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European Court of Human Rights

In: European Journal of Health Law
Authors:
Tom Goffin Professor of Health Law, Faculty of Medicine and Health Sciences, University of Ghent Ghent Belgium

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Joseph Dute Emeritus Professor of Health Law, Faculty of Law, Radboud University Nijmegen The Netherlands

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Open Access

These summaries are based on the provisional text of the judgements of the European Court of Human Rights. These judgments are still subject to editorial revision before their reproduction in Reports of Judgments and Decisions. For the full provisional text, see: http://www.echr.coe.int.

Many cases of the European Court of Human Rights with regard to COVID-19 and human rights are still pending. We refer to the following document: https://www.echr.coe.int/Documents/FS_Covid_ENG.pdf for an overview with regard to these cases.

ECHR 2022/2 Case of Botoyan vs. Armenia, no. 5766/17

The Facts

On 6 February 2008 the applicant fell on the stairs and broke her left leg. On the same date she was taken by ambulance to Artik Medical Centre, a public hospital under the control of the Shirak regional authority. According to the applicant’s medical file, she was admitted to Artik Medical Centre at 10.30 p.m. on 6 February 2008. The file further stated that the applicant had been admitted for inpatient treatment in the surgical department and was diagnosed with a closed comminuted fracture of the left distal tibia (lower leg bone) with significant displacement. On 7 February 2008 Dr A.A., a general surgeon at Artik Medical Centre, operated on the applicant. The surgery included the insertion of metal implants into her leg to stabilise the bone fracture. The applicant’s medical file also stated the type of medical intervention, its date and time and the type of anaesthetic administered. According to the medical file, the applicant had been informed that she had received treatment under the public healthcare system. This was confirmed by her signature in the relevant part of the file.

According to the Government, prior to the surgery the applicant was informed orally of the consequences, in particular, that she would be able to walk but not in the same way as before. The Government averred that the applicant had also been informed that the surgery would be performed free of charge under the public healthcare system. The applicant partially contested this argument, claiming that she had only been informed of the financial aspects of the surgery but not as to the possible risks of the medical intervention. Nor had she been informed of the origin of the metal implants used – she had not been asked to pay for them and they had not been obtained under the public healthcare system.

On 13 March 2008 the applicant was discharged. She was not provided with any medical documents attesting to her state of health. Following her discharge from hospital, the applicant remained under Dr A.A.’s supervision: he visited her several times at home, enquired about her condition and personally treated her wound. In the meantime, the applicant’s wound became infected, she suffered from fevers regularly and her leg started to hurt. On 26 May 2008 the applicant was operated on by Dr K.K., a traumatologist at G. Gyulbenkyan Surgical Hospital in Gyumri. During the operation the metal implants were removed from her leg. She remained under medical supervision for a month following discharge.

The Law

Alleged Violation of Article 8 of the Convention

Relying on Article 8 of the Convention, the applicant complained that her disability had resulted from inadequate medical care received at Artik Medical Centre. She also complained that there had been no specific regulations relating to orthopaedic surgery in force at the relevant time and that she had not been informed of the nature and risks of the procedure before her operation. She lastly complained of the lack of an effective mechanism enabling her to hold accountable those at fault and obtain adequate redress.

(i) General remarks

It is well established that although the right to health is not as such among the rights guaranteed under the Convention or its Protocols,1 the High Contracting Parties have, parallel to their positive obligations under Article 2 of the Convention, a positive obligation under Article 8, firstly, to have in place regulations compelling both public and private hospitals to adopt appropriate measures for the protection of their patients’ physical integrity and, secondly, to provide victims of medical negligence with access to proceedings in which they can, where appropriate, obtain compensation for damage.2

The Court reiterates that the principles which emerge from its case-law under Article 2 of the Convention in the field of medical negligence also apply under Article 8 when it comes to breaches of physical integrity that do not involve the right to life.3

The Court notes that there is nothing to indicate that the damage to the health of the applicant was caused intentionally. Furthermore, no issue of knowingly endangering an individual’s physical integrity by denial of access to relevant treatment was raised either at domestic level or before the Court. Nor was there any question of a systemic or structural dysfunction in hospital services. Therefore, the present case does not fall within the two exceptional categories of cases directly engaging State responsibility for the acts and omissions of healthcare providers. Under these circumstances, the Court was unable to find a Convention breach on the sole basis of the doctor’s alleged negligence in performing the medical procedure on the applicant. The applicant’s complaints, however, mainly refer to the absence at the material time of a relevant regulatory framework, the failure to provide her with information about the procedure and the associated risks and an inadequate response from the authorities.

(ii) Absence of a relevant regulatory framework

In the context of alleged medical negligence, the States’ substantive positive obligations relating to medical treatment are limited to a duty to have in place an effective regulatory framework compelling hospitals, whether private or public, to adopt appropriate measures for the protection of patients’ health.

Having regard to the material before it, the Court takes note of the fact that at the material time there was a requirement that medical practitioners hold a licence corresponding to their specialisation to practise certain types of medical activity (namely section 18 of the Medical Care Act). At the same time, there were no legal regulations regarding the surgical specialisms of general surgery and traumatology and orthopaedics or regarding the procurement of orthopaedic appliances.

The Court takes further note of the fact that it was established in the course of the criminal proceedings relating to the applicant’s complaints of medical malpractice that her surgery had been performed by a medical practitioner who did not have the relevant specialisation. It was also established that during the surgery in question, metal implants not officially obtained by Artik Medical Centre had been placed in the applicant’s leg. These facts are not in dispute between the parties.

That said, the Court observes that although it was indicated in the additional forensic report that the nature of the applicant’s trauma had required specialist treatment which was not within the scope of Dr A.A.’s qualifications, the experts nevertheless concluded that her surgery had generally been performed correctly and that the complications which had arisen at the post-operative stage were not directly linked to the fact that she had not been operated on by a relevant specialist. In addition, even though they did not specifically address the question of the possible link between the post-operative complications experienced by the applicant and the metal implants used during her surgery, the forensic experts found no established link between those complications and any failures, omissions or errors on the part of the personnel of the Artik Medical Centre.

The Court notes in this connection that the mere fact that the regulatory framework may be deficient in some respect is not sufficient in itself to raise an issue under Convention. It must be shown to have operated to the patient’s detriment. In the Court’s opinion, in the present case there is insufficient evidence to demonstrate that the regulatory deficiencies mentioned operated to the applicant’s detriment. That is, in the material before the Court there is insufficient evidence to indicate that the deficiencies at issue led or contributed to the damage caused to the applicant’s health.

(iii) Informed consent

The Court has stressed the importance for individuals facing risks to their health to have access to information enabling them to assess those risks. It has considered it reasonable to infer from this that the Contracting States are bound, by virtue of this obligation, to adopt the necessary regulatory measures to ensure that doctors consider the foreseeable consequences of a planned medical procedure on their patients’ physical integrity and to inform patients of these consequences beforehand, in such a way that the latter are able to give informed consent.

With regard to this case, the Court notes that there was a relevant legal framework allowing individuals facing risks to their health to have access to information enabling them to assess those risks. In particular, a patient had the right to be informed of, inter alia, the methods of diagnosis and treatment of the disease and the related risks, as well as the consequences and results of treatment. Furthermore, a patient’s consent to a medical procedure, which could be given in writing at the request of the patient or the relevant medical practitioner, was a necessary precondition for receiving the proposed treatment. Thus, the Court does not consider that the regulatory framework for obtaining a patient’s informed consent was defective.

(iv) Access to a procedure capable of establishing the relevant facts, holding accountable those at fault and providing the applicant with appropriate redress

In determining whether the State has fulfilled its positive procedural obligation to set up an effective independent judicial system, the Court examines whether the available legal remedies, taken together, as provided for in law and applied in practice, secured the effective legal means capable of establishing the relevant facts, holding accountable those at fault and providing appropriate redress to the victim.4

At the same time, the Court notes that the choice of means for ensuring that the positive obligations under the Convention are fulfilled is in principle a matter that falls within the Contracting State’s margin of appreciation. There are different avenues for ensuring that Convention rights are respected, and even if the State has failed to apply one particular measure provided by domestic law, it may still fulfil its positive duty by other means. However, for this obligation to be satisfied, such proceedings must not only exist in theory but also operate effectively in practice.

With respect to this case, the Court observes that the applicant initially complained about her treatment by Dr A.A. to various State agencies and then sought to establish the latter’s liability in criminal proceedings. In those proceedings she alleged, in particular, that she had been the victim of medical malpractice, which had resulted in serious damage to her health, and that she had not been informed about the risks of the medical intervention she had undergone. She did not bring a civil claim for damages, arguing that it would have been ineffective.

In this connection, the Court reiterates that in view of the broad margin of appreciation enjoyed by the High Contracting Parties in laying down their healthcare policy, and in choosing how to comply with their positive obligations and organise their judicial systems, there is no basis on which to hold that the Convention requires a special mechanism which facilitates the bringing of medical malpractice claims at domestic level. It should further be borne in mind that in discharging their positive obligations towards the alleged victims of medical malpractice, the authorities must also have regard to counter-considerations, such as the risk of unjustifiably exposing medical practitioners to liability, which can compromise their professional morale and induce them to practise, often to the detriment of their patients, what has come to be known as “defensive medicine”.5

Furthermore, in medical negligence cases, where the infringement of the right to physical integrity is not caused intentionally, the positive procedural obligation, which concerns the requirement to set up an effective judicial system, will be satisfied if the legal system affords victims a remedy in the civil courts, either alone or in conjunction with a remedy in the criminal courts, enabling any liability of the doctors concerned to be established and any appropriate civil redress to be obtained. Disciplinary measures may also be envisaged.6 In such cases, therefore, the Court, having regard to the particular features of a respondent State’s legal system, has required applicants to make use of the legal avenues whereby they could have their complaints of medical negligence duly considered. This is because of the rebuttable presumption that any of those procedures, notably civil redress, are in principle apt to satisfy the State’s obligation to provide an effective judicial system. Therefore, the positive procedural obligation under Article 8 to set up an effective judicial system did not necessarily call for a criminal-law remedy on the facts of the instant case. However, if deemed effective, such proceedings would by themselves be capable of satisfying the procedural obligation of Article 8.7

In the present case, the Court observes that the criminal-law remedy was made available to the applicant and that she pursued it. In view of the facts of the present case and the state of the domestic criminal law, her recourse to the criminal-law remedy does not appear unreasonable. This is also evident from the fact that the domestic authorities instituted criminal proceedings and carried out a criminal investigation into the possibility that the damage to the applicant’s health had been caused by the negligent performance of Dr A.A.’s professional duties.

The investigation into the applicant’s allegations of malpractice, with reference to the findings of experts, the objectivity of which was at no point questioned by her, did not reveal a direct causal link between the damage to her health and the medical treatment provided to her by Dr A.A. Although it was established that Dr A.A. had operated on the applicant without having the relevant qualifications for the surgery in question and had implanted metal devices of unknown origin into her leg, the investigative bodies and, subsequently, the courts found that he was not subject to criminal liability. The Court notes here that, except in cases of manifest arbitrariness or error, it is not its function to call into question findings of fact made by the domestic authorities, particularly when it comes to scientific expert assessments, which by definition call for specific and detailed knowledge of the subject.8

That said, the Court observes that at no point during the investigation or court proceedings were the applicant’s complaints with regard to the absence of her informed consent to the surgery and its possible risks examined. Notably, the courts carrying out a judicial review of the decisions of the investigative authorities did not decline jurisdiction to examine the applicant’s complaints in that regard. The Court further observes that, after it was established that the metal implants used during the applicant’s surgery had not been officially sourced by the hospital but had been left with Dr A.A. by another patient more than a year before the surgery, the applicant specifically complained about the fact that the investigation had failed to clarify whether those metal implants had been good for use and whether there was a link between Dr A.A.’s actions and the complications she had experienced. However, her complaints in this regard were also either left unexamined or rejected with reference to the absence at the relevant time of regulations concerning the sourcing of metal implants, without addressing the substance of the applicant’s complaint in that regard.

In the Court’s view, the matters raised by the applicant concerned important factual issues pertaining to the medical care provided to her and the possible liability of the health professionals involved, which called for a proper examination. However, as noted above, those matters were not addressed in the course of the criminal proceedings, which leads the Court to conclude that they did not meet the requirement of thoroughness.

In view of the above shortcomings, the Court considers that the criminal proceedings in the present case were not effective for the purposes of Article 8. It is further necessary to examine whether the applicant had a civil-law remedy available to her. In particular, considering that the applicant only pursued the criminal-law remedy, the Court has to determine whether it was incumbent on her to pursue the civil-law remedy in order to dispose of the obligation to exhaust domestic remedies. This requires establishing, firstly, whether the civil-law remedy was effective in theory and in practice at the relevant time; that is to say that the remedy was accessible, capable of providing redress in respect of the applicant’s complaints and offered reasonable prospects of success and, secondly, whether it would pursue essentially the same objective as the criminal-law remedy, that is to say, whether the civil-law remedy would add any essential elements that were unavailable through the use of the criminal-law remedy.9

The Government argued that the applicant could have brought a civil action against Artik Medical Centre on the basis of Articles 1058 and 1062 of the Civil Code. They relied on two examples of domestic case-law where the civil courts had examined medical negligence claims. It appears that in Armenia compensation for damage to health can in principle be claimed under tort law or contract law. Indeed, the domestic case-law relied on by the Government shows that medical negligence claims have been the subject of adjudication before the civil courts. That said, the Court notes, however, that compensation for non pecuniary damage is not included in the general right to compensation under domestic law. In particular, although Article 17 of the Armenian Civil Code includes the possibility of claiming compensation for non-pecuniary damage, it is clear from other articles of the same Code that such a possibility is strictly limited to claiming compensation for non-pecuniary damage from the State for an established violation by State or local governance bodies or their officials of the fundamental rights guaranteed under the Convention. In so far as the Government argued that, Artik Medical Centre being a public hospital, the applicant could have claimed compensation for non pecuniary damage from the State directly under Article 162.1 of the Civil Code, as amended since 1 January 2016 to provide for the possibility of claiming compensation for non-pecuniary damage for a violation of the rights protected by the Armenian Constitution and the Convention, the Court observes the following. It is true that while those provisions entered into force long after the applicant’s operation which gave rise to her complaints, it appears that in principle her claim would not be statute-barred. That said, the Court notes that the newly introduced Article 162.1 of the Civil Code states that a person may claim compensation for non pecuniary damage from the State if a violation has been established by a judicial ruling. At the same time, the newly introduced Article 1087.2 of the same Code, which sets out the relevant procedure, provides that a claim against the State for compensation for non pecuniary damage may be submitted to a court together with a claim seeking to establish a breach of the rights guaranteed by the Convention. The Court observes, however, that in accordance with the current practice, the domestic courts require that a claim for compensation for non-pecuniary damage for a violation of a Convention right be based on a decision of the prosecuting authority or a court ruling obtained in another set of judicial proceedings. Furthermore, there is nothing to suggest that under domestic law a public hospital can be subject to litigation as a State or administrative body in the civil or administrative courts. The Court observes, in this connection, that section 1 of the Armenian Medical Care Act expressly states that public hospitals are not State bodies, while it does not follow from section 3 of the Fundamentals of Administration and Administrative Procedure Act that a public hospital could be considered an administrative body within the meaning of that provision. Therefore, having regard to the above-mentioned provisions of domestic law and in the absence of any domestic case-law provided by the Government, the Court finds that there is nothing to support their argument that compensation in respect of non-pecuniary damage could be claimed from the State directly in relation to the activity of a public hospital. Besides, the present case does not fall within the two exceptional categories of cases directly engaging State responsibility for the acts and omissions of healthcare providers. In those circumstances, it is very doubtful what prospects of success, if any, a claim seeking to establish a breach of Article 8 of the Convention by the State on account of the alleged medical malpractice by Dr A.A. could have had so that, as argued by the Government, it could have resulted in compensation for non-pecuniary damage based on Article 162.1 of the Civil Code.

In these circumstances, the Court finds that it has not been established that there was an effective civil-law remedy capable of providing redress in respect of the applicant’s complaints and offering reasonable prospects of success. In view of this finding, the Court considers that it is not necessary to further determine whether the civil-law remedy would have pursued essentially the same objective as the criminal-law remedy.

The Government also claimed that the applicant had had disciplinary remedies available to her. They further argued that an administrative action against the results of the consultations held following the applicant’s complaints to various State agencies had constituted an effective remedy for her complaints. The Court observes that in Armenia there are no professional disciplinary bodies with the authority to examine cases of medical malpractice. It is true that disciplinary measures may be applied by the relevant authorities, including the Ministry of Health. However, those measures are connected to employment regulations rather than the establishment of medical malpractice as such. As to the argument that the applicant could have contested the results of the consultations held by the Department of Health, the Court notes that the Government did not provide any examples of domestic administrative case-law where a “minutes of a consultation”, that is, the transcript of a meeting, had been considered an administrative decision subject to administrative judicial review. The Court observes, in this connection, that under domestic administrative law a person can seek a judicial review of an “administrative decision” which has been defined in the law as “a decision, instruction, order or other individual legal action” which has been adopted by an administrative body and which creates rights and obligations for the person concerned. At the same time, section 3 of the Armenian Fundamentals of Administration and Administrative Procedure Act, which sets out the types of administrative bodies with the authority to adopt administrative decisions, defines territorial governance bodies as governors. Furthermore, section 55 of the same act states that a written administrative decision must indicate the body, including the court, to which an appeal can be made and contain the official stamp of the administrative body which has adopted it. The Court observes that none of those requirements were met in the minutes of the consultations concerned.

The effectiveness of this remedy therefore appears highly questionable, all the more so since it is not clear what type of redress the applicant could have been provided with had she pursued such a complaint. In view of the foregoing, the Court considers that it cannot be said that the State provided the applicant with an effective procedure enabling her to bring her medical malpractice claim and obtain compensation for the medical malpractice to which she alleged to have fallen victim.

(v) Conclusion

For these reasons, the Court dismisses the Government’s objection of non-exhaustion of domestic remedies and concludes that there has been a violation of Article 8 of the Convention.

1

See ECHR, 28 November 2000, Fiorenza v. Italy (dec.), no. 44393/98; ECHR 11 juli 2006, Pastorino and Others v. Italy (dec.), no. 17640/02; and ECHR 12 October 2010, Dossi and Others v. Italy (dec.), no. 26053/07.”

2

See ECHR Trocellier v. France (dec.), no. 75725/01, ECHR 2006 XIV; ECHR 2 June 2009, Codarcea v. Romania, no. 31675/04; ECHR 25 September 2012, Spyra and Kranczkowski v. Poland, no. 19764/07; ECHR 15 January 2013, Csoma v. Romania, no. 8759/05; ECHR 23 September 2014, S.B. v. Romania, no. 24453/04.

3

See ECHR, 19 December 2017, Lopes de Sousa Fernandes v. Portugal [GC], no. 56080/13.

4

See ECRH 19 July 2018, Sarishvili-Bolkvadze v. Georgia, no. 58240/08, para. 79.

5

See ECHR 17 March 2016, Vasileva v. Bulgaria, no. 23796/10, and ECHR 2 May 2017 Jurica v. Croatia, no. 30376/13.

6

see ECHR Calvelli and Ciglio v. Italy [GC], no. 32967/96, ECHR 2002 I, and ECHR, Vo v. France [GC], no. 53924/00, ECHR 2004 VIII.

7

See ECHR 25 June 2019, Mehmet Ulusoy and Others v. Turkey, no. 54969/09.

8

See ECHR 21 October 2004, Počkajevs v. Latvia (dec.), no. 76774/01.

9

See ECHR 16 October 2018, Dumpe v. Latvia (dec.), no. 71506/13.

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