SL?RJ\.IE COLRT OF TH: ST{TE Of \E\\ \'ORK::Tlt::)T:T ......................x

ELLIOTT BENNETT-GUERRERO. M.D.

OR!GIIIAL

lndex N-o. //i aOa loZ

NOTICI, OFVERIFIED PETITION

Petitioner,

In a Mafier Pursuant to Arlicle 78 ofthe Civi] practice

Law and Rules

,against-

THE TRUSTEES OF COLLMBIA L]NTVERSITYIN THE CITY OF NEW YORK AND GER.AI-DFISC]IBACH, Dated Pur-chased and Filedl

Jaov "c-) 23, 2 o 13

Respondents.

--- ------------x

PLEASE TAKE NOTICT] THAT:

Upon the annexed Petition, verified on the 23rd day of January, 2003 by Elliott

Bennett-Guerrero ("Be1x1ett-Guen,]ro"), and the Exlibits ainexed thercto: and all pdor proceediigs

had herein, an application will be made to the Nerv York SLLpteme Court, County ofNew york, in

Room 130, at the Courthouse, located at 60 Centre Street, New York, New york, on the l,lth day

ofFebruary, 2003, at 9:30 a.m., or as soon thercafter as counsel may be heard, for an Orcler-and

Judgement under New York Civil Praclice Larv and Rules ("CpLR") Anicle 78:

FELEDJUN 2 5 2003

couur{?uJu-!oJ. orne s

(1) declaring that the sanctions imposed against Bennett-Guerero by Respondents

are arbitrary, capricious, an abuse ofdiscretion, illegaland invalid and restraining Respondents lio1n

:npo"ir5 ard o-:np emerl ng dny .uch sdnc.ion.

(2) restraining Respondenls ftom resticting in any 1rafl]cr Bennett Guerreto's

ability to conduct, pursue, and publish all clinical resea-ch to the same extent as any other- faculty

men]ber and provided such research is in compliance with applicable mlcs and reglrlatiol1sl

(3) enjoining Coiumbia Univemity and Gerald Fischbach from inrposing aid/or

implementing any further sanctions against Bennett-Guerero by virlue of his participctioD in

Protocol # 9256 or his institution olthis proceeding;

(4) direcling Respondents to reinstate Bennett-Guerero's positions andtitlcs as

Assistant Professor, Departnent of Anesthesiology and Chief of the Cardiac Alesthcsiology

Division;

(5) ordering Respondents to pay Bennett-Guen ero's incidenlal danages,

including his legal fees and disbursements incurred in this proceeding; and

(6) for sucl] other and furlher diflorcnt reliefas lhe Colut deems.just ar]d proper

under the circumslances.

Pursuant to CPLR 7804(c) answering papers, if :tny, shall bc scrved upon the

undersigned at least five (5) days p or to thc retum date ofthis petition.

New York Count] is designated as the \_etrue oi _rh; ptc=e .d1trs ca rie tcss

residence and principal place ofbusiness address ofthe parties hereto.

Datedi New York, New YorkJanuary 23, 2003

You$, etc.,

MORRISON COHEN SINGER & WEINSTEIN, LLP

750 Lexington AvenueNew Yo*, New York 10022(212) 73s 8600

FILEDJuN 2 5 ?003

counr\E$Jffforrrce

Atlomols for PetitionerEliiot Bennett-Guenero

SLTREI'IE COURT OF THE STATE OF NEW YORK

::NlY of N:w y:Rr( _,__________________ _ x

ELLIOTT BENNETT-GLIERRERO, M.D.

Petitioner,

In a Matter Pusuant to Arlicle 78 ofthe Civil PracticeLaw and Rules

-against-

THE TRUSTEES OF COLUMBLA LNTV-ERSITY INTHE CITY OF NEW YORK AND GERALDFISCHBACH,

Rcspondellts

tndcx No. lot 9co lasNrah"e't . t lae /ozVERIFIED PETT T'ION

IAS Pafi

Assigned toHon I FILffi.M

JUN 2 5 2003

couu{?lJ#ornerPetitioner Elliott Bennetfcuerero, M.D. ("Bennett-Guerero"), by and through his

counsel, Morison Cohel Singer & Weinstein, LLP, respectl'ully alleges as follows:

Nature Of This Proceeding

L This ploceeding is brought by Betulett-cuenero, a highly regarded Neu'York

liceised physician and boald certified cadiac anesthesiologist, who holds a facult) appoilitme t .tt

Iespondent Colmrbia University,r and ',r'ho until recentl), was rhe Chief of the Cardiac

Anesthcsiology Division at Columbia Presbyteri:ur Nledical Center. lor an Order and Judgement

pr-eventing respondents ColunbiaUnivelsity a,rd Gerald Fischbach ("Fischbach") from: (a) imposing

rDuring the relevant period, Bennett-Guerrero also held a medical staff appointment andclinical admit'ting privileges at Columbia Presb)terian N,ledical Center, a hospital affiliated withColumbia University. For puryoses of this veiilled petition, respondent Tmslees of ColumbiaUniversity in lhe City of New York, Columbia University, Columbia College of Physlcians andSugeons and all departnents thereof, and ColumbiaPresbltedanMedical Center will be collectivelyref,-laed to as "Columbia Univcrsity."

conncction \\ ith IRB approved resear-ch protocol +9256 (describcd more full\.belou ), because anv

such sanctjons are arbitrary, capicious, an abuse oldiscretion, illegal and inviLlid and ate, amone

other things, in complete violation ofhis due proccss dghts accorded by Columbia Lnivcrsity,s orvn

applicable policies and procedules as well as those nandated by federal regulations: and (b)

rcstricting in any manner Bennett-Guencro's abihty to conduct. jlut-sue. and publish all research to

the same extent as any other faculty memb er so long as such research complies rvith applicable ru1cs

and regulatiolls.z Bennett-GLrenerc also seeks continuation ofhis title and positio|r as Assistant

Professor, Deparlment ofAiesthesiology and rcinstatement oflis title and position as Chiefofthe

Cardiac ,\resthesioiogy Division, $'hich tities and positions were wrongfully and sumrrrarily

removed in early Januaty 2003 as a result of the Respondents, improper and u,rongful actions.

Finally, Bennett Guerrero seeks incidental danages, including r.easonabic attomeys, fces ancl costs.

2. At the crux ofthis proceeding, and lving in the balance, is nothing less than

the entire career and reputation of an e)itlemely dedicated and capable medical phlsicim and

tesearcher. Upon infonnation and bcliel with the exception of tlte facts containe.l herein, no

conccrns have erer been raised as to Beanett Gueneio,s professional credentials and intcgrity. or

his cadng. skill or character as a physician. or hjs cledicarion, ability and conduct as a clinical

instructor and nedical researcher'. Indeed, Bennett-Guen elo's reputation as aclinician andclinical

investigator and researcher was stellar botlt within and outside of Collrmbia University. Hc has

previouslv conducted numerous clinical rcsearch trials with other in\.cstigators ai plestigioLts

'?Bennett-Guerrero repeatedly offered to have his r.esearch subject to monitoring and suchrequests havebeen dcnied. Heispreparedtoha!eamonjtorasacoidiiiontorcsurrinqallresearch.

institutions that resulted in publications in highly cited medical joumals and has, in lact, over one-

hundred (100) scientific publications to his credit. Hc x.as routinely inr'iLed ro give lecturcs atmajol

national and intemational scientific meetings and ar his still youl.lg age ltolds the promisc lor a long

career that will benefit patients rvorldwide, particularly tlTough his commitmcnt to pioieedn-s

clinical rcsearch with hopes to impro\.e thc rinderstanding of hrman illness that nay lead to

improved palient treatncnt and care.

3 - Yct, notwithstiurding his ulimpeachable replrtation, as a rcsult ofthe bad lairh

machinations of respondent Fiscl]bach and othors and rheir blatanl and intentional disr.egard ol

Columbia University's o*.n intemal policies and procedur.es, as well as thosc itnposed by fedcral

regulalions, including the deoial ofthe most basic and fundanrental procedural rights to which lre

was entitled, Bennell-Guenero no| slards at the eclge ofaprecipice in his careerwithltis r.eputation

unfairly and maliciously maligned. As is unfo Ltnately not uncommon, anonyrnolLs accusels:

believed to be nembers ofhis depar'tment rl,ith a personal aninrus against Bennett-Guenero as thc

sing star of the department, levied unfounded charges against hil11 in connoctjon \!ith one ofthe

research protocols in which he pafiicipated. Instead ofaddressingthe charges expeditiously and in

lhe marmer required by Columbia University's own applicable procedur.es and fedcral regulations,

horvcver, Fischbach and Columbia University's IRB chose to pllrsue secret procecdings nowherc

justified in ColLrmbia Universily's applicable policies and plocedules. 'fhe anorrymous accusers

were never formallyidentified and Bennett-Guerrcro $'as not allowed to revierv, much less confront,

the alleged evidence against him. He was also intentionally misled about tlte process and ellectively

r-e tricd onthe samc cl]arges overand over untilrespondeit Fischbach achicved the resulthc \\,anted

- a result wl]ich he hoped rvould deflcct from his own responsibility arld that ofhis wife, who was

a member of Colunbia University's IRB, lor the failiigs in procedure and overcight by casting

bliunc rvhere it was not duc, i.e., on the shouldcls ofBeinert Gucrrero. Moreover- respondenl

Fischbach failed to identify or address l.iis own conflict of interest due to his wile being a nember

ofthe IRB.

4. Not only were Bermett-Guerrerc,s procedural nghts trampled upolt with

inexplicable disdain, but he was singled our for rchibution when other physicians responsible lor

conduct and approval ofthe study at issue were ignored. He was also p unished in a manner, upon

infon'nalion and beliei u.l]ich is unprecedented and inconsistent with the tleahnent of other

physicians and rese.rchers both at Col'mbia university and at other similar educatiolal institLrtions

even if the charges $'ere true, which they are not. Indeed, \\,.ithout justification, hc has been

summarily baned indchnitely lrom pursuing clin;cal research, rvhich is tantanount l1l the medical

community to a finding that he has committed the nost eglegious fomt ofscientific ntisconduct e'cn

though Respondents have sepatately staled that he has not committed any scientific misconduct.

Perhaps worst ofall, the imposition ofsever-e, arbitrary, and unprccedented sanctions are based on

accusalions that were made in bad faith and are u,,rsupported by any fair reading ofthc recortl and

the applicable regulations. Such sanctiolls havc to date had and continue to have a serious

detrimental impact ot'l Bennett-Guelaero,s reputation and career.

Jurisdiction Alrd Venue

5. The Coud has j urisdiction over this pr oceeding pursuant to CPLR 3 01 , 7E0l

and 7803. Venue is ploper in this county pursuant to CPLR 506(b) and 780,1('tr).

6. Bennell-Guereroisanindi\rduall\riira:.sr:r;s:::::;::;.1:\.r':a:lia::.-

New York. Bennett-Gueraerc is amedical doctor duly licenscd in the State ofNc\\'York. Acop!

ofBennetl-Gueflero's C.V. is annexed as Exhibit A and incorporated hercin

7. Upon information and belief, Columbia University is an tndependenl,

privately suppoficd, nonsectarian educational instilution, charlered by the State ofNelv York, and

organized as a not-for-profit corporatjon, localed in the City ofNe\\' York. Columbia Univcrsity is

conprised of a liumber of schools of higher lcarning, one of lhich is the Columbia College oI

Physicians & Slugeons. Colurnbia University is govomed byits Board ofTrustees.

E. Fischbach is the executive vice president for Health aid Biomedical Sciences

at Columbia Universily and is thc Dear of the Faculty of Medicine at Columbia Unjversity.

Fischbachwas directly respon sible for directing the ploceedings at issuc and personally imposed all

ofthe relevant sanctions. Upon infomation and belief, his wife, Ruth L. Fischbach, Ph.D., M.P.E.,

is a Professor ofBioethics at Columbia Universit-\' aid Director ofthe Center for Biocthics :rnd in

Decenber 2000 was appointed as a member of Columbia UDiversity's IRB.

9. The lnstitutional Review Board ("IRB") of Columbia Univcrsity is and was

at all rclevant times responsible for, among other things, evaluating all resoarch protocols lo be

implemented at Columbia University and assisting and advising rcsearchers regardirg compliance

with all applicable procedures and regulations.

10. Dr. Margaret Wood ("Dr. Wood") was at all relevant timcs a tenured

Profcssor of Aresthesiology and the Chaiman of the Anesthcsiology Depafinent of Columbia

The Rele\ rnr Parrier And Fnririi{

.__:: .: :.t: 1

Bcnnen-Guerr.'ro.

11. The U.S. Depaflnlent for Heahh and Hurnan Senices, Otlice lbr Human

Research Protection (..OHRp',) is the Federal Govemmental office responsible lor lulfilling the

requirements of the public Health Senice Act, including, alnong other thiogs, nonitoring ancl

exercising compliance oversight for the protection of hunan subjects in research conducted or_

suppor.ed by any colnponent of the Department of Hearth and Human Senices and providing

clarihcation a'd guidance for both Fe<rerar and non-Federar sectors conceming the irvolvement ofhumans in researclr.

12. The Office ofscientiflc Integrity (,,OSf,) is an offlce in the Oflice ofrhe

Director ofthe National hstitutes ofHealth_ The OSI oversees the implemenration ofall policres

and procedures ofthe public Health Sen.ice Act that are related to scientiflc nrisconduct.

The Protocol

13. In or about Arrgust, 1999, Dr. Heather Manspeizcl, as rhe principal

Investigator, tirst subnitled to the IR B lbr revierv ancl approval a proposed study which $.as

ultimately entitled "Effect of dillerens intl61q1l6lr5 fluids on t]romboelastography al1d other

parameters dudng cardiac surgery,' (,,protocol 9256,, or ..the protocol,,). Co investigators invoh ed

in the Protocor $'ith Dr. Manspeizer incruLred Betulett-Guerrero a,'d Dr. Berend Mets, rhen an

Associate Vice-Chair. Residency Education and Associate professor of Clinical Anesthesiology,

Depaltment of Anesthesiology.

14. App.oximafel), 500,000 patients undergo cardiac surgery each year in the

United States. All cardiac surgical p atients receive several liters ofintravenous fluidduring surgerl,.

: -:. ,

FcurLltrnlrai::rt;-iiuro..:;-rrl;:,-. -::;:::.r-.:.:::4.:::::::::::::::--.:--::-: -:

buL the dataregarding the reletive safely and elficac-v oflhe lour (4) lluids renains rrnclear Rescarch

Protocol #9256 lvas designed to address this equipoise through a single center randomized Lrlind

study ol the four (4) intravenous fluid rcginens in patients undergoing coronary artery bl'pass

graliing ("CABG") and/or valve su1gery.

15. Each of the four ('1) fluids to be utilized in the Protocol welc previously

approvcd by the U.S. Depatlment ofHcalth and Human Selviccs' Food and DIug Administration

("FDA") and were routinely administercd to surgical patients

16. Care lor paticnts included in the Prolocol \\'as roLLdne erccpt: (1) several

teaspoons ofblood \\'as withdra$r fron the palient; ard (2) patients received one (l) ofthe four (4)

FDA approved fluids dlr ng their surgcry.

l'7. Included in the initial Plotocol that x'as submitted to thc IRB for apploval

r,ere the olhcial packagc inserls for the lbur'(,1) fluids that would bc involved in the Pr-otocol, r\ hich

inserls identifiedthe risks and side-effects ofthe fluids. These insens has beenprc\ ious11' approved

by the FDA.

LE. The entire Prolocol was rcvjcwed and ultintately appro|ed by expcl1s from

the Coiumbia University depaitner'lts ofSurgery, Nfedictne and Aresthesiology, as recluired by the

]RB.

19. In Octobq ol 1999, the Protocol was prescnted to Colunbia University

cardiac surgeons at their scheduled weekly meetings.

2A. Bascd o11 com meDts and cdtiques receivcd tom lhese surgeons, the plotocol

\\'as revised. Thc revisions included, anong othcr things, an expansion ofthe endpoints and a

change of the official title.

21. In November 1999, following discussion and dcliberation, including

discussio[ ofthe potential inpact ofthese fluids on coagu]ation, thc protocol and patient consent

fomr, as revised afler presentation to the Columbia UniveNity Surgeois, rvas appr.oved by the full

board ofthe IRB.

22. The proposed patie11t conscnt fonn to be used in conncction with the protocol

was edited by the IRB and was subsequently lully approved by thc full board ol'the IRB.

23. In Decenber 1999, at the suggcstiorl of Bennett-Guer re1o, a volunta4, cmail

was sent by the investigators to all Caldiac Anesthesia Attending physicians at Colunbia

Presbylerian Medical Centcr, pror,iding said attending phlrsicians with information concening rhe

Protocol and soliciting questions or input.

24. No questions or concenN \{ere voiced to Bemetlcuerero or Dr. Wood by

any of the Cardiac Anesthesia Atrending physicians that receivcd the email in Decelnber of 1999.

25. Bascd on thc IRB's approval ofthe rcvised protocol and the lack ofcomncnt

or concem ftom the Cardiac Ancsthesia Altending physicians, the protocol was implementcd in

Dccember 1999.

26. Enrollment in tte Protocol lasted for a period ofapproximatell,lbutecn ( 14)

months. beginniog in December of 1999 and cortinuing until February of 2001.

srud\ r ene\\ a1 \\ as conpleted and executed \ ith re spect to the Proto co 1 b y the Prirrcip al Invest i gator

al lhe lime, Dr. Manspeizer.

28. The Protocol thereafter enrolled an additional 100 patients, bringing the total

number ofpafiicipants in lhe Protocol to 200.

29. During this period, an jnlonn,ll independent safety analysis was also

completed. This independcnt saleiy analysis was suggestcdby Bennett Guenero amd implemenlecl

b-v the investigators as an additional sal'ety net fol the pafticipants in the Protocol. It $,as not

required by thc IRB, Respondents or any other body or rcgulation

30. In or about December 2000, approxilnatcly a year after enrollmcnt in thc

program began and after the study re11ewai, Bemeti-Gueraero assuned the role of the P ncipal

Investigator in the Protocol.

31. During this entile time period, no allegatiolls conceming the conduct ofthe

Protocol were expressed to Bcnnctt-Guerero or', upoi infollration and belie1, to his Chaiman.

Columbia Universitv's Policies and Procedures With RespectTo Alleeations OI Scientific Misconduct

32. Columbia Urriversity has a specific set ofpolicies and procedures that it is

requied to inrplenent to invcstigate allegalions olscientjfic nliscondLrct (Exhibit B hercto, $'hich

appeaN as Appendix F to Columbia University's Facully Handbook). The lederal reglrlations related

to such research contain a similar-set olrequired procedures and protections (Exhibit C hereto).

33. "Scientific Misconduct" is defined as "fabrication, falsification, plagiarisn,

ot otllef practices lhat setioasl! aleiate frorrt tltose tltttt tre connonly accepte.l x,ithin llte

scien rtc cotfituuni1tfor proposing, cotlducting, or rcpoftihg rcsealclr. It does not incllrde honest

al \ 5fi.102).

34. Among other things, Columbia Universit"v's applicable proccdurcs rcgarding

Scicr'rtihc MiscondlLct provide in peftil-Ient part as follo$'sl

. The person alloging the nisconduct should "consult The Connnittee on the ConductofScience."

"lT]he person alleging Inisconduct should bring his or her concem to the attentionofthe faculty nember directly responsible lbr the individual whose actions arc inquestion [Dr. Wood]."

"hr response to an allegation ofmisconduct the Vicc Prcsident lor l-Iealth Sciences

[Fischbach] rvi11 initiate a pleliminaly review {or inqrir'}) wlich may be followed byan investigation. An inquirf consists of information gathedng and initial factinding to detcmine whether an allegation or apparcnt instance of misconduclwafirrt5 dn ir' esrierLion. '

"Nluch as the accuser ]nay wish to ha!e his,/her anon\]nirv prorected, such protectioninfiinges on the rights ofthe accused. . . . Ifan inquiry is initiatecl the Conmittcemust mako cvery elfo to protcct the dghts ofthe accuser but not his/het ideilily."

Thc accused "mlrst be protected Bom penalty and public knou{edge of anyaccusation until.judged cu$ab1c. Therelore, the Lhiversity should do nothing toimpede the ability ofthe accused to continue rvith his'hcr u'or* during the period ofthc inquiry and investigation unless the Vice President lFischbach] dccms the inte maction is lr,arrantcd such as ilterim suspcnsion of\1ork because ofpossib]c advcGeconscquences ofcontinucd lesearch oi the weli-being ofhuman subjects. In thisinstance, il will be necessdy lor thc Vice President [Fischbach] ro i.lbnr theappropriate olfice ofthe Urlited StaLes Dep.rtment of Health and HunaD Sen,icesthat an inquiry in undq way. The accused must bc infomted ofthis notificarion."

If any inquiry is commenced, "prccautions u'i11 be taken against real or apparcotconflicts ofinterest on thc pa ofthose involved in the inquiry."

"The chajryerson ofthe involved depaftr]]crt lDr. Wood] or the instituLe or centerdircctor \\'ill be infbnned" that an incllLiry has conmenced.

The accused "u.jll be notified that an inqrLil-a'is in progress."

10

''The accused $ ill ha\ e ihe opplrrr[nrn io m--i \\ rih lile ood\ iond aii.! r'n; irqJi.,to Leam the allcgalrons. !o respord to d1e allegalions boih orall) rn and \\nting tsrc]and to leam the jdentity ofthe individual(s) making the allegalions."

"A wdtten report shall be prep:ued by the body conducting thc inquiry that states

what cvidence was reviewed, sunmaaizes relevant interyiews and sels fo h theconclusions reached. A copy oflhe reporl shall be given to the accuscdto commcntupon it and any such cornments shall bc part ofthe record of the inqlLiry."

"Should review of the inquirl indicate that sulficient caLrse exisls for an

investigation. the Vice President [Fischbach] nust, in accordance riith ledetalregulations, rellort that decision to the Depatment of Health and Human Servicesand, in addition rvill pronptly notify the person(s) suspected of nisconduct, theindividual(s) naking the allegations, the individual(s) directly responsible lor theperson(s) suspecled of nlisconduct, lhe depaltnent chairpcrson [Dr. \\ ood] orinstitute or centcr dircctor, the President, and the general counsel lo the Universitl,.The Vice President lFischbach] nray suspend the investigator's research activitiesduring thc invcstigation. . . . If resealch activities are suspcnded, all sponsonngagencies are to be infomed by the Vice Prcsident IFischbach]."

The Vice President fFischbach] rrill appoint an ad /ror committee comprisingwhatever experts are needed for the investigation to be car-ried out thoroughly, fairlyand pronptly. In consliluting the Committee, precalLtions will be taken against rcalor apparent conflicts of intqcst. It is suggcsted th,3 con'rmittcc includer (a) one ormore pelsons $.ith expertjse in the scientific area in question; (b) persons from atleast two faculties of the University; (c) at least one penon liom oulside theUniversity. No person with prior involvement in the matter under investigationshould sene on the conlmittee."

The accused has the right to appear before fie connittee to present testinlony on hisbehall

Thc accused has the right to be acconpanied bycounsel for advisorypurposcs lvhenappearing before thc cornnittee.

Thc accused has a rigl'rt to a copy ofa tape-recording which shail be nade ofhis owl1testimony.

The accused has a right to "examine the comnittcc's lllc ofdocumcnts, to rcceivea draft ofthe committee's final repofi, and lo comnent on it in \rriting and/or byappearing belore lhe committec to prcsent arguments in rebuttal."

The accuscd has the right to a finding delermined by majority vote on the basis ofevidence r-eviewed."

11

"An expeditious solution ofthese nlatters is essenfial. In generul, an inatuitt shaultlbe completed within 60 days and tot iuyestigution shoul.l be contpterctl t, irhin l:0dafs a-ftheir respectite inceptions. The accused m:1 requcst thc r rhc Vtte prestdent

IFischbach] acceleratetheproceedingsshouldtheprocessappeartobcurlrrecessarill/prololged. Should the response ol the Vice presidcnt be unsatisfactofr' to thoaccuscd. he.ll. n,r)alpe"l oth<.\e\Lt,\e..on-.tteeo tl - Fr.ulrl r,.]i, I .

"A copy ofthe lindings ofthe investigation shall bc seit ro . . . the chairman oftheapprop ate department [Dr. Wood] or instjtutc or center director to the accused andlo lhe accuser "

. Ifmisconduct is found, Fischbach ,.shall iniblm,,the president, the general counsel.the approptiate office $,ithin tle Deparlment of Health antl Human Senices, 1naccordance with federaL legulations aod to any other indivitluals privy to thcinvestigation.

. "The accused ret.lins rhe righl to appeal a1l findings to the provosl ofthe University.ln the abscnce of such an appeal. the Vice prcsidenr [Fischbach] shall imposesanctions in accordimcc with University Statutcs, bl, laws andpractices. Theaccusedshall also have the right to appcal such sanctions to the pro\,;st ofthe Universitv.,,

(Exhibit B).

Anonymous Allegations Of Scientific llisconduct AgainstBeunett-Guerrero In ConnectioD With The protocol AndColumbia University,s Respqule To Same

35. Upon infomration and beliel, on Novenber 2g.2000 ifnot earlier, tlvo (2)

a''onl,lnous accuscrs! beiieved tobe doctors \\.itltin Bennctt_Guerrerc's depar-tmentwho thenselvcs

pafiicipated in the Protocol and never voiced any concem or complaint to Bennett-G[enero or his

Chaimran, first nade accusations of scjeutiftc ntisconduct against Be lett_cue]Tero to thc

-\drdnistrative Dir.ector ofthe IRB with respcct to thc protocol.

36. Thc initial allegations ofscientific misconduct (substantively addressed at:ll

61-98 i4lp) apparently included, among other thi[gs, ..allegalions,, th,!t: (a) Bennett-Guerero did

12

notllllormtheIRBandsrud\panicipanisoi;;t..;l::....,:l.--:.:i-:-.::--::::::-,:

puryose ofthe study tiom rhe IRB and studypa icipanrs by omirting marerial in[omalion itom !h-

Prctocol, the consent lo1m and the lalperson summary regarding the iltent to study tl]e impact ol

these FDA approved fluids on patients and not nerely a "TEG" tcst; (c) Bennett-GlLerrero lailed to

obtaill IRB pemission to modify the Protocol after initial approval by the IRB; (d) lhe approvecl

fluids administered during the Protocol were administered in an unsale manncr; (e) protocol

palticipants wereharmed; and (1) Bennett-Guerrcro lailed to repod ccrlain adveISe events to the IRB

and Columbia Univcrsity oIficials.

37. It is beyond serious dispute that such allegations failu,ithin the dctinition of

"Scientific Misconduct" and ldggcredthe ColutrrbiaUnivcrsityprocedures set forlh in thepreceding

section and at Exhibit B. Yet, in vioiation ofthose procedurcs and thejr professional responsibility.

the accusers did not report their concems to Bennett Guerrero,s Chainnan, Dr. Wood. Moreover.

Columbia University failed to advise Bennctt-Guerrero ofthese allegations until more than eight (g)

months later. lnstead of follorving Columbia University's mandated procedutes jbr addlessing

allcgations of scientil'lc misconduct consistent with federal r.egulations (co pare Er6ibit B tdjll

Exhibit C), the IRB conducted an allegedly ,,random,, auclit of tl.ie prorocol soon theleafter

prcsumably as aresult ofthe allegations. That audit resr.rlted in afindingofno se ous issues *,ith

the Protocol and conduct ofthe study.

38. Upon inlbrmation and belief, unsatistied qith the t-esults ofthe allegedly

"random" audit, nearly eight (8) nonths later, on July 30, 2001, the anonlmous accusers apparently

t3

asain repcarcd their accusalions against Be rell-GuelTero lbmtally ln a $riiing djrecled Io

respot]del]t Fischbac]r.l

39. After receipt ofthe Ju1y, 2001 letter, Fischbach still lailed to 1bl1ow tle

applicab le proc edures andpolicies lor addrcssing allegations olScientific Misconduct. Instead, he

ignorcd the policies and procedures specifically designe.l to protect the dghts ofBcnnett-Guerrero

Ln recognition of the significant stigma and impact thal such allcgations have on a physiciim's

reputation ilnd career, and opted to design his o$r] whimsical procedures no\,/hcrc statcd in \\'rjting

or e!er fonnally enunciated.

40. Fischbach thus directed nn arbitrary audit process and immedialely halled

enrollment jn all of Bcnnett-Cucn-ero's research studies, thereby inflicting danage belore any

inquiry had cven bcen conductcd ir direct violation of thc applicable rules. Even so, Fischbach

laiied to provide Bennett-Cuerero $.ith the specilics of thc alicgations made by thc anon)mous

accuscrs or to afford him any ofthe protections set forth ii those policies and p|ocedures.

,11. Thus, from July, 2001 rhrough October 26, 2001, all ofBennett-GlLeraero's

research was haltcd. Upon inlbmration and belief, this intenm sanction in and of itself \\as far

greater than any punisl'ment neted out at Columbia Univercity and other siiilar institutions after

an investigation has concluded that therc has in fact been scientific misconduct, yct this sanctionwas

imposed belore any inquiD, had even takcn place lnuch less an investigation concludcd.

42. Nevenheless, during tlis time, Bennctt-Cucrrcro x as invcstigated bv a secret

committee, \\'hosc melnbers Rcspondents relused to identify, alldxith whom Bcnnett-Guenero was

pennitted no direct contact. In Octobq, 2001, the fu]] IRB hcld a rrcctirg and adoptcd thc ropofi

rI1 is uncertain at this tirne ho\\' much Fischbach kne$' ofthe allegations prior to this lime.

14

and findings o lthe secret conlmittee which \\, erc not disclosed to Bennett Gu,irrq o. Indeed. he rvas

not allowed to review an.v ofthe evidence or findings and lvas not even infonlcd ofthe specific

allegations.

43. Based upon such report, the IRB permitted the re-opening ofcnroilment in

all ofBennett-Guerrero's studies, witlt certain modifications, on October 26, 2001, and the natter

appeared to be concluded.a

44. On February 19, 2002. howevel, apparently unhappy with the conclusion of

the sccrct committce and the result reached, Fischbach sent yet mother lctter to Bennett-Guenero

and Dr. \Vood advising them that Bennen-Guerrcro was prohibited lrom publishing the resuhs ol

thc Protocol "until this mattcr is resolved." Upon infonnation and belie l, after delivcrl ofthis lettcr,

Fischbach did nolhing to attenpt to resolve the matter or to furthe. conxnunicate l\,,ith Bennett-

Guerrero

45. Therefore, on Ap l 14, 2002, Bennett-Guenero sent a letter to Fischbach

raising specihc <luestions and concen]s regarding the app:rent lack ofdue process beilg alforde<1

to him and the lack ofnoticc to the OHRP (Exhibit D hereto). Aliet receiving no response lronr

Fischbach, on April 29, 2002, Bennett-Guenero sent a follo$Lup letter to Fischbach sceking a

response to fiis questions in the letter.dared April 14, 2002 (Exhibit E hereto).

46. Finally, on May 8, 2002, Fischbach advised Bennert-Guenero by lotter that

Dr. Harvey Collen ("Coiten") would re-exanrine the endre matter, stating that the mattels will be

asignificantly, Bennett-Guenero $,as subjcct to monitoring of lis research activiticstherea{ter lor a period of at least thee (3) nonths. Upon infonnation and belief, althoughRespondents have refused to provide the monitoring roports. the monitor. lvho tvas a member oithelRB, had notling but positive renarks on Bennett-Guerrero,s rosearch activities.

l5

addressed qLrickly and resoh'cd, )er he still lailed to respoid direcrly to Berxrefi Cuenero s slated

questions and concoms (Exhibit F hereto). Fischbach clearly had an agenda in mind lor tlis third

review and a pre-ordained conclusion that he lvas bent on receiving.

4'1 . Aftel Bennett-Guerrcro expressed concems that tlis rvas auother attempt to

reopen issues previously resolved by the IRB on Octobcr 26, 2001 simply to obtair.t a result mote

favolable to the anon],utous accuscrc and Fischbach, Colten inlol1ned Dr. Wood, who relayed it to

Betulett-Guerrero, that the so,called "Colten Comnittee" was not a disciplilury contmittee and that

Bennett-Guenero did not need an attorney to procced.

48. Upon information and beliei the Colten Conmittee was not conposed of

appropriale individuals inaccordance with therequirements fora conmiftee investigating scientific

nisconduct allegations (see Exhibit B). Indeed, menbers of the Colren Coilmittee had ciear

conflicts ofinterest *'hich q'ere not addrcssed. Some mernbers had themselves padicipated inthe

review and approval process ofthe Pr.otocol. Fischbach himselfhad conflicts ofinterest since his

wile was a nember of the IRB and upon infomation and beliel \\,as inr,olr ed in fie ongoing

oversight and review of the Protocol, and upon infonnation and belicl he $,as responsible lor

supervision ofthe prior procedunl revir3lvs ofthe protocol. Ofcourse, oo noticc was evcrprovidcd

to Bcmett-Gueraero thal there was an i11quiry or investigation ofhiln pemonally rn plogress.

49. Nearlyayear and a halfafterthc allegationswere hrct ntade, on Jr y1,2002.

Bennett Cuerero was interrogatedbythe Colten Committee. The questioning \\,as disorganizeal and

he was effectively prevented fiom responding to the allegations that he belicved to have been made

against hin in what rvas a blatant ellorl to push lbr a predetermited resLrlt.

t6

50. The hnal reporl oflhe Colten Contmittee I'as dteD not issued lbr nore than

two (2) rnonths thereaftel, and when it was ultimately issued in September, 2002. it was not sharcd

with Bennett-Gue11ero or Dr. Wood, his Chairman, and Bemefl-Guerrero \1,as not permittcd to

comment orally or in writing on the same (in clear violation ofthe applicable procedures).

51. OnSepientber26, 2002,Bennett-Guerero met \1ith Fischbach. Duringthis

meeting, Fischbach stated that he had consultcd lvith yet another committcc regarding sanctions and

that he intended to impose sanctions against Bemett-Gueraero, includilig all those eventually

imposed as well as a tlreatened intent not to rene\v Bennett GuerrcLo,s en1plo)mcnt. Upon

inlbrmation and belief, such sanctions werebeing imposed over the objection ofDr. Wood, Benne[-

Guerrero's Chaimr;:n

52. Fischbach also indicated that a letter would be delivered to the OHRP rvitlin

da),s not$,ithstanding Bemett-Guerrero's concems about the acculacy ofthe inlormation that woulal

be contained in such lett€r. Bennett-Guerero was denied the oppofiunily to rcvie$, the lctter in

advance.

5 3 - On Septembcr 27, 2002. tlnough his undersigtied altomey, Bennett Gucrrero

requested a meeling \\.ith Columbia Uni\, eIS ity,s counsel and requested a postponement ofthe letter

to the OHRP until the accuacy ofthe contents ofsuch letter could be verified. Columbia Universitl,

denicd the request to postpone sending the letter to the OHRP, but a$eed to mcet wilh BennetF

Cuenero and his counsel on October l, 2001. One day befbre thc scheduled nceting, Coluntbia

University dclivered fie disputed lettcl to the OHRp wlich letter cootained a number of

inaccuracies a]rd lailed to reflect lirlly and accwately the relcvant record.

11

5,+. Colunrbia Lnirersrtl s counscl dten rnrireti a subnlssion in thc natire oii

requesl fbr reconsideration ftom Bennett-Guenero and instrllcted Bctutett-Guelrelo that there was

no fomal avenue of administrative appcal ftom the decision of Fischbach. Bennetr-G$enerc

thereafter made requcsts for cortain documents in an attempt to clarily the accusations that \\,ere

le'ied againsthim and forevidence supporting the findings ofthc'arious committees in counection

with the Protocol and the sanctions that were to be iltlposed against Bennett Cueuero. Ihc majo t),

ofthe requested infomtation was not loflhconting or was delivclcd in an incomplete and rcdacterl

mannef,

55. Mosr rccenlly, on January 7. 2003, through Dr. Woocl, Fischbach dcljvered

toBe rett-Guerrero a letter (dated December 27, 2002) which stated rhat in addition to the sanctions

pleviously imposed (which were never fomally irnposed), elfective June, 2003 Bennett Guenero

will be relnoved from his position as Assistant professor, Depallment ol ,Anesthesiology alld

demoted to a new position and title for a one yeaf pedod (Exhibit G hereto).

Respondents' Blatant Violations Of Columbia Universit"r'sOwn -Applicable Procedures For _Addressing Allegations

Scienlifi nduct As I'[ Bv }-erler

56. It is beyond serious dispute that Respondents Columbia Unilersiry and

Fischbach deprived BennetFGucnero ofthe rolo$'ing fundamcntar rights to $hich he was entitrecl

pLrrsua''t to columbia uoiversitv's orvn applicablcprccedures for addressing a]legations ofscientihc

nisconduct (Sgq'l11 32-3,1 above and Exhibit B) including, auong olher violations:

i. The anon)rmous accuseLs did not adlise The Committee onthe Corduct of Science or Dr. \\rood, the faculty memberdirectly lesponsible lor Bennett-Guefero, or BcnneLtGuertero ofthc al]eged misconduct;

l8

ll.

ll1.

tv_

vlt.

lx.

x.

viii. Fischbach did not repofi that an investigation had conrmencedto thcDcpaftInent ofHealth and Human Services, Dr. Wood,the Columbia University President or the ColumbiaUnivcr sity gencral counsel;

Bennett-Gucrrero was not protectcd lrom penalty and publicknowledge ofthe accusalions during inquiry and investigationof the alleged misconduct and his research was impropeilysuspended;

Neither Bennet-Guenero norDr. Wood, as Chairperson ofthcinvolved depaftrnent, was infon'ncd that Fischbach intenclecl

to conmence a fomal inquiry;

Bennetl-Gueraero was not permitted lo meet with the

inquiring body to leam ofthe allegations against him; in facthe u,as not foimally advised ofthe allegalions ihat weie made

against hiln;

Bennelt-Guelaero was notpermitted to respond to the alleged

rllegaLion. ord..) o- in 'r r ting d.rrinb the irq.t.ry.

Bennett-Guerero was not permitted to leam the identity ofthe individuals making the alleged accusatiolls;

No w'itterl rcpoft of any inquiry stating the eviclencereviewed, slLnxnarizing tbe relevant intqa/iews and settingforth any conclusions was given to Bennett-Guerrero forconlnent, which commerts rlerc lequired to bcconc part ofthe ofhcial record:

Fischbach did not infom the sponsoling agencies pdor tosuspending Be1'mett-Cuelrero's r escarch activities pending a

fu11 investigation;

Bcnnctt-Guerrero u,as effeclively denied lhe right lo be

accompanied by counsel during his tcstimony to thcconmittee conducting the investigation, having been

spccificaily informed that the committee was not a

disciplinary committce and that counsel was not required;

Bennett-Guenero rvas denied timely access to a copy of a

tape-recording of his testil'nony;

t9

xt1. Betulett Cuenero $,as deried thc right to e\iuninc theconmittee's hle of docrulents, including sumiraries of allindividuals intervi cwed:

xiii. Bennett-Guerero was deniedtheright to rcceive adraftofthccommiltee's final report ofthe investigation and to conmenton it in rvriting or by appearing before the comnittee topresent arguments in rcbuttal;

xiv. Bennett-Guerero \r,as denied the ght to an cxpeditioussolution to the allegations (Columbia Uoiversitv's orvnpolicies and the federal regulations require an inquirynormallyto be completed within 60 days and aninvestigationnormally to be completed wtthin 120 dal,s - here neariy nvo(2) years elapsed between the filst accusations a.,rdFischbach's latcst imposition of sanctions);

xv. Neither Bennett-Guerero nor Dr. Wood as the chaiman ofthe appropriate depafiment, received acopyoftlte findings ofthe irvestigation;

xvi. Bennett-Guerrero was deoied the dght to appeal 10 thcexecutive conx1ittee ofthe Faculty Council, being advisedtltere was 4q right to appeal this matter; and

xvii. Bennett-Gucrero \.as denied the right to appeal theit'npositio[ of sanctions to thc provost of ColumbiaUniversity, again being advised he had qq r.ight to appeal.

(eeq Exhibir B).

5'7. Even separate and apa11 fiom the written procedur.al protections set fofih by

Colunbia University specifically lor addressing the allegations at issue, Respondents, treatnent of

Beturett-Gue[ero is u'iprecedcnted and abhonent to anynotion ofdue process and r'air trcarnent and

should deeply offend any fair-mindcd individual.

58. Even after various recluests by Ber ett-Guerrero and his counsel and the

a'bitrary imposition ofsaoctions against Bennett-Guerrero, Respondents Coito''bia Universit\, and

Fischbach inexplicably conlinue to refuse to identifl. thc anonyl|ous accuscrs ancl to pror ide rhc

completc record that sopported the hndings a11d sanctions.

59. Under thc circumstances, it is dillicult to i agine a more rcprehensiblc and

nlalicious violatiol'l ofan individual's stated rights. For a Dean ofaD edLrcational institution sLrch

as Columbia Ulivelsity to conduct himsclf in such a manner clearly cdes our fo1 judicial

inlen'cntion. Upon information and beliel Fischbach has willfully and inlenrionally engaged in the

abovc-referenced improper activities and imposed the arbitrary and rmsuppofted sanctions with

inteitional or'reckless intent to hann the career and reputalion of Bcnnett-Guerrqo.j

60. Given the nature of Columbia L-niversity's actions and tlte passage ofti e,

thc procedulal infinr'rities alone recluire that all the relief requested in this \reri1'icd petition be

grantod*ithout even addressing the substantive n''erits ofthe allegations h'ricd. Neverlheless, \\.hat

akes the conduct even mor-e outageous is that the subslantivo allegatjons ar-e not suppofled bythe

rccord and ate without merit.

Bennett-Guerrero Did Not Enqaggln Scientific },Iisconduct

61. As set loith more fu11y belorv. each ofthe investigatoN, including Bcnnelr

Guerrero, attcmpted to follow in good faitrr arl appricable policics and proccdues to ensuie thc sarery

of the parlicipanrs and the integ ty of the research process. Bennett-Guerrero did in fact

.rb.tar i:lir cot_p.) \ ll a rppltc.Lhle -ule. . nd te3 tl"t o.,.

iUpon inlbmation and belief, Respondents also rvillfully antl inrentionally disseminated"confidential" infonnation co.ceming this matter to third paftjes in a funher a[empt to harm thereputatioo ofBennett-Guerrero and in ftmhcr violation ofthe policies and procedues ofcolumbiaUniversity and the fcderal rlrles and regulations. Specifically, it appears that photographs allegedlyclepicting "unsafe" worldng conditions during the protocol were shown to physicial1s and sulgeonswho were not in'olved in the Protocor or Coru'nbia uni'e'sity's impropcr re'iews olthe protocor.

21

A. The Consent Fo1m

62. The patient/pafiicipant consent loml for the plotocol \vas reviewed and

approved by the IRB prior to enrollment ofthe fiISt patient in the protocol.

63. Anong other things, the consent form identifies the fbllou mg:

a. The title ofthe protocol;

b. Thc procedures utilizcd in implementing the protocol;

c. The loreseeable risks associated \\.ith the protocol:

d. Altenatives to pa(icipating rn tho prolocol;

e. The cost's and conpensation associated with pafticipatiig in the

Protocol;

I The confidentiality associated with piuticipation in the protocoi:

g. A statement that pafticipation in the protocol is completely voluntary;

h. An idenijfication ofthe persons to contact ifapatient/participant has

questions regarding the Protocol; and

i. A {bnnal statenent of consent to pa icipate in tho protocol to be

signed by each patient/pallicipant.

61. The consent lorm identifies the following procedures to bc employcd in

implementing the Protocol:

Ifyou decide to participate in this stlrdy, we will give you one oflourfluids during surgcry. The decisiou of whjch of these 4 approvedfluid to give you wiil be bascd on chance, that is you have a 25%chance (1 i114 chance) ofreceiving any one olthese lbur approvedfluids. The four fluids are called Lacratod Ringers, 57u Albumin insaline, 6% Hetastarch in saline, and Hextend rrr. As is clone routinelvd rrng lteart 5urget). rll( lluid u ill be rorr nt.rere,t rnror gl dl ..1\:(a catheter or plastic tube insefied into one ofJ'our veins as a routine

21

part olyour snrgery). Yourdoclo$ $.illgive youthrs tluidto rcplaceblood and fluid that is routinely lost dlr ng swgery. You \\'ill begiven lhe fluid based on inlormation from monitors that are routinelyused dudng srugery.

Parl ofthe studyinvolved taking blood samples (less than 3 teaspoonslotal) at six diflerent time points fronl a catheter (plastic tube) thatyou \\'i]l havc in one of your blood vessels as pafl of ]our routinecale. Since this tube will be inserted for your routinc carc, you willnot experience any additional discomforl (or have any addilionalneedle slicks) as a result olyourparticipating in this study. Lessthan3 teaspoons ofblood rvill be taken altogether ddring surgery and inthe intensive care unit. Taking this blood will not inoease yoruchances of needing a blood tlanslusion. This blood will be used totest how your blood is clotting. The results liom this test will not be

used by the docto$ to gride your care.

An additional part ofthe study involved visiting you after surgery tosee how you are doing You will bo visitcd in thc intcnsivc care uritand when you go to a reg0lar hospital room lo see how you arefeeling. You will not bc asked to take any tests or fill oui imy

swgerv (which, of course, were many; for example, bleeding) since thesc dsks rvere t&l: both

"foreseeable" and the result ofpadicipation in the study.

B. The Specific Accusations

65. The consent fonn (apprc!ed by the IRB) identified certain "lotcseeable" dsks

associated with pafiicipation in the Pro1oco1.

66. The consenl fomt did not disclose the sks relating to the underl]'ing hearl

6'l. Asdiscussed above, and upon information and belief, the accusatious included

allegations that: (i) the IRB was nisled as to the true puryose ofthe Protocol, (ii) the consent lomr

did not disclose certain loresecable dsks; (iii) ercess levels of fluids u'crc utilizedt (iv) Bennett

23

Guerrero faiLecl to repod celtaii adverse cvents to the IRB; (\') there were advelse eflects to bunan

pa icjpants; and (vi) the fluids involved in the study were prepared in iul unsafe mamer'

68. Notably, the Colten Committee cletermined lhat thelc was no 'dvcrse

ellecl

to hunan health as a result ofthe Protocol and that there \\'as no scientific nisconducl

69. Each of fhe unsuppofied accusations is untrue lor at lcast lhc lollowrng

reasons:

(i) The PurDosc oflhe Protocol

T0. Bennett-Guerero did not mislead the lRB because the lRB \\'as provided with

more than adequatc infonnalion aluring the revien'process so as to be a\\'are that the tevised and hnal

Protocol was not n]elely a "TEG" study, butrather lhat one ofthe objectives was lo assess the lmpact

ofthese FDA approved fluids on patients

'71. Priolto the approval ofthe IRB' the investigators contactedthe surgeons and

presented the Prctocol to the Cardiac Surgeons at their $eekly meeting Discussion at thrs meeting

resulted in an expansion of the 1ial into more of an outcome stud"v as it]dicated by the m:rny

"recolded outcon:res" that \\'erc addeal to the Protocol prior to apploval by the IRB and the change

in the study title itsell

'72. It is clear that pdor to approval, thc IRB knelv the Protocol lvas an outcone

study and did not ask the irlvestigators to revise tlle lalperson sumilary and consent lonn to reflect

f[rtl]er the "outcome" natwe ofthis t al

(ii)

'73.

cucrreio failed to

The Consenl Fonn Disclosed The Foreseeable Risks

Upon infomtation and beliel the anonlmous accusers allege that Bennell-

disclose significant bleeding as a loreseeable risk

71

'14. The consent lom for this study, however, was approved by the IRB alier

extensive review and discussion over a four (4) month period. For example, priorto approval therc

rvas bothrvitten and verbal conmunication with members ofthe IRB and outside expefis about the

potential impact ofone ofthe Protocol's fluids, Hespan, on coagulation. This discrLssion took into

account infomution including but not limited to known clinical trials as well as lhe package inserls

for the lour (4) fluids.

75. In fact, the IRB requested at the beginning oftheir Protocol review that the

investigators submitthepackage inserts for-all four (,1) FDA approved fluids and theywereprovided.

76. Based on their reviell, the IRB nembers and experts from the departments

ofnedicine and surgery agreed with the investigators that the "theoretical elfects ofthis Iluid on

coagulation" did not make clinically signihcant bleeding a "forcseeable risk." Hence, they did not

request that the risk ofbleeding be addcd to the dsks section of the consenl fonn.

7E. Finally, Protocol paticipants participated based on a consent fonn that was

created in good laith by a team ofexperts, notjust Dr. B(]nnett-Guerrero.

(iiD Fluid Volumes

79. Among other charges, it was alleged that though not cited in the Protocol, the

volun]e ofone ofthe fluids (6% Hetastarch in 0.9% NaCl) used in the study exceeded the amounts

that *.ere approved by the FDA.

'7'7 . The investigators and the IRB at the time clealiy believed that all ''loreseeablc

risks" were disclosed

25

package insei

merit.

In fact, neither the FDA nor the manulactuer ofrhis fluid (as indicated by lhe

the fluid in question) state an upper volume iimit so rhis allcgation is without

(iv) RePQlllilgAdverseEvents

81. Arothercharge is thatDr. Beirett Guefforo failed to repolt all adversc events

to lhe IRB, specifically events ofbleeding.

82. At all times the investigators believed that they were conrplying rvith lRB

regulations regardjng adverse event reporting. Deaths were reported promptly. Other events werc

not repofted because none were believed to fulhll the IRB,s criteria of serious A41 uncxpected and

related to the stlrdy.

83. Ofsignificant note, the IRB did not complain $,hen Dr_ Manspeizer, tlte initial

Princjpal lnvestigator ofthe Protocol, did 1lot repod qq adverce elfects at thl] time ofthe sludy

renewal, at which time apprcaimately 100 patients had been eniolled.

84. It is clearlyinpossible for 1 00 patients to undergo cardiac swgery at a tcrtiary

care center with 'rone

of these patients having any complications/adverse events to the caraliac

surgqJ.

85. In fact, all (100%) of patients bleed aftcr cardiac surgery so it would be

ludicrous and without import to report all patients.

86. Moreover, the investigators looked at tlte results lor the fiIst 100 patients ( -25

patients per study group) in a blinded andlysis a11d there was no trend that$'ouid suggestthat patients

in any gloup were being harmed-

E0.

for

26

E7. ln fact, the evenl "takeback lor bleeding" is not even significantly differcnt

statistically at study completion (200 patients, !50 patients per study $oup).

(v) Alleqation ofAdverse Elfects on Patients

88- Upon infonnation rind belief, the imonlanous accuserc allcgcd thai

89. There is no evidence ofpalient hamr as a result oflhe P1otocol. Morcovcr,

the invostigation by the Colten Conmittee detemined thcre was no patieut hann.

90. [n fact, compiication rates il1 this study were the same or lower than the

complication rates obserr'ed inpaiients receiving similar treatments thal were not pafiicipants inthc

studv.

(vi) AllegationofunsafePreparatia4illui{1q

91. Upon information and beliei the anonyrous accusers alleged that Bennetl

Gucrrero prepared the Protocol's fluids in an ulmafe manncr.

implementation ofthe Prolocol resulted in patient ha1m.

92. No evidence was presented, ho*ever, that the study fluids were prepared in

::n lnsale manner

93. The procedure used was approved by dre IRB with consultation {iom the

Research Phannacv

94

was aware of how tl'le

95.

Ph:rnnacy.

The IRB was fu11y arvare th at the investigatorswerepreparingthese fluids and

study fluids were being prepared.

The IRB never requested that th,- study fluids be prepared by the Resealch

21

96. The sinlple and sterilo protocol used lor preparing the fluids rvas perlormed

by trained in<lividua1s. FlLrid "preparation ' did not involve "mixing" or weighing out and addition

ofpowders, gg, sodium and chloride powder, to fluid or compounding

g'7. In fact, theProtocol involved tansfering the FDA approved fluid to asterile

bag (nranufaclrLred specifically for this purpose) using the includcd "spike alid key" systen which

insures sterility. A tiny amount (1 m1) ofyellorv FDA approved stedle multivilamin was added lo

each fluid (to make them all have a yellow hue).

98. In any event, tfiere is no evideDce that aliy patient was hanned by the use of

the IRB approved procedure for fluid prcpantion.

Respondents Sinsled O

99. Notwithstanding the team effort ofsevelal inv€stigatols in connection with

the Protocol, only B ennetFcuerero was singled out for review, audit and sanctions as a rcsult oflhe

anon),1nous accusers' allegations conceming the Protocol.

100. Upon infotmation a]1d belief, no other investigator who participaled in the

study, or who reviewed and approved it, has been subject to any inquiry or discipline.

101. Upon infonnation and belief, Respondents skewed the reality of the

teant$oup effolt in an attempl lo single out Bennett-Guelaero and deflect possible 'rilicism fronr

the IRB and the Respondents, including specifically the polential impact onFischbach and his wife

102. In fact, Resporrdents' ovelall tono and theme appeaN to evincc a deliberate

intent to discredit Bennett-Gue1aerc as an individual and an iivestigator'

28

103. Recent jnvestigationsbythe OHRP regarding othcr Colunbia Linivcrsiry and

columbia Presblterian Medical center protocols that failed to comply with fbderal regulations

lu1lher illustrate the inequitable treatnent of Bennett-Guerrero.

104. For example, in sevemi ofthese protocols, it appcars the investigators di.l not

even submit the protocols 10 the IRB for review and approval, ye1 upon infomratio[ and beiief, no

sanctions were imposed by Respondents o11lhephysicians at issue, much less the cxtreme sanctions

imposed on Bennett-Guenero.

1 05 . In one p rotocol, investigators failed to disclose a ..risk ofdeath.,, Agai11 Lr po n

jnformation and beliel no sanctions rvere imposed by Respondents.

Deficiencies With Columbia Universitv's IRB

106. Unbelcrownst to Bennett-Cuenero at the time, the IRB was woefully

inconpetent in the perfomance and discharge of its obligations. Upon infomafion and bcliel

respondent Fischbach and his rvife (who was a member of the [RB) were atvare of the IRB,s

deficiencies rurd laiied to take approp ate action in a timely manne. to address them. Then, in an

effot to dellect some ofthe {bcus and blame lol the IRB,s problems, respondent Fischbach chosc

to pursue Bennett-Gue11ero in connection witl the protocol.

107. As a lestament to the serious and now acknowledged deficiencies with the

IRB, Columbia University recently engaged in a systematic overhaul ofthe IRB, which overhaul is

ongoing. Indeed, due to such deficiencies, all protocols are now scnt ro wcstem rRB, an outsi.le,

independent contractor lor review and processing. Such a drastic move is tantamount to an

institutional admission ofthe extrene and gloss natLue ofthe IRB's probrems for which Bennett-

Guerrero is still wrongfrlly fielding the blame.

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108. Upon inlomation and beliel noie olthese dcficicncies u'ere properly and

thoroughly considered during the various reviews ofthe Protocol or the investigation of Bennett-

Guerrero prior to the imposition ofsanclions against Bennett-Guerrero for alleged deliciencies in

a Prolocol approved by the lRB.

Damases To Bennett-Guerrero's Career And Rep_!lt4dg4

109. The damages suffered by Bennett-Cuerrero arc far-reaching and ale

siguificartly.broader than those suffered as a result ofthe sanclions imposed to date by Col nbia

Univel sity. For example, as early as October, 2002, rumors were circulatiig lhat Bennett Guerero

had been fired by Columbia University as a result of improp eties in his research. Based on thesc

rumors, third parties have reconsidered speaking engagenents and other endeavols they have

undcrtaken with Bennett-Guerrero. Moleover, as a result ofthe suspension ofhis rcsearch, he and

other physicians working with him have been deprived ol signi{icant research oppofiunities and

patients have been deprived ofpotentially beneficial therapies and hoatnents.

FIRST CAUSE OF ACTION(DECLARATORY JUDGMENT)

1 10. Bennett-Cuerero repeats and realleges the allegations contained in paragraphs

1 tl ough 109 herein as if set forth in full.

I 1 L As a rcsult of the forcgoing, the sanctions imposed by Columbia University

1 12. Therefore, Bennett-Guerrero is entitled tojudgn]errt declaring that each ofthe

sanctions imposed by Colnmbia University and Fischbach is arbitrary, capricious, an abuse of

discretion, illegal atd invalid.

SECOND CAUSE OF ACTION(INJUNCTION)

1 1 3 . Bennett-Gue[ero repeats ard rea]leges the allegations contained in p N.ragraphs

1 through 109 herein as ifset forth in full.

114. As a result ofthe foregoing, Beinett-Guefiero is entitledto apreliminaryand

permanentinjunctionprohibiting and restraining ColumbiaUliversity andFischbach ftom imposing

and/or implementing any previously imposcd sanctiot]s against Bennett-Cucrrcro, including (a)

restraining Respondents from restricting in any manner Bennett-Guerrcro's ability to condlLct,

pusue, md publish all clinical research to the samc cxtcnt as any othcr faculty lnembei and provided

such research is in compliance with applicable rules and regulatiolls; (b) enjoining Columbia

UniversityandFischbach from imposing and,/orimplementing any further sanctions againstBennett

Guerrero by vidue of his pafiicipation in IRB approved Protocol #9256 or his i11s1i1ution of this

proceedilg; and (c) directing Respondents to reinstate Be1x1ett-Gueraero's positions and titlcs as

Assistant Professor, Department of Anesthesiology and Chief of the Crrdirc Ancsthcsiology

Division.

WHEREFORE, it is respectfully requested that the Couft enter ajudgmcnt:

1. Decl:uing that the sanctions imposed against Bennett-Guenelo by

Respondents are arbitrary, capricious, an abuse of discretiot], illegal and invalid and Iestraining

Respondents from imposing and/or implementing any such sanction;

3l

2 Restraining Respon'lents from resticting in any marmer Bemett-Gue ero's

ability to conduct' pursue' and publish a1l clinical research to the same extent as any other faculty

menlber and provided such research is rn compliatLce with applicable mles and regulations;

3 Enjoining Colunbia University and Gerald Fischbach ftom imposing and/or

implementing any further sanctions against Bennett-Guerero by virtue of his parlicipation in

Protocol # 9256 or his institution ofthis ?roceeding;

4. Direoting Respondents to rcinstate Bennett-Guenero's positions and titles as

Assistant professor, Departnent of Anesthesioiogy and chief of the cardiac Anesthesiology

Division;

5 Ordering Respondents to pay Bennett-GuelTero's in'idental damages'

ircluding bis legal fees and disbursements incuned in this proceedirg; and

6 For suci'l other and further different relief as the Courl deems iust and proper

under the circumstances

Dated: New York, New York

January 23, 2003

MORzuSON COHEN SINGER AND WEINSTEN{' LLP

FITED Ellott Bennett-Guerrero

?50 Lering4on A\ enoe

New York, New York 10022

(212) ?3s-8600

JUN 2 5 ?003

counrlHJfffornce

for Petitioner

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