GOVERNMENT ACCOUNTAB I L I TY

PROJ ECT, Plaintiff,
v.
U.S. DEPARTMENT OF H EAL TH AND HUMAN SERVI CES; U.S . FOO D & DRUG ADMI NI STRATI ON, De fe nd ants . UNITED STAT ES DIS TRICT COURT F OR THE D ISTRIC T OF CO LU M BIA

Civil Action No. 07-1702 ( CKK)

M EM OR

AN DU M OP IN ION (Mar ch 9, 2010) The a bove-c aptioned ca se ar ises out of a re quest filed by Plaintiff, the Gover

nment Acc ountability

Project, pursua

nt to the Fre edom of Information Ac t (“F OIA”) , 5 U.S.C. § 552 et seq. , s e e kin g the dis c los ur e and re le a se of

a g e nc y re c or ds c on sis tin g of

c lin ic a l st

ud y data reg ardingthe drugciprofloxacin (“ cipro” ). Plaintiff has name d as De fenda nts in thi s action the United States Depa

rtment of He alth and Human Ser vices (“ HHS”) a

nd the United States F ood and Dr ug Administration (“F DA”) (collec tively “De fenda

nts”). Curre ntly

pendingbefor e the Court are the par

ties’ cr oss-motions for summary judgme nt. The Court has conduc ted a
se arc hin g re vie w o f t

he pa rt ie s’ mot ion s a

nd re sp on siv e br ie fi ng , th e e xhibi ts atta c he d to tho se filings, the r eleva

nt case law as w ell as statutory and re g ulatory

provisions, and the entire rec ord here in. The lone dispute re maining in this ca se is the proprie ty of De fenda

nts’ reda ctions from the re sponsive documents. Specific ally , Def endants re dacte d cer

tain information from the documents at issue pursua nt to two separate FO I A Exempti ons — Ex emption 4 (confide ntialSeePl.’s Cross-MSJ /Opp’n at 5, n. 1 (“ In light of the descr iptions provided in the 1 De fe nd ant’ s [ sic ] Vaughn index, P laintiff does not see k patient information that the De fenda nt has withheld pursua

nt to FOIA exemption 6.”). Th e Court

pr e vio us ly

a dv ise d th e pa

rt ie s th a t it

str ic tly a dh e re s to the te xt of

L oc a l Civ il 2 Rul e 7( h) (1 ) a

nd “ a ssume s f

a c ts i de nti fi e d b y

the mov ingpa

rt y in i ts s tate me nt o f m a te ri a l f a c ts are a dmi tte d, un le ss s uc h a fa c t is c on tr ov e rt e d in

the state me nt o f g e nu ine iss ue s f ile d in opposition t o the motion.” See, e .g. Fe b. 19, 2009 Orde r, Doc ket No. [18] . Def endants filed a statement of mate rial fa cts as to which ther e is no g enuine dispute (“ Def s.’ Stmt”) in compliance with the Court’s require ment, albeit in truncated form c onsisting of only three stated fa cts. Plaintiff, however , failed to e ither re spond to Defe ndants’ stateme nt or file its own statement of 2 commerc ial information) a nd Ex emption 6 (persona l privacy information). Upon r eview of Def endants’ ope ning motion and Vaughn index, P laintiff now conc edes that the information wi thh e ld p ur su ant t o E xemp tio n 6 is p ro pe rl y e xemp t un de r F OIA. Ac c or din g ly , D e fe nd ants ’ 1 [19] motion for summary is GRANTED-I

N-PART as conc eded insofa r as De fenda

nts assert that they proper ly withheld information under Ex emption 6. Plainti ff c ontinues to challeng e the
va lid ity of De fe nd ants ’ r e da c tio ns purs ua nt t o E xemp tio n 4 , h ow e ve r, arguin g that D e fe nd ants have no t me t th e ir

burd e n o f d e mon str a tin g that th e mate ri a l in dis pute may

be pr op e rl y

wi thh e ld as conf idential commerc ial information. The Court a g ree s and there fore DENI ES-I N-PART the Def endants’ [19] mot ion for summary judgme nt and GRANTS the Plaintiff’s [20] cross-motion fo r s umm ary

jud g me nt w ithre sp e c t to the pr op ri e ty of De fe nd ants ’ w ithho ldi ng s p ur su ant t o Exe mpt ion

4. De fe nd ants are the re fo re dir e c te d to dis c los e to P la int if f a ll i nf or matio n p re vio us ly reda cted a s confidential c onsumer information under Exemption 4, for the rea sons set forth. I. BACKG ROUND The fa cts of this case are straig htforwa rd. Plaintiff submitted a FOIA re quest to the FD A on J une 27, 2007, see king doc uments conce rning cer tain clinical study

data r eg ardingthe drug ciprofloxacin. Def

s.’ Stmt. ¶ 1. Specifica lly , Plaintiff reque sted the followingtwo cate g ories of

2materia l fac ts. Accor dingly , the Court shall cite exclusively to Defe ndants’ stateme nt of materia l fa c ts a s w e ll a s to e vid e nc e in t he re c or d ( inc lud ingthe de c laratio ns su bmi tte d b y

the pa rt ie s) wher e appr opriate, to provide information not cover ed by Def endants’ statement. The Court fi nd s th a t th e re is n o g e nu ine dis pute ov e r t he fa c tua l is su e s th a t are mate ri a l to re so lut ion of thi s case . De fe nd ants have su bmi tte d th e Se c on d D e c lara tio n o f N anc y

B . Sa g e r i n s up po rt

of the ir 3 motion for summary

judgme nt. Ms. Sage r is the Dire ctor of the Division of I nformation Disclosure Policy

(“D I DP”) within the Center for Dr ugEvaluation and Rese arc h (“CDER”) at the FD A. Sag er D ecl. ¶

1. She has super

visory authority over D I DP, which proc esses a nd responds to re quests made pur suant to FOIA for doc uments in the possession of CDER, and offe rs the attac hed dec laration based upon her persona l knowledg e and inf ormation about which she has be come knowle dg eable throug h her r eview of officia l ag ency

rec ords within CDER’s control. Id. ¶¶ 2, 4. 3 documents re lating to c ipro: (ii) in elec tronic for

m, . . .: [a] ll g oniometry (joint ang le motion measureme nt) data, inc ludi ng but no t li mit e d to , a ll p a ssi ve ra ng e of mot ion of joi nts , b y

pr oto c ol, measure d in deg ree s , re co rded from all subjects and sor ted by site or investig ator number, subjec t or numeric ide ntification number, the joints m easur ed, the dates of me a sure me nt a

nd inf or mati on on

the a g e of

the su bje c t at e nr oll me nt o r f ir st measure ment in months or y ear s, or birth month a nd y ear , perta ining to domestic a nd fore ign c linical trial studies 1001169 and 100201; and (ii) in paper form: all FDA Division of Scientific Investig ations (“D SI ”) repor ts and re c or ds , d ome sti c and

outsi de of

US, c on c e rn inga ll D SIins pe c tio ns pe rt a ini ngto clinical trial studies 1001169 and 100201. Def s.’ MSJ , Att. 1 (Second De clar ation of Na ncy B. Sag er) (her einaf

ter, “ Sag er D ecl.” ) ¶ 6; see 3 also Compl., Docket No. [1] , ¶ 6. Havingrec eived no r esponse f rom Def endants to its FOIA re quest, Plaintiff filed the instant lawsuit on September 25, 2007, se e ge ne ra lly Compl., and subsequently moved for jud g me nt o n th e ple a din g s b a se d u po n D e fe nd ants ’ f

a ilure to p ro du c e any

re c or ds re sp on siv e to the pendingFOIA re quest, see Pl.’s Mot. for J . on the Pleading s, Docke t No. [5] . In response , Def endants filed a

Motion for an Open Am erica Stay
. SeeDef s.’ Mot. to St ay , Docke t No. [7]
.4

On Au g us t 4, 20 08 , th is C ourt iss ue d a me mor and

um o pin ion

and or de r d e nyingDe fe nd ants ’ reque st for an Open Am erica stay and g ranting -in-par

t Plainti ff’ s motion for judgme nt on the ple a din g s in so fa

r a s Pla int if

f s ou g ht a jud g me nt t

hat D e fe nd ants we re re qu ir e d to pr oc e ss i ts FOIA re quest and re lease the documents on a rolling ba sis. See G ov’t Ac countability Project v. HHS , 568 F. Supp. 2d 55, 56 (D.D .C. 2008). Def endants we re dire cted to re port bac k to the Court wi th a n e sti mate a s to the vo lum e of the re qu e ste d r e c or ds , th e tim e by wh ic h D e fe nd ants
e xpe c te d to be g in p ro c e ssi ngthe F OIA r e qu e st, and ho w l on g the y

e xpe c te d it

to t ake to f

ull y proce ss the reque st. Id. at 57. Ba sed upon De fenda

nts’ response , the Court set a sche dule for D efe ndants’ produc tion of the re sp on siv e do c ume nts and pr ov ide d Pl a int if

f a dd iti on a l ti me to r e vie w the do c ume nts to deter mine if any

issues remaine d for litigation. See9/22/08 Min. Order. In addition, the Court require d the par

ties to submit a joint status report advisingas to whethe r any disputes remaine d
nece ssitating fur

ther litigation. Id. The pa rties completed the production and r eview pr ocess a s
re qu ir e d, the re a ft e r a dv isi ngthe Court that th e y ha d b e e n una

ble to r e so lve a ll d isp ute s r e latin g to Plaintiff’s FOIA re quest. See2/1 9/0 9 O rd e r, Do c ke t N o. [18]; see also Def s.’ Stmt. ¶¶ 2-3 (i nd ic a tin g that D e fe nd ants pr ov ide d Pl a int if f w iththe re sp on siv e do c ume nts in t wo se pa ra te installments on October 22, 2008 a nd ag ain on Dec ember

2, 2008). The pa

rties there fore pr oc e e de d to fi le the pe nd ingc ro ss- mot ion s f or summa ry jud g me nt. B ri e fi ngon

the mot ion s is now complete, a

nd the matter is ripe for the Court’ s adjudication.

II. LEGAL STANDARD I n revie wing a motion for summary judgme nt under F OI A, the Court must conduct a de
novo revie w of the r ecor d. See5 U.S.C. § 552(a)(4) (B ). In the FO I A context, “ de novo revie w5

require s the Court to ‘asce rtain whe ther the a g ency has sustained its burden of demonstratingthat the documents re quested . . . a re e x empt from disclosure under [] FOI A.’” Assassinati on Arc hiv es &Re

se ar c h Ct r. v. Cent. Intelligenc e Age ncy , 334 F.3d 55, 57 ( D.C. Cir. 2003) (q u o t i n g Summers v . Dep’ t of Justice , 140 F.3d 1077, 1080 ( D.C. Cir. 1998)). Summary judgme nt is proper whe n “the plea dings, the discovery [i f any] and disclosure mater ials on file, and any aff idavits show that there is no g enuine issue a s to any materia l fac t and that the movant is entitled to judgment as a matter of la

w.” F ed. R. Civ. P. 56(c). Un de r F OIA, a ll und e rl yingfa c ts a nd inf e re nc e s a re ana ly zed in t he lig ht m os t f

avo ra ble to the FOIA re quester; a s such, only afte r an a g ency

seekingsummary

judgme nt proves that it has fully discharg ed its FOIA obligations is s ummary judgme nt appropriate. Mo or e v . A sp in , 9 16 F. S u p p 3 2 , 3 5 (D
. D. C
. 1 9 9 6 ) ( ci t i n g W eisberg v. D ep’t of Justice , 705 F.2d 1344, 1350 ( D.C. Cir. 1983)). In opposing a

motion for summary

judgme nt, a par

ty must offer mor e than c onclusory statements. See B roaddrick v. E xec . Off. of President , 139 F. Supp. 2d 55, 65 (D.D .C. 2001) (c i t i n g Laningham v. U.S. Navy , 813 F.2d 1236, 1241 ( D.C. Cir. 1987)). Congr ess ena cted F OI A for the purpose of introducing transpar ency to gove rnment activities. See Ste rn v. Fed. B ureau of Inve stigati on , 7 37 F .2 d 8 4, 88 (D .C. Cir . 1 98 4) . Co ng re ss
rema ined sensitive, howeve r, to the nee d to achieve balanc e betwe en this objective a nd the
vu lne ra bil ity of “ le g iti mate g ov e rnme nta l and pr ivate int e re sts [that] c ou ld b e ha rm e d b y re le a se of ce rtain ty

pes of infor

mation.” Criti cal Mass Energy Project v. Nuc lear Regulatory Comm’n , 97 5 F .2 d 8 71 , 8 72 (D .C. Cir . 1 99 2) (e n b anc ); se e als o S um me rs , 1 4 0 F
. 3 d

a t1 0 7 9
. A c c o r d i n g l y, FOIA provides nine e x emptions pursuant to which an a g ency may withhold requested information. See5 U .S. C. § § 5 52 (a )( 4) (B ), (b )( 1) -( 9) . T he a g e nc y mus t de mon str a te the va lid ity6

of any exemption t hat it asserts. See id. ; Bec k v. D ep’t of Justice , 997 F.2d 1489, 1491 ( D.C. Cir. 1993) (“ [c] onsistent with the purpose of the A ct, the burde n is on the ag ency to justi fy wi thh old ingre qu e ste d d oc ume nts ” ). I n a dd iti on , s umm ary jud g me nt m ay

be g ra nte d o n th e ba sis of the a g ency ’s ac company ing a ffidavits or de clar ations if they descr ibe “the justifications for
no nd isc los ur e wi th r e a so na bly sp e c if ic de ta il, de mon str a te that th e inf or matio n w ithhe ld l og ic a lly falls within the claimed e x emption, and ar e not controve rted by either c ontrary

evidenc e in the
rec ord nor e vidence of ag ency bad fa ith.” Military Audit Project v. Casey , 656 F.2d 724, 738 (D.C. Cir. 1981). These aff idavits may

be submitted by

an off icial who coor dinated the se arc h, and nee d not be from e ach individual who pa rticipated in the se arc h. See Safe Card Servs. v. Se c. & Exc h. Comm’n , 926 F.2d 1197, 1200 ( D.C. Cir. 1991). An ag ency

also has the bur den of de tailing what proportion of the infor mation in a document is non-exempt and how that mater ial is dispersed throug hout the document. Mead Data Cent. Inc. v . U.S. Dep’ t of Air Force , 566 F.2d 242, 261 ( D.C. Cir. 1977). Any non-exempt information that is rea sonably seg reg able f

rom the re quested re cords must be disclosed. Ogelsby v. U.S. De p’t of Army , 79 F.3d 1172, 1178 ( D.C. Cir. 1996). In addition, district courts are
re qu ir e d to c on sid e r s e g re g a bil ity iss ue s su a s

po ntee ve n w he n th e pa

rt ie s h ave no t sp e c if

ic a lly raised suc h claims. Trans-Pac. Policing Agree ment v. U .S. Customs Serv. , 177 F.3d 1022, 1028 (D.C. Cir. 1999). III . LE G AL DI SCU SSIO N As ind ic a te d a

bo ve , th e so le iss ue re ma ini ngin t his c a se is t

he pr op ri e ty

of De fe nd ants ’ withholdings pursua

nt to Ex emption 4. Specifica lly , Def endants have re dacte d the followingtwo
c a te g or ie s o f i nf

or matio n und e r E xemp tio n 4 . F ir st, wi th r e sp e c t to Pla int if f’ s r e qu e st f

or a ll7

g on iom e tr

y (j oint ang le mot ion

me a sure me nt) data , in

e le c tr on ic fo rm , p e rt a ini ngto d ome sti c and for eig n clinical trial studies 1001169 and 100201, D efe ndants have withheld all such “data . .
. conce rn[ing] the cipro ora l suspension administered to some of the patients in the two studies.” Sa g e r D e c l. ¶

15 ; see also Def

s.’ MSJ , Att. 5 ( Vaughn index Table B) (her einaf ter, “ Table B ”). Second, with re spect to Plaintiff’s re quest for a ll reports and r ecor ds, in paper f orm, conc erning DSIinspections of the c linical trial studies 1001169 and 100201, De fenda nts withheld “the names of c ontrac tors and subcontra ctors, the location of Ba y er’ s network, investig ators, and
c on su lta nt e nti tie s to wh ic h d oc tor s invo lve d in the c lin ic a l st

ud ie s w e re pa id c on su lta

nts /
c on tr a c tor s. ” Sa g e r D e c l. ¶ 16 ; see also Def

s.’ MSJ , Att. 4 ( Vaughn index Table A) (he reina fter, “Ta ble A”)
. Documents may

be withheld under

Ex emption 4 if they

constitute “trade secr ets and
commerc ial or financ ial information obtained f rom a pe rson [that is] privileg ed or c onfidential.” 5 U.S.C. § 552(b)(4). D efe ndants conc ede that “the instant ca se implicates only confide ntial
commerc ial information, not trade secr ets.” De fs.’ MSJ at 4. Acc ording ly , the re dacte d information may

be prope rly

withheld only

if Def endants de monstrate that such material is (a ) “commer cial or f

inancial infor

mation” that has be en (b) “obtained f rom a pe rson and that is (c )

“ c on fi de nti a l” in n a tur e . In th is c a se , Pl a int if f d oe s n ot d isp ute that th e inf or matio n at is su e is
c omm e rc ia l or

fi na nc ia l in fo rm a tio n o bta ine d f ro m a pe rs on , b ut r a the r c ha lle ng e s o nly Def endants’ a ssertion that the information withheld is “confidential.” SeePl. ’s Cr os sMSJ /Opp’n at 8-10. Deter mination of whether

information is confidential de pends “in pa rt on whethe r it was provided to the g overnme nt voluntarily or under compulsion.” McD onnell Douglas Corp. v.The manne r in which drugcompanies submit information to the FD A as pa rt of the dr

ug 4 application proc ess has be en fully explained by

previous dec isions in t his Circuit. See, e .g., Public Citiz en He alth Research G roup v. FDA , 185 F.3d 898, 901 ( D.C. Cir. 1999) (her einaf ter, “Public Citiz en He alth Research G roup II ” ); W ebb v. H HS , 6969 F.2d 101, 102- 03 (D.C. Cir. 1982). Def

endants do not make an ar g ument that the information qualifie s as conf idential under 5 the first prongconsideringthe ef fec t of disclosure on the g overnme nt’s ability to obtain simi lar information in the future
. SeeDef s.’ MSJ at 6. 8 Nat’l Aeronautics & Space A dmin. , 1 80 F .3 d 3 03 , 3 04 (D .C. Cir . 1 99 9) . In th is c a se , D e fe nd ants
asser t and Plaintiff does not dispute that the g overnme nt require s submissi on of the infor mation at issue as pa

rt of the dr

ug application proc ess. See Def s.’ MSJ at 5-6; Pl.’s Cross-MSJ /Opp’n at 8. As su c h, the inf

or matio n “ wi ll b e c on sid e re d c on fi de nti a l on ly if dis c los ur e wo uld

be lik e ly 4 either ( 1) to impair the g overnme nt’s ability to obtain nece ssary

information in the future ; or (2) to cause substantial harm to the compe titive posit ion of the per son from whom the infor mation was obtaine d.” McD onnell Douglas , 1 8 0 F. 3 d at 3 0 5 (q u o t i n g Criti cal Mass Energy Project , 975 F.2d at 879 (rea ffirmingtest of Nat’l Parks & Conservation Ass’n v. Morton , 498 F.2d 765, 770 (D.C. Cir. 1974), but confiningit to cases of c ompelled disclosure) ). Def endants in this case argue that the infor mation at issue qualifies as c onfidential pursuant to the latter

prong , i.e. , th e “ c omp e tit ive ha rm ” pr on g . D e fs .’ MSJ at 6. In o rd e r t o 5 show competitive har

m, the FDAmust demonstrate both “a ctual compe tition and a likelihood of substantial competitive injury .” CNA Fin. Corp. v. Donov an , 830 F.2d 1132, 1152 ( D.C. Cir. 1987). A “ competitive injury ” is one “ flowing from the a ffirmative use of pr oprietar y information by

competitors.” Public Citiz en He alth Research G roup v. FDA , 704 F.2d 1280, 1291, n. 30 (D.C. Cir. 1983) (he reina fter, “ Public Citiz en He alth Research G roup I ”) ( internal quotation marks omitted). “No a ctual adve rse e ffe ct on competition need be shown,” a nd “[t] he9

court ne ed only

exercise its judg ment in view of the nature of the materia l sought a nd the competitive circ umstances in which the [subm itters] do busi ness, re lying a t least in part on rele vant and c redible opinion testimony .” Nat’l Parks , 547 F.2d at 683. As the D.C. Circuit has made c lear , “the c ourt nee d not conduct a sophisticate d economic a naly sis of the likely

eff ects of disclosure,” but “[c]onclusory and g ener alized alleg ations of substantial competitive har m, of
course , are unacc eptable a nd cannot support a

n ag ency ’s dec ision to wit hhold reque sted documents.” Public Citiz en He alth Research G roup I , 704 F.2d at 1291 (internal c itations and quotation marks omitted). Ul t i m at el y , t h e C o u rt fi n d s t h atDe fe n d an t s h av e f ai l edt o m ee tth ei r b urd en o f s h o wi n g a

“ a lik e lih oo d o f s ub sta

nti a l c omp e tit ive inj ur

y .” As is d isc us se d in

de ta il b e low , D e fe nd ants have pr offe red only

vague and c onclusory

alleg ations in support of their cla im that relea se of the information at issue will likely cause competitive har

m. Accor dingly , even a ssuming that Def endants have suff

iciently shown the existence of a ctual compe tition, Defenda nts’ motion for summary judgme nt must be denied. Proof of bo th “ac tual competition and a likelihood of
su bs tanti a l c omp e tit ive inj ur y ” is n e c e ssa

ry to d e mon str a te that th e mate ri a l at is su e is confide ntial commerc ial information exempt from disclosure unde r F OIA Exempti on 4, see CNA Fin. Corp. , 8 30 F .2 d at 11 52 , a nd De fe nd ants have fa ile d to sh owthat th e latte r r e qu ir e me nt i s met in this case. Be fore turning to Defe ndants’ ar g uments specific to the issue of substantial competitive inj ur y , h ow e ve r, the Court

fi rs t a dd re sse s D e fe nd ants ’ r e pe a te d r e fe re nc e s in the ir br ie fi ngto
cer tain statutory

and re g ulatory

provisions that gove rn the F DA’s public disclosure obligations. Up on an in iti a l r e a din g of

De fe nd ants ’ m oti on

and su pp or tin g me mor and a , it

is d if fi c ult toI ndeed, D efe ndants have moved to withhold the information as exempt only under 6 FOIA Exempti on 4 — and not under FOIA Exempti on 3 as we ll, which”per mits t he g overnme nt to w ithho ld i nf

or matio n ‘ sp e c if

ic a lly e xemp te d f

ro m di sc los ur e by

statut e ’” in c e rt a in circ umstances. Public Citiz en, Inc . v. Rubbe r Mfrs. Ass’n , 533 F.3d 810, 813 ( D.C. Cir. 2008) (quoting 5 U.S.C. § 552(b)(3))
. 10 dis c e rn wh e the r D e fe nd ants purp or t to re ly up on the se pr ov isi on s a s su

bs tanti ve su

pp or t f or the ir decision to withhold the material in this case . Caref ul review , howeve r, make s clea r that Def endants do not

aff irmatively

rely on these provisions to justify the withholdings at issue. Whil e De fenda

nts do refe r to these pr ovisions at various points throughout their br iefing , they at no time advanc e an a

rgument that the re levant statutes and/or regulations prohibit the ag ency from disclosing the information in dispute. Nonethele ss, give n the somewhat obscure nature of 6 Def endants’ a

rguments on this point and cognizant of the importance of ensuringa cle ar r ecor d, the Court pa us e s b ri e fl y

to d e lin e a te the e xac t c on tou rs of De fe nd ants ’ r e lia

nc e on the se pr ov isi on s. First, in ar g uing that actual c ompetition ex ists, Defenda nts ex plain that FDAregulations “explicitly

prohibit the ag ency

from ac knowledg ing the exis tence of a pe nding dr ug application unless the exist ence has alre ady been a cknowledg ed by

the manufa cture r,” a

nd that, even the n, the “F DA ca

nnot disclose any

information re g ardinga pendingapplication until that application i s a p p r o v e d
. ” D e f

s . ’ M S J a t7 ( c i t i n g 2 1 C
. F
. R
. § § 3 1 2
. 1 3 0 , 3 1 4
. 4 3 0 ( c ) & ( d ) )
. A c c o r d i n g l y, Def endants urg e that the a

bsence of evide nce r eg arding the number a

nd ty pe of now -pending drugapplications for

cipro produc ts should not be read a s indicating a lac k of ac tual competition in t he c ipr o ma

rk e t, a s th e F DAc ann ot c omm e nt o r p ub lic ly dis c los e su c h a

pp lic a tio ns ; Def endants instead dir ect the Court to evide nce r eg ardingthe number of alre ady approve d new drugapplications (“NDAs” ) and a bbreviated new dr

ug applications (“ ANDAs” ) for cipro11

products — the e x istence of which may

be publicly

disclosed — as proof

that actua l competition exis ts. See id. a t 6- 7; se e als o De fs .’ Op p’ n/R e ply a t 2- 3. At

no po int , h ow e ve r, do De fe nd ants
argue that th e inf

or matio n at is su e in t

his c a se is s ub

je c t to the se sp e c if

ic re g ulator

y pr ov isi on s; that is , D e fe nd ants make no argume nt t hat th e y are pr e c lud e d f

ro m r e le a sin g the wi thh e ld
mate ri a l be c a

us e it i s d ra wn fr om a pe nd ingdr

uga pp lic a tio n a

nd the re fo re c ann ot b e pu

bli c ly disclosed. Se e ge ne ra lly

Def s.’ MSJ ; Defs.’ Opp’n/Reply
. Second, De fenda

nts refe r the Court to 21 U.S.C. § 355(l)(1) a nd its im plementing regulations located at 21 C.F.R. § 314.430(f). See Def s.’ MSJ at 8; Def

s.’ Opp’n/Reply

at 3. These pr ovisions gover

n the “[p]ubl ic disclosure of safe ty and ef fec tiveness data” submitt ed as part of a n NDA or ANDA. See21 U. S.C. § 3 55 (l )( 1) ; 21 C.F .R. § 3 14 .4 30 (f ). As De fe nd ants
no te , 2 1 U .S. C. § 35 5( l) (1 ) p ro vid e s th a t [s] afe ty and ef fec tiveness data and information which has been submitt ed in a n [new drugapplication] for a dr ug and which ha s n ot previously been disc losed to the public shall be made available to the public, upon reque st, unless ex traordina ry circ umstances a

re shown–
*** (E) upon the eff

ective date of the a

pproval of the first application under subsection (j) of this sec tion whic h ref ers to such drugor upon the date upon which t he appr oval of a

n application under

subsection (j) of

this section which re fer s to suc h drug could be made e ffe ctive if such a n application had been submitted. 21 U.S.C. § 355(l)(1). The FDA ’s implementing r egulation, 21 C.F.R. § 314.430(f), mirr ors the statut or y pr ov isi on , p ro vid ingthat: [a] ll safety

and ef fec tiveness data a

nd information which have bee n submitt ed in an a pp lic a tio n an d whi c h h ave no t pr e vio us ly be e n d isc los e d to the pu

bli c are ava ila

ble to the pu bli c , upo n re qu e st, a t the tim e any on e of the fo llo wi nge ve nts oc c ur s unle ss extraordinary

circ umstances a

re shown:12 *** (5 ) F or a pp lic a tio ns su

bmi tte d und e r se c tio n 505 (b ) o f t he a c t [ i.e., new dr

ug applications], the effe ctive d at e o f the a pproval of the first abbre viated a pp lic a tio n su bmi tte d und e r s e c tio n 5 05 (j ) o f t he a c t [ i.e. , abbre viated new drugapplications] which ref ers to s u ch d ru g, or the date on which the approva l of an abbreviate d application under section 505(j) of the ac t which ref ers to such dr

ug could be made eff

ective if such an a bbreviated application had bee n submitt ed. 21 C.F.R. § 314.430(f)
. Th e F DAa sse rt s —

and Pla int if f d oe s n ot d isp ute — th a t it wa s n ot r e qu ir e d to automatically

disclose the withheld g oniometry data r elatingto the cipro ora l suspension under these provisions as ther e cur rently is “no approve d ANDA r efe renc ing the NDA f or the c ipro oral suspension, nor would an AN DA be e ligible f or appr oval . . . had one been submitted.” Id. Acc ording ly , beca

use the F DA wa s not require d to relea se the data re lating to the c ipro oral suspension under these provisions and bec ause the FDAhas re lease d all other re quested information conc erningthe ra w g oniometry

data, the F DA re prese nts that it has “provided plaintiff with all of the g oniometry (joint ang le motion measureme nt) data . . . that was re quired to b e dis c los e d p ur su ant t o 2 1 U .S. C. § 35 5( l) (1 )( E) and 21 C.F .R. § 3 14 .4 30 (f

)( 5) .” De fs .’ MSJ
a t 8; se e als o Sag er D ecl. ¶ 14 (“In acc ordanc e with 21 U.S.C. § 355(l)(1)( E) and 21 C.F .R. § 314.430(f) (5), a ll of the responsive data per taining to c ipro products for which abbr eviated ne w dr uga pp lic a tio ns [] eit

he r h ave be e n a

pp ro ve d o r c ou ld h ave be e n a pp ro ve d w e re pr ov ide d to plaintiff.”)
. Plaintiff, however , has not cha lleng ed the F DA’s c ompliance with its disclosure obligations under 21 U.S.C. § 355(l)(1)( E) and 21 C.F .R. § 314.403(f)( 5). Consequently , the question of whethe r the F DA has f ully complied with these provisions is not presently befor e theWhil e the Court nee d not, and does not, dec ide whethe r such a n argument would have 7 merit, eve n if asser

ted, it notes that the particula r statutory

and re g ulatory

provisions quoted by De fe nd ants a dd

re ss o nly the F DA ’s affirm ative disclosure oblig ations. See 21 U.S.C. § 355(l)(1) (E) ( “Safe ty

and ef fec tiveness data a

nd information . . . shall be made available to the pu bli c , u po n r e qu e st, un le ss e xtra or din ary c ir c ums tanc e s a

re sh ow n . . . .” ); se e als o 21 C.F.R. § 314.403(f) (5) ( “All safe ty and ef fec tiveness data a

nd information . . . ar e ava ilable to the public, upon reque st, at the time any one of the following events oc curs unless e x traordina ry circ umstances a

re shown . . . .” ). These provisions stand in direct contra st to other sections of the implementing r egulations — not cited by Def endants — that dire ctly

prohibit public disclosure of ce rtain information. See, e .g., 21 C.F .R. § 3 14 .4 30 (g ) ( “ Th e fo llo wi ngdata and inf or matio n in an application or abbre viated application are not available f or public disclosure unle ss . . . .”). SeeDef s.’ MSJ at 8 (e x plaining that the withheld materia l does not fall within the 8 cate g ory of information that the FDA is re quired to disclose unde r these pr ovision and theref ore c on c lud ing , w ith out f

ur the r e xplanatio n, that “ the data re latin g to t

he c ipr o o ra l su sp e ns ion

[thu s] continues to meet the standa rd set for th in National

Parks , a nd F DApr op e rl y

wi thh e ld i t pursuant to Exempti on 4”). 13 Court, and the F DA’s r epre sentations on that point are immater ial. Moreove r, the Court emphasizes that while Def endants a ffirmatively

argue that the r eleva

nt statutory

and re g ulatory pr ov isi on s d o n ot require them to disclose the ra w data r elatingto the cipro ora l suspension, they do not argue the r ever se — i.e., t h a tt h e p r o v i s i o n s e x p l i c i t l y prohi bit them from disclosing the wi thh e ld m a te ri a l. Se e ge ne ra lly Def s.’ MSJ at 8; Def

s.’ Opp’n/Reply

at 3-4. Nor

do 7 Def endants a rgue that these provisions are some how re levant to the dete rmination of whethe r information may

be withheld as “ confide ntial commerc ial information” unde r Exemption 4. See ge ne ra lly Def s.’ MSJ ; Defs.’ Opp’n/Reply . Although D efe ndants appe ar to have made the assumption in thi s case that safe ty and ef fec tiveness data a lway s qualifies as c onfidential consumer inf

ormation that must be withheld under F OI A Exempti on 4, unless and until the FDA is obligate d to disclose the mater ial under 21 U .S.C. § 355(l)(1)(E) and 21 C.F.R. § 314.403(f) (5), they

have not e x plicitly

advanc ed any

such ar g ument and prof

fer no leg al or 8 fac tual support for suc h an assumption. As such, De fenda nts’ citations to and relianc e on the14

above- quoted statutory

and re g ulatory

provisions are ir

rele vant to the only

question now befor e t h e C o u rt—

n am e l y , w h e t h e r

t h e r e d a c t e d

i n f o r m at i o nw a s p r o p e r l y

w i th h e l d un d e r F O IA Ex emption 4. Withthat un de rs tand ing , th e Court tur ns no w t o th e me ri ts o f D e fe nd ants ’ a rgume nts specific to the question of whethe r the infor mation in disput e is proper ly char acte rized as
c o n f i d e n t i a l c o m m e r c i a l i n f

o r m a t i o np ur s u an tt o E x e mp t i o n4
. A s i n d i c a t e d p r e v i o u s l y, Def endants a ssert that the withheld mate rial qualifies a s confidential unde r the “ competitive harm” prong , which re quires proof of “a ctual compe tition and a likelihood of substantial
c omp e tit ive inj ur

y .” De fe nd ants ’ s ole e vid e nc e tha t di sc los ur e of

the inf or matio n in dis pute
wo uld lik e ly re su lt i n “ su

bs tanti a l c omp e tit ive inj ur y ” is a s f oll ow s, re pr int e d in

fu ll: I f [the] FDAwer e to disclose the inf o rm at i o n that the ag ency has withheld as c o n f i d e n t i a l c o n s u m e r i n f

o r m a t i o n , a c o mp e t i t o r c o u l d u s e th a t [] i n f o r m a tio n to su pp or t it s o wn ne w d ru g a pp lic a tio n [] w ith out havin g to i nc ur the tim e and

e xpe ns e involved in de veloping the information itself. In addition, the owner of the prote ctedbut-improperly -re lease d information could sue [the] FDA on the grounds that [the] F DA ’s re le a se je op ardized its c omp e tit ive mark e t by pr ov idi ngc omp e tit or s w ith c ri tic a l in fo rm a tio n th a t c ou ld s pe e d u p th e de ve lop me nt o f a

c omp e tin g pr oje c t. Sa g e r D e c l. ¶

17 . T his a sse rt ion , h ow e ve r, is c on c lus or y in n a tur e and

wh oll y ins uf fi c ie nt t o support a findingthat the information at issue is prope rly exempt under FO I A for thr ee pr incipal
rea sons. F ir st, Ms. Sa g e r h a s n ot d if fe re nti a te d b e tw e e n th e c a te g or ie s o f i nf or matio n w ithhe ld i n this case. As pr eviously

discussed, De fenda

nts redac ted two basic c ateg ories of infor mation: (1) all g oniometry

(joint ang le motion measureme nt) data c oncer ning the cipro ora l suspension; and (2 ) t he name s o f c on tr a c tor s and su bc on tr a c tor s, the loc a tio n o f B ay e r’ s n e tw or k, inv e sti g a tor s, and consultant e ntities. Ms. S ag er, how ever , has fa iled to discriminate betwe en the ty pes15

information at issue, instead br oadly claiming that rele ase of

either c ateg ory

of information, without dist inction, would likely result in substantial competitive injury . Such a blanke t statement is wholly

unpersua sive. Second, the e x planation lacks a ny supporting de tail demonstrating that a compe titor could, in fac t, use the withheld mater ial “to support its own new drug application [] without havin g to i nc ur

the tim e and

e xpe ns e inv olv e d in

de ve lop ingthe inf

or matio n it se lf

.” De fe nd ants ’ briefingsimil arly

fails to elucidate on how a c ompetitor could utiliz e either cate g ory of inf or matio n at is su e to i ts a dv anta g e , in ste a d b ro a dly a sse rt ingon ly

that “ the wi thh e ld information could per

mit a compet[ing] ge neric manufa cture r to more e asily desig n around the pate nt( s) .” De fs .’ Op p’ n/R e ply a t 3; see also Def

s.’ MSJ at 9 (indicating, without explanation, that r e le a se may

“ pr ov id[e ] co mpe tit or s w ithc ri tic a l in fo rm a tio n th a t pe rm it the c omp e tit or to
mor e qu ic kly

and e a sil y de ve lop a

c omp e tin g pr od

uc t” ). Th e c on c lus or

y natur e of De fe nd ants ’ explanation on this point is fatal to their motion. Although it is true that this “court ne ed not
c on du c t a so ph ist ic a te d e c on omi c ana ly sis of the lik e ly e ff e c ts o f d isc los ur e ,” it i s n on e the le ss
we ll s e ttl e d th a t su c h “ [c]o nc lus or y and g e ne ra lize d a lle g a tio ns of su bs tanti a l c omp e tit ive ha

rm ”
a s a sse rt e d b y

De fe nd ants “ are un a c c e pta ble and c ann ot s up po rt

an a g e nc y ’s de c isi on

to w ithho ld reque sted documents.” Public Citiz en He alth Research G roup I , 704 F.2d at 1291 (D.C. Cir. 19 83 ) ( int e rn a l c itatio ns and qu otatio n ma

rk s o mitte d) . F or

thi s r e a so n, “ c ourt s in

thi s Ci rc uit routinely reje ct Exempti on 4 arguments that are g rounded in g ener alizations.” In De fense of An im als v . Na t’ l I

ns t. o f H e alt h , 543 F. Supp. 2d 70, 79 (D.D .C. 2008) (listing ca ses).Al tho ug h n ot d isp os iti ve , th e Court no te s th a t D e fe nd ants have fa ile d to e ve n e xpla in 9 the ac tual source of the infor mation in disput e. While it is appar ent from the F OI A re quest that the mater ial at issue per

tains to two particular

clinical studies, Def

endants have not identified the 16 The D.C. Circuit’s opinion in Public Citiz en He alth Research G roup II is of particula r assistance in evaluatingwhether an ag ency

has prof fer ed evide nce suf

ficient to demonstrate the propriety of its withholdings under E x emption 4. I n that case , the plaintiff cha lleng ed the F DA’s decision to withhold information included in five investig ational new dr ug applications as confide ntial commerc ial information. See P ublic Citi zen He alth Research G roup II , 185 F.3d at 900. The D.C. Circuit held that the inter venor- defe ndant had met its burden of nondisclosure a s to four of the five a

pplications at issue bec ause its proff ere d evidenc e of c ompetitive harm wa s “suff iciently specific ” to support a f

inding that r elea se would ca use it substantial competitive harm. See id. at 905-06. The Court of Appea ls held, howeve r, that the interve nor-de fenda nt had fa ile d to me e t it s b ur de n w ithre sp e c t to the fi ft h a pp lic a tio n b e c a

us e it h a d p re se nte d “ on ly conclusory

alleg ations that disclosure would ca use compe titive harm.” Id. at 9 0 6
. Ins o d o i n g, the cour t rejec ted as insuffic ient the interve nor-de fenda nt’s broad a ssertions that, for e x ample, disclosure “ ‘would re veal substantial basic rese arc h’ as we ll as ‘disease models . . . that have been de veloped [] at gre at expense,’” and that the infor mation at issue “‘ha [d] signific ant value . . . [and would be applica

ble] to any

drugproduct . . . of a

simil ar c hemical ty

pe.’” Id. De fe nd ants ’
asser tions in t his case a

re substantially

simil ar to — if not more conclusory in nature tha

n — the explanation that the D.C. Circuit found to be insufficient in Public Citiz en He alth Research Group II. Def

endants off

er no e x planation whatsoe ver a s to how a compe titor could use the information at issue to support their own dr ug applications, simply

concludingthat such information could be use d in some unspecifie d manner to the submitt ers’ disadvantag e. 9a c tua l in div idu a l or e nti ty that su bmi tte d th e inf

or matio n to the F DAno r h ave the y sp e c if ic a lly i n d i ca t edt h e m an n er

i nwh i ch s u ch i n fo rm at i o nwa s o ri gi n al l y s u b m i t t edt o th e F DA (a l th o u gh Def endants’ br iefingstrong ly sug g ests that the mater ial was submitted as par t of a drug application). A s the Court’s inquiry focuse s on the substantial competitive harm that disclosure would cause “to the entity that submitt ed the infor

mation,” see J

udicial W atch, Inc. v . FDA , 449 F.3d 141, 148 ( D.C. Cir. 2006), Def endants’ f ailure to a ctually

identify the entity or individual that su bmi tte d th e inf

or matio n is ind ic a tiv e of

the g e ne ra l in su ff

ic ie nc y of the De fe nd ants ’ evidenc e on this point. 17 Rather than pr ovide any

evidenc e par

ticular to the a lleg ed har

m that would result from the disclosure of the information at issue in this case, D efe ndants instead re ly heavily on previous D.C. Circuit decisions in which the cour t has g ener ally

observe d that cer

tain information submitt ed to the F DA as pa rt of a dr ug application may

be exempt under F OIA Exempti on 4. See De fs
. ’s M S J at 6 (q u o t i n g Judicial W atch Inc . v. FDA , 449 F.3d 141, 148- 49 (D.C. Cir. 20 06 )) ; see also De fs
. ’ O p p ’n / R ep l y at4 (q u o t i n g W

ebb v. H HS , 696 F.2d 101, 103 ( D.C. Cir. 1982)). De fenda

nts’ relianc e is misplaced. Such obse rvations re g ardingthe g ener al nature of submissi ons to the FDAare not a substitute for a spe cific showingby Def endants that the materia l in this case is confidential commer cial information. “Ex emption 4 does not cate g orica lly

exempt all information” submitt ed in a dr ug application to the F DA; instead, the g overnme nt retains the bur den of de monstrating that the specific information withheld in any p art i c u l ar i n s t an c e qu a l i f

i e s a s c o n f

i d e n t i a l c o m m e r c i a l i n f

o r m a t i o ne x e mp tun d e r

F O IA Ex emption 4. Judicial W atch , 4 49 F .3 d at 14 9. De fe nd ants have no t me t th a t bu rd e n in thi s
case . Def

endants’ f ailure to do so, by

itself, require s that the Court deny Def endants’ motion for summary

judgme nt, as the “G overnme nt ‘ultimately has the onus of pr oving that the [documents] are exempt from disclosure.’” Public Citiz en He alth Research G roup II , 185 F.3d18

at 9 0 4 (q u o t i n g Nat ’l

As s’n o f G ov ’t Em plo y e es v . Ca mp be ll , 593 F.2d 1023, 1027 ( D.C. Cir. 1978)). It is not t he plaintiff’ s burden to show a n absenc e of c ompetitive harm. Id. at 905. Nonethele ss, the Court briefly notes that Plaintiff has submitted the decla ration of Juan N. Wal te rs pie l, M .D ., F .A .A .P. , a bo ard c e rt if ie d p e diatr ic inf

e c tio us dis e a se sp e c ia lis t w ith experience in the use of quinolones such a s cipro. SeePl.’s Cross-MSJ /Opp’n, Att. 1 (De clar ation of Juan N. Walterspiel) (her einaf ter, “ Walterspiel Dec l.”), ¶ 1. With respec t to the g on iom e tr

y data wi thh e ld b y

the F DA , D r. Wal te rs pie l ave rs that it wo uld be imp os sib le fo r any c omp e tit or to g le an inf or mation o n t he s pe c if

ic composition of a formulation of ciproflax in or al suspension from g oniometry data. The only meaning ful i n fo rmation that a c ompetitor could rea sonably g lean f rom go n i o m etry

data is that the ora l suspension perfor med in a manne r equa l to other formulations as far as joint safe ty is conce rned, and that fac t the FDAhas ana ly zed and alr eady

made a vailable to the public. Id. ¶ 9. De fenda

nts make no ef

fort to addr ess this particular statement in their combined opposition/ reply

nor have they

provided a

ny additional evidenc e to support their c onclusory but contra ry position t hat a “ competitor could use [the withheld] information to support its own new drugapplication.” Se e ge ne ra lly Def s.’ Opp’n/Reply . Their f

ailure to do so fur

ther illustrates the inadequa cy

of De fenda

nts’ explanation for withholding the material at issue. Dr. Walterspiel’s
asser tion that it would be impos sible for a competitor to use the r aw data at issue in a manne r that would result in substantial competitive harm to the submitter of the inf ormation is theref

ore uncontested. Th ir d a nd fi na lly , D e fe nd ants ’ s tate me nt a ve rr ingthat th e ow ne r o f t he inf or matio n c ou ld sue the F DA for

rele ase of

the information — eve n if true — is not the ty pe of a lleg ed har

m that qualifies as a

“compe titive injury ” under FOIA Exempti on 4. The D.C. Circuit has made clea r that a “c ompetitive injury ” is one “ flowing from the a ffirmative use of pr oprietar y information byDef endants have also fa iled to expl ain on what leg al basis the owne r of the inf ormation 10 at hand c ould sue the F DA in this case. A bsent such an e x planation, Ms. Sag er’ s conclusory statement is wholly

insufficient to demonstrate that disclosure w ould in fact risk e x posing the FDAto the threat of a law suit. According ly , even if this statement were rele vant to the Court’s pr e se nt i nq

uir y , it wo uld no ne the le ss b e ins uf

fi c ie nt t o s up po rt

De fe nd ants ’ d e c isi on

to w ithho ld the information. 19 competitors.” Public Citiz en He alth Research G roup I , 704 F.2d at 1291, n. 30 (internal quotation marks omitted). The F DA’s own f ear that it may

be sued by

the submitter of the information is irrele vant to the inquiry at hand. 10 Ac c or din g ly , a s D e fe nd ants have fa ile d to pr ov ide su ff ic ie nt e vid e nc e to s up po rt the ir po sit ion that di sc los ur e of

the re da c te d in fo rm a tio n w ou ld r e su lt i n s ub sta nti a l c omp e tit ive ha

rm , and a s th e re is n o d isp ute a

bo ut a n is su e of fa c t mate ri a l to the De fe nd ants ’ b ur de n o n th a t po int , the Court finds that summary judgme nt in favor of

Plaintiff is warra

nted insofar

as it asserts that Def endants have improper ly

withheld information under Ex emption 4. Defe ndants’ [19] motion for summary

judgme nt is therefor e DEN I ED and Plaintiff’s [20] cross-motion for summary jud g me nt i s G RA

NT ED wi th r e sp e c t to the pr op ri e ty of De fe nd ants ’ w ithho ldi ng s p ur su ant t o Exe mpt ion

4. De fe nd ants are dir e c te d to re le a se to P la int if f a ll i nf or matio n p re vio us ly

wi thh e ld as conf idential commerc ial information, as set f orth in Table B of the Sag er D ecla ration. F ina lly , a s e xpla ine d a

bo ve , und e r D .C. Cir c uit

pr e c e de nt, dis tr ic t c ourt s a re re qu ir e d to
c on sid e r s e g re g a

bil ity iss ue s sua sponte even when the pa rties have not specifica lly raised suc h claims. Trans-Pac. Policing Agree ment , 177 F.3d at 1028. I n this case, ne ither par ty has ra ised the issue. Se e ge ne ra lly

De fs .’ MSJ; Pl. ’s Cr os s- MSJ/O pp ’n . N e ve rt he le ss, the Court

mus t
ensure that the g overnme nt has disclosed all re asonably seg reg able infor

mation. Id. F ir st, wi th respe ct to the mater ial withheld under Exemption 4, the Court has now order ed that all re quested20

no n- e xemp t in fo rm a tio n b e dis c los e d to Pla int if f; a s su c h, se g re g a

bil ity is n o lo ng e r at is su e wi th respe ct to that materia l. Second, with respe ct to the information withheld under Ex emption 6 — which Plaintiff does not dispute is proper ly exempt — the Court finds that Defenda nts have
su ff ic ie ntl y de mon str a te d th a t th e y

have re le a se d a ll r e a so na bly no n- e xemp t in fo rm a tio n. Ms. Sag er e x plains in her dec laration that the releva nt documents wer e re viewed “ pag e-by -pag e and line-by -line” a

nd that the re dactions we re the n re- revie wed f or ac cura cy . Sag er D ecl. ¶ 8. The Vaughn index attached to Ms. Sag er’ s decla ration fur ther indicates that Def

endants only

reda cted specific ref

ere nces to patient initi als, patient hospital admission dates, names of low-leve l employ ees a

nd other identify

ing inf ormation. SeeTable A . Acc ording ly , the Court finds that Def endants have disclosed a ll reasona bly seg reg able infor

mation. IV . C ON CL USI ON F or the re a so ns se t f

or th a bo ve , D e fe nd ants ’ [1 9] mo tio n f or summa ry jud g me nt i s GR AN TE D- I N- PAR T a s c on c e de d to the e xten t D e fe nd ants a sse rt that in fo rm a tio n w a s p ro pe rl y wi thh e ld p ur su ant t o E xemp tio n 6 . D e fe nd ants ’ [1 9] mo tio n f or summa ry jud g me nt, ho we ve r, is DENI ED -I

N- PAR T a

nd Pla int if f’ s [20 ] cr os s- mot ion

fo r s umm ary

jud g me nt i s G RA

NT ED wi th respe ct to the proprie ty

of De fenda

nts’ withholdings pursua

nt to Ex emption 4. Defe ndants are there fore direc ted to disclose to Plaintiff all information previously reda cted a s confidential
c on sume r i nf

or matio n und e r E xemp tio n 4 . A n a pp ro pr iate Or de r a c c omp anie s th is Memorandum Opinion. Date: Ma rch 9, 2010 /s/ CO LLEEN K OLLA R- K OTEL LY Un i t edS t at es Di s tri ct J u d ge