For The Defense, October 2010 - DRI Today

D R U G A N D M E D I C A L D E V I C Enal intent was not relevant. Her lawyer saidthat she was finished in the pharmaceuticalindustry. The pharmaceutical companyalso agreed to pay $2.3 billion to settle civiland criminal allegations. According to theDepartment of Justice, six whistleblowerswere to collect $102 million from the federalshare of the funds alone, with one formersales manager collecting $50 million.Discovering hidden,incomplete, or delayedadverse event reportsare red flags indicatingdeeper problems than youmay have anticipated.You can learn one very important lessonfrom this scenario: when you represent acompany in civil litigation before criminalmatters have exploded, you should adviseyour client and all potential witnesses topreserve all documents and evidence andnot to destroy evidence or otherwise alterdocuments. This may require good coordinationbetween you and in-house counselor your in-house contacts to ensure thatyour client practices preservation, such asissuing litigation holds. You may need toexplain in-depth to small- to medium- sizedcompanies the duty to preserve evidence asthey may not be as familiar with litigationnor have as extensive in-house legal departmentsas larger entities. Preservation ofevidence is not unique to cases with possiblecriminal allegations. However, due tothe serious repercussions of failing to preserveevidence and the increased incentiveof certain individuals to attempt to destroyevidence, it is helpful to emphasize preservation’snecessity. Remember employeelaptops, text messages, and current communicationmodes.It hardly needs be said that initially somepeople become fearful of criminal overtonesin a case and will react by trying to covertheir tracks, whether they have somethingto hide or not. Accordingly, in appropriate52 n For The Defense n October 2010cases, when discussing the evidence preservationobligation with your client andwitnesses, it is helpful to emphasize thatfederal authorities and savvy plaintiffs’ attorneyscan and often do uncover attemptsto destroy, or actual destruction of, evidence,including alteration or deletion ofe-mails, electronic communications, anddocuments. You can tell your client andwitnesses that their hard drives may be inspectedin discovery and may be seized byauthorities, leading inspectors to uncoverattempted destruction. Furthermore, independentthird parties, such as ISP providersor related persons or entities, may receivesubpoenas, again leading opponents to discoverthe evidence that your client or witnessesattempted to destroy.It is important to emphasize thatattempting to destroy evidence can lead tocriminal charges of obstruction of justicewith possible monetary penalties and sentences.When handling civil actions, youshould make company contacts aware thatsuch behavior generally compounds theseverity of a situation for both individualsand a company, sometimes even resultingin terminating sanctions.As a civil litigator, if you become awarethat documents have been destroyed, donot ignore the situation. How you handleevidence destruction or alteration requiresa highly fact- specific evaluation, but youmust still deal with it, even if no ill will wasinvolved. You, of course, will have an obligationto perform a diligent search for documents.If documents have been destroyed,you may have to advise responsible partiesto secure personal counsel.Limit Document RequestsIn the event that your client has alreadyprovided documents to the government,obtain inventory lists of the documentsfrom criminal counsel so that you can evaluateappropriately the risk in the civil matterand whether they have use in the civillitigation. Expect a plaintiff’s counsel torequest these documents and be preparedto assert appropriate objections to preventwholesale production of documents. Limityour obligations to produce evidence to theextent that you can through objection, limitationof the scope of discovery, and agreementwith opposing counsel.Plaintiffs’ counsel might also file Freedomof Information Act requests fordocuments produced in government investigations.Production of documents inresponse to such requests are often slow,though, and an aggressive plaintiff’s counsel’sbest source of documents is the civildiscovery process. Regardless, you willwant to know which documents a plaintiff’scounsel may already have or will have accessto through Freedom of Information Actrequests or from third parties. Demand alldocuments obtained by a plaintiff’s counselso that you know what he or she knows.That said, if documents have been collectedin a criminal action, think aboutwhether you may use those documents tosimplify the discovery process in the civilmatter if warranted. At times, you will findthe documents for the criminal action toolimited or too sizable for efficient use in acivil action. However, a company may haveexpended significant effort and expense torespond to government subpoenas addressinga similar matter already so the companycan realize significant cost savingsif civil and criminal council collaborate tocoordinate discovery.Uncover Adverse Events andFDA Warning LettersLong before indictment or your client’sand its executives’ criminal woes hit theWall Street Journal and the nightly news,you may unearth clues that more complicatedissues underlie your case than youinitially thought from which you must protectyour client. To uncover those areas andto properly protect and advise your client,you will need to investigate your client’sadverse event reports, both those reportsthat have been made publicly available andthose that as yet have only been disclosedinternally within the company. It is prudentat the outset of a case to obtain alladverse event reports about alleged injuriesand alleged product defects in yourcivil case. Your pharmaceutical or medicaldevice client will undoubtedly havean extensive adverse event reporting system,as required under applicable federallaw. To the extent that these adverse eventreports refer to related investigations andcorrective actions, know them inside andout. Discovering hidden, incomplete, ordelayed adverse event reports are red flagsindicating deeper problems than you may