W. KENNEDY SIMPSON. WRIGHT, ROBI SO, McCAMMO, OSTHIMER & TATUM Richmond, Virginia

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1 W. KENNEDY SIMPSON THOMPSON MILLER & SIMPSON PLC 734 West Main Street, Suite 400 Louisville, Kentucky Telephone (502) Facsimile (502) Cell Phone (502) PRACTICE SUMMARY Product liability, medical malpractice and legal malpractice defense litigation THOMPSO MILLER & SIMPSO PLC Louisville, Kentucky June present STITES & HARBISO Louisville, Kentucky , WRIGHT, ROBI SO, McCAMMO, OSTHIMER & TATUM Richmond, Virginia EDUCATIO AL BACKGROU D University of Kentucky College of Law Lexington, Kentucky J.D., 1978 Staff, Kentucky Law Journal President, Phi Delta Phi Legal Fraternity Washington & Lee University Lexington, Virginia B.A., Economics, cum laude Honor Roll, Deans List JUDICIAL CLERKSHIPS Law Clerk Hon. Thomas A. Ballantine, Jr. Judge, U.S. District Court, Western District of Kentucky Law Clerk Hon. Boyce M. Clayton Justice, Supreme Court of Kentucky

2 EDITORIAL POSITIO S Editor - Annual Survey of Product Liability Law Tort & Insurance Law Journal (ABA) ( ) Editorial Board - Pharmaceutical & Medical Device Bulletin (Law Journal Newsletters) (2001) PUBLICATIO S Legal Malpractice Law State By State (Kentucky Section) ABA Section of Litigation 2011) Off-Label liability of Drug & Medical Device Manufacturers Twenty-Fourth Annual Medical Device Seminar Coursebook (MEDMARC 2011) Fifty State Survey of Legal Malpractice Law (Kentucky Section) (ABA Section of Litigation 2009) Product Liability Defenses: A State-by-State Compendium (3d ed.) (Kentucky section) (DRI 2007) Current Issues in Medical Device Litigation (FDA Amendments Act of 2007), ABA Section of Litigation Product Liability Committee & Mass Torts Litigation Committee Coursebook (ABA 2007) Medical Malpractice from A-Z, National Business Institute Seminar Coursebook (NBI 2007) Off-Label Liability of Drug & Medical Device Manufacturers, DRI Drug & Medical Device Seminar Coursebook (DRI 2007) Tackling Advanced Medical Malpractice Issues (Notable Kentucky Expert Witness Cases) National Business Institute Seminar Coursebook (NBI 2006) Drug & Medical Device Recalls Drug and Medical Device Litigation Seminar Coursebook (ACI 2005) Developments (editor) 38 Tort & Insurance Law Journal 625 (ABA 2003) Fifty State Survey of Expert Witness law in Pharmaceutical and Medical Device Litigation (Kentucky section) (ABA 2002) Industry Gifts to Physicians - The New Frontier? Rx for the Defense (DRI 2002) Developments (editor) 37 Tort & Insurance Law Journal 621 (ABA 2002) Product Liability Defenses: A State-by-State Compendium (2d ed.) (Kentucky section) (DRI 2001) Fifty-State Survey of FDCA-Related Tort Causes of Action (Kentucky section) (ABA 2001) FDA Reporting Requirements for Drugs & Medical Devices Product Liability Megaconference III Coursebook (ABA June 2001) 2

3 Defending Scientific Literature & Clinical Studies DRI Drug & Device Seminar Coursebook (DRI May 2001) Developments (editor, preemption and evidence sections) 36 Tort & Insurance Law Journal 505 (ABA 2001) Developments (editor, preemption section) 35 Tort & Insurance Law Journal 553 (ABA 2000) State-By-State Survey of the Law Regarding Potential Liability For Off Label Use of Drugs and Medical Devices (Kentucky section) (ABA 1999) The Admissibility of Expert Opinions in Federal Courts The Evolution of Daubert A Practical Guide to a Daubert Challenge, Fourth Annual Drug & Medical Device Conference Coursebook, American Conference Institute, (December 1999) Federal Protection for Biomaterials Suppliers, 16 Food, Drug, Cosmetic and Medical Device Law Digest 35 (March 1999) Developments (preemption section) 34 Tort & Insurance Law Journal 573 (ABA 1999) Developments (preemption section) 33 Tort & Insurance Law Journal 605 (ABA 1998) Damage Issues in Drug and Medical Device Litigation, Mealey s Drug and Medical Device Seminar Coursebook (Mealey s Publications 1997) Medical Device Exemptions: Sixth Circuit Sets the Pace, 15 Product Liability Law and Strategy (March 1997) Developments (preemption section) 32 Tort & Insurance Law Journal 383 (ABA 1997) Over-the-Counter Drug Liability: Defense Perspective, Mealey s Drug & Medical Device Seminar Coursebook (Mealey s Publications 1996) Developments (preemption section) 31 Tort & Insurance Law Journal 383 (ABA 1996) Medical Device Preemption State of the Union, 1 Mealey s Litigation Reports: Drugs and Medical Devices 27 (January 1996) Ninth Circuit Swims Against Preemption Tide, 14 Product Liability Law and Strategy 5 (December 1995) Overview of the FDA Regulatory Process, DRI Drug & Device Seminar Coursebook (DRI 1995) 3

4 Developments (preemption section) 33 Tort & Insurance Law Journal 605 (ABA 1998) Developments (preemption section) 30 Tort & Insurance Law Journal 523 (ABA 1995) Developments (products liability defenses section) 29 Tort & Insurance Law Journal 352 (ABA 1994) Product Liability Desk Reference: A Fifty-State Compendium Little, Brown & Co. (1993, 1994, 1995, 1996) (Kentucky section) (co-author) Investigational Drugs Likely Have Immunity, 12 Product Liability Law and Strategy 3 (September 1993) Developments (products liability defenses section) 28 Tort & Insurance Law Journal 354 (ABA 1993) Medical Device Ruling May Have Broader Impact, 11 Product Liability Law and Strategy 1 (February 1993) Developments (drug and medical device section) 27 Tort & Insurance Law Journal 336 (ABA 1992) Product Liability Defenses: A State-by-State Compendium (Kentucky section) ( DRI 1992) Developments (preemption section) 26 Tort & Insurance Law Journal 371 (ABA 1991) Virginia Natural Death Act, 5 VSB Health Law ews 2 (June 1989) Case report (expert testimony/damages), 1 Journal of Civil Litigation 23 (1989) Discovery Abuse, Abuse of Process, and Sanctions for Rule 11 Violations, 1987 Kentucky Bar Association Annual Meeting Coursebook Note (constitutional law), 66 Kentucky Law Journal 127 (1978) SEMI AR PRESE TATIO S Off-Label Liability of Drug & Medical Device Manufacturers, Twenty-Fourth Annual Medical Device Seminar, MEDMARC, Yosemite (June 2011) FDA Regulation of Drugs and Medical Devices, Defending Drug and Medical Device Litigation: A Primer for Young Lawyers, DRI, Chicago (September 2010) 4

5 FDA Regulation of Drugs and Medical Devices, Defending Drug and Medical Device Litigation: A Primer for Young Lawyers, DRI, Chicago (September 2008) Current Issues in Medical Device Litigation (FDA Amendments Act of 2007), ABA Section of Litigation Product Liability Committee & Mass Torts Litigation Committee Seminar, New Orleans (October 2007) Medical Malpractice from A-Z, National Business Institute, Louisville (October 2007) FDA Regulation of Drugs and Medical Devices, Defending Drug and Medical Device Litigation: A Primer for Young Lawyers, DRI, Chicago (September 2007) Off-Label Use is Lawful, Clinically Beneficial and Medically Necessary, DRI Drug & Medical Device Seminar, San Francisco (May 2007) Effectively Managing a Medical Device Recall, Drug and Medical Device Litigation, American Conference Institute, Chicago (June 2006) Tackling Advanced Medical Malpractice Issues, National Business Institute, Louisville (June 2006) Drug and Medical Device Recalls, Drug and Medical Device Litigation, American Conference Institute, New York City (December 2005) FDA Regulations, Defending Drug and Medical Device Litigation: A Primer for Young Lawyers, DRI, Chicago (September 2005) FDA Post-Sale Powers, Product Liability Advisory Council Spring Conference, Quebec (April 2004) FDA Regulations, Defending Drug and Medical Device Litigation: A Primer for Young Lawyers, DRI, Chicago (September 2002) Medical Terminology in Kentucky, Lorman, Louisville (August 2002) ABOTA Masters in Trial, Kentucky Bar Association Annual Convention, Lexington (June 2001) FDA Reporting Requirements for Drugs & Medical Devices, Product Liability Megaconference III, ABA, Amelia Island (June 2001) Defending Scientific Literature and Clinical Studies, DRI Drug and Medical Device Seminar, Chicago (May 2001) Kentucky Evidence Workshop, PESI, Louisville (April 2001) Defending Scientific Literature & Clinical Studies, DRI Drug & Device Seminar, Chicago (May 2001) Kentucky Evidence Workshop, PESI, Louisville (April 2000) Federal Preemption in Products Liability Litigation, Products Liability Course, Brandeis School of Law, Louisville (April 2000) 5

6 The Battle of the Experts After Daubert and Its Progeny, Fourth Annual Drug & Medical Device Litigation Conference, American Conference Institute, New York City (December 1999) Defenses in Pharmaceutical Drug Litigation, Mealey s Fen-Phen Litigation Conference, Philadelphia (October 1999) Maneuvering Through the Minefield: Representing Drug and Medical Device Manufacturers in a Changing Environment, DRI Annual Meeting, New York City (October 1999) Common Mistakes in Medical Malpractice Litigation, Winning the Cancer Case Seminar, Resource Development, Inc., New Orleans (April 1999) FDA Drug and Device Regulation, DRI Drug & Device Young Lawyers Seminar, Philadelphia (March 1999) Preemption in Product Liability Litigation, Products Liability Committee, IADC Mid-Year Meeting, Scottsdale, Arizona (February 1999) (videotape) Medical Device Preemption, American Conference Institute Drug and Medical Device Conference, North Carolina (December 1998) Expert Witnesses, Forensic Economics Class, Bellarmine College (April 1998) Beyond Preemption: The Impact of FDA Regulation in Drug and Medical Device Litigation, American Conference Institute Drug and Medical Device Litigation, New York City (December 1997) Damage Issues in Drug and Medical Device Litigation, Mealey s Drug and Medical Device Seminar, West Palm Beach, Florida (November 1997) *Seminar Co-Chair Dealing With Healthcare Providers in Medical Device Litigation, Tenth Annual Medical Device Seminar, Blackwell Sanders, MEDMARC, HIMA, Kananaskis Village, Alberta, Canada (June 1997) Psychological Injury Mock Trial, Kentucky Bar Association Annual Convention, Louisville, Kentucky (June 1997) Federal Preemption in Products Liability Litigation, Kentucky-Mississippi- Tennessee Defense Lawyers Seminar, Sandestin, Florida (April 1997) Over-the-Counter Drug Liability: Regulatory Aspects and Defenses, Mealey s Drug & Medical Device Seminar, West Palm Beach, Florida (November 1996) Eleven Common Mistakes in Personal Injury Litigation, Kentucky Academy of Trial Attorneys Personal Injury Seminar, Covington, Kentucky (July 1996) Warnings in Drug and Medical Device Litigation, DRI Drug & Device Young Lawyers Seminar, Philadelphia, Pennsylvania (October 1995) How to Make the FDA Regulatory Process Understandable to a Jury, DRI Drug & Medical Device Seminar, Seattle, Washington (May 1995) 6

7 REPORTED DECISIO S Larkin v. Pfizer, 2004 WL (Ky. 2004) (allergy drug - learned intermediary adopted) Wood v. Wyeth-Ayerst Laboratories, 82 S.W.3d 849 (Ky. 2002) (diet drug - medical monitoring rejected) Thomas v. Glaxo Wellcome, Inc., 20 Fed. Appx. 478 (6 th Cir. 2001) (migraine drug - summary judgment affirmed) Welsh v. Galen of Virginia, Inc., 71 S.W.3d 105 (Ky. App. 2001) (medical malpractice - evidence) Hill v. R.J. Reynolds Tobacco Co., 44 F. Supp. 2d 837 (W.D. Ky. 1999) (tobacco - common knowledge defense) Clark v. Danek Medical, Inc., 64 F. Supp. 2d 652 (W.D. Ky. 1999) (medical device - fraud on FDA) Watkins v. R.J. Reynolds Tobacco Co., 1998 U.S. Dist. LEXIS (E.D. Ky. 1998) (tobacco - dismissal) Love v. Danek Medical, Inc., 1998 U.S. Dist. LEXIS (W.D. Ky. 1999) (medical device - product defect) Boker v. Corning, Inc., 1997 U.S. App. LEXIS (6 th Cir. 1997) (medical device - relation back - summary judgment affirmed) eihoff v. Surgidev Corp., 950 S.W. 2d 816 (Ky. 1997) (medical device - preemption) Copass v. Monroe County Medical Foundation, 900 S.W. 2d 617 (Ky. App. 1995) (medical malpractice - venue) Michals v. William T. Watkins Memorial United Methodist Church, 873 S.W. 2d 216 (Ky. App. 1994) (asbestos - fear of future injury - summary judgment affirmed) Kinser v. Ciba-Geigy Corp., 837 F. Supp. 217 (W.D. Ky. 1993) (herbicide - FIFRA preemption - summary judgment granted) Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d (6 th Cir. 1993) (drug - design defect, Comment k, causation - case became Illustration for Restatement (Third) of Torts) Gordon v. The Procter & Gamble Distributing Co., 789 F. Supp (W.D. Ky. 1992) (drug idiosyncratic reaction - summary judgment granted) ucor Corp. v. General Electric Co., 812 S.W. 2d 136 (Ky. 1991) (roof collapse - statute of response) Munn v. Pfizer Hospital Products Group, Inc., 750 F. Supp. 244 (W.D. Ky. 1990) (medical device - privity - summary judgment granted) Snawder v. Cohen, 749 F. Supp (W.D. Ky. 1990) (drug - warranty - summary judgment granted) 7

8 Albright v. The Upjohn Company, 788 F.2d 1217 (6 th Cir. 1986) (drug - Rule 11 sanctions affirmed) Hurley v. Downing, 1985 Ky. App. LEXIS 675 (Ky. App. 1985) (auto accident - statute of limitations) Ginter v. orthwestern Mutual Life Insurance Co., 576 F. Supp. 627 (E.D. Ky. 1984) (life insurance misrepresentation - evidence) BRIEFS U.S. Supreme Court Amicus Brief, DRI, Iolab Corp. v. Hunter, No (U.S. 1997) ACADEMIC APPOI TME TS Faculty, IADC Trial Academy Stanford University Law School (August 2004) Visiting Instructor of Law, University of Louisville School of Law ( ) Trial Skills Course (Fall 1994, 1995, 1996) Mock Trial Competition (Winter 1995, 1996, 1997) Attorney Coach, Louisville Collegiate School, Kentucky High School Mock Trial Competition (District Champion, State Final Four) (2000) CERTIFICATES A D AWARDS Kentucky Super Lawyers Who s Who Legal Product Liability Defense Louisville Magazine Top Lawyers National Board of Trial Advocates Board-Certified ( ) Wake Forest University Law Practice Management Program (1995) National Institute for Trial Advocacy Basic Trial Skills Course (1982) Kentucky Bar Association Continuing Legal Education Award (1994, 1997, 2000, 2001, 2004, 2006) USA Today Road Warrior Ironman Finisher - Hawaii (1997, 2006), Louisville (2007, 2008, 2009) PROFESSIO AL MEMBERSHIPS Council on Litigation Management (2009-present) Litigation Counsel of America (2009-present) Product Liability Advisory Council (2000-present) 8

9 International Association of Defense Counsel (1995-present) Drug, Device & Biotech Committee (Newsletter Vice Chair ) American Board of Trial Advocates (1999-present) Virginia State Bar (1981-present) Defense Research Institute (1981-present) Drug and Device Committee (Steering Committee 1994-present) (Chair - FDA Regulation Subcommittee ; Chair - Monograph Subcommittee ) Products Liability Committee Kentucky Defense Counsel, Inc. (1981-present) American Bar Association (1981-present) Tort & Insurance Practice Committee (Vice-Chair 2002-present) Louisville Bar Association (1981-present) Kentucky Bar Association (1981-present) House of Delegates ( ) COURT ADMISSIO S United States Court of Appeals, Fourth Circuit (1988 present) United States Court of Appeals, Sixth Circuit (1980 present) United States District Court, Eastern District of Arkansas (2010 present) United States District Court, Western District of Arkansas (2010 present) United States District Court, District of Connecticut (2007 present) United States District Court, Central District of Illinois (2009 present) United States District Court, Northern District of Illinois (2007 present) United States District Court, Eastern District of Kentucky (1982 present) United States District Court, Western District of Kentucky (1979 present) United States District Court, Eastern District of Michigan (1988 present) United States District Court, Northern District of New York (2010 present) 9

10 United States District Court, Eastern District of Virginia (1988 present) United States District Court, Western District of Virginia (2010 present) Supreme Court of Kentucky (1978 present) Virginia Supreme Court ( ) CIVIC A D POLITICAL ACTIVITIES Olmsted Parks Conservancy Board of Directors (2005-present) African American Heritage Foundation Board of Directors (2005-present) General Counsel Bingham Fellow (2001) Leadership Louisville (1998) Actors Theatre of Louisville Board of Directors ( ) Chair, Nominating Committee ( ) YMCA of Greater of Louisville Board of Directors ( ) Washington & Lee Alumni - Louisville Chapter Board of Directors ( ) St. Francis In The Fields Episcopal Church Vestry ( ) Focus Louisville (1997) American Red Cross, Louisville Chapter Board of Directors ( ) Triathalon U.S.A. Board of Directors, Mideast Region ( ) Louisville Fund for the Arts Board of Directors ( ) 10

11 PERSO AL I FORMATIO RESIDE CE SPOUSE CHILDRE 4100 Lime Kiln Lane Louisville, Kentucky (502) Sara Flemer Simpson Tierney Simpson Will Simpson Palmer Simpson 11

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