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:The 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 For The Defense n October 2010added to the defense team to ensure that everyoneupdated on new information, searchterms, and production efforts with any ongoingsupplemental discovery process.The 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. The 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-
ies, such as the types of data, how suchinformation is governed, and where relatedinformation may be copied. A data mapshould be up-to-date, a resource that setsout significant details of an organization’sdifferent active data creation and storagesystems—e-mail, instant messaging,voicemail, network storage and file servers,application and file types, workstationdistributions, remote user setup, and distributionof mobile devices—and backupprotocols for each system involved in thelitigation. Data maps should also includedetails on the names and roles of key datagatekeepers, the IT and records managementpersonnel who manage and controla company’s document creation anddestruction technologies. Some organizationsalready have data maps of their computersystems. For those organizationsthat do not, counsel will have to interviewrecord custodians and collect informationabout where and how the organizationsstore information and then use that informationto craft a data map for the litigators.It is also important to periodicallyupdate document searches to properlyadhere to the ongoing obligation for supplementalproduction. To help satisfy thisduty, parties can collect and preserve ESIby creating defensible copies of the evidence.It is possible to make copies of filesor create images of entire disk drives, segregateand store the information in a protectedrepository, and at the same timeeliminate cumulative information. Deduplicationand date metadata will allowcounsel to quickly identify new documentsfrom ones that were previously collectedto satisfy ongoing production obligations.With live products, a useful way toensure effective supplemental productionis to record the MP5 or SHA1 hash valueof all documents. In litigation involvingactively marketed products, the same documentsare often simultaneously editedby a client and prepared for production bycounsel. A company needs the ability toconsistently identify new and altered documents.Using the MP5 of SHA1 hash values,a company can create an exception reportto determine if changes to documents mayimpact the litigation.In helping to implement these collectionand production strategies, attorneys shouldnot worry about over- preserving. It costsonly a few thousand dollars to build a largeserver to host a copy of the data created ina live “production” environment. As longas the directory format for data in the productionenvironment is kept when copyingdata to the preservation server, mostprocessing software can capture all thenecessary fields to ensure a complete production.This process will also allow counselto quickly tag the files already collectedto identify new files. When it is time tocollect, counsel can connect an encryptedUSB device to the preservation server andtransport the relevant content for reviewand production.Third Steps: Keep It Privilegedand ConfidentialCounsel can protect against inadvertentdisclosures and limit turnover by identifyingall counsel and executing nonwaiveragreements.Identify CounselParties involved in the manufacture ofpharmaceutical or medical device productsshould take care to avoid unwanteddisclosure of documents. During the discoveryfor a live product, a company cangenerate many documents due to regulatorychanges. Members of the organizationtypically will communicate with a varietyof legal actors, such as liability attorneys,regulatory attorneys, and often, documentcounsel. In that environment, there is a realrisk that some documents will may mistakenlyreceive responsive tags, resulting ininadvertent disclosure.Although a party can move for thereturn of inadvertently disclosed information,a court may deny the request and findthat the disclosure waived privilege. See,e.g., Victor Stanley, Inc. v. Creative Pipe,Inc., 250 F.R.D. 251, 267–68 (D. Md. 2008)(holding that the disclosure of 165 documentsto an opposing party waived anyprivilege or work- product protection); Figurasv. P.R. Elect. Power Auth., 250 F.R.D.94, 98 (D.P.R. 2008) (holding the circumstancessurrounding a disclosure waivedany privilege regarding an inadvertentlyproduced document); Atronic Int’l, GMBHv. SAI Semispecialists of Am., Inc., 232F.R.D. 160, 164 (E.D.N.Y. 2005) (findingthat inadvertent disclosure of e-mails constitutedwaiver of attorney- client privilege).The efficiencies createdby automation andautomated documentationcan be significant.To prevent disclosure of documentscontaining attorney- client privileged orproprietary information, it is crucial toidentify all counsel involved with a clientand ensure that they maintain opencommunication with one another. A goodprophylactic measure is to create a comprehensivelist of attorney names, firm names,attorney domains, for example, “harrisbeach.com,”and common contractionsfor all firms, such as “Harris Beach,” andthen enter these terms into the litigationdocument review platform. All documentsin the platform can then be automatically“flagged” for all of the terms on that list. Asnew attorneys become involved in the litigation,counsel can perform another searchto flag new documents for additional privilegereview. Privilege reviewers can performan additional final review to uncoverany remaining documents tagged withprivilege flag terms that escaped noticeduring earlier reviews.Utilize Nonwaiver AgreementsAnother important tool for protecting sensitiveinformation is a nonwaiver agreement.Inadvertent production of privilegeddocuments is likely to occur during discoveryof electronically stored information.See Hopson v. Mayor and City Councilof Baltimore, 232 F.R.D. 228, 232 (D. Md.2005) (noting the volume and forms ofe-material make privilege review difficultand time- consuming). To prevent inadvertentdisclosures, parties can sign anonwaiver agreement. This agreement isessentially a contract, often in the formof a court order, stipulating that inadvertentdisclosure of privileged or proprietaryinformation, trade secrets, or employeematerials will not be considered a waiver.See id. (“agreements protect respondingE-Discovery, continued on page 84For The Defense n October 2010 n 37
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