THE TRANSFER OF MEDICAL INFORMATION
MARIA BOTTIS *
Medical tradition on informing patients has always been one of silence. In the Hippocratic oath, there is no obligation to inform a patient whatsoever; on the contrary, the oath dictated that the physician should perform duties calmly, concealing most things from the patient and revealing nothing of the patient’s future or present condition. This, coupled with an equally strong obligation to keep medical information secret (confidentiality), led to an almost perfect condition: the physician ought to tell the patient nothing at all, while he was simultaneously forbidden to talk to anyone but the patient himself. This was, indeed, a very silent profession.[1]
The situation is legally much more different today, at least in the US and Europe. Under the modern doctrine of informed consent, which originates from a series of unauthorized and catastrophic medical interventions, a physician is obliged to transfer to the patient particular medical information.[2]
Consent to treatment has been for a much longer time a central feature of the medical act; it may seem bizarre now but physicians have, in the past, led patients to the operating room and engaged in totally different surgery than what they had said they were doing (if they had said anything at all).[3] The justification given was, obviously, that secrecy was in the patient’s best interests, as otherwise the patient (usually a woman) might have refused surgery.
These were, in short, the “Middle Ages” of the informed consent doctrine, the age of the tort of battery and not the tort of negligence, as an ‘informed consent’ tort.
Judges and even, physicians, were not hesitant to state that totally unauthorized medical intervention consists battery and of course, as such, it is contrary to the most basic tenets of a human rights based society. Medical paternalism in this sense was condoned by neither jurists nor doctors. But the essence of informed consent is not that batteries should be avoided also in a medical environment.
With a clear weight favoring the “consent” of the “informed consent” issue, we have many international legal sources to invoke when it comes into question. The European Convention of Human Rights and Biomedicine (Oviedo, 1997), especially refers to the obligation to inform patients. Focusing on consent, Article 5 sets a general rule that “An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks”.
Under Article 10 of the Convention, with which not everyone agrees, deals with informing a patient before a medical intervention or even, independently of an intervention in that, “everyone has the right to respect for private life in relation to information about his or her health. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed”.
This is a nice set of rules, dictating that a patient should know at least the purpose and nature of a proposed intervention, and its consequences and risks. Article 10 is even wider (‘information about health’) but it is, as a start, difficult to assume that this generally drafted Article obliges doctors to offer ‘general’ information about health; its stress is more on who has the right (‘everyone’) than on who is obliged to fulfil its meaning.[4] On legal sources for informed consent, one can list many more than this Convention, as a series of legal texts of varying source and power cover the same topic (judgments, statutes etc.).
What the set of rules come to is, in principle, that patients are entitled to information on:
a. the nature and purpose of an intervention;
b. prognosis with treatment and prognosis without treatment;[5]
c. alternatives to proposed treatments;[6]
d. risks of the intervention proposed;[7]
e. consequences of the intervention; and
f. possibly, other information.
Listed is a collection from what various judgments have come to, from the US, Australia, European countries and other countries, more in order to give the picture of what types of medical information have been held essential and that should have been transferred to the patient. Courts have found that they had to deal with situations much more different from a patient entering the operating room without knowing what was going to occur; patients have been complaining in courts they should have known, for example, that their doctor is HIV positive, or an alcoholic etc.
What we must stress, in any case, at this point is that the list portrays a big step towards protecting a patient’s autonomy. Although not every country has accepted all of this information as mandatory to be given to the patient, we can see a movement towards offering more information, and actually never less. The target is to protect a patient’s freedom to choose treatment freely and based upon significant and relevant information.
Up to this point I believe that it is clear that the whole discussion about the transfer of medical information from a physician to a patient has been centred around a proposed intervention-for example, a surgical procedure. But the duty to inform covers a much more wide domain than this. Some courts, for example, have accepted that a physician has to disclose that he may have conflicts of interests, research and economic interests in a patient’s treatment.[8]
The transfer of information to third parties, instead of the patient is also a possibility, which widens physician’s obligation. Also, in some cases, the question arises whether the physician is obliged to give to the patient important information about himself, such as, for example, that he may be HIV positive, or an alcoholic. In the Behringer case,[9] for example, the court held that a surgeon infected with the HIV virus is obliged to disclose this to prospective surgery patients.
A third party may be a legally recognized recipient of information if he is, in some way, in danger, irrespective of a medical act.
In the famous Tarasoff case,[10] a psychiatrist was treating a patient who repeatedly threatened to kill a fellow student he was in love with. The patient suffered from paranoid schizophrenia. In the end, he did kill his fellow student and her parents sued on the basis that she or them should have been informed about these threats, overcoming the physician/patient privilege in the case of do severe danger to life. The Supreme Court of California accepted the suit and declared that in these cases, there is a duty to warn the party on danger. Another way a third party may become involved in a physician/patient relationship is, for example, when the physician discovers that a patient is HIV positive but declines to inform his spouse about it.
Newer cases refer to the possible obligation of a physician to disclose risks such as his experience, qualifications and success rates with the proposed procedure.
In Barriocanal v. Gibbs,[11] it was accepted that proper disclosure included that the physician lacked experience with the particular surgical intervention and that the patient could leave for a more suitable, in his case, hospital. There are many cases in this line. Obviously, what happens is a steady expansion of the informed consent doctrine, to cover areas such as statistics related to a particular physician, such as how many times he has performed this type of surgery, whether he had failures with other patients etc.
The possible content of disclosure is not the only crucial question in informed consent cases. Also important is which standard of disclosure will be used. In the UK, the professional standard still applies, meaning that a physician shall disclose whatever another competent physician would disclose as well. In the US and Europe, the standard is the reasonable patient standard: the physician is obliged to disclose whatever a reasonable patient in the patient’s condition would need to know[12]. Another standard, the particular patient standard, reinforces patient autonomy and choice much more as it stresses the importance that the physician discloses all information that the particular patient he deals with needs to know. But due to obvious problems of patient hindsight, this standard has not been adopted.
Expert testimony on the content of disclosure follows the standard of disclosure to be used. Where the professional standard is the rule, expert testimony that a reasonable doctor would proceed with the transfer of the information is a necessary part of the file. On the contrary, where the reasonable patient standard is followed, no expert testimony is necessary, even if it would be helpful.
The law has moved from a limited disclosure to a much wider one, and, in most jurisdictions, from a diligent physician standard to a reasonable patient standard. This way, we have moved from a state where the medical profession plays with its own rules to a state where the patient is recognized as an autonomous human being to be protected, in so far, however, that he is also a reasonable patient. This in itself is contradictory; autonomy means perhaps first and foremost, the liberty to take unreasonable, irrational decisions, even medical ones. From what we know, of course not all patients decide ‘reasonably, whatever this may mean in every particular situation.
Additionally, the state has to protect reasonable and ‘unreasonable’ citizens/patients alike and not “substitute” ‘unreasonable’ decisions with ‘reasonable’ ones.
Closely connected to this, the extent of physician liability in damages is also an important question, as for example, would we accept damages in a case where no physical damage occurred, but a patient was operated upon by an HIV positive surgeon without knowing of the HIV status? What if in this case, there was a complication of the surgery, but still, unrelated to the HIV status? To which extent, that is, will a state accept to protect the patient’s autonomy? What answer will the state give to a complaint that “I would never have consented to be operated upon by a surgeon who has done this surgery only eight times before”, “the surgeon did not inform me that radiation was also an option, albeit with a smaller success rate”, “there was a miniscule risk of paralysis but I would have consented to surgery even if I knew about it”?
These are perhaps ‘light-looking’ autonomy-related “breaches” of the physician’s ‘promise’, in a world where, however, in medical schools we still teach doctors what to do and not what to say, or how to say it, we teach them good medical practices and not effective communication with people; courses of medical ethics, to which informed consent belongs, are, usually, elective. Physicians are taught to be or at least seem sure of what they ‘order’, to refrain from acknowledging any uncertainties at all, to keep up the distances between them and ‘laymen’ (their patients).
Entering medical law and ethics under the wider domain of human rights law is a positive step. In this sense, informed consent actions do add to human rights laws development. On the other hand, we must not forget that lawyers have tended to add informed consent claims to negligence claims that were difficult to prove; that there is both proper and improper use of informed consent actions and lastly, but not least, that where we have, as in Greece, a total reversal of the burden of proof of consent (it is the doctor who must proved that the patient consented, after being properly informed not the patient to prove that he was not informed), then we must re-examine the whole situation from the human rights point of view, yes, but of doctor’s rights, as a defendant, as well.
In Greece, as in other countries, informed consent forms have started to being used approximately since the early 2000s. Usually they offered general information about a procedure and contained information such as “the patient accepts that she has been informed about the risks and consequences”. Courts, understandably, have not declared these forms as concrete proof of proper disclosure. As time went by, big hospitals and clinics engaged in drafting more detailed informed consent forms, which however continued to be signed almost just before surgery.
Doubts about what, if anything, can be proven by informed consent forms continue to be raised, but on the other hand, physicians who need to protect themselves from self-serving testimonies about what was or was not told, have started to ask fellow doctors to be present while they inform a patient. The question whether all conversations should be taped has also been raised. But having a third party as a witness while one is receiving medical care (in this case, information) or knowing that you are being taped definitely alters the nature of a physician/patient relationship, a relationship which should be founded upon mutual trust.
At the same time, laws on the transfer of medical information must take into account the conditions of the delivery of health care. It is difficult to insist that a doctor at his last hours of his 36 hours service in a hospital must inform in detail patients - often patients who need special instruction; also, their abilities to understand medical information may not be the best.
Simultaneously, it is also dangerous to draft laws without connecting them to the problem that medical negligence actions cause to the health care system. In a time when a suit for medical negligence has become almost the norm rather than the exception after an adverse medical outcome, under the ‘theory’ that the plaintiff has, at least, nothing to lose, we must seriously think about whether a healthcare system can indeed absorb these costs.
Returning to the individual rights view of informed consent issues, we have spoken extensively about autonomy, privacy, informational liberty/privacy etc.; also about equal treatment of patients. But disease or illness, bear social meanings as well, not only medical connotations and in this sense, it remains to be explored what is, in fact, the social meaning of illness and what equality between doctor and patient may mean. This needs to be discussed as there is constant reference to a “shared decision-making” between doctor and patient (as an ideal model of a “process” form of informed consent) and as yet, we do not seem to know how to separate what the doctor’s role is in transferring information to a patient and what is, afterwards, the patient’s role in this model of “shared decision-making”. In the end, as the medical negligence crisis goes, we can detect many physicians who would prefer patients to make decisions alone, if this would absolve them from any liability for these decisions.
As an example, at the beginnings of the 2000s, in the biggest maternity hospital on Greece, expectant mothers were informed about risks that their foetuses have Down Syndrome with written recommendations (“amniocentesis recommended”). As amniocentesis carries a risk to lose the foetus and civil lawsuits started being filed, the recommendation changed to “you are in a high/low risk for Down Syndrome”). In this sense, there was nowhere written what the patient should do, but there was an understanding that if the patient belonged to a high risk case, then the patient should decide for amniocentesis.
Meanwhile, lawsuits were being filed, not only when a foetus was aborted, but also when a baby was born with Down Syndrome as an amniocentesis had not been recommended/performed. So, experts in prenatal medicine were caught into the middle, a sort of “damned if you do/damned if you don’t” situation: they could be sued in both situations, of recommending and of not recommending a risky test. As time went by, they opted for a yet another way to inform patients: “your risk for Down Syndrome is 1 over 250”. They refrained form recommending or not recommending the test and in a way, “threw” the decision upon the patient. This way, they believed, there could not be a suit at all: the patient decides whether this is a risk she can, or cannot take.
There are, of course, medical standards on this matter, but they prefer, as much as they can, of course, to ignore them, if this ascertains that they are safe from liability.
So fears of liability alter the content and the way of medical disclosure. This is a different pattern of doctor/patient discourse, a pattern where the doctor prefers, necessarily, to offer information but to take part in as less medical decisions as possible. Patient autonomy in its reign, albeit for the wrong reasons, means, as exposed here, that patients are not only ‘autonomous’ in their decision-making; they are also left alone to decide whatever they “want”, while the doctor is absent of this process. This is, I believe, an abandonment, as the patients cannot ‘process’ a big part of the medical information they receive.
We use to state that the party having the most information is the most powerful party, “information is power” and so on. But in this case, it remains to be seen whether the patient is indeed empowered because the doctor gives her even a ton of information and then, leaves the scene. True, people and patients most of all, make decisions very often founded on irrational factors and fears. And equally true, people, and patients, file unfounded, unjust claims all the time against their doctors.
We need to re-examine not only the laws on the transfer of medical information in general, but more importantly, how to re-instate and protect the integrity of the doctor/patient relationship, the trust between them, as we know that patient autonomy means very little, when it is separated, and almost entirely, from this essential bond.
[Editor’s Note: In an Australian context, the High Court of Australia in Rogers v Whittaker [992] 175 CLR 479 found that a medical practitioner must ensure that a patient has been fully advised of the material risks inherent in that treatment or procedure, as well as ensuring that a patient has given appropriate consent to the carrying out of medical treatment or a medical procedure. A risk is material "if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it, or if the medical practitioner is or should reasonably be aware that a particular patient, if warned of the risk, would be likely to attach significance to it"].
* Maria Bottis, Lecturer, Ionian University, Greece
Footnotes
[1] See generally Katz J., The Silent World of Doctor and Patient, The Free Press, New York, 1986.
[2] For some basic rules on this see Rozovsky F., Consent to Treatment: A Practical Guide, Little Brown & Co., Boston, 1990.
[3] In Pratt v. Davis, the surgeon excised Mrs Davis’s uterus and ovaries to treat her for epilepsy without informing her of what he was really going to do, as he “wished her to come to the operating room without violence”. (Pratt v. Davis, 118 Ill. App. 161, 1905). In Schloendorff v. New York Hospital (211 N.Y. 125, 1914), the surgeon removed a fibroid tumor from Mrs Schloendorff, over her clear objection to any operation whatsoever.
[4] For this reason, no all commentators refer to Art. 10 of the Convention as relevant to informed consent, but on the contrary, they mention Art. 5 as the only article dealing with informed consent to treatment.
[5] The prognosis with treatment relates to statistical data on a favourable outcome. On prognosis without treatment, in Truman v. Thomas, 611 P. 2d 902 (Cal. 1980), the California Supreme Court held that a physician has a duty to disclose to a patient the consequences of her refusal to submit to the test the physician proposes (in this case, it was a Pap smear test and the patient refused it, due to financial reasons etc, but she, as it turned out, did not know that this was, potentially, a life-saving test of cancer).
[6] Some courts accept the obligation to inform about alternative procedures which carry greater risks than the one the physician proposes. Gemme v. Goldberg, 626 Atl. 2d 318, 326 (Conn. Ct. App. 1993). However, the alternative must be legitimate and accepted, even by a small percentage of physicians (example: giving birth at home has been held not an ‘alternative’ to hospital birth, to be disclosed, Lienhard v. State, 431 N.W.2d 861, Minn. 1988).
[7] In Salgo v. Leland Stanford Jr. University Board of Trustees (317 P. 2d 170, Cal. Dist. Ct. App. 1957), in which we first see the phrase “informed consent”, Salgo’s legs were paralysed after an aortography, a new procedure at 1954, carrying severe risks of paralysis about which Salgo knew nothing at all.
[8] Moore v. Regents of the University of California, 793 P. 2d 479 (Cal. 1990). See also Rodwin M., Physician’s conflicts of interest: the limitations of disclosure, New Eng. J. Med 321 (1989), one of the first paper on this matter.
[9] Behringer Estate v Princeton Medical Center 595 A.2d 1251 (NJ Super.Ct 1991).
[10] Tarasoff v. Regents of the University of California, 17 Cal. 3d 425, 551 P.2d 334, 131 Cal. Rptr. 14 (Cal. 1976).
[11] 697 A.2d 1169 (Del. 1997).
[12] Canterbury v. Spence, 464 F. 2d 772 (D.C.Cir. 1972).
Copyright 2009. Greek Legal and Medical Conference