E.M. AND OTHERS v. ROMANIA
Inadmissible
Alvina Gyulumyan;Ján Šikuta;Johannes Silvis;Josep Casadevall;Luis López Guerra
1. The applicants, E.M., C.M. and I.L.M., are Romanian nationals who were born in 1939, 1962 and 1964 respectively and live in Bucharest. The first applicant is the mother of the second and third applicants. They were represented by Mr I. Olteanu, a lawyer practising in Bucharest. 2. The Romanian Government (“the Government”) were represented by their Agent, Ms C. Brumar, of the Ministry of Foreign Affairs. 3. The facts of the case, as submitted by the parties, may be summarised as follows. 4. Mr I.M., a reserve colonel (colonel în rezervă), was the first applicant’s husband and the second and third applicants’ father. On 30 May 2005 he died in hospital, aged seventy-three, following an operation and a twoweek convalescence period. 5. On 22 April 2005 Mr I.M. developed symptoms of icterus (a yellow discoloration of the skin or whites of the eyes, indicating excess a bile pigment in the blood) and, together with the applicants, went to the military clinic for a consultation. He underwent some tests and was immediately admitted to the Carol Davila Central Emergency Military Hospital (“the hospital”) for further investigations and treatment. His diagnosis was “cholestatic jaundice due to cholestatic calculus – left renal lithiasis clinically significant for approximately three days” (icter colestatic prin calcul colestatic – de circa trei zile litiază renală stânga). Neither the patient nor his family was informed of the diagnosis. An ultrasound scan performed that evening in the hospital revealed a pancreatic tumour and the patient was prescribed treatment by the doctor on duty, Dr C.D. After two days of treatment, the jaundice disappeared. The treatment continued for two more days. 6. On 26 and 27 April 2005 Dr C.D. ordered further examinations of the patient’s abdomen, pancreas and bile ducts. I.M. thus underwent a computerized tomography scan (a form of X-ray examination in which the X-ray source and detector rotate around the object to be scanned and the information obtained can be used to produce cross-sectional images by computer) on 3 May 2005 and an ultrasound endoscopy on 6 May 2005. An MRI test (magnetic resonance imaging, a non-invasive method of examination of body organs by recording the responses to radio waves, or other forms of energy, of different kinds of molecules in a magnetic field) was recommended but never carried out. Throughout this time, the applicants were at the hospital with the patient, but they were allegedly not given any information by the medical team. Dr C.D. conferred with his colleague Dr R.P. and decided, on the basis of the test results, that the patient probably had a pancreatic tumour of a kind requiring surgery. According to the applicants, neither the patient nor his family was properly informed of the diagnosis, the nature of the intervention, its risks, or its actual duration. The medical team told them that they were going to perform a “routine” operation lasting about an hour and a half, and which had a 100 % chance of success. 7. On 18 May 2005 Dr R.P., assisted by Drs C.D., V.S., and S.V., and by the specialist anaesthetist Dr D.C., performed the surgery and removed the tumour along with parts of the patient’s pancreas, stomach and duodenum. The intervention lasted for some seven hours. 8. The tests run after the surgery showed that the tumour had been benign. 9. The applicant was placed in the intensive care unit under the supervision of Dr D.C. He remained there until his death. The family was not officially allowed access to the intensive care unit until two days before the patient’s death. For the first few days after the operation, the patient’s general state was stable. However, his general health started to deteriorate and he developed a high fever. He was prescribed broad spectrum antibiotics, which were provided by his family, pending the results of further blood tests. 10. On 26 May 2005 blood tests were ordered and the results revealed the presence of two types of bacteria: klebsiella and meticillin-resistant staphylococcus. 11. Meanwhile, his health continued to deteriorate and he finally slipped into a coma. He was in this state when, on 27 May 2005, Dr R.P. operated on him again to remove an abscess and some blood clots which had formed after the first operation. 12. On 28 May 2005 the applicants spoke with the anaesthetist on duty, who – in Dr D.C.’s absence – acquainted them with the patient’s real diagnosis and informed them of the type of surgery he had undergone on 18 May and of the suspicion of a bacterial infection. On the evening of 28 May 2005 the patient died of septic shock and multiple organ dysfunctions; he was taken to the hospital mortuary. 13. The third applicant signed a discharge form provided by the hospital, which read: “... [we] request that no autopsy be performed as the cause of death is known and we have no complaints concerning the treatment and care provided by the medical and paramedical personnel.” 14. The applicants collected the deceased’s personal belongings and found that the medicine they had brought to the hospital had not been administered to the patient. 15. On 30 May 2005, while her father’s body was still in the hospital mortuary, the second applicant brought the case to the attention of the College of Doctors. She sent her complaint to both the Bucharest branch and the National Chamber of the College, by e-mail and by normal post. She informed both associations that her father had contracted a bacterial infection while in the intensive care unit of the hospital and asked that an autopsy be performed before the burial, which was scheduled for the following day. 16. The disciplinary committee of the Bucharest College of Doctors gave no reply to the request for an autopsy but opened an investigation into the patient’s death, hearing evidence from the applicants and the doctors. It gave its decision on 12 October 2005, ruling that no medical errors had been made, but reprimanding Dr R.P. for his failure to seek the patient’s consent before the surgery, as required by Law no. 46/2003. 17. The applicants objected to the committee’s conclusions and their appeal was heard by the superior disciplinary committee of the National College of Doctors. 18. Drs S.V. and V.S. from the medical team that had performed the surgery on 18 May 2005 submitted written statements to the effect that together they had sought the patient’s written consent before the intervention and that the consent form had been attached to the file. The statements were typewritten and identical. The head of the surgery department at the hospital submitted a written statement clarifying that no patients had been operated on in that period without a consent form being attached to their file. Dr I.P., a specialist doctor from a different hospital, was asked to comment on the treatment choices made by Dr R.P. He gave his opinion on 11 January 2006, stating that, in general, icterus was a condition that required surgical intervention under any circumstances, and that – according to the guidelines – the surgery performed in Mr I.M.’s case had presented a certain risk, but one that had not been increased by the patient’s age; he also considered that the postoperative complication and ensuing death had fallen within the generally accepted risks for such an operation. 19. On the basis of the evidence presented, on 7 July 2006 the National College of Doctors terminated the disciplinary proceedings against Dr R.P. Relying on the two written statements given by the two doctors, the authority considered it established that the patient’s consent had been obtained but that the consent form had been lost. 20. The second applicant lodged an action for the decision adopted on 7 July 2006 to be quashed, pointing out that Drs R.P. and D.C. (the anaesthetist) had disregarded the patient’s rights and well-being in that they had failed to perform all the requisite tests before the operation, in particular an MRI scan, and had failed to inform either the patient or his family of the real diagnosis and the risks of the surgery and to obtain the patient’s consent before the intervention; she also contended that the postintervention care had been deficient. She reiterated that the patient had contracted a bacterial infection in hospital, which in her opinion had contributed to his death. 21. On 14 March 2007 the Bucharest County Court gave judgment in the case. It noted that a criminal investigation had taken place, that the medical experts consulted by the prosecutor had expressed the opinion that the patient’s death had not been caused by medical error, and that on the basis of that opinion the case had been closed (see paragraph 26 below). It therefore dismissed the applicants’ action and upheld the decision of the National College of Doctors. 22. The second applicant appealed against the decision delivered by the County Court, but in a final decision of 23 November 2007 the Bucharest Court of Appeal dismissed the appeal and upheld the findings of the lower court. 23. On 14 June 2005 the second applicant lodged a criminal complaint against the doctors who had treated her father, naming in particular the two surgeons Drs R.P. and C.D. and the anaesthetist, Dr D.C. They addressed their complaint to the prosecutor’s office attached to the High Court of Cassation and Justice and the Bucharest military prosecutor’s office. As the doctors were career officers, the military prosecutor took over the case and opened an investigation into involuntary manslaughter. 24. Dr R.P. gave a statement before the military prosecutor. He maintained that the patient’s death had not been directly caused by the surgery and that it had been impossible to establish the cause of death beyond doubt as the family had refused an autopsy. Dr D.C. declared that the patient had received adequate treatment and his death had not been caused by medical negligence. 25. The prosecutor sought the advice of the Mina Minovici National Institute for Forensic Medicine (“the National Forensic Institute”), asking it to explain the nature and cause of death, whether the treatment had been appropriate to the diagnosis, whether there had been errors of medical practice and conduct (erori de tehnică şi conduită medicală) and, if so, how such errors had contributed to the patient’s death. 26. On 6 September 2005 the National Forensic Institute issued an expert medical report regarding the case. It took into account the patient’s medical log during his stay in the hospital and the opinion expressed in general terms about Mr I.M.’s condition by Dr B.M., a specialist surgeon at a different hospital from the one where the patient had been treated. It concluded that the cause of death had been multiple organ failure and sepsis occurring during the evolution of a post-surgical abscess. It considered that the treatment had been appropriately determined and administered and that there had been no medical errors at any stage (diagnosis, medical treatment, surgery and post-surgical care). 27. On the basis of the conclusions of the expert medical report, on 13 October 2005 the prosecutor decided not to prosecute Drs R.P. and C.D. 28. The first and second applicant objected to the outcome of the prosecutor’s investigation. They pointed out, in particular, that the expert medical report had failed to examine the question of the bacterial infection contracted in the hospital and that the prosecutor had not taken account of the absence of consent for the surgery. 29. On 8 December 2005 the Chief Prosecutor of the Bucharest Military Prosecutor’s Office dismissed the above-mentioned complaints, finding, in particular, that the expert medical report had not confirmed the applicants’ allegations. 30. The applicants lodged a complaint against that decision with the Bucharest Military Court; as they became more familiar with the expert medical report, they raised several objections to it and asked that the case be remitted to the prosecutor for further investigation. On 7 April 2006 the court dismissed their complaint as illfounded, on the basis of the medical report of 6 September 2005. 31. The second applicant appealed against that decision. She contested the accuracy of the expert medical report, stating that Dr B.M. was not an accredited medical expert, and that the conclusions of the report were flawed. She requested that a new expert examination be carried out. She also complained that at the hospital the applicants had been informed of a diagnosis that was different from that appearing on the official documents presented by the hospital as evidence, and that it had only been on the basis of the erroneous diagnosis that her brother had signed the discharge form concerning the autopsy. In any case, she considered that her father’s death had been suspicious, as it had followed what appeared to be a good recovery; moreover, since the presence of hospital bacteria had been identified, an autopsy should anyway have been performed with or without the family’s endorsement. She also pointed out in this connection that as soon as they had become aware of the misrepresentation by the hospital, the applicants had appealed to the College of Doctors to demand an autopsy in the case. The second applicant emphasised the absence of informed consent from either the patient or his family before the operation and pointed out that that failure on the part of the hospital had prevented them from making informed decisions, for instance seeking a second opinion from a specialist doctor. 32. In a final decision of 6 November 2006 the Bucharest Territorial Military Court dismissed the appeal. The court referred to the conclusions reached by the College of Doctors, which, in its opinion, had given an exhaustive account of the facts and was better placed than the courts to give a specialist opinion. 33. On 30 May 2005 the second applicant forwarded to the Ministry of Defence a copy of the complaint she had sent to the College of Doctors on the same day. The Ministry of Defence was responsible for the administration of the hospital. Later on she expanded the complaint, claiming that the hospital had also failed to provide the patient with clerical assistance when he was dying. 34. On 14 and 30 June 2005 the Medical Department of the Ministry of Defence replied to the second applicant’s complaint. It informed her that the medical treatment given to her father had been adequate and that the surgery performed had fallen within the generally accepted range as regards the risk of complications and fatality, given the patient’s age (seventy-three) and medical history. It also stated that the procedures for sterilisation of instruments in the hospital were in accordance with the existing guidelines and beyond reproach. 35. The Patients’ Rights Act (Law no. 46/2003) expressly states that there is an obligation to inform a patient about any surgical intervention proposed, the risks involved in the surgery, alternative treatment, and the diagnosis and prognosis (Article 6). The Law also regulates the patient’s right to seek a second medical opinion (Article 11). According to Article 37 of the Act, a breach of a patient’s rights may result in disciplinary or criminal action, depending on the applicable law. 36. The judgment delivered in Eugenia Lazăr v. Romania (no. 32146/05, §§ 41-54, 16 February 2010) describes in detail the relevant domestic law and practice concerning the delivery of expert forensic reports and the authorities competent to issue them, as well as the relevant domestic law and practice concerning the civil liability of medical staff. 37. Under Article 4 of the Hospital Act (Law no. 270/2003), the hospital has to ensure adequate standards of accommodation, hygiene and food as well as the prevention of hospital-acquired infections, in accordance with the regulations issued by the Minister of Health and Family. The hospital is liable for any damage sustained by patients as a result of the quality of the medical treatment or because of the standards of accommodation, hygiene, food and the prevention of hospitalacquired infections if such damage is established by the competent authorities. Under the same provision, where the damage is caused through medical fault, the liability lies with the person who committed the tort (răspunderea este individuală).