december 9-11, 2013 | marriott marquis | new york, ny th

DECEMBER 9-11, 2013 | Marriott Marquis | New York, NY

Register Now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed

DRUG and MEDiCal DEviCEl i t i G a t i o N

18th Annual

Expert Strategies for Leading Litigators & In-House Counsel

The must attend drug and medical device litigation event that will provide expert insights unavailable at any other forum, including how to:

• UTILIZEaninnovatorliabilitytheorywhenarguingforgenericpreemption

• SuccessfullyREMOVEaputativeclasscasefromstatetofederalcourt

• DEVELOPeffectivestrategiesforMANAGINGunexpectedproductsafetyrisksandissuesarisingfromeffortstoobtaindiscoverycrossinginternationalboundaries

• CULTIVATEamediarelationsstrategytofaceanadverseeventorgovernmentinvestigationheadon

• USEcomplexscientificevidencetopersuadethejurythatuseoftheproductdidnotcausetheplaintiff ’sinjury

• COMMUNICATEnewinformationpromptlytohealthcarepractitionersvia“DearDoctor”letters

• ESTABLISHincross-examinationthatproductriskswerecontainedonthelabelandwerenotwithheldbythecompany

Featuring a “who’s who” of in-house attorneys in the trenches of products liability litigation:

Distinguished Co-ChairsCatherine Kassenoff ExecutiveCounselandExecutiveDirector-HeadofU.S.LitigationandGovernmentInvestigationsBoehringerIngelheimUSACorp

The Honorable William S. Duffey, Jr.DistrictJudge,N.D.Georgia

The Honorable David HerndonChiefJudge,S.D.Illinois

The Honorable Richard KramerJudgeSanFranciscoSuperiorCourt

The Honorable Theodore A. McKeeChief JudgeU.S. Court of Appeals for the Third Circuit

The Honorable Christopher NuechterleinMagistrateJudge,N.D.Indiana

The Honorable Cynthia M. RufeDistrictJudge,E.D.Pennsylvania

The Honorable John TunheimDistrictJudge,DistrictofMinnesota

The Honorable Kaymani D. WestMagistrateJudge,DistrictofSouthCarolina

Judicial Insights

LeadSponsors: CocktailHost: SupportingSponsors:

Sponsoredby:

AbbottMedicalOpticsAllerganBayerCorporationBiogenIdecBiometBoehringerIngelheimBristol-MyersSquibbCoCardinalHealth

CelgeneCorporationCovidienC.R.Bard,Inc.DaiichiSankyo,Inc.EliLillyandCompanyGEHealthcareGlaxoSmithKlineJohnson&Johnson

MedtronicNovartisPharmaceuticalsCorporationPfizerInc.PurduePharmaTevaPharmaceuticalsW.L.Gore

FDA Keynote Address Kelsey A. Schaefer

AssociateChiefCounselforEnforcement

OfficeofChiefCounsel U.S.FoodandDrug

Administration

Judicial Insights on Multidistrict Litigation The Honorable

John G. Heyburn II ChairmanJudicialPanelonMultidistrictLitigation

Earn CLE

ETHICS Credits

Added Networking

Opportunities with

In-House Counsel

Michael Parini SeniorVicePresident&ChiefLitigationCounselPfizerInc

Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed

Ailyn AbinCorporateCounsel,LitigationCelgeneCorporation

Patricia A. BarbieriDeputyGeneralCounsel,LitigationandEmploymentLegalAffairsDaiichiSankyo,Inc.

Kenneth F. BaumPartnerGoldmanIsmailTomaselliBrennan&BaumLLP

Andrew T. BaymanPartnerKing&SpaldingLLP

Erin M. BosmanPartnerMorrison&FoersterLLP

Donald P. BunninSeniorLitigationCounselAllergan,Inc.

Debra L. BurnsSeniorCounsel,Litigation/InvestigationsGEHealthcare

Abigail M. ButlerPartnerFaegreBakerDaniels

Sharon L. CaffreyPartnerDuaneMorrisLLP

Alexander G. CalfoPartnerBarnes&ThornburgLLP

Candice CiresiSeniorCorporateCounsel,VascularTherapiesCovidien

Lori CohenShareholderGreenbergTraurigLLP

Christopher D’AngeloPartnerMontgomery,McCracken,Walker&Rhoads,LLP

Greg A. DadikaAssociateGeneralCounsel,LitigationC.R.Bard,Inc.

Adam DeutschVicePresidentandAssociateGeneralCounsel-Litigation,InvestigationsandRiskManagementBiomet,Inc.

Ranjit S. DhindsaPartnerHollingsworthLLP

Kathleen Erickson DiGiornoSeniorLegalDirectorMedtronic,Inc.

Jan DoddPartnerNortonRoseFulbright

The Honorable William S. Duffey, Jr. DistrictJudgeU.S.DistrictCourt,N.D.Georgia

Amy R. FitermanPartnerFaegreBakerDaniels

Melissa A. GeistPartnerReedSmithLLP

Edward W. GereckeShareholderCarltonFields

Charna GerstenhaberVicePresidentandHeadofLitigationNovartisPharmaceuticalsCorporation

Julie HardinPartnerReedSmithLLP

Jill HarrisonCounselW.L.Gore&Associates,Inc.

Max C. Heerman PrincipalLitigationCounselMedtronic,Inc.

The Honorable David Herndon ChiefJudgeU.S.DistrictCourt,S.D.Illinois

The Honorable John G. Heyburn IIChairmanJudicialPanelonMultidistrictLitigation

Timothy HowardAssistantCounselMerck&Co.,Inc.

Michael HoweAssociateGeneralCounselBiogenIdec

Michael HulkaGeneralCounsel,LillyOncology&ImCloneSystemsSeniorDirector,AssistantGeneralCounselEliLillyandCompany

James W. HustonPartnerMorrison&FoersterLLP

Sidney KanazawaPartnerMcGuireWoodsLLP

Brandee KowalzykPartnerNelsonMullinsRiley&ScarboroughLLP


Heidi KrausPartnerFanelliHaagandKilgerPLLC

John P. Lavelle, Jr.PartnerMorgan,Lewis&BockiusLLP

Jason D. MaxwellVicePresident&AssociateGeneralCounsel–LitigationCardinalHealth

The Honorable Theodore A. McKeeChiefJudgeU.S.CourtofAppealsfortheThirdCircuit

Jennifer Mingus MountcastlePartnerThompsonHineLLP

Dwight O. MoxieSeniorCounsel-LegalDepartmentAllergan,Inc.

The Honorable Christopher NuechterleinMagistrateJudgeU.S.DistrictCourt,N.D.Indiana

Michael PanagrossiAssociateGeneralCounselPurduePharmaL.P.

John J. PeaseSeniorCounselTevaPharmaceuticals

Steve PhillipsSpecialCounselMedtronic,Inc.

Jennifer Quinn-BarabanovPartnerSteptoe&JohnsonLLP

Janet M. RichardsonDivisionCounsel,LegalAbbottMedicalOpticsInc.

The Honorable Cynthia M. RufeDistrictJudgeU.S.DistrictCourt,E.D.Pennsylvania

Kelsey A. SchaeferAssociateChiefCounselforEnforcementOfficeofChiefCounselU.S.FoodandDrugAdministration

Kim M. SchmidExecutiveManagingPartnerBowmanandBrookeLLP

Steven M. SelnaPartnerDrinkerBiddle&ReathLLP

Jeffrey B. ShapiroPartnerArnstein&LehrLLP

Eric W. SitarchukPartnerMorgan,Lewis&BockiusLLP

Kaspar StoffelmayrVicePresident&AssociateGeneralCounselBayerCorporation

Vincent A. Thomas, CPA, CFF, CVA, ABVSeniorManagingDirectorForensic&LitigationConsultingCo-Leader,U.S.IntellectualPropertyPracticeFTIConsulting

Brennan TorregrossaAssistantGeneralCounselGlaxoSmithKline

The Honorable John TunheimDistrictJudgeU.S.DistrictCourt,DistrictofMinnesota

Lisbeth A. WarrenAssistantGeneralCounselJohnson&Johnson

Jonathan WassermanVicePresident&AssociateGeneralCounsel,Litigation&GovernmentInvestigationsBristol-MyersSquibbCo.

The Honorable Kaymani D. WestMagistrateJudgeU.S.DistrictCourt,DistrictofSouthCarolina

John D. WinterPartnerPattersonBelknapWebb&TylerLLP

Robert K. Woo, Jr. PartnerKing&SpaldingLLP

Pamela J. YatesPartnerKayeScholerLLP

Kevin ZielkeMemberDykemaGossettPLLC

CO-CHAIRS:Catherine KassenoffExecutiveCounselandExecutiveDirector-HeadofU.S.LitigationandGovernmentInvestigationsBoehringerIngelheimUSACorp

Michael PariniSeniorVicePresident&ChiefLitigationCounselPfizerInc

2

DISTINGUISHED FACULTY

DRAwN FROM THE bEST THAT THE bAR, THE bENCH, AND THE INDUSTRY HAS TO OFFER

As Pressure on the Drug & Device Industries Continues to Mount, be a Part of the Products Liability Event that Shapes Industry Policies and Strategies

3Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed

Forthepast17years,leadingdrugandmedicaldevicelawyershavegatheredinNewYorktonetworkwiththeirpeers,andcraftstrategiestosurmountnewlitigationchallenges.Nowinits18thyear,ACI’S DRUG AND MEDICAL DEVICE LITIGATIONiswidelyregardedastheyear’spremierproductsliabilityforum.

Network with the “who’s who” of the products liability space

Thisyear’s speaking faculty is comprisedofmore than20 in-housecounsel, leadingproducts liability litigators for the top lawfirms,prominent government enforcers, and renowned members of the state and federal bench, providing advice for defeating claims andlitigatingmoreefficiently.WearepleasedtoannouncethatKelsey A. Schaefer, Associate Chief Counsel for Enforcement in the Office of General Counsel at the FDAwillbeofferingkeynoteremarks.

Hear how your industry peers are responding to Crises caused by adverse events and government investigations

A crisis management plan is becoming increasingly important to drug and device manufacturers.When faced with a product recall,government investigation,or respected journal thatnegativelydiscussesoneofyourproducts,yourcompanyneedsaproactivemediarelations strategy. In-house counselmust coordinate crisis effortsbetween the legal andbusiness sideof thebusiness andknowwhentobringintheexpertiseofoutsidecounseloraPRfirm.Expertspeakerswillhelpyoutodevelopacrisischecklisttousebefore,duringandafterthemanufacturer’sresponse.

Highly tailored track sessions enable attendees to focus on core areas of interest

Inresponsetoindustryfeedback,thisyear’sconferencewillfeaturetwodistincttracks–oneaimedathoningyourtrialstrategies,andtheotheraimedatthebiggestchallengesfacedbyin-housedruganddeviceattorneys.Overthecourseofanafternoon,attendeeswilllearnthelatesttrialtactics,fromVoir DiretoDaubert,withcommentarybyThe Honorable John Tunheim.Forattendeesofthein-housetrack,challengessuchasCase Management,Duty to Train,andGovernment Investigationswillbeaddressed.

Recurring highlights of this annual program include:

• Multiple networking opportunitiesincludinglunches,breaksandcocktailreceptions

• ComplimentaryparticipationinthePre-conference Speed Networkingfacilitatedbyin-housecounsel

• The Judicial Panelfeaturing7 renowned state and federal jurists,eachwithdistinguishedrecordsofindustrymasstortsoversight

• Post-ConferenceBusinessDevelopmentMasterClassonSelecting and Evaluating Outside Counsel

NEW THIS YEARPre-Conference Workshop – A 50-State Drug & Med Survey: Drilling Down into the State-Specific Legislation that Impacts Drug & Medical Devicewillprovideanopportunityforpractitionerstolearnvaluablefundamentalsthatwillenableyoutobeabetteradvocateforyourcompanyandclientandseguenicelyintotherestoftheprogram.

Sinceitsinception,NewYorkCityhasbeenthebackdropforDrugandMedicalDeviceLitigation,providingmanyexcellentnetworkingopportunitiesforthe400+ drug and medical device industry professionalsattendingtheconference.

Registerearlytoensurebestpricing.Groupdiscountsareavailable.Call1-888-224-2480,faxyourregistrationto1-877-927-1563,orvisitusonlineatwww.drugandmed.com.

JointheACI: Drug and Medical Device LitigationgrouponLinkedInto‘meet’yourpeerspriortothestartoftheconference;andfollowusonTwitter@DrugandMedforindustrynewsandexclusivediscounts.

IlookforwardtoseeingyouinDecember!

KindRegards,

StaceyB.Evans,J.D.SeniorProgramDirector

Withpreemptionattheforefrontofall litigators’minds,itcanbedifficult tokeep trackof all thedifferent state legislation that canimpactyour trial strategy.Additionally,practitioners strugglewithconsumer fraud concerns and patient efficacy claims. This Pre-ConferenceWorkshopwillserveasaninvaluablefoundationfortheremainderoftheconference.Expertswilldiscuss:

Preemption• Applyingpreemptiondecisionsinotherindustriestothedrug

anddeviceindustries• Understandingtheinterplaybetweenpreemptionandthe

FDAregulatoryprocess• Dealingwithstatecourtjudgesindifferentjurisdictions• Minimizingtherisksofpenalizinginnovativedrugmanufacturers• Pleadingaroundpreemptionandhowthesecasesarebeing

defended• AnalyzingtheStengeldecisionanditsapplicationtomedical

devicepreemption• Updatinglabelstoconformwithbrandmanufacturers• Addressingparallelclaims

ConsumerFraud• AnalyzingfraudontheFDAallegations• PreventingplaintiffsfrompresentingfraudontheFDA

evidence• Insulatingthemanufacturerfromliabilityforfailuretowarn

claimswhenithascompliedwithFDAstandards• SeekingabroadapplicationoftheBuckmanfraudonthe

FDApreemptiondecisiontoallclaimsthatamanufacturerfraudulentlywithheldinformationfromFDA

PatientSafety• Exploringmanufacturers’dutywithrespecttopatientsafety• Determiningwhatinformationmustbecommunicated

tothepublic• Educatingplaintiff ’scounselonaproduct’sefficacy• ProactivelyapproachingFDAtoupdateaproduct’s

label/blackboxwarning

Pre-Conference workshop:A 50-State Drug & Med Survey: Drilling Down into the State-Specific Legislation that Impacts Drug & Medical Device Litigation [including preemption, consumer fraud and patient safety]

9:30 a.m. – 12:30 p.m. (Registration and Continental Breakfast at 8:45 a.m.)

Pre-Conference Group Speed Networking Facilitated by In-House Counsel

3:00 p.m. – 5:00 p.m. (Registration begins at 2:15 p.m.)

Attendees at this year’s conference will be able to participate in aunique, interactive,networkingsessionthatservesasagreatkickofftotheconference.Included in your registration cost,youcanmeetyourindustrypeersfromacrossthecountry,asyouaredividedintotopic-specifictablestomeetandshareinsightswithin-housecounsel.Whenthebellrings,attendeeswillmoveontothenexttable,foradifferent topicdiscussion. In-Housecounselwilloffer their analysisonthecomplexlitigationchallengescurrentlyfacingpharmaceuticalandmedicaldevicemanufacturers.Asyoubegintoconsidertheissuesaddressedateachtableandmeetnewcolleagues,youwillimmediatelybegintoreapthebenefitsoftheleadingproductsliabilityforum.

Topicsofdiscussionwillinclude:

• Hellholejurisdictions• Punitivedamages• Newanddevelopinglegaltheories• Failuretowarn• StateandfederalFalseClaimsAct• Genericandbrandmanufacturersasco-defendants• Managingjointlydefendedlitigationwithallianceor

collaborationpartners

4

Theprocessofselectingofoutsidecounseliscrucialtothesuccessorfailureoflegalservicesperformedbylawfirmsforcorporations.Thedrugordevicemanufacturerneedstocarefullyvetpotentiallaw firms and define the needs brought on by various cases.In-housecounselwillgiverarelyheardinsightson:

• Whatistheprocessforbecomingamanufacturer’spreferredprovider?Howdothe“littleguys”getinthegame?

• Strategiesforincreasingoutsidecounselperformancewhiledecreasingcost

• Whatmeasuresareinplacetocontinuetooptimizeresources?- metricsforeffectivenessandefficiency

• Whatisaneffectiveandfairwaytoassesscounsel’sperformance?


Edward W. GereckeShareholderCarltonFields(Tampa,FL)

Ailyn AbinCorporateCounsel,LitigationCelgeneCorporation(Summit,NJ)

Donald P. BunninSeniorLitigationCounselAllergan,Inc.(Irvine,CA)

5:00 p.m. Pre-Registration and Welcoming Cocktail Reception Hosted by:

MONDAY, DECEMbER 9, 2013

Janet M. RichardsonDivisionCounsel,LegalAbbottMedicalOpticsInc.(SantaAna,CA)

Steve PhillipsSpecialCounselMedtronic,Inc.(Philadelphia,PA)

Lisbeth A. WarrenAssistantGeneralCounselJohnson&Johnson(NewBrunswick,NJ)

Post-Conference business Development Master Class on Selecting and Evaluating Outside Counsel

3:30 p.m. – 5:30 p.m. (Registration begins at 3:15 p.m.)

5

Eachyearmorethan21,000in-housecounsel,attorneysinprivatepracticeandotherseniorexecutivesparticipateinACIevents–andthenumberskeepgrowing.

Guaranteed Value Based on Comprehensive Research

ACI’s highly trained teamof attorney-producers arededicated, full-time, todeveloping the content and scopeof our conferencesbasedoncomprehensiveresearchwithyouandothersfacingsimilarchallenges.Wespeakyourlanguage,ensuringthatourprogramsprovidestrategic,cuttingedgeguidanceonpracticalissues.

Unparalleled Learning and Networking

ACIunderstandsthatgainingperspectivesfrom–andbuildingrelationshipswith–yourfellowdelegatesduringthebreakscanbejustasvaluableasthestructuredconferencesessions.ACIstrivestomakeboththeformalandinformalaspectsofyourconferenceasproductiveaspossible.

American Conference Institute: The leading networking and information resource for counsel and senior executives.

Theprocessofselectingofoutsidecounseliscrucialtothesuccessorfailureoflegalservicesperformedbylawfirmsforcorporations.Thedrugordevicemanufacturerneedstocarefullyvetpotentiallaw firms and define the needs brought on by various cases.In-housecounselwillgiverarelyheardinsightson:

• Whatistheprocessforbecomingamanufacturer’spreferredprovider?Howdothe“littleguys”getinthegame?

• Strategiesforincreasingoutsidecounselperformancewhiledecreasingcost

• Whatmeasuresareinplacetocontinuetooptimizeresources?- metricsforeffectivenessandefficiency

• Whatisaneffectiveandfairwaytoassesscounsel’sperformance?

• Negotiatingfeearrangementsandmonitoringperformanceandbillingpracticesofoutsidecounsel- outliningexpectations

• HowimportantareChambersrankingsandsurveys?• In-housecounselpetpeevesoftheiroutsidecounsel–what

behavior/activities/styleshouldbeavoided?• Howdocompaniesselectwhichoftheirpreferredproviders

worksonwhichcase?• Understandingthegrowingpartnershipbetweenthegeneral

counselandtheCEO• Matchingtheuniqueskillsetoftheattorneytothetechnical

andlegaldemandsofthematterinordertomaximizetheresultsofyourlegalspend

In-house counsel for: • pharmaceuticalcompanies• medicaldevicecompanies• biotechcompanies• healthcareorganizations

Attorneys practicing in:• pharmaceuticals• medicaldevices• productsliability• masstort• complexandmultidistrictlitigation• healthcare• complexclassactions

WHO YOu WIll MEET

Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMedRegister now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed

wEDNESDAY, DECEMbER 11, 2013

Patricia A. BarbieriDeputyGeneralCounsel,LitigationandEmploymentLegalAffairsDaiichiSankyo,Inc.(Parsippany,NJ)

Kathleen Erickson DiGiornoSeniorLegalDirectorMedtronic,Inc(Minneapolis,MN)

Heidi KrausPartnerFanelliHaagandKilgerPLLC(former General Counsel Abon Pharmaceuticals LLC)

7:00 Registration & Welcome Breakfast

8:00 Co-Chairs’ Opening Remarks

Catherine KassenoffExecutiveCounselandExecutiveDirector-HeadofU.S.LitigationandGovernmentInvestigationsBoehringerIngelheimUSACorp(Ridgefield,CT)

Michael PariniSeniorVicePresident&ChiefLitigationCounselPfizerInc(NewYork,NY)

8:15 Case Study from Mensing to Bartlett: Determining Whether Design Defects Claims are Preempted for Generic Manufacturers and the Potential Liabilities

Catherine KassenoffExecutiveCounselandExecutiveDirector-HeadofU.S.LitigationandGovernmentInvestigationsBoehringerIngelheimUSACorp(Ridgefield,CT)

Erin M. BosmanPartnerMorrison&FoersterLLP(SanDiego,CA)

Jan DoddPartnerNortonRoseFulbright(LosAngeles,CA)

John P. Lavelle, Jr.PartnerMorgan,Lewis&BockiusLLP(Philadelphia,PA)

• Whoismakingthedeterminationofaproduct’sefficacy?- FDA- plaintiff- brandedmanufacturer- juries

• Ensuringproductsareaccompaniedbytheproperlabeling

• Mirroringthesafetylabelofthebrand-namecompanyandalertingtheFDAwhenevertheylearnofanadverseeventrelatedtotheirproducts

• Clarifyingthe‘failuretowarn’standardanditsapplicationtodrugsafety

• Exploringthetensioninthelawwherebrandeddrugsaresubjecttocertainproductliabilitysuits,butthegenericversionsarenot

• AnalyzingeffortswithintheFDAandCongresstoimposeliabilityongenerics

• CraftingpreemptionargumentswhenthereisnoobviouscommentfromtheFDA

• Utilizingthenovellegaltheoryofinnovatorliability• Pleadingaroundpreemption–howarenegligent

training/claimsbeingdefended?• UnderstandingtheimplicationsoftheStengeldecision

ondevicemanufacturers’preemptionarguments• Definingthemanufacturer’sdutywithrespecttosafety

andpubliccommunication

• Addressingplaintiffs’parallelclaims- summaryjudgmentmotions- discoverychallenges- examplesofclaims

• CanbrandedmanufacturersbeliableforfailuretopublishinthePDR?

9:15 FDA Keynote Address

Kelsey A. SchaeferAssociateChiefCounselforEnforcementOfficeofChiefCounselU.S.FoodandDrugAdministration(SilverSpring,MD)

9:55 Morning Coffee Break

Hosted by:

10:10 Judicial Insights on Multidistrict Litigation

The Honorable John G. Heyburn IIChairmanJudicialPanelonMultidistrictLitigation

10:40 Bolstering the Defense Position: Effectively Defeating Class Certification

Michael PanagrossiAssociateGeneralCounselPurduePharmaL.P.(Stamford,CT)

Jennifer Quinn-BarabanovPartnerSteptoe&JohnsonLLP(Washington,DC)

Amy R. FitermanPartnerFaegreBakerDaniels(Minneapolis,MN)

John D. WinterPartnerPattersonBelknapWebb&TylerLLP(NewYork,NY)

• RemovingcasesonthebasisoftheClassActionFairnessAct(CAFA)

• AnalyzingthegrowingtrendofusingDaubertmotionstodefeatclasscertification- plaintiffstrategiesfordefendingthesechallenges

• Successfullyremovingaputativeclasscasefromstatetofederalcourt

• Defeatingplaintiffclaimsofnumerosity,commonality,typicality,andadequacy-of-representation

• Refutingaplaintiff ’sproofofclasswideliabilitytiedtothedrugordevice

• UnderstandingCourts’commonalitystandardandtheenforceabilityofclassactionwaivers

• Attackingclassdefinitionatthepleadingstage–overbreadthandascertainability

• Defensetacticsforpresentingfavorableeconomicanalysisinclassactionlitigation

• Usingdenialofclasscertoffensively

6 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed

DAY 1: TUESDAY, DECEMbER 10, 2013

11:40 Crisis Management & Litigation Preparedness: How Drug and Device Manufacturers Can Minimize Risk and Maintain Consistency When Litigation Looms

Timothy HowardAssistantCounselMerck&Co.,Inc.(NorthWales,PA)

Jonathan WassermanVicePresident&AssociateGeneralCounsel,Litigation&GovernmentInvestigationsBristol-MyersSquibbCo.(NewYork,NY)

Kenneth F. BaumPartnerGoldmanIsmailTomaselliBrennan&BaumLLP(SantaMonica,CA)

Kevin ZielkeMemberDykemaGossettPLLC(Detroit,MI)

Moderatedby:

Melissa A. GeistPartnerReedSmithLLP(Princeton,NJ)

• Pre-LitigationCrisisManagement–Developingastandardsetofpoliciesandprocedurestocounteractthesilomentalityfollowinga“signalingevent”

7Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed

Continuing Legal Education CreditsAccreditationwillbesoughtinthosejurisdictionsrequestedby the registrants which have continuing educationrequirements.This course is identified asnontransitionalforthepurposesofCLEaccreditation.

ACIcertifiesthattheactivityhasbeenapprovedforCLEcreditbytheNewYorkStateContinuingLegalEducationBoard in the amountof12.5hours, including0.5ethicscredits.Anadditional3.5credithourswill apply toMasterClassA and2.5 credithours toMasterClassBparticipation.

ACIcertifiesthatthisactivityhasbeenapprovedforCLEcreditbytheStateBarofCalifornia in theamountof10.5hours, including0.5ethicscredits.Anadditional3.0credithourswillapplytoMasterClassAand2.0credithourstoMasterClassBparticipation.

You are required to bring your state bar number to complete theappropriate state forms during the conference. CLE credits areprocessedin4-8weeksafteraconferenceisheld.

ACIhasadedicatedteamwhichprocessesrequestsforstateapproval.PleasenotethateventaccreditationvariesbystateandACIwillmakeeveryefforttoprocessyourrequest.

Questions about CLE credits for your state?Visit our online CLEHelpCenteratwww.americanconference.com/CLE.

CLE Credits

• Cultivatingamediarelationsstrategytofaceanadverseeventorgovernmentinvestigationheadon

• Trainingongooddocumentcreationandretentionpractices• Analyzingtheimpactontheattorney-clientprivilege,

eDiscoveryanddocumentpreservation• AssessingtheScience–Frequentlyoverlookedconceptsthat

mustbeappliedtoassessthestrengthsandweaknessesofthescientificbasisforcriticismsandsupportoftheproduct

• Coordinatingcrisismanagementeffortsbetweenthelegalandbusinesssidesofthebusiness

• Developingacrisischecklist–considerationsbeforeandafterthemanufacturer’sresponse

• Respondingonceamedicaljournaltanksoneofyourproducts- FDA- talkingtothepress- talkingtoemployeesandshareholders

• Preservingemails,draftsandotherdocumentsduringtheflurryofmediaandinvestigatoryactivity

• Protectingdocumentsthatwillbesubjecttodiscovery• Toolstopreventthelitigationfromovertakingbusiness

objectives• Assessingthebusinessandreputationalrisksandconsequences• Decipheringthescienceandworkingwithsalesand

marketingteamstobringlitigationsensitivitytotheprocess• Bringinginoutsidecounseltogirdyourselfforthecoming

litigation

12:50 Networking Lunch for Speakers and Delegates

Hosted by:

A B

bREAKOUT SESSION 1 | 2:00 p.m. - 3:15 p.m. (Choose A or b)


Conducting Successful Voir Dire and Selecting the Right Jury: Novel Strategies, Tactics and Ethical Considerations

Lori CohenShareholderGreenbergTraurigLLP(Atlanta,GA)

Sidney KanazawaPartnerMcGuireWoodsLLP(LosAngeles,CA)

WithCommentaryby:


• Understandinguniquejurorpreconceptionsindruganddevicecases–howdothesedifferfromtraditionaljurorattitudes?

• Identifyingproblemjurors–productspecificapproaches• Exploringdifferentmethodologiesandlinesofquestioning

forselectingajury• Ethicalconsiderationsinselectinganddismissingspecific

jurors• Addressingbiasesagainstlargemanufacturersand

minimizingtheimpactofnegativemediacoverage- gaugingwhatjurorswillnotlikeaboutthemanufacturer

• Effectivelyusingjuryquestionnaires• Framingquestionsformaximuminformationandcandor• Increasingthechanceofselectingtherightjurybyknowing

whattolookforwhenretainingjuryconsultants• Predictingjurorfavorabilitythroughpsychological

techniques• Analyzingtheimpactofrunawayjuriesonverdictsin

pendingcases- bestpracticesforreigninginrunawayjuries

• Managingunanticipatedjurormisconduct• Preventingjurorsfromaccessingelectronicinformation

aboutthecase• Conveyingtojurorstheimportanceofhavingaculture

ofcomplianceandpatientsafety

In-House Round Table: best Practices for Case Management

Debra L. BurnsSeniorCounsel,Litigation/InvestigationsGEHealthcare(Wauwatosa,WI)

Candice CiresiSeniorCorporateCounsel,VascularTherapiesCovidien(Plymouth,MN)

Jill HarrisonCounselW.L.Gore&Associates,Inc.(Flagstaff,AZ)

Michael HoweAssociateGeneralCounselBiogenIdec(Weston,MA)

Jason D. MaxwellVicePresident&AssociateGeneralCounsel–LitigationCardinalHealth(McGawPark,IL)

Moderatedby:

Julie HardinPartnerReedSmithLLP(Houston,TX)

• Establishinganeffectiveandbeneficialrelationshipbetweenin-houseandoutsidecounsel

• Enhancingcollaborationamongtheentirelegalteam,streamliningcommunicationsandsharingofkeyinformation

• Balancinggovernmentinvestigationswithdecreasedmonetaryresources- protectingboththecompanyandindividualemployees- doingmoreinternally

• Assigningin-houseattorneystomonitorindividuallawfirmsandmanagingthoserelationships

• Retainingexternallawyersthatunderstandadrugordevice’sapplicationprocessaswellastheepidemiologyoftheproductindispute

• Bringingthee-discoveryprocessin-houseandcreatingacompetente-discoveryteam

• Techniquesforresolvingcasesexpeditiously• Whenisitcosteffectivetousenationalcounsel?Regionalcounsel?

- maximizingcontributionoflocalcounsel• Settinglimitsonoutsidecounsel• Moreeffectivelysharingresourcesamongthedefenseteam• Successfulmethodsfordiscoverythathaveresultedinlowercosts• Placingmoreeffectiveemphasisonlitigationavoidance• Specifyinghowmattersaretobestaffed

- limitsonusageofnewassociates- clientconsentforchangesinassignedattorneys- settingdiversityrequirements

3:15 p.m. Afternoon Refreshment Break Hosted by:

CbREAKOUT SESSION 2 | 3:30 p.m. - 4:30 p.m. (Choose C or D)


DControlling the witness and the Testimony: Practical Strategies for Conducting a Direct Examination of the Company witness

Alexander G. CalfoPartnerBarnes&ThornburgLLP(LosAngeles,CA)

Ranjit S. DhindsaPartnerHollingsworthLLP(Washington,DC)

Jeffrey B. ShapiroPartnerArnstein&LehrLLP(Miami,FL)

WithCommentaryby:


• Selectinganeffectiveexpertwitness:detailingthecharacteristicsofapersuasivedefenseexpertwitness–whatcharacteristicstolookforandwhattoavoid

• Structuringtestimonyforcourt–discussingpotentialsubjectsfordirectandcross

• Ensuringthattheexpertcanexplaintheentiretheoryofthecaseinaclearconcisefashionduringhisorhertestimony–lowtechandhightechapproaches

• Personalizingandhumanizingthecompany• Utilizingrepetitiontohelptheissuesinkinwiththejury

- strategicuseofdemonstrativesandexhibitsandcourtrulesaboutpre-trialdisclosure

• Gettingtheexperttotruthfully(andfavorably)providerelevanthistory

• Showingthatthecompanyendeavoredtodowhatwasbestforpatientsafetyandtookimmediateactioninlightofpatientsafetyconcerns

• Usingcomplexscientificevidencetopersuadethejurythatuseoftheproductdidnotcausetheplaintiff ’sinjury

• Understandingwhentousemedicaljournalreports,notingevidentiarystatecourtlimitations

• Establishingfertilegroundforcross-examination• Keepingtrackofinformationthatiscommunicated

totheexpertforprivilegepurposes• Ethicalobligationsofcounselwhenutilizingexpertsin

druganddevicelitigation• Demonstratingthatcompanydidnotactirresponsibly

inputtingtheproductonthemarket• Howtoshowthatadverseeventresultswerenot

statisticallysignificant

Combatting Claims Against Device Manufacturers for Failure to Adequately Train Physicians and Managing the Proliferation of Dear Doctor Letters

Max C. Heerman PrincipalLitigationCounselMedtronic,Inc.(Minneapolis,MN)

Brandee KowalzykPartnerNelsonMullinsRiley&ScarboroughLLP(Atlanta,GA)

James W. HustonPartnerMorrison&FoersterLLP(SanDiego,CA)

• UnderstandingtheliabilityimplicationssurroundingDearDoctorLetters- FDAdraftguidance- communicatingnewinformationpromptlytohealthcare

practitioners• IsaDearDoctorletterwithinthescopeofthedefendant’s

dutytowarn?- causationevidence

• Defendingagainstplaintiffs’“failure-to-communicate”claims• Addressingnegligenceclaimsattheoutsetofapotential

lawsuit• Providingtrainingonnewandemergingmedicaldevices

andnoveltechnologies• Determiningwhatconstitutes“adequate”traininginthe

mindsoftheCourt- takingaffirmativeactiontotrain

• Hiringaconsultantsurgeontohosttrainingsessionsanddemonstratealiveprocedure

• Mitigatingtheliabilityrisksofsalesrepsintheoperatingroom

• Disseminatingaprepguideforphysicianswithdifferenttechniquestouse,issuesthattheyhaveseenwiththeproduct

• Whoisatthefrontlineofcommunicationwhenaphysicianhasaspecifictargetedquestionaboutthedeviceitself?


E F

bREAKOUT SESSION 3 | 4:30 p.m. - 5:30 p.m. (Choose E or F)

Post-Government Investigation, Now what? Analyzing the Potential Litigation Ramifications for Pharmaceutical and Medical Device Manufacturers

Dwight O. MoxieSeniorCounsel-LegalDepartmentAllergan,Inc.(Irvine,CA)

Steven M. SelnaPartnerDrinkerBiddle&ReathLLP(SanFrancisco,CA)

Eric W. SitarchukPartnerMorgan,Lewis&BockiusLLP(Philadelphia,PA)

• Handlingderivativelawsuitsstemmingfromagovernmentfine/settlement- demonstratingthatthecompanydidnotbreachitsfiduciary

dutytoshareholders• Combattingambitiousplaintiffsfilingfollow-onclassactionsuits

- practicalstrategiesforkeepingthesesuitsatbay• Minimizingtheimpactofagovernmentinvestigationona

potentialjuryverdict• Dealingwiththeexpandeduseofinvestigativesubpoenas,

broadenedtheoriesofliability,andpronouncedcriminalandregulatorypenalties

• Howdoesinteragencycoordinationimpactcivilandgovernmentcases?

• Defeatingplaintiffs’effortstointroduceevidenceaboutgovernmentenforcementactionsinproductliabilitycases

• Handlingparallelcivilandgovernmentinvestigations

5:30 Conference Adjourns to Day 2

Strategically Using Daubert in Cross-Examination to Establish Important Defense Themes

Vincent A. Thomas, CPA, CFF, CVA, ABVSeniorManagingDirectorForensic&LitigationConsultingCo-Leader,U.S.IntellectualPropertyPracticeFTIConsulting(Chicago,IL)

Sharon L. CaffreyPartnerDuaneMorrisLLP(Philadelphia,PA)

Pamela J. YatesPartnerKayeScholerLLP(LosAngeles,CA)

WithCommentaryby:


• DecidingwhentofileaDaubertmotion• Utilizingthecross-examinationtoknockouttheother

side’scaselaw• Positioningthecompanyfromadiscoverystandpoint

forsummaryjudgment• Avoidingthetrapofreinforcinginjury/loss• Challengingmethodologythroughananalysisofthe

underlyingscience• Focusingonassumedorinaccuratefactswhichthe

opposingexpertmayhavereliedoninforminghisopinion- discreditingthroughlackofexpertiseand/orpreparation

• Challengingthefoundationoftheplaintiff ’sexperttestimonybyasking“howdidyouarriveatthatconclusion?”

• Developingacross-examinationmethodologythatcreatesacompellingtrialrecordoneachandeveryDaubertfactorthatmaycallintoquestionthetechnicalorscientificreliabilityoftheprofferedopinions

• Persuadingthecourtthattheprofferedopinionsdonotamounttoscientificknowledgebecausetheyarenotscientificallyreliable

• Highlightingareaswhereopposingexpertagreeswithyourownexperttobolsteryourexpert’scredibility

• Understandinghowgoverninglawshouldshapethewayyoupresenttoanexpert

• Challengingthequalityofthepeerreview–determiningtheacceptableindustrystandard

• Howtoimpeachwitnesscredibility- dilutingtheplaintiffwitnessopinion

• Whatlevelofproofisexpectedwhenchallenginganexpert?

5:30 p.m. Networking Cocktail Reception Hosted by:


DAY 2: wEDNESDAY, DECEMbER 11, 20137:15 Registration & Networking Breakfast

8:00 Co-Chairs’ Opening Remarks

8:15 United States v. Caronia One-Year Later: The Impact of the First Amendment Argument on Off-Label Communication

Michael HulkaGeneralCounsel,LillyOncology&ImCloneSystemsSeniorDirector,AssistantGeneralCounselEliLillyandCompany(Indianapolis,IN)

Paul Kaufman AssistantU.S.AttorneyChiefofCivilHealthcareFraudU.S.Attorney’sOffice,EasternDistrictofNewYork(Brooklyn,NY)

John J. PeaseSeniorCounselTevaPharmaceuticals(Horsham,PA)

• BreakingdowntheCaroniadecisionandthecurrentstateofoff-labelcommunicationpractices- truthful,non-misleadingoff-labelspeech

• Analyzingtheincreasingclaimsagainstsalesrepsandthecausesofactionalleged

• Focusingonthe‘intenttomisbrand’ratherthanthe‘promotionofoff-labeluse’

• Defendingagainstplaintiffsusingtheregulatorylimitationsondruganddevicemarketingasaspringboardfortortiousclaims

• ExploringthecurrentrelationshipbetweenFDAandthemanufacturersinlightofCaronia

• Definingappropriateinteractionsbetweensalesrepsandphysicians

• Creatingcomplianceprotocolstoreducetheriskofoff-labelcommunications

• Developingappropriateproductpromotionpoliciesandresponsestophysicians’unsolicitedrequestsforinformation

• Reigninginroguesalesrepswhoengageinillegaloff-labelpromotion

• Illustratingpotentialconsequencesoffailingtoabidebycompanypoliciesandstandards

9:15 Exploring New Approaches to Bellwether Trial Selection Procedures and Emerging Best Practices for the Consolidation of Mass Torts

Greg A. DadikaAssociateGeneralCounsel,LitigationC.R.Bard,Inc.(MurrayHill,NJ)

Charna GerstenhaberVicePresidentandHeadofLitigationNovartisPharmaceuticalsCorporation(EastHanover,NJ)

Kim M. SchmidExecutiveManagingPartnerBowmanandBrookeLLP(Minneapolis,MN)

Robert K. Woo, Jr. PartnerKing&SpaldingLLP(Atlanta,GA)

Moderatedby:

Abigail M. ButlerPartnerFaegreBakerDaniels(FortWayne,IN)

• Determiningfactorsfortryingacaseandhowtoselectwhichcasetotry

• Selectingissuesthathavethebestchanceofeliminatingfutureclaims

• Understandingthepurposeandbenefitsofabellwethertrial

• Organizingyourmasstortsothatthereisafairandobjectivewayofmovingthecasealong

• Ensuringthatyouhavetherightfront-endlogisticsandproceduraldefensestrategiesinplace

• Implementingtechniquesfororganizingandtrackingavoluminousamountofdata

• WhenshouldtagalongsbetransferredtoanexistingMDL?• Coordinatingbetweenstateandfederalcourtproceedings

andimplementingefficientprocessesfordoingso• Minimizingtheenormouscostsinvolvedandthe

gamesmanshipthatgoesonforbothsides• Analyzingwhatstrategiesareworkingwelltomovethe

MDLalongmoreefficiently

10:25 Morning Coffee Break

Hosted by:

10:40 View from the Bench: Current Judicial Views on Pharmaceutical and Medical Device Litigation

The Honorable William S. Duffey, Jr. DistrictJudgeU.S.DistrictCourt,N.D.Georgia

The Honorable David Herndon ChiefJudgeU.S.DistrictCourt,S.D.Illinois


The Honorable Theodore A. McKeeChiefJudgeU.S.CourtofAppealsfortheThirdCircuit

The Honorable Christopher NuechterleinMagistrateJudgeU.S.DistrictCourt,N.D.Indiana

The Honorable Cynthia M. RufeDistrictJudgeU.S.DistrictCourt,E.D.Pennsylvania

12

© American Conference Institute, 2013


The Honorable Kaymani D. WestMagistrateJudgeU.S.DistrictCourt,DistrictofSouthCarolina

Moderatedby:

Andrew T. BaymanPartnerKing&SpaldingLLP(Atlanta,GA)

In products liability cases, there are often parallel federal andstateproceedings,withnumerousdepositions.Whenyouhaveparallelcasesaddressingthesameissues,whichjudgedoyoucall?Which time limits apply? If the state court action is ahead ofthe federal action,do theydefer?This sessionwill offer a rareopportunity to hear the perspectives of renowned jurists fromthestateandfederalbench,withanopportunityforattendeestoaskquestions.Gainvaluableunderstandingofhowmembersofthebenchcoordinateandmanagestateandfederalproceedingsinpharmaceuticalanddevicemasstortactions.

12:00 Networking Luncheon for Speakers & Delegates

1:00 A Good Offense is the Best Defense: Effective Use of Social Media in Products Liability Litigation

Brennan TorregrossaAssistantGeneralCounselGlaxoSmithKline(Philadelphia,PA)

Jennifer Mingus MountcastlePartnerThompsonHineLLP(Columbus,OH)

• Uncoveringinconsistenciesintheplaintiff ’sclaimbyperusingsocialmediasitesforphotosandvideos

• Conductingasocialmediaanalysisofprospectivejurorsbeforecommittingtoaspecificjury

• Understandingstatelawsregardingfriendingjudgesandgovernmentofficials

• Knowingwhencommentsmadeonlinecanbecomepartoftheevidentiaryrecord- alertingemployeestotheramificationsoftweets,blogs

andpostsonpotentiallitigation- establishingacorporaterecordretentionpolicyapplicable

tosocialmedia• Meetingtherequisitefoundationalelementsofsocialmedia

authentication• Makingsuccessfulobjectionstokeepoutdamagingposts

andmessages• Ensuringthatuncoveredinformationcanbepreserved,

storedanddatestamped• Sendingaretentionlettertoplaintiff ’scounseltoprevent

deletionofinformationorprofilesfromsocialmediawebsites

EthicalConsiderations

• Delineatingbetweenethicalandunethicalsocialmediaresearchwhenlearningmoreaboutaplaintifforjuror

• Findinginformationwithoutaformaldiscoveryprocess• Avoidingconductthatcouldbeconsidered“pretexting”or

deceptiveasproscribedbystaterulesofprofessionalconduct

2:00 Afternoon Refreshment Break

2:15 Coordinating Litigation Efforts Across Borders: Analyzing Product Liability Trends Outside the U.S. and the Impact on U.S.-Based Litigation

Adam Deutsch VicePresidentandAssociateGeneralCounsel-Litigation,InvestigationsandRiskManagementBiomet,Inc.(Warsaw,IN)

Kaspar StoffelmayrVicePresident&AssociateGeneralCounselBayerCorporation(Pittsburgh,PA)

Christopher D’AngeloPartnerMontgomery,McCracken,Walker&Rhoads,LLP(Philadelphia,PA)

• Assistinginternationallegalteamswithnecessaryproductinformationandmanagingtheculturalandlanguagebarriers

• Identifyinginternationaljurisdictionsthatmaybepotentiallyproblematicforthedrugordevicemanufacturer

• Findinglocalattorneyswhoreallyunderstandthelawsandregulationsofthecountryyouarebeingsuedin

• Puttingtogetherdefensepacketsthatcanbeutilizedinothercountries

• Developingeffectivestrategiesformanagingunexpectedproductsafetyrisksandissuesarisingfromeffortstoobtaindiscoverycrossinginternationalboundaries- depositionsofforeignpersonnel- discoveryofforeignlabeling,regulatory,scientific,and

corporatedocuments• Whatimpactdoesevidencerelatedtoyourdrugordevice

inaforeigncountrieshaveintheU.S.?- determiningwhatevidenceisadmissibleandinadmissible

• AnalyzingthelatesttrendsintheinterplaybetweenproductliabilityandcriminalliabilityinEurope

• UsingFDAapprovalasevidenceofnon-defectivenessoutsidetheU.S.- educatingnon-U.S.judgesandlegislators- coordinationbetweencommunicationofFDAand

FDA-likeentitiesinothercountries• Understandingforeigncourts’viewonmasstortlitigation

3:15 Main Conference Concludes

3:30p.m.–5:30p.m.

Post-Conference Business Development Master Class on Selecting and Evaluating Outside Counsel

(seepage5fordetails)

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CONFERENCE-AT-A-GLANCEM

orni

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noon

Even

ing

8:45WorkshopRegistration

9:30A50-StateDrug&MedSurvey:DrillingDownintotheState-SpecificLegislationthatImpactsDrug&MedicalDeviceLitigation[includingpreemption,consumerfraudandpatientsafety]

2:15GroupSpeedNetworkingRegistration

3:00GroupSpeedNetworkingFacilitatedbyIn-HouseCounsel

7:00Registration&WelcomeBreakfast

8:00Co-Chairs’OpeningRemarks

8:15CaseStudyfromMensingtoBartlett:DeterminingWhetherDesignDefectsClaimsarePreemptedforGenericManufacturersandthePotentialLiabilities

9:15FDAKeynoteAddress

9:55MorningCoffeeBreakHostedby:

10:10JudicialInsightsonMultidistrictLitigation

10:40BolsteringtheDefensePosition:EffectivelyDefeatingClassCertification

11:40CrisisManagement&LitigationPreparedness:HowDrugandDeviceManufacturersCanMinimizeRiskandMaintainConsistencyWhenLitigationLooms

12:50NetworkingLuncheonforSpeakersandDelegatesHostedby:

2:00BREAKOUTSESSION1(ChooseAorB)A. ConductingSuccessfulVoirDireand

SelectingtheRightJury:NovelStrategies,TacticsandEthicalConsiderations

B. In-HouseRoundTable:BestPracticesforCaseManagement

3:15AfternoonRefreshmentBreakHostedby:

3:30BREAKOUTSESSION2(ChooseCorD)C.ControllingtheWitnessandtheTestimony:

PracticalStrategiesforConductingaDirectExaminationoftheCompanyWitness

D.CombattingClaimsAgainstDeviceManufacturersforFailuretoAdequatelyTrainPhysiciansandManagingtheProliferationofDearDoctorLetters

7:15Registration&NetworkingBreakfast

8:00Co-Chairs’Remarks

8:15United States v. Caronia One-YearLater:TheImpactoftheFirstAmendmentArgumentonOff-LabelCommunication

9:15ExploringNewApproachestoBellwetherTrialSelectionProceduresandEmergingBestPracticesfortheConsolidationofMassTorts

10:25MorningCoffeeBreakHostedby:

10:40ViewfromtheBench:CurrentJudicialViewsonPharmaceuticalandMedicalDeviceLitigation

12:00NetworkingLuncheonforSpeakersandDelegates

1:00AGoodOffenseistheBestDefense:EffectiveUseofSocialMediainProductsLiabilityLitigation

2:00AfternoonRefreshmentBreak

2:15CoordinatingLitigationEffortsAcrossBorders:AnalyzingProductLiabilityTrendsOutsidetheU.S.andtheImpactonU.S.-BasedLitigation

3:15MainConferenceConcludes

3:30Post-ConferenceBusinessDevelopmentMasterClass:In-HouseCounselPerspectiveonSelect-ingandEvaluatingOutsideCounsel

5:00Pre-RegistrationandWelcomingCocktailReceptionHostedby:

4:30BREAKOUTSESSION3(ChooseEorF)E.StrategicallyUsingDaubertinCross-

ExaminationtoEstablishImportantDefenseThemes

F.Post-GovernmentInvestigation,NowWhat?AnalyzingthePotentialLitigationRamificationsforPharmaceuticalandMedicalDeviceManufacturers

5:30NetworkingCocktailReceptionHostedby:

Pre-Conference Monday, December 9, 2013

Day OneTuesday, December 10, 2013

Day Twowednesday, December 11, 2013

SPONSORS

Lead Sponsors:

Greenberg Traurig LLP is one of the largestlaw firms in the United States with anunprecedented domestic and global presence,

1,750attorneysandgovernmentalaffairsprofessionals,andmorethan30locationsintheUnitedStates,LatinAmerica,Europe,theMiddleEastandAsia.Asanintegralpartofthefirm’s 600+ member litigation practice, GT’s Pharmaceutical, Medical Device & HealthCareLitigationteamoffersclientsunmatchednationalcoverage,aswellassophisticationandexperienceinmanagingcomplex,high-profilecasesforawiderangeofclients.Themorethan100attorneyteamissupportedbycomplementaryresourcesintheareasofhealthcarelawandregulation,governmentalinvestigations,governmentalaffairsandintellectualproperty.Formoreinformation,pleasevisitwww.gtlaw.com.

Dykema serves business entities worldwide on a wide range ofcomplexlegal issues.Dykemalawyersandotherprofessionalsin13U.S.officeswork inclosepartnershipwithclients todeliver

outstanding results, unparalleled service and exceptional value in every engagement.For more information, please visit www.dykema.com and follow Dykema on Twitterhttp://twitter.com/Dykema.

Morgan Lewisisagloballawfirmwith1,600attorneysin 24 offices worldwide. Our comprehensive lifesciences practice includes more than 200 lawyers,

scientists and other technical specialists, many with advanced degrees, who have theexperience andcapability to represent the full life cycleofFDA-regulatedproducts.Ourstrengthisourabilitytoworkcollaborativelyacrossseveralpracticeareas,suchasproductsliability, consumer fraud, government investigations and FDA regulatory counseling andcompliance,toprovidestrategicsolutionsforthemulti-facetedchallengesourclientsface.MorganLewisoffersextensivecapabilitiesanddecadesofexperiencecoordinatingcomplexnationallitigation,inadditiontoprovidingefficient,powerfulsolutionsfortheincreasinglydemanding discovery environment. We are nationally recognized for our leadership andinnovation in developing alternative fee structures. For more information, please visit www.morganlewis.com.

Pharmaceutical and medical device companies turn toMorrison & Foerster for their most important productliabilitymatters.Wehaveakeenunderstandingoftheissuesthey face; the ability to convey their scientific and medical

defensestojuries;andtheknow-howtoadviseontheirregulatory,liabilityandrecallissues.www.mofo.com.

14

The 18th Annual Drug & Medical Device Litigation Conference Appreciates The Support Of The Following Organizations

Cocktail Hosted by:

Supporting Sponsors:

King & Spaldingisaninternationallawfirmwithmorethan800lawyersin17officesacrosstheUnitedStates,Europe,theMiddleEastandAsia.Morethan300ofourlawyers,scientistsandconsultantsarededicatedtorepresentinglifesciencescompanies,withspecializedexperienceateverystageoftheproductlifecycle.Weaddtothisarangeoftrialexperiencethatisincreasinglyunusualinlargefirms.ElevenKing&Spaldinglawyerswereidentifiedas‘lifesciencesstars’inthefirst-evereditionofLMGLifeSciences.Inaddition,thefirmwasrecommendedintheareasofFDA-medicaldeviceregulatory,governmentinvestigations/fraud&abuseandproductliability.Formoreinformation,pleasevisitwww.kslaw.com.


Withmorethan500conferences intheUnitedStates,Europe,AsiaPacific,andLatinAmerica,American Conference Institute (ACI)providesadiverseportfoliodevotedtoprovidingbusinessintelligencetoseniordecisionmakerswhoneedtorespondtochallengesspanningvariousindustriesintheUSandaroundtheworld.

Asamemberofoursponsorshipfaculty,yourorganizationwillbedeemedasapartner.Wewillworkcloselywithyourorganizationtocreatetheperfectbusinessdevelopmentsolutioncateredexclusivelytotheneedsofyourpracticegroup,businesslineorcorporation.

Formoreinformationaboutthisprogramorourglobalportfolioofevents,pleasecontact:

Wendy TylerHeadofSales,AmericanConferenceInstitute

Tel: 212-352-3220 x5242 [email protected]

Global Sponsorship Opportunities

Fresh from a multi-million dollar renovation, the New York Marriott Marquis brings the energy ofManhattantoyourdoor,convenienttorestaurants,BroadwayShows,andtheheartofTimesSquare.NYCistheperfectbackdropforaDecemberconference.

Conference Venue

Lead Media Partner:

Sponsored by:

Baker Sterchi Cowden & Rice LLC has built a reputationasaleadingpharmaceuticalandmedicaldevicedefensefirm,handlingthelitigationneedsofpharmaceuticalcompaniesand

medicaldevicemanufacturersacrossthecountry.Wehaveservedasnationalcoordinatingandnationaltrialcounselforsuchcompaniesinmasstortcasesandmulti-districtlitigation.Wearetriallawyersskilledatunearthingfactsandinterpretingcomplicatedmedicalconceptsandlegalissues.Wearededicatedtoachievingtheclient’sgoalsasquicklyandeconomicallyaspossible.Formoreinformation,pleasevisitwww.bscr-law.com.

Barnes & Thornburghasnearly80attorneysdedicatedspecificallytomedicaldevice,drug,toxictort,andmasstortlitigation.Thefirmhasservedasnationallitigationcounselforleadingmedical

devicecompaniesfornearly30years,litigationcounseltoseveralofthenation’slargestdrugmanufacturers,andmulti-jurisdictionaldevicecounsel.Formoreinformation,pleasevisitwww.btlaw.com.

Faegre Baker Daniels LLP product liability lawyers representpharmaceutical and medical device manufacturers worldwide. With750lawyersandconsultantsintheU.S.,UKandChina,ourfirmoffers

integratedservicestohelpachievethegoalsoflifesciencescompaniesrangingfromemergingstartups to multinational corporations. We have served as national, regional and localdefensecounselinmajorpharmaceuticalandmedicaldeviceproductliabilitylitigation.Ourprofessionalsaggressivelydefendclaimsincomplexmasstort,toxictort,multi-districtandclassactionlitigation.Inaddition,wecounselclientsonproductliabilityriskmanagement,regulatorycompliance,reimbursementandmore.OurpracticeissupportedbyournationalLifeSciencesindustrygroupthatincludesourWashingtonD.C.consultingarm,FaegreBDConsulting.Formoreinformation,pleasevisitwww.FaegreBD.com.

Nelson Mullins attorneys have experience in complexpharmaceutical and medical device litigation, ranging from

multijurisdictionallitigationtoindividualcases.Wehavetriedmultiplepharmaceuticalanddevicecasestoverdictandhaveworkedtosimplifycomplexscientificissuesforjurors.Wealsoworktoidentifyandmanagerisksinadvanceoflitigation.Formoreinformation,pleasevisitwww.nelsonmullins.com.

Patterson Belknap delivers legal services acrossmorethan20practicegroups.Wefrequentlyserve

asnationalandregional litigationcounselformajorpharmaceuticalcompaniesandothermanufacturers.Ourlawyershavehandledall levelsoftrialsandappealsandareskilledinmakingcomplexscienceunderstandabletojuriesandjudges. Formoreinformation,pleasevisit www.pbwt.com.

Nationally recognized for providing superior client service, Thompson Hine serves premier businesses worldwide. The lawyers in ourPharmaceuticalandMedicalDeviceLitigationpracticehavetheknowledge

and experience to develop practical, efficient solutions to the challenges pharmaceuticalandmedicaldevicecompaniesfacewhenconfrontedwithpersonalinjury,commercial,orconsumerlitigation.Formoreinformation,pleasevisit www.ThompsonHine.com.

Drinker Biddle is a full-service national law firm with nearly650 lawyers.Wehandleall typesandaspectsofproducts liabilitylitigation and frequently serve as trial counsel and national

coordinating counsel in suits defending prescription drugs, over-the-counter drugsand medical devices including orthopedic implants, antibiotics, contraceptives andantipsychotics.Formoreinformation,pleasevisitwww.drinkerbiddle.com.

FTI Consulting has created and shaped its multi-facetedintellectualpropertypracticewiththeexpresspurposeofhelpingorganizationsdealwiththeinherentandemergingcomplexitiesof

successful intellectualpropertymanagement, includingcreation, strategyandgovernance,assessmentof assets, licensing and acquisition, andprotection, enforcement anddefense.The Intellectual Property group at FTI Consulting consists of a prestigious, integratedteamofhighly trainedprofessionals that canprovide anunmatchedbreadthof in-depthconsultingandexpertwitnessassistancetocorporationsandtheircounselacrosstheentireintellectualpropertylifecycle.Formoreinformation,pleasevisitwww.fticonsulting.com.

Norton Rose Fulbrightisanationallyrecognizedpartnerto industry in managing high-stakes litigation involving

pharmaceuticals and medical devices. Our lawyers devote their practice to the defenseof clients in contentious proceedings before courts and regulatory authorities acrossthe US and the world. While focusing on efficient and strategic solutions to complexlitigation,ourlawyershavesuccessfullytriedcasesinthetoughestvenuesagainstthemostformidable opponents. With over 3800 lawyers in 54 offices, we can provide integratedadvice on both domestic and cross-border matters. For more information, please visitwww.nortonrosefulbright.com.

Reed Smith’sLifeSciencesHealthIndustry(LSHI)Groupiscomprisedofmorethan250professionalsacrossnumerouscorporate,regulatory,

andlitigationpracticeareaswhoarededicatedtoclientswhohelpsavepatients’livesandpreservetheirhealth,whetherthroughbiotechnology,pharmaceutical,medicaldevice,lifesciencesordeliveringhealthcare.ReedSmith’sLSHIGroupisconsistentlyrecognizedbyleading industry publications as one of the premier life sciences practices nationally andinternationally.

Bowman and Brooke LLP is a nationally recognizedtrial firm with one of the largest product liability

practicesinthecountry.Thefirm’snearly200attorneysdefendavarietyofcorporateclients,including many Global 500 and internationally basedcompanies, in widely publicizedcatastrophicinjuryandwrongfuldeathmatters,andinothercomplexlitigationthroughoutall50 states.BowmanandBrooke’s lawyers regularly represent their clients and try casesincourthousesacrosstheUnitedStates.OurDrugandMedicalDeviceLitigationpracticeiscomprisedofexperiencedtrial lawyers servingasnational, regionaland localcounsel insomeoftoday’smosthighprofileindividualandmasstortlitigation.Withapassionanddriveformasteringcomplexmedical,scientific,epidemiological,engineeringandregulatoryissues, Bowman and Brooke’s lawyers deliver legal representation that is innovative, costconscious and complements core business objectives. For more information, please visit www.bowmanandbrooke.com.

Arnstein and Lehr celebrates its 120th anniversary in2013andisknownforitssuccessasnational,regionalandlocalcounselinthedefenseofcomplexclaimsagainstthemanufacturersofmedicaldevices,genericandbrandname

pharmaceuticalsandbiologics.Formoreinformation,pleasevisitlegalnews.arnstein.com.

15

The 18th Annual Drug & Medical Device Litigation Conference Appreciates The Support Of The Following Organizations


Law360isaone-stopsourceoflitigation,policy,anddealnewsacrossawidespectrumoflegalpracticeareasandregulatedindustries,includingproductliabilityandlifesciences.Everybusinessday,ournationwideeditorialstaffcoversemerginglitigation,regulationandlegislation,majortransactions,andpersonnelmovesatthetopfirms.Law360’scoveragerunsthegamut–fromconcisearticlesoncomplexeventsandtheirimplicationstoregularanalysisfromleadinglegalpractitioners.Weareamust-haveresourceforattorneyswhowanttostayontopoftheirpracticeareaandaheadofthecompetition.

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o ConferenceandGroupMeet�Up $2195 $2395 $2595

o I cannot attend but would like information on accessing the ACI publication library and archive

o I would like to receive ClE accreditation for the following states: ___________________. See ClE details inside.

*ELITEPASS is recommended for maximum learning and networking value.

Gain Added Insights at a Pre or Post Conference Workshop:

MONDAY, DECEMBER 9, 2013A 50-State Drug & Med Survey: Drilling Down into the State-Specific Legislation that Impacts Drug & Medical Device Litigation [including preemption, consumer fraud and patient safety]

WEDNESDAY, DECEMBER 11, 2013Post-Conference Business Development Master Class: In-House Counsel Perspective on Selecting and Evaluating Outside Counsel

DECEMBER 9-11, 2013 | Marriott Marquis | New York, NY

DRUG and MEDiCal DEviCEl i t i G a t i o N

18th Annual

Expert Strategies for Leading Litigators & In-House Counsel

december 9-11, 2013 | marriott marquis | new york, ny th

Documents