N O T FO R PUB L ICAT IO N UNITED STATES C OUR T OF APPEALS FOR THE NINTH C IR C UIT
GOLDWATER

INSTITUTE, Pla i ntiff-Appe lla

nt,
v. U.S. DEPAR T M ENT OF HEALTH & HUM AN SER

VIC ES, De fe nda n t-Appe l le e . No. 19-15615 DC No. 2:15 c v -1055 SR B
M EM O R ANDUM *

Appe a l from

the Unite d

Stat e s Distric t C ourt for the Distric t of Ariz o na Susa n R . B olton, Distric t Judge , Pre siding Argue d a nd Subm itte d Fe brua

ry 7, 2020 Ariz ona State Unive rsity , Phoe nix, Ariz ona B e fore : TASHIM A , HUR W ITZ, a nd M ILLER , C irc uit Judge s. Goldwa te r Institutesubm itte d a

Fre e dom of Inform at ion Ac t (FOIA) re que st to the Food a

n d Drug Adm i nistra

tion (FDA), se e k ing re c ords re late d to the
a pprova l of ZM a

pp, a n inve stiga

tiona l drug inte nde d

for use in tre ating pe rsons infe c te d with theEbola

virus. The distric t c ourt re lie d on FDA re g ulations to 

# FIL ED
MAR 24 2020 M OLLY C. DW Y E R, CLERK U. S. CO URT O F APPEALS

* This disposition is not a ppropria te for public at ion a

nd is not pre c e de nt e xc e pt a s provide d

by Ninth C irc uit R

ule 36-3.c onc lude tha t the e ntire c onte nts of theFDA’ s Inve stiga t iona l Ne wDrug (IND) file on ZM a pp we re e xe m

pt from disc losure unde r FOIA Exe m ption 4, 5 U.S.C . § 552(b)(4), a

nd gra nte d sum m ary judgm e nt in fa

vor of the De pa

rtm e n t of He a lth
and Hum an Se rvic e s (HHS). Goldwa te r tim e l y a ppe a ls. W e have jurisdic tion pursua nt to 28 U.S.C . § 1291, a nd we re vie w the grant of sum m a ry judgm e nt de novo. Animal Le gal De f. Fund v . FDA , 836 F.3d 987, 990 (9th C i r. 2016) (e n

ba nc ) (pe r c uriam ). W e va c ate the orde r granting sum m ary judgm e nt a

nd re m a nd for furthe r proc e e dings. 1. The distric t c ourt e rre d in a l lowing theFDA to re ly on its re gula

tions gove rning the c onfide ntia l ity of IND file s to withhold the e ntire ZM a

pp file , 1 ra the r tha n re quiring thea g e nc y

to m e e t its burde n

of showing tha

t a pat ic ula r FOIA
e xe m ption a pplie s to the re c ords it withhe ld. S e e Hamdan v . U.S. De

p’t of J ustic e , 797 F.3d 759, 772 (9th C ir. 2015); C iv il Be at Law

C tr. for the Pub. Inte re

st, Inc . v . C trs. for DiseaseC

ontrol & Pre v e ntion , 929 F.3d 1079, 1089 (9th C ir. 2019) (“ [O] ur ge ne ra l FOIA re quire m e nt [is] tha t, ‘ [t] o justify

withholding, the gove rnm e nt m

ust provideta ilore d re a sons in re sponse to a FOIA re q

ue st. It m ay

1 Se e , e .g. , 21 C .F.R . §§ 601.50 (providing, in pa rt, tha t the e xiste nc e of an IND notic e will not be disc lose d unle s s pre viously public ly disc lose d), 601.51 (sim ila rly providing, in pa

rt, tha t inform ation in a

biologic a l produc t file is not ava ila ble for public disc l osure unle ss pre viously disc lose d). 2not re spond with boile rpla te or c onc lusory

sta te m e nts.’ ” (quoting Shannahan v

. IRS , 672 F.3d 1142, 1148 (9th C ir. 2012))). B y c onc luding tha

t FDA re gula

tions gove rning IND a

pplic at ions ba

rre d disc losure of the IND file in toto, the c ourt e sse ntia lly

c onc lude d tha

t the FDA
re gula tions a re c ote rm inous with Exem ption 4. This a

pproa c h, howe ve r, is inc o nsiste nt with FOIA’ s “ pro-disc losure purpose ” and the re quire m e nt tha t we inte rpre t its e xe m

ptions na rrowly
. Animal Le

g a l De f. Fund v . USDA , 933 F.3d 1088, 1096 (9th C ir. 2019). In orde r to c la im

Exe m ption 4, the

FDA m ust e s ta blish tha t the inform ation is (1) c om

m e rc ia l or fina

nc ia l, (2) obta ine d from

a pe rson, a nd (3) privile ge d or
c onfide ntia l. 5 U.S.C . § 552(b)(4); Food Mk tg. Inst. v . Argus Le ade r Me dia , 139 S. C t. 2356, 2362 (2019). The FDA’ s Vaughn inde x a

nd a ffidavits did not a

ddre ss the re quire m e nts of Exe m ption 4, but c ite d only

FDA re gula

tions gove rning IND
a pplic ations. On a

ppe a l, the FDA a ga in re lie s on broa d, ge ne ra l a rgum e nts a

bout the c onfide ntia l ity

of IND file s, rathe r tha

n a ddre ssing thespe c i fic doc um e nts a t issue he re and showing how the y fa ll unde r Exe m

ption 4 of FOIA. “

No e ffort is
m a de to ta ilor the e xpla

n ation to the

spe c ific doc um e nt withhe ld.” W ie ne r v . FBI

, 943 F.2d 972, 978–79 (9th C i r. 1991).

3Whe n e xam ine d unde r the re quire m e n ts of Exe m ption 4, the

FDA’ s bla

nke t
re fusa l to produc e any

re c o rds from the IND file doe s not wa rran t sum m ary judgm e nt in its fa

vor. For e xam

ple , a lthough the

FDA a rgue s tha t a ll re c o rds at issue we re obta ine d from

a pe rson a s re quire d by

Exe m p tion 4, so fa

r a s we are
a ble to de te rm ine from

the re c ord, tha

t is inc orre c t. Of the 58 re c ords Goldwa te r
se e k s, it a ppe ars from

the Vaughn indic e s tha

t 41 a re inte rna l FDA e m a i ls, a nd 3
are FDA e m a ils to others. 2 Only 11 of the re c ords sought a re c orre sponde nc e from the c om m e rc ia l a nd e xpa nde d a c c e ss IND sponsors (line s 38, 60, 72, 80, 81, 83, 85, 89, 101, 105, a

nd 109). Two of the

re c ords a re from the fore ign tre atm e nt provide r (line s 82 a

nd 86), a nd one is the e xpa

nde d a c c e ss IND sponsor’ s subm ission of upda

te d form s (line 107). The FDA’ s broa d a sse rtion is insuffic ie nt to e s ta b lish tha t a ll of the i nform ation in the doc um e nts is obtaine d “ from a pe rson” for purpose s of Exe m p tion 4.

2 The following line s in the Vaughn inde x a re inte rna l FDA e m a ils: 2, 3, 7, 8, 13, 16, 19, 22, 23, 27-34, 41, 43, 44, 47-50, 56-58, 76, 79, 91-98, 100, 104, 111, a nd 113. Line 18 is a

n “ FDA e m a il to c om

m e rc ia l a nd e xpa nde d a c c e ss IND sponsors re sponding to em a il da te d 08/01/14 a

t 7:30 PM and a d dre ssing tim ing of e xpa nde d a c c e s s IND subm ission.”Line 103 is a n “ FDA e m a i l to e xpa

nde d a c c e ss IND sponsor a

nd third pa

rty tre atm e n t provide r holding the ZM a pp to be im

porte d for use unde r the e xpa

nde d a c c e ss IND num

be r and disc ussing subm

ission of pa pe rwork.” Line 110 is a

n “ FDA e m a il to e xpa

n d e d a c c e ss a

nd c om m e rc i a l IND sponsors re sponding to the e m a il da te d 09/14/14 a

t 7:04 PMre ga

rding im porta tion of ZM a pp for use unde r e xpa

nde d a c c e ss IND.”

4Nor do the a ffidavits subm itte d e sta blish tha t the withhe ld doc um e nts
c onta in c o nfide ntia l c om

m e rc ia l or fina

nc ia l inform ation c ove re d by Exe m ption 4. The a ge nc y ’ s a

rgum e nt boils down to the a s se rtion tha

t the doc um e nts must
c onta in suc h inform at ion be c a use the y are in the IND file
. 3 B ut this is insuffic ie nt unde r FOIA. S

e e W ie ne r , 943 F.2d a

t 983 (re je c t ing the C IA’ s re lia

nc e on a n
a ffidav it tha

t sta t e d, without justific ation, tha t “ ‘ disc losure of [the withhe ld] portions re a sona

bly c ould be e xpe c te d to le a d to ide ntific ation of thesourc e of the inform at ion’ ” ). The FDA m ay , of c o urse , re ly on a ffidavits to e sta

blish tha t c e rta in doc um e nts a

re e xe m pt from disc losure , but it m

ust suffic ie ntly

e xpla in why

the doc um e nts qua lify

unde r Exe m

ption 4. Se e , e .g., Hamdan , 797 F.3d a t 774 (FB I
a ffidav its ga

ve spe c ific e xpla

n ations for withholding of pa rtic ula r groups of doc um e nts); Be rman v . C IA , 501 F.3d 1136, 1139–44 (9th C ir. 2007) (C IA de c la ra tion e xpla ine d inform ation in docum e nts a nd possible c onse que nc e s of disc losure ); Lion Raisins Inc
. v . U.S. De p’t of Agric

. , 354 F.3d 1072, 1080 (9th

3 The re a son give n

in the Vaughn inde x for withholding line s 3,7, 16, 18, 23, 38, 60, 72,79, 91, 92, 93, 94, 95, 101, 103, 105, 107, 109, 110, a nd 111 wa s that “ the doc um e nt is prote c te d from disc losure by

FDA re gula

tions be c a use it pe rta ins to ZM a

p p, a n inve stiga tiona l ne w drug, a

nd a n e xpa n de d a c c e ss IND for e m e rge n c y

tre atm e nt use of ZM a

pp.” C f

. Hamdan , 797 F.3d a

t 775 (“ the sa

m e e xpla nation wa s not re p e ate d unthinkingly for e a c h doc um e nt” ). 5C ir. 2004) (USDA de c l ara tions inc lude d “ d e t a ile d a nd spe c ific de sc riptions”of doc um e nts withhe ld a

nd the c om

pe titive ha

rm that c ould re sult from

the ir disc losure ), ov e rrule d i n part on other grounds by Animal Le

gal De f . Fund, 836 F.3d at 990. W e do not disc ount theFDA’ s e xpre sse d polic y c onc e rns re ga

rding the ne e d to prote c t c onfide ntia l inform ation in IND a p plic at ions. None the le ss, on the pre s e nt re c ord, the a ge nc y ha s fa ile d to m e e t

its burde n of e sta

blishing tha

t the doc um e nts it withhe ld a

re e xe m pt from disc losure unde r Exe m

ption 4. W e the re fore va c ate an d re m an d so tha t the distric t c ourt c an de te rm ine whe the r, unde r
e sta blishe d FOIA c rite ria , the doc um e nts a t issue are e xe m

pt from disc losure unde r Exe m ption 4. As pa

rt of its re v ie won re m a

n d, the distric t

c ourt m a y a lso c onside r whe the r inform ation in the doc um e nts is e x e m

pt from disc losure unde r Exe m

ption 5 or Exe m

ption 6. 4 2. On re m and, the distric t c ourt a l so m u st m ake a

finding of
se gre ga bility a s to a ny doc um e nts whic h the c ourt c onc lude s the a ge nc y m ay

4 Goldwa

te r c ha l le nge s only the distric t c o urt’ s de te rm ination a s to Exe m ption 4, ra ising no c ha lle nge a bout re c ords withhe ld unde r Exe m p tions 5 a nd 6. Howe ve r, the distric t c ourt did not spe c ify in its Ja nua ry 2018 orde r whic h re c o rds we re e xe m

pt unde r Exe m

ptions 5 a

nd 6. Although Goldwa

te r origina lly sought 58 re c ords, the pa

rtie s se e m e d to a gre e at ora l a rgum e n t tha

t a s fe w a s 29 doc um e nts m ight be at issue on a ppe a l unde r Exe m

ption 4. 6withhold. Se e Hamdan , 797 F.3d a t 778–79 (“ W e have he ld tha t ‘ [i] t is re ve rsible
e rror for the distric t c ourt “ t o sim ply a pprove the withholding of a n e ntire doc um e nt without ente ring a finding on se gre ga

bility , or the la c k the re of,” with
re spe c t to tha

t doc um e nt.’ ” (quoting W ie n e r , 943 F.2d a

t 988)); Yone moto v . De

p’t of Ve te rans Affairs , 686 F.3d 681, 688 (9th C i r. 2012) (“ An a g e nc y m ay withhold only tha t inform at ion to whic h the e xe m ption a pplie s, a nd so m u s t provide a ll

‘ re a sona bly se gre ga ble ’ portions of tha

t re c ord to the re que ste r.” (quoting 5 U.S.C
. § 552(b))), ov e rrule d in part on othe r grounds by

Animal Le

gal De f. Fund , 836 F.3d at 990. V ACAT E D and RE M ANDE D . Goldwa t e r sha ll re c ove r its c osts on
a ppe a l.

7