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

4. Medical Errors, Negligence, and Litigation I.Medical Errors II.Relationship of Medical Errors to Negligence III.Why do People Sue their Doctors? IV.Potential Solutions to the Problem of Medical Errors

5. Medical Errors, Negligence, and Litigation I.Medical Errors II.Relationship of Medical Errors to Negligence III.Why do People Sue their Doctors? IV.Potential Solutions to the Problem of Medical Errors

6. Definitions Error –Failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e. error of planning) Adverse Event (AE) –An injury caused by medical management rather than the underlying condition of the patient Preventable Adverse Event –An adverse event attributable to an error Source – IOM, 2000

7. Relationship of Medical Errors to Adverse Events Medical Errors AE Preventable AEs

8. Epidemiology of Medical Errors California Medical Insurance Feasibility Study (1974) –20,864 hospital admissions –4.65 injuries per 100 hospitalizations Harvard Medical Practice Study (1984) – 30,121 hospital admissions in NY state –Reported adverse events (AE’s) –3.7% of admissions had an AE

9. Harvard Medical Practice Study Category of Disability Adverse Events (%) Minimal impairment, recovery 1 mo 56,042 (56.8%) Moderate impairment, recovery >1 to 6 mo 13,521 (13.7%) Moderate impairment, recovery > 6 mo 2,762 (2.8%) Permanent impairment, < 50% disability 3,807 (3.9%) Permanent impairment, > 50% disability 2,550 (2.6%) Death 13,451 (13.6%) Source – Brennan, 1991

10. Harvard Medical Practice Study Type of Event Proportion of Events with Serious Disability Operative Wound infection 17.9 Technical complication 12 Late complication 35.7 Nontechnical complication 43.8 Surgical failure 17.5 All24 Non-operative Drug-related14.1 Diagnostic mishap 47.0 Therapeutic mishap 35.4 Procedure-related28.8 System and other 36 All25.3 Source – Leape, 1991

11. Quality in Australian Health Care Study Reviewed 14,179 admissions in 1995Reviewed 14,179 admissions in 1995 16.6% of admissions had an AE’s16.6% of admissions had an AE’s –Permanent disability 13.7% –Death 4.9% 51% of events preventable51% of events preventable Source – Wilson, 1995

12. To Err is Human IOM releases report To Err is Human (2000)IOM releases report To Err is Human (2000) –Estimates 44,000 to 98,000 unnecessary deaths each year due to medical error –Estimated 1,000,000 excess injuries due to medical error –Numbers based on the MPS and extrapolated to the general population

13. Deaths due to Medical Error 44,000 to 98,000 unnecessary deaths each year44,000 to 98,000 unnecessary deaths each year –More Americans are killed in US hospitals every 6 months than died in the entire Vietnam War –Death rate equivalent to three “jumbo” jet crashed every two days

14. Are medical errors the 5 th leading cause of death in the U.S.? Some important caveats about these numbers

15. Where do these numbers come from and why might they be overestimated Methods of the MPS –Physician implicit judgment –Causality of death difficult –Kappa statistics low Overcoming these shortcomings –Utilizing more reviewers –Requiring greater agreement –Requiring assessment of overall prognosis

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

17. Views of the Public on Medical Errors Percentage of adults experiencing an errorPercentage of adults experiencing an error –Medication or medical error 22% –Mistake at the physician’s office or hospital 10% –Wrong medication or dose 16% Source- The Commonwealth Fund, 2001

18. Views of Practicing Physicians and the Public on Medical Errors ResponsePhysicians (N = 831) Public (N = 1207) P Value All Respondentspercent Error made in own or family member’s care3542<0.001 Health consequences: (Serious)1824<0.001 Respondents reporting an error Parties who had “a lot” of responsibility for the error: (Doctors) 7081<0.001 Health professional told respondent an error had been made 3130<0.001 Possible solutions to the problem of medical errors Increasing lawsuits for malpractice123<0.001 Hospital reports of serious medical errors should be: Confidential8634<0.001 Made public1462<0.001 Source- Blendon, 2002

19. Why Do So Many Mistakes Occur?

20. Human Error Extensively studied in other industriesExtensively studied in other industries Cognitive psychologists divide errors into:Cognitive psychologists divide errors into: –Errors occurring in “automatic mode” SlipsSlips –Occur during fatigue, interruptions, anxiety –Errors occurring in “problem solving mode” MistakesMistakes –Occur due to incomplete knowledge and the tendency to apply rules to simplify problem solving

21. Why is medicine so susceptible? Lack of awareness to the problemLack of awareness to the problem “Culture of Silence”“Culture of Silence” –Blame and shame mentality System constraintsSystem constraints –Staffing problems –Fatigue –Knowledge requirements –Communication and continuity of care

22. Medical Errors, Negligence, and Litigation I.Medical Errors II.Relationship of Medical Errors to Negligence III.Why do People Sue their Doctors? IV.Potential Solutions to the Problem of Medical Errors

23. All Errors are not Negligent Medical negligence –Failure to meet the standard of practice of an average qualified physician practicing in the specialty in question  Occurs not merely when there is an error, but when the degree of error exceeds the accepted norm

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

26. Proportion of Adverse Events Involving Negligence Type of Event Proportion of Events Due to Negligence Operative Wound infection 12.5 Technical complication 17.6 Late complication 13.6 Non-technical complication 20.1 Surgical failure 36.4 All17.0 Non-operative Drug-related17.7 Diagnostic mishap 75.2 Therapeutic mishap 76.8 Procedure-related15.1 System and other 35.9 All37.2 Source – Leape, 1991

27. Rates of Adverse Events and Negligence by Specialty SpecialtyRate of Adverse Events (%) Rate of Negligence (%) Orthopedics4.122.4 Urology4.919.4 Neurosurgery9.935.6 Thoracic and cardiac surgery10.823.0 Vascular surgery16.118.0 Obstetrics1.538.3 Neonatology0.625.8 General surgery7.028.0 General medicine3.630.9 Other3.019.7 P value<0.00010.64 Source – Leape, 1991

28. Percent of Negligent Injuries that File a Claim California Medical Insurance Feasibility Study Harvard Medical Practice Study 10% 13% All Negligent Injuries

29. 1000 280 36 All Injuries All Negligent Injuries Files a Claim 13% of Negligent Injuries Results in a Claim

30. 42% of public report a medical error42% of public report a medical error 66% reported serious consequences such as severe pain, substantial loss of time at work or school, disability or even death66% reported serious consequences such as severe pain, substantial loss of time at work or school, disability or even death Only 6% had suedOnly 6% had sued

31. Disposition of Claims According to the Rating of the Plaintiff's Injury and Degree of Disability RatingNo. of Closed Cases Settled for Plaintiff Mean Settlement no (%)$ Type of injury No adverse event2410 (42)28,760 Adverse event136 (46)98,192 Negligent adverse event95 (56)66,944 Disability None2410 (42)28,760 Temporary144 (29)38,857 Permanent87 (88)201,250 All claims4621 (46)55,853 Source – Brennan, 1996

32. Logistic-Regression Analysis of Predictors That A Claim Would Be Settled in Favor of the Plaintiff PredictorOdds Ratio (95% confidence interval) P Value Permanent Disability29.7 (1.41-621.4)0.003 Negligent adverse event0.2 (0.01-4.1)0.32 Adverse event0.7 (0.1-7.1)0.79 Low income0.1 (0.0-1.5)0.10 Age < 21 yr0.6 (0.0-10.6)0.73 > 59 yr1.8 (0.2-17.5)0.61 Source – Brennan, 1996

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

36. Medical Errors, Negligence, and Litigation I.Medical Errors II.Relationship of Medical Errors to Negligence III.Why do People Sue their Doctors? IV.Potential Solutions to the Problem of Medical Errors

37. Reasons Why People Sue Their Doctors Advised to sue by influential other32Advised to sue by influential other32 Needed money24Needed money24 Believed there was a cover-up24Believed there was a cover-up24 Child would have no future23Child would have no future23 Needed information20Needed information20 Wanted revenge, license19Wanted revenge, license19 Percent Expressing Concern Source - Hickson, 1992

38. Malpractice Risk Malpractice activity is disproportionate among physiciansMalpractice activity is disproportionate among physicians 75% - 85% of awards, settlement costs over a 5- year period made on behalf of75% - 85% of awards, settlement costs over a 5- year period made on behalf of 1.8% of internists 6.0% of obstetricians 8.0% of surgeons Source- Sloan, 1989, Bovbjerg, 1994

39. Malpractice Activity and Patient Complaints Physician Characteristic Total Physicians (N = 645) Mean Number of Complaints Surgeons (N = 219) No lawsuits (N = 102) No lawsuits (N = 102)6.1 1 lawsuit (N = 82) 1 lawsuit (N = 82)16.7 2 or more lawsuits (N = 35) 2 or more lawsuits (N = 35)35.1 Non-surgeons (N = 426) No lawsuits (N = 361) No lawsuits (N = 361)4.7 1 lawsuit (N = 57) 1 lawsuit (N = 57)9.2 2 or more lawsuits (N = 8) 2 or more lawsuits (N = 8)4.6 Source – Hickson, 2002

40. Nine Percent of Physicians Account for Fifty Percent of the Complaints % of Complaints % of Physicians Source – Hickson, 2002

41. Communication and Malpractice Claims Primary Care Physicians (n = 59) VariableNo Claims (n = 29)Claims (n = 30)P- Value Visit length, min18.315.0< 0.05 No. of utterances per 15-min visit: Content Asks questions- medical18.316.9NS Gives information – medical28.526.3NS Process: Facilitation (Physician)19.411.9< 0.05 Orientation (Physician)14.511.2< 0.05 Affect Laughs (Physician)4.83.4< 0.05 Laughs (Patients)7.87.5NS Source – Levinson, 1997

42. Communication and Malpractice Claims Prior Malpractice Claims Group Category of complaint, %No ClaimsHigh FrequencyP - value Physician-patient communication8.227.60.01 Would not talk6.723.50.01 Did not listen1.97.10.01 Humanity of a physician4.817.40.01 Yelled4.89.20.15 No concern for me as a person1.48.70.01 Source – Hickson, 1994

43. Medical Errors, Negligence, and Litigation I.Medical Errors II.Relationship of Medical Errors to Negligence III.Why do People Sue their Doctors? IV.Potential Solutions to the Problem of Medical Errors

44. Malpractice Litigation

45. Relationship between Malpractice Claims History and Subsequent Obstetric Care Physician Group No. of Charts with Adverse Outcomes Total No. of Relevant Errors No. of Cases of Subjective Substandard Care No Claims 4287 High Frequency 1702 Source – Entman, 1994

46. Malpractice as a Barrier to Safety Physicians overestimate the risk of being suedPhysicians overestimate the risk of being sued Less likely to report errors as a resultLess likely to report errors as a result

47. Malpractice Reform Reforms include –No-fault –Enterprise liability No-fault system used in other countries

48. Increased Regulations IndustryIndustry –Leapfrog Consortium Private OrganizationsPrivate Organizations –National Patient Safety Foundation –Joint Commission on the Accreditation of Healthcare Organizations Federal LegislationFederal Legislation

49. Other Potential Solutions Learn lessons from other industriesLearn lessons from other industries –Aviation, Military, Nuclear Power Development of IT infrastructuresDevelopment of IT infrastructures –POE, Communication –Less reliance on memory Restriction on working hoursRestriction on working hours –AAMC proposed guidelines (80 hour week) Greater staffing to patient ratiosGreater staffing to patient ratios –Improved nursing jobs Organizational CultureOrganizational Culture

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

52. Litigation and Clinical Research Traditional Claims –Lack of appropriate “informed consent” Clinical model already exists New Claims –New Arguments Defective products, negligence, fraud –Larger number of defendants IRB’s, Investigators, ethicists –Class action suits

53. Why Suits Related to Research will Probable Continue to Rise Research has historically been noncompliant with regulations Fraud claims produce more punitive damages Conflicts of interest and investigators “motives” Regulations of research versus “customary practice” Institutions are inclined to settle quickly

54. Impact of Rising Litigation on Clinical Research Improved human subjects protection System for compensation Increased cost of research Less people for IRBs Research oversight takes a legalistic approach –“defensive research”