Everything You Always Wanted to Ask a Lawyer about Ethics Committees Panelists: MORTON COHEN JAY HARTZ
Schwartz (as moderator): It should come as no surprise that we will get three different answers to the same question since we have three lawyers on the panel. The law is a matter of policy, and there is usually no single "right" answer to these questions. Each lawyer will come to a question from a very different perspective and bring a different approach to the answer. The first question from the audience is: "Can ethics committees he held legally liable if they do not make any mandating decisions?"
Hartz: I think it is unlikely that ethics committees are going to be liable under most circumstances. Ethics committees operate most frequently in making recommendations. I don't believe there is going to be any great exposure to liability on behalf of committees. There was one lawsuit filed in Los Angeles which named committee members in the Bouvia case. That case, as I understand it, has essentially been dropped. The notion that the ethics committee members had essentially made the decision was based on testimony of the attending physician, who said, "It wasn't my decision, I just listened to them." He sort of passed the buck to the committee. That's the only one I'm aware of in which a lawsuit has been filed.
ROBERT SCHWARTZ ROBYN SHAPIRO
Shapiro: I would agree that it would be highly unlikely, but I do not think it is impossible. A committee could be part of the information which was used by the attending physicians to come to a certain decision on patient care. For that reason, I think that perhaps, if there was gross negligence in the process, a committee and/or its members may be exposed to liability. This is not to get anyone unnecessarily fearful, because I think it will take gross negligence, such as a total inability, unwillingness, or failure to ensure that certain basic procedures were comprehensive and fair or that input was received from all the relevant members of the ethics committee and deliberations were carried out thoughtfully and conscientiously. Cohen: In order to prove Bob Schwartz's point about diversity of opinion among lawyers, I believe that liability is quite possible, and it will depend, of course, upon the circumstances, the methodology, or the particular ethics committee; that is, whether in fact there was reliance and to what extent there was reliance on the committee, thereby involving the committee directly in the decision making. There are all kinds of ways to avoid that from occurring, but much will have to do with the manner in which the committee is
From a panel presentation at the first Annual Congress of Healthcare Ethics Committees, San Francisco, California, April 1991. Cambridge Quarterly of Healthcare Ethics (1992), 1, 33-39. Printed in the USA. Copyright © 1992 Cambridge University Press 0963-1801/92 $5.00 + .00
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Panel Presentation
created and with the process used in decision making. Developing model decision-making procedures is what committees should be doing. It just seems to me that if there is sufficient reliance and sufficient decision making by the ethics committee, the committee might be liable, and paying attention to the processes used for making decisions will be proven to be prudent measures. Schwartz: Let me go further and suggest what you can do about this and about the litigation phobia which so often strikes medical institutions. It is an incredible waste of energy for people on ethics committees to be worried about whether they are liable. If, in fact, this is a concern, you might want to contact your hospital counsel and get a letter that says the hospital will indemnify you, protect you, provide you legal services if you are sued for your work on the committee. A letter with such protection should put your mind at ease and allow you to move on to substantive issues.
There are other practical problems concerning the documentation of case consultation in the records, such as "Who is going to do it?" or "After what review?" and "With what consensus by the other committee members?" If any one person on the committee writes what happened, you are unlikely to get 100% agreement from the other committee members about what happened. Additionally, if the committee chair, for example, writes in the chart, the committee is then, in practical terms, a decision maker and not an advice giver. We address this problem by inviting the attending physician to attend the case consultation meeting and then he or she can write in the patient's chart whatever was found to be valuable from the case consultation. The committee keeps its own minutes, recorded by a secretary, about what the nature of the conversation was in the ethics committee. I think that if push came to shove those minutes would be discoverable and that the committee members would be There are several questions from the audi- subject to subpoena; but in terms of writing ence involving records: "We have been gettingin the charts, we do not do it. different opinions regarding whether or not to Hartz: I've seen other practices in which the document our ethics consultations in the pa- chair writes something in the record, saying tient's medical record. Would you comment on le- there was a consultation of such and such gal problems with such documentation?" a date, the following people were in attenShapiro: With respect to charting committee dance and a recommendation was prodeliberations, let me share my experience vided. I've seen a third model in a neonatal about what we do on the eight ethics com- committee, in which there is a fairly lengthy mittees on which I serve in Wisconsin. In and elaborate note written directly into the Wisconsin, there is a state statute that pro- patient's medical record by the committee vides certain protection to hospital commit- chair that lays out basically what happened, tees doing peer review. It is my notion that i.e., who was there and what the recommost of what the ethics committee does is mendation was. not peer review, so that categorizing a comNow my sense is that if you look at the mittee one way as opposed to another (that situation from the perspective of a possible is, "medical staff" rather than "administra- lawsuit —you have somebody unhappy tive" or filing the records in one way or an- with what happened and they later want to other) is not going to make a difference in attack the decision —if there is no reference terms of whether or not these records are whatsoever in the medical record to an discoverable. ethics committee consultation, won't that 34
Ask a Lawyer about Ethics Committees
appear a little strange? If everything else in the course of treating the patient and consulting about the patient is documented in the medical record, but here is this big secret that happened, how much credibility does that give the committee in the process of consulting about this patient? My personal view is that it would be appropriate to make some record in the medical record of this having occurred. With regard to the question, "Who should write it?" I think it could be the attending physician. I think it could also be the chair of the ethics committee. I don't have a strong feeling that it makes an enormous difference on that point one way or the other. I think in the end, if there is an unhappy plaintiff who is going to pursue litigation, it is going to come out essentially the same; that is, they are going to want to try to pursue discovery of the people on the ethics committee and then that would play out under the respective state law. Shapiro: What if the attending physician knew at the end of the meeting that he or she was not going to follow the advice of the ethics committee and specifically said, "I don't want anything written in the chart about this"? Hartz: That's an interesting question, but it seems to me that if the posture the attending physician takes is, "Thank you very much for your recommendation, but I am going to do something different," then I believe there is a strong need for him or her to document carefully in the chart why the decision was made and how their rationale differs from that raised by the committee. Now, if I were a physician who took that position, I would not particularly want that reflected in the chart. However, I think that if the attending physician seeks a consultation with the ethics committee in the same way he or she seeks a consultation about a specific medical problem (the physician ulti-
mately has to make a decision about whether or not to consult the committee), it should be documented, and the physician should proceed with what he or she is doing. So, on balance, I still would tend to think that it is appropriate to have some documentation of the consultation. Again, I think it really questions the integrity of the ethics committee to be an invisible resource that is not documented anywhere. Schwartz: And of course, the model of ethics committees coming to conclusions and deciding what the appropriate course of treatment should be is not the most common model. I suspect the more usual model is one of committee discussion of all the issues. There are many hospitals that do indicate in the chart that the ethics committee was convened and discussed the case; and that is all that is put in the chart. Cohen: I agree with Jay generally and have told people that they ought to chart this rather than not because it looks too evasive to have failed to chart it when you are subsequently doing a deposition or something of that nature. Schwartz: Next question, "What should an ethics committee do when the hospital attorney has no background or knowledge of medical ethics?"
Hartz: One of the things that you see over and over again is that most lawyers do not know very much about bioethics. This is not very surprising if you look at what most lawyers do on a day-to-day basis; medical ethics is a very small and esoteric piece of it. So, to say that the hospital lawyer might not be very well versed in bioethics is not surprising in many cases. What needs to be done about it? It seems to me several possible approaches are available. One way is to try and ensure that the attorney gets some education on the issues so that he or she will be sensitive and aware 35
Panel Presentation
of them. Another approach is to find some other attorney who has some interest and knowledge in these issues and involve that attorney either on the ethics committee or in some other way as an interface between the committee and the regular hospital attorney. Sometimes I think this can be done by a committee requesting an attorney with some specialized expertise to participate as a special advisor to the committee. You need, of course, to deal with the "local politics" of the situation so that the main hospital lawyer doesn't feel attacked or that his or her business is about to run away, but those things can be done. Cohen: Another consideration is whether the attorney is a member of the committee or is merely an advisor to it with regard to what the hospital is willing or unwilling to do. So, that's the threshold that needs to be addressed, "Is the hospital attorney generally going to be a member of the ethics committee itself?" Jay, in your experience, when the attorney is a member of the ethics committee, is the result that the committee then turns to the attorney and says, "Well, we know what is ethical, but what is legal?" Hartz: I have had that experience in all cases where there has been a lawyer on the ethics committee; that is, what tends to happen a lot is that everybody looks to one end of the table where the lawyer sits and asks, "What is the answer?" or "Is that legal?" and the lawyer says, "Yes, it's legal, it's fine," or "No, it isn't." That, in some cases, will end the discussion. One of the things that is important is for the lawyer to know the limits of what the lawyer's role is, which is not to try to direct or push the discussion one way or another through sort of a recitation of legal fears but rather to just assure that the decision making is not so far out in the perimeter of what the legal limits are that there will be problems and to also participate as any other committee member 36
would. But, I have not seen a big difference in outcome based upon whether or not the lawyer is the hospital attorney. Schwartz: In fact, given what you've said about "outcome" and about the role of lawyers, you would have a pretty powerful argument that lawyers are not particularly useful on hospital ethics committees. This would not be true of Institutional Review Boards; lawyers may have a great deal of value. Of course, committee members may want legal advice, but getting professional advice from your counsel is a lot different than having the lawyer present and actively participating in committee deliberations. Shapiro: I think there is a huge missing piece as to how all these questions pan out —and that is, "What is the role of the committee?" If the role of the committee is to be patient advocate, then it may be very inappropriate for a number of reasons to have in-house counsel sitting on the committee. On the other hand, if the role of the committee is to protect the institution, then it may be very appropriate for the in-house counsel to be on the committee. And, I do not know that our ethics committees have done a very good job of clarifying their roles —which has to be done first. Schwartz: There are a number of questions dealing with legal terms and concepts, the first is, "What is the legal essence of decisional capacity?"
Shapiro: We have a very new healthcare statute in Wisconsin which defines "incapacity" for purposes of medical treatment decision making, and I think it does a pretty good job of it. I am not saying that this applies everywhere, but basically the statute says that a person is incapacitated if the answer to the following three questions is "No": "Can this person (a) receive the relevant material information about the proposed treatment, (b) process that information in
Ask a Lawyer about Ethics Committees
accordance with his or her own value system, and then (c) make and communicate a choice?" If the answer is "Yes" to all those, then the person has capacity. Cohen: The legal essence of decision-making capacity depends a great deal upon the decision for which capacity is at risk. For example, there is a considerable difference between the decision to waive right to counsel in the case of the person who has been indicted for fraud versus the decision to discontinue treatment. Decision-making capacity will also have something to do with the way in which the treatment is being afforded. If you are about to force treatment on a nonconsenting mentally ill individual, it may be that the courts will require, particularly if the treatment is highly intrusive, a far higher threshold of decision-making in capacity than if you are dealing with a situation in which the individual is passive and the form of treatment is considerably less intrusive. So, there are ranges which are used in different situations, and you have to be considerate of those distinctions, i.e., the form of the intrusion and the protection of the individual as the courts see it. Schwartz: The medical literature is quite interesting on decisional capacity. It says, "This is a legal concept; it is not within the expertise of medicine." If you read the reported law cases they say, "We rely and look to the testimony of doctors." It is one of those rare areas neither law nor medicine has been particularly anxious to claim. Each is only willing and eager to hand it off to the other. Cohen: It seems that in some places the courts want to depend on the doctors while retaining the right to make the final decision; that is, they are saying, "You folks come up and testify before us and we will tell you who has, or who lacks, capacity." There is a California case involving forcible
treatment of a mentally ill individual saying, "This is a legal determination, just as insanity is, but to make that determination we will have to listen to the doctors who will tell us what to do." Schwartz: Next question, "Would you please share some legal insights into medical futility and the treatment/nontreatment decisions based on that determination?"
Hartz: That is difficult to answer in terms of anything that I am aware of that the courts have said. In terms of medical futility, we have to assume a spectrum of possibilities. At the far extreme end of that spectrum is the circumstance where a patient asks for a treatment that has absolutely no relevance to the problem —they want chemotherapy for a headache and you are supposed to do that because they want it. I do not think you would have any difficulty in saying, "Sorry, we are not going to do that." Moving further down that spectrum you get closer to a situation where the treatment does have some effect or does do something to continue the patient's comfort or existence, in the context of a continued use of a respirator for example, and I am not aware of any court decisions that have said it is permissible to discontinue because the physician does not think that it is worth proceeding. We are going to have to face this question, but the context of the decision is actually made somewhat more difficult by the approach that the courts have taken so far in decision making in this area, which tends to focus on "What does the patient want?" Now all of a sudden, some people are saying, "We don't care anymore what the patient wants, we want to make a decision because we think that the patient or the patient's representative is being unreasonable in their wants and demands." I think that is a conceptual leap the courts are going to have to deal with. 37
Panel Presentation
Cohen: There is some material out there in some of the cases; for example, there was a case in which the court looked at a situation where a person in an institution who was voluntarily institutionalized said, "No, I do not want the treatment that you are giving me." It's the other side of the futility situation, I think, and what the courts said in that case was, "Well, the doctor does not have the responsibility to give the patient something which the patient does not want." Now the assumption here is that the patient has capacity to make decisions, but I would assume in a surrogate decision-making situation the same process occurs, but I am extrapolating here. I am not sure this is the way other cases will go, but I do not see the courts telling physicians, "This is what you have to do" against physicians' wishes. Shapiro: In looking for guidelines in this area of futility, we would be somewhat remiss in this discussion not to mention the Baby Doe laws as they apply to physicians and parents making decisions. The definition of futility for the care of very ill infants says basically that futility is when the infant is irreversibly comatose, or the survival of the infant is virtually futile and the treatment under the circumstances would be inhumane (however that should be defined). Schwartz: From the audience another ques-
is not taking a blood sample and testing the blood, I would think in California that you probably would be able to do it. It is not like for HIV, where there is a particular statute which says that you cannot, and I would tend to think that perhaps it could be done without formal process here. Cohen: I do not know of a statute on this in California, though I think in terms of some of the law out there in regard to various public situations around the country there has been at least a court order for a consistent statute saying that you can bypass parental consent in certain circumstances. Schwartz: Where it is therapeutically necessary to provide adequate treatment for the child, if the immediate test is necessary, it would be hard to imagine that it would not be permitted. Shapiro: I think that is a real unanswered medical question in and of itself. That is why I've asked neurologists what they really need to test for, and I've not heard what I would consider sound answers. Schwartz: And finally, "What legal issues do you perceive arising out of the new Patient SelfDetermination Act in the course of its initial period of implementation?"
Hartz: Basically, the act says that you have to give notice and information; I would not see that as being a particularly litigious istion, "Can we test a newborn infant for drugs sue, or one that is likely to generate a lot of without parental consent or knowledge?" problems. There are two main issues that Shapiro: Not in Wisconsin. We have a new seem to me to arise: "How much informastatue which allows for testing of infants tion do you have to give, and what format with the mother's consent; and then, if there is it going to be in?" And, I assume and is a positive result, there are all sorts of im- hope that groups within each state and each plications in terms of going to Child Protec- area will help develop common documentation Services. But, the consent has to come tion that everyone can use and look to, unless from a parent; although at this point it is the institution is so unique in the patients not widely followed. with whom it deals and therefore some other type of procedure seems appropriate. Hartz: In California, I am not aware of any similar statute. My thinking would be that Secondly, "What institutions or entities are the testing could be done, assuming that it obligated to provide the information?" My 38
Ask a Lawyer about Ethics Committees
sense is I do not think it is going to be a hotly litigated area or one about which there will be great problems. I have the sense that the federal regulators are not going to be particularly picky about exactly how many apostrophes you have in the third sentence of the form that you put together, and I would frankly be surprised if there was much that came out of this by way of enforcement. I think that the power of the law is not an enforcement problem, it is really an invitation and requirement to put out some information. If there are problems that arise from that, they are going to be problems from patients knowing more about what their rights are and demanding them. But that is not going to be a piece of litigation arising under the statute, it is going to be based on the patient's rights to refuse. Schwartz: No one is suggesting that it will give rise to many legal problems. The enforcement mechanism is cutting off Medicare and Medicaid funds and that is not discretionary. If a covered institution does not comply, the government must cut off funding, and that is a really substantial threat. On the other hand, all that a covered institution must do to comply is file a statement saying it is complying. On the other hand, to the extent that there are ambiguities in the requirements of the Act, you can reasonably expect the government to accept the certificates as long as there is a good faith effort. Cohen: I had initially thought that there is not likely to be too much in the way of litigation around this Act, and I have not seen anything to suggest otherwise, but now I am wondering whether there might be
problems with regard to interpreting it. Specifically, will there be conflicts around what is sufficient in order to obtain informed consent? Hartz: The essence of the Act is just to "give information/' as distinguished from "ensure that informed consent takes place/' so certainly to the extent that you raise expectations of patients about abilities to make decisions for themselves, you possibly increase the likelihood that issues of informed consent and the like are going to raise themselves more frequently. But under the statute itself, I do not see that it is going to generate dispute of great magnitude. Schwartz: Hospitals and others covered by the Act will have to have a written statement of the state law on terminating treatment, which must include statute law and judge-made law, and also a written account of the institution's policy that will carry that law into effect. The Act will generate a lot of policy making, and we will certainly be fortunate if much of that policy is made in consultation with, or maybe even by, the ethics committees. There is a fabulous opportunity for healthcare institutions to actively use the Patient Self-Determination Act to do something valuable. I hope that healthcare institutions will be asking, "How can we really serve the purpose of this legislation?" If that question is answered honestly, the chances of any kind of liability or any kind of sanctions are virtually zero. Ultimately, good ethics and good medicine make law, as I hope that the debate over the Patient SelfDetermination Act will show.
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Schwartz (as moderator): It should come as no surprise that we will get three different answers to the same question since we have three lawyers on the panel. The law is a matter of policy, and there is usually no single "right" answer to these questions. Each lawyer will come to a question from a very different perspective and bring a different approach to the answer. The first question from the audience is: "Can ethics committees he held legally liable if they do not make any mandating decisions?"
Hartz: I think it is unlikely that ethics committees are going to be liable under most circumstances. Ethics committees operate most frequently in making recommendations. I don't believe there is going to be any great exposure to liability on behalf of committees. There was one lawsuit filed in Los Angeles which named committee members in the Bouvia case. That case, as I understand it, has essentially been dropped. The notion that the ethics committee members had essentially made the decision was based on testimony of the attending physician, who said, "It wasn't my decision, I just listened to them." He sort of passed the buck to the committee. That's the only one I'm aware of in which a lawsuit has been filed.
ROBERT SCHWARTZ ROBYN SHAPIRO
Shapiro: I would agree that it would be highly unlikely, but I do not think it is impossible. A committee could be part of the information which was used by the attending physicians to come to a certain decision on patient care. For that reason, I think that perhaps, if there was gross negligence in the process, a committee and/or its members may be exposed to liability. This is not to get anyone unnecessarily fearful, because I think it will take gross negligence, such as a total inability, unwillingness, or failure to ensure that certain basic procedures were comprehensive and fair or that input was received from all the relevant members of the ethics committee and deliberations were carried out thoughtfully and conscientiously. Cohen: In order to prove Bob Schwartz's point about diversity of opinion among lawyers, I believe that liability is quite possible, and it will depend, of course, upon the circumstances, the methodology, or the particular ethics committee; that is, whether in fact there was reliance and to what extent there was reliance on the committee, thereby involving the committee directly in the decision making. There are all kinds of ways to avoid that from occurring, but much will have to do with the manner in which the committee is
From a panel presentation at the first Annual Congress of Healthcare Ethics Committees, San Francisco, California, April 1991. Cambridge Quarterly of Healthcare Ethics (1992), 1, 33-39. Printed in the USA. Copyright © 1992 Cambridge University Press 0963-1801/92 $5.00 + .00
33
Panel Presentation
created and with the process used in decision making. Developing model decision-making procedures is what committees should be doing. It just seems to me that if there is sufficient reliance and sufficient decision making by the ethics committee, the committee might be liable, and paying attention to the processes used for making decisions will be proven to be prudent measures. Schwartz: Let me go further and suggest what you can do about this and about the litigation phobia which so often strikes medical institutions. It is an incredible waste of energy for people on ethics committees to be worried about whether they are liable. If, in fact, this is a concern, you might want to contact your hospital counsel and get a letter that says the hospital will indemnify you, protect you, provide you legal services if you are sued for your work on the committee. A letter with such protection should put your mind at ease and allow you to move on to substantive issues.
There are other practical problems concerning the documentation of case consultation in the records, such as "Who is going to do it?" or "After what review?" and "With what consensus by the other committee members?" If any one person on the committee writes what happened, you are unlikely to get 100% agreement from the other committee members about what happened. Additionally, if the committee chair, for example, writes in the chart, the committee is then, in practical terms, a decision maker and not an advice giver. We address this problem by inviting the attending physician to attend the case consultation meeting and then he or she can write in the patient's chart whatever was found to be valuable from the case consultation. The committee keeps its own minutes, recorded by a secretary, about what the nature of the conversation was in the ethics committee. I think that if push came to shove those minutes would be discoverable and that the committee members would be There are several questions from the audi- subject to subpoena; but in terms of writing ence involving records: "We have been gettingin the charts, we do not do it. different opinions regarding whether or not to Hartz: I've seen other practices in which the document our ethics consultations in the pa- chair writes something in the record, saying tient's medical record. Would you comment on le- there was a consultation of such and such gal problems with such documentation?" a date, the following people were in attenShapiro: With respect to charting committee dance and a recommendation was prodeliberations, let me share my experience vided. I've seen a third model in a neonatal about what we do on the eight ethics com- committee, in which there is a fairly lengthy mittees on which I serve in Wisconsin. In and elaborate note written directly into the Wisconsin, there is a state statute that pro- patient's medical record by the committee vides certain protection to hospital commit- chair that lays out basically what happened, tees doing peer review. It is my notion that i.e., who was there and what the recommost of what the ethics committee does is mendation was. not peer review, so that categorizing a comNow my sense is that if you look at the mittee one way as opposed to another (that situation from the perspective of a possible is, "medical staff" rather than "administra- lawsuit —you have somebody unhappy tive" or filing the records in one way or an- with what happened and they later want to other) is not going to make a difference in attack the decision —if there is no reference terms of whether or not these records are whatsoever in the medical record to an discoverable. ethics committee consultation, won't that 34
Ask a Lawyer about Ethics Committees
appear a little strange? If everything else in the course of treating the patient and consulting about the patient is documented in the medical record, but here is this big secret that happened, how much credibility does that give the committee in the process of consulting about this patient? My personal view is that it would be appropriate to make some record in the medical record of this having occurred. With regard to the question, "Who should write it?" I think it could be the attending physician. I think it could also be the chair of the ethics committee. I don't have a strong feeling that it makes an enormous difference on that point one way or the other. I think in the end, if there is an unhappy plaintiff who is going to pursue litigation, it is going to come out essentially the same; that is, they are going to want to try to pursue discovery of the people on the ethics committee and then that would play out under the respective state law. Shapiro: What if the attending physician knew at the end of the meeting that he or she was not going to follow the advice of the ethics committee and specifically said, "I don't want anything written in the chart about this"? Hartz: That's an interesting question, but it seems to me that if the posture the attending physician takes is, "Thank you very much for your recommendation, but I am going to do something different," then I believe there is a strong need for him or her to document carefully in the chart why the decision was made and how their rationale differs from that raised by the committee. Now, if I were a physician who took that position, I would not particularly want that reflected in the chart. However, I think that if the attending physician seeks a consultation with the ethics committee in the same way he or she seeks a consultation about a specific medical problem (the physician ulti-
mately has to make a decision about whether or not to consult the committee), it should be documented, and the physician should proceed with what he or she is doing. So, on balance, I still would tend to think that it is appropriate to have some documentation of the consultation. Again, I think it really questions the integrity of the ethics committee to be an invisible resource that is not documented anywhere. Schwartz: And of course, the model of ethics committees coming to conclusions and deciding what the appropriate course of treatment should be is not the most common model. I suspect the more usual model is one of committee discussion of all the issues. There are many hospitals that do indicate in the chart that the ethics committee was convened and discussed the case; and that is all that is put in the chart. Cohen: I agree with Jay generally and have told people that they ought to chart this rather than not because it looks too evasive to have failed to chart it when you are subsequently doing a deposition or something of that nature. Schwartz: Next question, "What should an ethics committee do when the hospital attorney has no background or knowledge of medical ethics?"
Hartz: One of the things that you see over and over again is that most lawyers do not know very much about bioethics. This is not very surprising if you look at what most lawyers do on a day-to-day basis; medical ethics is a very small and esoteric piece of it. So, to say that the hospital lawyer might not be very well versed in bioethics is not surprising in many cases. What needs to be done about it? It seems to me several possible approaches are available. One way is to try and ensure that the attorney gets some education on the issues so that he or she will be sensitive and aware 35
Panel Presentation
of them. Another approach is to find some other attorney who has some interest and knowledge in these issues and involve that attorney either on the ethics committee or in some other way as an interface between the committee and the regular hospital attorney. Sometimes I think this can be done by a committee requesting an attorney with some specialized expertise to participate as a special advisor to the committee. You need, of course, to deal with the "local politics" of the situation so that the main hospital lawyer doesn't feel attacked or that his or her business is about to run away, but those things can be done. Cohen: Another consideration is whether the attorney is a member of the committee or is merely an advisor to it with regard to what the hospital is willing or unwilling to do. So, that's the threshold that needs to be addressed, "Is the hospital attorney generally going to be a member of the ethics committee itself?" Jay, in your experience, when the attorney is a member of the ethics committee, is the result that the committee then turns to the attorney and says, "Well, we know what is ethical, but what is legal?" Hartz: I have had that experience in all cases where there has been a lawyer on the ethics committee; that is, what tends to happen a lot is that everybody looks to one end of the table where the lawyer sits and asks, "What is the answer?" or "Is that legal?" and the lawyer says, "Yes, it's legal, it's fine," or "No, it isn't." That, in some cases, will end the discussion. One of the things that is important is for the lawyer to know the limits of what the lawyer's role is, which is not to try to direct or push the discussion one way or another through sort of a recitation of legal fears but rather to just assure that the decision making is not so far out in the perimeter of what the legal limits are that there will be problems and to also participate as any other committee member 36
would. But, I have not seen a big difference in outcome based upon whether or not the lawyer is the hospital attorney. Schwartz: In fact, given what you've said about "outcome" and about the role of lawyers, you would have a pretty powerful argument that lawyers are not particularly useful on hospital ethics committees. This would not be true of Institutional Review Boards; lawyers may have a great deal of value. Of course, committee members may want legal advice, but getting professional advice from your counsel is a lot different than having the lawyer present and actively participating in committee deliberations. Shapiro: I think there is a huge missing piece as to how all these questions pan out —and that is, "What is the role of the committee?" If the role of the committee is to be patient advocate, then it may be very inappropriate for a number of reasons to have in-house counsel sitting on the committee. On the other hand, if the role of the committee is to protect the institution, then it may be very appropriate for the in-house counsel to be on the committee. And, I do not know that our ethics committees have done a very good job of clarifying their roles —which has to be done first. Schwartz: There are a number of questions dealing with legal terms and concepts, the first is, "What is the legal essence of decisional capacity?"
Shapiro: We have a very new healthcare statute in Wisconsin which defines "incapacity" for purposes of medical treatment decision making, and I think it does a pretty good job of it. I am not saying that this applies everywhere, but basically the statute says that a person is incapacitated if the answer to the following three questions is "No": "Can this person (a) receive the relevant material information about the proposed treatment, (b) process that information in
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accordance with his or her own value system, and then (c) make and communicate a choice?" If the answer is "Yes" to all those, then the person has capacity. Cohen: The legal essence of decision-making capacity depends a great deal upon the decision for which capacity is at risk. For example, there is a considerable difference between the decision to waive right to counsel in the case of the person who has been indicted for fraud versus the decision to discontinue treatment. Decision-making capacity will also have something to do with the way in which the treatment is being afforded. If you are about to force treatment on a nonconsenting mentally ill individual, it may be that the courts will require, particularly if the treatment is highly intrusive, a far higher threshold of decision-making in capacity than if you are dealing with a situation in which the individual is passive and the form of treatment is considerably less intrusive. So, there are ranges which are used in different situations, and you have to be considerate of those distinctions, i.e., the form of the intrusion and the protection of the individual as the courts see it. Schwartz: The medical literature is quite interesting on decisional capacity. It says, "This is a legal concept; it is not within the expertise of medicine." If you read the reported law cases they say, "We rely and look to the testimony of doctors." It is one of those rare areas neither law nor medicine has been particularly anxious to claim. Each is only willing and eager to hand it off to the other. Cohen: It seems that in some places the courts want to depend on the doctors while retaining the right to make the final decision; that is, they are saying, "You folks come up and testify before us and we will tell you who has, or who lacks, capacity." There is a California case involving forcible
treatment of a mentally ill individual saying, "This is a legal determination, just as insanity is, but to make that determination we will have to listen to the doctors who will tell us what to do." Schwartz: Next question, "Would you please share some legal insights into medical futility and the treatment/nontreatment decisions based on that determination?"
Hartz: That is difficult to answer in terms of anything that I am aware of that the courts have said. In terms of medical futility, we have to assume a spectrum of possibilities. At the far extreme end of that spectrum is the circumstance where a patient asks for a treatment that has absolutely no relevance to the problem —they want chemotherapy for a headache and you are supposed to do that because they want it. I do not think you would have any difficulty in saying, "Sorry, we are not going to do that." Moving further down that spectrum you get closer to a situation where the treatment does have some effect or does do something to continue the patient's comfort or existence, in the context of a continued use of a respirator for example, and I am not aware of any court decisions that have said it is permissible to discontinue because the physician does not think that it is worth proceeding. We are going to have to face this question, but the context of the decision is actually made somewhat more difficult by the approach that the courts have taken so far in decision making in this area, which tends to focus on "What does the patient want?" Now all of a sudden, some people are saying, "We don't care anymore what the patient wants, we want to make a decision because we think that the patient or the patient's representative is being unreasonable in their wants and demands." I think that is a conceptual leap the courts are going to have to deal with. 37
Panel Presentation
Cohen: There is some material out there in some of the cases; for example, there was a case in which the court looked at a situation where a person in an institution who was voluntarily institutionalized said, "No, I do not want the treatment that you are giving me." It's the other side of the futility situation, I think, and what the courts said in that case was, "Well, the doctor does not have the responsibility to give the patient something which the patient does not want." Now the assumption here is that the patient has capacity to make decisions, but I would assume in a surrogate decision-making situation the same process occurs, but I am extrapolating here. I am not sure this is the way other cases will go, but I do not see the courts telling physicians, "This is what you have to do" against physicians' wishes. Shapiro: In looking for guidelines in this area of futility, we would be somewhat remiss in this discussion not to mention the Baby Doe laws as they apply to physicians and parents making decisions. The definition of futility for the care of very ill infants says basically that futility is when the infant is irreversibly comatose, or the survival of the infant is virtually futile and the treatment under the circumstances would be inhumane (however that should be defined). Schwartz: From the audience another ques-
is not taking a blood sample and testing the blood, I would think in California that you probably would be able to do it. It is not like for HIV, where there is a particular statute which says that you cannot, and I would tend to think that perhaps it could be done without formal process here. Cohen: I do not know of a statute on this in California, though I think in terms of some of the law out there in regard to various public situations around the country there has been at least a court order for a consistent statute saying that you can bypass parental consent in certain circumstances. Schwartz: Where it is therapeutically necessary to provide adequate treatment for the child, if the immediate test is necessary, it would be hard to imagine that it would not be permitted. Shapiro: I think that is a real unanswered medical question in and of itself. That is why I've asked neurologists what they really need to test for, and I've not heard what I would consider sound answers. Schwartz: And finally, "What legal issues do you perceive arising out of the new Patient SelfDetermination Act in the course of its initial period of implementation?"
Hartz: Basically, the act says that you have to give notice and information; I would not see that as being a particularly litigious istion, "Can we test a newborn infant for drugs sue, or one that is likely to generate a lot of without parental consent or knowledge?" problems. There are two main issues that Shapiro: Not in Wisconsin. We have a new seem to me to arise: "How much informastatue which allows for testing of infants tion do you have to give, and what format with the mother's consent; and then, if there is it going to be in?" And, I assume and is a positive result, there are all sorts of im- hope that groups within each state and each plications in terms of going to Child Protec- area will help develop common documentation Services. But, the consent has to come tion that everyone can use and look to, unless from a parent; although at this point it is the institution is so unique in the patients not widely followed. with whom it deals and therefore some other type of procedure seems appropriate. Hartz: In California, I am not aware of any similar statute. My thinking would be that Secondly, "What institutions or entities are the testing could be done, assuming that it obligated to provide the information?" My 38
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sense is I do not think it is going to be a hotly litigated area or one about which there will be great problems. I have the sense that the federal regulators are not going to be particularly picky about exactly how many apostrophes you have in the third sentence of the form that you put together, and I would frankly be surprised if there was much that came out of this by way of enforcement. I think that the power of the law is not an enforcement problem, it is really an invitation and requirement to put out some information. If there are problems that arise from that, they are going to be problems from patients knowing more about what their rights are and demanding them. But that is not going to be a piece of litigation arising under the statute, it is going to be based on the patient's rights to refuse. Schwartz: No one is suggesting that it will give rise to many legal problems. The enforcement mechanism is cutting off Medicare and Medicaid funds and that is not discretionary. If a covered institution does not comply, the government must cut off funding, and that is a really substantial threat. On the other hand, all that a covered institution must do to comply is file a statement saying it is complying. On the other hand, to the extent that there are ambiguities in the requirements of the Act, you can reasonably expect the government to accept the certificates as long as there is a good faith effort. Cohen: I had initially thought that there is not likely to be too much in the way of litigation around this Act, and I have not seen anything to suggest otherwise, but now I am wondering whether there might be
problems with regard to interpreting it. Specifically, will there be conflicts around what is sufficient in order to obtain informed consent? Hartz: The essence of the Act is just to "give information/' as distinguished from "ensure that informed consent takes place/' so certainly to the extent that you raise expectations of patients about abilities to make decisions for themselves, you possibly increase the likelihood that issues of informed consent and the like are going to raise themselves more frequently. But under the statute itself, I do not see that it is going to generate dispute of great magnitude. Schwartz: Hospitals and others covered by the Act will have to have a written statement of the state law on terminating treatment, which must include statute law and judge-made law, and also a written account of the institution's policy that will carry that law into effect. The Act will generate a lot of policy making, and we will certainly be fortunate if much of that policy is made in consultation with, or maybe even by, the ethics committees. There is a fabulous opportunity for healthcare institutions to actively use the Patient Self-Determination Act to do something valuable. I hope that healthcare institutions will be asking, "How can we really serve the purpose of this legislation?" If that question is answered honestly, the chances of any kind of liability or any kind of sanctions are virtually zero. Ultimately, good ethics and good medicine make law, as I hope that the debate over the Patient SelfDetermination Act will show.
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