Columbia Drug Study: Elliott Bennett-guerrero V. Columbia University

SL?RJ\.IE COLRT OF TH: ST{TE Of

::Tlt::)T:T

\E\\

\'ORK OR!GIIIAL

......................x

ELLIOTT BENNETT-GUERRERO. M.D. Petitioner, In a Mafier Pursuant to Arlicle 78 Law and Rules

lndex N-o.

ofthe Civi] practice

//i

aOa loZ

NOTICI, OF VERIFIED PETITION

,against-

THE TRUSTEES OF COLLMBIA L]NTVERSITY IN THE CITY OF NEW YORK AND GER.AI-D FISC]IBACH,

Dated Pur-chased and Filedl

Jaov "c-) 23,

Respondents.

---

2

o

13

------------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:

FELED JUN 2 5 2003

couur{?uJu-!oJ.

orne s

(1)

declaring that the sanctions imposed against Bennett-Guerero by Respondents

are arbitrary, capricious, an abuse

:npo"ir5 ard o-:np emerl

(2)

ofdiscretion, illegaland invalid and restraining Respondents lio1n

ng dny .uch sdnc.ion.

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, undersigned at least five (5) days

p

or to thc retum date

if

:tny, shall bc scrved upon the

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 York January 23, 2003

You$, etc., MORRISON COHEN SINGER & WEINSTEIN, LLP

Atlomols for Petitioner Eliiot Bennett-Guenero 750 Lexington Avenue New Yo*, New York 10022 (212) 73s 8600

FILED ?003 JuN 2 5

counr\E$Jffforrrce

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 Practice Law and Rules -against-

tndcx No.

lot 9co las

Nrah"e't . t lae /oz

VERIFIED

PETT T'ION

IAS Pafi

THE TRUSTEES OF COLUMBLA LNTV-ERSITY IN THE CITY OF NEW YORK AND GERALD FISCHBACH,

Assigned to

Hon

I

FILffi.M JUN 2 5 2003

Rcspondellts

couu{?lJ#orner Petitioner 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 and clinical admit'ting privileges at Columbia Presb)terian N,ledical Center, a hospital affiliated with Columbia University. For puryoses of this veiilled petition, respondent Tmslees of Columbia University in lhe City of New York, Columbia University, Columbia College of Physlcians and Sugeons and all departnents thereof, and ColumbiaPresbltedanMedical Center will be collectively ref,-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 Professor, Deparlment ofAiesthesiology and rcinstatement

ofhis title and positio|r

oflis title

and position as

as Assistant

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

2.

ancl costs.

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 such requests havebeen dcnied.

Heispreparedtoha!eamonjtorasacoidiiiontorcsurrinqallresearch.

institutions that resulted in publications in highly cited medical joumals and has, in lact, over onehundred (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

the alleged evidence against r-e

-

to revierv, much less confront,

him. He was also intentionally misled about tlte process and ellectively

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

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

are based on

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

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

3

01 ,

7E0l

The Rele\ rnr Parrier And

6.

Fnririi{

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

7.

as

Exhibit A and incorporated hercin

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\\'

conprised of a liumber of schools of higher lcarning, one of

York. Columbia Univcrsity

lhich is the Columbia

College

is

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

.__::

.: :.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
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 Investigator, tirst subnitled to the IR B lbr revierv ancl approval

Manspeizcl, as rhe principal

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

23.

lully approved by thc full board ol'the IRB.

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

25.

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

of

1999.

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

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

(

14)

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

completed. This independcnt saleiy analysis was suggestcdby Bennett Guenero b-v the

amd

also

implemenlecl

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 Respect To 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 Conduct

ofScience."

"lT]he person alleging Inisconduct should bring his or her concem to the attention ofthe faculty nember directly responsible lbr the individual whose actions arc in question [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 by an investigation. An inquirf consists of information gathedng and initial fact inding to detcmine whether an allegation or apparcnt instance of misconducl wafirrt5 dn ir' esrierLion. ' "Nluch as the accuser ]nay wish to ha!e his,/her anon\]nirv prorected, such protection infiinges on the rights ofthe accused. . . . Ifan inquiry is initiatecl the Conmittce must 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 any accusation until.judged cu$ab1c. Therelore, the Lhiversity should do nothing to impede the ability ofthe accused to continue rvith his'hcr u'or* during the period of thc inquiry and investigation unless the Vice President lFischbach] dccms the inte m action is lr,arrantcd such as ilterim suspcnsion of\1ork because ofpossib]c advcGe

oi the weli-being ofhuman subjects. In this instance, il will be necessdy lor thc Vice President [Fischbach] ro i.lbnr the appropriate olfice ofthe Urlited StaLes Dep.rtment of Health and HunaD Sen,ices that an inquiry in undq way. The accused must bc infomted ofthis notificarion." conscquences ofcontinucd lesearch

If

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

"The chajryerson ofthe involved depaftr]]crt lDr. Wood] or the instituLe or center dircctor \\'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 the conclusions reached. A copy oflhe reporl shall be given to the accuscdto commcnt upon 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 ledetal regulations, rellort that decision to the Depatment of Health and Human Services and, in addition rvill pronptly notify the person(s) suspected of nisconduct, the individual(s) naking the allegations, the individual(s) directly responsible lor the person(s) suspecled of nlisconduct, lhe depaltnent chairpcrson [Dr. \\ ood] or institute or centcr dircctor, the President, and the general counsel lo the Universitl,. The Vice President lFischbach] nray suspend the investigator's research activities during thc invcstigation. . . . If resealch activities are suspcnded, all sponsonng agencies are to be infomed by the Vice Prcsident IFischbach]."

The Vice President fFischbach]

rrill

appoint an ad /ror committee comprising whatever experts are needed for the investigation to be car-ried out thoroughly, fairly and pronptly. In consliluting the Committee, precalLtions will be taken against rcal or apparent conflicts of intqcst. It is suggcsted th,3 con'rmittcc includer (a) one or more pelsons $.ith expertjse in the scientific area in question; (b) persons from at least two faculties of the University; (c) at least one penon liom oulside the University. No person with prior involvement in the matter under investigation should sene on the conlmittee." The accused has the right to appear before

fie connittee

to present testinlony on his

behall Thc accused has the right to be acconpanied bycounsel for advisorypurposcs lvhen appearing before thc cornnittee. Thc accused has testimony.

a rigl'rt

to a copy ofa tape-recording which shail be nade ofhis owl1

The accused has a right to "examine the comnittcc's lllc ofdocumcnts, to rcceive a draft ofthe committee's final repofi, and lo comnent on it in \rriting and/or by appearing belore lhe committec to prcsent arguments in rebuttal." The accuscd has the right to a finding delermined by majority vote on the basis evidence r-eviewed." 11

of

"An expeditious solution ofthese nlatters is essenfial. In generul, an inatuitt shaultl be completed within 60 days and tot iuyestigution shoul.l be contpterctl t, irhin l:0 dafs 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 tho accuscd. 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 ofthe

approp ate department [Dr. Wood] or instjtutc or center director to the accused and lo lhe accuser "

.

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

.

"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 impose sanctions in accordimcc with University Statutcs, bl, laws andpractices. Theaccused shall also have the right to appcal such sanctions to the pro\,;st ofthe Universitv.,,

(Exhibit B). Anonymous Allegations Of Scientific llisconduct Against Beunett-Guerrero In ConnectioD With The protocol And Columbia 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. 61-98

i4lp)

Thc initial allegations ofscientific misconduct (substantively addressed

at:ll

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 these

FDA approved fluids on patients and not nerely

a

ol

"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

38.

ofthe study.

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

,11. research was

ofthe protections set forth

ii

those policies and p|ocedures.

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

haltcd. Upon inlbmration

greater than any punisl'ment neted out at Columbia Univercity and other an

in and of itself \\as far

and belief, this intenm sanction

siiilar

institutions after

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

rI1

a

rrcctirg

and adoptcd thc ropofi

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 BennettGuerrero

45.

Therefore, on

Ap l

14, 2002, Bennett-Guenero sent a letter to Fischbach

raising specihc
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

46.

April

14, 2002

(Exhibit E hereto).

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 activitics therea{ter lor a period of at least thee (3) nonths. Upon infonnation and belief, although Respondents have refused to provide the monitoring roports. the monitor. lvho tvas a member oithe lRB, 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

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

s slated

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

t6

a

predetermited resLrlt.

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. da),s not$,ithstanding

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

rvitlin

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

requested

a

-

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

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

University dclivered

fie

l, 2001.

One day befbre thc scheduled nceting, Coluntbia

disputed lettcl to the

OHRp wlich letter

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

11

cootained a number of

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. toBe

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

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's Own -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 on the Corduct of Science or Dr. \\rood, the faculty member directly lesponsible lor Bennett-Guefero, or BcnneLt Guertero ofthc al]eged misconduct;

l8

ll.

Bennett-Gucrrero was not protectcd lrom penalty and public knowledge ofthe accusalions during inquiry and investigation of the alleged misconduct and his research was impropeily suspended;

ll1.

Neither Bennet-Guenero norDr. Wood, as Chairperson ofthc involved depaftrnent, was infon'ncd that Fischbach intenclecl to conmence a fomal inquiry;

tv_

Bennetl-Gueraero was not permitted lo meet with the inquiring body to leam ofthe allegations against him; in fact he 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 of the individuals making the alleged accusatiolls;

vlt.

No w'itterl rcpoft of any inquiry stating the

eviclence

reviewed, slLnxnarizing tbe relevant intqa/iews and setting forth any conclusions was given to Bennett-Guerrero for conlnent, which commerts rlerc lequired to bcconc part of the ofhcial record:

viii.

Fischbach did not repofi that an investigation had conrmenced to thcDcpaftInent ofHealth and Human Services, Dr. Wood,

the Columbia University President or the

Columbia

Univcr sity gencral counsel;

lx.

Fischbach did not infom the sponsoling agencies pdor to suspending Be1'mett-Cuelrero's r escarch activities pending a fu11 investigation;

x.

Bcnnctt-Guerrero u,as effeclively denied lhe right lo be accompanied by counsel during his tcstimony to thc

conmittee 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.

xiii.

Betulett Cuenero $,as deried thc right to e\iuninc the conmittee's hle of docrulents, including sumiraries of all individuals intervi cwed: Bennett-Guerero was deniedtheright to rcceive adraftofthc commiltee's final report ofthe investigation and to conment on it in rvriting or by appearing before the comnittee to present arguments in rcbuttal;

xiv.

Bennett-Guerero \r,as denied the ght to an cxpeditious solution to the allegations (Columbia Uoiversitv's orvn policies and the federal regulations require an inquiry normallyto be completed within 60 days and aninvestigation normally to be completed wtthin 120 dal,s - here neariy nvo (2) years elapsed between the filst accusations a.,rd Fischbach's latcst imposition of sanctions);

xv.

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

xvi. xvii.

Bennett-Guerrero was deoied the dght to appeal 10 thc executive conx1ittee ofthe Faculty Council, being advised tltere was 4q right to appeal this matter; and

Bennett-Gucrero \.as denied the right to appeal the it'npositio[ of sanctions to thc provost of Columbia University, 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

59.

a11d

sanctions.

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 as Columbia Ulivelsity

to conduct himsclf in such a manner clearly cdes our

sLrch

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 .rb.tar i:lir cot_p.) \ ll a

research process. Bennett-Guerrero

rppltc.Lhle -ule. . nd te3 tl"t

did in fact

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 the reputatioo ofBennett-Guerrero and in ftmhcr violation ofthe policies and procedues ofcolumbia University and the fcderal rlrles and regulations. Specifically, it appears that photographs allegedly clepicting "unsafe" worldng conditions during the protocol were shown to physicial1s and sulgeons who 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

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

Protocol;

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 oflour fluids during surgcry. The decisiou of whjch of these 4 approved fluid to give you wiil be bascd on chance, that is you have a 25% chance (1 i114 chance) ofreceiving any one olthese lbur approved fluids. The four fluids are called Lacratod Ringers, 57u Albumin in saline, 6% Hetastarch in saline, and Hextend rrr. As is clone routinelv d rrng lteart 5urget). rll( lluid u ill be rorr nt.rere,t rnror gl dl ..1\: (a catheter or plastic tube insefied into one 21

ofJ'our veins as a routine

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

Parl ofthe studyinvolved taking blood samples (less than 3 teaspoons

lotal) at six diflerent time points fronl a catheter (plastic tube) that you \\'i]l havc in one of your blood vessels as pafl of ]our routine cale. Since this tube will be inserted for your routinc carc, you will not experience any additional discomforl (or have any addilional needle slicks) as a result olyourparticipating in this study. Lessthan 3 teaspoons ofblood rvill be taken altogether ddring surgery and in the intensive care unit. Taking this blood will not inoease yoru chances of needing a blood tlanslusion. This blood will be used to test 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 to see how you are doing You will bo visitcd in thc intcnsivc care urit and when you go to a reg0lar hospital room lo see how you are feeling. You will not bc asked to take any tests or fill oui imy

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

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

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

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

pa icjpants; and (vi) the fluids involved in the study

68.

were prepared in iul unsafe mamer'

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

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

lor at lcast lhc lollowrng

69.

Each of fhe unsuppofied accusations is untrue

(i)

The PurDosc

T0.

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

reasons:

oflhe Protocol

as to be a\\'are that the

tevised and hnal

"TEG" study, butrather lhat one ofthe objectives was lo

assess the lmpact

more than adequatc infonnalion aluring the revien'process so

Protocol was not n]elely

a

ofthese FDA approved fluids on patients

'71.

Priolto the approval ofthe IRB'

the investigators contactedthe surgeons and

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

resulted in an expansion of the

1ial into more of an outcome stud"v

as it]dicated by the m:rny

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

'72.

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

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

f[rtl]er the "outcome" natwe ofthis

t

al

(ii)

The Consenl Fonn Disclosed The Foreseeable Risks

'73.

Upon infomtation and beliel the anonlmous accusers allege that Bennell-

cucrreio failed to disclose significant bleeding

as a loreseeable

71

risk

'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, rvas

bothrvitten

and verbal conmunication with members

priorto approval therc

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

investigators submitthepackage inserts for-all four

76.

(,1)

oftheir Protocol review that the

FDA approved fluids and theywereprovided.

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. '7'7

.

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

risks" were disclosed

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.

25

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

E0.

package

insei for the fluid in question)

state an upper volume

iimit

so rhis allcgation is without

merit.

(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. care center with

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

'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-

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

implementation ofthe Prolocol resulted in patient ha1m.

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.

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

The IRB was fu11y arvare th at the investigatorswerepreparingthese

fluids and

was aware of how tl'le study fluids were being prepared. 95.

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

Ph:rnnacy.

21

96.

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

by trained in
ofpowders,

gg,

"mixing" or weighing out

and addition

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 each

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

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. the Protocol, only B

Notwithstanding the team effort ofsevelal inv€stigatols in connection with

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

102.

In fact, Resporrdents' ovelall tono and theme appeaN to evincc

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

28

wife

a deliberate

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

to pursue Bennett-Gue11ero in connection

107.

lol the IRB,s problems, respondent Fischbach chosc

witl

the protocol.

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 BennettGuerrero is still wrongfrlly fielding the blame.

29

108.

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

thoroughly considered during the various reviews ofthe Protocol or the investigation of BennettGuerrero 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

1

tl

10.

Bennett-Cuerero repeats and realleges the allegations contained in paragraphs

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

1

3

.

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

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 such research is

as any

othcr faculty lnembei and provided

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 Assistant Professor, Department of Anesthesiology and Chief

as

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 ability to conduct'

ero's in any marmer Bemett-Gue resticting from Restraining Respon'lents extent as any other faculty research to the same clinical a1l publish and pursue'

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

ftom imposing and/or and Gerald Fischbach University Colunbia Enjoining in virtue of his parlicipation by Bennett-Guerero sanctions against implementing any further

3

ofthis ?roceeding; Protocol # 9256 or his institution

4.

to rcinstate Bennett-Guenero's Direoting Respondents

positions and titles as

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

5

Ordering Respondents

to pay

damages' Bennett-GuelTero's in'idental

and incuned in this proceedirg; disbursements and fees legal ircluding bis and proper as the Courl deems iust relief different further and For suci'l other

6

under the circumstances

York Dated: New York, New January 23, 2003 AND WEINSTEN{' LLP MORzuSON COHEN SINGER

FITED ?003 JUN 2 5

counrlHJfffornce

for Petitioner Ellott Bennett-Guerrero ?50 Lering4on A\ enoe

New York, New York 10022 (212) ?3s-8600

32