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Formalities, Good Faith, and Tissue Donation
Medicolegal Issues Formalities, Good Faith, and Tissue Donation FRANCIS HELMINSKI, J.D.
After a patient died in a Veterans Administration hospital, a resident physician asked the next of kin to sign two identical autopsy forms, one of which was stamped "Eye Donor." The family signed, despite orally objecting to donation of tissue. Nevertheless, the patient's eyes were removed because other hospital staff were unaware of the objection. The family sued the hospital and eye bank. The Federal District CASE Mr. L. died in a Veterans Administration (VA) hospital in Minnesota. Afterward, a resident physician met with Mr. L.'s family. The resident asked the widow and an adult daughter to sign two forms for authorization of an autopsy. The forms were identical, except one was stamped "Eye Donor." The women told the resident that they refused to consent to the donation of Mr. L.'s tissue. Nevertheless, they signed the Eye Donor form because the resident described it as a "formality." A staff member who had not heard the family ' s objections contacted an eye bank. The eye bank sent an enucleator to the hospital. The enucleator examined the Eye Donor form and, satisfied that the form was complete, removed the eyes. The patient's family brought a suit against the hospital and eye bank, claiming $150,000 in damages. The grounds were (1) interference with a dead body, (2) intentional infliction of emotional distress, and (3) negligent infliction of emotional distress. The Federal District Court in Minnesota dismissed all claims after a pretrial hearing on the basis of the Uniform Anatomical Gift Act.1 That act, which has been adopted in some variation in every state and the District of Columbia, confers legal immunity if its consent provisions were followed in "good faith." The court fortuitously decided that the defendants acted in good faith in reliance on the Eye Donor form, but failure on the part of hospital staff to note the patient's previous objections to donation and confuFrom the Legal Department, Mayo Clinic Rochester, Rochester, Minnesota. This article is not intended to be legal advice. Readers should consult individual counsel for recommendations associated with any issues discussed. Address reprint requests to Mr. Francis Helminski, Legal Department, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905. Mayo Clin Proc 1994; 69:985-986
Court in Minnesota dismissed the case before trial on the basis that both defendants were immune from liability because of the Uniform Anatomical Gift Act. Clear policies communicated to staff and separate autopsy and donation forms can help to avoid confusion and legal difficulties. (Mayo Clin Proc 1994; 69:985-986) sion surrounding institutional consent procedures could have resulted in the opposite decision and a finding of liability at trial. DISCUSSION Donation of tissue for transplantation is governed by state law. In order to regulate consent for such donations, all states and the District of Columbia have adopted some version of the Uniform Anatomical Gift Act. All versions provide that personnel who act in good faith in procuring consent will not be liable in a lawsuit.2 The Anatomical Gift Act does not define good faith. Because no previous Minnesota cases had discussed good faith in this context, the Minnesota court looked elsewhere for precedents, finding two in New York and Tennessee. In the New York case,3 a man claimed that his son's eyes had been wrongfully removed. A woman had falsely told the hospital that she was the son's wife, and then she signed donation forms. The New York court decided that the eye bank and hospital were entitled to dismissal of the lawsuit based on their good faith. The court defined good faith as "honest belief, me absence of malice and the absence of design to defraud or to seek an unconscionable advantage."3 The court decided that justifiable reliance on what seems to be a valid donation form is acting in good faith. The same reasoning was adopted in me Tennessee case,4 in which an apparently valid form signed by a person claiming to be the donor's adult grandson was sufficient protection from liability. On the basis of those cases, the Minnesota court decided that the local eye bank was entitled to legal immunity. The enucleator examined what seemed to be a valid autopsydonation form stamped Eye Donor, which was signed by the family. The enucleator did not learn of any objections
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to the donation until after he had removed the patient's eyes. The court thought that the question of good faith immunity for the VA hospital was more complex. The plaintiffs tried to overcome the good faith defense of the hospital by claiming that the hospital had direct knowledge that the patient himself did not want to donate any organs. Periodically during his 2-month hospitalization, Mr. L. was asked by hospital staff whether he wished to be an organ donor. He consistently refused. On the basis of those answers, the plaintiffs argued, the VA hospital should have known that the patient did not want to donate his organs. Hospital staff, however, made no notes in the patient's record of his negative responses to donation requests. Such notations are unnecessary in the Minnesota version of the Anatomical Gift Act,2 although they are necessary in versions adopted in many other states.1 The court refused to interpret an absence of notations as a lack of good faith. The court pointed out that the resident who obtained the signatures, although confused about the procedure, also acted in good faith. He thought he was complying with hospital formalities by having the Eye Donor form signed as part of the autopsy consent process. Finally, all other employees of the hospital who saw the Eye Donor form relied on it in equal good faith. In summary, the court pointed out that the Uniform Anatomical Gift Act is designed to balance two competing policy interests. There is the need for donations of eyes and other organs for transplantation and research purposes. Time is usually of the essence in securing donated organs at the time of the donor's death. The Act allows hospitals and physicians to ascertain with a high degree of certainty when someone is willing to donate organs, and to arrange for the prompt removal and preservation of donated organs. The Act also recognizes the religious and moral sensibilities of those who
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do not wish to donate organs. The Act does not compel organ donations nor does it establish a presumption that organs will be donated. The good faith exception to civil and criminal liability is designed for situations such as the one before the court, where because of confusion, an organ is removed without genuine consent.1
CONCLUSION This case illustrates the potential difficulties of failure to note objections to donation. The VA hospital staff failed to note in the patient's chart his several refusals to consent to donation. In this case, that failure in itself showed no absence of good faith, but the court could well have decided that such poor documentation would preclude immunity for the VA hospital. Moreover, the actions of the resident in having the family sign a form clearly intended to authorize donation, when family members had communicated to him their objection to donation, were the source of confusion and could also have resulted in liability. Clear internal policies are necessary for the donation consent process. Such policies must be communicated to personnel responsible for obtaining consent or noting lack of consent. Wholly separate, well-labeled forms for autopsy and for donation can avoid confusion. The shortage of organs for donation is acute. Every instance of family members viewing themselves victimized by a hospital "hungry for tissue" reinforces always-present public suspicion of the donation process. REFERENCES 1. Lyon v United States, 843 F Supp 531 (D Minn 1994) 2. Minn Stats 525.9221(c) 3. Nicoletta v Rochester Eye and Human Parts Bank, Ine, 519 NYS2d 928 (Sup Ct 1987) 4. Hinze v Baptist Memorial Hospital, 1990 WL 121138 (Tenn App 1990)
After a patient died in a Veterans Administration hospital, a resident physician asked the next of kin to sign two identical autopsy forms, one of which was stamped "Eye Donor." The family signed, despite orally objecting to donation of tissue. Nevertheless, the patient's eyes were removed because other hospital staff were unaware of the objection. The family sued the hospital and eye bank. The Federal District CASE Mr. L. died in a Veterans Administration (VA) hospital in Minnesota. Afterward, a resident physician met with Mr. L.'s family. The resident asked the widow and an adult daughter to sign two forms for authorization of an autopsy. The forms were identical, except one was stamped "Eye Donor." The women told the resident that they refused to consent to the donation of Mr. L.'s tissue. Nevertheless, they signed the Eye Donor form because the resident described it as a "formality." A staff member who had not heard the family ' s objections contacted an eye bank. The eye bank sent an enucleator to the hospital. The enucleator examined the Eye Donor form and, satisfied that the form was complete, removed the eyes. The patient's family brought a suit against the hospital and eye bank, claiming $150,000 in damages. The grounds were (1) interference with a dead body, (2) intentional infliction of emotional distress, and (3) negligent infliction of emotional distress. The Federal District Court in Minnesota dismissed all claims after a pretrial hearing on the basis of the Uniform Anatomical Gift Act.1 That act, which has been adopted in some variation in every state and the District of Columbia, confers legal immunity if its consent provisions were followed in "good faith." The court fortuitously decided that the defendants acted in good faith in reliance on the Eye Donor form, but failure on the part of hospital staff to note the patient's previous objections to donation and confuFrom the Legal Department, Mayo Clinic Rochester, Rochester, Minnesota. This article is not intended to be legal advice. Readers should consult individual counsel for recommendations associated with any issues discussed. Address reprint requests to Mr. Francis Helminski, Legal Department, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905. Mayo Clin Proc 1994; 69:985-986
Court in Minnesota dismissed the case before trial on the basis that both defendants were immune from liability because of the Uniform Anatomical Gift Act. Clear policies communicated to staff and separate autopsy and donation forms can help to avoid confusion and legal difficulties. (Mayo Clin Proc 1994; 69:985-986) sion surrounding institutional consent procedures could have resulted in the opposite decision and a finding of liability at trial. DISCUSSION Donation of tissue for transplantation is governed by state law. In order to regulate consent for such donations, all states and the District of Columbia have adopted some version of the Uniform Anatomical Gift Act. All versions provide that personnel who act in good faith in procuring consent will not be liable in a lawsuit.2 The Anatomical Gift Act does not define good faith. Because no previous Minnesota cases had discussed good faith in this context, the Minnesota court looked elsewhere for precedents, finding two in New York and Tennessee. In the New York case,3 a man claimed that his son's eyes had been wrongfully removed. A woman had falsely told the hospital that she was the son's wife, and then she signed donation forms. The New York court decided that the eye bank and hospital were entitled to dismissal of the lawsuit based on their good faith. The court defined good faith as "honest belief, me absence of malice and the absence of design to defraud or to seek an unconscionable advantage."3 The court decided that justifiable reliance on what seems to be a valid donation form is acting in good faith. The same reasoning was adopted in me Tennessee case,4 in which an apparently valid form signed by a person claiming to be the donor's adult grandson was sufficient protection from liability. On the basis of those cases, the Minnesota court decided that the local eye bank was entitled to legal immunity. The enucleator examined what seemed to be a valid autopsydonation form stamped Eye Donor, which was signed by the family. The enucleator did not learn of any objections
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to the donation until after he had removed the patient's eyes. The court thought that the question of good faith immunity for the VA hospital was more complex. The plaintiffs tried to overcome the good faith defense of the hospital by claiming that the hospital had direct knowledge that the patient himself did not want to donate any organs. Periodically during his 2-month hospitalization, Mr. L. was asked by hospital staff whether he wished to be an organ donor. He consistently refused. On the basis of those answers, the plaintiffs argued, the VA hospital should have known that the patient did not want to donate his organs. Hospital staff, however, made no notes in the patient's record of his negative responses to donation requests. Such notations are unnecessary in the Minnesota version of the Anatomical Gift Act,2 although they are necessary in versions adopted in many other states.1 The court refused to interpret an absence of notations as a lack of good faith. The court pointed out that the resident who obtained the signatures, although confused about the procedure, also acted in good faith. He thought he was complying with hospital formalities by having the Eye Donor form signed as part of the autopsy consent process. Finally, all other employees of the hospital who saw the Eye Donor form relied on it in equal good faith. In summary, the court pointed out that the Uniform Anatomical Gift Act is designed to balance two competing policy interests. There is the need for donations of eyes and other organs for transplantation and research purposes. Time is usually of the essence in securing donated organs at the time of the donor's death. The Act allows hospitals and physicians to ascertain with a high degree of certainty when someone is willing to donate organs, and to arrange for the prompt removal and preservation of donated organs. The Act also recognizes the religious and moral sensibilities of those who
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do not wish to donate organs. The Act does not compel organ donations nor does it establish a presumption that organs will be donated. The good faith exception to civil and criminal liability is designed for situations such as the one before the court, where because of confusion, an organ is removed without genuine consent.1
CONCLUSION This case illustrates the potential difficulties of failure to note objections to donation. The VA hospital staff failed to note in the patient's chart his several refusals to consent to donation. In this case, that failure in itself showed no absence of good faith, but the court could well have decided that such poor documentation would preclude immunity for the VA hospital. Moreover, the actions of the resident in having the family sign a form clearly intended to authorize donation, when family members had communicated to him their objection to donation, were the source of confusion and could also have resulted in liability. Clear internal policies are necessary for the donation consent process. Such policies must be communicated to personnel responsible for obtaining consent or noting lack of consent. Wholly separate, well-labeled forms for autopsy and for donation can avoid confusion. The shortage of organs for donation is acute. Every instance of family members viewing themselves victimized by a hospital "hungry for tissue" reinforces always-present public suspicion of the donation process. REFERENCES 1. Lyon v United States, 843 F Supp 531 (D Minn 1994) 2. Minn Stats 525.9221(c) 3. Nicoletta v Rochester Eye and Human Parts Bank, Ine, 519 NYS2d 928 (Sup Ct 1987) 4. Hinze v Baptist Memorial Hospital, 1990 WL 121138 (Tenn App 1990)