# Appendix — Greenville Women's Clinic v. Bryant

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URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386014_1354%3A2

## Record

- **Collection:** Supreme Court brief
- **Document type:** Appendix
- **Published:** January 1, 2001
- **Citation:** 531 U.S. 1191

## Text

No. 00-__ Be» esr Court, U.S.
00 798 Nov 172000

' OFFICE OE THE CLERK

Supreme Court of the United States

+ age Informed consent for an abortion is already required by state law. See
S.C. Code Ann. § 44-41-30 and § 44-41-310 et seq (Law Co-op Supp.
1997).

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14. Section 204 sets forth detailed personnel requirements.
The facility must obtain and verify professional and
personal background information on every employee
and must develop and implement a written orientation
program for new staff members, to include orientation
on the other policies and procedures. A formal, written,
inservice training program must also be planned and
provided for all employees and volunteers, and records
kept of attendance. The inservice training of all
employees and volunteers must include four specified
areas -- infection control, fire protection, confidentiality
and patient rights, and licensing regulations. Written
job descriptions must be prepared and reviewed
annually, and a personnel file containing various
mandated information must be kept on all employees.
Annually, each employee must have a tuberculin skin
test or, if previously positive, a chest x-ray to determine
whether tuberculosis is present. If tuberculosis is
diagnosed, the facility must provide treatment and
investigate employee contacts. 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.
According to the medical evidence in this case, this
would include such ordinary illnesses as a common
cold. In addition, all professional and allied health
professional staff members must be certified by the
American Red Cross or American Heart Association as
capable of performing CPR, although only one such
certified person must be with patients when they
undergo the abortion procedure and during the recovery

period.

15. Section 205 sets forth requirements for the clinical
staff, which encompasses all physicians, nurses, and
allied health professionals. Abortions may only be

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performed by physicians licensed to practice medicine
in South Carolina who are also “properly qualified by
training and experience to perform pregnancy
termination procedures.” S.C. Code Regs. 61-12,
Section 205.C.1. The regulation, however, provides no
guidance on the additional credentials required beyond
that of a medical license to meet this qualification
standard. The facility 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. 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 facility, and the
registered nurse must be “on duty to provide or
supervise all nursing care” during preparation, the
procedure, recovery, and discharge. S.C. Code Regs.
61-12, Section 205.D.2. Licensed practical nurses may
be employed so long as they work under the
supervision and direction of a registered nurse.
Ultrasounds may only be conducted by physicians or
ultrasound technicians who have documented evidence
of completion of a training course in ultrasonography.
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.

Sections 206 through 208 of the regulation require the
facility to comply with state statutory sections
pertaining to the dissemination of information to
women seeking abortions and to obtaining consent to
perform the procedure, each of which already contains
penalty provisions for the failure to comply. Thus,
these portions of the regulation do nothing more that
impose a second layer of penalties (indeed, the most

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severe Class I penalties) for the conduct already

punishable under the statutory sections incorporated
within the regulation.

Section 209 of the regulation requires the facility to
“have written policies and procedures to assure the
individual patient the right to dignity, privacy, safety,
and to register complaints with [DHEC].” S.C. Code
Regs. 61-12, Section 209. A copy of the patient rights
must be conspicuously displayed, and a copy must be
signed by each patient and included in the patient’s
medical record. However, no guidance is provided as
to what specific information must be included in these
documents.

Part III of the regulation sets forth requirements for
“Patient Care.” Additional “patient care policies and
procedures designed to ensure professional and safe
care for patients” must be developed, S.C. Code Regs.
61-12, Section 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, special examinations, lab
procedures and consultations which will be required,
and ultrasonography procedures); details regarding the
actual abortion procedure (including the use of [V’s,
fluids, analgesia, anesthesia, and tissue examination and
disposal); details regarding post-procedure care and
recovery room care, including emergency care;
“{p]rovisions for education of the patient, family and
others, as appropriate in pre and post-procedure care,”
S.C. Code Regs. 61-12, Section 301.F.; plans for
follow-up care, including arrangements for a
postoperative visit and specific instructions in the event

of an emergency; procedures for the management and
referral of high-risk conditions; procedures for the

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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 facility); and procedures for
the registration of fetal death or death certificates.

Section 303 of the regulation imposes detailed
requirements concerning emergency drugs which must
be kept on the premises, and specifies seven medical
conditions for which drugs and equipment must be
available. In addition, the regulation mandates the
presence of a refrigerator with “[a] thermometer
accurate to +/- 3 degrees Fahrenheit.” S.C. Code Regs.
61-12, Section 303.C. A specific method of preparing
medications for administration is mandated, including a
requirement that a sink and counter be in the area.

Section 304 requires laboratory services to be
performed in compliance with the requirements already
mandated by the Clinical Laboratory Improvement
Amendments of 1988, (“CLIA”), 42 U.S.C.A. § 263a
(West 1991).° 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. In
addition, the physician must perform a test to determine
Rh factor. If the patient is Rh positive, an additional
Du variant test is required. Rh (D) immune globulin
must be administered if the patient is determined to be
Rh negative. Testing for chlamydia and gonorthea is

® The court notes, however, that CLIA-88 has been subsequently
amended, see 42 U.S.C. § 263a (West Supp. 1998).

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mandatory, but testing for syphilis serology and
performance of a Papanicolaou (pap) smear must only
be offered to the patient.

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. S.C. Code Regs. 61-12, Section
305.A. The facility must maintain equipment and
services to render emergency resuscitative and life-
support procedures pending transfer. And the facility
must notify, in writing, the local ambulance service of
the location of the facility and the nature of the medical
problems which may result from abortions.

Section 306 mandates that the facility 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, intravenous fluids, “[a] clock
with a sweep second hand,” sterile suturing equipment
and supplies, an adjustable examination light, and
soiled linen and waste containers. S.C. Code Regs. 61-
12, Section 306.

Section 307 mandates that the facility have
“{a}rrangements ... for consultation or referral services
in the specialties of obstetrics/gynecology,
anesthesiology, surgery, psychiatry, psychology,
clinical pathology and pathology, clergy, and social
services, as well as any other indicated field, to be
available as needed.” S.C. Code Regs. 61-12, Section
307. The regulation does not specify whether the

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“arrangements” must be in writing, nor does it specify
the number of clergymen or types of religious
counseling which must be made available.

Section 308, entitled “Quality Improvement,” again
mandates a written plan for a quality improvement
program for patient care and designation of an
individual responsible for coordinating the program.
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.”
S.C. Code Regs. 61-12, Section 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,” S.C. Code Regs. 6i-
12, Section 308.B, but the regulation does not specify
what criteria are acceptable or required. The process
must incorporate a quarterly review of a minimum of
five percent of the medical records per quarter, 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.” S.C. Code Regs. 61-12,
Section 308.E. The facility administrator must review
the findings of the program and ensure corrective
actions are taken. The program must also identify and
establish indicators of quality care, specific to the
facility, that must be monitored and evaluated. Annual
review of the results is also required.

Part IV of the regulation 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

Se et etl ae hee

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information. Of particular concern to the plaintiffs in
this case, the section requires a face sheet with patient
identification data, including the name of the patient’s
husband in additien to the name, address and telephone
number of a person to be notified in the event of an
emergency. The records are required to be kept
confidential by the facility (although no such
requirement is imposed upon DHEC inspectors who
obtain them) and must be stored for a minimum of 10
years. Section 403 requires the preparation of
additional reports, including a record of every accident
or incident occurring in the facility which involves
patients, staff, or visitors. If it results in serious injury,
the accident or incident must be self-reported to DHEC.
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.
S.C. Code Regs. 61-12, Section 403.B.

Part V of the regulation, 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 facility; provisions for syringe and
needle handling and storage; and provisions for
managing infections waste in accordance with another
DHEC regulation already governing such matters. In
addition, the facility must prepare and post a disaster
preparedness plan for evacuation in the event of a fire
or other emergency. All parts and portions of the
facility are generically required to be kept “in good
repair and operating condition,” and “free of hazards.”
S.C. Code Regs. 61-12, Section 503.A. In addition,
the section requires that “{a]ll wooden surfaces shall be

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sealed with a non-lead based paint, lacquer, varnish, or
shellac that will allow sanitization.” Id, A written
preventive maintenance program must be developed
and implemented for patient monitoring equipment and
tested in accordance with manufacturer’s specifications,
but not less than annually. Records of maintenance and
testing must be kept.

Part VI of the regulation is entitled “Infection Control
and Sanitation.” It 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. The regulation contains provisions
mandating “adequate” linens and “proper laundering,”
and provides that “[a] sufficient supply of cloth or
disposable towels shall be available so that a fresh
towel can be used after each handwashing.” S.C. Code
Regs. 61-12, Section 603. It specifically prohibits
towel-sharing. The regulation also generically requires
that the facility “be kept neat, clean, and free from
odors,” mandates specific requirements for cleaning
methods to be used and prohibits others, and imposes
requirements for refuse and waste disposal. S.C. Code
Regs. 61-12, Sections 604 & 605. Section 606 requires
that “[a}ll outside areas, grounds and/or adjacent
buildings shall be kept free of rubbish, grass, and weeds
that may serve as a fire hazard or as a haven for insects,
rodents and other pests,” and that all “[o]utside stairs,
walkways, ramps and porches shall be maintained free
from accumulations of water, ice, snow, and other
impediments.” S.C. Code Regs. 61-12, Section 606.

Part VII of the regulation, entitled “Fire Protection and
Prevention,” provides detailed requirements for fire-
fighting equipment and systems, an evacuation plan,
training of employees in the evacuation plan,

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mandatory fire drills at least once every three months,
maintenance of fire equipment, and maintenance of
records proving compliance with the provisions.

Part VIII of the regulation sets forth detailed
requirements for the “Design and Construction” of
abortion facilities. There is no grandfathering provision
(unlike other DHEC regulations governing medical and
patient care facilities) -- rather all facilities must be in
full compliance within two years. The requirements are
set forth in overwhelming detail, rendering a summary
of them impossible. By way of example, however, the
regulation governs the number and size of procedure
and recovery rooms, specifies the design and equipment
required in toilet rooms, regulates the direction of the
“{ajir flow” within the sterilization rooms, S.C. Code
Regs. 61-12, Section 807.F., 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
72 and 76 degrees), regulates the facility’s air supply
and exhaust, regulates design criteria for clinic
entrances, sets forth specific requirements for the
“janitor’s closets,” S.C. Code Regs. 61- 12, Section
807.0., and specifies the corridor glazing materials,
wall finishes, wall bases, and interior finish materials
that must be present. The regulation also regulates
water supply and plumbing within the facilities.

Part [X of the regulation sets forth additional
“Prerequisites for Initial Licensure” of the facility,
including plan and construction approval by DHEC,
and specifies the documentation required to be
submitted with the facility’s initial application for
licensure.

Finally, Part X of the regulation, entitled “General”

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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.” S.C. Code Regs. 61-
12, Part X. As noted previously, a violation of such an
unspecified requirement is considered a Class III
violation of the regulation.

At the trial of the case, defendants sought to enter
several “stipulations” concerning their intended
interpretation of certain requirements of the regulation.
First, as to Section 102.F.2., which grants DHEC
inspectors the right to copy medical records without a
confidentiality provision, defendants assert that DHEC
“policy” would protect the confidentiality of these
records, as would the provisions of S.C. Code Ann. §§
44-7-310 and 315 (Law Co-op. Supp. 1997). Second,
as to Section 307 which requires the facility tc make
“[a]rrangements” with various specialties, aefendants
contend that the section does not require written
“agreements” with such specialties, but only that the
physician attempt to assist the patient in obtaining a
referral when such services are indicated and/or
requested by the patient. Third, as to Section 205(C)(2)
which requires the facility to enter into a signed written
agreement with at least one physician board certified in
obstetrics and gynecology (if one is not on staff) and
who has admitting privileges at a local hospital,
defendants sought to delete the board-certification
requirement. Finally, as to Section 602.C.1 which
requires daily autoclave testing, defendants admit this is
an error and that it should be weekly testing. Plaintiffs
have not joined in these “‘stipulations.” Instead, they
contend that defendants’ proposals are efforts to rewrite
the regulation.

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D. Abortion Services in South Carolina

According to the evidence in this case, there are no
abortion providers in South Carolina who perform
elective abortions (those not associated with medical
complications) in the second trimester of pregnancy.
All of the plaintiffs in this action limit their services to
abortions during the first trimester of pregnancy.

Plaintiffs in this case currently use the suction curettage
procedure during the first trimester for elective
abortions. The 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
relatively safe and quick medical procedure performed
between six and fourteen weeks 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. 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 | in 100, serious complications are rare. The rate
for complications requiring hospitalization is only
about | in 2000. And the mortality rate is 1 in 100,000,
which is about 25 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

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resulted in a woman’s death in this state.

35. Physicians in South Carolina, including Dr. Buffkin
and Dr. Campbell, also perform medical abortions to
terminate pregnancies located outside the uterus (suck
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. It involves
the performance of a routine blood test to measure the
patient’s hormone levels, followed by the injection of a
drug (methotrexate) into the patient’s arm. There is no
recovery time after the injection, and only mild vaginal
bleeding. Follow-up care consists of rechecking the
patient’s hormone levels several days after the
injection, and rechecks thereafter at seven day intervals.
Although currently limited in use to the termination of
ectopic pregnancies, methotrexate and a second drug,
RU- 486, are currently being used in research protocols
for use in terminating intrauterine pregnancies.

36. Regulation 61-12 applies to abortion clinics performing
five or more first trimester abortions and/or a single
second trimester abortion per month. It is undisputed
that second trimester abortions are significantly more
risky to the health of women than first trimester
abortions. Because the plaintiffs in this case only
provide abortions during the first trimester of
pregnancy, plaintiffs’ challenge to the regulation is
limited to its application to providers of first trimester
abortions in South Carolina. Accordingly, the court
will express no opinion as to the constitutionality of
Regulation 61-12 as applied to facilities which may
seek to perform second trimester abortions in the
future.’

7 Regulation 61-12 contains an additional section, Section 309 under Part
Ill “Patient Care,” which mandates additional qualifications which the

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E. The Drafting and Promulgation of Regulation 61-12

37. At the trial of this case, several DHEC employees and a
DHEC consultant testified concerning the drafting and
promulgation of Regulation 61-12. The testimony
reveals that the regulation was not tailored to further the
state’s legitimate interest in preserving and protecting
the tiealth of women seeking first trimester abortions
and that the drafters took no meaningful steps to ensure
that it would serve that purpose. Nor did they attempt,
in any meaningful fashion, to determine the financial
impact the regulation might have on the provision of
first trimester abortion services in the state.

38. First, DHEC officials were not aware of any public
health problem associated with facilities providing
abortions in South Carolina and did not investigate
whether there were any such public health problems
prior to drafting the regulation. Indeed, it is undisputed
that DHEC promulgated the regulation solely in
response to the legislative directive contained within
S.C. Code Ann. § 44-41-75. }

39. After the legislation requiring licensure of abortion
clinics was passed, Mr. Alan Samuels with DHEC was
charged with the responsibility for supervising the
drafting and promulgation of the regulation. Although
Mr. Samuels has some experience in health care

performing physician must possess, additional equipment which must be
on hand, and additional medical tests which must be administered for
second trimester abortions. Defendants have offered an additional
“stipulation” regarding its provisions. Although not relevant to the
challenge before this court, the section lends some support to the court's
finding that second trimester abortions are more risky and raise different
concerns than first trimester abortions.

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administration, he has received no formal medical
training or education. Upon completion of his college
education, Mr. 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, Mr. 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 the
DHEC Health Licensing Division, and has now retired.

Although Mr. Samuels provided some input and edits
during the drafting process, he did not personally draft
any portions of the regulation. Rather, he delegated the
primary drafting responsibility to Mr. George Moore,
who was the Director of Outpatient and Home Care
within the Division of Health Licensing. Mr. Samuels
admitted that he knew very little about abortion
procedures or the differences between first trimester
and second trimester abortions when the regulation was
promulgated. His testimony also reveals that he
personally 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 Mr. Samuels, Mr. Moore has some education and
experience with hospital administration, but has
received no formal medical training or education. After
receiving an undergraduate degree, Mr. 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

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the medical services corps where he performed
administrative duties associated with health care
facilities and hospitals. During his service, Mr. Moore
received a masters degree in hospital administration.
Upon his retirement from military service in 1988, Mr.
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 Mr.
Samuels asked him to assume primary responsibility
for the drafting of the regulation. In preparation for
drafting the regulation, however, Mr. Moore also 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 the regulation
(Fire Protection and Prevention/Design and
Construction), Mr. Moore turned to Mr. William
Lafferty, who was the Director of Health Facilities
Construction with DHEC. Like Mr. Samuels and Mr.
Moore, Mr. Lafferty has received no formal medical
training or education. He testified that in drafting these
portions of the regulations, he made no effort to
determine whether the requirements were medically
appropriate for facilities performing only first trimester
abortions and that this was not his orientation. Mr.
Lafferty also testified that he 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 the regulation was not made by Mr.
Lafferty.

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43. According to Mr. 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 the
new regulation 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 defendants, 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.

44. 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. Mr. Moore testified that departmental
practice currently allows the copying of medical
records during a complaint investigation and that
DHEC would maintain the confidentiality of the
records. However, there is no provision in Regulation
61-12 which would mandate such confidentiality and
defendants have pointed to no other state laws or
regulations which would, in the court’s opinion,
adequately protect a patient’s confidential medical
records. In addition, the court notes that the DHEC
regulation governing ambuiatory surgical centers
contains a specific provision protecting the

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confidentiality of medical records. See S.C. Code
Regs. 61-91, Section 1001.E (providing that records
may only be removed from the premises by subpoena
or court order).

45. Furthermore, defendants presented no evidence
comparing the patient risks presented in other types of
facilities regulated by DHEC with those presented in
physicians’ offices or clinics performing first trimester
abortions, with the possible exception of ambulatory
surgical centers. However, the medical evidence
presented reveals, and there is little dispute, 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.* Yet a comparison of the
regulations reveals that in many ways Regulation 61-12
imposes requirements more stringent than those
imposed upon ambulatory care centers. Furthermore,
there is no evidence in the record as to how DHEC
formulated the regulations applicable to ambulatory
surgical centers, or whether they received substantial
assistance from medical professionals during the
drafting process. Accordingly, the mere fact that some
of the requirements contained within Regulation 61-12
are similar to those contained within the ambulatory
surgical center regulation is of little assistance to this

8 Indeed, the regulation itself recognizes this distinction. Under the
regulation, licensed abortion clinics are restricted to performing abortions
within 18 weeks Imp. Clinics performing abortions beyond 14 weeks
imp must meet the additional patient care requirements in Section 309 of
the regulation (which requires additional physician qualifications,
medical equipment, and mandatory laboratory tests). Abortions beyond
18 weeks 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 up to 26 weeks Imp. See S.C. Code Regs.
61-12, Section 302.

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court in determining whether they are appropriate
requirements to impose upon a physician or clinic
performing only first trimester abortions.

Although the DHEC officials testified that they
primarily utilized existing South Carolina regulations as
the basis for the challenged regulation, defendants have
pointed to additional sources of information to defend
the regulation. First, there is testimony that Mr. Moore
obtained copies of abortion regulations from North
Carolina and Tennessee. However, Mr. Moore did not
speak with anyone in those states about the regulations
or how they had affected maternal health and, in any
event, the requirements of Regulation 61-12 exceed
those contained in the regulations of these neighboring
states. There is also testimony that Mr. 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”). However,
with the exception of Planned Parenthood, which
requires its affiliates to comply with its standards unless
an exception is granted, the majority of the standards
reviewed by Mr. Moore are not mandated standards of
medical care. Rather, they are guidelines which must
be accommodated to the needs of a particular facility
and its patients through the exercise of physician
judgment and discretion. Furthermore, a comparison of
Regulation 61-12 with the standards and guidelines
offered in support of the regulation reveals that DHEC
in fact far exceeded even those guidelines.

According to witnesses presented by both sides of this
controversy, ACOG is a well-respected, nationwide

organization of obstetricians and gynecologists which
serves to develop and further the standard of care in this

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specialty. During the drafting process, the general
counsel of ACOG wrote a letter to DHEC expressing
concern that the requirements of the regulation 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, Mr. Moore requested limited input and
comments from two medical personnel associated with
DHEC. The first, Richard Goodrich, M.D., 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. While he is of the opinion
that the portions of the regulation 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
the regulation’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 the regulation’s

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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 affect women’s health
issues.

Mr. Moore also sought some limited input from Robert
Lawyer, R.N., who was Director of Nursing for DHEC.
Mr. 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, he
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 only asked by Mr. Moore and Mr. Samuels to
review and provide input concerning discrete portions
of the regulation, primarily those governing nursing
care. Mr. 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 facility and
available to come to the recovery room if necessary.
Unlike Dr. Goodrich, however, he interprets the

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regulation as requiring the “on duty” registered nurse to
be on the premises. In formulating his opinion, Mr.
Lawyer did not conduct any research on abortion
practices in South Carolina, nor did he consult with
nursing professionals who specialize in abortion
procedures. Mr. Lawyer testified that while he is aware
that the regulation 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.

50. 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 professionals during the drafting process and
rejected ACOG’s offer of assistance. As some support
for the text of the regulation, defendants contend that
the drafters conducted a “mock inspection” of Planned
Parenthood’s facility in Columbia, South Carolina and
determined that the facility met the great majority of the
regulation’s requirements. The evidence presented,
however, reveals that the drafters simply toured the
facility 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 indicated for first trimester abortions, nor
does the evidence support a finding that DHEC
received any meaningful input from Planned
Parenthood physicians prior to or during the early
stages of the drafting process.?

9 In addition, DHEC places great reliance upon the fact that Planned
Parenthood is not a plaintiff in this action. According to the testimony of
a Planned Parenthood representative, Planned Parenthood did not
participate in the lawsuit for political reasons, but agrees that the

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51. After this initial drafting process was concluded, DHEC
issued a proposed regulation and held public hearings
as mandated by the APA. Some of the suggestions
made during this public comment period resulted in
changes to the regulation, including some suggestions
made by Planned Parenthood and the plaintiffs in this
case. 7

52. On January 23, 1996, DHEC submitted the regulation
to the South Carolina Legislature for approval, as
required by the APA. Because the legislature took no
action on the regulation within 120 days after its
submission, it became automatically effective upon
publication in the State Register on June 28, 1996.

53. Plaintiffs filed this lawsuit the day before the
regulation’s publication date. As noted previously, this
court enjoined its implementation on July 19, 1996 via
a temporary restraining order, which the parties agreed
to continue pending a determination on the merits of
plaintiffs’ claims.

F. Testimony of Local Providers of Surgical Care

54. At the trial, Dr. Terry Buffkin, Dr. Thomas Campbell,
Dr. William Lynn, and Dr. Richard Manning testified
concerning the regulation at issue and its probable
effect on the health of women and the availability of
abortions in South Carolina.

55. Dr. Terry Buffkin is board certified in obstetrics and
gynecology, licensed to practice medicine in South

regulation is largely unnecessary and, as a whole, unduly burdensome.
The court finds the absence of Planned Parenthood as a plaintiff in this
action to be irrelevant to the determination of the issues before it.

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aT.

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Carolina, a fellow in ACOG, a member of numerous
state and local medical organizations, and has been
granted admitting privileges at two local hospitals. He
and his partner, Dr. Campbell, have been performing
first trimester abortions at GWC since 1978.

Dr. Buffkin testified that first trimester suction
curettage abortions can be safely performed in a
physician’s office, clinic, ambulatory surgical center or
hospital. Ambulatory surgical centers, however, are
typically used for more invasive type procedures (such
as tubal ligations and laparoscopic procedures), and
hospitals would be appropriate only if the patient has
other significant medical problems which might
complicate the procedure (such as heart disease). Dr.
Buffkin also testified that medical abortions can be
safely performed for ectopic pregnancies in a
physician’s office or clinic setting.

Dr. Buffkin testified that he is aware of no public health
problem with the provision of abortion services in
South Carolina and that he is aware of no physicians or
others who are providing inadequate health care in
regard to first trimester abortions in South Carolina.

Dr. Buffkin testified that GWC already complies with
some, but not all, of the requirements of Regulation 61-
12. For example, Dr. Buffkin testified that they do not
perform all of the medical tests mandated by the
regulation as a matter of course, but rather perform only
those medical tests that are indicated based upon the
patient’s history, risk factors, and physical examination.
He testified that the ACOG guidelines are not, and
should not be, mandated standards of medical care, and
that they can be varied from without compromising

good patient care.

aa

60.

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Dr. Buffkin testified that the regulation will not
improve the health care of women seeking first
trimester abortions in the state. He further testified that
the regulation will directly increase the cost of abortion
services to patients in South Carolina because it
mandates the performance of unnecessary and
expensive tests. It will also increase costs by imposing
detailed administrative, structural, and other
requirements which, although perhaps appropriate in an
ambulatory surgical center or hospital environment, are
not necessary in a small clinic or physician’s office
where the staff interacts daily. Dr. Buffkin also opined
that the detailed requirements carry significant hidden
costs in the nature of penalties and legal fees to
challenge cited violations in the future. Finally, Dr.
Buffkin is of the opinion that the increased cost of
abortion services will result in a number of women
either delaying the procedure or being unable to obtain
the procedure, both of which increase the health risks to
the pregnant woman.

Dr. Thomas Campbell is also a licensed physician in
South Carolina, board certified in obstetrics and
gynecology, and has been granted admitting privileges
at several local hospitals. He is also of the opinion that
Regulation 61-12 will increase the cost and decrease
the availability of abortion services in South Carolina.
Dr. Campbell testified that the detailed provisions of
the regulation are unnecessary and inappropriate for a
clinic performing first trimester abortions, and that they
will not improve the health of women seeking abortions
in South Carolina.

Dr. William Lynn is also licensed to practice medicine
in South Carolina, is board certified in obstetrics and
gynecology, and has been granted admitting privileges
at a local hospital. He has been performing first

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trimester abortions continuously since 1980. Dr. Lynn
testified that he is aware of no public health problem
associated with the provision of abortions in South
Carolina. It is his opinion that the regulation will
greatly increase the cost of abortion services in South
Carolina, may make it impossible for some physicians
to continue to offer abortion services, will not enhance
women’s health or increase the level of medical care in
the community, and will make it more difficult for
women to obtain reasonable abortion care in a safe
setting. He further opines that the regulation is
inappropriate for a first trimester abortion clinic and is
instead more suited to a hospital environment. Dr.
Lynn testified that the regulation mandates standards of
care and costs which are contrary to the current trend of
moving miedical care away from hospitals and into
outpatient facilities and physicians’ offices to decrease
costs.

Dr. Richard Manning is also board certified in
obstetrics and gynecology, and is licensed to practice
medicine in South Carolina and five other states. He
currently serves as medical director of CWMC and
performs first trimester abortions on a regular basis. He
shares the opinion that the regulation will increase the
cost of abortions and will not improve health care, and
that the detailed regulations, while possibly appropriate
for a large hospital, are unnecessary for a small clinic
performing first trimester abortions where people work
together and communicate daily.

In addition to the testimony of the plaintiff providers,
plaintiffs presented expert testimony of a well-qualified
general surgeon licensed to practice medicine in South
Carolina. According to the testimony of this witness,
licensed physicians currently perform a number of
surgical procedures in their private offices --

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particularly those which do not require the use of
general anesthesia -- because it is significantly quicker,
less expensive, and more comfortable for the patient.
The surgeon’s testimony, in conjunction with the other
medical evidence presented by the parties, reveals that
the risks and potential complications associated with
surgeries typically performed in the office setting by
general surgeons are substantially similar to those
associated with first trimester abortions. Significantly,
the general surgeon testified that physicians’ offices in
which such comparable procedures are performed,
including his own, would not comply with a number of
the requirements imposed by Regulation 61-12, yet
would meet appropriate standards of surgical care.

Plaintiffs also presented the testimony of a clinical
assistant professor of nursing at the University of South
Carolina, who has observed and/or participated in a
total of twenty-five to fifty abortions performed in the
first and second trimesters of pregnancy, and who
currently provides follow-up care to women who have
received abortions. According to this witness, licensed
practical nurses are competent to provide nursing care
during the abortion and recovery period, and such
nursing care is adequate to meet the needs of the
patients. The witness was further of the opinion that
requiring a registered nurse to supervise all nursing care
in a facility performing only first trimester abortions is
unnecessary if a physician is supervising care, and that
it is permissible to allow a licensed practical nurse to
observe the recovery of an abortion patient while the
physician is in another room in the facility. In addition,
the witness opined that, under current standards of
practice, a registered nurse who is supervising nursing
care in lieu of a physician would be unable to provide
direct patient care.

65.

66.

67.

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G. Additional Expert Testimony Presented

At the trial, the parties presented conflicting testimony
of independent experts on the medical appropriateness
of Regulation 61-12 and whether it would further or
harm maternal health in South Carolina. This
testimony is summarized below.

1. David A. Grimes, M.D.

Plaintiffs called as an expert Dr. David A. Grimes. Dr.
Grimes is a board certified physician in preventive
medicine, with a specialty in public health, obstetrics
and gynecology. He has over 25 years of experience
with abortion procedures, as well as extensive
experience in public health and abortion safety. He was
asked to review the regulation by plaintiffs for the
purposes of this case.

According to Dr. Grimes, ACOG and NAF publish
guidelines and standards for abortion care to provide
guidance to physicians in providing such care. They
are not, however, a mandated standard of care.. Rather
physicians must be allowed to exercise their discretion
in applying the guidance documents to meet the
individual needs of their practices and patients.

Dr. Grimes also testified that it is not good medical
practice to force costs upon patients which are not
justified by the potential health benefits and that, in the
private sector, this type of mandated medical care
would not be tolerated by patients or, under managed
care, by the insurance industry. Dr. Grimes testified
that Regulation 61-12 will not further the health of
women seeking abortions in South Carolina and, if
enacted, will harm the health of women in South
Carolina. It is his opinion that most of its requirements

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are medically unnecessary and unduly burdensome to
women and abortion providers.

By way of example, Dr. Grimes testified that the
sections requiring written policies and procedures on
patient rights, quality improvement and operating
procedures are unnecessary for a physician’s office or
small clinic, although they may be appropriate for a
hospital. Similarly, clinical staff meetings are
appropriate for a hospital, but not a physician’s office
where the employees work together in a small
environment. According to Dr. Grimes, the mandatory
medical testing requirements are medically baseless and
a misuse of public health resources, and that these are
the types of medical care decisions which should be
made by a physician in consultation with the patient
based upon individual risk factors and needs. For
example, a mandatory urine pregnancy test imposes
additional costs, but is superfluous if the physician has
already confirmed pregnancy through a blood test or
ultrasound. And a urinalysis is not necessary in all
cases, and is not required prior to surgery even in a
hospital environment. Dr. Grimes is also of the opinion
that the physical plant requirements are burdensome
and will not result in the improved health and safety of
women. While some may be appropriate to a hospital
or facility which deals with open wounds, this is not the
case with a first trimester abortion. In addition, Dr.
Grimes is of the opinion that the copying of medical
records is a violation of patient confidentiality. As he
points out, the patient can give written consent for the
release of medical records if the patient has a
complaint.

2. Dr. Stanley K. Henshaw

70. Dr. Stanley K. Henshaw also testified via videotaped

71.

72.

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deposition. Dr. Henshaw received a Ph.D in sociology

_ from Columbia University and a bachelor’s degree in

physics from Harvard College. He 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 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 out-of-state to obtain the procedure. 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.

3. Charles J. Ward, M.D.

At the trial of this case, defendants called as an expert
Dr. Charles J. Ward, who is also board certified in
obstetrics and gynecology, and a fellow of ACOG and
the American College of Surgeons. However, while
Dr. Ward has attended to patients experiencing
spontaneous and missed abortions (or miscarriages), he

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has no experience in providing elective abortions and
no particularized expertise in abortion practice or public
health -- nor has he witnessed an intended abortion. He
has also not performed any gynecological surgery for
approximately four years.

Dr. Ward agrees that abortion is one of the safest
surgical procedures performed in the United States, and
is also of the opinion that the majority of physicians
practice to an acceptable level of care. However, Dr.
Ward opined that Regulation 61-12 will improve the
safety and well-being of women seeking abortions in
South Carolina. More specifically, Dr. Ward testified
that Regulation 61-12 incorporates, for the most part,
current national standards applicable to the
performance of abortions, will impose no burden upon
medical providers who perform abortions in South
Carolina, and will not hinder the medical judgment of
physicians or their discretion in the performance of the
procedure. Dr. Ward believes that the regulation is not
only consistent with good medical practice, but
medically necessary to protect the health and safety of
women seeking abortions.

However, Dr. Ward formulated no opinion on whether
implementation of the regulation would affect the cost
or availability of abortions in South Carolina. He
conducted no analysis on whether the costs associated
with regulatory compliance would pose a substantial
obstacle to women seeking abortions or whether it _
would have the effect of harming women. Rather, Dr.
Ward only opines that compliance with Regulation 61-
12 will not impose a significant burden upon physicians
who are already practicing to the standard of care
reflected in the regulation. According to Dr. Ward,
costs of providing medical care should not influence the
provision of care and, in contrast to the testimony of

76.

77.

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Dr. Grimes and the general surgeon, opined that “you
do not weigh the dollar when you're practicing good
medicine.” Tr. at 1041.

H. Credibility of the Witnesses

Having observed the witnesses’ demeanor and listened
to their testimony, the court finds the testimony of Drs.
Buffkin, Campbell, and Lynn to be credible based upon
their extensive knowledge, training, and experience in
providing first trimester abortions in South Carolina.
Although they are owners of the abortion clinics
challenging the regulation at issue, they are licensed to
practice medicine by the State of South Carolina and
are all board certified in obstetrics and gynecology.
They have also been provided admitting privileges to
hospitals in this state. Furthermore, they have been
performing first trimester abortions in South Carolina
on a regular basis for many years and there is no
credible evidence that they have been providing
services which do not meet acceptable standards of
medical care. Nor is there any evidence that their
patients have experienced significant complications
from the abortion procedures.

Dr. Manning, whose testimony was submitted by
deposition, is also licensed to practice medicine in this
state and is board certified in obstetrics and
gynecology. He has been performing first trimester
abortions in this state for a number of years with no
evidence of significant complications or an inadequate
standard of care. His opinions are consistent with those
of Drs. Buffkin, Campbell, and Lynn, and the court find
his testimony to be credible as well.

The court also finds Dr. Grimes’ testimony to be
credible. Dr. Grimes has over 25 years of experience

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with abortion procedures, as well as specialized
knowledge in abortion safety and public health. He too
has provided testimony consistent with that of the other
physicians who testified.

The court finds the testimony of the general surgeon to
be particularly credible. Although he does not perform
abortion procedures, he is a general surgeor licensed to
practice medicine in this state and has provided
valuable testimony about the current acceptable
practice of performing surgery in an office setting and
the general safety and tolerable risks associated with
that practice.

Having observed the demeanor and testimony of Dr.
Ward, the court discounts substantial portions of the
evidence he submitted. Like Dr. Grimes, Dr. Ward was
not involved in drafting Regulation 61-12 and was
hired to review the regulation solely as an expert
witness in this case. However, although Dr. Ward is
board certified in obstetrics and gynecology, he has not
performed any gynecological surgery in several years,
has no experience in providing elective first trimester
abortions, and has no particularized expertise in
abortion practice or public health. In recent years, Dr.
Ward has been hired primarily by parties in litigation as
an expert witness in medical malpractice cases. He has
also worked in academia, but has had limited
involvement in the hands-on practice of medicine.
Thus, Dr. Ward’s expertise in areas determinative to
this case is limited. In addition, Dr. Ward has
formulated no opinion as to the regulation’s probable
effect on the cost or availability of abortions in South
Carolina -- factors which this court is required to
consider in determining the constitutionality of the
regulation. Furthermore, Dr. Ward appears to
substantiate his opinion through a belief that the cost of

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medical services is irrelevant to the provision of quality
medical care -- an opinion which the court finds is
contrary to the current trends and realities in the
practice of medicine. aor

With regard to the DHEC medical witnesses, Dr.
Goodrich and Mr. Lawyer, their testimony was
presented to the court via depositions and an
assessment of their credibility is more difficult. Having
reviewed the deposition excerpts provided, however,
the court notes that their experience with the provision
of abortion services has been limited at best or occurred
many years ago. For these reasons, the court discounts
to a degree the value of their testimony.

I. Costs to Comply with the Regulation

In compiling anticipated costs to comply with
Regulation 61-12, plaintiffs independently reviewed the
regulation and calculated the costs of bringing their
respective clinics inte compliance. In the case of the
design and construction requirements, plaintiffs
retained an outside construction specialist to inspect
their facilities and provide a renovation estimate to
comply. Plaintiffs presented evidence that CWMC
would require renovations costing approximately
$27,235, that PSMC 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. In addition, plaintiffs
presented detailed cost estimates to comply with the
regulation’s additional requirements -- such as the costs
associated with developing and implementing the
numerous programs and policies, conducting the
administrative reviews, ensuring the required staff
training, and hiring additional staff. In each case, the

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costs were broken down into one-time costs, annual
costs, and per-procedure costs. These figures were, in
turn, provided to a certified public accountant who
calculated the average “cost per-procedure” impact.

83. Defendants contend that the plaintiffs’ cost figures are
“grossly inflated,” although not intentionally so. For
example, they have variously contended as to certain
items that plaintiffs misread the regulatory
requirements or misinterpreted them, or that they have
inaccurately estimated or improperly included costs
associated with professional and staff time which will
be taken by their compliance efforts. They have also
taken issue with plaintiffs’ inclusion of the cost
associated with hiring a registered nurse to supervise
nursing care, contending that the clinics can replace an
existing licensed practical nurse and allow the
registered nurse to both supervise and provide hands-on
care. As to Dr. Lynn, defendants contend that he has
demonstrated poor business practices which are the
cause of his much higher compliance costs. Thus,
defendants have taken plaintiffs’ estimates, adjusted
them for the errors they perceive, and provided the
court with an alternative cost increase figure.

84. Nevertheless, it is readily apparent that Regulation 61-
12 will impose substantial start-up costs upon abortion
providers in this state, and substantial annual costs to
maintain compliance. As with any other business, these
costs will be passed along to the patients in the form of
increases in the price of receiving abortion services.
And, of course, additional direct costs will be imposed
upon plaintiffs through the performance of the
mandatory medical testing.

85. Currently, a first trimester suction curettage abortion
costs between $325 and $480, depending upon the

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gestational age, the type of sedation or anesthesia
needed, and the medical testing indicated. According
to the evidence presented, Regulation 61-12 will raise
the cost of each abortion service in South Carolina in
the following ranges:!°

For CWMC, the cost will increase $36.48 to
$75.03;

For PSMC, the cost will increase $93.09 to
$170.39;

For Dr. Lynn’s Beaufort practice, the cost will
increase $115.67 to $367.50;

For GWC, the cost will increase $22.68 to 32.39.

86. At trial, the parties entered into the following
stipulations of fact concerning the cost of complying
with certain specific provisions of the regulations, as
follows:

When directly billing physicians, laboratories
in South Carolina generally charge between
$20.00 and $40.00 per sample to perform a
combined test for chlamydia and gonorrhea.

When directly billing physicians, laboratories
in South Carolina generally charge between
$17 and $30 per sample to test for the Du
variant.

10 The lowest figure represents defendants’ revision of plaintiffs’
estimates. The highest figure represents plaintiffs’ estimate. Neither,
however, takes into account the standard 15% profit factor which
plaintiffs’ accountant testified would be appropriate.

A-147

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. Se

The range in charges for these tests varies due
to a number of factors, including the number
of samples that the physician submits to the
laboratory for such tests. Discounts are
generally offered when more tests are
submitted.

A set of surgical instruments for performing
the suction curettage abortion costs
approximately $200.

87. Having reviewed all of the evidence presented, the
court agrees with plaintiffs, and finds as a fact that
compliance with Regulation 61-12 will be a costly
endeavor which will result in a substantial rise in the
cost of abortion services. The court also finds that the
substantial alterations that Dr. Lynn must undertake in
his practice, and the resulting extraordinary per
procedure cost (even by defendants’ estimate) will
likely force him to cease performing abortions in his
Beaufort office and, thereby, eliminate entirely the
availability of abortions in this area of the state.!!

'! Defendants have sought to minimize the impact from the closure of
Dr. Lynn’s Beaufort office by pointing to Planned Parenthood’s plans to
open a Clinic there in the future. However, as of the trial in this case,
Planned Parenthood had not raised sufficient funds to open a clinic in the
area. Furthermore, under the current plans, Planned Parenthood would
not provide abortions up to 13.9 weeks (as Dr. Lynn does), and would
offer the service for fewer hours and days. Simply stated, Planned
Parenthood’s potential to fill the void left by Dr. Lynn in this area of the
State is speculative at best.

88.

89.

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The court also finds as a fact, based upon the medical
and other testimony presented, that the increased cost of
providing abortions resulting from the regulation 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.

J. Additional Findings

Based upon all of the reliable and credible evidence in
this case, the court finds 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 relatively
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.

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. Offices
and «linics that provide less than five first trimester
abortions per month, however, are for inexplicable
reasons exempt from any regulation or licensure by
DHEC, and the patients seeking an abortion there are
free to decide in consultation with their physicians what
tests are appropriate.

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91. First trimester suction curettage abortions are
comparable in terms of risks, diiration 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,
endometriai biopsies, hysteroscopies, and insertion of
intrauterine devices for birth control. Physicians’ offices
performing such procedures are, however, also not
subject to DHEC regulation or oversight. Nor are their
patients subjected to mandatory tests.

92. 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 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. These physicians’ offices
are likewise not subject to DHEC regulation or _
oversight, nor are their patients subjected to mandatory
tests.

93. 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. There is 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

94.

95.

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abortions performed in South Carolina is greater than the
national average. On the contrary, it appears that South
Carolina has experienced a similar, if not lower, average
complication rate. All of the witnesses with knowledge
of the issue testified that they are aware of no serious
medical complications resulting from the performance of
a first trimester abortion in this state, and it is
uncontested that the challenged regulation was drafted
by DHEC in response to the state legislative directive
and not in response to a public health problem in this
State.

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. They engaged in virtually
no research, investigation or other efforts to determine
what types of requirements would be necessary or
advisable for the 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.

Despite their admitted lack of medical knowledge in
general and of abortion procedures in particular, the
drafters of Regulation 61-12 also 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 Mr. Lawyer as to discrete portions of the
regulation. Furthermore, DHEC either rejected or
ignored an offer by ACOG to assist in the drafting
process. While DHEC was under no legal obligation to

96.

97.

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consult with ACOG or to accept their assistance during
the drafting process, ACOG is unanimously considered
by the witnesses in this case -- including those presented
by defendants -- to be a well-respected medical
organization dedicated to improving the standard of
health care in the field of obstetrics and gynecology.
DHEC’s rejection of their assistance further
demonstrates their lack of interest in ensuring that the
regulation 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.

Although it is uncontroverted that first trimester
abortions are significantly less risky to the health of
women than second trimester abortions, an existing
South Carolina regulation governing second trimester
abortions was utilized as a starting point for the new
regulation. With the exception of Section 309 of
Regulation 61-12, the drafters drew no distinction
between first and second trimester abortions in the text
of the regulation. In addition, the drafters admitted that
virtually no such distinctions were considered during the
drafting process.

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
orientation during the drafting process was to _
standardize its health care and facility regulations and to
codify existing departmental practices. 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. In particular, while

98.

99.

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DHEC has pointed to its regulation governing
ambulatory surgical centers as support for Regulation
61-12, it is undisputed that offices and clinics that
provide first trimester abortions provide services that are
significently 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, that those
imposed upon ambulatory surgical centers.

The Planned Parenthood, NAF, and ACOG standards
and guidelines relied upon 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 medieal 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 current Regulation 61-12
imposes requirements which greatly exceed them.

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. Based upon the evidence presented, the court
finds that Regulation 61-12 will significantly increase
the cost of abortion services in South Carolina. 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. 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

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abortion.

100. Most likely as a result of these deficiencies in the
drafting process, Regulation 61-12 consists of a myriad
of detailed and costly provisions that were neither
designed to further the health of women seeking first
trimester abortions in South Carolina nor likely to
accomplish this goal. Indeed, by imposing additional
costs and impediments to women seeking abortions, the
regulation may have the unintended effect of increasing
the risk of adverse health conditions. The infirmities in
the regulation are pervasive and a comprehensive
recitation of the unnecessary and/or unduly burdensome
provisions is neither possible nor necessary. A few
examples should suffice:

a. Part I -- The first, and most immediate, problem
with Regulation 61-12 is found in its definitions of an
abortion and of an abortion clinic, which in turn
determines its scope. The applicability of the
regulation is not limited to suction curettage abortions,
or even to surgical abortions -- nor is it limited to
clinics operated by hospitals or non-physicians. And
unlike the ambulatory surgical center regulation, there
is no exemption for privately operated physicians’
practices. Thus, the regulation will be immediately
applicable to any facility (other than a hospital) in
which any second trimester and/or five or more first
trimester abortions are performed per month -- thereby
encompassing within it a private physician’s office. An
abortion is defined as “[t]he use an instrument,
medicine, drug, or other substance or device with intent
to terminate the pregnancy of a woman, known to be
pregnant, for reasons other than to increase the
probability of a live birth, to preserve the life or health
of the child after live birth, or to remove a dead fetus,”
S.C. Code Regs. 61-12, Section 101.A., and would,

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therefore, include the medical abortions currently being
used to terminate ectopic pregnancies. DHEC’s own
consultant, Dr. Goodrich, did not realize the definition
was so all encompassing, and does not attempt to assert
that the stringent provisions of Regulation 61-12 would
be appropriate for a facility or physician performing
only medical abortions. Furthermore, by directing that
the regulation be applied to any facility performing five
or more first trimester abortions per month, DHEC has
ensured its applicability to all abortion and family
planning clinics, as well as to all physicians who
choose to regularly perform (i.e. more than five times
per month) first trimester abortions in their private
practice -- yet it in no way regulates or limits the
discretion of a licensed physician who performs the
identical abortion procedures in his office on a less
frequent basis.

b. Part II -- Administration and Management. This
portion of Regulation 61-12 is permeated with
unnecessary requirements governing physician
qualifications, staffing, and staff training. By way of
example, the regulation requires physicians and clinics
to hire a registered nurse to supervise all nursing care in
the facility regardless of the fact that a licensed
physician is present in the facility to supervise all
medical care, including nursing care. The reliable and
credible evidence presented reveals 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. Clearly, a
licensed physician is capable of supervising nursing
care in the room in which he is performing the
procedure. And defendants have offered no persuasive

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reason why a physician cannot supervise the nursing
care of patients during the recovery process simply
because the physician may be another room for a brief
period of time. Indeed, 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.

Similarly, the court finds inadequate justification for
requiring physicians who perform first trimester
abortions to have admitting privileges at a local hospital
or a written transfer agreement with a physician who
has such privileges. The state has a legitimate interest
in ensuring that all outpatient surgery patients have
access to appropriate emergency care when needed.
And all of the abortion providers involved in this case,
for example, have such privileges or have verbal
transfer agreements to ensure that their patients will
receive appropriate emergency care should the need
arise. Plaintiffs contend that many physicians would be
resistant to entering a written transfer agreement with
abortion providers because, under other portions of the
regulation, the agreement would be subject to copying
and potential public dissemination. The court finds this
to be a reasonable concern, given the controversial
nature of abortions and the absence of any evidence that
verbal transfer agreements have not in the past, or
would not in the future, adequately meet the state’s
interest in this regard.

Other provisions of the regulation would seem to
appear reasonable at first blush, but fail upon closer
examination. For example, a requirement that all health
care personnel receive tuberculin skin testing would
appear to be very reasonable from a public health
standpoint. However, DHEC has not required such
testing of ali health care personnel -- choosing instead

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to impose the costly testing only upon clinics and
physicians’ offices which perform abortions on a
regular basis. Defendants have offered no justification
for arbitrarily requiring this testing of all abortion care
workers, but not all other health care workers. Nor
does it appear that they could do so. Similarly,
Regulation 61-12’s requirement that all allied health
care personnel in abortion clinics receive CPR training
would appear reasonable, but it too is a requirement
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.
Furthermore, the credible evidence reveals that while it
is prudent for all health care facilities and physicians’
offices to have an employee trained in CPR available at
all times, the regulation’s requirement that all abortion
clinic employees be trained is clearly unnecessary given
the extremely low probability that a patient undergoing
a first trimester abortion procedure will need such
drastic treatment. And in keeping with the regulation’s
pervasive tendency to “overdo” every requirement,
Sections 206-208 of the regulation do no more that
require facilities and physicians to comply with laws
they are already obligated to obey, on pain of additional
penalties.

c. Part II]. Patient Care. The level of policies and
procedures required by this Part, as well as the
extensive inservice training requirements and other
policies required in Part II of the regulation, are also
costly endeavors unsubstantiated by a medical need.
As succinctly testified to by many of the medical
experts in this case, such requirements may be
appropriate for large medical care facilities with large
staffs that do not interact on a daily basis. However,
Regulation 61-12 arbitrarily imposes it upon every
clinic and every physician’s office which performs five

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or more first trimester abortions per month — regardless
of the number of staff or hours of operation.

Furthermore, this portion of Regulation 61-12
unnecessarily restricts the medical discretion and
judgment cf treating physicians who are already
licensed by this state and subject to oversight by the
State Board of Medical Examiners. By mandating the
presence of certain medical equipment and the
performance of certain medical testing, Regulation 61-
12 constitutes a regulatory intrusion into the physician-
patient relationship and directly imposes costs upon
patients which are not medically indicated a majority of
the time -- simply because the patient has chosen to
undergo an elective abortion. For example, there is no
reason to charge a patient seeking an abortion for a
urine pregnancy test when the physician has already
confirmed the pregnancy by other means (such as by a
blood test or ultrasound). Nor has a rational
explanation been offered for the regulation’s mandate
that every woman undergo (and pay for) testing for
certain sexually transmitted diseases (but not others),
without regard to whether such tests are medically
indicated and indeed even when the physician
determines that they are not, simply because the woman
has chosen to obtain a first trimester abortion from a
physician who performs them on a regular basis.
Section 307’s requirement that abortion providers have
“consulting” arrangements with various specialists
before they can obtain a license to operate is also
medically unnecessary and unduly burdensome. The
court has been made aware of no convincing reason
why licensed physicians are not capable of exercising
appropriate discretion in recognizing and acting upon
the medical needs of their patients in this regard.

The regulation also inexplicably imposes

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requirements concerning access to emergency drugs
which are not imposed upon any other physicians and
which, instead of improving health care, may well harm
health care by imposing obstacles to accessing the
drugs by the providers themselves. The equipment and
supplies required by the regulation will also increase
the costs of providing abortions in the state, and require
equipment not necessary for the safe performance of
the first trimester abortion procedure.

d. Part IV. Medical Records and Reports. This
portion of the regulation also suffers from serious
infirmities. For example, the apparent requirement that
a woman seeking an abortion provide the name of her
spouse in addition to an emergency contact is a
medically and legally unnecessary requirement which
imposes a substantial obstacle in the path of a woman
who, for personal reasons, may wish not to disclose this
information.

e. Parts V, VI, and VII of Regulation 61-12 suffer
from similar infirmities. While a number of the
provisions in these Parts would appear reasonable, they
do not hold up under closer scrutiny. First, the
provisions for “Functional Safety and Maintenance,”
“Infection Control and Sanitation,” and “Fire Protection
and Prevention” are not imposed upon physicians’
offices where less than five first trimester abortions are
performed per month, or where comparable surgical
procedures are performed regardless of the frequency.
For example, initially it would appear that regulations
in the area of infection control and sanitation would be
quite reasonable. However, they would be no more or
less necessary in a first trimester abortion clinic than in
a physician’s office performing fewer than five
procedures per month or in a physician’s office
performing comparable procedures.

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In addition, the section is often duplicative of OSHA
requirements, and admittedly requires autoclave testing
with a frequency that is far greater than what is
medically appropriate. Other of the provisions invite
arbitrary enforcement (such as generically requiring
that a facility be kept “free of hazards”), or impose
requirements (such as the posting of a disaster
preparedness plan and conducting quarterly fire drills)
which may be appropriate for a large clinic or hospital,
but not a small physician’s office. In summary, these
parts, and indeed the entire regulation, is pervaded with
unnecessary regulatory requirements which are
selectively, and without medical justification, imposed
upon physicians and clinics solely because they
perform first trimester abortions on a regular basis.

f. Part VIII, entitled “Design and Construction,”
suffers from similar problems. It imposes 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. At trial, defendants presented the
testimony of a well-qualified architect, who endorsed a
majority of the design and construction requirements as
being appropriate recommendations for a state of the art
medical facility. This court has no doubt that the
architect’s designs are excellent ones. However, the
reliable and credible medical evidence presented at trial
leaves little doubt 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. Indeed, a
number of the requirements are not purported to be

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ones advancing the interest of improving the health care
for abortion patients, but rather are life safety issues in
the event of a disaster, fire or other event requiring
evacuation. Furthermore, business occupancies which
meet the design and construction requirements of
standard building codes sufficiently meet these life
safety concerns, and have not been required to
“upgrade” to state of the art design and construction
standards.

The additional requirements, which are advanced as
unique to the medical field, simply find no justification
in medical necessity. For example, there is no evidence
supporting a need for physicians to install additional
bathroom equipment and emergency call buttons or that
they have a recovery area separate from the procedure
area. Nor is there any evidence to indicate 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. Indeed, there is no evidence that this
need has ever arisen from the performance of a first
trimester abortion in this state (or elsewhere). And, of
course, physicians performing surgical procedures of
comparable invasiveness and risk are not required to
renovate their offices to meet a similar requirement.
Perhaps least defensible of all is the fact that abortion
facilities are required to fully comply with the design
and construction requirements within two years from
licensure, while facilities admittedly performing much
riskier procedures (including ambulatory surgical
centers) are grandfathered.

g. Part IX. Prerequisites for Initial Licensure. This

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portion suffers from similar problems as the design and
construction portion of the regulation, requiring
numerous certifications and laboratory test results
concerning various parts of the facility (such as the
carpets and draperies) without any evidence that the
requirements will further the goal of protecting
women’s health in South Carolina.

h. Finally, Part X of the regulation, in conjunction
with Section 103.C., grants to DHEC unfettered power
to “manage[ ]” abortion providers “in accordance with
the best practices as interpreted by the Department,”
S.C. Code 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,” S.C. Code Regs. 61-12,
Section 103.C. Simply put, in addition to the burdens
imposed by Regulation 61-12’s comprehensive,
detailed provisions, the regulation imposes 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.

II. CONCLUSIONS OF LAW
A. Due Process and the Right to Privacy
1. Introduction
“Abortion is recognized as a fundamental right

protected by the Due Process Clause of the Fourteenth
Amendment.” Manning v. Hunt, 119 F.3d 254, 259

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(4th Cir. 1997).!2 This has been the case since Roe v.
Wade, when the United States Supreme Court held that
the “right of privacy ... founded in the Fourteenth
Amendment’s concept of personal liberty and
restrictions upon state action ... is broad enough to
encompass a woman’s decision whether or not to
terminate her pregnancy.” 410 U.S. 113, 153 (1973).
Under Roe, state laws and regulations restricting the
right could only be allowed if they were supported by a
compelling state interest and were narrowly drawn to
express the interest. See id. at 155.

2. The Supreme Court in Roe, however, recognized that
the right to choose “is not unqualified,” id. at 154, and
that it must be considered against important and
legitimate state interests in preserving and protecting
the health of the pregnant woman and in protecting the
potentiality of human life, see id. at 154, 162. To assist
in weighing the competing interests of the woman and
the state, the Roe Court adopted a “trimester
framework,” designed to delineate when the state’s
interest became sufficiently compelling to justify the
state’s limitation of or infringement upon the right.
Specifically, the state’s interest in the health of the
pregnant woman was considered to be compelling at
the end of the first trimester, after which time the state
could “regulate the abortion procedure to the extent that
the regulation reasonably relat[ed] to the preservation
and protection of maternal health.” Id. at 163. Prior to
that point in time, however, the abortion decision was
to be left to the physician’s medical judgment, in
consultation with the woman. See id. After viability,
the state’s interest in potential life became compelling,

12 The Fourteenth Amendment states in pertinent part that “... nor shall
any State deprive any person of life, liberty, or property, without due
process of law.” U.S. Const. amend. XIV.

A-163

and the state was free to regulate and even prohibit the
abortion procedure except when an abortion was
necessary to preserve the life or health of the mother.
See id. at 163-64.

In the years following Roe, application of its trimester
framework resulted in almost no regulation being
permitted during the first trimester of pregnancy. See
Planned Parenthood of Southeastern Pennsylvania v.
Casey, 505 U.S. 833, 872 (1992). But because a
woman’s constitutional liberty to have some freedom to
terminate her preghancy was not unlimited, “[tJhe
extent to which the legislatures of the States might act
to outweigh the interests of the woman in choosing to
terminate her pregnancy was the subject of debate both
in Roe itself and in decisions following it.” Id. at 853.

In Casey, a majority of the United States Supreme
Court reaffirmed the “essential holding” of Roe,
maintaining that a woman’s right to choose an abortion
is a fundamental one protected by the Due Process
Clause of the United States Constitution, but one which
must be weighed against the state’s legitimate interests
in preserving and protecting the health of women
seeking abortions and in the potentiality of human life.
See Casey, 505 U.S. at 846. A plurality of the Court,
however, rejected the rigid trimester framework of Roe.
Although maintaining that “the line should be drawn at
viability, so that before [viability] the woman has a
right to choose to terminate her pregnancy,” Casey, 505
U.S. at 870, the Casey plurality sought to reaffirm, and
afford more weight, to 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. at 846. Specifically, the plurality
observed that:

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[t]hat portion of the decision in Roe ha{d]
been given too little acknowledgment and
implementation by the Court in its subsequent
cases. Those cases decided that any
regulation touching upon the abortion decision
must survive strict scrutiny, to be sustained
only if drawn in narrow terms to further a
compelling state interest.

Id. at 871.

Noting that “not every law which makes a right more
difficult to exercise is, ipso facto, an infringement of
that right, id. at 873, the Casey plurality articulated an
‘undue burden’ standard as ‘the appropriate means of
reconciling the State’s interest with the woman’s
constitutionally protected liberty,” Casey, 505 U.S. at
876, thereby seeking to modify the standard for
evaluating state regulations which impact the abortion
decision prior to viability, including those within the
first trimester of pregnancy. After viability, the State
could continue to “regulate, and even proscribe,
abortion except where it is necessary, in appropriate
medical judgment, for the preservation of the life or
health of the mother.” Id. at 879 (internal quotation
marks omitted).

As noted by the Fourth Circuit, “[t}he difficulty
presented to lower federal courts following Casey lies
in the fact that only three justices -- Justices O’Connor,
Kennedy, and Souter -- have specifically adopted this
undue burden standard.” Manning, 119 F.3d at 260.
The Fourth Circuit, however, “deem{[ed] it proper to
follow the trend clearly set by other courts” and to
apply the “undue burden” test to challenges brought
against state laws regulating abortion. Id. at 261.

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A question remains, however, as to what plaintiffs must
show to successfully mount a facial challenge to an
abortion regulation. In United States v. Salerno, 481
U.S. 739 (1987), the Supreme Court held that a party
asserting a facial challenge to a legislative Act is
required to “establish that no set of circumstances exists
under which the Act would be valid,” id. at 745. The
fact that the Act “might operate unconstitutionally
under some conceivable set of circumstances is
insufficient to render it wholly invalid.” Id. Since
Casey was decided, however, the circuits have been
divided on the issue of whether the Supreme Court sub
silentio overruled Salerno’s “no set of circumstances”
test for facial challenges to state laws regulating
abortion, requiring instead that the challenger only
show “that in a large fraction of the cases in which [the
law] is relevant, it will operate as a substantial obstacle
to a woman’s choice to undergo an abortion.” Casey,
505 U.S. at 895; see Manning, 119 F.3d at 268-69, n. 4
(discussing division of authority on the issue); Planned
Parenthood of the Blue Ridge v. Camblos, 155 F.3d
352, 358-59 n. 1 (4th Cir. 1998) (en banc) (same); id. at
381 n. 14 (same); id. at 389 n. 2 (Michael, J.
concurring) (concluding Salerno no longer applies in
this context).

In granting plaintiffs’ motion for a temporary
restraining order on July 19, 1996, this court ruled that
it intended to follow those courts which had held that
Casey implicitly superseded the Salerno “no set of
circumstances” test for challenges to abortion
regulations. Since that time, however, the Fourth
Circuit has touched upon the conflicting views on this
issue, albeit not directly deciding it. In Manning, the
court applied the Salerno standard of review to an

abortion statute, but plaintiffs did not challenge its
applicability. See Manning, 119 F.3d at 268-69. In

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dicta, however, the three-member panel suggested that

the court would nonetheless apply the Salerno standard
until the Supreme 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. at 269 n. 4; see also Camblos, 155 F.3d at 381 n. 14
(noting the Manning dicta, but not deciding the
question); id. 155 F.3d at 389 n. 2 (Michael, J.,
concurring) (asserting that the Casey undue burden test
must be applied to facial challenges to abortion
restrictions).

9. -Asaresult of the uncertainty which remains concerning
the appropriate standard to be applied in this case, the
court will review Regulation 61-12 under both the -
Casey and Salerno standards. In addition, the court is
mindful that, when presented with a challenge to the
constitutionality of a state statute, it should construe the
law, if possible, to avoid a finding of
unconstitutionality. See Ohio v. Akron Reprod. Health
Ctr., 497 U.S. 502, 514 (1990); Camblos, 155 F.3d at
383. However, “federal courts are without power to
adopt a narrowing construction of a state statute [to
avoid constitutional difficulties] unless such a
construction is reasonable and readily apparent.””

10.

ll.

12.

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Virginia Soc’y for Human Life, Inc. v. Caldwell, 152
F.3d 268, 270 (4th Cir. 1998) (quoting Boos v. Barry,
485 U.S. 312, 330-31 (1988)) (emphasis in original).

2. The Undue Burden Test

Under Casey, the State of South Carolina may regulate
the performance of abortions, even those during the
first trimester of pregnancy, in order to further
legitimate state interests in the health of the mother and
the life of the fetus. However, the woman maintains
her fundamental right “to choose to have an abortion
before viability and to obtain it without undue
interference from the State,” Casey, 505 U.S. at 846,
(emphasis added) and “the State’s 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,” id.
(emphasis added).

In Casey, the Supreme Court was presented with
constitutional challenges to various provisions in a
Pennsylvania statute governing informed consent,
parental consent, recordkeeping and reporting
requirements, and a medical emergency exception.
Thus, the plurality opinion focused on the state’s
legitimate interest 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 [that] 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.” Id. at 878.

Nevertheless, the Casey plurality also provided

13.

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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 879.

The types of burdens that may be imposed by state
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:

[nJumerous forms of state regulation might
have the incidental effect of increasing.the
cost or deceasing 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 this decision does
the power of the State reach into the heart of
the liberty protected by the Due Process
Clause.

14.

15.

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Id. at 874 (emphasis added).

Furthermore, “[nJot all burdens on the right to decide
whether to terminate a pregnancy will be undue.” Id.
at 876.

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 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 (emphasis added).

Although the Casey court was not presented with
regulations similar to those at issue in this case,
previous Supreme Court cases provide additional
guidance as to the appropriate level of regulations
designed to protect the health of women seeking
abortions. First, in Roe, the Supreme Court
recognized that:

abortion in early pregnancy, that is, prior to
the end of the first trimester, although not
without its risk, is now relatively safe.

Mortality rates for women undergoing early
abortions, where the procedure is legal, appear

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to be as low as or lower than the rates for
normal childbirth. Consequently, any interest
of the State in protecting the woman from an
inherently hazardous procedure, except when
it would be equally dangerous for her to
forego it, has largely disappeared. Of course,
important state interests in the areas of health
and medical standards do remain. The State
has a legitimate interest in seeing to it that
abortion, like any other medical procedure, is
performed under circumstances that insure
maximum safety for the patient.

Roe, 410 U.S. at 149-150 (emphasis added). In
addressing permissible state regulation to serve the
legitimate goal of maternal health after the first
trimester of pregnancy, the Roe court held that:

a State may regulate the abortion procedure to

the extent that the regulation reasonably
relates to the preservation and protection of

maternal health. Examples of permissible
state regulation in this area are requirements
as to the qualifications of the person who is to
perform the abortion; as to the licensure of
that person; as to the facility in which the
procedure is to be performed, that is, whether
it must be a hospital or may be a clinic or
some other place of less-than-hospital status;
as to the licensing of the facility; and the like.

Id. at 163 (emphasis added). Applying these principles
in the companion case of Doe v. Bolton, 410 U.S. 179
(1973), the Court simultaneously invalidated a Georgia
law requiring that all first trimester abortions be
performed in a licensed hospital where the state failed
to show that only the hospital environment could ensure

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the quality of the operation and the protection of the
patients. Id. at 195.

16. Later, in City of v. . for
Health, Inc., 462 U.S. 416 (1983), the Supreme Court
was presented with a challenge to an Ohio ordinance
which, among other things, required all second
trimester abortions to be performed in a hospital.
Reaffirming the prohibition against over-regulation of a
relatively safe surgical procedure, the Court held that:

[t}he State’s discretion to regulate on th{e]
basis [of maternal health] does not ... permit it
to adopt abortion regulations that depart from
accepted medical practice... If a State
requires licensing or undertakes to regulate the
performance of abortions during this period,
the health standards adopted must be
“legitimately related to the objective the State
seeks to accomplish.”

Id. at 431 (quoting Doe, 410 U.S. at 195). The Court
then invalidated the ordinance, holding that it “imposed
a heavy, and unnecessary, burden on women’s access to
a relatively inexpensive, otherwise accessible, and safe
abortion procedure.” Id. at 438.!3

17. Circuit courts of appeal called upon to address the
propriety of comprehensive health regulations, after
Roe but before Casey, have similarly invalidated them

'3 The Supreme Court in Casey overruled those parts of Akron which
were “inconsistent with Roe’s statement that the State has a legitimate
interest in promoting the life or potential life of the unborn,” see Casey,
505 U.S. at 870, but reaffirmed the essential holding of Roe. Thus, the
Akron decision continues to inform this court as to the propriety of
regulations purportedly enacted to further the state’s interest in maternal
health.

18.

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when there was an insufficient nexus between the
nature of the medical procedure and the extent of the
regulation. See e.g., Birth Control Ctrs., Inc. v. Reizen,
743 F.2d 352, 364-65 (6th Cir. 1984) (invalidating
detailed, specific regulatory criteria governing the
physical layout of abortion facilities, staffing
requirements, and equipment requirements); Ragsdale
v. Turnock, 841 F.2d 1358 (7th Cir. 1988) (invalidating
portions of a similar licensure regulation which
mandated, among other things, detailed physical plant
requirements, policies and procedures, and staff
training requirements.)

The plurality opinion in Casey rejected the trimester
framework of Roe in order to afford greater recognition
to the states’ legitimate interests in maternal health and
potential life during the first trimester of pregnancy.
Thus, Casey may fairly be said to now allow states to
regulate in areas previously thought to be improper, i.e.
medical facilities performing first trimester abortions.
However, there is no indication that the Supreme Court
would now approve state regulation which substantially
disregards the training, discretion and judgment of the
licensed physician performing the relatively safe, first
trimester suction curettage abortion. On the contrary,
the Casey Court repeatedly reaffirmed the essential
holding of Roe and specifically counsels this court to
examine purported health regulations for medical
necessity. Casey, 505 U.S. at 879. In addition, Roe’s
discussion regarding the relative health care needs of
abortion patients is consistent with the medical
evidence presented in this case -- indeed, it can be fairly
concluded that advances in medical care have rendered
the first trimester abortion an even safer procedure
today. At a minimum, Roe and Casey counsel this
court to be particularly mindful of the relative safety
and low risks associated with first trimester abortions in

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evaluating whether the requirement of Regulation 61-

12 are medically necessary, and in evaluating whether

they reasonably relate to the stated goal of protecting

and preserving the health of women seeking such

abortions in the State of South Carolina. See Casey, 2
505 U.S. at 878. :

19. Guided by these precedents, the court concludes that
the State of South Carolina has a legitimate interest
from the outset of pregnancy in protecting the health of
women seeking abortions, and that this interest is
sufficiently important to allow the State to regulate
abortion providers, including providers which limit
their services to abortions during the first trimester of
pregnancy. See Casey, 505 U.S. at 876. Furthermore,
this interest would allow the state to regulate, within the
boundaries of Casey and its predecessors, such matters
as the qualifications of the person performing the
procedure, the facilities in which abortions are
performed, and the availability of medical care after the
procedure and in the event of an emergency. See Roe,
410 USS. at 149-50, 163.

20. However, just as the woman’s fundamental right to
obtain an abortion is not limitless, the state’s power to
regulate in these areas is not unfettered. To withstand
constitutional scrutiny, Regulation 61-12 must first be
designed to further the state’s legitimate goal of
protecting and preserving the health of women seeking
abortions and must be reasonably related to that goal.
See Casey, 505 U.S. at 878; Roe, 410 U.S. at 163.
Casey and its predecessors inform us that health
regulations which are unnecessary, not reasonably
related to maternal health, or which depart from
accepted medical practice, cannot withstand
constitutional scrutiny and must be invalidated. See
Casey, 505 U.S. at 878; Akron, 462 U.S. at 431; Roe,

21.

22.

y eS

A-174

410 U.S. at 163. Furthermore, even if Regulation 61-
12 furthers the interest of protecting and preserving the
health of women seeking abortions, the regulation
cannot stand if it imposes an undue burden on a
woman’s fundamental right to obtain an abortion, see
Casey, 505 U.S. at 877-78, as a regulation which 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.

a. S.C. Code Regs. 61-12 was not designed to and
does not further the state’s legitimate interest
in maternal health.

Having carefully reviewed the evidence presented in
this case, the court concludes that Regulation 61-12 is
unconstitutional under the Due Process Clause of the
United States Constitution because it was not designed
to and does not further the state’s legitimate interest in
maternal health.

Although the DHEC officials responsible for drafting
and finalizing Regulation 61-12 may have set out to
promulgate some portions of the regulation to serve the
state’s interest in promoting and preserving the health
of women seeking abortions, they have failed in that
endeavor. Simply put, they have gone too far --
imposing costly requirements that are at best medically
unnecessary and at worst contrary to accepted medical
practice.

As an initial premise, the court agrees with plaintiffs’
contention that defendants may not rewrite the
regulation to correct its constitutional infirmities.
Defendants may not offer such “stipulations” without
plaintiffs’ consent, and they are more properly

24.

yn

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considered to be concessions by defendants that there
are defects in the sections referenced. Nor can the court
consider them to be a reasonable interpretation of the
language of the referenced sections. The statutory
sections which are relied upon to ensure confidentiality
are contained within a separate chapter of Title 44 of
the South Carolina Code of Laws. Even if they were
applicable to abortion facilities, the language is
insufficient to ensure the confidentiality of patients
seeking abortion services. The remainder of the
proffered “stipulations” are clearly intended to rewrite
the text of the sections at issue.

Furthermore, the court concludes that the infirmities in
the regulation go far beyond those sections which
defendants seek to correct through their stipulations.
Rather, the evidence in this case reveals, and the court
concludes, that the very drafting and promulgation
process surrounding Regulation 61-12 ensured its
failure to serve the permissible constitutional goal of
preserving and protecting the health of women seeking
abortions.

The evidence is undisputed that a first trimester
abortion is a relatively safe medical procedure with
minor risks to the health of the woman. However, the
DHEC officials charged with the task of drafting and
promulgating Regulation 61-12, while possessing some
expertise in the area of hospital administration, had no
formal medical education or training, sought no
significant input or assistance from knowledgeable
medical professionals, rejected assistance from a
reputable medical organization, and conducted no
meaningful inquiry into what standards of care should
be mandated in view of the relatively minor risk level
associated with a first trimester abortion procedure.
Instead, the DHEC officials have conceded that the

26.

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regulation was drafted primarily from the prior state

regulation governing second trimester abortion facilities

and from other DHEC regulations governing other
types of health care facilities and procedures, in an
attempt to “standardize” its health care regulations. '4
Thus, it is hardly surprising that the regulation imposes
numerous requirements which are medically
unnecessary for the safe performance of first trimester
abortions.

The medical evidence exposing the constitutional
infirmities is overwhelming. Plaintiffs have presented
this court with extensive testimony and evidence
proving that first trimester abortions can be and are
being safety performed in existing physicians’ offices
and clinics, and that South Carolina is not currently
experiencing any public health problem with the
performance of first trimester abortions. Regulation
61-12, however, imposes extensive, unduly restrictive,
and costly requirements upon physicians and clinics
which, in some cases, conflict with or go beyond
accepted medical practice for first- trimester abortions

14 DHEC may have a legitimate interest in standardizing its health care
regulations and codifying existing departmental practices. However, this
court is not called upon to decide whether this interest has been
appropriately served. DHEC did not adopt new regulations applicable to
all outpatient care facilities, including abortion clinics. Nor did DHEC
adopt new regulations which would be applicable to all physicians
performing surgical procedures in their offices or even to all physicians
performing abortions in their practices. Instead, DHEC promulgated
extensive medical care regulations aimed solely at abortion providers
who regularly perform abortion procedures, without meaningful input
from medical professionals and without regard to the safety needs and
risks specific to the abortion procedure. And many of the requirements
contained within Regulation 61-12 go beyond even those requirements
imposed upon, for example, ambulatory surgical centers which clearly
perform surgical procedures which carry an increased risk to the health
and safety of its patients.

d

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and which collectively impose substantial costs and
other burdens upon the providers and the patients.
Every part of the regulation, and nearly every section,
contains requirements which are unnecessary to the
provision of quality health care to women seeking
abortions or are not designed, by DHEC’s own
admission, to further that interest. And the regulation
as a whole imposes burdensome requirements that far
exceed those applicable to physicians’ offices which
perform procedures which are substantially similar, and
in some cases identical, to a first trimester suction
curettage abortion.

27. The specific requirements of Regulation 61-12 which
find no basis in medical necessity are too numerous to
mention, and the extensive nature of the regulation and
its obviously unnecessary detail cannot be fully
appreciated without a complete reading of its text. The
unnecessary provisions permeate virtually every
section, and to identify them individually and recount
the evidence demonstrating their excessiveness could
double the length of this order. If called for, this court
would not hesitate to accept the task; but after spending
months reviewing all aspects of this case, the court
cannot help but conclude that the constitutional
problems with this regulation are so numerous and
pervasive that their elimination would leave a hollow
regulation. A few examples should suffice. '5

28. Asan initial matter, Regulation 61-12 is riddled with
unnecessary requirements that place excessive burdens
on physicians’ offices and clinics solely because five or
more first trimester abortions are performed there per
month. In isolation many of the provisions would
sound like good ideas; however, the testimony from the

'S Additional examples can be found in the court’s findings of facts.

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medical experts whom this court found credible reveals
that many of these individual provisions contain
requirements that should not be mandated in every case
as this regulation would dictate. For example, testing a
person for particular sexually transmitted diseases
might sound like a good idea. But where there are no
symptoms or other accepted medical reasons or risk
factors to justify such a test, there is no reason to test a
woman for them just because she seeks an abortion.
Yet this, as an example, is what several of the
provisions do -- they require the physicians affected by
the regulation to abdicate their own medical judgment
and to test every pregnant woman who wants an
abortion for selected sexually transmitted diseases,
regardless of the medical justification.'© Similarly, the
regulation requires the administration of a urine
pregnancy test to all women, regardless of whether the
physician has confirmed the pregnancy through other
means.

29. Not only does the regulation mandate medical tests that
the testimony shows to be uncalled for, but it also
places administrative burdens on the clinics which are
clearly inappropriate to medical offices of such small
sizes as these offices and clinics. For example, DHEC
has mandated -- without regard to the number of staff
or size of the clinic -- the development of extensive
policies and procedures, frequent staff meetings, formal
inservice training and required staff certifications, and
medical testing of employees which, while probably

16 Defendants apparently seek to have this court conclude that the
selected diseases are much more prevalent in women seeking abortions or
that abortion clinics present a public health problem in this regard. Even
assuming such a finding would support the regulatory requirement,
defendants have simply presented insufficient evidence to support such a
finding.

30.

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appropriate for a hosp‘al or large outpatient surgical
center, are unnecessary in a small physician’s office or
clinic. With regard to the design and construction
requirements, the refusal to grandfather existing clinics
is unprecedented and no explanation has been given as
to why existing abortion clinics are compelled to be in
full compliance within two years, while other regulated
health care facilities (including ambulatory surgical
centers which admittedly perform more risky and
invasive surgical procedures) are subjected to less
stringent design and construction regulations and are
permitted to perform surgery in their existing facilities
until t

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386014_1354%3A2. Public record. Not legal advice.