F OR P UBLICATION



### UNIT E D ST AT E S CO URT O F APPE AL S FO R T H E NINT H CIRCUIT

P L A N N E D P A R

E N T H O O D A R

I Z O N A , I N C .; W I L L I A M R I C H A R D S O N , M.D., DB A Tucson W omen’s Center; W I L L I A M H. R I C H A R

D S O N , M.D., P.C., DB A Tucson W omen’s Center,

Plaintiffs-Appellants

,

v

.

W I L L I A M H U M

B L E , Director of the Ariz ona Department of Health Services, in his official capacity

,

Defendant-Appellee

. N o. 14-15624

D.C. No. 4:14-cv-01910- DCB

OPI NI ON

A ppeal from the United States District Court for the District of Ariz o na David C. B ury , District J udg e, Presiding

Arg ued and Submitted May 13, 2014—San F rancisco, California

F iled J une 3, 2014

B efore: Susan P. Graber, W illiam A. F letcher, and Richard A. Paez , Circuit J udg es.

Opinion by

J udg e W

. F letcherP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 2

SUMMARY *

Civil Rights

The panel r eversed the district court’s denial of plaintiff’s motion f or a preliminary injunction and remanded with instructions t h a t the district c o urt issue the requested injunction in an act ion seeking to enjoin enforcement of an Ariz ona statute, Ariz

. Rev. Stat. § 36- 449.03(E)(6), a nd its implementing reg ulation, Ariz

. Admin. Code § R9-10- 1508(G), which restrict the manner in whi c h c ertain medications may

be used to perform abortions.

The panel assumed without deciding that the Ariz ona law, which restricts the use o f an off-label evidence-based reg ime of medication abortions, passed rational ba s i s review a nd moved d irectly to the application of the undue burde n t est. The panel held that p laintiffs introduced u n co n t r overted evidence that the Ariz ona law substantially burdened women’s access to abortion services, and Ariz ona introduced

no e vidence that the law advanced in any way Ariz ona’s interest in w omen’s health. The panel concluded that on the record before it, the burden imposed by the Ariz ona law was undue wit h i n t he meaning of P lanned Parenthood of Se. Penn. v. Casey
, 505 U.S. 8 33, 876 (1992)

, and Gonzal e s v

. Carhart

, 550 U.S. 124 (2007)

. T he p anel therefore held that the d istrict court abused its discret i o n when it h eld that plaintiffs were u nlikely to succeed o n the merits of their undue burden claim.

* T h is su m m ary co n stitu

tes n o part o f th e o p in io n o f th e co u rt. It h as b een p rep ared b y

co u rt staf

f f o r th e co n v en i en ce o f

th e read er.P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 3

COUNSEL

Alice J

. Clapman (arg

ued), Helene T

. Krasno f f

, P lanned Parenthood F ederation o f America, W ashing ton, D.C., for Plaintiffs-Appellants Planned Parenthood Ariz ona, I n c.

David B rown, J uli e Rikelman, Tiseme Z eg ey e, Center for Reproductive Rig hts, New York, New Y ork, for PlaintiffsAppellants William Richardson, M.D. a n d W illiam H

. Richardson M.D., P.C., DB A Tucson W omen’s Center.

L awrence J

. Rosenfeld, Squire Sand ers L L P, Phoenix

, Ariz ona, for Plaintiffs-Appellants.

Robert L awrence Ellman (arg ued), Solicitor General, G

. Michael Try on, Senior L itiga t i o n Counsel, and T h omas C. Horne, Attorney General, Ariz ona Attorney G eneral’s Office, Phoenix , Ariz o na, for Defendant-Appellee.

Kimberly A. Parker, W ilmer Cutler Pickering Hale and Dorr L L P, W ashing ton, D.C., f or A mici Curiae American Colleg e of Obstetri c i a n s a

nd Gy necolog ists and the American Medical Association.

Denise Mary B urke, Americans United for L ife, Washing ton, D.C., for Amici Curiae Ariz ona L eg islators.

OP INION

W

. F L ETCHER, Circuit J udg e:

Plaintiffs Planned Parenthood Ariz ona, I nc., Dr. W illiam Richardson, and Tucson Women’s Center a ppeal the districtP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 4

court’s denial of t heir motion for a preliminary injunction. Plaintiffs s e ek to enjoin enforcement of an Ariz ona statute, Ariz

. Rev. Stat. § 36-449.03(E)(6), and its imp l ementing

re gulation, Ariz

. Admin. Code § R9-10-1508(G), which restrict the manner in which certain medications may be used
to perform abortions. T h e district court denied the preliminary injunction because it found that plaintiffs had not shown a likelihood of success on the merits. W e reverse.

I . B ackg round

“B efore 2000, most first-trimest e r abortions were

s urg ical, performed by a procedure commonly known a s

vacuum aspiration o r suction curettag e.” Planned Parenthood Sw. Ohio Re

gion v. DeW

ine
, 696 F .3d 490, 494 (6th Cir. 2012). I n 2000, the F ood and Drug Administration (“F DA”) first approved the use of m e d i c ations to perform abortions. I

d.

A. Medication Abortion Reg imens

The far-and-away most common method of medication abortion e mploy s a combination of two prescription drug s, mifepristone (sometimes known a s RU-486) an d m i s o p r o stol. Mifepristone ends p reg nancy by blocking the hormon e prog e sterone, thereby causing th e f ertiliz ed eg g to detach from the u terine wall. Miso p r o s t ol c auses the uterus to contract and e x p e l i t s contents. I n 2000, the F DA approved mifepristone for use in medication abortions under the brand

name Mifeprex

. The a pproved d r u g label for Mifeprex described an “on-label” r eg imen requiring a woman t o take 600 millig rams of mifepristone orally at a clinic, return to the

c linic two day s later to take 400 microg rams of misoprostol orally

, and return ag ain for a f o l l o w -u p visit. These threeP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 5

clinic visits a

re in a d d i t i o n to the visit A riz ona law requires for a woman to receiv e an in-person consultation with her d o ctor at least twenty -four hours before an abortion. S e e Ariz

. Rev. Stat. § 36-2153. C l i n i cal evidence submitted b y Mifeprex ’ s manufacturer established this on-label reg imen to be safe and effective throug h seven weeks of preg nan c y , o r 49 day s from the w oman’s last menstru a l period ( “L MP”). The F DA has approved misoprostol only for the treatment o f stomach ulcers.

W h en the F DA approved mifep r i s tone for use in ab o r t i o n s, it imposed restrictions on mifepristone’s marketing

a nd distribution—but not o n its u se—under the FD A ’s “Subpart H” reg ulations. See 21 C.F .R. § 314.520. These

r e s t r i c t i o n s re q u i r e t h e m a n u f a c t u r e r t o d i s t r i b u t e mifepristone o nly to doctors who sig n an ag reement “stating that he or she possesses the necessary qualifications and will adhere to the other r equirements.” One Subpart H restriction requires doctors to ag ree to provide each patie n t “ a copy o f the Medication Guide and Patient A g reement” and obtain the patient’s sig nature on the Patient A g r eement. I n the Patient Ag reement, the p a tient attests th a t s h e “understand[ s] ” the steps involved in the on-label reg imen. The patient ag rees to “follow my p rovider’s advice about when to take each drug

. ” The Subpart H restrictions, Medication Guide

, a nd Patient Ag reement do not require doctors to administer mifepristone accordi n g t o t he on-label r eg imen. Cline v. Okla. Coal. for Reprod. Justice
, 313 P.3d 253, 261 n.17 (Okla. 2 0 1 3 ) (per curiam).

B y the time the F DA approved Mifeprex ’s label, studies already showed that a differen t r eg imen for medication abortion was safe and e f f e ctive throug h nine w eeks o f
preg n ancy , or 63 day s L MP (instead of 4 9 day s L MP). ThisP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 6

reg imen r equires taking 200 m illig rams (instead of 600 millig rams) o f mifepristone orally at the clinic, taking 800 microg rams o f misoprostol two day s later at home (instead o f
at the clinic) by dissolving t h e d r u g between the cheek a nd
g um, and then returning to th e clinic for a follow-up visit. Consistent with common terminolog y , w e call this o f f

- label

r eg imen the “evidence-based” reg imen. Dr. Richardso n states in a sworn declaration that “virtually all a b o r t ion providers” now use the evidence-based reg imen. He further states, “F ew if any [ providers] use the [ on-label] method.” Th e A merican Colleg e of Obstetricians and Gy necolog ists strong ly favors the evidence-based reg imen over the on-label
reg imen. B r i ef for American Colleg e of O bstetricians & Gy necolog ists and the American Medical A ss’n a s Amici Curiae at 7–8. Notably

, the district court f ound that the evidence-based reg imen is

considered the b est practices

. . . by practicing doctors.

. . . [ T ] here is a clear advantag e to the current protocol because it may be used throug h the 9th week of preg nancy , n o t just throug h the 7th week, whic h is sig nificant because many women d o not discover their
pr eg nancies until a

pprox imately 4 9 day s, which is the end of [ the] 7th week. . . . Also, risk factors from medi cal abortions

. . . have been reduced or eliminated by the curr e n t [ e v i d e n c e

- b a s e d ] r e g i m e n ; m e d i c a t i o n abortion now has a l ower rate of ong oing
preg n ancies a nd fewer surg ical interventions

are necessary to complete t he abortion procedure.P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 7

Medication abortions n ow acco unt for 41 percent of all first-trimester abortions performed a t Planned Parenthood

c l i n i cs n ationwide. I n 2012 in Ariz ona, 43 percent of a l l abortions performed d

uring the first n ine weeks of p reg nancy

w e r e m e d i c a t i o n a b o r t i o n s

. P l a i n t i f f s p r e s e n t e d uncontroverted e vidence in the d i s t r ict court that many

women who choose medication abortion s t r ong ly prefer it

over surgi c a l abortion. Medication abortion is less invasive than surg ical abortion, whic h i s a particularly important consideration for survivors of rape or sex ual abuse. F urther,

some women h ave medical conditions that make medication abortion sig nificantly safer than surg ical abortion. The d i s t rict court f

ound that “medication abortion is e x tremely safe and safer than the alternative surg ical procedure, which is also a very

safe procedure.”

Since the F DA approved mifepristone in 2000, there have been eig ht known deaths from infection in wom e n u sing earlier off-label r eg imens ( a fatality rate of less than 0.0005 percent). The F D A investig a ted these eig ht cases and f ound

no causal connection between the infe ct i ons and the u se o f mi f e p ristone o r misoprostol. A study conducted in 2013
survey ed the most recent six y ears of data and found no infection-related deaths o ut of 7 11,556 medication abortions performed under the current evidence-based reg imen. J ames Trussell e t al., Reduction in Infection-Related Mortality Since Modifications in the Regimen of Medical Ab o r t i on , 89 Contraception 193, 195 (2014).

The on-label reg imen fails to terminate the preg nancy in about 1 percent of cases, and as many as 8 percent of w omen following the on-label r e g imen require surg ical-abortion procedures to stop h eavy bleeding caused by the medications. The evidence-based reg imen f ai l s in about 0 .5 percent o fP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 8

cases, and fewer than 2 percent of women require subsequent
surg ical-abortion p rocedures. B ecause of the larg er d ose o f mifepristone required b y the on-label reg imen, the drug s for the on-label reg imen cost $160 more than for the evide ncebased reg imen. The o n-label reg imen also increases costs b y requiring an additional c linic visit. F inally

, the e videncebased reg imen allows women to take mi s oprostol in their homes, e l i m i nating the risk that they will pass their
preg n ancies, a process involving heavy bleedin g a nd cramping

, during their trip home from the second clinic visit.

B . F DA Approval

W h en the F DA approves a drug

, it does so on the basis o f evidence of clinical t ri a l s submitted by the drug ’s manufacturer. The F DA g enerally does not conduct its o wn trials. According to plaintiffs’ ex pert Dr. L isa Rarick, w ho participated as an F D A official in the approv a l p rocess for mifepristone, the F DA “does not authoriz e p r o t ocols for drug s

. . . . Rather, approval of [ a d r u g ] allows the d rug sponsor to advertise and promote the d r u g for a particular use.” The drug ’s manufacturer also submits a proposed label for approval. The label “prov ides p h y sicians with g uidance about h ow to u s e a drug in accordance with how the d rug sponsor requested and received F DA approval for its use.” The label “does not impos e b i nding oblig ations on phy sicians.” The “F DA does not require a manu f a c t u r er to update a drug ’s [ label] for new uses or protocols,” and there rarely a re sufficient economic incentives for the manufacturer to do so.

According to Dr. Rarick, the F DA “neither prohibit[ s] nor discourag e[ s] ” off-label use of F DA-approved drug s. I n fact, “the F DA has repeatedly a c k n o wledg ed that off-label use isP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 9

common and is som e t i m e s required by g o o d medical practice.” I

n a 1982 “F DA Drug

B ulletin,” the F DA stated:

The [ Federal F o od, D rug , a n d Cosmetic] A ct d o es not

. . . limit the manner in which a phy sician may use an approved drug

. Once a product h as been approv e d for marketing

, a phy sician may p rescribe it f or uses or in
treatment reg imens or p atient populations that

a r e not included in approved labeling

. Such “unapproved” o r, more precisely

, “unlabeled”

uses may be appropriate and rational in certain circumstances, and may , in fact, reflect approaches to drug therapy that have been

ex tensively reported in medical literature.

. . . Valid new uses for drug s already on the market are often

. . . confirmed by wellplanned and e x ecuted c linical in v e stig ations. B e fore such advances c an be ad d ed to t h e a p p r o v ed l a b e l i n g, h o we ver, data substantiating th e effectiveness of a new use

or reg imen must be sub m itted by the manufacturer to [ the] F DA f or evaluation. This may take time and, w ithout the initiative of th e drug manufacturer whose product is involved, may never o cc u r. F or that reason, accepted medical practice often includes d rug

use that is not reflected in approved d rug labeling

.

12 F D A Drug B ulletin 5 (1982). The F DA has consistently

ma i n t ained that position. S e e U .S. F ood & Drug Admin., “Off-Label” and Investigational Use o f Marke ted Drugs,P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 10

Biologics, and Medical Devices - Information Sheet ( Aug

. 10, 2 0 1 1 )

, h t t p : / / w w w

. f

d a

. g o v / R e g u l a t o r y I n f

o r m a t i o n / Guidances/ucm126486

. htm. Off-label use of drug s is especially common in p ediatrics, oncolog y , and g y necolog y and obstetrics.

C. Ariz ona L eg islation

I n 2012, the Ariz ona leg islature passed House B ill 2036,

a collection of statutory a me n dments reg ulating abortion. The amendment a t i s s ue in this case r eg ulates medication abortion. I t provides:

The director [ of the Ari z o n a Department o f Health Services] shall adopt r ules relating t o the a bortion p roc edure. A t a minimum these rules shall require

. . . [ t] hat any medication, drug or other substance used t o i nduce an abortion is admini s t e red in compliance with the protocol t h a t is authoriz ed by the United Stat e s [ F ] ood and [ D] rug [A] dministration and that is outlined in th e fi n al printing labeling instructions f

or that medication, d

rug or substance.

Ariz

. Rev. Stat. § 36-449.03(E)(6). Defen d a nt W illiam Humble, D i rector of A riz ona’s D epartment of Health Services, adopted an implementing reg ulation as required b y the amendment. Ariz

. Admin. Code § R9-10-1508(G). The
reg ulation had an effective date o f April 1, 2014. W e refer to the a mendment a

nd r eg ulation c ollectively as “the A r i z o na law.”P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 11

The leg islature descr i b e d its purpose in passing the Ariz ona law a s “[ p] r otect[ ing ] w omen from the dang erous and potentially deadly off-label use of abortion-inducing drug s, such a s, for ex ample, mifepristone” and “[ e ] nsur[ ing ] tha t p hy sicians abide by the protocol tested [ sic] a nd approved by the United States F ood and Drug Administration for such abortion-inducing drug s.” The leg isla tive finding s describe v arious h e a l t h risks from the use of mifepristone, including risks of infection and hemorrhag e. The d i s t rict
court found that the Ariz ona leg islature provided no “supporting evidence f

or any asserted leg islative f a c t .” The
court observed that “the risks a s s ociated with medication abortions, relied on by the State as the r eason for adopting the [ on-label] protoc o l

, have b een substantially reduced o r eliminated” by

the evidence-based reg imen.

D. Challeng e to the Ariz ona L aw

There are currently ten abortion p rovider s in Ariz ona, located in three o f the state’s fiftee n counties. Planned Parenthood A riz ona, I nc. (“PPAZ ”), provides abortions at its clinics in Glendale, Tempe, Tucson, and F lag staf f. PPAZ performs medication a

bortions according to the evid en c e

based reg ime n. The Glendale, Tempe, and Tucson c linics provide both surg ical and medication abortions. The F lag staff clinic provides only medication abortions. PPAZ ’s F lag staff clinic is the only ab o rt i o n provider in northern Ar i z o na. The nex t closest provider is in Glendale, which is located, on averag e, 160 miles from locations in n o rthern Ariz ona; it is 372 miles away from some locations. I n 2013, PPAZ provided 6,667 abortions for w omen throug h 63 day s L MP. Thirty

- e i ght percent were medication a bortions. Twenty -six percent of these medication abortions occ u rr ed after 4 9 d ay s L MP. B ecause they occurred after 49 day sP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 12

L MP, such abortions would n ot h ave been available if PPAZ had been required to follow the on-label reg imen.

PPAZ ’s F lag s taff clinic used to provide medication abortions throug h a

n advanced practice clinician instead of a doctor, but Ariz ona banned that practice in 2 011. The F lag staff clinic could not provide abortions of any kind until F ebruary 2014, when it found a doctor to perform medication abortions. During the period when the F lag staff clinic could
not perform abortions, sig n ificantly fewer women in northern Ariz ona obtained abortions than before 2011.

Dr. Richards on owns and operates Tucson W o men’s Center, where he provides surg ical and medication a bortions. Dr. Richardson performs medication abortions according to the evidence-based reg imen. I n 2013, he provided abortions to 932 women, 660 of whom were nine weeks preg nant (63 day s L MP) or less. Of those 6 60 wom en, 43 percent chose medication abortion.

PPAZ
, Dr. Richardson, and Tucson Wo m e n ’ s C e n ter sued Director Humble in his official c apacity

, seeking d eclaratory and injunctive relief aga i n s t the Ariz ona law. F o r convenience, w e refer to the defendant as “Ariz ona.” Plaintiffs broug ht their claims on behalf of themselves, their patients, a

nd the phy sicians the y employ

. See Isaacson v

. Horne
, 716 F .3d 1 2 13, 1221 (9th Cir. 2012), ce r t

. de nied

, 134 S. Ct. 905 (2014). Plaint i f f s moved for a preliminary i n j u n c t i o n , a s s e r t i n g t h a t t h e A r i z o n a l a w i s unconstitutional l y vag ue, violates women’s fundamental rig hts t o a bortion and b odily integ rity

, and violates equal protection. The district court denied the motion. I t found that the evidence-based reg imen “is considered the b e st p ractices,” and that Ariz ona had not presented any evide n c eP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 13

to support its leg islative finding s o r to show that the law actually adv ances women’s health. I t treated these finding s

as leg ally irrelevant. I t held that the Ariz ona law is not v ag ue and does not violate equal p r o tection or a woman’s r ig ht to bodily integ rity

. I t held f urther that the law r atio n ally advances Ariz ona’s interest in women’s health and does not impose an u n due burden o n Ariz ona women’s rig ht to abortion.

Plaintiffs timely appealed a nd filed an emerg ency motion for an injunction p e n ding appeal. A motions pa n el o f t his
court enjoined enforcement of the Ariz ona la w p e nding appeal and ex pedited the appeal. See P lanned Parenthood of A r i z

. , Inc. v. H

umble

, No. 14-15624 ( 9th Cir. Apr. 8, 201 4 ) (order g ranting emerg ency injunction).

I I . Discussion

A . Standard for Preliminary I njunctions

W e revi ew the district court’s denial of a preliminary injunction for abuse of discretion. A lliance for the W ild Rockies v. Cottrell

, 6 32 F .3d 1127, 1131 ( 9 t h C ir. 2011). R e l iance “on an erroneous leg al standard” is an abuse o f d i scretion. I

d. (internal quotation marks omitted). W e revie w the district court’s leg al c o nclusions de novo and its factual finding s for clear error. Id.

“A p laintiff seeking a preliminary in j u n ction must establis h that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the a bsence of preliminary relief, that the balance of equities tips in his favor, and that an i n j unction is in the public interest.” W inter v. Natural Res

. Def. Co u n ci l, Inc.
, 555 U .S. 7, 20 (2008). “ ‘[ S] eriousP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 14

questions g o ing to the merits’ and a balance of hardships that tips sharply t o wards the plaintiff c a n support issuance of a preliminary injunction, so long as the plaintiff a lso shows that there is a likelihood of irreparable injury and th a t t he injunction is in the public in t e r e st.” Alliance for the W ild Rockies

, 6 32 F .3d at 1 135. “[ T ]he deprivation o f constitutional rig hts ‘unquestionably constitutes irreparable injury .’” Melend

r e s 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. I nterpretation of the Ariz o na L aw

The parties disag ree a

bout the correct interpretation of the Ariz ona law. Plaintiffs arg ue that, under a proper reading o f i t s tex t, the law flatly prohibits all medication abortio n s

. Ariz ona disag rees. I t a

rg ues that the law allows me d ication abortions, but only if they are performed in accordance with the on-label reg imen. We need not resolve this dispute. W e

assume f or the purposes of our analy sis that Ariz ona’s interpretation of the law is correct.

2. Undue B urden

Plaintiffs arg ue that the Ariz ona law is unco n s titutional because it imposes an undue burden on a woman’s rig ht to abortion. See Planned P a renthood of Se. Penn. v. Casey
, 505 U.S. 833, 876 (1992). I n Casey
, a p lurality of the Supreme Court rejected both strict scrutiny and rational-basis review of abortion reg ulations, h olding instead th a t laws
reg ulating pre-viability a

bortions are unconstitutional if they impose an “undue burden” o n a woman’s rig ht to abortion. Id. at 8 7 6. Casey recog n iz ed that states h ave leg itimateP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 15

“interests in maternal health a nd prote c t i ng fetal life [ that] can, in some c ircumstances, justify reg ulations of abortion.” Tucson W oman’s Clinic v. Eden

, 379 F .3d 531, 5 39 ( 9th Cir. 2004). The undue burden test seeks to balance those interests with a woman’s fundamenta l ri g h t to abortion. See id. The only interest A riz ona a s s er ts in this case is its interest in women’s health.

Our undue burden analy sis starts with Casey ’s p l u rality opinion. See Isaacson
, 716 F

. 3d at 1222 n.8. The p lurality

ex p lain e d

, “A finding of an u ndue burden is a shorthand for the conclusion that a state reg ulation has the purpose or effect of placing a substant i al obstacle in the path of a w oman seeking an abortion of a nonviable fetus.” Casey
, 505 U .S. at 877. Of the four Supreme Court ca ses addressing abortion since Casey
, o nly Gonzales v. Carhart

, 550 U.S. 124 (2007), provides meaning ful g uidance on how to ap ply Casey ’s undue burden test. Cf. Ayotte v. P lanne d P a r enthood 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 b urden); Mazurek v. Armstrong
, 520 U.S. 969, 972 ( 1997) ( per curiam) ( a d d r essing the evidence r equired to support a finding of improper leg islative purpose). Gonzales emphasiz ed the balance struck by Casey
, holding that a state may “reg u lat[ e] the medical profession in order to promote respect f or life,” so long as the state do e s not act irrationally or “impo se an undue burden” on a

w o m a n’s r ig ht to abortion. 550 U.S. at 158. I t held tha t a court reviewing a n abortion reg ulation “must determine whether the [ r eg ulation] furthers the leg itimate interest of the G o vernment in protecting the life of the fetus that m a y become a child.” Id. at 146.P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 16

The analy sis in both Casey a n d Gonzales focused on state laws p urporting to advance the state’s interest in f e tal life. H e r e, however, the Ariz ona law purports to adva n c e Ariz ona’s interest in women’s health. W e wrote in Eden

,
[ Casey ’s] a

pplication of the “ u ndue burden” standard is often n ot e x tendable in obvious
way s to the co n t ex t of a law purporting to promote maternal health.

I n the contex t of a law purporting t o promote fetal life, whatever obstacles that law places in the way of women seeking abortions log ically serve the interest the law purports to p r o m o t e

— f

e t a l life—because they w i l l prevent s o m e w o m e n f r o m o b t a i n i n g abortions. B y contrast, in the contex t of a law purporting to promote maternal health, a law that is poorly drafted or w hich is a pretex t for anti-abortion reg ulation can both pl a ce obstacles in the way of women seeking

a b o rtions and fail to serve the purpo r t e d interest very

closely , or at all.

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

I n E den , we described our approach to apply ing Casey ’s undue burden test. Under E den

, w e compare the ex tent o f the burden a law imposes o n a woman’s rig ht to abortion with the streng th of the state’s justification for the law. See id. at 542. The more substantial the b u rden, the strong er the s t ate’s justification for the la w must be to satisfy the undue burden test; conversely

, the strong e r the state’s justification, the
g reater the burden may b e be f o r e it becomes “undue.” OnP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 17

one ex treme, Eden described cases where “a purported health
reg ulation fails to rationally promote an interest in maternal health on its face.” Id. at 540. I n such a case, the reg ulation fails even rational-ba s i s review, and “the undue burden
sta n d a rd is not trig g e red a t all.” I d. On the other ex treme, laws that are “harmless” o r t h a t have only an “incidental effect” o n a

bortion r equire little justification. Mazurek

, 520 U.S. at 972; Casey
, 505 U.S. at 874. I n cases b e t w e en those two ex tremes, we must w e i g h the burdens ag ainst the state’s justification, a sking wh e t h e r and to what ex tent the challeng ed reg

ulation actually advances the state’s interests. I f a b urden sig nificantly ex c eeds what is n ecessary to advance the state’s interests, it is “undue.” See W ebster’s Third New I nt’l D ictionary 2 492 (1993) (defining “ undue” a s “ex c essive” or “unwarranted”).

Our approach in E

den follows from Ca s e

y , in which the plurality wrote that “ [u] nnecessary health re gulations that have the purpose or effect of presenting a substantial obstacle
to a woman seeking

an abortion impose an undue burden on the rig ht.” 505 U.S. at 878 (emphasis added); see Eden

, 379 F .3d at 542 (rely

ing on evidence t h a t a reg ulation was “unnecessary as a matter of public health”). W hether a reg ulation 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 t o inform the w oman’s f

ree c ho ice, not hinder it.” Casey
, 505 U.S. at 877. The same is true for laws pur porting 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

, w ith some ex ceptions, minors to g et consent from their pare n t s b efore o btaining an abortion. Id. at 899. TheP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 18

plurali ty did so based on the state’s “quite reasonable

a s s umption that minors will benefit from consultation wi t h their parents and that children will often not realiz e that their parents have their best interests at heart.” Id. at 895. At the

same time, a m a

j o rity of the Court struck down a law requiring married women seeking a b ortions first to notify their husbands. Id. at 887–95. The Court dist i n gu i s hed the parental consent law from the spousal notification law based

on the st a t e ’ s comparatively weaker justification in the second instance. W h ile the state could assume t h a t m i n ors mig ht not r ealiz e 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-B irth A bortion B an Act of 2003 only after finding that the Act would advance the state’s interest in fetal life b y “encourag [ ing ] some women to carry the[ ir] infant to full
t e r m , thus reducing the absolute number of late-term abortions.” 550 U.S. at 160. I mportantly for this c ase, Gonzales held that a c ourt apply ing the u n d ue burden test should not “place dispositive weig ht on [ leg islative] finding s. The Court r e tains an independent c o n stitutional duty to review factual f

inding s where const itutional rig hts are at stake.

. . . Uncritical de f

e rence to [ the leg islature’s] f actual finding s in these cases is inappropriate.” Id. at 165–66.

I n Planned Parenthood of W isconsin, Inc. v

. Van Hollen

, 738 F .3d 7 86 (7th Cir. 2013), the Seventh Circuit adopted an approach m u c h like ours in E d en

. The court affirmed a preliminary injunction ag ainst a W isconsin law that r equired abortion providers’ doctors to have admitting privileg es 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 p r o t e c tion o f women’s health. Id. at 789. As in Eden

, t h eP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 19

Seventh Circuit analy

z e d whether the W isconsin law actually advanced that interest a

nd found, on the record before it, that the law did not. See id. at 789–91, 797–98. The court wrote, “The cases that d eal w ith abortion-related statutes soug ht to be justified on medical g r ounds require not only evidence

. . . that the medical g rounds ar e leg itimate but also that the

s t a t u t e not impose an ‘undue burden’ on women seekin g abortions. The feebler the medical g r ounds, the likelier the burden, even if slig ht, [ is] to be ‘undue’ in the sense o f disproportionate or g r atuitous.” Id. at 7 98 (citations omitted).

The d i s t rict court in this case did not cite or discuss our decision in Eden

. I t relied instead on decisions o f the F ifth and Six th Circuits. See Planned Parenthood o f Greater Tex. Surgical H

ealth Servs. v

. A bbott

, No. 13-51008, 2014 W L 1257965, at *7–8 (5th Cir. Mar. 2 7, 2014); DeW ine
, 696 F .3d
at 5 13–18 (opinion of McKeag ue, J .). I n apply ing the undue burden tes t , the F ifth and Six th Circuits consider the state’s justification o nly for the very limited pu r pose of a pply ing rational-basis review. O nce an abortion r e gulation survives rational-basis review, these circuits p a y n o attention to whether the reg ulation h a s been shown act u a l l y to advance the state’s leg itimate interes t s. I n Abbott

, the F ifth Circuit held that courts ma y n o t consider the streng th of the state’s justification, stating that an a bortion reg ulation need o nly be supported by “rational speculation.” 2014 W L 1 257965, at *7–8 (i nternal quotation marks omitted). I n DeW ine
, the Six th Circuit analy

z e d whether an Ohio abortion reg ulation

was an undue burden without considering the streng th of the state’s justification for the reg ulation. 696 F .3d at 513–18.

W e conclude that Abbott and DeW ine are i n c o n sistent with the undue burden test as articulated and applied in Casey and Gonzales

. The F ifth a n d Six th Circuits’ approach fails toP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 20

recog niz e that the undue burden test is contex t-specific, and that both the severity of a burden and the streng th of t he state’s justification can vary d epending o n the circumstances. See Eden

, 379 F .3d at 541 (citing Casey
, 505 U.S. at 9 0 1). W e adhere to the approach i n Eden and Van H ollen

, which requires us to weig h the e x t e n t of the burden a g ainst the streng th of the state’s justification in the co n t ex t of e ach individual statute or reg ulation.

W e assume without deciding that the Ariz ona law passes rational-basis review and move directly to the application o f the undue burden test. See Ede n , 3 7 9 F.3d at 540–41. I n order to show an u n due burden, plaintiffs must show that, “‘in

a larg e fraction of the cases in which [ the law] is relevant, it will operate as a substantial obstacle to a woman’s choice to underg o an a

bortion.’” Id. at 5 39 (quoting Casey
, 505 U.S.
at 895) (alteration in Eden ). W e limit our inqu i r y t o “the
g roup for w hom the law is a restriction, not the g roup for whom the law is irrelevant.” Casey
, 505 U.S. at 894. Under this limitation, we address the burden on women w h o, in the absence o f the Ariz ona law, would receive medication ab o rtions under the evidence-based reg imen. See id. at 894–95.

W e start with the streng th of Ariz ona’s just i f i c a t ion for the law. O n the reco r d b e fo r e us, Ariz ona has presented no evidence whatsoever that the law furthers any interest in women’s h ealth. The district court found that there w as no “supporting evidence f

or any asserted leg islative fact,” a nd that the evidence-based reg imen has a “clear advantag e” over the on

- l a b e l reg imen. F o r e x ample, the Ariz ona leg islature cited the da n ge r o usness of mifepristone in support o f requiring the on-label re gi men, but the on-label reg imen

r e quires three times more mifepristone than the evide n c e

-P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 21

based reg imen. As the district court found, the F DA not only

ex p ects off-label use but encourag es it as part of the effective practice o f medicine. The Supreme Court itself has noted that of f -label use “is an a ccepted and necessary corollary of the F DA’s mission.” Buckman Co. v. P laintiffs’ Legal Com m

. , 531 U.S. 341, 350 (2001); a ccord id. at 350

– 5 1 & n.5. Ariz ona arg

ues that the law prohibits not just safe e videncebased reg imens for medic at i on abortion but also other, dang erous o ff-label r eg imens

. B ut the record contains no evidence that any such dang erous r eg imen ex ists or has ever been used by any abortion provider. T h erefore, on the current record, the Ariz o n a law appears wholly “unnecessary as a matter of [ women’s] health.” Eden , 379 F .3d at 542.

W e turn now to the burden imposed by the Ariz ona law. Eden provides a nonex haustive list o f factors relevant to whether a law imposes an undue burden. F irst, “ [ a]

s i gnificant increase in the cost o f abortion or the supply of abortion providers and clinics can, at some point, con s t itute

a substantial obstacle to a sig nificant n umber of women.” 379 F .3d at 541. Under this factor, p l aintiffs may rely on such evidence as “testimony that o n e provider may b e forced
to stop practicing medicine.” Id. at 5 42. Second, we may

c o n sider evidence that a law “delay s and deters patien t s obtaining abortions, and that d elay in abortion increases health risks.” Id. T hird, we may consider a law’s “stig matiz ing of abortion practice and usurping of providers’ ability to ex e r c i s e m e d ical judg ment.” Id. at 543. We may also consider the way s in which an abortion reg ulation interacts with w o men’s lived ex perience, socioeconomic factors, a nd other abortion reg

u lations. See Casey
, 505 U.S.
at 887–94 ( rely ing on the effect of domestic abuse on w omen seeking abortions); Van Hollen

, 7 3 8 F .3d at 796 (citing the cumulative effect of d ifferent abortion reg ulations);P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 22

McCormack v

. Hiedeman

, 694 F .3d 1004, 1016–18 (9th Cir. 2012) (describing the intersection o f socioeconomic f actors and abortion reg

u lations).

Plaintiffs introduced evidence that medication abortion is

a common procedure strong ly favored over surg ical abortion by many women. D uring the eig hth and ninth weeks o f
preg n ancy , the Ariz ona law requires these women to underg o surg ical abortions rather than medica t i o n abortions. During the first seven weeks of p reg nancy , the law requires them to underg o the on-label reg imen for medication abortions. F o r

a si gn i f icant number of women, the law will effectively b an medication a b o rtions outrig ht because many women do not discover they are preg nant before 49 day s L MP, the last day the on-label reg imen is available under the l a w

. E v en for

women who d iscover their pr e gn ancies earlier, practical considerations, such a s the frequency with which clinics can

see patients a

nd the difficulties women face in obtaining time off from w ork or transportation to a clinic, ma y e f f e ctively preclude medication a bortion before 4 9 d ay s L MP. According to the sworn declaration o f B eth Otterstein, the main clinician at PPAZ ’s F lag staff clinic, some w o men so strong ly p r efer medication abortion, and so object to surg ical abortion, that they w ill foreg o a bortion entirely if they cannot obtain a medication abortion.

Taking into consideration the cost of the ex tra dosag e of medicine and of the clinic time i m p o s e d by the r equired additional visit, the on-label reg imen c osts at least $200 more than the evidence-based reg imen. The additional clinic visit also increases costs to the patient for transpo r t a t ion, g as, lodg ing

, and the time she must take off from work. Plaintiffs’ evidence shows that these i n creased costs would reduce the number of women who r e c eive abortions, many of whom,P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 23

including 40 p ercent of PPAZ ’s patients, are poor. Plaintiffs introduced evidence from abortion p r oviders that, for these
women, the additional costs are sig nificant a nd sometimes prohibitive. Plaintiffs introduced a sworn declaration from the medical director o f Planned Parenthood of Greater O hio (“PPGO”), who declared that after Ohio limited medication abortions to the o n-label reg imen, 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 F lag staff clinic may have to c lose if it is limited to performing on-label medication abortions. Otter s t ei n described that as “a likely possibility

. ” Plaintiffs provided specific reasons, tied to the predicted decrease in women w ho would obtain medication abortions, to ex plain why the F l a gs t aff clinic mig ht be compelled t o c lose for economic reasons. Plaintiffs’ evidence shows that the closure o f the F lag staff clinic would sig nificantly reduce t h e n umber of Ariz ona women w ho receive abortions. I f the F lag staff cl i n i c closes, women in northern Ariz ona who want medication abortions will have to make f our v isits to the Glendale clinic. Each visit will require, on averag e, a 321-mile round trip. Some women will have to travel up to 7 44 miles round-trip fo r each visit. Otterstein declared that, during the period between 2011 a nd 2014 when PPAZ ’s F lag staf f c linic could not provide abortions, many patients said t h e y could not travel to the Glendale clinic and would have to foreg o abortions entirely

. During that peri o d

, 4 8 percent f e w er women in northern Ariz ona received medication a b o rtions from PPAZ, and 35
p ercent fewer received any abortion from PPAZ
, compa r e d with the pre-2011 period. I n 2012, 31 percent fewer w omen in Ariz o na’s three northeaster n c o unties received anyP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 24

abortio n f rom any provider compared with 2010, w h en the F lag staff clinic was providing medication abortions.

F inally

, p laintiffs introduced evidence that the A r i z o na law may delay abortions, thereby increasing health risks. See Eden

, 379 F .3d at 542. Dr. D aniel G rossman , a boardc e rtified obstetrician-g y n ecolog ist, provided a swor n declaration in which he cited a W ashing ton study that found “that rural w omen who had to travel more than 75 miles to obtain an ab o rtion w ere two to three times more likely than

women travelling less than 75 m i l es to terminate after 12 weeks.” Dr. Grossman declared that “delay ing a bortions until later in preg nancy drives up the ri s k s of complications.” I f the F lag staff clinic closes, most women in northern A riz o na will have to travel more than 75 additional miles to obtain an abortion. Althoug h there may be cases in which additional travel time does not in itself rise to the level of an u n d u e burden, this factor must be evaluated on a case-by -case basis and balanced ag ainst the streng th of th e s t ate’s interest. Casey , 505 U.S. at 885–86.

Plaintiffs have introduced uncontroverted evidence that the Ari zona law substantially burdens women’s access to abortion services, and Ariz ona has introduc e d no evidence
t h a t the law advances in any way its interest in women’s heal t h

. Plaintiffs’ evidence shows that the Ariz o na law “usurp[ s]

. . . providers’ ability to ex ercise medical ju d g ment,” Eden

, 379 F .3d at 543, by requiring them to administer a less safe, less effect ive treatment reg imen. See B rief f or American Colleg e of Obstetricians & Gy necolog ists and the American Me dical Ass’n as Amici Curiae a t 13–17. The district court found that “medication abortion is

ex tremely safe and safer than the alternative surg ical procedure.” I t also found that the evidence-based reg imen isP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 25

safer a nd more effective than the o n- l a b el r eg imen. On the record before us, we conclude that the burden imposed by the Ariz ona law is undue within the meaning of Ca s e y and Gonzales

. See Casey
, 5 05 U.S. a t 8 77; Gonzales

, 550 U .S. at 146, 158. W e therefore hold that the district court abused its d i s c r e tion when it h eld that plaintiffs were unlikely to succeed on the merits of their undue burden claim.

On the current record, the burden imposed by the A riz o na l a w is undue even if some women who are deni e d a medication abortion under the e v i dence-based reg imen will nonetheless obtain an a

bortion. Neither the S u p r eme Court

nor this court has ever h eld that a burden must be a bsolute to be undue. S

ee Eden

, 3 79 F

. 3d at 540–43 (not requiring evidence that women wo u l d be totally p revented from obtaining abortions). Evidence in the record shows that

women in A riz ona will be burdened with a s ig nificant increase in the cost o f medication, and that many women will be delay ed in, or d eterred from, seeking a n a bortion if the

ev i dence-based reg imen is foreclosed to them. The availability of on-label medication abortions d uring the first

seven w eeks of preg nancy , a nd of surg ical abortions thereafter, therefore does not prec l ude a finding of undue burden.

The Court in G onzales upheld the federal ban on late-term dilation and ex traction abortion (“D& X”), citing the availability o f a safe alternative late-term procedure, dilation and evacuation abortion ( “D& E”). 550 U.S. at 166–67. B ut Gonzales did not hold that the ex istence of a safe alternative procedure is, in itself, d eterminative. The undue b u r d en claim in Gonzales was b a s e d only on the law’s failure to

a l low D& X when required to p rotect a woman’s h ealth. I d

. at 161–67. Gonzales d id not address the relevance of safeP L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 26

alternative p roce d u r es in challeng es based on o ther kinds o f burden. And in G onzales

, the c halleng e d law left in place “a commonly used an d generally a c cepted method” that was very similar to the one it banned. Id. at 165. T h e refore, the burden in Gonzales w as slig ht, whi le the g overnment’s interest in fetal life w as sufficient to justify the burden. Here, the Ariz ona law imposes a g r eater burden and is not justified by any interest. Moreover, f or women betw e e n 4 9 a n d 63 day s L MP, the Ariz ona law prohibits medication ab o rtion entirely

, leaving surg ical a b o r tion a s the only leg al alternative. I n contrast t o D & E and D& X
, medication abortion and surg ical abortion a r e v ery dissimilar procedures.

The c ourt in Van H

ollen g ranted a preliminary injunction
ag ainst the enforcement of the W isconsin law on the g r ound that “the medical g rounds th u s far p resented

. . . are feeble,
y et the b urden g reat.” 738 F .3d at 798. Here, the “medi c al
g rounds thus far presented” are not mere l y “ f e eble.” They

are non-ex istent. On the current r e c o r d

, t he Ariz ona law imposes an u ndue—and therefore unconstitutional—burden

on women’s access to abortion. W e there fore conclude, at this stag e of the proceeding s, that plaintiffs have shown that they are likely ultimately to succeed on the merits of their undue burden claim.

I n its brief to us, Ariz ona does not arg ue that plaintiffs have n ot shown a l i k e l i h o o d of irreparable harm or that the balance of hard s h i p s a nd the public interest do n ot favor a preliminary i njunction. See Alliance for the W ild Rockies

, 632 F .3d at 1135. Therefore, any arg ument based o n t h e se factors is waived. See Thompson v. Runnels

, 705 F .3d 1089, 110 3 ( 9th Cir. 2013). B ecause we h old that plaintiffs have shown a likelihood of suc c e s s on their u ndue burden c laim,P L A N N E D P A R

E N T H O O D A R

I Z O N A V

. H U M B L E 27

w e d o n o t reach their other claims. W e ex press no v iew o n the merits of those claims.

Conclusion

W e h old that plaintiffs h ave shown a likelihood of success

on their claim that the Ariz ona law imposes an undue burden

on a woman’s rig ht to abort i o n

. W e therefore r e verse the district court’s denial of p laintiffs’ motion for a prelim inary injunction and remand with instructions to issue the requested preliminary

injunction.

REVERSED and REMANDED.