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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
The Honorable Richard KramerJudgeSanFranciscoSuperiorCourt
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?
Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
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)
8 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
Conducting Successful Voir Dire and Selecting the Right Jury: Novel Strategies, Tactics and Ethical Considerations
Lori CohenShareholderGreenbergTraurigLLP(Atlanta,GA)
Sidney KanazawaPartnerMcGuireWoodsLLP(LosAngeles,CA)
WithCommentaryby:
The Honorable John TunheimDistrictJudgeU.S.DistrictCourt,DistrictofMinnesota
• 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)
9Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
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:
The Honorable John TunheimDistrictJudgeU.S.DistrictCourt,DistrictofMinnesota
• 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?
10 Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
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:
The Honorable John TunheimDistrictJudgeU.S.DistrictCourt,DistrictofMinnesota
• 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:
11Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
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 Richard KramerJudgeSanFranciscoSuperiorCourt
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
Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
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)
ET
HI
CS
13Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
CONFERENCE-AT-A-GLANCEM
orni
ngA
fter
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.
Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
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
Register now: 888-224-2480 | www.drugandmed.com | Follow us on Twitter @DrugandMed
Law360isaone-stopsourceoflitigation,policy,anddealnewsacrossawidespectrumoflegalpracticeareasandregulatedindustries,includingproductliabilityandlifesciences.Everybusinessday,ournationwideeditorialstaffcoversemerginglitigation,regulationandlegislation,majortransactions,andpersonnelmovesatthetopfirms.Law360’scoveragerunsthegamut–fromconcisearticlesoncomplexeventsandtheirimplicationstoregularanalysisfromleadinglegalpractitioners.Weareamust-haveresourceforattorneyswhowanttostayontopoftheirpracticeareaandaheadofthecompetition.
R E g i s t R a t i o n f o R m Registration feeThe fee includes the conference‚ all program materials‚ continental breakfasts‚ lunches and refreshments.
Payment PolicyPayment must be received in full by the conference date. All discounts will be applied to the Conference Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to individuals employed by the same organization.
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Hotel informationAmerican Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate. Please contact the hotel directly and mention the “ACI’s Drug & Med” conference to receive this rate:Venue: Marriott Marquis HotelAddress: 1535 Broadway, New York, NY 10036Reservations: 1�877�303�0104or1�212�398�1900
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o ACh Payment ($uSD)Please quote the name of the attendee(s) and the event code 845l14 as a reference.For uS registrants:bank Name: hSbC uSAAddress: 800 6th Avenue, New York, NY 10001Account Name: American Conference InstituteuPIC routing and transit Number: 021-05205-3uPIC Account Number: 74952405Non�uS residents please contact Customer Service for Wire Payment information
5 Easy Ways to Register
MAIL American Conference Institute 45 West 25th Street, 11th Floor New York, NY 10010
PHONE 888-224-2480
FAX 877-927-1563
ONLINE www.drugandmed.com
EMAIL CustomerService @AmericanConference.com
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ContaCt dEtaiLs NAME PoSItIoN
APProVING MANAGEr PoSItIoN
orGANIZAtIoN
ADDrESS
CItY StAtE ZIP CoDE
tElEPhoNE FAX
EMAIl tYPE oF buSINESS
Fee Per DeleGATeSpecialflatrate$1395forin-housecounselfromdrug,deviceandbiotechnologycompanies
Register&PaybySep27,2013 register & Pay by Nov 1, 2013 register after Nov 1, 2013
o elITePASS*: Conference,GroupMeet�Up,50 State Survey Workshop & Business Development Master Class
$3195 $3395 $3595
Conference,GroupMeet�Up&1Workshopo I will attend 50 State Survey Workshopo I will attend Business Development Master Class
$2795 $2995 $3195
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