Judge for the District of Maryland, sitting
by designation. |
| [9] | The opinion of the court was delivered by: Niemeyer, Circuit Judge |
| [10] | PUBLISHED |
| [11] | Argued: January 27, 2000 |
| [12] | Reversed by published opinion. Judge Niemeyer wrote the opinion, in which
Judge Smalkin joined. Senior Judge Hamilton wrote a dissenting opinion. |
| [13] | OPINION |
| [14] | This case presents the important question of whether South Carolina's
regulation establishing standards for licensing abortion clinics -Regulation
61-12 of the South Carolina Department of Health and Environmental Control,
S.C. Code Ann. Regs. 61-12 (eff. June 28, 1996) -- violates the Due Process
Clause and the Equal Protection Clause of the Fourteenth Amendment by placing
an undue burden on women's decisions to seek abortions and by distinguishing
between clinics that perform a specified number of abortions and those that
do not. Two abortion clinics and an abortion provider filed this action,
on behalf of themselves and their patients, facially challenging the constitutionality
of the Regulation. The district court concluded that the Regulation violated
both of these clauses of the Fourteenth Amendment, declared the Regulation
"invalid," and enjoined its enforcement. |
| [15] | As amplified herein, we reverse this decision and uphold the constitutionality
of Regulation 61-12 because (1) the Regulation serves a valid state interest
and is little more than a codification of national medical- and abortion-association
recommendations designed to ensure the health and appropriate care of women
seeking abortions; (2) the Regulation does not "strike at the [abortion]
right itself," Planned Parenthood v. Casey, 505 U.S. 833, 874 (1992)
(joint opinion of O'Connor, Kennedy, and Souter, JJ.); (3) the increased
costs of abortions caused by implementation of the Regulation, while speculative,
are even yet modest and have not been shown to burden the ability of a woman
to make the decision to have an abortion; and (4) abortion clinics may rationally
be regulated as a class while other clinics or medical practices are not. |
| [16] | I. |
| [17] | Prior to 1995, South Carolina regulated clinics at which secondtrimester
abortions were performed. See S.C. Code Ann. §§ 44-41-20(b), -70(b) (Law.
Co-op. 1985); S.C. Code Ann. Regs. 61-12 (1982) (entitled "Minimum
Standards for Licensing Clinics Performing Abortions"). The regulation
under this earlier statute contained chapters covering abortion-clinic management,
laboratory facilities and procedures, medical records and reports, clinic
design and construction, and patient-care areas. See S.C. Code Ann. Regs.
61-12 (1982). |
| [18] | In 1995, the South Carolina legislature amended its statute to require
any "facility in which any second trimester or five or more first trimester
abortions are performed in a month" to be licensed as an abortion clinic
by the Department of Health and Environmental Control ("DHEC").
S.C. Code Ann. §§ 44-41-10(C), -75(A) (West Supp. 1999). In addition, it
directed the DHEC to promulgate regulations concerning sanitation, housekeeping,
maintenance, staff qualifications, emergency equipment and procedures to
provide emergency care, medical records and reports, laboratory, procedure
and recovery rooms, physical plant, quality assurance, infection control,
and information on and access to patient follow-up care necessary to carry
out the purposes of this section. Id. § 44-41-75(B). |
| [19] | The DHEC responded by promulgating Regulation 61-12, effective June 28,
1996. See S.C. Code Ann. Regs. 61-12 (West Supp. 1998) (hereinafter "Regulation
61-12" or "the Regulation"). |
| [20] | In developing Regulation 61-12, the DHEC built on the pre-existing version
of its Regulation 61-12, as well as other DHEC regulations covering different
types of healthcare facilities. The DHEC also consulted various medical
standards and guidelines issued by medicalcare organizations, including
groups dedicated to protecting abortion rights. These sources included:
(1) Standards for ObstetricGynecologic Services (7th ed. 1995), issued by
the American College of Obstetricians and Gynecologists ("the ACOG");
(2) Manual of Medical Standards and Guidelines (1994), issued by Planned
Parenthood, which the manual describes as encouraging affiliates "to
develop abortion services if such a need exists in the community and resources
are available for conducting a safe and effective program"; and (3)
Standards for Abortion Care (1988), a set of standards, the "purpose"
of which is "to promote high quality care for all women seeking abortions"
and "serve as a useful resource for local and state agencies charged
with safeguarding the public's health," issued by the National Abortion
Federation, which the standards describe as "an organization specifically
committed to the provision and accessibility of high quality abortion services
for all women." The DHEC also reviewed abortion regulations from other
states and referenced the Guidelines for Construction and Equipment of Hospital
and Medical Facilities (1992-93), a document issued by the American Institute
of Architects, which purports to provide "model standards" for
"constructing and equipping new medical facility projects" and
for "renovation or replacement work." |
| [21] | In addition to consulting established sources, the DHEC conducted public
hearings, during which it received suggestions from the abortion clinics
that are parties to this case, incorporating some of them in new Regulation
61-12. The new Regulation, entitled "Standards for Licensing Abortion
Clinics," S.C. Code Ann. Regs. 61-12 (West Supp. 1998), contains ten
parts which address a range of medical, safety, and administrative requirements: |
| [22] | Part I, "Definitions and Requirements for Licensure," defines
an abortion clinic as "[a]ny facility, other than a hospital . . .
in which any second trimester or five or more first-trimester abortions
per month are performed." Id. § 101(B). It makes the operation of an
abortion clinic without a license illegal. See id. § 102(A). It provides
for periodic inspections, including at least one annually, and grants inspectors
the authority to copy all documents required in the course of inspections.
See id. § 102(F). And it authorizes sanctions for noncompliance with the
Regulation in the form of monetary penalties, as well as denial, suspension,
or revocation of the license. See id. § 103. |
| [23] | Part II, "Administration and Management," requires every facility
to formulate and review annually its policies and procedures. See id. §
201(B). It requires that each clinic maintain various administrative documents
on file. See id. § 203. Every employee is required to complete in-service
training and undergo a tuberculin skin test, see id. § 204(B), (F), and
any employee diagnosed with a contagious disease is prohibited from performing
certain work at the clinic, see id. § 204(D). It requires that every abortion
be performed by a physician who is licensed by the State and requires that
every clinic be affiliated with a physician who has admitting privileges
at a local hospital. See id. § 205(C). A registered nurse must supervise
all nursing care, and an ultrasound test may be conducted only by a person
who has completed a course in ultrasonography. See id.§ 205(D), (F). Each
facility must display a copy of a statement specifying patients' rights,
including the rights to dignity, privacy, and safety. See id. § 209. |
| [24] | Part III, "Patient Care," provides that each facility must have
certain written patient-care policies and procedures to ensure professional
and safe care and that no clinic may serve patients whose needs exceed the
clinic's resources and capabilities. See id. § 301. Specified drugs and
tools must be present, see id.§ 303, and laboratory services must be available,
either on site or through an arrangement with a laboratory, see id. § 304(A).
A number of laboratory tests must be performed, including a urinalysis and
testing for sexually transmitted diseases. See id. § 304(B), (C), (D). Staff
at abortion clinics must have admitting privileges at a local hospital or
have documented arrangements for emergency transfer to a hospital. See id.
§ 305(A). And facilities that perform abortions beyond the 14th week of
pregnancy must meet additional requirements. See id . § 309. |
| [25] | Part IV, "Medical Records and Reports," requires that every
abortion clinic maintain and retain for ten years specified categories of
information and requires that the documents be treated as confidential.
See id. § 401, 402. Abortion clinics must report to the DHEC all abortions
performed, any fetal deaths meeting certain criteria, and any accidents
or incidents. See id. § 403. |
| [26] | Part V, "Functional Safety and Maintenance," requires written
safety policies and procedures and a disaster-preparedness plan and sets
standards for maintenance, requiring that facilities be kept in good repair.
See id. §§ 501-503. |
| [27] | Part VI, "Infection Control and Sanitation," requires certain
daily sterilization procedures, see id. § 602, mandates proper laundering
of linen and washable goods, see id. § 603, and requires the facility to
be kept neat, clean, and free of insects, see id . § 604. Garbage and waste
are required to be disposed of in a manner designed to prevent transmission
of disease. See id. § 605. Outside areas must be maintained so as to minimize
fire hazards, havens for insects and rodents, and unsafe conditions from
accumulations of water, ice, and snow. See id. § 606. |
| [28] | Part VII, "Fire Protection and Prevention," requires clinics
to have particular fire-fighting equipment and an evacuation plan and to
conduct fire drills and inspections. See id.§ 701. |
| [29] | Part VIII, "Design and Construction," requires that each abortion
clinic have facilities for the care of each patient that meet applicable
design and construction laws. See id. §§ 801, 802. New buildings or additions
must satisfy building code requirements. See id. §§ 803, 804. Each facility
must provide an adequate number of examination or procedure rooms, and each
procedure room must have a suitable table and other equipment. See id. §
807(A), (B). Recovery areas must meet particular requirements and there
must be a room for temporary storage of waste, as well as an area to accommodate
sterilization procedures. See id. § 807(E), (F). |
| [30] | Part IX, "Prerequisites for Initial Licensure," sets forth the
necessary documentation for obtaining a license from the DHEC and the certification
that must be acquired for various physical items. |
| [31] | Finally, Part X states that conditions which arise and have not previously
been addressed in the Regulation must be managed in accordance with the
best practices as interpreted by the DHEC. |
| [32] | On June 27, 1996, one day before Regulation 61-12 was to take effect,
the Greenville Women's Clinic, the Charleston Women's Medical Clinic, Inc.,
and Dr. William Lynn (collectively, the "abortion clinics") brought
this action seeking a declaratory judgment that Regulation 61-12 is unconstitutional
on its face because, among other things, it would violate their due process
and equal protection rights, as well as those of their patients. They also
sought an order enjoining enforcement of the Regulation and requesting attorneys
fees and costs pursuant to 42 U.S.C. § 1988. The district court issued a
temporary restraining order on June 19, 1996, which, by consent of the parties,
was converted to a preliminary injunction. Finally, on February 5, 1999,
the district court declared the Regulation invalid in its entirety. The
Greenville Women's Clinic, which has operated in Greenville, South Carolina,
since 1978, has two licensed physicians who perform a combined average of
more than 2,700 abortions per year. The physicians at the clinic testified
that even prior to the promulgation of Regulation 61-12, their clinic operated
in substantial compliance with its requirements. They estimated that the
additional cost of full compliance would be $22.68 per abortion. The district
court found that, prior to the Regulation's promulgation, the cost of an
abortion was between $325 and $480 if the abortion was not complicated and
was performed during the first trimester. The court found that the additional
cost of full compliance for Greenville Women's Clinic would be in the range
of $23-$32 per abortion. |
| [33] | The Charleston Women's Medical Clinic, Inc., which has operated in Charleston,
South Carolina, for about 28 years, performs, on average, more than 2,400
abortions per year. That clinic is operated by a licensed physician and
a licensed practical nurse. The district court found that compliance with
Regulation 61-12 by the Charleston Women's Medical Clinic would cost between
$36 and $75 per abortion. |
| [34] | Dr. William Lynn, who is a licensed physician, has conducted his practice
since 1980 from two locations -- in Beaufort, South Carolina (approximately
70 miles southwest of Charleston) and in Greenville, South Carolina. Dr.
Lynn performs, on average, more than 900 abortions each year at the two
sites. He testified that Regulation 61-12 would require him to undertake
costly modifications to his Beaufort facility, and the district court found
that his cost per abortion would increase by an amount between $116 and
$368. The district court also concluded that the increased costs for Dr.
Lynn's Beaufort facility would "likely force [Dr. Lynn] to cease performing
abortions in his Beaufort office." Greenville Women's Clinic v. Bryant,
66 F. Supp. 2d 691, 717 (D.S.C. 1999). |
| [35] | There was no direct evidence about how many other abortion clinics in
South Carolina would be affected by the Regulation or about the extent of
any such impact. No woman who wanted an abortion or who claimed to be threatened
by Regulation 61-12 was made a party to the action or testified before the
district court, and no survey evidence of women in South Carolina was presented
to demonstrate the likely effect that Regulation 61-12 would have on their
decisions to obtain an abortion. |
| [36] | Following a bench trial, the district court concluded that the Regulation
"serve[s] no legitimate state interest . . . [g]iven the lack of evidence
that the regulation will operate to improve the health care currently being
received in this state." Greenville Women's Clinic, 66 F. Supp. 2d
at 735. It continued that even if it did serve a valid purpose, the Regulation
"places a substantial obstacle in the path of women seeking first trimester
abortions and, thereby, imposes an undue burden on the woman's fundamental
right to choose to undergo the procedure." Id. The undue burden, the
court found, resulted from increased costs, delays in the ability to obtain
abortions, decreased availability of abortion clinics, increased distances
to travel to clinics, unlimited inspections of clinics, and compromises
to patient confidentiality. See id. at 735-36. Accordingly, the court held
that Regulation 61-12 violated women's Fourteenth Amendment due process
rights. See id. at 736. The district court also ruled that the Regulation
violated the abortion clinics' equal protection rights under either a strictscrutiny
or a rational-basis standard of review because the Regulation "singles
out physicians and clinics where abortions are performed regularly . . .
and imposes upon them requirements which are not imposed upon comparable
procedures and not even upon all physicians who perform first trimester
abortions." Id. at 742. Finally, the district court, acting under 42
U.S.C. § 1988, awarded the abortion clinics attorneys fees and costs in
the amount of $324,040. |
| [37] | South Carolina appeals from the district court's judgment declaring Regulation
61-12 unconstitutional and enjoining its enforcement and from the award
of attorneys fees. |
| [38] | II. |
| [39] | South Carolina contends first that the district court's due process analysis
is supported by neither the record nor the law. It maintains that Regulation
61-12, which is based on national healthcare standards for abortions, is
rationally related to protecting the health of women seeking abortions,
"even if such regulations might have the incidental [e]ffect of causing
the price to obtain an abortion to increase." South Carolina notes
that the abortion clinics and their experts agree as to the appropriateness
of the national standards incorporated in the Regulation, and the Greenville
Women's Clinic, the largest of the plaintiffs, admitted that it was already
in substantial compliance with virtually all of the Regulation's requirements.
The State argues that to the extent any clinic does not comply with Regulation
61-12, compliance will improve the quality of medical care for women seeking
abortions. South Carolina also argues that the evidence does not support
the conclusion that the increased cost of an abortion would impose a substantial
obstacle for women in South Carolina seeking abortions. |
| [40] | The abortion clinics respond that the Regulation does not further a valid
state interest because (1) it creates costly and unnecessary requirements
which are more likely to harm than to protect the health of abortion patients
and (2) the DHEC's drafting process indicates that the DHEC was not concerned
with protecting the health of such women. The clinics acknowledge that the
DHEC may have relied on standards and guidelines of national medical groups,
but they argue that these are just that -- standards and guidelines -- and
are neither designed to serve as mandatory directives nor appropriate for
that purpose. Finally, the abortion clinics contend that, in any event,
Regulation 61-12 imposes an undue burden on women seeking abortions in South
Carolina because it would increase the price of abortions and force Dr.
Lynn to cease performing abortions at his Beaufort facility. |
| [41] | The abortion clinics undertook a heavy burden in bringing a facial challenge
to the constitutionality of Regulation 61-12. Because of the nature of facial
challenges, they could not present the district court with a concrete factual
circumstance -- a particular case or controversy -- to which to apply the
Regulation. The clinics therefore must argue about the Regulation's impact
generally and prospectively, the type of action typically undertaken by
legislatures, not courts. Because a trial on a facial challenge can focus
only on arbitrarily selected hypotheticals to which the Regulation might
apply, a court is required to speculate about the Regulation's overall effect. |
| [42] | In this case, for example, the district court was not given -- and could
not be given -- any data from South Carolina patients about the impact that
particular costs had on their decision to seek an abortion. It was given
only estimates by "experts." Accordingly, the impact of the Regulation
in any given situation could only have been anticipated. Such anticipation,
however, is generally not an appropriate basis on which to strike down statutes
and regulations. See Bowen v. Kendrick, 487 U.S. 589, 612-13 (1988) (noting
that "[i]t has not been the Court's practice" to strike down a
statute on a facial challenge "in anticipation" of particular
circumstances, even if the circumstances would amount to a "likelihood"). |
| [43] | Because of the conceptual difficulties that attend to ruling on the constitutionality
of a statute in the abstract, the Supreme Court has held that "[a]
facial challenge to a legislative Act is, of course, the most difficult
challenge to mount successfully, since the challenger must establish that
no set of circumstances exists under which the Act would be valid."
United States v. Salerno, 481 U.S. 739, 745 (1987); see also Rust v. Sullivan,
500 U.S. 173, 183 (1991) (a facial challenge will fail if an act "can
be construed in such a manner that [it] can be applied to a set of individuals
without infringing upon constitutionally protected rights"). |
| [44] | In Planned Parenthood v. Casey, 505 U.S. 833 (1992), the Supreme Court
ruled that a statute regulating abortion was invalid because "in a
large fraction of cases in which [it] is relevant, it will operate as a
substantial obstacle to a woman's choice to undergo an abortion." Id.
at 895 (majority opinion) (emphasis added). Whether this holding displaced
the Salerno standard for facial challenges in abortion cases has been the
subject of considerable debate among the circuits. Compare, e.g., Planned
Parenthood v. Lawall, 180 F.3d 1022, 1025-27 (9th Cir. 1999) (applying Casey
standard to facial challenge to abortion restriction); Women's Med. Prof'l
Corp. v. Voinovich, 130 F.3d 187, 193-96 (6th Cir. 1997) (same); Jane L.
v. Bangerter, 102 F.3d 1112, 1116 (10th Cir. 1996) (same); Planned Parenthood
v. Miller, 63 F.3d 1452, 1456-58 (8th Cir. 1995) (same); Casey v. Planned
Parenthood, 14 F.3d 848, 863 n.21 (3d Cir. 1994) (same), with Barnes v.
Moore, 970 F.2d 12, 14 n.2 (5th Cir. 1992) (per curiam) ("we do not
interpret Casey as having overruled, sub silentio, longstanding Supreme
Court precedent governing challenges to the facial constitutionality of
statutes"); see also Okpalobi v. Foster, 190 F.3d 337, 354 (5th Cir.
1999) (noting that subsequent Fifth Circuit decisions were arguably inconsistent
with application of the Salerno standard). This circuit, sitting en banc,
acknowledged the uncertainty as to which standard applies but declined to
resolve the issue. See Planned Parenthood v. Camblos, 155 F.3d 352, 358-59
& n.1 (4th Cir. 1998) (en banc) ("Because we conclude . . . that
the [challenged abortion regulation] is facially constitutional under either
the Salerno or the Casey standard, we need not, and do not, decide which
of these two standards applies in facial challenges to abortion statutes").
Previously, a panel of this court had stated its agreement with the Fifth
Circuit position in Barnes v. Moore, observing that until the Supreme Court
specifically overrules Salerno in the abortion-regulation context, "this
Court is bound to apply the Salerno standard as it has been repeatedly applied
in the context of other abortion regulations reviewed by the Supreme Court
. . . and in the context of challenges to legislative acts based on other
constitutional grounds." Manning v. Hunt, 119 F.3d 254, 268 n.4 (4th
Cir. 1997) (emphasis added). |
| [45] | While we believe that the observation in Manning was part of the court's
holding because application of Salerno was necessary to the ruling in that
case and not dictum, we add the observation that the logic of the Salerno
test is necessary to show deference to legislatures, particularly in light
of the limitation imposed by Article III of the Constitution that the judiciary
act only in cases and controversies. See U.S. Const. art. III, § 2. As we
explain below, when the abortion clinics are confronted with Salerno's requirement
that no set of circumstances exists under which Regulation 61-12 would be
valid, they fail, if for no other reason, because the impact on the Greenville
Women's Clinic is so modest. Even when we apply a less deferential standard
than that articulated in Salerno, we nevertheless conclude in this case
that the record provides no evidence from which to conclude that Regulation
61-12 would present a "substantial obstacle" to "a large
fraction" of women in South Carolina who might seek an abortion at
a clinic subject to Regulation 61-12. Casey, 505 U.S. at 895 (majority opinion). |
| [46] | The record contains evidence from several abortion providers, only one
of which would be adversely affected in any significant way in providing
abortion services, Dr. Lynn's Beaufort facility. Moreover, even for women
in Beaufort, no evidence suggests that they could not go to the clinic in
Charleston, some 70 miles away. Nor are we provided with evidence of the
impact that Regulation 61-12 would have on other South Carolina abortion
clinics. Thus, inherent in our discussion of the impact that Regulation
61-12 would have on women's abortion rights is the inability to decide a
concrete case; we must speculate about the impact on all relevant women
to determine, under the Casey standard, whether a large fraction would encounter
a substantial obstacle to their choice to seek an abortion, an analysis
that the record simply does not permit. Thus, on the abortion clinics' failure
to present evidence that would satisfy either of the possible standards,
we fall back on the Regulation's presumptive constitutionality. |
| [47] | The principles of the abortion right itself are now well-established.
Beginning in 1973, women were found to have a fundamental right grounded
in the Fourteenth Amendment to end a pregnancy by aborting the life of the
fetus. See Roe v. Wade, 410 U.S. 113, 153-56 (1973); see also Maher v. Roe,
432 U.S. 464, 474 (1977). The Court in Roe stated that the "right of
privacy . . . is broad enough to encompass a woman's decision whether or
not to terminate her pregnancy." Roe, 410 U.S. at 153. |
| [48] | Following Roe, which recognized that the abortion-decision right was not
absolute but subject to some regulation by the states, the Supreme Court
decided numerous cases that uncovered difficulties in applying Roe and created
widespread confusion. Accordingly, in 1992, the Court in Casey reexamined
Roe and restated the applicable principles. In Casey, the Court rejected
the trimester framework of Roe and adopted a revised "undue burden"
standard to apply to challenged abortion regulations. Casey, 505 U.S. at
872-74 (joint opinion of O'Connor, Kennedy, and Souter, JJ.). But it reaffirmed
the "essential holding" of Roe -- that a woman has a constitutional
right to "choose to have an abortion before viability and to obtain
it without undue interference from the State." Id. at 846 (majority
opinion). The scope of this right, however, is framed by the State's "legitimate
interests from the outset of the pregnancy in protecting the health of the
woman and the life of the fetus that may become a child." Id. |
| [49] | Most recently, in Stenberg v. Carhart, 530 U.S. ___, No. 99-830 (U.S.
June 28, 2000), the Supreme Court reaffirmed the principles articulated
in the joint opinion in Casey that: (1) a woman has a constitutional right
"to choose to terminate her pregnancy" before viability of the
fetus; (2) any State law that imposes an"undue burden" on the
woman's right to choose to terminate her pregnancy before fetal viability
is unconstitutional; and (3) a State may regulate postviability abortions
"except where [they are] necessary, in appropriate medical judgment,
for the preservation of the life or health of the mother." 530 U.S.
at ___, No. 99-830, slip op. at 2 (internal quotation marks and citations
omitted). |
| [50] | In preserving the right of a woman to choose to have an abortion, the
Court in Casey emphasized that the right is grounded in the liberty protected
by the Fourteenth Amendment -- "[t]he controlling word in the cases
before us is `liberty.'" 505 U.S. at 846 (majority opinion); see also
id. at 871 (joint opinion of O'Connor, Kennedy, and Souter, JJ.) ("The
woman's right to terminate her pregnancy before viability is . . . a component
of liberty"). And the liberty so recognized is defined as the right
of a woman herself-- not her husband, her parent, her doctor, or others
-- to make the decision to have an abortion. Id. at 877 (joint opinion of
O'Connor, Kennedy, and Souter, JJ.); see also Stenberg, 530 U.S. at ___,
No. 99-830, slip op. at 27. Only when the State unduly burdens the ability
of a woman to make the abortion decision "does the power of the State
reach into the heart of the liberty protected by the Due Process Clause."
Casey, 505 U.S. at 874 (joint opinion of O'Connor, Kennedy, and Souter,
JJ.). |
| [51] | Accordingly, to the extent that state regulations interfere with the woman's
status as the ultimate decisionmaker or try to give the decision to someone
other than the woman, the Court has invalidated them. See Casey, 505 U.S.
at 887-98 (majority opinion) (striking down provision which required a physician
performing an abortion on a married woman to obtain a statement from her
indicating that she had notified her husband); Thornburgh v. American College
of Obstetricians and Gynecologists, 476 U.S. 747, 767 (1986) (invalidating
reporting requirements that "raise the specter of public exposure and
harassment of women who choose to exercise their personal, intensely private,
right, with their physician, to end their pregnancy"); Bellotti v.
Baird, 443 U.S. 622, 643 (1979) (plurality opinion) (ruling that "if
the State decides to require a pregnant minor to obtain one or both parents'
consent to an abortion, it must also provide an alternative procedure whereby
authorization for the abortion can be obtained" (footnote omitted));
Planned Parenthood v. Danforth, 428 U.S. 52, 74 (1976) (holding that "the
State does not have the constitutional authority to give a third party an
absolute, and possibly arbitrary, veto over the decision of the physician
and his patient to terminate the patient's pregnancy"). |
| [52] | On the other hand, state regulations that do not"reach into the heart"
of the protected liberty do not violate the abortion-decision right. Casey,
505 U.S. at 874 (joint opinion of O'Connor, Kennedy, and Souter, JJ.). If
a regulation serves a valid purpose -- "one not designed to strike
at the right itself" -- the fact that it also has "the incidental
effect of making it more difficult or more expensive to procure an abortion
cannot be enough to invalidate it." Id. One such valid purpose is a
State's effort to "further the health or safety of a woman seeking
an abortion." Id. at 878. Of course, if such health regulations are
unnecessary and have the "purpose or effect of presenting a substantial
obstacle to a woman seeking an abortion," they will be found to "impose
an undue burden on the right." Id. |
| [53] | In maintaining the distinction between state regulations that trammel
the woman's right to choose to have an abortion-- those that impose an undue
burden -- and those that merely have an incidental effect on the woman's
decision, the Court has upheld, both before Casey and in Casey, various
regulations, the costs and effects of which, while amounting to interference
and intrusion, did not reach the core of the protected liberty. See, e.g.,
Casey, 505 U.S. at 886 (majority opinion) (upholding 24-hour waiting period
although it would require a woman to make two visits to a doctor and increase
the woman's exposure to abortion protestors); id . at 900-01 (upholding
a recordkeeping and reporting provision that would increase the cost of
some abortions); Webster v. Reproductive Health Services, 492 U.S. 490,
530 (1989) (O'Connor, J., concurring) (regulation requiring medical tests
is constitutional where"the cost of examinations and tests that could
usefully and prudently be performed . . . would only marginally, if at all,
increase the cost of an abortion"); Planned Parenthood v. Ashcroft,
462 U.S. 476, 490, 505 (1983) (upholding requirement for a pathology report
that would impose a "small cost"). Only when the increased cost
of abortion is prohibitive, essentially depriving women of the choice to
have an abortion, has the Court invalidated regulations because they impose
financial burdens. See Akron v. Akron Ctr. for Reproductive Health, 462
U.S. 416, 434-39 (1983) (holding unconstitutional a hospitalization requirement
for certain abortions that more than doubled the cost of such abortions). |
| [54] | In the case before us, the South Carolina legislature directed the DHEC
to promulgate regulations to address medical and safety aspects of providing
abortions, as well as the recordkeeping and administrative practices of
abortion clinics. As directed, the DHEC drafted Regulation 61-12, building
on the existing regulation, which applied to second-trimester abortion clinics,
and consulting abortion regulations from other states. The DHEC also obtained
and incorporated guidelines for outpatient facilities published by the American
Institute of Architects, as well as standards and guidelines issued by the
ACOG, Planned Parenthood, and the National Abortion Federation. Indeed,
Regulation 61-12 largely tracks these medical standards and guidelines. |
| [55] | For example, the National Abortion Federation requires that all medical
staff at member facilities be proficient in CPR, and the ACOG recommends
specific plans for training personnel in CPR; Regulation 61-12 requires
that all professional staff members be certified to perform CPR. See S.C.
Code Ann. Regs. 61-12, § 204(C). The National Abortion Federation recommends
that nursing-care providers receive training and orientation; the Regulation
requires that each facility have and execute a written orientation program.
See id. § 203(E). The ACOG recommends that physicians who perform abortions
in their offices provide for prompt emergency treatment or hospitalization;
the Regulation requires that each facility have an agreement with a doctor
who has hospital admitting privileges. See id. § 205(C)(2). The National
Abortion Federation recommends that a registered nurse or physician be responsible
for a variety of components of the abortion procedure and requires that
a registered nurse monitor recovering patients if general anesthesia has
been used; the Regulation requires that a licensed registered nurse supervise
nursing care. See id. § 205(D)(1). The National Abortion Federation requires
that emergency drugs be kept on hand to treat seven specific conditions;
the Regulation requires the availability of drugs to treat the exact same
conditions. See id. § 303(A)(1). The National Abortion Federation states
that testing for gonorrhea and chlamydia may be routinely provided; the
Regulation requires testing for gonorrhea and chlamydia prior to each abortion
procedure. See id. § 304(C). The ACOG and the National Abortion Federation
recommend that counseling be offered; the Regulation requires that arrangements
be made for consultation. See id. § 307. The ACOG recommends retaining accurate
medical records for each patient for the time period required by law; the
Regulation requires that such records be retained for ten years. See id.
§ 401. The ACOG recommends specific plans and procedures for health and
safety; the Regulation requires written policies and procedures for safety.
See id. § 501. The ACOG recommends that the examining room contain facilities
for sterilization; the Regulation sets out specific sterilization procedures.
See id. § 602. The ACOG recommends procedures for disposing of contaminated
waste supplies; the Regulation requires specific treatment of refuse and
waste disposal. See id. § 605. The ACOG recommends procedures for proper
use of fire equipment, and the National Abortion Federation recommends regular
emergency drills; the Regulation requires firefighting equipment, alarm
systems, and fire drills. See id. § 701. Planned Parenthood requires procedure
rooms large enough to accommodate a stretcher or gurney, post-procedure
recovery rooms, and dressing rooms, and the National Abortion Federation
requires that the operating table be located in a room of adequate dimensions,
illumination, and ventilation; the Regulation requires particular physical
facilities at abortion clinics, such as procedure rooms with doors wide
enough to accommodate a stretcher or wheelchair, recovery rooms, storage
rooms, and a dressing room. See id.§ 807. Planned Parenthood requires a
battery-operated light source for emergency backup; the Regulation requires
emergency power and lighting. See id. § 809. |
| [56] | The national standards promulgated by such medical groups as the ACOG,
the National Abortion Federation, and Planned Parenthood indisputably aim
to protect the health of women seeking abortions and one states explicitly
that it is intended to "serve as a useful resource for local and state
agencies charged with safeguarding the public's health." National Abortion
Federation, Standards for Abortion Care (1998). In relying upon such standards,
the DHEC was appropriately focused on ensuring that abortion is "performed
by medically competent personnel under conditions insuring maximum safety
for the woman." Akron, 462 U.S. at 430 n.12 (quoting Connecticut v.
Menillo, 423 U.S. 9, 11 (1975) (per curiam)). A witness for the abortion
clinics testified that guidelines from organizations such as the ACOG and
the National Abortion Federation "provide our best current assessment
as to what is appropriate care." The witness explained that the ACOG
has "only one interest," the healthcare of women, and if a doctor
"deviate[s] from [the ACOG guidelines and standards] without a documented
reason for [the] deviation, in a court of law it will be construed as malpractice."
The witness recognized that the ACOG's guidelines "are commonly used
and relied upon by obstetricians and gynecologists nationwide to determine
the standard and the appropriate level of care for their patients,"
and that the National Abortion Federation standards are "a distillate
of extensive experience by highly skilled and experienced [abortion] providers." |
| [57] | This testimony on behalf of the abortion clinics should itself be sufficient
to establish that Regulation 61-12 was reasonably designed to promote South
Carolina's valid interest in women's health. But the DHEC was also entitled
to draw support for its use of the standards from the observations made
by the Supreme Court in abortion cases that the ACOG and National Abortion
Federation standards indicate the "general medical utility" of
a particular procedure. Ashcroft, 462 U.S. at 487 n.10; see also Akron,
462 U.S. at 435-37 (relying on changes in the ACOG standards, among others,
to demonstrate lack of justification for hospitalization requirement); Simopoulos
v. Virginia, 462 U.S. 506, 517 (1983) (upholding abortion regulations after
noting that "[o]n their face, the . . . regulations appear to be generally
compatible with accepted medical standards governing outpatient second-trimester
abortions" (citing publications from groups including the ACOG)); see
also Stenberg, 530 U.S. at ___, No. 99-830, slip op. at 18 (discussing the
ACOG's "medical opinion" in analyzing the appropriateness of "[m]edical
treatments and procedures"). Regulation 61-12 thus indisputably represents
a reasonable attempt to further the health of abortion patients in South
Carolina. |
| [58] | The abortion clinics argue that Regulation 61-12 exceeds and, in some
cases, conflicts with the recommendations of these national groups. Further,
they assert that the recommendations are just that -recommendations -- and
that requiring clinics to follow them will not necessarily safeguard or
improve the health of abortion patients. The abortion clinics also note
that some officials of these medical groups do not support mandatory compliance
with the recommendations. |
| [59] | While Regulation 61-12 does in some instances exceed the standards of
the ACOG, Planned Parenthood, and the National Abortion Federation, the
bulk of the provisions comport with those guidelines, and any deviations
are not substantial. Any contrary claim is belied by the abortion clinics'
own testimony in this case. One of the doctors who owns the Greenville Women's
Clinic, when asked whether Regulation 61-12 was "consistent with what
you would consider to be the appropriate standards for abortion practice,"
responded that "[m]ost parts of the regulation we already comply with
and do, but because it's good medical practice." Another abortion-clinic
doctor testified that he complied with a number of the Regulation's provisions
because "any doctor that's licensed by the State of South Carolina
and any doctor that's completed an OB/GYN residency successfully would do
that in the normal operation." The fact that not all healthcare professionals
agree with the adoption of each specific aspect of the Regulation is immaterial
in light of South Carolina's "considerable discretion" in adopting
licensing requirements aimed at the health of women seeking abortions. Simopoulos
, 462 U.S. at 516 ("In view of its interest in protecting the health
of its citizens, the State necessarily has considerable discretion in determining
standards for the licensing of medical facilities"). |
| [60] | Moreover, contrary to the district court's suggestion, see Greenville
Women's Clinic, 66 F. Supp. 2d at 732, there is no requirement that a state
refrain from regulating abortion facilities until a public-health problem
manifests itself. In Danforth, for example, the Court upheld health measures
that "may be helpful" and"can be useful." 428 U.S. at
80, 81. It cannot be gainsaid that a regulation incorporating the recommendations
of the leading institutional authorities in the field of abortion provision
aims to "further the health or safety of a woman seeking an abortion."
Casey, 505 U.S. at 878 (joint opinion of O'Connor, Kennedy, and Souter,
JJ.). Because South Carolina's Regulation 61-12 "appear[s] to be generally
compatible with accepted medical standards governing . . . abortions,"
Simopoulos, 462 U.S. at 517, we cannot reasonably conclude that the Regulation
was not directed at promoting South Carolina's valid interest in a woman's
health. |
| [61] | Even though Regulation 61-12 is directed at the valid objective of safeguarding
the health of women seeking abortions, it may still be invalid if, in serving
this objective, it unduly burdens "a woman's ability to make th[e]
decision" to terminate a pregnancy. Casey, 505 U.S. at 874 (joint opinion
of O'Connor, Kennedy, and Souter, JJ.). Thus, having determined that Regulation
61-12 serves a valid purpose, we must still consider whether the cost imposed
by the lawfully directed regulation presents "a substantial obstacle
to a woman seeking an abortion." Id. at 878. But a regulation is not
rendered invalid simply because it makes it "more difficult or more
expensive to procure an abortion," id. at 874, as "[a]ll abortion
regulations interfere to some degree with a woman's ability to decide whether
to terminate her pregnancy," id. at 875. In making this undue-burden
assessment, the Supreme Court has repeatedly emphasized that the focus must
be aimed more directly at the ability to make a decision to have an abortion
as distinct from the financial cost of procuring an abortion. |
| [62] | The district court found that enforcement of Regulation 61-12 would increase
the cost of obtaining an abortion in varying amounts, depending on the abortion
clinic. The Greenville Women's Clinic, which purports to follow national
medical standards for providing abortions, indicated that it substantially
complies with the requirements of Regulation 61-12 and that full compliance
would cost about $23. At the Charleston Women's Medical Clinic, the cost
increase would be between $36 and $75. On the other hand, Dr. Lynn, who
operates abortion clinics in Beaufort and Greenville, testified that he
would have to make so many changes to his Beaufort facility that compliance
would require him to cease providing abortions at that facility. |
| [63] | The record does not contain information indicating the manner in which
Regulation 61-12 would actually affect any South Carolina woman's decision
to seek an abortion. This is not due to a failure of proof but a problem
inherent in conducting a facial challenge to the Regulation. The most that
the parties could do in a preenforcement case is to speculate about the
Regulation's impact. While they can reasonably forecast some cost increases,
they can only surmise how any cost increase would affect a particular woman's
decision to seek an abortion. |
| [64] | Even accepting the speculative figures relied upon by the district court,
we believe the court erred in concluding that at the two major clinics in
this case -- the Greenville Women's Clinic and the Charleston Women's Medical
clinic -- the impact from the expense of implementing Regulation 61-12 was
unduly burdensome. While the $23-$75 increased cost per abortion due to
compliance might make it "more difficult" and would make it "more
expensive to procure an abortion," there is no evidence that it would
impose an undue burden on "a woman's ability to make th[e] decision
to have an abortion." Casey, 505 U.S. at 874 (joint opinion of O'Connor,
Kennedy, and Souter, JJ.). As to Dr. Lynn's Beaufort clinic, no evidence
suggests that women in Beaufort could not go to the clinic in Charleston,
some 70 miles away. |
| [65] | Both Casey and pre-Casey decisions support the conclusion that predicted
costs to raise medical standards do not amount to an undue burden on a woman's
choice to obtain an abortion. In Casey, the Court considered a mandatory
24-hour waiting period, which the lower court had found would often cause
"a delay of much more than a day because the waiting period requires
that a woman seeking an abortion make at least two visits to the doctor"
and would increase the exposure of women seeking abortions to the "harassment
and hostility of anti-abortion protestors." 505 U.S. at 886 (joint
opinion of O'Connor, Kennedy, and Souter, JJ.). As a result, the lower court
concluded that the State regulation would especially burden women with the
fewest financial resources, who had to travel long distances, and who needed
to explain their absences to their husbands or to others. See id. Yet the
Supreme Court upheld the provision, stating that "on the record before
us, and in the context of this facial challenge, we are not convinced that
the 24-hour waiting period constitutes an undue burden." Id. at 887
(emphasis added). The Casey Court also upheld a recordkeeping and reporting
provision, under which every facility that performed abortions had to file
with the State a detailed report on every abortion, as well as quarterly
statistical data. Because this information was a "vital element of
medical research," it could not "be said that the requirements
serve no purpose other than to make abortions more difficult," even
though the provision "might increase the cost of some abortions by
a slight amount." Id. at 901 (majority opinion). |
| [66] | Similarly, in Ashcroft, the Court upheld a reporting requirement because,
"[o]n its face and in effect," it was reasonably related to accepted
medical standards and constituted common medical practice, 462 U.S. at 487,
505, even though the provision raised the cost of an abortion, see id. at
490. In contrast, the Court in Akron struck down a provision requiring that
all second-trimester abortions be performed in a hospital because the evidence
indicated that the cost of an abortion would double and second-trimester
abortions were "rarely performed" in hospitals. 462 U.S. at 435. |
| [67] | In the case before us, as in Casey, the district court found that the
Regulation would "caus[e] delays in the woman's financial ability to
obtain an abortion" and would "increas[e] the distance a woman
has to travel to obtain an abortion," thereby increasing the cost of
an abortion. 66 F. Supp. 2d at 735. But again, in the context of a facial
challenge and in the absence of any evidence in the record about how the
cost would affect women's ability to make a decision, we conclude that the
clinics have failed to demonstrate that the Regulation places any serious
burden on a woman's ability to make an abortion decision. |
| [68] | Moreover, the increased costs claimed by the three abortion providers
are particularly modest when one considers that their purpose is to protect
the health of women seeking abortions. And there is no evidence that the
ability of any woman to obtain an abortion or to decide to obtain an abortion
would be frustrated by these particularized costs. To conclude that any
of the figures in this case would place an obstacle in the path of a woman's
right to choose to have an abortion would necessitate the formulation of
an arbitrary cost threshold beyond which a price increase may not pass.
This would irrationally hamstring the State's effort to raise the standard
of care in certain abortion clinics, the procedures and facilities of which
do not adequately safeguard the health of their patients, simply because
the clinics' performance falls so far below appropriate norms that the expense
of upgrading their practices and equipment exceeds the arbitrarily defined
amount. |
| [69] | Nor does it unduly burden a woman's right to decide to obtain an abortion
that DHEC officials may inspect abortion clinics and copy necessary documents.
Such inspections ensure compliance with health-care standards, an end which
the copying provision also furthers. See Danforth, 428 U.S. at 79, 81 (noting
that a statute which allowed medical records to "be inspected and health
data acquired by local, state, or national public health officers"
did not have a "legally significant impact or consequence on the abortion
decision or on the physician-patient relationship" (internal quotation
marks omitted)). This is particularly so in view of the Regulation's requirement
that "[a]ll records shall be treated as confidential," thereby
respecting patients' privacy. See id. at 80 (noting that proper respect
for patient's confidentiality was a factor in upholding reporting requirement);
cf. Whalen v. Roe, 429 U.S. 589, 602 & n.29 (1977) ("disclosures
of private medical information to . . . public health agencies are often
an essential part of modern medical practice even when the disclosure may
reflect unfavorably on the character of the patient"). |
| [70] | In short, South Carolina Regulation 61-12 serves a valid purpose, "one
not designed to strike at the right itself," and it is not invalid
simply because it has the incidental effect of making it modestly more difficult
or more expensive to procure an abortion. Casey, 505 U.S. at 874 (joint
opinion of O'Connor, Kennedy, and Souter, JJ.). |
| [71] | III. |
| [72] | South Carolina also contends that the district court erred in finding
that Regulation 61-12 violates the Equal Protection Clause. The Regulation
applies to facilities that perform one second-trimester abortion or five
or more first-trimester abortions per month, but does not apply to facilities
that perform fewer than five abortions per month or that perform no abortions
at all. South Carolina argues that this classification is rationally related
to its interests in regulating those facilities that perform abortions on
a regular basis and notes that an abortion is recognized to be "a unique
act fraught with consequences that go beyond mere medical complications." |
| [73] | The abortion clinics argue that because Regulation 61-12 "targets
abortion providers and their patients, treats them differently than providers
and patients of comparable medical procedures, and directly impacts the
exercise of the right to abortion," we must review the Regulation under
a standard of strict scrutiny. The abortion clinics contend that, under
the strict-scrutiny standard, the Regulation cannot be upheld because it
is not narrowly drawn to protect the health of women seeking abortions since
their safety "is no more or less compelling than the safety of patients
undergoing comparable procedures," which the State does not regulate.
At its essence, the Equal Protection Clause requires that "all persons
similarly situated . . . be treated alike." Cleburne v. Cleburne Living
Ctr., Inc., 473 U.S. 432, 439 (1985); Reed v. Reed, 404 U.S. 71, 77 (1971).
But this directive does not deny States "the power to treat different
classes of persons in different ways." Reed, 404 U.S. at 75. Most regulations
define groups to which they apply or to which benefits are conferred and
when any such group is defined, of necessity, the regulation favors or disadvantages
other groups. See Romer v. Evans, 517 U.S. 620, 631 (1996). To withstand
scrutiny under the Equal Protection Clause, therefore, a classification
generally "must be reasonable, not arbitrary, and must rest upon some
ground of difference having a fair and substantial relation to the object
of the legislation." Reed, 404 U.S. at 76 (internal quotation marks
and citation omitted). If, however, a regulation "impinges upon a fundamental
right protected by the Constitution," Perry Educ. Ass'n v. Perry Local
Educators' Ass'n, 460 U.S. 37, 54 (1983), or"operates to the peculiar
disadvantage of a suspect class," Massachusetts Bd. of Retirement v.
Murgia, 427 U.S. 307, 312 (1976), then the classification will be strictly
scrutinized. While classifications in legislation ordinarily will be upheld
against an equal protection challenge if"there is any reasonably conceivable
state of facts that could provide a rational basis for the classification,"
FCC v. Beach Communications, Inc., 508 U.S. 307, 313 (1993), a regulation
subject to strict scrutiny will be upheld only if it is justified by a compelling
state interest, see Roe, 410 U.S. at 155. |
| [74] | In Roe, the abortion-decision right was found to be fundamental. 410 U.S.
at 154-55, 162-63; see also Maher v. Roe, 432 U.S. 464, 474 (1977). But
following Casey, that conclusion may be in doubt. The Casey decision does
not refer to the abortion-decision right as fundamental and does not apply
the traditional strict-scrutiny standard which protects fundamental rights.
Rather, the Court adopted an "undue burden" standard. Casey, 505
U.S. at 874 (joint opinion of O'Connor, Kennedy, and Souter, JJ.); see also
Stenberg, 530 U.S. at ___, No. 99-830, slip op. at 2. Indeed, any regulation
that does not "strike at the [abortion] right itself" is assessed
by asking not whether it serves a compelling state interest, but whether
it "serves a valid purpose." Casey, 505 U.S. at 874 (joint opinion
of O'Connor, Kennedy, and Souter, JJ.) (emphasis added). The dissenting
opinion by Chief Justice Rehnquist characterizes the joint opinion in Casey
as follows: Roe decided that a woman had a fundamental right to an abortion.
The joint opinion rejects that view. Roe decided that abortion regulations
were subject to "strict scrutiny" and could be justified only
in the light of "compelling State interests." The joint opinion
rejects that view. Id. at 954 (Rehnquist, C.J., dissenting). |
| [75] | But because we have concluded in Part II that South Carolina's Regulation
61-12 does not place an undue burden on a woman's ability to make an abortion
decision, there is no need to resolve whether it remains a fundamental right
for an equal protection analysis and thus requires application of the strict-scrutiny
standard. See Harris v. McRae, 448 U.S. 297, 312, 322 (1980) (having concluded
that a law restricting federal funding for abortion violated no constitutionally
protected right, the Court held it was unnecessary to analyze whether the
law infringed a fundamental right for equal protection purposes). And likewise
the equal protection analysis of a regulation applicable to abortion clinics,
and not other medical clinics, would not be conducted under the strict-scrutiny
standard. No authority exists to support a conclusion that abortion clinics
or abortion providers have a fundamental liberty interest in performing
abortions free from governmental regulation. See, e.g., Birth Control Centers,
Inc. v. Reizen, 743 F.2d 352, 358 (6th Cir. 1984). Moreover, physicians
as a group are not a suspect class. See Attorney Gen. of New York v. Soto-Lopez,
476 U.S. 898, 906 n.6 (1986) (recognizing suspect classifications to include
those based on race, alienage, or national origin). Accordingly, because
we are not considering a regulation that impinges on a fundamental right
or that is directed at a suspect class, we review South Carolina Regulation
61-12 under the Equal Protection Clause by applying a rational-basis standard
to determine whether the Regulation's classification of physicians who perform
one second-trimester abortion or five or more first-trimester abortions
per month is rationally related to a valid governmental purpose. |
| [76] | The rationality of distinguishing between abortion services and other
medical services when regulating physicians or women's healthcare has long
been acknowledged by Supreme Court precedent. Beginning with Roe itself,
the Court recognized not only the special medical interest of the women
seeking abortions but also the State's interest in protecting prenatal life.
See 410 U.S. at 150. The long stream of cases that followed Roe has only
heightened an awareness that for purposes of regulation, abortion services
are rationally distinct from other routine medical services, if for no other
reason than the particular gravitas of the moral, psychological, and familial
aspects of the abortion decision. As the Court in Casey observed: |
| [77] | [T]he abortion decision . . . is more than a philosophic exer cise. Abortion
is a unique act. It is an act fraught with conse quences for others: for
the woman who must live with the implications of her decision; for the persons
who perform and assist in the procedure; for the spouse, family, and soci
ety which must confront the knowledge that these proce dures exist, procedures
some deem nothing short of an act of violence against innocent human life;
and, depending on one's beliefs, for the life or potential life that is
aborted. Casey, 505 U.S. at 852 (majority opinion). |
| [78] | Similarly in Harris, the Supreme Court noted that it was rational for
Congress to authorize federal reimbursement for medical necessities, but
not for medically necessary abortions: "Abortion is inherently different
from other medical procedures, because no other procedure involves the purposeful
termination of a potential life." 448 U.S. at 325 (emphasis added).
And again in Danforth, the Court rejected the argument that "the State
should not be able to impose any recordkeeping requirements [on abortion
providers] that significantly differ from those imposed with respect to
other, and comparable, medical or surgical procedures." 428 U.S. at
80-81. In the same case, the Court applied the identical analysis to uphold
a provision requiring that a woman certify in writing that her consent to
the abortion was freely given and not the result of coercion, "[d]espite
the fact that apparently no other . . . statute . . . requires a patient's
prior written consent to a surgical procedure." Id. at 66-67. |
| [79] | We thus conclude that South Carolina has a rational basis for regulating
abortion clinics while not regulating other healthcare facilities. See Williamson
v. Lee Optical, 348 U.S. 483, 489 (1955) ("The problem of legislative
classification is a perennial one, admitting of no doctrinaire definition.
. . . [T]he reform may take one step at a time, addressing itself to the
phase of the problem which seems most acute to the legislative mind. . .
. The legislature may select one phase of one field and apply a remedy there,
neglecting the others"). |
| [80] | The only question remaining is whether the line drawn by Regulation 61-12
at five abortions per month is rationally related to its purpose of protecting
the health of abortion patients. When it is recognized that the State interest
is in regulating those facilities that are in the business of providing
abortions, drawing the line at those performing five abortions per month
is rational. While anyone could say that it is just as rational to draw
the line at ten abortions per month or three abortions per month, this type
of line-drawing is typically a legislative function and is presumed valid.
See Murgia, 427 U.S. at 314. Indeed, line-drawing of this type is not only
typical of legislation, it is necessary. Thus, the Americans With Disabilities
Act provides that the right to be free from discrimination because of one's
disability is granted to an employee of a company with 15 employees, but
not to an employee of a company with only 14 employees. See 42 U.S.C. §
12111(5)(A). Similarly, Title VII of the Civil Rights Act of 1964 prohibits
discrimination on the basis of race, color, religion, sex, or national origin
by employers with 15 or more employees, but not employers with 14 or fewer
employees. See 42 U.S.C. § 2000e(b). The statute books are filled with similar
examples. See, e.g., the Family and Medical Leave Act, 29 U.S.C. § 2611(2)
(giving rights only to employees employed 12 months or longer); the Comprehensive
Crime Control Act of 1984, 18 U.S.C. § 3559(c)(1) (mandating a sentence
of life imprisonment for persons convicted of three serious violent felonies).
In a similar vein, South Carolina permits persons 16 years or older to obtain
a driver's license, denying a license to persons 15 years or younger. See
S.C. Code § 56-1-40; see also S.C. Const. art. XVII, § 14 (persons 18 years
or older have "full legal rights and responsibilities"). In each
of these instances, persons falling on one side of the line are treated
differently from those on the other. But this result is inherent in legislation.
Under rational-basis review, we need to determine only whether the line
is drawn in a manner that reasonably furthers the legislative concern. |
| [81] | In this case, South Carolina elected to regulate the business of providing
abortions and determined that five per month would distinguish the abortion
clinic from the facility performing abortions incidental to another medical
practice. The selection of this number is reasonably related to the State's
legitimate interest in promoting and protecting the health of women visiting
abortion clinics, and therefore the actual placement of the line is not
a decision that the courts may second-guess. No more than the abortion regulations
examined by the Supreme Court in Danforth and Harris does the South Carolina
regulation before us contravene the limitations of the Equal Protection
Clause. |
| [82] | IV. |
| [83] | It is regrettable that our good colleague in dissent would rule on the
basis that abortion is like any other simple medical procedure that is directed
at injury or disease. Thought of in this way, it is understandable that
he, like the district court, might find many of South Carolina's regulations
unnecessary. Why have inspections, keep records, and minimize the medical
risks for only the abortion procedure, when such a protocol is not mandated
for comparable medical practices addressing injury and disease? But the
importance of the deeply divided societal debate over the morality of abortion
and the weight of the interests implicated by the decision to have an abortion
can hardly be overstated. As humankind is the most gifted of living creatures
and the mystery of human procreation remains one of life's most awesome
events, so it follows that the deliberate interference with the process
of human birth provokes unanswerable questions, unpredictable emotions,
and unintended social and, often, personal consequences beyond simply the
medical ones. |
| [84] | In adopting an array of regulations that treat the often relatively simple
medical procedures of abortion more seriously than other medical procedures,
South Carolina recognizes the importance of the abortion practice while
yet permitting it to continue, as protected by the Supreme Court's cases
on the subject. A woman in South Carolina who has determined to abort the
life of a fetus can do so without significant interference from South Carolina's
regulations and be assured thereby of a dignified and safe procedure. That
these regulations impose a modest cost increase for increased medical safety
and a modest compromise to privacy in the form of inspections and recordkeeping
serves the complex public interests on the subject -- the interests expressed
by both those who favor abortion and those who oppose it. Society's last
word on this subject has not been spoken. But South Carolina's regulations
incidental to the exercise of the abortion right should, in the meantime,
be respected. |
| [85] | V. |
| [86] | Because we reverse the district court's judgment finding Regulation 61-12
unconstitutional, we also reverse the district court's award of attorneys
fees made under 42 U.S.C. § 1988 to the abortion clinics. The clinics are
no longer prevailing parties. See Alexander S. v. Boyd, 113 F.3d 1373, 1388
(4th Cir. 1997); Clark v. Township of Falls, 890 F.2d 625, 626-27 (3d Cir.
1989). |
| [87] | REVERSED |
| [88] | A. |
| [89] | Prior to 1995, the State of South Carolina only required licensing of
physicians' offices or other facilities in which second trimester abortions
were performed. See S.C. Code Ann.§§ 44-41-20(b), -70(b) (Law. Co-op. 1995).
On January 3, 1995, the South Carolina legislature amended Chapter 41 of
Title 44 to require licensing by the South Carolina Department of Health
and Environmental Control (DHEC) of any non-hospital medical facility in
which five or more first trimester abortions are performed in a month. See
id. § 44-41-75(A) (West Supp. 1999). This legislation also required DHEC
to promulgate regulations concerning "sanitation, housekeeping, maintenance,
staff qualifications, emergency equipment and procedures to provide emergency
care, medical records and reports, laboratory, procedure and recovery rooms,
physical plant, quality assurance, infection control, and information on
and access to patient follow-up care necessary to carry out the purposes
of this section." Id. § 44-41-75(B). Pursuant to this enabling legislation,
DHEC promulgated a regulation, entitled "Standards For Licensing Abortion
Clinics," see S.C. Code Ann. Regs. 61-12 (Regulation 61-12), which
sets forth detailed requirements that an abortion clinic*fn1
must comply with in order to obtain and maintain a license to perform abortions. |
| [90] | On June 27, 1996, the day before Regulation 61-12 temporarily went into
effect, Greenville Women's Clinic (GWC) and Charleston Women's Medical Clinic,
Inc. (CWMC), two medical clinics which offer first trimester abortion services
in South Carolina, and Dr. William Lynn (Dr. Lynn), a physician that owns
and operates medical practices in Beaufort and Greenville, South Carolina,
brought this action against Douglas Bryant (Bryant) as the Commissioner
of DHEC, the Governor of the State of South Carolina, and the Attorney General
of the State of South Carolina challenging the constitutionality of Regulation
61-12. On the same day, the plaintiffs filed a motion for a temporary restraining
order, or, in the alternative, for a preliminary injunction. |
| [91] | On July 19, 1996, the district court granted the plaintiffs' motion for
a temporary restraining order and enjoined the defendants from enforcing
Regulation 61-12, pending a hearing on the issuance of a preliminary injunction.
The district court never held a hearing on the issuance of a preliminary
injunction because, prior to the hearing date, the parties agreed to continue
the injunction pending a decision by the district court on the merits. |
| [92] | Following a six day bench trial, the district court, on February 5, 1999,
held that Regulation 61-12 was constitutionally infirm on due process and
equal protection grounds. See Greenville Women's Clinic v. Bryant, 66 F.
Supp. 2d 691, 724-43 (D.S.C. 1999). The district court also held that, in
light of both South Carolina law and the text of Regulation 61-12, Regulation
61-12 was not subject to the doctrine of severability. See id. at 743-44.
On April 13, 1999, the district court awarded the plaintiffs $324,040.61
in costs and attorneys' fees. Bryant and the Attorney General of South Carolina
appeal both the district court's decision on the merits and the order awarding
costs and attorneys' fees. The Governor of South Carolina appeals only the
district court's order awarding costs and attorneys' fees.*fn2 |
| [93] | B. |
| [94] | Located in Greenville, South Carolina, GWC provides gynecological services,
including abortions through fourteen weeks of pregnancy measured from the
pregnant woman's last menstrual period (lmp).*fn3
Drs. Terry Buffkin and Thomas Campbell, two physicians licensed to practice
in South Carolina and board certified in obstetrics and gynecology, own
and operate GWC. On average, GWC performs approximately 2,746 first trimester
abortions per year. |
| [95] | Located in Charleston, South Carolina, CWMC also provides gynecological
services, including abortions through 12.5 weeks of pregnancy measured from
the pregnant woman's lmp. On average, CWMC performs 2,408 first trimester
abortions per year. |
| [96] | Dr. Lynn owns and operates two medical practices, one in Beaufort, South
Carolina, the other in Greenville, South Carolina. Dr. Lynn is licensed
to practice medicine in South Carolina and is board certified in obstetrics
and gynecology. As part of his practice, Dr. Lynn performs abortions through
13.9 weeks of pregnancy measured from the pregnant woman's lmp. On average,
Dr. Lynn performs 407 first trimester abortions per year in his Beaufort
office and 536 first trimester abortions per year in his Greenville office. |
| [97] | All of the abortions performed at GWC, CWMC, and Dr. Lynn's two practices
are first trimester abortions. In fact, there are no abortion providers
in South Carolina who perform elective abortions (those not associated with
medical complications) in the second trimester of pregnancy.*fn4 |
| [98] | The most common first trimester abortion procedure performed by the plaintiffs
is the suction curettage procedure. The suction curettage procedure is also
utilized for spontaneous miscarriages. Although not wholly without risks,
it is undisputed that a suction curettage abortion during the first trimester
of pregnancy is a safe and quick medical procedure performed between six
and fourteen weeks after a woman's lmp.*fn5
It involves dilating the cervix, inserting a suction catheter into the uterus,
and applying suction to remove the contents of the uterus. Although the
patient is usually in the procedure room for a total of ten minutes, the
procedure itself only takes approximately two to five minutes. It involves
no incision and a minimum of bleeding. The procedure is also performed under
general anesthesia or by applying a numbing medicine around the cervix.
After the procedure, patients usually walk to the recovery area, where their
pulse and blood pressure are monitored, and they are checked for any abnormal
bleeding. Possible complications from the suction curettage procedure are
fainting from vasovagal response, uterine perforation, excessive bleeding,
infection, and retained tissue in the uterus. However, while the total complication
rate for the procedure is about one in one hundred, serious complications
are rare. The rate for complications requiring hospitalization is only about
one in 2000. And the mortality rate is one in 100,000, which is about twenty-five
times less risky than carrying a pregnancy to term. There is no evidence
in this case that a first trimester suction curettage abortion has ever
resulted in a woman's death in South Carolina. |
| [99] | Physicians in South Carolina, including Dr. Buffkin and Dr. Campbell,
also perform medical abortions to terminate pregnancies located outside
the uterus (such as in the fallopian tube) during the first six to seven
weeks of pregnancy. A medical abortion is an even safer procedure than the
suction curettage procedure. It involves the performance of a routine blood
test to measure the patient's hormone levels, followed by the injection
of a drug (methotrexate) into the patient's arm. There is no recovery time
after the injection, and only mild vaginal bleeding. Follow-up care consists
of rechecking the patient's hormone levels several days after the injection,
and rechecks thereafter at seven-day intervals. Although currently limited
in use to the termination of ectopic pregnancies, methotrexate and a second
drug, RU486, are currently being used in research protocols for use in terminating
intrauterine pregnancies. |
| [100] | C. |
| [101] | Currently, South Carolina does not require licensing of physicians' offices
outside of the abortion context. Furthermore, physicians licensed to practice
medicine in South Carolina are not subject to DHEC regulation, but rather
are governed by the South Carolina State Board of Medical Examiners. See
S.C. Code Ann. §§ 40-47-5 to 40-47-270 (West Supp. 1999). The State Board
of Medical Examiners handles the examination and licensure of physicians
within South Carolina, complaints against physicians, the suspension and
revocation of licenses when appropriate, and the imposition of civil penalties
and other sanctions against physicians. With the exception of standard building
codes imposed by their particular locales, physicians' offices are not subject
to any mandated design and construction requirements. Notably, unlike abortion
clinics, physicians' offices that do not perform five or more abortions
per month are not subject to the requirements of Regulation 61-12. |
| [102] | Regulation 61-12 is divided into ten "Parts." Part I of Regulation
61-12 sets forth "Definitions" and general"Requirements for
Licensure" of abortion clinics. Part I defines an abortion as "[t]he
use of an instrument, medicine, drug, or other substance or device with
intent to terminate the pregnancy of a woman, known to be pregnant, for
reasons other than to increase the probability of a live birth, to preserve
the life or health of the child after live birth, or to remove a dead fetus."
S.C. Code Ann. Regs. 61-12, § 101(A). Part I defines an abortion clinic
as "[a]ny facility, other than a hospital . . . in which any second
trimester or five or more first trimester abortions per month are performed."
Id. § 101(B). |
| [103] | In order to operate an abortion clinic, the clinic must first obtain a
license from DHEC. See id. § 102(A). Prior to the issuance of a license,
the abortion clinic must undergo a pre-licensure inspection. See id. § 102(F).
Once the initial license is obtained, the abortion clinic must be inspected
annually in order to obtain renewal of the license. See id. §§ 102(F), (H).
In addition, Regulation 61-12 provides that the abortion clinic is subject
to unannounced inspections by DHEC, see id. § 102(F)(1), during which DHEC
inspectors "have access to all properties and areas, objects, records
and reports, and shall have the authority to make photocopies of those documents
required in the course of inspections or investigations." Id. § 102(F)(2). |
| [104] | Upon a determination by DHEC that an abortion clinic is in violation of
"any statutory provision, rule or regulation relating to the operation
or maintenance of such facility," DHEC may deny, suspend, or revoke
the license. Id. § 103. In addition, DHEC may assess a monetary penalty
up to $5,000 for each violation. See id. § 103(F). The amount of a penalty
is based upon the specific provision at issue, which has been preassigned
as either a Class I, II, or III violation, with a Class I violation being
the most serious. See id. |
| [105] | Part II concerns the "Administration and Management" of the
abortion clinic. Section 201 requires an abortion clinic to develop and
implement detailed written policies and procedures for the operation of
the clinic, which must include, at a minimum, policies and procedures to
assure compliance with all federal, state, and local laws which govern the
clinic; the designation of a person to whom responsibility for operation
and maintenance of the abortion clinic is delegated and the establishment
of methods for holding the person responsible; personnel policies and procedures,
including in-service training requirements; a facility-wide quality improvement
program, including statistical summaries and a written plan of implementation;
a policy and procedure for patient rights and grievance procedures; functional
safety and maintenance policies and procedures; a policy and procedure for
incident reporting; and policies and procedures for obtaining informed consent
from the patient. See id. § 201(B). In addition, the abortion clinic's policies
and procedures must include a provision for annual review and evaluation
of the clinic's other policies and procedures, as well as for its management
and operation. See id. |
| [106] | Section 203 requires an abortion clinic to maintain on file all current
policies and procedures concerning the operation of the clinic, memoranda
of agreements and credentialing documentation, a copy of Regulation 61-12,
annual elevator safety inspections, and annual heating, ventilation, and
air conditioning inspection reports. See id. §§ 203(A)-(E). |
| [107] | Section 204 sets forth detailed personnel requirements for each abortion
clinic. The abortion clinic must obtain and verify professional and personal
background information on every employee, see id. § 204(A), and must develop
and implement a written orientation program for new staff members, to include
orientation on the clinic's other policies and procedures, see id. § 204(E).
A formal, in-service training program must also be planned and provided
for all employees and volunteers, and records kept of attendance. See id.
§ 204(F). The in-service training of all employees and volunteers must include
four specified areas--infection control, fire protection, confidentiality
and patient rights, and licensing regulations. See id. Written job descriptions
must be prepared and reviewed annually, see id. § 204(G), and a personnel
file must be maintained on each employee and contain the employee's current
job description that reflects the employee's responsibilities and work assignments,
documentation of the employee's orientation, in-service education, appropriate
licensure (if applicable) and tuberculin skin testing, see id.§ 204(H).
Annually, each employee must have a tuberculin skin test or, if previously
positive, a chest x-ray to determine whether tuberculosis is present. See
id. § 204(B). If tuberculosis is diagnosed, the abortion clinic must provide
treatment and investigate employee contacts. See id. Employees and volunteers
are also banned from working if they have any infected wounds, boils, sores,
acute respiratory infections, or any other contagious disease or illness.
See id.§ 204(D). In addition, all professional and allied health care staff
members must be certified by the American Red Cross or the American Heart
Association as capable of performing CPR, although only one such certified
person must be with patients when they undergo the abortion procedure and
during the recovery period. See id. § 204(C). |
| [108] | Section 205 sets forth requirements for the clinical staff of an abortion
clinic, which encompasses all physicians, nurses, and allied health professionals.
See id. § 205(A). Abortions may only be performed by physicians licensed
to practice medicine in South Carolina and who are also "properly qualified
by training and experience to perform pregnancy termination procedures."
See id. § 205(C). The abortion clinic must also obtain and maintain signed,
written agreements with at least one physician board certified in obstetrics
and gynecology who has admitting privileges at a local hospital which provides
obstetrical and gynecological services. See id. All nursing care is required
to be under the supervision of a registered nurse licensed in the State
of South Carolina, regardless of the presence of a physician in the abortion
clinic, and the registered nurse must be "on duty to provide or supervise
all nursing care" during preparation, the procedure, recovery, and
discharge. Id.§ 205(D). Licensed practical nurses may be employed so long
as they work under the supervision and direction of a registered nurse.
See id.§ 205(E). Ultrasounds may only be conducted by physicians or ultrasound
technicians who have documented evidence of completion of a training course
in ultrasonography. See id. § 205(F). Finally, the entire clinical staff
must participate in quarterly meetings to review and analyze clinical experiences,
and minutes must be kept and maintained of each meeting. See id. § 205(B). |
| [109] | Section 209 requires an abortion clinic to "have written policies
and procedures to assure the individual patient the right to dignity, privacy,
safety, and to register complaints with[DHEC]." Id. § 209(A). A copy
of the patient's rights must be conspicuously displayed, and a copy must
be signed by each patient and included in the patient's medical record.
See id. § 209(B). |
| [110] | Part III of Regulation 61-12 sets forth requirements for "Patient
Care." Additional "patient care policies and procedures designed
to ensure professional and safe care for patients" must be developed,
id. § 301, and must include, but are not limited to, policies and procedures
for admission criteria; physician and nurse responsibilities; details regarding
the pre-operative procedures (including history and physical examinations,
special examinations, lab procedures and consultations which will be required,
and ultrasonography procedures); details regarding the actual abortion procedure
(including the use of IVs, fluids, analgesia, anesthesia, and tissue examination
and disposal); details regarding post-procedure care and recovery room care,
including emergency care; provisions for education of the patient, family
and others, as appropriate in pre- and post-procedure care; plans for follow-up
care, including arrangements for a post-operative visit and specific instructions
in the event of an emergency; procedures for the management and referral
of high-risk conditions; procedures for the transfer of patients when needed;
procedures for infection control and sanitation (including duties and responsibilities
of an infection control committee which are, in turn, charged with the responsibility
of developing and implementing specific patient care and administrative
policies to investigate, control, and prevent infections in the clinic);
and procedures for the registration of fetal death or death certificates.
See id. §§ 301(A)-(K). |
| [111] | Section 303 of Regulation 61-12 relates to an abortion clinic's pharmaceutical
services. Section 303 requires every abortion clinic to maintain an emergency
supply of drugs and medicines to treat, at a minimum, the following conditions:
(1) cardiac arrest; (2) seizure; (3) asthmatic attack; (4) allergic reaction;
(5) narcotic toxicity; (6) hypovolemic shock; and (7) vasovagal shock. See
id. § 303(A). In addition, Section 303 mandates that the medicines must
be prepared in an area that contains a sink and a counter. See id. § 303(D). |
| [112] | Section 304 requires laboratory services to be performed in compliance
with the requirements already mandated by the Clinical Laboratory Improvement
Amendments of 1988 (CLIA-88), 42 U.S.C. § 263a.*fn6
See S.C. Code Ann. Regs. 61-12, § 304(A). It further requires the physician
to perform a urine pregnancy test (unless fetal heart beats or movements
are identified on physical examination), a urinalysis which includes albumin
and glucose examination, and a hematocrit or hemoglobin test. See id. §
304(B). In addition, the physician must perform a test to determine Rh factor.
See id. If the patient is Rh positive, an additional Du variant test is
required. See id. Rh(D) immune globulin must be administered if the patient
is determined to be Rh negative. See id. Testing for chlamydia and gonorrhea
is mandatory, while testing for syphilis serology and performance of a Papanicolaou
(pap) smear must be offered to the patient. See id. § 304(C). |
| [113] | Section 305 provides additional requirements for emergency care. It requires
that "[a]ll staff and/or consulting physicians" have admitting
privileges at one or more local hospitals that provide appropriate obstetrical/gynecological
services or have in place documented arrangements approved by DHEC for the
transfer of emergency cases when hospitalization becomes necessary. Id.§
305(A). The abortion clinic must maintain equipment and services to render
emergency resuscitative and life-support procedures pending transfer. See
id. § 305(B). And the abortion clinic must notify, in writing, the local
ambulance service of the location of the clinic and the nature of the medical
problems which may result from abortions. See id. § 305(C). |
| [114] | Section 306 requires an abortion clinic to purchase and maintain specific
equipment and supplies, including such items as "[a] bed or recliner
suitable for recovery," oxygen, mechanical suction, resuscitative equipment,
emergency medications and intravenous fluids, "[a] clock with a sweep
second hand," sterile suturing equipment and supplies, an adjustable
examination light, and soiled linen and waste containers. Id. §§ 306(A)-(I). |
| [115] | Section 307 requires an abortion clinic to make"[a]rrangements .
. . for consultation or referral services in the specialties of obstetrics/gynecology,
anesthesiology, surgery, psychiatry, psychology, clinical pathology and
pathology, clergy, and social services, as well as any other indicated field,
to be available as needed." Id. § 307. |
| [116] | Section 308, entitled "Quality Improvement," mandates a written
plan for a quality improvement program for patient care and designation
of an individual responsible for coordinating the program. See id. § 308(A).
Specific requirements include ongoing monitoring and evaluation of "patient
care services, staffing, infection prevention and control, housekeeping,
sanitation, safety, maintenance of physical plant and equipment, patient
care statistics, and discharge planning services." Id. § 308(B). Evaluation
of patient care is required to be "criteria-based, so that certain
actions are taken or triggered when specific quantified, predetermined levels
of outcomes or potential problems are identified." Id. § 308(C). The
process must incorporate a quarterly review of a minimum of five percent
of the medical records per quarter, but not less than five records per quarter
shall be reviewed, see id. § 308(D), and must include a means of obtaining
input from families of patients if they are "involved in the care and
services provided by the facility." Id.§ 308(E). The abortion clinic
administrator must review the findings of the program and ensure corrective
actions are taken. See id. § 308(F). The program must also identify and
establish indicators of quality care, specific to the abortion clinic, that
must be monitored and evaluated. See id. § 308(G). Annual review of the
results is also required. See id. § 308(H). |
| [117] | Part IV of Regulation 61-12 sets forth requirements for "Medical
Records and Reports." Section 401 begins by setting forth detailed
requirements for the preparation and maintenance of medical records, which
must include, at a minimum, twenty categories of information. See id. §
401. Section 401 requires a face sheet with patient identification data,
including but not limited to, the patient's name, address, telephone number,
social security number, date of birth, the father and mother's name if the
patient is a minor, the husband's name, and the name, address, and telephone
number of a person to be notified in the event of an emergency. See id.
§ 401(A)(1). The records are required to be kept confidential by the abortion
clinic (although no such requirement is imposed upon DHEC inspectors who
obtain them) and must be stored for a minimum of ten years. See id. § 402. |
| [118] | Section 403 requires the preparation of additional reports, including
a record of every accident or incident occurring in the abortion clinic
which involves patients, staff, or visitors. See id. § 403(B). If it results
in serious injury, the accident or incident must be selfreported to DHEC.
See id. Serious injuries"include, but are not limited to," accidents
and incidents that lead to hospitalization or death (other than of a fetus)
and adverse drug reactions. Id. |
| [119] | Part V of Regulation 61-12, entitled "Functional Safety and Maintenance,"
requires additional policies and procedures, including, but not limited
to, safety rules and practices for personnel, equipment, gases, liquids,
drugs, supplies, and services; provisions for investigating accidents on
the premises; provisions for disseminating safetyrelated information to
employees and users of the abortion clinic; provisions for syringe and needle
handling and storage; and provisions for managing infectious waste in accordance
with another DHEC regulation already governing such matters. See id. §§
501(A)-(B). In addition, the abortion clinic must prepare and post a disaster
preparedness plan for evacuation in the event of a fire or other emergency.
See id. § 502(A). All parts and portions of the abortion clinic are generically
required to be kept "in good repair and operating condition,"
and "free of hazards." Id.§ 503(A). In addition, "[a]ll wooden
surfaces shall be sealed with a non-lead based paint, lacquer, varnish,
or shellac that will allow sanitization." Id. A written preventive
maintenance program must be developed and implemented for patient monitoring
equipment and tested in accordance with manufacturer's specifications, but
not less than annually. See id. § 503(B). Records of maintenance and testing
must be kept. See id. |
| [120] | Part VI of Regulation 61-12 is entitled "Infection Control and Sanitation."
Part VI requires policies and procedures be established in writing to assure
safe and aseptic treatment and protection of all patients and personnel
against cross-infection. See id. § 601(A). Part VI also sets forth specific
requirements for sterilization, including daily testing of the autoclave
and a log of results, as well as periodic calibration and preventative maintenance
as necessary, but not less than annually. See id. §§ 602(B)-(C). This part
of Regulation 61-12 also requires that the abortion clinic "be kept
neat, clean, and free from odors," id. § 604(A), mandates specific
requirements for cleaning methods to be used and prohibits others, and imposes
requirements for refuse and waste disposal, see id.§§ 604(A)-(C), 605. Section
606 requires that "[a]ll outside areas, grounds and/or adjacent buildings
shall be kept free of rubbish, grass, and weeds that may serve as a fire
hazard or as a haven for insects, rodents and other pests," and that
all "[o]utside stairs, walkways, ramps and porches shall be maintained
free from accumulations of water, ice, snow, and other impediments."
Id. § 606. |
| [121] | Part VII of Regulation 61-12, entitled "Fire Protection and Prevention,"
provides detailed requirements for fire-fighting equipment and systems,
an evacuation plan, training of employees in the evacuation plan, mandatory
fire drills at least once every three months, maintenance of fire equipment,
and maintenance of records proving compliance with the provisions. See id.
§§ 701-03. |
| [122] | Part VIII of Regulation 61-12 sets forth detailed requirements for the
"Design and Construction" of abortion clinics. There is no grandfathering
provision (unlike other DHEC regulations governing medical and patient care
facilities)--rather, all abortion clinics must be in full compliance within
two years. See id.§ 804. The requirements are set forth in detail, rendering
a summary of them unproductive. Of note, Part VIII governs the number and
size of procedure and recovery rooms, specifies the design and equipment
required in toilet rooms, regulates the direction of the air flow within
the sterilization rooms, mandates a minimum width for doors and corridors,
sets forth specific requirements for heating and air conditioning (the unit
must be capable of maintaining a temperature between seventy-two and seventy-six
degrees), regulates the abortion clinic's air supply and exhaust, regulates
design criteria for abortion clinic entrances, sets forth specific requirements
for the janitor's closets, and specifies the corridor glazing materials,
wall finishes, wall bases, and interior finish materials that must be present.
See id.§§ 807(A)-(Y). Part IX of Regulation 61-12 sets forth additional"Prerequisites
for Initial Licensure" of the abortion clinic, including plan and construction
approval by DHEC, and specifies the documentation required to be submitted
with the abortion clinic's initial application for licensure. See id. Part
IX(A)-(B). Part X of Regulation 61-12, entitled "General," states
in its entirety that "[c]onditions arising that have not been addressed
in these regulations shall be managed in accordance with the best practices
as interpreted by the Department." Id. Part X. |
| [123] | D. |
| [124] | As noted earlier, prior to 1995, the State of South Carolina only required
licensing of physicians' offices or other facilities in which second trimester
abortions were performed. See S.C. Ann. §§ 44-41-20(b), -70(b) (Law. Co-op.
1995). Effective, January 3, 1995, Chapter 41 of Title 44 was amended as
follows: |
| [125] | (A) A facility in which any second trimester or five or more first trimester
abortions are performed in a month must be licensed by [DHEC] to operate
as an abortion clinic and must comply with the provisions of Article 3 [the
Woman's Right to Know Act]. |
| [126] | (B) The department shall promulgate regulations concern ing sanitation,
housekeeping, maintenance, staff quali fications, emergency equipment and
procedures to provide emergency care, medical records and reports, laboratory,
procedure and recovery rooms, physical plant, quality assurance, infection
control, and infor mation on and access to patient follow-up care neces
sary to carry out the purposes of this section. Id. § 44-41-75 (West Supp.
1999). |
| [127] | Pursuant to this enabling legislation, DHEC promulgated Regulation 61-12. |
| [128] | After the legislation requiring licensure of abortion clinics was passed,
Alan Samuels (Samuels) of DHEC was charged with the responsibility for supervising
the drafting and promulgation of Regulation 61-12. Although Samuels has
some experience in health care administration, he has received no formal
medical training or education. Upon completion of his college education,
Samuels served in the United States Army for twenty-four years, where he
served with the adjutant general corps and the medical services corps as
a personnel officer and hospital inspector. After leaving military service,
Samuels began employment with DHEC, where his duties consisted of inspecting
various types of health care facilities for compliance with existing regulations.
He was eventually promoted to the position of director of DHEC's Health
Licensing Division, and now is retired. |
| [129] | Although Samuels provided some input and edits during the drafting process,
he did not personally draft any portions of Regulation 61-12. Rather, he
delegated the primary drafting responsibility to George Moore (Moore), who
was the Director of Outpatient and Home Care within DHEC's Division of Health
Licensing. Samuels testified that, when Regulation 61-12 was promulgated,
he knew very little about abortion procedures or the differences between
first trimester and second trimester abortions. The record reflects that
Samuels conducted no meaningful study or research into the differences between
a first and second trimester abortion, and conducted no meaningful inquiry
into what regulatory requirements were appropriate for facilities performing
only first trimester abortions. |
| [130] | Like Samuels, Moore has some education and experience with hospital administration,
but has received no formal medical training or education. After receiving
an undergraduate degree, Moore joined the United States Army where he served
twenty-five years. He spent the early part of his service in the adjutant
general corps performing general administrative duties, after which time
he transferred to the medical services corps where he performed administrative
duties associated with health care facilities and hospitals. During his
service, Moore received a master's degree in hospital administration. Upon
his retirement from military service in 1988, Moore began employment with
DHEC, inspecting hospitals and nursing homes for compliance with existing
regulations. He was later promoted to Director of Outpatient and Home Care
within the Division of Health Licensing, the position he held when Samuels
asked him to assume primary responsibility for the drafting of Regulation
61-12. |
| [131] | In preparation for drafting Regulation 61-12, however, Moore took no meaningful
steps to educate himself about first trimester abortions, how they differed
from second trimester abortions, or what requirements would be appropriate
for a facility which performed only first trimester abortions. |
| [132] | For assistance with Parts VII and VIII of Regulation 61-12, Moore turned
to William Lafferty (Lafferty), who was the Director of Health Facilities
Construction with DHEC. Like Samuels and Moore, Lafferty has received no
formal medical training or education. In drafting these portions of the
regulations, Lafferty made no effort to determine whether the requirements
were medically appropriate for facilities performing only first trimester
abortions. Lafferty also approached the design and construction requirements
from the standpoint of new construction requirements and anticipated that
existing facilities would be grandfathered. The decision to include a mandatory
two-year compliance provision in that portion of Regulation 61-12 instead
of a grandfather provision was not made by Lafferty. |
| [133] | According to Moore, the pre-existing South Carolina regulation governing
second trimester abortions was utilized as a starting point for the new
regulation, and many of the additional provisions of Regulation 61-12 were
simply adopted or derived from DHEC regulations governing other types of
health care facilities. They included regulations governing ambulatory surgical
centers, renal dialysis facilities, community residential care facilities,
day care facilities for adults, outpatient facilities for chemically dependent
persons, habitation centers for the mentally retarded, residential treatment
facilities for children and adolescents, nursing homes, and facilities providing
home health care and hospice services. According to the DHEC officials,
DHEC sought to standardize its regulations governing medical facilities
and medical care so that the licensing requirements would have consistent
wording, and to codify existing departmental practices. According to the
DHEC officials, this attempt to standardize its regulations and to codify
existing practices included DHEC's desire to grant its inspectors the authority
to copy medical records in all medical facilities. According to Moore, departmental
practice currently allows the copying of medical records during a complaint
investigation. Moreover, Moore testified that DHEC would maintain the confidentiality
of the records even though there is no provision in Regulation 61-12 that
mandates such confidentiality.*fn7 |
| [134] | Although the DHEC officials testified that they primarily utilized existing
South Carolina regulations as the basis for drafting Regulation 61-12, there
is evidence in the record that the DHEC officials consulted other points
of reference. First, Moore obtained copies of abortion regulations from
North Carolina and Tennessee, though he did not speak with anyone in those
states about the regulations or how they had affected maternal health. Second,
Moore reviewed standards and guidelines issued by the Planned Parenthood
Federation of America, Inc. (Planned Parenthood), the National Abortion
Federation (NAF), and the American College of Obstetricians and Gynecologists
(ACOG). The standards and guidelines published by Planned Parenthood, NAF,
and ACOG are not mandated standards of care which can or should be imposed
on licensed physicians. Rather, they are guidelines which should be followed
with due regard for the medical judgment of the treating physician and the
special needs of the patients that they serve. |
| [135] | Du |