Information Note on the Court’s case-law 213

December 2017

Lopes de Sousa Fernandes v. Portugal [GC] - 56080/13

Judgment 19.12.2017 [GC]

Article 2

Positive obligations

Article 2-1

Life

Alleged medical negligence resulting in patient’s death: no violation

Effective investigation

Failure to conduct adequate and timely inquiry into death resulting from suspected medical negligence: violation

Facts – In November 1997, following an operation for the extraction of nasal polyps, the applicant’s husband developed bacterial meningitis, which was not detected until two days after he had been discharged from hospital. He was re-admitted to hospital several times, sufferi ng from acute abdominal pain and diarrhoea. He died three months after the operation from the consequences of septicaemia caused by peritonitis and hollow viscera perforation.

In 1998 the applicant wrote a letter of complaint to the authorities stating tha t she had received no response from the hospitals to explain the sudden deterioration in her husband’s health and his death. In response to her letter, the Inspector General for Health initiated an investigation and eventually, in 2006, ordered the opening of a disciplinary procedure against one of the doctors; however, those proceedings were stayed pending the outcome of criminal proceedings that had been started in 2002. The criminal proceedings ended in 2009 with the doctor’s acquittal on a charge of hom icide with gross negligence. In separate proceedings the Medical Association regional disciplinary council decided to take no further action after concluding that there was no evidence of misconduct or medical negligence. Lastly, a civil action for damages commenced by the applicant in 2003 was dismissed in a judgment of 2012 that was ultimately upheld by the Supreme Administrative Court in 2013.

In the Convention proceedings, the applicant complained under Article 2 about the death of her husband in hospital as a result of a hospital-acquired infection and of carelessness and medical negligence. She further complained that the disciplinary, crimin al and civil authorities to which she had applied had failed to elucidate the precise cause of the sudden deterioration in her husband’s state of health and about the duration and outcome of the domestic proceedings.

In a judgment of 15 December 2015 a Ch amber of the Court held, by five votes to two, that there had been a violation of Article 2 (right to life) of the Convention, under its substantive head, and unanimously, a violation of Article 2 under its procedural head.

Law – Article 2

(a) Substantive limb – After reviewing its case-law in medical negligence cases, the Court considered it necessary to clarify its approach as follows.

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

Even in cases where medical negligence is established, the Court would normally find a substantive violation of Article 2 only if the relevant regulatory framework failed to ensure proper protection of the patient’s life. Where a Contracting State has made adequate provision for securing high professional standards among health professionals and the protection of the lives of patients, matters such as an error of judgment on the part of a health professional or negligent coordination among health profession als in the treatment of a particular patient cannot be considered sufficient of themselves to call a Contracting State to account from the standpoint of its positive obligations under Article 2 of the Convention to protect life.

The question whether there has been a failure by the State in its regulatory duties calls for a concrete rather than an abstract assessment of the alleged deficiencies. In this regard, the Court’s task is not normally to review the relevant law and practice in abstracto , but to dete rmine whether the manner in which they were applied to, or affected, the applicant gave rise to a violation of the Convention. Therefore, the mere fact that the regulatory framework may be deficient in some respect is not sufficient in itself to raise an i ssue under Article 2. It must be shown to have operated to the patient’s detriment.

It must, moreover, be emphasised that the States’ obligation to regulate must be understood in a broader sense which includes the duty to ensure the effective functioning o f that regulatory framework. The regulatory duties thus encompass necessary measures to ensure implementation, including supervision and enforcement.

On the basis of this broader understanding of the States’ obligation to provide a regulatory framework, th e Court has accepted that, in the very exceptional circumstances described at (a) and (b) below, the responsibility of the State under the substantive limb of Article 2 of the Convention may be engaged in respect of the acts and omissions of health-care pr oviders, namely where:

(a) an individual patient’s life is knowingly put in danger by denial of access to life-saving emergency treatment; this exception does not extend to circumstances where a patient is considered to have received deficient, incorrect or delayed treatment; or

(b) where a systemic or structural dysfunction in hospital services results in a patient being deprived of access to life-saving emergency treatment and the authorities knew about or ought to have known about that risk and failed to take the necessary measures to prevent that risk from materialising, thus putting patients’ lives, including that of the particular patient concerned, in danger.

The Court was aware that on the facts it may sometimes not be easy to distinguish between c ases involving mere medical negligence and those where there is a denial of access to life-saving emergency treatment, particularly since there may be a combination of factors which contribute to a patient’s death. For a case to fall in the latter category , the following factors, taken cumulatively, must be met: (i) the acts and omissions of the health-care providers must go beyond a mere error or medical negligence, in so far as those health-care providers, in breach of their professional obligations, deny a patient emergency medical treatment despite being fully aware that the person’s life is at risk if that treatment is not given; (ii) the dysfunction at issue must be objectively and genuinely identifiable as systemic or structural in order to be attribu table to the State authorities, and must not merely comprise individual instances where something may have been dysfunctional in the sense of going wrong or functioning badly; (iii) there must be a link between the dysfunction complained of and the harm wh ich the patient sustained; and (iv) the dysfunction at issue must have resulted from the failure of the State to meet its obligation to provide a regulatory framework in the broader sense indicated above.

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The Court found on the facts that there was not sufficient evidence of (i) a denial of healthcare, (ii) a systemic or structural dysfunction affecting the hospitals where the applicant’s husband was treated or (iii) a fault attributable to the health-care professionals going beyond a mere error or medi cal negligence or failure by the health-care professionals to discharge their professional obligations to provide emergency medical treatment. The case thus concerned allegations of medical negligence, which meant that Portugal’s substantive positive oblig ations were limited to the setting-up of an adequate regulatory framework compelling hospitals, whether private or public, to adopt appropriate measures for the protection of patients’ lives. Having regard to the detailed rules and standards laid down in t he domestic law and practice of the respondent State in the area under consideration, the Court considered that the relevant regulatory framework did not disclose any shortcomings as regards the State’s obligation to protect the applicant’s husband’s right to life.

Conclusion : no violation (fifteen votes to two).

(b) Procedural limb – The Grand Chamber reiterated that the procedural obligation under Article 2 in the context of health care required, inter alia , that the proceedings be completed within a re asonable time. Apart from the concern for the respect of the rights inherent in Article 2 in each individual case, the prompt examination of cases concerning medical negligence in a hospital setting was also important for the safety of all users of health- care services. The length of all three sets of domestic proceedings in the applicant’s case (disciplinary, criminal and civil) had been unreasonable.

In addition, for the purposes of the procedural obligation of Article 2, the scope of an investigation fac ed with complex issues arising in a medical context could not be interpreted as being limited to the time and direct cause of the individual’s death. Where there was a prima facie arguable claim of a chain of events possibly triggered by an allegedly negli gent act that may have contributed to the death of a patient, in particular if an allegation of a hospital-acquired infection is concerned, the authorities may be expected to conduct a thorough examination into the matter. No such examination had been cond ucted in the instant case in which the domestic courts, instead of carrying out an overall assessment, approached the chain of events as a succession of medical incidents, without paying particular attention to how they may have related to each other.

In s um, the domestic system as a whole, when faced with an arguable case of medical negligence resulting in the death of the applicant’s husband, had failed to provide an adequate and timely response consonant with the State’s obligation under Article 2.

Concl usion : violation (unanimously).

Article 41: EUR 23,000 in respect of non-pecuniary damage; claim in respect of pecuniary damage dismissed.

(See also the section on “Liability of health professionals” in the Factsheet on Health )

© Council of Europe/European Court of Human Rights This summary by the Registry does not bind the Court.

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