FlLED - aboutlawsuits-wpengine.netdna-ssl.com · 6/21/2012 · I FlLED Electrcnically oÇ26-2012t12¡05:40 PM Joey Ordqna Hâslings Clefiof lhE Cor,¡rt Transadion# æ14ÆB1 I 2

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FlLEDElectrcnically

oÇ26-2012t12¡05:40 PMJoey Ordqna Hâslings

Clefiof lhE Cor,¡rtTransadion# æ14ÆB1

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vaíPetÊr C. \Vclhenll Eeq., l.IV Bar * +414Lirrdsay Eabu Esq., l.fv Bar ë l2l&U'HITE & WETIIERALL, L,[.F9345 W. St¡nsaRoa4 Sæ. 100Ias Vcgac,NV 89t48Teh ?02-83&8500Fax:7.02-837-5081Attoneysþr PIùryI

KEVIN PIilI,LIP$ an indivÍdual

Plqtntifl[vs.

IN THE SECOND JI'DISIAL DISTRICT COT'RT OF lgE STATE OFNEYADA

IN A¡ID FORTEE COI'NTY OF WASHOE

C¡soNo. CVt24t li3

IleptNo. t0

C.R- BARD,INC., nfrreþ corporatio4BARD PERIPIIERAL VASCIII-AR" INC. ¡¡.{rizmacorpontioqsnd DOES I throueh t00inchrslve,

fufenfunts.

COMPLAITTT

Plaitú¡f KEYIN PHILLPS, by¡odthougþbirundersignedattomcys, hecebysrodefe¡ril¡nn

C.F' BARD, IÌ.!C.: BARD PERIPHERAL V,¡{SCULAR,INC.; qrd DOES I through lü} (colleaivol¡

thc "Defcod¿r¡ts') and atlege as follorpr:

PARTIES

Pt¡lnttff

l. P¡ahdf Kcvln Philllps at ell tÍmæ ælcu¿nt b this acdm rcsided in ¡nd oonti¡rro¡ to

¡oside in RÊûo, Netfi¡dâ. On August 4, 2005, PlaiDtiffwrdavemtpl¡cc¡ncnrt of e Rccovcr¡@ Filt¿r, Thc

RÊcoltsfy(D Filûer nfuequemly failed and nigratcd b PlahtüPs rlgbt mium corsing lifc türedÊû¡ng

OOMN-AINT FIOR DA¡vÍAGES

Case 3:12-cv-00344-RCJ-WGC Document 1-1 Filed 06/21/12 Page 4 of 27

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injury md damago. Plainífrrras cfl¡ged !o utdergo eiclensÌve mediccl hoarÞent md carc, íncluding

cûËrg€ncl' ope' etqgeqy on April 30, 2010. Plåint¡ffhâs q¡trcred urd will conthuc b s¡ffu signific¿¡t

medloal orpeoses, pa¡n md strerlng loss of e4io¡'rncot of lifq disab¡¡ity, and otbcr losses. Pl¡intitr

will rcquirc mgoing mpdical cs¡e to monitq the frsch¡t€d stmùs in Plaùrtifs bodyto cnsnrrc thatthøy

do not csr¡so ñ¡nug iniury.

2. Pl¡intiffr+æc¡usêdto rmdcrgo cmsrgensyopc¡nheattsurgerya¡¡d ortensivem€diaal

ss ¡r¡$tltof tho failr¡reoflbcRæovor¡@Fillerm¡nt¡f¡sh¡¡€ilbyDe.ftndarts, Plsindtrhss nffcßcd ¡rd

will conrinuo to n¡ftr sigtiñca¡t medical qpasos¡ ortrcme pain and suftring, loss of enjo¡nelrt oflifq disdbility, aod othcr losses.

Ilefc¡rd¡ub

3. Defeudant C.R. Bü4 Ino, CBilìd") is a corrpor*ion duly organlzod and ørising rrndcn

tho larvs of tho st¡tc of Dclarvurc ¡Dd hås iC pincipal placc fn Ncw Jerscy. Ba¡d at all times reler¡¡nt t¡o

this ætion, desÍgncd, set spccifications, manufaohr€d, prcpared, compounded, asses¡bled, ¡¡occsssq

mukctd dirtibutd andsoldtbÊRecovcry@F'rlH Systcmand G2@Filter S¡ntc,rnto be implantedln

palicots fbrurglout ûË U¡itêd StatEC inoluding Nevada.

4. DcfudaúBa¡d P€rþh€t€l Vasoular,Ino. C'BPI/) is a uúolly onncd $¡bs¡d¡¡rrt

oorporalion ofdændmt Bm4 with its pÍncipal place of buslness st 1625 qtest 3nt Smet, Tcurpo,

fuízoü- BPV at'¡ll times rpler¡mt to ihis et¡ori, d€s¡grroq sor opeciEcatiom, manufuoü¡rcd, ptqrccd,

compoundd assablod,proæd mukciddÍsEibr¡tc4and soldtbcRccoveryrDFiltcrSystc,m und

thc Gj¿OFilterqrrcmto bcimplamcd inpmicmtsthrorrgþorttlrcUnitod Sraæq hotr¡dingNcvadÀ

5. All rcfeceoces to'Dcfcndmtf'hpreaftcrshÂll ¡efcc b defcnd¡flts Baü{ BPrt/, ¡od DOES

I ùroryh 100.

6, Tho tue nanes, iderilirieç or copaoities, wbcther indivldual, associrþ corporatc or

sthcruiso of dcfeodang, DOES 1 thlough 100, inch¡sivÊ, arcrmhown to plainríffwho,lhc¡eforp, suês

oaüd dofc¡¡d¡nlsþ such fictltiotts nars¡. Wbcn ths huo nameg tdentltie¡ or c¡pacidc¡ of c¿ld

ñctítiouslydesignatod deftodants a¡c asccttalno4 plaintitrwÍll ae¿k learæ of Co¡¡¡r to a¡nÐd th¡s

coupls¡r¡t b i¡scrt lbo Èr¡e nmroq ldcotitÍcr, ard/or copecirles of DOB Deftndar¡ts, iogp{h€f wüh ûc

Fopcc úargí¡g allegalions 'g¡inct ssid DÔB Defi¡rda¡ts.

COMPI.AINT FIOR DAMAGES


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7. Plaintifris infonned urd belicrcs, md thcreon alleges thd caeh ofthe defcndants sucd

hcreln æ eDOEdefødast is rcsponsíble in some manær forlhê ads, ønís.s¡sns, aud conducq which

prcxímacly rcs¡ttd in and/or was ¡ sr¡betantíal cotrÍhdqg ftctor in Plaintitrr lqjruies,

.IIrRlSpÍ;FoN ÁNp vEr{r)lE

8. Plahlitrbss suffctcd damages in ¿o amounttbat øsæeds the jruisdictional rnìpirnwn

9. Vcnr¡o ir poper ín thíc Cot¡rt, as the facts and círu¡mstaûc6 l¡¡ding to lnjurice oocr¡ræd

in the cou¡rty of It/ashoq Nevada

GENERAL FACTUAL ALI.EGATIONg

10. Plaintfffbrin$th¡s case fo¡ ætiospersoml injruies Plaintitrs¡ftrcdssrcsultofa

srrgically implmted medical derricc, horpn s a Recovery@ Pitler S¡'súem (hccaffer lRccovery

Filtcf), f¿iling and mlgrafing within Plaintifs body and cu¡siug roriorx and ongoing Dh]rstcâ!,

m¡otio¡ral, srd eoonomio damagcs

ll. ThcRccoveryOFlltermsderignÞ4msrlr&cü¡red,preparcd,,assrbled,

prooessed, labete4 mulcets4 dishib,utÊd, anrl ¡old by Defendants Êom appmxiæately April 2003

lbot¡gh Augps æ05 for rhc pæ'vottion of blood clots (thrombi) from bavolling Éom thc lowcr portione

ofthe body to the heart and hrngs.

t2. hior to Plaíntitrbcing i¡nflEntad wiü ; RpcoverJr{Ð Filter tn earty 2005, Defeutla¡t

lilfty sDd should h¡vohown lbat thc dcvicowas defectþe and unreasuubly fu,ìnter olia,

tbofollowing ¡EBEons:

a- Dof¿odsds ñileal to conduct any clinîcel bcting n¡ch as ânimal sh¡dics, !o daffiminc

howlhodsrdoc wo¡rld frmctio¡ onoepe¡mrncntty implautod i,nthelnrmanborly.

, b. DefendanE kneìy md/or should b¿vc horur thal tbe Reoorrer¡û Fi¡&r had h¡gh rafê

Êtcúrc, mierdoq üd errcæivÊ tittiûg rud petforatiö¡ thp vcn¿ cav¡ wull once Ímplanbd inthc

hr¡nm body. Dcfcod¡¡ts lcrw and/or should have hortm lhat ilch failurcs cÐrposËd pa¡icots to srríoug

lqiudôs, itrgh¡d¡Dg deaür; he¡uouù¡ge; cudfadpcticardht tssÐonade c¡¡diåc ârrhyrbiôüdoûhÊs

sl¡trtptom¡ eimilartom¡ocâ¡d¡al Írffim¡ sÊ\'ert and perdscot¡abq perforuimr of dssuc, ycssçb a¡d

org¡ns; and ùubilityto rcmovethcdstticc. Uponinfønatîon ândboti{, Dcfcnda¡ts aþohegor

shuld h¡vc ltnortl tb¡t ccrrain condido¡ or postlmplurt poccdrrres, suctr as mcbid oberdty or opel

CPMPI¡IINT FOR DAlyf¡{OES


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abdominat proccdurrs, could afrest ttro safsty and futeg¡ity ofthe device. Fffier, Defdant¡ kncut or

¡hould h¿vE knom that these risks for Recove'r¡l0 Filter wûrË ad'sc st¡bstsntiaily higlrer thnr other

similardwices.

c. Furthr, Dsfmdets ktrËw and/or should havc ltnorr¡ tùrt fhÊ RÊcolrcfJrto filhr conlai¡ed

corrditions, whiolr Dcfendaat¡ rfd not inten{ which rcsuhcd in ths dcvicc aot pcrformfurg æ nfely rnd

the ordlnary consumer wot¡ld cxpcct

d. Dæpitebeing *warooflbæerisks,Defendantsnime¡r,escnûed, smiüed, rnd/orfüledto

poúde adeqtratc wunfutg¡ of these risks or insuuctiou¡ for safe use.

e. Evco wbc,n Defendans deslgned urd bcgror mrlscting wbat thsy aUegÊd to bc s dcldoo '

ü!t spccifcally roduced thesc rislß, lhÊy slíll È¡led to ís$¡Þ s recdl or noti$ po¡nmers tb¡t ¡ safEr

dcvioc was avetl¡blc.

À INFERIOR\MNA CAYA FILTDRS CENERALLY

13. Infedor vonn cava (fr/C') 6ltem fi¡st c¡i¡ne ou to th medical uarkst ¡n the 1960's OvÊr

the yeas, medical devlce m¡nr¡&ctr¡rcrs harn i¡troduccd scy€ral diffarc¡rt dosigns of IVC filtrs.

14. An IVC filtêr is a devico tbat is deslgned lo fflter or *c¿tch" blood olots (cûllcd

'$¡ombi) th¡tmvol ûor¡ tho lowcrpodíoru of theborty to thc hcrt rnil luogs. IVC üttcrsnry br

desigrred fo be implnted, cilher permnnently or leurpmuitn ín the hl¡man body, morc rpcc¡floa{y,

withln lhs lîf€rim Ycnâ cavÐ

15. Thc lderlor vto¡ oava is a win tb¡t rctums blood to the h€æt from tho lowor portions of

thc tody. ID ccrts¡n pooplE for vríous æasons, th¡ombi tavcl ûom thÊ vessels inttc le$ üd pehi$

thrcugh the r¡er¡¿ carn and i¡to tbo lungs. Oflcn tincs, thæe thombi dorelop ln tbe deep leg velns

Thecc thnombi ¡¡e called 'deç vein thrcmbods' or *DVT'. Onco tb¡onbi ¡oaoh ths lu¡gp, th€ü ilsmruidered þilrnonary Grrtbolio or TE . Pulmonary crnboli pûcrêntrisks þ Ìnurrühcalth Thcy caD,

mil oûendo, ¡ccr¡ltin d€ath,

I 6. Cêßt¡i¡ peoplc are at incrcasod risk fc the dsrrclopmart of DYT or PE. For inshûcc,

so¡rmncrrybo uodøgoæ læ orhlp jolnt nplacomeut st¡rg€r)t b sttlsk for da'cloplbg pVfæn. OUcee

patiepts a¡s BIso d i¡croa¡ed risk f6 DVT/PF- So bo arc pooplc who hnle vasular di¡e¡¡es or rryùom

çOMPI,AINT FOR DAIIAOES


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bare arpcrieuccd pnevíors shokes. A nrunbe¡ of other conditions ¡EÊdisposc people to dweþ DVTÆE

includlng'cooguloprthies' md clouing diso¡dors

17. Thoscpeoploat ri*forDVT/PEcarrrrndcrìgonedical ücahørtto managcthc ridsFor

c*amplc. r domc may prescríbc medic*ions liko Hcporinn Warfârirl or lovcoox to rcgutatc thc cloting

facbr of the blood. In sonre pcoplo who e¡c ât b¡gh rid< for DVTPE, or who cmnot nar¡agp their

oo¡dilione wlth mcdicatio¡g ph¡rsiciars rnay rccommcnd $rg¡caüy implantÛrg an ÍVC fiIb to prwcnt

ttromboembolitic crycnts.

t 8. A.s rilcd aborre, wC Ëttcrs har,ç boeo ,on

the market frr decades. The ffrst IVC ûltcrs

rn¡rkeÈrt wsrc pcrmanent filtcr* Thcsc dcpiccs wc¡p designod to bc l€fr ín a patícml's IVC pc,unanently

a¡dhaw tooglàrm follow-up data(of rrpæ20ycan rnd longer) flrpportingthêiruscand cfficacy.

Begftming in 2000, mar¡uf¡clu¡ers aleo began markc{iug uhat re knov,n as optional or ¡ctiwable

filars. Thesc ñlters uo dedgncd so tl¡at they car be surglcally removcd ftom a paticnt aier the r¡sk of

PB hß subsided. These IVC filtcr designs, howcvcr, wee not Í¡¡tcndcd to ¡to¡inwirhÍn thd i¡fumsn bod)

for h&ftmin¡re periods of tlme. In other words, the inftial dcsígns of ¡ctiã/Dblc IVC filtc,t¡ werc

inradedtoft,rnâin inpl"ffid forefinileperiodoftima Thc Rcoovcry0 Filtrr $yrerr ¡nd lhc

subse4uørtG2tÞ Filtermmhcn¡rcdbyBard and BPVare oramplesofretrlcv¡blc filtcrs"

B. THERECO\IERYFILIER@

t FDA Clcrnnce rnd Inûendcd U¡e

19. In 2002, Bard and BPV stùmiücd ¿ notification of inænt to the FDA to ma¡ket tbe

"RocovoÍ¡0 Fitttr Sy$ftm'(tnrctfter"ncoovtry0n or"Rccovtr¡0 FilH? for lhcp'ruvcntion of

rconr,eot pulmonay smbolls¡n.by placemeut ln tlrc infcdor vcna cæa.t OuNolsntcr nrzltz,úÉ,

FDA clca¡d thc Rcoovø¡0 Filtff fur må¡kc*lDg urd usc in tbc prwcntio'n of rccurrent prlmonar¡r

t Bmd md BP\r lubmÍüod thc notífication under Scctlon 510(k) qf thË U¡ltêd Sats Food, Drue ¡ndCornrstis ¡{ctfiA,cf) of 1976.fLl U,S,C. 321a seql Tho 510(k} revÍewproccss rcquircs rny cntityc¡rgpgpd iu tbs dee¡gn, måfiìtrâsb¡nc, di¡üibution or naúcting of ¡ devioe lnteoded fot bu¡n¡n uss ooonry ræ fUe 90 days before it intends to ma¡kct lhe devlce od to caisblish lb¡t lho dsvice issubsh¡t¡åily equivulcntto alegnltymadctotlprçdic&detdcc, 8l CF.R- g$ 807.8t,807.92(a)Q)).Substmtiat equìvulencs m¡anc th¡ttlro ngw dcvicè hås thc ¡roc inúcndcd us andtcc.htologicalaù¡nctcrigtics ar thopredicatc dwioc, This cppmvat procesc allowr amanufacürcrb b¡pass thcrlgorous safety ctrtdry rûqtúrcd þ the prc.mukot ry'rwal p.ooc.ss.

g)ÛPI.ADTT FORDAÑIAOES


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srnbolíffi vir pcrmamnt phceme¡¡t in thc vena car¿ h tho foilowing sit¡¡aioos: (a) pttlmonry

th,ombocmbolísmuùeoarrtlcoagulantsucconüaindlcde{ (b) Ëltt¡rË of anticoagular[ùcrapy fot

ttromboembolic dieeasq (c) cmcqgoncy hcatmcd fo[ov',Íng massivc puhnonar¡r embolism u,hãa

rntiiipatø Uencüts ofconvmtbnal therapy arc rcducod; æd (d) chronic, rccnurcntpulmonty embolist¡

wbcre anticoagulåDt tb€rryy b¡s frilcd or is contralridlcded"

20, In A¡nit 2003, Bard and BPV submicod a $cstion 510(Ð pncnadaû notificadon offrrtcnt

to ¡na¡lrct the R€cov€ry@ F¡lt€r &r lbÊ additionat inænded use of opllorul reffievøL The FDA clea¡cd

this additional intcodcd use on luly 25r 2003.

21. Bnded BPV bcgru actrnllymarkctingthpdcvicc in Apr¡l2003,butdidnotbcginñrll

m¡rlrot mlease urtil 2004. Bad üd ÐPV være auue thc thc Rcævery@ Ettcr uns also r¡scd

e)ßtËilsivÊtl' off-lsþ|, including for purcly prophylacdû reasoEr for üauma patiens or patieols witb

rçcoming rurgedes suc;h as bariaric proccduru.

it TVh¡t I¡ It ¡nd Hm'I¡ It Urcd

22. Thc Rccovcry@ Filtcr ao¡¡íds of two (2) lercls of sìx (O radially dÍstrihüed NIÎINOL

struts thf ro dcsígncd to snchor thc f,tËr hio thÊ inûrior vcn¡ cav¿ and to cabh any ccrbolidng

olots. TbErE a¡c cix short stn¡t+ trrbioh oe oonmonlyrc$ræd to as ûs arm+ end six loog str¡ts, whicù

are oomnonly reftrred to as thc hgs, E¿ch *ut ts hdd togetltr by a si4lo ooncction to a oap locatcd

at tte ùop ofthE devíca Accordürg ùo th Pdstrt ñled ftr thls devlco, the short struts arc p,tlnuily for

'ocnuingf or 'þositionlng' withln tbe vcna c¡rq and tho long strls with ctachcd boolcs ue dcsigncd

to pinadly prwcnt the dwicc fiom mig¡Uing in rcsporuo io 'Irormat rccpirAorf mgv€meilt' or

'þuLnonlqy ernbolisn,-

23. As noted abov€, the Recowrl¡Þ Fllter ls coosür¡GlÉd \rth NIllNOt whicrh ie rn

acru¡m rbat rta¡¡de forMcl¡cl Titanit¡nrNaval ùd¡¡¡æo l¡boruory. MTINOL posrrssos "dr¡pe

mcmory.'lhat is, MTINOL will chmge shapc accotdi¡gto cåangee intcmporature, arid ftcnr, rËtshèitÁ

prÍorsbryo aftcr reûrnhrg to ¡ls ¡,D¡tial hmpçmtüa Whoplaoed ín salfuo,ÎhçrËfrrc, tbËNITNOt

strr¡ts bçûonssoÊ ond caD b€ rtnightcncd o allowdeliræry th¡ough ¡ m¡nll diø¡ct!ßc,athstcr, Tte

mctal skr¡t¡lbco ¡c¡sstn¡ôthcdrulginsl sh¡pÊûùmrvümËd tobdytcmpffsù¡¡G i¡tbcvcn¿c¡v¡.

coMPIrt¡lIT DIOR DAMAOBI


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24. Tho Recovor¡@ fificr is itrsütÊd by a cathctor that ¡s gurdd Uy r plgtsiciar througþ a

blood vessol hb tlie lnfcrior vcoa cava. Tba Recovcr:r@ Filter is dæignod to bo ¡ctia'ed in a similr

fashior'

ffi InhoreutRlsb of tboRccovery@ Flltcr

25. The ReaoverytD Filtcr ls prrolrc to an r¡ueasonahly Hgh dsk of faihuç and patimt njuy

following placeurelrt in thc hr¡mm body. Multþle surðos hwc nportod Bard'e Recovtr¡¡@ Fihôr tô

haw a ftasnrs ¡nd mlgntloa rae raoging fmm 2lYeb SlJo/o. \Vbeo sudr failrnec occur, ¡b¡¡ds ofibe

devioeq thË enfÍrcdevice mn Èn'cl to the bcart, wh¡r'e itcsncaueo cadiac hmpooade, perfordion of

thc ahi¡l *rll, myocardial infarctbn and dsatb- Thæc ftacu¡rod ¡berds may also bæome bo errbedded

iu lissuc or mignts to locations, suÊh Ês the lungq enroh rhat thoy arc too daugcrous to rrsrova Thcso

paüents ru orpoæd to a life{ns of ñ¡h¡¡e risk

26 Ttc Rccorcrr0 Filtct similady posce a high rist of tiltirg and perfcatÍng thc veoa cerra

watls. When such åitt¡¡s$ ocorr, thc dwico cur ptrbrafo tho dr¡odtnr¡u¡, sû¡åll bolrcL r¡re{er, rryh¡ch

lcrd to rcilropÊEitoneal hemalornas, srn¡ll-bowel obcht¡.dond! o<ærtded periods of scvecu pairg anrd/or

death" Furthcß, givcn thp tisks of íniury in úcnptirry to remow dcviccs lhåt have pcrfo¡ated thc v€nâ

cavg tho dev¡cÞ m¿y bG i¡rs¡nov¡blc, Tlcsa pciørts ms frpcd wl*r a lÍÈtima of ñ¡tr¡rô ¡islr

27. The Rccovory Filte¡ f¡ilr¡¡ts dcsoribod abovo öccrr d r subshfüally higber ñte thnn

with othcrlVC filtors.

. 28. Tho adr¡crsc event rqrorh (AERs) ¡¡socided wlù fVC fiItrr dcúce¡ dcmo¡rtntog thd

Bard's fVC Fittcrs uc f¿r qpp ponp o Cwiæ ñílurs_.tbcn¿¡s othcr sim¡lq qyç*29, Ibese f¡ílu¡es æ aüribüt¡blc,inpa+ tothc fsctth!ûthoRecoveqñFlltcrrvædoclgned

so as to bo rm¡blc ûo w¡thst¡rd the normal a¡a¡o¡nicsl and phySologicat loading c,yclcc'c*crted íz yfvo.

30. In addido¡t æ dËigp dcftcts, tüc RÈcovctf0 File sofrGrs ftom rnanufaúdng dsferts.

Tbeec mmuÈcouing defecæ i¡rchde, brut a¡s ibttì¡Dittd to, thce*isteoce of'dnnu unrkings'and

ci¡sr¡mfrr€oti¡l grindÎlg Dårkinp ou lhe e¡üG¡ior ofthc sr¡¡face oftbc devloa lihcp,rosence ofthÊsê

dmrna*hgsmd/or cítumfcrcutÌ¡I grlndh¡gEârkin$ frutheroompronisc¡lbc rtrusturat ¡ntegrity of

lhÊ dçt icÊ ü,üilþ b, vtyo.ID püdculâr, thc Rccovcry F.rltra ie proao to ftil al or ncar üe locsti,on of dnrp

marlfngr/cirururf,eæntial grtndíqg Erkingson lho ¡Euts of 6c dwica. Putalmply, ûe Rccovcry Filk

COMPI,ATNT FOR. Dâ}.ÍA(BS


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is notof srficicr¡t stenglb tD wilhsfônd m¡md phcaacntuilhb tho hunanbody, The pastucc of thc

afsrcmerrtioned erdÊrior mfi¡uñcû¡dng dcftcts ¡¡¡&cs thc rlwícc morc susceptiblc to f¡llr¡e.

. tv. lüh¡t B¡rd and BPV Knsw or Should Ewo l(nown

31. Batd and BPV kneyr that[o al¡nicsl testlng rucih as mimal rtudíes, wa¡ conduded to

dstçnn¡ne $hÊûbcr lhe Recovcqp Filtcr would pcrform safely onoo irnplantcd in the bumar body and

objcctcd to norm¡l Jn vivo sttsscE

32, Som afterihe Rccover¡¡l0 Filtcr'¡ inf¡oducfion ûo thc ¡n¡¡tet in 2003, Bard ¡nd BPV

begnn recciving large nùmbrsofadvqsc etrcnt ro"orls (AERg") fiom health we p'rovidersrcpodng

thât tbo Rocovery@Filter ws ùacûut¡g or nigrating post implan¡adon ad tbst Ê¡ctr¡cd pieccs urüor

ihe entirc dwlce wGrE mig¡ating tb¡ougbout the hunm bodS hcluding ûo lbe hært and lungr, Bård Ðd

BPV also rcodvod large numbem'of AERI tqorting thar úrc Rccorrcry@ Filtcr was ftr¡¡d to havc

exccssiræly tilted ard/or pcrforated úË inferi(,r vena crva poet-iurplanhtion. Tbese frih¡¡cs werç often

assoclatcd wltlr rrports of scverc pafent þiruier sush as:

a- deatb

b. hanorrhage;

c" carUhøþicadlal tamponadc(prssur€ causcdþ acollcctionofbloodinthe¿¡eaarotudthÊ heârth

d. c¡diac snhythmi¡ a¡d otùø s¡mpbms sim¡lrto myocudial inñrgtion;

c. severoudporsi¡tc,utpaín;

f, and perfontions of tísmr, wsssl¡ andorgaus..

??. W¡thÍnûÊf¡stlæ¡rof Â¡ll mrlcet¡etesseofthoRscorrr,rl¡@ Filt€r,BEdüdBPV

æaeived d leact 32 ABRs reporlÍng that thc RecowrylD Ftltcr håd üactned ln v/yo ard at leôs, 22 ABß¡

rcpordng tbattheeoti¡t d¡rviccb¡dmieralÞd tnvlvo. Ofûo22rqodedmigradør SIh¡æs,atleutn¡nÊ

(9) uprc rcporæd to havc b'csa sssociA¡d with patient deàth.

34. From 2003 fuough SGpÉBbr 2005, Bârd and BPV ¡eoeir¡ed cver growing nr¡nhcn of

AER¡ ttpøt¡ng thc abovo dcscribd ftilurus and paticnt injuios. Dcftndants loem or shouldbrve

known th¿t tha Èilrro ratss assooiatÉd u'lth thg BËoovrrJÐ Filter werc srùdantldly blglror than othcr

similr products on ths rrûd¡eú,

y, M¡rhot T9llhdrer¡|, butno Roc¡Il

@MPI/UIII FORDAMAGES


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15. ür lû!0 2004 or early 2005 Brd aod BPV, wÍthot¡t nodfying cæsmtne of tha dosip and

manufagh¡ring flars¡ irùaeni in ihe Rccovtr¡O Filûer, begm redesÍgn¡ng ihc Recovcr¡ÍÐ F¡lter in at

atteurpl lo con€ct those llawe. Tho redesigned filter is known ag the @O Filtef, wbich slandE for

s€cüd gencration Rccotrery@ Filter. Oncc Ba¡da¡¡d BPV b¡rl obt¡tned EDA clearanco t0 DsûÊû the

rodcsipred produci in or a¡ound tugust 2005, Bard and BPV qu¡aty stomed nå¡kÊüry tlo RÊcov€rJ@

Filtcc- Bsdand BPV ftileaL however,to mekemy efroÉto notí$consrrme¡s ofthe úsklnherentinthc

rrsc of the Rcoovcry@ Filter.

C. TffE C¿@ilLTERSYSTEÞI

36. On August 10, 2005, Ba¡d and BPV s¡bnitæd a Sesdon 510ft) prcmarkct nptiËcúlon of

intent to ma¡kct tic G2O Filwr for üæ ptwenlion of ¡ecurcnt pulnonsry embolism vi¿ placarrørt in thc

ínfcdor vcna cava Ba¡il a¡d BI / citËd the Rccovcry@ Filter as tho snbsarrdally cquivalem pedicatc

derticÊ, Bard ¡nd BPV tEtçd tbât thË difrercncas ber$Þôn tho ltecovcr¡@ Piltcr a¡rd the CÏ2tÐ Filteq were

primarily dimcnsional srd nri riateriat ctangee or ¡dditiimal oomponemts vrcrc addêd. On August 29,

2005, the EDA cleued the Recovery@ Fìlftr fot tbc sâmc ini*¿ø ,n r as the Rccover¡p Flltcr, arcept

thd it rms not glê¡rpd fø rctin able r¡¡o.1

37. Baratând BPV mrftad tbG2ÐFítteræhaving'ahancod franñrrcrcaistauccrË

"inrproved oenæring" 8ud Tncreasod m¡g¡ttÍqr resislaDcc." Hor¡'svrr, Bard aod BPV agdn ålled to

cofldt¡o| adoquate clinÍcal tesling $¡ch a$ fldmål sudicg b cns¡eth* thc devicp mr¡td perforrr aafely

andefectivoly onco implanted in the.hr¡m¡¡ body and subjentod Inylwst€ssÊs- Not zurpridngty, the

O2@ Filter's dcsígn carses lt to bc of í¡rsffcicnt br@ty md strongthto wilhrand ¡onn¡l invtw

body shesscswithìnthc hwnan body ¡o as to resîst Aaú¡r¡ng nlgating tilting and/orpcforaling tbo

i¡¡fcriø vena cava

38. Also, likc its pædcccssor, ln addiüonio design defccb, thÊ G2@ Filær suffeæ fro¡n

mmufaoturíng dcfcúts. Thess manrfartuing doÊctr lnclude, brn. ro not limitcd b, tt¡ cn<istmcs of

"draw m¡rldngr'md oÍrctmfercnti¡l gdnd¡ng markhgs onüêodÊ.ior oftha sruhcc ofûe dwica The

pcscncoof thcse draw marlingr and/or eirtulnfeteûdal glndingmarlingr ñutbcr conpronisË ttq

ltlo IiDA did¡otdcrðp@O Filtcrbbcured$ r¡ef|owbtr ûlcrr¡utl lmr¡y 151200¡.

COMPI¡ì¡NT BOR D/iMAGES


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sütrytrüat integdty of thc G2tÞ Filtør whil c h vtw.In pfldcuttr, the O2@ Filær is prono lo fall at or nca¡

the locrtion of d¡aw mukingdcircr¡mfc¡cotial griDding nrkinç on lhe sl¡uts of tbc dsvica Prú sinplS

thc G2lþ Fütçr is not òf s¡ffisicnr $rcngth !o *irhdand nornsl plåcË,üÊnt wltbln the hr¡mn body. thc

prtscoce of tba aforcrnentioned orterior marlrfacluring dÊfrûÎs rnakÊs the de¡vicc morc nrsccplfblo to

frdgucfhilure.

39. Thrs, rhe G2O Filtr shÆca similu dcfoots ûd hÊrlth dskr as iu predicato devicc,

40, As with tbe Recover¡¡@F¡lter, Bed and BPV inmedlaÞlybcgatr rec¿iyinglargo

muobcrs of AERsrrpo¡Ëng tt¡t lbè 02lo Flltswas, Inter øIlø,fiaoturing migrating, arceerívcþ filting

and perforating rho vcna carn once Implmtcd. TbesE faihres wrp again of,cn assodabd wíth tpotls of

serrcre paticnt inluics such as:

t dcattç

b. hqnonh¡ge;

c, ccdiacþericadlal tarnponade (¡æs*ure çhisod by a collcstion of blood in tbsatra ¡rou¡d tbc beart);

d" csúdiap q¡ilùylbrota o¡d othcr eymplome eimil¡r to rnyocordial infarclioni

o. ssveneandpocistantpin;

f, and ierforalíons oftis¡r¡c, ycssols &d organs.

41. Def,ø¡dants rÊprasent thc ñac'h¡¡e ratc of thc CiÍltÐ F¡F to ba l.Wo. Buscd upon a Ëriiru'

of the daa arrailablo in ùo public domain (including tl¡ö FDA MAIJDB dâfÂbå$ stadslics and tb¿

prrbtished medioal li!üatu¡Ë), lliii replosurtation dWs nd açs¡¡¡tcly ref,oot tbs tue lncidtnos of dwioe

ËacrureforûeG20filt r,

42, A rwiav of the lvlAUDE dâhbasç frm lhe years 200+2ß08 rweals daû¡ to esbblish thsl

the Büd and B,FV's wn¡ cavn ñttcrs (lnctuallng lhc GZ(D Filær) do rcsponrÍblo fc tbo nqio¡ig of all

reported advcnrE cvE¡F rçlatcd b inftriu vom c¡\¡t fillas,

D. BARI' ÅTTD BP\PS KNOWLEI'GE OF Tru ruSK OF FAILT'NE illDRESIILTINCDAI{GENS

43. Upon infruusdor md bsl¡d, Pla¡ndtr¡l¡cge* rhrt rs cuty as 20f13, Bcd and BPlr rucre

ælucandh¡d lcnowtcdge of thc frsttbtltlrc Rrcovu¡t@Flltcrwa¡deftadvpmdu¡co¡onabty

dangemrs and was caxùng lq¡ury md dcalhlo padents wbo h¡¡l ¡eccivcd Ìr Sidldn Bfl¡d a¡d BPV

, OOI{PLAINTFORDÁMAOBS


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wgrs Ewrtc rs culy as 2005 td thc G2@ F¡ltÊr SystÊm w¡s defective a¡d urressoDably dangerous md

was carulnginJury anil dcalh to palicute uho had rccciwd it"

M, DatB cståbl¡shcs ttat ths faitr¡rc ratos of ùe Rncovcr¡r@ Pllær a¡rd G2@ Filtcr refutrc

cxøedingly higbcn tban rhe ¡atc thal Bard and BPV haræ ín thc past, and cuncotly conünuo !o pttblish

tho mcdicel con¡nr¡ntty, membecs of tho pubtic. Fluthct, Burd md BPV ìvett awarÞ ot should b¿vc

boc¡r aur¡,e th¡t &e Rccovcry@ Flltef Dd GzO Filt¡f hlr ô suU¡tantir¡tty hþbcr failure rdcs than do

othcrsirnilar poûrots on ùc markeil, yet Defeorlauls h¡ve faíled ûo wrn con$rmtrs sf thl¡ fact

45. Upon hformatiør and beliet ftom the lime thc G2@ FiItæ Systeur becanc atrailablc on

tbc r6ket,tho Dcftod¡¡s Bo¡d and BPVcr¡rbu*ed onænggrcsslve cmpaig¡ cf "offl¡bel

ouræcning t¡rc G2O Filtct Syctcnr- ThÍs Includd rÊDrcssnlatioos made to physici¡ns, heåIthctrc

profcsuionals, rnd olher membtrs of ihe medical corrmuity ihat rhe G2@ Filtc¡ Sysærn was ¡afc and

affestive fo¡ rctictablc uso prlor O tlre FDA approving ths G2O Filtor Sysûan fur rcnievable usc.

46. Tte conû¡stof Br¡d md BPV as elleged in this C.ornplaintconlih¡þs wiltñ¡l, wanton,

goss, and outagcous corporq ooudwt thst dernoustaþs a consciot¡s disreglrd forthe saÈty of

Pla¡nt¡tr Brúd ü¡d BPV bâd astuEl knowledge of lbo dangers presented by the Recovotl'Filte@ and

02@ Filtn, yct coruèiously lhiled !o act rctsonably to:

a. Iufom or wam Plairrtif, PlaÍntifs ph¡rsiciang or llrc public æ lægs ofthesodangqe;

. b. Estâblishmdmainuin anadequatc qu¿lity andpost-marlßtsttrveillancesystcm;u¡d

o, RÊcaltiheRrcovcry@F¡lterandG2(DFilbrftomthemrkct

47. Desp¡Þ h¿v¡ng knowledge æ oarly as 2003 of úic uucrsonably dmgeroru a¡¡d dsfediw

natr¡¡c of tbe R¡covery@ Filtcr, Bud snd BPV consaior¡sty dietegrrded thE knowurlsks and co¡tl¡ued

fo ¡cûfirËly må¡tct a¡rd oftt for salo lhe R¡ootær¡@ Ed G2O Filtã Syslans.

48. Pt¡indËñ¡ther ¡lleges th¡t the Defendants actcd In willful, u'ârbn, gross ald total

disrcgå(d for lbc hc¡llh ¡nd safæy of tbe r¡¡crs c cott$¡mem of ttælr Rooovu¡¡@ Filbr aud 02lD Filbr

SptÊoq ar{od to sowe their oun ¡nterost$ ûnd hEving rlctcon to hor¡v ¡nd consciouly dísregnrdiqg tbc

subs|mtíal risk that thoir producú mìEht tdll u cignificstrtty bårfn påtiÊotC or dgnificantly iqiurc tho

COMPT,AINT FOR DA!úAOBS


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rlgþtr of othen conscloruly prrrsued a counc of conduci knowíng th¡t st¡ph oonduct created a

subrffitlâl risk of sigplfcant h¡rm to olber persons'

spEclr, Ic FA(nU-AL.ALTEGATIONS AS TO P-LAqt'ilFF

49, OuAugr¡st +,2005, Plaíntifrunderu¡cm nrgical plsccneût of a Ræover¡ß FÍltcr.

50. This R¡covery@ Filtcr devico luas desigpoq mu&ctutç{ prepared, tompound€d,

asse,mbled,proeæssc{ nar*øod, dísbibutcd, and rcld by Defcndånþ Bfid a¡d BPV.

51. Tbè R€corrcrytÞ Filter srùsequertly fa¡led ¡¡d r¡ignt€d to Plsintitrs heo¡t There tbe

devÍcc perforded Pt¡intìfs heart ¡nd co¡scd sevele urd life 6rcatening complictüons. Plaintiffryu

çuscd to undcrgp octcnsivo mcdicâl bÊalnËat and câ¡o, inoluding erncrgÊücy ôpcn surgEry on Apdl 30

2010. Pl¡inftrb¡s sr¡trercd and will cmdnuc to suffcr stglifiaanf ¡ndícûl etçensc+ ærn and sr¡ffedng

lossof eqiotrmfltof lifc, disability, md orhcrlo¡sæ. Plalntiffwillreq¡rlre mgoingmedic¡t ca¡eb

monitor tho damago be sufrered ûom thÊ ft¡lÊd .nd dofcctive deryica

ßuApuL[NT CONCEAI¡|EI{T

s2. Any applicrblc *atr¡tcs oflimitation har¡e beeotolled þ tbc kmwins ¡¡rd astive

cqrcealmeot and donlal of må¡Êr¡at facts knouü by Deftnd¡ols whctt tbey had a duty to disclosc tlmsc

hots. Tùoy havc kÊptPla¡nt¡trignoruú ofvilål ir¡fornalion æsenü¡l b thc pursuit ofthclr claim*

withorú utr1' ûult or lask of diligørco on Plaintiffs parq for thc porpose of otnalning delay oo PlailtiÊPs

part in f¡ling on thair cs¡ses of adion, Ðafeüdar$' Êsndul€üt e.ôrioea¡m.nt did rcs¡lt in srch detay.

53. Ddqrd¡nts û¡e €sloppçd ûom rclylng or thc ahtulo of limit¡tiæ defeuse bÊcausË

Defcndants åiled to tinelydlsclosc, amolgoùcr lHqts, ñcl¡ wfulcnc¡ng thc dtfcslive and

r¡nreasonably dægctot¡s Dât¡rË of lhe Rpcovqú and Gl|DFÍlta Systcms'

54. Pl¡ir¡tiffand PlainliEs hcalth crl provÍdcrs oouldnotrcason¡bly hcr¡c diecovcrcd ths

sl¡im¡ ¡¿flsberd¡ rurlil at ths ca¡lîegt tho dsvioe wns dÍscovcrodb havc mlgræd to andperforatal

Pl¡intitrs bes¡t

55. îhe Defcoda¡ts ¡¡c anif wtce rmdø aconfinuing dr¡ty O dlsclo¡c the hr¡a ch¡raglcr,

qualit'' ¡nd na¡uro of the dsrr¡ca tht w¡s fnploÞd h Plù|itr, brut insæail lhcy conc¡alcd thcut"

Dcfenduts' oonducr, as dcecribod tn this oomphlnt, amoume to oonduct purpogety comniüêd, whlch

COMPI.ÅINT TOft. DAMAGBS


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Defendants must hsw realizod rras dangemu¡,,hepdless a¡d reoklcss, withorrt regard to tho

oonsequeûoæ or the dghts and safcty of Plalndff

cgRBplu\TE/vrcARlorrs LIABILITI'

56- At all times herein mentimeù e¡ch of tbo Dcfcndæts was tho ageat, seo*ant, paftcr, co-

conspÍrabr md/orþint vcnhrrtr of cach of ths othcr Dsfe¡rda¡¡ts bcrdn and ças r atl thes opcrdfug

and aoring within lho purposc and æope ofsaid agcncy, gertice, emplo¡rncnt, ptttËrslúP' conspirac¡'

müorjoint nentrræ an¡l.rendeæd ¡ubgflil¡al ¡ssistaocà ud encouragemedto fho olhe¡r Defcndanæ,

knowíng thât tbei¡ collcctíve condræt co¡rstitled ¿ breach ofduty owed to ths Plaiutifr.

57 . lbers rÐdsts aad,.st åll ür!€s b¡rein meotiomcd, the¡e odstcd e rnity of i¡rlere,rt in

orvmrsHp betrrcon c€rbin Dêf€üfu urd othpr ccrùin Defcndanls n¡cb ih¡l æy ÍndÍvidrratity ane

separahncss betwpcn tbc ccrtain Dcfçnd¿nts hôE ccascd and thcso Dofrndant¡ arc lhc olter cgo ofthc

othcr ccrtain Dcfe¡rdants aail excrtcd oontol ovcr tbosc Defendads. Adhcrcncc to thc fiøion of tl¡a

sepratc exirtenco ofth¡ec c¿rtrin'pofendants ac cntities disdnst ûom olbpr cert¡i¡ Defeodsnts wtlpermit an abrisc of ürc corporatc ptrvílcgs md would suctlon r fraud ¡nd/q rmrld promotc injrsrice.

58. Ar alt tin€s hsrein ¡rpntioned, Defendants, ond eosh of úErq rvcru cngaged in tbo

bruincss o[, or $srÊ successo¡g in intor€st to, cntitíes cogagod in lho h¡¡iness ofresearcùing dcs[gp¡ng

fo¡rnuluine; ooupounding, æetlng raanrûcturln& produclng Dror€ssing, irss€rùbl¡ry inspecdng;

distibutlq& nârkc{ing¡ labcltng prcnoling psclogin& pra*r¡bilg üd/or advrrtieing for salg urd

selling products for rse þ the Pt¡¡ntifi. Ac such, each Def€ndant ls índividuall¡ as wcll as joiilly rnó

svc¡ally, liùlc !o thE Plaintifr for Pl¡intifs dam¡ges.

59. At dl tl¡nes beceln nrcntlond tho officc'rr and/or di¡ccors of thc Defeodånts nmed

harcìn porticípaæd i¡q t¡uthqizcd and/c di¡tcted the prcducdm and ¡nomotion of tho aforr'raenliosd

poduob wbao they kneq or wilh thc cxcrcisa of ¡ea¡on¡ble care snd diligcoca rhould bave knorq of

thc hø¡ù md da¡gp¡ous propcodtics of said prcduas, *,i,¡un Uy actively pardcipned in ùê brt¡olß

oondr¡st ùatrusultd In the lnjruics n¡fFarcd by tbe Plaintitr

ililIil

uil

CIMPLAII{T FOR D.IMAOFII


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NRST CAUSE OTÅC-TIONNEGLIGENCS

60. Phìndffre'allegos arrd inootporatce by rufcnencc each a¡d cvery allcgdon oontained in

rhe forcgoiogporagrapbo ts though fully sÊt õrlhb€rË¡tr.

61. At all times rçlcvant tô this cil¡se of actioq ths Dcfendauts BEq BPV, ûrd DOES I

¡çú.rç ir the business of fçsigning, dcvclopÍng seüing spocifisd¡ors, manufacû¡dn& nrilkêting, solling

aml distríbrúIng ths Recovcry(D snd G2(D Filt¡c

62, Defcndantc desi¡nod, m¡¡uf¡ctr¡¡ed, mâ¡l<ctËd, ittspêctÊd, labelod, pronotcd, distibutod

:rnrl sold thc Rccorrery@ Filter that wss lnplaoæd b Plsiûtitr

63. Dôftnd¡Dtr bad a dwy to exersise reoson¡ble and pudent care in the dcvelopnent,

rcsti¡rË, desig4 manufaø¡¡e iuspe+tioq uarketing, laboling, pronotio4 dlsÈih¡tion ard sale of the

tirr:or.ergÐFilGr æasto rrroídeleosing othsso fo¡csecsble rndtrnrcasonablcrÍskeofhåÌn,

64. DefÉnd¡nts lil¿w or rcaronably should h¡vo lmDwn th¿t ttn RecovcrylÐ Fiher wus

Jungerous orwrs tikelybbodrdguoru whcn r¡scd iniBinþûdod orrcasonàblyfo¡csccableEsmer.

65. At lho tirne ofnaur¡frctrut a¡d sale ofibc Rccovcr¡¡@ Filtêr (20Û2 unlil Oefobcr2005),

l.rcfbndants tncw or¡hoùldbgve knountlrat thc Rccovery@ Filtn

a. W¡s dæigred aod nsnuf¡cü¡rËd in such I ¡DÊtrrtr to qs b prcsGNú

unreasonåblê rísk of&aÊúurc ofportions oftbe device;

b. Was desigped md nmufactt¡¡ed so ss to preccort er¡measonúlc riskof6e dsvicc md/,orportious ofthc devicc; rnüor

s. rüæ designed ad m¡nuftcn¡¡ed so as to prcaËott r¡n¡eoson¡ble ¡isk ofthetÍlting æd/orpufordug thc vooa cavawall;

d" tr/a¡ deslgncd a¡d uanr¡factrr¡Êd to h¡ve r¡nrcason¡hlo md i¡rsr¡ffisieot sEurgfhsüusft¡rE¡ ilsgrity !o s,¡úgtand norrnal placcuørt witùin the hunan body-

66. Atthe timê ofmuufrsturc and sale oflhß Rpcovor¡Ð FlltÊr (20û2 rut¡l Ootobcrr 200Ð,

t.lclbrrd¡nß l¡rlerv or should hsvË knorun thd usütg tha Rcæveqr@ FlilÊr h its intûdçd ust or in a

rcrsonably fo¡rsscabh ma¡mcr c¡oaÞd a elgnfficûtt dsk of a potlent ntrecirrg cevec health sidc cffecg

irrcluding, but mt limitcd to: hernorúragc¡ aant¡ac/pcrica¡Oñat tâmpooâdÊ; crdiao urb¡bnia ¡nd otbcr

.s¡*nrplorns sirnilarto uryoordhl lnfaniíon¡ perfotations oftíss¡ê, vccsels atd orgpns; and otherreverË

t4OOùÍP!^AI$ÎPOA.DAIyI OES


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pcrsotrå¡ inju¡Íes a¡d diseases, uihioh are permanont ln natu¡Ê, includlng butnot limiæd to, ded¡t

pairr and mentrl mgrdsh, scrring aod disñgure,mnÇ 4í'.'nishedeqioyment of lifg contínued

medical ca¡e ¡nd ù,eÐhncm duc to cå¡t¡tc iqiuíoVlllness proximarcly caused þ the dwice; and the

continucd rlsk ofrequiriog addirìonal medical e¡d nrgþal procedures including gencral anestl¡esia, wÍft

úeûdsnt dd( oflife threattning oonpllcaüoru.

67. Defuidanrs lcrcw or rcosonably should bave known thd consumcrs of the Recover¡p

Filter rvould not ¡calize lhe ¡langcr assocÍucd wiü trsing tho dovicc in ib intendçd use ard/or ín a

rusonably forcsc'cablc urô¡¡ncr.

. 68. Dúndsnts b¡cacbed lhcir to duty b ¿xerclse ¡easo¡rablc a¡d podent cam Ín the

devcloprunÇ tæt¡ngn desigq manr¡factu¡e, inspectior¡ marbting, labeling pmmotior¡ distibution a¡rd

salo of the Recoverr¡@ FiIþr in, emong othcr ways, the folloviag acts a¡d omission¡:

a DËsi$úng ¡nd distibuting a product in whichthe¡' locul or¡hould have lcrown thætheIikelibood s¡d sc*crity ofpoteilis¡ hnrm ñom the prduct exceeded the burden of trHngsafety measures to redwo or aroid harrr;

b. Dcaig[¡ng and disEibuting aproduct in whiclr thôy hreû or sbo¡¡ld hs\,Þ knoun lhat thelikolihood and sevedty of potenlial h¡¡m from the proiluct ørceedod tho likelihood ofpotential harrn fi,om other derrice ¡vail¡blo for tbe seme ptupose;

c. Faillng ûo use rcasonable cut ln m¡nufæu¡¡ing the product aod producÍng a pmduc tbard¡trcßÊd from thcir dcsign or epccificatÍons or &om other. tlptcsl u[its ûom thc sancproducion line;

d" Pailíng to use ¡coson¡blc cs¡s to warl o¡ inftruct, rncludiug pre and post srite, Plaindff,Plaintitrr phyrioinps, or the gcüctà¡ health carc cornmunity¡bor¡tthç Rccowry@ Filtcr'snrbstantially dmgp¡or¡s condition or aboU facg mrikíngtbeproduct UÏely tbte '

daogcror¡q

e. Failiog ûo perform reaso¡¡ble pru aod post-Dårkst tcsliugof the Rcoover¡¡@ Filte,ttodeþrrm¡ûowl¡Étbcr ornot the prodrrctw¡ssrßfor its intcnded r¡se;

f, Failing !o provideadequæ inshrrctions, grlideliaes, and safsty¡recaufions, includiag¡neand post eele, æ those persons to uhom it was nasonably foreseesblc would pr€scüibs,' r¡sE andimpladtheRecover¡OPilter;

g Advertising, rnukcting e¡d recommendirg tùc r¡ss of thc Rccovcg@ Filær, wLilcconcealÍng mdftililgto dlsslocê oru¡anrofthedaogrre knowubyDefeurdmtstobecon¡ectd with æd lnbcrcot in tùs rse of the Rccow4@ Filter¡

@MII"AINIFORDAMAGE{¡


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h- Represcntiug thtt lbe Reoover¡,@ Filter rryas safe for its in&nded ræe when in frsgDvfendåDll knEwand shor¡ldhaveknown thoproductwæ not safE forits intended

PüP0/Sô¡

¡. Contínuing narurfucture aod sale of the RccovcrJr@ Ftlt€r with ùe knowlcdgcthat $Idproduct was d¡ng$ot¡r ¡nd not rcasonably safq ald friling to comply with FDA good

mætfacùrríng regulations;

j. Failingto ruc ¡casouabls rndprrrdcnt caro ln tbe design, rcscaßù, maü¡f¿cü¡re, maldcrrcþmcot of thc Rccovtry@ Fllhr so as to avoid ¡he risk of saior¡s harm associ¡ledwfth rhc r¡se of ttro Reoovcr¡¡@ Filtor;

k Advenrising; ruarkaing; promotiug and selliûg Ræov!trJ@ Filtsr for r¡scs olhcr thm as

approved snd ird¡cåtcd in the proórct's labsl;

t Fall¡¡g !o qrtahlÍsh an adequato çrality ¡ssurüD€ progntn rscd in the manufocnning oftl¡eRçûovcA/O Fitt€f,

m. Failing b cstablish u¡d maint¡ín and adcqualo surveillancc prog¡un.

69. A rcasorrablo manfacüuer, disüibutor, c selle¡r r¡nder th¿ siule'orsimil¡rcircr¡msønces

would not have Gmggd in thc btfo¡E-rncnlioncd acls and omÍssions-

70. As a dircc and poximate resultof thc forcgging nelígput ac$ aod omissions by

Dcfendmt+ Plainlitrhas suffcred End wÍll continus to suff€r ssrioul phpicat üfruies, ccunomio lose,

loss ofcr¡io¡mrent of life, dÍsabil¡ty, ¡¡d oftff loeses, in ¡n amot¡ntlo bo detfiminËd ¡t hial.

sEcJÐND CATTSEO,F ACTTONsTRr.çT pRorlucTs LIÁBrIJIY - rArLUnA TO rVÂnN

71. Plaistif re.allegss md inoorporatæ by mferenoe caoh md orruy ellcgntion containcd in

tbe ftrcgolngparagraphs as though ftrlly set brth bcmh.

fZ Defcndants ddgned, sct spedûcadoDs, unnufaoûutd, pre,parc4 corryor¡nA"4,

ascurblad, proc¡cased, markaoil,lâbEleq dlsùibutc4 md soldlho Reoover¡@ Filtcr, includlngth¿ onc

luplantcd into Pla¡ndtr, Ìnto lù€ ffcû¡n of cor¡mp¡cc and in thc oor¡¡¡c of sooe, dfuEstly Bdvertised s¡d

marha¡¡l tbe devioo to conr¡rmËrl or pcrære rcsponsible for coruu¡¡er¡,

Tl. At tto tinc Dcfendmt¡ dcsigne{ m¡mfasturcd, prcparod, compormdd asscmbled,

prtracs¡cd"rnå¡ketoq labsled, d¡stribr¡þd, andsold lbsdwÍæinio thesü€an ofcom¡nersc,I)cferdurts

Iocw or should hrvc Lnorm tbc dovico prtsnnel æ r¡¡rea¡on¡ble danger to useæ ofiho prodnct wben

CüúH.AINT Fì04. ÞirÀdA(Ë8


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pr¡tto its ¡¡t€Ddod and æasonably andclprbd rsa Speciñcully, Defendauts loes, or sbould bsYe hþun

rtt¡e timo they m¡uufa¿tre{ lâbotê{ d¡sführd ¡nd sold thc Recovcn¡S Fíltçr, rvhich wus implanted

ln Plainti , that tbo RnæveryO Fill,rr, lntar alla,posod a sígnilicant and highÊr ¡islc tbm oúø simila¡

dselces of deçtcê filuË (Êrstr$Ê, mignrioq tiltirry, and perforation ofthc vcnac¡vawll) and rceullin¡

se¡iot¡s rqiruiæ. Upon ldornatiøandbcliefi, Htn¡lmb ¡Isokneu, oruhouldbrveknon¡ntbatcert¡in

conditìow orpost-ïmplmtprdftq sìrch as morbid obesity or opoo abdooionl procoduts, ooun

dect thc safêty md intcg¡ity of thc do'ice.

74. Ihcæforc, DeÈndaats had a dutyto wa¡n oftl¡e ¡iskof harm associalcd lrith the rmof

thc dsvioc and to plovide rdcqualc instuotio¡s on tbc safc ¡nd pmtler l¡sc oftbe dcvica Defeod¡¡rs

fuherhad adr*y to uarn of dangcn and propers¡fsty Ínttttsdo¡ls that it becane awa¡e of even aîcr

tbe dwice was dlstibuÞd and implantcd lû Pla¡nt¡tr

15. DcspÌtê ú¡s dut}', Doftndatrt! &llcd b adequâtely unm of materiat facls rcg¡rding lhc

safety ud offiaacy ofthc RËcoytrrlo Filler, aod frulbsr ñIled to adequately povidc insüuctions orths

saÞ and popec uso of the dËvioe.

?6, No hcalü c¡¡t providet, irrcluding PlainliFs, or pcticnt wpt¡ld h¡ve used fho devlco ilthc rnamrerdircold had those fscts becn made lcnowato the pesqibing be¡ltbca¡cp¡ovidcrs and/o¡

ultimao ueerc ofthc dgvico.

' n . f¡e heattU r¡r*s assoct¡rcd witl¡ thc devio¿ as deçgdbed herein re of sr¡ch s nåû,rÊ thåt

oú¡råry cøsumôrs utuld not havc rtadily æcogp¡zrd tbc potmtial trrm'

78. Plahtitrs¡d Pl¡i¡titrs heatth caro providars rupd the dcviaê in rnosn¡l ct¡stûmâry,,

't"

IütËr¡dcd, ald ftrcseeable müDßr, nandy ae a surg¡Es[y implanted devicc uscd to prwcnt pulmonary

cmbolisoß.

79. there,fmô, thc Rccovc,r¡t@ Flltcr Ímplantd I¡ Plaintiffwrs dc&ctfu¡c a¡rd uûcaronåbly

dangorous at tbs dmc of relsass i¡to ths ñesm of cotnmcrcc due b imdoquåtc $'üring& labellæ

aod/oc i¡sfrucüonr acccnnpanying tbo product

80. Tåo Recover¡0 F¡lreû inplmtcd inPt¡iutifrw¡s in the såmp coDdit¡on ¡s wben itias

mam¡acn¡c{ inryectê{ madrctal,l¡beled, pronotod,dl¡tlbntsd andsotdþD@ndurls.

COMPI-A¡NT FOR DAITIAGES


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I L As ¡ dÍrwt md prorßiú¡b ¡Ëst¡lt of Defeilhlds' l¡ck of sufficient nnrning a¡d/or

ìnetn¡ctíonçPlaintifiba¡ s¡fiqedandwlll csntiruÊto ¡ufrcr¡øloru pbydcali4lur¡e$ ccononic loss,

loss of cqioyment of lifc, disability, and othcr loescq in an amount to bo dstcrrtríncd at kíal.

rElBpc, AUsEqFACrroNsrRrcT pRoDucrr¡ IJAÐ...E ¡TY - p,

Esr, F.r! ,p,EFEc,Ts

tL Ptai¡tiffre.allegss aod incorporatos by refcncnoe e¡ch and evcry alleguiou coutained in

tbc foregoing püågrapb¡ ås thoueh fi¡¡ly sct forth hÊrçin

83. At¡ll tîmes relevant ûo this action, Dcfoodams dcvd;ped, tsstsù designod,

ma¡uf¡ctued" i¡$peoteq labele,( pronotd disùibutod and sold i¡ûo tbË cbÊa¡¡ of comne¡cc thc

Ræowr¡l0 Filtcr, i¡oludÍng thc o¡p inptonted in PlaiiliË,

84. theRccovery@FilterwaroEcctodfo, xr¿l díd,raachitsintonded o*o*r**lto.rt¡ubat¡ntial chmgp inthe conditionlnwhichitwas ÍnwhcnitleftDefeüdants'posscssion. Inthe

¡lterntivc, any changes tlrat rryerc mado to Rcoovcry0 Ftlær lnptantcd ln Platr¡titru¡É$E reasonably

forËoceblc to Þcfcûdmls.

85. TbeRecovcry@ F¡ltar¡üplanted lnPlaíntifrums deftaiwindesignbccausc itåild bperñro in ¡ m¡¡ucr reasonahly expectsd þ consuucrs $vør its natruc a¡rt Inb¡¡ded ft¡nòtion

86. TbG RÈcovï'f¡/(Ð Filtcr ¡tplû¡td i¡ Pl¡iuitrr+,as defectlvr ln desþn, in thst its dslcs ofha¡m o<cccded ifs claimedbüofits.

87. Plaintifi¡rid Plalntlffs hcaltb carc províden used the Reco\,€r',@ Filtcr in a man¡er that

mmnably fgesecable to Defcodantg.

88. Noilhcr Plalatifr, no¡ Plal¡rtìF¡ he¡lth ca¡e providcrs could beve by ûe exerc¡se ofrc¡sø¡¡blc ca¡sdisoovcrcd thc dwit¡cs dcftsdvc condition orpüccircd it¡ u¡tasm¡ble dangors prior to

Plaintiffs implaoûation viith th¿ ¡lsvict.

89. . As a di¡act and p¡qrd¡nsle rtsult of lbtr REûov€rJr|D Filt¡r's defcctivc design, PlrÍntÍffbar

glftred and will coutinue b $rff€r sedoru pbts¡cåt ldruiec, crsromic lors, loss of cnJoymcnt of llfedisåbility, ed othoc l,oss€q in tr ¡mo¡¡nt to bã dterm¡nd at hi¡l

FOT'RTH CAUSE OFACTIONsBIçt BA,Op,UcTs TIaBTIJTY - rt[ANrn4CTnRrNc r], Eppqr

COMPI.ANTFORDAìTACB}


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9ù Plalndffre-altoges and lncorporates by rcferenco each and wc'ry ollegadon conbined In

tbe forbgoing paragraphs as though ñ¡lly set forth hcruin.

91. Dofcûd¡ûts desige4 sct çecificaüons, månufacture{ prcparcd, mnpormde{

asscmble4 p¡occßsE4 na*ae4 labeled, ösüíhnod, aud sold thc Rncovcr¡@ Filttt tbd u¡ae inplmcd

into Plqintifr,

92, Thc Racover¡@ F¡lb¡mplånted ln Plalndfrconhlned a condítion, which D€feüd¡nt did

not intcrrd, attbc tirrc itlcft Ddc¡ìdsnts' co¡rt¡ol and poscssion.

93. Plaintíffatd Phiotif ¡ heatth cara grovidetr r¡æd lhe devico h a mqnnq th¿t wa¡

reasonably foresceable lo Defe¡rdants.

94. AE s tcst¡lt of this cqnd¡t¡ori, lhc producf i4il¡rËd Plsiñtrand ñtled to perform as sefbly

as the ordinary oo¡¡st¡mer would ecrpcct wheu used in a rcaronably forcseeable maruer.

y5, ' As a dilwt and poxirnatc rcslt of the ReooveryfD Filterrs mamrfrcarring defcst,

PlainliËh¡s sr¡ffered â$l vilt osntíDue to'suffcr scrioire phys¡cat íqiuies, ecolomic loss, losc of

enjoyment of l¡fc, dicability, urd olher l,osscs, in an aüornt to bc daernind al tÍat,

ErrE çêulpoFAcrfo.N. BRßACH Or TMPLTED ïi'ARRANTY,OF MEBçÍI,ANTABIL_ rry

96. Plaintiff¡e'alleges aud iæorporates by refemoe each snd wcry allcg¡tiotr coil¡ind in

lhc forcgoingpâragapüu aslhougb ftlly rcû forlhhercin

97. At all tíDGË r€lèvånt to t¡is ædon, Defenduts deeigned rcsearchd developed,

manuÊcEued, bst€d,labeted, ínspected, advcrtiscd, prouotad, markete4 sold, md dl¡üihúed inro ülfücan of c¿¡uercc rho Rocovcq@ Filter for use as a srrglcally implantcd dcvlcc usod to ¡rcvcut

pulmomry cmbolìsms urd fr¡ rrscs othcr thÃr u appruvcd and ind¡cated in tlß foduct's infiuaions,

$raurtnglr aûd lsbcls.

9s. At the tlne and plæo of the råle, dlstibution, a¡rd supply of tbc Defendans' Rccovcry0

Filter Systãm ûo Ploiittitrby way of Plaintitr¡ bsafth cnro providors and medlcal ftcil¡t¡es, D€f€ûdaús

crprcssly rcpesenhd ai¿ nm¡a¡re¿, þ laboling malüists $rbm¡têd srilh ûrc producç rU, ns

Reøvcry0 filh Systarr rvas ¡& a¡rd cftctivo ftr its i¡rænded and loænably foreseeable usc.

@MPIAINT POR DÂ¡yIACES


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99, Defend¡nts l¡çw of thc i¡rtendcd md rusonably foteseeable use oflhc Rccortcr¡0 Fil!æ,

a¡ thc tine tùcy mrkcled, solü and disüih¡bd lhs poduct for usc by PtaÍntiq, and impliedly unrradat

the poduct to bc of mcrshmtåblc quallty' and safc and ñt for its isteqded usc.

IO0. Dof€Ðdar¡ts implledlyropræcntod and warra¡tcd to üs heahhca¡e comüun¡tlf Ploûnt¡ü

and Plâ¡dtrs bealth cuc providcs, thd thc Recovcry{D Filter was safe md of mücbtngôlo qr¡atity and

f¡t for lhe ordlnârl, pt¡rposo for which tho prÐdnct wås inûadod and uarlrctc¡l to bc usê¿

l0l. The ¡cfrtsc¡rt¿Éon¡ and inpliedvrarantiæ m¡dc by Defçodan$ wcne åls€, miElesdi¡g;

urd ir¡pq¡rate boca¡¡ss tho Rccover¡r@Filtcnwu dsf€ct¡ve, unsâfe, unrcasonably dmgemus, and notof

mcrshrnt¡bÌe qu¡lity, when uscd ¡tr ils inteúded and/or rcasonnbly forcsccablc mrrrÊr. Spaciñcalln at

thc timc of Plaintiffe prrchass of tho R¡covcry@ Flllsr from tlrc lÞfeod¡¡rti, tù¡oudh Pl¡i¡titrs

plrysiciure urd medic¡l faeilities, it was not in ¡ machant¡blc condidoq intbd:

ù tt was desigped ín s¡ch a msnûer s! as to bo pmnc lo ¿ statisî¡cf,lty high l¡cldcûc{' of faiture, lncludiug ftrctrre., migratior¡ ø<cessívc tildng and perforatbn of lhoinùdqvtn¿ceva;

It war dccignod in such a mamrecso ¡s io rcsult in a statisticalty signifis¿¡¡¡

incÌdonæ of iniu¡y to ùe organs ond an*om¡r, ud

Il was ¡uanuåctr¡rcd in $lcb a ¡u¡nnpr so tbat tbc ecctrcior sur&ce of thcRÊc.ryerylÐ Filtcr System vm inadequalety, inproperly a¡d ¡nappropnoælyprepared md/or ffntshed caxing thc dcvlce towcalcen r¡d ft¡'I,

Itz. PlEintifrmdPlaì¡tlfs hcalthoarcproviders rcasonablyrçlied onthenrpcnior*ill æd

judgrreot of DefÊodmts es ibe designers, rascarchors and m¡nuf¡ctr¡¡crs of th p,rodrrcg as to wh¿ther

Rpco,r€fytÞFilæru¡as of rnerptnnt¡Lle'$ulityudisfcand giñr ¡tsinftfldedusc,"i rfro dii onftI¡¡pl¡d ulrranty of mcrohantatflity and fitness fur the pardcular rro and purpose for whitlr lho

RÊcoycnJr0 F¡ltø u¡¡s manufisù¡rpd a¡¡d sold"

103. Ddcr¡dmts pbccd thc RcoovcryO Filterln¡o the gEcam of conneæe in a defraivg,

ururfg, ud rm¡easonåbly daogcmur csnditioq md the prodrtct was cxper{ed to and did r€åcù PlâiDdtr

wlthorn subshntialchango in the oondition in wbicü üË RÊcorrÐ,tÐ Filter wae ¡¡aru&ctr¡¡ed ud sold.

104. Ddcndanß bæacåcd thcir ùnplicd wmanty bccause thclr Rccovery0 Ftlter ums not ñt

br its inHrded usaand pr4poco.

b.

CO¡vOÍ¡{¡¡.¡T FOR DÂIr,IAGES


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105. As apmximate¡wultofDeÊodants breac.hingtbeirinpliedwanantico, Plaimitrbâg

sufieæd rnd will oondnue ûo suffer scrious physical rnjui"s, econmnic loss, lo6s ofsqioyrnent of llfe,

di$bil¡ty, ¡nd other losses, ln an mrmt to bË detÊrmined at tial.

SIKüI CAUSE OT'ACITONNEGLTcE$rf Ìg^çREp.BBËpilrrATrON

106. Plaintiffro-alleges and incorporaler by refc,rrnce each and cvery allegafon conti¡rd in

the forcgoing po¡agfaphs as though ñrlþ set forth bercin

107. Al all times ralcvert to thïs case, and as deta¡l ed, stqnz, Daførdants negligcntly

Plaintifi, Plai¡dfPs hoalth crop,ovidcr* ¡nd tho geú¡cml¡üDd¡cal commrrnlgwlthf¡lseoriftcofiect

in&'nndion, oromittcd or ñllcd ùo drsclose mtcrirl information co¡ccnriry the Recover¡¡O Filter,

irtcluding but Dotl¡mit€d to, misreprcscntations rclating !o üc blbwíng subjcct aleas:

a. Tbc sa&tyof tho RccsncryD Flltcr;

b. Thc efEcaoy ofthe Rccovery@ Fittsr;

c. Thertcof f¡ilt¡rsof theRccovery@ Filter; aod

¿ TheapprovcdusesoftheRccovø¡@FiltÊr.

108. The hfqripâtion disÈibt¡tÊd by DsfËr¡då$ts to the pubþ thc modical cornmunlty md

PtaÍ¡ütrs hc¡lth orc pnovídens rvas in the fom of tq>orts, p¡çgs ¡eleases, advertis¡Dg carngaÍg¡s,

l¡beling Dd€rlals, ptint advËrtlslmgott, comm€rcial mcdi¡ cont¡lning matcrial Ep$,bcntations, süich

wrc f¡lsc and rnbl€ed¡Dg, and co¡¡hÌneil oûrissions a¡d conccå¡merit ofths trrth ¿þut ths dnngÊrs of

r¡sc of lhe Ræovry{O Filær. Defcnd¡nts made the forcgoing nrisrepræffitio'ns l¡owl¡U tbd,thgt

weæ ftlsÊ on wi¡hout reason¡ble bssis. Thæe mat€dsls includËd instilctío¡¡ fquse md warning

docrure,nt th¡t rms included in ûe paclcage oftbo Recover¡t F¡lær tbd was implanted in Plointiff

109. DcfÊûdarib' inæût qüd Fúposo in m*ing theso miscepresørtatio¡s wrs to dspeive ffid

dcftar¡d tho publlo anil ¡hc mcdic¡l cnurmunity, including PlairrtifPs bÊoÍh Gæ p¡ovidcrs; b g¡in thc

co¡ñdcnce ofthcpublic andthe medlcal communlty, lncludlngPlaffiff¡ heatth cue provldcrs; ofrbcly assrrru tbcsr of thc quallty of thc Recovery@ Flltr and lts ñtncse for u*; and b lnduoo tùe

a¡d the uedicat conmunity, ìncluding PlaintiF¡ hcalthcarc pmovidcrs to rcquc4¡ccon¡¡en4

trrÀtcilibc, tnplam, ¡n¡qh¡¡c, and continuc to r¡sc ttrc Ræqwn¡Ð Fîltsr.

CþITDL INT FORD/ìì{AGE¡


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I10. Ihe foregoingæ,prescoialions md ø¡isgions þ Defe,ndanrs were in f¡ci lhlse. The

&covcry@ Filter ls notsafe, üg md cffcc{ivo for bum¡¡ use h itr ¡üt€nd€d and reasonably forcscc¡blc

maûncÍ. The t¡se of tho Rccovery@ Filter ishærdor¡s lo thc uscr's health, and raíd devioe has a scrioru

Fopensítyto slusÊ r¡têrs to s¡fffer ærious injuries, lncluding without limlurioq the þirri4 Plafo¡tÍtr

$ffffçd, F\rrlbsr, thc dwico has asignifiomlly higher rate of faih¡c srd ínjrrry than do othcr

comparable devices.

I I l. In rcliance r{nn tbe folsc ¡nd negfigent misre,presentrtio¡rs and omissions r¡¡de by

Dcfendnrts, Phistiffand Plai¡tiffs bsû¡ü caro providas were lndr¡ced to, and did trse the Rccover¡ÃÞ

Fllær,tbcrebycausingPla¡nt¡frto n¡sbin seye¡! and pcmransntpcrronal ¡njüi€s"

ll2. Defendants lcnerv md had ¡eason to how that Plal¡tíü, Plaintiffs bealth care poviden,

and the gcoe¡al medical comuuity did not have the ability to dacrnrÍne the.tne fao:t¡ Ínúentionally

and/or negligeotly concealed ¡nd miseprc*øted by Defcrrdauts, and would not lraræ pnescribed and

implantcd oamo, if tho truo &sts ¡egn¡ding tho device had not been conoeôled and mËÈpresented by

DdÊüdarÌb.

I13. Defenil¡ttts had sole accsss lo m¡teriol ficb concerning thc defective ¡r¡tr¡¡e of the

product ild ir prope'nslty io caue serior¡s and daagcoous side etrectc in the form of dange,lors injuics

ud danagec to persons who æ irnplantcd with the Recovery@ Fi¡t€r.

I 14. At the tirtro Defe,ndants ñiled to disclo¡c a¡¡d misreprcsented the bregoing facre a¡d at

the time Pl¡intiffuaed the RccovÊry@ F¡lt€r, Pl¡intiffmd Plalntifls health care provtders werÊ

of sdd Defadarts' negllgcnt misrcprræntrtions and omissions..

f 15. Plâinlitr, Plù¡tifls he¡lth care providere urd general medical coramuntty reasonably

rclied uponmisrcpcscutattons and omissions m¡dc by Defendanlr wharc the concealed and

misæpæscoted frcæ wr¡¡c critic¡l ¡o understa¡d¡ng tho n¡e darigers inhcrent in iho r¡sêofrha

F¡ltor.

116. Plalntitrand Plahdffs health cue provldeds reliaace on the foregoing

miscpcseoladonc and omissio¡¡ þ Dcfeodants' was tbe dlrpst and poximate c¡r¡sc ofPlslnttt|e

injruics as described he¡ein.

uil

OOMPLûIIÙT FOR D/IIIÍAGES


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SBt¡EI{TH CAUSE OF ACTTOND-EJ]EPTTVE, TRAÐE PRACTTCT

ll7. At âll rolütüt tinres, tho ffindants oommittcd dcccptlvc tadc pacticcs as dcfined ín

NRS Chaplcr 598, i¡ that Defendinr, md ercù of them:

a l&nwhglymadcafalscrËftÊsÊûþ$mas toû¡ec.h¡ragtedsr¡cs, ingr€d¡eûs, u$€s,btneû6, alt¿rations ûr gthtilier of goods u scrvicce for sals or leaæ m ¿ falsercprcrenladon as to the spoasorsbip, approvnl, sürq¡s, afiliatiou or ccruoctiotr of a peæonüærÊwitl¡ INRS 598.09t 5(Ðl¡

b. Knowingly made olhcr fslsc ¡€ptËsËûlåt¡ons h a ua¡s¡ctlon afie+tiag these plaintiffet¡[Rs 598.0e15(15)l;

c. F¡lled to dlsplose a mcE¡hl ftst ln oonnædo¡ wíth thc snl¿ o¡ lease of goods c services

INRS 598.0923(2[ a¡d

d" Mådo asstions of soisntifo, olinlcal orquantifiable fa¡* inan advcnise¡nent whichwot¡ld oa¡¡so a rusonablc persoû ro boliwe thût tho assortiol¡ is tr¡e witbour ftctrrallyobjecdræ scicutific' clinical or qurntÍfiabls ovldcnoc which subsûhntiatedthe ¡sscrtion atfhc üme It was made [NRS 598.095(lXaD

llE. As a dirwt andptoximalo rcs¡ltof Defendanrs' commí¡sion ofdeceptÍve tradc practÍces,

Pl¡intifrg sr¡$ãÊd injury and damagcs rs dcss¡ibed abovc.

PT'NTTTI'B DAMACES ALLEGATIONS

I19. Plalntlff¡+,allegw €achånd eycry rllegatÍon i¡r thls Conphint and incorporates each

alþEdon inlo this Counf, as if set fortù $ t€û$h, in its cntirety

lm. Phittlfiis cnt¡tled to an awud ofpruitive antl erenplary damages b¡sed upo¡

Defendant¡' inte'ttlonal, willfirl, knowÍng ËaudulenL n¡licio¡u actt, omission$ urd conducÇ ¡ld thcir

courpletc md total rcokless diuegard for the public safety and welfam-

l2t. Defend¡nts had knowledge ot utd werp inposresslon oferridence deinonstr¡tlng thsf al¡Ê

R coltÊD/OFUtËrwas defecdwa¡d srbrmtialtyhþherfailureralc

ú¡n d¡d orbr slnllu devices mtha

& ft¡fotu or wa¡n Pl¡inrífor h¿r heatth ca¡ep¡ovlders of tbp dntgcrs;

. b. Toætabliú a¡dmaint¡l¡an adequoæqrulf¡y snd poct"ma¡lcEû ¡urræilla¡cesystEr¡; and

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OOMPKIINT ION, DA¡IIAOES


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a. RÊcâlltbeRecovcr¡¡'{ÐFilterûomthem¡¡ket

122^ Dofendants åoted to scrve thcir orvn lnterèstg and bavlng reasons to l¡ow and

conscioruly disægading tbc sr¡bianti¡l rÍsk that rhdr product migh kill or sigpificanrly barm polienlq

or.gignlñcmtly rqiup thc ¡igbts of otbÊrs, and conscísusly puoed a course of cosduct linowhg ürat

sußå condust ctÊatd a s¡¡ha¡ti¡l risk of stgniffcanl h:¡m to orlier persoltrg.

123. As r dirÊst, prûrdfraio, and legal rcsult ofDefendants' tots and omiss¡on¡ adcssrÍbed

bcûE¡q and Plaintifrimplantetlon Ðith Dcftndants' defeotivoproduct, Plå¡nüfrhas su$erÈd and wíll

contl¡ruc to ntfrer scrioùs phyrlcal ínj*i.s, æonomio losq loss of enjqrment of lifg disability, md oücr

lossan, in m ¡mo¡¡nt to be dete¡rnlned at Èial.

PRAW&FO, ILIrAììrAGpS

LISREFORE, Phfntiff Kevin Phillips prays for relidin lhe fom-of enùy of Judgmart agrins

Ddcndrnts, and ctch of them jointly and severally, on lho entirc Complai4 as follows:

t. Geffral damago* according to proofdüre tÍmo of Uiah2. Mcdical ant other spcctal damages, pûsl, Dnes€dú, and fuh¡re, according m

proof at the tÍme of ti¡l¡3. For prc-judgmcnt and post-judgment íntercst ptrsnunt b tho laws of tbc Statc

ofNevada;4. Cost¡ofsuitlæu¡redhereln;5. PtuitÍved¡rnagce;6. Sush sth rrlicf thecor¡rt deemsJurt ard propa.

ArT¡SIr{ArIoIPur¡uant to NRS¡ U198.030

The rrndersipad doec hcreby afirm thar thc peccding docn¡nent docs not contà¡tr thc Sosíal

Scauity numbm of any person

Datsd: AFrilZA,2OlzS/TIITE & WETTTERALIô LtP

t-^€Pctsr C. ì[feîl¡erall, Esq.,liw Bar # ¡14t4

ti¡dsty Eaûor, Esq., lW Bt # l2l&49345 W. Sr¡nsctRoûd, Ste. 100I¡¡Vee6,NV 89148TeL ?û2-&18{5fl}Fax¡ 702-E37-5081Åaonuyfor Platntlf

Oolvft AlN? FoR DAIvÍAOES


Documents

FlLED - aboutlawsuits-wpengine.netdna-ssl.com · 6/21/2012 · I FlLED Electrcnically oÇ26-2012t12¡05:40 PM Joey Ordqna Hâslings Clefiof lhE Cor,¡rt Transadion# æ14ÆB1 I 2