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 EDuces Tecum Special Grand Jury, Sept., 1986Term, 659 F. Supp. 628 (D. Md. 1987); butsee Martindell v. International Tel. and Tel.Corp., 594 F.2d 291, 295–296 (2d Cir. 1979).Coordinate with Criminal CounselIt is most important that you ensure thatthe defenses in civil and criminal actionsare consistent. If a company has hiredBe wary because agrand jury subpoena fortestimony may supersedea protective ordercriminal counsel to represent its interestsin criminal proceedings, coordination iscrucial. You will need to help the companyfight a two-front war, coordinating of positionsand defenses when possible to ensureconsistency in theme and positions.Be Skeptical—Question Your SourcesThe U.S. Securities and Exchange Commission(SEC) files a civil complaint againstthe manufacturer of a synthetic blood substituteand several of its corporate officersalleging that they fraudulently misrepresentedthe status of applications for FDAapproval of its product. Your client is oneof the executives, a senior vice presidentof regulatory affairs for the company. Yourclient could face civil penalties and administrativedebarment. Dr. Ras, your client’sphysician, calls you at the behest of yourclient to tell you that your client has cancer.Specifically, Dr. Ras tells you that yourclient was diagnosed with stage III colorectalcancer that has spread to his stomachand abdominal cavity. Your client providesyou with a letter from Dr. Ras stating thatyour client is undergoing surgery and chemotherapy.You move to sever your clientfrom the criminal action. Over the ensuingmonths, your client’s physician tells youthat the cancer has spread to your client’slymph nodes and subsequently provides anaffidavit stating that your client’s cancer isnow a stage IV cancer, your client is undergoingchemotherapy, radiation, and tumor54 n For The Defense n October 2010removal surgery, and your client has an 8 to15 percent- chance survival rate. You periodicallyprovide information to the court.The court severs your client’s action fromthe SEC litigation, stays the action, andlater stays final judgment, effectively endingthe litigation against your client. Otherexecutives, including the senior vice presidentand general counsel and the formerpresident and chief executive officer, signconsent decrees and agree to pay civil penaltiesof $40,000 to $120,000.Unfortunately, you learn that you haveeffectively perpetrated a fraud on the court.Your client does not and did not have terminalcancer. The “Dr. Ras” who called youwas actually your client. The affidavits thatyou submitted were actually phony affidavitsfrom your client. Your client ultimatelyconsents to a judgment in the SEC case,agrees not to work for any publicly tradedcompany, and to pay a $150,000 fine. He iscriminally indicted and ultimately is sentencedto 36 months in prison and fined$50,000 for concocting his terminal cancerstory.Sound far-fetched? It actually happened.Biopure Corp. was the company underinvestigation for its company’s Hempopureblood substitute in 2005, and Howard P.Richman was the former senior vice presidentof regulatory affairs who was ultimatelysentenced in 2009. Ex- Biopure ExecGets 36 Months In Jail For Faking TerminalCancer, 14 Mealey’s Emerg. Drugs &Devices, Issue # 20 (2009); see also Indictmentin United States v. Howard P. Richman,No. 1:08-cr-10282-MLW-1, Sept. 24,2008; Sentencing Hearing in United Statesv. Howard P. Richman, No. 1:08-cr-10282-MLW-1, Oct. 5, 2009.Your witnesses also may have countervailinginterests. Before indictments andwell before a company may even know thatthe government has initiated investigations,the government may have interviewed witnessesand obtained information. Well overseven months before Stryker and its seniormanagers were indicted in October 2009, aterritory manager agreed to waive indictment,submitted an agreed statement offacts, and pled guilty to a count of misbrandinga medical device. See Waiver ofIndictment, United States v. Demming, No.08-CR-10379-NG, Feb. 6, 2009 (D. Mass);Agreed Statement of Facts, United States v.Demming, No. 08-CR-10379-NG, Feb. 10,2009 (D. Mass.). Phones or communicationdevices of employees and witnesses mayalso be tapped. Current employees may alsoseek to be whistleblowers, whether yourclient engaged in truly actionable conductor not, for moral or monetary reasons andmay file a lawsuit under the qui tam provisionsof the False Claims Act.So what is the point? It is without questioncritical to locate and interview ordepose key witnesses with knowledge ofthe facts who will certainly be involved inyour case. However, witnesses will havecountervailing interests if criminal chargesrear their head, complicating your client’sdefense of the civil action. Be carefulwith and skeptical of information that youreceive from your clients when criminalactions exist or loom. As you gather factsfrom key witnesses, conscientiously delveinto the possible personal motivations of acompany’s employees. As you collect documentsfrom employees, impress uponthem that a plaintiff’s counsel will oftenuncover misrepresentations and obfuscations,which will make matters worsefor the company. Thoroughly review documentsand follow up in missing areas.Perform independent investigations andmeet with witnesses personally as necessaryto ensure that your defense theme anddefense of the case is based on fact, not outlandishtales.As for potentially hostile witnesses, usethe discovery process to determine a plaintiff’sawareness of and contact with potentiallyadverse witnesses so that you can findthose witnesses and possibly depose them.Advise on the Need for Separate CounselMake sure that you advise employee witnessesthat you represent the company.Absent potential or actual criminalaspects, company counsel can often representemployees of the company in depositionsand other proceedings. However, ifyou anticipate potential criminal actions,advise involved employees to obtain personalcounsel to protect their interests.If an employee hires a personal attorney,coordinating defenses is still possible,although it clearly raises concernsof the confidentiality of communicationswith defense counsel for that employee.Criminal, continued on page 86
Robson ForensicDrug & Medical Device ExpertiseBiomechanical EngineeringExpert: Mari S. Truman, P.E.• Orthopedic medical devices: Instruments andimplants for skeletal trauma/joint reconstruction• Design safety assurance• Device performance requirements• Product warnings• Biomechanics: Impact & injuryMari has nearly 30 years experience in product design and developmentin orthopedic medical devices, including implants and instruments.Mari draws on her strong knowledge of design controlprocesses, failure modes and effects analysis, clinically relevant tissueloading, design safety assurance including device performancerequirements and warnings, during her medical device litigation reviews.Mari has qualified as an expert in biomechanics in variousstate and federal courts.MariS.Truman@robsonforensic.comBiomechanical EngineeringExpert: Valentina Ngai, Ph.D.• Medical devices: instruments, implants andassistive devices• Premarket & postmarket wear testing• Kinematic & kinetic testing• Device performance requirements• Biomechanical implants & instrumentsDr. Ngai is an expert in biomechanical engineering. She has beenconducting research in biomechanics for nearly a decade, includingfive years of research conducted for the Department of OrthopedicSurgery at Rush University Medical Center. Dr. Ngai provides investigations,reports, and testimony toward the resolution of disputes andlitigation involving the testing and performance of medical implantsand devices. She has been published in the Journal of Biomechanics,Wear, and the Journal of Engineering in Medicine.vngai@robsonforensic.comToxicologyExpert: Michael J. McCabe, Jr., Ph.D.• Autoimmune & chronic inflammatory diseases• Allergies and other hypersensitivity reactions• Immunotherapeutic drugs and biologicals• Vaccine efficacy and safety• Chemotherapeutic agents• Vitamins and supplementsDr. McCabe is a nationally-recognized immunologist and toxicologist.His experience includes more than 25 years as a biomedicalresearcher and teacher in academia. He served on numerousgovernment review panels charged with assessing the safetyof xenobiotics that target immune/inflammatory processes. Heapplies his knowledge and experience to a broad array of drughypersensitivity and toxicity matters. Dr. McCabe has providedexpert testimony in both state and federal courts.mmccabe@robsonforensic.comEngineers, Architects, Scientists & Fire InvestigatorsBiomechanical EngineeringExpert: Jamie R. Williams, Ph.D.• Medical devices: instruments, implants andassistive devices• Premarket & postmarket mechanical testing• Foreseeable use and misuse• FDA submissions & recalls• Biomechanics: impact & injuryDr. Williams has nearly 15 years experience conducting mechanicaltesting on a variety of medical devices. As a biomedical engineer shehas investigated numerous medical device cases involving metal andnonmetal devices, including meshes. Her extensive background intissue biomechanics allows her to analyze complex cases, while herbackground in teaching provides the experience to explain these difficultconcepts in an easily understood way. Dr. Williams has qualifiedas an expert in biomechanics in various state and federal courts.jwilliams@robsonforensic.comBiomedical EngineeringExpert: Larry Fennigkoh, Ph.D., P.E.• Electrical medical devices: instruments & implants• Medical instrumentation & equipment• Biomedical engineering design• Product applications & warnings• Human physiology• Non-medical electrical devicesDr. Fennigkoh is a biomedical and electrical engineer who hasinvestigated numerous injuries and deaths associated with avariety of medical and non-medical electrical devices. Havingworked in hospitals for over 20 years, he understands not onlythe pathophysiology of injuries, but also the many ways in whichthey may be caused. Dr. Fennigkoh is a professor of biomedicalengineering, a Registered Professional Engineer and is boardcertified in clinical engineering.LarryFennigkoh@robsonforensic.comDrug WarningsExpert: William J. Vigilante, Jr., Ph.D.• OTC & prescription medication labeling• Warning & instruction design• Risk perception• Consumer knowledge & understanding• Product design and product usability• DTC advertising of prescription medicationDr. Vigilante has numerous scientific presentations and publicationsexamining the factors that affect consumers ability to readand understand OTC and prescription medication instructions andwarnings. His research has been presented to and utilized by theFDA in the formulation of OTC medication labeling requirementsand ensuring the fair balance of risk and benefit information inprescription drug advertising. Dr. Vigilante has testified in manystate and federal courts.wvigilante@robsonforensic.comwww.robsonforensic.com800.813.6736
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