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Medical errors, negligence, and litigation
 

Medical errors, negligence, and litigation

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  • In the cases of medical error, the majority of incidents are related to mistakes made during operating procedures. Mistakes can range from failing to correct the problem the patient went in for to operating on the wrong body part altogether. It is important in the case of an operation gone wrong to establish whether the problem is down to a common surgical risk or to medical negligence of any of the healthcare providers involved in the surgery. Where a healthcare provider can be identified as being negligent, a claim for medical negligence can be process
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  • 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.

Medical errors, negligence, and litigation Medical errors, negligence, and litigation Presentation Transcript

  • 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
    • Medical Errors
    • Relationship of Medical Errors to Negligence
    • Why do People Sue their Doctors?
    • Potential Solutions to the Problem of Medical Errors
  • Medical Errors, Negligence, and Litigation
    • Medical Errors
    • Relationship of Medical Errors to Negligence
    • Why do People Sue their Doctors?
    • Potential Solutions to the Problem of Medical Errors
  • 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
  • Relationship of Medical Errors to Adverse Events Medical Errors AE Preventable AEs
  • 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
  • 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
    • Reviewed 14,179 admissions in 1995
    • 16.6% of admissions had an AE’s
      • Permanent disability 13.7%
      • Death 4.9%
    • 51% of events preventable
    Source – Wilson, 1995
  • To Err is Human
    • 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
  • Deaths due to Medical Error
    • 44,000 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
  • 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
    • 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
  • 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
    • Percentage 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
  • 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
    • Extensively studied in other industries
    • Cognitive psychologists divide errors into:
      • Errors occurring in “automatic mode”
        • Slips
          • Occur during fatigue, interruptions, anxiety
      • Errors occurring in “problem solving mode”
        • Mistakes
          • Occur due to incomplete knowledge and the tendency to apply rules to simplify problem solving
  • Why is medicine so susceptible?
    • Lack of awareness to the problem
    • “ Culture of Silence”
      • Blame and shame mentality
    • System constraints
      • Staffing problems
      • Fatigue
      • Knowledge requirements
      • Communication and continuity of care
  • Medical Errors, Negligence, and Litigation
    • Medical Errors
    • Relationship of Medical Errors to Negligence
    • Why do People Sue their Doctors?
    • Potential Solutions to the Problem of Medical Errors
  • 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
  • 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
    • 42% 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 death
    • Only 6% had sued
  • 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
    • Medical Errors
    • Relationship of Medical Errors to Negligence
    • Why do People Sue their Doctors?
    • Potential Solutions to the Problem of Medical Errors
  • Reasons Why People Sue Their Doctors
    • Advised to sue by influential other 32
    • Needed money 24
    • Believed there was a cover-up 24
    • Child would have no future 23
    • Needed information 20
    • Wanted revenge, license 19
    Percent Expressing Concern Source - Hickson, 1992
  • Malpractice Risk
    • Malpractice activity is disproportionate among physicians
    • 75% - 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
  • 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
    • Medical Errors
    • Relationship of Medical Errors to Negligence
    • Why do People Sue their Doctors?
    • Potential Solutions to the Problem of Medical Errors
  • 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
    • Physicians overestimate the risk of being sued
    • Less likely to report errors as a result
  • Malpractice Reform
    • Reforms include
      • No-fault
      • Enterprise liability
    • No-fault system used in other countries
  • Increased Regulations
    • Industry
      • Leapfrog Consortium
    • Private Organizations
      • National Patient Safety Foundation
      • Joint Commission on the Accreditation of Healthcare Organizations
    • Federal Legislation
  • Other Potential Solutions
    • Learn lessons from other industries
      • Aviation, Military, Nuclear Power
    • Development of IT infrastructures
      • POE, Communication
      • Less reliance on memory
    • Restriction on working hours
      • AAMC proposed guidelines (80 hour week)
    • Greater staffing to patient ratios
      • Improved nursing jobs
    • Organizational Culture
  • “ 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
    • 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
  • 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
  • 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”