Appendix — Greenville Women's Clinic v. Bryant

No. 00-__ Be» esr Court, U.S.

00 798 Nov 172000

' OFFICE OE THE CLERK

Supreme Court of the United States

+ age <ege — <s-

IN THE

GREENVILLE WOMEN’S CLINIC; CHARLESTON WOMEN’S MEDICAL CLINIC,

INCORPORATED; WILLIAM LYNN, M.D., on behalf of themselves and their

patients seeking abortions,

Petitioners,

—

DoucLas 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; GOVERNOR OF SOUTH CAROLINA,

Respondents.

ON PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

APPENDIX TO PETITION FOR WRIT OF CERTIORARI

RANDALL HILLER BONNIE SCOTT JONES

850 Wade Hampton Boulevard (Counsel of Record)

« Greenville, South Carolina 29609 JANET BENSHOOF

(864) 232-0026 SIMON HELLER

PRISCILLA J. SMITH

MAYA MANIAN

The Center for Reproductive

Law & Policy

120 Wall Street

New York, New York 10005

(917) 637-3600

Counsel for Petitioners

34 ee

. 2 ERSTE Ts aay I RS

Table of Contents

Greenville Women’s Clinic v. Bryant,

yore AC Gh Ay. eens In A-1

Greenville Women’s Clinic v. Bryant,

66 F. Supp. 2d 691 (D.S.C. 1999) oo. A-101

Greenville Women’s Clinic v. Bryant, Nos. 99-1319,

99-1710 and 99-1725, Denying Petition for

Rehearing and Rehearing En Banc

(Atte Cor. Sem: BS; DE isis istics seis stssctisiacces A-202

Plaintiffs’ Exhibit 10: South Carolina Regulation

61-12 (“Standards of Licensing Abortion

ig RRP Piate inapi ree I ORE MPR Pa SN Nie CR A-205

Excerpts from Plaintiffs’ Exhibit 15: American

College of Gynecologists: Standards:

Obstetric-Gynecological Services, 7th ed.

Py WU i Recessed ees A-261

Excerpts from Plaintiffs’ Exhibit 16: American

College of Obstetricians and

Gynecologists: Guidelines for Women’s

pT De ES) SR ne oe A-270

Plaintiffs’ Exhibit 26: Letter to George R. Moore

from General Counsel for the American

College of Obstetricians and

Gynecologists dated May 3, 1995 oo... A-283

ii

Excerpts from Defendants’ Exhibit 18: National

Medical Division, Planned Parenthood

Federation of America, Inc.: Manual of

Medical Standards and Guidelines

CRevined NERtCI TDS ).....cccccssccsecesccoscsseccocsscees A-288

Excerpt from Defendants’ Exhibit 18: National

Abortion Federation, ““A Resource for

NAF Members Faced with Legislative

Bodies or Regulatory Agencies Proposing

Regulation of Abortion Service” ................... A-290

Excerpts from Defendants’ Exhibit 18A: National

Abortion Federation: Standards for

ph.) an A-292

Excerpts from Testimony of Terry L. Buffkin............ A-300

Excerpts from Testimony of William L. Lynn............ A-310

Excerpts From Testimony of Steven J. Fass............... A-312

Excerpts from Testimony of |

Thomas William Campbell, Jr.................0.04. A-316

Excerpts from Testimony of Lorraine D. Maguire ..... A-318

Excerpts from Testimony of Linda O. Morphis.......... A-320

Excerpts from Testimony of Alan Samuels................ A-322

Excerpts from Testimony of David A. Grimes............ A-324

Excerpts from Testimony of William R. Lafferty.......A-337

Excerpts from Testimony of George Moore............... A-339

EES

iii

Excerpts from Testimony of Charles J. Ward... A-343

Excerpts from Deposition Testimony of

Stanley K. Henshaw... ccccccccssecsccs. A-345

Excerpts from Deposition Testimony of

Richard Booth ciscsiecescseoseee... A-357

Excerpts from Deposition Testimony of

PT BUR occas tge a A-359

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UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

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 WOME; ’’S CLINIC;

CHARLESTON WOMEN’S MEDICAL

CLINIC, INCORPORATED; WILLIAM LYNN,

MD, on behalf of themselves and their

patients seeking abortions,

Plaintiffs-Appellees,

Vv.

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.

No. 99-1319

No. 99-1710

A-2

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. No. 99-1725

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.

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)

Argued: January 27, 2000

Decided: August 15, 2000

Before NIEMEYER, Circuit Judge,

HAMILTON, Senior Circuit Judge, and

Frederic N. SMALKIN, United States District Judge

for the District of Maryland, sitting by designation.

Reversed by published opinion. Judge Niemeyer wrote the

opinion, in which Judge Smalkin joined. Senior Judge

Hamilton wrote a dissenting opinion.

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.

OPINION

NIEMEYER, Circuit Judge:

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,

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S.C. Code Ann. Regs. 61-12 (eff. June 28, 1996) -- violates

the Due Process Clause and the Eaual 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.

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.

I

Prior to 1995, South Carolina regulated clinics at which

second- trimester 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

SS

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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).

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). 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”).

In developing Regulation 61-12, the DHEC built on the

preexisting 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 medical care

organizations, including groups dedicated to protecting

abortion rights. These sources included: (1) Standards for

Obstetric-Gynecologic Services (7th ed. 1995), issued by the

American College of Obstetricians and Gynecologists (“the

ACOG”); (2) Manual of Medical Standards and Guidelines

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(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.”

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:

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

AT

course of inspections. See id. § 102(F). And it authorizes

sanctions for non-compliance with the Regulation in the form

of monetary penalties, as well as denial, suspension, or

revocation of the license. See id. § 103.

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.

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

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facilities that perform abortions beyond the 14th week of

pregnancy must meet additional requirements. See id. § 309.

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.

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. :

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.

Part VII, “Fire Protection and Prevention,” requires

clinics to have particular firefighting equipment and an

evacuation plan and to conduct fire drills and inspections.

See id. § 701.

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

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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).

Part LX, “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.

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.

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

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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.

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.

Dr. William Lynn, who is a licensed physician, hes

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).

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

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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.

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.” Jd. 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 strict scrutiny

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.” Jd. 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.

South Carolina appeals from the district court’s judgment

declaring Regulation 61-12 unconstitutional and enjoining

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its enforcement and from the award of attorneys fees.

II

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.

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

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because it would increase the price of abortions and force Dr.

Lynn to cease performing abortions at his Beaufort facility.

The abortion clinics undertook a heavy burden in

bringing a facial challenge to the constitutionality of

Regulation 61-12. Because of the natur : 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

cari focus only on arbitrarily selected hypotheticals to which

the Regulation might apply, a court is required to speculate

about the Regulation’s overall effect.

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”).

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);

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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”).

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.” Jd. 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, 14n. 2

(Sth 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

(Sth 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

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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).

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). |

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

A-16

provided with evidence of the impact that Regulation 61-12

wuld ‘nave vn Vite Guat Carviina dportion 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.

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.

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

A-17

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.

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 post-viability 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).

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. /d. 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

A-18

Souter, JJ.).

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”).

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.). Ifa

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.” Jd. One such valid purpose is a State’s effort

to “further the health or safety of a woman seeking an

abortion.” /d. at 878. Of course, if such health regulations

A-19

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.

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).

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

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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.

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

Nationa! Abortion Federation states that testing for gonorrhea

and chlamydia may be routinely provided; the Regulation

requires testing for gonorrhea and chlamydia prior to each

A-21

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

gurey, 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.

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

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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 US. 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.”

This testimony on behalf of the abortion clinics should

itself be sufficient to establish that Regulation 61-12 was

ceasonably 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 mace 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); Simmopoulos v. Virginia, 462

U.S. 506, 517 (1983) (upholding abortion regulations after

A-23

noting that “[oJn 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.

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.

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

substantiai. Any contrary claim is belied by the abortion

clinics’ own testimony in this case. Gne 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

A-24

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”).

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 USS. 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.

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 US. 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

A-25

obstacle to a woman seeking an abortion.” Jd. at 878. Buta

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.

The district court found that enforcement of Regulation

61-12 would increase the cost of obtaining an abortion in

varying amounts, depending on the abortioa 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.

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.

Even accepting the speculative figures relied upon by the

A-26

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 wou'd 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, (join. 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.

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.” /d. 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

A-27

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.” Jd. at 901

(majority opinion).

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. :

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.

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.

A-28

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.

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 healthcare 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’).

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

A-29

procure an abortion. Casey, 505 U.S. (joint opinion of

O’Connor, Kennedy, and Souter, JJ.).

Il

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.”

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

vy. 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

A-30

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.

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

A-31

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).

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 clinicsor 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

A-32

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.

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:

[T]he abortion decision ... is more than a philosophic

exercise. Abortion is a unique act. It is an act fraught

with consequences 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 society which must confront the

knowledge that these procedures 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). 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

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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 US.

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, “[dJespite the fact that

apparently no other ... statute ... requires a patient’s prior

written consent to a surgical procedure.” Jd. at 66-67.

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”).

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

US. 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

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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.

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.

——

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IV

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 protecol 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.

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

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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.

Vv

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).

REVERSED

HAMILTON, Senior Circuit Judge, dissenting:

After a six-day bench trial, the district judge, who

presently is a judge on this court, wrote a ninety-four page

decision setting forth innumerable factual findings which

lead inexorably to the legal conclusions that South Carolina

Code Annotated Regulation 61-12 violates both the Due

Process and Equal Protection Clauses of the United States

- Constitution and that the unconstitutional portions of

Regulation 61-12 are not severable from the constitutional

portions. Cavalierly, the majority today sets aside this

thorough and meticulous decision rendered by our esteemed

colleague without identifying a single finding of fact made

by him as being clearly erroneous. To accomplish this tour

de force, the majority is compelled to set up and defeat a lack

of evidence straw man. Unlike the majority, I believe the

exhaustive and detailed factual findings made by the district

judge amply support, more accurately compel, the decision

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rendered by him. Because I am in complete agreement with

the district judge’s holdings that South Carolina Code

Annotated Regulation 61-12 violates both the Due Process

and Equal Protection Clauses of the United States

Constitution and that the unconstitutional portions of

Regulation 61-12 are not severable from the constitutional

portions, I dissent.

I

The constitutional issues presented in this case were hotly

contested by the parties at trial, with each side putting forth

extensive evidence in support of their respective positions.

Based on the evidence presented, the district court resolved

many factual disputes by making detailed findings of fact.

Because many of the district court’s factual findings are

completely ignored by the majority, I set forth below the

procedural history and facts of this case.

A

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

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care necessary to carry out the purposes of this section.” /d.

§ 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 ' must comply with in order to obtain

and maintain a license to perform abortions.

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 StateofSouth

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.

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

| An abortion clinic is defined as “[a]ny facility, other than a hospital ...

in which any second trimester or five or more first trimester abortions per

month are performed.” S.C. Code Ann. Regs. 61-12, § 101(B).

Accordingly, the definition of abortion clinic includes any physician’s

office in which five or more first trimester abortions per month are

performed.

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by the district court on the merits.

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 piaintiffs $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.

B

” 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 (Imp).? 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.

2 Although the Governor of South Carolina appeals only the district

court’s order awarding costs and attomeys’ fees, for ease of reference, I

will refer to Bryant, the Governor of South Carolina, and the Attorney

General of South Carolina as the defendants.

3 Pregnancy is measured either from the date of a woman’s Imp or

from conception, which is generally considered to occur two weeks after

a woman's Imp. Accordingly, eight weeks after the Imp is equivalent to

six weeks from the date of conception. Under Regulation 61-12, the first

trimester of pregnancy ends at fourteen weeks after the Imp. See S.C.

Code Ann. Regs. 61-12, § 103(S).

A-40

Located in Charleston, South Carolina, CWMC also

provides gynecological services, including abortions through

12.5 weeks of pregnancy measured from the pregnant

woman’s Imp. On average, CWMC performs 2,408 first

trimester abortions per year.

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 Imp. 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.

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.*

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

4 Because the plaintiffs in this case only provide abortions during the

first trimester of pregnancy, the plaintiffs’ challenge to Regulation 61-12

is limited to its application to providers of first trimester abortions in

South Carolina. Accordingly, I express no opinion as to the

constitutionality of Regulation 61-12 as applied to facilities that may seek

to perform second trimester abortions in the future.

A-41

woman’s Imp. 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.

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

5 By way of comparison, according to one of the plaintiffs’ experts

whose testimony was credited by the district court, having a first trimester

suction curettage abortion is safer than having a shot of penicillin in a

physician's office.

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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, RU-486, are currently being used in research

protocols for use in terminating intrauterine pregnancies.

C

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.

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

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remove a dead fetus.” S.C. Code Ann. Regs. 61-12, §

101(A). Part I defines an abortion clinic as “(ajny facility,

other than a hospital ... in which any second trimester or five

or more first trimester abortions per month are performed.”

Id. § 101(B).

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.” Jd. § 102(F)(2).

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, Il, or III violation,

with a Class I violation being the most serious. See id.

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

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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.

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).

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

A-45

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 J

patients when they undergo the abortion procedure and

during the recovery period. See id. § 204(C).

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. Jd. § 205(D).

A-46

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).

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].” /d. § 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).

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

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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).

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).

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.6 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,

6 CLIA-88 has been amended, see 42 U.S.C.A. § 263a (West 1999).

This amendment has no relevance to this case.

A-48

while testing for syphilis serology and performance of a

Papanicolaou (pap) smear must be offered to the patient. See

id. § 304(C).

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. Jd. § 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).

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. Jd. §§ 306(A)-(I).

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 E

field, to be available as needed.” Jd. § 307.

Section 308, entitled “Quality Improvement,” mandates a

written plan for a quality improvement program for patient

care and designation of an individual responsible for

A-49

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.” Jd. § 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.” Jd. § 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).

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

A-50

them) and must be stored for a minimum of ten years. See id.

§ 402.

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 self-reported 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. Jd.

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 safety-related —

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.” Jd. § 503(A). In addition, “alll

wooden surfaces shall be sealed with a non-lead based paint,

lacquer, varnish, or shellac that will allow sanitization.” Jd.

A written preventive maintenance program must be

developed and implemented for patient monitoring

equipment 2 .d 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.

ay

Part VI of Regulation 61-12 is entitled “Infection Control

A-51

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 a!so 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 “[oJutside stairs, walkways, ramps and

porches shall be maintained free from accumulations of

water, ice, snow, and other impediments.” Jd. § 606.

Part VII of Regulation 61-12, entitled “Fire Protection

and Prevention,” provides detailed requirements for

firefighting 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.

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

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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.” /d. Part X.

D

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:

(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

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of Article 3 [the Woman’s Right to Know Act].

(B) The department shall 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 (West Supp. 1999). Pursuant to this enabling

legislation, DHEC promulgated Regulation 61-12.

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.

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

A-54

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.

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.

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.

For assistance with Parts VII and VIII of Regulation 61-

A

TT

A-55

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.

According to Moore, the preexisting 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

A-56 :

that DHEC would maintain the confidentiality of the records

even though there is no provision in Regulation 61-12 that

mandates such confidentiality. 7 7

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

ACOQG 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.

During the drafting process, the general counsel of

ACOG wrote a letter to DHEC expressing concern that the

requirements of Regulation 61-12 would not enhance patient

well-being or safety and offering DHEC the assistance of

ACOG in the drafting of an appropriate regulation. The

DHEC drafters declined ACOG’s assistance.

After an initial draft of Regulation 61-12 was completed,

7 Interestingly, DHEC’s regulation governing ambulatory surgical

centers contains a specific provision protecting the confidentiality of

medical records. See S.C. Code Ann. Regs. 61-91, § 1001(E) (providing

that records may only be removed from the premises by subpoena or

court order).

A-57

Moore requested limited input and comments from two

medical personnel associated with DHEC. The first, Dr.

Richard Goodrich (Dr. Goodrich), is a licensed physician,

board certified in obstetrics and gynecology, who practiced

in Zanesville, Ohio until he retired. After his retirement, he

moved to South Carolina and became a consultant with

DHEC in the area of maternal and child health. During his

medical practice, however, Dr. Goodrich performed only two

abortions, both of which were due to medical complications.

Furthermore, Dr. Goodrich was not asked to and did not draft

any portion of Regulation 61-12. Rather, he was only asked

to review discrete portions of the regulation dealing

exclusively with medical events and medical testing, and he

conducted no review of and provided no input on the

majority of the regulatory requirements. Although he is of

the opinion that the portions of Regulation 61-12 that he

reviewed are appropriate medical standards of care, he

testified that the same standards would be appropriate for

physicians’ offices in which comparable obstetrical and

gynecological surgical procedures are performed. Dr.

Goodrich further testified that he did not recommend

Regulation 61-12’s requirement of physician qualifications

beyond state licensure, and acknowledged that he did not

know how the required “training and experience”

qualifications could be determined under the regulation. Dr.

Goodrich also interpreted Regulation 61-12’s requirement

that a registered nurse be “on duty” as requiring that a

registered nurse have ultimate responsibility, and not that a

registered nurse should or needs to be on the premises at all

times. Dr. Goodrich further testified that, while he has no

specific experience with medical abortions, it would not be

his intent to cover the provision of medical abortions under

the regulation. He acknowledged, however, that the

regulation as drafted would in fact cover such abortions.

Finally, Dr. Goodrich testified that he is aware of no existing

problem with abortion providers in South Carolina and has

no opinion as to how the cost and availability of abortions

A-58

affect women’s health issues.

Moore also squght some limited input from Robert

Lawyer, R.N. (Lawyer), who was Director of Nursing for

DHEC. Lawyer received his bachelor of science degree in

nursing while in the United States Army, and later received a

masters degree in health services management and business

administration. He has some experience with providing

nursing care for first and second trimester abortions

performed in a military hospital. After retiring from the

Army in 1989, Lawyer began working with DHEC. He is

currently nurse manager with the Division of Health

Licensing, where his primary duty is the inspection of

various health care facilities for compliance with existing

regulations. He too was asked by Moore and Samuels to

review and provide input concerning discrete portions of

Regulation 61-12, primarily those governing nursing care.

Lawyer is of the opinion that, for first trimester abortions, a

registered nurse should either personally monitor the patient

or supervise all patient care, unless the physician is present in

the abortion clinic and available to come to the recovery

room if necessary. Unlike Dr. Goodrich, however, he

interprets Regulation 61-12 as requiring the “on duty”

registered nurse to be on the premises. In formulating his

opinion, Lawyer did not conduct any research on abortion

practices in South Carolina, nor did he consult with nursing

professionals who specialize in abortion procedures. Lawyer

testified that while he is aware that Regulation 61-12 would

apply to facilities performing only medical abortions, he has

no knowledge of what nursing skills are required in the

context of medical abortions or whether they would require a

registered nurse as opposed to a licensed practical nurse.

With the exception of these limited consultations with

medical personnel associated with DHEC, the drafters of

Regulation 61-12 did not seek any input from medical

A-59

ACOG’s offer of assistance. As some support for the text of

Regulation 61-12, the defendants contend that the drafters

conducted an inspection of Planned Parenthood’s abortion

clinic in Columbia, South Carolina and determined that the

clinic met the great majority of Regulation 61-12’s

requirements. The evidence credited by the district court,

however, reveals that the drafters simply toured the clinic

and, during one such visit, may have spoken briefly to a

Planned Parenthood physician. There is no evidence that the

physician was asked to comment upon the regulatory

requirements or whether they were medically necessary for

first trimester abortions. Moreover, there is no evidence in

the record to support a finding that DHEC received any

meaningful input from Planned Parenthood physicians prior

to or during the early stages of the drafting process.

After the initial drafting process was concluded, DHEC

issued a proposed regulation and held public hearings as

mandated by South Carolina law. Some of the suggestions

made during this public comment period resulted in changes

to Regulation 61-12, including some suggestions made by

Planned Parenthood and the plaintiffs in this case.

On January 23, 1996, DHEC submitted Regulation 61-12

to the South Carolina legislature for approval as required by

South Carolina law. Because the legislature took no action

on Regulation 61-12 within 120 days after its submission, it

became effective automatically upon publication in the State

Register on June 28, 1996.

E

Based on the evidence presented at trial, the district court

made detailed findings concerning Regulation 61-12 and its

probable effect on the health of women in South Carolina,

the cost of obtaining a first trimester abortion in South

Carolina, and the availability for obtaining a first trimester

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abortion in South Carolina. First, based on the evidence in

the record, the district court found that the first trimester

suction curettage abortion is one of the safest surgical

procedures that can be performed. The procedure lasts

approximately two to five minutes and has a low overall

complication rate. Suction curettage abortions can be, and

are currently being, safely performed in physicians’ offices

and outpatient clinics, except where the patient has particular

medical conditions that would require the procedure to be

performed in an ambulatory surgical center or hospital.

Medical abortions are also quick medical procedures that can

be safely performed in a physician’s office or outpatient

clinic. See Greenville Women’s Clinic, 66 F. Supp. 2d at

718.

Second, the district court found that physicians’ offices

and clinics that provide less than five first trimester abortions

per month perform identical procedures to those which

provide five or more first trimester abortions per month, and

the risk to the patient undergoing the abortion procedure is

identical. See id.

Third, the district court found that first trimester suction

curettage abortions are comparable in terms of risks,

duration, and invasiveness to a variety of obstetrical and

gynecological surgical procedures which are frequently

performed in physicians’ offices in South Carolina. These

would include suction curettage procedures performed on

women who have experienced an incomplete spontaneous

abortion, dilation and curettage procedures, endometrial

biopsies, hysteroscopies, and insertion of intrauterine devices

for birth control. See id.

Fourth, the district court found that first trimester suction

curettage abortions are also comparable in terms of risks,

duration, and invasiveness to a variety of non-

obstetrical/gynecological surgical procedures that are

A-61

frequently performed in physicians’ offices in South

Carolina. These would include the removal of subcutaneous

lipomas and cysts, minor breast biopsies, and the removal of

implanted ports and catheters which have been inserted into

large veins in the neck and collarbone region for use in

administering chemotherapy and dialysis. See id.

Fifth, the district court found that South Carolina is not

currently experiencing a public health problem related to the

provision of first trimester abortions by licensed physicians,

nor was the state experiencing such a problem when

Regulation 61-12 was promulgated. The district court found

no evidence that the plaintiffs or any other abortion providers

in South Carolina are providing inadequate care to women

seeking abortions or that the rate of complications from

abortions performed in South Carolina is greater than the

national average. On the contrary, the district court found

that South Carolina has experienced a similar, if not lower,

average complication rate. See id. at 718-19.

Sixth, the district court found that, although the principal

draftsmen of Regulation 61-12 have some expertise in

hospital and health care administration, they have no training

or education in the provision of hands-on medical care and -

little knowledge of the medical needs of women seeking first

trimester abortions in South Carolina. See id. at 719. The

district court found that they engaged in virtually no research,

investigation, or other efforts to determine what types of

requirements would be necessary or advisable for the

abortion procedure, or what types of requirements would

further or hinder the state’s interest in maternal health. Nor

did DHEC officials possess or seek information concerning

the present safety of first trimester abortions or the relative

risks associated with the procedure. See id.

Seventh, the district court found that, despite their

admitted lack of medical knowledge in general and of

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abortion procedures in particular, the drafters of Regulation

61-12 sought only minimal input and assistance from

knowledgeable medical experts during the drafting process,

choosing to rely solely upon the limited review and advice of

Dr. Goodrich and Lawyer as to discrete portions of the

regulation. See id. Furthermore, DHEC either rejected or

ignored an offer by ACOG to assist in the drafting process.

Although DHEC was under no legal obligation to consult

with ACOG or to accept their assistance during the drafting

process, the district court found that ACOG is unanimously

considered to be a well-respected medical organization

dedicated to improving the standard of health care in the field :

of obstetrics and gynecology. See id. According to the :

district court, DHEC’s rejection of ACOG’s assistance

further demonstrated DHEC’s lack of interest in ensuring that

Regulation 61-12 actually met the proffered goal of

promoting maternal health and is consistent with the

testimony of the DHEC witnesses that such a goal was not

their primary motivation during the drafting process. See id.

Eighth, the district court found that, although it is

uncontroverted that first trimester abortions are significantly :

less risky to the health of women than second trimester :

abortions, an existing South Carolina regulation governing 4

second trimester abortions was utilized as a starting point for

Regulation 61-12. With the exception of Section 309 of

Regulation 61-12 which specifically pertains to second

trimester abortions,’ the DHEC drafters drew no distinction

between first and second trimester abortions in the text of the

regulation. In addition; the DHEC drafters admitted that

virtually no such distinctions were considered during the

drafting process. See id.

8 Section 309 mandates additional qualifications which the performing

physician must possess, additional equipment which must be on hand,

and additional medica! tests which must be administered for second

trimester abortions. See S.C. Code Ann. Regs. 61-12, §§ 309(A)-(D).

A-63

Ninth, the district court found that, instead of attempting

to tailor Regulation 61-12 to the particularized medical needs

of women seeking first trimester abortion services in South

Carolina, DHEC’s goal during the drafting process was to

standardize its health care and facility regulations and to

codify existing departmental practices. See id. at 719-20.

According to the district court, to the extent this was done, it

was done without any meaningful inquiry or assessment as to

whether the requirements would further the state’s interest in

maternal health and without assessing whether first trimester

abortions were comparable to the procedures performed in

the other facilities regulated by DHEC. See id. at 720. The

district court further found that clinics that provide first

trimester abortions provide services that are significantly less

risky, invasive, and lengthy than the services offered in

ambulatory surgical centers, yet many of the requirements of

Regulation 61-12 are as stringent, or in some respects more

stringent, than those imposed upon ambulatory surgical

centers.? See id.

? In fact, Regulation 61-12 recognizes that the risks and potential

complications of surgical procedures typically performed in ambulatory

surgical centers are significantly higher than those associated with first

trimester abortions. Under Regulation 61-12, licensed abortion clinics

are restricted to performing abortions through eighteen weeks of

pregnancy measured from the pregnant woman’s Imp. See S.C. Code

Ann. Regs. 61-12, § 302(A). Abortion clinics performing abortions

beyond fourteen weeks of Pregnancy measured from the pregnant

woman’s Imp must meet the additional patient requirements in Section

309 of Regulation 61-12, which requires additional physician

qualifications, medical equipment, and mandatory laboratory tests. See

id. § 302(B). Abortions beyond eighteen weeks of pregnancy measured

from the pregnant woman’s Imp must be performed in a hospital,

although a licensed ambulatory surgical center that is also licensed as an

abortion clinic may perform abortions on patients through twenty-six

weeks of pregnancy measured from the pregnant woman’s Imp. See id. §

302(A).

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Tenth, the district court found that Planned Parenthood,

NAF, and ACOG standards and guidelines relied upon in

part by DHEC are recommendations by the respective

organizations and are not fairly characterized as mandated

standards of care which can or should be imposed upon

licensed physicians as regulatory requirements. Rather, they

are guidelines which should be followed with due regard for

the medicai judgment of the treating physicians and the

special needs of the patients they serve. Even if some of the

existing guidelines could, in isolation, be appropriate matters

for regulation, the district court found that Regulation 61-12

imposes requirements which greatly exceed the guidelines.

See id.

Eleventh, the district court found that, in imposing the

detailed requirements of Regulation 61-12, the DHEC

drafters also failed to take any meaningful steps to evaluate

the costs of compliance or its impact upon the availability of

abortion services in South Carolina. See id. Based upon the

evidence presented, the district court found that Regulation

61-12 will significantly increase the cost of abortion services

in South Carolina. See id. The district court found that this

increase in the cost of abortion services will delay a

significant number of women from obtaining the procedure

and, in some cases, result in their inability to obtain the

procedure. See id. The district court further found that, as a

pregnancy advances, the medical risks associated with

abortion increase, and a full term pregnancy and childbirth is

much more risky to the physical health of a woman than a

first trimester abortion. See id.

Twelfth, the district court found that Regulation 61-12

contained a myriad of detailed and costly provisions that

were medically unnecessary and, thus, were neither designed

to further the health of women seeking first trimester

abortions nor likely to accomplish this goal. For example,

with respect to Part I of Regulation 61-12, the district court

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observed that its definition of an “abortion” included medical

abortions currently used to terminate ectopic pregnancies.

See id. at 721. However, all of the evidence in the record,

including the testimony of Dr. Goodrich, suggested that

Regulation 61-12’s stringent requirements were medically

unnecessary for a physician or abortion clinic that performed

only medical abortions.

With respect to Part II, the district court found that this

portion of Regulation 61-12 is permeated with unnecessary

requirements governing physician qualifications, staffing,

and staff training. See id. The district court observed that

Regulation 61-12 requires physicians and clinics to hire a

registered nurse to supervise all nursing care in the abortion

clinic regardless of the fact that a licensed physician is

present in the clinic to supervise all medical care, including

nursing care. See id. The district court found that it is within

accepted medical practice, both within the abortion context

and in physicians’ offices performing comparable surgical

procedures, for a physician to hire licensed practical nurses

(who command a lower salary than registered nurses) so long

as they act under the supervision of the attending physician.

See id. . The district court found that the defendants offered

no persuasive reason why a physician could not supervise the

nursing care of patients during the recovery process simply

because the physician may be in another room for a brief

period of time. See id. In making this finding, the district

court recognized that even DHEC’s own medical consultant,

Dr. Goodrich, opined that a registered nurse need not be on

the premises to supervise care -- only that the nurse have

overall supervisory duties. See id.

Also with respect to Part II, the district court found that

Part II’s requirement that all abortion clinic health care

personnel receive tuberculin skin testing is medically

unnecessary in view of the fact that DHEC has not required

such testing of all health care personnel and did not offer any

A-66

justification for arbitrarily requiring this testing of all

abortion care workers, but not all other health care workers.

See id. at 722.

The district court also found that Regulation 61-12’s

requirement that ail allied health care personnel in abortion

clinics receive CPR training, as opposed to having one

qualified person at the clinic at all times, was medically

unnecessary in view of the fact that this requirement is

imposed solely upon abortion providers who perform,

according to all of the witnesses, one of the safest surgical

procedures that is performed in this country, and DHEC did

not offer any justification for arbitrarily imposing this

requirement. See id.

With respect to Part III, the district court found that the

level of policies and procedures required by this part, as well

as the extensive in- service training requirements and other

policies required in Part II, are costly endeavors

unsubstantiated by a medical need. See id. The district court

observed that such requirements may be appropriate for large

medical care facilities with large staffs that do not interact on

a daily basis. See id. However, according to the district

court, Regulation 61-12 arbitrarily imposes it upon every

clinic and every physician’s office which performs five or

more first trimester abortions per month -- regardless of the

number of staff or hours of operation. See id.

The district court also found that it was medically

unnecessary to have every woman undergo (and pay for)

testing for certain sexually transmitted diseases (but not

others), without regard to whether such tests are medically

indicated and indeed even when the physician determines

that they are not, simply because the woman has chosen to

obtain a first trimester abortion from a physician who

A-67

performs them on a regular basis.!° See id. The district court

further found that Section 307’s requirement that abortion

providers have “consulting” arrangements with various

specialists before they can obtain a license to operate is

medically unnecessary and unduly burdensome because no

evidence was presented relating to why licensed physicians

are not capable of exercising appropriate discretion in

recognizing and acting upon the medical needs of their

patients in this regard. See id. at 722-23.

Also with respect to Part III, the district court found’that

Regulation 61-12 inexplicably imposes requirements

concerning access to emergency drugs which are not imposed

upon any other physicians. See id. at 723. The district court

also found that the equipment and supplies required by

Regulation 61-12 will also increase the costs of providing

abortions in South Carolina, and require equipment

unnecessary for the safe performance of the first trimester

abortion procedure. See id.

With respect to Part IV, the district court found that this

part of Regulation 61-12 was particularly troubling. For

example, the district court found that the requirement that a

woman seeking an abortion provide the name of her spouse

in addition to an emergency contact is a medically

unnecessary requirement which imposes a substantial

obstacle in the path of a woman who, for personal reasons,

may not wish to disclose this information. See id. The

district court also found that, although the abortion clinic was

required to keep patient records confidential, nothing

prohibited DHEC from publicizing these records once it

'0 Of note, the district court found that the defendants presented

insufficient evidence to support a finding that sexually transmitted

diseases are more prevalent in woman seeking abortions or that abortion

clinics present a public health problem in this regard. See Greenville

Women’s Clinic, 66 F. Supp. 2d at 733 n.16.

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obtained them pursuant to an inspection. See id. at 702.

With respect to Part VIII, the district court observed that

this part of Regulation 61-12 imposed extensive and detailed

design and construction requirements for abortion facilities,

which far exceed building code requirements applicable to

other physicians’ offices, including those that perform

identical and comparable procedures. See id. at 723. The

district court found that these extensive requirements, while

perhaps appropriate for a hospital or large ambulatory

surgical center, are not justified by expected medical benefits

to the women undergoing the relatively safe, first trimester

suction curettage abortion in a small physician’s office or

clinic. See id.

Also with respect to Part VIII, the district court found

that additional requirements, which were advanced as unique

to the medical field, had no justification in medical necessity.

For example, the district court found no evidence supporting

a need for an abortion clinic to install additional bathroom

equipment and emergency call buttons or that it have a

recovery area separate from the procedure area. See id. at

724. The district court further found that no credible

evidence was presented demonstrating that physicians should

be required to widen their doors and corridors to a width

sufficient to accommodate both an ambulance stretcher and a

person walking alongside to perform cardiopulmonary

resuscitation, particularly given the unanimous testimony that

a first trimester abortion is a relatively safe procedure with

infrequent complications. See id. The district court found no

evidence that this need had ever arisen from the performance

of a first trimester abortion in South Carolina or elsewhere.

See id. Finally, the district court observed that physicians

performing surgical procedures of comparable invasiveness

and risk are not required to renovate their offices to meet a

similar requirement. See id.

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With respect to Part IX, the district court found that this

part of Regulation 61-12 required numerous certifications

and laboratory test results concerning various parts of the

abortion clinic (such as the carpets and draperies) without

any evidence that the these requirements would further the

goal of protecting women’s health in South Carolina. See id.

With respect to Part X, the district court observed that, in

conjunction with Section 103(C), Part X grants to DHEC

unfettered power to “manage [ ]” abortion providers “in

accordance with the best practices as interpreted by the

Department,” S.C. Code Ann. Regs. 61-12, Part X, and to

cite providers with a Class III violation and penalty if DHEC

observes a condition deemed to be “against the best practices

as interpreted by the Department,” id. § 103(C). The district

court found that Part X imposed upon abortion providers the

additional burden of determining and complying with -

standards or practices not specified in the regulation, but

which DHEC may in the future find to be “best” for an

abortion clinic. See Greenville Women’s Clinic, 66 F. Supp.

2d at 724.

Finally, the district court found that a first trimester

suction curettage abortion in South Carolina currently costs

between $325 and $480, depending on the gestational age,

the type of sedation or anesthesia needed, and the medical

testing indicated. See id. at 717. The district court further

found that Regulation 61-12 would raise the cost of each

abortion performed by the plaintiffs in the following

ranges:!!

'l The lowest figure represents the defendants’ revision of the

plaintiffs’ estimates of complying with Regulation 61-12. The highest

figure represents the plaintiffs’ estimate. The district court observed that

neither figure, however, takes into account the standard 15% profit factor

which the plaintiffs’ accountant testified would be appropriate. See

Greenville Women’s Clinic, 66 F. Supp. 2d at 717 n.10

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(1) For CWMC, the cost will increase between $36.48

and $75.03; .

(2) For Dr. Lynn’s Greenville practice, the cost will

increase between $93.09 and $170.39;

(3) For Dr. Lynn’s Beaufort practice, the cost will

increase between $115.67 and $367.50;

(4) For GWC, the cost will increase between $22.68 and

$32.39.!2

See id. The district court found that the substantial

alterations that Dr. Lynn would have to undertake to bring

his Beaufort practice in compliance with Regulation 61-12

will likely force him to close his practice, thereby eliminating

the availability of abortions in this area of South Carolina.!3

12 At trial, the parties entered into several notable stipulations

concerning the cost of complying with certain specific provisions of

Regulation 61-12:

(1) When directly billing physicians, laboratories in South Carolina

generally charge between $20 and $40 per sample to perform a

combined test for chlamydia and gonorrhea.

(2) When directly billing physicians, laboratories in South Carolina

generally charge between $17 and $30 per sample to test for the

Du variant.

(3) When directly billing physicians, laboratories in South Carolina

charge between $7 and $20 per sample to perform a test for

syphilis and between $10 and $22 to perform a test from a pap

smear.

13 At trial, the plaintiffs presented evidence that, to comply with

Regulation 61-12, CWMC would require renovations costing

approximately $27,235, that Dr. Lynn’s Greenville practice would require

renovations costing approximately $2,700, that Dr. Lynn’s Beaufort

office would need renovations costing approximately $12,256, and that

GWC would need renovations costing approximately $3,700.

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See id. The district court also found that the increased cost of

providing abortions and/or the closure of the only abortion

clinic in one area of a state resulting from Regulation 61-12

will prevent a significant number of women from obtaining

an abortion or, at a minimum, delay them from obtaining the

abortion, both of which carry increased risks to the health of

women.'4 See id. at 718. The district court found that, asa

pregnancy advances, the medical risks associated with an

abortion procedure increase, and a full term pregnancy is

more risky to the physical health of a woman than a first

trimester abortion. See id. at 720.

F

Based on the findings of the district court summarized

above, the district court concluded that Regulation 61-12

violated the Due Process and Equal Protection Clauses of the

Fourteenth Amendment. See id. at 724-43. With respect to

the Due Process Clause, the district court held that

'4 The district court’s finding in this regard was premised on the

testimony of the plaintiffs’ expert, Dr. Stanley Henshaw, who is currently

deputy director of research at the Alan Guttmacher Institute in New York,

where he conducts studies relating to family planning and abortion

services. Dr. Henshaw testified that an increase in the price of abortion

procedures prevents a number of women from obtaining abortions and

causes other women to delay their abortions until further along into their

pregnancies. Dr. Henshaw also testified that relatively small increases in

the cost of an abortion will have this effect, and that an increase of just

$25 can be expected to prevent one or two out of every 100 low-income

women seeking an abortion from being able to obtain one. Dr. Henshaw

also testified that a decrease in the number of abortion providers in South

Carolina will result in a decrease in the number of women who are able to

obtain an abortion in the state, and a Corresponding increase in the

number of women who must travel to obtain the procedure, e.g., from

Beaufort to Savannah, Georgia and/or Charleston, South Carolina. Such

a need to travel will, in turn, reduce the ability to obtain an abortion or

result in a delay in obtaining the abortion. And the need to travel carries

its own costs, which will increase the overall cost of obtaining the

abortion and compound the financial problem.

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Regulation 61-12 failed to pass constitutional muster under

either the facial invalidity standard set forth in United States

v. Salerno, 481 U.S. 739 (1987), or the undue burden test set

forth in Planned Parenthood v. Casey, 505 U.S. 833 (1992)

(plurality joint opinion of O’Connor, Kennedy, and Souter,

J.J.). See Greenville Women’s Clinic, 66 F. Supp. 2d at 727-

37. With respect to the undue burden standard set forth in

Casey, the district court held that Regulation 61-12 did not

serve and was not designed to serve the state’s interest in

maternal health. See id. at 730-35. To the contrary, the

district court concluded that Regulation 61-12 would likely

harm the health of women in South Carolina. See id.

Accordingly, the district court concluded that Regulation 61-

12 was unconstitutional under Casey. See id. at 735. The

district court also concluded that even if Regulation 61-12

furthered the state’s interest in maternal health, the burdens

imposed by Regulation 61-12 upon abortion patients and

providers constituted an undue burden on a woman’s right to

have an abortion prior to viability. See id. at 735-43. With

respect to the standard set forth in Salerno, the district court

concluded that Regulation 61-12 was unconstitutional in all

of its applications and, therefore, could not stand under

Salerno. See id. at 736-43.

With respect to the Equal Protection Clause, the district

court held that Regulation 61-12 violated the Equal

Protection Clause under both the strict scrutiny test and the

more lenient rational basis test. See id. at 737-43. With

respect to the rational basis test, the district court held that

Regulation 61-12 failed that test because it singles out

physicians and abortion clinics performing five or more first

trimester abortions per month from other physicians and

clinics performing four or less first trimester abortions per

month and/or other virtually identical procedures and places

additional and onerous burdens upon physicians and abortion

clinics which are neither justified by actual differences nor

rationally related to the state’s legitimate interest in

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protecting the health and safety of women seeking first

trimester abortions. See id. at 740-43.

Finally, the district court concluded, in light of both

South Carolina law and the text of Regulation 61-12, that

Regulation 61-12 was not subject to the doctrine of

severability.'5 See id. at 743-44,

=

A

The Due Process Clause of the Fourteenth Amendment

States that: “nor shall any State deprive any person of life,

liberty, or property, without due process of law.” U.S. Const.

amend. XIV, § 1. “Although a literal reading of the Clause

might suggest that it governs only the procedures by which a

State may deprive persons of liberty, ... the Clause has been

understood to contain a substantive component as well, one

barring certain government actions regardless of the fairness

of the procedures used to implement them.” Casey, 505 U.S.

at 846, (plurality joint opinion of O’Connor, Kennedy, and

Souter, J.J.) (citation and internal quotation marks omitted).

A woman’s right to have an abortion is recognized as a

fundamental right protected by the substantive component of

the Due Process Clause of the Fourteenth Amendment. See

Roe v. Wade, 410 U.S. 113, 155-66 (1973); see also Manning

v. Hunt, 119 F.3d 254, 259 (4th Cir. 1997). '6

'S In light of its ruling that Regulation 61-12 violated the Due Process

61-12: (1) was unconstitutionally vague; (2) violated the abortion

patients’ confidentiality rights; and (3) violated the Establishment Clause

of the First Amendment.

' Because Regulation 61-12 applies to first trimester abortion

providers, the plaintiffs have standing to challenge the constitutionality of

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In Roe, the Supreme Court overturned a Texas statute

prohibiting abortions unless an abortion was necessary to

save the life of the mother. See 410 U.S. at 117. The Roe

Court held that the right of personal privacy includes the

right to have an abortion, but that the right “is not unqualified

and must be considered against important state interests in

regulation.” /d. at 154. The Court determined that because

abortion is a fundamental right, state abortion regulations

should be analyzed under the strict scrutiny standard of

review, and are, therefore, valid only if the regulation can be

justified by a compelling state interest and if the regulation

was narrowly drawn to further only that legitimate state

interest. See id. at 155. According to the Court, the state’s

interest in preserving and protecting the health of the mother

and in protecting potential human life increase in

substantiality as the woman approaches term, becoming

compelling at some point in the pregnancy. See id. at 162-

63.

The Roe Court found that during the first trimester of

pregnancy the decision to abort must be left to the wishes of

the mother and the judgment of the mother’s physician; that

during the time after the first trimester but before viability of

the fetus, the state could regulate the abortion decision in

ways reasonably related to maternal health; and that after

viability, the state could regulate or proscribe abortion except

when necessary to preserve the life or health of the mother.

See id. at 164-65.

Since Roe, the Court has struggled to formulate a precise

standard for reviewing facial challenges to abortion

regulations. In Salerno, the Court explained that

the regulation. See Virginia v. Am. Booksellers Ass'n, 484 U.S. 383, 392

(1988); Doe v. Bolton, 410 U.S. 179, 188 (1973).

A-75

[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. The fact that [an Act] might operate

unconstitutionally under some conceivable set of

circumstances is insufficient to render it wholly

invalid, since we have not recognized an

“overbreadth” doctrine outside the limited context of

the First Amendment.

481 U.S. at 745. Thus, under Salerno, a facial challenge to a

statute will fail if the statute has any constitutional

application. Following Salerno, the Supreme Court applied

Salerno’s “no set of circumstances” test in a few pre-Casey

cases involving abortion statutes. See, e.g., Rust v. Sullivan,

500 U.S. 173, 183 (1991).

In Casey, however, the Court held that an abortion law is

unconstitutional on its face if, “in a large fraction of the cases

in which [the statute] is relevant, it will operate as a

substantial obstacle to a woman’s choice to undergo an

abortion.” 505 U.S. at 895. Although Casey did not

expressly overrule Salerno, it is inconsistent with Salerno.

Under Salerno, no factual showing of unconstitutional

application can render a law unconstitutional if it has any

constitutional application. Under Casey, a factual showing of

unconstitutional application in “a large fraction of the Cases”

where the law applies can render a law unconstitutional, even

if it has some constitutional application.

In Casey’s wake, many circuit courts held that Casey

displaced Salerno in the abortion context. See, e.g., Planned

Parenthood v. Lawall, 180 F.3d 1022, 1027 (9th Cir. ) (“In

light of our previous suggestion, combined with the great

weight of authority holding that Casey has overruled Salerno

in the context of facial challenges to abortion statutes, we

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apply Casey’s undue burden standard in determining the

facial constitutionality of [the statute at issue].”), amended by

193 F.3d 1042 (9th Cir. 1999); Women’s Med. Prof’ Corp. v.

Voinovich, 130 F.3d 187, 193-96 (6th Cir. 1997) (concluding

that Salerno is inapplicable to facial challenges to abortion

regulations and applying Casey’s undue burden standard),

cert. denied, 523 U.S. 1036 (1998); Jane L. v. Bangerter, 102

F.3d 1112, 1116 (10th Cir. 1996) (noting the difference _

between Casey and Salerno and applying Casey’s undue

burden standard to facial abortion challenge); Planned

Parenthood v. Miller, 63 F.3d 1452, 1458 (8th Cir. 1995)

(choosing to follow “what the Supreme Court actually did --

rather than what it failed to say -- and apply the undue-

burden test” to facial abortion challenge); Casey v. Planned

Parenthood, 14 F.3d 848, 863 n.21 (3d Cir. 1994) (noting

that Supreme Court in Casey “set a new standard for facial

challenges to previability abortion laws’). The Fifth Circuit

has applied the Salerno test to a facial abortion challenge

after Casey, see Barnes v. Moore, 970 F.2d 12, 14 (Sth Cir.

1992), but its application of Salerno has not been consistent,

see Sojourner T. v. Edwards, 974 F.2d 27, 29-31 (Sth Cir.

1992) (striking down statute banning abortions as clearly

unconstitutional under Casey, even though it permitted

abortions to save the life of the mother and, therefore,

arguably passed constitutional muster under Salerno ), and

the Fifth Circuit has yet to resolve the inconsistency. See

Okpalobi v. Foster, 190 F.3d 337, 354 (Sth Cir. 1999) (noting

inconsistency but declining to address it because challenged

law failed under both Casey and Salerno ).

However, our circuit never resolved the Salerno/Casey

question, despite what the majority might have one believe.

See ante at 12-13. In Manning, we applied the Salerno

standard of review to an abortion statute, but the plaintiffs

did not challenge its applicability. See 119 F.3d at 268 n.4.

In dicta, however, the court suggested that we would

nonetheless apply the Salerno standard until the Supreme

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Court explicitly overruled it, stating that

[i]t is not the province of the court of appeals to

predict how the Supreme Court will ultimately rule

on an issue. Casey does not specifically overrule

Salerno. At the moment, the most that can be Said is

that three Justices have indicated a desire to do so.

Until the Supreme Court specifically does so, though,

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.

Id.; see also Planned Parenthood v, Camblos, 155 F.3d 352,

381 n.14 (4th Cir. 1998) (en banc) (noting the Manning

dicta but not deciding the question), cert. denied, 525 U.S.

1140 (1999); id. at 389 n.2 (Michael, J., concurring in the

judgment) (asserting that Casey’s undue burden test must be

applied to facial challenges to abortion restrictions).

The Salerno/Casey question was finally resolved by the

Supreme Court in Stenberg v. Carhart, No. 99-830, 2000 WL

8258899 (U.S. June 28, 2000). In that case, a Nebraska

physician brought a facial challenge to Nebraska’s “partial

birth” abortion statute. As interpreted by the Supreme Court,

the Nebraska statute banned the performance of second

trimester dilation and extraction (D&X) abortions, commonly

referred to as “partial birth abortions,” and the performance

of dilation and evacuation (D&E) abortions, the most

commonly used method for performing previability second

trimester abortions. The Supreme Court applied Casey and

concluded that the Nebraska statute was unconstitutional for

two independent reasons. First, the Court concluded that the

Nebraska statute was unconstitutional because the statute

lacked any exception for the preservation of the health of the

mother and the record evidence disclosed that, in some

_ circumstances, a D&X abortion would be the safest abortion.

See Stenberg, No. 99-830, 2000 WL 825889, at *10-14.

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Second, the Court concluded that, because the Nebraska law

applied to the performance of D&E abortions, the most

commonly used method for performing previability second

trimester abortions, the resulting fear of prosecution,

conviction, and imprisonment felt by physicians who

perform D&E abortions amounted to an undue burden on a

woman’s right to have an abortion. See id. at *15-19.

In this case, the district court did not resolve the

Salerno/Casey question. See Greenville Women’s Clinic, 66

F. Supp. 2d at 726-27. Instead, the district court analyzed

Regulation 61-12 under both standards and held that

Regulation 61-12 failed to pass constitutional muster under

either the Salerno or Casey standard. See id. at 727-37.

Here, being bound by Stenberg, I only need to evaluate

Regulation 61-12 under the principles set forth in Casey, as

contrary to the majority’s intimation, see ante at 12-13,

Salerno, in the abortion context, is not recognized as the law

by the current Supreme Court.

In Casey, the Supreme Court established the undue

burden test for determining whether a statute restricting

abortions could pass constitutional muster. Under Casey, a

statute is invalid on its face if it places an undue burden on a

woman’s right to have an abortion before the fetus attains

viability. See 505 U.S. at 878. An undue burden exists if the

state regulation has the effect of placing a substantial

obstacle in the path of a woman’s choice to obtain an

abortion before the fetus attains viability. Jd. at 877-78. A

statute that creates a substantial obstacle for a large fraction

of those women affected by the regulation creates an undue

burden and is facially unconstitutional. See id. at 894-95.

Thus, in Casey, the Court rejected Roe‘s trimester

framework, but left intact a woman’s fundamental right “to

choose to have an abortion before viability and to obtain it

without undue interference from the state.” Jd. at 846. In

reaching this conclusion, the Court recognized that the state’s

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interests prior to viability “are not strong enough to support a

prohibition of abortion or the imposition of a substantial

obstacle to the woman’s effective right to elect the

procedure.” Jd. ;

In Casey, the Supreme Court was presented with

constitutional challenges to various provisions in a

Pennsylvania statute governing informed consent, parental

consent, record-keeping and reporting requirements, and a

medical emergency exception. See id. at 844. Thus, the

plurality opinion primarily focused on the state’s legitimate

interests in the potentiality of human life -- holding that to

promote this “profound interest in potential life, throughout

pregnancy the State may take measures to ensure that the

woman’s choice is informed, and measures designed to

advance this interest will not be invalidated so long as their

purpose is to persuade the woman to choose childbirth over

abortion” and they do not impose an “undue burden on the

right.” Jd. at 878.

Nevertheless, the Casey plurality also provided guidance

by addressing the state’s concomitant, and equally legitimate,

interest in preserving and protecting the health of women

seeking abortion services -- of particular relevance to the

challenge in this case. Specifically, the Casey plurality held

that as

with any medical procedure, the State may enact

regulations to further the health or safety of a woman

seeking an abortion. Unnecessary health regulations

that have the purpose or effect of presenting a

substantial obstacle to a woman seeking an abortion

impose an undue burden on the right.

Id. at 878 (emphasis added).

The types of burdens that may be imposed by state

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regulation are varied in nature, but clearly include financial

burdens which restrict or prohibit the exercise of the right.

As noted by the Casey plurality:

Numerous forms of state regulation might have the

incidental effect of increasing the cost or decreasing

the availability of medical care, whether for abortion

or any other medical procedure. The fact that a law

which serves a valid purpose, one not designed to

strike at the right itself, has the incidental effect of

making it more difficult or more expensive to procure

an abortion cannot be enough to invalidate it. Only

where the state regulation imposes an undue burden

on a woman’s ability to make the decision does the

power of the State reach into the heart of the liberty

protected by the Due Process Clause.

Id. at 874; see also id. at 901. Furthermore, “[n]ot all

burdens on the right to decide whether to terminate a

pregnancy will be undue.” Jd. at 876. As the Casey plurality

noted:

A finding of an undue burden is a shorthand for the

conclusion that a state regulation has the purpose or

effect of placing a substantial obstacle in the path of a

woman seeking an abortion of a nonviable fetus. A

statute with this purpose is invalid because the means

chosen by the State to further the interest in potential

life must be calculated to inform the woman’s free

choice, not to hinder it. And a statute which, while

furthering the interest in potential life or some other

valid state interest, has the effect of placing a

substantial obstacle in the path of a woman’s choice

cannot be considered a permissible means of serving

its legitimate ends.

Id. at 877. Accordingly, the court must first determine

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whether Regulation 61-12 furthers the State’s interest in

maternal health, which is the siate interest the defendants

contend Regulation 61-12 was designed to serve. See id.; id.

at 900-01 (“The collection of information with respect to

actual patients [which, under the statute at issue, will remain

confidential] is a vital element of medical research, and so it

cannot be said that the requirements serve no purpose other

than to make abortions more difficult.”). If Regulation 61-12

furthers the state’s interest in maternal health, the court must

next determine whether Regulation 61-12 imposes an undue

burden on a woman’s right to seek an abortion. See id. at

877, 901.

In this case, a careful review of the record discloses that

Regulation 61-12 does not further the State’s interest in

maternal health. With respect to whether Regulation 61-12

furthers the state’s interest in maternal health, I note that the

Supreme Court has not provided much guidance in this area.

However, several pre-Casey cases do provide some insight.

For example, in Roe’s companion case, Doe v. Bolton, the

Court invalidated a Georgia law requiring that all firs

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