Medical error, deception, self-critical analysis, and law's impact a comparative examination

Law in Japan: A Turning Point

Volumn , Issue , 2007, Pages 404-432

  Leflar, Robert B ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 67649201828     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (131)

1. Alice L. Bhasale et al., "Analyzing Potential Harm in Australian General Practice: An Incident-Monitoring Study", Medical Journal of Australia 169(1998):73
2. Charles Vincent et al., "Adverse Events in British Hospitals: Preliminary Retrospective Record Review", British Medical Journal 322(2001):517;
3. Department of Health [United Kingdom], An Organisation with a Memory (London: The Stationery Office, 2000);
4. "Gesundheitsministerkonferenz, Ziele für eine einheitlichen Qualitätsstrategie im Gesundheitswesen" [Health Minister's Conference, Goal for a Unified Quality Strategy in the Health Care System] (http://www.gesetzeskunde.de/Rechtsalmanach/Gesundheitswesen/ gesundheitsministerkonferenz.htm) (1999) (Germany) (accessed March 23, 2005);
5. Emmy M. Sluijs and Cordula Wagner, Kwaliteitssystemen in zorginstellingen: De stand van zaken in 2000 [Quality Systems in Health Care Institutions: The State of Affairs in 2000] (Utrecht: Nivel, 2000) (Netherlands);
6. Synnöve Ödegård, "Säkerheten i vården bör fokusera på prevention: Låar av flyget, kärkraftsverken och offshoreindustrin" [Prevention Should Be the Focus of Measures in Health Care: Lessons to Be Learned from the Aviation, Nuclear Energy, and Offshore Oil Industries], Läkartidningen (1999): 3068 (Sweden).
7. "President Discusses Medical Liability Reform", White House press release, January 5, 2005 (http://www.whitehouse.gov/news/releases/2005/01/ 20050105-4.html) (visited March 23, 2005);
8. Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2005, H. R. 534, 109th Cong. (2005). Prime Minister Koizumi's Council for Regulatory Reform has proposed a major restructuring of hospital care, one primary aim of which is the improvement of patient safety.
9. Sōgō kisei kaikaku kaigi [Council on Regulatory Reform], "Kisei kaikaku no suishin ni kansuru daiichiji tōshin" [First Report Regarding Promotion of Regulatory Reform] (December 11, 2001), chap. 1.1 ("Medical Care"), (http://www8.cao.go.jp/kisei/en/011211report/1.html) (English translation) (visited February 9, 2004). Of course, in both cases the executive is attempting to enlist the public's concern over patient safety for partisan advantage.
10. Michael L. Millenson, "Moral Hazard vs. Real Hazard: Quality of Care Post-Arrow", Journal of Health Policy and Law 26(2001):1069, 1074.
11. Stephen D. Small and Paul Barach, "Patient Safety and Health Policy: A History and Review", Hematology/Oncology Clinics of North America 16(2001):1463.
12. Troyen A. Brennan et al., "Incidence of Adverse Events and Negligence in Hospitalized Patients: Results of the Harvard Medical Practice Study I", New England Journal of Medicine 324(1991):370;
13. Lucian L. Leape et al., "The Nature of Adverse Events in Hospitalized Patients: Results of the Harvard Medical Practice Study II", New England Journal of Medicine 324(1991):377;
14. Russell Localio et al., "Relation between Malpractice Claims and Adverse Events due to Negligence: Results of the Harvard Medical Practice Study III", New England Journal of Medicine 325(1991):245.
15. Eric J. Thomas et al., "Incidence and Types of Adverse Events and Negligent Care in Utah and Colorado", Medical Care 38(2000):261.
16. Linda T. Kohn et al., eds., To Err Is Human: Building a Safer Health System (Washington, DC: National Academy Press, 2000).
17. Troyen A. Brennan, "Reporting of Errors: How Much Should the Public Know?" Effective Clinical Practice 3(2000):298.
18. Quality Interagency Coordination Task Force [United States], Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact; Report of the Quality Interagency Coordination Task Force to the President (Rockville, MD: Quality Interagency Coordination Task Force, 2000).
19. National Quality Forum, Serious Reportable Events in Healthcare: A Consensus Report (Washington, DC: National Quality Forum, 2002).
20. Small and Barach, "Patient Safety and Health Policy", 1468, 1470-71.
21. Jill Rosenthal et al., Medical Errors and Adverse Events: A Report of a 50-State Survey (Portland, ME: National Academy for State Health Policy, 2000);
22. Kohn et al., To Err Is Human, 254-65.
23. Ofer Feldman, Politics and the News Media in Japan (Ann Arbor: University of Michigan Press, 1993), 17, 22-25;
24. and John C. Campbell, "The Media and Policy Change in Japan", in Susan J. Pharr and Ellis S. Krauss, eds., Media and Politics in Japan (Honolulu: University of Hawai'i Press, 1996).
25. Yumiko Ono, "In Japan, a Doctor Shakes up Medicine in Malpractice Case", Wall Street Journal, June 10, 2002, A1
26. "Court Fines Medical Staff for Heart, Lung Mix-up", Japan Times, September 21, 2001.
27. "Nurses Get Suspended Sentences in Hiroo Malpractice Case", Japan Times, December 28, 2000;
28. "Cover-up of Patient's Death Gets Director Suspended Term", Japan Times, August 31, 2001.
29. "Two Doctors Arrested in Malpractice Death", International Herald Tribune/Asahi shinbun, June 29, 2002, 1.
30. "2 Doctors Indicted for Girl's Death", International Herald Tribune/Asahi shinbun, July 20-21, 2002, 22.
31. "Three Urologists Held over Patient's Death; Inexperienced Doctors Read from Manual While Performing Surgery", Japan Times, September 26, 2003;
32. "Jikei Medical School Fires Three Doctors Standing Trial for Malpractice Death", Japan Times, December 27, 2003.
33. Kohn et al., To Err Is Human, 86-108.
34. Lucian L. Leape et al., "Promoting Patient Safety by Preventing Medical Error", Journal of the American Medical Association 280(1998):1444;
35. David Blumenthal, "Making Medical Errors into 'Medical Treasures, '" Journal of the American Medical Association 272(1994):1867.
36. Joint Commission on Accreditation of Healthcare Organizations, Hospital Accreditation Standards (Oak Brook, IL: Joint Commission Resources, 2002), 200, Standard LD.5.2;
37. JCAHO Sentinel Event Policy and Procedures (January 2002), available at (http://www.jcaho.org/accredited+organizations/hospitals/sentinel +event/index.htm) (visited February 16, 2004).
38. Harold Bressler, "The Sentinel Event Policy: A Response by the Joint Commission", Journal of Health Law 33(2000):519, 531 and n. 38 (2000) (views of JCAHO general counsel).
39. "Medicare and Medicaid Programs; Hospital Conditions of Participation: Quality Assessment and Performance Improvement", Federal Register 68(2003):3435
40. (codified at 42 C. F. R. § 482.21).
41. Troyen A. Brennan, "The Institute of Medicine Report on Medical Errors-Could It Do Harm?" New England Journal of Medicine 342(2000):1123, 1125.
42. Bryan A. Liang, "Risks of Reporting Sentinel Events", Health Affairs 19(5) (September-October 2000):112.
43. Representative peer review statutes include, e.g., Ala. Code Ann. § 22-21-8 (2001);
44. Ark. Code Ann. § 16-46-105 (Michie 2001);
45. Minn. Stat. Ann. §§ 145.61 and 145.64 (West Supp. 2002).
46. Bredice v. Doctors Hospital, Inc., 50 F. R. D. 249, 250-51 (D. D. C. 1970)
47. aff 'd, 479 F.2d 920 (D. C. Cir. 1973).
48. Donald P. Vandegrift, Jr., "The Privilege of Self-Critical Analysis: A Survey of the Law", Albany Law Review 60(1996):171;
49. Daniel Mulholland, "Unanticipated Consequences of Unanticipated Outcomes Disclosures", Journal of Health Law 35(2002):211, 214-19 (surveying statutes and case law as applied to hospital reports to JCAHO).
50. Kohn et al., To Err Is Human, 120-21;
51. Susan O. Scheutzow, "State Medical Peer Review: High Cost but No Benefit-Is It Time for a Change?" American Journal of Law and Medicine 25(1999):7, 28;
52. Melissa Chiang, "Promoting Patient Safety: Creating a Workable Reporting System", Yale Journal on Regulation 18(2001):383, 400-401.
53. John C. Lincoln Hosp. v. Superior Court, 768 P.2d 188 (Ariz. Ct. App. 1989);
54. Chicago Trust Co. v. Cook County Hosp., 698 N. E.2d 641 (Ill. App. Ct. 1998);
55. Columbia/HCA Healthcare Corp. v. Eighth Judicial Dist. Court, 936 P.2d 844 (Nev. 1997).
56. William D. Bremer, "Scope and Extent of Protection from Disclosure of Medical Peer Review Proceedings relating to Claim in Medical Malpractice Action", American Law Reports, ALR 5th, Annotations and Cases, 69 (Rochester, NY: Lawyers Cooperative Publishing, 2000), 559.
57. Bressler, "The Sentinel Event Policy", 532-33.
58. Syposs v. United States, 63 F. Supp. 2d 301 (W. D. N. Y. 1999).
59. Contra, Weekoty v. United States, 30 F. Supp. 2d 1343 (D. N. M. 1998).
60. Kohn et al., To Err Is Human, 123.
61. Rae M. Lamb et al., "Hospital Disclosure Practices: Results of a National Survey", Health Affairs 22(2) (March-April 2003):73.
62. American Medical Association, Current Opinions of the Council on Ethical and Judicial Affairs E-8.12, "Patient Information" (updated 1994).
63. National Patient Safety Foundation, "Talking to Patients about Health Care Injury: Statement of Principle", at (http://www.npsf.org/html/ statement.html) (2000) (visited February 16, 2004);
64. Stephen Jencks, "Public Reporting of Serious Medical Errors", Effective Clinical Practice 3(2000):299, 30 1 ("Almost all ethicists agree that the patient has an absolute right to know what has happened and whether what has happened is the result of an error").
65. Joint Commission on Accreditation of Healthcare Organizations, Hospital Accreditation Standards, 73, Standard RI.1.2.2.
66. Nancy LeGros and Jason D. Pinkall, "The New JCAHO Patient Safety Standards and the Disclosure of Unanticipated Outcomes", Journal of Health Law 35(2002):189.
67. Aaron D. Twerski and Neil B. Cohen, "Comparing Medical Providers: A First Look at the New Era of Medical Statistics", Brooklyn Law Review 58(1992):5;
68. Robert B Leflar, "Infōmudo konsento o koete-Iryō jōhō no kōkai to chiryō kekka ni motozuku iryō teikyōsha hyōka no reimei" [Beyond Informed Consent: Public Access to Medical Information and the Dawn of Physicians' Accountability for the Results of Medical Treatment], trans. Hiroo Sono, Hokkaido Law Review 44(1994):1039;
69. Mark R. Chassin et al., "Benefits and Hazards of Reporting Medical Outcomes Publicly", New England Journal of Medicine 334(1996):394.
70. Judith Hibbard et al., "Does Publicizing Hospital Performance Stimulate Quality Improvement Efforts?" Health Affairs 22(2) (March-April 2003):84.
71. David Dranove et al., "Is More Information Better? The Effects of 'Report Cards' on Health Care Providers", Journal of Political Economy 111(2003):555.
72. David Brown, "Hospitals Will Be Rated on Their Performance", Washington Post, December 13, 2002, A1.
73. Kokuritsu daigaku igakubu fuzoku byōinchō kaigi jōchi iinkai [National University Hospital Presidents' Conference], Iryō jiko bōshi no tame no anzen kanri taisei no kakuritsu ni tsuite-Nakama hōkoku [Interim Report: Establishing Safety Systems for the Prevention of Medical Accidents] (Tokyo: MHLW, 2000).
74. Ministry of Health, Labor and Welfare, "Risuku manējimento manyuaru sakusei shishin" [Guidelines for the Creation of Risk Management Manuals] (2000).
75. Takashi Yokota et al., "Will Accident Reports Filed in Hospitals in Japan Be Used in the Future as Evidence in Malpractice Lawsuits?" American Journal of Emergency Medicine 19(2001):597.
76. Best's Aggregates and Averages, Property-Casualty, 2001 ed. (Oldwick, NJ: A. M. Best Co., 2001), 238.
77. Kazue Nakajima et al., "Medical Malpractice and Legal Resolution Systems in Japan", Journal of the American Medical Association 285(2001):1632, 1633, 1638.
78. Best's Aggregates and Averages, Property-Casualty, 238;
79. Nakajima et al., "Medical Malpractice and Legal Resolution Systems in Japan", 1632;
80. Nakajima et al., "Medical Malpractice and Legal Resolution Systems in Japan", 1633 (table 1).
81. U. S. Department of Health and Human Services, Confronting the New Health Care Crisis: Improving Health Care Quality and Lowering Costs by Fixing Our Medical Liability System (Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services, 2002), 16 (table 6), available at (http://aspe.hhs.gov/daltcp/reports/litrefm.pdf) (visited February 16, 2004).
82. Tatsuo Kuroyanagi, "Iryō jiko soshō no shori ni tsuite" [The Management of Medical Accident Litigation], Hō no shihai 130(2003):5, 12 (fig. 1).
83. William M. Sage, "Reputation, Malpractice Liability, and Medical Error", in Virginia A. Sharpe, ed., Promoting Patient Safety: An Ethical Basis for Policy Reform (Washington, DC: Georgetown University Press, 2004), 159-83.
84. (Kyoto Dist. Ct., July 12, 2005), Hanrei jihō 1907(2005):112, 124-25;
85. (Tokyo Dist. Ct., Jan. 30, 2004), Hanrei taimuzu 1194(2006):243 (Hiroo Hospital civil case).
86. ["Disclose Physicians' Names" in National Hospital Medical Accident: Information Board Sets Standards], Asahi shinbun, January 9, 2002, evening edition, 1.
87. Interview with Professor Katsuya Uga (University of Tokyo Faculty of Law), August 7, 2003.
88. Interview with Kazuhiro Araki, July 29, 2003.
89. Shozo Ota, "Reform of Civil Procedure in Japan", American Journal of Comparative Law 49(2001):561;
90. and Toshiro M. Mochizuki, "Baby Step or Giant Leap? Parties' Expanded Access to Documentary Evidence under the New Japanese Code of Civil Procedure", Harvard Journal of International Law 40(1999):285, 299-30 9.
91. (Sup. Ct., Nov. 12, 1999), Minshū 53(8) (1999):1787 (holding that bank ringisho are for internal use and not subject to discovery) (Fuji Bank Case).
92. (Tokyo High Court, July 15, 2003), Hanrei jihō 57(2003):1842;
93. Hanrei taimuzu 298(2003):1145 (Saitama Medical University case).
94. Ministry of Health, Labor and Welfare, Shōrei 111 (August 30, 2002), available at (http://www.mhlw.go.jp/topics/bukyoku/isei/i-anzen/2/kaisei/ index.html) (visited February 16, 2004).
95. "Medical Accident Tally at 15, 000", International Herald Tribune/Asahi shinbun, April 24, 2002.
96. Interview with Kazuhiro Araki, July 29, 2003.
97. Ministry of Health, Labor, and Welfare, "Iryō ni kakaru jiko jirei jōhō no toriatsukai ni kansuru kentō-bukai hōkokusho" [Report of the Subcommittee for the Study of the Handling of Information on Medical Accident Events] (2003).
98. " 'Erabareru byōin' no jidai" [The Era of Hospital Choice], Aera, November 4, 2002, 34-39;
99. "Daichōgan shuyō 103 byōin, 'shujutsu jisseki' wa konna ni chigau" [Vast Differences in Colon Cancer Surgery Results at 103 Leading Hospitals], Sunday Mainichi, July 28, 2002, 44-49;
100. "Kanja ya chiiki ni hirakareta byōin, jōhō kōkai de shinrai kankei jōsei e" [Accountable Hospitals: Building Trust with Patients and Community through Information Disclosure], Nikkei Business, August 20, 2001, 118-19.
101. James A. Filkins, "'With No Evil Intent': The Criminal Prosecution of Physicians for Medical Negligence", Journal of Legal Medicine 22(2001):467
102. George J. Annas, "Medicine, Death, and the Criminal Law", New England Journal of Medicine 333(1995):527 (criminal prosecution of physicians for patients' deaths "extraordinarily rare").
103. Filkins, "With No Evil Intent", reports convictions upheld for reckless or intentional acts in Pennsylvania v. Youngkin, 427 A.2d 1356 (Pa. Super. Ct. 1981) (involuntary manslaughter);
104. People v. Einaugler, 618 N. Y. S.2d 414 (N. Y. App. Div. 1994) (reckless endangerment);
105. Wisconsin v. Chem-Bio Corp. (reckless homicide) (discussed at 477-78 of the Filkins article);
106. and People v. Klvana, 15 Cal. Rptr. 2d 512 (Cal. App. 1992) (second-degree murder).
107. Utah v. Warden, 813 P.2d 1146 (Utah 1991).
108. United States v. Billig, 26 M. J. 744 (1988) (military case);
109. Colorado v. Verbrugge, No. 98CA0262, 1999 WL 417965 (Colo. App. June 24, 1999).
110. Donald C. Barrett, "Annotation, Homicide Predicated on Improper Treatment", American Law Reports, ALR 3rd, Annotations and Cases, 45 (Rochester, NY: Lawyers Cooperative Publishing, 1972), 114, 142-49.
111. Kara M. McCarthy, "Note, Doing Time for Clinical Crime: The Prosecution of Incompetent Physicians as an Additional Mechanism to Assure Quality Health Care", Seton Hall Law Review 28(1997):569, 607-13.
112. "'Shohoteki misu': Iryō kago yūhatsu keiji saiban 73-ken: Kyūdai joshu bunseki" ["Elementary Mistakes": 73 Criminal Cases Triggered by Medical Malpractice, Kyushu University Researcher Finds], Nishi Nippon shinbun, August 25, 2003, available at (http://www.nishinip pon. co.jp/media/news/news-today/20030 825/morning-news001.html) (last visited August 26, 2003)
113. Hideo Iida and Issei Yamaguchi, Keiji iryō kago [Criminal Medical Malpractice] (Tokyo: Hanrei taimuzu-sha, 2001), 1 (reporting 137 prosecutions brought in the fifty years following the end of World War II).
114. Keihō [Criminal Code], Law No. 45 of 1907
115. Ishihō [Physicians' Act], Law No. 201 of 1948, as amended by Law No. 1 of 2002, art. 21.
116. Nihon hōi gakkai, "'Ijōshi' gaidorainu" [Guidelines on 'Unnatural Death'] (1994), reprinted in Toshiharu Furukawa, "Shinryō kōi ni kanren shita kanja no shibō, shōgai no hōkoku ni tsuite" [Reporting to Police of Patients' Deaths and Injuries Connected with Medical Acts], Nihon geka gakkai zasshi 104(2003):9, 13-14.
117. Hitoshi Saeki, "Ijō shitai no todokede gimu to mokuhiken" [The Duty to Report Unnatural Deaths and the Right to Remain Silent], Jurisuto, no. 1249(2003):77;
118. and Yasushi Kodama, "Ishihō 21-jō o meguru konmei" [The Confusion Surrounding Article 21 of the Physicians' Act], Jurisuto, no. 1249(2003):72.
119. (Sup. Ct., Apr. 13, 2004), Keishū 58(4) (2004):247 (Tokyo Hiroo Hospital case).
120. Futoshi Iwata, "Kashitsu ni yoru iryō kago ni taisuru keijiteki kisei: Nichibei hikaku-kō" [Regulation of Medical Malpractice through Criminal Negligence Actions: Japan-U. S. Comparative Research], in Yasushi Kodama, ed., Iryō anzen suishin ni kansuru hōteki mondai ni kansuru kinkyū: Heisei 14-nendo kinkyū seika hōkokusho [Research Report on Legal Problems in the Promotion of Medical Safety] (2003), 6 (on file with author).
121. Robert B Leflar, "Informed Consent and Patients' Rights in Japan", Houston Law Review 33(1996):1, 9 and nn. 22-23.
122. Hideo Tanaka and Akio Takeuchi, "The Role of Private Persons in the Enforcement of Law: A Comparative Study of Japanese and American Law", Law in Japan: An Annual 7(1974):34.
123. David T. Johnson, The Japanese Way of Justice: Prosecuting Crimes in Japan (New York: Oxford University Press, 2002).
124. Steven S. Kraman and Ginny Hamm, "Risk Management: Extreme Honesty May Be the Best Policy", Annals of Internal Medicine 131(1999):963 (describing Lexington, Kentucky, Veterans Administration Hospital's successful policy of openness toward patients and apology in cases of error);
125. Jonathan R. Cohen, "Apology and Organizations: Exploring an Example from Medical Practice", Fordham Urban Law Journal 27(2000):1447 (same; legal analysis).
126. Tsuneko Kunou, A Promise to Akiko: A Mother's Notes (Berkeley, CA: Creative Arts Book Co., 1998).
127. Sandra M. Gilbert, Wrongful Death: A Memoir (New York: W. W. Norton, 1995);
128. and "Blunt Instruments: Medicine, Law and the Death of Nancy Lim", at (http://www.nancylim.org) (visited February 16, 2004).
129. Kuniko Nagao, Musume kara no shukudai [Homework from My Daughter] (Tokyo: Soushisha, 1988)
130. Fumie Sugino, "Waribashi ga nō ni sasatta wagako" to "daibyōin no taido" [The Chopstick Stuck into Our Child's Brain, and the Giant Hospital's Attitude] (Tokyo: Shōgakukan, 2000).
131. "Higaisha no tachiba ni tatta shihō: Hikinige jiko de musuko o nakushite" [Toward a Justice System That Stands on the Victims' Side: Son Lost in Hit-and-Run], Gekkan shihō kaikaku 2(1999):15-17(1999), available at (http://www2.tky.3web.ne.jp/~norin/katayama.html) (visited February 16, 2004).