Connect
MJA
MJA

When informed consent goes poorly: a descriptive study of medical negligence claims and patient complaints

Andrew J Gogos, Richard B Clark, Marie M Bismark, Russell L Gruen and David M Studdert
Med J Aust 2011; 195 (6): 340-344. || doi: 10.5694/mja11.10379

Summary

Objective: To describe the frequency, characteristics, and outcomes of medicolegal disputes over informed consent.

Design and setting: Retrospective review and analysis of negligence claims against doctors insured by Avant Mutual Group Limited and complaints lodged with the Office of the Health Services Commissioner of Victoria that alleged failures in the informed consent process and were adjudicated between 1 January 2002 and 31 December 2008.

Main outcome measures: Case frequency (by medical specialty), type of allegation, type of treatment.

Results: A total of 481 cases alleged deficiencies in the informed consent process (218 of 1898 conciliated complaints [11.5%]; 263 of 7846 negligence claims [3.4%]). 57% of these cases were against surgeons. Plastic surgeons experienced dispute rates that were more than twice those of any other specialty or subspecialty group. 92% of cases (442/481) involved surgical procedures and 16% (77/481) involved cosmetic procedures. The primary allegation in 71% of cases was that the clinician failed to mention or properly explain risks of complications. Five treatment types — procedures on reproductive organs (12% of cases), procedures on facial features excluding eyes (12%), prescription medications (8%), eye surgery (7%) and breast surgery (7%) — accounted for 46% of all cases.

Conclusions: The typical dispute over informed consent involves an operation, often cosmetic, and allegations that a particular complication was not properly disclosed. With Australian courts now looking to patient preferences in setting legal standards of care for risk disclosure, medicolegal disputes provide valuable insights for targeting both quality improvement efforts and risk management activities.

  • Andrew J Gogos1
  • Richard B Clark2
  • Marie M Bismark3
  • Russell L Gruen4
  • David M Studdert3,5

  • 1 Royal North Shore Hospital, Sydney, NSW.
  • 2 Avant Mutual Group Limited, Melbourne, VIC.
  • 3 Melbourne School of Population Health, University of Melbourne, Melbourne, VIC.
  • 4 Department of Surgery, The Alfred Hospital, Monash University, Melbourne, VIC.
  • 5 Melbourne Law School, University of Melbourne, Melbourne, VIC.

Correspondence: d.studdert@unimelb.edu.au

Acknowledgements: 

This study was supported by a Linkage Grant from the Australian Research Council (LP0989178), with partner contributions from the Office of the Health Services Commissioner of Victoria, the Victorian Department of Health, and Avant Mutual Group Limited. David Studdert was supported by a Federation Fellowship from the Australian Research Council. Russell Gruen was supported by a Career Development Award from the National Health and Medical Research Council.

Competing interests:

No relevant disclosures.

  • 1. Berg JW, Appelbaum PS, Lidz CW, Parker LS. Informed consent: legal theory and clinical practice. 2nd ed. New York: Oxford University Press, 2001.
  • 2. Dolgin JL. The legal development of the informed consent doctrine: past and present. Camb Q Healthc Ethics 2010; 19: 97-109.
  • 3. Sugarman J, McCrory DC, Powell D, et al. Empirical research on informed consent. An annotated bibliography. Hastings Cent Rep 1999; 29 (1): S1-S42.
  • 4. Meisel A, Roth LH. Toward an informed discussion of informed consent: a review and critique of the empirical studies. Ariz Law Rev 1983; 25: 265-346.
  • 5. Leclercq WKG, Keulers BJ, Scheltinga MRM, et al. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg 2010; 34: 1406-1415.
  • 6. Studdert DM, Mello MM, Gawande AA, et al. Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med 2006; 354: 2024-2033.
  • 7. Weiler PC, Hiatt HH, Newhouse JP, et al. A measure of malpractice: medical injury, malpractice litigation, and patient compensation. Cambridge, Mass: Harvard University Press, 1993.
  • 8. Krumholz HM. Informed consent to promote patient-centred care. JAMA 2010; 303: 1190-1191.
  • 9. Landis J, Koch G. The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159-174.
  • 10. Australian Institute of Health and Welfare. Medical labour force [for the years 2002–2008]. Canberra: AIHW. (Cat. Nos. HWL 30, 32, 39, 41, 42, 45 and AUS 131.)
  • 11. Dawes PJ, Davison P: Informed consent: what do patients want to know? J Royal Soc Med 1994; 87: 149-152.
  • 12. Newton-Howes PA, Bedford ND, Dobbs BR, Frizelle FA. Informed consent: what do patient want to know? N Z Med J 1998; 111: 340–342.
  • 13. Canterbury v Spence 464 F.2d 772 (DC Cir 1972).
  • 14. Rogers v Whitaker (1992) 175 CLR 479.
  • 15. Hong Chuan Lay v Dr Eddie Soo Fook Mun [1998] 5 CLJ 251.
  • 16. B v Medical Council (High Court, Auckland HC11/1996, 8 July 1996).
  • 17. Geoghegan v Harris [2000] 3 IR 536.
  • 18. Reibl v Hughes [1980] 2 SCR 880.
  • 19. Studdert DM, Mello MM, Levy MK, et al. Geographic variation in informed consent law: two standards for disclosure of treatment risks. J Emp Leg Stud 2007; 4: 103-124.
  • 20. Studdert DM, Thomas EJ, Burstin H, et al. Negligent care and malpractice claiming behavior in Utah and Colorado. Med Care 2000; 38: 250-260.
  • 21. Berwick DM. Escape fire. Designs for the future of health care. San Francisco: Jossey-Bass, 2004.

Author

remove_circle_outline Delete Author
add_circle_outline Add Author

Comment
Do you have any competing interests to declare? *

I/we agree to assign copyright to the Medical Journal of Australia and agree to the Conditions of publication *
I/we agree to the Terms of use of the Medical Journal of Australia *
Email me when people comment on this article

Responses are now closed for this article.