35
SM, Ludwig J, Baldus WP. Fulminant hepatitis; Mayo clinic experience with 34 cases. Mayo Clin Proc 1985; 60: 289-92. 5. Christensen E, Bremmelgaard A, Bahnsen M, Andreasen PB, Tigstrap N. Prediction of fatality in fulminant hepatic failure. Scand J Gastroenterol 1984; 19: 90-96. 6. Tygstrup N, Rannak L. Assessment of prognosis in fulminant hepatic failure. Semin Liver Dis 1986; 6: 129-37. 7. O’Grady JG, Gimson AES, O’Brien CJ, et al. Controlled trials of charcoal haemoperfusion and prognostic factors in fulminant hepatic failure. Gastroenterology 1988; 94: 1186-92. 8. Editorial. Transplantation for acute liver failure. Lancet 1987; ii: 1248-49. 9. Ducci H, Katz R. Cortisone, ACTH and antibiotics in fulminant hepatitis. Gastroenterology 1952; 21: 357-74. 10. Ware AJ, Jones RE, Shorey JW, Combes B. A controlled trial of steroid therapy in massive hepatic necrosis. Am J Gastroenterol 1974; 62: 4. Rakela J, Lange
130-33. 11. Redeker AG, Schwartzer IL, Yamahiro HS. Randomisation of corticosteroid therapy in fulminant hepatitis. N Engl J Med 1976; 294: 728-29. 12. Gregory PB, Knauer CM, Kempson RL, Miller R. Steroid therapy in severe viral hepatitis. N Engl J Med 1976; 294: 681-87. 13. European association for the study of the liver. Randomized trial of steroid therapy in acute liver failure. Gut 1979; 20: 620-23.
14. Berger RL, Liversage RM, Chalmers TC, Graham JH, McGoldrick DM, Stohlman F. Exchange transfusion in treatment of fulminating hepatitis. N Engl J Med 1966; 274: 497-501. 15. Redeker AG, Yamahiro HS. Controlled trial of exchange-transfusion therapy in fulminant hepatitis. Lancet 1973; i: 3-6. 16. Silk DBA, Hanid MA, Trewby PN, et al. Treatment of fulminant hepatic failure by polyacrylonitrile-membrane haemodialysis. Lancet 1977; ii:
20. Gimson
AES, Braude S, Mellon PJ, Canalese J, Williams R. Earlier charcoal haemoperfusion in fulminant hepatic failure. Lancet 1982; ii: 681-83. 21. Bismuth H, Caistang D, Ericzon BG, et al. Hepatic transplantation in Europe. Lancet 1987; ii: 674-76. 22. Powell LW. Liver transplantation: an update for physicians. Aust NZ J Med 1989; 19: 369-77. 23. Ringe B, Pichlmayr R, Lauchart W, Muller R. Indications and results of liver transplantation in acute hepatic failure. Transplant Proc 1986; 18 (suppl 3): 86-88. 24. Bismuth H, Samule D, Gugenheim J, et al. Emergency liver transplantation for fulminant hepatitis. Ann Intern Med 1987; 107: 337-41. 25. Peleman RR, Gavaler JS, van Thiel DH, et al. Orthotopic liver transplantation for acute and sub-acute hepatic failure in adults. Hepatology 1987; 7: 484-89. 26. Vickers C, Neuberger J, Buckels J, McMaster P, Elias E. Transplantation of the liver in adults and children with fulminant hepatic failure. J Hepatol 1988; 7: 143-50. 27. Emond JC, Aran PP, Whitington P, Broelsch CE, Baker AL. Liver transplantation in the management of fulminant hepatic failure. Gastroenterology 1989; 96: 1583-88. 28. Bernuau J, Goudeau A, Poynard T, et al. Multivariate analysis of prognostic factors in fulminant hepatitis B. Hepatology 1986; 6: 648-51. 29. O’Grady JG, Alexander GJM, Hayllar KM, Williams R. Early indicators of prognosis in fulminant hepatic failure. Gastroenterology 1989; 97: 439-45. 30. Berk PD, Goldberg JD. Charcoal haemoperfusion. Gastroenterology 1988; 94: 1228-30. 31. Berk PD. Artificial liver: a baby delivered prematurely. Gastroenterology
1-3.
1978; 74: 789-90.
17. Opolon DP, Nusinovici V, Grainger A, Darnis F. Treatment of encephalopathy during fulminant hepatic failure during haemodialysis with high permeability membrane. Gut 1978; 19: 783-93. 18. Chang TMS. Haemoperfusion over a microencapsulated absorbant in a patient with hepatic coma. Lancet 1973; ii: 1371-72. 19. Gazzard BG, Portmann B, Weston MJ, et al. Charcoal haemoperfusion in the treatment of fulminant hepatic failure. Lancet 1974; i: 1301-07.
32. Chalmers TC. Randomized clinical trials in surgery. In: Vargo RL, Delaney JP, eds. Controversies in surgery. Philadelphia: Saunders, 1976: 3-11. 33. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomised trials requiring prolonged observation of each patient. Part 1: design. Br J Cancer 1976; 34: 585-612.
VIEWPOINT Medical
One of the
litigation and the quality of care
concerns voiced by doctors about the inexorable increase in medical litigation is seemingly whether quality of health care will be affected. The suggestion is that litigation leads to defensive medicine (both the avoidance and the reduction of risk taking), discourages quality assurance, and reduces the availabilty of health care. If these outcomes are true, litigation is a major obstacle to high quality care. Are such claims justified and is there any evidence to support them?
principal
The evidence Studies in the US over the past 30 years in which groups of clinicians were asked to report on changes in their own practice provide the main evidence,l-6 but interpretation of the results is difficult. In all but one survey, no more than 35% of doctors responded (the exception being 65%’’). Additionally, there will have been recall bias because of the retrospective design of the studies, which required doctors
to
report how their clinical behaviour had altered over many
Moreover, the respondents were also asked to assess the contribution that fear of medical litigation had made to such changes. In view of such methodological difficulties, such surveys can only identify possible adverse effects of litigation rather than provide reliable measures of the impact of such effects. The latter can be partly achieved by the use of a quasi-experimental design that exploits differences in medical litigation rates between similar populations; only one such study (which compared California, a high litigation area, with North Carolina, where there have been relatively few malpractice claims) has adopted this approach.2 The results, based on a 54% response, did not support the notion that litigation was encouraging poor quality care. However years.
ADDRESS: Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK (N. Black, MD).
36
that
study, carried out almost 20 years ago, may not accurately depict the relation between litigation and quality of care today. Despite the lack of well-designed studies, the effect of litigation on quality of care can be examined by assessment of the circumstantial evidence on which claims have been based. Four potentially harmful consequences need to be considered. Risk avoidance Doctors may be reacting to the fear of litigation by avoiding specialties, procedures, and patients that they perceive carry a high risk of leading to a malpractice claim. Thus, in the US, many obstetricians/gynaecologists no longer practise obstetrics;7 general practitioners (GPs) have stopped certain procedures-eg, intravenous pyelograms, because of the possibility of inducing an allergic reaction to the dye.8 In a survey in 1987 of doctors working in Maryland, risk avoidance (negative defensive medicine) was reported by 17% of specialists in internal medicine, 32% of GPs, and 38% of obstetrician/gynaecologists.6 Does such action damage the quality of care available? If risk avoidance
concentration of services in the hands of fewer specialised doctors and institutions, it may enhance rather than lower the quality of care. In some areas of health care, better outcomes are achieved at higher volumes of activity.9 Another example of risk avoidance is the tendency for doctors to avoid taking on the care of certain patients. Charles et al5 found that as many as 49 % of doctors who had been sued reported that they now refused litigious patients, while another survey suggested that doctors were now screening for such patients, although detailed methods were not reported.8 That some patients might not be able to obtain medical care at all need not only be a product of litigation: patients who complain a lot in the UK may have great difficulty in finding a GP with whom to register. Risk avoidance may also mean a complete withdrawal from medical practice. In the US, significantly more doctors who had been sued than colleagues who had not said that they were thinking about retiring early (43% vs 30%) and that they would discourage their children from pursuing medicine as a career (32% vs 19%).5 Claims that such trends can be seen in England and Wales have already been made: the senior vice president of the Royal College of Obstetrics and Gynaecologists has reported "very deep concern in his discipline about its future and the level of recruitment" (BMA Information Sheet,1 S 161/16.1.89). The reasons for such changes in recruitment are not clear. Other potential causes include the increasing proportion of women entrants to the medical profession for whom a hospital-based career is less attractive than it is for their male colleagues, and the poorly organised postgraduate training offered by many hospital specialties by comparison with developments in areas such as general practice, psychiatry, and public health medicine. leads
to a
Risk reduction
Litigation is also claimed to lead to risk reduction (positive defensive medicine). Because of a fear of the consequences of failing to act, doctors undertake more investigations and interventions than they would otherwise have done. Supporters of this claim have largely based their case on two examples-namely, the use of caesarean section and
diagnostic tests.
Obstetricians have commonly cited fear of litigation as a for the increase during the past 20 years of the caesarean section rate in most industrialised countries.1o However, there have been similar increases in countries with widely varying patterns of litigation. 11 Fear of litigation has probably made only a small contribution to the world-wide increases in the caesarean rate, since there are several other factors that will have contributed to the observed trends-ie, demographic changes that lead to a higher proportion of older mothers and more repeat operations; the widespread introduction of fetal monitoring; new indications such as breech presentation and low birthweight; staff shortages which discourage obstetricians from risking vaginal deliveries; time benefits for staff and patients if the time of delivery is controlled; new anaesthetics that have changed the perceived risk to benefit ratio; and greater reimbursement than for a vaginal delivery. Litigation has also led to an increase in the use of diagnostic tests.3,sHowever, as with the previous example, several other potential influences have to be taken into account:12 the development of multiple autoanalysers; the reduction in unit costs (particularly in relation to other health care costs) in countries where there is competition between laboratories; audit systems with incentives that encourage inappropriate tests (eg, if it is easier to monitor performance according to the number of tests done rather than time spent with a patient, more tests will be substituted for more doctor-time); and payment systems, such as fee-for-service, that provide a financial incentive to doctors. As with caesarean section, support for the view that fear of litigation has probably played only a small part in the increase in the use of tests comes from West Germany where there have been similar trends without any increase in the rate of litigation."
reason
Discouragement of quality assurance Doctors have reported that fear of litigation has discouraged them from collecting clinical information (recording less pertinent information in medical records,5 decrease in necropsy rates, &c) for auditing their work. In Ontario, clinical audit stopped completely when it became clear that the findings were not exempt from subsequent litigation. By contrast, results of other studies have suggested that litigation has encouraged doctors to review the quality of their work and try to improve it. 57% of respondents of a survey in the US claimed to keep better recordswhereas in another survey 59% were monitoring their patients more closely and 44% consulted colleagues more often about the progress of care. Weisman et al6 found that doctors believed
they were providing more information to patients about the risks and benefits of procedures. Reduced availability of health
care
Litigation is said to reduce the availability of health care in three ways: it involves doctors in lengthy legal matters, causes ill-health in those doctors involved, and escalates health care costs. Although legal proceedings take doctors away from their patients, a major impact on health care availability is unlikely: in the US between 1978 and 1983, only 3-7 days over 5 years were lost for each doctor incurring claims.3 The health of doctors who have been the recipients of malpractice claims seems to deteriorated Doctors who had been sued reported significantly more symptoms of stress-
37
induced illness than did their colleagues. However, even if this association is causal, which factor is the cause and which is the effect is not clear. In addition, there was no significant difference in either the prevalence of depressive symptoms or of the onset or exacerbation of physical illnesses. Health care costs may increase as a result of litigation for two reasons: there are the direct costs of insurance premiums or defence organisation subscriptions, legal proceedings, court expenses, and loss of income ;8 and risk reduction may lead to additional, unnecessary medical care. These costs will ultimately be passed on to the patient-in the US, increased feesand in the UK (in the context of cash limited budgets), reduced services. However, the extent to which litigation has serious financial consequences for health care provision is difficult to assess. In the US, the annual increase in malpractice premiums varies from 15 to 50% in different states:l4 this will have led to hospital price increases of about 3% per annum, a third of overall health care inflation. Thus, although litigation has made a substantial contribution to inflation in the US, it has not been the principal reason for the cost explosion, as some have suggested. In Britain, defence society subscriptions accounted for £ 60 million in 1987-88 (about 0-25% of expenditure on health care)." There would have to be huge increases in malpractice claims for such a small proportion of total expenditure to have a large impact on health care inflation.
provide a framework However, before such
to
encourage
higher quality
care.
conclusions are reached, systematic evidence is needed of how, for example, the quality of nursing care has been shaped by nurses’ very different legal circumstances. Will practice that does not conform to established guidelines be covered by defence society subscriptions, and, if not, will doctors in clinical research need higher rates of cover? If so, the cost of research would increase and doctors would be discouraged from improving existing methods of treatment and care.
Finally, irrespective of the impact of changes in liability, the cost of medical litigation may yet prove to be damaging to the quality of care. If the recent annual increase in litigation costs in Britain of about 75% were to continue, by 1992, litigation would account for about 2% of health care expenditure compared with 0-25% in 1987; by 1996 this would have risen to 12% (if we assume a steady 2% per annum increase for demographic trends and new technology). With the constraints of cash-limited budgets, such changes could only be accommodated by substantial reductions in the availability of services. Although there is scant evidence to show any damaging effects of medical litigation at present, the story may be different in the future.
REFERENCES a malpractice suit upon physicians in Connecticut. JAMA 1961; 176: 1096-1101. 2. Tancredi LR, Barondess JA. The problem of defensive medicine. Science
1.
Discussion
Litigation does not seem to be damaging the quality of medical care. There is little evidence that risk reduction is on the increase;12 the effects on quality assurance activities are unclear; and claims for reductions in the availability of health care seem to be exaggerated. At the same time, there are some grounds for the claim that risk avoidance may actually enhance quality by discouraging low volume practitioners. Likewise, difficulties with recruitment to some specialties may hasten improvements in career and training opportunities. If further studies
were
to
lend support
to
these
important general question would remain unanswered. When do particular legal arrangements enhance the quality of care, and with what possible adverse effects? Supporters of the present system say that a doctor’s individual liability may be a spur to achieving high standards of care, whereas others argue that it has not provided adequate supervision of medical standards. An alternative proposal is no-fault compensation; but, as critics have pointed out, such a system does not attribute blame to those responsible, and thus would not be an incentive to improve the quality of care." A third approach, and the one that doctors working in the National Health Service from 1990 will adopt, transfers liability from individual practitioners to employers. Thus, health authorities will have to take full responsibility for doctors’ actions and therefore will need to ensure that their staff provide a high quality service--ie, to encourage quality assurance in medicine. Clinical protocols and guidelines will have to be consulted, since they will provide definitions of good practice and act as a defence in malpractice claims.1S,16 Use of clinical guidelines may only be acceptable when employers accept full legal and financial responsibility for the actions of conclusions,
an
doctors in their employment, as they currently do for other health service staff.17 Such a system might not only ensure that litigation does not damage the quality of care, but also
Wyckoff
RL. The effects of
1978; 200: 879-82. 3. Zuckerman S. Medical malpractice: claims, legal costs, and the practice of defensive medicine. Health Affairs 1984; 3: 128-34. 4. American College of Obstetrics and Gynaecology. Professional liability insurance and its effects: report of a survey of ACOG’s membership. Washington DC: ACOG, 1985.
5. Charles SC, Wilbert JR, Franke KJ. Sued and nonsued physicians’ self-reported reactions to malpractice litigation. Am J Psychiatry 1985; 142: 437-40.
6. Weisman CS, Morlock LL, Teitelbaum MA, Klassen AC, Celentano DD. Practice changes in response to the malpractice litigation climate. Results of a Maryland physician survey. Medical Care 1989; 27: 16-24. survey of obstetrical practice activity in Florida. J Florida Med Assoc 1983; 70: 293-96. 8. Perry S, Lehrman D. Defensive medicine, malpractice, and patient satisfaction. In: Shanahan M, ed. Proceedings of an international symposium on quality assurance in health care. Chicago: Joint Commission on Accreditation of Hospitals, 1987.
7.
Davenport OW. A
9. Luft HSA, Garnick DW, Mark D, McPhee SJ, Tetreault J. Volume of services in hospitals or performed by physicians. In: The quality of medical care: information for consumers. Washington DC: Congress of US Office of Technology Assessment, 1988: 165-83. 10. Macfarlane A, Mugford M. An epidemic of Health 1986; 11: 38-42.
caesareans? J Maternal Child
C, Dingwall R, Fenn P, Harris D. Medical negligence. Compensation and accountability. London: Kings Fund Institute,
11. Ham
1988. 12. Danzon PM. Medical malpractice. Theory, evidence, and public policy. Cambridge, Massachusetts: Havard University Press, 1985.
13. Somers HM. The malpractice controversy and the quality of patient care. Milbank Memorial Fund Quarterly, Health and Society 1977; 55: 193-232.
Jessee WF. Litigation, quality, and use of health services. In: Shanahan M, ed. Proceedings of an international symposium on quality assurance in health care. Chicago: Joint Commission on Accreditation of Hospitals 1987. 15. Hill G. We shall all be changed (editorial). J Med Defence Union 1988; 49. 16. Jones MA, Morris AE. Defensive medicine: myths and facts. J Med Defence Union 1989, 40-42. 17. Harvey IM, Roberts CJ. Clinical guidelines, medical litigation, and the current medical defence system. Lancet 1987; i: 145-47. 14.
SM, Ludwig J, Baldus WP. Fulminant hepatitis; Mayo clinic experience with 34 cases. Mayo Clin Proc 1985; 60: 289-92. 5. Christensen E, Bremmelgaard A, Bahnsen M, Andreasen PB, Tigstrap N. Prediction of fatality in fulminant hepatic failure. Scand J Gastroenterol 1984; 19: 90-96. 6. Tygstrup N, Rannak L. Assessment of prognosis in fulminant hepatic failure. Semin Liver Dis 1986; 6: 129-37. 7. O’Grady JG, Gimson AES, O’Brien CJ, et al. Controlled trials of charcoal haemoperfusion and prognostic factors in fulminant hepatic failure. Gastroenterology 1988; 94: 1186-92. 8. Editorial. Transplantation for acute liver failure. Lancet 1987; ii: 1248-49. 9. Ducci H, Katz R. Cortisone, ACTH and antibiotics in fulminant hepatitis. Gastroenterology 1952; 21: 357-74. 10. Ware AJ, Jones RE, Shorey JW, Combes B. A controlled trial of steroid therapy in massive hepatic necrosis. Am J Gastroenterol 1974; 62: 4. Rakela J, Lange
130-33. 11. Redeker AG, Schwartzer IL, Yamahiro HS. Randomisation of corticosteroid therapy in fulminant hepatitis. N Engl J Med 1976; 294: 728-29. 12. Gregory PB, Knauer CM, Kempson RL, Miller R. Steroid therapy in severe viral hepatitis. N Engl J Med 1976; 294: 681-87. 13. European association for the study of the liver. Randomized trial of steroid therapy in acute liver failure. Gut 1979; 20: 620-23.
14. Berger RL, Liversage RM, Chalmers TC, Graham JH, McGoldrick DM, Stohlman F. Exchange transfusion in treatment of fulminating hepatitis. N Engl J Med 1966; 274: 497-501. 15. Redeker AG, Yamahiro HS. Controlled trial of exchange-transfusion therapy in fulminant hepatitis. Lancet 1973; i: 3-6. 16. Silk DBA, Hanid MA, Trewby PN, et al. Treatment of fulminant hepatic failure by polyacrylonitrile-membrane haemodialysis. Lancet 1977; ii:
20. Gimson
AES, Braude S, Mellon PJ, Canalese J, Williams R. Earlier charcoal haemoperfusion in fulminant hepatic failure. Lancet 1982; ii: 681-83. 21. Bismuth H, Caistang D, Ericzon BG, et al. Hepatic transplantation in Europe. Lancet 1987; ii: 674-76. 22. Powell LW. Liver transplantation: an update for physicians. Aust NZ J Med 1989; 19: 369-77. 23. Ringe B, Pichlmayr R, Lauchart W, Muller R. Indications and results of liver transplantation in acute hepatic failure. Transplant Proc 1986; 18 (suppl 3): 86-88. 24. Bismuth H, Samule D, Gugenheim J, et al. Emergency liver transplantation for fulminant hepatitis. Ann Intern Med 1987; 107: 337-41. 25. Peleman RR, Gavaler JS, van Thiel DH, et al. Orthotopic liver transplantation for acute and sub-acute hepatic failure in adults. Hepatology 1987; 7: 484-89. 26. Vickers C, Neuberger J, Buckels J, McMaster P, Elias E. Transplantation of the liver in adults and children with fulminant hepatic failure. J Hepatol 1988; 7: 143-50. 27. Emond JC, Aran PP, Whitington P, Broelsch CE, Baker AL. Liver transplantation in the management of fulminant hepatic failure. Gastroenterology 1989; 96: 1583-88. 28. Bernuau J, Goudeau A, Poynard T, et al. Multivariate analysis of prognostic factors in fulminant hepatitis B. Hepatology 1986; 6: 648-51. 29. O’Grady JG, Alexander GJM, Hayllar KM, Williams R. Early indicators of prognosis in fulminant hepatic failure. Gastroenterology 1989; 97: 439-45. 30. Berk PD, Goldberg JD. Charcoal haemoperfusion. Gastroenterology 1988; 94: 1228-30. 31. Berk PD. Artificial liver: a baby delivered prematurely. Gastroenterology
1-3.
1978; 74: 789-90.
17. Opolon DP, Nusinovici V, Grainger A, Darnis F. Treatment of encephalopathy during fulminant hepatic failure during haemodialysis with high permeability membrane. Gut 1978; 19: 783-93. 18. Chang TMS. Haemoperfusion over a microencapsulated absorbant in a patient with hepatic coma. Lancet 1973; ii: 1371-72. 19. Gazzard BG, Portmann B, Weston MJ, et al. Charcoal haemoperfusion in the treatment of fulminant hepatic failure. Lancet 1974; i: 1301-07.
32. Chalmers TC. Randomized clinical trials in surgery. In: Vargo RL, Delaney JP, eds. Controversies in surgery. Philadelphia: Saunders, 1976: 3-11. 33. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomised trials requiring prolonged observation of each patient. Part 1: design. Br J Cancer 1976; 34: 585-612.
VIEWPOINT Medical
One of the
litigation and the quality of care
concerns voiced by doctors about the inexorable increase in medical litigation is seemingly whether quality of health care will be affected. The suggestion is that litigation leads to defensive medicine (both the avoidance and the reduction of risk taking), discourages quality assurance, and reduces the availabilty of health care. If these outcomes are true, litigation is a major obstacle to high quality care. Are such claims justified and is there any evidence to support them?
principal
The evidence Studies in the US over the past 30 years in which groups of clinicians were asked to report on changes in their own practice provide the main evidence,l-6 but interpretation of the results is difficult. In all but one survey, no more than 35% of doctors responded (the exception being 65%’’). Additionally, there will have been recall bias because of the retrospective design of the studies, which required doctors
to
report how their clinical behaviour had altered over many
Moreover, the respondents were also asked to assess the contribution that fear of medical litigation had made to such changes. In view of such methodological difficulties, such surveys can only identify possible adverse effects of litigation rather than provide reliable measures of the impact of such effects. The latter can be partly achieved by the use of a quasi-experimental design that exploits differences in medical litigation rates between similar populations; only one such study (which compared California, a high litigation area, with North Carolina, where there have been relatively few malpractice claims) has adopted this approach.2 The results, based on a 54% response, did not support the notion that litigation was encouraging poor quality care. However years.
ADDRESS: Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK (N. Black, MD).
36
that
study, carried out almost 20 years ago, may not accurately depict the relation between litigation and quality of care today. Despite the lack of well-designed studies, the effect of litigation on quality of care can be examined by assessment of the circumstantial evidence on which claims have been based. Four potentially harmful consequences need to be considered. Risk avoidance Doctors may be reacting to the fear of litigation by avoiding specialties, procedures, and patients that they perceive carry a high risk of leading to a malpractice claim. Thus, in the US, many obstetricians/gynaecologists no longer practise obstetrics;7 general practitioners (GPs) have stopped certain procedures-eg, intravenous pyelograms, because of the possibility of inducing an allergic reaction to the dye.8 In a survey in 1987 of doctors working in Maryland, risk avoidance (negative defensive medicine) was reported by 17% of specialists in internal medicine, 32% of GPs, and 38% of obstetrician/gynaecologists.6 Does such action damage the quality of care available? If risk avoidance
concentration of services in the hands of fewer specialised doctors and institutions, it may enhance rather than lower the quality of care. In some areas of health care, better outcomes are achieved at higher volumes of activity.9 Another example of risk avoidance is the tendency for doctors to avoid taking on the care of certain patients. Charles et al5 found that as many as 49 % of doctors who had been sued reported that they now refused litigious patients, while another survey suggested that doctors were now screening for such patients, although detailed methods were not reported.8 That some patients might not be able to obtain medical care at all need not only be a product of litigation: patients who complain a lot in the UK may have great difficulty in finding a GP with whom to register. Risk avoidance may also mean a complete withdrawal from medical practice. In the US, significantly more doctors who had been sued than colleagues who had not said that they were thinking about retiring early (43% vs 30%) and that they would discourage their children from pursuing medicine as a career (32% vs 19%).5 Claims that such trends can be seen in England and Wales have already been made: the senior vice president of the Royal College of Obstetrics and Gynaecologists has reported "very deep concern in his discipline about its future and the level of recruitment" (BMA Information Sheet,1 S 161/16.1.89). The reasons for such changes in recruitment are not clear. Other potential causes include the increasing proportion of women entrants to the medical profession for whom a hospital-based career is less attractive than it is for their male colleagues, and the poorly organised postgraduate training offered by many hospital specialties by comparison with developments in areas such as general practice, psychiatry, and public health medicine. leads
to a
Risk reduction
Litigation is also claimed to lead to risk reduction (positive defensive medicine). Because of a fear of the consequences of failing to act, doctors undertake more investigations and interventions than they would otherwise have done. Supporters of this claim have largely based their case on two examples-namely, the use of caesarean section and
diagnostic tests.
Obstetricians have commonly cited fear of litigation as a for the increase during the past 20 years of the caesarean section rate in most industrialised countries.1o However, there have been similar increases in countries with widely varying patterns of litigation. 11 Fear of litigation has probably made only a small contribution to the world-wide increases in the caesarean rate, since there are several other factors that will have contributed to the observed trends-ie, demographic changes that lead to a higher proportion of older mothers and more repeat operations; the widespread introduction of fetal monitoring; new indications such as breech presentation and low birthweight; staff shortages which discourage obstetricians from risking vaginal deliveries; time benefits for staff and patients if the time of delivery is controlled; new anaesthetics that have changed the perceived risk to benefit ratio; and greater reimbursement than for a vaginal delivery. Litigation has also led to an increase in the use of diagnostic tests.3,sHowever, as with the previous example, several other potential influences have to be taken into account:12 the development of multiple autoanalysers; the reduction in unit costs (particularly in relation to other health care costs) in countries where there is competition between laboratories; audit systems with incentives that encourage inappropriate tests (eg, if it is easier to monitor performance according to the number of tests done rather than time spent with a patient, more tests will be substituted for more doctor-time); and payment systems, such as fee-for-service, that provide a financial incentive to doctors. As with caesarean section, support for the view that fear of litigation has probably played only a small part in the increase in the use of tests comes from West Germany where there have been similar trends without any increase in the rate of litigation."
reason
Discouragement of quality assurance Doctors have reported that fear of litigation has discouraged them from collecting clinical information (recording less pertinent information in medical records,5 decrease in necropsy rates, &c) for auditing their work. In Ontario, clinical audit stopped completely when it became clear that the findings were not exempt from subsequent litigation. By contrast, results of other studies have suggested that litigation has encouraged doctors to review the quality of their work and try to improve it. 57% of respondents of a survey in the US claimed to keep better recordswhereas in another survey 59% were monitoring their patients more closely and 44% consulted colleagues more often about the progress of care. Weisman et al6 found that doctors believed
they were providing more information to patients about the risks and benefits of procedures. Reduced availability of health
care
Litigation is said to reduce the availability of health care in three ways: it involves doctors in lengthy legal matters, causes ill-health in those doctors involved, and escalates health care costs. Although legal proceedings take doctors away from their patients, a major impact on health care availability is unlikely: in the US between 1978 and 1983, only 3-7 days over 5 years were lost for each doctor incurring claims.3 The health of doctors who have been the recipients of malpractice claims seems to deteriorated Doctors who had been sued reported significantly more symptoms of stress-
37
induced illness than did their colleagues. However, even if this association is causal, which factor is the cause and which is the effect is not clear. In addition, there was no significant difference in either the prevalence of depressive symptoms or of the onset or exacerbation of physical illnesses. Health care costs may increase as a result of litigation for two reasons: there are the direct costs of insurance premiums or defence organisation subscriptions, legal proceedings, court expenses, and loss of income ;8 and risk reduction may lead to additional, unnecessary medical care. These costs will ultimately be passed on to the patient-in the US, increased feesand in the UK (in the context of cash limited budgets), reduced services. However, the extent to which litigation has serious financial consequences for health care provision is difficult to assess. In the US, the annual increase in malpractice premiums varies from 15 to 50% in different states:l4 this will have led to hospital price increases of about 3% per annum, a third of overall health care inflation. Thus, although litigation has made a substantial contribution to inflation in the US, it has not been the principal reason for the cost explosion, as some have suggested. In Britain, defence society subscriptions accounted for £ 60 million in 1987-88 (about 0-25% of expenditure on health care)." There would have to be huge increases in malpractice claims for such a small proportion of total expenditure to have a large impact on health care inflation.
provide a framework However, before such
to
encourage
higher quality
care.
conclusions are reached, systematic evidence is needed of how, for example, the quality of nursing care has been shaped by nurses’ very different legal circumstances. Will practice that does not conform to established guidelines be covered by defence society subscriptions, and, if not, will doctors in clinical research need higher rates of cover? If so, the cost of research would increase and doctors would be discouraged from improving existing methods of treatment and care.
Finally, irrespective of the impact of changes in liability, the cost of medical litigation may yet prove to be damaging to the quality of care. If the recent annual increase in litigation costs in Britain of about 75% were to continue, by 1992, litigation would account for about 2% of health care expenditure compared with 0-25% in 1987; by 1996 this would have risen to 12% (if we assume a steady 2% per annum increase for demographic trends and new technology). With the constraints of cash-limited budgets, such changes could only be accommodated by substantial reductions in the availability of services. Although there is scant evidence to show any damaging effects of medical litigation at present, the story may be different in the future.
REFERENCES a malpractice suit upon physicians in Connecticut. JAMA 1961; 176: 1096-1101. 2. Tancredi LR, Barondess JA. The problem of defensive medicine. Science
1.
Discussion
Litigation does not seem to be damaging the quality of medical care. There is little evidence that risk reduction is on the increase;12 the effects on quality assurance activities are unclear; and claims for reductions in the availability of health care seem to be exaggerated. At the same time, there are some grounds for the claim that risk avoidance may actually enhance quality by discouraging low volume practitioners. Likewise, difficulties with recruitment to some specialties may hasten improvements in career and training opportunities. If further studies
were
to
lend support
to
these
important general question would remain unanswered. When do particular legal arrangements enhance the quality of care, and with what possible adverse effects? Supporters of the present system say that a doctor’s individual liability may be a spur to achieving high standards of care, whereas others argue that it has not provided adequate supervision of medical standards. An alternative proposal is no-fault compensation; but, as critics have pointed out, such a system does not attribute blame to those responsible, and thus would not be an incentive to improve the quality of care." A third approach, and the one that doctors working in the National Health Service from 1990 will adopt, transfers liability from individual practitioners to employers. Thus, health authorities will have to take full responsibility for doctors’ actions and therefore will need to ensure that their staff provide a high quality service--ie, to encourage quality assurance in medicine. Clinical protocols and guidelines will have to be consulted, since they will provide definitions of good practice and act as a defence in malpractice claims.1S,16 Use of clinical guidelines may only be acceptable when employers accept full legal and financial responsibility for the actions of conclusions,
an
doctors in their employment, as they currently do for other health service staff.17 Such a system might not only ensure that litigation does not damage the quality of care, but also
Wyckoff
RL. The effects of
1978; 200: 879-82. 3. Zuckerman S. Medical malpractice: claims, legal costs, and the practice of defensive medicine. Health Affairs 1984; 3: 128-34. 4. American College of Obstetrics and Gynaecology. Professional liability insurance and its effects: report of a survey of ACOG’s membership. Washington DC: ACOG, 1985.
5. Charles SC, Wilbert JR, Franke KJ. Sued and nonsued physicians’ self-reported reactions to malpractice litigation. Am J Psychiatry 1985; 142: 437-40.
6. Weisman CS, Morlock LL, Teitelbaum MA, Klassen AC, Celentano DD. Practice changes in response to the malpractice litigation climate. Results of a Maryland physician survey. Medical Care 1989; 27: 16-24. survey of obstetrical practice activity in Florida. J Florida Med Assoc 1983; 70: 293-96. 8. Perry S, Lehrman D. Defensive medicine, malpractice, and patient satisfaction. In: Shanahan M, ed. Proceedings of an international symposium on quality assurance in health care. Chicago: Joint Commission on Accreditation of Hospitals, 1987.
7.
Davenport OW. A
9. Luft HSA, Garnick DW, Mark D, McPhee SJ, Tetreault J. Volume of services in hospitals or performed by physicians. In: The quality of medical care: information for consumers. Washington DC: Congress of US Office of Technology Assessment, 1988: 165-83. 10. Macfarlane A, Mugford M. An epidemic of Health 1986; 11: 38-42.
caesareans? J Maternal Child
C, Dingwall R, Fenn P, Harris D. Medical negligence. Compensation and accountability. London: Kings Fund Institute,
11. Ham
1988. 12. Danzon PM. Medical malpractice. Theory, evidence, and public policy. Cambridge, Massachusetts: Havard University Press, 1985.
13. Somers HM. The malpractice controversy and the quality of patient care. Milbank Memorial Fund Quarterly, Health and Society 1977; 55: 193-232.
Jessee WF. Litigation, quality, and use of health services. In: Shanahan M, ed. Proceedings of an international symposium on quality assurance in health care. Chicago: Joint Commission on Accreditation of Hospitals 1987. 15. Hill G. We shall all be changed (editorial). J Med Defence Union 1988; 49. 16. Jones MA, Morris AE. Defensive medicine: myths and facts. J Med Defence Union 1989, 40-42. 17. Harvey IM, Roberts CJ. Clinical guidelines, medical litigation, and the current medical defence system. Lancet 1987; i: 145-47. 14.
