DAVID M. STUDDERT Melbourne Law School & School of Population Health University of Melbourne 207 Bouverie Street, Carlton VIC 3053 Email: [email protected] ______

PLACE OF BIRTH: Melbourne, Australia

CITIZENSHIP: Australian, American (dual nationality)

EDUCATION:

1998 Sc.D. Harvard University 1995 M.P.H. Harvard School of Public Health 1992 LL.B. University of Melbourne 1992 B.A. University of Melbourne (First Class Hons.)

EMPLOYMENT:

2007 - Federation Fellow, University of Melbourne Professor, Faculty of Law & Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne

2007 - Adjunct Professor of Law & Public Health, Harvard School of Public Health

2004 - 2006 Associate Professor of Law & Public Health, Harvard School of Public Health

2000 - 2003 Assistant Professor of Law & Public Health, Harvard School of Public Health

1998 - 00 Policy Analyst, RAND

1995 - 96 Research Associate, Department of Health Policy & Management, Harvard School of Public Health

1993 - 94 Policy Advisor to the Hon. Marie Tehan, M.P., Minister for Health, Victoria, Australia

1992 - 93 Attorney, Blake Dawson Waldron 2 Updated: 1.7.08 ACADEMIC APPOINTMENTS:

1990 - 92 Resident Tutor, Trinity College, University of Melbourne 1995 - 96 Research Associate, Harvard School of Public Health 1996 - 98 Research Associate, Division of General Medicine, Brigham & Women's Hospital 2000 - 03 Assistant Professor, Harvard School of Public Health 2000 - Consultant, RAND 2004 - 07 Associate Professor, Harvard School of Public Health 2007 - Adjunct Professor, Harvard School of Public Health

LICENSURE AND CERTIFICATION:

1993 - Barrister and Solicitor of the Supreme Court of Victoria

FELLOWSHIPS, AWARDS AND HONORS:

1988 Warden's Scholarship, Trinity College 1992 Degree with First Class Honors, University of Melbourne 1994 Tuition scholarship, Harvard School of Public Health 1995 Sophie B. Samdperil Health Law Essay Award 1996, 1997 Taplin Fellow, Harvard School of Public Health 1997-98 Fellow in Medical Ethics, Harvard Medical School 2000 Runner-Up, Award for Best Paper of 1999, Society of General Internal Medicine (with Eric J. Thomas et al.) 2000-04 Independent Scientist Award (KO2), Agency for Healthcare Research and Quality 2001 New Investigator’s Award for Excellence in Abstract Submission, American Public Health Association 2004 Alice S. Hersh New Investigator Award, AcademyHealth 2006 Federation Fellow, Australian Research Council

MEMBERSHIPS, OFFICES AND MAJOR COMMITTEE ASSIGNMENTS:

1991 Trinity College Senior Common Room, President 1992-93 Human Rights Advisory Committee, Red Cross Society, Australia 1995 Class of 1995 Vice President, Harvard School of Public Health 1997-98, 00-06 Human Subjects Committee, Harvard School of Public Health 1999-00 Planning Committee, Association of Health Services Research, Annual Meeting 2000 1998-00 Human Subjects Committee, RAND

3 Updated: 1.7.08 1999-00 Chair, Health Law Initiative, Institute for Civil Justice & RAND Health 1999-00 Research Advisory Group, Institute for Civil Justice, RAND 2002-03 Dean’s Health Disparities Working Group 2006 Co-Chair, Human Subjects Committee, Harvard School of Public Health 2007 - Board Member, Trinity College, University of Melbourne 2007 - Chair, Research Advisory Committee of the Primary Care Research Unit, Department of General Practice, University of Melbourne 2008 - Chair, Ethics Review Committee, School of Population Health, University of Melbourne 2008 - Deputy Head, School of Population Health, University of Melbourne

PROFESSIONAL ASSOCIATIONS AND ACTIVITIES

AcademyHealth (US) National Health Lawyers Association (US) Public Health Association of Australia American Public Health Association Ad hoc reviewer for: British Medical Journal Journal of Law, Medicine & Ethics Health Affairs Journal of Policy Analysis and Management Inquiry Lancet Medical Care Institute of Medicine Medical Journal of Australia International Journal for Quality in Health Care New England Journal of Medicine JAMA

RAND (technical reports) Journal of Health Politics, Policy, and Law Social Science & Medicine Joint Commission Journal on Quality and Safety

MAJOR RESEARCH INTERESTS:

1. Health law and regulation 2. Dispute resolution 3. Compensation systems 4. Medical malpractice and quality of care 5. Injury and disability policy 6. Medical ethics

4 Updated: 1.7.08 5 Updated: 1.7.08 RESEARCH FUNDING INFORMATION

Past: 1995-96 Henry J. Kaiser Family Foundation Regulation of mid-level providers Principal Investigator ($US11,344)

1996-97 National Institutes of Health/Center for Alternative Medicine Research, Harvard Medical School Medical malpractice implications of alternative medicine Co-Principal Investigator ($US34,580)

1995-98 Robert Wood Johnson Foundation Utah-Colorado Medical Practice Study Investigator ($US1,850,000)

1997-98 Department of Health and Family Services, Australian Commonwealth Government International collaborative study of medical injury Investigator ($US119,561)

1998-99 U.S. Department of Labor Federal managed care liability reform Investigator ($US80,700)

1998-00 Robert Wood Johnson Foundation Evaluation of National Practitioner Data Bank Investigator ($US319,985)

1999-01 RAND, Institute for Civil Justice, Core Funds HIV Discrimination in the Workplace, Principal Investigator Principal Investigator ($US27,150)

1999-02 U.S. Department of Labor Coverage Decision-Making in Managed Care Co-Principal Investigator ($US999,932)

1999-02 State of California, Department of Industrial Relations Disability Measurement and Return-to-Work Investigator ($US1,700,190)

2002-03 Commonwealth Fund Legal Approaches to the Business Case for Quality Investigator ($US49,850)

6 Updated: 1.7.08 2002-03 United States Department of Labor External Review of Benefit Denials by Managed Care Organizations Investigator ($US498,115)

2000- 04 Agency for Healthcare Research and Quality KO2 Independent Scientist Award Principal Investigator ($US342,509)

2004-05 Commonwealth Fund Legal Implications of Physician Clinical Performance Measurement Principal Investigator ($US15,027)

2003-05 National Institutes of Health Industry-Sponsored Research Contracts: An Empirical Study of Policies and Practices at Academic Medical Centers Investigator ($US161,676)

2002-05 Pew Charitable Trusts An Empirical Investigation of the Pennsylvania Malpractice Environment Investigator ($US332,179)

2001-05 Agency for Healthcare Research and Quality Malpractice Insurers’ Medical Error Surveillance and Prevention Study Principal Investigator ($US4,205,759)

2004-05 Harvard University/Kennedy School of Government Disclosing adverse events: costs and litigation implications Co-Principal Investigator ($US82,579)

2004-05 Harvard Interfaculty Program for Health Systems Improvement Caps On Noneconomic Damages: Efficacy and Equity Investigator ($US57,268)

2005-07 Commonwealth Fund International Approaches to Medical Injury Compensation Principal Investigator ($US92,607)

7 Updated: 1.7.08 Current:

2004-08 Robert Wood Johnson Foundation Design of a Reliable System of Medical Justice Investigator ($US1,500,000)

2006-08 National Institutes of Health Effectiveness of Self-Regulation of Adverse Event Reporting in Cancer Trials Investigator ($US250,00)

2007.11 Australian Research Council Using Law To Improve Population Health and the Quality of Health Care Services (Federation Fellowship) Principal Investigator ($A2,230,000)

TEACHING EXPERIENCE:

1990-92 Resident Tutor Trinity College, University of Melbourne 10 undergraduate students

1995-96 Health Planning in Developing Countries: Cost-Effectiveness Analysis and Priority Setting Techniques Harvard School of Public Health 50 international health students (Teaching Fellow for Prof. Christopher Murray)

1995-98 Law and Public Health, Harvard School of Public Health 10-20 public health students

1996-98, Capstone Course in Health Law 00- Harvard School of Public Health 10 lawyers

1996-98, Ethical Basis of the Practice of Public Health 01- Harvard School of Public Health 60-80 physicians

2001- 06 Health Policy and Law Harvard School of Public Health 15-25 public health students/lawyers

8 Updated: 1.7.08 INVITED PRESENTATIONS (selected, last 5 years):

2002 Promoting Patient Safety: An Ethical Basis for Policy Deliberation, Expert panel member, project team member, and presenter, Hastings Center for Bioethics, Garrison, New York 2002 Empirical Measures of Nursing Home Litigation in the United States, Defense Research Institute’s Nursing Home Litigation Conference, Chicago, IL 2002 Disclosure and Communication in Patient Safety, Harkness Fellows’ Symposium, Commonwealth Fund, Washington, D.C. 2002 Liver Transplantation for Foreign Patients, Harvard Ethics Consortium, Harvard Medical School 2002 A New System of Medical Justice, Common Good Conference, Brookings Institution, Washington, D.C. 2002 Coverage Appeals in Managed Care, Quality of Care Rounds, Harvard School of Public Health, Boston, MA 2003 Creating a Malpractice Liability System to Support Improved Patient Safety, Kaiser Permanente, San Francisco, CA 2003 Disclosing Medical Error, 2nd Annual Patient Safety Conference, Agency for Healthcare Research and Quality, Washington, D.C. 2003 Using Medical Malpractice Data to Study Patient Safety, Workshop, Agency for Healthcare Research and Quality, Washington, D.C. 2003 On Selling No-Fault, AEI-Brookings Joint Center for Regulatory Studies, Washington, D.C. 2003 Dispute Resolution Mechanisms for Workers’ Compensation, California Commission on Health and Safety and Workers’ Compensation, Los Angeles, CA 2003 The Empirical Study of Medical Injury, Escuela Valenciana de Estudios para la Salud, Valencia, Spain 2003 Managing QI in the Regulatory Environment, Masters in Health Care Management Program, Harvard School of Public Health 2003 Professionalism, Harkness Fellows’ Symposium, Commonwealth Fund, Nashville, Tennessee 2003 Impact of Advocacy on Outcomes of Coverage Decisions in Managed Care, AcademyHealth Annual Research Meeting, Nashville, Tennessee (panel chair) 2003 External Review of Benefits Denials, California Department of Managed Health Care, Sacramento, CA 2003 Benefit Design and Medical Management, California Healthcare Foundation Round Table, University of California, Berkeley, CA 2003 The Medical Malpractice Crisis, Liability Prevention for Medical and Surgical Practitioners (Harvard Medical School, CME), Boston, MA 2004 Medical Malpractice: Performance and Reform. Kennedy School of Government’s Health Care Delivery Policy Group Meeting, Scottsdale, AZ 2004 Alternatives to Damages Caps, Legislative briefing, Harrisburg, PA 2004 Patient Safety and the Medical Liability System. Northern Ohio Medical Association, Cleveland, OH 2004 Error and Tort Law, Harkness Fellows’ Conference, Commonwealth Fund, New York,

9 Updated: 1.7.08 NY 2004 Patient Safety and Risk Management: Building a Successful Marriage, AHRQ Annual Patient Safety Conference, Washington, DC 2004 Policies to Foster Patient Safety, Commonwealth Fund Colloquium: Patient Safety Five Years After “To Err Is Human,” National Academy of Sciences, Washington, DC 2004 Injury Compensation Systems, Commonwealth Fund 2004 Symposium on Health Care Policy, Washington, DC 2005 Injury Compensation Under a Tort Regime, Accident Compensation Commission, Auckland, New Zealand 2005 Medical Error and Malpractice Litigation in the United States, Dean’s Public Lecture, University of Melbourne School of Law 2005 Reforming Tort Law, Public Lecture, University of Sydney School of Law 2005 Medical Malpractice in the United States, Patientforsakring (Patient Compensation Association) Stockholm, Sweden 2005 Injury Compensation Policies in the United States, Patientforsikringen (Patient Compensation Authority), Copenhagen, Denmark 2005 Health Care Complaints, Harkness Fellows’ Conference, Commonwealth Fund, Boston, MA 2005 Ethical Issues in Injury Compensation, Ethics Lecture, Fox Hill Village, Westwood, MA 2005 Reinventing Injury Compensation, Brookings Institution, Washington, D.C. 2005 Medical Malpractice and Patient Safety, Grand Rounds, Department of Medicine, University of Texas-Houston Medical Center, Houston, TX 2005 Disclosure of Medical Injury to Patients, Grand Rounds, Department of Medicine, University of Illinois, Champagne-Urbana, IL 2005 Frivolous Litigation: Fact or Fantasy?, J.D. and Elizabeth A. Epstein Lecture, University of Illinois School of Law, Champagne-Urbana, IL 2005 Structure of Health Courts, Common Good Conference, Brookings Institution, Washington, D.C. 2005 Relationship Between Claims, Errors, and Outcomes of Litigation, Governance Workshop, Georgetown Law School 2006 Frivolous Litigation, Institute of Civil Justice and Journal of Empirical Legal Studies Conference on Medical Malpractice, RAND, Santa Monica, CA 2006 Obstetrics Litigation and the Role of the Expert Witness, Boston Obstetrical Society, Boston MA 2006 Learning Error Prevention from Malpractice Claims, Keynote Address, Annual Conference, American Society of Health Risk Managers, San Diego, CA 2006 Obstetrics Litigation, Grand Rounds, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA 2007 Tort System Performance & Effectiveness of Tort Reform: Insights from America, Keynote Address, IIR Medico-Legal Conference, Melbourne, Australia 2007 American Health Policy – Just Cautionary Tales? School of Population Health Seminar Series, University of Melbourne, Australia 2007 Disclosure of Medical Injury, Open Disclosure Education Forum., Medical Defense Association of Victoria, Melbourne, Australia 2007 Deconstructing negligence. Melbourne Law School Faculty Seminar Series, University of Melbourne, Australia 10 Updated: 1.7.08 2007 Do Tort Reforms Work? Keynote Address, Law Institute of Victoria Medico-Legal Conference, Melbourne, Australia 2008 Health courts, administrative compensation and patient safety, Medical Accidents Conference, Buchman Faculty of Law, Tel Aviv, Israel 2008 Administrative compensation and patient safety, Annual Address to the Medico-Legal Society of Victoria, Melbourne, Australia

ORIGINAL ARTICLES:

1. Gruskin S, Studdert DM. A selected bibliography of women's health and human rights. Health and Human Rights 1995;4:477-497.

2. Studdert DM, Brennan TA. AIDS and the Americans With Disabilities Act. Annals of the American Academy of Political and Social Science 1997;551:84-100.

3. Studdert DM, Brennan TA. Deterrence in a divided world: medical malpractice law in an era of managed care. Behavioral Sciences & the Law 1997;15:21-48.

4. Studdert DM, Thomas EJ, Zbar BI, Newhouse JP, Weiler PC, Brennan TA. Can the United States afford a no-fault system of compensation for medical injury? Law & Contemporary Problems 1997;60:1-34.

5. Saphier CJ, Thomas EJ, Studdert D, Brennan TA, Acker D. Applying no-fault compensation criteria to obstetric malpractice claims. Primary Care Update Ob-Gyns. 1998;5:208-209.

6. Studdert DM, Eisenberg DM, Curto DA, Miller FH, Kaptchuk TJ, Brennan TA. Medical malpractice implications of alternative medicine. Journal of the American Medical Association 1998;280:1610-1615.

7. Studdert DM, Brennan TA. Clinical trials in developing countries: scientific and ethical issues. Medical Journal of Australia 1998;169:545-548.

8. Studdert DM. Direct contacting, data sharing, and employee risk selection: new stakes for patient privacy in tomorrow’s health insurance markets. American Journal of Law & Medicine 1999;25:233-65.

9. Studdert D. A comment on the “collaborative planning” model. Advances in Mind-Body Medicine 1999;15:101-04.

10. Gresenz CR, Hensler DR, Studdert DM, Dombey-Moore B, Pace NM. A Flood of Litigation? Predicting the Consequences of Changing Legal Remedies Available to ERISA Beneficiaries. Issue Paper 184. Institute for Civil Justice, RAND, 1999.

11 Updated: 1.7.08 11. Thomas EJ, Studdert DM, Newhouse JP, Zbar BIW, Howard KM, Williams EJ, Brennan TA. Costs of medical injuries in Colorado and Utah in 1992. Inquiry 1999;36:255-264.

12. Studdert DM. Liability issues in the delivery of alternative medicine. Journal of the American Medical Women’s Association 1999;54:173-76.

13. Studdert DM, Sage WM, Gresenz CR, Hensler DR. Expanding managed care liability: what impact on employment-based health coverage? Health Affairs Nov-Dec 1999;18(6):7-27 [Lead article].

14. Studdert DM, Brennan TA. The problems with punitive damages in lawsuits against managed-care organizations. New England Journal of Medicine 2000;342:280-284.

15. Studdert DM, Thomas EJ, Burstin HR, Zbar BI, Orav EJ, Brennan TA. Negligent care and malpractice claiming behavior in Utah and Colorado. Medical Care 2000;38(3):250-260.

16. Thomas EJ, Studdert DM, Burstin HR, Orav EJ, Zeena T, Williams EJ, Howard KM, Weiler PC, Brennan TA. Incidence and risk factors for adverse events and negligent care in Utah and Colorado in 1992. Medical Care 2000;38(3):261-271.

17. Studdert DM, Fritz L, Brennan TA. The jury is still in: Florida's Birth-Related Neurological Injury Compensation Association after a decade. Journal of Health Politics, Policy and Law 2000;25(3):499-526.

18. Studdert DM, Brennan TA, Thomas EJ. Beyond dead reckoning: Measures of medical injury burden, malpractice litigation, and alternative compensation models from Utah and Colorado. Indiana Law Review 2000;33:1643-86.

19. Thomas EJ, Studdert DM, Runciman WB, Webb RK, Sexton EJ, Wilson RM, Gibberd RW, Harrison BT, Brennan TA. A comparison of iatrogenic injury studies in Australia and America I: context, methods, casemix, population, patient and hospital characteristics. International Journal for Quality in Health Care 2000;12:371-78.

20. Runciman WB, Webb RK, Helps SC, Thomas EJ, Sexton EJ, Clark RB, Studdert DM, Brennan TA. A comparison of iatrogenic injury studies in Australia and America II: reviewer behavior and quality of care. International Journal for Quality in Health Care 2000;12:379-88.

21. Studdert DM. Alternative treatments for weight loss: caveat emptor. Critical Reviews in Food Science & Nutrition 2001;41(1):29-31.

22. Studdert DM, Brennan TA. Toward a workable model of “no-fault” compensation for medical injury in the United States. American Journal of Law & Medicine 2001;27:225-252.

12 Updated: 1.7.08 23. Studdert DM, Brennan TA. No-fault compensation for medical injuries: the prospect for error prevention. Journal of the American Medical Association 2001;286:217-223.

24. Fitzjohn J, Studdert DM. A compensation perspective on error prevention: Is the ACC medical misadventure scheme compensating the right sort of injury? New Zealand Medical Journal 2001;114:432-434.

25. Studdert DM, Bhattacharya J, Schoenbaum M, Warren B, Escarce JJ. Personal choices of health insurance by managed care experts. Medical Care 2002;40:375-86.

26. Thomas EJ, Lipsitz S, Studdert DM, Brennan TA. The reliability of medical record review for estimating adverse event rates. Annals of Internal Medicine 2002;136:812-816.

27. Gresenz CR, Studdert DM, Campbell N, Hensler DR. Patients in conflict with managed care: A profile of appeals in two HMOs. Health Affairs 2002;21(4):189-196.

28. Studdert DM. Charges of HIV discrimination in the workplace: The Americans With Disabilities Act in action. American Journal of Epidemiology 2002;156:219-229.

29. Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk factors for retained instruments and sponges after surgery. New England Journal of Medicine 2003;348:229-235.

30. Studdert DM, Gresenz CR. Consumer protection in managed care: enrollee appeals of pre- service coverage denials at two HMOs. Journal of the American Medical Association 2003;289:864-870.

31. Studdert DM, Mello MM, Brennan TA. Medical monitoring for pharmaceutical injuries: tort law for the public’s health? Journal of the American Medical Association 2003;289:889-894.

32. Mello MM, Studdert DM, Brennan TA. The Leapfrog standards: ready to jump from marketplace to courtroom? Health Affairs 2003(2):46-59.

33. Lamb RM, Studdert DM, Bohmer RMJ, Berwick DM, Brennan TA. Hospital disclosure practices: results of a national survey. Health Affairs 2003(2):73-83.

34. Stevenson DG, Studdert DM. The rise of nursing home litigation: findings from a national survey of attorneys. Health Affairs 2003(2):219-229.

35. Ransom SB, Studdert DM, Dombrowski MP, Mello MM, Brennan TA. Reduced medical- legal risk by optimal obstetrical clinical pathway implementation: a case-control study. Obstetrics and Gynecology 2003;101:751-755.

36. Mello MM, Studdert DM, Brennan TA. The new medical malpractice crisis. New England Journal of Medicine 2003;348:2281-2284.

13 Updated: 1.7.08 37. Gawande AA, Zinner MJ, Studdert DM, Brennan TA. Analysis of errors reported by surgeons at three teaching hospitals Surgery 2003;133:614-621.

38. Mello MM, Studdert DM, Brennan TA. The rise of litigation in human subjects research. Annals of Internal Medicine 2003:139:40-45.

39. Kapur K, Grezenz CR, Studdert DM. Managing care: utilization review in action at two capitated medical groups. Health Affairs 2003 (Jan–June);W3275-W3-282.

40. Burns JP, Mello MM, Studdert DM, Puopolo AL, Truog RD, Brennan TA. Results of a controlled clinical trial on care improvement for the critically ill. Critical Care Med 2003;31:2107-2117.

41. Studdert DM, Mello MM, Burns JP, Puopolo AL, Galper BZ, Truog RD, Brennan TA. Conflict in the care of patients with prolonged stay in the ICU: types, sources, and predictors. Intensive Care Medicine. 2003;29:1489-1497.

42. Studdert DM, Burns JP, Mello MM, Puopolo AL, Truog RD, Brennan TA. Nature of conflict in the care of pediatric intensive care patients with prolonged stay. Pediatrics. 2003;112:553-558.

43. Mello MM, Rimm EB, Studdert DM. The McLawsuit: the fast food industry and legal accountability for obesity. Health Affairs 2003;22:207-216.

44. Mello MM, Kelly CN, Studdert DM, Brennan TA, Sage WM. Hospital behavior in a tort crisis: observations from Pennsylvania. Health Affairs 2003;22:225-233.

45. Waters TM, Studdert DM, Brennan TA, Thomas EJ, Almagor O, Mancewicz M, Budetti PP. Impact of the National Practitioner Data Bank on resolution of malpractice claims. Inquiry 2003;40:283-294.

46. Mello MM, Burns JP, Truog RD, Studdert DM, Puopolo AL, Brennan TA. Decision making and satisfaction with care in the pediatric ICU: findings from a controlled clinical trial. Pediatric Critical Care Medicine 2004;5:40-47.

47. Studdert DM, Mello MM, Brennan TA. Medical malpractice. New England Journal of Medicine, 2004;350:283-292.

48. Grezenz CR, Studdert DM. Disputes over coverage of emergency department services: a study of two health maintenance organizations. Annals of Emergency Medicine, 2004;43:155-162.

14 Updated: 1.7.08 49. Mello MM, Studdert DM, Brennan TA. The pharmaceutical industry versus Medicaid: what limits on state initiatives to control prescription drug costs? New England Journal of Medicine, 2004:350:608-613.

50. Bloche MG, Studdert DM. A quiet revolution: law as an agent of health systems change. Health Affairs 2004;23(2):29-42.

51. Studdert DM, Yang YT, Mello MM. Are damages caps regressive? A study of jury verdicts. Health Affairs 2004;23:54-67.

52. Mello MM, Studdert DM, DesRoches CM, Peugh J, Zapert K, Brennan TA, Sage WM. Caring for patients in a malpractice crisis: physician satisfaction, the physician-patient relationship, and quality of care. Health Affairs 2004;23:42-53.

53. Kachalia A, Studdert DM. Professional liability issues in graduate medical education Journal of the American Medical Association 2004;292:1051-1056.

54. Studdert DM, Stevenson DG. Nursing home litigation and tort reform: a case for “exceptionalism.” The Gerontologist 2004;44:588-595.

55. Studdert DM, Mello MM, Brennan TA. Financial conflicts of interest between physicians and pharmaceutical companies: self-regulation in the shadow of federal prosecution. New England Journal of Medicine 2004;351:1891-1900.

56. Mello MM, Clarridge B, Studdert DM. Academic medical centers’ standards for clinical- trial agreements with industry. New England Journal of Medicine 2005;352:2202-2210.

57. Studdert DM, Mello MM, DesRoches CM, Peugh J, Zapert K, Brennan TA, Sage WM. Defensive medical practice by physicians at high risk of malpractice litigation. Journal of the American Medical Association 2005;293:2609-2617.

58. Kachalia A, Choudhry NK, Studdert DM. Emerging physician responses to the malpractice crisis. Journal of Law, Medicine, & Ethics Fall 2005: 416-428.

59. Gresenz CR, Studdert DM. External review of coverage denials in managed care. Journal of Empirical Legal Studies 2005;2:449-468.

60. Brennan TA, Gawande AA, Thomas EJ, Studdert DM. Accidental deaths, saved lives, and improved quality. New England Journal of Medicine 2005;353:1405-1409.

61. Mello MM, Clarridge B, Studdert DM. Clinical investigators’ views of ethical standards for industry-sponsored clinical trials. Accountability in Research 2005;12:163-191.

15 Updated: 1.7.08 62. Mello MM, Studdert DM, DesRoches CM, Peugh J, Zapert K, Brennan TA, Sage WM. Effects of a malpractice crisis on specialist supply and patient access to care. Annals of Surgery 2005;242:621-628.

63. Gold J, Studdert DM. Clinical trial registries: a reform that is past due. Journal of Law, Medicine, & Ethics Winter 2005;33:811-820.

64. Bismark MB, Brennan TA, Paterson R, Studdert DM. Relationship between adverse events and quality of care complaints in New Zealand: a descriptive analysis of complainants and non- complainants. Quality & Safety in Healthcare 2006;15:17-22.

65. Kwaan M, Studdert DM, Zinner M, Gawande AA. Incidence, patterns, and prevention of wrong-site surgery. Archives of Surgery, 2006:141:353-357.

66. Rogers SO, Gawande AA, Kwaan M, Puopolo AL, Yoon C, Brennan TA, Studdert DM. Analysis of surgical errors in closed malpractice claims at four insurers. Surgery 2006;140:25-33.

67. Studdert DM, Mello MM, Gawande AA, Gandhi TK, Kachalia A, Yoon C, Puopolo AL, Brennan TA. Claims, errors, and compensation payments in medical malpractice litigation. New England Journal of Medicine 2006;354:2024-33.

68. Kesselheim A, Ferris T, Studdert DM. Will physician-level clinical performance measures increase risks of malpractice litigation? Journal of the American Medical Association 2006;295:1831-34.

69. Mello MM, Studdert DM, Brennan TA. Obesity: public health law’s new frontier. New England Journal of Medicine 2006;354:2601-10.

70. Kesselheim AS, Studdert DM. Characteristics of physician experts who testify frequently in malpractice litigation over severe birth injuries Obstetrics & Gynecololgy 2006;108:273-279.

71. Bismark MB, Brennan TA, Davis PB, Studdert DM. Claiming behavior in a no-fault system of medical injury: a descriptive analysis of claimants and non-claimants. Medical Journal of Australia 2006;185:203-207.

72. Gandhi TK, Kachalia A, Thomas EJ, Puopolo AL, Yoon C, Brennan TA, Studdert DM. Missed and delayed diagnoses in the ambulatory setting. Annals of Internal Medicine 2006;145:488-496.

73. Mello MM, Studdert DM, Kachalia A, Brennan TA. Health courts and accountability for patient safety. Milbank Quarterly 2006;84:459-482.

16 Updated: 1.7.08 74. Bismarck MB, Dauer EA, Paterson R, Studdert DM. Patients’ motives for medico-legal action following medical injury in New Zealand. Canadian Medical Association Journal 2006;175:889-894.

75. Studdert DM, Mello MM, Gawande AA, Brennan TA, Wang YC. Disclosure of medical injury to patients: an improbable risk management strategy. Health Affairs 2007;26(1):215- 226.

76. Studdert DM, Mello MM, Jedrey CM, Brennan TA. Regulatory and judicial oversight of nonprofit hospitals. New England Journal of Medicine 2007;356:625-631.

77. Kachalia A, Gandhi TK, Gawande AA, Puopolo AL, Yoon C, Poon E, Thomas EJ, Brennan TA, Studdert DM. Missed and delayed diagnoses in the emergency department: a study of closed malpractice claims from 4 liability insurers. Annals of Emergency Medicine 2007;49:196-205.

78. Mello MM, Studdert DM, Schumi J, Brennan TA, Sage WM. Changes in physician supply and scope of practice during a malpractice crisis: evidence from Pennsylvania. Health Affairs 2007;26:w425-w435.

79. Studdert DM, Mello MM, Levy MK, Gruen RL, Dunn EJ, Orav EJ, Brennan TA. Geographic variation in informed consent law: two standards for disclosure of treatment risks. Journal of Empirical Legal Studies 2007;4:103-124.

80. Greenberg CC, Regenbogen SE, Studdert DM, Lipsitz SR, Rogers SO, Zinner MJ, Gawande AA. Patterns of communication breakdowns resulting in injury to surgical patients. Journal of the American College of Surgeons 2007;204:533-530.

81. Mello MM, Studdert DM, Thomas EJ, Yoon C, Brennan TA. Who pays for medical errors? An analysis of adverse event costs, the medical liability system, and incentives for patient safety improvement. Journal of Empirical Legal Studies 2007;4:835-860.

82. Gallagher T, Studdert DM, Levinson W. Disclosing harmful medical errors to patients: recent developments and future directions. New England Journal of Medicine 2007;356:2713-2719.

83. Singh H, Thomas EJ, Petersen LA, Studdert DM. Medical errors involving trainees: a study of closed malpractice claims from 5 insurers. Archives of Internal Medicine 2007;167:2030-2036.

84. Regenbogen SE, Greenberg CC, Studdert DM, Lipsitz SR, Zinner MJ, Gawande AA. Patterns of technical error among surgical malpractice claims: an analysis of strategies to prevent injury to surgical patients. Annals of Surgery 2007;246:705-711.

17 Updated: 1.7.08 85. Kesselheim AS, Studdert DM. The role of professional organizations in regulating physician expert witness testimony. Journal of the American Medical Association 2007;298:2907-2909.

86. Studdert DM, Mello MM. When tort resolutions are “wrong”: predictors of discordant outcomes in medical malpractice litigation Journal of Legal Studies, 2007;36(2):S47-S78.

87. Kachalia A, Mello MM, Brennan TA, Studdert DM. Beyond negligence: avoidability and medical injury compensation. Social Science & Medicine 2008;66:387-402.

88. Yang YT, Studdert DM, Subramanian SV, Mello MM. Impact of liability pressure on the supply of obstetrician-gynecologists. Journal of Empirical Legal Studies 2007;36(2):S47- S78.

89. Mello MM, Studdert DM, Dauer EA. Experimentation with “health courts”: issues under state constitutional law. Harvard Journal on Legislation 2008;45:59-105.

90. Mello MM, Studdert DM. Deconstructing negligence: the role of individual and system factors in causing medical injury. Georgetown Law Journal 2008;96(2):600-623.

91. Studdert DM. Can liability rules keep pace with best practice? Medical Journal of Australia 2008;188: 380-381.

92. Barringer PJ, Studdert DM, Kachalia AB, Mello MM. Administrative compensation of medical injuries: a hardy perennial blooms again. Journal of Health, Politics, Policy, & Law 2008;33(4):725-760.

93. Kesselheim AS, Studdert DM. Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005. Annals of Internal Medicine 2008;149:342-349.

94. Studdert DM. Management or avoidance of medical malpractice crises? Time to choose. Chest (accepted for publication: 1 August, 2008)

95. Kelaher M, Cawson J, Miller J, Kavanagh A, Dunt D, Studdert DM. Use of breast cancer screening and treatment services by Australian women aged 24-44 years following Kylie Minogue’s breast cancer diagnosis International Journal of Epidemiology doi: 10.1093/ije/dyn090 (e-version; print version citation forthcoming).

96. Pirkis J, Neal L, Dare A, Blood RW, Studdert DM. Legal bans on pro-suicide websites: An early retrospective from Australia (in press: Suicide and Life Threatening Behavior, 2008).

18 Updated: 1.7.08 97. Kesselheim AS, Studdert DM. Professional oversight of physician expert witnesses: an analysis of complaints to the Professional Conduct Committee of the American Association of Neurological Surgeons, 1992-2006 (accepted for publication: Annals of Surgery, 2008).

98. Yang YT, Mello MM, Subramanian SV, Studdert DM. Relationship between malpractice litigation pressure and rates of cesarean section and vaginal birth after cesarean section (accepted for publication: Medical Care, 2008).

99. Studdert DM. Management or avoidance of malpractice crises? Time to choose (accepted for publication: Spine, 2 August, 2008)

100.Siegal G, Mello MM, Studdert DM. Use of criteria other than negligence to compensate medical injury: lessons from the Florida and Virginia birth injury compensation programs (accepted for publication: American Journal of Law & Medicine, 13 August 2008).

Under revision/review:

101. Mello MM, Studdert DM. Understanding medical malpractice damages caps (under review: various law journals 2007).

102. Kesselheim AS, November MT, Lifford KL, McElrath TF, Puopolo AL, Orav EJ, Studdert DM. Risk factors for adverse neonatal outcomes following non-reassuring fetal heart rate patterns during labor (under review: British Journal of Obstetrics & Gynecology, 2007).

103. Weingart SN, Saadeh MG, Simchowitz B, Gandhi TK, Nekhlyudov L, Studdert DM, Puopolo AL, Shulman LN. Missed and delayed breast cancer diagnoses: process failures and risk factors (under review: Archives of Internal Medicine, 2008)

BOOK CHAPTERS:

1. Studdert DM, Brennan TA, Thomas EJ. What have we learned since the Harvard Medical Practice Study? In: Rosenthal MM, Sutcliffe KM (eds) MEDICAL ERROR: WHAT DO WE KNOW? WHAT DO WE DO? San Francisco, CA: Jossey-Bass, 2002. (pp.3-33.)

2. Studdert DM. Lessons from incidence and prevalence studies of medical injury: A view from the United States. In: Aranaz A (ed) RESEARCH INTO MEDICAL ERRORS. Valencia, Spain: Escuela Valenciana de Estudios para la Salud, 2003.

3. Studdert DM, Brennan TA. No-fault compensation for medical injuries: the prospect for error prevention. In: Hatlie MJ & Youngberg BJ (eds) THE PATIENT SAFETY HANDBOOK. Sudbury, MA: Jones & Bartlett, 2004.

19 Updated: 1.7.08 4. Studdert DM, Mello MM, Brennan TA.. Medical malpractice. In: Anderson RA (ed). MEDICAL MALPRACTICE: A PHYSICIAN’S SOURCEBOOK. Totowa, New Jersey: Humana Press, 2004.

5. Studdert DM. On selling “no-fault” In: Sharpe VA (ed.) ACCOUNTABILITY PATIENT SAFETY AND POLICY REFORM. Georgetown University Press, 2004.

6. Mello MM, Studdert DM. The medical malpractice system: structure and performance. In: Sage WM and Kersh RT (eds). MEDICAL MALPRACTICE AND THE U.S. HEALTH CARE SYSTEM: NEW CENTURY, DIFFERENT ISSUES. New York: Cambridge University Press, 2006.

7. Brennan TA, Mello MM, Studdert DM. Liability, patient safety, and defensive medicine: what does the future hold? In: Sage WM and Kersh RT (eds). MEDICAL MALPRACTICE AND THE U.S. HEALTH CARE SYSTEM: NEW CENTURY, DIFFERENT ISSUES. New York: Cambridge University Press, 2006.

LETTERS:

1. Studdert DM, Brennan TA. The problems with punitive damages in lawsuits against managed-care organizations. New England Journal of Medicine 2000;342(23):1758.

2. Studdert DM, Brennan TA. Legal implications of practicing alternative medicine. Journal of the American Medical Association 1999;281:1699.

3. Mello MM, Studdert DM, Brennan TA. Quality improvement efforts. Health Affairs 2003;22(3):247-248.

4. Stevenson DG, Studdert DM. Bad nursing homes’ human toll. Health Affairs 2003;22(4):263.

5. Gresenz CR, Studdert DM. In reply: Coverage disputes and the prudent layperson standard. Annals of Emergency Medicine 2004; 44:426-426

6. Kwaan MR, Studdert DM, Zinner MJ, Gawande AA. Wrong-site surgery. Archives of Surgery 2006;141:1050. 7. Kesselheim AS, Studdert DM. Clinical performance measures and malpractice—reply. Journal of the American Medical Association. 2006;196:1589-1590. 8. Kesselheim AS, Studdert DM. Expert witnesses in neurological birth injury litigation— reply. Obstetrics & Gynecology 2006;108:1553.

9. Gandhi TK, Kachalia A, Studdert DM. Missed diagnoses in ambulatory care—reply. Annals of Internal Medicine 2007;146:470-71. 20 Updated: 1.7.08 10. Singh H, Thomas EJ, Petersen LA, Studdert DM. Resident supervision and the electronic medical record—reply. Archives of Internal Medicine 2008;168:1118.

REVIEWS AND OTHER EDUCATIONALLY RELEVANT PUBLICATIONS

1. Tehan MT, Studdert DM. Cause for inspiration: How the best and worst of the US experience can inform a vision for the Australian health care system. Momentum. Sept 1994 (Part I), Oct 1994 (Part II).

2. Tehan MT, Studdert DM. Microeconomic Reform, Women, Health and Welfare. Melbourne: Department of Health and Community Services, October 1993.

3. Tehan MT, Paterson J, Studdert DM. A Profile of Reform in Victoria’s Public Hospital System. Melbourne: Department of Health and Community Services, January 1994.

4. Studdert DM, Brennan TA. Legal considerations in referral to alternative medicine. Forum. 1999;19(6):11-13.

5. Studdert DM, Brennan TA. Legal considerations in referral to alternative medicine. Journal of Medical Practice Management. Nov/Dec 1999:1-3 (Reprint)

6. Studdert DM, Brennan TA. The patient safety case for compensation system reform. Forum 2003;23(1):7-9.

7. Hanscom RB, Mello MM, Powers RP, Schaefer MA, Sato L, Studdert DM. Legal liability and protection of patient safety data (monograph commissioned by the Institute of Medicine’s Committee on Patient Safety Data Standards, 2003)

8. Studdert DM. Patching holes in the medical malpractice system is no longer enough. RAND Review 2004;28(2):35-37.

21 Updated: 1.7.08