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For The Defense, October 2010 - DRI Today

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have anticipated. If you discover a numberof similar adverse event reports existbut that reporting to the FDA about theadverse events has been incomplete, determinethe reporting criteria for your clientbecause inconsistently maintaining standardsfor reporting certain adverse events tothe FDA is a pitfall.Perform a parallel investigation of thepublic, federal, Manufacturer and UserFacility Device Experience (MAUDE) database,or a comparable database for theproduct at issue and the alleged productdefect. Remember that those informationsources are public, readily available toyour opponent, and favored by plaintiffs’attorneys.Even more important, in cases involvingpotential or actual criminal actions,investigations, or indictments, you shouldobtain relevant FDA warning letters and<strong>For</strong>m FDA-483s and review them. <strong>The</strong>ymay provide notice to you about potentialor upcoming criminal charges. A <strong>For</strong>m 483is the form that the FDA uses to providea manufacturer with a report identifyingand discussing deficiencies in manufacturing,labeling, and other issues after inspectionof facilities as is required under section704 of the Food, Drug, and Cosmetic Act.An experienced plaintiff’s counsel will alsorequest and pursue warning letters andall related documents. FDA warning lettersand 483 forms are also publicly available.Thus, a plaintiff’s counsel may be wellaware of the information that they containif your client has received any. Accordingly,review publicly available information, forexample, information made available bythe FDA, to identify relevant documents.Unlike finding adverse event reports,finding warning letters often signifies thatyour client faces a situation closer to apotential criminal action. <strong>For</strong> example, theFDA issued a warning letter to Stryker onApril 25, 2008. <strong>The</strong> warning letter was sentabout 10 months before the governmentcharged a low-level Stryker sales representativeand about a year and a half beforeStryker and four of its executives wereindicted. See Waiver of Indictment, UnitedStates v. Demming, No. 08-CR-10379-NG,Feb. 6, 2009; Agreed Statement of Facts,United States v. Demming, No. 08-CR-10379-NG, Feb. 10, 2009 (D. Mass.). Thiswarning letter was extensive.<strong>The</strong> FDA warned Stryker in the letterthat Stryker had failed to obtain an investigationaldevice exemption (IDE) beforeinitiating a clinical investigation. <strong>The</strong> FDAalso noted that it was aware that some ofthe sales force submitted false InstitutionalReview Board (IRB) documentationregarding IRB approval of the company’sproducts. <strong>The</strong> FDA further wrote thatStryker had failed to adequately establishand maintain procedures to ensure complaintanalysis and complaint files, qualityaudit reports, quality records, returnedproducts and other sources of informationto identify existing and potential causesof nonconforming product, and it identifieddeficiencies in Stryker’s correctiveand preventive action (CAPA) system. <strong>The</strong>FDA inspection discussed in the letter hadfound that Stryker’s products were misbrandedbecause it did not meet its MDRrequirements after it received a report suggestingthat devices were involved in adeath or serious injury. <strong>The</strong> letter alsorevealed that the FDA had not been notifiedor had been notified late of 33 reportableadverse events. Clearly, you shouldconduct research into a warning letter’sdetails involving the product at issue inyour case to make sure that you understandthe dangerous areas in your civil litigation,namely whether risk stems fromsales and promotion, design, FDA compliance,clinical trials, adverse event reporting,manufacturing, or another area. Also,identify the potential individuals involved,including whistleblowers and individualswho the government will probably investigateor charge with crimes because theseindividuals can become key targets for theplaintiffs in your case.Know the Criminal AllegationsIf one of your client’s employees is indictedduring the course of your litigation or hasalready been indicted, research the indictmentand the underlying basis. Determinewhether the same or a substantially similarproduct is involved in both the indictmentand the civil action that you havebeen asked to defend. Identify those individualsinvolved in the indictment. Identifyhow the claims at issue in your case areimplicated, if at all. If the civil and criminalcases are unrelated, you will have toassert appropriate objections to discoveryFinding warning lettersoften signifies that yourclient faces a situation closerto a potential criminal action.requests from the plaintiff, limiting discoveryto the product at issue, and readyyourself to fight all discovery requests forinformation related to the indictment andrelated facts, as well prepare to challengethe admissibility of that discovery.If the criminal allegations are clearlyon point, determine how your case isimpacted. <strong>For</strong> example, in the case involvingStryker, the criminal allegationstouched on numerous potential civil, legalissues, including failure to warn, defectivedesign, negligence, failure to comply withFDA rules and regulations, fraud, misrepresentation,and punitive damages claims,among others.Exercise Care with Depositionsand InterrogatoriesWhen you uncover criminal issues inyour litigation it is important to take intoaccount potentially incriminating evidencein responding to civil discovery requests,particularly before answering interrogatories,to questions during depositions, orbefore responding to requests for admissions.In appropriate circumstances, considerfiling a protective order to limit thescope of discovery or to address potentiallyincriminating testimony. That said, youmust aggressively defend the company inthe civil actions, which necessitates meetingyour discovery obligations.Pursue a detailed, stipulated protectiveorder to preserve the confidentialityof confidential documents and controversialtestimony. Firmly enforce the order,filing documents under seal as necessary.However, be wary because a grandjury subpoena for testimony may supersedea protective order, making that orderunenforceable, unreliable, and affectingFifth Amendment rights against selfincrimination.In Re Grand Jury Subpoenas<strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong> n 53

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