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The Legal Development of the Informed Consent Doctrine: Past and Present

Published online by Cambridge University Press:  22 December 2009

JANET L. DOLGIN
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Extract

For millennia physicians were admonished to obscure the details of patients’ illnesses and poor prognoses. The Hippocratic ethic precludes physicians from including patients in medical decisionmaking. That ethic demanded of doctors that they “[p]erform [their duties] calmly and adroitly, concealing most things from the patient … revealing nothing of the patient's future or present condition.”

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Special Section: Open Forum
Information
Cambridge Quarterly of Healthcare Ethics , Volume 19 , Issue 1 , January 2010 , pp. 97 - 109
Copyright
Copyright © Cambridge University Press 2010

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References

1. Jay Katz, Reflections on informed consent: 40 years after its birth, American College of Surgeons, Committee on Ethics; available at http://www.facs.org/education/ethics/katzlect.html (last accessed 29 Sept 2009).

2. Hippocrates, Decorum 297 (W. Jones, trans. 1967) Cambridge, MA: Harvard University Press (cited in Katz, Reflection on Informed Consent, supra note 1). Some medical schools have given up the Hippocratic Oath, once routinely recited by new graduates at medical school graduation ceremonies. Other schools have changed the language of the oath. Thane Josef Messinger, A Gentle and Easy Death, 71 Denver University Law Review 175, 218, n. 367 (1993).

3. Gerald Dworkin, Can you trust autonomy? 33 Hastings Center Report 42–44 (2003).

4. Schloendorff v. The Society of the New York Hosp., 105 North Eastern Reporter 92 (Court of Appeals of N.Y. 1914).

5. In 1932, President Herbert Hoover appointed Cardozo to a seat on the U.S. Supreme Court.

6. 105 North Eastern Reporter at 93.

7. Professor Paul Lombardo (Director of the Program in Law and Medicine, University of Virginia, Center for Biomedical Ethics) has reconstructed the story surrounding Mary Schloendorff's case. Paul A. Lombardo, Phantom tumors and hysterical women: Revising our view of the Schloendorff case, 33 Journal of Law, Medicine & Ethics 791 (2005). The story of the Schloendorff case, related below, relies on Lombardo's account.

8. Despite Cardozo's declarations about the right of patients to refuse care, Schloendorff ultimately lost the case because the court concluded that the hospital was protected by the doctrine of charitable immunity from tort liability. 105 North Eastern Reporter at 95.

9. Assault and battery cases may differ from informed consent cases. There may be a different assessment of damages, different elements of proof may be relevant, and the statute of limitations may differ. Mark Fowler, Note, Appointing an Agent to Make Medical Treatment Choices, 84 Columbia Law Review 985, 989 n.21 (1984). In New York, informed consent cases are classed along with medical malpractice cases and, thus, like medical malpractice cases, “must be commenced within 2 years and 6 months of the act giving rise to the cause of action.” Allan Schwartz, Assault – Civil Aspects, 6A New York Jurisprudence 2nd, Assault, Section 19 (Statute of Limitations) (2006). Schwarz notes, however that “[w]here a patient suffers injury as a result of a medical operation performed contrary to the patient's instructions … such an operation has been held to constitute a trespass upon the body and the basis for an action in assault. In such a case, the 1-year statute of limitations [of assault and battery cases] applies.” Id.

10. E. Haavi Morreim, Medial Research Litigation and Malpractice Tort Doctrines, 4 Houston Journal of Health Law & Policy 1, 53–54 (2003). Morreim notes as well that consent cases brought through a battery cause-of-action may involve accusing the physician of a crime or, at least, of an intentional tort. Moreover, battery claims open physician–defendants to punitive damages. Id.

11. Schloendorff v. N.Y. Hospital is illustrative. Mary Schloendorff consented to an ether exam but not to removal of her uterus.

12. This second condition may involve surgery on the wrong body part (e.g., one limb instead of the other) or the “substitution of one treatment for another.” E. Haavi Morreim, Medical Research Litigation and Malpractice Tort Doctrines, 4 Houston Journal of Health Law & Policy 1, 58 (2003).

13. See, e.g., Pugsley v. Privette, 263 South Eastern Reporter 2nd 69 (Virginia 1980) (state supreme court affirmed jury award of damages in battery against an obstetrician who treated a patient who had given consent to be treated by a different physician). The state supreme court explained:

[I]t avails little to argue now that no good purpose would have been served by Dr. Hall's presence, or that had Dr. Hall been present the same operation would have been performed and the same complications would have arisen. It was Mrs. Privette's body on which the operation was to be performed, and the decision was one peculiarly for her to make. The fact is that Mrs. Privette wanted Dr. Hall present, and he was not there. The jury has found that because of this the consent for the defendant to operate had been revoked by the plaintiff. The hazard to a physician of performing an operation without the consent of the patient is dramatically illustrated by this case.

Id. at 901.

14. Salgo v. Leland Stanford Junior University Board of Trustees, 317 Pacific Reporter 2nd 170 (California Court of Appeals 1957).

15. 317 Pacific Reporter 2nd at 181.

16. Id.

17. Jay Katz, Informed Consent—A Fairy Tale? Law's Vision, 39 University of Pittsburgh Law Review 137 (1977).

18. Jay Katz, Reflections on Informed Consent: 40 Years After Its Birth, American College of Surgeons, Committee on Ethics; available at http://www.facs.org/education/ethics/katzlect.html (last accessed 29 Sept 2009).

19. Canterbury v. Spence, 464 Federal Reporter Second Series 772 (United States Court of Appeals for the District of Columbia 1972).

20. Cobbs v. Grant, 8 California Reports 3rd 229 (1972).

21. This section describes the development and legal rules underlying the informed consent doctrine through reference to the D.C. case, Canterbury v. Spence, 464 Federal Reporter 2nd series 772 (United States Court of Appeals for the District of Columbia 1972).

22. A more detailed account of these changes can be found in Janet L. Dolgin, The Evolution of the “Patient”: Shifts in Attitudes About Consent, Genetic Information, and Commercialization in Health Care, 34 Hofstra Law Review 137 (2005).

23. See, e.g., Milton C. Regan, Jr., Family Law and the Pursuit of Intimacy 6, 9–10 (New York University Press 1993).

24. This form of relationship between patient and doctor is described more fully in Janet L. Dolgin, Debating Conflicts: Medicine, Commerce, and Contrasting Ethical Orders, 35 Hofstra Law Review 705 (2006).

25. These changes, including the creation of Medicare and Medicaid, the soaring costs of healthcare, the consequent advent of managed care, and the technological developments of the late 20th and early 21st centuries have been widely documented. See, e.g., Roy Porter, ed., The Cambridge History of Medicine (Cambridge University Press 2006); Paul Starr, The Social Transformation of Medicine (Basic Books 1982).

26. Donald Okun, What to Tell Cancer Patients: A Study of Medical Attitudes, 175 Journal of the American Medical Association 1120 (1961).

27. D.H. Novack, R. Plumer, R.L. Smith, H. Ochitill, G.R. Morrow, & M. Bennett, Changes in Physicians’ Attitudes Toward Telling the Cancer Patient, 241 Journal of the American Medical Association 897, 898 (1979).

28. Canterbury v. Spence, 464 Federal Reporter 2nd series 772 (United States Court of Appeals for the District of Columbia 1972).

29. This information was actually conveyed to Jerry Canterbury's mother, described by the court as a “poor widow” “who lived in West Virginia and could be reached through a neighbor's phone.” Canterbury's mother signed a consent form, but only after the surgery had been performed. There was contradictory testimony about whether she had consented orally before the surgery.

30. 464 Federal Reporter 2nd series at 778.

31. A fall immediately after the surgery resulted in paralysis from the waist down. Dr. Spence performed a second operation at that time. The court explained that after the second operation Canterbury's “control over his muscles improved somewhat.”

32. The trial court concluded that Canterbury “had failed to produce any medical evidence indicating negligence on Dr. Spence's part in diagnosing appellant's malady or in performing the laminectomy.” 464 Federal Reporter 2nd series at 778. The trial court judge did not refer to the physician's failure to “divulge the possible consequences of the laminectomy.” Id. at 779. One commentator suggested that the absence of evidence as to physician and hospital negligence was “inexplicable, … save an inability to secure any expert witness willing to bridge the community of silence to testify against one of their own.” Emmanuel O. Iheukwumere, Doctor, Are You Experienced?: The Relevance of Disclosure of Physician Experience to a Valid Informed Consent, 18 Journal of Contemporary Health Law & Policy 373, 389 (2002).

33. 464 Federal Reporter 2nd series at 788.

34. Canterbury, 464 Federal Reporter 2nd series at 787. The court noted: “In broad outline, we agree that ‘[a] risk is thus material when a reasonable person, in what the physician knows or should know to be the patient's position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.’“ Id. at 787 (quoting Jon R. Waltz & Thomas W. Scheuneman, Informed Consent to Therapy, 64 Northwestern University Law Review 628, 640 (1970)).

In contrast to the usual rule, the Supreme Court of Oklahoma adopted a subjective standard that looked not to what a reasonable person would find material but to what a particular patient would find material. Scott v. Bradford, 606 Pacific Reporter 2nd 554, 559 (Oklahoma 1979). The court explained that the Canterbury court's approach could be criticized for

backtracking on its own theory of self-determination. The Canterbury view certainly severely limits the protection granted an injured patient. To the extent the plaintiff, given an adequate disclosure, would have declined the proposed treatment, and a reasonable person in similar circumstances would have consented, a patient's right of self-determination is irrevocably lost. This basic right to know and decide is the reason for the full-disclosure rule. Accordingly, we decline to jeopardize this right by the imposition of the "reasonable man" standard.

Id. at 559.

35. New York's statute provides:

Lack of informed consent means the failure of the person providing the professional treatment or diagnosis to disclose to the patient such alternatives thereto and the reasonably foreseeable risks and benefits involved as a reasonable medical, dental or podiatric practitioner under similar circumstances would have disclosed, in a manner permitting the patient to make a knowledgeable evaluation.

N.Y. Public Health Law, Section 2805-d (2) (2006). Thus the statute looks to practice among other healthcare providers but precludes courts’ relying on a standard of practice that provides almost no information; that preclusion is accomplished with the phrase “in a manner permitting the patient to make a knowledgeable evaluation.” Id. The statute further requires the plaintiff to show that

a reasonably prudent person in the patient's position would not have undergone the treatment or diagnosis if he had been fully informed and that the lack of informed consent is a proximate cause of the injury or condition for which recovery is sought.

Id., Sec. 2805-d (3).

36. N.Y. Public Health Law, Section 2805-d (1) (2006).

37. See Logan v. Grennwich Hospital Association, 465 Atlantic Reporter 2nd 294, 300 (1983) (citing Alan Meisel & Lisa D. Kabnick, Informed Consent to Medical Treatment: An Analysis of Recent Legislation, 41 University of Pittsburgh Law Review 407, 425 (1980)).

38. AMA, Code of Medical Ethics, Principle 8.08; available at http://www.ama-assn.org/apps/pf_new/pf_online (last accessed 11 Dec 2006). In Culbertson v. Mernitz, 602 North Eastern Reporter 2nd 98 (1992), the Indiana Supreme Court noted this shift within the profession between the early 1970s, when Canterbury was decided, and 1992 (when Culbertson was decided). By 1992, the court reported patients did not need to fear that the “reasonably prudent physician standard” would “destroy[] the patient's right of self-decision.” Id. at 103. In supporting this assertion, the court referred to the incorporation of the informed consent rule in the AMA's Code of Medical Ethics. Id.

39. NY Public Health Law, Sec. 2805-d(1) (2006).

40. See, e.g., Truman v. Thomas, 611 Pacific Reporter 2nd 902 (Supreme Court of California 1980) (requiring disclosure of information about reasons to have a pap smear); Gates v. Jensen, 595 Pacific Reporter 2nd 919 (Supreme Court of Washington 1979) (requiring that information about glaucoma tests be communicated to patient with symptoms).

41. Truman v. Thomas, 611 Pacific Reporter 2nd 902, 906 (Supreme Court of California 1980). The California court explained that Mrs. Truman had apparently refused the test because of the cost involved or because she did not “feel like it.” Furthermore, there was no evidence that she understood the danger of refusing the test. The court thus concluded:

Under these circumstances, a jury could reasonably conclude that Dr. Thomas had a duty to inform Mrs. Truman of the danger of refusing the test because it was not reasonable for Dr. Thomas to assume that Mrs. Truman appreciated the potentially fatal consequences of her conduct. Accordingly, this court cannot decide as a matter of law that Dr. Thomas owed absolutely no duty to Mrs. Truman to make this important disclosure that affected her life.

Id. at 907.

42. American College of Surgeons, Code of Professional Conduct, http://www.facs.org/fellows_info/statements/stonprin.html (last accessed 10 Sep 2008).

43. Mark A. Hall, Mary Anne Bobinski, & David Orentlicher, Medical Liability and Treatment Relationships, 222, 223 (Aspen Publishers 2005).

44. New York law, for example, delineates four exceptions to the informed consent requirement. These include an exception for a commonly known risk (Section 2805-d(4)(a)), for a patient who proclaimed his or her willingness to proceed with treatment regardless of the risk involved or who “assured” the healthcare provider that he or she did not want to be informed of risks (Section 2805-d(4)(b)), cases in which “consent by or on behalf of the patient was not reasonably possible (Section 2805-d(4)(c)), and cases in which the healthcare provider concludes that disclosure “could reasonably be expected to adversely and substantially affect the patient's condition” (Section 2805-d(4)(d)).

45. A Pennsylvania court concluded that a patient may waive the right to information about a proposed form of care, and that if the patient waives that right, the physician need not communicate relevant information. Stover v. Association of Thoracic and Cardiovascular Surgeons, 635 Atlantic Reporter 2nd 47 (Pennsylvania Superior Court 1993). Stover involved a plaintiff who suffered complications after heart value surgery. She sued the surgeon group responsible for her care. The court held for the patient because the defendants were not able adequately to demonstrate that the plaintiff–patient had indeed waived the right to receive information about the surgery and its risks. The court explained: “There is nothing in the record indicating that appellee stated anything resembling ‘I don't want to hear anything about the operation,’ or ‘Stop! You've told me enough. I'll leave it up to you.’ We find no merit to this last of appellants' arguments.” Id. at 1056.

46. The therapeutic exception is one of two exceptions noted in Canterbury. The other is the emergency exception. 464 Federal Reporter Second Series at 789.

47. See, e.g., N.Y. Public Health Law, Section 2805-d(4)(d) (2006).

48. In Canterbury v. Spence, 464 Federal Reporter 2nd series 776 (1972), Judge Robinson acknowledged the “therapeutic” exception, but explained that it should be used only with care because “otherwise it might devour the disclosure rule itself.” He continued: “The privilege does not accept the paternalistic notion that the physician may remain silent simply because divulgence might prompt the patient to forego therapy the physician feels the patient really needs.” 464 Federal Reporter 2nd series at 789.

49. Alan Meisel and Loren Roth concluded from their study of the informed consent rules in clinical settings that often the doctrine as viewed by lawmakers does not harmonize with what occurs in fact:

Patients receive information; consent forms get signed. But rarely do doctors sit down with patients and provide them with thorough explanations of treatment options and then seek their consent to one or another. Instead, information is often given to patients not to enable them to choose, but to encourage them to cooperate with doctors and to comply with decisions that have already been made, not by patients as law envisions, but by doctors.

Alan Meisel & Loren H. Roth, Toward an Informed Discussion of Informed Consent: A Review and Critique of the Empirical Studies, 25 Arizona Law Review 265, 334 (1983).

50. See, e.g., Cobbs v. Grant, 502 Pacific Reporter 2nd 1 (Supreme Court of California 1972).

51. 545 North Western Reporter 2nd 495 (Supreme Court of Wisconsin 1996).

52. The case is unusual for a number of reasons. Among other things, Dr. Kokemoor had informed the patient that the risk of death or disability was about 2%. He also explained that the risk of the procedure he proposed (operating on a basilar, bifurcation aneurysm) was comparable to that of “routine procedures such as tonsillectomies, appendectomies and gall bladder surgeries.” In fact, the court explained,

[E]ven the most accomplished posterior circulation aneurysm surgeons reported morbidity and mortality rates of fifteen percent for basilar bifurcation aneurysms. Furthermore, the plaintiff introduced expert testimony indicating that the estimated morbidity and mortality rate one might expect when a physician with the defendant's relatively limited experience performed the surgery would be close to thirty percent.

Id. at 506. Although the court's decision was not premised on a cause-of-action in deceit or fraud, the court was clearly troubled by the doctor's apparent exaggerations and falsifications. Wisconsin's highest court remanded the case to the trial court. The parties settled before the case was retried. See Aaron D. Twerski & Neil B. Cohen, The Second Revolution in Informed Consent: Comparing Physicians to Each Other, 94 Northwestern University Law Review 1, 8 (1999).

53. Some commentators have viewed the decision in Kokemoor as primarily a response to a doctor's misrepresentation of his or her qualifications and skills rather than as a broad rule proclaiming that physicians should provide their patients with provider-specific information as part of the informed consent process. See, e.g., Heyward H. Bouknight, III, Note, Between the Scalpel and the Lie: Comparing Theories of Physician Accountability for Misrepresentations of Experience and Competence, 60 Washington & Lee Law Review 1515, 1530 (2003) (describing the case to be about “a doctor's deceitful responses to patient inquiries”). It should, however, be noted that the court did not expressly predicate its decision on inaccurate responses by the doctor to the patient’s questions.

54. Howard v. University of Medicine & Dentistry of New Jersey, 800 Atlantic Reporter 2nd 73 (Supreme Court of New Jersey 2002).

55. 800 Atlantic Reporter 2nd at 82.

56. 800 Atlantic Reporter 2nd at 83.

57. In some states (e.g., Pennsylvania, see Duttry v. Patterson, 771 Atlantic Reporter 2nd 1255 (Supreme Court of Pennsylvania 2001)), physicians, though precluded, of course, from providing patients with false information, are not required to answer such questions.

58. Emmanuel O. Iheukwumere, Doctor, Are You Experienced?: The Relevance of Disclosure of Physician Experience to a Valid Informed Consent, 18 Journal of Contemporary Health Law & Policy 373, 419 (2002).

59. See Kaskie v. Wright, 589 Atlantic Reporter 2nd 213, 217 (Pennsylvania Superior Court 1991). Kaskie was decided 5 years before Kokemoor, but expressly considered and rejected the rule on which the court in Kokemoor relied. See, generally, Mark Hall, Caring, Curing, and Trust: A Response to Gatter, 39 Wake Forest Law Review 447, 450 (2004).

60. See, e.g., Albany Urology Clinic, P.C. v. Cleveland, 528 South Eastern Reporter 2nd 777 (Supreme Court of Georgia 2000) (reversing appellate court decision that doctor was obliged to disclose his cocaine use to his patients); Whiteside v. Lukson, 947 Pacific Reporter 2nd 1263 (Washington Court of Appeals 1997) (holding that surgeon was not obliged to inform patient of his inexperience performing laparoscopic cholecystectomy procedure).

61. Hall, supra note 53, at 450–1.

62. William Sage, The Lawyerization of Medicine, 26 Journal of Health, Politics, Policy & Law 1179 (2001).