Andrea K. Scott, Esq.
Resume
EDUCATION
University of Virginia School of Law, Charlottesville, VA
J.D. (1989)
Yale University, New Haven, CT
Ph.D. program in Anthropology and Archeology (1974 – 1976)
M.A. in Anthropology and Epigraphy (1975)
Princeton University, Princeton, N.J.
B.A., magna cum laude, in Anthropology and East Asian Studies (1974)
Thesis, summa cum laude
Swarthmore College, Swarthmore, PA
Freshman year (1970 – 1971)
HONORS
Virginia Law Review, Editorial Board (1988 -1989)
University of Marroquin, Guatemala City, Guatemala
Honorary Doctorate of Philosophy (“HPhD”), Anthropology (1984)
National Science Foundation, Doctoral Fellowship (1975)
Academic and Music Scholarships (violin):
Yale University; Princeton University; Swarthmore College (1970 -1976)
Lincoln Center Award, Award for contributions to the arts; Solo violinist (1969)
Carnegie Hall & Leonard Bernstein Young People’s Concert Series, Solo Violinist (1962 – 1964)
PROFESSIONAL LICENSE
Pennsylvania State Bar Number 61637
EMPLOYMENT
Bioethics International Ltd, Los Angeles, CA
President and CEO (Feb 2005 – present)
Bioethics, Regulatory Affairs and Technology Development, Los Angeles, CA
Consultant and Attorney (1994 - present)
Cooper, Kardaras & Scharf, Pasadena, CA
Litigation Associate (1991-1994)
Milbank, Tweed, Hadley & McCloy, Los Angeles, CA
Litigation Associate (1989 -1991)
Bryan, Cave, McPheeters and McRoberts, Los Angeles, CA
Litigation Associate (Summer 1988)
The Honorable John W. Bissell, United States District Court for the District of New Jersey [sitting by designation for the Third Circuit during summer] (Newark, NJ)
Judicial Internship (Summer 1987)
HONORARY AND ACADEMIC APPOINTMENTS
International Brain Mapping and Intra-operative Surgical Planning Symposium
[IBMISPS]; Los Angeles, CA
Advisory Board Member; Bioethicist (2005)
Albert B. Sabin Vaccine Institute at Georgetown University, Washington, D.C.
Board of Directors: Bioethicist (1995 - present)
Jonas Salk Foundation, La Jolla, CA
Bioethicist to Dr. Salk (1994 – 1998)
Focused on preparation of international clinical trials for prophylactic AIDS vaccine.
Loma Linda University Research Board of Advisors, Loma Linda, CA
General Counsel and Bioethicist (1992 -1997)
Loma Linda University Medical Center and Graduate School, Loma Linda, CA
Visiting lecturer in Law and Medicine (1989 - 2002)
Conducted grand rounds conferences; Lectures; Precepts regarding diverse range of issues in law and medicine including ethics of technology introduction; Allocation of scarce health care resources; Telemedicine law; International versus U.S. standards; Conflicts of interest; Patient rights; Informed consent; Patient Self-Determination Act; Advance directives; Right to refuse treatment; Right to die; Organ donation; Gender discrimination in the medical community; Female genital mutilation; Human Genome Project; Stem cell research.
REPRESENTATIVE CONSULTING
Cedars-Sinai Medical Center, Laser Research and Technology Development Program, Los Angeles, CA
Consultant in Biomedical Ethics, Regulatory Affairs, and Technology Development (1994 – 2000) [pro bono]
Responsible for bioethics; Regulatory issues; Clinical trials and standards for the development of new laser technologies and medical procedures.
Loma Linda University, School of Medicine and Graduate Studies Program,
Loma Linda, CA
Co-chair of Joint Bioethics Committee (1996 -1997)
Provided feedback to Advisory Board as ethical issues arose in the practice of medicine at Loma Linda Medical Center; Advised Board regarding professional ethics and bioethics as problems occurred during research at Medical Center and Graduate School; Developed Professional Responsibility and Bioethics Guidelines for the University.
James J. Neal, Esq. (Prosecuting Attorney), States of California and Georgia
Mullen v. Nezhat, et al., No. E23339 (Sup. Ct. Los Angeles County, CA 1994; Sup. Ct. Fulton County, GA 2001) (1995 - 2001)
Responsible for evaluation of alleged Bioethics and Regulatory fraud, including issues of education; Licensing and credentialing; Fraud in medical records; Research; Publications and patient billing; Adequacy of informed consent; Waiver of patients’ rights form(s); False advertising; Regulatory violations.
Luce, Forward, Hamilton & Scripps, San Diego, CA
Expert Witness and Bioethicist, 3M Corp., et al. v. Hartford Accident & Indemnity Co., et al. (1995 -1997)
Responsible for developing case strategy; Evaluating compliance with regulatory and bioethics standards; Providing expert testimony in this silicone breast implant case.
Expert Witness and Bioethics Consultant, Dow Corning Corp. v. Hartford Accident & Indemnity Co. (1995 - 1996)
Responsible for case strategy; Evaluating compliance with regulatory and bioethics standards; Providing expert testimony in this breast implant case.
Jonas Salk Foundation, La Jolla, CA
Biomedical Ethics Advisor (1994 - 1998)
Responsible for developing biomedical ethics framework for international clinical trials of prophylactic AIDS vaccine.
General Electric Company, General Electric Medical Systems, Milwaukee, WI
Steering Committee Member, International Clinical Investigations Program for Interventional Magnetic Resonance Therapy (“MRT”) (1994 - 1997)
Responsible for setting bioethics standards and assuring regulatory compliance within the United States and abroad (Europe, Asia, Africa) during international clinical trials of the MRT system.
Loma Linda University Research Board of Advisors, Loma Linda, CA
General Counsel and Bioethics Advisor (1992 - 1997)
Legal counsel to supervisory board in all areas of research; Development and testing of devices, with focus on the development and introduction of new technologies; Conflicts of interest between government, private industry and academia; Assessment of outcomes research.
Nashville Research Associates, P.C., Nashville, TN
Regulatory Affairs and Bioethics Consultant (1997)
Consultant to owner of pharmaceutical clinical trials corporation in connection with termination of Clinical Director for alleged failure to comply with Good Clinical Practices Guidelines and alleged fraudulent manipulation of medical research data; Negotiated contractual termination of Clinical Director; Corrected medical research data for all affected trials in order to comply with Guidelines; Re-established proper status of Corporation with the Food and Drug Administration (“FDA”).
NATIONAL POLICY CONSULTING
Society of Photoinstrumentation Engineers ("SPIE") and American Institute of Medical and Biological Engineering ("AIMBE"), Joint Policy Committee on Health Care Technology Policy, Bellingham, WA
Committee Member and Chair of Sub-Committee on Regulatory Affairs, Bioethics and Legal Issues (1995 - 2002)
Focused on generating guidelines for testing of new moderate and high risk medical devices in human subjects research and clinical trials.
Lawrence Livermore National Laboratory ("LLNL"), Center for Health Care Technologies, Livermore, CA
Advisory Committee Member (1994 - 1999)
Bioethics counsel advising LLNL about status and prioritization of existing and new programs; Oversight of cost-effectiveness and communications among government; Universities and private sector participants.
Institute of Electrical and Electronics Engineers ("IEEE"), Washington, DC (1994 – 2000)
Health Care Engineering Policy Committee:
Chair, Subcommittee on Bioethics, Regulations and Standards (1994 - 1995)
Bioethicist and legal counsel in charge of identifying and resolving biomedical and legal problems in various areas of new medical technology and health care.
Institute of Electrical and Electronics Engineers ("IEEE"), Washington, DC (1994 – 2000)
Workforce Committee:
General Counsel (1994 - 2000)
Legal counsel responsible for addressing problems in research dissemination; Advised Committee concerning employment law and labor relations within the engineering community.
Engineering, Medicine and Biology Society, (“EMBS”), Washington, DC
Professional Ethics Committee:
Bioethicist and General Counsel (1994 - 2002)
Responsible for developing guidelines and standards in the engineering of new devices in clinical trials; Provided insight to engineers in their efforts to introduce and disseminate new biomedical technologies.
PUBLIC SERVICE
Pacific Heart, Lung & Blood Institute (“PACHLAB”), Scientific Advisory Board,
Los Angeles, CA
Chief Ethics Officer (2004)
Pro bono Bioethics Services for Private Individuals, Los Angeles, CA
Consultant and Attorney (1995 – present)
Devoted approximately one-third to half of total practice time to assisting individuals and families whose cases deserved representation but whose financial resources were lacking.
University of Virginia Ad Hoc Bioethics Committee, Charlottesville, VA
Committee Member (1988 -1989)
Drafted legislation amending the Anatomical Gifts portions of the Virginia Code (Sections 32.1 - 289 et seq. [1968]), to permit anencephalic infants to become organ donors.
Guatemala - North America Association, Washington, DC
Founder and Chairman (1984 -1989)
Established non-profit inter-American relief organization promoting medical, Educational; Agricultural assistance to the Maya Indians in the Peten and the Highlands of Guatemala.
SOCIETIES & MEMBERSHIPS
American Bar Association
Health Law Section
Administrative Law and Regulatory Practice Section
Science and Technology Law Section
American Health Lawyers Association (previously National Health Lawyers Association)
Biomedical Optics Society
Center for Telemedicine Law
Engineering, Medicine and Biology Society
The Hastings Center
Institute of Electrical and Electronics Engineers
International Society of Technology Assessment in Healthcare
Kennedy Institute of Ethics at Georgetown University
Pennsylvania Bar Association
Health Care Law Section
Administrative Law Section
Society of Photoinstrumentation Engineers
EDITORIAL ACTIVITIES
Journal of Biomedical Optics
Associate Editor for Law, Biomedical Ethics and Regulatory Affairs (1994 - 2003)
LECTURES & WORKSHOPS
EMBS/IEEE Ventura County Chapter Opening at California Lutheran University, Thousand Oaks, CA (Jun 2003)
Guest Lecturer, “Bioethics and the Law: What Engineers Need to Know.”
The Henry Samueli School of Engineering and Applied Science, UCLA Engineering Graduate Seminar Series, Los Angeles, CA (Dec 2002)
Guest Lecturer, “Bioethical and Legal Considerations in Engineering.”
The Henry Samueli School of Engineering and Applied Science, UCLA Engineering Graduate Seminar Series, Los Angeles, CA (Nov 2002)
Guest Lecturer, “Bioethical Issues in Engineering.”
The Henry Samueli School of Engineering and Applied Science, UCLA Engineering Graduate Seminar Series, Los Angeles, CA (Apr 2001)
Guest Lecturer, “Bioethics and the Law: An Introduction for Engineers.”
IEEE/Wescon North American Convention: “Biomedicine and Bioengineering – the Future of Medicine,” Los Angeles, CA (Sept 2002)
Faculty and Lecturer, “Bioethical and Legal Considerations in the Use of New Medical Technologies.”
The Henry Samueli School of Engineering and Applied Science, UCLA Engineering Graduate Seminar Series, Los Angeles, CA (Mar 2001)
Guest Lecturer, “Bioethics, Medicine, and the Law: A Checklist for Engineers.”
Cedars-Sinai Medical Center: Surgical Grand Rounds, Los Angeles, CA (Apr 2000)
Guest Lecturer, “Bioethical Issues in Surgery.”
American Society for Mechanical Engineers (ASME) 1997 Summer Bioengineering Conference, Sun River, Oregon (Aug 1997)
Member, Plenary Session on reducing health care costs through biomedical engineering.
Guest Lecturer: “Reduction in Legal Exposure through Proper Engineering, Testing and Implementation of New Technologies.”
SPIE and Biomedical Optic Society O-E Laser Conference: “Biomedical Ethics Program on Medical Technology Implications for Society,” San Jose, CA (Feb 1997)
Program Co-chair and Lecturer, "Allocation of Biomedical Engineering Resources in the Health Care System: Who Pays for Care and Who Receives It?"
Harvard Medical School Conference: "Progress in Angioscopy: New Interventional Techniques in Endovascular Grafting, 1996," Boston, MA (Dec1996)
Faculty and Special Invited Lecturer, "The Rights of and Risks to Physicians and Their Patients in an HMO Environment."
Cedars-Sinai Medical Center: Special Grand Rounds in Bioethics, Los Angeles, CA (Jan 1996)
Guest Lecturer, "Ethical and Legal Conflicts Between Physicians' Duties and Patients' Rights."
Harvard Medical School Conference: "Progress in Angioscopy: New Interventional Techniques in Endovascular Grafting, 1995," Boston, MA (Dec 1995)
Faculty and Special Invited Lecturer, "The Physician's Right to Deny Therapy and the Patient's Right to Refuse Treatment: Implications for the Vascular Surgeon."
SPIE 1995 Symposium on Information Communications and Computer Technology, Applications and Systems, Philadelphia, PA (Oct 1995)
Special Invited Lecturer, "Legal Barriers to the Implementation of the Internet."
Global Business Research: "How to Design, Implement and Market Outcomes Studies for the Medical Device Industry," Chicago, Il (Sept 1995)
Lecturer
- "How to Market Your Product to Managed Care Organizations Using an Outcomes Study"
- "The Use of Outcomes Studies in the Development and Marketing of New Technologies”
- "Bioethics and Regulatory Compliance in the HMO Environment."
International Society for Technology Assessment: "Symposium on Policy and Technology Transfer," Stockholm, Sweden
Lecturer and Panelist, "The Impact of Policy on Bioethical Issues in International Technology Transfer." (Jun1995)
SPIE/Whitaker Foundation/IEEE National Conference: "Health Care Technology Policy II - The Role of Technology in the Cost of Health Care: Providing the Solutions,"
Washington, DC (May 1995)
Plenary Session Chairperson; Steering Committee Member
Moderator; Lecturer
- "Ethics of Technology Introduction and Dissemination"
- "The Allocation of Scarce Resources in the Health Care System."
Stanford University Medical Center Workshop: "Endovascular Interventional Techniques Workshop, 1995," Stanford, California (Mar 1995)
Faculty and Lecturer, "Bioethical, Legal and Medical Ramifications of the Introduction of New Technologies."
Miami Heart Institute: "Interventional Cardiology Symposium, 1995," Snowmass, Colorado (Feb – Mar 1995)
Faculty and Lecturer
- "Training, Credentialing, Liability, and Ethical Issues in the Use of New Moderate and High Risk Devices"
- "The Patient's Right to Refuse Treatment and the Physician's Right to Deny Treatment."
Biomedical Optics Society/Photonics West, 1995 Conference, "Commercialization of New Biomedical Technologies," San Jose, CA (Feb 1995)
Lecturer and Panelist, "The Ethical, Legal, and Cultural Ramifications of Technology Introduction."
Food and Drug Administration (FDA): Center for Devices and Radiological Health, Staff College, Rockville, MD (Jan 1995)
Special Invited Lecturer, "The Implementation of Risk-Adjusted Training and Education Guidelines: Bioethics at Work."
Harvard Medical School Conference: "Progress in Angioscopy: New Interventional Techniques in Endovascular Grafting, 1994," Boston, MA (Dec 1994)
Faculty, "Bioethical and Legal Considerations in the Use of New Medical and Surgical Technologies."
Food and Drug Administration (FDA): Center for Devices and Radiological Health, Staff College, Rockville, MD (Nov 1994)
Special Invited Lecturer, "Ethical, Legal and Medical Issues In Technology Development And Dissemination."
IEEE 16th Annual International Conference: Engineering in Medicine and Biology Society, Workshop in Ethics (8 hours), Baltimore, MD (Nov 1994)
Co-Chair and Lecturer, Topics included 8 hours of classes regarding the law and ethics of technology introduction and assessment; Promulgation of guidelines and informed consent documents for new technologies and pharmaceuticals; Development of state and federal standards of care; Licensing and training issues; Patient confidentiality and privacy concerns; Conflicts of interest between academia and private industry.
IEEE/SPIE/Whitaker Foundation National Conference: "The Role of Technology in the Cost of Health Care," Washington, DC (Apr1994)
Rapporteur and Breakout Session Panelist, "The Role of Information Dissemination in Lowering Health Care Costs."
IEEE 15th Annual International Conference: Engineering in Medicine and Biology Society, San Diego, CA (Oct 1993)
Guest Lecturer, “Conflicts of Interest Between Venture Capitalists, Industry, Government and the Academic Community.”
BIOETHICS PUBLICATIONS
Ethical and Legal Parameters of Central Nervous System Repairs, in
International Brain Mapping and Intra-Operative Surgical Planning Symposium
Proceedings (Nov. 16-18, 2005) (to be published in 2006)
Andrea K. Scott & Warren S. Grundfest, Stem Cells and the Law: Fact Versus Fiction (To be submitted for publication 2006) (on file with authors).
Bioethical, Legal and Medical Ramifications of the Introduction of New Technologies, in Stanford University Medical Center's Endovascular Interventional Techniques, 1995. Course syllabus, Stanford University Medical Center, (Mar. 31, 1995).
Bioethical and Legal Considerations in the Use of New Medical Technologies, in Process in Angioscopy: New Interventional Techniques in Endovascular Grafting 1994. Course syllabus, Harvard Medical School (Dec. 6, 1994).
The Role of Information Dissemination in Lowering Health Care Costs: Rapporteur's Report, in Health Care Technology Policy I: The Role of Technology in the Cost of Health Care. 2307 SPIE Proceedings 256-58 [§B-IV] (ed. W.S. Grundfest) (April 27-29, 1995).
Gender Discrimination in the Medical Community,
11 Loma Linda University Bioethics Update 1 (June 1995).
Female Genital Mutilation: A Question of Law, Medicine or Anthropology?
10 Loma Linda University Bioethics Update 3 (Sept. 1994).
The Human Genome Project: Some Legal Ramifications for Newborns,
10 Loma Linda University Bioethics Update 2 (Mar. 1994).
Conflicts of Interest and the Clinical Engineer,
15 Proceedings, 15th Annual International Conference, IEEE Engineering in Medicine and Biology Society 687 (Oct. 1993).
Kevorkian and Assisted Suicide: Act of Murder or Active Compassion?,
8 Loma Linda University Bioethics Update 5 (Sept. 1992).
A Patient's Right To Refuse Blood Transfusions: The Rights of Privacy and Autonomy,
8 Loma Linda University Bioethics Update 5 (Feb. 1992).
In Vitro Fertilization And Divorce: A Legal Perspective,
6 Loma Linda University Bioethics Update 4 (Dec. 1990).
Note:
Death Unto Life: Anencephalic Infants as Organ Donors,
74 Virginia Law Review 1527 (1988).
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