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Malpractice Issues in Heart Transplantation

Published online by Cambridge University Press:  24 February 2021

Abstract

As organ transplantation procedures become accepted as standard medical practice, it is anticipated that the frequency of liability claims against transplant care providers will increase. This article examines current statutory and common law analyses of malpractice issues in transplantation, with particular attention given to issues of informed consent as they arise both for the organ donor and donee.

Type
Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1985

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Footnotes

*

Preparation of this article was made possible by support from the Office of Research and Demonstrations of the Health Care Financing Administration, Contract Number 500-81-0051.

References

1 In 1983, 172 heart transplants, 164 liver transplants, and 6, 112 kidney transplants were performed in the U.S. In 1980, 36 heart transplants, 15 liver transplants, and 4,697 kidney transplants were performed. R. Evans, The Need for and Cost of Liver Transplantation in the U.S. Update Number 38. National Kidney Dialysis and Kidney Transplantation Study (1984); R. Evans, D. Manninen, T. Overcast, L. Gamson, J. Yagi, K. Memkin, A. Jonsen, L. Bowen, J. Elworth, L. Hart, M. Hoe, C. Livak & A. Maier, The National Heart Transplantation Study: Final Report (1984) [hereinafter cited as Transplantation Study]; Health Care Financing Administration, End-Stage Renal Disease Program Highlights, 1983 (1984).

2 See, e.g., Strunk v. Strunk, 445 S.W.2d 145 (Ky. 1969) (mentally incompetent adult allowed by court order to donate a kidney to his brother due in part to strong relationship between brothers and perceived harm to incompetent individual if brother died); Little v. Little, 576 S.W.2d 493 (Tex. Civ. App. 1979) (authorizing removal of kidney from fourteen year old with Down’s syndrome for transplantation into brother); compare, Lausier v. Pescinski, 67 Wis. 2d 4, 226 N.W.2d 180 (1975) (no kidney removal allowed from mentally incompetent adult where he would gain no psychological benefit from donation). As to children without mental disability, see e.g., Hart v. Brown, 29 Conn. Supp. 368, 289 A.2d 386 (1972) (kidney donation allowed). See generally, Annot., 35 A.L.R.3d 692 (1971).

3 See, e.g., Sirianni v. Anna, 55 Misc. 2d 553, 285 N.Y.S.2d 709 (1967) (mother who volunteered to permit one of her kidneys to be transplanted into the body of her adult son after defendant surgeons had negligently removed the son’s kidneys could not recover from the surgeons for the resulting impairment to her health resulting from loss of one kidney); Moore v. Shah, 91 A.D.2d 755, 458 N.Y.S.2d 33 (1982) (kidney donor [son] had no cause of action for negligent diagnosis and treatment of donee [father]).

4 At common law, a number of actions could be maintained for taking flesh from a deceased person. A cause of action could be based on allegations such as “mayhem,” "mutilation of a corpse,” or “unauthorized autopsy."

5 Unif. Anatomical Gift Act (1980).

6 Although all jurisdictions have enacted some form of the UAGA, reference to statutory provisions hereinafter refer to the UAGA in 15 Real Prop. Prob. & Trial J. 825 (1980) (except where otherwise noted).

7 Unif. Anatomical Gift Act § 7(c) (1980).

8 The Act does not limit liability for treatment of the donor prior to death, however, or treatment of the live transplant recipient. Williams v. Hofmann, 66 Wis. 2d 145, 223 N.W.2d 844(1974).

9 See, Rose, , Medicolegal Problems Associated with Organ and Tissue Transplantations, in Legal Medicine 1982 85, 91 (Wecht, C. ed. 1982)Google Scholar; Jeddeloh, & Chatterjee, , Legal Problems in Organ Donation, 58 The Surgical Clinics of North America 245, 248 (1978)CrossRefGoogle ScholarPubMed.

10 66 Wis. 2d 145, 223 N.W.2d 844 (1974).

11 Wis. Stat. § 155.06(7)(c) (1974).

12 See, e.g., Raab v. Casper, 51 Cal. App. 3d 866, 872, 124 Cal. Rptr. 590, 593 (1975). Bad faith, by contrast, is evidenced by actual or constructive fraud, intent to mislead or deceive another, or a neglect or refusal to fulfill some duty or contractual obligation not prompted by an honest mistake as to one’s rights or duties, but instead prompted by some interested or similar motive. See also, Williams v. Hofmann, 66 Wis. 2d 145, 223 N.W.2d 844, 76 (1974).

13 Such a suit would probably be grounded on a charge of interference with a corpse and would likely involve a substantial claim for damages for emotional distress. See, e.g., Keeton, W. Keeton, R. Owens, D. and Dobbs, D., Prosser and Keeton on the Law of Torts 3 (5th ed. 1984)Google Scholar; 4 Restatement of Torts § 868 (1939). See also, Koerber v. Patek, 123 Wis. 453, 102 N.W. 40 (1905) (plaintiff entitled to recover where defendant was given permission to examine the decedent mother’s stomach but instead removed it).

14 Unif. Anatomical Gift Act § 6 outlines the means by which an anatomical gift may be revoked.

15 Unif. Anatomical Gift Act § 2(b)(c). The Act provides that a number of persons can be specified as the donee of the organ, including the intended recipient. See Unif Anatomical Gift Act § 3. If no donor is specified, the gift may be accepted by the deceased person’s attending physician. Unif. Anatomical Gift Act § 4(c). However, the physician who becomes a donee in this manner cannot participate in the procedures for removing and transplanting a heart. Id.

16 Unif. Anatomical Gift Act § 2(c).

17 Unif. Anatomical Gift Act § 7(b). The comments to section 7(b) of the Act adopt the view that no clear cut definition of death can be formulated and that “[n]o reasonable statutory definition is possible. The answer depends upon many variables, differing from case to case. Reliance must be placed upon the judgment of the physician in attendance."

18 Stason, , The Uniform Anatomical Gift Act, 23 Bus. Law. 919, 928 (1968)Google Scholar.

19 No. 2831 (Richmond, Va., Law. & Eq. Ct. May 23, 1972).

20 Id.

21 See Va. Code § 54-325.7 (Supp. 1981).

22 See Dispute over “Death" Stirs Medical Debate, Am. Med. News Oct. 3 , 1980, at 1, 12Google Scholar.

23 81 Misc. 2d 1002, 367 N.Y.S.2d 686 (N.Y. Sup. Ct. 1975).

24 N.Y. Pub. Health Law §§ 4300-4307 (McKinney 1977).

25 Id. at § 4306.

26 81 Misc. 2d at 1007, 367 N.Y.S.2d at 691.

27 See, Alabama—Ala. Code §22-31-1 (Supp. 1984); Alaska—Alaska Stat. §9.65.182 (Supp. 1980); Arkansas—Ark. Stat. Ann. § 82-537-538 (Supp. 1981); California—Cal. Health & Safety Code §§ 7180-7182 (West Supp. 1985); Colorado—Colo. Rev. Stat. § 12-36-136 (1984); Connecticut—Conn. Gen. Stat. Ann. § 19-139, (West Supp. 1981); Florida—Fla. Stat. § 382.085 (1985); Georgia—Ga. Code Ann. § 88-1715.1 (Supp. 1980); Hawaii—Hawaii Rev. Stat. § 327-C-l (supp. 1983); Idaho—Idaho Code § 54-1819 (Supp. 1984); Illinois—Ill. Ann. Stat. ch. 110.5 § 302 (Smith-Hurd Supp. 1984); Iowa—Iowa Code Ann. § 702.8 (West 1980); Kansas—Kan. Stat. Ann. § 77-205 (Supp. 1984); Louisiana—La. Rev. Stat. Ann § 9.11 (West Supp. 1985); Maryland—Md. Health Gen. Code Ann. § 5-202 (1984); Michigan—Mich. Stat. Ann. § 14.15 (1021) (Callaghan Supp. 1983); Montana—Montana Code Ann. § 50-12-101 (1983); Nevada—Nev. Rev. Stat. § 451.007 (1979); New Mexico—N.M. Stat. Ann. § 12-2-4 (1978); North Carolina—N.C. Gen. Stat. § 90-323 (Supp. 1979); Oklahoma — Okla. Stat. Ann. tit. 63, § 1-103 (g)(West Supp. 1981); Oregon —Or. Rev. Stat. § 146.001 (1981); Tennessee—Tenn. Code Ann. § 68-3-501 (Supp. 1981); Texas—Tex. Rev. Civ. Stat. Ann. art. 4447(t) § 1 (Vernon Supp. 1984); Virginia—Va. Code § 54-325.7 (Supp. 1982); West Virginia—W. Va. Code § 16-19-1 (Supp. 1980); Wyoming— Wyo. Stat. § 35-19-101 (Supp. 1984).

28 Several courts have recognized brain death standards in criminal homicide cases. See, e.g., State v. Fierro, 124 Ariz. 182, 603 P.2d 74 (1979) (removal of respiratory life support system was not the proximate cause of gunshot victim’s death); Commonwealth v. Golston, 373 Mass. 249, 366 N.E.2d 744, cert. denied, 434 U.S. 1039 (1978) (adopting a brain death standard to prove death homicide case). Brain death standards have also been judicially adopted in several civil cases. See, e.g., Tucker v. Lower, No. 2831 (Richmond, Va., Law & Eq. Ct. May 23, 1972) (wrongful death action involving claim of premature declaration of death of organ donor); New York City Health & Hosp. Corp. v. Silsona, 81 Misc. 2d 1002, 367 N.Y.S.2d 686 (Sup. Ct. 1975) (declaratory judgment on brain death standard under New York’s Anatomical Gift Act); In re Bowman, 94 Wash. 2d 407, 617 P.2d 731 (1980) (judicial adoption of the Uniform Determination of Death Act).

29 See President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Defining Death: A Report on the Medical, Legal and Ethical Issues in the Determination of Death (1980) [hereinafter cited as President’s commission].

30 Unif. Anatomical Gift Act § 7(c).

31 See, e.g., Kusanovich, , Medical Malpractice Liability and the Organ Transplant, 5 U. S. Fla. L. Rev. 223, 250-53 (1971)Google Scholar.

32 Jeddeloh & Chatterjee, supra note 9, at 248.

33 Id.

34 Williams v. Hofmann, 66 Wis. 2d 145, 223 N.W.2d 844 (1974) (good faith exemption applies to (a) the mechanics of giving and receiving anatomical gifts (b) the determination of time of death, and (c) procedures following death).

35 President’s Commission, supra note 29, at 1.

36 Id. at 2.

37 Committee on Forensic Pathology of the American College of Pathologists, Coroners Cases as Transplant Donors, 23 Bull. C. Am. Pathologists 45-47 (1969)Google Scholar; Davis, & Wright, , Influence of the Medical Examiner on Cadaver Organ Procurement, 22 J. Forensic Sci. 824 (1977)CrossRefGoogle ScholarPubMed.

38 An early attempt to suggest guidelines for cooperation was made by the Committee on Forensic Pathology of the College of American Pathologists in 1969. The Committee put forth the following guidelines for determining when to permit organ retrieval prior to autopsy. They suggested that organ retrieval not be permitted prior to autopsy in cases of:

  • — known or suspected homicide;

  • — body trunk injuries when major organs are desired;

  • — industrial accident;

  • — suspected poisoning;

  • — possible medical malpractice cases;

  • — two or more party vehicle accidents in which there are serious questions of liability; and

  • — apparent suicide in which there is serious suspicion of possible accident or involvement of another person.

Committee on Forensic Pathology of the American College of Pathologists, supra note 37, at 45-47.

39 See Davis & Wright, supra note 37.

40 Id.

41 The medical examiner is generally present at the time the organs are removed. If the medical examiner is not present, then the removing surgeon must detail in writing the surgical procedures used and the absence of injury to the affected area of the body. In order to show that the declaration of death and subsequent organ removal were not independent, intervening causes of death, the following facts are documented in writing:

  • — the circumstances surrounding the injury;

  • — the status of the victim when first viewed at the scene or examined at the hospital;

  • — the status of the victim at the hospital;

  • — documentation of the evidence leading to the declaration of death;

  • — documentation of absence of injury or other potential causes of death related to the donated organs; and

  • — documentation of the medical examiner’s or coroner’s autopsy findings.

42 Texas Stat. Ann. 49.25(6a) (Vernon 1979).

43 1 Health Law Center, Aspen Systems Corp., Hospital Law Manual §§ 6-7 (1983).

44 See e.g., Le Pelley v. Gresfenson, 101 Idaho 422, 614 P.2d 962 (1980); Winkjer v. Herr, 277 N.W.2d 579 (N.D. 1979).

45 See, e.g., Dunham v. Wright, 423 F.2d 940 (3d Cir. 1970); Pegram v. Sisco, 406 F. Supp. 776(W.D.Ark. 1976), aff'd mem., 547 F.2d 1172(8th Cir. 1976); Contreras v. St. Luke’s Hosp., 78 Cal. App. 3d 919, 144 Cal. Rptr. 647 (Cal. Ct. App. 1978).

46 Larsen v. Yelle, 310 Minn. 521, 246 N.W.2d 841 (1976). The physician may not tell an individual of the possibility of transplantation because he or she does not believe that the treatment is indicated for the particular patient. Case law has held that if the physician has a reasonable belief that an existing treatment would not work in a particular patient’s case, the physician need not suggest it. Harrigan v. United States, 408 F. Supp. 177 (E.D. Pa. 1976); Danner v. Vielleux, 322 A.2d 82 (Me. 1974). However, that belief must be reasonable, as indicated by the appropriate medical standard of practice. Therefore, whether or not the physicians’ duty to inform is excused depends upon the reasonableness of the assessment that treatment is not feasible in light of the legally accepted level of medical practice. It is likely that the level of sophistication required in making this determination will increase as transplantation becomes more widely accepted and acknowledged as a viable treatment alternative.

47 Holder, , Physician’s Failure to Obtain Informed Consent to Innovative Practice of Medical Research, 15 P.O.F.2d 711, 725Google Scholar.

48 At the present time approximately 80 percent of all heart transplant recipients will survive one year and 50 percent five years. These survival figures compare well with those for kidney transplant graft survival. See Evans, , Heart Transplants and Priorities, 1 Lancet 852, 852-53 (1984)CrossRefGoogle ScholarPubMed.

49 Holder, supra note 47, at 725.

50 Moreover, the physician may be reluctant to refer a patient to a distant center. Cardiac transplant centers tend to be clustered in metropolitan areas on the two coasts. As a result, residents of large geographical areas currently do not have ready access to a transplant center. However, the large centers typically draw patients from all over the country (and the world). If the physician should reasonably know of the possibility of recommending the patient to a transplant center, then presumably lack of proximity to a center should not be a decisive factor in determining whether the duty to inform exists. The patient’s decision to travel in order to seek treatment would likely be an issue involving personal considerations that fall within the patient’s sphere of decisionmaking.

51 Since the inception of transplantation programs, the shortage of donor organs has limited the number of transplantations that may be performed. The shortage of donor organs has led to a situation in which demand for the procedure outstrips the supply of transplant able organs. Waiting lists for many transplant programs have developed and may continue to grow as transplantation becomes more accepted within the medical community. A physician would undoubtedly argue either that no duty existed because there was no reasonable chance of acceptance into a transplant program, or that there is no causal relationship between the failure to refer and the harm to the patient, since there is no proof that the patient would have been accepted and would have survived surgery.

52 211 N.Y. 125, 105 N.E. 92 (1914).

53 Id. at 129-30, 105 N.E. at 93.

54 See Note, The Evolution of the Doctrine of Informed Consent, 12 Ga. L. Rev. 581, 582-86 (1978)Google Scholar.

55 Id.

56 Salgo v. Leland Stanford Jr., Univ. B. of Trustees, 154 Cal. App. 2d 560, 317 P.2d 170 (1957).

57 Some jurisdictions, however, still treat the cases as arising out of the law of assault and battery. There are two basic standards for determining a breach of duty in informed consent cases. The first standard is commonly known as the “professional standard.” It is based on the notion that the duty of a physician is limited to those disclosures that a reasonable medical practitioner would make under the same or similar circumstances. See, e.g., Karp v. Cooley, 349 F. Supp. 827 (S.D. Tex. 1972), aff'd, 493 F.2d 408 (5th Cir. 1974): Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093 (1960), reh'g denied, 187 Kan. 186, 354 P.2d 670 (1960). The second standard, the “reasonable patient standard,” bases the standard for disclosure on what the average, reasonable patient would want to know, rather than on what the average physician would disclose. See Canterbury v. Spence, 464 F.2d 772, 780-84 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (1972). For a discussion of the two standards, see Rosoff, A. , Informed Consent: A Guide for Health Care Providers (1981)Google Scholar.

58 See Rosoff, supra note 57.

59 Capron, , Informed Consent in Catastrophic Disease Research and Treatment, 123 U. Pa. L Rev. 340, 367-68 (1974)CrossRefGoogle ScholarPubMed.

60 Annas, , Consent to the Anticipated Heart: The Lion and the Crocodiles, 13 Hastings. Center Rep. 20 (1983)Google Scholar.

61 Id.

62 See Holder, supra note 47, at 725.

63 Rosoff, supra note 57, at 43.

64 Id.

65 See, e.g., Holt v. Nelson, 11 Wash. App. 420, 523 P.2d 211 (1974).

66 In general, persons selected as candidates for heart transplantation have a prognosis of survival that is less than 6 months. At Stanford University, the average duration of survival of patients selected for heart transplantation who failed to receive one due to the unavailability of a donor is 45 days. See Baumgartner, , Cardiac Homostrasplantation, 16 Current Problems in Surgery 2 (1974)Google Scholar. A similar figure is reported in the National Heart Transplantation Study based on data derived from six heart transplant programs. See Transplantation Study, supra note 1, at 21-15.

67 464 F.2d 772, 783-84 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (1972).

68 Id. at 794 n.138.

69 Id. at 787 (quoting Walz, & Scheuneman, , Informed Consent in Medical Malpractice, 64 Nw. U. L. Rev. 628, 640 (1970))Google Scholar.

70 464 F.2d at 787.

71 Cobbs v. Grant, 8 Cal. 3d 229, 244, 502 P.2d 1, 11, 104 Cal. Rptr. 505, 515 (1972).

72 If a particular patient is proved to have been aware of certain risks, however, those risks cannot form the basis of a claim of nondisclosure.

73 Immunosuppression is accomplished by infusing the donor’s tissue concurrently or properly timed with immunosuppressive drugs. There are three general groups of immunosuppressive drug regimens:

  • — Antiproliferative, antimetabolic, and autimotic agents that act on cells in their reproductive cycle; examples include azathioprine, methotrexate, cyclophosphamide, and vincristine;

  • — Agents that affect lymphoid tissue. Cyclosporine A is the most promising agent recently introduced; and

  • — Agents with specific immunosuppressive properties.

See generally Floersheim, , Pharmacologic Immunosuppressive Agents, 12 Transplantation Proceedings 315, 315-39 (1980)Google ScholarPubMed; Penn, , Lymphomas Complicating Organ Transplantation, 15 Transplantation Proceedings 2790, 2790-97 (1983)Google Scholar; Penn, , Problems of Cancer in Organ Transplantation, 2 Heart Transplantation 71, 71-77(1982)Google Scholar; Penn, , Tumor Incidence in Human Allograft Recipients, 11 Transplantation Proceedings 1047, 1047-51 (1979)Google ScholarPubMed.

74 In the National Heart Transplantation Study, it was determined that overall living heart transplant recipients (N= 150) experienced an average of 2.03 infectious episodes, deceased patients (N= 256) experienced 2.81 episodes, and all patients combined experienced 2.50 episodes (N. 406) Transplantation Study, supra note 1, at 23-1.

75 There are several varieties of rejection that transplant recipients may experience. They are generally described as: (1) hyperacute, (2) acute, and (3) chronic. See Wood, R., Renal Transplantation: A Clinical Handbook (1983)Google Scholar; see generally Kidney Transplantation: Principles and Practice (P.J. Morris ed. 1979). Ignoring these distinctions, it was deter mined in the National Heart Transplantation Study that the majority of patients experience between 1 and 3 rejection episodes. Living patients experienced an average of 2.46 episodes of rejection while deceased patients experienced 2.26 episodes. See Transplantation Study supra note 1, at 23-8.

76 Sheil, Transplantation and Cancer, cited in P.J. Morris, supra note 75, at 335-50; Rose, supra note 9, at 97. The mechanisms leading to cancer in the recipient include altered immune surveillance and immunoregulation of oncogenic virus, genetic factors, chronic antigenic stimulation, and the neoplastic actions of immunosuppressive drugs.

77 Id.

78 Peters, Reiter, & Boswell, , Transmission of Tuberculosis by Kidney Transplantation, 38 Transplantation 514 (1984)CrossRefGoogle ScholarPubMed.

79 See generally Kauffman, Lawson, Adams, & Sampson, , Post-transplant Hypersplenism, 11 Transplantation Proceedings 96, 96-99 (1979)Google Scholar.

80 Bush, Garovoy, & Tilney, , Variant Forms of Arthritis in Human Allografts, 11 Transplantation Proceedings 100, 100-103 (1979)Google Scholar.

81 See Ruderman, Poehling, Gray, Nardone, Goodman, & Seigler, , Orthopedic Complications of Renal Transplant in Children, 11 Transplantation Proceedings 104 (1979)Google ScholarPubMed.

82 Bricout, Huraux, & Jasmine, , A Virological Study of Interstitial Pneumoniae in Patients with Acute Lymphoid Leukemia Treated with a Combination of Methotrexate and 6—Mercapto Purine, 13 Eur. J. Cancer 479 (1977)CrossRefGoogle ScholarPubMed.

83 Capron, supra note 59, at 372 (use of new drug regimens will also involve FDA approval and Institutional Review Board procedures).

84 Id.

85 Of the patients who participated in the National Heart Transplantation Study, 79.5 percent were described as being employed prior to the transplant procedure. Following transplant, 31.6 percent of the living patients, were employed. Posttransplant, 66.3 percent of the living heart transplant recipients were described as “normal; no complaints; no evidence of disease" by transplant center staff. See Transplantation Study, supra note 1, at 24-9.

86 Obviously, newer programs will have to rely upon information gleaned from other centers. However, it may be more accurate, if enough data have been generated, to use the transplant center-specific information, since centers may vary considerably in their success rates. A problem with this approach, however, is that the figures may not reflect information about the center’s “real" rate of success, because there are no controls for the condition of the patients at the time of the transplant.

87 Legal liability for overstating the odds of successful results could be argued on the basis of breach of contract as well as on informed consent. A physician who “guarantees" results can be sued for breach of contract for failure to produce what was promised. Damages in such cases are not based upon the pain the patient suffers, but instead are based upon the difference in value between the result promised and that actually delivered.

The breach of contract theory is best illustrated by the classic case of Hawkins v. McGee, 84 N.H. 114, 146 A. 641 (1929). In Hawkins, a surgeon promised that he could perform a skin graft to replace scar tissue in a boy’s palm that would leave the boy with a “one hundred percent good hand.” The surgeon took the graft tissue from the boy’s chest. A short time later, of course, the palm began to grow dense, matted hair. The trial court denied any recovery, since the boy had not shown that the surgeon had been negligent or that having hair on one’s palm was any worse than having scar tissue. The appeals court reversed and explained that the proper question was whether the physician had made good on his promise. The measure of damages, the court announced, was the difference in values between the promised “perfect" hand and the hairy one delivered.

The key to Hawkins was the unconditional nature of the promise of good results. In general, however, courts are reluctant to use contract theory in medical treatment cases.

88 In the National Heart Transplantation Study, 66.4 percent of the patients indicated that they received assistance from private insurance in paying for their heart transplant operation. Despite this, however, 40.8 percent of the patients indicated that they had out-of- pocket expenditures. See Transplantation Study, supra note 1, at 28-41.

89 See Rosoff, supra note 57, at 38.

90 See Rosoff, supra note 57, at 53.

91 See, e.g., Karp v. Cooley, 493 F.2d 408, 422 (5th Cir. 1974) (No proof the heart transplantation and mechanical heart recipient would not have consented had the alleged undisclosed material risks been disclosed).

92 Katz, J. & Capron, A. M., Catastrophic Diseases: Who Decides What? 82-90 (1975)Google Scholar.

93 See generally, President’S Commission For The Study of Ethical Problems In Medicine And Biomedical And Behavioral Research, 1 Making Health Care Decisions 17 (1982)Google Scholar.

94 Contact and communication with the patient and the patient’s family can help decrease the incidence of litigation. Gregory, Medical Malpractice Prevention, in C. Wecht, supra note 9, at 182.

95 In almost all cases of malpractice the plaintiff must present expert medical testimony as to the applicable standard of care, and any deviation from that standard that has occurred in treatment of the patient. Where a legitimate, but not yet widely used procedure is involved, it may be difficult to obtain the testimony of an expert in the field because their numbers are small, and the professionals may be unwilling to testify in court. A good example is one of the few reported cases involving heart transplantation and an artificial heart. In Karp v. Cooley, 349 F. Supp. 827 (S.D. Tex. 1972), aff'd, 493 F.2d 408 (5th Cir. 1974), one of the chief obstacles to proving a claim of lack of informed consent to implantation of an artificial heart, and malpractice in the course of treatment, was lack of expert medical testimony at trial. At the time of the suit, Texas law required that the standard for informed consent be established through expert opinion of what a reasonable medical practitioner in a similar community and of the same school of medical thought would have disclosed to the patient regarding the proposed treatment. 493 F.2d at 420.

96 See Baumgartner, supra note 66, at 2.

97 Karp v. Cooley, 349 F. Supp. 827. In 1969, Haskell Karp was referred by his Chicago physicians to a Texas heart surgeon, Dr. Denton Cooley, for treatment of severe cardiac disease. Upon his admission to the Texas hospital, Mr. Karp initially rejected a recommendation by Dr. Cooley that he undergo a heart transplantation. Mr. Karp instead opted for a “wedge procedure" in which tissue from the diseased ventricle is removed so that the remaining tissue can function at its optimal level. The written and witnessed consent to this procedure stated, however, that if death appeared imminent, Mr. Karp’s heart would be removed and a mechanical substitute used until a donor heart became available. The mechanical heart had, at that time, been used only in animal experiments. Dr. Cooley also testified that he obtained verbal consent as well. Although Mrs. Karp also signed the consent form, there was conflicting testimony as to what Cooley told her about her husband’s condition and proposed treatment. Medical testimony established that during the procedure, Mr. Karp’s heart was failing, and therefore Dr. Cooley removed the heart and implanted the first artificial heart to be used in a human in Haskell Karp’s chest. Mr. Karp survived for 64 hours after surgery. During this time, Mrs. Karp and Dr. Cooley made public pleas for a cardiac donor. A donor heart was found, and was implanted, but Karp died on the day after the transplant. The autopsy attributed his death to bronchopneumonia and acute kidney failure. Mrs. Karp later filed suit against Dr. Cooley and his assistant surgeon for damages and wrongful death. She (and her sons) alleged that neither she nor her husband had been told about the number of animals on which the artificial heart had been tested nor the results of those tests, or of the serious risk of injury involved in use of the artificial heart, or that it was experimental. She also contended that Dr. Cooley had failed to tell her husband that another surgeon had said that Mr. Karp was not a good candidate for surgery. She therefore claimed that the consent was fraudulently obtained, that the surgery was negligently performed, and that by fraudulent and deceptive practices Mrs. Karp was used by the defendants to secure a human heart donor.

The trial court gave a directed verdict for the doctors, largely on the basis that Mrs. Karp had not produced expert medical opinion to establish any of her claims. As such, the trial court never faced some of the more complex issues of causation and damages that would have been presented if the plaintiff had obtained sufficient evidence of a standard of care and breach of that standard by the doctors. On appeal, the Fifth Circuit Court of Appeals ruled on alternative grounds that an informed consent claim could not be established because of lack of evidence of any causal connection between lack of informed consent and harm, since there was no evidence that the use of the mechanical heart had caused Mr. Karp’s death, and that Mr. Karp would not have consented had the alleged undisclosed risks been disclosed. 493 F.2d at 422.

98 See, e.g., McDermott v. Manhattan Eye, Ear & Throat Hosp., 26 A.D.2d 519, 270 N.Y.S.2d 955, aff'd without op., 18 N.Y.2d 970, 224 N.E.2d 717, 278 N.Y.S.2d 909 (1966) (plaintiff contended that cornea transplant that later failed was contraindicated; the court held in part that where an unsuccessful operation could produce no worse result than the result that would ensue if nothing were done, an expectation of success even less than that which might be anticipated under favorable circumstances warranted going ahead).

99 See, e.g., McDermott v. Manhattan Eye, Ear & Throat Hosp., 26 A.D. 519, 270 N.Y.S.2d 955 (because there was no evidence cornea transplant surgeon lacked necessary level of skill, a claim of negligent selection against hospital was rejected).

100 Copeland, & Stinson, , Human Heart Transplantation, 4 J. Curr. Probs. in Cardiology 1, 13-15 (1979)CrossRefGoogle ScholarPubMed.

101 See generally, Annot., 20 A.L.R. 4th 136 (1983).

102 Sheil, supra note 76, at 335.

103 But see Helling v. Carey, 83 Wash. 2d 514, 519 P.2d 981 (1974) (standard adopted by the profession itself can be found to be negligent); Harris v. Groth, 99 Wash. 2d 438, 663 P.2d 113 (1983) (health care provider must exercise that degree of care possessed by the reasonably prudent practitioner, not that of the “average practitioner.”).

104 Williamson v. Memorial Hospital, 307 So. 2d 199 (Fla. Dist. Ct. App. 1975) (advisory opinion).

105 Giambozi v. Peters, 127 Conn. 380, 16 A.2d 833 (1940).

106 Warvel v. Michigan Community Blood Center, 74 Mich. App. 440, 253 N.W.2d 791 (1977); Balkowitch v. Minneapolis War Memorial Blood Bank, Inc., 270 Minn. 151, 132 N.W.2d 805(1965).

107 States use various ways in which to define standard of care. Some are “local,” some are statewide, and some are national—in an area like transplantation, many would probably follow recent trends and use a national standard and look to the standard of care exercised by the national transplant community.

108 See Pererya, Toledo-, Organ Harvesting, cited in Basic Concepts in Organ Procurement, Perfusion and Preservation for Transplantation 57, 58 (Toledo-Pererya, L.H. ed. 1982)Google Scholar. It is currently felt that, due to the shortage of organs, donors with primary intercerebral tumors or low grade skin cancers may be accepted since the possibility of metastases from these cancers is remote. Sheil, supra note 76, at 335-350.

109 Toledo-Pereyra, supra note 108, at 57-58.

110 Id. at 57-59.

111 Copeland & Stinson, supra note 100, at 13-15.

112 63 Mich. App. 79, 234 N.W.2d 411 (1975).

113 Id. at 83, 234 N.W.2d at 414.

114 Id.

115 See, e.g., Helling v. Carey, 83 Wash. 2d 514, 519 P.2d 981.

116 Sheil, supra note 76, at 335; Copeland & Stinson, supra note 100, at 40-41.

117 Sheil, supra note 76, at 347.

118 Plaintiffs in several cases involving blood contaminated with serum hepatitus asserted liability based upon an implied warranty. The relevant U.C.C. provisions are § 2-314 (1976)—pertaining to an implied warranty of merchantability (covers fitness for ordinary uses); and § 2-315—dealing with the implied warranty of fitness for particular purposes. The U.C.C. applies directly only to sales of goods not services, and many cases argued on this theory focus on the question of whether providing blood constitutes a “sale.” However, some courts have extended the U.C.C. warranties to provision of services by analogy. Other cases allege strict liability in tort for sale of an unreasonably dangerous product. The Restatement (Second) of Torts (1965), section 402A provides that one who sells any product in a defective condition, unreasonably dangerous to the user or consumer or to his or her property, is liable if (a) the seller is engaged in the business of selling such a product, and (b) the product is expected to, and does, reach the user or consumer without substantial change in the condition in which it was sold. The rule applies even though the seller has exercised all possible care and preparation in the sale of the product, and the user or consumer has not bought the product from, or entered into any contractual relation to the seller.

119 47 Ill. 2d 443, 266 N.E.2d 897 (1970).

120 Id. This decision has since been effectively overturned by statute. See Ill. Ann. Stat. ch. 111.5, § 5102-03 (Smith-Hurd 1971).

121 Hoffman v. Misericordia Hospital, 439 Pa. 501, 267 A.2d 867 (1970). Overturned by statute, Pa. Stat. Ann. tit. 42 § 8333 (Purdon 1982).

122 Belle Bonfils Memorial Blood Bank v. Hansen, 195 Colo. 529, 530, 579 P.2d 1158, 1159(1978). The court noted that hospitals have generally been relieved of liability because a hospital’s sale of blood is incident to providing medical services. The blood bank’s liability was based on the theory that it was selling a product, i.e., blood, and was not supplying medical services.

123 DeBattista v, Argonaut-Southwest Ins. Co., 403 So. 2d 26 (La. 1981).

124 La. Rev. Stat. Ann. tit. 9, § 2797 (West Supp. 1985). Some states that have enacted legislation rejecting strict liability do not cover commercial blood banks. See, e.g., Wash. Rev. Code Ann. 70.54.120 (1985).

125 See, e.g., Shepard v. Alexian Bros. Hosp. Inc., 33 Cal. App. 3d 606, 109 Cal. Rptr. 132 (1973); St. Luke’s Hosp. v. Schnaltz, 188 Colo. 353, 534 P.2d 781 (1975); Fisher v. Sibley Memorial Hosp., 403 A.2d 1130 (App. D.C. 1979); Russell v. Community Blood Bank, Inc., 185 So. 2d 749, cert. denied, 196 So. 2d 115 (Fla. 1966); Lovett v. Emory Univ. Inc., 116 Ga. App. 277, 156 S.E.2d 923 (1967); Glass v. Ingalls Memorial Hosp., 32 Ill. App. 3d 237, 336 N.E.2d 495 (1975); Juneau v. Interstate Blood Bank, Inc., 333 So. 2d 354, cert. denied, 337 So. 2d 220 (La. 1976); Warvel v. Michigan Community Blood Center, 74 Mich. App. 440, 253 N.W.2d 791 (1977); Perlmutter v. Beth David Hosp., 308 N.Y. 100, 123 N.E.2d 792, reh'g denied, 308 N.Y. 812, 125 N.E.2d 869 (1954); St. Martin v. Doty, 493 S.W.2d 95 (Tenn. 1972); Foster v. Memorial Hosp. Ass'n., 219 S.E.2d 916 (W. Va. 1975); Koenig v. Milwaukee Blood Center, Inc., 23 Wis. 2d 324, 127 N.W.2d 50 (1964).

126 308 N.Y. 100, 123 N.E.2d 792 (1954), reh'g denied, 308 N.Y. 812, 125 N.E.2d 869 (1954).

127 Ill. Rev. Stat. ch. 91, § 181 (1977). These types of statutes have survived constitutional challenges under equal protection and special legislation theories. See, e.g., Bingham v. Lutheran Gen. & Decemers Hosps., 34 Ill. App. 3d 562, 340 N.E.2d 220 (1975).

128 Mich. stat. ann § 14.15 (9121) (Callaghan 1981).

129 Of course, difficulties will still be encountered in proving causation and damages.