Paths to Reducing Medical Injury: Professional Liability and Discipline vs. Patient Safety — And the Need for a Third Way

Kohn L.T. Corrigan J.M. Donaldson M.S. , eds., Committee on Quality of Health Care in America, Institute of Medicine, To Err Is Human: Building a Safer Health System (Washington, D.C.: National Academy Press, 2000 [book publication date — originally released November 1999]), available at <http://books.nap.edu/books/0309068371/html/R1.html#pagetop> [hereafter cited as IOM Report].

Examples of the national journalistic attention the IOM drew include R. Pear, “Group Asking U.S. for New Vigilance in Patient Safety,” New York Times, November 30, 1999, and R. Weiss, “Thousands of Deaths Linked to Medical Errors,” Washington Post, November 30, 1999, at A1.

See National Patient Safety Foundation, at <http://www.npsf.org/> (last visited September 6, 2001).

See generally Leape L.L. , “Promoting Patient Safety by Preventing Medical Error,” JAMA, 280 (1998): 1444–47 (founding and articulating the principles of the Foundation).

This paper does not defend any particular estimate of preventable injury.

there is some debate. A more important point is undebatable, however: Many injuries can clearly be prevented at relatively little cost. See generally Miller R.H. Bovbjerg R.R. , “Efforts to Improve Patient Safety in Large, Capitated Medical Groups: Description and Conceptual Model,” Journal of Health Politics, Policy and Law (forthcoming).

IOM Report, supra note 1.

For evidence of high levels of hospital injury, see Mills D.H. Boyden J.S. Rubsamen D.S. , Report on the Medical Insurance Feasibility Study (San Francisco: Sutter Publications, 1977 [sponsored jointly by the California Medical Association and California Hospital Association]).

summarized in Mills D.H. , “Medical Insurance Feasibility Study: A Technical Summary,” Western Journal of Medicine, 128 (1978): 360–65;.

Brennan T.A. , “Incidence of Adverse Events and Negligence in Hospitalized Patients: Results of the Harvard Medical Practice Study I,” N. Engl. J. Med., 324 (1991): 370–76;.

Thomas E.J. , “Incidence and Types of Adverse Events and Negligent Care in Utah and Colorado,” Medical Care, 38 (2000): 261–71. Critiques note high inter-rater variability and failure to adjust for preexisting risk of death or of continued illness or disability.

See, for example, Brennan T.A. , “The Institute of Medicine Report on Medical Errors—Could It Do Harm?,” N. Engl. J. Med., 342 (2000): 1123–25;.

McDonald C.J. Weiner M. Hui S.L. , “Deaths Due to Medical Errors Are Exaggerated in Institute of Medicine Report,” JAMA, 284 (2000): 93–94.

An airline crash that kills scores or hundreds of people makes headlines for some time. The Ford-Explorer-Firestone-Tire accidents have made headlines for over a year, prompting enormous expense of investigation and replacement of tires alone, and rupturing an industrial alliance that began in the early years of motoring. The total accident toll? About 174 deaths and some 700 injuries, according to yet another news article, on the morning that this note was drafted. Mayer C.E. Swoboda F. , “Broader U.S. Probe of Explorers Sought,” Washington Post, June 9, 2001, at E1.

See discussion in Bovbjerg R.R. , “Medical Malpractice: Research and Reform,” Virginia Law Review, 79 (1993): 2155–208.

James B.C. , “Quality Improvement in the Hospital: Managing Clinical Processes,” Internist, 34, no. 3 (1993): 11–13, 17.

More recently, similar approaches have been found to work to improve care for a significant community-acquired infection, pneumonia. Dean N.C. “Decreased Mortality after Implementation of a Treatment Guideline for Community-Acquired Pneumonia,” American Journal of Medicine, 110 (2001): 451–57.

Bates D.W. , “Effect of Computerized Physician Order Entry and a Team Intervention on Prevention of Serious Medication Errors,” JAMA, 280 (1998): 1311–16;.

Leape L.L. , “Pharmacist Participation on Physician Rounds and Adverse Drug Events in the Intensive Care Unit,” JAMA; 282 (1999): 267–70.

For a classic statement of these dichotomous ideal types across all types of injury, see Reason J. , “Human Error: Models and Management,” British Medical Journal, 320 (2000): 768–70.

calling the two the “person approach” and the “systems approach.” Reason is probably the world's leading authority, author of the seminal book Human Error (New York: Cambridge University Press, 1990). One of us elsewhere has characterized the dichotomy in health care as a “clash of paradigms” between law and medicine.

Johnson D.H. Shapiro D.W. , “The Institute of Medicine Report on Reducing Medical Error and Its Implications for Healthcare Providers and Attorneys,” The Health Lawyer, 12, no. 5 (2000): 1, 4–12. Another of us called it a battle between contending “camps” of liability-discipline and patient safety.

Bovbjerg R.R. , “Medical Safety: From Stories to Policy,” Health Affairs, 20, no. 2 (2001): 241–42.

A new obligation for medical practitioners and hospitals to report serious injuries from errors was recommended by the IOM Report, supra note 1, and demanded by many editorialists, advocates, and legislators since then.

See, for example, Editorial, “A Medical Nightmare: The Number of Lives Lost because of Errors Is Alarming; A New Monitoring Agency Is Warranted,” Albany Times Union, Dec. 1, 1999.

Leading industrial companies now strive for “zero defects” in production or, at most, a rate of defects “six sigmas” (standard deviations) from the mean, e.g., General Electric, “What is Six Sigma?,” at <http://www.ge.com/sixsigma/SixSigma.pdf> (last visited September 6, 2001). Such approaches are rare in health care. Chassin M. , “Is Health Care Ready for Six Sigma Quality?,” Milbank Quarterly, 76 (1998): 565–91.

How much expense is justified in the pursuit of safety is a complex issue beyond the scope of this article. It might seem that systems improvement necessarily costs money, but doing things right the first time can save money compared with having to fix them after the fact. James B.C. , “Improving Quality Can Reduce Costs,” Quality Assurance Review, 1, no. 1 (1989): 4.

See Brennan T.A. , “The Role of Regulation in Quality Improvement,” Milbank Quarterly, 76 (1998): 709–31 (noting that most legal interventions target “bad apples” and have little evidence showing beneficial effects on quality of care);.

Bardach E. , “Social Regulation as a Generic Policy Instrument,” in Salamon L.M. , ed., Beyond Privatization: The Tools of Government Action (Washington, D.C.: The Urban Institute Press, 1989): 197–230 (broader view of regulation, also emphasizing shortcomings, among them that regulators' “bad apple” mindset leads to harsh and counterproductive treatment of “good apples,” id. at 218).

Readers interested in the clash of the legal and the safety worldviews on causation are referred to an article by a former director of the Bureau of Aviation Safety at the National Transportation Safety Board, C.O. Miller, “‘Probable Cause’: The Correct Legal Test in Civil Aircraft Accident Investigations?” (based upon a presentation to the Lawyer-Pilots Bar Association, Tempe, Arizona, March 5, 1992), at <http://www.pr.erau.edu/∼case/library/reports3/8.html> (last visited September 7, 2001).

Many feel that more complex systems are inherently more predisposed to tolerate or even create errors. E.g., Feynman R.P. with Hey A.J.G. Allen R.W. , eds., Feynman Lectures on Computation (Reading, Massachusetts: Addison-Wesley, 1996).

Looking backward also raises the strong likelihood of hindsight bias, the human tendency to want to find a clear instrumentality that caused a deviation from expected occurrences. See, for example, Caplan R.A. Posner K.L. Cheney F.W. , “Effect of Outcome on Physician Judgments of Appropriateness of Care,” JAMA, 265 (1991): 1957–60;.

Woods D.D. Cook R.I. , “Perspectives on Human Error: Hindsight Bias and Local Rationality,” in Durso F. , ed., Handbook of Applied Cognitive Psychology (New York: Wiley, 1999): 141–71.

Reasons for doubting the effectiveness of such legal deterrent abound. See, for example, Tancredi L.R. Bovbjerg R.R. , “Rethinking Responsibility for Patient Injury: Accelerated-Compensation Events, A Malpractice and Quality Reform Ripe for a Test,” Law and Contemporary Problems, 54, no. 2 (1991): 147–77. More importantly, the evidence for much deterrent impact is very limited, as discussed infra.

See Miller Bovbjerg , supra note 3.

Risk managers theoretically perform this function within institutions and from within liability insurers, though traditional risk management did little to understand and prevent injuries, as noted in text infra. Various other sources of information may also serve to educate practitioners, including such publications as the Professional Liability Newsletter (Palo Alto, California), edited by one of us (Shapiro).

See Bovbjerg R.R. Sloan F.A. , “No Fault for Medical Injury: Theory and Evidence,” University of Cincinnati Law Review, 67 (1998): 53–123, n. 121.

See also McEwin R.I. , “No-Fault Compensation Systems,” in Bouckaert B. DeGeest G. , eds., Encyclopedia of Law and Economics, vol. 2, Civil Law and Economics (Cheltenham, England: Edward Elgar, 2000), available at <http://allserv.rug.ac.be/∼gdegeest/3600book.pdf>.

See Kessler D.P. McClellan M.B. , “Do Doctors Practice Defensive Medicine?,” Quarterly Journal of Economics, 111 (May 1996): 353–90 (strong tort reforms cut costs without harm to quality, suggesting that unfettered tort law raises costs and not quality).

The New York study of medical injuries tried to find a deterrent effect from legal liability, using injury data from hospital charts and liability information from variation within New York of claims rates and insurance premiums. See Harvard Medical Practice Study, Patients, Doctors, and Lawyers: Medical Injury, Malpractice Litigation, and Patient Compensation in New York (bound, duplicated report to N.Y. State Dep't of Health, 1990).

Their statistical findings suggested a positive relationship, but despite many re-estimations, they failed to reach conventional levels of statistical significance. This did not prevent the study team from publishing their results, Weiler P.C. , A Measure of Malpractice: Medical Injury, Malpractice Litigation, and Patient Compensation (Cambridge, Massachusetts: Harvard University Press, 1993), but it does prevent drawing reliable conclusions from it for policymaking. As the book noted, a single state's evidence from a single year's hospital charts is not a good data base from which to study deterrence.

Happily, some of these anecdotes have now been written down. Ludlam J.E. , Health Policy — the Hard Way: An Anecdotal Personal History by One of the California Players (Pasadena, California: Hope Publishing House, 1998), especially at 112–17. Readers who know of better evidence on medical liability's deterrent performance are invited to educate the authors.

See, for example, The Doctors' Company, Risk Management Sourcebook, at <http://www.thedoctors.com/rm/sb/index.htm> (last visited September 6, 2001) (especially the chapters on “Anger: A Root Cause Office Malpractice Claims” and “Effective Communication as a Claims-Prevention Technique”).

The IOM Report opens with the story of Betsy Lehman, a Boston Globe medical reporter, who died from an inadvertent overdose of chemotherapy. IOM Report, supra note 1, at 1.

Tinker J.H. , “Role of Monitoring Devices in Prevention of Anesthetic Mishaps: A Closed Claims Analysis,” Anesthesiology, 71 (1989): 541–46;.

Cheney F.W. , “Standard of Care and Anesthesia Liability,” JAMA, 261 (1989): 1599–603;.

Pierce E.C. Jr. , “Anesthesia: Standards of Care and Liability,” JAMA, 262 (1989): 773;.

Cheney F.W. , “The ASA Closed Claims Study after the Pulse Oximeter: A Preliminary Look,” American Society of Anesthesiologists Newsletter, 54, no. 2 (1990): 10–11;.

Crane M. , “Why Anesthesia Mishaps Became Rare,” Medical Economics, April 28, 1997.

E.g., Belli M.M. , “An Ancient Therapy Still Applied: The Silent Medical Treatment,” Villanova Law Review, 1 (1956): 250–89.

“Medical Safety and Secrecy” (four-article symposium), Health Affairs, 20, no. 2 (2001): 241–62.

In addition to secrecy, as David Studdert has pointed out to us, other factors leading to low use of discipline include regulatory “capture” of regulatory agencies by physicians and under-funding of agencies by state governments. For a good, but discouraging summary of the weak performance of legal approaches to quality of care, see Brennan, supra note 12.

The same author in Brennan T.A. Berwick D. , New Rules: Regulation, Markets, and the Quality of American Health Care (San Francisco: Jossey-Bass, 1996), proposed shifting toward “responsive regulation” (using various methods to achieve measurable good outcomes).

See generally Ayres I. Braithwaite J. , Responsive Regulation: Transcending the Deregulation Debate (New York: Oxford University Press, 1992) (urging less adversarial approach to U.S. regulation, more creative blend of regulatory persuasion and sanctions).

Anger about interpersonal relations and lack of information are two major reasons that people sue. See Sloan F.A. , Suing for Medical Malpractice (Chicago: University of Chicago Press, 1993);.

Hickson G.B. , “Obstetricians' Prior Malpractice Experience and Patients' Satisfaction with Care,” JAMA, 272 (1994): 583–87.

Moore S. Simon J.L. , It's Getting Better All the Time: 100 Greatest Trends of the Last 100 Years (Washington, D.C.: Cato Institute, 2000): 175 (graphs), citing National Safety Council, Accident Facts (annual), and other objective sources. Similar, although lesser, drops applied for all non-vehicular accident deaths.

See Caplow T. Hicks L. Wattenberg B.J. , The First Measured Century: An Illustrated Guide to Trends in America, 1900–2000 (Washington, D.C.: American Enterprise Institute, 2001): at 148–49 (companion volume to the PBS documentary of the same name).

Moore Simon , supra note 28, at 141.

Moore Simon , supra note 28, at 34–37;.

Caplow Hicks Wattenberg , supra note 28, at 134–37.

See, for example, IOM Report, supra note 1, at 61–62, 82–83.

Whether individual crashes are more deadly today is left to others to argue.

This discussion as well as the sidebar, “Confidential Incident Reporting in Aviation,” draw upon a detailed presentation of the aviation case in Billings C. , “Lessons Learned from Incident Reporting in Aviation,” in A Tale of Two Stories: Contrasting Views of Patient Safety, Report from a Workshop on Assembling the Scientific Basis for Progress on Patient Safety (Chicago: National Health Care Safety Council of the National Patient Safety Foundation at the American Medical Association, 1998): Appendix B, at 45–52.

National Aeronautics and Space Administration, Aviation Safety Reporting System, at <http://asrs.arc.nasa.gov/> (last visited September 7, 2001).

See also Sexton J.B. Thomas E.J. Helmreich R.L. , “Error, Stress, and Teamwork in Medicine and Aviation: Cross Sectional Surveys,” British Medical Journal, 320 (2000):745–49.

The aviation model has also influenced such a seminal thinker as James Reason, supra note 8.

For a combined legal-psychological perspective, see Katz J. , The Silent World of Doctor and Patient (New York: Free Press, 1984).

for thoughtful personal accounts of the culture of silence, see Health Affairs symposium, supra note 26.

Bovbjerg R.R. Shapiro D.W. , Protecting Error-Reporting Systems in Medicine from Legal Discovery (Washington, D.C.: Report to the Institute of Medicine, Committee on Quality of Health Care in America, July 1999), revised and published as chapter 6, “Protecting Voluntary Reporting Systems from Legal Discovery,” 94–113 in IOM Report,

supra note 1.

See also Mills D.H. , “Medical Peer Review: The Need to Organize a Protective Approach,” Health Matrix, 1, no. 1 (1991): 67–76.

See also Pear R. , “Incompetent Physicians Are Rarely Reported as Law Requires,” New York Times, May 29, 2001.

See, for example, Joint Commission on Accreditation of Healthcare Organizations, Conducting a Root Cause Analysis (Oakbrook Terrace, Illinois: Joint Commission on Accreditation of Healthcare Organizations, 1997).

See Medical Errors: Improving Quality of Care and Consumer Information: Joint Hearing Before the Subcommittees on Health & Environment and Oversight & Investigations of the Committee on Commerce and the Subcommittee on Health of the Committee on Veterans' Affairs, 106th Cong., 2d Sess., Serial No. 106-90 (February 9, 2000) (statement of Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations), available at <http://com-notes.house.gov/cchear/hearings106.nsf/a317d879d32c08c2852567d300539946/bf6714a3bdda9caa852568800004ba44?OpenDocument>.

See Bodenheimer T. , “The Movement for Improved Quality in Health Care,” N. Engl. J. Med., 340 (1999): 488–92;.

Freudenheim M. , “Big Companies Lead Effort to Reduce Medical Errors,” New York Times, Nov. 16, 2000, at C19.

See Bovbjerg Shapiro , supra note 35.

Personal communications within workshop on “Analysis of Patient Safety Legislation,” at “Communicating Risk and Safety in Health Care,” the 3rd Annenberg Conference on Patient Safety, on May 18, 2001, in St. Paul, Minnesota.

See, for example, Bovbjerg R.R. Sloan F.A. Blumstein J.F. , “Valuing Life and Limb in Tort: Scheduling ‘Pain and Suffering,’” Northwestern University Law Review, 83 (1989): 908–76.

See, for example, Marsteller J.A. Bovbjerg R.R. , Federalism and Patient Protection: Changing Roles for State and Federal Government, Occasional Paper No. 28 (Washington, D.C.: Urban Institute/Assessing the New Federalism, August 1999), available at <http://newfederalism.urban.org/html/occa28.html>;.

Toner R. , “News Analysis: After Patients' Rights, Vast Needs and Higher Hurdles,” New York Times, July 2, 2001, available at <http://www.nytimes.com/2001/07/02/politics/02AGEN.html>.

See, for example, Joint Commission on Accreditation of Healthcare Organizations, supra note 38 (method in context of serious hospital injuries);.

Wilson P.F. , Root Cause Analysis: A Tool for Total Quality Management (Milwaukee: ASQC Quality Press, 1993) (general use).

Lawsuits are now often blocked by judicial interpretations of ERISA preemption. See, for example, Sage W.M. , “‘Health Law 2000’: The Legal System and the Changing Health Care Market,” Health Affairs, 15, no. 3 (1996): 9–27;.

See also Studdert D.M. , “Expanded Managed Care Liability: What Impact on Employer Coverage?,” Health Affairs, 18, no. 6 (1999): 7–27.

Compare Sage W.M. Hastings K.E. Berenson R.A. , “Enterprise Liability for Medical Malpractice and Health Care Quality Improvement,” American Journal of Law & Medicine, 20, nos. 1 & 2 (1994): 1–28 (arguing for accountable health plan as locus of responsibility).

Abraham K.S. Weiler P.C. , “Enterprise Liability and the Choice of the Responsible Enterprise,” American Journal of Law & Medicine, 20, nos. 1 & 2 (1994): 29–36 (arguing for hospital responsibility). Especially in hindsight, the hospital advocates present far more persuasive arguments.

These observations about market developments in managed care are presented as stylized facts; readers seeking detailed descriptions of health insurance trends are referred to Gabel J. , “Job-Based Health Insurance in 2001: Inflation Hits Double Digits, Managed Care Retreats,” Health Affairs, 20, no. 5 (2001): 180–86;.

Robinson J.C. , “The End of Managed Care,” JAMA, 285 (2001): 2622–28.

This observation explains how the Physician Insurers Association of America (representing liability carriers for doctors) has not supported open-ended expansions of liability against managed care plans, whereas the American Medical Association has. Personal communication from PIAA, 2001.

See also Crane M. , “Why Premiums Are Soaring Again,” Medical Economics, 78, no. 13 (2001): 132–45.

See Liang B.A. , “Error in Medicine: Legal Impediments to U.S. Reform,” Journal of Health Politics, Policy and Law, 24 (1999): 27–58.

See generally Bovbjerg R.R. Tancredi L.R. Gaylin D.S. , “Obstetrics and Malpractice: Evidence on the Performance of a Selective No-Fault System,” JAMA, 265 (1991): 2835–42;.

Wadlington W. , “Editorial — Medical Injury Compensation: A Time for Testing New Approaches,” JAMA, 265 (1991): 2860;.

Bovbjerg R.R. Sloan F.A. , “No Fault for Medical Injury: Theory and Evidence,” University of Cincinnati Law Review, 67 (1998): 53–123;.

Studdert D.M. Brennan T.A. , “No-Fault Compensation for Medical Injuries: The Prospect for Error Prevention,” JAMA, 286 (2001): 217–23;.

Studdert D. M. Brennan T.A. , “Toward a Workable Model of ‘No-Fault’ Compensation for Medical Injury in the United States,” American Journal of Law & Medicine, 27 (2001): 225–52.

Tancredi L.R. Bovbjerg R.R. , “Advancing the Epidemiology of Injury and Methods for Quality Control: ‘ACEs’ as an Outcomes-Based System for Quality Assurance,” Quality Review Bulletin, Journal of Quality Assurance, 18 (June 1992); 201–09.

Davis R. , “Hospital Mistakes Must Be Disclosed: Accreditation at Risk if Patients Aren't Told,” USA TODAY, June 28, 2001, at 1A, available at <http://www.usatoday.com/usatonline/20010628/3440087s.htm>. Conventional wisdom may be slowly changing to hold that patients are not more likely to sue if told candidly of problems.

See Crane M. , “What to Say if You Made a Mistake,” Medical Economics, 78, no. 16 (August 20, 2001): 26–36.

The health-care system of the federal Department of Veterans Affairs has moved in both directions — to make disclosure routine, and to protect individual clinicians from liability, though the system is still liable in tort under federal rules.

See Kraman S.S. Hamm G. “Risk Management: Extreme Honesty May Be the Best Policy,” Annals of Internal Medicine, 131, no. 12 (1999): 963–67.

See also Department of Veterans Affairs, “VA Leads Nation in Patient Safety,” News Release (December 7, 1999), available at <http://www.va.gov/pressrel/patsafe.htm>.