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For The Defense, October 2010 - DRI Today

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D R U G A N D M E D I C A L D E V I C EAttorneys’ Playbook:<strong>The</strong> Xs and Os of E-DiscoveryDefine the nature, scope and total valueof the litigationIdentify potential custodians and datarepositories that may have informationrelevant to the litigationIdentify a point person in the ITdepartment who will assumeresponsibility for discovery and maypotentially testifyIssue legal hold notices to each recordcustodian and suspend routineautomated deletion for each repositoryEvaluate accessibility of each datasourceEvaluate the relevance of eachrepositoryDetermine cost, operational impact andmethods for instituting a legal holdDevelop collection methodology forresponsive data repositoriesPrioritize data collection to minimize riskof relevant data loss, while identifyingissues that may surface such as databeing encrypted or password protectedIdentify and implement other reasonablemethods to prevent the inadvertentdestruction of potentially relevantmaterialsPrepare for meet and confer withopposing counsel under FRCP Rule28(f)(2) to discuss preservation andultimate production of responsivedocumentsCraft agreement of Preservation Order,which clearly defines the measures youare taking as satisfying the preservationobligation36 n <strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong>added to the defense team to ensure that everyoneupdated on new information, searchterms, and production efforts with any ongoingsupplemental discovery process.<strong>The</strong> plaintiffs in Pension Committee providean example of the need for a wellinformeddiscovery czar. Almost all theplaintiffs in that case failed to either carryout comprehensive searches for documentsor supervise document collectionprocesses. Pension Comm., 685 F. Supp.2d at 477. One plaintiff assigned criticalcollection duties to an employee with noexperience conducting searches and providedno training, supervision, or contactwith counsel during the search process.Id. at 483. Another plaintiff, lacking knowledgeof the electronic filing system, hadtwo employees perform searches withoutsupervision or understanding of the extentof the search. Id. at 489. <strong>The</strong> court held thatthese failings constituted negligence orgross negligence and subjected the plaintiffsto monetary sanctions. Id. at 477, 497.Had the plaintiffs used a discovery czar tooversee and direct document collection,they may have avoided those sanctions.Not only can a discovery czar help ensureproper collection of materials, but shoulda dispute arise over the collection process,he or she can provide documentation andserve as a knowledgeable witness about aclient’s efforts to meet production duties.See, e.g., Pension Comm., 685 F. Supp. 2dat 477 (holding that the plaintiffs failed toadequately prepare records and witnessesin response to the court’s request for discoverydocumentation).Second Steps: Create a Game Planto Store and Retrieve DocumentsIt is imperative for an organization to demonstratethat it has taken the appropriatesteps to ensure the integrity of the informationcovered by a legal hold. Once aparty has identified the data relevant to itse- discovery duties, it must collect and processthis data efficiently and effectively. SeePension Comm., 685 F. Supp. 2d at 465. Partiesare free to preserve e-data in many differentways. See Scalera, 262 F.R.D. at 171;Cache La Poudre Feeds, 244 F.R.D. at 628(“[I]n the typical case, responding partiesare best situated to evaluate the procedures,methodologies, and technologiesappropriate for preserving and producingtheir own electronic data and documents.”)(internal quotations omitted). However,in producing those documents, partiesmust act in an open and cooperative manner.See In re Seroquel, 244 F.R.D. at 661–62 (holding the defendants’ search of theirrepositories secretive and inadequate). Aneffective system of ESI documentation,therefore, should be both efficient and easilyaccessible.ESI documentation is essential for drugand device companies facing litigation, asdocument collection duties will invariablyinvolve large data environments. See, e.g.,In re Seroquel, 244 F.R.D. at 654 (notingthe great challenge of e- discovery in litigationinvolving “development of a drugthat spent many years in development byan international corporation and has beendistributed worldwide”). A company’s electronicallystored information may exist inmany locations, including remote officesand off-site servers that are maintained bythird parties, and contract employees mayhave the responsibility of maintaining thisESI. In litigation, parties must prove effectivemanagers of these complex data systemsor else they become vulnerable tocourt sanctions. See id. at 661–62 (listingamong the defendant’s discovery failingsan unclear method of de- duplication, lateproduction of documents, and inadequateresponses to technical issues).Companies must, therefore, establish athorough system to identify their storeddocuments. See Sedona Conference, BestPractice Guidelines & Commentary forManaging Information and Records inthe Electronic Age 11 (2d ed. 2007), http://www.thesedonaconference.org/publications_html(“An organization should have reasonablepolicies and procedures for managinginformation and records.”). Importantdata management steps include identifyingrepositories to control the flow of documentsduring litigation, and using datamaps, disaster plans, and capital acquisitionreports to identify valuable discoveryinformation. Many pharmaceuticaland device makers also keep substantialamounts of information in enterprisesresource planning (ERP) environmentssuch as the one developed by SAP.A “content map” or “data map” helpsidentify repositories by recording the attributesof an organization’s data reposito-

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