UNITED STATE S DISTRICT COURT FO R T HE DI ST RI CT OF CO LU MB IA

_____________________________________ ) H E RB E R T T H O M A S , ) ) P l a i n t i f f , )

) v. ) Ci vilAc tio n N o. 08 -08 31 (E SH ) ) D E P A R T M E N T O F H E A L T H A N D ) H U M A N S E R

V I C E S , F O O D A N D ) D R U G A D M I N I S T R

A T I O N , )

) D e f e n d a n t . )

_____________________________________ )
MEMORANDUM OPINION AN D ORDER This matter is before the Court on defendant’s se cond motion for summary judgm ent. Fo r th e re aso ns stated , d ef en dant’ s m oti on

wi ll b e g ranted

in p art , and

de fe nd ant w ill be req

uir ed to supplement its decl aration. FACTU AL BAC KGROUND It i s und isp ute d th at p lai nti ff dir ect ed a re qu est un de r th e F ree do m

of Inf orm ati on Ac t (“FOIA”), 5 U.S.C. § 552, to the Food and Drug Administration ( “FDA”), which, after plaint iff
narro we d th e re qu est , s ou gh t

(1) the name and address of the ba nk where Biocine Scla vo, S.P.A., f/k/a Sclavo, S.P.A. conduct[s] its banking in It aly and the United States ; and (2) . . . t he name and address where Biocine Sc lav o’s , S PAf/k/a

Sc lav o’s , S PAso le Unit ed St ate s D istrib uto r: VOCO, INC ., f/k/[a] SLAV O, INC. 5 M an sar d C ourt W ayne, New Jersey 07470 Fed. I.D. # 13-27712263 SIC # 5129 conduct[s] its bank tr ansactions in the United St ates.- 2 -

De f. ’s M ot. fo r S um

m . J ., Ex . 1 (L ett er f

rom H. Th om as t o F DA , July 23 , 2 00 7) ( “F OI A Request”). Us ingBi oc ine Sc lav o’s nam e an d li cen se n um be r, d ef en dant s ear ch ed

the FD A d ata

ba ses it d eem ed m os t li ke ly t o c ontai n re sp on siv e d oc um ents: the FD A’ s C enter fo r B iol og ic Evaluation and Rese arch’s ( 1) Regulatory M anagement System – B iologics Li censing Application da tabase (a nd its prede cessor dat abase), (2) Docum ent Accountabil ity and Tracki ng System (and its predece ssor databa se), and (3) records and fil es transferr ed to the federal records system. Se e De cl. of

Su san Fr antz- Bo hn

¶¶ 1 , 7 , 8 , 1 0, Fe b. 12 , 2 00 9 (“ Fr antz- Bo hn De cl. ”) (anne xe d to De f. ’s M ot. fo r S um m . J .). Th ese search es r ev eal ed that B ioc ine Sc lav o h ad

be en issued li censes for thir teen biologi cs products, a ll of which were revoked by 1993. Id. ¶ 11 . T his
search als o e sta bli sh ed that in acc ord an ce w iththe Fe de ral Re co rds Ac t, a ll r elated rec ord s h ad been transferr ed to stora ge at a federal records ce nter, id. ¶ 13, and that r ecords rel ating to one license t hat was revoked i n 1979 had since been de stroyed in t he normal course, id. ¶ 14 . In
res po ns e to de fe nd ant’s req ue st f or “ all do cum ents r elatin g to [B ioc ine ] S clavo ,” id. ¶ 13, the fe de ral rec ord s ce nte r f

orw ard ed sixbo xe s co nta ini ng ap pro xim ate ly 1 5, 00 0 p ag es o f d oc um ents, id. ¶ 15. Six FDA em

ployees spenta total of more than 50 hours sea rching the s ix boxes of documents, and all documents were searche d twice by different indi viduals. Id. ¶¶ 15-16. Because some of the docum ents were in I talian, t hey were also se arched speci fically for the Itali an words for bank, bank account, ba nk note, a nd savings bank. Id. ¶ 17 . T he search loc ate d no documents containing the na me and/or address of a bank used by Biocine Sclavo or it s U.S. distri butor. Id. ¶ 18 . O n th is b asi s, de fe nd ant m ov ed a se co nd tim e f or s um m ary jud gm ent.- 3 -

In opposing defendant’ s motion for summary judgm ent, plaint iff raises two issue s relat ing to t he ag en cy ’s s ear ch . F irs t, c iti ng 21 C. F. R. §§ 20 .8 1 and 20 .1 12 as a

uth ori ty, he ass ert s th at a lic en se a pp lic ant is req

uir ed to s ub m it the nam e an d a dd res s o f i ts U .S . b ank, the ve ry inf orm ati on he is s eek ing . P l.’ s O pp ’n ¶ ¶ 4, 6. Ap parentlydo ub tin g th e ad eq ua cyof the FD A’ s review of the recor ds, plainti ff asks this Court to conductan in camera review of the 15,000 pages of documents retrieved from the federal re cords cente r. Id. ¶ 8. In i ts r ep ly, the FD A s tat es that the r egulations plainti ff cites do not support hi s contenti on and that an in camera rev iewis unwarranted. Se e Def.’s Reply at 2-3. Second, pla intiff contends thatthe recor d does not est ab lis h whe the r de fe nd ant se arc he d f or r eco rds rel ate d to the parti cu lar U. S. dis tri butor , VOCO, Inc. Pl.’s Opp’n ¶ 3. In reply, de fendant merely repeats t hat it “di d not find any documents containing the na me and/or address of the bank used by Bioci ne Sclavo or it s U.S. distri butor.” Def.’s Reply at 2. DI SC US SI ON Under Rule 56 of the Federal Rule s of Civil Procedure, a motion for summary judgm ent must be granted if the pleadi ngs and evidence on fil e show that ther e is no genuine i ssue of material fact, and thatthe moving party is enti tled to j udgment as a m atter of law. An de rso n v . Liberty Lobby, Inc ., 47 7 U .S . 2 42 , 2 47 (19 86 ). I n a FO IAsu it, anag en cyis e nti tle d to summ ary judgment once it sati sfies its bur den of dem onstrati ng that no material fact s are in di spute and that ithas conducted a s earch rea sonably calc ulated to unc over all r elevant i nform ation, Wei sb erg v. Dep’t of Just ice, 745 F.2d 1476, 1485 (D.C. Cir. 1984), which eitherhas been rel eased to the requestoror is exempt from disclosure. Stu de nts Ag ain st G en oc idev. De

p’t of S tate, 257 F.3d 82 8, 83 3 (D .C . C ir. 20 01 ). T o c ha lle ng e su cha sh ow ing , th e n on -m ov ing party“m us t se t f ort h- 4 -

sp eci fi c f act s sh ow ingthat th ere is a ge nu ine iss ue fo r tr ial ,” Fe d. R. Ci v. P. 56 (e) , th at w ou ld permit a reasonable jury to find in hi s favor. Laningham v. U.S. Navy, 813 F.2d 1236, 1241 (D.C. Cir. 1987). To show that its s earch was rea sonable, the a gency must dem onstrate that when “viewing the fa cts in t

he lig ht m os t f

av ora ble to t he req ue ste r, . . . [i t] ‘ha s co nd

uc ted a se arc h re aso na

bly cal cu lat ed

to u nc ov er a ll r ele vant d oc um ents. ”’ Steinberg v. Unit ed States Dep’t of Justic e, 23 F.3d 548, 552 (D.C. Cir. 1994) (quoting Weisberg, 745 F.2d at 1485). The agency must show that itused “methods which can be reasonably expected t o produce the i nform ation reque sted.” Oglesby v. Dep't of the Army, 92 0 F .2 d 5 7, 68 (D .C . C ir. 19 90 ); seeals o C am pb ell v. Un ite d Sta tes De p' t of Ju sti ce , 164 F.3d 20, 27 (D.C. Cir. 1998)

. In assessi ng the reasonableness of the search, a cour t is guided by pr inciples of reasonableness
. Oglesby, 920 F.2d at 68. The reasonable ness of a search i s not deter mined by its results , but by the method of the search it self. Weisberg, 745 F.2d at 1485. A search need notbe exhaustive
. Mille r v. U.S. Dep’t of Stat e, 779 F. 2d 13 78 , 1 38 3 (8 th C ir. 19 86 ). “ Th ere is n o re qu ire m ent th at an a ge nc y s ear chev ery rec ord sy ste m .” Oglesby, 920 F.2d at 68. An agency's failure to find a par ticulardocument does not undermine the determination tha t the sear ch was adequate. Wilber v . CIA, 355 F.3d 675, 678 (D .C . C ir. 20 04 ); Nation Magazine, W ashingt on Bureau v. United Stat es Customs Serv., 71 F.3d 885, 892 n.7 (D.C. Cir. 1995). Rather, the stand ard

of rea so na ble ne ss whic h w e ap ply

to a ge nc y s ear chpro ced

ure s . . . req

uir es a search re asonably cal culated t o uncover the soughtmaterials. . . . [T]he [agency] is not req uir ed
. . . to acc ount f

or d oc um ents whic h th e re qu est or h as i n s om e w ayide nti fi ed if it has made a diligent sea rch for those documents in the pl aces in which t hey might be expected to be found . . . .- 5 -

Mille r, 779 F.2d at 1384-85. However, “if the sufficienc y of the agency’s ide ntificati on or retrie va l pr oc ed

ure is g enuin ely

in i ssu e, summ ary

jud gm ent is no t in

ord er. ” Weisberg, 627 F.2d at 370. Th e B ioc ine Sc lav o S ear chan d R ev iew Pl aintif f, rel yin g o n 2 1 C .F .R . § § 2 0. 81 an d 2 0. 11 2, co nte nd s th at B ioc ine Sc lav o w as req uir ed to s ub m it the inf

orm ati on he is s eek ing . P l.’ s O pp ’n ¶ ¶ 4, 6. Gi ve n th at d ef

en dant d id not produce the information sought, plainti ff doubts both the adequacy of the sea rch and the review of the documents that were l ocated. The plai n text of the regul ations on which pl aintiff relies , however, does not re quire a li cense appli cant to submit the name and address of the applicant ’s U.S. bank. Se e 21 C. F. R. §§ 20 .8 1, 20 .1 12 . In fa ct, the cit ed

reg ulatio ns do no t re lat e even remotely to such a r equirement, and the Court i s not aware of any such re quirement. Because plaint iff has not shown there is a ny reason to as sume that the FDA ever had a recor d of the lice nsee’s U.S. bank, he has al so not shown that t here is any ba sis on which to doubtthe thoroughness of defendant’s search of approximately 15,000 pages of docum ents. Consequentl y, pla int if f h as n eithe r id entif

ied a g enuin e is su e o f m ate ria l f act on thi s p oint no r es tab lis he d th at
an in camera rev iewis w arr anted . A s p lai nti ff rai ses no oth er i ssu es w ithres pe ct t o th e se arc h fo r re co rds rel ate d to Bi oc ine Sc lav o, summ ary jud gm ent w ill be grante d w ithres pe ct t o th e f irs t portion of plaint iff’s FOIA request: “(1) the name and address of the bank where Bioci ne Sc lav o, S. P. A. , f

/k/ a S clavo , S .P .A . c on du ct[ s] its bank ing in I tal y and the Un ite d S tat es. ” D ef

.’s Mot. for Summ . J., Ex. 1.- 6 -

Th e V OC O, Inc . S ear ch Pl aintif f a lso ch all en ge s d ef

en dant’ s se arc h b eca

us e it is n ot c lear th at d ef

en dant s ear ch ed its datab ase s f

or r eco rds rel ate d to VO CO , In c. Pl .’s Op p’n ¶ 3. Ind eed , d ef

en dant’ s sw orn statement claims only that i t searche d by using Biocine Scl avo’s name and license number. Fr antz- Bo hn

De cl. ¶ 8. It d oe s n ot c lai m that it search ed fo r do cum ents b y u sin g V OC O, Inc .’s
nam e an d d oe s n ot e xp lai n why , in lig ht o f p lai nti ff

’s F OI A r eq

ue st, a se arc h th at d id n ot u se VO CO Inc .’s nam e as a se arc h te rm wa s n on eth ele ss o ne rea so na bly cal cu lat ed

to u nc ov er a ll rel ev ant in fo rm ati on . N or d oe s d ef en dant’ s re ply

sq uarel y a dd

res s p lai nti ff

’s c ha lle ng e. It merely repeats tha t it “di d not find any documents containing t he name and/or address of the U.S. bank used by Biocine Scl avo or its U.S. dist ributor,” among those docum ents it r etrieve d by using Biocine Scl avo’s name and license number as sear ch terms. Se e De f. ’s R ep ly at 2. It m ay well be the ca se that defendant ’s searc h was reasonable , but defendant has not pr ovided the information necessary to s upport such a det ermination. Accordingly, s umm ary judgment will be de nie d w ith out pr eju dic e as to t he sec on d p art

of pla int if f’ s F OI A r eq

ue st: (2)
. . . th e n am e an d a dd

res s whe re B ioc ine Sc lav o’s , S PAf/k/a Sc lav o’s , S PAso le Unit ed St ate s D istrib uto r: VOCO, INC ., f/k/[a] SLAV O, INC. 5 M an sar d C ourt W ayne, New Jersey 07470 Fed. I.D. # 13-27712263 SIC # 5129 conduct[s] its bank tr ansactions in the United St ates. De f. ’s M ot. fo r S um

m . J ., Ex . 1 . D ef

en dant w ill be req

uir ed to s up ple m ent it s d ecl aratio n w ith respect t o the reasonableness of its s earch for this information.- 7 - CONCLUS ION AND ORDE R For the reas ons stated, i t is here by ORDERED that de fe nd ant’s m oti on fo r sum m ary jud gm ent [ #2 2] is GR

AN TE D I N PART and DENIED WITHOUT PREJUD ICE IN PAR T . It is g ranted

wi th r esp ect

to pla int if f’ s re qu est

fo r in fo rm ati on

rel ati ng to B ioc ine Sc lav o, an d it is d en ied as t o p lai nti ff

’s req ue st f or i nf orm ati on rel ati ng to V OC O, Inc . It is FURTHER

ORDERED that on

or b ef ore Au gu st 2 7, 20 09 , d ef

en dant s ha ll f

ile a
su pp lem ent to its de clarat ion expla ini ng why it s se arc h u sin g o nly the Bi oc ine Sc lav o f

irm ’s name and license number was reasonably cal culated t o uncover all relevantinformation req ue ste d in the sec on d p art

of pla int if f’ s F OI A r eq

ue st. If pla int if f h as anyfu

rth er o bje cti on

to defendant’s supple ment, he m ust file his oppos ition on or be fore September 15, 2009.

/s/ ELLEN SEG AL HUV ELLE United States DistrictJudge Date: August 11, 2009