Medical Mistakes – A Romanian Approach

Abstract

In Romania, the medicolegal (forensic) expertise report is created in any case of medical malpractice, at the request of the police, the prosecutor’s office, or the court of law. These reports are created for both deceased and alive patients when they or their relatives file a complaint. These forensic medical reports may or may not be taken into consideration by the court of law in the process of each particular trial. In the following chapter, we shall present two cases in which the physicians were accused of malpractice under the Romanian jurisdiction, one in which the court did not take the forensic report into consideration and another case in which, based on the report, the physician was deemed innocent.

1. Introduction

Romania ranks first in the EU in terms of the share of deaths from treatable causes. If at the European level the average of the 27 states is 91 deaths due to treatable causes per 100,000 inhabitants, in Romania the figure is 210 per 100,000 inhabitants [1]. Out of which, a fair share of deaths occurs due to medical mistakes in diagnosis or treatment.

Romania, as a member state of the EU, in accordance with Directive 24/2011 of the European Parliament and the Council, is obliged to own patient protection systems and means of compensation in case of emerging prejudice in medical assistance [2].

Worldwide, there are two options for assessing compensation for patients in case of prejudice: the system based on the mistake/error/negligence of health service providers, which involves taking actions in the court of law, and the system based strictly on compensating patients in case of prejudice (the no-fault system), which does not investigate the culpability of health service providers but only the severity of the prejudice; thus, in the first phase, the courts are not requested to arbitrate these situations. Romania has a mixed system, which is mainly focused on identifying and holding accountable all those who are guilty of the respective prejudice [3].

Although there were projects of implementing a medical malpractice law [4], they were not finalized; the definition of this legal entity is included in Law 95/2006 (which is the fundamental law of healthcare system organization in Romania). Thus, art. 653 defines medical malpractice as “the professional error committed in the exercise of the medical act […], causing damage to the patient, involving the civil liability of the medical staff and the supplier of medical, sanitary, and pharmaceutical products and services” [5].

Medical malpractice is evaluated in Romania by various extrajudicial committees, which, however, cannot determine the amount of compensation to be paid to those prejudiced: the malpractice committee of the college of physician (institution that offers the free practice license to doctors, which can, under certain conditions, suspend or cancel the right to free practice), or the Malpractice Committee of the Directorate of Public Health.

The first committee, when acknowledging the existence of a medical error, has the role of recommending disciplinary sanctioning of the accused doctor, and the second one establishes the guilt or innocence of the medical personnel, but without having the possibility of applying any penalties. Neither of these two committees has the role of establishing the amount of compensation the prejudiced patients.

The compensation of the patients is done either amicably, through negotiation between the accused physician, the insurance company with which he has malpractice insurance and the patient, or judicially, in a criminal or civil trial. Anytime the outcome leads to the court of law, the judge will be able to give a ruling only after a medicolegal expertise report is provided [5].

The forensic medical expertise report is only performed at the request of the police, the prosecutor’s office, or the court in case of medical malpractice, regardless of whether the injured patient is alive or deceased. The court may or may not take into account the conclusions of the specialty committees or those of the forensic expertise report [5].

When preparing the forensic medical report, the evaluation of the medical data also involves whether during the diagnostic or therapeutic procedures, the medical guidelines issued for each type of pathology by the Ministry of Health, respectively. The diagnostic and treatment protocols (which represent the adaptation of the guidelines to the particular conditions of each healthcare institution) have been followed accordingly.

According to the Romanian Health Law [6], the healthcare institutions in which prejudice-producing medical acts take place have a civil liability for the damages caused to the patients due to medical mistakes.

The amount of compensation is established by the court and includes the evaluation of material prejudice (additional medical expenses summed with the unacquired income during working incapacity period) and moral prejudice (physical pain, esthetic, juvenile, and sexual prejudice) [7].

To bring further exemplification of the subject, we used sources out of our own medical case history, combined with the information that we identified on the website of the Ministry of Justice regarding the evolution of these cases. Only cases that have been finalized from a judicial point of view and are closed for more than 5 years ago have been used. The cases have been rendered anonymous.

2. Case presentation

2.1 Case number 1

Criminal Law Decision no. xxxx/2015 of the court of appeal:

On November 172006, a 5-year-old girl was admitted to a city hospital for a productive cough that started 12 hours before coming to the hospital; pediatrician X injected her with an amp of ampicillin, 5 minutes later the child went into cardiorespiratory arrest.

The patient presents unsatisfactory response to the resuscitation maneuvers in the first 15 minutes, thus being transferred to a specialized university clinic, having the following referral diagnosis: “1. Cardiorespiratory failure. 2. Cardio-respiratory arrest. 3. Pulmonary edema. 4. Cerebral edema. 5. Coma gr. II.” She was intubated for 2 days, then the following therapeutic plan was established and given to the patient:

The therapeutic plan had the following objectives:

• Ensuring adequate respiratory function (aspiration of secretions, aerosol therapy with ACC, administration of mucolytics-expectorants, change of position, tapping, anti-infective treatment, and oxygen therapy in case of need) and maintenance of metabolic balance through parenteral nutrition and nutrition via nasogastric tube.

• Anti-infective treatment using multiple antibiotic therapies (2–3 antibiotics), antimycotic, and iv gamma-globulin. The antibiogram for Klebsiella pneumoniae as well as that for Pyocyanin (pseudomonas aeruginosa bacterium) (both multiresistant germs) required the introduction of ciprofloxacin in the therapeutic plan as well.

• Control of the cerebral edema, Neuro-roborant (restorative) therapy, muscle relaxants, and anticonvulsants.

• Physiotherapy, hepatoprotective and cholestasis treatment, stress ulcer prevention, antithermic measures, central venous catheter heparinization, and anemia treatment.

The evolution was undulating with periods of improvement (improvement of coma and control of infection) alternating with periods of aggravation (clinical-biological signs of serious infection, marked agitation, and convulsions). She presented allergic-type manifestations during treatment with ciprofloxacin (which was discontinued) and the picture of an anaphylactic shock at the first administration of ampicillin.

After receiving medical care, during repeated hospitalizations, for over 4 months, she was discharged from the hospital with the following diagnosis: “Deafferentation syndrome with decerebration outline, spastic tetraplegia, post CPR status, anaphylactic shock to ampicillin. Left vocal cord paralysis. Bronchopneumonia with pseudomonas aeruginosa, klebsiella and enterobacter. Grade II respiratory insufficiency. Drug-induced toxic hepatitis. Acute rotavirus enterocolitis. Mycotic stomatitis. Deficient and intra-infectious anemia, Weight hypotrophy.”

The opinion of the Malpractice Committee of the County Medical College was requested, which, by decision no. x/2007, has established the following:

Following the deliberations, the following aspects were retained:

1. The initial clinical diagnosis: Acute bronchopneumonia and acute respiratory failure were established correctly and later confirmed (Children's Emergency Clinical Hospital).

2. The therapeutic attitude was appropriate to the presumptive clinical diagnosis, by associating anti-inflammatory, antispasmodic, steroid medication with a first-line antibiotic—ampicillin—which the patient received repeatedly for recurrent respiratory infections.

3. The intravenous route of administration is a usual practice in pediatrics, and the combination of hydrocortisone hemisuccinate and ampicillin is allowed intravenously.

4. The alleged anaphylactic shock caused by ampicillin cannot be proven, and the prolonged apnea may have originated from the strong productive cough with viscous tracheobronchial secretions; the previous good tolerance to ampicillin, tested in the previous administrations of this antibiotic to the patient, was taken into account.

5. The cardiorespiratory resuscitation maneuvers performed immediately by the medical staff of the pediatric department and continued by the anesthesiologist, led to the recovery of cardiac functions and spontaneous breathing; the prolonged apnea time caused the remaining clinical picture: Deafferentation syndrome with decerebration outline. Spastic quadriplegia after resuscitated cardiorespiratory arrest: The duration of effective cardiorespiratory resuscitation was determined by the location of the pediatric and intensive care wards on different floors, within the city hospital.

6. Dr. X, pediatrician did not commit medical errors.

This opinion was challenged, requesting the opinion of the Higher (National) Discipline Committee of the College of physicians:

By recording all existing medical data, in this case, the college of physicians considered the diagnostic attitude to be appropriate, the clinical (fever, hyper-leukocytosis >20,000 1/m, neutrophilia 81 %) and biological symptomatology justifying the presumption of bacterial respiratory infection and consequently the administration of treatment based on antibacterial antibiotics.

The anamnestic data specify the previous use of ampicillin, without adverse reactions, the intracutaneous testing of ampicillin not being indicated in this case—in accordance with the therapeutic guidelines. As for the diagnosis of respiratory and cardiac syncope through viscous bronchopulmonary secretions, this is less likely in a preschool girl, being much more likely that of anaphylactic shock.

The veracity of this diagnosis, difficult or impossible to verify through clinical explorations, was proven by the repetition of the anaphylactic accident induced by ampicillin in February 2007.

Regarding the therapeutic attitude, considering the clinical symptoms described (fever, cough, dyspnea, and pulmonary rales) in the conditions of hyper-leukocytosis and neutrophilia, the administration of treatment with ampicillin was a correct measure.

Regardless of the presumed diagnosis, the cause of the cardiorespiratory syncope, the therapeutic measures used (PEV—hydrosaline, airway clearance, administration of adrenaline and hydrocortisone hemisuccinate followed by assisted ventilation, cardiac massage, etc.) were adequate. The promptness of the resuscitation maneuvers and the therapeutic attitude throughout the hospitalization were correctly adapted to the clinical status of the patient.

The following are concluded:

1. Anaphylactic reactions to drugs represent very rare iatrogenic events (below 0.01 % of all ampicillin administrations).

2. The allergenic risk of antibiotics from the penicillin and cephalosporin groups is known, but these reactions are unpredictable, with cases of anaphylactic shock to ampicillin being described in the literature even without known previous exposure and side effects.

3. The patient is known with previous exposure to ampicillin, without adverse reactions and without presenting any risk factors—atopy or previous allergic manifestations.

4. To establish the diagnosis of anaphylactic risk to ampicillin, unfortunately, there are no specific screening methods, and the ampicillin cutaneous test is not recommended for people without suspicion of allergy to penicillin-type antibiotics, as it lacks diagnostic relevance.

5. In the present case, the intensity of the anaphylactic reaction was particularly high, considering the absence of any clinical attenuation that was supposed to appear due to simultaneous administration of hydrocortisone hemisuccinate with ampicillin.

The Higher Disciplinary Committee concludes that the facts and circumstances did not constitute a deviation from good medical practice and decides. According to art. 26 and art. 31, chapter III of the regulation on the organization and development of the activities of the disciplinary committees to reject the appeal and uphold decision no. x/2007 dated 05.11.2007 issued by the local disciplinary committee of the County College of Physicians.

The official medicolegal report records all medical data and concludes that:

The committee assesses the case of the minor, as a case of anaphylactic shock to ampicillin, of very high intensity, in a person who did not present in her personal history an atopic terrain or allergic manifestations, without being able to completely exclude a respiratory and cardiac syncope through aspiration of viscous bronchopulmonary secretions. We appreciate that both the diagnostic and therapeutic attitudes, in this case, were in accordance with the level of current medical knowledge, without being able to conclude a deficiency in the provision of medical care attributable to the doctor.

The patient’s parents also hired a private forensic expert, who prepared an expert opinion, by which he sustained the medical fault by stating that the doctor is guilty of not performing an ampicillin cutaneous test.

Since there are two forensic expertise reports with divergent conclusions, a report of new forensic expertise is requested to be made by the Higher Commission within INML-Bucharest. In the conclusions formulated, INML Bucharest states that there are no errors committed by Dr. X, given that the cutaneous test for ampicillin is not recommended, being devoid of diagnostic relevance.

Disregarding the forensic conclusions and the ones elaborated by the Disciplinary Committee of the College of Physicians, the court of appeal sentences the doctor to pay the civil parties the following amounts:

• To the civil side Y. The sum of 100,000 euros as moral damages, the amount of 3000 lei as a monthly annuity from 17.11. 2006 to 02.04.2014, and the amount of 2916 lei as monthly life annuity from 02.04.2014 until the physical and mental infirmity ceases.

• To the civil parties Z. and W. The sum of 96,000 lei as civil compensation for material damages and the sum of 50,000 euros each as civil compensation for moral damages.

• To the civil side V in the amount of 2106 lei monthly starting from 04/30/2007, in the amount of 1206 lei from 05/07/2007 as civil compensation for material damages consisting of unrealized income.

Regarding the penal aspect of the trial, the court considered that as far as this head of accusation is concerned, the case cannot be judged due to the occurrence of the statute of limitation (prescription).

2.2 Case number 2

On November 13, 2016, at 12:10 am, a 63-year-old man was hospitalized urgently for retrosternal pain and anxiety, the clinical symptoms starting 3 hours before presentation to the emergency room; the diagnosis recorded in the medical records is acute myocardial infarction (the electrocardiogram performed shows ST-segment elevation in V1-V5).

The patient’s condition and monitored parameters improve during hospitalization in response to the treatment administered. At 2:30 p.m., the patient presents cardiorespiratory arrest—cardiorespiratory resuscitation maneuvers are performed without success, and the patient is declared dead at 3:20 p.m.

During hospitalization, the request to transfer the patient to the Cardiology Department of the Cluj-Napoca Heart Institute is accepted, a transfer that cannot be carried out due to the lack of authorized medical personnel to transport him by ambulance and the impossibility of using a helicopter due to unfavorable weather conditions.

According to the medical protocols, conventional treatment is administered, which includes:

• Sodium heparin—5000 units;

• Plavix 75 mg 8 tablets;

• Aspenter one 75 mg tablet;

• Mialgin—3 ml of 2 ml dilution plus 8 ml physiological serum;

• Nitronal—3 vials (30 ml with 20 ml physiological serum) were administered by injectomat 1 ml/hour;

• Atacand of 8 mg one tablet;

• Simvastatin of 10 mg one tablet.

The patient stabilizes after the administration of the medication, but later at 2:30 p.m., he suffers a cardiorespiratory arrest for which cardiopulmonary resuscitation is performed. According to the existent medical protocols, cardiorespiratory resuscitation maneuvers are performed by administering adrenaline 14 ampoules, cordarone 2 ampoules and an electric shock, plus cardiac massage, manual ventilation, and oxygen therapy.

Thrombolytic drugs, such as reteplase and streptokinase, were not available in the emergency room at the present hospital.

The treatment applied at presentation is stipulated in the acute myocardial infarction treatment protocol and was administered with the approval of the cardiologist from the Cluj-Napoca Heart Institute.

From the address issued by the hospital, we assess the following statements:

The city hospital does not have a department for emergency admissions, and the emergencies are organized and admitted by the emergency room system. There is no emergency physician, and the emergency room nightshifts are provided by doctors from other specialties that are available in the hospital (internists, gastroenterologists, and neurologists), which have no competence in the administration of thrombolytic drugs. There is no corresponding equipment to supervise the thrombolytic treatment.

There were no thrombolytic drugs at the hospital pharmacy either before or on 11/13/2016.

Order 1706/2007 regarding the management and organization of emergency reception units and departments, in art. 37 and 39, explicitly states that category IV hospitals (the city hospital is a category IV-a hospital) that do not have emergency departments due to lack of human or material resources will organize the reception of emergencies in the emergency room system.

In the event that the hospital cannot provide the definitive treatment through thrombolysis, it has the obligation to organize the transfer of the patient, in the shortest possible time, to a hospital with a higher level of competence, which has the ability to apply the definitive treatment, usually a regional hospital or at least one that is registered as a competence level II hospital (art. 1.8 and art. 7 of the Order of the Ministry of Health no. 1764/2006).

In the event that the patient requires transfer to another health unit, the doctor on call organizes the transfer in accordance with the existent legal provisions. The transfer decision is taken by the doctor on call together with the doctors on call from the health unit to which the respective patient is to be transferred.

In this case, contact was made with the on-call doctor from the cardiology department of the Cluj-Napoca Heart Institute in order to transfer the patient with acute myocardial infarction under medical supervision (a certain kind of ambulance was requested, with the necessity of having a physician on board due to the current status of the patient) receiving the acceptance for the transport, but the transfer was not carried out, due the lack of specialized medical personnel necessary.

Furthermore, due to the fact that the physician requested was already carrying out another emergency transport, another physician was requested from home to carry out the transfer either to Cluj-Napoca or to the Bistrita County Hospital, which has an emergency reception unit and a cardiology department where the thrombolytic treatment and necessary specialized physicians are available. The transfer did not take place due to the impossibility of transport, and the patient died two hours from the presentation in the emergency room.

The order of the Ministry of Health mentioned above also specifies in letter “E” point 35, for emergency department type 1 and 2 the mandatory existence of thrombolytic medication, although for the emergency reception room these can be mandatory or not (+/−). For the emergency room system (also existent at the hospital in which the patient was admitted), the mandatory existence is not stipulated for this medication.

Following the evaluation of the medical data from the present file, as well as the additional documents requested by the members of the hospital’s committee, the following answers are stated:

1. Based on the medical documents and the actions of the medical personnel, it cannot be established with accuracy whether the patient’s death could have been prevented in the case of transfer to another hospital unit, with superior equipment.

2. According to the medical report issued by the Cardiology Department-County Hospital, the doctor on call requested the transfer of the patient according to the protocol provided for the situation of acute myocardial infarction type STEMI.

3. The medical treatment administered to the patient at the city hospital, from the time of admission until death, was adequate to the symptoms, diagnosis, and equipment owned by the hospital.

4. We consider that in the case of a patient who suffered an acute myocardial infarction, myocardial revascularization (invasive or medicinal; we specify that none of the methods were available in the hospital) was indicated. We cannot say whether the patient would have survived if such an intervention had been applied.

5. In the patient’s medical situation, we consider that transport to another hospital unit, with superior equipment, was indicated. We cannot establish whether the patient would have survived a transport to the Heart Institute in Cluj-Napoca.

The conclusions of the autopsy are as follows:

Macroscopic anatomic-pathological diagnosis:

• Myocardial and coronary sclerosis. Aortic atherosclerosis. Acute myocardial infarction.

• Hepatic steatosis.

• Congested viscera (stasis).

The histopathological exam confirmed the autopsy findings.

1. The death of the patient was nonviolent.

2. It was due to acute cardiocirculatory failure caused by an acute myocardial infarction.

3. Death may date from November 13, 2016.

According to the medical report issued by the Cardiology Department-County Hospital, the medical treatment administered to the patient at the city hospital, from the time of admission until death, was adequate to the symptoms, diagnosis, and equipment of the hospital.

“We consider that in the case of the patient who suffered an acute myocardial infarction, myocardial revascularization (invasive or medicinal; we specify that none of the methods were available in the hospital in question) was indicated. We cannot say whether the patient would have survived if such an intervention had been applied.”

“In the patient’s medical situation, we consider that the transport to another hospital unit, with superior equipment, was indicated. We cannot establish whether the patient would have survived a transport to the Heart Institute in Cluj-Napoca.”

The prosecutor’s office found that there was no fault on the part of the doctor, closing the case. The solution was not contested.

3. Conclusions

1. In Romania, medical malpractice can be filed in different forums, with different results, as follows:

   • For the simple ascertaining of malpractice, without any other consequences (with the exception of the situation where they are self-assumed by the doctor and assumed by the insurance company with which the respective doctor has malpractice insurance), there is the Malpractice Committee of the Directorate of Public health.

   • For the disciplinary sanction of the physician in the context in which he deviated from the legal provisions, there is the Disciplinary Committee of the College of Physicians.

   • In order to establish the guilt in the court of law, this having criminal and civil consequences, there is the possibility that the injured patient or the deceased patient’s relatives should address the police, the prosecutor’s office, or directly the court of law, in which case the forensic expertise report is mandatory. In this situation, apart from the official forensic expertise report, any of the parties can hire a private forensic expert, who will compile an expert opinion.

2. The court may take into account any of the conclusions of the committees or the forensic expertise reports or may disregard them when a sentence is established. This is one of the reasons why Romania pays large sums of money to people who were initially convicted and who challenged the sentences at the European Court of Human Rights.

3. In the presented cases, we assess both of these situations in which the court did or did not take into consideration the forensic medical reports created for the case. Regarding the multiple malpractice complaints filed in Romania, these reports have a major importance in determining the guilt of the physician, changing the outcome of the trial and serving as supportive measures in concluding these cases.

Conflict of interest

The authors declare no conflict of interest.

Appendix

In Romania, the medical emergency ward system is divided by the extension and medical personnel it has—an emergency department is a more extensive unit that benefits from more specialized physicians while an emergency room is a smaller, emergency reception unit (which, like in the cases presented, does not have access to certain medication or specialized physicians in this domain).

Abbreviations

EU	European Union
INML	The National Institute of Legal Medicine.
STEMI	ST-elevation myocardial infarction