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Medical Errors, Negligence, and Litigation Harvey Murff, M.D.,M.P.H. Center for Improving Patient Safety Vanderbilt University
Estimated Deaths Due to Medical Error Source – The Philadelphia Inquirer
How Hazardous Is Health Care? (Modified from Leape) Dangerous (>1/1000) Regulated Ultra-Safe (<1/100K) HealthCare Bungee Jumping Mountain Climbing Driving Chemical Manufacturing Chartered Flights Scheduled Airlines European Railroads Nuclear Power Numbers of encounter for each fatality Total lives lost per year
Medical Errors, Negligence, and Litigation ,[object Object],[object Object],[object Object],[object Object]
Medical Errors, Negligence, and Litigation ,[object Object],[object Object],[object Object],[object Object]
Definitions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Source – IOM, 2000
Relationship of Medical Errors to Adverse Events Medical Errors AE Preventable AEs
Epidemiology of Medical Errors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Harvard Medical Practice Study Source – Brennan, 1991 13,451 (13.6%) Death 2,550 (2.6%) Permanent impairment,  > 50% disability 3,807 (3.9%) Permanent impairment,  < 50% disability 2,762 (2.8%) Moderate impairment, recovery > 6 mo 13,521 (13.7%) Moderate impairment, recovery >1 to 6 mo 56,042 (56.8%) Minimal impairment, recovery 1 mo Adverse Events (%) Category of Disability
Harvard Medical Practice Study Source – Leape, 1991 36 System and other 35.4 Therapeutic mishap 25.3 All 28.8 Procedure-related 47.0 Diagnostic mishap 14.1 Drug-related Non-operative 24 All 17.5 Surgical failure 43.8 Nontechnical complication 35.7 Late complication 12 Technical complication 17.9 Wound infection Operative Proportion of Events with Serious Disability Type of Event
Quality in Australian Health Care Study ,[object Object],[object Object],[object Object],[object Object],[object Object],Source – Wilson, 1995
To Err is Human ,[object Object],[object Object],[object Object],[object Object]
Deaths due to Medical Error ,[object Object],[object Object],[object Object]
Are medical errors the 5 th  leading cause of death in the U.S.? Some important caveats about these numbers
Where do these numbers come from and why might they be overestimated ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Other investigators have suggested with a better methodology the number of deaths per year from medical errors is closer to 5000 Source – Hayward, 2001
Views of the Public on Medical Errors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Views of Practicing Physicians and the Public on Medical Errors Source- Blendon, 2002 <0.001 62 14 Made public <0.001 34 86 Confidential Hospital reports of serious medical errors should be: <0.001 23 1 Increasing lawsuits for malpractice Possible solutions to the problem of medical errors <0.001 30 31 Health professional told respondent an error had been made <0.001 81 70 Parties who had “a lot” of responsibility for the error:  (Doctors) Respondents reporting an error <0.001 24 18 Health consequences: (Serious) <0.001 42 35 Error made in own or family member’s care percent All Respondents P Value Public  (N = 1207) Physicians  (N = 831) Response
Why Do So Many Mistakes Occur?
Human Error ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why is medicine so susceptible? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Medical Errors, Negligence, and Litigation ,[object Object],[object Object],[object Object],[object Object]
All Errors are not Negligent ,[object Object],[object Object],[object Object]
Negligent Medical Injuries  Sources- Mills et al. (1977), Brennan et al. (1991), IOM (1999). All Hospitalizations Negligent Injuries  (1-2%)
Percent of Injuries due to Negligence California Medical Insurance Feasibility Study Harvard Medical Practice Study 17% 28% AE’s AE’s
Proportion of Adverse Events Involving Negligence Source – Leape, 1991 35.9 System and other 76.8 Therapeutic mishap 37.2 All 15.1  Procedure-related 75.2 Diagnostic mishap 17.7 Drug-related Non-operative 17.0 All 36.4 Surgical failure 20.1 Non-technical complication 13.6 Late complication 17.6 Technical complication 12.5  Wound infection Operative Proportion of Events Due to Negligence Type of Event
Rates of Adverse Events and Negligence by Specialty Source – Leape, 1991 0.64 <0.0001 P value 19.7 3.0 Other 30.9 3.6 General medicine 28.0 7.0 General surgery 25.8 0.6 Neonatology 38.3 1.5 Obstetrics 18.0 16.1 Vascular surgery 23.0 10.8 Thoracic and cardiac surgery 35.6 9.9 Neurosurgery 19.4 4.9 Urology 22.4 4.1 Orthopedics Rate of Negligence (%) Rate of Adverse Events (%) Specialty
Percent of Negligent Injuries that File a Claim California Medical Insurance Feasibility Study Harvard Medical Practice Study 10% 13% All Negligent Injuries All Negligent Injuries
1000 280 36 All Injuries All Negligent Injuries Files a Claim 13% of Negligent Injuries Results in a Claim
[object Object],[object Object],[object Object]
Disposition of Claims According to the Rating of the Plaintiff's Injury and Degree of Disability Source – Brennan, 1996 55,853 21 (46) 46 All claims  201,250 7 (88) 8 Permanent  38,857 4 (29) 14 Temporary  28,760 10 (42) 24 None  Disability 66,944 5 (56) 9 Negligent adverse event 98,192 6 (46) 13 Adverse event 28,760 10 (42) 24 No adverse event Type of injury $ no (%) Mean Settlement Settled for Plaintiff No. of Closed Cases Rating
Logistic-Regression Analysis of Predictors That A Claim Would Be Settled in Favor of the Plaintiff Source – Brennan, 1996 0.61 1.8 (0.2-17.5) > 59 yr 0.73 0.6 (0.0-10.6) < 21 yr Age 0.10 0.1 (0.0-1.5) Low income 0.79 0.7 (0.1-7.1) Adverse event 0.32 0.2 (0.01-4.1) Negligent adverse event 0.003 29.7 (1.41-621.4) Permanent Disability P Value Odds Ratio (95% confidence interval) Predictor
1000 280 6 All Injuries All Negligent Injuries Files a Claim 30 2% of Negligent Injuries Results in a Claim
Negligent Injuries that Did Not Result in a Claim 27,179 adverse events due to negligence 26,764 with no malpractice claim (98%) 415 malpractice claims (2%) 14,180 with strong evidence of negligence 12,858 with disability 7462 with disability < 6 mo (58%) 5396 with disability  ≥  6 mo (42%) Source – Localio, 1991
“ Medical-malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care” Source – Localio, 1991
Medical Errors, Negligence, and Litigation ,[object Object],[object Object],[object Object],[object Object]
Reasons Why People Sue Their Doctors   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Percent Expressing Concern Source - Hickson,  1992
Malpractice Risk ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Malpractice Activity and  Patient Complaints Source – Hickson, 2002 4.6 2 or more lawsuits (N = 8) 9.2 1 lawsuit (N = 57) 4.7 No lawsuits (N = 361) Non-surgeons (N = 426) 35.1 2 or more lawsuits (N = 35) 16.7 1 lawsuit (N = 82) 6.1 No lawsuits (N = 102) Surgeons (N = 219) Mean Number of Complaints Physician Characteristic Total Physicians (N = 645)
Nine Percent of Physicians Account for Fifty Percent of the Complaints % of Complaints % of Physicians Source – Hickson, 2002
Communication and Malpractice Claims Source – Levinson, 1997 Affect < 0.05 3.4 4.8 Laughs (Physician) No. of utterances per 15-min visit: NS 7.5 7.8 Laughs (Patients) < 0.05 11.2 14.5 Orientation (Physician) < 0.05 11.9 19.4 Facilitation (Physician) Process:  NS 26.3 28.5 Gives information – medical NS 16.9 18.3 Asks questions- medical Content < 0.05 15.0 18.3 Visit length, min P- Value Claims  (n = 30) No Claims (n = 29) Variable Primary Care Physicians (n = 59)
Communication and Malpractice Claims Source – Hickson, 1994 0.01 8.7 1.4 No concern for me as a person 0.15 9.2 4.8 Yelled 0.01 17.4 4.8 Humanity of a physician 0.01 7.1 1.9 Did not listen 0.01 23.5 6.7 Would not talk 0.01 27.6 8.2 Physician-patient communication P - value High Frequency No Claims Category of complaint, % Prior Malpractice Claims Group
Medical Errors, Negligence, and Litigation ,[object Object],[object Object],[object Object],[object Object]
Malpractice Litigation
Relationship between Malpractice Claims History and Subsequent Obstetric Care Source – Entman, 1994 2 0 17 High Frequency 7 8 42 No Claims No. of Cases of Subjective Substandard Care Total No. of Relevant Errors No. of Charts with Adverse Outcomes Physician Group
Malpractice as a Barrier to Safety ,[object Object],[object Object]
Malpractice Reform ,[object Object],[object Object],[object Object],[object Object]
Increased Regulations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Other Potential Solutions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
“ Physicians and nurses need to accept the notion that error is an inevitable accompaniment of the human condition, even among conscientious professionals with high standards.  Errors must be accepted as evidence of system flaws not character flaws.” Leape, 1994
Litigation in Human Subjects Research
Litigation and Clinical Research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why Suits Related to Research will Probable Continue to Rise ,[object Object],[object Object],[object Object],[object Object],[object Object]
Impact of Rising Litigation on Clinical Research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Medical errors, negligence, and litigation

  • 1. Medical Errors, Negligence, and Litigation Harvey Murff, M.D.,M.P.H. Center for Improving Patient Safety Vanderbilt University
  • 2. Estimated Deaths Due to Medical Error Source – The Philadelphia Inquirer
  • 3. How Hazardous Is Health Care? (Modified from Leape) Dangerous (>1/1000) Regulated Ultra-Safe (<1/100K) HealthCare Bungee Jumping Mountain Climbing Driving Chemical Manufacturing Chartered Flights Scheduled Airlines European Railroads Nuclear Power Numbers of encounter for each fatality Total lives lost per year
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  • 7. Relationship of Medical Errors to Adverse Events Medical Errors AE Preventable AEs
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  • 9. Harvard Medical Practice Study Source – Brennan, 1991 13,451 (13.6%) Death 2,550 (2.6%) Permanent impairment, > 50% disability 3,807 (3.9%) Permanent impairment, < 50% disability 2,762 (2.8%) Moderate impairment, recovery > 6 mo 13,521 (13.7%) Moderate impairment, recovery >1 to 6 mo 56,042 (56.8%) Minimal impairment, recovery 1 mo Adverse Events (%) Category of Disability
  • 10. Harvard Medical Practice Study Source – Leape, 1991 36 System and other 35.4 Therapeutic mishap 25.3 All 28.8 Procedure-related 47.0 Diagnostic mishap 14.1 Drug-related Non-operative 24 All 17.5 Surgical failure 43.8 Nontechnical complication 35.7 Late complication 12 Technical complication 17.9 Wound infection Operative Proportion of Events with Serious Disability Type of Event
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  • 14. Are medical errors the 5 th leading cause of death in the U.S.? Some important caveats about these numbers
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  • 16. Other investigators have suggested with a better methodology the number of deaths per year from medical errors is closer to 5000 Source – Hayward, 2001
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  • 18. Views of Practicing Physicians and the Public on Medical Errors Source- Blendon, 2002 <0.001 62 14 Made public <0.001 34 86 Confidential Hospital reports of serious medical errors should be: <0.001 23 1 Increasing lawsuits for malpractice Possible solutions to the problem of medical errors <0.001 30 31 Health professional told respondent an error had been made <0.001 81 70 Parties who had “a lot” of responsibility for the error: (Doctors) Respondents reporting an error <0.001 24 18 Health consequences: (Serious) <0.001 42 35 Error made in own or family member’s care percent All Respondents P Value Public (N = 1207) Physicians (N = 831) Response
  • 19. Why Do So Many Mistakes Occur?
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  • 24. Negligent Medical Injuries Sources- Mills et al. (1977), Brennan et al. (1991), IOM (1999). All Hospitalizations Negligent Injuries (1-2%)
  • 25. Percent of Injuries due to Negligence California Medical Insurance Feasibility Study Harvard Medical Practice Study 17% 28% AE’s AE’s
  • 26. Proportion of Adverse Events Involving Negligence Source – Leape, 1991 35.9 System and other 76.8 Therapeutic mishap 37.2 All 15.1 Procedure-related 75.2 Diagnostic mishap 17.7 Drug-related Non-operative 17.0 All 36.4 Surgical failure 20.1 Non-technical complication 13.6 Late complication 17.6 Technical complication 12.5 Wound infection Operative Proportion of Events Due to Negligence Type of Event
  • 27. Rates of Adverse Events and Negligence by Specialty Source – Leape, 1991 0.64 <0.0001 P value 19.7 3.0 Other 30.9 3.6 General medicine 28.0 7.0 General surgery 25.8 0.6 Neonatology 38.3 1.5 Obstetrics 18.0 16.1 Vascular surgery 23.0 10.8 Thoracic and cardiac surgery 35.6 9.9 Neurosurgery 19.4 4.9 Urology 22.4 4.1 Orthopedics Rate of Negligence (%) Rate of Adverse Events (%) Specialty
  • 28. Percent of Negligent Injuries that File a Claim California Medical Insurance Feasibility Study Harvard Medical Practice Study 10% 13% All Negligent Injuries All Negligent Injuries
  • 29. 1000 280 36 All Injuries All Negligent Injuries Files a Claim 13% of Negligent Injuries Results in a Claim
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  • 31. Disposition of Claims According to the Rating of the Plaintiff's Injury and Degree of Disability Source – Brennan, 1996 55,853 21 (46) 46 All claims 201,250 7 (88) 8 Permanent 38,857 4 (29) 14 Temporary 28,760 10 (42) 24 None Disability 66,944 5 (56) 9 Negligent adverse event 98,192 6 (46) 13 Adverse event 28,760 10 (42) 24 No adverse event Type of injury $ no (%) Mean Settlement Settled for Plaintiff No. of Closed Cases Rating
  • 32. Logistic-Regression Analysis of Predictors That A Claim Would Be Settled in Favor of the Plaintiff Source – Brennan, 1996 0.61 1.8 (0.2-17.5) > 59 yr 0.73 0.6 (0.0-10.6) < 21 yr Age 0.10 0.1 (0.0-1.5) Low income 0.79 0.7 (0.1-7.1) Adverse event 0.32 0.2 (0.01-4.1) Negligent adverse event 0.003 29.7 (1.41-621.4) Permanent Disability P Value Odds Ratio (95% confidence interval) Predictor
  • 33. 1000 280 6 All Injuries All Negligent Injuries Files a Claim 30 2% of Negligent Injuries Results in a Claim
  • 34. Negligent Injuries that Did Not Result in a Claim 27,179 adverse events due to negligence 26,764 with no malpractice claim (98%) 415 malpractice claims (2%) 14,180 with strong evidence of negligence 12,858 with disability 7462 with disability < 6 mo (58%) 5396 with disability ≥ 6 mo (42%) Source – Localio, 1991
  • 35. “ Medical-malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care” Source – Localio, 1991
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  • 39. Malpractice Activity and Patient Complaints Source – Hickson, 2002 4.6 2 or more lawsuits (N = 8) 9.2 1 lawsuit (N = 57) 4.7 No lawsuits (N = 361) Non-surgeons (N = 426) 35.1 2 or more lawsuits (N = 35) 16.7 1 lawsuit (N = 82) 6.1 No lawsuits (N = 102) Surgeons (N = 219) Mean Number of Complaints Physician Characteristic Total Physicians (N = 645)
  • 40. Nine Percent of Physicians Account for Fifty Percent of the Complaints % of Complaints % of Physicians Source – Hickson, 2002
  • 41. Communication and Malpractice Claims Source – Levinson, 1997 Affect < 0.05 3.4 4.8 Laughs (Physician) No. of utterances per 15-min visit: NS 7.5 7.8 Laughs (Patients) < 0.05 11.2 14.5 Orientation (Physician) < 0.05 11.9 19.4 Facilitation (Physician) Process: NS 26.3 28.5 Gives information – medical NS 16.9 18.3 Asks questions- medical Content < 0.05 15.0 18.3 Visit length, min P- Value Claims (n = 30) No Claims (n = 29) Variable Primary Care Physicians (n = 59)
  • 42. Communication and Malpractice Claims Source – Hickson, 1994 0.01 8.7 1.4 No concern for me as a person 0.15 9.2 4.8 Yelled 0.01 17.4 4.8 Humanity of a physician 0.01 7.1 1.9 Did not listen 0.01 23.5 6.7 Would not talk 0.01 27.6 8.2 Physician-patient communication P - value High Frequency No Claims Category of complaint, % Prior Malpractice Claims Group
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  • 45. Relationship between Malpractice Claims History and Subsequent Obstetric Care Source – Entman, 1994 2 0 17 High Frequency 7 8 42 No Claims No. of Cases of Subjective Substandard Care Total No. of Relevant Errors No. of Charts with Adverse Outcomes Physician Group
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  • 50. “ Physicians and nurses need to accept the notion that error is an inevitable accompaniment of the human condition, even among conscientious professionals with high standards. Errors must be accepted as evidence of system flaws not character flaws.” Leape, 1994
  • 51. Litigation in Human Subjects Research
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Editor's Notes

  1. Introduction: I am very happy to be here today and I thank Nick for giving me the chance to talk to you today. I would like to talk about a very important issue in health care today.