Planned Parenthood Minnesota, North Dakota, South Dakota et al v. Noem et al

UNITED STATES DISTRICT COURT
DISTRICT OF SOUTH DAKOTA
SOUTHERN DIVISION
PLANNED PARENTHOOD MINNESOTA,
NORTH DAKOTA, SOUTH DAKOTA and
SARAH A. TRAXLER, M.D.,
Plaintiffs,
vs.
KRISTI NOEM, Governor, in official
capacity; JOAN ADAM, Interim
Secretary of Health, Department of
Health, in official capacity; PHILIP
MEYER, D.O.; President, South Dakota
Board of Medical and Osteopathic
Examiners, in official capacity,
Defendants.
4:22-CV-04009-KES
MEMORANDUM OPINION
AND ORDER GRANTING
PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION
Plaintiffs, Planned Parenthood Minnesota, North Dakota, South Dakota
and Sarah A. Traxler, M.D. (jointly referred to as Planned Parenthood), move
under Federal Rule of Civil Procedure 65 for a temporary restraining order and
preliminary injunction enjoining defendants, Kristi Noem, Joan Adam, and
Philip Meyer, D.O. (jointly referring to as state defendants), from enforcing
portions of South Dakota Administrative Rule 44:67:04:13. Docket 3. The court
granted the motion for a temporary restraining order on January 26, 2022, and
held an evidentiary hearing on the motion for preliminary injunction on
February 1, 2022. Docket 18; Docket 20. The state defendants resist Planned
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Parenthood’s motion. Docket 19. For the following reasons, the court grants
Planned Parenthood’s motion for a preliminary injunction.
BACKGROUND
I. 	Abortion Under the Status Quo in South Dakota
Planned Parenthood is a non-profit organization that operates a clinic in
Sioux Falls, South Dakota, where it offers a broad range of reproductive health
services, including medication and procedural abortions. Docket 1 ¶ 18. Its
Sioux Falls clinic is the only generally available abortion provider in the state.
Docket 5 ¶ 13. The clinic provides medication abortion through 11 weeks since
a patient’s last menstrual period (LMP) and procedural abortions through 13.6
weeks LMP. Id. ¶ 12. In 2021, Planned Parenthood performed 190 abortions at
its Sioux Falls clinic, about 40% of which were medication abortions. Id. ¶ 13.
And in 2020, of the 125 abortions performed at the clinic, 39.2% were
medication abortions. Docket 19-1 at 13.
South Dakota Department of Health’s 2020 Report of Induced Abortions
provides relevant insight on abortion patients in the state. See generally id. Of
the patients who received abortions in South Dakota in 2020, 44% reside
outside the two counties—Minnehaha and Lincoln—that comprise and
surround Sioux Falls. See id. at 5. Eighty-six percent of patients were not
married; a high school degree or less was the highest educational attainment
for 56% of patients. Id. at 7. Nearly two-thirds of patients already had one or
more living children. See id. at 9. Seventy-nine percent of patients had an
abortion through 11 weeks LMP. See id. at 11. Fifty percent reported that they
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“could not afford the child” as a reason for abortion; 17.6% reported that the
patient’s “emotional health was at risk” as a reason for abortion. Id. at 15.
Planned Parenthood provides additional statistics about its abortion
patients in Sioux Falls. Specific to medication abortion patients, about 24%
travel more than 150 miles round trip to reach the clinic and return home, and
11% travel more than 300 miles round trip. Docket 5 ¶ 41. These distances
and associated costs are doubled under the state’s existing two-appointment
requirement. Id. Many of Planned Parenthood’s patients rely on public
transportation, ride-sharing, or a borrowed car to reach the Sioux Falls clinic.
Id. ¶ 42. Thirty-one percent of medication abortion patients and 39% of all
abortion patients at the Sioux Falls clinic have income below 110% of the
federal poverty level.1 Id. ¶ 45. Many abortion patients experience domestic
violence, and some are unable to access healthcare without an abusive
partner’s interference. Docket 6 ¶ 33.
The most common method of medication abortion, and the method used
by Planned Parenthood, requires a two-drug regimen: first, mifepristone, and
second, misoprostol. Docket 5 ¶ 14; Docket 6 ¶ 11. This method causes a
patient to expel their pregnancy in a manner similar to miscarriage. Docket 5
¶ 14. Under existing South Dakota law, a person who wishes to receive a
medication abortion first must meet with a physician at the clinic to begin the
informed consent process. Docket 1 ¶ 28; see SDCL § 34-23A-56. This is the
1 “[I]n 2021, 110% of the [federal poverty level] for a family of one was an
annual income of $14,168, and $29,150 for a family of four.” Docket 5 ¶ 45.
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patient’s “first appointment.” At least 72 hours later, the person must return to
the clinic for the “second appointment” where the physician—the same
physician who met with the patient during the first appointment—dispenses
and administers mifepristone while the patient is at the clinic. Docket 5 ¶¶ 31-
32. During the second appointment, the physician also dispenses the second
drug, misoprostol, and instructs the person to self-administer it 24 to 48 hours
later at a location of their choosing. Id. ¶¶ 32, 34. The state defendants note
that the current FDA protocol calls for misoprostol to be administered 24 to 48
hours after mifepristone. Docket 19-2 ¶ 7. Medication abortion is safe for most
women through 11 weeks LMP. Docket 6 ¶ 25.
At the first appointment, medication abortion patients are given detailed
information about the medication abortion method, how and when they would
take the two medications, and what to expect in the process. Docket 5 ¶ 29.
They are also given the Mifeprex Medication Guide as required by the FDA. Id.
At the second appointment, the physician confirms that the patient wishes to
proceed with the abortion, the physician reviews what was discussed at the
first appointment, and the patient and physician finalize a follow-up plan that
is documented in the patient’s medical record. Id. ¶ 31.
At both appointments and throughout the medication abortion process,
physicians counsel patients about what effects may normally occur and what
symptoms may indicate a complication. Docket 6 ¶ 23. Patients are given the
chance to ask questions of their physician, and they are provided with
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information to reach a medical professional at any hour of any day. Docket 5
¶ 30; Docket 6 ¶ 23. Planned Parenthood states:
In the overwhelming majority of instances, providers can assess
patient 	concerns 	by 	phone, 	reassure 	them 	when 	they 	are
experiencing normal effects (such as cramping and bleeding), help
them manage these effects (e.g. with medications or interventions to
reduce pain), and as needed prescribe additional medications to help
them complete the process or schedule them for follow-up care.
Docket 6 ¶ 24. And in “extremely rare circumstances, providers refer patients
to the nearest hospital where emergency care is available.” Id. The state
defendants also note the availability of follow-up medical care that patients
avail themselves of when necessary. Docket 19-2 ¶¶ 25, 27, 28.
II. 	Abortion Under the New Regulation in South Dakota
The Department of Health promulgated Rule 44:67:04:13 regarding the
induction of medication abortions. This Rule was to take effect January 27,
2022. The Rule, discussed in greater detail below, requires a patient seeking a
medication abortion to attend 4 appointments at specific, regulated time
intervals: first, for informed consent; second, at least 72 hours later for
administration of mifepristone; third, 24 to 72 hours later for administration of
misoprostol; and fourth, “a follow-up appointment . . . on the 14th day after
taking the misoprostol[.]” S.D. Admin. R. 44:67:04:13 (2022). The third and
fourth clinic appointments are new, additional requirements to existing South
Dakota law.
III. 	Medication Abortion
Since receiving FDA-approval in 2000, over 4 million people in the United
States have completed a medication abortion. Docket 5 ¶ 17. Medication
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abortion is preferable to a procedural abortion for some people because it is
less invasive and offers flexibility in terms of the timing and location for
administering the second medication and ultimately completing the abortion.
Docket 1 ¶ 30; Docket 5 ¶ 15. Regardless of a patient’s preference, a
medication abortion is safer and medically indicated for some patients. Docket
5 ¶ 50. For patients with certain conditions, including cervical stenosis, uterine
fibroids, or obesity, a medication abortion presents fewer risks than a
procedural abortion. Id. ¶ 66. For patients with vulvodynia or vaginismus, a
procedural abortion is more painful. Id. Patients who have experienced rape or
other sexual violence may choose a medication abortion to feel more in control
and avoid having instruments placed in their vagina. Id.; Docket 6 ¶ 29.
As an alternative to a medication abortion, a patient may seek a
procedural abortion. In South Dakota, procedural abortion becomes the only
option for a patient seeking an abortion after 11 weeks LMP. Docket 6 ¶ 25. A
procedural abortion during the first trimester is performed by vacuum
aspiration; it requires that the patient’s cervix be dilated while a tube is
inserted through the vagina and cervix and into the uterus. Id. Suction is then
applied through the tube to empty the uterus. Id. A procedural abortion patient
typically receives sedation and/or local anesthesia. Id. In 2020 in South
Dakota, 58% of patients were under local anesthetic while 2.4% were under
general anesthetic. See Docket 19-1 at 14. As gestational age advances,
procedural abortion becomes more invasive, requiring increased dilation and
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possibly the use of forceps. Docket 6 ¶ 25. Many patients consider medication
abortion less invasive than procedural abortion. Id. ¶ 28.
Planned Parenthood and the state defendants dispute the safety of
medication abortion. Planned Parenthood argues that medication abortion is
“one of the safest procedures in contemporary medical practice, comparable in
safety to over-the-counter medications like ibuprofen and to antibiotics.” Id.
¶ 12; see also Docket 5 ¶ 16. According to the FDA, medication abortion has a
97.4% success rate, and complications are “extremely rare.” Docket 5 ¶ 16. For
the 2.6% of patients who require intervention following medication abortion,
the intervention is typically not urgent. Docket 5-2 at 2. Planned Parenthood
points to “[m]ultiple studies [that] have confirmed that far less than one
percent of patients experience serious complications from medication
abortion—a number that is significantly lower than the rate of serious
complications experienced by people who deliver a child.” Docket 5 ¶ 16.
The state defendants assert that “[m]edication abortions commonly lead
to complications, and at a rate higher than surgical abortions.” Docket 19-2
¶ 15. They point to a 2014 American College of Obstetricians and
Gynocologists bulletin that states “[c]ompared with surgical abortions,
medica[tion] abortion takes longer to complete, requires more active patient
participation, and is associated with higher rates of bleeding and cramping.” Id.
¶ 22 (first alteration in original). According to the FDA, “[a]bout 85% of patients
report at least one adverse reaction following administration of [mifepristone]
and misoprostol, and many can be expected to report more than one such
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reaction;” these adverse reactions include vomiting, headache, uterine
hemorrhage, viral infections, and pelvic inflammatory disease. Id. ¶ 23. Of the 4
million medication abortions that have taken place in the United States since
2000, over 4000 patients—or 0.1%—have experienced “adverse events”
following the use of mifepristone, including 24 deaths (0.0006%), 1,042
hospitalizations (0.026%), 599 blood transfusions (0.015%), and 412 infections
(0.0103%). Docket 19-2 ¶ 25. The state defendants assert that the FDA’s data
is not reliable due to underreporting, and they estimate a “30-fold”
underestimation of “adverse events.” Id. ¶ 27. If that were the case, the adverse
events would total 120,000, or 3% of 4 million. See id ¶ 25.
In support of their position, the state defendants point to a 2011
Australian study that found that 3.3% of patients who used mifepristone in
their first trimester required emergency room care, compared with 2.2% of
procedural abortion patients. Id. ¶ 17. In the same study, 5.7% of medication
abortion patients were admitted to a hospital following the abortion, compared
with 0.4% for procedural abortion patients. Id. The state defendants also rely
on a 2009 study in Finland that found that of women who had a medication
abortion, 15.6% experienced hemorrhaging, 6.7% had incomplete abortions,
and 5.9% required surgery to complete the abortion. Id. ¶ 18. The study
“indicated that hemorrhage and incomplete abortion are more common after
medical abortion” than procedural abortions. Id. Because mifepristone and
misoprostol may depress a patient’s immune system, medication abortion
patients can be more susceptible to infection. Id. ¶ 19. According to FDA data
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cited by the state defendants, medication abortion is more successful when
completed earlier in pregnancy. Id. ¶ 21 (“comparing successful mifepristone
abortions at 49 days (98.1%) to successful mifepristone abortions at 63 days
(92.7%)”). The state defendants and Planned Parenthood agree that the risks
that accompany abortion increase with gestational age. Id. ¶ 20; Docket 6 ¶ 36.
Until April 2021, an FDA Risk Evaluation and Mitigation Strategy (REMS)
required that mifepristone be dispensed at a clinic. Docket 6 ¶ 18. REMS “is a
drug safety program that the FDA can require for certain medications with
serious safety concerns.” Docket 19-2 ¶ 24 (cleaned up). The FDA suspended
the in-clinic administration requirement for mifepristone in April 2021, and it
eliminated the requirement in December 2021. Docket 6 ¶ 18. Still,
mifepristone may not be safe for all patients, and an in-person examination by
a physician is important to identify any contraindications. Docket 19-2 ¶¶ 11-
13. Citing the FDA, the state defendants assert that “prudent use of medication
abortion requires a follow-up in-person examination to ensure the abortion is
complete, i.e., all products of conception have been removed, and to confirm
the patient has not suffered serious complications.” Id. ¶ 14.
Unlike mifepristone, the FDA has never required that misoprostol be
dispensed in a clinic, whether it is prescribed for medication abortion or
another use. Docket 6 ¶ 19. Planned Parenthood asserts that this is because
misoprostol, when used following mifepristone, can cause uterine cramping
and vaginal bleeding as soon as two hours after administration, thus it is
important for patients to choose a safe and comfortable environment to self-
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administer misoprostol. Docket 5 ¶ 19. The original FDA-approved label for
mifepristone described that a patient would return to the clinic to receive
misoprostol. Docket 6 ¶ 14. But physicians prescribing the medication abortion
regimen have been permitted to, and in practice have, directed patients to self-
administer misoprostol at home. Id. The FDA altered mifepristone’s label in
2016, and stated
There is no medical rationale against permitting the woman to be
given the misoprostol on the day of the initial clinic/office visit and
self-administer it at a convenient time in the next 24-48 hours at
home. This would avoid another visit and the time, transportation,
loss of work, inconvenience, etc. that such a visit would involve.
Furthermore, given the fact that 22-38% of women abort within 3
hours 	and 	50-60% 	within 	5 	hours 	of 	[oral 	administration 	of]
misoprostol, it is preferable for the woman to be in a convenient,
safe place (home or at a support person’s location) for the expected
uterine cramping and vaginal bleeding to occur. Approximately 93%
of patients at 10 weeks [LMP] . . . expel their pregnancies within 24
hours of taking misoprostol.
Id. ¶ 15 (citation omitted). The FDA has also found that “rates of treatment
failure and of ongoing pregnancy were very similar regardless of whether
misoprostol was taken in-clinic or at another location.” Docket 5 ¶ 24. The
American College of Obstetricians and Gynecologists affirms that mifepristone
and misoprostol can be safely administered at home. Id. ¶ 25; Docket 6 ¶ 21.
Planned Parenthood states “[t]here is simply no medical value in requiring the
patient to return to the health center to obtain the misoprostol” and notes that
“the only care that would need to be provided at this third in-person dispensing
visit would be handing a patient the misoprostol.” Docket 5 ¶¶ 34, 36.
In 2019, the American Association of Pro-Life Obstreticians and
Gynecologists and the American College of Pediatricians petitioned the FDA to
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require three clinic appointments for a medication abortion, including a
separate appointment to dispense misoprostol. Docket 6 ¶ 16. The FDA denied
the petition’s request, noting that “studies support the efficacy of the
mifepristone, in a regimen with misoprostol when taken by the patient at
home. Therefore, we do not agree that an in-person visit is necessary to
manage administration of misoprostol.” Id.
Misoprostol is available at commercial pharmacies with a prescription
and can be used to treat gastric ulcers, incomplete abortions, miscarriage
management, postpartum hemorrhage, endometrial and cervical cancer, and
difficult IUD insertion/removal. Id. ¶¶ 13, 19, 31; Docket 1-4 at 1; Docket 19-2
¶ 9. Use of misoprostol to address incomplete abortion, management of
postpartum hemorrhage, and miscarriage management involves a higher risk of
bleeding than for use in a medication abortion. Docket 6 ¶ 31; see also Docket
5 ¶ 26 (“misoprostol as used in the medication-abortion regimen is at least as
safe as in these other contexts”). The FDA has never required that misoprostol
be dispensed at a clinic, even when used as part of a medication abortion.
Docket 5 ¶ 23. The only time a person taking misoprostol would be required to
have it dispensed by a physician during a separate clinic appointment is in
South Dakota under Rule 44:67:04:13. See infra; see also Docket 1-1 at 3-4.
Allowing patients to take misoprostol at home is especially important for
those patients who have been or are a victim of a controlling or abusive
partner. See Docket 6 ¶ 22. At-home administration of misoprostol by the
patient also reduces travel to the clinic and provides flexibility for the patient
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around work, parenting, and other responsibilities. Id. The South Dakota State
Medical Association, in comments submitted to the Department of Health,
notes that requiring misoprostol to be administered during a separate clinic
appointment is “unnecessary,” according to safety data. Docket 1-4 at 1. The
Association also states that taking mifepristone without subsequently taking
misoprostol leads to a risk of hemorrhage. Id. at 2. The Association concludes
that “the clinically unnecessary in-person dispensing requirement for
Misoprostol does nothing more than create another barrier for the patient that
may result in an increased risk of hemorrhage and bad outcome.” Id.
IV. 	Rule 44:67:04:13
On September 7, 2021, Governor Noem signed Executive Order 2021-12.
Docket 1-2 at 4. The Order sought to address “[i]mpending federal rulemaking”
regarding the 2011 REMS that restricted mifepristone to in-person dispensing.
Id. at 1; see also id. at 2 (referring to the REMS “for mifeprex and its approved
generic, mifepristone tablets”); Docket 6 ¶ 18. The Order directed the state
Department of Health:
to begin emergency rulemaking to be implemented pursuant to the
current FDA REMS, which has had a 20-year track record of helping
to 	protect 	women’s 	health 	with 	sound 	medical 	practice, 	to
accomplish the following:
a) 	With 	the 	proliferation 	of 	companies 	organizing 	to 	sell 	these
dangerous drugs online to young women, ensure that medicines,
drugs, or any other substances prescribed or dispensed with the
intent of terminating the pregnancy of 	a 	woman shall 	only be
dispensed by a physician licensed in South Dakota to a patient after
examining her in-person to rule out contraindications, including but
not limited to, ectopic pregnancy;
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b) Provide that no manufacturer, supplier, physician, or any other
person may provide any abortion-inducing drugs directly to women
in South Dakota via courier, delivery, telemedicine, or mail service;
c) 	Ensure 	abortion-inducing 	drugs 	shall 	not 	be 	dispensed 	or
provided in any school facility or on state grounds, including but not
limited to, elementary schools, secondary schools, and institutions
of higher education in this state. The abortion industry is targeting
young women via social media and school bathrooms are at risk of
becoming the new abortion clinics;
d) Remind licensed physicians dispensing or prescribing abortion-
inducing drugs they shall ensure that our state’s Informed Consent
laws are properly administered;
e) Develop an abortion clinic license specific to the pharmaceutical
nature of medical abortion in keeping with South Dakota’s existing
surgical abortion clinic licensing requirements (i.e. a license for “pill
only” clinics).
f) 	Collect 	empirical 	data 	on 	how 	often 	chemical 	abortions 	are
performed 	as 	a 	percentage 	of 	all 	abortions, 	how 	often 	women
experience complications that require medical follow-up (or a second
abortion), 	where 	the 	doctor 	prescribing 	or 	dispensing 	chemical
abortion is located, if she was coerced or sex trafficked and forced
to take the pills, and more.
g) As research shows that chemical abortion has four times greater
rate of complications that surgical abortion, the state has an interest
in collecting data on the rate of complications seen in our emergency
rooms and other medical facilities as a result of chemical abortions.
I 	am 	therefore 	directing 	the 	Department 	of 	Health 	to 	enhance
reporting requirements for this procedure so that we know how often
and how harsh the results are.
Docket 1-2 at 2-3.
During the rule making process, the Secretary of the Department of
Health stated that the Rule is “required per the Governor’s Executive Order
2012-12.” Docket 5-2 at 1. A state rule making form asked the Secretary “Why
is the rule[] needed?” The Secretary responded:
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To protect the health and safety of women that is at-risk due to the
expected FDA lifting of additional safety protocols regarding the use
of mifepristone and misoprostol. The rule requires the mifepristone
and misoprostol used for a medical abortion may only be prescribed
and dispensed by a licensed physician and administered in person
in a licensed abortion facility consistent with SDCL 34-23A, and to
require reporting of certain information.
S.D. Dep’t of Health, Form 14 Small Business Impact Statement Form 1
(Nov. 8, 2021), https://rules.sd.gov/Uploads/684_BusinessImpact
Statement.pdf (cited at Docket 5-2 at 1).
Following the rule making process, the Department of Health
promulgated Rule 44:67:04:13, which took effect on January 27, 2022, though
this court’s temporary restraining order enjoined its enforcement until
February 9, 2022. Docket 18 at 8. The Rule, in its entirety, states:
For the purpose of inducing a medical abortion, a pregnant woman
may only take the medications Mifepristone or Misoprostol up to
nine weeks after conception. Mifepristone and Misoprostol must be
prescribed and dispensed by a licensed physician in a licensed
abortion 	facility 	consistent 	with 	SDCL 	chapter 	34-23A 	and 	in
compliance with the applicable requirements in SDCL chapter 36-4.
A pregnant woman may only take Mifepristone at a licensed abortion
facility and only after informed consent has been obtained pursuant
to SDCL 34-23A-l0.1 and consistent with SDCL 34-23A-56. Before
dispensing 	Mifepristone. 	a 	physician 	shall 	provide 	the 	notice
required by SDCL 34-23A-l0.l(l)(h) and 34-23A-l0.1(3) ensuring that
the pregnant woman has notice that if she changes her mind about
the medical abortion and decides to carry the baby to term, it is
possible 	to 	reverse 	the 	effects 	of 	Mifepristone. 	After 	taking
Mifepristone and undergoing an observation period in the abortion
facility, the pregnant woman may return home. Between 24-72
hours after taking Mifepristone, if the pregnant woman decides to
continue with the medical abortion, the pregnant woman must
return to the licensed abortion facility to receive the proper amount
of Misoprostol. A licensed physician shall dispense the Misoprostol
to 	the 	pregnant 	woman 	in 	the 	same 	manner 	as 	required 	for
Mifepristone 	under 	this 	section. 	Neither 	Mifepristone 	nor
Misoprostol may be dispensed for the purpose of inducing a medical
abortion in any manner contrary to this section. The abortion facility
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staff shall monitor the pregnant woman for complications for a
medically necessary period following each administration of the
abortion-inducing medications and report the following information
to the Department of Health:
(1) 	Any complication that requires medical follow-up;
(2) 	The medical follow-up that was required resulting from
any complication;
(3) 	The facility where the medical follow-up was performed;
and
(4) 	If the pregnant woman was sex trafficked.
The 	abortion 	facility 	staff 	shall 	schedule 	a 	follow-up
appointment with the pregnant woman to return to the abortion
facility on the 14th day after taking the medication to confirm that
the fetus, placenta, and membranes have been fully expelled.
For the purposes of this section, the term, medical abortion,
means a procedure that uses medication to end a pregnancy.
S.D. Admin. R. 44:67:04:13 (2022). Rule 44:67:04:13 has an effective date of
January 27, 2022. Id. Violating a rule is a basis for revoking Planned
Parenthood’s license. S.D. Admin R. 44:67:01:05(1) (2006).
V. 	Effects of the Rule
Planned Parenthood points to several studies showing that when a law
requires multiple clinic appointments to obtain an abortion, patients face
delayed care or are prevented from obtaining an abortion. Docket 6 ¶¶ 53-54.
During the evidentiary hearing before this court, Planned Parenthood stated
that it was not aware of any other states that presently require three or more
clinic appointments to obtain a medication abortion. Planned Parenthood
states that “the Rule will harm [its] patients in numerous and unprecedented
ways, and will severely restrict access to abortion services in South Dakota, if
not end medication abortion entirely in the state.” Docket 5 ¶ 37. In her
affidavit, Dr. Traxler states that “[b]ased on the available evidence, I also
believe that the mandatory delay and extra trip for misoprostol required by this
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Rule will likely put patients at risk.” Id. ¶ 38. She points to a “recent double-
blind, placebo-controlled, randomized trial indicat[ing] that patients who
interrupt the medication-abortion regimen partway through—by taking
mifepristone but not following it with misoprostol within the recommended 24-
to-48-hour time frame—may be at increased risk of significant hemorrhage.”
Id.; see also Docket 6 ¶ 46. An interrupted regimen could also lead to an
incomplete abortion requiring follow-up medical care or a delay causing the
pregnancy to continue beyond the 13.6 weeks LMP when abortion is available
at the clinic. See Docket 6 ¶¶ 49-50. Dr. Traxler concludes that the mandatory
delay and separate third appointment required under the Rule thus increase
the likelihood that a patient will not be able to make it back to the clinic within
the recommended time-frame, if at all, for administration of misoprostol and
thus suffer the consequences of an interrupted regimen discussed above.
Docket 5 ¶ 39. Planned Parenthood also notes that because misoprostol should
ideally be administered within 48 hours after mifepristone, the period of time
during which a patient should return for the third appointment is actually
shorter than the 72 hours provided under the Rule. Docket 6 ¶ 44.
Planned Parenthood asserts that the mandatory delay and travel
necessitated by the third appointment will create obstacles for medication
abortion patients. See Docket 5 ¶¶ 39-40. Planned Parenthood asserts that
“most abortion patients are parents, most have low incomes, and many work
inflexible minimum-wage jobs.” Id. ¶ 40. Planned Parenthood asserts that the
cost of travel is an obstacle for patients given that many have low income and
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do not have personal transportation. Id. ¶ 45; see supra. Planned Parenthood
also states that the cost of travel is in addition to the cost of the abortion itself,
including for those who have health coverage through the Affordable Care Act
or Medicaid, neither of which cover abortion expenses except when the
patient’s life is in danger. Docket 5 ¶ 45. And each trip results in additional
costs for missing work, school, and childcare. Id. ¶ 46. Planned Parenthood
also states that each trip imposes an obstacle for patients who are trying to
keep their abortion private. Id. ¶ 47. This is particularly true, they note, for
survivors of abuse and sexual assault, who live under the watchful eye of their
abuser. Id. ¶ 48. Additional obstacles related to travel are unforeseen
circumstances, like unpredictable weather, that can delay travel or make it
impossible for a patient to arrive at the right appointment interval and for their
appointment time. See id. ¶ 44.
Planned Parenthood states that the third appointment would be
“effectively impossible to comply with an as operational matter.” Id. ¶ 51. It
argues that because of its clinic schedule and attending physicians’
availability, it would not be able to comply with the additional appointments
and the regulated time intervals under the Rule. Id. ¶¶ 53-60. There are
currently two abortion providers who live out of state and travel to Sioux Falls
so that the clinic can provide abortion services two or three times each month.
Id. ¶¶ 53-54, 57-58. Planned Parenthood plans to add two additional
physicians in 2022. Id. ¶ 55. The clinic currently schedules abortions four
weeks out. Id. ¶ 58. Planned Parenthood states that the personal and
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professional obligations of their physicians preclude them from traveling back
for a third appointment within 24 to 72 hours under the Rule. Id. ¶¶ 59-60. For
these reasons, Planned Parenthood states that the Rule would force the
organization to stop providing medication abortions and deprive patients of this
option. Id. ¶ 62.
Planned Parenthood states that it will have to reduce appointments by
30% if the Rule is enforced by the state defendants. Id. ¶ 68. This will lead to
delays for all patients seeking an abortion at the clinic, and the delay will
preclude some patients from seeking an abortion altogether because they will
be past 13.6 weeks LMP. Id. The delay in services is compounded by the
existing 4-week scheduling delay. Id. For those who are still able to complete
an abortion before 13.6 weeks LMP, Planned Parenthood notes that health
risks increase as the gestational age increases. Id. ¶ 69. Planned Parenthood
concludes that “[d]elays caused by the Rule will ultimately harm these
patients.” Id.
Planned Parenthood states that even if it was able to offer medication
abortions under the Rule, delays caused by a third appointment and physician
availability could push some patients past the 11 weeks LMP cut-off for a safe
medication abortion. Id. ¶ 74. It notes that in 2021, approximately 22% of
medication abortions at the clinic occurred at 10 weeks LMP, “which means for
a significant percentage of [] patients any further delays could push them out
of reach for a medication abortion.” Id. ¶ 74; see also Docket 6 ¶ 25.
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Planned Parenthood moves the court to enjoin “the Rule’s mandatory
delay and separate visit requirements for the dispensing of misoprostol.”
Docket 1 at 26.
LEGAL STANDARD
The “purpose of a preliminary injunction is merely to preserve the
relative positions of the parties until a trial on the merits can be held.” Little
Rock Fam. Plan. Servs. v. Rutledge, 984 F.3d 682, 690 (8th Cir. 2021) (quoting
Univ. of Tex. v. Camenisch, 451 U.S. 390, 395 (1981)); see also Dataphase Sys.,
Inc. v. C L Sys., Inc., 640 F.2d 109, 113 (8th Cir. 1981) (en banc) (a preliminary
injunction “preserve[s] the status quo until the merits are determined.”). When
ruling on a motion for a preliminary injunction, the court must consider (1) the
threat of irreparable harm to the moving party; (2) balancing this harm with
any injury an injunction would inflict on other parties; (3) the likelihood of
success on the merits; and (4) the public interest. Dataphase Sys., Inc., 640
F.2d at 113. “While no single factor is determinative, the probability of success
factor is the most significant.” Carson v. Simon, 978 F.3d 1051, 1059 (8th Cir.
2020) (cleaned up). The movant has the burden of persuasion on a motion for
preliminary injunction and must do so by a “clear showing.” Planned
Parenthood Minn., N.D., S.D. v. Rounds, 530 F.3d 724, 736 (8th Cir. 2008) (en
banc) (citing Mazurek v. Armstrong, 520 U.S. 968, 972 (1997) (per curiam)).
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DISCUSSION
I. 	Undue Burden Claim
A. 	Undue Burden Claim Under 42 U.S.C. § 1983
The state defendants argue that Planned Parenthood “cannot invoke 42
U.S.C. § 1983 to assert [] third-party rights, because the cause of action in
section 1983 allows litigants to assert only their own rights, and not the rights
of third parties.” Docket 19 at 11. At oral argument and in their brief, the state
defendants concede that Planned Parenthood has Article III standing. See id.
The issue is “whether the plaintiffs have identified a cause of action that
authorizes their lawsuit.” Id.; see Davis v. Passman, 442 U.S. 228, 239 n.18
(1979) (“cause of action is a question of whether a particular plaintiff is a
member of the class of litigants that may, as a matter of law, appropriately
invoke the power of the court.” (emphasis in original)).
The Eighth Circuit in Pediatric Specialty Care, Inc. v. Arkansas
Department of Human Services, 293 F.3d 472 (8th Cir. 2002), recognized that
third-party plaintiffs can bring a claim under § 1983. Id. at 478 (“[t]he provider
plaintiffs in this case have standing to assert the rights of their [] patients”).
The Seventh Circuit in Planned Parenthood of Wisconsin, Inc. v. Van Hollen, 738
F.3d 786 (7th Cir. 2013), came to the same conclusion in the context of
abortion litigation. There, the court identified numerous cases, including
Planned Parenthood of Southeastern Pennsylvania v. Casey, 505 U.S. 833, 903-
04 (1992) and Planned Parenthood of Central Missouri v. Danforth, 428 U.S. 52,
62 (1976), where “doctors and abortion clinics were found to have had standing
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. . . pursuant to section 1983.” Van Hollen, 738 F.3d at 795. Thus, the court
concluded that the “justiciability of such cases is not in question.” Id. Finally, a
district court in the Eighth Circuit, addressing the same issue, relied on the
analysis in Van Hollen when it concluded that the “Supreme Court has
repeatedly allowed abortion providers to raise the rights of their patients in
cases brought under § 1983[.]” Little Rock Fam. Plan. Servs. v. Rutledge, 397 F.
Supp. 3d 1213, 1264 (E.D. Ark. 2019) (citing Whole Woman’s Health v.
Hellerstedt, 579 U.S. 582 (2016); Gonzales v. Carhart, 550 U.S. 124 (2007);
Ayotte v. Planned Parenthood of N. New Eng., 546 U.S. 320 (2006); Bellotti v.
Baird, 428 U.S. 132 (1976)).
Here, the court finds the state defendants’ analysis of § 1983 ignores
multiple instances where the Eighth Circuit and the Supreme Court have
recognized a cause of action under § 1983 brought by abortion providers on
their own behalf and on behalf of their patients. See, e.g., Little Rock Fam. Plan.
Servs., 984 F.3d 682. Thus, Planned Parenthood’s undue burden claim is
properly brought under 42 U.S.C. § 1983.
B. 	Likelihood of Success on the Merits
“Success on the merits has been referred to as the most important of the
four factors.” Roudachevski v. All-Am. Care Ctrs., Inc., 648 F.3d 701, 706 (8th
Cir. 2011). When a challenged law was “implemented through legislation or
regulation[] developed through presumptively reasoned democratic processes,”
the court analyzes whether the movant is likely to succeed on the merits.
Rounds, 530 F.3d at 732 (quoting Able v. United States, 44 F.3d 128, 131 (2d
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Cir. 1995) (per curium)) (noting that “likelihood of success” is a higher standard
than a “fair chance” of success). Because the Rule is a state regulation
promulgated under South Dakota’s rule making process, the court will apply
the likelihood of success standard.2 At the preliminary injunction stage, “the
speculative nature” of the likelihood of success inquiry “militates against any
wooden or mathematical application of the test.” United Indus. Corp. v. Clorox
Co., 140 F.3d 1175, 1179 (8th Cir. 1998).
“[A] state cannot ‘impose an undue burden on the woman’s ability to
obtain an abortion.’ ” Hopkins v. Jegley, 968 F.3d 912, 914 (8th Cir. 2020)
(quoting June Med. Servs. L.L.C. v. Russo, 140 S. Ct. 2103, 2135 (2020)
(Roberts, C.J., concurring)). The “threshold requirement [is] that the State have
a ‘legitimate purpose’ and that the law be ‘reasonably related to that
2 The Eighth Circuit has not indicated whether the “likelihood of success”
standard applies to a state regulation promulgated by the executive branch at
the direction of an executive order. In Rounds, the Court relied on the Second
Circuit’s reasoning in Able: the likelihood of success standard applies when “a
party seeks to stay government action taken in the public interest pursuant to
a statutory or regulatory scheme[.]” 530 F.3d at 731 (emphasis added) (quoting
Able, 44 F.3d at 131). In Richland/Wilkin Joint Powers Authority v. U.S. Army
Corps of Engineers, 826 F.3d 1030 (8th Cir. 2016), the Eighth Circuit affirmed
the district court’s finding that the lower “fair chance of prevailing” standard
applied when plaintiffs sought to enjoin a construction project “authoriz[ed] . . .
pursuant to expert agency recommendation.” Id. at 1040-41. Here, Planned
Parenthood seeks to enjoin an administrative rule that was “required” by
executive order to be promulgated. See supra at 13. Whether this process is
akin to “adopting a complex statute through fulsome debate” is an open
question. See Richard/Wilkin Joint Powers Auth., 826 F.3d at 1040. Relying on
the word “regulation” in Rounds and Able, the court here applies the “likelihood
of success” standard.
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goal.’ ” June Medical, 140 S. Ct. at 2138. “So long as that showing is made, the
only question for a court is whether a law has the ‘effect of placing a
substantial obstacle in the path of a woman seeking an abortion of a nonviable
fetus.’ ” Id. (quoting Casey, 505 U.S. at 877).
1. 	Whether the Rule is reasonably related to a legitimate
purpose
Planned Parenthood argues that the Rule lacks a legitimate purpose
regarding the Rule’s mandatory third appointment for dispensing misoprostol;
and, even if there is a legitimate purpose, the Rule is not reasonably related to
that purpose. See Docket 4 at 11-14. The state defendants argue that rational
basis review applies to this issue. Docket 19 at 20. And under rational basis,
the state defendants conclude that the Rule is reasonably related to three
purported purposes that they identify and explain in their brief. Id. at 20-23.
The state defendants urge the court to apply the rational basis standard
articulated in Heller v. Doe, 509 U.S. 312 (1993):
A statute is presumed constitutional and “[t]he burden is on the one
attacking the legislative arrangement to negative every conceivable
basis 	which 	might 	support 	it,” 	whether 	or 	not 	the 	basis 	has
foundation 	in 	the 	record. 	Finally, 	courts 	are 	compelled 	under
rational-basis review to accept a legislature’s generalizations even
when there is an imperfect fit between means and ends.
Id. at 320 (cleaned up) (quoting Lehnhausen v. Lake Shore Auto Parts Co., 410
U.S. 356, 364 (1973); see also Docket 19 at 20.
But in Casey, the Supreme Court stated that “a statute which, while
furthering . . . [a] valid state interest, has the effect of placing a substantial
obstacle in the path of a woman’s choice cannot be considered a permissible
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means of serving its legitimate ends.” 505 U.S. at 877. And in Hellerstedt, the
Supreme Court held that it “is wrong to equate the judicial review applicable to
the regulation of a constitutionally protected personal liberty with the less
strict review applicable where, for example, economic legislation is at issue.”
Hellerstedt, 136 S. Ct. at 2309. That standard of “less strict review,” rational
basis, is well-established: that a law will be upheld “if there is any reasonably
conceivable state of facts that could provide a rational basis for the
classification” in the law. TCF Nat’l Bank v. Bernanke, 643 F.3d 1158, 1165
(8th Cir. 2011) (quoting FCC v. Beach Commc’ns, Inc., 508 U.S. 307, 313
(1993)).
Declining to use rational basis, the Supreme Court in Hellerstedt
explained:
[I]n Gonzales the Court, while pointing out that we must review
legislative “factfinding under a deferential standard,” added that we
must not “place dispositive weight” on those “findings.” Gonzalez
went 	on 	to 	point 	out 	that 	the 	“Court 	retains 	an 	independent
constitutional duty to review factual findings where constitutional
rights are at stake.”
Hellerstedt, 136 S. Ct. at 2310 (emphasis omitted) (internal citations omitted)
(quoting Gonzales, 550 U.S. at 165). In Gonzales, the Court looked to the
“recitals” of the challenged law to determine its purpose. 550 U.S. at 156.
Without similar recitals or legislative findings accompanying the challenged law
in Hellerstedt, the Court “infer[red] that the legislature sought to further a
constitutionally acceptable objective[.]” 136 S. Ct. at 2310. But there, the Court
also looked to the “great weight of the evidence” in front of the district court
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and its review of the benefits of the law to determine its purpose. Id. at 2311;
see also June Medical, 140 S. Ct. at 2138 (Roberts, C.J., concurring) (“Casey
discussed benefits in considering the threshold requirement that the State
have a “legitimate purpose” and that the law be “reasonably related to that
goal.”).
Here, the court finds that the Rule regulates a constitutionally protected
personal liberty, a person’s right to seek an abortion. See Hellerstedt, 136 S.
Ct. at 2309-10. Thus, the court will not apply rational basis review and will
apply the Supreme Court’s analysis in Hellerstedt and Gonzales to this
threshold issue.
The South Dakota Secretary of Health stated that the Rule was
promulgated because it was “required per the Governor’s Executive Order
2021-12.” Docket 5-2 at 1. Several purposes are readily apparent in the recitals
and directives in the Executive Order: (1) respond to FDA rulemaking lifting the
2011 REMS restricting mifepristone to in-person dispensing; (2) ensure that
mifepristone and misoprostol are dispensed in-person to medication abortion
patients by a physician after an in-person examination to rule out
contraindications; (3) restrict where abortion medications are dispensed and
bar telemedicine medication abortions; (4) reinforce the state’s informed
consent procedure; (5) collect empirical data on medication abortions; and (6)
enhance reporting requirements for medication abortions. Docket 1-2 at 2-3.
The Secretary’s subsequent summary of the Rule’s purposes is consistent with
the objectives identified in the Executive Order: respond to “the expected FDA
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lifting of additional safety protocols regarding the use of mifepristone and
misoprostol” to ensure that mifepristone and misoprostol are only “prescribed
and dispensed by a licensed physician and administered in-person in a
licensed abortion facility consistent with SDCL 34-23A, and to require
reporting of certain information.” S.D. Dep’t of Health, Form 14 Small Business
Impact Statement Form 1 (Nov. 8, 2021),
https://rules.sd.gov/Uploads/684_BusinessImpactStatement.pdf (cited at
Docket 5-2 at 1). Because Planned Parenthood seeks an injunction of the
mandatory third appointment and accompanying delay period, the court
focuses on the first three purposes, as identified above, that relate to the
administration of misoprostol in the Governor’s Executive Order.
First, Planned Parenthood argues that the Department’s stated purpose
of responding to FDA changes regarding both mifepristone and misoprostol is
misguided because the FDA has not recently taken action with regard to
misoprostol. Docket 4 at 12. Here, the record indicates that in 2021 the FDA
suspended, and later eliminated, the REMS that required in-person
administration of mifepristone. But the FDA, which has never required in-
person administration of misoprostol, has not recently made any change
regarding misoprostol. While the Executive Order did not incorrectly refer to
FDA changes regarding misoprostol, the Secretary’s explanation of the Rule
did. Thus, to the extent the Rule seeks to respond to FDA changes regarding
misoprostol, the Rule lacks a legitimate purpose.
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Second, Planned Parenthood argues that the purposes of banning
telemedicine abortions and requiring in-person dispensing of mifepristone and
misoprostol following an examination for counterindications are moot, because
existing state law requires two clinic appointments, including an examination,
before mifepristone and misoprostol are dispensed in-person. Id. at 13. Here,
Planned Parenthood has only established that these purposes are redundant
with existing law, not that they are illegitimate. Planned Parenthood states that
at-home administration of mifepristone is safe, but it does not argue that a ban
on telemedicine or requiring in-person dispensing (as opposed to
administration) are undue burdens on patients. Thus, the courts finds that the
second and third purposes are legitimate.
Alternatively and additionally, Planned Parenthood claims that the Rule’s
mandatory third appointment for the administration of misoprostol, and the
accompanying delay period, are not reasonably related to the Rule’s stated
purposes. Id. at 12-13. They argue that any further restriction on misoprostol
has no reasonable relation to anything in the Executive Order. See id.
Specifically, they point out that misoprostol is already dispensed by a physician
in the clinic; the Executive Order makes no mention of the need for an
additional appointment or a mandatory time delay. See id. And Planned
Parenthood argues that the Rule’s third appointment and time delay actually
put patients at greater risk and impose an undue burden. Id. at 14.
Here, the third appointment and mandatory time delay appear for the
first time in the Rule. Nothing in the Executive Order indicates a change in
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FDA regulations regarding misoprostol. And as the court discusses below, the
third appointment and time delay for misoprostol increase the risks to patients’
health. Thus, the court finds that the portion of the Rule sought to be enjoined
is not reasonably related to the purposes as stated by the executive branch.
Because the part of the rule challenged by Planned Parenthood fails to meet
this threshold requirement, that part of the Rule should be enjoined on this
basis alone. But to fully address the parties’ arguments regarding Planned
Parenthood’s facial and as-applied challenges to the Rule, the court proceeds
with the undue burden analysis.
2. 	Whether the Rule imposes an undue burden
To establish an undue burden, Planned Parenthood must demonstrate
that “in a large fraction of the cases in which [the Rule] is relevant, it will
operate as a substantial obstacle to a woman’s choice to undergo an abortion.”
Planned Parenthood of Ark. & E. Okla. v. Jegley, 864 F.3d 953, 958 (8th Cir.
2017) (quoting Casey, 505 U.S. at 895). “The Supreme Court has clarified that
“cases in which the provision at issue is relevant” is a narrower category than
“all women,” “pregnant women,” or even “women seeking abortions identified
by the State.” Id. (emphasis omitted) (quoting Hellerstedt, 136 S. Ct. at 2320);
see also Casey, 505 U.S. at 894-95. In Jegley, the Eighth Circuit found that
“because the contract-physician requirement only applies to medication-
abortion providers, the ‘relevant denominator’ here is women seeking
medication abortions in Arkansas.” Id. There are three issues that must be
resolved in order to determine whether Planned Parenthood has met their
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burden: (1) in what cases is the Rule “relevant”; (2) does the Rule create a
“substantial obstacle to a woman’s choice to undergo an abortion” in those
cases in which the Rule is “relevant”; and (3) is the substantial obstacle present
in a “large fraction” of the “relevant” cases. See, e.g., Planned Parenthood Minn.,
N.D., S.D. v. Daugaard, 799 F. Supp. 2d 1048, 1060 (D.S.D. 2011) (“the
relevant cases are those that involve a woman who has chosen to undergo an
abortion and would otherwise not consult with a pregnancy help center”);
Casey, 505 U.S. at 895 (limiting the relevant cases to “married women seeking
abortions who do not wish to notify their husbands of their intentions and who
do not qualify for one of the statutory exceptions to the notice requirement”).
Planned Parenthood claims that the Rule is relevant only to patients
seeking a medication abortion in South Dakota. Docket 24 at 15. They argue
that the Rule is an “actual restriction” only for medication abortion patients,
and not all of its abortion patients. Id. (citing Hellerstedt, 136 S. Ct. at 2320).
The state defendants argue that the denominator should include all people
seeking an abortion at Planned Parenthood because Planned Parenthood’s
undue burden argument rests on the effects the Rule would have on that
group. Docket 19 at 14.
Under Jegley and Casey, the court finds that the relevant cases, or
denominator, are limited to Planned Parenthood’s medication abortion patients.
But because part of Planned Parenthood’s undue burden argument rests on
effects on all its abortion patients, the court finds that the Rule is also relevant
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to that group as well. Thus, the court analyzes whether the Rule imposes a
substantial obstacle on a large fraction of patients in both groups.
The next step is to determine whether the Rule creates “a substantial
obstacle to a woman’s choice to undergo an abortion” for a “large fraction” of
relevant cases. See Daugaard, 799 F. Supp. 2d at 1060. The Supreme Court
“has made clear that a State may promote but not endanger a woman’s health
when it regulates the methods of abortion.” Stenberg v. Carhart, 530 U.S. 914,
931 (2000) (citations omitted). “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.” Casey, 505 U.S. at 878.
Concerning what constitutes a large fraction, the Supreme Court in
Casey addressed the constitutionality of, among other provisions, a “spousal
notification requirement.” Id. at 893. The relevant cases in Casey with regard
to that requirement were “married women seeking abortions who do not wish to
notify their husbands of their intentions and who do not qualify for one of the
statutory exceptions to the notice requirement.” Id. at 895. The Court held that
the requirement was unconstitutional under the “large fraction” test after it
found that the requirement was “likely to prevent a significant number of
[those] women from obtaining an abortion.” Id. at 893-94. This language and
reasoning indicates that the term “large fraction” should not be construed as
some numerical threshold that must be established. See id. The Eighth Circuit
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has recognized that 18% can constitute a “large fraction,” though it has not set
that number, or any number, as a brightline minimum. See Planned
Parenthood, Sioux Falls Clinic v. Miller, 63 F.3d 1452, 1462 & n.10 (8th Cir.
1995).
Planned Parenthood argues that the third appointment for dispensing
misoprostol, and the accompanying 24 to 72 hour delay for the third
appointment, impose substantial obstacles for medication abortion patients.
Docket 4 at 15-23. First, they argue that the Rule would eliminate access to
medication abortion. Id. at 15; Docket 24 at 15. On this point, the record
indicates that Planned Parenthood would not be able to comply with the Rule’s
third appointment and 24 to 72 hour delay requirements based on physician
availability. This result would affect 100% of Planned Parenthood’s medication
abortion patients. Medication abortion is safer for some patients than a
procedural abortion. A medication abortion is medically indicated for some
patients. And for those who are victims of domestic violence or rape,
medication abortion is preferable. The alternative, procedural abortion, is more
invasive—a fact that imposes an obstacle for patients who prefer the flexible
timing and lesser degree of bodily invasion of a medication abortion. Thus, the
court finds that the effect of eliminating medication abortion for all patients
who seek a medication abortion at Planned Parenthood is a substantial
obstacle for 100% of relevant cases, which constitutes a large fraction.
Second, Planned Parenthood argues that the third appointment for
dispensing misoprostol, and the accompanying 24 to 72 hour delay, for the
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third appointment, impose substantial obstacles for medication abortion
patients because, even if Planned Parenthood could implement the Rule, the
Rule is an unnecessary regulation. Docket 4 at 15-23. The record shows that
the FDA—an entity that both Planned Parenthood and the state defendants
point to as authoritative—does not require misoprostol to be administered by a
physician in a clinic. The FDA allows self-administration of misoprostol at a
location of the patient’s choosing. And the FDA recommends that it be
administered 24 to 48 hours after mifepristone, not 24 to 72 hours as is
permitted under the Rule. Specifically, the FDA has found that there is no
medical rationale against permitting self-administration of misoprostol. But
there is medical rationale for not requiring a separate clinic appointment for
the administration of misoprostol. The requirement of a third appointment
necessarily puts all medication abortion patients at greater risk of hemorrhage
or other complications because it requires an unnecessary trip to the clinic
that could be missed or delayed, thus interrupting the medication regimen.
Those unnecessary risks are burdens in themselves. The court finds that the
third appointment and mandatory delay are an unnecessary regulation and
thus a substantial obstacle for all patients seeking a medication abortion.
Planned Parenthood argues that even if it could comply, the Rule would
impose substantial travel and logistical obstacles on abortion patients, 40% of
whom are mediation abortion patients. Docket 4 at 20. Forty-four percent of
patients would have to travel to the Sioux Falls clinic from somewhere outside
the clinic’s two-county area. Twenty-four percent of patients would travel 150
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miles round trip, or 450 miles total for the three appointments required under
the Rule. For the many patients who rely on public transportation, ride-
sharing, or a borrowed vehicle, the likelihood that they could successfully
return for a third appointment time within the 24 to 72 hour delay period is
low. And because 39% of all patients are at or below 110% of the federal
poverty level, the third appointment adds to the already substantial financial
obstacles of travel. Patients’ travel obstacles are compounded by the fact that
just over half of patients have a high school degree or less education—a fact
that indicates patients have a low degree of flexibility to leave work. Nearly-two
thirds needs to arrange care for their other child or children, especially the
86% who are unmarried. In addition to these many obstacles to traveling to
their third appointment, patients face the obstacle of increased risk to health if
they are unable to timely return for the third appointment and receive
misoprostol to complete the abortion. For the 22% of patients who had a
medication abortion at 10 weeks LMP in 2021, the Rule imposes an obstacle by
risking that the third appointment will push them past 11 weeks LMP when
medication abortion is safest and available at Planned Parenthood. Because
people seeking an abortion in South Dakota must already travel to the Sioux
Falls clinic twice, requiring a third appointment at a specific time would further
compound patients’ financial, logistical, and health obstacles. The court finds
these requirements do “not merely make abortions a little more difficult or
expensive to obtain,” but rather amount to substantial obstacles for a large
fraction of medication abortion patients. See Casey, 505 U.S. at 893.
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Finally, Planned Parenthood argues that the Rule imposes a substantial
burden on all abortion patients, because the Rule would require the clinic to
end medication abortion services. Docket 4 at 18-19. This, in turn, would
congest Planned Parenthood’s already busy schedule of procedural abortions,
and thus would have a negative effect on the availability of procedural
abortions. Planned Parenthood asserts that, based on physician availability, it
would have to reduce appointments by 30% if the Rule’s third appointment and
mandatory delay are not enjoined. Planned Parenthood is already scheduling
abortions four weeks out. Abortions are safer and lower risk when performed
earlier in gestation. Thus, the added risk associated with delayed services for
all patients is a substantial obstacle for a large fraction of all patients.
At this stage, Planned Parenthood has made a clear showing that the
third appointment and mandatory delay impose substantial obstacles on a
large fraction of relevant cases regardless of whether the relevant cases consist
of all abortions in South Dakota or the smaller subset of medication abortions
only. Thus, the court finds that the Rule likely imposes an undue burden on
Planned Parenthood and its patients’ right to seek an abortion. And because
Planned Parenthood has made a threshold showing that it is likely to succeed
on the merits of its facial challenge to the Rule, the court proceeds to weigh the
other Dataphase factors as to the undue burden claim.3 Rounds, 530 F.3d at
732.
3 Alternatively, Planned Parenthood seeks as-applied relief in its complaint.
Docket 1 at 26. The state defendants do not dispute the evidence in the record
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B. 	Threat of Irreparable Harm
“The basis of injunctive relief in the federal courts has always been
irreparable harm and inadequacy of legal remedies.” Id. at 732 n.5 (quoting
Beacon Theatres, Inc. v. Westover, 359 U.S. 500, 506-07 (1959)). Under the
second Dataphase factor, the movant must show it is “likely to suffer
irreparable harm in the absence of preliminary relief[.]” Winter v. Nat. Res. Def.
Council, Inc., 555 U.S. 7, 20 (2008). “Constitutional violations, however brief,
are unquestionably irreparable.” Daugaard, 799 F. Supp. 2d at 1076. As
discussed above, Planned Parenthood has established that it is likely to
succeed on the merits with regard to enjoining enforcement of the Rule’s
mandatory third appointment. Thus, the court finds that this factor, the threat
of irreparable harm, weighs in favor of granting the preliminary injunction.
C. 	Balance of the Hardships
The balance of the harms factor calls for the court to balance the harms
that would result in the following scenarios: (1) if the preliminary injunction
was improperly denied because plaintiffs prevailed on the merits of the case;
and (2) if the preliminary injunction was improperly granted because
that medication abortion is medically and socially safer for some patients,
including those who wish to conceal their abortions from abusive partners.
Thus, Planned Parenthood is entitled to relief as-applied to patients for whom a
medication abortion is medically indicated and to patients who are at a health
or safety risk of making a return trip to the clinic for a third appointment. See
Jegley, 508 F. Supp. 3d 361, 392 (E.D. Ark. 2020); see also Planned
Parenthood Sw. Ohio Region v. DeWine, 696 F.3d 490, 494 (6th Cir. 2012);
Planned Parenthood Cincinnati Region v. Taft, 444 F.3d 502, 511-12, 514 (6th
Cir. 2006).
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defendants prevailed on the merits of the case. See Scotts Co. v. United Indus.
Corp., 315 F.3d 264, 284 (4th Cir. 2002) (“[W]hile cases frequently speak in the
short-hand of considering the harm to the plaintiff if the injunction is denied
and the harm to the defendant if the injunction is granted, the real issue in
this regard is the degree of harm that will be suffered by the plaintiff or the
defendant if the injunction is improperly granted or denied.”); see also Hillerich
& Bradsby Co. v. Christian Bros., Inc., 943 F. Supp. 1136, 1142 (D. Minn.
1996) (balancing the harms by looking at what the harm to the defendant
would be if the injunction were “improperly granted”).
If the preliminary injunction is improperly denied, many people will have
been unduly burdened by the Rule, and, in effect, delayed or precluded from
obtaining an abortion. The extent of the harm if the preliminary injunction
turns out to have been improperly granted is that the state defendants will
have been wrongly prevented from carrying out their official duties.
After balancing the harm to the parties, the court finds that all parties
are potentially exposed to harm if the preliminary injunction is found to have
been improperly granted or denied. But when considering the nature of the
parties’ interest that are at stake, the potential harm to Planned Parenthood’s
interests are more severe because the harms directly affect a constitutional
right. Thus, the court finds that the balance of the harms weighs in favor of
granting the preliminary injunction.
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D. 	Public Interest
As discussed above, Planned Parenthood has demonstrated by a clear
showing that it is likely to succeed on the merits of its undue burden claim.
There is a public interest in protecting the right to choose an abortion. And the
public has a clear interest in ensuring the supremacy of the United States
Constitution. While the public also has an interest in the enforcement of state
administrative rules, that interest is secondary to the public interest expressed
above. Thus, the court finds that this factor weighs in favor of granting the
preliminary injunction.
II. 	Equal Protection Claim
Planned Parenthood claims that the Rule’s differential treatment of
patients and providers using misoprostol for abortions violates the Equal
Protection Clause. They argue that the Rule treats patients taking misoprostol
for the purpose of terminating their pregnancy different than similarly situated
patients taking it for other purposes, for example to manage miscarriage or
postpartum hemorrhaging. This differential treatment “fails equal protection
review under any level of scrutiny,” and they cite the standard for both rational
basis and strict scrutiny. Docket 4 at 23. The state defendants argue that
rational basis applies, and under that standard the Rule does not violate the
Equal Protection Clause. Docket 19 at 23.
Under the Fourteenth Amendment, “[n]o State shall make or enforce any
law which shall . . . deny to any person within its jurisdiction the equal
protection of the laws.” U.S. Const. amend. XIV, § 1. And under the Equal
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Protection Clause in the Amendment, “all persons similarly situated shall be
treated alike.” Stevenson v. Blytheville Sch. Dist. # 5, 800 F.3d 955, 970 (8th
Cir. 2015) (quoting City of Cleburne v. Cleburne Living Ctr., 473 U.S. 432, 439
(1985)). The standard of review for regulations that “touch upon the right to an
abortion” is the undue burden standard. Planned Parenthood of Mid-Missouri &
E. Kan., Inc. v. Dempsey, 167 F.3d 458, 464 (8th Cir. 1999) (citing Casey, 505
U.S. at 871-74, 884-85); see also id. (“Since Casey, we have applied the undue
burden test in cases involving legislation that affects the right to abortion.”)
Here, the Rule requires that a physician administer misoprostol to a
patient at a third, separate clinic appointment only when prescribed in the
context of a medication abortion. For every other use of misoprostol, a patient
can self-administer the medication at a location of their choosing without a
separate, third appointment. As described above, the third trip and mandatory
delay are medically unnecessary, they increase health risks for medication
abortions patients, and they impose substantial obstacles for medication
abortion patients and all abortion patients. The record indicates that
misoprostol, when used for purposes other than medication abortion, is less
safe and increases the risk of bleeding, but in those contexts does not require a
separate, third appointment with a licensed physician. This finding further
establishes that the Rule is an unnecessary regulation. Applying the undue
burden standard, the court finds that the third appointment and mandatory
delay required by the Rule are unnecessary regulations and constitute an
undue burden on a patient’s right to choose an abortion. Thus, the Rule’s
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disparate treatment of misoprostol and abortion patients taking misoprostol
violates the equal protection clause.
Alternatively, the court reviews Planned Parenthood’s equal protection
claim under the rational basis standard. The state defendants argue that the
Rule’s overarching purpose is patient health. See, e.g., Docket 19 at 21-22. But
the record clearly shows that misoprostol is safer when taken in the context of
medication abortion than when taken for other medical purposes. But under
the Rule, patients are allowed to self-administer misoprostol when taken for
purposes other than medication abortion. The FDA, an entity the state
defendants cite to as authoritative on the subject, states that there is no
medical reason for a patient to return to a clinic for a separate appointment for
the administration of misoprostol. Notwithstanding the relative safety of
misoprostol when prescribed for a medication abortion, if the Rule were
concerned with patient health, it would recommend that misoprostol be
administered 24 to 48 hours after mifepristone, as the FDA recommends, and
not 24 to 72 hours later as the Rule requires. Medication abortion patients are
already examined for counterindications during their first two appointments, a
fact that further negates the state defendants’ argument in favor of patient
health. The court finds no rational basis for the third appointment and
mandatory delay for administration of misoprostol under the Rule. Thus, under
rational basis, the Rule violates the Equal Protection Clause.
Whether under heightened scrutiny for regulations touching upon the
right to an abortion, or under rational basis, Planned Parenthood has
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established by a clear showing that it is likely to succeed on its equal
protection claim. This is the most significant of the four preliminary injunction
factors. And because this claim carries with it similar constitutional
considerations as Planned Parenthood’s undue burden claim, the court finds
that the remaining three preliminary injunction factors weigh in favor of
granting the injunction. See supra.
CONCLUSION
Planned Parenthood has met its burden of establishing that the four
factors for a preliminary injunction weigh in its favor. Thus, it is
ORDERED that Planned Parenthood’s motion for preliminary injunction
(Docket 3) is granted. The state defendants are enjoined from enforcing the
third appointment for the dispensing of misoprostol and the mandatory delay
accompanying the third appointment. The state defendants are enjoined from
enforcing the pertinent part of the Rule against Planned Parenthood.
Specifically, the portion of the Rule enjoined is:
Between 24-72 hours after taking Mifepristone, if the pregnant
woman decides to continue with the medical abortion, the pregnant
woman must return to the licensed abortion facility to receive the
proper amount of Misoprostol. A licensed physician shall dispense
the Misoprostol to the pregnant woman in the same manner as
required for Mifepristone under this section.
Dated February 8, 2022.
BY THE COURT:
/s/ Karen E. Schreier
KAREN E. SCHREIER
UNITED STATES DISTRICT JUDGE
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