Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca9-14-15624/USCOURTS-ca9-14-15624-0/pdf.json

Nature of Suit Code: 950
Nature of Suit: Constitutionality of State Statutes
Cause of Action: 

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FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PLANNED PARENTHOOD ARIZONA,

INC.; WILLIAM RICHARDSON, M.D.,

DBA Tucson Women’s Center;

WILLIAM H. RICHARDSON, M.D.,

P.C., DBA Tucson Women’s Center,

Plaintiffs-Appellants,

v.

WILLIAM HUMBLE, Director of the

Arizona Department of Health

Services, in his official capacity,

Defendant-Appellee.

No. 14-15624

D.C. No.

4:14-cv-01910-

DCB

OPINION

Appeal from the United States District Court

for the District of Arizona

David C. Bury, District Judge, Presiding

Argued and Submitted

May 13, 2014—San Francisco, California

Filed June 3, 2014

Before: Susan P. Graber, William A. Fletcher,

and Richard A. Paez, Circuit Judges.

Opinion by Judge W. Fletcher

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2 PLANNED PARENTHOOD ARIZONA V. HUMBLE

SUMMARY*

Civil Rights

The panel reversed the district court’s denial of plaintiff’s

motion for a preliminary injunction and remanded with

instructions that the district court issue the requested

injunction in an action seeking to enjoin enforcement of an

Arizona statute, Ariz. Rev. Stat. § 36-449.03(E)(6), and its

implementing regulation, Ariz. Admin. Code § R9-10-

1508(G), which restrict the manner in which certain

medications may be used to perform abortions. 

The panel assumed without deciding that the Arizona law,

which restricts the use of an off-label evidence-based regime

of medication abortions, passed rational basis review and

moved directly to the application of the undue burden test. 

The panel held that plaintiffs introduced uncontroverted

evidence that the Arizona law substantially burdened

women’s access to abortion services, and Arizona introduced

no evidence that the law advanced in any way Arizona’s

interest in women’s health. The panel concluded that on the

record before it, the burden imposed by the Arizona law was

undue within the meaning of Planned Parenthood of Se.

Penn. v. Casey, 505 U.S. 833, 876 (1992), and Gonzales v.

Carhart, 550 U.S. 124 (2007). The panel therefore held that

the district court abused its discretion when it held that

plaintiffs were unlikely to succeed on the merits of their

undue burden claim.

* This summary constitutes no part of the opinion of the court. It has

been prepared by court staff for the convenience of the reader.

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PLANNED PARENTHOOD ARIZONA V. HUMBLE 3

COUNSEL

Alice J. Clapman (argued), Helene T. Krasnoff, Planned

Parenthood Federation of America, Washington, D.C.;

Lawrence J. Rosenfeld, Squire Sanders LLP, Phoenix,

Arizona, for Plaintiffs-Appellants.

Robert Lawrence Ellman (argued), Solicitor General, G.

Michael Tryon, Senior Litigation Counsel, and Thomas C.

Horne, AttorneyGeneral, Arizona AttorneyGeneral’s Office,

Phoenix, Arizona, for Defendant-Appellee.

Kimberly A. Parker, Wilmer Cutler Pickering Hale and Dorr

LLP, Washington, D.C., for Amici Curiae American College

of Obstetricians and Gynecologists and the American

Medical Association.

Denise MaryBurke, Americans United for Life, Washington,

D.C., for Amici Curiae Arizona Legislators.

OPINION

W. FLETCHER, Circuit Judge:

Plaintiffs Planned Parenthood Arizona, Inc., Dr. William

Richardson, and Tucson Women’s Center appeal the district

court’s denial of their motion for a preliminary injunction. 

Plaintiffs seek to enjoin enforcement of an Arizona statute,

Ariz. Rev. Stat. § 36-449.03(E)(6), and its implementing

regulation, Ariz. Admin. Code § R9-10-1508(G), which

restrict the manner in which certain medications may be used

to perform abortions. The district court denied the

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4 PLANNED PARENTHOOD ARIZONA V. HUMBLE

preliminary injunction because it found that plaintiffs had not

shown a likelihood of success on the merits. We reverse. 

I. Background

“Before 2000, most first-trimester abortions were

surgical, performed by a procedure commonly known as

vacuum aspiration or suction curettage.” Planned

Parenthood Sw. Ohio Region v. DeWine, 696 F.3d 490, 494

(6th Cir. 2012). In 2000, the Federal Drug Administration

(“FDA”) first approved the use of medications to perform

abortions. Id.

A. Medication Abortion Regimens

The far-and-away most common method of medication

abortion employs a combination of two prescription drugs,

mifepristone (sometimes known as RU-486) andmisoprostol. 

Mifepristone ends pregnancy by blocking the hormone

progesterone, thereby causing the fertilized egg to detach

from the uterine wall. Misoprostol causes the uterus to

contract and expel its contents. In 2000, the FDA approved

mifepristone for use in medication abortions under the brand

name Mifeprex. The approved drug label for Mifeprex

described an “on-label” regimen requiring a woman to take

600 milligrams of mifepristone orally at a clinic, return to the

clinic two days later to take 400 micrograms of misoprostol

orally, and return again for a follow-up visit. These three

clinic visits are in addition to the visit Arizona law requires

for a woman to receive an in-person consultation with her

doctor at least twenty-four hours before an abortion. See

Ariz. Rev. Stat. § 36-2153. Clinical evidence submitted by

Mifeprex’s manufacturer established this on-label regimen to

be safe and effective through seven weeks of pregnancy, or

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PLANNED PARENTHOOD ARIZONA V. HUMBLE 5

49 days from the woman’s last menstrual period (“LMP”). 

The FDA has approved misoprostol only for the treatment of

stomach ulcers.

When the FDA approved mifepristone for use in

abortions, it imposed restrictions on mifepristone’s marketing

and distribution—but not on its use—under the FDA’s

“Subpart H” regulations. See 21 C.F.R. § 314.520. These

restrictions require the manufacturer to distribute

mifepristone only to doctors who sign an agreement “stating

that he or she possesses the necessary qualifications and will

adhere to the other requirements.” One Subpart H restriction

requires doctors to agree to provide each patient “a copy of

the Medication Guide and Patient Agreement” and obtain the

patient’s signature on the Patient Agreement. In the Patient

Agreement, the patient attests that she “understand[s]” the

steps involved in the on-label regimen. The patient agrees to

“follow my provider’s advice about when to take each drug.” 

The Subpart H restrictions, Medication Guide, and Patient

Agreement do not require doctors to administer mifepristone

according to the on-label regimen. Cline v. Okla. Coal. for

Reprod. Justice, 313 P.3d 253, 261 n.17 (Okla. 2013) (per

curiam).

By the time the FDA approved Mifeprex’s label, studies

already showed that a different regimen for medication

abortion was safe and effective through nine weeks of

pregnancy, or 63 days LMP (instead of 49 days LMP). This

regimen requires taking 200 milligrams (instead of 600

milligrams) of mifepristone orally at the clinic, taking 800

micrograms of misoprostol two days later at home (instead of

at the clinic) by dissolving the drug between the cheek and

gum, and then returning to the clinic for a follow-up visit. 

Consistent with common terminology, we call this off-label

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6 PLANNED PARENTHOOD ARIZONA V. HUMBLE

regimen the “evidence-based” regimen. Dr. Richardson

states in a sworn declaration that “virtually all abortion

providers” now use the evidence-based regimen. He further

states, “Few if any [providers] use the [on-label] method.” 

The American College of Obstetricians and Gynecologists

strongly favors the evidence-based regimen over the on-label

regimen. Brief for American College of Obstetricians &

Gynecologists and the American Medical Ass’n as Amici

Curiae at 7–8. Notably, the district court found that the

evidence-based regimen is

considered the best practices . . . by practicing

doctors. . . . [T]here is a clear advantage to

the current protocol because it may be used

through the 9th week of pregnancy, not just

through the 7th week, which is significant

because many women do not discover their

pregnancies until approximately 49 days,

which is the end of [the] 7th week. . . . Also,

risk factors from medical abortions . . . have

been reduced or eliminated by the current

[evidence-based] regimen; medication

abortion now has a lower rate of ongoing

pregnancies and fewer surgical interventions

are necessary to complete the abortion

procedure.

Medication abortions now account for 41 percent of all

first-trimester abortions performed at Planned Parenthood

clinics nationwide. In 2012 in Arizona, 43 percent of all

abortions performed during the first nine weeks of pregnancy

were medication abortions. Plaintiffs presented

uncontroverted evidence in the district court that many

women who choose medication abortion strongly prefer it

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PLANNED PARENTHOOD ARIZONA V. HUMBLE 7

over surgical abortion. Medication abortion is less invasive

than surgical abortion, which is a particularly important

consideration for survivors of rape or sexual abuse. Further,

some women have medical conditions that make medication

abortion significantly safer than surgical abortion. The

district court found that “medication abortion is extremely

safe and safer than the alternative surgical procedure, which

is also a very safe procedure.”

Since the FDA approved mifepristone in 2000, there have

been eight known deaths from infection in women using

earlier off-label regimens (a fatality rate of less than 0.0005

percent). The FDA investigated these eight cases and found

no causal connection between the infections and the use of

mifepristone or misoprostol. A study conducted in 2013

surveyed the most recent six years of data and found no

infection-related deaths out of 711,556 medication abortions

performed under the current evidence-based regimen. James

Trussell et al., Reduction in Infection-Related Mortality Since

Modifications in the Regimen of Medical Abortion,

89 Contraception 193, 195 (2014).

The on-label regimen fails to terminate the pregnancy in

about 1 percent of cases, and as many as 8 percent of women

following the on-label regimen require surgical-abortion

procedures to stop heavy bleeding caused by the medications. 

The evidence-based regimen fails in about 0.5 percent of

cases, and fewer than 2 percent of women require subsequent

surgical-abortion procedures. Because of the larger dose of

mifepristone required by the on-label regimen, the drugs for

the on-label regimen cost $160 more than for the evidencebased regimen. The on-label regimen also increases costs by

requiring an additional clinic visit. Finally, the evidencebased regimen allows women to take misoprostol in their

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8 PLANNED PARENTHOOD ARIZONA V. HUMBLE

homes, eliminating the risk that they will pass their

pregnancies, a process involving heavy bleeding and

cramping, during their trip home from the second clinic visit.

B. FDA Approval

When the FDA approves a drug, it does so on the basis of

evidence of clinical trials submitted by the drug’s

manufacturer. The FDA generally does not conduct its own

trials. According to plaintiffs’ expert Dr. Lisa Rarick, who

participated as an FDA official in the approval process for

mifepristone, the FDA “does not authorize protocols for

drugs . . . . Rather, approval of [a drug] allows the drug

sponsor to advertise and promote the drug for a particular

use.” The drug’s manufacturer also submits a proposed label

for approval. The label “provides physicians with guidance

about how to use a drug in accordance with how the drug

sponsor requested and received FDA approval for its use.” 

The label “does not impose binding obligations on

physicians.” The “FDA does not require a manufacturer to

update a drug’s [label] for new uses or protocols,” and there

rarelyare sufficient economic incentives for the manufacturer

to do so.

According to Dr. Rarick, the FDA “neither prohibit[s] nor

discourage[s]” off-label use of FDA-approved drugs. In fact,

“the FDA has repeatedly acknowledged that off-label use is

common and is sometimes required by good medical

practice.” In a 1982 “FDA Drug Bulletin,” the FDA stated:

The [Federal Food, Drug, and Cosmetic]

Act does not . . . limit the manner in which a

physician may use an approved drug. Once a

product has been approved for marketing, a

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PLANNED PARENTHOOD ARIZONA V. HUMBLE 9

physician may prescribe it for uses or in

treatment regimens or patient populations that

are not included in approved labeling. Such

“unapproved” or, more precisely, “unlabeled”

uses may be appropriate and rational in

certain circumstances, and may, in fact, reflect

approaches to drug therapy that have been

extensively reported in medical literature.

. . . Valid new uses for drugs already on

the market are often . . . confirmed by wellplanned and executed clinical investigations. 

Before such advances can be added to

the approved labeling, however, data

substantiating the effectiveness of a new use

or regimen must be submitted by the

manufacturer to [the] FDA for evaluation. 

This may take time and, without the initiative

of the drug manufacturer whose product is

involved, may never occur. For that reason,

accepted medical practice often includes drug

use that is not reflected in approved drug

labeling.

12 FDA Drug Bulletin 5 (1982). The FDA has consistently

maintained that position. See U.S. Food & Drug Admin.,

“Off-Label” and Investigational Use of Marketed Drugs,

Biologics, and Medical Devices - Information Sheet(Aug. 10,

2011), http://www.fda.gov/RegulatoryInformation/

Guidances/ucm126486.htm. Off-label use of drugs is

especially common in pediatrics, oncology, and gynecology

and obstetrics.

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10 PLANNED PARENTHOOD ARIZONA V. HUMBLE

C. Arizona Legislation

In 2012, the Arizona legislature passed House Bill 2036,

a collection of statutory amendments regulating abortion. 

The amendment at issue in this case regulates medication

abortion. It provides:

The director [of the Arizona Department of

Health Services] shall adopt rules relating to

the abortion procedure. At a minimum these

rules shall require . . . [t]hat any medication,

drug or other substance used to induce an

abortion is administered in compliance with

the protocol that is authorized by the United

States [F]ood and [D]rug [A]dministration

and that is outlined in the final printing

labeling instructions for that medication, drug

or substance.

Ariz. Rev. Stat. § 36-449.03(E)(6). Defendant William

Humble, Director of Arizona’s Department of Health

Services, adopted an implementing regulation as required by

the amendment. Ariz. Admin. Code § R9-10-1508(G). The

regulation had an effective date of April 1, 2014. We refer to

the amendment and regulation collectively as “the Arizona

law.”

The legislature described its purpose in passing the

Arizona law as “[p]rotect[ing] women from the dangerous

and potentially deadly off-label use of abortion-inducing

drugs, such as, for example, mifepristone” and “[e]nsur[ing]

that physicians abide by the protocol tested [sic] and

approved by the United States Food and Drug Administration

for such abortion-inducing drugs.” The legislative findings

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PLANNED PARENTHOOD ARIZONA V. HUMBLE 11

describe various health risks from the use of mifepristone,

including risks of infection and hemorrhage. The district

court found that the Arizona legislature provided no

“supporting evidence for any asserted legislative fact.” The

court observed that “the risks associated with medication

abortions, relied on by the State as the reason for adopting the

[on-label] protocol, have been substantially reduced or

eliminated” by the evidence-based regimen.

D. Challenge to the Arizona Law

There are currently ten abortion providers in Arizona,

located in three of the state’s fifteen counties. Planned

Parenthood Arizona, Inc. (“PPAZ”), provides abortions at its

clinics in Glendale, Tempe, Tucson, and Flagstaff. PPAZ

performs medication abortions according to the evidencebased regimen. The Glendale, Tempe, and Tucson clinics

provide both surgical and medication abortions. The

Flagstaff clinic provides only medication abortions. PPAZ’s

Flagstaff clinic is the only abortion provider in northern

Arizona. The next closest provider is in Glendale, which is

located, on average, 160 miles from locations in northern

Arizona; it is 372 miles away from some locations. In 2013,

PPAZ provided 6,667 abortions for women through 63 days

LMP. Thirty-eight percent were medication abortions. 

Twenty-six percent of these medication abortions occurred

after 49 days LMP. Because they occurred after 49 days

LMP, such abortions would not have been available if PPAZ

had been required to follow the on-label regimen.

PPAZ’s Flagstaff clinic used to provide medication

abortions through an advanced practice clinician instead of a

doctor, but Arizona banned that practice in 2011. The

Flagstaff clinic could not provide abortions of any kind until

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12 PLANNED PARENTHOOD ARIZONA V. HUMBLE

February 2014, when it found a doctor to perform medication

abortions. During the period when the Flagstaff clinic could

not perform abortions, significantly fewer women in northern

Arizona obtained abortions than before 2011.

Dr. Richardson owns and operates Tucson Women’s

Center, where he provides surgical and medication abortions. 

Dr. Richardson performs medication abortions according to

the evidence-based regimen. In 2013, he provided abortions

to 932 women, 660 of whom were nine weeks pregnant (63

days LMP) or less. Of those 660 women, 43 percent chose

medication abortion.

PPAZ, Dr.Richardson, and Tucson Women’s Center sued

Director Humble in his official capacity, seeking declaratory

and injunctive relief against the Arizona law. For

convenience, we refer to the defendant as “Arizona.” 

Plaintiffs brought their claims on behalf of themselves, their

patients, and the physicians they employ. See Isaacson v.

Horne, 716 F.3d 1213, 1221 (9th Cir. 2012), cert. denied,

134 S. Ct. 905 (2014). Plaintiffs moved for a preliminary

injunction, asserting that the Arizona law is

unconstitutionally vague, violates women’s fundamental

rights to abortion and bodily integrity, and violates equal

protection. The district court denied the motion. It found that

the evidence-based regimen “is considered the best

practices,” and that Arizona had not presented any evidence

to support its legislative findings or to show that the law

actually advances women’s health. It treated these findings

as legally irrelevant. It held that the Arizona law is not vague

and does not violate equal protection or a woman’s right to

bodily integrity. It held further that the law rationally

advances Arizona’s interest in women’s health and does not

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PLANNED PARENTHOOD ARIZONA V. HUMBLE 13

impose an undue burden on Arizona women’s right to

abortion.

Plaintiffs timely appealed and filed an emergency motion

for an injunction pending appeal. A motions panel of this

court enjoined enforcement of the Arizona law pending

appeal and expedited the appeal. See Planned Parenthood of

Ariz., Inc. v. Humble, No. 14-15624 (9th Cir. Apr. 8, 2014)

(order granting emergency injunction).

II. Discussion

A. Standard for Preliminary Injunctions

We review the district court’s denial of a preliminary

injunction for abuse of discretion. Alliance for the Wild

Rockies v. Cottrell, 632 F.3d 1127, 1131 (9th Cir. 2011). 

Reliance “on an erroneous legal standard” is an abuse of

discretion. Id. (internal quotation marks omitted). We

review the district court’s legal conclusions de novo and its

factual findings for clear error. Id.

“A plaintiff seeking a preliminary injunction must

establish that he is likely to succeed on the merits, that he is

likely to suffer irreparable harm in the absence of preliminary

relief, that the balance of equities tips in his favor, and that an

injunction is in the public interest.” Winter v. Natural Res.

Def. Council, Inc., 555 U.S. 7, 20 (2008). “‘[S]erious

questions going to the merits’ and a balance of hardships that

tips sharply towards the plaintiff can support issuance of a

preliminary injunction, so long as the plaintiff also shows that

there is a likelihood of irreparable injury and that the

injunction is in the public interest.” Alliance for the Wild

Rockies, 632 F.3d at 1135. “[T]he deprivation of

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14 PLANNED PARENTHOOD ARIZONA V. HUMBLE

constitutional rights ‘unquestionably constitutes irreparable

injury.’” Melendres v. Arpaio, 695 F.3d 990, 1002 (9th Cir.

2012) (quoting Elrod v. Burns, 427 U.S. 347, 373 (1976)).

B. Success on the Merits

1. Interpretation of the Arizona Law

The parties disagree about the correct interpretation of the

Arizona law. Plaintiffs argue that, under a proper reading of

its text, the law flatly prohibits all medication abortions. 

Arizona disagrees. It argues that the law allows medication

abortions, but only if they are performed in accordance with

the on-label regimen. We need not resolve this dispute. We

assume for the purposes of our analysis that Arizona’s

interpretation of the law is correct.

2. Undue Burden

Plaintiffs argue that the Arizona law is unconstitutional

because it imposes an undue burden on a woman’s right to

abortion. See Planned Parenthood of Se. Penn. v. Casey,

505 U.S. 833, 876 (1992). In Casey, a plurality of the

Supreme Court rejected both strict scrutiny and rational-basis

review of abortion regulations, holding instead that laws

regulating pre-viability abortions are unconstitutional if they

impose an “undue burden” on a woman’s right to abortion. 

Id. at 876. Casey recognized that states have legitimate

“interests in maternal health and protecting fetal life [that]

can, in some circumstances, justify regulations of abortion.” 

Tucson Woman’s Clinic v. Eden, 379 F.3d 531, 539 (9th Cir.

2004). The undue burden test seeks to balance those interests

with a woman’s fundamental right to abortion. See id. The

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PLANNED PARENTHOOD ARIZONA V. HUMBLE 15

only interest Arizona asserts in this case is its interest in

women’s health.

Our undue burden analysis starts with Casey’s plurality

opinion. See Isaacson, 716 F.3d at 1222 n.8. The plurality

explained, “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.” Casey, 505 U.S. at

877. Of the four Supreme Court cases addressing abortion

since Casey, only Gonzales v. Carhart, 550 U.S. 124 (2007),

provides meaningful guidance on how to apply Casey’s

undue burden test. Cf. Ayotte v. Planned Parenthood of N.

New England, 546 U.S. 320, 323 (2006) (addressing only the

scope of equitable relief); Stenberg v. Carhart, 530 U.S. 914,

938 (2000) (interpreting a statute in a way that the state

conceded imposed an undue burden); Mazurek v. Armstrong,

520 U.S. 969, 972 (1997) (per curiam) (addressing the

evidence required to support a finding of improper legislative

purpose). Gonzales emphasized the balance struck byCasey,

holding that a state may “regulat[e] the medical profession in

order to promote respect for life,” so long as the state does

not act irrationally or “impose an undue burden” on a

woman’s right to abortion. 550 U.S. at 158. It held that a

court reviewing an abortion regulation “must determine

whether the [regulation] furthers the legitimate interest of the

Government in protecting the life of the fetus that may

become a child.” Id. at 146.

The analysis in both Casey and Gonzalesfocused on state

laws purporting to advance the state’s interest in fetal life. 

Here, however, the Arizona law purports to advance

Arizona’s interest in women’s health. We wrote in Eden,

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16 PLANNED PARENTHOOD ARIZONA V. HUMBLE

[Casey’s] application of the “undue burden”

standard is often not extendable in obvious

ways to the context of a law purporting to

promote maternal health.

In the context of a law purporting to

promote fetal life, whatever obstacles that law

places in the way of women seeking abortions

logically serve the interest the law purports to

promote—fetal life—because they will

prevent some women from obtaining

abortions. By contrast, in the context of a law

purporting to promote maternal health, a law

that is poorly drafted or which is a pretext for

anti-abortion regulation can both place

obstacles in the way of women seeking

abortions and fail to serve the purported

interest very closely, or at all.

379 F.3d at 539–40 (citations omitted).

In Eden, we described our approach to applying Casey’s

undue burden test. Under Eden, we compare the extent of the

burden a law imposes on a woman’s right to abortion with the

strength of the state’s justification for the law. See id. at 542. 

The more substantial the burden, the stronger the state’s

justification for the law must be to satisfy the undue burden

test; conversely, the stronger the state’s justification, the

greater the burden may be before it becomes “undue.” On

one extreme, Eden described cases where “a purported health

regulation fails to rationally promote an interest in maternal

health on its face.” Id. at 540. In such a case, the regulation

fails even rational-basis review, and “the undue burden

standard is not triggered at all.” Id. On the other extreme,

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laws that are “harmless” or that have only an “incidental

effect” on abortion require little justification. Mazurek,

520 U.S. at 972; Casey, 505 U.S. at 874. In cases between

those two extremes, we must weigh the burdens against the

state’s justification, asking whether and to what extent the

challenged regulation actually advances the state’s interests. 

If a burden significantly exceeds what is necessaryto advance

the state’s interests, it is “undue.” See Webster’s Third New

Int’l Dictionary 2492 (1993) (defining “undue” as

“excessive” or “unwarranted”).

Our approach in Eden follows from Casey, in which the

plurality wrote that “[u]nnecessary 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.” 505 U.S. at 878 (emphasis added); see Eden,

379 F.3d at 542 (relying on evidence that a regulation was

“unnecessary as a matter of public health”). Whether a

regulation is necessary depends on whether and how well it

serves the state’s interest. “[T]he 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.” Casey,

505 U.S. at 877. The same is true for laws purporting to

protect women’s health: they “must be calculated” to advance

women’s health, “not hinder it.” Id.

Under this approach, the plurality in Casey upheld a law

requiring, with some exceptions, minors to get consent from

their parents before obtaining an abortion. Id. at 899. The

plurality did so based on the state’s “quite reasonable

assumption that minors will benefit from consultation with

their parents and that children will often not realize that their

parents have their best interests at heart.” Id. at 895. At the

same time, a majority of the Court struck down a law

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requiring married women to get consent from their husbands. 

Id. at 887–95. The Court distinguished parental consent from

spousal consent based on the state’s comparatively weaker

justification in the second instance. While the state could

assume that minors might not realize their own best interests,

it could not “adopt a parallel assumption about adult women.” 

Id. at 895.

Similarly, the Court in Gonzales upheld the federal

Partial-Birth Abortion Ban Act of 2003 only after finding that

the Act would advance the state’s interest in fetal life by

“encourag[ing] some women to carry the[ir] infant to full

term, thus reducing the absolute number of late-term

abortions.” 550 U.S. at 160. Importantly for this case,

Gonzales held that a court applying the undue burden test

should not “place dispositive weight on [legislative] findings. 

The Court retains an independent constitutional duty to

review factual findings where constitutional rights are at

stake. . . . Uncritical deference to [the legislature’s] factual

findings in these cases is inappropriate.” Id. at 165–66.

In Planned Parenthood of Wisconsin, Inc. v. Van Hollen,

738 F.3d 786 (7th Cir. 2013), the Seventh Circuit adopted an

approach much like ours in Eden. The court affirmed a

preliminary injunction against a Wisconsin law that required

abortion providers’ doctors to have admitting privileges at a

hospital within thirty miles of the provider’s clinic. See id. at

787, 798. The state’s only justification for the law was

protection of women’s health. Id. at 789. As in Eden, the

Seventh Circuit analyzed whether the Wisconsin law actually

advanced that interest and found, on the record before it, that

the law did not. See id. at 789–91, 797–98. The court wrote,

“The cases that deal with abortion-related statutes sought to

be justified on medical grounds require not only evidence . . .

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that the medical grounds are legitimate but also that the

statute not impose an ‘undue burden’ on women seeking

abortions. The feebler the medical grounds, the likelier the

burden, even if slight, [is] to be ‘undue’ in the sense of

disproportionate or gratuitous.” Id. at 798 (citations omitted).

The district court in this case did not cite or discuss our

decision in Eden. It relied instead on decisions of the Fifth

and Sixth Circuits. See Planned Parenthood of Greater Tex.

Surgical Health Servs. v. Abbott, No. 13-51008, 2014 WL

1257965, at *7–8 (5th Cir. Mar. 27, 2014); DeWine, 696 F.3d

at 513–18 (opinion of McKeague, J.). In applying the undue

burden test, the Fifth and Sixth Circuits consider the state’s

justification only for the very limited purpose of applying

rational-basis review. Once an abortion regulation survives

rational-basis review, these circuits pay no attention to

whether the regulation has been shown actually to advance

the state’s legitimate interests. In Abbott, the Fifth Circuit

held that courts may not consider the strength of the state’s

justification, stating that an abortion regulation need only be

supported by “rational speculation.” 2014 WL 1257965, at

*7–8 (internal quotation marks omitted). In DeWine, the

Sixth Circuit analyzed whether an Ohio abortion regulation

was an undue burden without considering the strength of the

state’s justification for the regulation. 696 F.3d at 513–18.

We conclude that Abbott and DeWine are inconsistent

with the undue burden test as articulated and applied in Casey

and Gonzales. The Fifth and Sixth Circuits’ approach fails to

recognize that the undue burden test is context-specific, and

that both the severity of a burden and the strength of the

state’s justification can vary depending on the circumstances. 

See Eden, 379 F.3d at 541 (citing Casey, 505 U.S. at 901). 

We adhere to the approach in Eden and Van Hollen, which

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requires us to weigh the extent of the burden against the

strength of the state’s justification in the context of each

individual statute or regulation.

We assume without deciding that the Arizona law passes

rational-basis review and move directly to the application of

the undue burden test. See Eden, 379 F.3d at 540–41. In

order to show an undue burden, plaintiffs must 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.’” Id. at 539 (quoting Casey, 505 U.S.

at 895) (alteration in Eden). We limit our inquiry to “the

group for whom the law is a restriction, not the group for

whom the law is irrelevant.” Casey, 505 U.S. at 894. Under

this limitation, we address the burden on women who, in the

absence of the Arizona law, would receive medication

abortions under the evidence-based regimen. See id. at

894–95.

We start with the strength of Arizona’s justification for

the law. On the record before us, Arizona has presented no

evidence whatsoever that the law furthers any interest in

women’s health. The district court found that there was no

“supporting evidence for any asserted legislative fact,” and

that the evidence-based regimen has a “clear advantage” over

the on-label regimen. For example, the Arizona legislature

cited the dangerousness of mifepristone in support of

requiring the on-label regimen, but the on-label regimen

requires three times more mifepristone than the evidencebased regimen. As the district court found, the FDA not only

expects off-label use but encourages it as part of the effective

practice of medicine. The Supreme Court itself has noted that

off-label use “is an accepted and necessary corollary of the

FDA’s mission.” Buckman Co. v. Plaintiffs’ Legal Comm.,

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531 U.S. 341, 350 (2001); accord id. at 350–51 & n.5. 

Arizona argues that the law prohibits not just safe evidencebased regimens for medication abortion but also other,

dangerous off-label regimens. But the record contains no

evidence that any such dangerous regimen exists or has ever

been used by any abortion provider. Therefore, on the current

record, the Arizona law appears wholly “unnecessary as a

matter of [women’s] health.” Eden, 379 F.3d at 542.

We turn now to the burden imposed by the Arizona law. 

Eden provides a nonexhaustive list of factors relevant to

whether a law imposes an undue burden. First, “[a]

significant increase in the cost of abortion or the supply of

abortion providers and clinics can, at some point, constitute

a substantial obstacle to a significant number of women.” 

379 F.3d at 541. Under this factor, plaintiffs may rely on

such evidence as “testimony that one provider may be forced

to stop practicing medicine.” Id. at 542. Second, we may

consider evidence that a law “delays and deters patients

obtaining abortions, and that delay in abortion increases

health risks.” Id. Third, we may consider a law’s

“stigmatizing of abortion practice and usurping of providers’

ability to exercise medical judgment.” Id. at 543. We may

also consider the ways in which an abortion regulation

interacts with women’s lived experience, socioeconomic

factors, and other abortion regulations. See Casey, 505 U.S.

at 887–94 (relying on the effect of domestic abuse on women

seeking abortions); Van Hollen, 738 F.3d at 796 (citing the

cumulative effect of different abortion regulations);

McCormack v. Hiedeman, 694 F.3d 1004, 1016–18 (9th Cir.

2012) (describing the intersection of socioeconomic factors

and abortion regulations).

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Plaintiffs introduced evidence that medication abortion is

a common procedure strongly favored over surgical abortion

by many women. During the eighth and ninth weeks of

pregnancy, the Arizona law requires these women to undergo

surgical abortions rather than medication abortions. During

the first seven weeks of pregnancy, the law requires them to

undergo the on-label regimen for medication abortions. For

a significant number of women, the law will effectively ban

medication abortions outright because many women do not

discover they are pregnant before 49 days LMP, the last day

the on-label regimen is available under the law. Even for

women who discover their pregnancies earlier, practical

considerations, such as the frequency with which clinics can

see patients and the difficulties women face in obtaining time

off from work or transportation to a clinic, may effectively

preclude medication abortion before 49 days LMP. 

According to the sworn declaration of Beth Otterstein, the

main clinician at PPAZ’s Flagstaff clinic, some women so

strongly prefer medication abortion, and so object to surgical

abortion, that they will forego abortion entirely if they cannot

obtain a medication abortion.

Taking into consideration the cost of the extra dosage of

medicine and of the clinic time imposed by the required

additional visit, the on-label regimen costs at least $200 more

than the evidence-based regimen. The additional clinic visit

also increases costs to the patient for transportation, gas,

lodging, and the time she must take off from work. Plaintiffs’

evidence shows that these increased costs would reduce the

number of women who receive abortions, many of whom,

including 40 percent of PPAZ’s patients, are poor. Plaintiffs

introduced evidence from abortion providers that, for these

women, the additional costs are significant and sometimes

prohibitive. Plaintiffs introduced a sworn declaration from

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the medical director of Planned Parenthood of Greater Ohio

(“PPGO”), who declared that after Ohio limited medication

abortions to the on-label regimen, the number of medication

abortions performed by PPGO dropped by almost 65 percent. 

One of PPGO’s clinics was forced to stop providing abortions

entirely.

Plaintiffs also introduced evidence that PPAZ’s Flagstaff

clinic may have to close if it is limited to performing on-label

medication abortions. Otterstein described that as “a likely

possibility.” Plaintiffs provided specific reasons, tied to the

predicted decrease in women who would obtain medication

abortions, to explain why the Flagstaff clinic might be

compelled to close for economic reasons. Plaintiffs’ evidence

shows that the closure of the Flagstaff clinic would

significantly reduce the number of Arizona women who

receive abortions. If the Flagstaff clinic closes, women in

northern Arizona who want medication abortions will have to

make four visits to the Glendale clinic. Each visit will

require, on average, a 321-mile round trip. Some women will

have to travel up to 744 miles round-trip for each visit. 

Otterstein declared that, during the period between 2011 and

2014 when PPAZ’s Flagstaff clinic could not provide

abortions, many patients said they could not travel to the

Glendale clinic and would have to forego abortions entirely. 

During that period, 48 percent fewer women in northern

Arizona received medication abortions from PPAZ, and 35

percent fewer received any abortion from PPAZ, compared

with the pre-2011 period. In 2012, 31 percent fewer women

in Arizona’s three northeastern counties received any

abortion from any provider compared with 2010, when the

Flagstaff clinic was providing medication abortions.

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24 PLANNED PARENTHOOD ARIZONA V. HUMBLE

Finally, plaintiffs introduced evidence that the Arizona

law may delay abortions, thereby increasing health risks. See

Eden, 379 F.3d at 542. Dr. Daniel Grossman, a boardcertified obstetrician-gynecologist, provided a sworn

declaration in which he cited a Washington study that found

“that rural women who had to travel more than 75 miles to

obtain an abortion were two to three times more likely than

women travelling less than 75 miles to terminate after 12

weeks.” Dr. Grossman declared that “delaying abortions until

later in pregnancy drives up the risks of complications.” If

the Flagstaff clinic closes, most women in northern Arizona

will have to travel more than 75 additional miles to obtain an

abortion. Although there may be cases in which additional

travel time does not in itself rise to the level of an undue

burden, this factor must be evaluated on a case-by-case basis

and balanced against the strength of the state’s interest. 

Casey, 505 U.S. at 885–86.

Plaintiffs have introduced uncontroverted evidence that

the Arizona law substantially burdens women’s access to

abortion services, and Arizona has introduced no evidence

that the law advances in any way its interest in women’s

health. Plaintiffs’ evidence shows that the Arizona law

“usurp[s] . . . providers’ ability to exercise medical

judgment,” Eden, 379 F.3d at 543, by requiring them to

administer a less safe, less effective treatment regimen. See

Brief for American College of Obstetricians & Gynecologists

and the American Medical Ass’n as Amici Curiae at 13–17. 

The district court found that “medication abortion is

extremely safe and safer than the alternative surgical

procedure.” It also found that the evidence-based regimen is

safer and more effective than the on-label regimen. On the

record before us, we conclude that the burden imposed by the

Arizona law is undue within the meaning of Casey and

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Gonzales. See Casey, 505 U.S. at 877; Gonzales, 550 U.S. at

146, 158. We therefore hold that the district court abused its

discretion when it held that plaintiffs were unlikely to

succeed on the merits of their undue burden claim.

On the current record, the burden imposed by the Arizona

law is undue even if some women who are denied a

medication abortion under the evidence-based regimen will

nonetheless obtain an abortion. Neither the Supreme Court

nor this court has ever held that a burden must be absolute to

be undue. See Eden, 379 F.3d at 540–43 (not requiring

evidence that women would be totally prevented from

obtaining abortions). Evidence in the record shows that

women in Arizona will be burdened with a significant

increase in the cost of medication, and that many women will

be delayed in, or deterred from, seeking an abortion if the

evidence-based regimen is foreclosed to them. The

availability of on-label medication abortions during the first

seven weeks of pregnancy, and of surgical abortions

thereafter, therefore does not preclude a finding of undue

burden.

The Court in Gonzales upheld the federal ban on late-term

dilation and extraction abortion (“D&X”), citing the

availability of a safe alternative late-term procedure, dilation

and evacuation abortion (“D&E”). 550 U.S. at 166–67. But

Gonzales did not hold that the existence of a safe alternative

procedure is, in itself, determinative. The undue burden

claim in Gonzales was based only on the law’s failure to

allow D&X when required to protect a woman’s health. Id.

at 161–67. Gonzales did not address the relevance of safe

alternative procedures in challenges based on other kinds of

burden. And in Gonzales, the challenged law left in place “a

commonly used and generally accepted method” that was

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very similar to the one it banned. Id. at 165. Therefore, the

burden in Gonzales was slight, while the government’s

interest in fetal life was sufficient to justify the burden. Here,

the Arizona law imposes a greater burden and is not justified

by any interest. Moreover, for women between 49 and 63

days LMP, the Arizona law prohibits medication abortion

entirely, leaving surgical abortion as the only legal

alternative. In contrast to D&E and D&X, medication

abortion and surgical abortion are very dissimilar procedures.

The court in Van Hollen granted a preliminary injunction

against the enforcement of the Wisconsin law on the ground

that “the medical grounds thus far presented . . . are feeble,

yet the burden great.” 738 F.3d at 798. Here, the “medical

grounds thus far presented” are not merely “feeble.” They

are non-existent. On the current record, the Arizona law

imposes an undue—and therefore unconstitutional—burden

on women’s access to abortion. We therefore conclude, at

this stage of the proceedings, that plaintiffs have shown that

they are likely ultimately to succeed on the merits of their

undue burden claim.

In its brief to us, Arizona does not argue that plaintiffs

have not shown a likelihood of irreparable harm or that the

balance of hardships and the public interest do not favor a

preliminary injunction. See Alliance for the Wild Rockies,

632 F.3d at 1135. Therefore, any argument based on these

factors is waived. See Thompson v. Runnels, 705 F.3d 1089,

1103 (9th Cir. 2013). Because we hold that plaintiffs have

shown a likelihood of success on their undue burden claim,

we do not reach their other claims. We express no view on

the merits of those claims.

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Conclusion

We hold that plaintiffs have shown a likelihood of success

on their claim that the Arizona law imposes an undue burden

on a woman’s right to abortion. We therefore reverse the

district court’s denial of plaintiffs’ motion for a preliminary

injunction and remand with instructions to issue the requested

preliminary injunction.

REVERSED and REMANDED.

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