skip to Main Content
Patient Information And Consent To New Treatment Methods

by Emmanuel Laskaridis, LL.M. (Heidelberg), Dr. iur. (Heidelberg), Teaching Assistant at the Law School of Athens University, Barrister at Law in Athens, Member of the Greek National Authority for Human Assisted Fertilisation

A. THE RELATIONSHIP BETWEEN THE MEDICAL AND LEGAL SCIENCE

Medicine and law have been differentiated since thousands of years and are now methodologically categorized in different scientific domains. Medicine   appertains to the exact and natural sciences whereas law is a theoretical science. However, these two bear many similarities. Firstly, they both belong to the field of human sciences. Another interesting element is the utilization of common terminology, although in a different conceptual content. A characteristic example is the term “pathogenesis.” The medical science deals with the pathogenesis of body parts and organs while the law with that of legal relationships. The term “attack” is also met in both sciences. Medicine faces the attack of microorganisms and acts against the human body (i.e. virus infections or injuries resulting to fractures) while the legal science is focused on attacks – infringements – against legal rights. “Remedy” constitutes another term used in both sciences. Medicine is engaged with the remedial action to restore the patient`s health and law with the remediation of infringements to legal rights. The medical science seeks an effective therapeutic remedy; the legal science seeks the correct legal and evidential grounds of the remedy filed against subjects of law. Moreover, professionals in both fields are bound to observe the rule of professional confidentiality. Finally, doctors as well as lawyers have a restraining role in health and societal pathogenesis respectively and are, thus, rarely called upon to play a preventive role. Nevertheless, prevention proves to be more useful than suppression. This is why the Medical Code of Conduct, that forms part of the Greek national legislation,[1] should be of concern to every diligent doctor prior to the disruption of her/his trusting relationship with a patient. It would even be desirable that the Code be used for sufficient knowledge of the respective rights and obligations of the parties and the boost of trust between them.

B. PROPER INFORMATION AND LEGAL CONSEQUENCES OF ITS OMISSION

I. The necessity of patient’s proper information and consent

A relation of trust is based on good communication. The relation between the doctor and the patient does not constitute an exception to this rule. The phenomenon of poor transparency and inadequate information to the patient has been observed in reports to the State Ombudsman.[2] For example, the non-inscription of the doctor`s name (by placement of a special sign on him/her or in an apparent spot of his/her office)[3] is a common phenomenon; as a result, the patient is not acquainted with the person who is entitled to intervene on his/her body or to whom he/she discloses sensitive personal data.[4] This incident had occurred in the Gennimata General University Hospital of Athens. Similar incidents of lack of trust towards the medical world also occur in cases of omission of display of the operating hours (e.g. cash desk) in healthcare institutions.[5] This has been observed in the University Hospitals of Heraklion and Zante. Meanwhile, forms of poor or inadequate information are also met in the private sector.

In all the aforementioned cases, the non-information of the patient undermines his/her trust to the doctor or the legal person that provides medical services. The patient is not aware of the doctor`s projected actions, as well as of his rights and obligations. This is a seriously unsafe situation as it jeopardizes the spirit of patient-doctor trust. Besides, our legal order attributes a higher standard of trust to persons that enjoy an outstanding social status, such as doctors.[6]

In the dawn of the 20th century, the matter of patient’s proper information and consent did not arise as intensively and imperatively because of the doctor`s status as a “God” that could save patients from any harm to their health. Nowadays, the medical model is completely different. Medicine is patient-centered and not doctor-centered anymore. The cause of this change is found in the Second World War and the experiments actualized by medical scientists cooperating with the Third Reich in its duration. Subsequently, in the 1960`s and 1970`s, the term “bioethics” was introduced. Thereupon, the doctor did not decide himself for the shake of the patient`s health: theologists, patient representatives and jurists had a say in the treatment option.[7]

II. Legal consequences of poor or non-information

In the first place, any intervention to the patient`s body constitutes illegal violation of the physical element of his/her personality.[8] Such a violation does not exist only if the patient consents; otherwise, the doctor might be accused of illegal violence or physical injury. However, consent always presupposes patient’s proper information which is related to the principle of transparency in the public sphere (e.g. the obligation of a civil servant to state his/her capacity). Particular emphasis should be attributed to providing the patient with information concerning the advantages and disadvantages of a given treatment method,[9] as well as to comparing applicable methods when there is a possibility of choice. When the information provided is inadequate or when no information is provided at all, the patient`s consent is invalid and renders any medical action thereof an illegal infringement of the patient`s personality right.[10] On the contrary, a valid consent excludes the illegality of the intervention in the patient`s personality. Consequently, the patient`s consent to bodily harm[11] or artificial termination of pregnancy (as long as the law provides for it)[12] is valid. Thereby, the illegality of the action disappears; it has been realized lege artis and according to the patient`s valid consent.

The level of the doctor`s fault for non-information differentiates the subordination and legal consequences in common law. In case of unintentional omission of information there is negligence whereas in case of intentional omission there is battery and assault.[13] English courts often accept that inadequate information does not nullify the patient`s consent[14] in order to avoid conviction of the doctor for battery which would have burdensome legal consequences. As a result, the acceptance of negligence for cases of poor or non-information is constantly on the rise.[15] However, this policy of English courts has been criticized in doctrine by Ian Kennedy because it does not sufficiently serve the patient`s interest.[16] He argues that the notion of battery should be interpreted in a more wide sense so as to include cases where there is no physical touch of the doctor with the patient such as in the determination of medication.[17] Contrarily, in the Greek legal order, as in the rest of the Continental Europe, the kind of the doctor`s fault does not affect the legal consequences. Specifically, the doctor shall pay the same compensation irrespectively of his/her negligence or intent in not providing the patient with sufficient and clear information. The kind of fault could only be decisive for awarding non-material damages.[18] In this report we shall analyze the obligation of information focusing on the necessary terms which such information must meet in order for the patient`s consent to be considered valid.

C. THE FOUR BASIC QUESTIONS CONCERNING PATIENT INFORMATION

Regarding the obligation to inform the patient there are five fundamental questions a lawyer needs to answer in order to examine whether the information has been proper.

I. Who (obliged to inform).

The doctor is always responsible to proceed with the information.[19] By no means can the paramedical personnel or assistants (e.g. the nurse) fulfill this obligation given its personal character according to Art. 651 of the Greek Civil Code.[20] This need for a personal observance of this obligation is rational since the doctor is the only one that can accurately and comprehensibly inform the patient and answer to any illustrative questions, given his/her complete acquaintance with the diagnosis and the treatment. The paramedical personnel can only be of secondary assistance; for example, by distributing informative leaflets and providing general information.[21] Nevertheless, it should be noted that flexibility has emerged in recent German jurisprudence concerning this requirement of the doctor to personally execute medical acts. It was even judged that the diagnosis through assistant doctors of the responsible doctor and their guidance via phone in the placement of a catheter does not breach the principle of personal observance and does not constitute defective diagnosis.[22]

An issue arises in case of defective patient information regarding the liability of the Director of the medical institution (as an administrative organ) with a purely coordinating role. It is aptly argued that he/she is not obliged to inform the patient but only to distribute responsibilities and, consequently, to define the responsible doctor in every given case. His/her substantive role is to coordinate the procedure of information. In case of omission of this coordination, the Director shall be liable. But it is rather rare to accept exclusive liability of his/hers either because the doctors` action is interconnected or due to evidential difficulty. Thereupon, as correctly supported in Greek doctrine,[23] the coordinating doctor and the responsible doctor are severally liable.

There is also an ambiguity as to whether the referrer doctor is liable on the basis of information for matters touching upon the expertise of the doctor to whom the patient has been referred to. For instance, in case of an endurance test, both the referring pathologist and the cardiologist that undertook the patient did not inform him/her of a risk possibility of 0,05%.[24] In this case the law provides that every doctor has respectively an obligation to inform the patient. [25] Otherwise, both doctors are severally liable. The patient may choose against whom he/she shall claim damages and the doctors shall seek the damages paid from each other. However, the doctrine disagrees with the belief that the liability of the referring doctor is then extremely broad.

According to theory,[26] the referral doctor should only be responsible for informing about the reasons of the referral, while the obligation to inform about the risks, the effects of the treatment, the method to be followed and other issues lies with the treating doctor. The transfer of the information obligation from the treating doctor to another doctor is only possible under an agreement with the patient.[27]

II. Who (subject of information).

The doctor must always inform the patient personally. That is to say, there should be personal contact between a doctor and a patient, and it is not enough to provide leaflets,[28] because the patient may need to be assisted by the doctor to understand the leaflet due to lack of specific knowledge or even rarely due to illiteracy or ignorance of the Greek language.[29]

Third persons, other than the patient, should not in principle be informed because the patient’s health data are sensitive personal data.[30] Even after a patient’s death, the protection of the patient takes precedence over the hereditary interests of relatives (e.g. invalidation of a will due to psychiatric illness), as the Code of Medical Ethics in Article 14§8 requires proof of inheritance privilege for access to the deceased patient’s file.[31] Exceptionally, relatives are only informed when they are legal representatives of the patient or have self-interest such as in the case of a husband’s sterilization, which affects the right to reproduce of another person; so it is necessary to inform the other.[32]

In case of an underage patient, the parents of the child should be informed, specifically both of them, because they share parental responsibility in the family law (CC 1510§1). Consequently, both parents should sign the relevant medical treatment contract as legal representatives of the child.[33] At this point, it is worth mentioning the case of the German Federal Court, also known as the “uninformed father.”

This case examined the recipient of information in order to perform an operation in the heart of a child with Down syndrome and a cardiological problem.[34] The mother consented in writing and signed for the operation that was required. The surgery was successful, but after a while, the mother turned against the doctors because she claimed that both parents should have consented. According to the law, that was right, but the German Federal Court justified the doctors not only for the sake of avoiding bureaucracy but also because the consent of both parents would be contrary to their own interests to the extent that it would overload their psychological condition, and eventually jeopardize even the child’s own interest (e.g. in case of excessive delay of the appropriate intervention). Certainly, mutual consent is not required in two cases: a) in emergency situations and b) in routine interventions.

III. How (way of updating).

According to the law, information is not required to be in written form. The patient may and must be informed orally by the attending doctor.[35] However, for reasons of proof, it is preferable to provide this information in writing, or to note receipt of information provided by the treating doctor in the patient`s medical file.[36] Recordings are also a valid means of proof.[37] This should be done under the treating doctor`s responsibility, since he has the burden of proof of having informed the patient.[38]

The update should not be massively realized but separately to each patient. Otherwise, sensitive personal data may be violated, as well as the patient’s trust in the doctor. Secondly, if the information is massive, there will be insufficient time for the patient to ask questions.[39] For the aforementioned reasons the provision of information documents is a recommended way, though insufficient because a patient may need clarification. The doctor should ask and confirm whether patients have questions. The more personal the nature of the information is, the more valid the consent of the patient will be.[40]

Patient information can generally be distinguished in the following stages:[41] a) Diagnostic, according to which the patient is informed about the imminent medical act and the risks involved b) The therapeutic, according to which the patient is informed about the treating method, as well as for alternative forms of treatment; and c) the postoperative, where the patient is informed about the consequences of the operation, e.g. That there will be no sense of touch after surgery.[42]

IV. When (update time).

The patient should be timely informed, which means not just before or during a medical act. In Germany it was initially argued that the patient should be informed 24 hours before the medical act,[43] but subsequently this time lapse was considered too short and was rejected.[44]

For example, in the Dyson J case, eight patients turned against a dentist because they had visited the doctor for a typical dental hygiene check, and the dentist applied to them other dental operations (e.g. large seals, dentifrices, addition etc.).

These acts were considered intentional physical injury to the patients on behalf of the doctor with the purpose of a profit and led to the revocation of the dentist’s permission. In particular, it was considered that there was no timely information of the patients who almost compulsorily suffered them during their dental checks, having no time to decide.

In another case,[45] in the German Federal Court, it was required to perform a thyroid patient’s intervention. The patient was informed of this, but not of the risk of laryngeal nerve injury, which the patient eventually suffered. The doctor was convicted because the patient was informed on the risks, duration and other evidence of the operation 24 hours prior to surgery, but his appointment for this operation was arranged much earlier. The briefing should have been made when arranging the appointment, so that the patient can be informed of all possible risks. 24 hours before the surgery, the patient felt obliged to undergo this intervention and did not have the time to think and decide freely. In this case, consent was not free, because the patient did not consider the pros and cons. The same thing happened in a case of the Independent Authority of Greece`s Ombudsman, in which a patient underwent bone marrow transplantation, without consent before the first treatment was carried out. The post-authorization (after the beginning of chemotherapy) does not remove any unlawful nature of the act.[46]

D: THE FIFTH QUESTION: HOW MUCH

I. The Extent of the obligation for information 1.    

1. Search for identification criteria in foreign case law

According to the most prevalent point of view, the patient must be informed to the extent that is necessary and he/she desires. Consequently he/she should know the type, the meaning and the procedure of the treatment not to every detail, but until the point that is crucial for causing his/her approval or denial.[47] In particular in order to assess the extent of the required information given to the patient by the treating doctor, it is appropriate to refer to Article 914 of the Civil Code. There, causal link between unlawful and culpable acts that caused the damage and loss-making effect is required inter alia as a condition of tort. The doctor has the responsibility to provide all information in the sense that he must prove that even if he had informed the patient he/she would have made the same choice.The principle mentioned above applies to the English law as was proven for instance in the Pearce v. United Bristol Healthcare NHS Trust (1998)[48] case in which a pregnant woman, at her ninth month of pregnancy, fearing the child`s death due to prolonged pregnancy, addressed to her gynecologist and stated that she wanted to give birth to her child either through the use of artificial pains method or via cesarean section. The doctor thought that cesarean was not appropriate because it would be of high risk and the body of the pregnant woman would take a lot of time to recover. The woman agreed with the doctor’s opinion but a few days later the child died within the mother’s uterus. Given the fact that the risk was 1%, and the doctor didn’t inform her because he thought it was not necessary due to her panic and bad psychological condition, the following questions arise: Firstly, if the doctor should have informed her of such low failure percentage and, secondly, if the woman being aware of that percentage would have changed her mind on giving birth through a natural procedure. Concerning the first question, it was judged that considering the woman`s psychological condition it was right not to inform her of the low percentage of the risk because it would deteriorate her psychological condition (subjective criterion). For this reason, the doctor was acquitted both in the first and the second degree courts. Both courts decided negatively on the second question as well, considering that even if the pregnant woman was informed of the risk she would not have changed her attitude. Nevertheless, the delimitation of the obligation to inform, as of any major obligation,[49] is a very important task. This is because broader boundaries involve both non-fulfillment and inadequate fulfillment of the obligation and, on the other hand, even tort, to the extent that they invalidate the consent of the patient (C.C. 914 in conjunction with C.C. 57). As when we define the doctor`s other obligations (e.g. keeping medical records)[50] we must delimitate the extent of the obligation for information through criteria.One such a criterion is the behavior of a reasonable diligent man (objective criterion), in other words how he would react even if he had been properly informed. In international case law, an objective or subjective criterion is not uniformly followed. For instance, at the Reibl v. Hughes case,[51] Canada’s Supreme Civil Court has ruled in favor of adopting an objective criterion for the expected behavior of the patient. In particular, the court stated that: “the doctor must provide the patient with sufficient information so that an average (objectively) prudent person in the patient’s position would be able to perceive the consequences of a medical intervention”. At that specific case, the patient – due to a stroke – underwent endarterectomy (slab removal from the artery), which caused him paralysis and sexual impotency. This patient was not aware of the urgency of the operation and -considering it necessary – he immediately consented. The Canadian Court of Appeal declared that his consent was invalid and that he suffered a severe bodily damage. The patient knew that undergoing the surgery was a risk, but he had mistakenly believed that not doing so was more dangerous. He would retire after 18 months, a privilege that he lost because after the medical intervention he was unable to work and did not fill in the required stamps. If he was aware of the possible dangers of the surgery, he would postpone the surgery for 18 months to retire and then attempt it. In this case, although there was a written consent from the patient, he was given reimbursement for the damage due to the lack of information given to him.The aforementioned Canadian Court decision for the gynecologist’s liability was towards the same direction. In this case, the subjective perception and consideration of the pregnant woman prevailed and not the objective criterion of the average prudent person who may be affected by the awareness of the risk of death of the pregnant woman. The subjective criterion was also taken into account by the German Federal Court[52] in a case concerning a new drug which was in an experimental phase and of which the treating doctor did not inform the patient, i.e. that it could affect his vision and that is why regular ophthalmologic testing is required. The fact that he would have found out that it was uncertain whether there were any adverse effects on vision, if he had read the directions of the medicine, did not influence the extent of the obligation. It was considered that even if the average prudent person would read them, responsibility did not lie with this specific patient who did not perform monthly ophthalmological examinations but with his treating doctor who did not inform him about these controls and the fact that an influence on his visual ability might occur.A similar factual situation accompanied by a similar court decision is that of the Poynter v. Hillingdon Health Authority case,[53] where the parents of a 15-month old child, who died after a heart transplant, had been informed of the usual dangers but not about the lack of oxygen in the brain (brain damage-serious disability).[54] Given that this risk was less than 1% and given that parents did not ask relevant questions about rare risks in order to be informed and request the preventive Bolam Test, it was considered that there was no liability for incomplete information on behalf of the treating doctors. The same result, but with a different reasoning, is also observed in Wells v. Surrey AHA.[55] In this case, the patient was not informed of all the consequences of the sterilization he had received, but his consent was considered valid in order to exclude the doctor`s punishment for tort of battery.[56] Especially in English case law, there is a limitation of the obligation to provide information, namely information shall be provided about the potentially high risks.

2. The Greek case-law

This limitation of the extent of the information obligation – doubtful in terms of ethics and bioethical accuracy – is selectively applied in Greek case law. Thus, for example, in the Areios Pagos` decision 424/2012[57] it was considered that a risk of death from a tetracycline test with a probability of 0.05% should be reported, whereas in a prenatal test case[58] where parents were not informed of probability 1 in 280 chances to give birth to a child with Down’s syndrome, it was considered legitimate not to be informed.  However, it is common in neither decision was there a reference of the subjective or objective criterion.

The above stand when the doctor applies conventional diagnostic and therapeutic methods. In Greek case law, there is not a uniform position as to the legal consequences of poor patient information. In some cases, it is applied excessively strict, leading to excessive amounts of non-material damage.[59] In others, however, no particular interest is given.

This was observed, for example, in a judgment of the Thrace Court of Appeal[60] in a case of patient injury involving the use of a medical device and in particular a sword, which was overheated without the fault of the ophthalmologist and caused a slight severe physical injury to the patient’s face. The fact that the methods applied by the surgeon ophthalmologist are accepted by medical science and that he could not anticipate and prevent in any way the sudden damage of the medical device led to his acquittal. More recent jurisprudence would probably punish the ophthalmologist for not informing the patient of the risks of such an operation.

In any case, it is accepted that the patient is not properly informed through a single general and vague document in which the patient is in fact required to consent to any medical practice carried out in his or her body. In a specific case,[61] a patient, who was introduced into a surgical section due to “right-wing inflammation”, was asked to sign a statement in which “he was informed by the doctors about his condition and fully trusted the medical staff of the department to implement any diagnostic method and treatment by any means, with full knowledge of all life-threatening risks in their application.” The patient refused and because of his refusal he received “disciplinary exempt” from the surgical department. It is clear that the specific text of the above statement does not meet the medical practitioner’s obligation to fully inform the patient, as an abstract reference is made to the serious risks that the patient may face, without specifying the dangers, while asking patients’ “white consensus” for a series of actions that are not clearly defined, substantially depriving the patient of the right to choose a method or not.

II. The difficult subject of choosing scientific method

1. The Code of Medical Ethics

The doctor is responsible for choosing the method to follow in the diagnostic and therapeutic procedure, e.g. the choice of the appropriate method is subject to his/her discretion. The effectiveness of a method and its superiority over another, based on acceptable medical science result, must be the criterion.[62] The doctor’s freedom to choose the most appropriate method consists of the decision whether to undergo any treatment, the non-obligation to carry out a particular medical method or pharmaceutical treatment, and the doctor’s discretion to choose which method is most suitable for the patient.[63] If two methods are considered equal and the doctor decides that both are judged fit for the patient’s specific condition, then the choice belongs to the patient, who will give his consent after thorough information. The patient’s right of self-determination is the limit of the doctor’s discretion. According to this right, the doctor cannot attempt an act to which the patient does not consent (even if this act proves to improve his health), but he must respect the patient’s will. Therefore, the doctor’s freedom of conscience does not legitimize the continuation of a treatment when the patient does not desire such continuation.[64]

2. New therapeutic methods and case law

The most difficult choice of treatment method is when one is new and there are not many studies on its risks and effectiveness. However, the application of new methods is necessary for the advancement of medical science.[65] In this case, the question arising is whether the doctor has the right to choose the scientific method to be followed by himself or if this decision is a personal decision of the patient. The fact that only the doctor is fully aware of the risks and benefits of new healing methods is in favor of making the decision on his own. However, a decision without knowledge or involvement of the patient’s will would undermine the free development of the personality of the patient to choose the treatment method to be applied to him, and consequently such a practice would be in conflict with Article 5 §1 of the Greek Constitution. A middle ground solution is to let the patient decide but with his prior knowledge of the pros and cons of the treatment method by the doctor.

However, following the wider liberal model of our time,[66] we should rather accept that the decision to apply new therapeutic methods should be assigned to the informed patient. This conclusion was reached by the German Federal Court in the case of the “Racz Catheter”, where the orthopedic therapist, in order to cope with a back pain due to a Vertebral stenosis at the spine, applied treatment via a Racz catheter, which was “partially appropriate”.[67] The information leaflet that was searched in the medical records stated that the patient had been informed of the risk involved in the application of this method such as quadriplegia, bladder and rectal discomfort as well as the advantages of this method against the conventional invasive method and namely the elasticity and precision of the Racz catheter.

The doctor suggested the patient deviating from the conventional method and the intervention through the catheter on the intervertebral discs. The patient signed that he was informed and consented. During surgery on the patient’s spinal canal via catheter placement from the bladder tube on March 7, 2001 severe spinal cord pains were observed, despite the three injections of “anesthetic cocktail” he had get (Cortisone, enzyme and sodium chloride solution) and continued until the following day, and finally numbness was noted in the posterior and left thighs with parallel dysfunction of the bladder and rectum, whereupon the catheter was removed.

A claim for reimbursement of the patient due to a severe medical error was rejected by the second degree Court because there were no instructions for this new treatment method, the breach of which would have led to the acceptance of a medical error. All medical acts were judged by the German Court of Appeal as “lege artis” due to the fact that the patient had been informed of the possible known risks of this intervention. However, these thoughts were not accepted by the German Federal Court, who considered that the doctors should have inform the patient accurately about the pros and cons of the conventional and the new method by comparing them and relegated the case for the determination of the amount of reimbursement and the moral damages due to inadequate information and thus unlawful harm to the personality of the patient.[68]

A determining factor in accepting medical liability for lack of information is the causal link between the omission and the damage. If, for example, the patient has been informed of the risk that eventually occurred, but not of the risks that eventually did not occur, it should be considered that the information given were complete, according to the German Federal Court. This was accepted in the Robodoc case,[69] where a new robotic machine was used to cut and implant the femoral head, for whose use all dangers were unknown. However, the patient was informed by the medical team who used it, to be at risk of contracting the sciatic nerve, which eventually occurred during surgery. However, since the patient was informed of the specific risk, the information given was considered complete and the patient’s consent was valid. It was even considered that the patient should be able to determine, if he prefers the old method with the known risks or the new taking into account the advantages, but also the fact that certain risks remain unknown.

The patient claimed he would not be injured if another conventional method was applied. The doctors, however, explained to the patient all the alternative conventional methods and presented their positive and negative aspects. In 2005, studies had shown an increased risk of complications with respect to the destruction of the nerve from laser application in relation to manual surgery. However, such indications or assertions did not exist in 1995 according to the professor-expert. The doctor is free to choose the right therapeutic method and this contributes to medical advancement. On the other hand, the patient was informed about the benefits, the disadvantages, and the risks of the method, so the doctor was not convicted and the claim for damages was not accepted. It is, therefore, clear that the physician should inform the patient by comparing the positive and negative aspects of the old and the new methods, but the weighting of the disadvantages and benefits lies with the patient, even if he chooses the most unfavorable method to his health.[70]

3. New medicines and their application choice

Even in the peculiar case of new drug tests, the rule for exempting doctors from liability remains the same: comparing old medications with new drugs and informing the patient of the fact that not all of the risks involved in its application have been identified. In addition, the doctor who suggests new medication should also recommend regular checkups. For example, if it is not known whether it affects vision, regular (monthly) ophthalmologic tests should be proposed. If the doctor does not give this information and the patient experiences visual impairment, the doctor will be liable for inadequate information.[71]

With regard to the application of medicines, the Greek courts dealt with a case in which an aesthetic institute used a medicine manufactured by the Institute’s doctor in contravention with the commonly recognized methods of medical science and misrepresenting the method as a widely recognized and absolutely safe one. This operation resulted in a malformation in the chest of the patient (edema and small tumors) over a period of time, which was also due to the application of the completely inappropriate, privately prepared medicine. Both the violation of medical rules (medical error) and the inadequate information of the patient led the Greek Supreme Court in condemning the Institute to pay damages, both material and moral, to the patient.[72]

E. CONCLUSIONS

Informing the patient not only ensures his/her autonomy but also transfers the responsibility for choice of the healing method to them, as freedom also entails responsibility. The doctor no longer needs to patronize the patient`s “benefit” and health but simply to present the negative and positive consequences of any old or new medical method.

The extent of the doctor’s obligation to inform the patient is extended when new treatments are applied because, prior to their application, the practitioner should also be aware of the risks that cannot be ruled out but their probability is not proven due to the lack of research results as for example the effect on the vision of a new drug or the effect of entering a new kind of Racz catheter in the urinary and gastrointestinal system.

A lack of reference to the unexplained risks of new methods is balanced by prompting the patient for continuous medical checks at the stage of applying these new methods or taking the new drugs. Like Alexander the Great was asking for divination before beginning his conquests, so is – and must be – the ignorant of medical methods entitled to ask his doctors what is likely to follow. This patient-doctor information relationship strengthens trust between them and makes it immune. Then the lawyer becomes unnecessary and shall stay silent in admiration of this harmonious relationship.

 

 

[1] See law 3418/2005, Official Journal of the Greek Government Α 287/28-11-2005). [in greek]

[2] Indicatively State Ombudsman cases No. 149065, 157738 & 159858. [in greek]

[3] See Circular of the Directorate for State-Citizen Relations f. 18/15584/10-07-2006, also referred to in the 2012 Code of Good Administrative Behaviour. [in greek]

[4] State Ombudsman cases No. 14906 & 157738. [in greek]

[5] State Ombudsman case No. 164864. [in greek]

[6] Laskaridis, Εqualization of the legal force of private and public certificates, Digesta 2009, p. 358. [in greek]

[7] Psaroulis-Voultsos, Elements of bioethics, p. 17 (2010) [in greek]; Laskaridis, Elektronische Patientenakte, pp. 302-304 (2013).

[8] Georgiades, General Principles of Civil Law, §12 No. 2 (2012). [in greek]

[9] Androulakis-Dimitriades, The obligation of patient information, p. 282 (1993) [in greek]. Concerning the legal consequences of defective information in Germany see Heinz, Anforderungen an Aufklärung und Dokumentation, Rechtsfolgen, Hessisches Ärzteblatt, pp. 688 & 692 (2012).

[10] Greek Civil Code, Art. 57.

[11] Greek Criminal Code, Art. 308 §2.

[12] Greek Criminal Code, Art. 304.

[13] Indicatively: Reibl v Hughes 114 DLR (3d) 1; Creutzfeldt-Jakob Disease Litigation (1995) 54 BMLR 1 (QBD); Appleton and Others v. Garrett 34 BMLR 23 (QBD).

[14] Characteristic distinction between “real” and “effective” consent. See J. Briston`s opinion on Chatterton v. Gerson [1981] QB 432 (QBD).

[15] Jackson, Medical Law, p. 267 (2006).

[16] Ian Kennedy, The Fiduciary Relationship and its Application to Doctors in P.BIRKS, WRONGS AND REMEDIES IN THE TWENTY-FIRST CENTURY, pp. 111-114 (Clarendon Press Oxford 1986).

[17] Jackson, Medical Law, p. 267 (2006).

[18] Stathopoulos, General Contract Law, §8 No. 75 (2004). [in greek]

[19] Analogously: the personal relation in employment relationship, Greek Civil Code, Art. 651.

[20] Supra note 9, pp. 226-227; Fountedakis, Medical civil liability, p. 293; Panagopoulou-Koutnatzi, Interpretation of the Code of Medical Law, Art. 3 para. 1. [in greek]

[21] Dougalis, Interpretation of the Code of Medical Law, Art. 11 para. 3 citing Androulakis-Dimitriades (2013). [in greek]

[22] «Katheter Racz», 2007 BGH NJW, 2774 para. 6.

[23] Papadopoulou-Klamari, The mediacal team, Greek Symposium of Medical Law and Bioethics (2014); supra note 9, p. 227 [in greek]; in cases of organizational omissions concerning information see 1998 BGH, NJW, 1784.

[24] Athens Civil Court of First Instance 1449/2007, 1006 Armenopoulos (2009) [in greek]; Chester v. Afashar (2004) UKHL 41, 3 WLR 927.

[25] Greek Code of Medical Law, Art. 11 para. 1 and 12 para. 2.

[26] Kanellopoulou-Botti, Interpretation of the Code of Medical Law, Art. 11 No. 3-5. [in greek]

[27] Heinz, Hessisches Ärzteblatt, pp. 688, 691 (2012).

[28] Laskaridis, Telemedicine and Civil Liability, Presentation at the Greek Congress of Medical Law and Bioethics (2014). [in greek]

[29] Androulakis-Dimitriades, The obligation of patient information, p. 219-221 (1993); Bergmann, Die Arzthaftung pp. 68-69 (1999). [in greek]

[30] Law 2472/1997, Art. 2 lit. (b).

[31] Laskaridis, Interpretation of the Code of Medical Law, Art. 14 No. 20 citing State Ombudsman case No. 164352. [in greek]

[32] Androulakis-Dimitriades, The obligation of patient information, pp. 221-225 (1993). [in greek]

[33] Supra note 29.

[34] BGH 20.06.1988 – VI 2R 288/87, NJW 1988, 2946.

[35] Androulakis-Dimitriades, The obligation of patient information, p. 251 (1993) [in greek]; Heinz, Anforderungen an Aufklärung und Dokumentation, Rechtsfolgen, Hessisches Ärzteblatt,  pp. 688-689 (2012); Zweibrücken, GesR 2005, p. 23.

[36] BGH NJW 1985, 1399; Heinz, Hessisches Ärzteblatt 688-690 (2012); BGH MedR 1996, pp. 272 & 274. Laskaridis, Elektronische Patientenakte, pp. 57-58 (2012); Androulakis-Dimitriades, supra note 35, p. 258; supra note 26, Art. 11 No. 17.

[37] OLG Brandenburg Appeal GesR 2007, 575.

[38] BGH NJW 1985, 1399; Androulakis-Dimitriades, supra note 35, p. 258; supra note 26, Art. 11 No. 17.

[39] Bergmann, Die Arzthaftung, pp. 78-79 (1999).

[40] Heinz, Hessisches Ärzteblatt, pp. 688-690 (2012).

[41] Androulakis-Dimitriades, supra note 35, pp. 261-269; Bergmann, Die Arzthaftung pp. 66-67 (1999); Heinz, Hessisches Ärzteblatt, pp. 688-689 (2012); Kanellopoulou-Botti, Medical liability for poor or non-information of the patient in the Greek and English law, pp. 84-93(1999) [in greek]; Fountedaki, Civil Medical Liability, pp. 178-180 (2003). [in greek]

[42] Thessaloniki`s Court of Appeal 1905/2002, paras. 386-394.

[43]Bergmann, supra note 39 p. 72; OLG Koblenz, 5 U 1298/07, Jan. 30th, 2008.

[44] BGH, NJW 1998, 2734; BGH NJW 1992, 2351.

[45] BGH NJW 1992, 2351.

[46] State`s Ombudsman Case No. 11330.2/00/30-10-2002. [in greek]

[47] Androulakis-Dimitriades, supra note 35, pp. 271-272; Kanellopoulou-Botti, Medical liability for poor or non-information of the patient in the Greek and English law pp. 132-142(1999); Meimari, Contact as a substantial factor in the medical act in Kanellopoulou-Botti, Medical Liability and Bioethics, pp. 58-58 (2014). [in greek]

[48] 48 BMLR 118.

[49] Androulakis-Dimitriades, supra note 35, pp. 130-132; Kanellopoulou-Botti, Interpretation of the Code of Medical Law, Art. 11 No. 1. [in greek]

[50] Laskaridis, Elektronische Patientenakte, pp. 30-63 (2003); Laskaridis, The obligation to keep medical records, Digesta, pp. 294 & 302-304 (2005) [in greek]; Laskaridis, Interpretation of the Code of Medical Law, Art. 14 No. 4. [in greek]

[51] 114 DLR (3d) 1. See commentary: Mason/McCall Smith/Laurie, Law and Medical Ethics No. 10.89, 10.91, 10.98, 10.115, 10.121 (2002); Jackson, Medical Law, p. 276(2006).

[52] BGH NJW 2007, 2767, 2769 para. [20].

[53] 37 ΒΜLR 192.

[54] Jackson, Medical Law, pp. 289-290 (2006).

[55] The Times, 29 July 1978.

[56] Jackson, supra note 54, p. 266.

[57] «NOMOS”; Kanellopoulou-Botti, Interpretation of the Code of Medical Law, Art. 11 No. 3-4. [in greek]

[58] Piraeus Court of the First Instance 4591/2009, Digesta, 417-443.

[59] ibidem.

[60] Thrace Court of Appeal 62/2001, “NOMOS”.

[61] State`s Ombudsman Case No 13218/26-11-2001, Criminal Justice, 153-157 (2002). [in greek]

[62] Panagopoulou-Koutnatzi, Interpretation of the Code of Medical Law, Art. 3 No. 2. [in greek]

[63] ibid.

[64] Ibid, Art.  3 No. 3; Athens Court of Appeal 5512/2003, “Justice”, p. 198 (2004).

[65] Robodoc case ΒGH NJW 2006, 2477, 2476, para. [14].

[66] Trokana, Human Reproduction: Private autonomy and boundaries, p. 8-15 (2013). [in greek]

[67] Robodoc case ΒGH NJW 2006, 2477, 2476, para. [14].

[68] BGH NJW 2007, 2774 paras. [31] & [32].

[69] Robodoc case, BGH NJW 2006, 2477.

[70] ibid.

[71] BGH NJW 2007, 2767-2769.

[72] Areios Pagos  (Greek Supreme Court) 1250/2003, “Criminal Justice”, 1251 (2004).

Back To Top