Investigación Científica y Tecnológica

Liliana Marcela Tamara P.*, Sofía Helena Jaramillo S.**, Luis Eduardo Muñoz P.***

* Médica Universidad del Rosario. Especialista en Bioética Universidad El Bosque, especialista en Auditoria de salud Universidad Santo Tomás, Candidata a magíster en Protección Social Universidad Santo Tomás, médica forense del Grupo de Clínica Forense, regional Bogotá, GC-RB, Instituto Nacional de Medicina Legal y Ciencias Forenses de Colombia INMLCF. Bogotá, Colombia. Correspondencia: Carrera 13 No. 7-46, Bogotá, Colombia. Correo electrónico: ltamara@medicinalegal.gov.co, drltamara@yahoo.com

** Médica Universidad Juan N. Corpas. Médica forense del Grupo de Clínica Forense, regional Bogotá, GC-RB, Instituto Nacional de Medicina Legal y Ciencias Forenses de Colombia INMLCF. Bogotá, Colombia. Correo electrónico: sofijasa@yahoo.com

*** Médico Universidad El Bosque. Médico forense del Grupo de Clínica Forense, regional Bogotá, GC-RB, Instituto Nacional de Medicina Legal y Ciencias Forenses de Colombia, INMLCF. Bogotá, Colombia. Correo electrónico lemunoz@medicinalegal.gov.co

Recibido: febrero 14 de 2011. Enviado para modificaciones: mayo 15 de 2011. Aceptado: junio 14 de 2011.

Background. Information on medical liability lawsuits is critical for the formulation and implementation of policies, programs and actions pertaining to patient safety. There is no systematic information at present in the Colombian health sector regarding adverse outcomes resulting in professional liability lawsuits.

Objective. To characterize the cases of alleged professional liability analyzed in the Bogota Chapter of the Clinical Forensics Group of the National Legal Medicine and Forensic Sciences Institute of Colombia between 2006-2010.

Methods. A descriptive, uni and bivariate analysis of the forensic expert reports available was conducted.

Results. Information was gathered for 402 cases. 77 % occurred in Bogota, 69.2 % were associated with women, the mean age was 36.4 years, and the private healthcare providers accounted for 52 % of the total. 80 % of the lawsuits were filed against the State and directly against the practitioners, and 59 % were criminal cases. The percentage of medical specialties involved most frequently was distributed as follows: 41 % in obstetrics and gynecology, 45 % in other surgical areas, 6 % in clinical areas and 5 % in pediatrics. The most frequent diagnoses were: fetal death of unexplained cause, accidental puncture or laceration during a procedure. 45 % of forensic reports were prepared by clinical or surgical specialists. The conclusion in 225 reports was that the case was the result of a complication, whereas in 165 the conclusion referred to a deviation from standard practice.

Medical liability lawsuits are a current, complex and costly issue that concerns healthcare institutions and practitioners, patients and their relatives, legislators, judicial authorities and resource administrators, to name a few. They are just the tip of the iceberg of the core issue in healthcare and diseases, which is patient safety. Patient safety involves standards, practices and systems related to the prevention of iatrogenic injuries, but policies designed to approach medical liability have generally focused on rulings that are limited to damages and on insurance reforms, without effectively addressing the underlying problem: the prevention of medical errors and malpractice. (1).

In 1999, the report “To Err is Human” (2) determined that there were more deaths due to medical errors in the United States than deaths due to car accidents, breast cancer and AIDS. “Medical error” was defined as the failure to perform an action as planned, or as the use of the wrong plan to achieve a goal. Since then, many countries and the sectors involved be gan to develop policies, programs and actions designed to mitigate the detrimental outcomes based on initiatives proposed by physicians and other healthcare professionals, including the use of registry systems, education, feedback and implementation of clinical practice guidelines. Institutions that implemented initiatives for reporting medical errors (3) went on to establish clinical standards, develop the use of information technology and create rules and regulations designed to improve patient safety (4). The report revealed that the main hurdles to the implementation of these measures included cultural issues, limited resources, information focused on the way to improve patient safety for professional liability reasons, and lack of scientific research.

At the present time, there is no systematic information in the Colombian health sector regarding adverse outcomes leading to medical liability lawsuits. Consequently, there is no context within which to guide policies, programs and projects involving or addressing patient safety.

The National Legal Medicine and Forensic Sciences Institute of Colombia (INMLCF) is the public agency in charge of providing assistance and scientific and technical support to the justice sector in the area of legal medicine and forensic sciences throughout the Colombian territory (5). The Institute analyzes cases of alleged professional liability at the request of the various authorities that hear the allegations; however, this information is not shared in a systematic way with the health sector. In order to close this gap, this research by a group of the INMLCF attempts to characterize the cases that the Institute was asked to analyze because of alleged professional liability during a selected period of time.

Information was gathered of the forensic expert reports on professional liability prepared between January 1st, 2006 and December 31st, 2010, available in the files of the Bogota Chapter of the Clinical Forensics Group (GC-RB) of the Colombian INMLCF. A uni- and bivariate descriptive statistical analysis was conducted in two phases: the first phase focused on sociodemographic variables, diagnoses, procedures, institutions, specialties and authorities involved in the cases gathered; and the second phase focused on the content and structure of the forensic expert pertaining to the reports prepared.

Information on 535 reports related to 402 cases was collected. This figure corresponds to 82 % of the reports written during the study period. An additional 11 were included, corresponding to the first report on some of the cases that occurred in previous years, in order to have complete information about the cases.

SOCIODEMOGRAPH IC ASPECTS

Of the people affected, 69.2 % were women. The mean age was 36.4, the median 34.5 and the mode 38 years, with an age range between 1 and 84 years. Figure 1 shows the distribution of the cases by age and gender.

There were 104 cases of pregnant women. Gestational ages ranged between 9 and 41 weeks, and no data were available in 14 cases. The mean gestational age was 35.2 weesk, and the mode was 40 weeks. In 56 % of cases, the gestational age ranged between 37 and 41 weeks.

In 77 % of cases, Bogota was the city where the healthcare providers under investigation were practicing or where the subjects of the lawsuit received care. The rest were distributed throughout the rest of the country.

ASPECTS OF TH E GENERAL SOCIAL HEALTHCARE SYSTEM

Private providers accounted for 51.99 % (209 cases), public providers accounted for 43.28 % (174 cases), and there was no information available for the remaining 4.72 % (19 cases).

In terms of the level of complexity of the healthcare providers, 60 % of cases corresponded to levels 2 and 3.

Sixteen per cent corresponded to care provided by specialists in their offices or in institutions specializing in a given area (ophthalmology, otolaryngology, plastic surgery, among others).

The distribution is shown in Figure 2.

In over 50 % of cases, the type of Benefit Plan Administrator was not recorded in the expert report. In those cases where the information was available, 55 % belonged to the contributive regime.

LEGAL ASPECTS

Information about the individuals or institutions against whom the lawsuit was filed was available in 48 % of cases. This case distribution is shown in Figure 3, indicating that lawsuits were filed directly against the practitioners or the State through its different agencies.

The distribution of the authorities requiring the reports is shown in Figure 4, indicating that the vast majority were in the criminal area.

SPECIALTIES INVOLVED

Of the cases analyzed, 15 (3 %) were related to non-medical professions: aesthetics 7, nursing 6, and physical therapy 2. The remaining cases involved medical liability.

The following was the distribution according to the most frequent type of specialties: surgical areas other than obstetrics and gynecology 45 %, obstetrics and gynecology 41 %, clinical areas 6 %, and the remaining 5 % in pediatrics. Four cases involved general medicine. Table 1 shows the distribution according to the most frequent medical specialties.

Regarding other specialties, the following is the order according to frequency: vascular surgery, neurology, urology, pediatric surgery, dermatology, neonatology and pediatric urology, maxillofacial surgery, cancer surgery, pneumology, gastroenterology, oncologic gynecology, cardio vascular surgery, pediatric cardiovascular surgery, spine surgery, head and neck surgery, transplant surgery, breast surgery, thoracic surgery, pediatric vascular surgery, pediatric endocrinology, hematology, pediatric hemato-oncology, alternative medicine, pediatric pneumology, pediatric neurology, pediatric oncology and radiology.

Of the diagnoses giving rise to the lawsuits, 181 were found in the International Classification of Diseases (ICD-9) when the extrapolation was done. The most frequent were fetal death due to unexplained cause, accidental puncture or laceration during a procedure, other poorly defined causes of death, and infections secondary to a procedure. Table 2 shows the number of cases due to the most frequent diagnoses.

Diagnoses were categorized by case in accordance with the classification of the study on the prevalence of in-hospital adverse events in Latin America (IBEAS) (1), resulting in 100 cases of surgery performed in the wrong site and surgical lesions. Consequently, 24 % of the diagnoses were related to inadvertent or noticed lesions caused during surgery. There were only two cases of surgery performed in the wrong site. In 39 cases (9.7 %), the diagnoses giving rise to the lawsuits were associated with hospital-acquired infections. There were 7 cases of adverse reactions to medications, 4 cases of burns during care and one event secondary to transfusion. No cases were found in any of the other categories established in the IBEAS study.

In 136 cases, death occurred during the act of medical care under challenge. In 57 cases (14 %), death was associated with gynecological and obstetric care and involved fetuses or neonates. Table 3 contains a list of the conditions associated with fetal death.

Forensic Expert Report

Of the expert reports, 246 (45.58 %) were prepared by clinical or surgical specialists, and 227 by specialists in obstetrics and gynecology, orthopedics, forensic medicine and physiatry of the INMLCF.

Seventy-nine specialists were consulted through inter-institutional agreements with universities, and the most frequent consultations were 19 in obstetrics and gynecology, 14 in ophthalmology and 11 in plastic surgery.

A literature review was done for 176 reports (39 %), including national guidelines in 54 (10 %) and the use of search engines for Evidence Based Medicine (EBM) in 23. The number of papers or books used as bibliographic references ranged between 1 and 92. The average number of articles per report was 6, with a mode of 1 article reviewed for every report.

The number of days between the occurrence of the events leading to the lawsuit and the submission of the forensic expert reports ranged between 1 and 5,611 days (15.3 years), with a mean of 1,408 days (3.8 years).

Regarding the forensic conclusion, 225 reports referred to a complication^(a)., 14 referred to an iatrogenic effect^(b), 20 referred to the natural course of the disease, 2 concluded that it had been an accident^(c), and in 165 cases the opinion was that care had deviated from the healthcare standard^(d).

Of the 165 reports that concluded that medical care had deviated from the healthcare standard, in 48 cases (29 %) a definitive forensic disability was ruled, ranging between 15 and 90 days, with a mean of 39 and a mode and median of 35 days.

Twenty-eight reports established some degree of patient liability in the incidence of the outcome that played in favor of the lawsuit. In 46 % of cases, some of those factors included non authorization of treatments, lack of follow-up to the diagnostic process, non-compliance of treatments, the presence of mental disorders, cigarette smoking, and a self-inflicted burn in one case of a diabetic patient.

In 29 reports it was determined that administrative factors had influenced the outcomes that led to the lawsuit, including such things as the lack of timeliness not associated with medical aspects in 39 % of cases, the inadequate level of care and failure to refer the patient, failure to provide medications, failure to authorize the services, and/or absence of a clinical chart.

Thirteen reports determined additional factors that influenced the outcomes that led to the lawsuits, as follows: delivery of medications with no possibility of determining if there had been a medical prescription, contamination of the amputation site at the place where the injury occurred, concomitant diseases, management by incompetent personnel, occurrence of the injury in a place far removed from a healthcare site, and weather conditions that prevented transfer by air.

ISSUES RELATED WITH JUDICIAL AUTHORITIES

The questionnaire requested by the judicial authorities was responded in 167 reports (31 %), in which the number of questions ranged between 2 and 74 per questionnaire, with a mean of 9 and a mode of 4. The most frequent range was 3-10 questions. In 61 expert reports, the experts suggested that other researches should be conducted by judicial authorities such as technical reviews in other sites (specialist offices, third level university hospital or public network hospitals, scientific societies), as well as administrative investigations or other conducted by the territorial authority in charge of the health oversight and by the Courts of Ethics.

Some authors suggest that the number of allegations regarding health services has increased in Colombia over the past few years. However, no systematic action has been undertaken by the institutions in charge of analyzing this information in order to demonstrate that this increase is real.

This analysis is aimed at characterizing the lawsuits filed in Bogota based on the professional liability reports prepared by the INMLCF group.

According to Mejía (6), expert reports were the cornerstones of proof in criminal proceedings before the implementation of the New Criminal Accusatorial System (Law 906, 2004/Colombia). Later, López (7), in a review of expert reviews, recommends their contextualization, although no publications reflecting what happens with them have appeared so far.

Considering this situation, this review presents an initial demographic profile of the individuals on whose behalf the lawsuits were filed. Most of them are women of child-bearing age, one quarter of whom are pregnant. This suggests acute awareness of what a new life represents and of its impact on individuals, couples, families, and society as a whole.

The peak of distribution by age was between 25 and 39 years. This fact reveals that there is an impact on the productivity of the individuals and of society as a whole as a result of unemployment, absence from work due to prolonged hospital stays and disabilities, as has been shown by the interaction between morbidity, mortality and economic development. (8)

In terms of health providers, they were distributed between private and public, with a slightly lower involvement on the part of the latter, reflecting a difference between reality and the policies that tend to favor health service provision through private institutions and the usual criticisms raised against them (9).

The majority of patients belonged to the contributive system and almost one quarter of them had access to private services. These elements require additional research in order to find evidence of the impact of the effectiveness of the care provided by public and private providers. That impact could be measured on the basis of the lawsuits, fault and the strategies for improvement in the two areas, on the one hand and, on the other, in accordance with society’s perception about liability for the outcomes, depending on the sector and the type of financial contribution made by the plaintiff.

Most of the cases occurred in secondary and tertiary level care institutions, where complexity is greater and more serious and severe clinical conditions are treated, and where the people’s expectations regarding the natural cause of the disease as well as the professionals’ ability to provide care are usually higher.

Lawsuits were mostly filed against the State or directly against the professionals. In general, they were criminal proceedings, a mechanism that goes against the report “To Err is Human” that states that “when an error is made in healthcare, blaming an individual does little to ensure greater safety of the healthcare system or to prevent other people from erring. Error prevention and patient safety enhancement require a systems approach in order to modify the underlying conditions”. Further analysis is required in view of the vulnerability of these two agents that, in the eyes of society, must respond to the effects of lawsuits in improving quality of care, as well as to the social and economic impacts of those lawsuits for the individual and for the Colombian society as a whole.

Almost half of all the lawsuits originated in obstetric and gynecological interventions. As mentioned above, social awareness regarding motherhood, added to other factors associated with the perception of reproduction and its successful outcome, and with global campaigns for the reduction of maternal and child mortality, intensify the reaction to adverse morbidity and mortality outcomes related to pregnancy and birth.

In 25% of cases, the most frequent diagnosis was an accidental puncture or laceration during a surgical procedure. This fact warrants an analysis of the historical role that surgeons continue to play and how with new technological approaches to disease, there is a greater need for training and increased expertise to be gained through advanced methods, including simulation (10).

As pertains to the expert reports, 45 % were prepared by clinical and surgical specialists, or with their participation. A literature review was done in less than half of the reports; 10 % were based on National Guidelines and it was found that Evidence Based Medicine is only just starting to be used.

The gap between legal and scientific knowledge is not easily overcome. Although in many cases it is possible to base the analysis on basic medical concepts, peer support is usually required in order to contextualize the actions under challenge. In the light of rigorous scientific standards, the level of scientific evidence is low, although for the legal system, the forensic expert is still valid. (11)

One third of the reports could not arrive at a final conclusion, generally due to the lack of documentation or relevant information. In their conclusions, almost half of the reports indicated that the outcome was a complication inherent to a procedure. In 30 % of cases it was determined that medical performance deviated from the standard of care. However, only in 9 % were medical-legal disability and sequelae ruled because no causality link was established between non-compliance with the standard and the ensuing damage. Thirteen per cent of the reports identified the concomitant occurrence of other factors contributing to the damage, including patient-related factors, administrative factors or others. This picture of the conclusions at which forensic physicians arrived in their analyses, almost half of them belonging to the specialty of the defendant physicians, suggests a discrepancy between the damages ruled and the relation with the medical performance under question. Consequently, it is imperative to undertake studies designed to analyze the factors that influence the filing of the lawsuits as well as the preparation of the expert reports.

Changes in the health and judicial systems involve reassessing the analyses of lawsuits resulting from alleged professional liability. There is a need to work on a legislative and legal development specifically for Colombia in the area of malpractice and medical errors in order to ensure that no opportunities will be missed for improving healthcare quality and effectiveness.

Considering the number of diseases as well as of diagnostic, therapeutic and support processes, there is a need to disaggregate and to analyze specific timings and contexts in order to weigh the effect of each condition, action or omission on the process as well as on the partial and final outcomes.

This kind of analysis is varied and requires a specific specialized infrastructure that provides sufficient elements to the justice sector coming from an already complex health system. Such an infrastructure must be based on the reality of the lawsuits filed in the country and must be provided with the necessary resources in terms of specialized, competent and skilled staff with experience in both sectors. It also requires information technologies to handle current and historical data in order to establish relevant contexts in each case and area. Additionally, it is imperative to assure an objective and impartial approach that avoids the need to resort to other sources of financing, an essential prerequisite for the transparency of the expert work.

The progress achieved by the health sector in terms of National Guidelines and scientific research is a valuable asset in the process of analyzing alleged medical errors. The same is true of the work done by oversight agencies that have required the establishment of institutional protocols and procedures, and of standards for performance verification and healthcare processes.

The health sector, in the process of improving the system in order to prevent medical errors, must receive systematic feedback of the proceedings conducted by the justice sector against medical actions. Moreover, the forensic service must also receive feedback concerning the rulings of the judges and the value and flows of the proceedings.

We are grateful to the archive and clerical staff of the GC-RB head office, for their valuable help in locating the documents needed for this research.

a.An adverse outcome resulting from a diagnostic or therapeutic intervention that may be frequent, infrequent or foreseeable but not always avoidable, despite management in accordance with the current healthcare standards.

b.An expected adverse outcome inherent to the medical or surgical practice that is completely foreseeable but never avoidable.

c.Unexpected situation that is unforeseeable and unavoidable and creates damage.

d.It must be understood that the analysis of the healthcare standard is disaggregated for each moment when an action was required. This being so, there may be situations that deviate from the healthcare standard but are not causally related to the damage created.

1. Clinton H, Obama B. Making patient safety the centerpiece of medical liability reform. NEJM. 2006; 354(21):2205-8.

2. Kohn LT, Corrigan JM, Donaldson MS, editors. To err is human. Building a safer Health System. (Washington, D.C.) National Academy Press. 1999. Institute of Medicine. Committee on Quality of Health Care in America. (312 pantallas). Disponible en: URL: http://www.nap.edu/catalog.php?record_id=9728

3. Leape L. Reporting of adverse events. N Engl J Med. 2002;347:1633-38: (11 pantallas). Disponible en: URL: http://www.nejm.org/doi/full/10.1056/NEJMNEJMhpr011493

4. Fernandez B, Larkins F. Medical malpractice: the role of patient safety initiatives. CRS Report for congress. 2005. Congressional Research Service. The library of Congress. (56 pantallas) Disponible en: URL: http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3209201242005.pdf

5. Ley aprobada. República de Colombia. Estatuto orgánico de la Fiscalía. Ley 938 de 2004. Diario oficial 45.778 (Dic.30,2004)

6. Mejía FJ. El dictamen pericial en los procesos de responsabilidad penal médica. Médico Legal (on-line). 2003;9(4): (7 pantallas). Disponible en: URL: http://www.medicolegal.com.co/rml/files/articulos/der_med_v9_r4.pdf

7. López M. Implicaciones de los dictámenes periciales. Médico legal (online). 2005;11(3): (9 pantallas). Disponible en: URL: http://www.medicolegal.com.co/rml/files/articulos/resp_jur_1_v11_r3.pdf

8. Brenner MH. Commentary: Economic growth is the basis of mortality rate decline in the 20th century- experience of the United States 1901-2000. Int J Epidemiol. 2005 (citado 28 Jul 2005);(34):1214-21: (18 pantallas). Disponible en: URL: http://ije.oxfordjournals.org/content/34/6/1214.full.pdf

9. Marriott A. Optimismo ciego: los mitos sobre la asistencia sanitaria en países pobres. Oxfam Internacional. Feb 2009. Informe No.: 125. Disponible en: URL: http://www.oxfam.org/sites/files/bp125-blind-optimism-spanish.pdf

10. Gómez LM. Entrenamiento basado en la simulación, una herramienta de enseñanza y aprendizaje. Rev. Colomb. Anestesiol. 2004;(32)3:201-8.

11. Escobar F. El testimonio experto del profesional de la salud a la luz del nuevo sistema acusatorio colombiano. Rev. Fac. Med. (Bogotá). 2004;(52)4:245-6.